Sign in

    Biontech SE (BNTX)

    Q3 2024 Summary

    Published Feb 18, 2025, 5:23 PM UTC
    Initial Price$80.22July 1, 2024
    Final Price$119.93October 1, 2024
    Price Change$39.71
    % Change+49.50%

    What went well

    • BioNTech's BNT327, a bispecific antibody targeting PD-L1 and VEGFA, has shown encouraging efficacy data in triple-negative breast cancer (TNBC), with a confirmed objective response rate of 74% in a Phase I/II study, regardless of PD-L1 status, indicating strong potential for this asset.
    • The company is advancing multiple Phase II/III trials with BNT327 in various indications, including small cell lung cancer and TNBC, aiming for fast paths to market, which could significantly enhance BioNTech's oncology portfolio.
    • BioNTech's robust mid- and late-stage pipeline includes 10 ongoing Phase II or III trials, demonstrating significant scale at current R&D spend levels, indicating efficiency and potential for future growth.

    What went wrong

    • BioNTech is lowering its revenue guidance to the low end of the range due to lower demand and pricing in low- and middle-income countries within the Pfizer territory.
    • There is uncertainty regarding the increase in R&D spending as BioNTech expands its number of Phase III programs, potentially pressuring financial resources, and the company is reluctant to provide guidance on future R&D expenses.
    • Key pipeline products, such as BNT327 (the VEGF/PD-L1 bispecific antibody), are still in early to mid-stage clinical trials, which may delay their time to market and face competition, while upcoming data readouts lack clarity, adding to investor uncertainty.

    Q&A Summary

    1. Guidance Lowered to Low End
      Q: Why did you adjust guidance to the low end?
      A: We specified our guidance to the low end due to low demand and low pricing in some low and middle-income countries within the Pfizer territory, despite very good Q3 performance generated dominantly by revenues in high-income countries.

    2. EUR 600 Million Provisions for Disputes
      Q: How much have you accrued for contractual disputes?
      A: We have accrued around EUR 600 million year-to-date for contractual disputes with licensees and collaborators. Given the legal situation, we cannot provide precise details on these disputes at this time.

    3. Fastest Path to Market for BNT327
      Q: What are the fastest-to-market indications for BNT327?
      A: We believe small cell lung cancer could be one of the leading indications for BNT327. We initiated a Phase II trial and plan to start the Phase III portion in the coming months, potentially representing a fast path to market.

    4. Upcoming BNT327-TNBC Data and Survival Benchmarks
      Q: What's the survival benchmark for upcoming BNT327-TNBC data?
      A: We plan to provide updates at the 15 and 18-month overall survival marks for BNT327 in triple-negative breast cancer. This compares to pembrolizumab, which has achieved a median OS of 15 to 23 months depending on patient CPS scores. We have recently reported PFS data reaching about 13 months and still ongoing. ,

    5. R&D Spending and Phase III Expansion
      Q: How will R&D spending change with expanding Phase III programs?
      A: While it's too early to provide specific guidance, we feel comfortable with the current EUR 2.4 to EUR 2.6 billion R&D spending level. We aim to control costs while investing wisely, particularly in promising compounds like BNT327. Currently, we have 10 ongoing Phase II or III trials, showing significant scale in our pipeline at this R&D level.

    6. Confidence in Survival Endpoints for BNT327
      Q: How confident are you in beating standard of care in survival endpoints?
      A: We are encouraged that improved PFS is translating into overall survival with BNT327. In TNBC, we see substantial PFS improvement without the steep drop-off seen with bevacizumab. We believe we can definitely answer this question in the next 3 months for TNBC, small cell lung cancer, and second-line NSCLC.

    7. COVID-Flu Combination Vaccine Progress
      Q: What's the latest on the COVID-flu combo program after missing endpoints?
      A: We're working with Pfizer on our next-generation flu COVID vaccine combination program. It's too early to give a precise roadmap, but we plan to provide updates over the course of 2025. We believe issues in the initial trial can be addressed through further optimization of the construct, supported by early evidence.

    8. NESTOR Individualized Platform Updates
      Q: What's the progress on your NESTOR individualized platform?
      A: We are expanding NESTOR into the adjuvant space, with trials running in adjuvant colorectal cancer (interim analysis end of next year), adjuvant pancreatic cancer with Genentech, and muscle-invasive urothelial cancer. We are also reading out our trial in first-line melanoma and will disclose more at our Innovation Day next week.

    9. Combining BNT327 with TROP2 ADC BNT325
      Q: What's your strategy for combining BNT327 with TROP2 ADC?
      A: We are exploring the safety of combining BNT325 (TROP2 ADC) with BNT327, starting with lower doses and escalating to higher doses. We aim to understand any potential additive toxicity, particularly stomatitis, but do not expect overlapping toxicities due to BNT327's tolerable safety profile.

    10. Differentiation Strategy for BNT327
      Q: How can BNT327 be differentiated if clinical profiles are similar to competitors?
      A: We believe there is significant room for differentiation through clinical strategy, including combinations with other agents. We see applicability across many tumor types and plan to initiate combination trials, including with ADCs, starting in 2025. This combination strategy and clinical execution are key differentiators for the large opportunity we see with BNT327.

    11. BNT327 Safety Profile Compared to Bevacizumab
      Q: How does BNT327's safety profile compare to historical data with bevacizumab?
      A: Compared to historical safety profiles, BNT327 shows reduced side effects, including lower rates of bleeding and significantly lower hypertension rates. This may be due to the anti-VEGF interaction being more targeted to the tumor site, reducing activity in PD-L1 negative areas.

    12. Details on BNT327 Trial Designs
      Q: Can you provide details on the design of upcoming BNT327 trials?
      A: We will disclose more details on study designs and benchmarks for our BNT327 trials at our Innovation Day next week, including information on pivotal trials we are planning.

    13. Guidance on Other Oncology Assets
      Q: When will we hear updates on other oncology assets like BNT312 or BNT314?
      A: Our intention is to bring data forward upon trial completion, likely next year for BNT312. We prefer to disclose data at medical meetings once it has been fully analyzed and accepted for publication. We plan to update our pipeline disclosure schedule going into early next year.

    Related Publications