With a positive phase 3 readout, Novartis is planning an FDA approval application for Pluvicto in metastatic hormone-sensitive prostate cancer later in 2025.
Novartis is launching a $10 billion share buyback to be completed by year-end 2027 as new drug launches accelerate.The move comes as Novartis’ second-quarter sales of $14 billion met Wall Street’s expectations, growing 12% year over year. Notably, radioligand therapy Pluvicto has “returned to really robust growth,” Novartis CEO Vas Narasimhan said on a conference call Thursday. The PSMA-targeted agent has finally shown some life after two disappointing quarters in a row. In the second quarter, Pluvicto’s sales reached $454 million, good for 22% growth over the first three months of 2025.An FDA nod in pre-taxane, PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in late March has started to contribute to Pluvicto’s momentum, as the med enjoyed 40% quarter-on-quarter growth in new patient starts in the U.S.Quarterly new-to-brand prescriptions increased by 60% in the community setting, which made up about 58% of Pluvicto’s total scripts in Q2. Novartis has identified penetration in the community setting as an important factor for Pluvicto’s long-term success.Pluvicto’s radioactive nature mandates that it be dosed at qualified treatment sites. As of quarter two, Novartis estimates that 9 out of 10 patients now live within 30 miles of one of Pluvicto’s 670 active treatment centers, Narasimhan noted.“We believe we have the right footprint now, maybe with some limited addition, and really now are focusing on driving additional depth in these sites, particularly within the urology setting, where we see strong, strong uptake, as well as targeted expansion in certain regions,” Narasimhan said. Meanwhile, Novartis could be looking at another label expansion opportunity with Pluvicto. On Thursday, the company revealed that the phase 3 PSMAddition trial in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint, showing the “statistically significant and clinically meaningful” benefit of Pluvicto plus existing standard of care on delaying progression or death versus existing therapy alone.The trial also observed a “strong positive trend” toward improved overall survival, Narasimhan said on the call.Novartis expects to apply for the mHSPC indication soon this year based on FDA feedback. The company plans to provide the FDA with the final radiographic progression-free survival analysis during the review, as well as an updated overall survival look, Narasimhan told investors on the call.The mHSPC population is roughly of the same size as mCRPC but with more competition, Narasimhan noted. On Thursday’s call, a Goldman Sachs analyst noted that a few experts have suggested that they may think twice about radioligand therapy in hormone-sensitive patients, who tend to be younger, because of the drug’s potential side effects related to continence and sexual function.But Narasimhan suggested that doctors are generally satisfied with Pluvicto’s tolerability profile, and that the sexual function problem is rather a consequence of some other hormonal therapies that patients are taking. The chief executive still stands by his peak sales projection for Pluvicto, which has been set at above $5 billion.Besides Pluvicto, Kisqali’s recent expansion into certain presurgical treatment of HR-positive, HER2-negative breast cancer is progressing well, according to Novartis. U.S. sales of the drug doubled year over year, reaching $750 million in the second quarter. The drug now occupies 61% U.S. new-to-brand share in the early-stage setting within the CDK4/6 inhibitor class.Overall, Kisqali’s $1.2 billion haul during the quarter beat analysts’ consensus estimates by 10%. The disappointment of the quarter came from Novartis’ second-largest product, Cosentyx, which, despite a 7% sales growth year over year, missed analysts’ expectations by 7%.Cosentyx is facing some “short-term headwinds” in the U.S., including the impact from the Medicare Part D redesign and the 340B federal drug price discount program, as well as a “market-wide slowdown in China,” Narasimhan said. Competition from UCB’s Bimzelx in the relatively new hidradenitis suppurativa indication also took a toll on Novartis’ drug.Nevertheless, Narasimhan said the company remains fully confident in Cosentyx’s $8 billion-plus peak sales guidance, with mid-single-digit-plus growth expected over the coming years.A major threat is coming for Novartis’ top-selling med, heart combo Entresto, which pulled in $2.4 billion in sales in the second quarter, up 24% compared with the same period last year.Novartis’ bid to block U.S. generic entry to Entresto has hit some setbacks lately. While rival MSN Pharmaceuticals is not yet able to launch its copycat version, that scenario looks increasingly likely this year as the legal battle continues to play out.Novartis has indicated that Entresto will lose market exclusivity in mid-2025. Once the floodgates are open, Novartis expects multiple generic companies to launch at the same time, potentially causing a “deep” erosion for Entresto starting from the second quarter of a competitor's rollout, CFO Harry Kirsch said on a separate call with reporters Thursday.Kirsch will retire after 22 years with the company, including about 13 years as CFO, Novartis announced Thursday. Mukul Mehta, currently head of business planning and analysis, digital finance and tax, will take over the CFO title effective March 16, 2026.