Q3 2024 BioNTech SE Earnings Call
Okay.
Welcome to biotech third quarter 2024 earnings call I would like to hand, the call over to Michael Hawker Beech stomach from either direct or indexed or relations. Please go ahead.
Michael Hawker: Thank you.
Michael Hawker: Good morning, and good afternoon. Thank you for joining <unk> third quarter 2020 core 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 sections of our website.
Michael Hawker: 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.
Michael Hawker: Forward looking statements in this call are subject to significant risks and uncertainties and speak only as of the date of this conference call.
Michael Hawker: <unk> no obligation to update or revise any of these statements.
Michael Hawker: On slide three you can find the agenda for today's call today I am joined by the following members of Biotics management team, who is chief Executive Officer, and co founder of them stretching Chief Medical Officer and cofounder Holstein.
Michael Hawker: Officer, and Ryan Richardson, Chief strategy Officer, with this I would like to hand over to her.
Speaker Change: Thank you Mike are there come to all those joining us today and we'll be keeping my introduction gotta be used per day.
Speaker Change: Significant achievements during the first quarter, including advancements across our oncology pipeline and a strong start to the seasonal part of our COVID-19 vaccine franchise.
Speaker Change: Our progress in this quarter a bit on what has already been an impactful year.
Speaker Change: To highlight.
Speaker Change: Houston in three areas.
Speaker Change: Yes, if we got a court now.
Speaker Change: 19 vaccine leadership the.
Speaker Change: <unk> successfully launched updated vaccine targeting the latest variance distribution now underway in multiple regions globally.
Speaker Change: In oncology, we have presented our progress in tooth.
Speaker Change: Priority areas, namely our bi specific immuno modulator PMT three to seven patents with Biofuels and our <unk> cancer vaccine portfolio.
Speaker Change: As part of our pipeline progress, we set numerous clinical updates across our oncology pipeline.
Speaker Change: At the ESMO Congress.
Speaker Change: We and our partner biopsy.
Speaker Change: F kicked off the broad global development of P&C three to seven.
Speaker Change: Our bi specific antibody targeting PD, one and VEGF.
Speaker Change: The data presented at ESMO and at comfort Anthos earlier this year.
Speaker Change: The Pan cancer potential of this priority asset and support our clinical development plan that will touch on today and discuss in greater detail at our innovation series next week.
Speaker Change: We took significant steps forward in the execution of our clinical development plan. This.
Speaker Change: This quarter and dosed the first patient into optimization studies in small cell lung cancer and triple negative breast cancer to inform the pivotal studies in both indications.
Speaker Change: With regard to our vaccine portfolio.
We announced earlier in the quarter that hour after SaaS fix that and on a cancer vaccine candidate BMT Bang Bang Bang met.
Speaker Change: Met the primary endpoint in the ongoing randomized.
Speaker Change: To tie.
Speaker Change: BNP 111 in combination with great General anti PD one agents.
Speaker Change: In patients with stage, three and stage four kokinis melanoma.
Speaker Change: This preliminary result, underscores our belief in the confirmatory potentially of our mrna vaccine technology, which is a key pillar of our oncology strategy.
Speaker Change: Over the half taking another step to broaden our customers on a cancer vaccine development program.
Speaker Change: We and our partner Genentech has initiated a new randomized controlled phase two clinical trial.
Speaker Change: Our personalized cancer vaccine candidate in patients with bladder cancer in the adjuvant setting in combination with immune checkpoint inhibition.
Speaker Change: Our personalized vaccine program now includes four ongoing phase II clinical trial.
Speaker Change: In addition, during Q3, our in our core AI Dave.
Speaker Change: But we highlighted our in house AI company in study and provided an overview of <unk>.
Speaker Change: Context collected AI capabilities.
Speaker Change: This was an exciting event, where we showcased our commitment to building state of the.
Speaker Change: At AIG.
Speaker Change: Before I turn it over to ask them for a more detailed coverage of these achievements.
Speaker Change: I remind you of our overarching strategy for oncology.
Speaker Change: Biotech was established with the ambition to revolutionize cancer treatment.
Speaker Change: The development of <unk> based <unk>.
Speaker Change: <unk> piece.
Speaker Change: <unk> two personalized cancer vaccine.
Speaker Change: This approach remains at the forefront of our efforts to pioneer the next wave of cancer treatment aiming to tailor therapy to the individual genetic makeup of each patient's tumor.
Speaker Change: Building on this foundation, we are systematically assess next generation immune modulator with a focus on bi specific molecules that can engage more than one target.
Speaker Change: BMT free 27, our bi specific antibody targeting PD, one and <unk> eight.
Speaker Change: Is it matched as a key market in our pipeline.
Speaker Change: We believe that Vantiv treat 2007 has the potential to serve as a.
Speaker Change: Foundational component in the treatment regimens for multiple cancer types.
Speaker Change: Enhancing the effectiveness of our Terra project amounted cancer vaccines and other therapies towards.
Speaker Change: Targeting mechanism.
Speaker Change: <unk>. These mechanisms of action, we have recently expanded our portfolio to include targets immunotherapies, such as anti body drug conjugates and car T cell therapies.
Speaker Change: These modalities of a precise mechanisms for attacking cancer, providing new avenues for combination therapies, particularly for siting large metastatic tumor.
Speaker Change: Our integrated long term approach.
Speaker Change: Buying the synergistic tower project platform to optimize cancer treatment.
Speaker Change: Our strategy aims not only to address the existing challenges in cancer care.
Speaker Change: But also to significantly improve long term survival rates, even in patients with advanced disease States.
Speaker Change: We're continually evaluating the effectiveness of engineered components and innovative combinations.
Speaker Change: We can better identify the most promising treatment strategies for specific patient populations.
Speaker Change: Today I assume the discuss in more detail our progress on BNP fleet 27, and our expanding efforts an hour to operate on a cancer vaccine for them.
Speaker Change: To put that a key pillar of our strategy.
Speaker Change: Before I hand, handing over I would like to thank you all for your ongoing support as we entered a truly exciting period for biotech and progress towards our founding vision. Thank you.
Speaker Change: Thank you Glenn.
Glenn: Glad to be speaking with everyone. Today I will begin with our COVID-19 franchise.
Speaker Change: Ahead of this explanation seasoned regulatory and public health authorities' advice vaccine manufacturer to revive the antigen competition, probably authorized COVID-19 vaccine in line with the latest epidemiological data.
Speaker Change: Continuous evolution of the Costco and the emergence of variance and that's total each and every different recommendations for the PSX in space selection, we have been able to rapidly meet the different requirements.
Speaker Change: The second the ability of our mrna technology, which enables us to adapt our construct on relatively short notice.
Speaker Change: In Europe less than three weeks after the regulatory authority only come in this space.
Speaker Change: Jay and one spiked antigen in a COVID-19 vaccine for 'twenty four 'twenty five season, we were able to submit our application to the European regulator and we begin rolling out our updated vaccine shortly after July.
