Release Date: August 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioNTech SE (BNTX, Financial) achieved significant progress in its oncology pipeline, including the successful Phase 2 trial of its FixVac mRNA cancer vaccine for melanoma.
- The company initiated the launch of a new variant-adapted COVID-19 vaccine, with additional approvals expected soon.
- BioNTech SE (BNTX) expanded its partnership with CEPI to establish mRNA vaccine manufacturing capabilities in Rwanda, contributing to epidemic and pandemic preparedness in Africa.
- The company is advancing its combination therapy strategy, starting trials for its anti PD-1 VEGF bispecific antibody BNT327 and TROP2 ADC BNT325.
- BioNTech SE (BNTX) has a strong cash position of approximately EUR18.5 billion, providing strategic flexibility for long-term growth investments.
Negative Points
- BioNTech SE (BNTX) reported a net loss of approximately EUR808 million for the second quarter of 2024, compared to a net loss of about EUR190 million in the prior-year period.
- Total revenues for the second quarter of 2024 decreased to approximately EUR129 million from EUR168 million in the second quarter of 2023.
- Research and development expenses increased significantly to approximately EUR585 million in the second quarter of 2024, up from EUR373 million in the prior-year period.
- Sales, general, and administrative expenses rose to approximately EUR184 million in the second quarter of 2024, compared to EUR138 million in the prior-year period.
- The company recorded a provision related to a contractual dispute, contributing to a negative operating result of approximately EUR267 million for the second quarter of 2024.
Q & A Highlights
Q: What specific programs and settings trials do you think are most likely to launch in 2026? And if that's dependent on accelerated approval, what gives you confidence in accelerated approvals by that date?
A: We have a couple of different programs that could potentially launch in 2026. The first is BNT323, our HER2 ADC, which we think could achieve accelerated approval in second and third line endometrial cancer. Additionally, BNT122, our iNeST in adjuvant colorectal cancer, could also launch in that timeframe, pending further discussions with the FDA and strong data.
Q: Can you give us a sense of the historical controls you think are most appropriate for BNT111 FixVac in CPI refractory melanoma?
A: The controls we compare against are anti-PD-1, PD-L1 treatments and chemotherapies tested in this indication. We see a clinically meaningful benefit in objective response rate compared to these controls. However, it is too early to be specific about PFS and OS.
Q: Regarding the upcoming Phase 3 COVID flu combo data, what would be considered good data, and how would it impact the demand for the regular COVID vaccine?
A: Good data would include safety, immunogenicity, and efficacy comparable to the COVID-19 vaccine plus efficacy in the flu arm. If the data qualify for submission, we could potentially see approval for the 2025-2026 season.
Q: In the wake of the cemiplimab update, is there a specific internal oncology program that could benefit from accelerated investments?
A: We have multiple programs in non-small-cell lung cancer, including BNT316, BNT327, and a FixVac program. While we found the cemiplimab data encouraging, we decided to prioritize other programs. Genmab will take the program forward into Phase 3, and we retain an economic stake.
Q: How should we think about margin progression as your oncology pipeline progresses and you scale up manufacturing and invest in R&D and SG&A?
A: Our COVID business will continue to drive margins in the near term. For oncology, we expect margins similar to other companies in the field. We are working hard to bring down costs for internalized medicine candidates.
Q: Can you provide a ballpark figure for the ORR delta in the BNT111 trial in cutaneous melanoma?
A: Standard-of-care objective response rate for this patient population is around 10%. We aim to see something well above that, and our current data shows a clinically meaningful benefit. The safety profile is also very manageable.
Q: How does BioNTech's approach to BNT327 differ from competitors, and are you planning any head-to-head trials involving KEYTRUDA?
A: We see BNT327 as a highly compelling IO backbone for various combinations. We plan to pursue multiple indications and use it as a backbone for many of our pipeline assets. For indications where pembro is approved, we would compare BNT327 against the standard-of-care.
Q: Is there potential for an interim analysis for BNT122 in colorectal cancer that would allow you to look at the data earlier?
A: We hinted at a potential analysis by the end of 2025. The study endpoint is disease-free survival, and we expect part of the data to mature by then. Based on the results, we will decide on the next steps, including potential regulatory actions.
Q: Can you give us an idea of the capacity that the Mainz facility will provide in 2027 for iNeST, and is 122 approval contingent on the completion of that facility?
A: We can't comment on the exact capacity yet, but the facility is being built to act as a pilot facility if one of the personalized vaccine products is approved. We are also expanding our clinical trial capacity to start additional trials in 2025 and beyond.
Q: What are the programs you are most excited about or prioritizing for oncology combinations?
A: We are very excited about the IO ADC combination concept, particularly BNT327 combined with our TROP2 ADC, BNT325. We are also excited about BNT211, our Claudin 6 CAR-T cell in combination with our vaccine, which shows strong data in enhancing CAR-T cell persistence.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
