Moderna Q1 reveals COVID-19 vaccine sales stats: Biologics License Application to be submitted this month

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Pic:getty/marchmeena29 (Getty Images/iStockphoto)

Moderna has reported the first profitable quarter in the company’s history: after 10 years of research and several billion dollars of investment in its mRNA platform. The next step will be to start a rolling submission for a Biologics License Application (BLA) for its COVID-19 vaccine with the FDA this month.

Total revenue for the company was $1.9bn in Q1 (three months ended March 31, 2021): compared to $8m for the same period in 2020. Net income was $1.2bn for the quarter, compared to a net loss of $124m the year before.

Sales for 2021 are projected to total $19.2 billion. 

And looking forward, Moderna predicts that 2022 COVID-19 vaccine sales will exceed 2021’s sales.

Facts and stats: Moderna’s COVID-19 vaccine

With Q1 2021 representing the first full quarter of commercial sales of the vaccine (first authorized in December 2020), the company’s revenue increased in the quarter with a ramp up of international sales.

A total of 102 million doses were recognized as revenue: and sales of the vaccine totalled $1.7bn (grant revenue took the company's total up to $1.9bn)

It expects the number of doses to be delivered in Q2 to be in the region of 200-250 million doses.

Across 2021, Moderna has increased its base plan to 800 million doses: with the target of 1 billion doses. Based on the agreements signed to date, it is expecting a total of $19.2bn in sales.

On Tuesday, Pfizer also put figures on its COVID-19 vaccine sales: reporting $3.5bn in sales for Q1 and predicting $26bn for the year.

Past 2021, manufacturing scale up and partnerships mean the company is now in a position to negotiate agreements with markets it could not supply in 2021. Advance Purchase Agreements have already been signed with Israel and Switzerland, with more to follow.

“We are now actively engaged in discussions and agreements for 2022 with all of the governments we are currently supplying for 2021," says the company. 

"On top of that, new partnerships, like COVAX, for up to 466 million doses in 2022 and discussions with new governments in Asia, Middle East, Africa and Latin America, make us believe that our total advance purchase agreements for 2022 should be higher than those in 2021.”

In 2022, Moderna is targeting manufacturing capacity of 3 billion doses: although this figure will depend on the dosage of booster shots and its next generation vaccine. 

Meanwhile, the company has nearly doubled the size of its workforce from around 830 employees in March 2020 to 1,500 employees in March 2021.

In Q1, research and development expenses were $401m compared to $115m for the same period in 2020. The growth in spending was mainly due to increases in clinical trial expenses, manufacturing expenses, personnel related costs, and consulting and outside services, largely driven by mRNA-1273 clinical development (see below) and increased headcount.

In the pipeline: What next for COVID-19 vaccine?

Variants: The company this morning announced the results of its booster study. A single booster dose of 50 μg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1 - 'South Africa' and 'Brazil' strains) in previously vaccinated clinical trial participants.

Younger age groups: Initial analysis of the Phase 2/3 study of mRNA-1273 in adolescents aged 12-17 showed vaccine efficacy against COVID-19 of 96%; no serious safety concerns identified. A Phase 2 study in children aged 6 months to 11 years in ongoing.

Next generation vaccine: A Phase 1 study of mRNA-1283 is ongoing. This candidate, targeting Receptor Binding Domain and N-terminal Domain on the spike protein, is being developed as a potential refrigerator stable mRNA vaccine that will facilitate easier distribution and administration by healthcare providers. mRNA-1283 is intended to be evaluated for use as a booster dose for previously vaccinated or infected individuals as well as in a primary series for seronegative individuals.

Past COVID-19

Moderna currently has 24 mRNA development programs in its portfolio, with 14 having entered clinical studies.

Past COVID-19, its most advanced candidate is its Cytomegalovirus (CMV) vaccine, mRNA-1647, which is due to enter a pivotal Phase 3 study this year. Moderna owns worldwide commercial rights for this vaccine.

Meanwhile, its Epstein-Barr virus (EBV) vaccine, mRNA-1189, is set to start a Phase 1 study this year. (There is no approved vaccine for EBV, and Moderna owns the worldwide commercial rights to mRNA-1189).

Moderna is also due to take its flu and HIV vaccines into Phase 1 trials this year, while its Zika vaccine is due to start a Phase 2 study.

The company’s pipeline also includes cancer vaccines, intratumoral immune-oncology systemic secreted & cell surface therapeutics, and localized regenerative therapeutic programs.