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.
At its annual R&D Day, Moderna (MRNA - Free Report) announcedseveral updates about the advancements in its pipeline and its business outlook for the next four years.
MRNA to Cut R&D Costs, Stops Five Pipeline Programs
Management implemented a portfolio prioritization and cost efficiencies program to reduce annual research and development (R&D) expenses and focus on products that are either nearing approvals or already on the market.
The firm reduced its overall R&D budget for the next four years (2025 to 2028) by nearly 20% to $16 billion. To meet these numbers, management decided to discontinue five pipeline programs as part of this prioritization program. This includes a preclinical vaccine candidate against the four endemic human coronaviruses and four early-stage programs — a study on RSV vaccine in infants, a KRAS-targeting cancer vaccine, a cancer drug and a drug for congestive heart failure.
Moderna expects to secure the FDA’s approval for 10 new products over the next three years. To achieve this goal, management intends to submit three regulatory filings seeking the FDA’s approval before this year’s end. This includes fresh regulatory filings for mRNA-1283 (next-generation COVID-19 vaccine) and mRNA-1083 (COVID-19 and influenza combination vaccine). Management also plans to file a regulatory filing for RSV vaccine mResvia seeking label expansion for use in high-risk adults aged 18-59 years. mResvia is currently approved for use in older adults aged 60 years and older.
To accelerate the regulatory timeline for these three filings, MRNA intends to support each of these filings with a priority review voucher (PRV). Using these vouchers brings down the FDA’s review period for each filing by a period of four months. In this regard, management updated its R&D budget for 2024, increasing it to $4.8 billion, up from the previous guidance of $4.5 billion. This rise is primarily driven by the purchase of these PRVs.
For 2025, MRNA expects R&D expenses to be between $4.2 billion and $4.5 billion. Management expects to save costs starting in 2027, where it expects R&D costs to be between $3.6 billion and $3.8 billion.
MRNA’s Sales Guidance Fails to Impress Investors
While management issued fresh sales guidance for full-year 2025, it also revised the previously issued sales outlook for 2028.
Moderna expects to generate revenues between $2.5 billion to $3.5 billion in 2025. The Zacks Consensus Estimate for 2025 revenues stands at $4.1 billion.
For 2026-2028, management expects sales to grow at a CAGR of more than 25%, driven by new product launches. This revised guidance was lower than the sales guidance issued by MRNA last year. Per the previous guidance, management expected an additional $10-$15 billion in annual sales of cancer, rare and latent disease therapies by 2028.
Post the announcement, shares of Moderna were down more than 12% on Thursday. The above sales guidance did not sit well with investors which were either lowered by management or were below Wall Street expectations.
In the year so far, the stock declined 29.9% compared with the industry’s 0.8% fall.
Image Source: Zacks Investment Research
Other Financial Guidance
The company projects selling, general and administrative (SG&A) expenses for 2025 to be between $1.0 billion and $1.2 billion. For 2026-2028, management expects selling expenses to rise incrementally while the general and administrative portion of the expenses is expected to remain flat during this period.
Moderna also said it plans to break even on an operating cash cost basis in 2028, two years later than the previously announced goal of 2026.
Pipeline Updates
Cancer Therapy
Moderna is developing mRNA-4157, an investigational individualized neoantigen therapy (INT), in partnership with Merck (MRK - Free Report) . Moderna/Merck are evaluating mRNA-4157 in two pivotal phase III studies for melanoma and non-small cell lung cancer (NSCLC) indications. Since the onset of this year, Moderna/Merck initiated three new clinical studies evaluating mRNA-4157 across cutaneous squamous cell carcinoma (CSCC), renal cell carcinoma and muscle-invasive bladder cancer indications.
Both Moderna and Merck intend to focus on the late-stage studies evaluating mRNA-4157. The companies have been engaged in discussions with the FDA, which does not support accelerated approval based on data from mid-stage studies.
Influenza Vaccine
Management provided an update on its seasonal influenza vaccine candidate, mRNA-1010. It plans to start a confirmatory late-stage study evaluating mRNA-1010’s vaccine efficacy, using funds secured from Blackstone Life Sciences. The company had previously planned to seek accelerated approval from the FDA based on data from previously completed clinical studies on the vaccine.
Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with GSK plc’s (GSK - Free Report) Fluarix and Sanofi’s (SNY - Free Report) Fluzone HD. The GSK vaccine is approved for use in individuals aged six months and older. The Sanofi vaccine is approved for use in older adults aged 65 years and above.
Others
Moderna is evaluating its CMV vaccine candidate mRNA-1647 in the pivotal phase III CMVictory study in women aged 16 to 40 years. Data from this study is expected as early as 2024-end.
Management announced plans to start a pivotal late-stage study on its norovirus vaccine candidate mRNA-1403. It is also on track to begin generating pivotal data from separate phase I/II studies on its methylmalonic acidemia (MMA) and propionic acidemia (PA) therapies.
Our Take
Moderna, once a financial powerhouse due to its COVID-19 vaccine, is now facing uncertainty in maintaining demand for its COVID-19 vaccine. The company's revenue forecasts for its RSV vaccines also remain uncertain, given the recently issued CDC recommendations, which trim down a market that already has two major competitors — GSK and Pfizer. The FDA's reluctance to grant accelerated approval to mRNA-4157 dampens the prospect of an early product launch.
