Novartis has a lot cooking with new drug launches, and the company is not letting potential U.S. tariffs on pharmaceuticals get in the way of its progress.
With recent indication additions, breast cancer drug Kisqali, radioligand therapy Pluvicto and third-generation tyrosine kinase inhibitor Scemblix all delivered double-digit year-over-year sales growth in the first quarter of 2025. Meanwhile, kidney disease drugs Fabhalta and Vanrafia are in the early days of their commercialization.
The rollout of Kisqali in early-stage breast cancer has been top on investors’ minds given the $4 billion peak sales potential Novartis has pegged to the indication.
In the first quarter, Novartis collected $956 million in global Kisqali sales, a 52% increase compared with the same period last year. The figure beat Wall Street’s estimates by 5%, according to analysts with ODDO BHF.
With an FDA approval in the postoperative adjuvant setting in September, Kisqali has grown its new-to-brand share to 60%, Novartis CEO Vas Narasimhan told investors on a call Tuesday. And 56% of those newly added prescriptions are coming from the patient population that’s unique to Kisqali’s label, as opposed to those shared with Eli Lilly’s rival CDK4/6 inhibitor Verzenio, he said.
In addition, considering Kisqali's tied-for-the-lead market share in the metastatic setting, the drug is on track to meet its $8 billion total peak sales goal set by Novartis, Narasimhan said.
By comparison, Pluvicto appears to need some extra work. For the second quarter in a row, Pluvicto’s sales have missed analysts’ expectations. While the prostate cancer drug saw sales grow 20% year-over-year to $371 million, the number landed 7% below consensus estimates.
Pluvicto won a key FDA nod at the end of March to treat PSMA-positive metastatic castration-resistant prostate cancer before taxane-based chemotherapy. This expansion has yet to be reflected in Pluvicto’s quarterly sales, though, as it takes about four to seven weeks for new patients to get treated after necessary scans and lab tests, Narasimhan explained.
Initial uptake of Pluvicto for pre-taxane treatment will come from existing treatment centers that have been prescribing the radiopharmaceutical in the post-taxane setting. Novartis expects these accounts will drive Pluvicto’s growth in the second half of the year
But to realize Pluvicto’s full potential, Novartis needs to expand its reach in the community and urology settings over time, as well as treat more patients at each center, Narasimhan said.
Of the 620 treatment sites that Novartis has enlisted, only about half are running at a target number of patients, Narasimhan noted.
Pluvicto is already gaining traction in the community setting for the post-taxane indication, with 4,000 total scripts as of the first quarter, which marked an 11% increase versus the prior-year level, according to Narasimhan. But it’ll take a combination of efforts to meet Novartis’ targets, he acknowledged, including making doctors more comfortable with the medicine, building capacity for imaging and easing the referral process.
“We’re also continuing to increase—and have increased—our promotional spend,” the chief executive said. “We’ve doubled our field force, and are maintaining a very robust direct-to-consumer advertising campaign.”
Thanks to strong growth from eight priority brands, Novartis beat analysts’ expectations with $13.2 billion sales in the first quarter, good for 12% growth year over year.
The Swiss pharma raised its full-year 2025 guidance and now expects sales to grow at a high-single-digit percentage compared with 2024.
Projecting confidence amid tariff uncertainty
Novartis is “fully comfortable” with this year’s projection, as well as its near-term guidance, because the company has baked in potential effects from the expected U.S. tariffs on pharmaceuticals, Narasimhan said during a separate press call with reporters.
“In general, we believe we can manage through the tariffs for this year, and then we’ll have to, step by step, manage for subsequent years,” Narasimhan said.
“Our goal, as I mentioned, is [to] have 100% of our products produced in the U.S. for the U.S.,” he continued. “We do have a little bit of a lower mix at the moment, but that, again, is something we believe is manageable.”
To achieve that made-in-U.S. target, Novartis earlier this month unveiled a $23 billion plan to build and expand 10 U.S. facilities over the next five years. This includes the build-out of four new manufacturing facilities and two more new radioligand therapy production sites.
During Tuesday’s investor call, Narasimhan acknowledged that the company could have made the investment plan sooner.
“This is a strategic decision to say that the U.S. is our most important single market from a growth and revenue standpoint, and we want to be in a position to be able to produce all of our key medicines end-to-end in the U.S.,” he said.
“I think independent of who’s president, it’s prudent for us to be able to have our supply chain stable inside the United States,” he added.