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Moderna’s boom days are beginning to look like a thing of the past as the biotech is preparing for declining Covid-19 vaccine sales, and heavy investments in R&D on the flu, RSV and potential cancer vaccines. The company reported a predicted drop in income but stuck to its annual sales forecast of $5 billion for its COVID-19 vaccines on Thursday’s Q4 and full year 2023 investors call . That’s less than a third of what the company hauled in for 2022 in Covid vaccine sales, which totaled $18.4 billion. A little less than half of that 2023 figure, or $2 billion, is expected in the first half of this year. Moderna has advance purchase agreements for Covid vaccines with Canada, Kuwait, Switzerland, Taiwan and the UK, as well as 2022 deferral contracts including Japan, the EU and South Korea. There are ongoing talks with the US for 2023 commercial contracts, and the “potential” for more sales to the EU, Japan, Australia, Asia and Latin America. “Given this need we estimate the U.S, fall 2023 Covid market volume to be approximately 100 million doses,” said Arpa Garay, chief commercial officer at Moderna, during today’s Q4 call. “We based this assumption after looking at 2022 vaccination rates and including potential recommendations for two-dose booster series for high risk individuals.” While the total revenue was $19.3 billion for 2022, compared to $18.5 billion in 2021, the increase was mostly because of increased sales of Covid vaccines, according to the company’s press release . Moderna also reported several major quarterly charges including $297 million in inventory write-downs related to expired Covid vaccines, related cancellation charges of $281 million, and an expense for unutilized manufacturing capacity and related contract manufacturing organization charges of $376 million. “These charges, other than royalties, are driven by costs associated with surplus production capacity, overall lower demand and a shift to our most recent Omicron-targeting COVID-19 bivalent booster, mRNA-1273.222,” the company said. Focus is now shifting to its vaccine candidates against RSV, the seasonal flu and cancer as the company branches out to get more products approved, while its vaccine remains the only one on the market. Company leaders reiterated that its RSV vaccine, mRNA-1345, received breakthrough therapy designation from FDA in January, and Moderna is planning on filing for regulatory approval this year. Moderna announced yesterday that its personalized cancer vaccine in combination with Merck’s blockbuster cancer drug Keytruda as adjuvant treatment for patients with high-risk melanoma also received breakthrough therapy designation, and the company is planning on starting a Phase III trial this year with a plan to move into non-small cell lung cancer too. Moderna has a serious competitor in BioNTech , which is developing vaccines in advanced melanoma, ovarian cancer and non-small cell lung cancer, as well as its individualized vaccine, RO7198457. “Ultimately, we’ll go first into other adjuvant indications where we think there’s the most immediate biologic benefit, or biologic rationale for potential benefit that we’ll be looking to demonstrate,” said company president Stephen Hoge. “But obviously, as others start to move into the space, if they show benefits in other lines of therapy, we will absolutely want to proceed very quickly in those directions as well.”

CAMBRIDGE, MA / ACCESSWIRE / November 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older. Spikevax Bivalent Original/Omicron BA.4-5 contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant BA.4-5. mRNA-1273.222 now joins Moderna's BA.1 variant targeting vaccine, mRNA-1273.214, which was approved in Japan in September. "COVID-19 continues to be a public health threat in Japan, with ongoing rates of infections driven by Omicron subvariants. mRNA-1273.222 is designed to provide broader and more durable immune response against Omicron BA.4-5, which are the main subvariants circulating in Japan," said Rami Suzuki, President & Representative Director of Moderna Japan. "We are grateful for this approval decision and are committed to bringing this vaccine to the people of Japan as soon as possible." Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4-5-targeting bivalent vaccine. A Phase 2/3 trial for mRNA-1273.222 is currently underway. Takeda Pharmaceutical Co. Ltd. continues to provide distribution support for Spikevax Bivalent Original/Omicron BA.4-5 under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period. Authorized Use Spikevax Bivalent Original/Omicron BA.4-5 is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. One 0.5 mL dose is provided intramuscularly. About Moderna In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit or . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company's COVID-19 Vaccine (mRNA-1273.222, or Spikevax Bivalent Original/Omicron BA.4-5); the breadth and durability of response against Omicron BA.4-5 from mRNA-1273.222; and the authorization of mRNA-1273.222 in adults ages 18 years and older by the Ministry of Health Labor and Welfare. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments, or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof. Moderna Contacts: Media: Luke Mircea Willats Director, Corporate Communications Luke.Mirceawillats@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View source version on accesswire.com: