We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Moderna (MRNA) Q3 Earnings Lag Estimates, Pipeline Advances
Read MoreHide Full Article
Moderna Inc (MRNA - Free Report) incurred loss of 59 cents per share in the third quarter of 2020, wider than the Zacks Consensus Estimate of a loss of 43 cents and the year-ago loss of 37 cents. Loss widened year over year due to higher research & development costs to support clinical development, especially its coronavirus vaccine candidate, mRNA-1273.
Revenues in the quarter were $157.9 million, which comfortably beat the Zacks Consensus Estimate of $77.52 million. In the year-ago quarter, revenues were $17 million. The significant increase in revenues was driven by grants, especially from an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) related to development mRNA-1273.
Quarter in Details
Collaboration revenues were $12.2 million, up 183.6% year over year. 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) .
Grant revenues were $145.7 million compared with $3.7 million in the year-ago quarter. Please note that the company has received a funding commitment of up to $955 million from BARDA to develop its coronavirus vaccine candidate so far this year.
General and administrative expenses were up 72.3% to $48.5 million, primarily attributable to increased headcount and mRNA-1273 vaccine candidate development-related activities. Research & development expenses increased 187.9% to $344.5 million, largely due to increased headcount and mRNA-1273’s clinical development as well as rise in clinical trial expenses, largely for mRNA-1273.
The company ended the quarter with $3.97 billion in cash and cash equivalents, compared with $3.07 billion as of Jun 30, 2020. Please note that the company recorded customer deposits of approximately $1.1 billion in the third quarter, related to supply agreements formRNA-1273, following a potential emergency use authorization or regular approval.
Coronavirus Vaccine Update
The company completed enrollment of 30,000 patients in the phase III COVE study evaluating mRNA-1273 as COVID-19 vaccine last week. The study includes 37% of patients from diverse communities and 42% patients at high-risk of severe disease. However, there was no update on timeline of data readout from the study. The company stated that it will conduct two interim analyses of the COVE study to decide the future course of the study. Data from the first interim analysis is expected next month. The company will have post-second dose two-month safety follow-up data on mRNA-1273 by the end of November. This data has been requested by the FDA to support regulatory submission for an emergency use authorization for mRNA-1273. The company also announced initiation of rolling submission in the United Kingdom and Canada and also received confirmation of eligibility for submission of marketing authorization application in Europe. Moreover, Moderna expects to have approximately 20 million doses ready for the United States by year-end.
Moderna’s shares were up 8.4% on Oct 29 following the earnings release, presumably on encouraging pipeline progress, especially its coronavirus vaccine candidate, and significant cash resources to support ongoing clinical development. It also turned cash flow positive during the third quarter. The company expects 2021 to be an important inflection year as it will potentially launch COVID-19 vaccine and will have the resources to scale up. Shares of Moderna have surged 245% so far this year against the industry’s 7.8% decline.
Other Pipeline Update
Moderna has 21 mRNA investigational candidates with 13 candidates in clinical development stage. Apart from mRNA-1273, other advanced mRNA pipeline candidates include mRNA-1647, mRNA-4157 and VEGF-A (previously AZD8601).
The company announced positive interim data from a phase II study on its Cytomegalovirus virus vaccine candidate, mRNA-1647. It plans to initiate a phase III study on the candidate in 2021. Moderna is evaluating mRNA-4157, its personalized cancer vaccine in combination with Merck’s Keytruda in a phase II study for the adjuvant treatment of high-risk resected melanoma. Worldwide commercial rights to the candidate are shared by Moderna and Merck.
Moderna is developing VEGF-A for patients with ischemic heart disease undergoing coronary artery bypass grafting surgery in a phase II study. The study is being led by AstraZeneca.
