Novartis Reports Strong Q2 2025 Results with Kisqali Leading 64% Growth Surge
核心洞察
Novartis delivered robust Q2 2025 financial performance with net sales growing 11% in constant currency to $14.1 billion, driven by strong performance from key growth drivers including Kisqali, Entresto, and Pluvicto.
Kisqali emerged as a standout performer with 64% global growth and 100% growth in the US, fueled by momentum from the recently launched early breast cancer (搜索) indication and continued market share gains in metastatic breast cancer (搜索).
The company achieved significant pipeline milestones including positive Phase III results for Pluvicto in hormone-sensitive prostate cancer (搜索) and FDA accelerated approval for Vanrafia (搜索) in IgA nephropathy (搜索).
Novartis delivered another strong quarter with double-digit sales and core operating income growth, driven by exceptional performance from its key growth drivers and important pipeline milestones. The Swiss pharmaceutical giant reported Q2 2025 net sales of $14.1 billion, representing 11% growth in constant currency, with core operating income up 21% to $5.9 billion.
Kisqali Leads Growth Momentum
The standout performer was Kisqali (ribociclib), which generated $1.18 billion in sales with remarkable 64% growth globally and 100% growth in the US market. The CDK4/6 (搜索) inhibitor's exceptional performance was fueled by strong momentum from the recently launched early breast cancer (搜索) indication as well as continued share gains in metastatic breast cancer (搜索) across all regions.
"Novartis delivered another strong quarter, with double-digit sales and core operating income growth. We continue to drive strong performance on our ongoing launches for Kisqali, Pluvicto, and Scemblix, demonstrating the replacement power in our portfolio," said Vas Narasimhan, CEO of Novartis.
Other key growth drivers included Entresto with $2.36 billion in sales (+22% constant currency), Kesimpta at $1.08 billion (+33%), and Scemblix reaching $298 million (+79%). Pluvicto showed encouraging demand uptake with $454 million in sales (+30%), particularly following its pre-taxane metastatic castration-resistant prostate cancer (搜索) approval in the US.
Pipeline Milestones and Regulatory Wins
Novartis achieved several significant pipeline milestones during the quarter. The Phase III PSMAddition trial for Pluvicto in PSMA (搜索)+ metastatic hormone-sensitive prostate cancer (搜索) met its primary endpoint at a prespecified interim analysis, showing statistically significant and clinically meaningful benefit in radiographic progression-free survival. The study also demonstrated a positive trend in overall survival favoring the Pluvicto arm.
The company secured FDA accelerated approval for Vanrafia (搜索) (atrasentan) for reducing proteinuria in adults with primary IgA nephropathy (搜索) at risk of rapid disease progression. Vanrafia can be seamlessly added to supportive care and used as a foundational therapy in this patient population.
Additional regulatory progress included completed US and EU submissions for OAV101 IT (搜索) (onasemnogene abeparvovec) in patients with spinal muscular atrophy (搜索), marking an important milestone for the company's gene therapy portfolio.
Strong Financial Performance and Capital Allocation
The company's core operating income margin reached 42.2%, increasing 340 basis points in constant currency, mainly driven by higher net sales. Core earnings per share grew 24% to $2.42, while free cash flow surged 37% to $6.3 billion, driven by higher net cash flows from operating activities.
Based on the strong performance and confidence in future growth, Novartis raised its full-year 2025 guidance for core operating income, now expecting low teens growth compared to the previous guidance of low double-digit growth. Sales are still expected to grow high single digit for the full year.
The company announced initiation of an up-to $10 billion share buyback program to be completed by year-end 2027, reflecting its robust balance sheet and confidence in mid and long-term growth prospects. During the first half of 2025, Novartis repurchased 48.8 million shares for $5.3 billion.
Expanding Therapeutic Portfolio
Beyond oncology, Novartis continued to strengthen its position across core therapeutic areas. In neuroscience, the Phase II PIVOT-HD study of votoplam in Huntington's disease (搜索) met its primary endpoint of reduction in blood Huntingtin (搜索) protein levels at Week 12 (p<0.0001), with durable, dose-dependent lowering observed through Month 12.
The company also reported positive results from a Phase II study with remibrutinib in food allergy (搜索), which met its primary endpoint with statistically significant and clinically meaningful benefit. These data support remibrutinib's potential as a first-in-class oral BTK (搜索) inhibitor that reduces the risk of severe allergic reactions, including anaphylaxis.
Looking ahead, Novartis expects 15 submission-enabling data readouts over the next two years, underscoring the strength of its late-stage pipeline across cardiovascular-renal-metabolic, immunology, neuroscience, and oncology therapeutic areas.