NEW YORK – Sales of Roche's Phesgo, an injectable treatment combining older HER2-targeted drugs Herceptin (trastuzumab) and Perjeta (pertuzumab), continued to steadily climb during the first half of 2024, as the firm rolled it out in new regions of the world.
Revenues from Phesgo, which Roche markets for HER2-positive breast cancer patients, increased 60 percent at CER during the first half of the year to CHF 799 million ($835.45 million), compared to CHF 517 million in H1 2023. The company has been able to convert 41 percent of patients on older HER2 therapies to Phesgo, including patients in five new countries where Roche launched Phesgo in the past three months.
Increased demand for Phesgo contributed positively to Roche's oncology division and overall pharmaceuticals business. The firm's oncology division recorded CHF 9.62 billion in revenue in H1 2024, compared to CHF 9.78 billion in H1 2023, which is a 2 percent dip year over year in Swiss francs but a 4 percent increase in CER. The overall pharmaceutical business brought in CHF 22.64 billion in H1 2024, up 5 percent at CER from CHF 22.51 billion in H1 2023. The firm's diagnostics business contributed CHF 7.21 billion in the first half of this year, up 5 percent at CER from CHF 7.27 billion in the first half of 2023.
For the six months ending June 30, Roche's total revenues, including both drug and diagnostics sales, were CHF 29.85 billion, compared to CHF 29.78 billion in H1 2023, unchanged in Swiss francs but up 5 percent on a CER basis.
As expected, increased Phesgo uptake did lower sales of Herceptin and Perjeta, which are both treatments for HER2-positive breast cancer, and Herceptin is also indicated for HER2-positive gastric cancer. In H1 2024, sales of Herceptin dipped 11 percent at CER to CHF 740 million from CHF 878 million in H1 2023. Sales of Perjeta, Roche's bestselling oncology product, declined 2 percent at CER to CHF 1.92 billion from CHF 2.08 billion in the year-ago period.
At CER, the firm's HER2-targeting antibody-drug conjugate Kadcyla (trastuzumab emtansine), which Roche markets for HER2-positive breast cancer, recorded a 6 percent increase in revenue in H1 2024, bringing in CHF 999 million versus CHF 1.00 billion in H1 2023. Kadcyla sales mainly increased in China.
Roche's HER2 franchise, comprising Phesgo, Herceptin, Perjeta, and Kadcyla, grew 5 percent at CER to CHF 4.5 billion during H1 2024.
In addition to its HER2 franchise, Roche markets several other precision oncology products, including the ALK inhibitor Alecensa (alectinib) for ALK-positive non-small cell lung cancer. Alecensa brought in CHF 766 million in the first half of the year, up 7 percent at CER from CHF 758 million in H1 2023. The sales growth in the US was driven by new patient starts, while in China, the drug was recently included again on the National Reimbursement Drug List as an adjuvant treatment. In Europe, Alecensa last month also garnered approval as an adjuvant treatment based on data from the Phase III ALINA study, which pitted the ALK inhibitor against chemotherapy. The drug netted US Food and Drug Administration approval for the same indication in April, and the National Comprehensive Cancer Network now includes Alecensa as a category 1 recommended treatment in the adjuvant setting.
Sales of Roche's immune checkpoint inhibitor Tecentriq (atezolizumab) were CHF 1.80 billion, up 2 percent at CER from CHF 1.85 billion in the first half of 2023. The PD-L1 inhibitor, which Roche markets for numerous cancer indications including certain patients with PD-L1-positive NSCLC, lost some ground in the US due to competition from other immune checkpoint inhibitors, but that was more than offset by its uptake in international markets, particularly in Germany, Roche Pharmaceuticals CEO Teresa Graham said on a call to discuss the Swiss drugmaker's 2024 half-year earnings Thursday morning.
Going forward, she said Roche expects Tecentriq to grow in the low-single-digit range. The firm recently launched a subcutaneous injection version of the checkpoint inhibitor, which Graham said has strong uptake in the countries where it is approved. For example, in the UK, Roche has been able to convert 32 percent of patients from the infusion to the subcutaneous injection. Roche is expecting to receive US approval for the subcutaneous injection during the second half of 2024.
Later this year, Roche is eager to begin marketing a new oncology agent, the PI3Kα inhibitor inavolisib. During the first half of the year, Roche filed for FDA approval for inavolisib as a first-line treatment for patients with PIK3Cα-mutated hormone receptor-positive, HER2-negative breast cancer after endocrine therapy. The agency granted priority review status to this application and is expecting to issue a decision by Nov. 27. Roche is also seeking inavolisib's approval in the same setting in the EU.
"We are going to keep investing here to realize the full potential of this best-in-class medicine in hormone receptor-positive breast cancer," said Graham, estimating a CHF 2 billion peak sales opportunity for inavolisib.
Roche also had some disappointments in the first half of the year. For instance, the firm had to discontinue the Phase III SKYSCRAPER-06, the Phase III SKYSCRAPER-15, and the Phase II SKYSCRAPER-05 trials of its anti-TIGIT drug tiragolumab in various PD-L1-positive NSCLC indications after these studies failed to meet their primary endpoints.
Outside of the oncology franchise, Roche scrapped development of the Pompe disease gene therapy SPK-3006 because study results didn't meet the firm's internal expectations, according to Graham. Meanwhile, Graham pointed out several new molecular entities that Roche added recently to its pipeline, including a cMET-targeting antibody-drug conjugate that it licensed from MediLink Therapeutics and a CD19- and CD20-targeting allogeneic CAR T-cell therapy.
Roche's net income for the first half of 2024 declined to CHF 6.70 billion, or CHF 10.23 per share, from CHF 7.56 billion, or CHF 10.10 per share, during H1 2023.
The drugmaker is raising its full-year guidance and is now expecting its revenues to grow in the mid-single-digit percent range in 2024. The firm is projecting its core EPS will grow in the high-single-digit percent range in 2024.