We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Moderna (MRNA) Reports 2023 Business View & Pipeline Updates
Read MoreHide Full Article
Moderna (MRNA - Free Report) announced several updates about the advancements in its pipeline as well as its business outlook for 2023.
The company reported that it expects to record around $18.4 billion as preliminary revenues from product sales in 2022, generated entirely from its COVID-19 vaccines. This figure exceeds our expectations as it beats our model estimate of $18.0 billion. The figure also falls within the previously provided management guidance of $18-$19 billion.
The company also expects to incur around $3.3 billion in R&D expenses for 2022. Management expects to close the year with cash and cash equivalents of around $18.0 billion.
Shares of Moderna have declined 16.9% in the past year compared with the industry’s 17.3% fall.
Image Source: Zacks Investment Research
Updates 2023 Guidance
Moderna expects to record a minimum of around $5.0 billion from COVID vaccine sales in 2023, based on confirmed advance purchase agreements and contract deferrals. Management also reported that this figure does not include product sales in the United States or new contracts with Europe, Japan and other key markets.
Management is also focused on shifting the supply of its COVID-19 vaccines from government contracting to commercial distribution. Per a WSJ article, Moderna is expected to price its COVID-19 vaccine in the range of $110-$130 per dose.
Moderna also announced plans to increase investment in R&D expenses. It expects to spend around $4.5 billion in 2023. This is a sharp increase from the company’s previous R&D expenses as it focuses on expanding its market portfolio to include products other than its COVID-19 vaccine.
Pipeline Updates
Currently, Moderna has 48 programs in active development, with 36 programs undergoing clinical studies.
Currently, Moderna has three late-stage candidates — mRNA-1647, mRNA-1345 and mRNA-1010 — in its pipeline, which are being developed as cytomegalovirus (CMV) vaccine, respiratory syncytial virus (RSV) vaccine and influenza vaccine, respectively.
With regard to mRNA-1010, management expects to report data from the immunogenicity study evaluating the influenza vaccine in adults in first-quarter 2023 while the data from the efficacy study evaluating the vaccine in older adults is expected later this year during the winter season.
Management believes that the late-stage study evaluating its RSV vaccine has accrued sufficient cases required to complete its first interim efficacy analysis.
Last month, Moderna and partner Merck (MRK - Free Report) reported positive data from the phase IIb KEYNOTE-942 study, which evaluated their personalized cancer vaccine (PCV) candidate mRNA-4157/V940 combined with Merck’s blockbuster cancer drug Keytruda heavily treated melanoma patients. Data from the study showed that the mRNA-4157 combined with Merck’s Keytruda exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%.
Based on the above data, Moderna and Merck plan to discuss these results with regulatory authorities and also plan to start a phase III study in melanoma patients late this year. Moderna and Merck also intend to expand the study of the PCV vaccine to additional tumor types.
Moderna also announced the advancement of two new candidates to clinical-stage development. These include mRNA-0184, its heart failure treatment candidate, which is being evaluated in a phase Ib study in patients with stable heart failure. Another candidate is VX-522, an investigational mRNA-based therapy for cystic fibrosis (CF), which is being developed in collaboration with Vertex Pharmaceuticals (VRTX - Free Report) .
Last month, Vertex announced that the FDA cleared the investigational new drug (IND) application seeking approval to start clinical studies on VX-522. While Vertex is responsible for leading the preclinical and clinical development of therapies, Moderna is responsible for mRNA and lipid nanoparticle process development and manufacturing. Moderna is also eligible to receive milestone payments and royalties on sales of potential products resulting from this partnership with Vertex.
Management also announced that it had purchased a new priority review voucher (PRV). With this purchase, the company has a total of two PRVs which it plans to use to accelerate the review of two regulatory filings.
In the past 60 days, estimates for Allogene’s 2022 loss per share have narrowed from $2.39 to $2.38. In the same period, the loss per share estimate for 2023 has narrowed from $2.84 to $2.82. Shares of Allogene have declined 54.0% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Moderna (MRNA) Reports 2023 Business View & Pipeline Updates
Moderna (MRNA - Free Report) announced several updates about the advancements in its pipeline as well as its business outlook for 2023.
