Headcount: 4,500
Revenues: $18,479 (-9%)
Net Income: $10,071 (-8%)
R&D: $$1,641 (+62%)

BioNTech’s commercial COVID-19 vaccine revenues for 2022 were $18.3 billion, a decrease of $1.8 billion compared to the previous year as demand for the vaccine declined. Since December 2020, the German biotech’s COVID-19 vaccine (Comirnaty) has been fully licensed, granted conditional marketing approval, or approved or licensed for emergency or temporary use in more than 100 countries and regions worldwide. Approximately 2 billion doses of Comirnaty were invoiced in 2022.

The company’s collaboration with Pfizer dating back to a 2018 agreement to jointly develop an mRNA-based influenza vaccine, put BioNTech on the map globally. The alliance later aimed to rapidly advance COVID-19 vaccine candidates into human trials based on BioNTech’s proprietary mRNA vaccine platforms, with the goal of providing rapid worldwide access to the vaccine leveraging Pfizer’s regulatory capabilities and global manufacturing and distribution network.

Together with Pfizer, BioNTech continued its global COVID-19 vaccine leadership in 2022: The companies developed and launched two first-to-market Original/Omicron-adapted bivalent vaccines that address the Omicron BA.1 and Omicron BA.4/BA.5 sublineages, respectively. Approximately 550 million doses of the variant-adapted vaccines were invoiced in 2022.

In the past year, BioNTech also accelerated and broadened its clinical stage pipeline and achieved multiple clinical milestones. In oncology, its pipeline of 20 programs across 24 ongoing trials is designed to address various cancer indications. Last year, BioNTech started five first-in-human clinical trials and was able to provide a clinical proof of concept across multiple modalities, including BNT211, a novel cell therapy candidate for the treatment of patients with CLDN6-positive relapsed or refractory advanced solid tumors, as well as for its next-generation checkpoint immunomodulator candidate BNT312, which BioNTech is developing in collaboration with Genmab with the aim of treating solid tumors.

In infectious diseases, BioNTech had 6 programs in 10 ongoing clinical trials by the end of 2022, including clinical trials of two next-generation COVID-19 vaccine or vaccine component candidates, a COVID-19 and influenza combination mRNA vaccine program and vaccine candidates against shingles (all partnered with Pfizer), HSV-2 infection (partnered with the University of Pennsylvania) and malaria.

BioNTech invested $1.6 billion in R&D in 2022 to further develop its platforms, drive forward its preclinical and clinical trials, and accelerate the development of its later-stage product candidates. These investments also funded activities to enhance its manufacturing technology and infrastructure, as well as its digital infrastructure. One example of the company’s investment in manufacturing technology is its BioNTainers—modular mRNA-manufacturing facilities based on a container solution. The solution consists of one drug substances module plus one formulation module, with each module built of at least 6 ISO sized containers. Each BioNTainer is a high-tech clean room equipped with state-of-the-art manufacturing solutions.

In 2022 and early 2023, BioNTech announced multiple complementary acquisitions and collaborations to strengthen its technology platforms, digital capabilities and infrastructure. In oncology, it entered into 3 new collaborations and expanded its existing collaboration with Genmab. In Early 2023, BioNTech agreed to acquire its long-lasting strategic collaboration partner InstaDeep in order to augment its internal capabilities and enable its transformation into a potentially leading AI and machine learning-driven company.

Headcount: 3,100
Revenues: $21,490
Net Income: $11,655
R&D: $1,075 (+47%)

TOP SELLING DRUGS  

The world’s most widely used Covid-19 vaccine put this burgeoning German biotech on the Top 20 map, with vaccine sales of $21.3 billion in 2021. To put the company’s revenue growth in perspective, BioNTech brought in $546 million in 2020 with earnings of $17 million, compared to 2021 revenues of $21.5 billion and $11.7 billion earnings. At year-end BioNTech had upwards of 3,100 full-time employees, compared to approximately 1,940 in 2020.

In August 2021, following the Emergency Use Authorization issued in December 2020, COMIRNATY became the first Covid-19 vaccine to be granted approval by the FDA to prevent Covid-19 in individuals 16 years of age and older. The vaccine has since been authorized in babies as young as 6 months.

Co-founded in 2008 by professors Ugur Sahin, M.D., Chief Executive Officer, Özlem Türeci, M.D., Chief Medical Officer, and Christopher Huber, M.D., the company’s collaboration with Pfizer dating back to a 2018 agreement to jointly develop an mRNA-based influenza vaccine, put BioNTech on the map globally. The alliance later aimed to rapidly advance Covid-19 vaccine candidates into human trials based on BioNTech’s proprietary mRNA vaccine platforms, with the goal of providing rapid worldwide access to the vaccine leveraging Pfizer’s regulatory capabilities and global manufacturing and distribution network. During the clinical development stage, BioNTech and its partners provided clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

News and developments

Most recently, BioNTech and Pfizer said the two companies would begin human testing with next-generation vaccines that aim to protect against a wide variety of coronaviruses later this year. Their experimental efforts go beyond the current approach include T-cell-enhancing vaccines designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.

