Amgen Highlights MariTide, IMDELLTRA Pipeline Progress and Growth Priorities

Amgen’s growth momentum remains strong: Its six key growth drivers rose 26% year over year in the second quarter, helping total revenue exceed $10 billion, up 10%, with 22 products posting double-digit sales growth. IMDELLTRA advanced in small-cell lung cancer: A Phase III combination study showed significant improvements in overall survival, progression-free survival and response rates, while an FDA label update shortened monitoring requirements after the first two doses. MariTide and other pipeline programs are progressing: MariTide’s broad Phase III obesity program has completed enrollment in obstructive sleep apnea studies and is testing monthly or less-frequent dosing, while Amgen also advances late-stage programs including olpasiran, dazodalibep and multiple biosimilars.

Amgen NASDAQ: AMGN outlined its growth priorities, late-stage pipeline progress and capital-allocation framework during a Morgan Stanley conference, as newly appointed Chief Financial Officer Thomas Dittrich emphasized execution, financial discipline and cash-on-cash returns. Dittrich, who previously spent nearly a decade at Amgen before serving as CFO at three public companies, said his focus will extend beyond traditional finance to include strategy, transformation and operations. He said the company intends to prioritize investments that support commercial growth and pipeline development while maintaining its longstanding capital-allocation approach.

“Our strategy or hierarchy is very clear,” Dittrich said. “It’s about really, number one, funding innovation, and then number two, funding the business to bring that innovation to as many patients as possible.” He said Amgen’s six growth drivers—Repatha, EVENITY, TEZSPIRE, its rare-disease portfolio, innovative oncology products and biosimilars—collectively grew 26% year over year in the second quarter and represented nearly 70% of product sales. Total quarterly revenue exceeded $10 billion, up 10% from a year earlier, while 22 products posted double-digit sales growth, according to Dittrich.

Dittrich highlighted phase III results from DeLLphi-305, which evaluated IMDELLTRA in combination with durvalumab as a first-line maintenance treatment for extensive-stage small-cell lung cancer. He said the study showed statistically significant and clinically meaningful improvement in overall survival, progression-free survival and objective response rate compared with durvalumab alone. Amgen is advancing IMDELLTRA through phase III studies in first-line extensive-stage and limited-stage small-cell lung cancer, as well as work intended to support more convenient administration. The company estimates the combined addressable population for those programs at about 28,000 U.S. patients. The FDA also approved an IMDELLTRA label update that reduces recommended monitoring for the first two doses to six to eight hours from the start of treatment, compared with a prior recommendation of 22 to 24 hours, Dittrich said.

Elsewhere in the pipeline, Amgen reported positive phase III top-line results for TEZSPIRE in eosinophilic esophagitis and positive phase III data for TEPEZZA in Japanese patients with chronic thyroid eye disease. The company is also advancing MariTide, dazodalibep and xaluritamig in phase III development. Jay Bradner, Amgen’s executive vice president of research and development, artificial intelligence and data, said two phase III studies of dazodalibep in Sj...