Secukinumab

Novartis CEO Vas Narasimhan suggested that investors focus more on the growths of the Swiss pharma's newer drugs such as Kisqali, Pluvicto, Scemblix and Kesimpta. Novartis has started to feel the squeeze from generics to its top-selling drug, heart therapy Entresto.The erosion was obvious. After MSN Pharmaceuticals opened the floodgates to Entresto generics in the U.S. late July, sales of Entresto went from a 22% year-on-year increase at constant currencies in the second quarter to a 1% decline in the third quarter.The drug’s third-quarter sales were $1.88 billion, down from $2.36 billion during the three months that ended in June. In the U.S., specifically, Entresto brought in 13% fewer sales than a year ago, dropping below $800 million in the third quarter.After years of lawsuits and petitions with the FDA, Novartis failed to secure an injunction against generics of the heart failure and hypertension therapy before the key patent exclusivity expired. The Swiss pharma is still in litigation with a generic manufacturer and the FDA, according to the company’s third-quarter financial report.While Wall Street had expected Entresto’s decline, the slowdown of Novartis’ second-top-selling product, inflammatory and autoimmune disease treatment Cosentyx, came as a bit of a surprise. Compared to a 6% sales growth at constant currencies in the second quarter, the drug saw sales dip 1% in the third quarter to slightly below $1.7 billion.Cosentyx sales were affected by a one-time $74 million rebate adjustment in the U.S., as well as pricing discounts outside the U.S., according to Novartis. But these one-time effects were only part of Cosentyx’s problem. Novartis has been playing defense in the relatively new market of hidradenitis suppurativa (HS) after UCB’s rival biologic Bimzelx entered the chronic skin condition field in November 2024.After an initial dip, Cosentyx has reached a “stabilization of the performance” in HS, Novartis CEO Vas Narasimhan said on the company’s third-quarter earnings call Tuesday. The drug now holds 52% of the new-to-brand share in treatment-naïve patients and 50% overall in the disease setting.The company has become better at convincing doctors to step up Cosentyx dosing rather than switching patients off the drug if they don’t respond well, Narasimhan said, explaining that now Novartis is turning its focus to overall HS market expansion.However, Narasimhan acknowledged that the market growth has been slower than what Novartis had originally expected.“We continue to see this as a $3 billion to $5 billion-plus market, but it’s clearly going to take longer for that market to develop,” Narasimhan said. Despite those two brands underperforming, Novartis still delivered 7% groupwide sales growth at constant currencies, reaching $13.9 billion in the third quarter, thanks to a group of newer medicines. And Narasimhan suggests investors move on from the aging blockbusters, too.“I would focus much more on the dynamic growth you saw in the quarter on Kisqali, Pluvicto, Scemblix, Kesimpta, all of which, to my eyes, were ahead of consensus,” Narasimhan said on the call. “That’s where I think the focus should be now looking ahead for the company.”Leading the charge was Kisqali, whose $1.33 billion haul marked a 68% increase year over year at constant currencies. The drug is benefiting from an early breast cancer indication, where it’s leading the CDK4/6 competition with 63% new-to-brand share in the U.S.Kisqali is only in the middle of its growth story, according to Narasimhan. In early breast cancer, the drug boasts an advantage over Eli Lilly’s Verzenio thanks to a broader label that also includes patients without nodal involvement. In that exclusive population, more than 60% of eligible patients are still not on a CDK4/6 inhibitor, he said.Meanwhile, the Kisqali launch in the early breast cancer indication is only just beginning outside the U.S., where the drug registered 37% sales growth at constant currencies during the third quarter. The first launch markets are trailing on a similar trajectory as in the U.S., Narasimhan said. In Germany, Kisqali’s monthly new-to-brand share in the early cancer setting was at 77% as of July, according to Novartis.The biggest beat of the quarter for Novartis came from Kesimpta, which brought in $1.22 billion sales on the strength of a 44% year-over-year increase at constant exchange rates, or 9% ahead of analysts’ expectations.The growth was impressive considering increased competition in multiple sclerosis, including the September 2024 entry of a subcutaneous version of Roche’s popular biologic Ocrevus. Asked by one analyst on Tuesday’s call whether any unusual factors contributed to the drug’s performance, Novartis CFO Harry Kirsch confirmed it was “mainly underlying