Aug 4, 2026 earnings call — Late-stage oncology progress and guidance revision
BioNTech revised full-year 2026 revenue guidance to EUR 1.6 billion to EUR 1.9 billion.
Revenue $0.1B (est $0.2B) · EPS $-3.70 (est $-2.40)
Key quotes
"We are targeting more than 17 late-stage and pivotal trial readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment."
"This decline mainly reflects lower demand for our COVID-19 vaccine in the U.S."
"As shown on the slide, with respect to the second pillar, we started the execution on our up to $1 billion share repurchase program and repurchased an amount of $152 million so far."
Analyst Q&A 11
Why choose metastatic CRPC first
Q (Cory Kasimov): Analyst asked why Elfe-D (B7-H3 ADC) was picked to go to Phase III in metastatic CRPC and what makes the ADC competitive.
A: Management said the key was seeing durable disease control plus an excellent safety profile so long-term dosing is possible. They noted many ADCs have hematosuppression, stomatitis or ILDs, but their B7-H3 shows tolerability and patients dosed for more than a year without significant ILD so far.
"So what is very encouraging for our B7-H3 is the combination of durable disease control plus the so far excellent safety profile that we are seeing for this B7-H3." — Ugur Sahin (CEO)
Timing of upcoming data readouts
Q (Tazeen Ahmad): Analyst asked which data updates to expect for the rest of the year, how guidance changed, whether China Pumitamig Phase III TNBC data is still due this year, and whether results will be via press release or at meetings.
A: Management said readouts are event driven and events in the China TNBC study are taking longer, so that readout is pushed to 2027. They also said the Pumita Phase II in first-line CRCC in China will report later because more chemo combinations were added, and listed major near-term milestones: Gotistobart Part 2 interim (NSCLC squamous second-line with docetaxel), the BNT113 Phase III interim for PFS later this year, and a trastuzumab study in HER2-low HR+ metastatic breast cancer.
"So with regard to changed milestones and specifically also the China interim analysis test, even for first-line TNBC, we are continuously monitoring events and the data readouts are event driven." — Özlem Türeci (FOUNDER)
How Pumitamig may differ from rivals
Q (Xiaochuan Dai): Analyst asked what preclinical, efficacy, safety or biomarker features make Pumitamig differentiated versus other VEGF–PD-1 bispecifics.
A: Management said bispecifics share improved binding to PD-1 or PD-L1, and their molecule uniquely binds PD-L1 in the tumor microenvironment, which may give a double tumor-directed effect. They cautioned that whether this yields differentiated efficacy must be shown, and true differentiation will come from combining Pumitamig with their ADCs and other compounds.
"We have one feature, which we believe is differentiating with our molecule binding to PD-L1 in the tumor microenvironment." — Ugur Sahin (CEO)
Benchmarks for T-Pam in HER2-low breast cancer
Q (Daina Graybosch): Analyst asked what specific outcome or threshold T-Pam must exceed in HER2-low breast cancer and how different outcomes could affect regulatory or launch plans.
A: Management said T-Pam is being developed broadly, including endometrial cancer and a Phase III in HR+ HER2-low breast cancer, and they are running signal-seeking studies combining T-Pam with Pumita. For the breast cancer trial they referenced published benchmarks: median PFS around 9 to 13 months and 18-month median OS of about 85% from other studies and approved treatments.
"With regard to our breast cancer study, the benchmarks are, if you compare with published benchmarks, median PFS in the range of 9 to 13 months and 18-month median OS of around 85% according to other studies in this indication and approved treatments." — Özlem Türeci (FOUNDER)
Capital allocation and pipeline focus
Q (Geoffrey Meacham): Analyst asked how the company is prioritizing capital and whether pipeline cuts are from overlapping indications or competition.
A: Management said their capital priorities remain unchanged: they will fully fund priority Phase III programs and build commercial capabilities, keep flexibility for external opportunities, and continue the authorized share buyback. They also said they continuously review the pipeline to focus resources on highest value programs and may reduce or stop noncore assets; this year they will use combination trials to identify winners and expect to pick Phase III candidates in 2027, including partner assets.
