Moderna’s stock price on the Nasdaq fell on Friday, by 10%, as its diluted earnings per share from the fourth quarter of 2022 came out at $3.61. That represented a drop of 68% compared to $11.29 from the same period in 2021. Additionally, while the revenue was higher than in 2021, higher costs meant that Moderna’s net income was almost $8.4bn, 31% lower than that of 2021.
Costs growing
Moderna’s growing costs stemmed partly from increases in clinical expenses related to its late-stage vaccine pipeline for respiratory syncytial virus (RSV), seasonal flu and cytomegalovirus (CMV). They also included expenses related to Moderna’s approved COVID-19 vaccine such as the write-off of vaccines that have exceeded their shelf-life and expenses for unused manufacturing space.
At the same time, the company pointed the finger at stagnating demand for its COVID-19 vaccine. As pandemic fatigue sets in, Gavi, the Vaccine Alliance is seeing a fall in vaccine demand around the world and especially in low-income nations.
Expectations for 2023
Going into this year, Moderna expects at least $5b in COVID vaccine sales revenue. Most of the sales are expected in the latter half of 2023.
"2022 was another impressive year for Moderna, with over $19bn in revenue and significant clinical breakthroughs across our portfolio,” said Stéphane Bancel, chief executive officer of Moderna.
“We continue to provide our Omicron-targeting bivalent vaccines worldwide, with the latest real-world evidence highlighting the continued protection of our vaccines against hospitalization and death."
Moderna’s research and development activity remains high in 2023, with 48 programs in development. The company plans to increase its R&D spending from $3.3bn in 2022 to $4.5bn in 2023.
In addition to its COVID-19 vaccine programs, Moderna is working to commercialize its other vaccine candidates. In the first half of 2023, the company plans to submit an application to the US Food and Drug Administration (FDA) for the market approval of its RSV vaccine candidate in older adults. The first potential RSV vaccines are currently in development by Pfizer and GSK, with U.S. FDA decisions expected later this year.
Another vaccine that has big potential for Moderna is its therapeutic cancer vaccine MRNA-4157/V940, which was granted Breakthrough Therapy Designation by the U.S. FDA this week. The candidate, combined with MSD’s immune checkpoint inhibitor Keytruda, wowed the biotech industry in late 2022 when it showed the potential to treat late-stage melanoma in a phase 2b trial.
It’s not all plain sailing for Moderna, however, as its influenza vaccine candidate mRNA-1010 showed mixed results in interim data from a phase 3 trial earlier this month. While the vaccine provided protection from influenza A, mRNA-1010 failed to show that it was as effective against influenza B as an existing vaccine.
Nonetheless, the company has many other non-vaccine projects on the go, having signed a collaboration deal with Life Edit Therapeutics last week to develop in vivo gene editing therapies. And two of its candidates for treating rare genetic diseases were seen as within the five frontrunners in the non-vaccine mRNA therapeutics spaces.