(How to build a $10 billion company without really trying)
VIR Biotechnology (Vir) is turning itself from a tiny company into a Fortune 500 enterprise in 4 quarters. It's accomplishing that without any of the "usual" assets of a pharma company — production capacity and testing facilities.
VIR takes a different process to creating biologic drugs allowing it to enter and dominate a key market. In many ways Vir is engaging capacity and capabilities in the biotech marketspace as ‘fabless’ semiconductor firms use the design, fab, and packaging firms in that marketspace.
Back in 2017, Humabs BioMed, a Swiss Company, bought Vir Biotechnology to combine their technologies. Vir continued to obtain funding in an “A” and “B” round from key investors such as SoftBank, the Bill and Melinda Gates Foundation, and others.
A few years later, in February 2020 Vir announced an agreement with leading Chinese enterprise WuXi Biologics to jointly work on clinical development, manufacturing, and commercialization of Vir’s proprietary antibodies. WuXi Biologics retained marketing rights in Greater China and Vir everywhere else. Vir completed an agreement where work to deliver antibodies as a product. In addition the relationship provided a domestic champion in a likely key market. Vir used an opportunity to access resources and markets allying with a much bigger enterprise player.
In April 2020 Vir elected Samsung Biologics (an Alien Invader featured in another EkaLore release) to manufacture, Vir’s then unproven, and untested, drug VIR-7831 for $362M
Starting from March 2020, in May 2020 Vir and Biogen announced work, paying Biogen up to $100M, to develop cells, clinical, and commercial manufacturing processes for Vir. The objective was to develop designs to be transferred to Vir’s global partners’ facilities designed for advanced biologics production. Biogen was to conduct cGMP clinical manufacturing in the U.S. and transfer to Samsung Biologics.
In April 2020 GlaxoSmithKline (GSK) and Vir Biotechnology (Vir) created a collaboration with GSK funding $250M to research and develop solutions for the newly pandemic Sars-Cov2 (Covid-19). The media announcement referenced GSK’s functional genomics, CRISPR screening, and AI resources to identify anti-coronavirus compounds targeting cellular host genes. Vir brought Vir-7831 (now GSK4182136) and Vir-7832 molecules to the collaboration. Like many other R&D projects announced in early 2020 the parties wanted to find treatments for Covid-19.
With these steps Vir put in place the resources (capacity), expertise (manufacturing), and experience to market (compliance and marketing) to successfully exploit the drug candidate Vir-7831/7832.
In January 2021 Vir/GSK was seen as behind Eli Lilly and Regeneron as they had EUA approvals and distribution for their monoclonal antibody products against Covid-19. AstraZenaca, using antibodies from post-Covid-19 patients also was racing to deliver a drug treatment. Regeneron was seen as picking a less risky product path with some future product risks.
In May 2021 GSK/Vir was granted EUA from the US FDA. Canada followed in July 2021, UK's MHRA December 2021, EU EMA December 2021, and WHO January 2022.
In December 2021 Samsung Biologics was authorized by the FDA to manufacture Vir-7831.
Procurement: $279,862,800.00 (September 24, 2021)
Procurement: $651,094,500.00 (November 15, 2021)
Procurement: $945,107,496.00 (January 10, 2022)
In January 2022 Vir-7831, sotrovimab, now named Xevudy, is the only approved monoclonal antibody treatment for Omicron Covid-19. Xevudy, according to the Acting FDA Commissioner Janet Woodcock (Jan 28, 2022), 'And of course, there is a monoclonal that does neutralize the virus, the GSK-Vir monoclonal, but it is in short supply.' The US Government has bought approximately 1M doses thru January 2022 at a cost of $1.876B with delivery thru 1H 2022. Vir/GSK announced that approximately 1.7M doses had been sold worldwide with 2M doses planned manufacturing for 1H2022 and a higher rate in 2H2022. The competitive Regeneron treatment sold $8.1B in 2021 and, with the Eli Lilly treatment, is now regarded as ineffective and not be used against the Omicron Covid-19 variant.
For treatment of Omicron Covid-19 Xevudy is a primary global treatment in ‘one shot (infusion or IM).’ . Solutions from Pfizer (Paxlovid) and Merck (Molnupiravir) take days to administer and have significant side effects and limitations.
Vir Biologics is emerging, like BioNTech and Moderna, as an Alien Invader by:
1) Deploying capital to obtain resources impossible for a drug developer
2) Using medical expertise to apply new treatments and medical techniques
3) Partnering to gain the development, manufacturing, regulatory, and sales opportunities.
Enterprise revenue for Vir will go from a million or so to billions in 4 quarters of delivery. Bringing the critical drug R&D Vir has pulled in ‘biotech fab’ resources and larger regulatory expertise. Going the last process to deliver to customers Vir can participate in a global marketspace.
If you’re a competitor, or a supplier to the CDMO and you’re wondering how to deal with the opportunities and challenges the rise of Vir, BioNTech and Moderna, set up a time with a Senior Analyst at Ekalore – www.ekalore.com/contact
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