Roche Predicts 2022 Revenue Decline Due to COVID-19, Biosimilar Competition

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Despite a positive start to 2022 with the approval of Vabysmo for two severe eye diseases and strong sales across multiple divisions, Swiss pharma giant Roche predicts a revenue slowdown related to its COVID-19 products and the increasing challenge of biosimilar drugs.

On Monday morning, Roche announced it anticipated losing between $2 and $5 billion related to COVID-19 medicines and diagnostics. The company also predicted losses of around $2.6 billion due to new biosimilar drugs challenging revenue streams generated by some of its branded products. In particular, Roche pointed to biosimilar challenges to cancer drugs Avastin, Rituxan and Herceptin. Roche said sales of those three drugs have already slowed by nearly $595 million in combined revenue. The company is seeing particularly high biosimilar competition in China.

Outside of those excepted losses, the company anticipates group sales growth up to 9%, according to its quarterly financial report.

In the first quarter of 2022, group sales increased 10%, the company said. The largest driver was its diagnostics division, which saw 24% growth. That was largely driven by demand for COVID-19 tests, the company said. That strong sales growth is not expected to continue. Pharmaceuticals saw a 6% growth in sales. The division was driven by sales of drugs including multiple sclerosis medication Ocrevus, which generated sales of more than $1.5 billion, hemophilia drug Hemlibra, which earned nearly $900 million, breast cancer medicine Phesgo, spinal muscular atrophy drug Evrysdi and Ronapreve, a drug for COVID-19 sold primarily in Japan.

Roche also pointed to potential new drivers based on possible European approval of new medicines and new indications for existing drugs. In the first quarter, the Committee for Medicinal Products for Human Use recommended approval of mosunetuzumab as a treatment for follicular lymphoma and expanded approval for Tecentriq in early-stage non-small cell lung cancer. If these medications receive the green light from the European Medicines Agency, Roche said Tecentriq will be the only immunotherapy available for certain patients with early-stage NSCLC in Europe. Also, mosunetuzumab will be the first CD20xCD3 T-cell engaging bispecific antibody available to treat follicular lymphoma.

Weeks ago, CHMP recommended the approval of Polivy for the treatment of previously untreated diffuse large B-cell lymphoma, the most common form of non-Hodgkin lymphoma. Roche said the Polivy treatment regimen is the first therapy in more than two decades to significantly improve the outcome of this type of hematological cancer.

While Roche’s oncology pipeline has been a powerhouse, the company did note two clinical failures during the first quarter. The Phase III SKYSCRAPER-02 study, which assessed the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC), failed to meet its co-primary endpoint of progression-free survival.

Earlier this month, Roche also announced that the Phase II acelERA trial assessing its oral selective estrogen receptor degrader (SERD) giredestrant failed to meet the primary endpoint of progression-free survival in people with a certain form of advanced breast cancer. However, efficacy data were encouraging with a more pronounced benefit in patients with higher dependence on estrogen receptor activity. Roche noted that overall survival data is still immature. Results from the acelERA trial will be presented at a medical meeting later this year.

“As expected, we started the year with strong demand for our diagnostics base business, our broad portfolio of COVID-19 tests and our new medicines. I am particularly pleased about the progress we are making in developing our product pipeline, including positive new data in neurology as well as in severe eye diseases,” Roche Chief Executive Officer Severin Schwan said in a statement.

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