Moderna Highlights Respiratory Product Pipeline at JP Morgan Healthcare Conference

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Sales of Moderna’s COVID-19 vaccine dropped from $18.4 billion in 2022 to $6.7 billion in 2023, which was ultimately above projections, the company announced in a business update presented at the at 42nd annual JP Morgan Healthcare Conference.^1,2

The significant decline in people seeking immunizations for COVID-19 products last year comes at a time when the virus is still surging worldwide. The decline resulted in shares of Moderna dropping by approximately 45% last year; however, the shares are up more than 60% following a drop to approximately $70 per share in November 2023. Moderna projected that it would reach the lower end of its forecast range of $6 billion to $8 billion.¹

"In 2023, we achieved $6.7 billion in product sales and resized our COVID-19 manufacturing footprint for the endemic setting. Our team significantly increased our COVID-19 market share to 48% in the US," Stéphane Bancel, chief executive officer of Moderna, said in a press release. "We are preparing for the launch of Moderna's second product, our [respiratory syncytial virus (RSV)] vaccine. 2024 is going to be an exciting year for the Company with multiple milestones across our nine late-stage programs. Through these product launches, we are focused on returning to sales growth in 2025."¹

The $6.7 billion in unaudited sales includes approximately $6.1 billion in COVID-19 vaccine sales, and approximately $0.6 billion of deferred revenue related to its efforts with GAVI, The Vaccine Alliance, the company stated. Cash, cash equivalents, and investments at the end of last year exceeded $13 billion.

In its forecast for its COVID-19 franchise this year, Moderna projects profitability in anticipated sales scenarios for 2024 and into the future. It currently projects approximately $4 billion in product sales in 2024, most of which it anticipates in the second half of 2024, mainly from COVID-19 vaccine sales and the launch of its mRNA-based RSV vaccine.

Findings from a pivotal Phase III trial demonstrated favorable clinical safety and efficacy data for the investigational RSV vaccine mRNA-1345. In findings published in The New England Journal of Medicine, a single dose of the vaccine produced lower incidence of RSV-associated lower respiratory tract disease (LRTD) as well as RSV-associated acute respiratory disease compared with placebo in those aged 60 years and older.³

mRNA-1345 consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein and uses the same lipid nanoparticles as the Moderna COVID-19 vaccines. In July, Moderna filed marketing authorization submissions for mRNA-1345 for the prevention of RSV-associated LRTD and acute respiratory disease in adults aged 60 years and older.⁴

Moderna stated that it expects regulatory approvals beginning in the first half of 2024.

“Moderna will enter the RSV market with a strong competitive profile as the only pre-filled syringe product available at the time of launch, along with robust efficacy data, a well-established safety and tolerability profile, and widespread consumer awareness and demand established in 2023,” the company stated in a press release.¹

In terms of other Moderna respiratory vaccines, the next-generation, refrigerator-stable COVID-19 vaccine mRNA-1283 is currently in a pivotal Phase III study, with data expected during the first half of 2024.

The seasonal flu vaccine mRNA-1010 produced consistently acceptable safety and tolerability results in a trio of Phase III trials. In the P303 trial, the vaccine achieved all immunogenicity endpoints, showing higher titers compared to a currently licensed vaccine. Moderna said it intends to file for approval in 2024. A Phase III trial of Moderna’s combination seasonal flu and COVID-19 vaccine mRNA-1083 has completed enrollment, with data expected this year.

A pivotal Phase III study of the company’s cytomegalovirus vaccine candidate mRNA-1647 has completed enrollment and is accruing cases to analyze its efficacy, safety, and immunogenicity in preventing primary infection in women of childbearing age. Efficacy data are expected in 2024.

In oncology, Moderna’s individualized neoantigen therapy (INT) mRNA-4157 showed a potential clinical benefit in Phase III trials. The clinical program, conducted in partnership with Merck, is enrolling patients with resected high-risk (stage III/IV) melanoma and completely resected stage II, IIIA, or IIIB non-small cell lung cancer. For 2024, Moderna said both companies are accelerating these clinical studies to address additional tumor types in 2024.

The results of a three-year analysis of a Phase IIb study analyzing INT in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in patients with resected high-risk melanoma showed improved recurrence-free survival, with a 49% lower risk of recurrence or death and a 62% drop in the risk of developing distant metastasis or death.

Moderna said it anticipates returning to organic sales growth in 2025, projecting to break even in 2026 following product launches and disciplined investment.

References

1. Moderna Provides Business and Pipeline Updates at 42nd Annual J.P. Morgan Healthcare Conference. Moderna. News release. January 9, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Provides-Business-and-Pipeline-Updates-at-42nd-Annual-J.P.-Morgan-Healthcare-Conference/default.aspx

2. Moderna Announces Advances Across mRNA Pipeline and Provides Business Update. Moderna. News release. January 9, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Advances-Across-mRNA-Pipeline-and-Provides-Business-Update/default.aspx

3. Wilson E, et al. Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. Journal Article. 2023. New England Journal of Medicine. PG - 2233-2244. VI - 389 IP - 24 DOI: 10.1056/NEJMoa2307079. https://www.nejm.org/doi/full/10.1056/NEJMoa2307079. December 14, 2023 389(24):2233. Accessed January 10, 2024.

4. Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345. News release. Moderna. July 5, 2023. Accessed January 10, 2024. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Global-Regulatory-Submissions-For-Its-Respiratory-Syncytial-Virus-RSV-Vaccine-MRNA-1345/default.aspx