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Moderna (MRNA) Beats on Q3 Earnings & Sales, Expects Lower COVID Demand

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Moderna (MRNA - Free Report) reported an adjusted loss (excluding non-cash charges) of $1.39 per share for the third quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of $2.01. In the year-ago quarter, the company registered earnings of $2.53 per share.

The company reported a loss of $9.53 after accounting for non-cash charges of $3.1 billion related to resizing and tax allowances. A third of this loss was attributed to improving future cost of sales by resizing its manufacturing capacity for COVID-19 vaccines.

Revenues in the quarter were $1.83 billion, beating the Zacks Consensus Estimate of $1.33 billion. Total revenues declined 46% 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 44% year over year to $1.76 billion due to lower sales volume compared with the year-ago period’s levels.

Management reported an increase in the company’s U.S. market share for COVID-19 vaccines to 45% this year (based on most recent data), compared to 36% in 2022.

Grant and collaboration revenues were $74 million compared with $244 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 $442 million, up 59% year over year. The upside can be attributed to increased spending in commercialization activities to support the launch of the company’s COVID-19 vaccine in the U.S. commercial market.

Research & development expenses were $1.2 billion, up 41% from the year-ago period’s levels. The significant increase was primarily attributable to higher clinical costs and personnel-related expenses.

Financial Outlook

For 2023

Moderna revised its product revenue guidance for 2023.

The company now expects full-year COVID-19 vaccine sales to be at least $6 billion, compared to the previously issued guidance range of $6.0 billion and $8.0 billion. However, the sales are still dependent on U.S. vaccination rates. Management expects the vaccination trend to be consistent with the previous year’s fall period.

The company also raised its combined R&D and SG&A expenses to be approximately $6.3 billion in 2023 (previously $6.0 billion, with nearly $4.8 billion in R&D. It expects capital expenditures to be around $0.9 billion (previously $1.0 billion).

Beyond 2023

The company expects its COVID-19 franchise to be profitable from 2024 onwards after incurring significant charges on resizing its manufacturing capacity this year. Management plans to adjust its investments in R&D and SG&A based on its sales performance. It does not expect to raise additional equity to fund its business plans.

Moderna expects to generate $4 billion in product revenues, driven mainly by sales of its COVID-19 vaccine and the launch of its RSV vaccine. This forecast by management was way lower than what several Wall Street analysts had projected. In fact, the Zacks Consensus Estimate for full-year 2024 revenues stood at $6.3 billion.

Shares of Moderna were down 15% in pre-market trading on Nov 2, likely due to this lower-than-expected 2024 projections. In the year so far, the stock has declined 57.6% compared with the industry’s 23.5% fall.

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With the plan to launch multiple products and make disciplined investments, it intends to achieve organic sales growth by 2025 and expects to break even in 2026. It expects an ending cash balance of around $9 billion in 2024 and between $6.0-$7.0 billion in 2025.

Pipeline & Other Updates

Currently, Moderna’s late-stage pipeline has six phase III programs. These include therapies and vaccines targeting multiple indications like cytomegalovirus (“CMV”), respiratory syncytial virus (“RSV”), influenza and individualized neoantigen therapy (“INT”).

In July, 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.

Apart from COVID and RSV, the company is evaluating multiple candidates — including CMV, INT and influenza — in late-stage studies. During third-quarter 2023, Moderna reported encouraging data from a phase III immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating an enhanced formulation of flu vaccine mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared to the vaccines marketed by GSK and Sanofi.

mRNA-4157 is being co-developed with Merck. After the companies reported that the INT therapy achieved its primary and key secondary endpoints in a phase IIb study in the first half of 2023, a pivotal phase III study was initiated in July 2023 to evaluate the vaccine in melanoma patients. Over time, Moderna and Merck intend to expand mRNA-4157 in other oncology indications, including non-small cell lung cancer (“NSCLC”).

Moderna also started a late-stage study on mRNA-1083, its investigational combination vaccine against influenza and COVID-19, in older adults (50 years and older).

 

Zacks Rank & Stocks to Consider

Moderna currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $5.09 to $5.10. During the same period, earnings estimates for 2024 rose from $4.56 to $4.59. Shares of Ligand lost 20.2% in the year-to-date period.

Ligand beat earnings estimates in three of the last four quarters while missing the mark on one occasion. The company has delivered an earnings surprise of 52.47% on average. In the last reported quarter, Ligand’s earnings beat estimates by 86.84%.

In the past 30 days, Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 22 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 8 cents. Shares of DVAX have gained 32.5% in the year so far.

Dynavax beat estimates in two of the trailing four quarters and missed in the remaining two, witnessing an average earnings surprise of 25.78%. In the last reported quarter, Dynavax’s earnings beat estimates by 133.33%.

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