Novavax Reports Third Quarter 2021 Financial Results and Operational Highlights
- Received EUA for NVX-CoV2373 in Indonesia in partnership with Serum Institute of India
- Completed regulatory submissions in the U.K., Australia, Canada, New Zealand, EU, India, the Philippines and to the WHO
- Expect to submit complete regulatory package to the U.S. FDA by end of 2021
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2021.
"We are excited by the significant progress made over the quarter, including our landmark milestone of gaining the first regulatory approval for our COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "With additional regulatory submissions around the world, we are prepared to deliver our vaccine globally. We believe the highly encouraging results from our six-month booster study complement the strong efficacy demonstrated by NVX-CoV2373 to date, and we remain confident that our vaccine will serve as an important tool to fight COVID-19 in the years to come."
Third Quarter 2021 and Recent Highlights
COVID-19 Vaccine Regulatory Pathway
Received emergency use authorization (EUA) from National Agency of Drug and Food Control of the Republic of Indonesia, in partnership with Serum Institute of India Pvt. Ltd. (SII)NVX-CoV2373 to be marketed by SII under the brand name COVOVAX™Novavax completed multiple regulatory submissionsU.K. Medicines and Healthcare products Regulatory Agency (MHRA) for conditional marketing authorizationAustralia Therapeutic Goods Administration (TGA) for provisional approvalHealth Canada for authorizationNew Zealand Medsafe for provisional approvalWorld Health Organization (WHO) for emergency use listing (EUL)European Medicines Agency (EMA) (submitted all final data and modules)SII, our licensee, completed multiple regulatory submissions for our COVID-19 vaccineDrugs Controller General of India (DCGI) and the Philippines for EUAWHO for EULExpect to submit the complete regulatory package to the U.S. FDA by the end of 2021
COVID-19 Vaccine Advanced Purchase Agreements
Executed advance purchase agreement with European Commission to supply a minimum of 20 million doses and up to 100 million initial dosesOption to purchase an additional 100 million doses through 2023
COVID-19 Vaccine Manufacturing and Supply
Achieved capacity of 100 million doses per month as of the end of the third quarter of 2021, on track to achieve capacity of 150 million doses per month by the end of the fourth quarter of 2021, and expect to have capacity in excess of 2 billion annual doses in 2022Collaborated with licensed manufacturers to enable distribution of NVX-CoV2373 globallyExpanded partnership with SII through a supply agreementTakeda Pharmaceutical Company Limited finalized agreement with government of Japan's Ministry of Health, Labour and Welfare for purchase of 150 million doses, with anticipated distribution in 2022
COVID-19 Vaccine Clinical Development
Completed crossover arms in U.K. Phase 3, South Africa Phase 2b, PREVENT-19 Phase 3, and pediatric expansion of PREVENT-19 trialsOngoing pediatric expansion of PREVENT-19 Phase 3 trialCompleted enrollment of 2,248 adolescents aged 12-17 years across up to 75 sites in the U.S.Expect to have a regulatory package available for global submission in the first quarter of 2022Advanced booster study in the Phase 2 portion of U.S. and Australia Phase 1/2 trialData from 6-month booster study demonstrated positive resultsWild-type neutralizing antibodies increased more than 4-fold versus primary vaccination seriesCross-reactive functional antibodies to the Delta (B.1.617.2) variant strain detected after primary vaccination series and increased more than 6-fold following boostingInitiated twelve-month booster dose for select participants following completion of 6-month booster study
Combination Vaccine
Completed enrollment of Phase 1/2 clinical trial for COVID-NanoFlu™ combination vaccine in Australia across 10 sitesEnrolled 642 healthy adults aged 50 to 70 yearsEvaluating the safety, tolerability and immune response of a COVID-NanoFlu combination vaccine formulated with Matrix-M™ adjuvantData is expected in the first half of 2022
Publication Highlights
Final analysis from multiple Phase 3 trials accepted by a peer-reviewed journal and posted via the preprint server on medRxiv.orgPREVENT-19 U.S. and Mexico studyU.K. influenza co-administration sub-studyFinal analysis from pivotal Phase 3 clinical trial for NanoFlu™ published in The Lancet Infectious DiseasesFinal analysis from Phase 2 Australia and U.S. dosing regimen study published in PLOS Medicine
Corporate Highlights
Strengthened corporate leadership with executive hiring and promotionsJim Kelly as Executive Vice President, Chief Financial Officer and TreasurerDenny Kim, M.D. as Senior Vice President, Chief Safety OfficerMarco Cacciuttolo, Ph.D. promoted to Senior Vice President, Process and Analytical DevelopmentRaburn Mallory, M.D. promoted to Senior Vice President, Head of Clinical Development
Financial Results for the Three Months Ended September 30, 2021
Novavax reported a net loss of $322.4 million, or $4.31 per share, for the third quarter of 2021, compared to a net loss of $197.3 million, or $3.21 per share, for the third quarter of 2020.
Novavax revenue in the third quarter of 2021 was $178.8 million, compared to $157.0 million in the same period in 2020. This increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government agreement and royalties under Novavax' licensing agreements.
Research and development expenses increased to $408.2 million in the third quarter of 2021, compared to $294.1 million in the same period in 2020. The increase was primarily due to the development and manufacturing for NVX-CoV2373.
General and administrative expenses increased to $77.8 million in the third quarter of 2021, compared to $56.9 million for the same period in 2020. The increase was primarily due to costs associated supporting our NVX-CoV2373 program.
As of September 30, 2021, Novavax had $1.9 billion in cash, cash equivalents and restricted cash, compared to $0.8 billion as of December 31, 2020. The increase in cash provided was primarily due to $1.2 billion in payments under advance purchase agreements recorded as deferred revenue and $565 million net proceeds raised through utilization of At-the-market (ATM) offerings during the first quarter of 2021. |
