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Moderna (MRNA) Q3 Earnings Miss, COVID-19 Vaccine Brings $5B
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Moderna Inc. (MRNA - Free Report) reported earnings of $7.70 per share for the third quarter of 2021, missing the Zacks Consensus Estimate of $8.96. The company had incurred a loss of 59 cents per share in the year-ago quarter. The significant growth in earnings was driven by strong year- over-year growth in revenues.
Revenues in the quarter were $4.97 billion, significantly missing the Zacks Consensus Estimate of $6.05 billion. In the year-ago quarter, revenues were $157 million. The significant increase in revenues was driven by the sales of its coronavirus vaccine, which is now approved for temporary/emergency use in several countries. Moreover, grants from an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) related to the development of the COVID-19 vaccine also drove revenues.
Moderna’s shares were down 13.8% in pre-market trading on Nov 4, following dismal third-quarter results. However, shares of the company have surged 231.2% so far this year against the industry’s 6.8% decrease.
Image Source: Zacks Investment Research
Quarter in Details
In December, Moderna received approval for the emergency use of its coronavirus vaccine, mRNA-1273. With this approval, the company got its first commercial product and recorded product revenues for the first time. The company received emergency use approval for mRNA-1273 by the World Health Organization (WHO) and health agencies in more than 60 countries.
Product sales, entirely from the COVID-19 vaccine, were $4.8 billion during the quarter. In the second quarter of 2021, product sales were $4.2 billion.
Grant revenues were $140 million compared with $145 million in the year-ago quarter. The company has a funding commitment from BARDA in place since last year to develop its coronavirus vaccine candidate.
Collaboration revenues were $19 million compared with $12 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) .
Selling, general and administrative expenses were $168 million compared with $48 million in the year-ago quarter. The significant increase was primarily attributable to increased headcount and commercialization-related activities for mRNA-1273 vaccine.
Research & development expenses were $521 million, up 51.5% from the year-ago period. The rise was largely due to increased higher clinical development costs for mRNA-1273.
The company ended the quarter with $15.3 billion in cash and cash equivalents, compared with $12.2 billion as of Jun 30, 2021.
2021 Guidance
Moderna expects products sales to be between $15 billion and $18 billion in 2021. The company had previously stated that it has advance purchase agreements for its COVID-19 vaccine worth $20 billion in place. However, the supply of some doses, scheduled for 2021, needs to be shifted to 2022 for certain factors including longer delivery lead times for international shipments.
Coronavirus Vaccine Update
Along with the earnings release, Moderna announced that the FDA has granted priority review to its biologics license application seeking approval for its COVID-19 vaccine, mRNA-1273. A decision is expected in April 2022.
During the quarter and last month, the COVID-19 vaccine was authorized for emergency use in adolescents in several countries including the European Union. However, the FDA extended the review period for Moderna’s authorization request for the use of the vaccine in adolescents to evaluate recent international analyses of the risk of myocarditis after vaccination. The review may not be completed before January 2022.
Last month, the booster dose of the vaccine was authorized for emergency use in the United States, Europe and several other health agencies across the world. The company is currently developing four variant-specific booster doses of its COVID-19 vaccine, with three being evaluated in phase II/III studies.
The company is engaged in discussions with the governments of different countries for advance purchase agreements for its COVID-19 vaccine and booster doses to supply in 2022 and 2023. The company has already signed similar agreements for initial doses worth approximately $17 billion along with options for additional doses worth approximately $3 billion for 2022. The company anticipates commercial booster market sales to be up to $2 billion in 2022.
Moderna announced new data from the phase II KidCOVE study, which demonstrated that the administration of the vaccine at the 50 µg dose level achieved 100% efficacy after two weeks of the first dose in children aged 6 years to under 12 years. The study continues to evaluate the vaccine in two to under six years and six months to under two years age groups.
A late-stage study is evaluating the vaccine in adults with a kidney or liver transplant. A phase I study is evaluating the company’s next-generation COVID-19 vaccine candidate, mRNA-1283. Initial data from the study were encouraging and the company is planning to start a phase II study shortly.
Other Key Pipeline Updates
Moderna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. Key among them are mRNA-1647 and mRNA-1345.
The company initiated a late-stage study to evaluate mRNA-1647 as a cytomegalovirus vaccine last month. A phase II/III study to evaluate mRNA-1345 as respiratory syncytial virus vaccine is expected to start later this year. Moderna is also developing a combination vaccine against coronavirus and flu virus.
