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Roche Q1 Pharmaceutical Revenues Grow 5 Percent With Contributions from Precision Cancer Drugs

NEW YORK – Roche reported on Monday a 5 percent increase in pharmaceutical revenues in the first quarter of 2022, with several personalized cancer medicines ranking among its top-selling products.

The Roche Group reported CHF 16.45 billion ($17.15 billion) in total sales during the three months ended March 31, up 10 percent from CHF 14.93 billion in Q1 2021.

Revenues for the pharmaceutical division were CHF 11.16 billion, up 5 percent compared to CHF 10.60 billion during Q1 2021. Compared to the year-ago quarter, pharmaceutical division revenues in the US increased 4 percent to CHF 5.49 billion; declined 5 percent in Europe to CHF 2.07 billion; increased 57 percent in Japan to CHF 1.34 billion; and decreased 1 percent in other international markets to CHF 2.26 billion.

The company's diagnostics division sales in Q1 2022 were CHF 5.29 billion, up 22 percent compared to CHF 4.33 billion in Q1 2021.

The HER2-targeted breast cancer drug Perjeta (pertuzumab), which became Roche's top-selling oncology drug last year, contributed CHF 993 million in Q1 2022, a 2 percent increase from the year-ago quarter.

Other drugs in Roche's HER2 targeted therapy franchise include the HER2 antibody drug conjugate Kadcyla (ado-trastuzumab emtansine), the older Herceptin (trastuzumab), and Phesgo (fixed-dose subcutaneous injection of pertuzumab/trastuzumab). Kadcyla netted revenues of CHF 511 million, a 9 percent increase from the prior year's quarter. Herceptin sales were CHF 607 million, down 19 percent from Q1 2021, largely due to biosimilar competition in various countries. Phesgo recorded revenues of CHF 146 million, up 410 percent compared to the same period last year, largely due to increased adoption in Europe and the US.

"We actually grew the HER2 franchise again, which is a new thing, because in recent quarters it has been affected quite significantly by the Herceptin biosimilar losses," Roche Pharmaceuticals CEO Bill Anderson said during a call to discuss the firm's Q1 financial performance. "Whereas now, [Roche saw] continued growth, particularly with Kadcyla and Phesgo … we were able to move into growth territory and hope to continue that for some time."

Roche's checkpoint inhibitor Tecentriq (atezolizumab), which treats a variety of tumor types including first-line PD-L1-positive advanced non-small cell lung cancer, netted revenues of CHF 825 million in Q1 2022, an 8 percent increase from Q1 2021. Anderson explained that although Tecentriq's revenues might look like they're flattening out over sequential quarters, this reflects a significant price cut for the drug in Japan, and Roche's decision to withdraw Tecentriq's bladder and triple-negative breast cancer indications in the US.

The FDA had previously granted accelerated approval to these indications, but the company decided to pull them from the market after confirmatory trials failed to meet primary endpoints. The impact of those withdrawals "are basically washed out now," Anderson said, noting that Tecentriq sales in the US are steadily increasing quarter over quarter, helped by its launch as an adjuvant treatment for stage II to IIIA, PD-L1-positive NSCLC patients. 

"Further growth for Tecentriq will come from additional penetration in liver cancer as well as launches that are now happening around the world in adjuvant lung cancer," Anderson said, highlighting that in Q1 in the US 72 percent of adjuvant NSCLC patients were assessed for PD-L1 expression. He estimated that Tecentriq is 49 percent penetrated in that market.

Alecensa (alectinib), a treatment for ALK-positive non-small cell lung cancer, brought in revenues of CHF 361 million during the quarter, a 23 percent increase from the prior-year period. Rozlytrek (entrectinib), a treatment for ROS1-positive NSCLC, brought in revenues of CHF 16 million, up 78 percent compared to Q1 2021.

During Q1, Roche announced that a much-anticipated trial pairing the anti-TIGIT drug tiragolumab and Tecentriq didn't significantly improve progression-free survival in small cell lung cancer patients compared to Tecentriq and chemotherapy. However, this year, the company is expecting several late-stage readouts of trials involving tiragolumab. For example, in Q2 Roche is expecting data from the Phase III SKYSCRAPER-01 trial, which aims to confirm the benefit of tiragolumab and Tecentriq as a first-line option for PD-L1-positive advanced NSCLC patients.

Roche also announced during the call that its selective estrogen receptor degrader (SERD) giredestrant had failed to meet its primary endpoint of progression-free survival in the Phase II acelERA trial, involving previously treated, estrogen receptor-positive, HER2-negative metastatic breast cancer patients. However, there was a more pronounced benefit with giredestrant over physicians' choice of treatment in patients with baseline ESR1 mutations.

Competitors like Radius Health and Menarini have also looked at the impact of ESR1 mutations in breast cancer patients receiving SERDs and found a greater magnitude of benefit in this subset. For example, in the EMERALD trial, comparing fulvestrant against Menarini/Radius Health's elacestrant in ER-positive HER2-negative metastatic breast cancer patients, elacestrant lowered the risk of death or disease progression by 30 percent in the all-comer population and by 45 percent in those with ESR1 mutations.

"While we missed on the primary endpoint, we saw an encouraging signal, which continues to bolster our confidence in both the first-line and adjuvant setting," Anderson said about acelERA. He explained that in the later-stage settings, most patients' tumors have become recalcitrant to estrogen blockade, while ESR1-mutated tumors remain responsive to the SERD. Patients in earlier disease stages, who have not yet had a chance to develop resistance to anti-estrogen treatment, should have better response to endocrine blockade, Anderson said.

Based on this rationale, Roche is betting giredestrant will be beneficial in an all-comer population in the first-line and adjuvant breast cancer settings. The company is planning to detail the results of acelERA at an upcoming medical conference.

Roche confirmed its revenue outlook for 2022, expecting sales to grow in the low-single digits at constant exchange rates. Excluding sales losses of between CHF 2 billion and CHF 5 billion related to COVID-19 medicines and diagnostics, and losses due to biosimilar competition of around CHF 2.5 billion, Roche projected that its Group sales will grow in the high-single digit range.