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Can Moderna's (MRNA) Launches Reduce COVID Sales Dependency?
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Moderna (MRNA - Free Report) is a commercial-stage pharmaceutical company primarily focused on discovering and developing messenger-RNA (mRNA) based therapies.
During the COVID-19 pandemic, the company launched its first marketed product in the form of its mRNA-based COVID-19 vaccine. Being one of the first-ever COVID-19 vaccine developers, Moderna generated robust product sales that helped the company transform from a clinical-stage pharmaceutical company to one of the most profitable commercial-stage biotech companies in the healthcare sector.
As COVID-19 infection cases have declined significantly, demand for the COVID vaccines has also dropped significantly, leading to a steep decline in Moderna’s sales and profits.
The higher-than-expected product sales helped the company boost its cash resources. MRNAis developing more than 40 mRNA-based investigational candidates in multiple stages of clinical studies.
Last year, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States and Europe. A potential launch is expected later this year. If approved, mRNA-1345 could be Moderna’s second product launch.
Apart from COVID and RSV, the company is currently evaluating multiple candidates — including cytomegalovirus (CMV), individualized neoantigen therapy (INT), influenza and a refrigerator-stable COVID vaccine — in late-stage studies.
During third-quarter 2023, Moderna reported encouraging data from a phase III immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating an enhanced formulation of flu vaccine mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with the vaccines marketed by GSK and Sanofi. Given the company’s timetable, we expect mRNA-1010 to be its third product launch, which is also expected in 2024.
Moderna has also completed enrolment in a pivotal phase III study on its CMV vaccine, mRNA-1647. In October 2023, the company advanced mRNA-1083, a combination vaccine against influenza and COVID-19, to late-stage development. Management intends to market this combination vaccine by 2025.
The INT therapy mRNA-4157/V940 is being developed by Moderna in collaboration with partner Merck (MRK - Free Report) . In the first half of 2023, Moderna/Merck reported that a phase IIb study evaluating INT therapy in melanoma patients achieved its primary and key secondary endpoints. Based on this data, Moderna/Merck initiated two separate pivotal late-stage studies in the second half of 2023 evaluating the INT in melanoma and non-small cell lung cancer (NSCLC) indications. Over time, the companies intend to expand mRNA-4157 in other oncology indications.
Based on the encouraging clinical progress of the above candidates, management is gearing up for their commercial launches over the next three years.
Apart from the above candidates, Moderna is also evaluating mRNA-based investigational candidates in multiple mid-stage and early-stage stages of clinical studies, targeting various indications, including the Zika virus. It expects to advance its propionic acidemia (PA) & methylmalonic acidemia (MMA) programs into pivotal studies this year.
However, the company’s target markets are highly competitive and dominated by large-cap pharma companies. Moderna’s COVID-19 vaccine already faces stiff competition from Pfizer (PFE - Free Report) , which directly competes with the company in the COVID-19 vaccine space. Pfizer also markets its own RSV vaccine, Abrysvo, which is approved for use in older adults and pregnant women. Pfizer is also evaluating a combination vaccine against influenza and COVID-19 in a mid-stage study.
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Can Moderna's (MRNA) Launches Reduce COVID Sales Dependency?
Moderna (MRNA - Free Report) is a commercial-stage pharmaceutical company primarily focused on discovering and developing messenger-RNA (mRNA) based therapies.
During the COVID-19 pandemic, the company launched its first marketed product in the form of its mRNA-based COVID-19 vaccine. Being one of the first-ever COVID-19 vaccine developers, Moderna generated robust product sales that helped the company transform from a clinical-stage pharmaceutical company to one of the most profitable commercial-stage biotech companies in the healthcare sector.
As COVID-19 infection cases have declined significantly, demand for the COVID vaccines has also dropped significantly, leading to a steep decline in Moderna’s sales and profits.
The higher-than-expected product sales helped the company boost its cash resources. MRNAis developing more than 40 mRNA-based investigational candidates in multiple stages of clinical studies.
Last year, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States and Europe. A potential launch is expected later this year. If approved, mRNA-1345 could be Moderna’s second product launch.
Apart from COVID and RSV, the company is currently evaluating multiple candidates — including cytomegalovirus (CMV), individualized neoantigen therapy (INT), influenza and a refrigerator-stable COVID vaccine — in late-stage studies.
During third-quarter 2023, Moderna reported encouraging data from a phase III immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating an enhanced formulation of flu vaccine mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with the vaccines marketed by GSK and Sanofi. Given the company’s timetable, we expect mRNA-1010 to be its third product launch, which is also expected in 2024.
Moderna has also completed enrolment in a pivotal phase III study on its CMV vaccine, mRNA-1647. In October 2023, the company advanced mRNA-1083, a combination vaccine against influenza and COVID-19, to late-stage development. Management intends to market this combination vaccine by 2025.
The INT therapy mRNA-4157/V940 is being developed by Moderna in collaboration with partner Merck (MRK - Free Report) . In the first half of 2023, Moderna/Merck reported that a phase IIb study evaluating INT therapy in melanoma patients achieved its primary and key secondary endpoints. Based on this data, Moderna/Merck initiated two separate pivotal late-stage studies in the second half of 2023 evaluating the INT in melanoma and non-small cell lung cancer (NSCLC) indications. Over time, the companies intend to expand mRNA-4157 in other oncology indications.
Based on the encouraging clinical progress of the above candidates, management is gearing up for their commercial launches over the next three years.
Apart from the above candidates, Moderna is also evaluating mRNA-based investigational candidates in multiple mid-stage and early-stage stages of clinical studies, targeting various indications, including the Zika virus. It expects to advance its propionic acidemia (PA) & methylmalonic acidemia (MMA) programs into pivotal studies this year.
However, the company’s target markets are highly competitive and dominated by large-cap pharma companies. Moderna’s COVID-19 vaccine already faces stiff competition from Pfizer (PFE - Free Report) , which directly competes with the company in the COVID-19 vaccine space. Pfizer also markets its own RSV vaccine, Abrysvo, which is approved for use in older adults and pregnant women. Pfizer is also evaluating a combination vaccine against influenza and COVID-19 in a mid-stage study.