The emerging biotech’s first commercial vaccine, for COVID-19, 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’s internal discovery platform is focused on mRNA, including off-the-shelf and personalized mRNA drugs, but opportunistic acquisitions have brought in targeted antibodies and cell therapies as well. As such, BioNTech is not overly reliant on any one key drug candidate or drug class at this point, and it is poised to tackle cancer via many different mechanisms.
Further, the company has a burgeoning vaccine pipeline for infectious diseases. In partnership with the Bill & Melinda Gates Foundation, BioNTech is developing vaccines for HIV and tuberculosis, and the company’s COVID-19 program in partnership with Pfizer and Fosun Pharma was built off an existing partnership with Pfizer for an influenza vaccine. The COVID-19 vaccine, Comirnaty (BNT162b2), quickly progressed through human trials, culminating in authorization in the United States and Europe in December 2020.
Financial Strength
BioNTech has historically burned through cash to fund research and development of its pipeline. The company has minimal debt on its balance sheet, as it has funded discovery and development with equity issues and collaboration payments from partnerships with large pharmaceutical firms. Outside of BioNTech’s COVID-19 vaccine candidates, we think the earliest approval could arrive in 2023, which would put the company on a path toward steady profitability. Management has taken advantage of a couple of opportunities to acquire early-stage assets and expand its geographic footprint to establish a U.S. research hub at low prices.
BioNTech’s revenue soared to EUR 5.3 billion in the second quarter, with roughly EUR 1 billion in direct revenue for its COVID-19 vaccine in BioNTech territories and EUR 4.1 billion in gross profit share and milestones from partners (chiefly Pfizer, which reported $7.8 billion in COVID-19 vaccine revenue in the quarter). BioNTech now expects full-year revenue from the COVID-19 vaccine of EUR 15.9 billion in 2021. Based on these changes, full global sales of Pfizer/BioNTech’s COVID-19 vaccine of $35 billion in 2021 and $39 billion in 2022, as sales in developing markets and third-dose booster sales to developed markets continue to grow. Increased our assumed probability of approval for Pfizer/ BioNTech’s flu program BNT161 from 60% to 70% given continuing validation of this technology in infectious diseases.
Overall, these changes boost our fair value estimate to $172 per share from $139. BioNTech (and peer Moderna) rapidly building a moat based on novel mRNA technology, although multiple potential competitors, significant uncertainty around the duration of COVID-19 revenue beyond 2022, and ongoing validation of this technology outside of COVID-19 prevent us from assigning BioNTech a moat at this time. While the initial series continues to show 90%+ efficacy at preventing severe disease, efficacy against symptomatic infection has been slowly declining, from a peak of 96% down to 84% in individuals that are more than four months past their second dose. Both Pfizer/BioNTech and Moderna have early phase 2 data showing that a third dose of their authorized vaccines significantly boosts neutralizing antibody activity against the original strain and variants, including the delta variant.
Bulls Say’s
BioNTech’s pipeline, which relies on expertise in mRNA and bioinformatics, will be difficult to replicate by competitors.
BioNTech will be able to command a premium price with its personalized cancer therapies, if successful.
The rapid development of COVID-19 vaccine Comirnaty bodes well for the rest of BioNTech’s pipeline and the future of its mRNA research platform.
Company Profile
BioNTech is a Germany-based biotechnology company that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company’s oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.
(Source: Morningstar)
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