Image: Bigstock
Moderna (MRNA) Q3 Earnings Miss, COVID-19 Vaccine Brings $5B
Moderna Inc. (MRNA - Free Report) reported earnings of $7.70 per share for the third quarter of 2021, missing the Zacks Consensus Estimate of $8.96. The company had incurred a loss of 59 cents per share in the year-ago quarter. The significant growth in earnings was driven by strong year- over-year growth in revenues.
Revenues in the quarter were $4.97 billion, significantly missing the Zacks Consensus Estimate of $6.05 billion. In the year-ago quarter, revenues were $157 million. The significant increase in revenues was driven by the sales of its coronavirus vaccine, which is now approved for temporary/emergency use in several countries. Moreover, grants from an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) related to the development of the COVID-19 vaccine also drove revenues.
Moderna’s shares were down 13.8% in pre-market trading on Nov 4, following dismal third-quarter results. However, shares of the company have surged 231.2% so far this year against the industry’s 6.8% decrease.
Quarter in Details
In December, Moderna received approval for the emergency use of its coronavirus vaccine, mRNA-1273. With this approval, the company got its first commercial product and recorded product revenues for the first time. The company received emergency use approval for mRNA-1273 by the World Health Organization (WHO) and health agencies in more than 60 countries.
Product sales, entirely from the COVID-19 vaccine, were $4.8 billion during the quarter. In the second quarter of 2021, product sales were $4.2 billion.
Grant revenues were $140 million compared with $145 million in the year-ago quarter. The company has a funding commitment from BARDA in place since last year to develop its coronavirus vaccine candidate.
Collaboration revenues were $19 million compared with $12 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) .
Selling, general and administrative expenses were $168 million compared with $48 million in the year-ago quarter. The significant increase was primarily attributable to increased headcount and commercialization-related activities for mRNA-1273 vaccine.
Research & development expenses were $521 million, up 51.5% from the year-ago period. The rise was largely due to increased higher clinical development costs for mRNA-1273.
The company ended the quarter with $15.3 billion in cash and cash equivalents, compared with $12.2 billion as of Jun 30, 2021.
2021 Guidance
Moderna expects products sales to be between $15 billion and $18 billion in 2021. The company had previously stated that it has advance purchase agreements for its COVID-19 vaccine worth $20 billion in place. However, the supply of some doses, scheduled for 2021, needs to be shifted to 2022 for certain factors including longer delivery lead times for international shipments.
Coronavirus Vaccine Update
Along with the earnings release, Moderna announced that the FDA has granted priority review to its biologics license application seeking approval for its COVID-19 vaccine, mRNA-1273. A decision is expected in April 2022.
During the quarter and last month, the COVID-19 vaccine was authorized for emergency use in adolescents in several countries including the European Union. However, the FDA extended the review period for Moderna’s authorization request for the use of the vaccine in adolescents to evaluate recent international analyses of the risk of myocarditis after vaccination. The review may not be completed before January 2022.
Last month, the booster dose of the vaccine was authorized for emergency use in the United States, Europe and several other health agencies across the world. The company is currently developing four variant-specific booster doses of its COVID-19 vaccine, with three being evaluated in phase II/III studies.
The company is engaged in discussions with the governments of different countries for advance purchase agreements for its COVID-19 vaccine and booster doses to supply in 2022 and 2023. The company has already signed similar agreements for initial doses worth approximately $17 billion along with options for additional doses worth approximately $3 billion for 2022. The company anticipates commercial booster market sales to be up to $2 billion in 2022.
Moderna announced new data from the phase II KidCOVE study, which demonstrated that the administration of the vaccine at the 50 µg dose level achieved 100% efficacy after two weeks of the first dose in children aged 6 years to under 12 years. The study continues to evaluate the vaccine in two to under six years and six months to under two years age groups.
A late-stage study is evaluating the vaccine in adults with a kidney or liver transplant. A phase I study is evaluating the company’s next-generation COVID-19 vaccine candidate, mRNA-1283. Initial data from the study were encouraging and the company is planning to start a phase II study shortly.
Other Key Pipeline Updates
Moderna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. Key among them are mRNA-1647 and mRNA-1345.
The company initiated a late-stage study to evaluate mRNA-1647 as a cytomegalovirus vaccine last month. A phase II/III study to evaluate mRNA-1345 as respiratory syncytial virus vaccine is expected to start later this year. Moderna is also developing a combination vaccine against coronavirus and flu virus.
Moderna, Inc. Price, Consensus and EPS Surprise
Moderna, Inc. price-consensus-eps-surprise-chart | Moderna, Inc. Quote
Zacks Rank
Currently, Moderna carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.