Roche revs up new launches—and a slew of data readouts—as it emerges from the biosim trough

Roche has some good news for AbbVie: There truly is hope for life after an enormous biosimilar assault.

But that good news comes with a bit of advice: It takes a lot of new drugs to get there.

The Swiss drugmaker’s pharma business grew in 2021 despite the 4.5 billion Swiss francs ($4.9 billion) that biosimilars carved out of its Big 3 cancer drugs. And though COVID-related sales did help—some $3 billion worth in its pharma division, between its Regeneron-partnered antibody cocktail and immunology therapy Actemra—the company’s newer drugs brought in 5.7 billion Swiss francs, helping drive pharma sales up 3% to 45 billion Swiss francs.

Ocrevus for multiple sclerosis and Hemlibra for hemophilia were growth stars once again, with Ocrevus’ 5.1 billion Swiss francs in sales guaranteeing its pole position as Roche’s biggest drug. That’s despite the pandemic, which has slowed down patient switches from other MS meds. And Hemlibra sales were up a massive 41% to 3 billion Swiss francs.

The pandemic has also slowed down cancer screenings, but Roche’s PD-L1 checkpoint inhibitor Tecentriq grew 24% to 3.3 billion Swiss francs, while Perjeta and Kadcyla, its breast cancer duo, brought in almost 6 billion Swiss francs together.

The company is expecting four new launches in 2022 and a steady flow of new data from its pipeline—more than one major readout a month, Roche’s pharma CEO, Bill Anderson, pointed out.

“Back when I was considering whether to go into the field of biotech, I dreamed of a year like that,” Anderson said Thursday during the company’s year-end earnings call.

RELATED: Roche, with an FDA nod for Vabysmo in hand, looks to challenge Regeneron's dominant Eylea

Anderson ticked off expectations for the stable of pharma products, particularly the new rollouts. For instance, the brand-new eye injection Vabysmo, the follow-up to aging Lucentis, was FDA-approved Friday for flexible dosing of up to four months between injections. Roche is getting good feedback from doctors about that label, Anderson said, and he’s expecting a “very strong launch.”

That’s a plus in Vabysmo’s quest to compete against market dominator Eylea from Regeneron, at least until Regeneron’s own next-gen rival hits the scene.

Evrysdi, Roche’s spinal muscular atrophy drug, is at the FDA for a potential launch in infants younger than two months. Tecentriq is rolling out in early breast cancer, and Anderson is chuffed about the level of PD-L1 testing that’s happening in that patient group—more than 70%, higher than Roche had expected going in.

Perhaps the most closely watched drug in Roche’s lineup, however, isn’t approved yet—and that’s gantenerumab, in development for Alzheimer’s disease. Roche has been predicting a readout from two large phase 3 trials in the second half of this year, and Thursday narrowed that to Q4. With Biogen’s Aduhelm launch sputtering—and its approval based on biomarker data, not evidence of clinical efficacy—there’s plenty of room for Roche, if those trials come up positive and show a true clinical benefit. And that is a big if.

RELATED: CMS' Biogen decision could spell problems for Lilly, Roche Alzheimer's drugs, half of surveyed neurologists say

Which brings us to the outlook for 2022 and beyond. Roche is expecting another 2.5 billion Swiss franc hit from biosims this year and 5 billion Swiss francs in COVID sales groupwide—which includes diagnostics—rather than 2021’s 7 billion Swiss francs. The company expects sales to come in flat or grow at low single digits.

And as for future margins, a topic visited repeatedly by analysts on Thursday’s call?

It really depends on the pipeline, CEO Severin Schwan said, again mentioning the 14 readouts expected this year. “If a good number of them are positive, don’t worry about margins,” Schwan said. “If it all goes down the drain, you can start worrying.”