Moderna (MRNA) This autumn Outcomes 2022

Modern on Thursday missed fourth-quarter earnings expectations as costs rose from excess manufacturing capacity and lower demand for its Covid-19 vaccine, the company’s only product on the market.

Moderna reported quarterly earnings of $3.61 per share, down 68% from the same period in 2021 when it posted $11.29 per share. The number fell short of the $4.68 per share Wall Street had been expecting.

The Boston-based biotech generated sales of $5.1 billion in the fourth quarter of 2022, in line with analysts’ expectations but down 30% from the same period in 2021.

Shares of Moderna fell as much as 4% in Thursday morning trading.

Moderna has signed deals for $5 billion worth of Covid vaccine supplies for 2023. The company expects additional sales in the US, Europe and Japan this year, but demand for the vaccines is falling as the pandemic subsides and vaccination is shifted to an annual schedule rather than repeat increases.

The US government also plans to stop buying shots for the public as early as this summer and move sourcing and distribution to the private market. Moderna estimates the U.S. market size at 100 million doses in fall 2023, said Arpa Garay, the company’s chief commercial officer.

Garay would not make any predictions about Moderna’s share of the US market in the fall of 2023. She said the company is in talks with customers about fall contracts.

Here’s how the company has performed versus Wall Street expectations, based on average analyst estimates compiled by Refinitiv:

• Adjusted result: $3.61 per share versus $4.68 expected
• Revenue: $5.1 billion vs. $5 billion expected

Moderna sold $18.4 billion worth of vaccines in 2022, up 4% year over year and the company’s all-time high for sales during the pandemic. The company reported net income of $8.4 billion in 2022, down 31% from 2021.

The company said its costs rose 25% in the fourth quarter. Those expenses included a $297 million write-off for vaccines that have passed their shelf life, $376 million for unused manufacturing capacity, and a $400 million license fee to the National Institute of Allergy and Infectious Diseases.

Though the Covid syringe remains Moderna’s only product on the market, the company plans to seek approval from the Food and Drug Administration for its vaccine, which protects older adults from respiratory syncytial virus, in the first half of this year. after reporting positive data from a clinical trial. Moderna expects FDA approval in late 2023 or early 2024.

Garay said Moderna will use the infrastructure already in place for Covid to bring the RSV vaccine to market. She declined to provide details on how much Moderna will charge for the RSV vaccine, but said the company will ensure patients have access to the vaccine regardless of their ability to pay.

The company has another potential commercial product in the works. Last week, Moderna said its flu vaccine candidate met the immune response target against influenza A, the most common type, in its study but failed against influenza B. Independent data monitors will review initial efficacy results for the vaccine in the first quarter of this year, the company said.

“If we see efficacy, that’s the gold standard for regulatory submissions and full approval,” said Dr. Stephen Hoge, President and Research Director of Moderna, on Thursday. “If we are not yet at that threshold, we look forward to subsequent interim analyzes in this study.”

The FDA has also identified Moderna and Merck’s personalized cancer vaccine as a breakthrough therapy that could accelerate development and regulatory review of the vaccine.