Image: Bigstock
MRNA Stock Falls 12% on Lowered Sales Outlook, R&D Budget Cuts
At its annual R&D Day, Moderna (MRNA - Free Report) announcedseveral updates about the advancements in its pipeline and its business outlook for the next four years.
MRNA to Cut R&D Costs, Stops Five Pipeline Programs
Management implemented a portfolio prioritization and cost efficiencies program to reduce annual research and development (R&D) expenses and focus on products that are either nearing approvals or already on the market.
The firm reduced its overall R&D budget for the next four years (2025 to 2028) by nearly 20% to $16 billion. To meet these numbers, management decided to discontinue five pipeline programs as part of this prioritization program. This includes a preclinical vaccine candidate against the four endemic human coronaviruses and four early-stage programs — a study on RSV vaccine in infants, a KRAS-targeting cancer vaccine, a cancer drug and a drug for congestive heart failure.
Moderna expects to secure the FDA’s approval for 10 new products over the next three years. To achieve this goal, management intends to submit three regulatory filings seeking the FDA’s approval before this year’s end. This includes fresh regulatory filings for mRNA-1283 (next-generation COVID-19 vaccine) and mRNA-1083 (COVID-19 and influenza combination vaccine). Management also plans to file a regulatory filing for RSV vaccine mResvia seeking label expansion for use in high-risk adults aged 18-59 years. mResvia is currently approved for use in older adults aged 60 years and older.
To accelerate the regulatory timeline for these three filings, MRNA intends to support each of these filings with a priority review voucher (PRV). Using these vouchers brings down the FDA’s review period for each filing by a period of four months. In this regard, management updated its R&D budget for 2024, increasing it to $4.8 billion, up from the previous guidance of $4.5 billion. This rise is primarily driven by the purchase of these PRVs.
For 2025, MRNA expects R&D expenses to be between $4.2 billion and $4.5 billion. Management expects to save costs starting in 2027, where it expects R&D costs to be between $3.6 billion and $3.8 billion.
MRNA’s Sales Guidance Fails to Impress Investors
While management issued fresh sales guidance for full-year 2025, it also revised the previously issued sales outlook for 2028.
Moderna expects to generate revenues between $2.5 billion to $3.5 billion in 2025. The Zacks Consensus Estimate for 2025 revenues stands at $4.1 billion.
For 2026-2028, management expects sales to grow at a CAGR of more than 25%, driven by new product launches. This revised guidance was lower than the sales guidance issued by MRNA last year. Per the previous guidance, management expected an additional $10-$15 billion in annual sales of cancer, rare and latent disease therapies by 2028.
Post the announcement, shares of Moderna were down more than 12% on Thursday. The above sales guidance did not sit well with investors which were either lowered by management or were below Wall Street expectations.
In the year so far, the stock declined 29.9% compared with the industry’s 0.8% fall.
Image Source: Zacks Investment Research
Other Financial Guidance
The company projects selling, general and administrative (SG&A) expenses for 2025 to be between $1.0 billion and $1.2 billion. For 2026-2028, management expects selling expenses to rise incrementally while the general and administrative portion of the expenses is expected to remain flat during this period.
Moderna also said it plans to break even on an operating cash cost basis in 2028, two years later than the previously announced goal of 2026.
Pipeline Updates
Cancer Therapy
Moderna is developing mRNA-4157, an investigational individualized neoantigen therapy (INT), in partnership with Merck (MRK - Free Report) . Moderna/Merck are evaluating mRNA-4157 in two pivotal phase III studies for melanoma and non-small cell lung cancer (NSCLC) indications. Since the onset of this year, Moderna/Merck initiated three new clinical studies evaluating mRNA-4157 across cutaneous squamous cell carcinoma (CSCC), renal cell carcinoma and muscle-invasive bladder cancer indications.
Both Moderna and Merck intend to focus on the late-stage studies evaluating mRNA-4157. The companies have been engaged in discussions with the FDA, which does not support accelerated approval based on data from mid-stage studies.
Influenza Vaccine
Management provided an update on its seasonal influenza vaccine candidate, mRNA-1010. It plans to start a confirmatory late-stage study evaluating mRNA-1010’s vaccine efficacy, using funds secured from Blackstone Life Sciences. The company had previously planned to seek accelerated approval from the FDA based on data from previously completed clinical studies on the vaccine.
Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with GSK plc’s (GSK - Free Report) Fluarix and Sanofi’s (SNY - Free Report) Fluzone HD. The GSK vaccine is approved for use in individuals aged six months and older. The Sanofi vaccine is approved for use in older adults aged 65 years and above.
Others
Moderna is evaluating its CMV vaccine candidate mRNA-1647 in the pivotal phase III CMVictory study in women aged 16 to 40 years. Data from this study is expected as early as 2024-end.
Management announced plans to start a pivotal late-stage study on its norovirus vaccine candidate mRNA-1403. It is also on track to begin generating pivotal data from separate phase I/II studies on its methylmalonic acidemia (MMA) and propionic acidemia (PA) therapies.
Our Take
Moderna, once a financial powerhouse due to its COVID-19 vaccine, is now facing uncertainty in maintaining demand for its COVID-19 vaccine. The company's revenue forecasts for its RSV vaccines also remain uncertain, given the recently issued CDC recommendations, which trim down a market that already has two major competitors — GSK and Pfizer. The FDA's reluctance to grant accelerated approval to mRNA-4157 dampens the prospect of an early product launch.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
MRNA Zacks Rank
Moderna currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.