BioNTech co-founder and CEO Ugur Sahin, MD

Pfizer and BioNTech plan to begin human clinical trials on their lead COVID-19 therapeutic candidate, an mRNA vaccine, by the end of this month, the companies said today, through a collaboration that could generate up to $748 million for the German biotech.

The companies announced plans last month to partner on BNT162, the first treatment to emerge from BioNTech’s accelerated COVID-19-focused development program, “Project Lightspeed.” BioNTech and Pfizer established a collaboration intended to draw upon BioNTech’s proprietary mRNA vaccine platforms, and Pfizer’s expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.

Pfizer and BioNTech plan to jointly conduct clinical trials for BNT162 and other COVID-19 vaccine candidates initially in the U.S. and Europe across multiple sites.

“We have already started working with Pfizer on our COVID-19 vaccine and are pleased to announce these further details of our ongoing collaboration, which reflects both companies’ strong commitment to move quickly to bring a safe and efficacious vaccine to patients worldwide,” BioNTech co-founder and CEO Ugur Sahin, MD, said in a statement.

Pfizer agreed to pay BioNTech $185 million upfront—consisting of $72 million cash and a $113 million equity investment—plus up to $563 million in payments tied to achieving milestones.

Pfizer and BioNTech also agreed to share development costs equally. Initially, Pfizer will fund 100% of those development costs, with BioNTech also agreeing to repay Pfizer its 50% share of these costs during commercialization of the vaccine.

The companies said they will jointly commercialize the vaccine worldwide except in China, where BioNTech is partnering with Fosun Pharma to jointly develop the vaccine. Fosun has agreed to make a $50 million equity investment, and pay BioNTech up to $85 million in additional upfront and milestone payments. The companies will share future gross profits from the sale of the vaccine in China.

$870M preliminary value

As a result of the Fosun partnership, BioNTech became the first COVID-19 vaccine developer to monetize its candidate before trials and regulatory approvals, SVB Leerink senior research analyst Daina M. Graybosch, PhD, wrote April 1 in an investor note. The firm assigned a preliminary value for BNT162 of $870 million—about $4 a share—based on an estimated launch in early 2022, , using a 30% probability of success, assuming 25% share of the global COVID-19 vaccine market, and the 50-50 partnership with Pfizer worldwide except China.

“On the whole, the most significant impact of the pandemic on BNTX is the attention it has brought on its mRNA platform and its potential application for a preventative vaccine,” Graybosch wrote, using the stock ticker symbol for BioNTech; the company went public last year.

BioNTech and partners, including CDMO Polymun, will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe, the companies said. BioNTech and Pfizer have agreed to scale-up manufacturing capacity at risk to provide worldwide supply of BNT162.

The scale-up will enable the companies to supply potentially “millions” of vaccine doses by the end of 2020, subject to technical success of the development program and approval by regulatory authorities. Production could be scaled up even further, to “hundreds of millions” of doses in 2021, according to BioNTech and Pfizer.

“Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” added Mikael Dolsten, chief scientific officer and president, worldwide research, development & medical, Pfizer. “I am proud of Pfizer’s collaboration with BioNTech and have every confidence in our ability to harness the power of science—together—to bring forth a potential vaccine that the world needs as quickly as possible.”

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