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Moderna (MRNA) Q4 Earnings Top, COVID-19 Vaccine Brings $7B
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Moderna Inc. (MRNA - Free Report) reported earnings of $11.29 per share for the fourth quarter of 2021, comfortably beating the Zacks Consensus Estimate of $9.83. The company had incurred a loss of 69 cents per share in the year-ago quarter. The significant improvement in the bottom line was driven by strong year-over-year growth in revenues.
Revenues in the quarter were $7.2 billion, beating the Zacks Consensus Estimate of $6.71 billion. In the year-ago quarter, revenues were $571 million. The significant increase in revenues was driven by the strong sales of its coronavirus vaccine, which is now approved or authorized for temporary/emergency use in several countries.
Moderna’s shares were up 4% in pre-market trading on Feb 24, following strong quarterly results. Shares of the company have declined 8.6% in the past year compared with the industry’s 38% decrease.
Image Source: Zacks Investment Research
Quarter in Details
Product sales, entirely from the COVID-19 vaccine, were $6.94 billion during the quarter. In the third quarter of 2021, product sales were $4.8 billion. The company delivered 297 million doses of its COVID-19 vaccine during the fourth quarter. The company had recorded product sales of $200 million in the year-ago period from delivery of 13 million doses following its first authorization in December 2020.
Grant revenues were $262 million compared with $341 million in the year-ago quarter. The company has had a funding commitment from BARDA in place since 2020 to develop its coronavirus vaccine candidate.
Collaboration revenues were $14 million compared with $30 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 $201 million compared with $79 million in the year-ago quarter. The significant increase was primarily attributable to increased headcount and commercialization-related activities for the mRNA-1273 vaccine.
Research & development expenses were $648 million, down 14.6% from the year-ago period. The decline was largely due to lower pre-launch inventory costs related to Spikevax, which was partially offset by rising clinical development costs for its pipeline.
The company ended the quarter with $17.6 billion in cash and cash equivalents, compared with $15.3 billion as of Sep 30, 2021.
Full-Year Results
Moderna reported revenues of $18.5 billion for 2021 compared with $803 million in 2020. In 2021, the company recorded earnings of $28.29 per share against a loss of $1.96 per share in the year-ago period.
2022 Guidance
Moderna has several advance purchase agreements for its COVID-19 vaccine with multiple countries for 2022 worth $19 billion. These agreements also include an option for the delivery of potential updated COVID-19 vaccine booster candidates aggregating to $3 billion.
The company has secured firm orders for the delivery of Spikevax to the United Kingdom, Canada, Taiwan, and Kuwait in 2023. It is currently in discussion for additional orders in 2023.
Coronavirus Vaccine Update
In January, the FDA approved Moderna’s biologics license application for its COVID-19 vaccine, mRNA-1273. The primary two-dose regimen of the vaccine has also received authorization for use in adolescents in many countries including Europe.
However, authorization for the use in adolescents of mRNA-1273 is pending in the United States. The FDA is yet to conclude on the benefit-risk profile of the primary two-dose regimen of the vaccine in this population. In October 2021, the FDA had informed that it will not be able to complete the review before January 2022.
During the fourth quarter, the booster of Moderna’s COVID-19 vaccine was authorized for use in adults in many countries including the United States and Europe.
The company is currently evaluating the primary two-dose regimens for use in children below 12 years. It is also evaluating an Omicron-specific booster candidate in a clinical study.
Along with the earnings release, Moderna announced that it would develop a bivalent COVID-19 vaccine booster candidate, mRNA-1273.214. The booster candidate will combine the Omicron-specific booster candidate and mRNA-1273 — developed to protect against the original COVID-19 strain.
Other Key Pipeline Updates
Moderna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. The leading among them are mRNA-1345 and mRNA-1647, evaluated in pivotal studies as a respiratory syncytial virus (RSV) vaccine and a cytomegalovirus (CMV) vaccine, respectively.
Along with the press release, Moderna announced two new development candidates — mRNA-1608 and mRNA-1468 — as Herpes simplex virus (HSV) therapeutic vaccine candidate and Varicella-zoster virus (VZV) vaccine candidate.
During the fourth quarter, the company initiated dosing in a phase I study evaluating its HIV vaccine mRNA-1644.
Moderna has regained all rights to its mutant KRAS vaccine, mRNA-5671, from its partner, Merck. Moderna is evaluating the next steps for the program. Currently, Merck is conducting a phase I study on mRNA-5671 as monotherapy or in combination with its anti-PD 1 drug, Keytruda. Please note that Moderna continues to develop personalized cancer vaccine candidate in collaboration with Merck.
Moderna is also developing different candidates in collaboration with AstraZeneca. The candidate under the collaboration with AstraZeneca is in early- to mid-stage studies targeting oncology and cardiovascular indications. The leading candidate being developed in partnership with AstraZeneca is AZD8601 as a treatment for ischemic heart disease in a phase II study.
Moderna is developing an mRNA therapeutic in collaboration with Vertex. Moderna and Vertex are developing the candidate to treat the underlying cause of cystic fibrosis. Vertex is planning to file an investigational new drug application to support the initiation of an early-stage clinical study in 2022.
