BioNTech SE (BNTX) Earnings

Management highlights

### Leadership Transition - Guido Oelkers will take over as CEO no later than February 1, 2027, selected for his proven track record scaling global innovation-driven biopharma businesses, with deep expertise launching commercial products focused on the U.S. market and experience across Europe and APAC. - Outgoing CEO Ugur Sahin will remain actively engaged to support a seamless onboarding transition. The leadership change reflects BioNTech's natural evolution from a pioneering research organization to a multi-product global biopharma. ### Oncology Pipeline Progress - Prometamic (investigational PD-L1/VEGF-A bispecific immunomodulator, partnered with BMS): Presented encouraging global Phase 2 data in first-line untreated advanced non-small cell lung cancer (NSCLC) combined with chemotherapy, with a 62.5% confirmed overall response rate across PD-L1 expression levels: 47.6% for PD-L1 TPS <1%, 77.8% for TPS 1-49%, and 100% for TPS ≥50%, with a manageable safety profile and no new signals. Data showed consistent efficacy between China and global populations across three high-unmet-need tumor types, supporting ongoing global Phase 3 development. Four registrational lung cancer programs are currently active. - Gotistobard (selective Treg depleting anti-CTLA-4 antibody, partnered with Oncocifor): Updated Phase 1 data in second-line metastatic squamous NSCLC post-chemotherapy and PD-(L)1 inhibitor showed a 54% reduced risk of death versus docetaxel (hazard ratio 0.46), with 63% 12-month overall survival versus 30% for docetaxel. The pivotal Phase 3 first interim analysis is expected in late 2026. - L3-TAPR dosantucan (LVD/BNT324, B7H3-targeted ADC, partnered with Duality Bio): Dosed the first patient in the Phase 3 trial for metastatic castration-resistant prostate cancer (mCRPC), the first Phase 3 indication for this asset. More than 1,000 patients have been treated across 10+ tumor types, with a favorable safety profile and demonstrated anti-tumor activity. - mRNA cancer immunotherapies: Autogen Sevomeran (individualized neoantigen therapy, partnered with Genentech) completed enrollment in the adjuvant colorectal cancer Phase 2 trial; the independent DSMB recommended continuing the trial without modification after an interim analysis, with final data expected in 2027. BNT113 (off-the-shelf HPV16-targeted FixVac immunotherapy) is in Phase 3 testing for first-line head and neck squamous cell cancer, with a PFS interim analysis expected in 2026. ### 2026 Planned Late-Stage Readouts - Three readouts are still expected in 2026: Gotistobard pivotal interim analysis in squamous NSCLC, BNT113 Phase 3 PFS interim analysis in head-neck cancer, and TPAM primary analysis in HER2-low hormone receptor-positive metastatic breast cancer. Two readouts were pushed to 2027: Prometamic Phase 3 in triple-negative breast cancer (China) and Gotistobard Phase 2 in second-line mCRPC.

Guidance

- Full year 2026 revenue guidance is revised downward to 1.6 to 1.9 billion euros, from prior guidance. Approximately 80% of the downward adjustment is driven by softer-than-expected global COVID-19 vaccine demand: the EMA allowed use of 2025 vaccine formula for the 2026 season, and Germany will use existing manufactured inventory instead of new doses, leading to significantly reduced 2026 sales in Germany. The remaining 20% of the adjustment reflects a push-out of expected MISON outlicensed milestone revenue, which will no longer be recognized in 2026. The majority of 2026 full-year revenue is still expected to be realized in the second half of 2026, including a planned 613 million euro recognition of VMS collaboration payments in Q3. - Adjusted R&D expense guidance is revised to 2 to 2.3 billion euros, reflecting ongoing cost optimization and prioritization of the late-stage pipeline, with expected continued cost savings from portfolio optimization in future years. - Adjusted SG&A expense guidance is maintained at 700 to 800 million euros, as the company continues gradual build-out of commercial capabilities for upcoming oncology product launches. - Capital allocation priorities remain unchanged: prioritize fully funding the core late-stage pipeline and commercial preparations, retain flexibility for attractive external corporate development and partnership opportunities, and return capital to shareholders via the authorized up to 1 billion euro share repurchase program. As of Q2 2026, 152 million euros in shares have been repurchased under this program.

