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Moderna (MRNA) Posts 2027 Biz View, Down 3% on Flu Jab Setback
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Moderna (MRNA - Free Report) announced several updates about the advancements in its pipeline and its business outlook for 2027.
Moderna expects product revenues from its respiratory vaccines to be between $8-$15 billion by the end of 2027. Based on this revenue guidance, it expects to generate operating profit between $4-$9 billion from the respiratory vaccines. Management intends to spend $6-$8 billion in additional R&D over the next few years.
Management provided an update on its late-stage seasonal influenza vaccine candidate, mRNA-1010. The company provided the first interim analysis from a phase III efficacy study (P302) conducted in the Northern Hemisphere evaluating mRNA-1010 against a licensed seasonal influenza vaccine.
The P302 study failed to accrue sufficient cases at interim analysis. The study did not meet the statistical threshold needed to declare early success. Based on this analysis, the independent data and safety monitoring board (DSMB) recommended the P302 study to continue efficacy follow-up till the next analysis.
A preliminary analysis of some participants in the P302 study also revealed that participants administered mRNA-1010 achieved geometric mean titer ratios consistent with superiority against the influenza A strains and consistent with non-inferiority against the influenza B strains. However, the study did not pre-specify success criteria for immunogenicity endpoints.
Moderna’s stock fell 3% on Apr 11, likely due to the second setback suffered by Moderna with mRNA-1010. The company faced a similar setback in February 2023 when it announced mixed results from another late-stage study (P301) evaluating mRNA-1010 against a licensed seasonal influenza vaccine conducted in the Southern Hemisphere. Data from the study showed that while mRNA-1010 showed promise against the influenza A virus, it did not show any improvement against the influenza B virus.
In the year so far, shares of Moderna have declined 13.6% compared with the industry’s 5.2% fall.
Image Source: Zacks Investment Research
Based on the above analyses of data from the P301 and P302 studies, management decided to add an update to mRNA-1010 to improve immunogenicity against the influenza B strains. Following this immunogenicity update, Moderna will initiate a phase III confirmatory study on the candidate by the end of this month.
Apart from mRNA-1010, Moderna also announced several other updates related to the development of its other pipeline candidates. Management expects to file for approval of its respiratory syncytial virus (RSV) vaccine mRNA-1345 before the end of this quarter. The filing will be supported by data from the pivotal phase III ConquerRSV study, which achieved its primary efficacy endpoints.
Management also announced that it has recently started dosing participants in a late-stage study with mRNA-1283, a next-generation refrigerator-stable COVID-19 vaccine. The company also announced the development of new pipeline candidates targeting Lyme disease and norovirus.
The advancements of its pipeline will enable Moderna to reduce its dependence on the COVID-19 vaccine, its sole marketed product. The product’s sales have started to plunge as the majority of the population across the globe has been immunized and governments across the world encourage their citizens to resume pre-pandemic behavior.
Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Certara (CERT - Free Report) , CRISPR Therapeutics (CRSP - Free Report) and EQRx . While Certara and EQRx sport a Zacks Rank #1 (Strong Buy), CRISPR Therapeutics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 43.9% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.
In the past 60 days, estimates for EQRx’s 2023 loss per share have narrowed from 66 cents to 58 cents. In the year so far, shares of EQRx have declined 25.6%.
Earnings of EQRx beat estimates in each of the last four quarters, witnessing an earnings surprise of 34.99%, on average. In the last reported quarter, EQRx’s earnings beat estimates by 73.68%.
In the past 60 days, estimates for CRISPR Therapeutics’ 2023 loss per share have narrowed from $8.21 to $7.35. Shares of CRISPR Therapeutics have risen 11.7% in the year-to-date period.
Earnings of CRISPR Therapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 3.19%, on average. In the last reported quarter, CRISPR Therapeutics’ earnings beat estimates by 39.22%.
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Moderna (MRNA) Posts 2027 Biz View, Down 3% on Flu Jab Setback
Moderna (MRNA - Free Report) announced several updates about the advancements in its pipeline and its business outlook for 2027.
Moderna expects product revenues from its respiratory vaccines to be between $8-$15 billion by the end of 2027. Based on this revenue guidance, it expects to generate operating profit between $4-$9 billion from the respiratory vaccines. Management intends to spend $6-$8 billion in additional R&D over the next few years.
Management provided an update on its late-stage seasonal influenza vaccine candidate, mRNA-1010. The company provided the first interim analysis from a phase III efficacy study (P302) conducted in the Northern Hemisphere evaluating mRNA-1010 against a licensed seasonal influenza vaccine.
The P302 study failed to accrue sufficient cases at interim analysis. The study did not meet the statistical threshold needed to declare early success. Based on this analysis, the independent data and safety monitoring board (DSMB) recommended the P302 study to continue efficacy follow-up till the next analysis.
A preliminary analysis of some participants in the P302 study also revealed that participants administered mRNA-1010 achieved geometric mean titer ratios consistent with superiority against the influenza A strains and consistent with non-inferiority against the influenza B strains. However, the study did not pre-specify success criteria for immunogenicity endpoints.
Moderna’s stock fell 3% on Apr 11, likely due to the second setback suffered by Moderna with mRNA-1010. The company faced a similar setback in February 2023 when it announced mixed results from another late-stage study (P301) evaluating mRNA-1010 against a licensed seasonal influenza vaccine conducted in the Southern Hemisphere. Data from the study showed that while mRNA-1010 showed promise against the influenza A virus, it did not show any improvement against the influenza B virus.
In the year so far, shares of Moderna have declined 13.6% compared with the industry’s 5.2% fall.
Image Source: Zacks Investment Research
Based on the above analyses of data from the P301 and P302 studies, management decided to add an update to mRNA-1010 to improve immunogenicity against the influenza B strains. Following this immunogenicity update, Moderna will initiate a phase III confirmatory study on the candidate by the end of this month.
Apart from mRNA-1010, Moderna also announced several other updates related to the development of its other pipeline candidates. Management expects to file for approval of its respiratory syncytial virus (RSV) vaccine mRNA-1345 before the end of this quarter. The filing will be supported by data from the pivotal phase III ConquerRSV study, which achieved its primary efficacy endpoints.
Management also announced that it has recently started dosing participants in a late-stage study with mRNA-1283, a next-generation refrigerator-stable COVID-19 vaccine. The company also announced the development of new pipeline candidates targeting Lyme disease and norovirus.
The advancements of its pipeline will enable Moderna to reduce its dependence on the COVID-19 vaccine, its sole marketed product. The product’s sales have started to plunge as the majority of the population across the globe has been immunized and governments across the world encourage their citizens to resume pre-pandemic behavior.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stocks to Consider
Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Certara (CERT - Free Report) , CRISPR Therapeutics (CRSP - Free Report) and EQRx . While Certara and EQRx sport a Zacks Rank #1 (Strong Buy), CRISPR Therapeutics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 43.9% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.
In the past 60 days, estimates for EQRx’s 2023 loss per share have narrowed from 66 cents to 58 cents. In the year so far, shares of EQRx have declined 25.6%.
Earnings of EQRx beat estimates in each of the last four quarters, witnessing an earnings surprise of 34.99%, on average. In the last reported quarter, EQRx’s earnings beat estimates by 73.68%.
In the past 60 days, estimates for CRISPR Therapeutics’ 2023 loss per share have narrowed from $8.21 to $7.35. Shares of CRISPR Therapeutics have risen 11.7% in the year-to-date period.
Earnings of CRISPR Therapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 3.19%, on average. In the last reported quarter, CRISPR Therapeutics’ earnings beat estimates by 39.22%.