Company Reports

BioNTech, founded in 2008 in Germany, has become a key player in the development of personalized mRNA cancer treatments. The emerging biotech's first commercial vaccine, for covid, received its first authorization in December 2020, and its early-stage pipeline and mRNA technology platforms have caught the eye of several large pharmaceutical companies, resulting in collaborations and partnerships. BioNTech has also used cash from its covid vaccine profits to acquire rights to a more diversified pipeline of biologic drug candidates in oncology, with launches potentially starting in 2027-28.

BioNTech reported second-quarter revenue of EUR 106 million, or a 59% year-on-year decline. Management lowered its guidance for full-year revenue to EUR 1.6 billion-EUR 1.9 billion, or 19% lower than previous guidance at the midpoint, citing lower covid vaccine demand and delayed milestone payments.

BioNTech, founded in 2008 in Germany, has become a key player in the development of personalized mRNA cancer treatments. The emerging biotech's first commercial vaccine, for covid, received its first authorization in December 2020, and its early-stage pipeline and mRNA technology platforms have caught the eye of several large pharmaceutical companies, resulting in collaborations and partnerships. BioNTech has also used cash from its covid vaccine profits to acquire rights to a more diversified pipeline of biologic drug candidates in oncology, with launches potentially starting in 2027-28.

BioNTech reported revenue of EUR 118 million, or a 35% year-on-year decline. Management reaffirmed its previous guidance and announced a stock buyback program of up to $1 billion over the next 12 months. Shares fell 4% from the previous day's close.

BioNTech reported full-year revenue of EUR 2.87 billion, or 4% growth. Revenue guidance for 2026 is EUR 2.0-EUR 2.3 billion, or a 20%-30% decline. The founders also announced they will step down by year-end to focus on a new mRNA-based company and will search for a successor in the meantime.

BioNTech, founded in 2008 in Germany, has become a key player in the development of personalized mRNA cancer treatments. The emerging biotech's first commercial vaccine, for covid, received its first authorization in December 2020, and its early-stage pipeline and mRNA technology platforms have caught the eye of several large pharmaceutical companies, resulting in collaborations and partnerships. BioNTech has also used cash from its covid vaccine profits to acquire rights to a more diversified pipeline of biologic drug candidates in oncology, with launches potentially starting in 2027-28.

BioNTech reported third-quarter revenue of EUR 1.5 billion, up 22% year on year, and a diluted loss per share of EUR 0.12. Management raised its full-year revenue guidance to EUR 2.6 billion-EUR 2.8 billion, a 38% increase at the midpoint.

At a Sept. 19 meeting, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend healthcare provider consultation prior to covid vaccination for individuals six months and older but voted against requiring a prescription.

The US Food and Drug Administration's Vinay Prasad issued a memo on Aug. 25 detailing the agency's evolving thoughts on the coadministration of vaccines and approval requirements. A meeting of the Advisory Committee on Immunization Practices is scheduled for Sept. 18-19.

BioNTech, founded in 2008 in Germany, has become a key player in the development of personalized mRNA cancer treatments. The emerging biotech's first commercial vaccine, for covid, received its first authorization in December 2020, and its early-stage pipeline and mRNA technology platforms have caught the eye of several large pharmaceutical companies, resulting in collaborations and partnerships. BioNTech has also used cash from its covid vaccine profits to acquire rights to a more diversified pipeline of biologic drug candidates in oncology, with launches potentially starting in 2026.

In the second quarter, the firm began dosing patients in three signal-seeking clinical trials to evaluate BNT327, its VEGF x PD-L1 bispecific, in combination with antibody-drug conjugates as treatments for various cancers. BioNTech reiterated full-year guidance of EUR 1.7 billion-EUR 2.2 billion.

Bristol-Myers Squibb and BioNTech have entered a collaboration to co-develop and commercialize BioNTech's BNT327, a clinical-stage PD-L1/VEGF-A bispecific antibody for treating cancer.

BioNTech reiterated its full-year guidance of EUR 1.7 billion-EUR 2.2 billion, which will mostly consist of covid vaccine revenue at the end of the year. It confirmed it is on track to file its application for BNT323 in endometrial cancer by the end of 2025.

BioNTech’s fourth-quarter results were in line with our expectations, but guidance for 2025 was below our expectations due to lower Comirnaty revenue. Additionally, the company narrowed its focus to adjuvant settings for its iNeST program (individualized cancer vaccines), after its Phase 2 trial in metastatic melanoma failed to demonstrate statistically significant improvement in overall survival. Although not entirely surprising, we remove sales of cancer vaccines for metastatic settings from our model. As a result of these adjustments, we lower our fair value to $126 per ADR from $143.

