Moderna, a pioneering biotechnology company, has transformed from a research-stage enterprise into a commercial powerhouse with a diverse clinical portfolio spanning infectious diseases, immuno-oncology, rare diseases, and autoimmune conditions. The company's first commercial product, the COVID-19 vaccine Spikevax®, has already impacted hundreds of millions of lives globally. However, Moderna's story extends far beyond its COVID-19 success, as it continues to leverage its mRNA platform to advance a robust pipeline of 40 development candidates across 47 programs, 43 of which are currently in clinical studies.

Financials

In the fiscal year 2023, Moderna reported annual revenue of $6,754 million and a net loss of $4,714 million. The company's annual operating cash flow was negative $3,118 million, and its annual free cash flow was negative $3,825 million. These financial results reflect the significant investments Moderna is making to advance its diverse pipeline and build out its global commercial, regulatory, sales, and manufacturing infrastructure.

During the first quarter of 2024, Moderna reported net product sales of $167 million, a significant decline from the $1,828 million reported in the same period of the prior year. This decrease is indicative of the evolving nature of the endemic COVID-19 vaccine market, which has transitioned toward a more seasonal commercial pattern. The company expects this trend to persist, resulting in further projected reductions in net product sales for its COVID-19 vaccine relative to 2023.

Business Overview

Despite the decline in COVID-19 vaccine sales, Moderna remains focused on its long-term strategy of diversifying its revenue streams and advancing its robust pipeline. The company's COVID-19 vaccine strategy for 2024 is centered on working with public health officials, healthcare providers, and pharmacies to increase vaccination coverage rates, particularly in the United States. In Europe, Moderna is actively participating in the 2024 tender process, which allows for up to 36 million doses per year for up to 4 years. In the Rest of the World, the company has reoriented its commercial teams to prioritize markets for greater commercial focus and impact, as evidenced by the recent contract with Brazil for 4.5 million doses.

Pipeline Progress

Moderna's pipeline progress extends well beyond its COVID-19 vaccine. The company is eagerly awaiting the approval of its respiratory syncytial virus (RSV) vaccine, which is expected to launch into a large market. In its first year, the older adult RSV market was $2.5 billion in sales, and analysts expect the older adults' market to grow between $6 billion and $8 billion per year. Moderna's RSV vaccine has a strong efficacy and safety profile in clinical trials and will be the only product available in a pre-filled syringe (PFS) presentation, which the company believes will ease the burden on pharmacies during the fall respiratory season.

In addition to its respiratory vaccine portfolio, Moderna is making significant strides in its latent virus vaccines, including cytomegalovirus (CMV) and Epstein-Barr virus (EBV). The company's CMV vaccine, mRNA-1647, has fully enrolled its Phase III trial, and Moderna is anticipating potential for Phase III efficacy data in 2024. The EBV vaccine candidate, mRNA-1189, has shown positive Phase I immunogenicity and safety data, and Moderna is now advancing towards pivotal trials.

Moderna's individualized neoantigen therapy (INT) program, developed in collaboration with Merck, continues to demonstrate promising results. The partners have initiated three new randomized clinical studies in additional tumor types in 2024, including a Phase 2 adjuvant treatment in patients with renal cell carcinoma, a Phase 2 adjuvant treatment in patients with high-risk muscle-invasive bladder cancer, and a Phase 2/3 neoadjuvant and adjuvant treatment in patients with cutaneous squamous cell carcinoma.

Liquidity

The company's financial position remains strong, with cash, cash equivalents, and investments totaling approximately $12.2 billion as of March 31, 2024. This robust balance sheet enables Moderna to continue investing in its pipeline and commercial operations. In March 2024, the company entered into a development and commercialization funding arrangement with Blackstone Life Sciences, which will provide up to $750 million in funding to support the advancement of Moderna's investigational mRNA-based influenza vaccine program.

Moderna's commitment to financial discipline is evident in its operating expense management. During the first quarter of 2024, the company's total operating expenses decreased by almost $800 million compared to the same period in 2023. This reduction was driven by lower spending in manufacturing, development, and selling, general, and administrative functions.

Outlook

Looking ahead, Moderna expects net sales for 2024 to be approximately $4 billion, which the company believes will be a low point as it expects to return to growth in 2025. The company anticipates cost of sales to be approximately 35% of product sales for the full year, down from 70% in 2023, reflecting improvements in manufacturing efficiency and expected reductions in inventory write-downs.

Conclusion

Moderna's diversified pipeline, strong financial position, and focus on operational efficiency position the company well to navigate the evolving COVID-19 vaccine market and continue advancing its broader therapeutic and vaccine programs. As the company continues to execute on its strategic priorities, investors will closely monitor the progress of its late-stage clinical candidates, including the RSV vaccine, CMV vaccine, and INT program, as well as the potential launch of its next-generation COVID-19 vaccine and flu vaccine programs.