BioNTech SE Q3 FY2024 earnings call

• COVID-19 vaccine: Successfully launched updated vaccines targeting the latest variant, with distribution underway in multiple global regions.
• Oncology pipeline: Advancements in oncology, including progress in bispecific immunomodulator BNT327 (partnered with Biotheus) and mRNA cancer vaccine portfolio. Presented clinical updates at ESMO Congress. Dosed first patients in optimization studies for small-cell lung cancer and triple-negative breast cancer. BNT111 mRNA cancer vaccine met primary endpoint in a trial for cutaneous melanoma. Initiated new Phase II clinical trial with Genentech for bladder cancer adjuvant treatment. Had inaugural AI Day highlighting in-house AI capabilities.

For the third quarter of 2024, total revenues were approximately €1.245 billion. Cost of sales was €179 million, research and development expenses were €550 million, sales, general and administrative expenses were €151 million, other operating results were approximately negative €355 million, net income was approximately €198 million, diluted earnings per share was €0.81, and cash and cash equivalents plus security investments reached approximately €17.8 billion. The increase in revenues compared to the third quarter of 2023 was largely due to earlier approvals of variant-adapted COVID-19 vaccines.

• Full-year 2024 revenues expected at the low end of the previous guidance range due to lower demand and pricing in some low- and middle-income countries within the Pfizer territory.
• Expect to report a loss for 2024 as continuing to invest in differentiating assets and technologies.
• Updated SG&A expense guidance lowered by €100 million to €600 million to €700 million and capital expenditures guidance reduced by €100 million to between €300 million and €400 million.

• Potential write-downs and other charges related to the 2024-2025 vaccination season, estimated to be approximately 10% of company revenues.
• Legal disputes and contractual disagreements, with approximately €600 million accrued year-to-date for contractual disputes.

Q: About data catalysts in 2025, specifically BNT323 in endometrial cancer, can you talk about the data expected and what's positive data?

A: Özlem Türeci said in 2025, data from a single-arm trial in second line endometrial cancer will be shared, showing efficacy and safety across HER2 positivity populations; positive data would be strong clinical activity and favorable safety.

Q: On BNT327, similar bispecifics have similar outcomes in small trials, was that expected and any differentiation?

A: Ugur Sahin said BNT327 is directed against PD-L1, potentially with advantage of being further enriched in tumor microenvironment; data so far overlaps but need to see if mechanistic difference translates to better response rate and durability, especially in PD-L1 positive tumors.

Q: For BNT327, when do AEs and reductions in dose for hypertension and proteinuria show up vs historical VEGF PD-L1 drugs, and rationale for biomarker-selected population in NSCLC?

A: Ugur Sahin said over 700 patients treated with BNT327, safety profile better than bevacizumab; BNT327 is an all-comer trial in NSCLC, stratifying by PD-L1 positivity.

Q: Clarify provision for contractual disputes, amount and related matters?

A: Jens Holstein said roundabout €600 million accrued year-to-date for contractual disputes with licensers and collaborators, related to disputes with some players, but precise details not given.

Q: Benchmark for survival in upcoming BNT327 TNBC data at San Antonio Conference, and interim data from global Phase 2 lung cancer trial?

A: Ugur Sahin said trial in TNBC is randomized against chemotherapy standard of care, PFS in single-arm trial reached above 13 months; Ryan Richardson said updates planned on 15-18 month OS mark in lung cancer trial.

Q: On TNBC Phase 3, CPS less than 10 or across all levels, and small-cell lung cancer Phase 3 vs chemo?

A: Ugur Sahin said first trial in TNBC is in patient population below 10% vs chemotherapy alone, and small-cell lung cancer Phase 3 is vs chemo plus centric.

Q: Guidance change despite Pfizer maintaining COMIRNATY guidance, and fastest to market for BNT327?

A: Jens Holstein said low demand and pricing in some countries led to guidance to low end; Ryan Richardson said small-cell lung cancer could be a fast path to market, with Phase 2/3 trial in coming months.

Q: Color on dosing strategies and safety for TROP-2 ADC BNT325 combination with BNT327?

A: Ugur Sahin said exploring combination to assess safety, starting with lower doses and escalating to determine safe dose profile and efficacy contribution.

Q: On PD-L1 VEGF 327, is it more about clinical execution for differentiation?

A: Ryan Richardson said combination strategy and clinical execution are differentiation angles, with small-cell lung cancer and chemo combinations as fast paths, and ADC combinations to follow.

Q: Learning on overall survival in breast and lung cancer indications and confidence for regulators?

A: Ugur Sahin said improved PFS in combinations like BNT327 with chemotherapy is not the usual bevacizumab pattern, suggesting potential OS translation, with PFS improvement sustained and not steeply dropping.

Q: Latest on flu-COVID combo program and second-gen trivalent mRNA flu vaccine?

A: Ryan Richardson said working with Pfizer on next-gen program, too early for precise roadmap but planning updates in 2025, with early evidence supporting optimization.

Q: Update on early mid-stage IO assets like 312 or 314?

A: Ryan Richardson said 312 (CD40x4-1BB program with Genmab) ongoing, data to be brought forward upon trial completion; other programs will be updated in medical meetings when relevant data is available.

Q: TROP-2 program and iNeST melanoma program status?

A: Özlem Türeci said BNT325 TROP-2 ADC combination trial exploring safe doses in TNBC, non-small cell lung cancer, etc.; iNeST is expanding into adjuvant settings with trials in colorectal, pancreatic, and muscle-invasive urothelial cancers, with data on first line melanoma to be disclosed at Innovation Day next week.

Q: R&D spending increase and ideal number of Phase 3 trials?

A: Jens Holstein said it's early for guidance, but currently comfortable with €2.4 billion-€2.6 billion R&D spend; Ryan Richardson said with current R&D level, already at significant scale in mid and late stage pipeline with 10 ongoing Phase 2/3 trials.