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Roche Q3 Pharma Revenues Decline 6 Percent Due to Lower Sales of COVID-19 Treatments


NEW YORK – Roche on Tuesday reported that its pharmaceutical business continued to perform well with help from several precision oncology drugs, despite declines in revenues from COVID-19 treatment.

For the three months ended Sept. 30, the company said overall revenues for the Roche Group declined 6 percent to CHF 14.74 billion ($14.80 billion) from CHF 15.97 billion in Q3 2021. Over the same period, revenues in the pharmaceutical division dipped 6 percent to CHF 10.84 billion compared to CHF 11.71 billion, and revenues in the diagnostics division decreased 4 percent to CHF 3.90 billion compared to CHF 4.26 billion.

"Just to put it into perspective, in pharma alone, we lost CHF 900 million versus last year just in the quarter due to Ronapreve and Actemra," two drugs for treating COVID-19, said Roche CEO Severin Schwan during a call to discuss the company's financials. "On the diagnostics side, to a lesser extent, we've seen declining sales minus CHF 400 million versus the previous year."

The company has also taken a CHF 1.5 billion hit to the sales of Herceptin (trastuzumab) and several other drugs from the entry of biosimilars, but the company's therapeutic pipeline is diversifying quickly, and these legacy drugs comprise a much smaller part of the pharmaceutical division, Schwan assured.

In the oncology therapy franchise overall, sales were down 1 percent over the nine months of 2022, William Anderson, CEO of Roche Pharmaceuticals, said during the call. In the company's HER2 therapy segment, Perjeta (pertuzumab) contributed CHF 1.03 billion in sales in Q3 2022, a 5 percent increase compared to CHF 1.01 billion in Q3 2021; revenues for Kadcyla (trastuzumab emtansine) grew 6 percent to CHF 516 million from CHF 501 million; and sales of Phesgo (pertuzumab/trastuzumab/hyaluronidase) grew 76 percent to CHF 201 million from CHF 117 million. Due to biosimilar competition, revenues of the company's first-generation HER2-targeted drug Herceptin declined 23 percent year over year to CHF 493 million in Q3 2022 from CHF 665 million in the year-ago period.

In the lung cancer segment, Alecensa (alectinib), a treatment for ALK-positive metastatic non-small cell lung cancer, contributed CHF 382 million in Q3 2022, an 11 percent increase from CHF 357 million in Q3 2021. This drug has become a leading treatment for this type of cancer in many major markets, Schwann highlighted.

Tecentriq (atezolizumab), a checkpoint inhibitor marketed for NSCLC and other tumor types, recorded revenues of CHF 934 million in Q3 2022, a 9 percent increase from CHF 878 million in Q3 2021. Next year, Roche is expecting readouts from several studies involving Tecentriq, including trials looking at single-agent adjuvant use of the immunotherapy in hepatocellular and head and neck cancer, as well as a trial in the neoadjuvant/adjuvant setting in triple-negative breast cancer.

In August, Roche said that IMscin001, a study evaluating a subcutaneous formulation of Tecentriq in advanced NSCLC patients, met its co-primary endpoints. The new formulation allows patients to receive Tecentriq via injection under the skin in "a matter of minutes," according to Roche, compared to the hour it takes for patients to receive the infusion.

Anderson noted during the call that Roche has designed this NSCLC study to show pharmacokinetic results and comparability to the IV version. Another study, looking at patients' preferences for either formulation, has also shown that patients would rather get the subcutaneous version than the IV, Anderson added. Roche will present this evidence to regulators in Q1 2023 and is expecting that the data will support the launch of the subcutaneous Tecentriq formulation not just in NSCLC but across the other tumor types for which the immunotherapy is marketed, Anderson said.

The Swiss drugmaker has high hopes for this new Tecentriq formulation based on the rapid uptake of Phesgo, the subcutaneous, fixed-dose version of Herceptin plus Perjeta, in countries with limited capacity to administer infusion drugs. According to Anderson, Phesgo now has an annual run rate of CHF 900 million, and 30 percent of customers have converted from the IV versions of the combination treatments to the subcutaneous version.

"Phesgo is going to continue to be a very important medicine for many years to come," Anderson said. He further highlighted that the firm has initiated the heredERA trial of Phesgo plus the selective estrogen receptor degrader giredestrant in first-line triple-positive metastatic breast cancer.

With regard to giredestrant, Anderson said the early data support development of this drug in estrogen receptor-positive breast cancer patients. In the acelERA trial, even though giredestrant failed to demonstrate a progression-free survival benefit against physician's choice of endocrine monotherapy in the overall ER-positive HER2-negative metastatic breast cancer patient population, there was more pronounced benefit with the SERD in patients with ESR1 mutations.

Then, in the coopERA trial, looking at giredestrant as a neoadjuvant treatment for ER-positive HER2-negative breast cancer, Ki67 has shown to be a biomarker of proliferation linked to improve long-term efficacy. The biomarker data from these two trials provide "strong signals" for the future development of giredestrant, Anderson said.

The company reaffirmed its 2022 full-year financial outlook and said it is expecting stable sales or sales growth in the low-single-digit range.