Novartis AG

The impact of pharmaceutical tariffs would be "significant," Novartis CEO Vas Narasimhan said. The opening salvo of second-quarter earnings calls this week came against President Donald Trump’s renewed calls for a tariff on pharmaceuticals.The long-threatened tariffs will arrive “probably at the end of the month,” the president suggested Tuesday. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we’re going to make it a very high tariff,” Trump added.While executives at both Johnson & Johnson and Novartis had a good financial story to tell this week, analysts and journalists were understandably eager to get the companies’ take on the tariff threat.On an earnings call with analysts Wednesday, J&J’s CEO Joaquin Duato was keen to deflect the conversation away from tariff uncertainty and toward praise for Trump’s “big, beautiful bill.”“It's hard to know what is going to happen ultimately with tariffs, but what we do know for sure is that the tax policies that just passed are already creating American jobs and driving innovation,” Duato said.“These very policies that just passed are the ones that have enabled our commitment to invest $55 billion in the U.S. in the next four years, and our goal is to be able to manufacture in the U.S. all the medicines that are consumed in the U.S. at the completion of that plan, and we are on our way of being able to do that,” he added.When it came to the broader impact of sweeping tariffs on imports from other countries plus the retaliatory tariffs some of those countries have imposed on the U.S. in turn, J&J also had a positive take.The New Jersey drug giant now estimates that the impact across 2025 will be around $200 million—half the $400 million suggested earlier in the year—with only its MedTech business affected.“We will look to reinvest the differential to continue to accelerate our pipeline and further power the launch of our new products—those on the market with new indications and those with near-term anticipated approvals,” J&J Chief Financial Officer Joseph Wolk told analysts on the same call.“We continue to monitor what the future years’ impact could be of tariffs on our business,” Wolk added. A 'significant' hit When Novartis unveiled its own second-quarter earnings results the following day, CEO Vas Narasimhan, M.D., gave a deeper insight into how the company would handle the “significant” hit from the pharmaceutical tariffs proposed this week.“I think [it] would clearly have an impact that I think we'd have to see on a product-by-product and situation [basis],” Narasimhan told journalists on an earnings call Thursday.The CEO suggested the 12-18 month tariff implementation timeline referenced by Trump might not be long enough for Novartis to transfer all necessary medicine production to the U.S.“Typically for most medicines, it's a three- to four-year horizon to move full production from one location to another,” he explained on the call. “We're working very hard to accelerate that as fast as we can, and it's our intention to keep the administration fully updated on all of our investments, the progress we're making, and hopefully demonstrate that we are making the investments that we committed to moving production over, and that could mitigate any potential tariffs.”“But again, this will all depend on the details,” Narasimhan added.The Swiss pharma has “adequate inventory” in the U.S. for the rest of the year, according to the CEO, who expressed hope that Novartis won’t face a worst-case scenario.“In terms of the specifics of the next few years, we'd have to see how the actual tariffs are structured,” he said. “We're hopeful that the administration gives consideration to companies like us who are making the investment to move our production into the U.S., and that would enable us to mitigate any of the impacts that may come.”“But we'll have to, of course, have those discussions and see how the tariffs are in fact rolled out,” he added.

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. 

BOSTON & SCCT ANNUAL MEETING, MONTREAL--(BUSINESS WIRE)--Elucid, an AI medical technology company focused on providing physicians with a more precise view of atherosclerosis to drive patient-specific therapeutic decisions, has made two additions to its Board of Directors. The company named Richard E. Kuntz, MD, MSc and Shamiram Feinglass, MD, MPH as board directors. The appointments will help guide Elucid as it accelerates its clinical research strategy, commercializes its flagship PlaqueIQ coronary plaque assessment technology, and continues development of its investigational FFR prediction model, based on PlaqueIQ. These appointments will help guide Elucid as it accelerates its clinical research strategy, commercializes its flagship PlaqueIQTM coronary plaque assessment technology, and continues development of its investigational FFR prediction model, based on PlaqueIQ. PlaqueIQ is the first and only FDA-cleared, non-invasive plaque analysis based on objective histology rather than subjective CCTA visual estimates. PlaqueIQ quantifies and classifies plaque morphology based on ground-truth histology, the gold standard for characterization of plaques. The software is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk. An experienced medical technology executive and clinical expert, Dr. Kuntz is former senior vice president and chief medical and scientific officer of Medtronic plc. Prior to joining Medtronic, he was the founder and chief scientific officer of the Harvard Clinical Research Institute (HCRI), a university-based contract research organization that coordinates National Institutes of Health (NIH) and industry clinical trials with the U.S. Food and Drug Administration (FDA). Dr. Kuntz has directed several multicenter clinical trials and has authored more than 250 original publications. Dr. Kuntz was an associate professor of Medicine at Harvard Medical School, chief of the division of Clinical Biometrics, and an interventional cardiologist in the division of cardiovascular diseases at the Brigham and Women’s Hospital in Boston. Dr. Feinglass is a managing director at Manatt Health working across the business, medical, and policy needs of health systems, life sciences, medical device, digital health and diagnostic companies globally. A global leader in health care, Dr. Feinglass has served as an executive and chief medical officer in large multi-national life sciences corporations including Danaher and Zimmer-Biomet. In parallel, she has driven policy changes alongside senior government officials around the world to influence health policy, regulation, and access. A former regulator at U.S. Centers for Medicare and Medicaid Services (CMS) and commander in the U.S. Public Health Service with extensive regulatory and legislative experience, Dr. Feinglass is on faculty at the John’s Hopkins Bloomberg School of Public Health, Department of Mental Health and is a member of the Board of Directors of Sandoz AG. “We are honored that Dr. Richard E. Kuntz and Dr. Shamiram Feinglass have joined Elucid’s Board of Directors,” said Elucid CEO Kelly Huang, PhD. “Rick lends an important and experienced interventional cardiology view, as well as expertise in clinical trial strategy and execution, and product innovation strategy. Coupled with Shami’s unparalleled expertise in market access, policy making, and regulatory strategy, the two will be invaluable as we push forward our vision of a future where cardiac care is personalized, precision patient care versus risk factor and population-based care.” About Elucid Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQTM image analysis software is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease. PlaqueIQ includes the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit elucid.com.