BioNTech, founded in 2008 in Germany, has become a key player in the development of personalized mRNA cancer treatments. The emerging biotech's first commercial vaccine, for covid, received its first authorization in December 2020, and its early-stage pipeline and mRNA technology platforms have caught the eye of several large pharmaceutical companies, resulting in collaborations and partnerships. BioNTech has also used cash from its covid vaccine profits to acquire rights to a more diversified pipeline of biologic drug candidates in oncology, with launches potentially starting in 2026.

Following President-elect Donald Trump’s Nov. 14 announcement of the nomination of Robert F. Kennedy Jr. as secretary of the US Department of Health and Human Services, there have seen several more nominations for leadership in the 13 HHS divisions, including Dr. Mehmet Oz (Centers for Medicare and Medicaid Services) on Nov. 19, Dr. Marty Makary (US Food and Drug Administration) and Dr. Dave Weldon (Centers for Disease Control and Prevention) on Nov. 22, and Dr. Jay Bhattacharya (National Institutes of Health) on Nov. 26. Overall, we think these selections show a consistent theme of introducing potential disruptive forces to US healthcare, although their lack of experience and the power of career staffers in these agencies could serve to blunt any significant proposed changes. We continue to see obesity drugs and vaccines as areas of potential scrutiny, although without any clarity on proposals, we’re not making any changes to our fair value estimates following these announcements.

President-elect Donald Trump announced on Nov. 14 that he is nominating Robert F. Kennedy Jr. to be secretary of the Department of Health and Human Services under his new administration in 2025. RFK Jr. has strong views on public health and, if confirmed, could use his position to make changes at several of the 13 HHS divisions. In our Nov. 8 note, we discussed the potential tailwinds of a Trump administration, including possible repeal of the Medicare negotiation provision in the Inflation Reduction Act, less Federal Trade Commission scrutiny of acquisitions, and a likely continuation of lower corporate taxes. However, if RFK’s nomination is confirmed, we expect more “wild card” headwinds to the industry will come to fruition. As the HHS covers the US Food and Drug Administration and the Centers for Disease Control and Prevention, an HHS secretary skeptical of vaccine and obesity drug benefits could work to erode public trust, put up roadblocks for approval of new vaccines, and prevent the CDC from recommending any vaccines that make it through the approval process. With less federal guidance, we think it is possible certain states could waver in support of broad mandates for childhood vaccines. All of these could weigh on sales of vaccines in the US, including covid vaccine makers Moderna and BioNTech and big biopharma vaccine makers like GSK (we model 14% of GSK revenue from US vaccine sales in 2024), Pfizer (12%), Merck (9%), and Sanofi (6%).

No-moat BioNTech reported EUR 1.2 billion in revenue in the third quarter, which is a 39% increase compared with the same period last year. The additional revenue is due to the earlier timing of approvals for BioNTech’s variant-adapted covid vaccines compared with last year. However, the company still expects full-year revenue to fall at the low end of its guidance range of EUR 2.5 billion to EUR 3.1 billion. We think the company’s outlook is dependent on the success of its oncology pipeline, including novel antibodies such as BNT327 (PD-L1 and VEGF bispecific), its iNeST platform (individualized cancer vaccines), and its FixVac platform (off-the-shelf cancer vaccines). We maintain our fair value estimate of $143 per ADR and await more detailed pipeline updates at its next investor event on Nov. 14.

BioNTech, founded in 2008 in Germany, has become a key player in the development of personalized mRNA cancer treatments. The emerging biotech's first commercial vaccine, for covid, received its first authorization in December 2020, and its early-stage pipeline and mRNA technology platforms have caught the eye of several large pharmaceutical companies, resulting in collaborations and partnerships. BioNTech has also used cash from its covid vaccine profits to acquire rights to a more diversified pipeline of biologic drug candidates in oncology, with launches potentially starting in 2026.

We’re maintaining our $143 per ADR fair value estimate for BioNTech following second-quarter results that put the firm on track to meet our full-year expectations. BioNTech reported EUR 129 million in revenue in the second quarter at the low point of seasonal demand for covid vaccines, and we still anticipate that the firm will see EUR 2.5 billion in revenue tied to covid vaccine sales and pandemic preparedness for the full year, which is at the low end of management’s reiterated guidance.