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Moderna (MRNA) Issues 2023 Preliminary Results, Stock Up 4%

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At the J.P. Morgan Healthcare Conference, Moderna (MRNA - Free Report) announced several financial updates on its business and updates on its pipeline progress.

Financial Updates

For 2023

Moderna reported unaudited/preliminary product sales of nearly $6.7 billion for 2023, which were generated in its entirety from the sales of its mRNA-based COVID-19 vaccine. This figure was in line with the company’s previously reported guidance outlook, wherein it expected full-year vaccine sales to be at least $6 billion.

The reported preliminary product sales figure was higher than what several Wall Street analysts had projected. This figure was better than our model estimates of $6.2 billion. Shares of Moderna were up 3.9% on Monday, likely due to this reason.

In the past year, the stock has lost 39.1% compared with the industry’s 12.9% fall.

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The unaudited $6.7 billion figure includes $6.1 billion in COVID-19 vaccine sales and the remaining $600 million in deferred revenues related to Moderna's efforts with GAVI, the global vaccine alliance.

Management reported an increase in the company’s U.S. market share for COVID-19 vaccines to 48% in 2023, compared with 37% in 2022.

Moderna expects to close the year with cash, cash balance and investments in excess of $13 billion. Full details for the fourth quarter and full year 2023 will be provided at the company’s earnings call on Feb 22.

For 2024 and beyond

Moderna reiterated its previously issued financial guidance for 2024 and beyond. It expects the COVID-19 franchise to be profitable from 2024 onward after incurring significant charges on resizing its manufacturing capacity last year.

Moderna expects to generate $4 billion in product revenues, mostly in the second half of the year, driven by sales of its COVID-19 vaccine and the launch of the RSV vaccine. 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.

Pipeline Updates

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

Last year, 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 approval is expected in first-half 2024, with a commercial launch later this year.

Apart from RSV, MRNA is evaluating multiple candidates — including CMV, INT and influenza — in late-stage studies. During third-quarter 2023, Moderna reported encouraging data from a late-stage study on flu vaccine mRNA-1010, which met all immunogenicity endpoints. Management is currently discussing this data with regulatory authorities and intends to file for regulatory approval later this year.

Management intends to report several data readouts this year. This includes data from pivotal late-stage studies on mRNA-1283, the company’s next-generation refrigerator-stable COVID-19 vaccineandmRNA-1083, theinvestigational combination vaccine against influenza and COVID-19. While data from both these studies are expected in first-half 2024, data from a pivotal late-stage study on the CMV vaccine is expected by the year’s end.

The INT therapy mRNA-4157 is being co-developed with Merck (MRK - Free Report) . After Moderna/Merck reported that the INT therapy achieved its primary and key secondary endpoints in a phase IIb study in the first half of 2023, two pivotal phase III studies were initiated in second-half 2023 evaluating the vaccine in melanoma and non-small cell lung cancer (NSCLC) indications. Later this year, Moderna and Merck intend to expand mRNA-4157 in additional tumor types.

Moderna also expects to advance its propionic acidemia (PA) & methylmalonic acidemia (MMA) programs into pivotal studies this year.

 

Zacks Rank & Key Picks

Moderna currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are CytomX Therapeutics (CTMX - Free Report) and Novo Nordisk (NVO - Free Report) . While CytomX sports a Zacks Rank #1 (Strong Buy), Novo Nordisk 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 CytomX Therapeutics for 2023 have swung from a loss of 10 cents per share to earnings of 2 cents. During the same period, estimates for 2024 have narrowed from a loss of 22 cents to a loss of 6 cents. Shares of CTMX have lost 44.8% in the past year.

CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing once, the average surprise being 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.

In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.62 to $2.42. During the same period, the earnings estimates for 2024 have risen from $3.07 to $3.14. Shares of NVO have surged 55.1% in the past year.

Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.

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