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Moderna Inc. MRNA reported earnings of $6.46 per share for the second quarter of 2021, beating the Zacks Consensus Estimate of $6.01. The company had incurred a loss of 31 cents per share in the year-ago quarter. The significant growth in earnings was driven by strong growth in revenues.
Revenues in the quarter were $4.4 billion, beating the Zacks Consensus Estimate of $4.29 billion. In the year-ago quarter, revenues were $67 million. The significant increase in revenues was driven by 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 development of the COVID-19 vaccine also drove revenues.
Despite strong second-quarter results, Moderna’s shares were down 3.8% in pre-market trading Aug 5, presumably due to the absence of any increase in guidance for 2021. However, shares of the company have surged 301.1% so far this year compared with the industry’s 1% increase.
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Quarter in Details
In December, Moderna received approval for 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 in several other countries including European Union so far in 2021.
Product sales, entirely from COVID-19 vaccine, were $4.2 billion during the quarter. In the first quarter 2021, product sales were $1.73 billion. The company has advance purchase agreements for mRNA-1273 with multiple countries worth $20 billion for 2021, which includes vaccine sales in the first half of 2021.
Grant revenues were $139 million compared with $38 million in the year-ago quarter. The company has received a funding commitment of up to $955 million from BARDA to develop its coronavirus vaccine candidate in 2021.
Collaboration revenues were $18 million compared with $29 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies including AstraZeneca AZN, Merck MRK and Vertex Pharmaceuticals VRTX.
Selling, general and administrative expenses were $121 million compared with $37 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 $421 million compared with $152 million in the year-ago period. The rise was largely due to increased higher clinical development costs for mRNA-1273.
The company ended the quarter with $12.2 billion in cash and cash equivalents, compared with $8.2 billion as of Mar 31, 2021.
Coronavirus Vaccine Update
Moderna delivered 302 million doses of mRNA-1273, including 199 million doses in the second quarter, across the globe during the first half of 2021.
The company expects to manufacture 800 million to 1 billion doses in 2021. The company anticipates to manufacture between 2 billion and 3 billion doses in 2022.
The company is engaged in discussion with governments of different countries, for advance purchase agreements for 2022 and 2023. The company has already signed similar agreements for initial doses worth approximately $12 billion along with options for additional doses worth approximately $8 billion for 2022.
Moderna shared final data from the phase III COVE study that had supported emergency use authorization for mRNA-1273 last year. The updated data demonstrated that the vaccine showed 93% efficacy, which was maintained after median follow-up of approximately six months post the second dose. The company also initiated rolling submission of a biologics license application, seeking full approval for mRNA-1273, with the FDA in June.
Initial data from a phase II/III study evaluating it in adolescents demonstrated vaccine efficacy of 96% in seronegative participants, who have received at least one injection. The company also received authorization for emergency/conditional use of the vaccine in adolescents 12 years of age and older in Europe and Japan last month. A similar regulatory application is under review in the United States.
A phase II study is evaluating mRNA-1273 in the pediatric population, aged 6 months to 11 years. 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.
A phase II study is evaluating a booster dose of mRNA-1273 or variant-specific vaccine candidate, mRNA-1273.351, in previously vaccinated individuals. Initial data from the study showed that the booster dose of either vaccine candidates increased neutralizing antibody titer responses against SARS-CoV-2 as well as two variants of concern, B.1.351 and P.1.
Other Key Pipeline Updates
Moderna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. Key among them include mRNA-1647, mRNA-1893 and mRNA-4157.
The company plans to start a late-stage study to evaluate mRNA-1647 as Cytomegalovirus vaccine later this year. A phase II study to evaluate mRNA-1893 as Zika virus vaccine is enrolling participants. A phase II study is evaluating mRNA-4157 in combination with Merck’s Keytruda as personalized cancer vaccine.
Moderna, Inc. Price, Consensus and EPS Surprise
Moderna, Inc. price-consensus-eps-surprise-chart | Moderna, Inc. Quote
Currently, Moderna carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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