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Moderna (MRNA) Stock Outperformed Industry YTD: Here's Why

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Despite the declining top line, shares of Moderna (MRNA - Free Report) continue to soar thanks to its encouraging pipeline updates and potential product launches over the next few years.

The company boasts of a pipeline of more than 40 mRNA-based investigational candidates across different stages of development, targeting multiple indications, including cancer and cardiovascular. Being one of the handful of makers of a COVID-19 vaccine, Moderna reaped the benefits of the COVID-19 pandemic, allowing it to strengthen its cash position significantly. This cash balance is helping management make increased investments in R&D to not only expand the company’s pipeline but also support its expected new product launches.

Investors are also encouraged by Moderna’s pace in advancing pipeline candidates. This was proven with the company’s COVID-19 vaccine, which was approved by the end of 2020. Earlier this month, some reports suggested that the U.S. government is in discussions with the company to set up a possible vaccine program aimed at preventing the spread of the H5N1 virus, also known as bird flu, in humans. An article from Barron’s confirmed that Moderna is evaluating a bird flu vaccine in a mid-stage study.

Moderna is currently gearing up for its second commercial product launch with its RSV vaccine, which is currently under FDA review. A final decision is expected by this month’s end. If the outcome is positive, a CDC advisory committee could also recommend using the vaccine in its meeting next month. Once approved by both regulatory agencies, a commercial launch is expected in third-quarter 2024.

Year to date, Moderna’s shares have surged 67.5% against the industry’s 5.7% fall.

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The company is progressing well with developing its pipeline. Moderna has multiple candidates in late-stage studies — mRNA-1647 [cytomegalovirus (CMV) vaccine], mRNA-1010 (influenza vaccine), Merck (MRK - Free Report) -partnered mRNA-4157/V940 [individualized neoantigen therapy (INT) targeting oncology indications] and mRNA-1083 (COVID-19 plus influenza combination vaccine).

Management is co-developing mRNA-4157 with Merck. Since the onset of 2024, the companies have initiated three new clinical studies in additional tumor types, including a phase II/III study in cutaneous squamous cell carcinoma (CSCC), the second most common form of skin cancer. Moderna/Merck also started two separate mid-stage studies in renal cell carcinoma and muscle-invasive bladder cancer indications, respectively.

Moderna and Merck are evaluating mRNA-4157 in two pivotal late-stage studies for melanoma and non-small cell lung cancer (NSCLC) indications. They also intend to evaluate mRNA-4157 across various other cancer indications throughout this year.

At an investor event held in March, management announced its decision to advance three vaccines to pivotal late-stage development, namely mRNA-1189 (for Epstein-Barr virus [EBV]), mRNA-1468 (for Varicella-Zoster virus [VZV]) and mRNA-1405 (for norovirus). The decision to advance these candidates is based on data from separate early-stage clinical studies, which showed that the vaccines were immunogenic and well-tolerated among the study participants.

By 2028, management intends to advance up to 50 new pipeline candidates in clinical development and launch 15 new marketed products. The successful development and potential commercialization of pipeline candidates will help the company reduce its dependence on its COVID-19 vaccine, which is currently the sole marketed product in its portfolio. With the end of the pandemic, demand for the COVID vaccines dropped significantly, leading to a steep decline in Moderna’s sales and profits.

Moderna is also engaged in ongoing discussions with health regulators for mRNA-1010 and intends to start seeking regulatory approvals later this year. Given management’s timetable, we expect the flu vaccine to be Moderna’s third commercial product launch, which is expected in second-half 2025.

 

Zacks Rank & Key Picks

Moderna currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Arcutis Biotherapeutics (ARQT - Free Report) and Heron Therapeutics (HRTX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.49 to $1.60. During the same period, the loss estimates per share for 2025 have improved from $1.77 to $1.14. Year to date, shares of Arcutis have surged 183.6%.

Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.

In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per sharehave improved from 22 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 9 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 102.4%.

Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.

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