Roche RHHBY announced that the European Medicines Agency has approved a prefilled syringe (PFS) of the ophthalmology drug Vabysmo (faricimab).

The regulatory body approved Vabysmo PFS for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

In the past three months, shares of Roche have lost 9.1% compared with the industry’s 14.3% decline.

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More on RHHBY’s Vabsymo PFS

The approval of the Vabysmo prefilled syringe in the EU offers a convenient way to administer this leading ophthalmology treatment for people with three of the most common causes of vision loss.

These three conditions —  nAMD , DME  and RVO — affect more than 9 million people in the EU.

The PFS delivers the same drug as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format.

Per Roche, Vabysmo PFS will be the EU’s first and only prefilled syringe containing a bispecific antibody to treat retinal conditions that can cause blindness. 

The FDA already approved the PFS for nAMD, DME and RVO in July 2024.

Vabysmo’s Growth Fuels RHHBY

The drug’s stellar performance has fueled Roche’s top-line growth since approval. Sales skyrocketed 79% to CHF 2.8 billion in the first nine months of 2024 on strong demand in all regions, mainly the United States.

The PFS approval should further drive growth.

Sales of Regeneron’s REGN blockbuster ophthalmology drug Eylea have been under pressure due to competition from Vabysmo. 

To counter the decline in Eylea sales, Regeneron developed a higher dose of Eylea HD. Regeneron plans to strengthen the Eylea HD product profile through the anticipated launch of its differentiated PFS by mid-2025.

Approval of new drugs and label expansion of the existing ones should bode well for Roche. Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel Roche’s top line as the company looks to fill up the dent in revenues caused by a decline in COVID-19-related sales. Competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin continues to hurt sales.

RHHBY’s Zacks Rank & Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked healthcare stocks are Gilead Sciences GILD and Bristol Myers BMY, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Gilead Sciences’ 2024 earnings have risen from $3.77 to $4.36 per share. Estimates for 2025 earnings per share have increased from $7.27 to $7.55 in the same time frame. GILD’s shares have risen 11.4% in the past three months.

Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.

Over the past 60 days, estimates for Bristol Myers’ 2024 earnings have increased from 75 cents to 91 cents per share. Estimates for 2025 earnings per share have increased from $7.04 to $7.17 in the same time frame. BMY’s shares have gained 13.7% in the past three months.

Bristol Myers’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.54%.

 

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