Novavax is exploring development of a Wuhan-coronavirus recombinant nanoparticle vaccine candidate, H.C. Wainwright analyst Vernon Bernardino tells investors in a research note. The company intends to develop a vaccine candidate from the genetic sequence of the coronavirus when it becomes available for research by the infectious disease community, which could be in the coming days, adds the analyst. He believes results from a vaccine lethal challenge study could be a positive catalyst later in Q1 for shares of Novavax. As such, Bernardino reiterates a Buy rating on Novavax with a $17 price target.
Reports Q2 revenue $92.1M, consensus $387.87M. As of June 30, 2021, Novavax had $2.1 billion in cash, cash equivalents and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided by operating activities for the first six months of 2021 was $807 million, compared to $93 million for the same period in 2020. The increase in cash provided was primarily due to $1.1 billion in payments under advance purchase agreements recorded as deferred revenue and the timing of payments to third parties.
Novavax announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, NVX-CoV2373, given six months after an initial two-dose regimen, elicited a 4.6-fold increase in functional antibody titers. Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta variant were more than 6-fold higher than the primary vaccination series. Complete data from the study will be submitted to a peer review publication and posted to a preprint server. The results come from an ongoing Phase 2 study in the U.S. and Australia in which select participants in the 5-microgram dose cohort received a 5-microgram booster dose 189 days after the initial two-dose regimen to examine the functional immune response. "The strong results from this study reinforce our confidence in the potential for a booster dose of NVX-CoV2373 to provide broad protection against disease, including from known and emerging variants," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "Given the evidence that natural and vaccine-induced immunity wanes over time, the continuation of our proactive clinical development program will be critical to understanding and demonstrating the effectiveness of our recombinant nanoparticle COVID-19 vaccine."
Novavax, with its partner, Serum Institute of India Pvt. Ltd., announced that the companies have filed regulatory submissions for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. The submissions were made to the Drugs Controller General of India and regulatory agencies in Indonesia and the Philippines. "Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax' transformation into a commercial global vaccine company," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with Serum Institute of India, and it demonstrates the power of global collaboration." SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data. A Good Manufacturing Practice joint site inspection of SII was successfully completed by DCGI in May 2021.
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Cantor Fitzgerald analyst Charles Duncan tells investors in a research note that the EU approved an Advanced Purchase Agreement with Novavax for NVX-CoV2373, under which Member States will be able to purchase up to 100M doses of '2373, with an option for 100M additional doses through 2021-2023. Part of the decision by the European Commission was based on Novavax's production capacity to supply the entire EU, which may signal that manufacturing bottlenecks have been resolved. The analyst made no change to his Overweight rating or $272 price target.
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The European Commission has approved its seventh Advanced Purchase Agreement with a pharmaceutical company to ensure access to a potential vaccine against COVID-19 in Q4 of 2021 and in 2022, the commission announced. Under this contract, Member States will be able to purchase up to 100 million doses of the Novavax (NVAX) vaccine, with an option for 100 million additional doses over the course of 2021, 2022, and 2023, once reviewed and approved by EMA as safe and effective. Member States will also be able to donate vaccines to lower and middle-income countries or to re-direct them to other European countries. "Today's contract complements an already broad portfolio of vaccines to be produced in Europe, including the contracts with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNtech-Pfizer, CureVac, Moderna and the concluded exploratory talks with Valneva. It represents another key step towards ensuring that Europe is well prepared to face the COVID-19 pandemic," the commission stated.
Novavax has reached an agreement with the European Commission for the purchase of up to 200 million doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. The agreement covers the purchase of up to 100 million doses of the vaccine with the option for an additional 100 million doses through 2023. Novavax is working to complete its rolling submission for NVX-CoV2373 to the European Medicines Agency in Q3, with delivery of initial doses expected to begin following approval. In a Phase 3 clinical trial with nearly 30,000 adults in the U.S. and Mexico, NVX-CoV2373 demonstrated 100% protection against moderate and severe disease and 90.4% overall efficacy. In a Phase 3 clinical trial conducted in the U.K. with approximately 15,000 adults, NVX-CoV2373 showed an overall efficacy of 89.7%, and more than 96% efficacy against the original strain of the virus.