BioNTech Exceeds Q3 Expectations, Lowers Full-Year Revenue Forecast

Driven by the early approval of its updated COVID-19 vaccine, BioNTech significantly outperformed analysts' expectations in the third quarter of 2024, marking its first quarterly profit of the year. However, the German biotech company also revised its annual outlook downward.

BioNTech released its third-quarter earnings report on Monday, reversing its losses earlier in the year and showing strong growth fueled by its variant-adapted COVID-19 vaccine. During the third quarter, the company earned $1.36 billion in sales, a notable increase from nearly $940 million in the same period in 2023. This figure far surpassed the consensus forecast, which estimated BioNTech's Q3 revenue to be almost $652 million, according to Zacks Equity Research.

In the third quarter, BioNTech reported a net profit of $216 million, the first profit it has recorded in 2024. This comes after incurring losses of over $340 million and nearly $885 million in the first and second quarters, respectively. On a per-share basis, BioNTech's profit was $0.88, while analysts had anticipated a loss of $2.01 per share.

The company's solid Q3 performance was attributed to the "earlier" approval of its variant-adapted COVID-19 vaccine. The FDA approved BioNTech's vaccine in August 2024 for use against the Omicron KP.2 variant for the 2024-2025 season. The previous year, FDA approval came in September.

Despite this quarterly success, 2024 has been challenging for BioNTech overall. The company's nine-month revenue stood at $1.7 billion, down from $2.55 billion during the same period the previous year. Although BioNTech posted its first quarterly profit this year, it has still faced losses exceeding $1 billion in 2024 to date.

Reflecting its financial struggles, BioNTech lowered its total revenue guidance for the year on Monday. The company now anticipates revenue to be at the lower end of its previous forecast range of $2.73 billion to $3.38 billion. This adjusted guidance considers the expected uptake of its updated COVID-19 vaccine, as well as potential inventory write-downs and other charges associated with its partnership with Pfizer.

During an investor call on Monday, CEO Ugur Sahin expressed optimism about the company's future prospects, highlighting BioNTech's progress in oncology development, particularly concerning its lead cancer candidate BNT327. BNT327 is a bispecific antibody targeting PD-L1 and VEGF-A, both validated cancer targets.

"BioNTech was founded with the goal of revolutionizing cancer treatment through the development of mRNA-based immunotherapies, especially personalized cancer vaccines," Sahin said during the call. The company aims to leverage its success with COVID-19 vaccines to advance a portfolio of next-generation cancer treatments, tailoring therapies to the individual genetic make-up of each patient's tumor.

Last month, BioNTech administered the first dose in a Phase II study testing BNT327 in combination with chemotherapy for treating locally advanced or metastatic triple-negative breast cancer. Data from this study will support launching a Phase III program for BNT327, scheduled to begin in 2025.

BioNTech is also developing BNT327 for non-small cell lung cancer. At the 2024 European Society for Medical Oncology Congress in September, the company presented Phase II data showing a 57.8% confirmed objective response rate in patients with EGFR mutations.

In addition to BNT327, BioNTech is working on BNT316, an anti-CTLA-4 monoclonal antibody, also known as gotistobart, for treating non-small cell lung cancer and platinum-resistant ovarian cancer. The company is also progressing with a portfolio of mRNA cancer vaccines currently in mid-stage studies.

"We are entering a catalyst-rich period for our company, particularly for our oncology portfolio," Chief Strategy Officer Ryan Richardson noted during the earnings call. BioNTech has more than 10 ongoing Phase II and III trials across various cancer types. "In the next 18 months, we expect multiple clinical data updates from these trials and will initiate several additional trials with registrational potential," Richardson added.