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Moderna (MRNA) Lags on Q4 Earnings, COVID Jab Sales Down Y/Y
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Moderna, Inc. (MRNA - Free Report) reported earnings of $3.61 per share for the fourth quarter of 2022, missing the Zacks Consensus Estimate and our model estimates of $4.66 and $4.48, respectively. Earnings declined 68% in the quarter. The year-over-year decline in the bottom line was due to lower revenues and higher operating expenses incurred during the fourth quarter.
Revenues in the quarter were $5.08 billion, which also missed the Zacks Consensus Estimate of $5.09 billion. Total revenues were down 29.5% year over year due to declining COVID-19 vaccine sales during the quarter. The total revenues were in line with our model estimates.
Moderna’s shares were down 3.4% in pre-market trading on Feb 23, likely due to the lower-than-anticipated earnings reported by management. In the past year, the stock has inched up 1.2% against the industry’s 8.8% fall.
Image Source: Zacks Investment Research
Quarter in Detail
Product sales, entirely from the sale of COVID-19 vaccines, were down 30.0% year over year to $4.86 billion due to lower sales volume compared with the year-ago period’s levels.
Grant and collaboration revenues were $225 million compared with $276 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including Merck (MRK - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) .
Selling, general and administrative expenses were $375 million, up 87% year over year. The upside can be attributed to increased spending in commercialization activities to support the company’s marketed products.
Research & development expenses were $1.2 billion, up 87% from the year-ago period’s levels. The significant increase was primarily attributable to higher clinical costs and personnel-related expenses.
The company ended the quarter with $18.2 billion in cash and cash equivalents compared with $17.0 billion as of Sep 30, 2022.
Full-Year Results
Moderna reported revenues of $19.3 billion for 2022, up 4.3% year over year.
For the full year, the company reported earnings of $20.12, down 29% year over year.
2023 Guidance
Moderna reiterated its product revenue guidance for 2023. Management expects to record a minimum of around $5.0 billion from COVID vaccine sales in 2023, based on confirmed advance purchase agreements and contract deferrals. Management also reported that this figure does not include product sales in the United States or new contracts with Europe, Japan and other key markets. The company expects to record approximately $2.0 billion in product sales in first-half 2023.
The company maintained combined R&D and SG&A expenses to be approximately $6 billion in 2022, with approximately $4.5 billion in R&D. It expects capital expenditure to be around $1.0 billion.
Pipeline Updates
Currently, Moderna has 48 programs in active development, with 38 programs undergoing clinical studies.
Moderna has three late-stage candidates — mRNA-1647, mRNA-1345 and mRNA-1010 — in its pipeline, which are being developed as cytomegalovirus (CMV) vaccine, respiratory syncytial virus (RSV) vaccine and influenza vaccine, respectively.
Last month, management announced that the pivotal phase III ConquerRSV study evaluating mRNA-1345 achieved the primary efficacy endpoints. Based on this result, management expects to submit for regulatory approval of mRNA-1345 in first-half 2023.
Earlier this month, Moderna reported mixed interim data from a pivotal phase III study evaluating the safety and immunogenicity study of mRNA-1010 in adults. While the vaccine showed promise against the influenza A virus, it did not show any improvement against the influenza B virus. Management is currently waiting for data from another ongoing late study on mRNA-1010 to determine its next steps. A decision is expected by the end of first-quarter 2023.
Last December, Moderna and partner Merck announced data from the phase IIb KEYNOTE-942 study evaluating their personalized cancer vaccine (PCV) candidate as an adjuvant treatment in melanoma patients. Data from the study showed that the PCV candidate, when combined with Merck’s blockbuster drug, Keytruda exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%. Based on this data, Moderna and Merck plan to start a late-stage study in adjuvant melanoma later this year.
Alongside its earnings results, Moderna also announced that its partner Vertex initiated a phase I study evaluating VX-522, an investigational mRNA-based therapy for cystic fibrosis (CF) indication. While Vertex Pharmaceuticals is responsible for leading the preclinical and clinical development of therapies, Moderna is responsible for mRNA and lipid nanoparticle process development and manufacturing. Moderna is also eligible to receive milestone payments and royalties on sales of potential products from the Vertex partnership.
eFFECTOR Therapeutics’ loss estimates for 2023 have narrowed down from 96 cents per share to 88 cents over the past 60 days. Shares of eFFECTOR have plunged 90.2% in the past year.
Earnings of EFTR beat earnings estimates in each of the trailing four quarters, delivering an average earnings surprise of 104.56%. In the last reported quarter, EFTR earnings beat estimates by 14.81%.