"We continue to fully fund our priority pipeline and the commercial capabilities needed to support these upcoming launches." — Ramón Zapata-Gomez (CFO)
Confidence in three interim readouts
Q (Akash Tewari): Analyst asked how confident the team is about positive interim analyses for HER2, CTLA-4, and the head-and-neck vaccine, and if one program is viewed more favorably.
A: Management said they are positive and have positive expectations for each trial but must wait for data. They highlighted that if Gotistobart data seen in the first part of Phase III are recapitulated, it would be a game-changing result versus the long-standing docetaxel standard in that indication.
"You know that if the data for Gotistobart that we have seen in the first part of the Phase III clinical trial is recapitulated, this would become a game-changing result in this indication." — Ugur Sahin (CEO)
Read-through from melanoma to CRC iNeST
Q (Terence Flynn): Analyst asked what read-through they would look for from Moderna-Merck adjuvant melanoma Phase III results to their iNeST colorectal cancer program.
A: Management said there is no read-through between melanoma and colorectal cancer due to very different biology and responsiveness to immunotherapy and antigen-specific T cells. They said they remain committed to adjuvant settings and cancers where checkpoint inhibitors have lower success, and that neoantigen vaccines differ by platform so cross-platform inference is difficult.
"So in terms of biology and indication, there we don't see any read-through opportunities." — Özlem Türeci (FOUNDER)
Why guidance cut by EUR 400 million
Q (Jessica Fye): Analyst asked how much of the EUR 400 million midpoint guidance reduction came from milestone pushouts, Germany using existing inventory, or softer COVID demand, and what partner milestone was pushed out.
A: Management said most of the guidance adjustment reflects weaker COVID-19 vaccination rates and the regulatory/public health environment, and that COVID revenue is back-end weighted into late Q3 and Q4. They noted an expected roughly EUR 613 million from the BMS collaboration for H2, said a license milestone expected in H2 was not the key driver, and quantified that about 80% of the change is COVID-related with the remainder from lost out-license milestones and market-specific effects like Germany being a direct market.
"I would say, if you would think about percentage, 80% is COVID-related completely and then the rest is the loss of the out-license milestones that we were expecting." — Ramón Zapata-Gomez (CFO)
ROSETTA Lung-02 endpoint change and timing
Q (Yaron Werber): Analyst asked if changing ROSETTA Lung-02 endpoint to PFS (not OS) could bring data sooner and when enrollment might finish; also whether the interim analysis changed.
A: Management said they cannot speculate on timing; PFS will read out earlier than OS but there is no guidance for final readout since it's event driven. They added that with the endpoint change the interim analysis for PFS could be an opportunity to file if positive, but they still can't say when due to event-driven timing and the large population being evaluated.
"The changed endpoint and the interim analysis for PFS, they become now an opportunity to file if it's positive." — Ugur Sahin (CEO)
Pumitamig in MSS colorectal cancer (CRC)
Q: Analyst asked how Pumitamig might be differentiated in MSS-CRC given limited checkpoint efficacy and immune-cold tumors, and what gives confidence its mechanism can overcome those challenges.
A: Management said they have no CRC data yet, and that the strongest evidence for differentiation in the bispecific class is objective response rates and durable disease control in PD-L1 negative populations. They pointed to TNBC data showing similar objective response rates across PD-L1 strata, said an interim CRC analysis will come in 2027 to test chemo combinations, and framed the broader opportunity as improving responses and durable control, opening indications where PD-1s are not approved, and combining Pumitamig with next-generation ADCs to control advanced disease with good safety.
"For example, in TNBC, we have documented data showing more or less the same rates of objective response in the patients, in PD-L1 positive, PD-L1 low positive and PD-L1 high positive patient population." — Ugur Sahin (CEO)
Read-through between squamous and non-squamous lung
Q (Mohit Bansal): Analyst asked how much success in squamous lung trials would read through to non-squamous, and what competitor data they'd watch to inform their own trials.
A: Management said histologies are different diseases and they would be cautious reading squamous results into non-squamous; they therefore separate both histologies in ROSETTA Lung-02 subtrials. They also noted data from their own programs and a competitor indicate PFS improvement in both histologies and they are cautiously optimistic this could translate into OS benefits.
"With regard to the read-through, in principle, these histologies are different diseases, right? So we would be very cautious to read from data in squamous to non-squamous or vice versa." — Özlem Türeci (FOUNDER)