Image: Bigstock
Moderna (MRNA) Q4 Earnings Top, COVID-19 Vaccine Brings $7B
Moderna Inc. (MRNA - Free Report) reported earnings of $11.29 per share for the fourth quarter of 2021, comfortably beating the Zacks Consensus Estimate of $9.83. The company had incurred a loss of 69 cents per share in the year-ago quarter. The significant improvement in the bottom line was driven by strong year-over-year growth in revenues.
Revenues in the quarter were $7.2 billion, beating the Zacks Consensus Estimate of $6.71 billion. In the year-ago quarter, revenues were $571 million. The significant increase in revenues was driven by the strong sales of its coronavirus vaccine, which is now approved or authorized for temporary/emergency use in several countries.
Moderna’s shares were up 4% in pre-market trading on Feb 24, following strong quarterly results. Shares of the company have declined 8.6% in the past year compared with the industry’s 38% decrease.
Image Source: Zacks Investment Research
Quarter in Details
Product sales, entirely from the COVID-19 vaccine, were $6.94 billion during the quarter. In the third quarter of 2021, product sales were $4.8 billion. The company delivered 297 million doses of its COVID-19 vaccine during the fourth quarter. The company had recorded product sales of $200 million in the year-ago period from delivery of 13 million doses following its first authorization in December 2020.
Grant revenues were $262 million compared with $341 million in the year-ago quarter. The company has had a funding commitment from BARDA in place since 2020 to develop its coronavirus vaccine candidate.
Collaboration revenues were $14 million compared with $30 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 $201 million compared with $79 million in the year-ago quarter. The significant increase was primarily attributable to increased headcount and commercialization-related activities for the mRNA-1273 vaccine.
Research & development expenses were $648 million, down 14.6% from the year-ago period. The decline was largely due to lower pre-launch inventory costs related to Spikevax, which was partially offset by rising clinical development costs for its pipeline.
The company ended the quarter with $17.6 billion in cash and cash equivalents, compared with $15.3 billion as of Sep 30, 2021.
Full-Year Results
Moderna reported revenues of $18.5 billion for 2021 compared with $803 million in 2020. In 2021, the company recorded earnings of $28.29 per share against a loss of $1.96 per share in the year-ago period.
2022 Guidance
Moderna has several advance purchase agreements for its COVID-19 vaccine with multiple countries for 2022 worth $19 billion. These agreements also include an option for the delivery of potential updated COVID-19 vaccine booster candidates aggregating to $3 billion.
The company has secured firm orders for the delivery of Spikevax to the United Kingdom, Canada, Taiwan, and Kuwait in 2023. It is currently in discussion for additional orders in 2023.
Coronavirus Vaccine Update
In January, the FDA approved Moderna’s biologics license application for its COVID-19 vaccine, mRNA-1273. The primary two-dose regimen of the vaccine has also received authorization for use in adolescents in many countries including Europe.
However, authorization for the use in adolescents of mRNA-1273 is pending in the United States. The FDA is yet to conclude on the benefit-risk profile of the primary two-dose regimen of the vaccine in this population. In October 2021, the FDA had informed that it will not be able to complete the review before January 2022.
During the fourth quarter, the booster of Moderna’s COVID-19 vaccine was authorized for use in adults in many countries including the United States and Europe.
The company is currently evaluating the primary two-dose regimens for use in children below 12 years. It is also evaluating an Omicron-specific booster candidate in a clinical study.
Along with the earnings release, Moderna announced that it would develop a bivalent COVID-19 vaccine booster candidate, mRNA-1273.214. The booster candidate will combine the Omicron-specific booster candidate and mRNA-1273 — developed to protect against the original COVID-19 strain.
Other Key Pipeline Updates
Moderna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. The leading among them are mRNA-1345 and mRNA-1647, evaluated in pivotal studies as a respiratory syncytial virus (RSV) vaccine and a cytomegalovirus (CMV) vaccine, respectively.
Along with the press release, Moderna announced two new development candidates — mRNA-1608 and mRNA-1468 — as Herpes simplex virus (HSV) therapeutic vaccine candidate and Varicella-zoster virus (VZV) vaccine candidate.
During the fourth quarter, the company initiated dosing in a phase I study evaluating its HIV vaccine mRNA-1644.
Moderna has regained all rights to its mutant KRAS vaccine, mRNA-5671, from its partner, Merck. Moderna is evaluating the next steps for the program. Currently, Merck is conducting a phase I study on mRNA-5671 as monotherapy or in combination with its anti-PD 1 drug, Keytruda. Please note that Moderna continues to develop personalized cancer vaccine candidate in collaboration with Merck.
Moderna is also developing different candidates in collaboration with AstraZeneca. The candidate under the collaboration with AstraZeneca is in early- to mid-stage studies targeting oncology and cardiovascular indications. The leading candidate being developed in partnership with AstraZeneca is AZD8601 as a treatment for ischemic heart disease in a phase II study.
Moderna is developing an mRNA therapeutic in collaboration with Vertex. Moderna and Vertex are developing the candidate to treat the underlying cause of cystic fibrosis. Vertex is planning to file an investigational new drug application to support the initiation of an early-stage clinical study in 2022.
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.