Segment performance

All figures are in euros. Q2 2026 total revenue was 106 million, down from 261 million in Q2 2025. The decline is driven by lower U.S. demand for the BioNTech COVID-19 vaccine, plus a one-time 2025 compensation payment from Pfizer for opting out of the shingles vaccine development program that did not recur. For the first half of 2026, total revenue was 224 million, also down year-over-year due to the same COVID-19 demand factors. Adjusted R&D expenses for Q2 2026 were 477 million, down from 509 million in Q2 2025, reflecting portfolio prioritization and cost-sharing from collaboration partners. Adjusted SG&A (Selling, General & Administrative) expenses for Q2 2026 were 198 million, up from 137 million in Q2 2025, driven by ERP infrastructure scaling, pre-launch preparation for late-stage oncology programs, and the addition of Q-Rack operations post-merger. For the first half of 2026, adjusted R&D expenses were 1,004 million (down year-over-year) and adjusted SG&A expenses were 349 million (up year-over-year), consistent with Q2 trends. As of Q2 2026 end, BioNTech held 16.6 billion in cash, cash equivalents and security investments, up from 16 billion at June 30 2025.

Risks & headwinds

- All forward-looking statements and pipeline development are subject to significant inherent risks and uncertainties, including the risk that positive early and mid-stage clinical data will not be replicated in late-stage pivotal trials. - COVID-19 vaccine demand continues to be unpredictable, with softer-than-expected demand negatively impacting 2026 revenue results. - Clinical trial readouts are event-driven, and unexpected delays in event accrual can push milestone timelines out beyond original projections, as seen with the two 2027 readout pushes disclosed in this call. - Cross-trial cross-regional efficacy comparisons cannot be confirmed as definitive until Phase 3 trials are completed, even with encouraging early consistency observed between Chinese and global data for Prometamic. - Market competition in the bispecific immunomodulator and ADC spaces means that even positive clinical data may not result in a commercially differentiated product.

Analyst Q&A

• Q: Why did BioNTech select metastatic CRPC as the first Phase 3 indication for LVD (B7H3 ADC), and what gives the company confidence in its competitive profile? /

  A: Management highlighted that LVD has shown both durable disease control and an excellent, tolerable safety profile. Unlike competing B7H3 ADCs that commonly face issues with hematosuppression, stomatitis, or interstitial lung disease (ILD), LVD has not had significant ILD events even in patients dosed for over a year. This favorable profile enables long-term use, which supports moving forward with the mCRPC Phase 3. (238 characters)

• Q: What changed to the 2026 milestone timeline, and is the Prometamic China Phase 3 triple-negative breast cancer readout still expected this year? /

  A: The Prometamic TNBC China study readout was pushed to 2027 due to slower-than-projected event accrual. Three key readouts remain on track for 2026: Gotistobard pivotal interim analysis in second-line squamous NSCLC, BNT113 Phase 3 PFS interim analysis in head and neck cancer, and TPAM primary analysis in HER2-low metastatic breast cancer. (241 characters)

• Q: What are the North Star priorities for BioNTech's current portfolio optimization and cost cutting initiatives? /

  A: Capital allocation priorities remain unchanged: fully fund the core prioritized late-stage pipeline and build required commercial capabilities, retain flexibility for attractive external opportunities to strengthen the portfolio, and return capital to shareholders via the authorized share buyback program. Pipeline reviews continuously reallocate resources to the highest strategic and value creation potential programs, deprioritizing non-core assets. This year is focused on testing combinations of Prometamic with the ADC portfolio to identify the most promising combinations to advance to Phase 3 in 2027. (367 characters)

• Q: What portion of the full year 2026 revenue guidance downward adjustment comes from COVID-19 demand versus the pushed-out milestone? /

  A: Approximately 80% of the guidance adjustment is entirely COVID-19 related, driven by lower expected demand, the EMA decision to allow last year's vaccine formula, and Germany's use of existing inventory. The remaining 20% comes from the outlicensed MISON milestone that is no longer expected to be recognized in 2026. Management confirmed the 613 million euro VMS collaboration revenue will still be recognized in the second half of 2026. (274 characters)