Moderna gears up for potential RSV vaccine launch this fall after better-than-expected first quarter – FiercePharma

With Modernas COVID-19 sales on the backfoot following the switch to an endemic vaccine market, the Massachusetts-based biopharma is busy laying the groundwork for its next potential mRNA shot in respiratory syncytial virus (RSV). And despite a head start in the field by competitors GSK and Pfizer, Moderna remains confident that its vaccine candidate, mRNA-1345, will still have a niche to fill.

Moderna currently expects initial approvals of its RSV vaccine to start rolling in during the first half of 2024, the company said in a press release. In turn, the company is eyeing a potential U.S. launch in the fall, which would capitalize on its established commercial efforts in the seasonal COVID-19 immunization market, Moderna explained.

RSV is a seasonal cold virus, but one that can cause severe breathing problems and pneumonia in the elderly, the very young and the immunocompromised.

With mRNA-1345s potential approval, Moderna would be wading into a fierce vaccine war already brewing between GSK and Pfizer, which won historic nods for their own RSV shots last May and have both already been raking in sales.

That said, Modernas mRNA vaccineif approvedwould be the only shot on the market in a pre-filled syringe, which could offer a potential convenience edge over its competitors, the companys CEO, Stphane Bancel, said on a call with investors Thursday.

By removing preparation steps before administering its vaccine, Moderna is hoping to ease the burden on pharmacists and clinicians and potentially alleviate wait times for patients, too. The companys own research has found that the prefilled presentation of its shot was three to four times more efficient than vaccines requiring reconstitution, Moderna explained in its release.

As the company prepares for its expected RSV rollout, Modernas medical team has been working with pharmacies and hospital networks literally on a daily basis to help spread the word about its vaccine candidates safety and efficacy profile, as well as the potential benefits of its prefilled syringe formulation, Bancel said.

Meanwhile, the company also feels its data package should help level the playing field by supporting a parity recommendation from the CDCs Advisory Committee on Immunization Practices (ACIP) post-approval, Moderna president Stephen Hogue said on the investor call.

Although Moderna expects its RSV vaccine to be a key revenue contributor moving forward, the company has yet to release guidance around potential sales of mRNA-1345, the companys chief financial officer, Jamey Mock, said.

Moderna touched on its RSV launch plans as it reported $167 million in first-quarter sales for the year, down a whopping 91% from the $1.9 billion it generated over the same stretch in 2023 when the company was still profiting off delivered doses deferred from 2022.

Nevertheless, the sharp decline in COVID-19 vaccine sales was to be expected and Modernas sales haul for the quarter still managed to come out ahead of consensus expectations of $93 million, William Blair analysts Myles Minter and Sarah Schram wrote in a note to clients Thursday.

The analysts called the sales decline unsurprising thanks to the market shift from pandemic to endemic and declines in previously expected vaccination rates.

Further, Modernas reported net loss of $1.2 billion in the quarter proved less severe than expected, the William Blair team added, crediting Moderna for its cost-saving efforts and reduced operating expenses.

For the COVID-19 vaccine business, Moderna is now taking a regional approach, Bancel told investors. In the U.S., the company is working with public health officials, healthcare providers and pharmacies to increase vaccination coverage rates across the country, the CEO explained.

Over in Europe, meanwhile, the company is actively engaged in a 2024 tender program that could see Moderna deliver millions of doses annually for up to four years, Bancel added.

And as for the rest of the world, Moderna is overhauling its commercial teams to help prioritize markets that provide greater commercial focus and impact, he explained. Bancel pointed to the companys recent agreement to provide Brazil with 12.5 million doses of its COVID shot Spikevax in the second quarter as a prime example of that strategy.

Looking ahead, the company reaffirmed its expectation to generate roughly $4 billion in 2024. That sum will likely represent a low point for the company ahead of a planned return to growth in 2025, Modernas CFO Mock said.

Read more:

Moderna gears up for potential RSV vaccine launch this fall after better-than-expected first quarter - FiercePharma