Regeneron's Eylea HD makes progress but doesn't dent the momentum of Roche's Vabysmo

With U.S. sales of $392 million in the third quarter, Regeneron’s high-dose version of Eylea is closing in on blockbuster sales in its first full year on the market.

The bad news for the company, however, is that while sales from Eylea HD increased by 29% sequentially, this didn't translate to a similar bump in overall U.S. revenue for the Eylea family of eye medications. From Q2 to Q3, franchise sales increased only marginally—from $1.535 billion to $1.537 billion.

With the report, Regeneron's share price dropped 10% by the middle of the day on Thursday.  

Eylea is locked in an intense fight for market share with Roche’s Vabysmo, which was launched in 2022. Last week, the Swiss company reported that worldwide third-quarter sales of Vabysmo were up 8% sequentially, from 947 million CHF ($1.09 billion) in the second quarter to 1,022 million CHF ($1.18 billion) in the third quarter.

Compared with the prior quarter ended in June, Roche said last week that Vabysmo’s wet age-related macular degeneration (AMD) share increased by 3 percentage points to 30%. In addition, the drug grew its market share by 3 percentage points to 22% in diabetic macular edema (DME) and by 5 points to 20% in retinal vein occlusion. In terms of new patient share, Vabysmo is capturing about 50% of treatment-naïve patients, up from around 40% in earlier quarters, the company added.

For its part, Regeneron believes Eylea HD has the “best-in-class profile,” according to chief scientific officer George Yancopoulos, M.D., Ph.D., who cited results from a trial of DME patients who switched from Eylea to Eylea HD.

There was more bad news last week for Eylea as Regeneron lost its bid to block Amgen’s biosimilar version of the treatment from entering the market. The California drugmaker said it plans to launch Pavblu “as soon as possible.”

“We know that there’s a biosimilar on the market for Eylea—not for Eylea HD—and we know it will be competitive, but we think we’ll be able to compete well,” Regeneron CEO Len Schleifer, M.D., Ph.D., said in a conference call.

For its part, Roche doesn’t envision Amgen’s biosimilar interfering with its sales of Vabysmo.

“We don’t see anything that should be slowing Vabysmo momentum down,” Teresa Graham, CEO of Roche’s Pharma sector, said last week.

On Thursday, Regeneron’s chief operating officer Marion McCourt also warned of “higher wholesaler inventory levels for Eyela HD,” at the end of the third quarter. This factor will negatively impact sales of the new product in the fourth quarter.

Beyond that, Regeneron is pointing to next year when it hopes to gain approval for Eylea HD in retinal vein occlusion and will bring the product to market in a pre-filled syringe.

“Next year we could see a little bit of an acceleration,” Schleifer said. “It’s a great product but these things don’t happen overnight.”

As for the company overall, Regeneron reported revenue for the quarter of $3.72 billion, which topped the analyst consensus and was an increase of 11% increase year over year and 5% sequentially.

Once again, Sanofi-partnered immunology powerhouse Dupixent did the heavy lifting. The drug generated sales of $3.8 million worldwide, good for a 23% year-over-year increase. Dupixent is now annualizing sales at more than $15 billion, Schleifer said.