Speaker Change: Anticipating our regional differences, we followed up with the development that submission for <unk> to debt.
Speaker Change: Sure.
Speaker Change: In the U K and regularly talk I'll, let Jay and one adaptive COVID-19 vaccine in July and allocated toward that this COVID-19 vaccine.
Speaker Change: On October <unk>.
Speaker Change: The United States, and Canada regulatory authorities recommended the use of <unk> two epilepsy, firstly niche for the presidency.
Speaker Change: And two weeks after a recommendation.
Speaker Change: Our rolling submission with the U S FDA and received approval for I'll keep it to adapt this vaccine in August.
Speaker Change: In Japan.
Speaker Change: Steve I'll, let Chad once approved.
Speaker Change: In August.
Speaker Change: Steve early screening recommendations that are proven hebei.
Speaker Change: 12, a timely delivery and early update.
Speaker Change: <unk>.
Speaker Change: Thus far the explanation of campaigns.
Speaker Change: Execution is such speed was enabled by our continued surveillance and nevertheless areas of concern by the strength of our new technology, which allows for scalable rapid production and youll to our expertise at navigating that regulatory landscape on that.
Speaker Change: Thanks Keith.
Speaker Change: We will continue to monitor evolving epidemiology of COVID-19, and to remain prepared to develop vaccines with adapted and agenda composition in line with regulatory recommendation.
Speaker Change: COVID-19 transition Glenn endemic infection pattern data on a weekly new hospital admissions due to infections caused by loss of pool and by square meter so different patterns of seasonality. This past season back in the prior year.
Speaker Change: 19 disease related hospitalization had two prominent.
Speaker Change: One in the winter and then the additional one in China and contract for influenza Donlin.
Speaker Change: Dominance.
Speaker Change: Fee increases and hospitalizations in the winter.
Speaker Change: The emergence of new evidence coupled with the waning of vaccine and infection.
Speaker Change: T indicates that.
Speaker Change: Sept ability to COVID-19 infection remains a concern after the <unk> explanation.
Different patterns of seasonality of it.
Speaker Change: That said COVID-19 may have an impact on regulatory guidelines to facilitate protection philosophy here recently U S authorities commended Oda and immuno compromised individuals with.
Speaker Change: And additional COVID-19 vaccine dose.
Speaker Change: Ministration of additional doses Nathan this season could contribute to improve <unk> coverage overtime mitigating the risks associated with evolving COVID-19 Berry.
Speaker Change: Given our current understanding of COVID-19 seasonality, yes, its burden on health care system. We are proud with our vaccine can contribute to mitigate the yen action and protect people around the world for COVID-19 with today's in hospitalized patients.
Speaker Change: Turning now to our oncology pipeline.
Speaker Change: IP platform immuno oncology clinical pipeline is continuing to advance and it is a rich source Carlos just catch it Keith.
Speaker Change: Novel novel combination that's requested a key pillar of our vision for oncology as you can see how all modalities, namely <unk> and <unk>.
Speaker Change: Hi, Doug.
Speaker Change: Last year, we presented in our pipeline and particularly useful in both clinical stage.
Speaker Change: This is a testament to our drive toward mid to late stage trials as part of our ambition to achieve multiple product options.
Speaker Change: The G box. Thank you.
Speaker Change: As it was pointed out we have a special focus on our RNA cancer vaccine portfolio and lobbying decreased 27 sets up clinical development program with <unk>, becoming a platform for unique combinations with summer.
Speaker Change: Other.
Speaker Change: <unk>.
Speaker Change: Thank you for attending seven is a bi specific antibody candidate that targets PDL one in Egypt, eight thus combining two complementary functions the binding of P&G for 8700, <unk> PD, one or two months, we saw extra T cell, killing of tumor cells and enriched.
Speaker Change: <unk> neutralization within the tumor microenvironment to create the cycle of that showed up normalization improve blood flow and to reduce hypoxia or consumer.
Speaker Change: Thank you for your 27 also reversed the negative effects of VEGF is signaling an infiltration and activation of immune cells and what's your lifestyle.
Speaker Change: By quarter localizing, the blockade of Pgi wasn't egfr signaling to the tumor and include 27 is designed to deliver superior anti tumor effects compared to individual packaging of PDL, one and VEGF eight with the potential to minimize the sports events.
Speaker Change: Associated with systemic anti VEGF <unk> here.
Speaker Change: But as the anti PDL, one and EGF antagonistic mechanisms being validated across numerous tumor types and in some cases in combination we have a roadmap for development of <unk> hundred 27.
Speaker Change: We and our path.
Speaker Change: Yes have created over 700 patients in clinical trials across a wide range of clinical indications with <unk> hundred 27, either as monotherapy or in combination with various standard of Catherine.
Speaker Change: In these early studies and decreased 27 demonstrated encouraging activity, Illinois combo therapy with a favorable safety profile that was shown to be generally the way we manage of it and design work with work events.
Speaker Change: David worked event.
Speaker Change: First with other Cherokee targeting PDL one.
Speaker Change: The data also indicate robust single agent activity for the antifreeze 27, and in combination with standard of care chemotherapy across tumor types of treatments.
Speaker Change: This extended data protection provides us with a solid foundation for making data driven decisions on potential indication and patient cohort for future potentially Registrational study.
Speaker Change: One of indications we have selected for further development of triple negative breast cancer <unk> the type of breast cancer, one of the poorest outcomes.
Speaker Change: Interestingly in the past that it can be seen we have observed a high objective response rate was encouraging with sponsors and long progression free survival, but the Ante Creek 27 in combination with Paclitaxel.
Speaker Change: Ethanol this year, we presented updated efficacy and safety findings from the ongoing phase one study in this indication across Britain tend to treat population of 42 patients. We observed a confirmed objective response rate of 74% importantly with parts.
Speaker Change: Those were shown to be clinically meaningful irrespective of PD lone status.
Speaker Change: Patients with PDL, one combined positive scores of TPS.
Speaker Change: No other than one confirmed objective response rate.
Speaker Change: <unk> was 76, 9% in patients with PDL, one EPS between one and 10. The confirmed objective response was 56 platform.
Speaker Change: And in patients with PDL, one Cps hung up and turn the confirmed.
Speaker Change: Jack definitely sponsor it was 100% we also accept rapid tumor shrinkage with a median time to response.
One nine months and then encouraging median duration of response of 11 seven months in the intensive treat population.
Weakness related adverse events upgrades.
Kurt and 57% of patients leading to treatment discontinuation and 12.
Speaker Change: 8%.
Speaker Change: In summary, we are encouraged by the potential PNG reached 77 in combination with chemotherapy to offer a clinically meaningful anti tumor activity, we got the self PDL, one status and by manager base.
Speaker Change: We have prioritized the planning of global trials and CNBC, we're unmatched niche remains high particularly for those with PDL one negative tumors.
Not as intuitive for college anti PD one treatment.
Speaker Change: We will be presenting additional data on <unk> at the San Antonio Breast cancer Conference next month.
