Amgen Highlights 26% Growth Drivers, IMDELLTRA Momentum and MariTide Potential

Amgen executives highlighted growth across its key commercial products, progress in late-stage development programs and a continued focus on profitability and cash returns during a Wells Fargo biotech and pharma discussion. Chief Financial Officer Thomas Dittrich, who recently returned to Amgen after an earlier nearly decade-long tenure, said the company has grown to more than twice its former size and now has a substantially broader portfolio. He said his priorities include execution, financial discipline, growth acceleration and maintaining Amgen’s long-standing focus on cash and capital allocation. Dittrich said Amgen’s six key growth drivers—Repatha, EVENITY, TEZSPIRE, rare disease, innovative oncology and biosimilars—grew 26% year over year in the second quarter and accounted for nearly 70% of product sales. Total revenue exceeded $10 billion, rising 10% from a year earlier, while 22 products posted double-digit sales growth, he said. Oncology and pipeline updates Executives pointed to recent Phase III results for IMDELLTRA in small cell lung cancer. Dittrich said the DeLLphi-305 study of IMDELLTRA combined with durvalumab as a first-line maintenance treatment for extensive-stage small cell lung cancer showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival and objective response rate compared with durvalumab alone. The company views the results as an inflection point for IMDELLTRA, which Dittrich said is becoming a standard of care in the second-line setting. Amgen is advancing a broad Phase III program in both extensive-stage and limited-stage small cell lung cancer and is pursuing more convenient administration. The combined U.S. addressable population across these programs is approximately 28,000 patients, according to Dittrich. Kaveh Niksefat, senior vice president of global marketing and access, said more than 2,000 sites are actively using IMDELLTRA in the U.S. He acknowledged that the current label’s 22-hour monitoring requirement for the first two doses can create an access barrier in community settings. Amgen has filed for a reduction to six to eight hours of monitoring in the U.S. and has a PDUFA date for that application, he said. In the DeLLphi-305 study, U.S. monitoring was reduced to one to two hours overall. Dittrich also cited positive top-line Phase III results for TEZSPIRE in eosinophilic esophagitis, a condition affecting more than 470,000 people in the U.S., according to the company. In addition, he said the Phase III OPTIC-J study of TEPEZZA in Japanese patients with thyroid eye disease met both primary endpoints without new safety...