Gotistobart

iStock, U. J. Alexander Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year. BioNTech released its third-quarter earnings report on Monday, finally stemming its losses this year and reporting strong year-over-year growth driven by its variant-adapted COVID-19 vaccine. In Q3, the company generated $1.36 billion in sales, up from nearly $940 million during the same period in 2023—and far ahead of the consensus forecast, which expected that BioNTech would bring in nearly $652 million in Q3, according to analytics firm Zacks Equity Research. BioNTech reported net profit in the quarter of $216 million—the first time it’s done so this year, after sustaining more than $340 million and almost $885 million in losses in the first and second quarters, respectively. On a per-share basis, BioNTech’s profit was $0.88, while analysts forecasted a loss of $2.01 per share The biotech attributed the strong performance in Q3 to the “earlier” approval for its variant-adapted COVID-19 shot, compared with the later regulatory nod the company secured in 2023. The FDA greenlit BioNTech’s vaccine in August 2024, allowing its use for the Omicron KP.2 variant for the 2024–2025 season. Last year, the FDA’s approval came in September . Still, 2024 has been difficult for BioNTech overall, reflected in its nine-month revenue of $1.7 billion, down from $2.55 billion during the same period last year. And despite recording its first quarterly profit this year, the biotech has still suffered more than $1 billion in losses in 2024 so far. Reflecting its financial challenges, BioNTech on Monday lowered its total revenue guidance for the year. The company now expects it to be in the lower end of its previously announced forecast range of $2.73 billion to $3.38 billion. BioNTech’s adjusted guidance reflects expectations regarding the uptake of its updated COVID-19 vaccine, as well as potential inventory write-downs and other charges associated with its partnership with Pfizer. In an investor call on Monday, CEO Ugur Sahin struck an optimistic note and focused on the company’s prospects in the coming years, touting the biotech’s progress in oncology development—particularly regarding its lead cancer candidate BNT327, a bispecific antibody that binds to PD-L1 and VEGF-A, both validated targets in cancer. “BioNTech was established with the ambition to revolutionize cancer treatment through the development of mRNA-based immunotherapies, particularly personalized cancer vaccines” Sahin said during the call. With its oncology pipeline, the biotech is looking to leverage its COVID-19 success to advance a portfolio of next-generation cancer treatments, “aiming to tailor therapies to the individual genetic make-up of each patient tumor.” Last month, BioNTech dosed the first patient in the Phase II study testing BNT327, in combination with chemotherapy, for the first- and second-line treatment of patients with locally advanced or metastatic triple-negative breast cancer. Data from this study will help the biotech launch a Phase III program for the bispecific, set to begin in 2025. BioNTech is also developing BNT327 for non-small cell lung cancer and at the 2024 European Society for Medical Oncology Congress in September 2024, the biotech unveiled Phase II data showing a 57.8% confirmed objective response rate in patients carrying EGFR mutations. In addition to BNT327, BioNTech is working on the anti-CTLA-4 monoclonal antibody BNT316, dubbed as gotistobart, for the treatment of NSCLC and platinum-resistant ovarian cancer. The company is also advancing a portfolio of mRNA cancer vaccines, which are in mid-stage studies. “We are entering a catalyst-rich period for our company, in particular for our oncology portfolio,” Chief Strategy Officer Ryan Richardson said during Monday’s earnings call, noting that BioNTech currently has more than 10 Phase II and III trials ongoing across various cancer types. “In the next 18 months, we expect multiple clinical data updates from these trials and we’ll initiate several additional trials with registrational potential.”