Speaker Change: We believe that PMT crude 27 blocks at launch is showing an increasingly validated mechanism of action, but dose optimization twice in the U S initiated recently allow us to create a robust scientific data package in terms of global development.
And kick off three waves of focus.
We plan to execute quickly moved broken it into three waves Trust. We are investigating the MQ27 combinations with standard of care chemotherapy as an intended path to market approach the data generated by our partner bio <unk>.
It's driven our decision to prioritize the planning of Registrational trials in small cell lung cancer.
Speaker Change: <unk> in non small cell lung cancer due to start in the next few months.
Speaker Change: Second we plan to evaluate the anti Creek 27, with our ABTS and some of these tumor types and additional indications. The first exploratory trial evaluating another P&G free 27 combination well started earlier this year with our proprietary trop two ADC <unk> hundred 20.
Speaker Change: Right. These novel combinations may open up new areas of activity slump Yankee for you 2007, we plan to initiate additional trials evaluating novel proprietary combinations of PNC 27, with Adcs before year end and over the next 12 months now.
We aim to expand with standard of care chemotherapy in novel combinations.
And ADC across sounds like indications and treatments.
Speaker Change: It is a strategic goal for us like small P&C frequency seven as part of novel novel combination.
Given our experienced clinical development team, which has an increasingly global footprint, a strong financial position and unique pipeline. We are confident that we are white position.
So it shouldn't be execute on this comprehensive clinical development strategy.
Speaker Change: Now to the other cornerstone of our oncology portfolio or <unk> cancer vaccine platforms I missed that.
Speaker Change: At six six.
In this type of Neo antigens, you are trucks electric new location in cancer cells that are unique to an individual to block.
Speaker Change: <unk>, our investigational vaccines that are being co developed with our partner Genentech and manufactured on demand to the person that is.
So then you get to a patient.
Speaker Change: <unk> targets might've been non relocated to my antigen shaft by a majority of patients with a given tumor type and our off the shelf cancer vaccine candidate.
The computational approaches to discovering in selecting these two different types of target antigen on one of our core competencies.
Speaker Change: I missed that but both use the same vaccine delivery technology, namely our proprietary <unk> platform today, we have ongoing trials in multiple disease settings and indications across both vaccine platform, we have reported translational and clinical data over the last.
Speaker Change: Couple of hits and huge that data updates from why people would try it.
Speaker Change: On this slide uptick.
Speaker Change: Corrugate save time that we have reported in the past across I'm, that's been fixed price indication. That's uridine mrna MTX based vaccines have been manageable that batch might safety profile as single agents in combination with anti PD, one PDL, one component and in combination with chemotherapy.
Speaker Change: Oh at the hotel also indicates that a lot of Jordan mrna based vaccine platform is highly proficient and introducing and expanding high magnitude functional and lumpiness to T cell responses in the majority of patients, which is a prerequisite for clinical activity.
Speaker Change: Furthermore, our data from smart emphasize patient cohorts indicates clinical activity alone and in combination with anti PD one PDL one.
In our <unk> program I would like to highlight two vaccine candidates for which we have important updates during the quarter for PMT, one encouraging our mrna vaccine candidate against HPV 16 positive cancer, we presented data from two trials at the edge.
Speaker Change: No conference one data set to watch from the safety run in cohort a potentially registrational phase two randomized trial head to merit.
This trial evaluated <unk> in combination with Templeton still not that.
Whereas the PEMCO alone and first line HPV 16 positive PDL, one positive head and neck squamous cell carcinoma. The data supports the tolerability of P and Q1, 13 and clinical activity in combination with Bengal and the induction of higher magnitude in Novo T cell responses against H.
<unk> 16 antigens encoded in the proxy in summary, we are encouraged by the data safety cohort. The second state effect investigator initiated phase one two trials exploring P&C one person at CNET agent in patients with low code.
And head and neck cervical and other HPV 616, driven customer NOLA, well got confirmed positive safety and Immunogenicity findings.
Speaker Change: Okay.
We reported topline finding clock well Q1 is <unk>, which is being investigated in patients with anti PD, one relapsed or refractory melanoma <unk> 11 in costs for melanoma associated antigen, which collectively cover them off at 90 plus percent of melanoma patients.
It's a highly immunogenic and.
In the randomized phase two clinical trial conducted in collaboration with Regeneron P&G won 11 is being evaluated in combination with anti PD one quadcopter.
Speaker Change: The trial enrolled 184 patients with PD, one refractory unresectable stage, three or four Hello, NOLA and comprises.
Of which one to evaluate the combination of the other to measure the activity of PD, one alone or semi pay monthly.
Speaker Change: The trial met its primary endpoint, achieving a statistically significant improvement in all our and objective response rate in the PNG 111 seem to be pretty much combination.
Speaker Change: As compared to a historical control of anti PD, one monotherapy in relapsed refractory patients based on lots of many clinical trials that perished they expected or a corona TRP checkpoint inhibitor in this setting.
Speaker Change: The patient population.
Speaker Change: The results we saw in the phase two study are consistent with that seen in the proceeding phase one trial in patients with advanced melanoma, who have exhausted treatment options <unk>.
Speaker Change: 11, a lower all in combination with an anti PD one component.
Speaker Change: Hi magnitude T cell responses against at least one targeted tumor associated antigen in all analyzed patients most of which were an uptick activity prior to losing.
Speaker Change: We plan to present supported data from the primary analysis after has a coupon.
The various fixed.
Daytop case provided in Q3.
Concept and free dimension thirsty for all mrna cancer vaccine technology that Cumulus uridine mrna chemistry and non according backbone that is engineered to make transportation portfolio and our proprietary geico pick formulation plus systemic delivery, which we are using it both of them had been expected.
Speaker Change: Yeah.
Secondly for our computational approach of swaps the vaccine Zika, which you might answer just in topics for our indication specific fixed debt pro forma candidate that's clear proof of concept for our strategy to combine synergistic modalities and the decades of PMT is evident into what's working.
Speaker Change: With the separation.
Got it.
Moving to auto Jim So we're not alone also known as PMT 122 hour individualized and RNA cancer.
Speaker Change: Cancer vaccine candidates based on our <unk> platform in development with our partner Genentech, we consider individualized cancer vaccines as a potential medical was like Kuwait and aggressive about high unmet medical need of Resectable cancer and its excellent often in their residual disease treatments.
We have demonstrated that our individualized vaccine candidates used in patients with actually with pancreatic cancer can induce the novel T cell responses that are specific to the individual nutrient tumor antigens and that's been a risk of recurrence of cancer patients with vaccine induced immune responses.
Speaker Change: What's the reduced over a three year follow up period, we have two <unk> randomized phase II trial evaluating our individualized cancer vaccine in the adjuvant setting mainly in pancreatic ductal adenocarcinoma, Peter and then colorectal cancer, the five year survival agent Peter off.
After infection is 10% and up to 75% of patients with P. Definitely that's even though they appear to know within our kids after adjuvant treatment for Ohio with colorectal cancer about two 5% of patients relapsed within five years after resection and.
