Pfizer (PFE) and BioNTech SE have concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States. The agreement includes an option for a further 100 million doses.
Deliveries are set to start by the end of 2020, subject to clinical success and regulatory authorization. The companies will now enter into contract negotiations with the European Commission.
The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech (BNTX) to date. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If regulatory approval for the BNT162b2 vaccine candidate is received, the European Commission would lead the process for allocation of the vaccine doses among the 27 EU Member States.
“Pfizer and BioNTech’s anticipated agreement with the European Commission is an important step forward in our shared goal to have millions of doses of a vaccine against COVID-19 available for vulnerable populations before the end of the year,” said Albert Bourla, CEO, Pfizer. “We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”
The BNT162 program is based on BioNTech’s mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. On July 27, Pfizer and BioNTech selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies.
In the late-stage trial, Pfizer and BioNTech are studying a 30µg dose level in a 2-dose regimen among up to 30,000 participants aged 18 to 85 years. The companies have selected 120 sites globally, including those in regions with significant expected SARS-CoV-2 transmission.
Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
To meet those anticipated quantities, the companies say that they have already produced sufficient supply for their 30,000 participant Phase 2/3 clinical trial and have begun to produce and stockpile their pandemic supply.
Shares in Pfizer are down 8% year-to-date, and the stock scores a cautiously optimistic Moderate Buy Street consensus. The average analyst price target of $43 indicates 20% upside potential from current levels.
“We have been impressed with the progress Pfizer has made with the vaccine to date and include risk-adjusted sales of ~$1.7Bn in 2021 and ~$1.2Bn in 2022 in our model, which could prove conservative given the additional deals the company has inked since we last updated our forecast” commented Mizuho Securities analyst Vamil Divan.
However, after the initial bolus the analyst assumes a steady rate of annual sales in the $500M-$600M range from 2024 onwards. According to Divan, this limits “the impact the vaccine can have on helping Pfizer navigate the time period beyond 2025 when the company will be facing a number of important patent expirations.” He has a buy rating on the stock and $43 price target. (See PFE stock analysis on TipRanks).
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