Novartis remibrutinib outlook faces scrutiny as MS trial data clouds growth case

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Novartis remibrutinib MS outlook

Highlights

Novartis maintained a remibrutinib peak annual sales target of over $4 billion in multiple sclerosis, despite late-stage trial results underwhelming analyst expectations and leading Barclays to cut its forecast.
Investors are scrutinizing Novartis’ pipeline as major products like Kisqali and Kesimpta face patent expirations around 2032, posing risk to $18 billion in combined peak sales.
Remibrutinib’s broader opportunity hinges on trial readouts for progressive multiple sclerosis by 2031 and hidradenitis suppurativa before Nov. 19, with Barclays assigning a $2 billion peak sales estimate but only 50% probability of success for the latter.

Trial data tests Novartis growth narrative

As reported by CNBC, Novartis CEO Vas Narasimhan says remibrutinib could become one of the company’s largest medicines and the drugmaker is maintaining a peak annual sales target of more than $4 billion for the experimental multiple sclerosis treatment. That stance is coming under pressure after detailed late-stage trial results showed the drug reduced relapses in relapsing multiple sclerosis by less than some analysts had expected, prompting Barclays to cut its peak sales forecast days earlier.

The issue is drawing added attention because Novartis is also reporting improved third-quarter profitability and sales growth as it moves past the sharpest patent cliff in its history, including the loss of key protection for heart drug Entresto. Barclays analysts say the market is already focusing on the next wave of patent expiries, with Kisqali and Kesimpta facing expirations around 2032 and together representing $18 billion in peak sales.

Novartis is guiding for more than $8 billion in total remibrutinib sales across indications, including uses beyond relapsing multiple sclerosis. A company spokesperson says Novartis views the drug mainly as a way to expand its multiple sclerosis portfolio rather than replace Kesimpta sales, targeting newly diagnosed patients, people on oral therapies and some patients on anti-CD20 treatments who may be eligible to switch.

Progressive MS and other uses support broader opportunity

Amit Bar-Or, a multiple sclerosis specialist at the University of Pennsylvania, says remibrutinib appears to offer a promising safety profile but is unlikely to control relapsing multiple sclerosis as effectively as high-efficacy antibodies such as Novartis’ own Kesimpta. He says the bigger commercial opportunity could emerge if ongoing trials show a benefit in progressive multiple sclerosis, where treatment options remain limited.

Remibrutinib is a BTK inhibitor, designed to reduce immune system activity that damages nerves in multiple sclerosis patients by regulating B-cell activity rather than eliminating the cells. Bar-Or says that approach could make BTK inhibitors safer over the long term than some existing treatments, but adds that there is not yet enough long-term safety data to confirm that advantage.

Morningstar analyst Jay Lee says Novartis’ forecast for more than $4 billion in peak multiple sclerosis sales for remibrutinib is possible, but not yet de-risked. He says the outlook depends on how the drug compares with Roche’s fenebrutinib, future pricing negotiations, whether tolerability advantages help patients remain on therapy longer and whether trials support switching patients from current treatments.

In the near term, Lee says the largest market for remibrutinib is likely to be patients switching from generic oral treatments, especially for tolerability reasons. Investors are also focusing on the RESHAPE trial, which is enrolling patients aged 40 to 70 who are taking Roche’s Ocrevus and is expected to read out in 2028, while a separate trial in progressive multiple sclerosis is expected to read out in 2031.

Beyond neurology, remibrutinib is already approved for certain forms of chronic hives. A late-stage trial in hidradenitis suppurativa is expected to read out before Nov. 19, with Barclays estimating a $2 billion peak annual sales opportunity in that indication but assigning only a 50% probability of success because of an unusual dose-response pattern in mid-stage trials and a history of late-stage failures in the disease.

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