Speaker Change: Excellent purity, so to summarize we aim to bring individualized cancer vaccine into bachelorette treatment setting in tumor types, where the unmet medical need is high as such we have expanded into a new indication with the startup of phase two trial is evaluating our individualized cancer vaccine candidate.
In the excellent treatment of muscle invasive <unk> carcinoma, which had started screening patients.
Speaker Change: The current treatments include new adjuvant chemotherapy, followed by suspect Tony and for eligible patients is it followed by excellent treatment with an immune checkpoint inhibitor.
Speaker Change: Hi, Kids survivor, among patients with metastatic <unk> cancer is about 8% excellent treatment of muscle invasive disease as an important opportunity to potentially avoid recurrence metastasis and improve overall survival.
Speaker Change: The randomized double blind multicenter phase two clinical trials and to evaluate alternative will not run as an adjuvant treatment with England checkpoint and the Mackenzie order market patients with pirates.
The trial is expected to enroll about 360 patients to evaluate the efficacy of PNG 122 in combination with renewable capacity ROI on the standard of care for this indication in the U S. The primary endpoint for this study investigator assessed disease, we provide right.
Speaker Change: Secondary objectives include overall survival and safety.
Speaker Change: Lastly, as a final note I would like to invite you to our upcoming innovation theorists day next week, where we will share additional details on these and other programs, although our indoor PRP pipeline.
With that I will now pass the presentation call off Pf OEM purchased them.
Speaker Change: Thank you Ed Lim and a warm welcome to everyone who has both in today's call.
Speaker Change: Let me start by reviewing our financial results for the three months ended September 32024.
The total revenues reported for the period were approximately 1.245 billion euros, mostly recorded in September compared to approximately 895 million euros for the third quarter of 2000.
Speaker Change: Great.
Speaker Change: The increase compared to the same period last year can be largely attributed to early approvals of Carlyle.
Barry undetected COVID-19 vaccine this year versus last year.
Speaker Change: Moving to cost of sales.
Speaker Change: Cost of sales amounted to approximately 179 million for the third quarter of 2024 compared to approximately 162 million euros for the comparative prior year period.
Speaker Change: Research and development expenses.
Speaker Change: <unk> 550 million euros for the third quarter of 2024 compared to approximately 498 million euros for the comparative prior year period.
Speaker Change: These expenses were mainly influenced by progressing clinical trials for our late stage oncology pipeline candidates.
Speaker Change: Sales general and administrative expenses amounted to approximately 151 million for the third quarter of 2024 compared to about 154 million euros for the comparative prior year period.
Speaker Change: SG&A expenses were primarily driven by personnel expenses.
The Companys other operating results amounted to approximately negative 355 million euros in the third quarter of 2024 compared to negative 9 million euros for the comparative prior year period.
Speaker Change: The other operating result was primarily influenced by accruals for contractual disputes.
Income taxes were realized with an amount of about 39 million euros in the third quarter of 2024 compared to approximately 67 million euros of accrued tax expenses for the comparative prior year period.
For the third quarter of 2024, we reported a net income of approximately 198 million euros compared to about.
Speaker Change: 161 million euros for the comparative prior year period.
Speaker Change: Our diluted earnings per share for the third quarter of 2024 amounted to 81 euro cents compared to <unk> 66 Euro cents for the comparative prior year period.
Speaker Change: As of September 32024, our cash and cash equivalents plus security investments reached approximately $17 8 billion euros.
Speaker Change: Strong balance sheet allows us to invest in future value creation. Consequently, we will continue to invest in maintaining our.
Speaker Change: Leading cash generative COVID-19 vaccine business and the development of our in blood therapies and in our core capabilities to support additional late stage trials and potential commercialization of our most encouraging oncology assets.
Speaker Change: We will continue to assume a Richard go no go decision, making across all development stages as part of our portfolio prioritization strategy. This allows us to maintain our focus on materializing the value in our pipeline.
Speaker Change: Turning to the next slide we see our financial guidance for the full year of 2024.
Speaker Change: We saw a strong quarter in terms of revenues, which included certain revenues that we previously anticipated in the last quarter of 2024 with this we expect full 2024 financial year revenues to be at the low end of the guidance range provided in our outlook.
Our guidance reflect some risk of write downs and other charges by our collaboration partner, Pfizer, which we estimate to be approximately 10% of company revenues.
Speaker Change: We will continue to monitor the risk of potential write downs to determine the full scope of charges related to the 2020 for 2025 explanation patients.
Speaker Change: In line with our disclosure earlier in the year, we expect to report a loss for the 2024 financial year as we continue to invest in our most differentiating assets and technologies.
We are committed to responsible and sustainable growth and with this updating our 2024 financial expenses guidance to indicate a decrease in estimated SG&A expenses and capital expenditures.
Speaker Change: Reflecting our focus on continued investment in our pipeline, we are maintaining our R&D expense guidance.
Speaker Change: We have lowered the initial full 2024 funds a year SG&A expense guidance by 100 million.
Speaker Change: From $700 million to $800 million to now 600 to 700 million euros.
Speaker Change: We also reduced our capital expenditure guidance by 100 million euros from the initial 2024 guidance range of between $400 million and 500 million to between 300 million inflow.
Speaker Change: Yeah.
Speaker Change: Please note that this guidance update for SG&A expenses, and Capex do not reflect any emanate collaborations licensing transaction that we may enter into in the future.
Any potential payments, resulting from the outcomes of ongoing and future legal disputes related activities, such as judgments or settlements.
Speaker Change: Other extra ordinary items, all of which may have a material effect on our results of operations and cash flows.
Speaker Change: In summary, we remain focused on executing the company's strategy highlighted by the progress across our pipeline.
Speaker Change: We have advanced and started.
Speaker Change: New dose optimization and potentially registrational trials and have shared encouraging data that demonstrate the potential of our product candidates.
Speaker Change: Hello oncology portfolio focus remains on investing.
Speaker Change: And note that the technologies that we believe can have the greatest impact on medical practice.
Speaker Change: Progressing our late stage programs efficiency towards potential approvals.
Speaker Change: Our cash position and financial discipline allows us to continue to invest in those assets with a highest disruptive potential and focus on generating value for patients and our shareholders.
Speaker Change: With that I would like to turn the call over to our Chief strategy Officer, Ryan Richardson for strategic outlook and concluding remarks. Thank you.
Ryan Richardson: Thank you John starting with COVID-19, we continue to execute on our successful launch of this season's Jan one and <unk>, two varian adopted vaccines and more than 40 countries and regions around the world.
In September we began distribution of our CIP to Varian adopted vaccine in Europe.
Speaker Change: Knowing the initial rollout of Jan one vaccines in July.
We expect additional markets, including the U K that received initial shipments of Jan one vaccine to transition to <unk> two deliveries in November.
The United States, we continue to expect vaccination rates. This year that are generally comparable to last year with potential for slightly higher volumes due in part to the earlier approval and rollout of vaccines and supported by a sits recommendation in October for a second dose of COVID-19 vaccine for individuals who are 65 or older or.
