Shares of Moderna (MRNA) plunged on Thursday after the company lowered its sales outlook for fiscal 21 and said that some of its planned Covid-19 vaccine deliveries will move into 2022.

EARNINGS: Moderna on Thursday morning reported third-quarter earnings per share of $7.70 and revenue of $5B, falling short of analysts' consensus estimates of $9.05 and $6.21B, respectively. At the same time, quarterly results were higher than a year ago, before the approval of Moderna's Covid-19 vaccine, when the company reported revenue of just $157M.

In a statement, CEO Stephane Bancel said: "We will not rest until our vaccine is available to anyone who needs it, and we are working hard to ensure our vaccine is available in low-income countries with approximately 10% of our 2021 volume and significantly more of our 2022 volume going to low-income countries. It is promising to see the real-world evidence showing that the Moderna COVID-19 vaccine shows sustainably high, durable efficacy,"

Looking ahead, Bancel said Moderna recently dosed the first participants in the Phase 3 study of its CMV vaccine and said the company looks forward to sharing data from the Phase 1 study of its flu vaccine candidate "soon."

PRODUCT SALES CUT: Moderna forecast fiscal 2021 product sales of $15B-$18B. The company said key variables impacting FY21 revenues include fewer doses for delivery in 2021 that will be shifted to early 2022. The company expects deliveries of its COVID-19 vaccine in FY21 to be between 700 million and 800 million doses at the 100 microgram dose level. In August, the company said it had signed agreements for sales of $20B, but Moderna cited longer delivery lead times for international shipments and other factors affecting the company’s production growth as reasons why some of the shots will be delivered in 2022 instead.

FY22 OUTLOOK: For fiscal 2022, Moderna sees revenue of $17B-$22B, in line with the $20.08B consensus. The company has signed approximately $17B of advance purchase agreements for delivery in 2022, it said. Subject to receipt of a BLA or sBLA for boosters prior to the fall booster season, the company anticipates commercial booster market sales could be up to $2B, it added.

WHAT'S NOTABLE: Pfizer (PFE) and BioNTech (BNTX) recently received approval for their Covid-19 vaccine for use in 5- to 11- year olds. Moderna has asked the Food and Drug Administration to authorize its vaccine for use in 12- to 17-year-olds, but the decision has been delayed as the agency evaluates whether the shots raise the risk of myocarditis after vaccination in boys. On October 31, Moderna said "The safety of vaccine recipients is of paramount importance to Moderna. The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence." It added that it will delay its request for EUA of mRNA-1273 at the 50 microgram dose level in the pediatric population while the FDA completes its review of the adolescent EUA request.

PRICE ACTION: In morning trading, Moderna shares are down nearly 17% to $288.59.