The companies recently announced data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted Covid-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech Covid-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2/3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a higher immune response against Omicron BA.1 as compared to the companies’ current Covid-19 vaccine.

These results were shared with the U.S. FDA and European Medicines Agency for discussions with the FDA Vaccines and Related Biological Products Advisory Committee on June 28.

Recent headlines

In an effort not to inundate with the more well-known news dating back to early 2021, the following covers the company’s more recent endeavors. BioNTech began construction for the initial mRNA manufacturing facility in Kigali, Rwanda, with a target for the first set of manufacturing BioNTainers to be delivered to the site by the end of 2022. The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries. The initial site will become a node in a decentralized end-to-end manufacturing network in Africa. All vaccines to be manufactured in the network will be dedicated to member states of the African Union.

The Rwandan facility, with a size of about 30,000 square meters, will be initially equipped with two BioNTainers (one for the production of mRNA, and one for the production of the formulated bulk drug product). The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech Covid-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities.

The estimated initial annual capacity of the Pfizer-BioNTech Covid-19 vaccine will be about 50 million doses. Manufacturing in the BioNTainers in Rwanda is expected to begin approximately 12 to 18 months after their installation.

Early this year, BioNTech and Pfizer announced plans to research, develop and commercialize a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a disease that impacts about one in three people in the U.S. during their lifetime. This is the third collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the Covid-19 vaccine collaboration initiated in 2020.

Under the shingles alliance, the companies will leverage a proprietary antigen technology identified by Pfizer’s scientists and BioNTech’s proprietary mRNA platform technology used in the companies’ Covid-19 vaccine. Clinical trials are planned to start in the second half of 2022. Pfizer will have rights to commercialize the potential vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries where BioNTech will have commercialization rights. The companies will share gross profits from commercialization of any product.

Pfizer will pay BioNTech $225 million upfront, including a cash payment of $75 million and an equity investment of $150 million. BioNTech is eligible to receive future regulatory and sales milestone payments of up to $200 million.

R&D update

BioNTech has 12 preclinical assets, 15 phase I candidates, and five in phase II development. They include messenger ribonucleic acid (mRNA), Engineered Cell Therapies (ECT), antibodies, and small molecule immunomodulators (SMIM). The company leverages multiple mRNA formats with distinct properties with the goal of developing a new class of versatile, tailored therapeutics with the potential to address a wide variety of diseases with high unmet medical needs.

The company’s Engineered Cell Therapies (ECT) programs target novel and known tumor-specific antigens, including patient-specific mutant neoantigens. Here, the company also leverages its mRNA vaccine technology to further boost T cell activation, expansion and persistence.

For its Antibodies (AB), the company applies multiple formats, including bispecific immune-activating antibodies and tumor antigen-specific targeted antibodies, in an effort to provide the best antibody therapeutics for each cancer indication. The company also aims to develop the next generation of small molecule immunomodulators (SMIM) to fully access the potential of Toll-like Receptors for cancer patients.

BioNTech was granted Fast Track Designation from the FDA for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform that uses a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer. The vaccine candidate is currently being investigated in a Phase 2 trial in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma.

With the Fast Track Designation, the development of BNT111 can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate BNT111’s development.

In in its efforts to boost its infectious disease business and to address drug-resistant infections driven by overuse of antibiotics, BioNTech is independently working on precision antibiotics that kill superbugs that have grown resistant to currently available anti-infectives. BioNTech is leveraging the technology of PhagoMed, which it acquired last October. PhagoMed’s Lysin Builder platform allows for the development of synthetic lysins that create targeted antibacterials. Lysins are enzymes produced by bacteriophages that break down bacterial cell walls and kill bacteria. The Lysin Builder uses prediction algorithms to design novel precision antibiotics that target and kill select groups of bacteria.

Lastly, in February, BioNTech paid $29 million for a preclinical T-cell receptor (TCR) program from Medigene, gaining a preclinical asset targeting PRAME, an antigen that is highly expressed in several solid tumors but largely limited to the testis in healthy tissues. The expression profile of PRAME led Medigene to genetically modify T cells to express both a TCR against the antigen and a PD1-41BB switch receptor designed to prevent inhibition in the tumor microenvironment.