Moderna, a biotechnology company specialising in mRNA medicines and vaccines, entered 2024 with 45 therapeutic and vaccine programmes, including nine in late-stage development. The company outlined an ambitious pipeline strategy, anticipated approximately $4 billion in product sales for 2024 and identified several clinical and regulatory milestones expected during 2024 and 2025.

Moderna, Inc., a biotechnology company developing mRNA-based therapeutics and vaccines, announced its business strategy and pipeline priorities for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference. Its plans focused on advancing nine late-stage programmes, preparing for the launch of its respiratory syncytial virus (RSV) vaccine and progressing candidates across infectious diseases, oncology and rare diseases.

“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 U.S,” stated Stéphane Bancel, Chief Executive Officer of Moderna. He added, “We are preparing for the launch of Moderna’s second product, our 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.”

The company reported approximately $6.7 billion in unaudited 2023 product sales. This figure included approximately $6.1 billion in COVID-19 vaccine sales and around $0.6 billion in deferred revenue recognised in connection with its work with Gavi, the Vaccine Alliance. Moderna also reported that its US COVID-19 vaccine market share had increased to 48% for the 2023 season to date, compared with 37% in 2022.

In a detailed presentation at the 42nd Annual J.P. Morgan Healthcare Conference, Moderna outlined its late-stage development pipeline and anticipated milestones for 2024 and 2025.

Respiratory vaccines

Moderna had submitted its RSV vaccine candidate, mRNA-1345, for regulatory approval for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 and older. The company expected regulatory approvals to begin in the first half of 2024. At the time of the announcement, the vaccine remained an investigational product awaiting regulatory decisions.

The company also highlighted its next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, currently in a pivotal Phase 3 study, with results expected in the first half of 2024.

The seasonal flu vaccine, mRNA-1010, had demonstrated acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 study (P303), the candidate met all immunogenicity endpoints, producing higher antibody titres than a currently licensed seasonal influenza vaccine. Moderna was in discussions with regulatory authorities and intended to submit an application in 2024.

Furthermore, Moderna’s pipeline includes a combination vaccine against seasonal flu and COVID-19, mRNA-1083. Its Phase 3 study was fully enrolled, and the company anticipated data in 2024.

Latent and other vaccines

Another important programme was the cytomegalovirus (CMV) vaccine candidate mRNA-1647. Its pivotal Phase 3 study was fully enrolled and accruing cases. The trial was evaluating efficacy, safety and immunogenicity in preventing primary CMV infection in women of childbearing age. Moderna anticipated potentially reporting efficacy data in 2024.

Oncology therapeutics

In the oncology sector, Moderna continues to demonstrate the potential clinical benefits of its Individualized Neoantigen Therapy (INT) programme, mRNA-4157 (also known as V940). In partnership with Merck, Phase 3 trials were underway in patients with resected high-risk stage III/IV melanoma and patients with completely resected stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). The companies also planned to expand the clinical development programme to additional tumour types in 2024.

“Compared to KEYTRUDA alone, this combination continued to show an improvement in recurrence-free survival, reducing the risk of recurrence or death by 49%, as well as in distant metastasis-free survival, reducing the risk of developing distant metastasis or death by 62%,” Bancel noted.

These figures came from a three-year follow-up analysis of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, announced by Moderna and Merck in December 2023. In patients with resected high-risk stage III/IV melanoma, the combination of mRNA-4157 and KEYTRUDA (pembrolizumab) reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared with KEYTRUDA alone. The findings were based on a planned analysis and did not establish regulatory approval or confirm the therapy’s benefit in other cancer types.

Rare-disease therapeutics

Moderna’s late-stage pipeline also included programmes for two rare metabolic disorders: propionic acidemia (PA) and methylmalonic acidemia (MMA). The company expected to advance its PA candidate, mRNA-3927, and its MMA candidate, mRNA-3705, into pivotal studies during 2024.

Financial outlook and growth strategy

The company’s financial framework for 2024-2026 projects approximately $4 billion in product sales for 2024, primarily due to COVID-19 vaccine sales and the launch of its RSV vaccine. Moderna anticipates returning to organic sales growth in 2025 and expects to break even in 2026 through product launches and disciplined investment.

Moderna’s development strategy builds on its experience with mRNA technology and its COVID-19 vaccine. The company’s diverse pipeline across infectious diseases, immuno-oncology, rare diseases, and other therapeutic areas demonstrates its commitment to leveraging mRNA technology to address a wide range of medical challenges.

As Moderna looks to the future, its focus remains on delivering transformative mRNA medicines to patients worldwide, aiming to make a significant impact on global healthcare. With a substantial development pipeline and a financial strategy centred on future product launches, the company was positioning itself for a new phase of growth beyond the COVID-19 vaccine market. Whether these objectives would be achieved depended on clinical outcomes, regulatory decisions and market uptake.