GERMANY – BioNTech has reported a substantial rebound in the third quarter of 2024, driven by the accelerated approval of its updated COVID-19 vaccine.
The German biotech firm recorded US $1.36 billion in revenue, a significant leap from the US $940 million generated in Q3 2023 and surpassing analysts’ expectations of US $652 million, as per Zacks Equity Research.
This performance marked the company’s first quarterly profit in 2024, amounting to US $216 million, equating to earnings of US $0.88 per share. This was a stark contrast to analysts’ forecasted loss of US $2.01 per share.
The company’s CEO, Ugur Sahin, attributed the strong quarterly performance to the early regulatory nod for its updated vaccine aimed at the Omicron KP.2 variant for the 2024–2025 season.
“This earlier approval positioned us ahead of last year’s timeline and contributed significantly to the positive outcomes we witnessed this quarter,” Sahin noted during an investor call.
Challenges and revised guidance
Despite a positive Q3, BioNTech’s overall performance in 2024 has been challenging. For the first nine months, the company posted US $1.7 billion in revenue, down from US $2.55 billion in the same period in 2023.
Losses in the first and second quarters amounted to over US $1 billion, underlining the difficult landscape BioNTech has navigated this year.
Reflecting these hurdles, the company revised its revenue forecast for the full year, placing expectations at the lower end of the previously projected range of US $2.73 billion to US $3.38 billion.
This adjustment accounts for factors like the uptake of the updated COVID-19 vaccine and potential inventory write-downs related to its partnership with Pfizer.
Promising oncology pipeline
In the face of fluctuating COVID-19 revenues, BioNTech has reinforced its commitment to expanding its oncology portfolio.
“BioNTech was established with the ambition to revolutionize cancer treatment through the development of mRNA-based immunotherapies, particularly personalized cancer vaccines,” Sahin said.
The biotech is looking to leverage its expertise gained during the pandemic to push forward novel cancer therapies.
Central to this strategy is BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, critical proteins implicated in cancer progression.
BioNTech dosed its first patient in a Phase II trial for BNT327, paired with chemotherapy, for the treatment of advanced triple-negative breast cancer in October 2024.
The company plans to use data from this trial to launch a Phase III study by 2025.
Additionally, promising results were presented at the 2024 European Society for Medical Oncology (ESMO) Congress, showing a 57.8% objective response rate in patients with EGFR-mutant non-small cell lung cancer (NSCLC).
Pipeline beyond BNT327
BioNTech’s broader oncology pipeline includes BNT316 (gotistobart), an anti-CTLA-4 monoclonal antibody under development for NSCLC and platinum-resistant ovarian cancer.
Additionally, the company is advancing its lineup of mRNA-based cancer vaccines, many of which have entered mid-stage clinical trials.
Ryan Richardson, BioNTech’s Chief Strategy Officer, highlighted the upcoming growth phase: “We are entering a catalyst-rich period for our company, particularly in oncology.
With over 10 Phase II and III trials currently underway, we expect significant clinical updates in the next 18 months and plan to initiate further trials with registrational potential.”
