BioNTech: BMS becomes a revenue mainstay — but the pipeline still has to deliver

BioNTech has slightly raised its revenue guidance for 2026. Instead of €1.6 billion to €1.9 billion, the company now expects €1.7 billion to €1.9 billion. However, the higher midpoint of the forecast does not signal an unexpected recovery in the vaccine business. Rather, development activities outside the COVID-19 business, including milestone and licensing payments, are increasingly contributing to revenue. BioNTech generated €1.289 billion in revenue in the third quarter and €1.513 billion in the first nine months. Net profit in the third quarter reached €184.5 million, compared with a loss in the same quarter last year. However, the company still recorded a net loss of €1.168 billion over the nine-month period.

Its financial position remains comfortable: At the end of the third quarter, BioNTech held €16.2 billion in cash and liquid securities. This gives the company considerable flexibility to continue financing the clinical development of its oncology pipeline. At the same time, the scale of its research and development expenses illustrates just how costly the transformation is: In the first nine months alone, these amounted to €1.856 billion under IFRS, or €1.583 billion on an adjusted basis.

Also notable: The presentation of the results to the press and investors also included a farewell to the company’s founding couple, Sahin and Türeci, although a concrete agreement on disentangling the various technology platforms and associated rights for transfer to the new startup founded by the two COVID-19 pioneers has yet to be reached. Management indicated that this would still take some time.

The farewell instead focused on the achievements of the two entrepreneurs who have shaped the company. The topics of site closures, layoffs and their financial consequences, including provisions and severance payments, would presumably have dampened the mood too much and were not even touched upon. According to a report in Handelsblatt, however, the works council has expressed considerable anger over the situation and poor communication in an open letter. There will undoubtedly be more to come.

BMS revenues take the lead: The composition of revenue is particularly revealing. In the third quarter, COVID-19 vaccines accounted for €554 million, while out-licensing generated €683 million. Of that amount, €613 million came from the collaboration with Bristol Myers Squibb (BMS) around the bispecific antibody pumitamig (BNT327/BMS-986545). Another €70 million came from a development milestone associated with a different out-licensed research program.

The BMS collaboration was therefore the largest single contributor to revenue in the third quarter, ahead of the COVID-19 vaccine business. The picture is somewhat different for the first nine months: Revenue from the BMS collaboration amounted to €613 million, compared with €673 million from vaccines. However, total out-licensing revenue of €683 million was already slightly higher than COVID-19 vaccine revenue over the nine-month period.

This represents an important shift in the business model. The €613 million does not represent recurring revenue from a marketed drug. It stems from the contractual structure of the BMS collaboration: A previously agreed option to terminate the contract had expired, making certain rights binding and allowing BioNTech to recognize the corresponding payment as revenue.

The collaboration includes an upfront payment of $1.5 billion and additional non-contingent payments totaling $2 billion through 2028. These were described in the original agreement as a kind of “birthday bonus,” payable on anniversaries of the contract signing. Potential development, regulatory and sales milestones of up to $7.6 billion could follow. Development costs and profits or losses are generally shared equally.

BMS has therefore become a central financing and development partner for BioNTech. The arrangement may sound familiar, and indeed, the model closely resembles the collaboration between Hamburg-based Evotec and BMS. In that case, however, the partnership focuses exclusively on preclinical drug candidates. The milestone payments are therefore likely to be lower than those involved in the Mainz company’s agreement.

The real commercial test, however, still lies ahead: Pumitamig must succeed clinically and eventually reach a market where both partners can recover their investments. The current revenue contribution should therefore not be equated with an established commercial drug business.

BioNTech’s biggest hope: Pumitamig is at the center of BioNTech’s oncology pipeline. The bispecific antibody blocks PD-L1 while simultaneously neutralizing VEGF-A. It therefore combines two mechanisms of action: Releasing an immunological brake and interfering with the formation of blood vessels that supply tumors.

The antibody originally came from Chinese biotech Biotheus, which BioNTech acquired for approximately $1 billion, plus subsequent milestone payments, following an initial collaboration. The approach is intended to alter the tumor microenvironment so that the immune system can attack cancer cells more effectively.

The development program has now become extensive. BioNTech reports seven registrational trials, five of which were initiated in 2026 alone. Pumitamig is being investigated in triple-negative breast cancer, colorectal and gastric cancer, and various forms of non-small cell lung cancer, among other indications. Additional studies are underway in small cell lung cancer, glioblastoma, pancreatic cancer, liver cancer and kidney cancer.

The next important step is the planned global Phase 3 ROSETTA-Breast-01 trial. It will investigate pumitamig in combination with Gilead’s antibody-drug conjugate (ADC) sacituzumab govitecan in previously untreated triple-negative breast cancer. The focus is on patients with low or no PD-L1 expression.

The combination is strategically interesting because it brings together two different approaches: Pumitamig is intended to influence the immune response and the tumor microenvironment, while sacituzumab govitecan, an ADC, delivers a cytotoxic substance directly to TROP2-expressing tumor cells.

For now, however, this remains a development program rather than a clinically established standard of care. Data presented to date from Phase 1/2 and Phase 2 studies have shown signs of activity, but these findings must be confirmed in larger controlled trials. The same applies to the results BioNTech presented at the ESMO Congress on pumitamig combinations in patients with brain metastases and difficult-to-treat tumors.

The competitive landscape is far from straightforward. One particularly relevant competitor is ivonescimab from Akeso and Summit Therapeutics, another bispecific antibody targeting PD-1 and VEGF-A. The candidate has already made clinical and regulatory progress in China and is being developed internationally in large trials.

But many other companies are also pursuing combinations of immune checkpoint inhibition and VEGF blockade. Pumitamig must therefore demonstrate not only that the concept works, but also that it offers a clinically meaningful advantage over existing and emerging treatments in the respective cancer types.

