Skip to main content
Premium Trial:

Request an Annual Quote

Roche Sees Strong Demand for Elevidys Gene Therapy Amid Steady Q3 Pharmaceutical Revenue Growth

Premium

NEW YORK – In the third quarter of 2024, Roche executives saw growing uptake of the gene therapy Elevidys (delandistrogene moxeparvovec-rokl), which it attributed to pent-up demand among families whose children have Duchenne muscular dystrophy (DMD).

The firm recorded CHF 137 million ($158 million) in Elevidys sales during the nine months ended Sept. 30, 2024. Roche didn't report Q3 2024 sales numbers or any comparable nine-month sales figures from 2023 for Elevidys, which was developed with Sarepta Therapeutics.

The uptake comes after the US Food and Drug Administration converted the gene therapy's June 2023 accelerated approval to full approval in June 2024 and expanded the product's label to include more patients. At the time of accelerated approval, Sarepta had announced a $3.2 million list price for the treatment.

The agency had originally granted accelerated approval to Elevidys as a treatment for ambulatory DMD patients between 4 and 5 years old, but with the label expansion the drug is now fully approved for patients 4 years and older with a confirmed DMD mutation, and it is approved on an accelerated basis for non-ambulatory patients in the same age range. 

Outside the US, Elevidys is approved in the United Arab Emirates, Qatar, Kuwait, Bahrain, and Oman. In a call to discuss the firm's Q3 2024 financial results, Roche Pharmaceuticals CEO Teresa Graham said that about 500 patients have received Elevidys around the world, and the company has seen families traveling to countries where the therapy is approved to seek treatment for children with DMD.

"Certainly, there are families who have been anxiously awaiting these approvals and are waiting for their opportunity to receive this treatment," Graham said. However, she said that doesn't necessarily mean there will be a drop in demand once that initial wave of children receive treatment.

"We believe that there is going to be a longer, steady revenue flow," Graham noted, while acknowledging that it's unclear exactly how steady that demand will be in 2025 and later. "We've said we expect this to be a couple billion-dollar market outside the US, and we stand by that assumption at the moment," she said, adding that "it will very much depend on how regulatory approvals and reimbursement flow." 

For the moment, Elevidys did not rank among Roche's top-selling precision medicine products, though certain precision oncology products, such as the HER2-targeted drug Perjeta (pertuzumab), remained bestsellers in the third quarter. 

In Roche's HER2 franchise, Perjeta recorded CHF 888 million in Q3 2024, down from the CHF 913 million in sales for the drug recorded in Q3 2023 but a 2 percent increase at constant exchange rates (CER). Over the same period, sales of Roche's other HER2-targeted drug Kadcyla (trastuzumab emtansine) grew 2 percent (and 7 percent at CER) to CHF 495 million from CHF 485 million. The fixed-dose HER2-targeted combination regimen Phesgo (pertuzumab/trastuzumab/hyaluronidase) recorded CHF 445 million in sales in Q3 2024, up 48 percent from CHF 300 million in the year-ago period or 55 percent at CER.

Sales of Alecensa (alectinib), a treatment for ALK-positive non-small cell lung cancer, contributed CHF 385 million in Q3 2024, up from CHF 368 million Q3 2023. Sales of Roche's PD-L1 inhibitor Tecentriq (atezolizumab) were CHF 905 million in Q3 2024, down from CHF 938 million in Q3 2023.

Revenue from the overall Roche group grew 6 percent, or 9 percent at CER, in Q3 2024 to CHF 15.14 billion from CHF 14.27 billion in Q3 2023, excluding the impact of sales declines from COVID-19-related products. Revenue from the Swiss drugmaker's pharmaceuticals division increased 7 percent, or 10 percent at CER, to CHF 11.62 billion from CHF 10.86 billion in the year-ago period.

Looking ahead, the drugmaker expects to grow revenues from its breast cancer portfolio following the US approval this month of the mutant PI3Kα inhibitor Itovebi (inavolisib) with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and the anti-estrogen therapy fulvestrant as a treatment for patients with advanced, PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer. Graham noted that the FDA not only approved the drug but granted it a "very strong" label that includes all patients resistant to endocrine therapy, not just those who become resistant within 12 months of starting therapy.

Graham is expecting regulators in the EU will approve Itovebi in the first half of 2025 and noted that China's National Medical Products Administration granted the drug breakthrough therapy designation and priority review. Roche subsidiary Genentech is evaluating Itovebi in four additional clinical trials — INAVO120, INAVO121, INAVO122, and INAVO123 — which, if successful, would expand Itovebi's use to earlier-lines of therapy and endocrine-sensitive patients. With that expanded pool of patients, Graham said, "we are convinced that Itovebi has peak sales potential of more than CHF 2 billion in HR-positive breast cancer alone." Beyond those trials, Genentech is also testing Itovebi in other tumor types, in which PIK3CA mutations play a significant role.

Roche confirmed that it is expecting group sales in 2024 to be in the mid-single-digit range at CER and that core earnings per share will grow in the high-single-digit range at CER, excluding the impact of tax dispute resolutions in 2023.