Speaker Change: Compromised.
Speaker Change: Internationally, we have seen the opening up of several private markets in countries like the UK, Japan, Switzerland, Australia, South Korea, Singapore and Brazil.
Speaker Change: This year, we have also increased our supplier pre filled syringes in a number of international markets.
Speaker Change: Epidemiology of COVID-19 over the last two years and the associated global demand for vaccination continue to support our view of the COVID-19 vaccines will be a sustainable market for the foreseeable future.
Speaker Change: We expect to maintain or even gain market share in a number of key markets this year versus last year.
Speaker Change: And believe that we are likely to enter a period with improved visibility into vaccine demand.
Speaker Change: One of the unique features of our COVID-19 vaccine business as its lean cost structure.
Speaker Change: Our partnership with Pfizer allows us to leverage its manufacturing infrastructure and global commercial capabilities, which we expect will continue to enable us to limit the opex flowing through our P&L.
Speaker Change: These features create the potential for us to generate significant cash flow from our COVID-19 business a feature we expect to benefit from in the future.
Speaker Change: Turning to the next slide we are entering a catalyst rich period for our company in particular for our oncology portfolio.
Speaker Change: Today, we have more than 10 phase two and three trials ongoing across multiple tumor types.
Speaker Change: In the next 18 months, we expect multiple clinical data updates from these trials.
Speaker Change: And we will initiate several additional trials with registrational potential.
Speaker Change: Data is expected in 2025 from both our mrna cancer vaccine platforms fixed back in <unk>.
Speaker Change: We also expect data updates for being <unk>, seven or anti PD lone VEGF by specific antibody <unk> hundred two three.
Speaker Change: Her to ABC.
Speaker Change: Before we conclude our planned remarks, I would like to invite everyone to watch our annual innovation series event on November 14th.
Speaker Change: This event will include a deeper dive into our oncology strategy, including plans for being 2327, and our mrna cancer vaccine candidates.
Speaker Change: We look forward to engaging with you later this month to share more on our plans to create value for patients society and shareholders.
Speaker Change: We would like to open the floor for questions.
Thank you.
Speaker Change: To ask a question. Please press star one one on your telephone and wait for your name to be announced to waste of your question. Please press star one on one again, we currently ask analysts to limit themselves to one question per person.
We will now take the first question.
Speaker Change: From the line of caffeine off much from Bank of America Securities. Please go ahead.
Speaker Change: Thank you good morning, and I. Appreciate your time I wanted to ask you about one of the data catalysts that you mentioned that's upcoming in 2025, perhaps to talk about this more in detail next week, but they're three to three specifically I believe you've got data coming for endometrial cancer.
Speaker Change: Can you talk about the level of data you expect to show next year for that program and what you're looking for in order to move forward.
Speaker Change: Okay.
Oh it testing. Thank you for this question.
Speaker Change: <unk> was about our endometrial cancer data with <unk> and what I can tell you about that is that in 2025.
Speaker Change: To share data from a single arm trial in second line endometrial cancer.
Speaker Change: We will be able to show efficacy data and safety data.
Speaker Change: Ross.
Speaker Change: Disciplined her tool positivity populations and this will be presented at one of our a major cancer conferences.
Speaker Change: And also what would be positive data in your mind for that program.
Speaker Change: Can you repeat.
Speaker Change: What would be positive data for that for that study and your mouth positive data, yeah, but without the final.
Speaker Change: What would justify to continue once the compound is a strong activity the clinical activity profile and a favorable safety and this is also what what we see in the data.
Speaker Change: And we see this across our different her tool expression methods.
Speaker Change: Thank you.
We will now take the next question.
Speaker Change: From the line of diner, Great Bush from Leerink partners. Please go ahead.
Hi, Thank you for the question I have one on the bed, Jeff PDL, one BMT three to seven.
I think we're all aware of a similar by specific that has.
Speaker Change: Our PD one side, whereas you have a PD L. One side and then small trials in similar indications like triple negative breast cancer. The two bi specifics look to have similar outcome.
Was that expected and what does that tell you about the mechanism and do you believe BMT three to seven could be differentiated and any indications. Thank you.
Speaker Change: Yeah.
Speaker Change: Hi, Thanks for the question.
Speaker Change: Yeah, that's a good question and at.
Speaker Change: The tentative date.
Speaker Change: Both bi specific.
Speaker Change: Link this activities of Northrop magazine.
And and authorizing PD, one PDL one into action.
Speaker Change: They have this in common.
Speaker Change: The biggest difference is that.
Speaker Change: We anticipate the seven its dorit against everyone.
Speaker Change: Rich.
Smith: I'm Smith.
With the potential advantage of being further enriched and the tumor microenvironment by binding to PD everyone.
Speaker Change: Oh vice versa yeah.
Speaker Change: Uh huh.
Speaker Change: And.
So adding to the binding of VEGF in the tumor might come down, but they said that they have so far.
Are there some overlap in clinical trials.
Speaker Change: As you as you mentioned look.
Speaker Change: Look similar from there to see that.
Speaker Change: Yes.
Speaker Change: This.
Potential mechanistic difference could translate into them.
Better response rate and better durability.
Typically in pediatric <unk> positive tumors.
Speaker Change: So we have to see that there is this slide in this direction, but but it's too early.
Speaker Change: Yeah.
Speaker Change: To.
Speaker Change: The validated.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: We'll now take the next question.
From the line of Gosh Tamari from Jefferies. Please go ahead.
Speaker Change: Hi, This is Kathy on for cash so for your bedroom PDL one by specific BMT three to seven when do the Aes and reductions in dose for hypertension Proteinuria show up in comparison to what we've seen historically for veg F. PDL, one when co administered it to us too.
Speaker Change: Separate drugs and additionally, once you're going forward with it to first line in SCLC, an all comers population and what's the rationale for going as a biomarker selected population.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Okay I'll take both parts of the question.
So the first question was what's the comparison with the historic or the story of a good safety profile.
Speaker Change: Particularly with Bevacizumab.
So there are now more than 700 patients treated.
Got it.
Speaker Change: It is.
Speaker Change: As new auto compound or in combination.
Speaker Change: Uh huh.
Speaker Change: The comparison, but it's still a code.
Speaker Change: Today, its very good safety profile clearly shows.
The views.
Speaker Change: Effect profiles.
Speaker Change: We got to the key T concerning paclitaxel devices smart.
Speaker Change: Bleeding.
Speaker Change: Hi, Pat.
Speaker Change: Tension.
Speaker Change: Foundation, a fifth pillar.
Speaker Change: We have not seen C C.
Speaker Change: Any significant increase of bleeding tasteless in this cohort.
Speaker Change: Which goes beyond to be honest, but it's absurd.
Speaker Change: The population for example could you run.
Speaker Change: PD one in February.
Speaker Change: And hypertension rate.
Speaker Change: Lower than.
Speaker Change: Historically.
Speaker Change: <unk> devoted to him up.