Gotistobart: Another advanced candidate is gotistobart (BNT316/ONC-392), a CTLA-4-targeting antibody being developed by BioNTech together with OncoC4. It is designed to selectively reduce regulatory T cells in the tumor microenvironment, thereby strengthening the immune response against the tumor.

The global Phase 3 PRESERVE-003 trial is investigating gotistobart as monotherapy in patients with metastatic squamous non-small cell lung cancer whose disease has progressed following platinum-based chemotherapy and PD-(L)1 treatment.

Data presented at the World Conference on Lung Cancer (WCLC) in September from the first, non-pivotal part of the trial showed a statistically significant improvement in overall survival compared with chemotherapy. According to the company, median overall survival was nearly doubled.

This is a clinically relevant signal in a difficult-to-treat patient population. However, the data come from the first part of the study. The decisive confirmation must come from the second part. Initial interim results are expected before the end of 2026 and will first be assessed by an independent data monitoring committee. Only then will it be possible to better evaluate whether gotistobart truly has the potential to gain regulatory approval.

Trastuzumab pamirtecan: Trastuzumab pamirtecan (BNT323/DB-1303) illustrates how reaching an advanced stage of clinical development does not automatically lead to a regulatory filing. The HER2-targeting ADC is being developed jointly with DualityBio and is undergoing Phase 3 testing in HER2-expressing uterine cancer and hormone receptor-positive, HER2-low metastatic breast cancer.

The breast cancer trial DYNASTY-Breast02 met its primary endpoint: Progression-free survival improved statistically significantly compared with chemotherapy selected by the investigator. However, BioNTech describes the effect as moderate. There is also a safety concern: More cases of interstitial lung disease were observed than in previous studies, including serious and fatal events.

BioNTech and DualityBio are therefore reviewing the totality of the breast and uterine cancer data before deciding on the next steps. The regulatory submission that had originally been expected can no longer be considered certain. The company is currently coordinating its future plans.

This matters in the competitive landscape: AstraZeneca and Daiichi Sankyo already have an established ADC in the HER2 and HER2-low space with trastuzumab deruxtecan (Enhertu), setting a high bar for new treatments. A statistically positive trial result alone is therefore not sufficient if the additional clinical benefit is limited and the safety profile is problematic.

The mRNA pipeline: The development of BioNTech’s mRNA cancer programs is likely to attract particularly close attention. The company emphasizes that mRNA immunotherapies remain a central pillar of its oncology strategy. However, the latest data show that the technology has yet to achieve the hoped-for clinical breakthrough in cancer treatment.

For BNT113, an mRNA immunotherapy targeting HPV16-positive head and neck tumors, the Phase 2/3 AHEAD-MERIT trial missed the first of its two primary endpoints in October. The combination with pembrolizumab failed to improve progression-free survival statistically significantly compared with pembrolizumab alone.

The trial will continue to evaluate overall survival. Under the prespecified study design, a significant overall survival benefit could still constitute a positive trial outcome despite the missed progression-free survival endpoint. That remains possible, but has not yet been demonstrated.

There is also a setback for autogene cevumeran (BNT122), an individualized neoantigen mRNA vaccine. The randomized Phase 2 trial in colorectal cancer following surgery and chemotherapy is being terminated early.

A separate Phase 2 trial in pancreatic cancer, however, is continuing, with patient recruitment completed in August. This shows that BioNTech is not abandoning its mRNA platform but is increasingly prioritizing development according to indication and clinical evidence.

A change in the collaboration with Roche/Genentech fits this strategy. BioNTech has exercised an option under which Roche will assume future research and development costs for the relevant program starting in January 2027. BioNTech will retain the right to receive royalties if the program succeeds. The ongoing pancreatic cancer trial is not expected to be affected. For BioNTech, this offers a way to reduce its financial burden while maintaining a stake in potential future success.

mRNA technology therefore remains part of the long-term strategy, but it is no longer the sole focus. Late-stage clinical development is now visibly centered on immunomodulators and ADCs.

The big picture: In its third-quarter report, BioNTech highlighted 15 clinical and operational milestones achieved during the first nine months and continued to expand its pipeline. At the same time, the individual programs illustrate how differently positioned the candidates actually are.

With seven registrational trials, pumitamig represents the broadest and most strategically important approach. Gotistobart has produced encouraging survival data but still needs to confirm them. Trastuzumab pamirtecan has met a Phase 3 endpoint, yet questions remain about its clinical added value and safety. Among the mRNA candidates, a missed progression-free survival endpoint and an early trial termination stand alongside a continuing pancreatic cancer program.

BioNTech’s €16.2 billion in liquid assets gives the company time to continue developing these programs. But financial resources cannot replace clinical proof of efficacy or the subsequent challenge of successfully commercializing medicines.

By 2030, the company aims to have brought several approved products to market. The latest report shows that the financial foundations are in place. Whether the pipeline can deliver on this ambition remains uncertain, particularly as competitors are not standing still and the growing diversity of combination approaches is making meaningful comparisons increasingly difficult.

The vast majority of these studies are being conducted in China, including those involving BioNTech. China, however, is known for granting provisional approvals relatively quickly following promising response rates in early-stage trials. This allows treatments to enter a broader market at an early line of therapy, where their actual difference from standard treatment can already be tested. Boehringer Ingelheim and, more recently, Bayer have taken this route through provisional approvals based on early-stage clinical data.

The decisive test for BioNTech is therefore not how many Phase 3 trials it has launched, but how many ultimately demonstrate a clear clinical benefit and secure regulatory approval. And whether faster approvals based on high response rates or even survival data from earlier-stage trials could end up turning the order of priorities in BioNTech’s pipeline upside down.