Moderna (MRNA) reported a strong third quarter Wednesday, boosted by ongoing advance purchase agreements, totaling $21 billion for the year, and an in-demand COVID-19 pipeline.
The U.S. government recently purchased 70 million more doses, including 4 million pediatric doses, for a fall booster campaign— which the Biden administration hopes to begin by next month. The $1.8 billion purchase represents a fraction of the 300 million dose total the U.S. has the option to exercise this year.
Moderna's earlier estimates for a BA.4/BA.5 variant-specific booster, which the U.S. government wants for the fall campaign, targeted October or November.
CEO Stéphane Bancel told Yahoo Finance Wednesday the company is in talks with the U.S. government, even as it prepares to start clinical trials for the specific booster this month.
"We are working really hard to get this to early fall. We are already making the BA.4/5 vaccine as we speak," Bancel said.
"We'll give more data as as we get closer to it, but we know how important it is. And know every day matters," he added.
Global demand outlook
The world is firmly in an oversupply situation for the original formulation of the vaccine, resulting in millions of unused doses as a result of reduced deliveries to the COVAX global distribution program and deferral of deliveries in Europe, according to the company's statement.
That has resulted in a loss of "$499 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, as well as a loss on firm purchase commitments of $184 million and an expense for unutilized external manufacturing capacity of $131 million," the company said.
Still, Moderna anticipates an uptick in sales by the fourth quarter based on its variant-specific boosters.
Europe has asked for an Omicron-specific booster while the U.S. is focused on a BA.4/BA.5 booster. Meanwhile, the company is looking for demand in other countries for variant-specific boosters later this year.
The COVAX countries are likely not to have any additional orders this year, and advance purchase orders for 2023 are still unknown.
Going Commercial in 2023
Meanwhile, the company has its sights set on a shift in market demand in 2023, and the potential to become part of a more competitive second generation COVID-19 vaccine market.
That would be geared towards seasonal shots and increased focus on non-government purchases, the company said Wednesday.
Moderna expects that by next year, the market will be far more fragmented than it currently is, and is already in talks with insurers, commercial distributors and pharmacies to set the framework for its debut on the private market.
To-date its sales have been to governments and public health authorities. The company anticipates that will continue abroad, but it is also looking for ex-U.S. private markets, according to the company's earnings guidance Wednesday.
Moderna's booster market share is largely in Europe and Asia, which contained the bulk of its total sales to-date for 2022.
Europe accounted for $3.9 billion and Asia-Pacific $3 billion of the $10.5 billion total through June of this year. The U.S. accounted for $2.7 billion.
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