Amgen Highlights MariTide, IMDELLTRA Pipeline Progress and Growth Priorities

Key Points

• 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.

IMDELLTRA, TEZSPIRE and Late-Stage Programs

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 Sjögren’s disease remain on track to report results in the second half of the year. The trials separately evaluate symptomatic and systemic forms of the autoimmune disease, using different outcome measures tailored to each population.

Bradner said the company is seeking statistically significant and clinically meaningful benefits, particularly in symptoms that affect patients’ daily activities. He noted that Amgen has not established a predefined regulatory strategy for a scenario in which only one of the two studies is positive.

Olpasiran and Cardiovascular Research

Amgen continues to develop olpasiran, an investigational small interfering RNA therapy targeting lipoprotein(a), or Lp(a), for cardiovascular risk reduction. Bradner said the company is awaiting detailed results from a competitor’s phase III Lp(a) study after the competitor disclosed that its trial missed its primary endpoint in the overall study population.

He said Amgen will examine factors including treatment response, baseline Lp(a) levels, LDL cholesterol control, patient subgroups, tolerability and potential effects from the COVID-19 period on cardiovascular-outcomes trials.

Bradner said olpasiran reduced Lp(a) by roughly 95% to 99% in prior clinical studies and is designed for quarterly administration. Amgen’s outcomes trial uses a higher Lp(a) entry threshold than the competitor’s study, according to Bradner, and evaluates a three-point major adverse cardiovascular event endpoint rather than a four-point endpoint that includes stroke.

Kave Niksefat, senior vice president of global marketing and access, said updated cardiovascular guidelines have helped drive broader use of Repatha and improved LDL cholesterol management. He cautioned, however, that guideline update timelines can be lengthy.

MariTide Program and Commercial Approach

Bradner said enrollment in Amgen’s broad phase III MariTide program has been strong, with enrollment in obstructive sleep apnea studies completed at the end of August. The overall program is expected to include about a dozen phase III trials spanning obesity and related conditions.

MariTide is designed for monthly or less-frequent dosing due to its monoclonal-antibody backbone, Bradner said. Amgen has previously disclosed activity with every-eight-week administration and has also discussed every-12-week maintenance dosing.

The company is using a three-step dose-escalation process—from 21 milligrams to 35 milligrams to 70 milligrams over two months—to manage gastrointestinal tolerability at treatment initiation. Bradner said Amgen expects phase III data to clarify whether earlier tolerability findings translate into a competitive profile.

Niksefat said Amgen plans to draw on commercial capabilities developed through its AmgenNow direct-to-consumer program, which has served 20,000 patients over the past year, including approximately 18,000 Repatha patients. The ultimate commercial approach for MariTide will depend on its final clinical profile, he said.

Biosimilars and Policy Discussion

Amgen said it is advancing a third wave of biosimilar candidates targeting KEYTRUDA, OPDIVO, OCREVUS and EYLEA HD. Its ABP 234 biosimilar candidate to KEYTRUDA met primary and secondary endpoints in a phase III study, with regulatory submissions planned for the second half of the year. The FDA has accepted Amgen’s biologics license application for ABP 206, its OPDIVO biosimilar candidate, for review, with agency action expected by year-end.

On policy, Niksefat said reimbursement, drug pricing, the 340B program and incentives for U.S. manufacturing remain active topics in Washington. He said Amgen expects to engage with policymakers from both parties but characterized the outlook ahead of the midterm elections as too early to assess.

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.

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