Roche posted a big Q1 sales gain. So why is the company expecting a slowdown later this year?

Roche delivered a double-digit sales increase in the first quarter, but CEO Severin Schwan still thinks the company’s full-year haul may come in flat versus 2021.

The Swiss pharma giant generated 16.4 billion Swiss francs ($17.2 billion) in revenues in the first quarter, up 11% at constant currencies. But COVID-19 products contributed a big portion of the growth, and Roche is expecting a slowdown for the group throughout the rest of the year.

Anti-inflammation drug Actemra, Regeneron-partnered COVID antibody Ronapreve and COVID diagnostics together delivered 2.8 billion Swiss francs of sales in the first three months, Schwan told reporters Monday. For all of 2022, though, the company only expects 5 billion Swiss francs from the products. That’d be a 2 billion Swiss franc decline over the prior year.

Roche’s sales for Ronapreve, which it markets outside the U.S., nearly tripled to 587 million Swiss francs. The COVID antibody combo was part of a pharmaceuticals business at Roche that grew revenues by 6% to 11.2 billion Swiss francs in the first quarter.

Roche’s pharma division showed some mixed signs during the period. The company’s top-selling med, multiple sclerosis blockbuster Ocrevus, reached an all-time high of 1.45 billion francs, an 18% increase, even though the pandemic is still affecting the broader MS market.

But Roche pharma chief Bill Anderson warned that Russia’s invasion of Ukraine is causing problems for the company’s longer-term clinical trials in neuroscience as about 20% to 30% of patients in MS trials have been coming from the two countries. For a phase 3b clinical trial testing a higher dose of Ocrevus and studies for experimental oral BTK inhibitor fenebrutinib for MS, Roche had to open additional sites in other countries, Anderson said.

Meanwhile, PD-L1 inhibitor Tecentriq appears to be slowing down. Despite a first-in-class FDA approval in October for the adjuvant treatment of certain patients with early-stage non-small cell lung cancer after surgery, Tecentriq sales declined sequentially for the second consecutive quarter to 825 million Swiss francs, the same level as the second quarter of 2021.

Roche attributes Tecentriq’s lagging sales partly to recent withdrawals of U.S. indications in triple-negative breast cancer and bladder cancer. Still, despite a year-over-year impact, Anderson noted that the effect has “washed out” from a quarter-over-quarter basis. But the checkpoint inhibitor took a beating in Japan. Roche took a mandated, significant price cut because it crossed a sales threshold, Anderson explained on a separate call with investors.

Nevertheless, the company still thinks the adjuvant lung cancer use and a first-in-class approval in previously untreated liver cancer could give the drug a boost in 2022. In the first quarter, about 72% early NSCLC patients who were getting adjuvant treatment were tested for the PD-L1 biomarker, Anderson said. Tecentriq, which is only allowed in PD-L1-expressing disease, was given to 49% among those tested in what Anderson called “a strong signal of early uptake.”

Elsewhere in Roche’s pharma department, biosimilars continue to wreak havoc—though to a smaller magnitude than in prior quarters. Copycats to Roche's cancer meds Herceptin, Avastin and Rituxan ate away 568 million Swiss francs from Roche’s top line in the first quarter. The company expects the full-year impact from biosimilars to reach about 2.5 billion Swiss francs.

Roche hopes some new medicines could help it weather the biosimilar turbulence. The company recently launched eye med Vabysmo, a challenger to Regeneron and Bayer’s Eylea. In two months on the U.S. market, the drug pulled in 21 million Swiss francs in sales.

Spinal muscular atrophy therapy Evrysdi nearly doubled sales to 226 million Swiss francs. The oral drug, a competitor to Biogen’s Spinraza, in now the most prescribed SMA treatment in the U.S. with more than 20% market share in new scripts, according to a Roche presentation. With an FDA priority review, Evrysdi is also on track to reach infants younger than 2 months old later this year.

Overall, Roche on Monday confirmed its 2022 projections. It's expecting groupwide sales to be stable or grow in the low-single digits at unchanged exchange rates. A winter surge in COVID cases might hit and drive up higher sales, Schwan said, but Roche doesn’t expect to see that scenario. Excluding COVID products and biosimilar impact, Roche sales grew high-single digits in the quarter, and it expects the same range for the full year.

Editor's Note: The story has been updated with additional comments from Bill Anderson on Tecentriq.