The company reported that it expects to record around $18.4 billion as preliminary revenues from product sales in 2022, generated entirely from its COVID-19 vaccines. This figure exceeds our expectations as it beats our model estimate of $18.0 billion. The figure also falls within the previously provided management guidance of $18-$19 billion.
The company also expects to incur around $3.3 billion in R&D expenses for 2022. Management expects to close the year with cash and cash equivalents of around $18.0 billion.
Shares of Moderna have declined 16.9% in the past year compared with the industry’s 17.3% fall.
Image Source: Zacks Investment Research
Updates 2023 Guidance
Moderna expects to record a minimum of around $5.0 billion from COVID vaccine sales in 2023, based on confirmed advance purchase agreements and contract deferrals. Management also reported that this figure does not include product sales in the United States or new contracts with Europe, Japan and other key markets.
Management is also focused on shifting the supply of its COVID-19 vaccines from government contracting to commercial distribution. Per a WSJ article, Moderna is expected to price its COVID-19 vaccine in the range of $110-$130 per dose.
Moderna also announced plans to increase investment in R&D expenses. It expects to spend around $4.5 billion in 2023. This is a sharp increase from the company’s previous R&D expenses as it focuses on expanding its market portfolio to include products other than its COVID-19 vaccine.
Pipeline Updates
Currently, Moderna has 48 programs in active development, with 36 programs undergoing clinical studies.
Currently, Moderna has three late-stage candidates — mRNA-1647, mRNA-1345 and mRNA-1010 — in its pipeline, which are being developed as cytomegalovirus (CMV) vaccine, respiratory syncytial virus (RSV) vaccine and influenza vaccine, respectively.
With regard to mRNA-1010, management expects to report data from the immunogenicity study evaluating the influenza vaccine in adults in first-quarter 2023 while the data from the efficacy study evaluating the vaccine in older adults is expected later this year during the winter season.
Management believes that the late-stage study evaluating its RSV vaccine has accrued sufficient cases required to complete its first interim efficacy analysis.
Last month, Moderna and partner Merck (MRK - Free Report) reported positive data from the phase IIb KEYNOTE-942 study, which evaluated their personalized cancer vaccine (PCV) candidate mRNA-4157/V940 combined with Merck’s blockbuster cancer drug Keytruda heavily treated melanoma patients. Data from the study showed that the mRNA-4157 combined with Merck’s Keytruda exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%.
Based on the above data, Moderna and Merck plan to discuss these results with regulatory authorities and also plan to start a phase III study in melanoma patients late this year. Moderna and Merck also intend to expand the study of the PCV vaccine to additional tumor types.
Moderna also announced the advancement of two new candidates to clinical-stage development. These include mRNA-0184, its heart failure treatment candidate, which is being evaluated in a phase Ib study in patients with stable heart failure. Another candidate is VX-522, an investigational mRNA-based therapy for cystic fibrosis (CF), which is being developed in collaboration with Vertex Pharmaceuticals (VRTX - Free Report) .
Last month, Vertex announced that the FDA cleared the investigational new drug (IND) application seeking approval to start clinical studies on VX-522. While Vertex is responsible for leading the preclinical and clinical development of therapies, Moderna is responsible for mRNA and lipid nanoparticle process development and manufacturing. Moderna is also eligible to receive milestone payments and royalties on sales of potential products resulting from this partnership with Vertex.
Management also announced that it had purchased a new priority review voucher (PRV). With this purchase, the company has a total of two PRVs which it plans to use to accelerate the review of two regulatory filings.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stock to Consider
Moderna currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Allogene (ALLO - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Allogene’s 2022 loss per share have narrowed from $2.39 to $2.38. In the same period, the loss per share estimate for 2023 has narrowed from $2.84 to $2.82. Shares of Allogene have declined 54.0% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.