Speaker Change: The mechanism for this.
Speaker Change: Can only be speculated.
Speaker Change: By linking the anti body.
Speaker Change: Part two P D a homerun.
Speaker Change: MTV is intact.
Speaker Change: <unk> is more tied to the tumor sites.
And less less active in the.
Speaker Change: PDL one negative areas.
Speaker Change: And this is of course encouraging provides in addition to it.
Speaker Change: Additionally, the argument beyond the <unk>.
Speaker Change: So far increased clinical activity.
For this compound class.
Speaker Change: So this was the first part the second part is it's a right.
Speaker Change: So we pushed out to two.
Speaker Change: To go into the oil come up population. The response the response to that is is that right.
Speaker Change: That our bi specific.
No that's shown in physical activity and not on the PDL one.
Speaker Change: Perfect great.
And to the Arizona low population, but also in populations, which do not express it.
Speaker Change: Yes.
Speaker Change: P D PDL, one or two P S right, which we sell to all of our data sets.
Speaker Change: You can see that the objective response rate.
The Kansas deal.
Speaker Change: Population is extremely encouraging we see something similar.
Speaker Change:
Speaker Change: Is that clear in the.
Speaker Change: The case now for clinical activity in the P. J Aron Knickerbocker slip relations and the second one.
Speaker Change: Our non small cell lung cancer, and I got closer to population with a vacuum hypothesis that we have is that this five specific anti body.
Speaker Change: Cody comes overcomes the limitations limitation of Oh.
Pure clinical activity in PD lone positive tumor and opens up.
Speaker Change: The potential to bring checkpoint blockade plus plus VEGF activity into two months. That's how it was the PDL one negative so the clinical trial in non small cell lung cancer is the oil come up probably but they're documenting.
Speaker Change: And collecting collecting samples for for.
Speaker Change: For today everyone.
Speaker Change: The Asian MBS participating patients according to daily one positivity.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Tucson, Fort Susan from CLK. Please go ahead.
Suzanne: Hi team. This is suzanne thanks for taking my question.
Suzanne: Maybe I missed it but can you clarify what the exact amount is that you have taken as a proficient for contractual disputes this year.
Speaker Change: Is this it or will there be more and can you indicate what this relates to <unk>.
Speaker Change: This is the ongoing patent disputes with our mrna pairs on the COVID-19 fixing or is there other contractual disagreements you are dealing with.
Speaker Change: <unk>.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Suzanne to take the questions. So I just stayed at the.
Speaker Change: The operating result, reflecting.
Speaker Change: You know these these positions that we have taken care of for contractual disputes with licenses and collaborators.
Speaker Change: Uh huh.
Speaker Change: At this point in time, given that the legal situation that we're in.
And I guess no precise messaging on what for what this is.
Speaker Change: There are a couple off of disputes that are related as I stated with some of the players and collaborators that we're working with.
Speaker Change: In total we have round about 600 million year to date for this and this is the amount that we feel.
Speaker Change: Is that a correct at this point in time.
Speaker Change: Thanks.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: Coming from the line of Terence Flynn from Morgan Stanley. Please go ahead.
Terence Flynn: Great. Thanks, so much for taking the question I was just wondering if you can tell us what you think the relevant benchmark is for survival for the upcoming <unk> data that we're going to see at the San Antonio Conference in December. Thank you.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Hi, what are you able to hear my question.
Speaker Change: Can you just repeat that sorry.
Speaker Change: Okay.
Speaker Change: Survival benchmark is for the upcoming <unk> data at the San Antonio Conference in December and then the second part of the question is it reasonable to expect some interim data from your global Phase III lung cancer trial next year. Thank you yep.
Speaker Change: Yep.
Speaker Change: Okay. Okay I can take the question.
Speaker Change: The title will be will be.
Speaker Change: We will be randomized and the like.
Speaker Change: Shipments of IP Ghansham on therapy.
Speaker Change: Okay.
Speaker Change: On the side of care.
Speaker Change: And the private status is.
Speaker Change: It's powered for.
Speaker Change: S M S.
Speaker Change: And the PFS is in this indication in the range of Uh Huh.
Speaker Change: Four to five months or S. I can't recall at the moment.
Speaker Change: Sure.
Speaker Change: Yeah, that's the official opening.
Speaker Change: Right I think we're gonna have updates pointed out to provide an update at the 15 in 18 months or less mark in terms of percentage evictions.
Speaker Change: And that's that's starting to get into a relevant zone turns when you look at the what kimbro is achieved and a similar indication which is.
Speaker Change: It is basically in the 15 to 23 up to 23 months median when it's depending on the patient mcps fiction absolutely.
Speaker Change: And the <unk> report.
Speaker Change: Part of it.
Speaker Change: Reported PFS data in.
Speaker Change: In the Sudan.
Speaker Change: The leaching, which is now about 13 months and still ongoing.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: We'll now take the next question.
Speaker Change: From the line of your own Werber from TD Colin. Please go ahead.
Speaker Change: Great maybe just a.
Speaker Change: Follow on Terence's question in on CNBC is the third in phase III to go for Cps less than 10, specifically in that cohort or would you go across all Cps levels in phase III.
Speaker Change: Then secondly on small cell.
Speaker Change: The primary gonna be head to head against chemo to centric or is it going to be against a chemo alone. Thank you so much.
Speaker Change: So the first the first part is intended in the patient population below 10%.
Speaker Change: And.
Speaker Change: <unk> be against chemotherapy alone.
Speaker Change: But the plan also saw them.
Speaker Change: We are in the evaluation of additional with additional costs.
Speaker Change: That 10% population.
Speaker Change: And can you just repeat the second part of your question.
Speaker Change: Yeah, Hey, Ryan and just switching to small cell lung cancer is the phase III.
Speaker Change: Going to be head to head against chemo, Oregon's chemo centric, thank you and small cell lung cancer.
Speaker Change: Cable cluster centric.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Jessica Fye from Jpmorgan Chase. Please go ahead.
Jessica Fye: Hey, guys. Good morning, Thanks for taking my questions.
Speaker Change: Two firstly on guidance of the various assumptions factoring into your guidance what changed to lead you to guide to the low end of the range, even though Pfizer I believe maintained its come on any guidance last week and then on the pipeline for <unk> seven the veteran PD lone by specific would you see it.
Speaker Change: Fastest to market indications and what's the right way to think about R&D spend as the company expands trials for this product. Thank you.
Speaker Change: Yes, Jessica let me take the first part of the question.
Speaker Change: So we've guided at the beginning of the year 2.5 to sleep on 1 billion based on of course certain scenarios.
Speaker Change: Year to date Q3 has been has been very very good.
Speaker Change: And.
Speaker Change: Excuse me so far year to date figure so far have been.
Speaker Change: Generated dominantly bye bye.
Speaker Change: Buy revenues that we generated in high income countries.
Speaker Change: We have seen though low end low demand and also low pricing and some of the low and middle income countries within the <unk> territory and therefore, we specified our guidance to the low end for this year.
