Amgen (NASDAQ:AMGN) 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.
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 findings.
Amgen is advancing MariTide, dasotralimab and xaluritamig in Phase III development. The company is also continuing development of olpasiran for cardiovascular risk reduction through Lp(a) lowering. Chief Medical Officer Paul Burton said Amgen wants to review detailed data from a competitor’s Phase III Lp(a) program, including the individual components of its four-point primary endpoint, baseline Lp(a) characteristics and the extent of Lp(a) reduction.
Commercial momentum and rare disease plans
Niksefat said Repatha grew 37% year over year in the second quarter, while new-to-brand prescriptions increased more than 50%. He said use has accelerated following publication of FOURIER-OLE data in primary prevention, with IQVIA data showing more than 16,000 new patients per week by the end of August. Growth is coming from both primary care and cardiology, he said.
Repatha also received approval for primary prevention in the European Union at the end of August, Niksefat said. Burton added that updated ACC/AHA multi-society lipid guidelines, as well as endorsement from the American Academy of Family Physicians, could support deeper penetration in primary care.
On UPLIZNA, Niksefat said the product grew about 90% year over year in the second quarter. In generalized myasthenia gravis, approximately half of patient volume is from treatment-naive patients and half is from patients switching therapies, he said. Burton said Amgen is expanding UPLIZNA into autoimmune hepatitis and plans to begin a study in CIDP soon.
Burton also discussed Amgen’s Sjögren’s disease program, which includes separate Phase III studies in systemic and symptomatic patient populations. He said Phase II data showed clinically important and statistically significant reductions in the respective systemic and symptom endpoints, along with biomarker reductions. The Phase III studies could stand independently, he said, with data expected in coming months.
Margins, MariTide and business development
Dittrich said Amgen remains committed to being a top-tier margin company, while being willing to let margins “flex slightly downwards” when investments can produce long-term value and cash-on-cash returns. The company is guiding for a 45% to 46% non-GAAP operating margin this year while continuing to invest in growth opportunities.
He said productivity initiatives, including process streamlining, systems and artificial intelligence, can help fund investments without forcing an either-or choice between margins and growth. While Amgen has a substantial internal pipeline, Dittrich said the company would pursue external innovation that meets its strategic-fit, cash-return, ownership and integration criteria.
Regarding MariTide, Burton said Amgen believes the obesity medicine is differentiated by potential dosing every eight weeks or quarterly, Phase II weight-loss results of 20%, and potential cardiovascular-related benefits observed in Phase II, including reductions in triglycerides, high-sensitivity C-reactive protein and blood pressure. The Phase III program includes chronic weight management, cardiovascular disease, sleep apnea and diabetes studies.
Niksefat said the company sees a potential role for MariTide in longer-term weight maintenance, particularly for patients who discontinue GLP-1 therapies. Amgen is studying lower-dose maintenance approaches in two long-term extensions and is also conducting a switching study.
About Amgen (NASDAQ:AMGN)
Amgen Inc is a biotechnology company that discovers, develops, manufactures and delivers medicines for serious illnesses. Its research focuses on areas including oncology, cardiovascular disease, inflammation, bone health, nephrology and rare diseases. The company uses biologic research, genetics and other advanced technologies to develop treatments intended to address significant unmet medical needs.
Amgen’s medicines include Enbrel for certain inflammatory diseases; Prolia and Evenity for bone-related conditions; Xgeva for complications associated with cancer and bone disease; Repatha for cardiovascular risk reduction; Otezla for inflammatory conditions; and Aimovig for migraine prevention.
