Roche's Vabysmo will rise above Eylea biosim threat, exec says, as DMD gene therapy Elevidys delivers sales surprise

By squeezing Regeneron’s Eylea, eye disease drug Vabysmo has become one of the biggest growth drivers for Roche. But will the potential imminent launch of a copycat to Eylea stifle Vabysmo’s market expansion?

Roche doesn’t think so.

“I think we don’t see anything that should be slowing Vabysmo momentum down,” Teresa Graham, CEO of Roche Pharmaceuticals, said during a press conference Wednesday.

In the third quarter, Vabysmo’s sales grew by 56% year over year to surpass 1 billion Swiss francs ($1.2 billion). The figure beat analysts’ expectations by 4%, according to ODDO BHF.

First approved by the FDA in early 2022, the bispecific antibody drug continues to expand its U.S. market share across indications. Compared with the prior quarter ended in June, Vabysmo’s wet age-related macular degeneration 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 and by 5 points to 20% in retinal vein occlusion, Graham told investors on a separate call Wednesday.

In terms of new patient share, Vabysmo is capturing about 50% of treatment-naïve patients, up from around 40% in earlier quarters, according to Graham.

But that growth rate faces a potential threat from biosimilars to Vabysmo’s archrival, Eylea. After a U.S. appeals court on Tuesday shot down Regeneron’s request for a temporary injunction against an Eylea biosimilar in a patent dispute, Amgen said it plans to roll out its FDA-approved copy, Pavblu, in the U.S. as soon as possible.

However, Graham argued that the introduction of Amgen’s Eylea biosimilar shouldn't have “any material impact” on Vabysmo’s growth trajectory.

Specifically, Graham said Roche expects the current 50-50 share split between novel drugs and biosimilars will continue in the ophthalmology market. Payers have not implemented any policy that would require patients use a biosimilar first, Graham noted. Before Eylea copycats, biosimilars to other VEGF inhibitors, Avastin and Lucentis, have been available.

Roche expects to see Vabysmo’s momentum continue in the U.S. as the company recently introduced a pre-filled syringe presentation. About 80% of prescribed Vabysmo volume has been switched from vials to the pre-filled syringe, according to Roche.

Vabysmo isn’t the only Roche med that’s going through a change in dosing form. In September, the Swiss pharma won back-to-back FDA approvals for subcutaneous versions of its multiple sclerosis drug Ocrevus and cancer immunotherapy Tecentriq.

Dubbed Ocrevus Zunovo, the under-the-skin version of the blockbuster CD20 antibody drug could represent an additional CHF 2 billion sales opportunity, Graham said during the investor call. As Roche’s top-selling drug, Ocrevus reeled in CHF 1.7 billion in sales in the third quarter, roughly flat compared with its second-quarter performance.

Already, about 80% of new patient starts for Ocrevus Zunovo are new to brand rather than switches from the IV formulation, Graham noted. Roche has not provided a target conversion rate for Ocrevus Zunovo.

“While we do think there will be some conversion from patients who are on IV to [subcutaneous Ocrevus], I think what we are actually more excited about is the opportunity to expand the use of Ocrevus in settings where, for whatever reason, IV isn’t as available,” Graham said.

Roche believes the subcutaneous version is opening up a new prescribing base for Ocrevus in the U.S., especially in smaller community settings where IV capacity is constrained.

While Vabysmo and Ocrevus are Roche’s largest assets by sales, the biggest surprise in the company’s third quarter actually came from Elevidys, the controversial Duchenne muscular dystrophy gene therapy that Roche markets outside of the U.S. through a licensing deal with Sarepta.

Elevidys’ third-quarter sales hit CHF 108 million, beating consensus estimates by a whopping 210%, according to Intron Health. That level of sales is stunning considering the commercial struggles for many other gene therapies and the fact that European regulators haven't approved the drug.

So far for Roche, Elevidys is primarily approved in the Gulf region, including countries such as Qatar and the United Arab Emirates. Four of the six ex-U.S. countries where Elevidys is approved currently have patients being treated or in screening, according to the company. Graham attributed the sales surprise partly to health tourism, a practice in which families travel to have their children treated.

In all, Roche expects ex-U.S. marketing of Elevidys will represent “a couple of billion-dollar market," depending on the scope of approvals and reimbursement policies, Graham said.

In response to an analyst’s question about whether Wall Street can use an annual sales run rate of CHF 400 million as a base, Graham said Roche will be able to provide a clearer picture in its full-year 2024 report.