Speaker Change: And then second question.
Speaker Change: I think your second question was speed to market with.
Speaker Change: What do we think would be the fastest to market for 327 is that correct.
Speaker Change: Yep.
Speaker Change: So I think we're going to provide more details at our innovation series event next week in terms of the.
Speaker Change: Paths to market, but I think what we can say now is that.
Speaker Change: We do think that small cell lung cancer could be want to be at the lead indications that we're looking at very closely we initiated a phase II trial and believe that we can start a phase III trial.
Speaker Change: Phase II three effects.
Speaker Change: So phase III portion of that trial.
Speaker Change: In the coming months.
Speaker Change: By first half next year, so that could represent one.
Speaker Change: Fast path to market, but of course, we're looking at others as well.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Corey customer from Evercore ISI. Please go ahead.
Speaker Change: Hi, Thanks for taking the question.
Corey: So your trop two ADC <unk> hundred two five it looks like an important part of your emerging combination strategy with three to seven.
Speaker Change: Looking at the clean trial Postini shows that you're you're evaluating a variety of different dosing combination. So wondering if you can add some color on on the dosing strategies and your confidence level that all three mechanisms together will not compromise safety. Thank you.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Dan.
Speaker Change: Uh huh.
Speaker Change: Uh huh.
Speaker Change: Exploration of combination is exactly also also directed to explore the safety of the molecule in combination.
Speaker Change: Okay.
Speaker Change:
Speaker Change: Two five.
Speaker Change: Trop two ADC comes is that does that.
Speaker Change: The safety profile that is characterized by my estimate.
Speaker Change: And then ask the question that you want to US is whether the combination combination that's been quickly to seven.
Speaker Change: What's happened has an adequate toxicity effects that.
Speaker Change: It's something that people are back to understand.
Speaker Change: We do not expect any Ida Ida overlapping toxicities.
Speaker Change: Seven.
Speaker Change: Is that a that was tabled with safety profile.
Speaker Change: Start with lower doses and then escalate as good at.
Speaker Change: Two two higher higher doses.
Speaker Change: <unk> assessed and safe dose.
Speaker Change: I don't think a safe dose cohort in our <unk>.
Speaker Change: What will be the cohort four also determining the contributions of efficacy.
Speaker Change: Uh huh.
Speaker Change: Doug.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Chris Schaper, Tony from Goldman Sachs. Please go ahead.
Speaker Change: Hi, This is Kevin on for Chris Thanks for taking our question.
Speaker Change: Just wanted to ask another one on the.
Speaker Change: PD Lone VEGF three to seven.
Speaker Change: So you touched on potential mechanistic differences with Ivan asked about earlier.
Speaker Change: If we can assume that the clinical profiles remained relatively similar.
Speaker Change: Do you believe this is a story more about clinical execution and if so how can you differentiate there. Thanks.
Speaker Change: Yeah.
Speaker Change: Yes. Thank you for the question, Kevin I'll start and then.
Speaker Change: But also too so I think that.
Speaker Change: We do think that there is sufficient excellent theres significant room for differentiation and clinical strategy and that's actually one of the main.
Speaker Change: Drivers that we're evaluating now because we do see applicability across many different tumor types and as Uber also alluded across different patient segments within tumor types.
Speaker Change: And I think one of the unique features of our portfolio in oncology is the combination agents that we could bring to bear with three to seven so I think we've talked about chemo combination as being likely the fastest path to market initially.
Speaker Change: And we've guided to a couple of early indications, but we're definitely thinking broader than that and we're thinking about ADC to southern combinations to follow shortly thereafter, our current thoughts would be to initiate those trials already in 2021st combinations potentially in 2025.
Speaker Change: Rather than waiting to do those in sequence and where we.
Speaker Change: We're also going to be evaluating other combinations as well.
Speaker Change: On the road. So I do think that that's a differentiation angle that we can that we're well positioned to exploit so it really comes down to a combination of.
Speaker Change: Combination strategy and also clinical execution and deep as potential differentiators for this large opportunity that we see.
Speaker Change: Great. Thank you.
Speaker Change: Thank you.
Speaker Change: We'll now take the next question.
Speaker Change: From the line of.
Thyroid: Thyroid from BMO capital markets. Please go ahead.
Speaker Change: Hi, This is actually on for Joe. Thanks for taking our question. So what are you learning about sort of our lower cost breast and lung cancer indications that you're looking at.
Speaker Change: What's your level of confidence that you can beat standard of care is given the importance of that.
Thyroid: To regulators.
Speaker Change: So I think we had a little bit of a of a buzz with the question. I think you were asking about the importance of overall survival is that correct.
Speaker Change: Yes, Sir.
Thyroid: What have you learned sort of overall survival across breast alive and well.
Thyroid: Conference, you're kind of giving you the importance of that endpoint to regulators.
Thyroid: Yeah.
Thyroid: Yeah, So we completely understand understand the rationale for this.
Thyroid: Question, particularly based on.
Thyroid: Disappointing with SaaS coming because we've actually come up with.
Thyroid: In many indications that can improve TF as such it's not translate into an MBR of cost plus cross connect.
Thyroid: Collecting our own in house data.
Thyroid: And we clearly see that.
Thyroid: Debt.
Thyroid: Maturing or S data unpublished data.
Thyroid: We are getting much more encouraged.
Thyroid: The improved PFS is indeed translating also into in OSB.
Thyroid: To remind you.
Thyroid: Debt on that piece.
Thyroid: P. S. S are important that we are seeing for example in T and C is more than substantially.
Thyroid: It's not just touched on it's not the per ton per ton and that is that.
Thyroid: It's that it's usually obsessed with speed, but see some are you actually be able to come up with.
Thyroid: That two to three months edition of the P. F S Yep.
Thyroid: And then.
Thyroid: The drop in P. M S.
Thyroid: Thus was a steep.
Thyroid: This Halloween.
Thyroid: The per ton that is obsessed with cumulative idea alone we are not seeing this yet.
Thyroid: Dfc.
Thyroid: Particularly particularly in.
Speaker Change: <unk> yeah.
Thyroid: Yeah.
Thyroid: The combined <unk> to seven <unk>.
Thyroid: This this chemotherapy.
Thyroid: There is a sustained peak PFS and the PFS does not go up in the pet on like a steep curve that goes slowly down.
Thyroid: <unk>.
Thyroid: This is this is the best the best <unk> for that.
Thyroid: Can translate to two oses.
Thyroid: Sure.
Thyroid: I think we can definitely answer the question.
Thyroid: Yes.
Thyroid: Next.
Thyroid: Next assessments for the first indications in which we are.
Thyroid: <unk> small cell lung cancer.
Thyroid: And.
Thyroid: Six nine months.
Thyroid: Nine months worth of lung cancer.
Thyroid: Yeah.
Thyroid: Okay.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Ellie Merle from UBS. Please go ahead.
Ellie Merle: Hey, guys. Thanks for taking the question. So that's slow Coalbed combo program I guess, what's the latest on that program. After the phase III and that's one of the endpoints.