Meanwhile, Moderna has resumed dosing patients in a phase I study evaluating human metapneumovirus and parainfluenza type 3 vaccine candidate, mRNA-1653. The study’s progress was disrupted due to COVID-19 related risks and restrictions.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Moderna (MRNA) Q3 Earnings Lag Estimates, Pipeline Advances
Moderna Inc (MRNA - Free Report) incurred loss of 59 cents per share in the third quarter of 2020, wider than the Zacks Consensus Estimate of a loss of 43 cents and the year-ago loss of 37 cents. Loss widened year over year due to higher research & development costs to support clinical development, especially its coronavirus vaccine candidate, mRNA-1273.
Revenues in the quarter were $157.9 million, which comfortably beat the Zacks Consensus Estimate of $77.52 million. In the year-ago quarter, revenues were $17 million. The significant increase in revenues was driven by grants, especially from an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) related to development mRNA-1273.
Quarter in Details
Collaboration revenues were $12.2 million, up 183.6% year over year. 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) .
Grant revenues were $145.7 million compared with $3.7 million in the year-ago quarter. Please note that the company has received a funding commitment of up to $955 million from BARDA to develop its coronavirus vaccine candidate so far this year.
General and administrative expenses were up 72.3% to $48.5 million, primarily attributable to increased headcount and mRNA-1273 vaccine candidate development-related activities. Research & development expenses increased 187.9% to $344.5 million, largely due to increased headcount and mRNA-1273’s clinical development as well as rise in clinical trial expenses, largely for mRNA-1273.
The company ended the quarter with $3.97 billion in cash and cash equivalents, compared with $3.07 billion as of Jun 30, 2020. Please note that the company recorded customer deposits of approximately $1.1 billion in the third quarter, related to supply agreements formRNA-1273, following a potential emergency use authorization or regular approval.
Coronavirus Vaccine Update
The company completed enrollment of 30,000 patients in the phase III COVE study evaluating mRNA-1273 as COVID-19 vaccine last week. The study includes 37% of patients from diverse communities and 42% patients at high-risk of severe disease. However, there was no update on timeline of data readout from the study. The company stated that it will conduct two interim analyses of the COVE study to decide the future course of the study. Data from the first interim analysis is expected next month. The company will have post-second dose two-month safety follow-up data on mRNA-1273 by the end of November. This data has been requested by the FDA to support regulatory submission for an emergency use authorization for mRNA-1273. The company also announced initiation of rolling submission in the United Kingdom and Canada and also received confirmation of eligibility for submission of marketing authorization application in Europe. Moreover, Moderna expects to have approximately 20 million doses ready for the United States by year-end.
Moderna’s shares were up 8.4% on Oct 29 following the earnings release, presumably on encouraging pipeline progress, especially its coronavirus vaccine candidate, and significant cash resources to support ongoing clinical development. It also turned cash flow positive during the third quarter. The company expects 2021 to be an important inflection year as it will potentially launch COVID-19 vaccine and will have the resources to scale up. Shares of Moderna have surged 245% so far this year against the industry’s 7.8% decline.
Other Pipeline Update
Moderna has 21 mRNA investigational candidates with 13 candidates in clinical development stage. Apart from mRNA-1273, other advanced mRNA pipeline candidates include mRNA-1647, mRNA-4157 and VEGF-A (previously AZD8601).
The company announced positive interim data from a phase II study on its Cytomegalovirus virus vaccine candidate, mRNA-1647. It plans to initiate a phase III study on the candidate in 2021. Moderna is evaluating mRNA-4157, its personalized cancer vaccine in combination with Merck’s Keytruda in a phase II study for the adjuvant treatment of high-risk resected melanoma. Worldwide commercial rights to the candidate are shared by Moderna and Merck.
Moderna is developing VEGF-A for patients with ischemic heart disease undergoing coronary artery bypass grafting surgery in a phase II study. The study is being led by AstraZeneca.
Meanwhile, Moderna has resumed dosing patients in a phase I study evaluating human metapneumovirus and parainfluenza type 3 vaccine candidate, mRNA-1653. The study’s progress was disrupted due to COVID-19 related risks and restrictions.
Moderna, Inc. Price, Consensus and EPS Surprise
Moderna, Inc. price-consensus-eps-surprise-chart | Moderna, Inc. Quote
Zacks Rank
Currently, Moderna is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>