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Moderna (MRNA) Lags on Q4 Earnings, COVID Jab Sales Down Y/Y
Moderna, Inc. (MRNA - Free Report) reported earnings of $3.61 per share for the fourth quarter of 2022, missing the Zacks Consensus Estimate and our model estimates of $4.66 and $4.48, respectively. Earnings declined 68% in the quarter. The year-over-year decline in the bottom line was due to lower revenues and higher operating expenses incurred during the fourth quarter.
Revenues in the quarter were $5.08 billion, which also missed the Zacks Consensus Estimate of $5.09 billion. Total revenues were down 29.5% year over year due to declining COVID-19 vaccine sales during the quarter. The total revenues were in line with our model estimates.
Moderna’s shares were down 3.4% in pre-market trading on Feb 23, likely due to the lower-than-anticipated earnings reported by management. In the past year, the stock has inched up 1.2% against the industry’s 8.8% fall.
Image Source: Zacks Investment Research
Quarter in Detail
Product sales, entirely from the sale of COVID-19 vaccines, were down 30.0% year over year to $4.86 billion due to lower sales volume compared with the year-ago period’s levels.
Grant and collaboration revenues were $225 million compared with $276 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including Merck (MRK - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) .
Selling, general and administrative expenses were $375 million, up 87% year over year. The upside can be attributed to increased spending in commercialization activities to support the company’s marketed products.
Research & development expenses were $1.2 billion, up 87% from the year-ago period’s levels. The significant increase was primarily attributable to higher clinical costs and personnel-related expenses.
The company ended the quarter with $18.2 billion in cash and cash equivalents compared with $17.0 billion as of Sep 30, 2022.
Full-Year Results
Moderna reported revenues of $19.3 billion for 2022, up 4.3% year over year.
For the full year, the company reported earnings of $20.12, down 29% year over year.
2023 Guidance
Moderna reiterated its product revenue guidance for 2023. Management expects to record a minimum of around $5.0 billion from COVID vaccine sales in 2023, based on confirmed advance purchase agreements and contract deferrals. Management also reported that this figure does not include product sales in the United States or new contracts with Europe, Japan and other key markets. The company expects to record approximately $2.0 billion in product sales in first-half 2023.
The company maintained combined R&D and SG&A expenses to be approximately $6 billion in 2022, with approximately $4.5 billion in R&D. It expects capital expenditure to be around $1.0 billion.
Pipeline Updates
Currently, Moderna has 48 programs in active development, with 38 programs undergoing clinical studies.
Moderna has three late-stage candidates — mRNA-1647, mRNA-1345 and mRNA-1010 — in its pipeline, which are being developed as cytomegalovirus (CMV) vaccine, respiratory syncytial virus (RSV) vaccine and influenza vaccine, respectively.
Last month, management announced that the pivotal phase III ConquerRSV study evaluating mRNA-1345 achieved the primary efficacy endpoints. Based on this result, management expects to submit for regulatory approval of mRNA-1345 in first-half 2023.
Earlier this month, Moderna reported mixed interim data from a pivotal phase III study evaluating the safety and immunogenicity study of mRNA-1010 in adults. While the vaccine showed promise against the influenza A virus, it did not show any improvement against the influenza B virus. Management is currently waiting for data from another ongoing late study on mRNA-1010 to determine its next steps. A decision is expected by the end of first-quarter 2023.
Last December, Moderna and partner Merck announced data from the phase IIb KEYNOTE-942 study evaluating their personalized cancer vaccine (PCV) candidate as an adjuvant treatment in melanoma patients. Data from the study showed that the PCV candidate, when combined with Merck’s blockbuster drug, Keytruda exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%. Based on this data, Moderna and Merck plan to start a late-stage study in adjuvant melanoma later this year.
Alongside its earnings results, Moderna also announced that its partner Vertex initiated a phase I study evaluating VX-522, an investigational mRNA-based therapy for cystic fibrosis (CF) indication. While Vertex Pharmaceuticals is responsible for leading the preclinical and clinical development of therapies, Moderna is responsible for mRNA and lipid nanoparticle process development and manufacturing. Moderna is also eligible to receive milestone payments and royalties on sales of potential products from the Vertex partnership.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stocks to Consider
Moderna currently has a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is eFFECTOR Therapeutics (EFTR - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
eFFECTOR Therapeutics’ loss estimates for 2023 have narrowed down from 96 cents per share to 88 cents over the past 60 days. Shares of eFFECTOR have plunged 90.2% in the past year.
Earnings of EFTR beat earnings estimates in each of the trailing four quarters, delivering an average earnings surprise of 104.56%. In the last reported quarter, EFTR earnings beat estimates by 14.81%.