The RSV market is turning out to be tougher than Moderna hoped.
Jamey MockThe company’s mResvia is the third RSV vaccine to enter a market dominated by GSK’s Arexvy and Pfizer’s Abrysvo. That pressure “led to a slower RSV ramp than previously expected,” CFO Jamey Mock told investors on a second-quarter earnings call Thursday.
It also played a role in Moderna’s decision to lower its full-year sales guidance by at least half a billion dollars. The company now expects $3 billion to $3.5 billion in sales (down from $4 billion), citing low European sales in 2024, potential deferrals for certain international sales into 2025, and an “increasingly competitive” market for both Covid and RSV.
The company’s stock $MRNA dipped 20% on Thursday afternoon.
GSK and Pfizer’s vaccines generated £62 million ($79 million) and $56 million in second-quarter sales, respectively. Moderna didn’t report second-quarter sales for mResvia — doses only started shipping in July. But as Leerink Partners analysts pointed out Thursday, the company will be up against “well-entrenched incumbents.”
Arexvy was the first vaccine approved for RSV in 2023 and quickly became the market leader. GSK is now focused on defending that position as Pfizer attempts to expand its reach. Both companies said on recent second-quarter calls that they were well-positioned for the upcoming RSV season.
“Based on what we can see, we will retain market leadership,” GSK’s chief commercial officer Luke Miels said on Wednesday, adding that the company is “very happy” with its contracting efforts for the 2024 season. “We’re on track to be a blockbuster.”
Pfizer’s chief US commercial officer Aamir Malik said the pharma giant has “significantly strengthened our contracting position,” and suggested that healthcare providers and pharmacies may prefer Abrysvo because it’s also approved as a maternal vaccine to protect infants in their first several months following birth.
Stephen HogeModerna’s president Stephen Hoge declined to comment on Pfizer’s approach on Thursday’s earnings call, but emphasized that “overwhelmingly the focus is on protecting older Americans.”
Moderna estimates that 40 million Americans are eligible for RSV vaccination. The company is focusing its initial launch efforts on pharmacies, touting its prefilled syringe as a potential differentiator that can save time and prevent errors.
While the CDC currently recommends only one lifetime dose for RSV vaccines, Hoge said that Americans would likely benefit from boosting as efficacy wanes over time.
“We continue to believe that as the public health story evolves, that recommending bodies — the CDC and ACIP — will look at the waning efficacy, the potential to boost people again and hopefully provide additional public benefit, and that eventually there will be recommendations for revaccination,” he said.
Flu combo vaccine and melanoma program
Moderna provided updates on two other high-profile programs: its Covid-flu combination candidate and its Merck-partnered individualized neoantigen therapy for melanoma.
The company said it’s in discussions with regulators on the next steps for the Covid-flu combo, which recently read out positive Phase 3 results.
CEO Stéphane Bancel said Moderna remains “keen to discuss” an accelerated approval for its melanoma program based on Phase 2 data, but first it wants to significantly enroll a confirmatory Phase 3 study and make progress on a manufacturing facility in Marlborough, MA. While Moderna didn’t lay out a clear timeline on Thursday, Hoge said that Moderna has “made great progress” on the Marlborough site.