Novartis dials up midterm sales projection, fleshes out Kisqali's $7B-plus goal

Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs.

The Swiss pharma now expects sales to grow by an average of 5% annually from 2022 to 2027, up from the previous estimate of 4%. Novartis is confident it will “consistently deliver” mid-single-digit growth rates in the longer term, CEO Vas Narasimhan told investors Tuesday.

Novartis looks to be on the right track. Sales excluding the now spun-out Sandoz franchise grew by 4% at constant currencies in 2022 to $41.3 billion, and the sales growth accelerated to 10% in the first nine months this year.

Several fast-growing medicines are fueling Novartis’ rosier outlook.

First up, Novartis improved the projection for its newly crowned top-selling product, heart failure combo Entresto. The company now expects peak sales to reach $7 billion, even assuming a U.S. patent cliff in mid-2025. The drug generated $4.6 billion sales in 2022 on the strength of a 37% year-over-year increase, and Novartis previously estimated that it could achieve more than $5 billion at peak.

Entresto continues to enjoy strong performance in the U.S. and Europe. But it’s the hypertension and heart failure expansions in China and Japan that now allow Novartis to raise its peak sales guidance, Narasimhan said.

Last year, Novartis made China and Japan key markets of focus, alongside the U.S. and Germany.

Besides Entresto, Novartis on Tuesday unveiled for the first time a peak sales number for breast cancer therapy Kisqali; the pharma giant believes the drug could reach $4 billion in its existing metastatic disease indications. The CDK4/6 inhibitor has become a key growth driver, with sales up 74% to reach $1.47 billion in the first nine months of 2023.

But investors’ attention is on a critical expansion opportunity for Kisqali as a postsurgical treatment for early-stage breast cancer. The closely watched NATALEE trial has met its goal, as Kisqali showed an efficacy profile for preventing invasive tumor recurrence or death that looks competitive to Eli Lilly’s Verzenio. Another analysis of the NATALEE study will be shared at the San Antonio Breast Cancer Symposium next week, and Novartis plans to file with the FDA by the end of the year.

Without giving a specific number, Novartis believes Kisqali could enjoy peak sales north of $3 billion in the postsurgical adjuvant setting alone.

Elsewhere, Novartis expects $4 billion in peak sales from multiple sclerosis injection Kesimpta, as well as multibillion in sales from radiotherapy Pluvicto and cholesterol drug Leqvio, respectively.

Novartis’ estimate for Pluvicto is rooted in its potential ability to move the PSMA-targeted drug in earlier lines of prostate cancer treatment. But that effort recently hit a setback. With immature overall survival data from the phase 3 PSMAfore trial, Novartis recently decided to delay its filing for Pluvicto as a pre-chemo treatment for metastatic castration-resistant prostate cancer.

As for Leqvio, the RNA interference drug likely has a long road ahead before sales could meaningfully tick up. Narasimhan pointed to some cardiovascular outcome studies that will read out between 2026 and 2028 to give Leqvio a clinical data boost and potentially expand into primary prevention of heart diseases.

Novartis on Tuesday said its core therapeutic areas are cardiovascular-renal-metabolic, immunology, neuroscience and oncology. Last year, as part of the revelation of a new strategy as a pure-play innovative medicines company, Novartis said it would focus on cardiovascular, immunology, neuroscience, solid tumors and hematology.

“Our thinking in each one of our therapeutic areas is to be very clear about the diseases we want to go after and making sure we have alignment in research, development and commercial on those diseases,” Narasimhan said during Tuesday’s event.