Amgen’s Phase III VESALIUS‑CV study, presented at the American Heart Association Scientific Sessions, demonstrated a 25 % relative reduction in the composite of coronary heart disease death, heart attack or ischemic stroke (3‑P MACE) among more than 12,000 high‑risk patients who had never experienced a cardiovascular event. The trial also reported a 36 % reduction in heart‑attack risk and a 19 % reduction in a broader 4‑P MACE composite, with numerical trends toward lower cardiovascular and all‑cause mortality. These findings confirm that Repatha protects patients in a primary‑prevention setting, a first for any PCSK9 inhibitor.
The 25 % benefit translates into a 1.5‑point absolute risk reduction over a median follow‑up of 3.5 years, meaning roughly 15 fewer events per 1,000 patients. Because the study population was largely diabetic (≈60 %) and had uncontrolled LDL‑C, the data support labeling Repatha for adults at high risk of major adverse cardiovascular events who have not yet had a heart attack or stroke. This expands the eligible patient base from the secondary‑prevention cohort to a much larger primary‑prevention market, potentially adding millions of new patients worldwide.
Amgen’s Q3 2025 earnings, released on November 4, showed revenue of $9.6 billion—up 12 % YoY—and GAAP EPS of $5.93, beating analyst consensus by $0.24. The beat was driven by a 40 % year‑over‑year increase in Repatha sales to $794 million, reflecting strong volume growth and pricing stability. Operating margin rose to 27.6 % from 25.1 % a year earlier, thanks to cost‑control initiatives and a favorable product mix. Management cited the VESALIUS‑CV data as a key driver of the sales momentum and reaffirmed confidence in the drug’s commercial trajectory.
CEO Robert A. Bradway highlighted that the trial “reinforces Repatha’s role as a cornerstone therapy for high‑risk patients and positions Amgen to capture a larger share of the primary‑prevention market.” He also noted that the company’s raised full‑year 2025 revenue guidance—$35.8 billion to $36.6 billion—reflects expectations of continued volume growth and the impact of the new indication. Analysts welcomed the guidance hike, noting that it signals management’s conviction that the expanded patient pool will translate into sustained sales growth.
The market reaction to the VESALIUS‑CV announcement was positive, with investors viewing the primary‑prevention data as a catalyst for future revenue growth. The trial’s results, combined with the Q3 earnings beat, reinforced Amgen’s competitive advantage over other PCSK9 inhibitors and broadened the company’s portfolio in the lipid‑lowering space. Looking ahead, the company’s focus on pricing strategies, direct‑to‑patient programs, and continued pipeline development positions it to capitalize on the expanded Repatha indication while maintaining profitability.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.