The biotech Thursday reported that second-quarter sales of its COVID shot dropped 94%. However, it expects $6 billion to $8 billion in revenue this year, up from a previous forecast of $5 billion.
Pictured: Moderna in Cambridge/iStock, hapabapa
While revenue is down, research and development spending is up for post-pandemic Moderna as the biotech looks to diversify its product portfolio. The mRNA company released its second-quarter earnings report Thursday, upping COVID-19 vaccine sales expectations for the rest of the year.
With Spikevax its only approved product, revenue for the second quarter was $344 million as COVID-related sales have dropped off significantly across the industry. By comparison, the same quarter last year brought in revenues of $4.7 billion. Still, Moderna reported a narrower-than-expected loss in the quarter and revenue that beat consensus estimates.
Moderna increased its expected sales for Spikevax to between $6 billion and $8 billion for the year, up from its previous forecast of $5 billion. On the earnings call Thursday, Chief Commercial Officer Arpa Garay said that while the company expects U.S. demand of 50 million to 100 million doses this fall “the key variable” will be vaccination rates. An updated version of Spikevax, targeting the XBB lineage has been submitted for regulatory approval ahead of the fall vaccination season.
“But the fact of the matter is, in this first transition year into a commercial endemic market it is difficult to accurately predict market volumes and predict how many Americans will come in this fall for their shots,” Garay said.
Net income in the second quarter was a $1.4 billion loss, attributed primarily to Moderna’s $1.1 billion R&D investment. R&D for the full year is expected to be $4.5 billion, driven by clinical trial expenses and an increase in headcount to support late-stage efforts. The company has about $14.6 billion on hand in cash.
Moderna is looking to diversify its revenue stream with a pipeline full of mRNA therapeutic candidates, including indications in oncology, cardiovascular, autoimmune and rare disease.
Vaccines for respiratory syncytial virus (RSV), flu and cytomegalovirus (CMV) are in the lead. Regulatory submissions have already been completed in the U.S., Europe and Australia for the RSV vaccine in older adults. Flu vaccine mRNA-1010 is now fully enrolled in a Phase III study with an update expected next quarter. The trial is intended to enable accelerated approval of the shot. The company’s CMV Phase III study is over 80% enrolled.
The company is expecting to launch up to five respiratory vaccines—RSV, seasonal flu, combination vaccines, next-gen COVID and flu—from 2024 to 2026.
Arguably the most anticipated candidate in the pipeline is the company’s partnered individualized neoantigen therapy (INT). Coupled with Merck’s blockbuster Keytruda, the two may have finally found success in the elusive cancer vaccine field.
The INT, mRNA-4157, has proven to reduce risk of recurrence or death by 44% when given with Keytruda to patients with high-risk stage III/IV melanoma after surgery, compared to Keytruda alone. A Phase III study is now commencing for patients with stages IIb through IV with the primary endpoint of recurrence-free survival.
Merck and Moderna are now adding an early-stage trial to assess mRNA-4157 with Keytruda in lung cancer. Moderna is scaling manufacturing to support clinical and commercial development of the personalized treatment, preparing to launch in the next one to three years “in multiple indications,” according to the company’s presentation Thursday.
On the earnings call, CEO Stephane Bancel boasted that this a “new era of diversified revenue stream” for Moderna with a robust pipeline that will result in an “unprecedented number of mRNA launches in a very short time.”
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
