Roche’s COVID-19 therapies Ronapreve and Actemra gave the drugmaker a sales boost a year ago amid a surge in infections. But as cases ebb and new coronavirus variants emerge, sales of the drugs are falling sharply.
Sales from Regeneron-partnered COVID antibody Ronapreve and anti-inflammation med Actemra slid nearly 1 billion Swiss francs year over year in the first nine months of 2022. About 900 million Swiss francs of the drop happened in the third quarter alone, Roche CEO Severin Schwan said during a conference call Tuesday.
Ronapreve’s revenue was nearly wiped out with a 92% decline to just 22 million Swiss francs in the third quarter. And Actemra sales plummeted 42% during the same period to 584 million Swiss francs.
To make things worse, biosimilars continue to wreak havoc on Roche’s portfolio. During the third quarter, one more Roche blockbuster product has joined the cancer troika—Avastin, Herceptin and Rituxan—on the U.S. biosimilar exposure list.
Roche’s Novartis-partnered age-related macular degeneration drug Lucentis started to face its first U.S. biosimilar from Biogen and its partner Samsung Bioepis in July. Thanks to the copycat entry, Roche’s Lucentis haul dipped 39% to 228 million Swiss francs in the third quarter in what Schwan described as a “more pronounced effect” than what the company had expected.
More competition is on the way. Coherus BioSciences in August won an FDA approval for a Lucentis interchangeable biosimilar, and the company plans to roll it out in October.
Luckily, Roche can lean on its newly launched eye drug Vabysmo for wet age-related macular degeneration and diabetic macular edema. Industry watchers believe the drug is a strong countermeasure to Lucentis losses and one that could even put up a fight against Regeneron and Bayer’s market-leading VEGF inhibitor Eylea, although a recent Eylea high-dose clinical win could complicate the rivalry.
Merely eight months into its launch, Vabysmo already collected 282 million Swiss francs by September, with 173 million Swiss francs coming in the third quarter. Some of Vabysmo’s sales came from prior Lucentis patients.
Currently, 85% to 95% Vabysmo’s business is from patients switching from other products, including about 15% to 20% from Lucentis and the rest from Eylea, Roche’s pharma chief Bill Anderson said on the call. The drug is also nearing phase 3 readouts this year in retinal vein occlusion.
As for the cancer trio of Avastin, Herceptin and Rituxan, biosimilars together ate away roughly 1.5 billion Swiss francs in sales so far this year. All told, Roche expects to take a 2.5 billion Swiss franc hit from biosimilars in 2022.
Roche has been counting on newer meds to compensate for the biosim losses. But in the third quarter, the new products were growing at a slower-than-expected pace. Multiple sclerosis drug Ocrevus, HER2-targeted breast cancer drug Perjeta, hemophilia therapy Hemlibra and PD-L1 inhibitor Tecentriq—Roche’s four top-selling drugs—all delivered third-quarter sales that were slightly below Wall Street consensus, according to ODDO BHF.
Roche’s oncology department as whole saw sales down 1% at constant currencies in the first nine months. In one important milestone, the FDA has in August accepted an application for Polivy in newly diagnosed diffuse large B-cell lymphoma, teeing up a decision by April 2, 2023, Anderson told investors on the call. The indication bears blockbuster potential given that the current standard of care has been unchanged for 20 years.
As Roche awaits an FDA decision, a first-line approval in Europe—and possibly off-label use in the U.S.—is already giving Polivy a revenue boost. The drug’s sales reached 113 million Swiss francs in the third quarter, compared with 177 million Swiss francs in the first half of 2022.
Meanwhile, a major focus among Roche investors is an upcoming readout of Alzheimer’s disease candidate gantenerumab, a topic that heavily occupied Tuesday’s conference call. The Swiss pharma is now expecting pivotal data from the GRADUATE trials at the end of November, Schwan said. The recent phase 3 success by Eisai and Biogen’s lecanemab has rekindled hope for the entire anti-amyloid antibody class.