Moderna (NASDAQ:MRNA) gave several updates on pipeline developments and its business outlook for 2023.
The company expects to make about $18.4 billion in preliminary sales revenue from its COVID-19 vaccines alone in 2022. This number is bigger than we thought it would be because it’s more than our model’s estimate of $18.0 billion. The number is also within the range of $18-$19 billion that management said before.
Also, the company expects to spend around $3.3 billion on R&D in 2022. The company’s management thinks there will be about $18 billion in cash and cash equivalents at the end of the year.
In the past year, Moderna stock has dropped 16.9%, which is less than the 17.3% drop in the industry as a whole.
Moderna Stock: Outlook for 2023
Moderna thinks it will sell at least $5 billion of COVID vaccines in 2023, based on confirmed advance purchase agreements and contract deferrals. Management says this number does not include sales in the United States or new contracts with Europe, Japan, or other key markets.
Management is also working to move its COVID-19 vaccine supply from contracts with the government to commercial sales. The WSJ says that each dose of the COVID-19 vaccine from Moderna will cost between $110 and $130.
Moderna also said it would spend more on research and development (R&D). In 2023, it plans to spend about $4.5 billion. This is a big jump from how much the company used to spend on research and development. This is because the company wants to expand its market portfolio beyond the COVID-19 vaccine.
News About the Pipeline
Moderna is currently working on 48 programs, and 36 are undergoing clinical trials.
Moderna has three late-stage candidates in its pipeline right now. These are mRNA-1647, mRNA-1345, and mRNA-1010, which are being developed as vaccines against cytomegalovirus (CMV), respiratory syncytial virus (RSV), and influenza, respectively.
Concerning mRNA-1010, management expects to release data from the immunogenicity study evaluating the flu vaccine in adults in the first quarter of 2023. Data from the efficacy study evaluating the vaccine in older adults will be released later this year during the winter season.
The company’s management thinks there are enough cases in the late-stage study of its RSV vaccine to do the first interim analysis of its effectiveness.
Last month, Moderna and its partner Merck (NYSE:MRK) said that the phase IIb KEYNOTE-942 study, which compares their personalized cancer vaccine (PCV) candidate mRNA-4157/V940 to Merck’s best-selling cancer drug Keytruda in patients with advanced melanoma, showed positive results. The study showed that combining mRNA-4157 with Merck’s Keytruda cut the risk of the disease coming back or dying by 44%.
Based on the above data, Moderna and Merck plan to discuss the results with regulatory officials and start a phase III study on melanoma patients later this year. Moderna and Merck also want to add more types of tumors to the research on the PCV vaccine.
Moderna also said that two new clinical-stage candidates had moved forward. One of these is mRNA-0184, a possible treatment for heart failure that is being tested on people with stable heart failure in a phase Ib study. Another candidate is VX-522, which is an investigational mRNA-based therapy for cystic fibrosis (CF) that is being made in partnership with Vertex Pharmaceuticals (NASDAQ:VRTX).
Vertex said last month that the FDA approved the application for an investigational new drug (IND) so that clinical studies on VX-522 could begin. Moderna is in charge of developing and making mRNA and lipid nanoparticle processes, while Vertex is in charge of developing therapies before and after they are used in people. Moderna could also get payments for reaching certain goals and royalties on any products that might sell due to this collaboration with Vertex.
Management also said that a new priority review voucher (PRV) had been bought. With this purchase, the company now has two PRVs. It plans to use these PRVs to speed up the review of two regulatory filings.
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