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GAITHERSBURG, Md. - Novavax, Inc. (NASDAQ:NVAX), a biotechnology company with a market capitalization of $1.47 billion and trailing twelve-month revenue of $1.08 billion, has completed the transfer of marketing authorization for its COVID-19 vaccine, Nuvaxovid, to Sanofi in the European Union, triggering a $25 million milestone payment to the company. InvestingPro analysis shows the company maintaining strong financial health with a gross profit margin of 57.18%.
The transfer enables Sanofi to assume full responsibility for commercial and regulatory activities for the protein-based, non-mRNA COVID-19 vaccine in the EU market, according to a company press release.
"The successful transfer of our EU marketing authorization to Sanofi is yet another step forward in ensuring global access to our protein-based, non-mRNA COVID-19 vaccine," said John C. Jacobs, President and Chief Executive Officer of Novavax.
Under the collaboration and license agreement, Novavax remains eligible for additional payments, including $25 million for marketing authorization transfer in the U.S. and $75 million upon completion of manufacturing technology transfer to Sanofi. Trading at a P/E ratio of 3.65, the company’s stock appears attractively valued relative to its earnings potential.
The agreement also includes potential milestone payments of up to $350 million for combination products developed by Sanofi that include Novavax’s COVID-19 vaccine and Matrix-M adjuvant. Novavax will receive tiered royalties from sales of both standalone and combination products.
Additionally, Novavax could receive up to $200 million for the first four products created by Sanofi using its Matrix-M adjuvant, and up to $210 million for each subsequent product, plus ongoing royalties.
In the U.S., Nuvaxovid is authorized for individuals 65 years and older, or those 12 through 64 years with underlying conditions that put them at high risk for severe COVID-19 outcomes.
The transaction advances Novavax’s corporate growth strategy while progressing the partnership with Sanofi established earlier.
In other recent news, Novavax, Inc. has made significant strides in various areas. The company has amended its collaboration with Sanofi to incorporate its Matrix-M adjuvant in Sanofi’s pandemic influenza vaccine candidate program, which could progress to Phase 3 trials pending further negotiations. Novavax also received a milestone payment from Takeda following Japan’s approval of its COVID-19 vaccine, Nuvaxovid, for initial immunization and booster use. Additionally, H.C. Wainwright has assumed coverage of Novavax with a Buy rating, citing the company’s unique technology as a positive factor.
In financial developments, Novavax announced the issuance of $225 million in convertible notes due in 2031, part of which involved exchanging existing notes due in 2027. This transaction was conducted under exemptions from registration under the Securities Act of 1933. Moreover, the U.S. Food and Drug Administration has approved updated COVID-19 vaccines, but with more restricted eligibility, primarily for those 65 and older or with specific health conditions. These developments highlight Novavax’s ongoing efforts in vaccine development and financial restructuring.
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