Thyroid: And what's your latest thinking around the timelines or the second Gen program with the trivalent mrna vaccine just Kevin Madonna expects Colons combo next year curious on.
Thyroid: And their strategy what their combination.
Speaker Change: Yes. Thanks for the question. So we're working with Pfizer now on our next generation suite Covid vaccine combination a combination vaccine program and I think it's a little too early to give you a precise roadmap, but we're hoping to give you in planning to give you updates.
Thyroid: Over the course of 2025.
Thyroid: Think needless to say I think this is a this is a program that has a.
Thyroid: For the full weight of Pfizer in bonds and check our R&D teams behind it and we do think that some of the problems that have been we're seeing enough of an initial trial.
Thyroid: Those can be addressed through further optimization of the construction. We have early evidence that supports that but I think before we give you a definitive roadmap.
Thyroid: I think what we'd like to generate a little more data and hopefully come out with that next year.
Speaker Change: Great. Thanks.
Speaker Change: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: From the line of Chi Tsang from HSBC Bank plc. Please go ahead.
Speaker Change: Hello.
Chi Tsang: Morning, Thanks for taking my question I have one on your oncology portfolio just wondered for the other assets apart from <unk> 27 to 395, especially on the I O space.
Speaker Change: In the next 12 months when we will begin to hear your update on specifically things like.
Speaker Change: <unk> 12, <unk> 14, those early stage mid stage assets. Thanks.
Speaker Change: Yeah.
Speaker Change: So I think.
Speaker Change: At $3 12 and of course, as the CD 44, and Bebe program with Genmab and that's under ongoing.
Speaker Change: It's an ongoing trials right now.
Speaker Change: Our intention is to to bring data forward if it.
Speaker Change: Upon that trials completion.
Speaker Change: We don't yet have data for that but it's likely going to be next year.
Speaker Change: And I think the other programs generally speaking our intention is to bring data out when we think we have something relevant to share we tend to do that in a preferred mode of a data disclosure is in medical meetings.
Speaker Change: And so of course that requires that you've got data in hand, and it's clean and been analyzed in and is accepted by public education. So we can't always give precise guidance on when every program will read out but I think.
Speaker Change: Those other programs are progressing and I think we would plan to update our pipeline disclosure schedule.
Speaker Change: Going into early next year.
Speaker Change: Thanks, a lot.
Speaker Change: Thank you we will now take the next question.
Speaker Change: From the line of Simon Baker from Redburn Atlantic. Please go ahead.
Simon Baker: Thank you for taking my question another one on BMT <unk> seven.
Simon Baker: And going back to <unk> question I, just wanted to double check that.
Simon Baker: The comments you made with respect to trial design were related to triple negative breast rather than.
Simon Baker: Farmed non small cell lung cancer study.
Speaker Change: That is indeed, the case is there anything you can say on the design of the outcome.
Speaker Change: It's first line study in terms of geography comparator.
Speaker Change: You mentioned stress the case, you already and in term results, but any detail would be much appreciated. Thank you.
Speaker Change: Simon I would like to refer you to our innovation day next week, where we would disclose in more detail.
Speaker Change: A couple of hours of study designs and benchmarks. We are comparing against a also are contextualized to our entire trial well also questions around <unk> hundred 27 pivotal trials, we are planning would it be.
Speaker Change: It's closed.
Speaker Change: Thank you very much.
Simon: Thank you.
Speaker Change: We will now take the next question.
Speaker Change: Yeah.
Speaker Change: From the line of Manav Must've Rockies from Deutsche Bank. Please go ahead.
Speaker Change: Hello, Thank you very much since my question was stolen.
Speaker Change: Basically I just wanted to ask on your ongoing confidence on your top two program, but also your nest Melanie.
Speaker Change: Melanoma program as well thank you very much.
Speaker Change: Yeah.
Speaker Change: Mhm.
Speaker Change: So the first question was about talk to ABC did I get that right. So are we.
Speaker Change: As you know our trop two ADC to antifreeze 27 is at an early stage of <unk>.
Speaker Change: Testing and in particular, we see a potential in combination with P&G free 27, which we see as we have already discussed as a platform.
Speaker Change: Combined with different Adcs.
Speaker Change: And has a combination trial, we just have to start to explore first of all it's a safe combination doses.
Speaker Change: It is going into this direction and is exploring CNBC non small cell lung cancer, and ovarian cancer and cervical cancer cohorts.
Speaker Change: Up to Oh, a trop, two ADC and Oh I P. M D C.
Speaker Change: Seven combination.
Speaker Change: Second question was about Ala I missed a lot of individualized.
Speaker Change: That's from yes, we are continuing to expand into the adjuvant space as you might know we have excellent.
Speaker Change: We have try its running in adjuvant colorectal cancer with an upcoming interim analysis.
Speaker Change: End of next year, we have started with our partner Genentech.
Speaker Change: A trial in the adjuvant setting of and pancreatic cancer are motivated and informed by our chase small phase one trial with however, exciting data and we just have started a search trial in this indication in the adjuvant setting.
Speaker Change: With muscle invasion in muscle invasive <unk> cancer.
Speaker Change: Also a randomized potentially a pivotal trial.
Speaker Change: So we saw the ongoing trials.
Speaker Change: And we are reading out our trial in first line melanoma, and we'll be able to disclose more about that.
Speaker Change: Upcoming our innovation day next week.
Speaker Change: And I would just add to that.
Speaker Change: Summary that we continue to believe that that says disruptive potential in particular in particular and those adjuvant settings. It also mentioned and were investing accordingly.
Speaker Change: The program.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: We will now take the last question.
From the line of Jay Olson from Oppenheimer. Please go ahead.
Jay Olson: Congrats on the progress and thank you for providing this update can you comment on the approximate level of R&D spending increase you expect in the next few years, considering how rapidly you're expanding the number of phase III programs in oncology.
Jay Olson: And is there an ideal number of phase III trials would optimize your organizational and financial resources. Thank you.
Speaker Change: Yes.
Speaker Change: Yeah, Yeah. Thanks for the question I mean, it's a bit early for any guidance says that we maintain.
Speaker Change: Turning to get now in November.
Speaker Change: I think we feel comfortable with the four to four to six that we currently have a running and you know on one hand, we want to control costs on the other hand of course, we want to invest wisely, we talk about three to seven and the potential of course, it will be not.
Speaker Change: Not very clever to not invest in that compound to just use. This example, specifically.
Speaker Change: But be assured that we control our costs going forward being at SG&A expenses will be net R&D expenses.
Speaker Change: Yeah, and with regard to the target pipeline I think it's safe.
Speaker Change: Very good question I would just note that with the current level of R&D spend again. This is just alluded to and we currently have.
Speaker Change: 10 ongoing phase II or III trials. Some of those are with partners. Some of those are fully by mitek self funded but I think it already shows you that we've already reached at this current R&D level pretty significant scale in the mid and late stage pipeline.
Speaker Change: Great. Thank you.
Speaker Change: Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: [music].