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Moderna (MRNA) Beats on Q2 Earnings & Sales, Raises '23 View

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Moderna (MRNA - Free Report) reported a loss of $3.62 per share for the second quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of $3.84. In the year-ago quarter, the company registered earnings of $5.24 per share. The year-over-year decline in the bottom line was due to lower revenues and higher operating expenses incurred during the quarter.

Revenues in the quarter were $344 million, beating the Zacks Consensus Estimate of $290.7 million. Total revenues declined 93% year over year due to lower COVID-19 vaccine sales during the quarter.

Quarter in Detail

Product sales, entirely from the sale of COVID-19 vaccines, were down 94% year over year to $293 million due to lower sales volume compared with the year-ago period’s levels.

Grant and collaboration revenues were $51 million compared with $218 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.

Selling, general and administrative expenses were $332 million, up 57% year over year. The upside can be attributed to increased spending in commercialization activities to support the company’s digital initiatives, marketed products and expansion.

Research & development expenses were $1.1 billion, up 62% from the year-ago period’s levels. The significant increase was primarily attributable to higher clinical costs and personnel-related expenses.

Raises 2023 Guidance

Moderna revised its product revenue guidance for 2023.

Management now expects full-year COVID-19 vaccine sales to be between $6.0 billion and $8.0 billion, depending on U.S. vaccination rates, a rise from the previous guidance of a minimum of around $5.0 billion. While $4.0 billion of the product sales will be from previously confirmed advance purchase agreements, the remaining $2.0-$4.0 billion is expected from additional sales based on commercial contracts signed in the United States and other markets. Management expects higher demand in the United States during the upcoming fall season, expected to be between 50 and 100 million doses.

Moderna’s shares were up 1.1% in pre-market trading on Aug 3, likely due to the raised guidance. In the year so far, the stock has declined 38.6% compared with the industry’s 13.0% fall.

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The company maintained combined R&D and SG&A expenses to be approximately $6.0 billion in 2023, with nearly $4.5 billion in R&D. It expects capital expenditures to be around $1.0 billion.

Pipeline & Other Updates

Last month, Moderna initiated regulatory submissions for the mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential launch is expected next year. Moderna is also evaluating the vaccine in an ongoing early-stage study in pediatric participants.

Moderna is developing more than 30 mRNA-based investigational candidates in different stages of clinical studies, targeting various indications, including cancer.Moderna is evaluating three candidates in late-stage studies — mRNA-1647 (cytomegalovirus (CMV) vaccine), mRNA-1010 (influenza vaccine) and mRNA-4157/V940 [personalized cancer vaccine (PCV)].

Alongside the Q3 results, Moderna also announced that it completed enrolment in the phase III immunogenicity study (P303) evaluating an enhanced formulation of mRNA-1010, which is expected to improve immune responses against the influenza B strain. Data from the P303 study is also likely to support the company’s regulatory filing for the vaccine’s accelerated approval. Data from the P303 study is expected before September 2023-end.

Management also reported that it completed over 80% of enrolment in the pivotal phase III study evaluating its CMV vaccine mRNA-1647.

Moderna and Merck reported new data from phase IIb evaluating mRNA-4157 in melanoma indication this June. Data from the study showed that mRNA-4157 combined with Merck’s Keytruda reduced the risk of distant metastasis or death by 65% compared with participants treated with Keytruda alone. The study previously achieved its primary endpoint of recurrence-free survival. Based on these positive results, Moderna/Merck initiated the phase III study on mRNA-4157 in melanoma patients last month.

 

Zacks Rank & Stocks to Consider

Moderna currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Caribou Biosciences (CRBU - Free Report) and Johnson & Johnson (JNJ - Free Report) ,each carrying a Zacks Rank #2 (Buy). You cansee the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Caribou Biosciences’ loss estimates for 2023 have narrowed from $1.91 to $1.63 per share in the past 30 days. During the same period, the loss estimates per share for 2024 have narrowed from $2.60 to $1.72. Year to date, Caribou Biosciences’ stock has risen 12.4%.

Caribou Biosciences beat earnings estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a negative earnings surprise of 1.36%. In the last reported quarter, CRBU delivered an earnings surprise of 4.17%.

In the past 30 days, estimates for J&J’s 2023 earnings per share have increased from $10.66 to $10.73. During the same period, theearnings estimates per share for 2024 have risen from $11.01 to $11.28. Shares of J&J are down 3.8% in the year-to-date period.

Earnings of J&J beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.58%. In the last reportedquarter, J&J’s earnings beat estimates by 7.28%.

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