operation growth—a little bit of inventory, but not much.”Elsewhere, radioligand therapy Pluvicto racked up $564 million sales, good for 45% growth year over year at constant currencies. Novartis is preparing an FDA filing for Pluvicto in metastatic hormone-sensitive prostate cancer by the end of the year, hoping to double the size of the drug’s target patient population.Moreover, the PCSK9 cholesterol drug Leqvio is on track for blockbuster status with $894 million sales in the first nine months of 2025, including $308 million during the third quarter.While Leqvio marked one of Novartis’ early investments in RNA therapies, the Swiss pharma has just agreed to pay $12 billion to acquire Avidity Biosciences, which is developing a new class of RNA therapeutics called antibody-oligonucleotide conjugates. The entire pharmaceutical industry is currently navigating policy changes in the U.S. Three companies—Pfizer, AstraZeneca and Merck KGaA’s EMD Serono—have signed “most favored nation” drug pricing deals with the Trump administration. Novartis is “meeting with the administration weekly to look at what are the best solutions we can come up with,” Narasimhan said on the investor call.Facing looming threats of U.S. tariffs on pharmaceuticals, Novartis in April unveiled a $23 billion U.S. investment plan. The majority of the investment will be related to R&D and reflected in Novartis’ financial statements as operating expenses, Kirsch explained on Tuesday’s call. Some of it will be capital expenditures, such as manufacturing expansions, but Kirsch said this part is more about reallocating resources from other parts of the world to the U.S., rather than increasing overall company spending.

Frankfurt: Swiss drugmaker Novartis met third-quarter profit forecasts on Tuesday, as fast growth of newer drugs offset a sharp slowdown in blockbuster heart drug Entresto as it comes under pressure from generics in the U.S. market. The results underscore why Novartis is on an aggressive deal-making spree this year, with a push for acquisitions and licensing deals worth up to $30 billion so far to bolster its drug pipeline as established treatments lose patent protection. The company, which has raised its outlook twice this year, confirmed its 2025 forecasts and said it expected net sales to grow by a "high single-digit" percentage and adjusted operating income to grow by a "low-teens" percentage. Operating income, adjusted for special items, rose 6% to $5.46 billion in the quarter, just slightly above consensus numbers cited by analysts of $5.4 billion. CEO SEES NO IMPACT FROM US TRADE TARIFFS CEO Vas Narasimhan said on an earnings call that the company did not expect a hit from U.S. trade tariffs, despite President Donald Trump threatening levies on drugmakers and pushing for lower drug prices for Americans and more local investment. "We expect five different groundbreakings before the end of the year at manufacturing sites in the U.S. So no impact from tariffs on our guidance for the remainder of this year and next year," said Narasimhan. He said talks over drug pricing with the U.S. administration were progressing well. Peers including Pfizer and AstraZeneca have already struck drug-pricing deals. In late September, Trump said he would impose a 100% tariff on imports of branded or patented pharmaceuticals, starting October 1, unless a drugmaker is building manufacturing facilities in the United States. NEW DRUGS VS GENERICS Novartis has been on a buying spree as it looks to firm-up its drug pipeline in the face of "increasing generic erosion" in the United States. This week it unveiled a $12 billion deal for U.S. biotech firm Avidity. Quarterly sales of its established heart drug Entresto, which lost patent protection this year, reached $1.88 billion in the third quarter, compared to $1.77 billion expected by analysts, according to LSEG data. That was largely flat versus a year ago, well down from its 20%-plus growth earlier in the year. REVENUE FROM TOP SELLER SEEN DECLINING Launched a decade ago, Entresto was Novartis' top-selling medicine in 2024 with sales of $7.82 billion worldwide. In July, a U.S. federal judge rejected Novartis' request to stop MSN Pharmaceuticals from selling a generic version. Analysts project revenue from the drug will surpass $8 billion this year, but will drop to about $6 billion in 2026, according to LSEG data. Sales of the firm's psoriasis drug Cosentyx, which faces competition in the treatment of certain types of psoriasis and arthritis from UCB's Bimzelx, were mostly flat year-on-year at about $1.7 billion. Sales of breast cancer drug Kisqali, launched last year, came in at $1.33 billion. (Reporting by Ludwig Burger in Frankfurt and Bhanvi Satija in London; Editing by Janane Venkatraman and David Holmes)>