Novartis is bracing for several losses of market exclusivity in the next five years, most notably for the company’s second-best-selling drug, Entresto. To hear CEO Vas Narasimhan tell it, the Swiss pharma is advancing more than enough programs to cushion the generics impact and drive growth in the long run, with or without acquisitions.
Generics to heart failure drug Entresto, Roche-shared eye therapy Lucentis and other drugs could leave a $9 billion hole in Novartis’ topline in 2026 compared with 2020 revenues. Still, the company expects to grow sales by at least 4% on average annually during the period, Narsimhan said during an investor event Thursday.
While Novartis can pull off about 1.5% annual growth simply from its already-marketed products, Narasimhan outlined 20 potential billion-dollar launch opportunities—including label expansions for existing meds—by 2026.
Entresto is expected to face U.S. copycat competition in 2025. Thanks to a recent FDA nod for heart failure patients with left ventricular ejection fraction below normal, Novartis has dialed up the drug’s peak sales estimate to above $5 billion.
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Leading the charge for Narasimhan’s blockbuster launch list is cholesterol therapy Leqvio, which awaits an FDA decision on Jan. 1. Others include freshly FDA-approved leukemia therapy Scemblix, radiotherapy Lu-PSMA-617 for prostate cancer, BeiGene-partnered PD-1 inhibitor tislelizumab, and more.
Meanwhile, psoriasis med Cosentyx, Novartis’ largest medicine by sales, just returned positive topline results in moderate-to-severe hidradenitis suppurativa from two phase 3 trials, Novartis said Thursday. The company is now planning regulatory filings in 2022.
The drugmaker is also hoping to repurpose its autoinflammatory disease treatment canakinumab for postsurgery adjuvant treatment of non-small cell lung cancer. That program is in phase 3, along with the potential adjuvant use of Kisqali in breast cancer. Further, Novartis is in late-stage testing for an intrathecal version of gene therapy Zolgensma in older spinal muscular atrophy patients.
All of the estimates come from Novartis’ existing projects. Still, a lot of the talk around Novartis these days is about how the company plans to spend the $20.7 billion cash from the sale of its longtime stake in Swiss rival Roche.
Novartis management is talking to key shareholders to gain their input, with a decision on the capital allocation expected in the coming months, Narasimhan said at the event. Half of investors are currently rooting for a big round of share buybacks, while others are urging the company to invest in bolt-on acquisitions, finance chief Harry Kirsch said. While Kirsch wouldn’t give a specific range of size for his definition of “bolt-on,” he did indicate that Novartis won’t go after large M&A deals.
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One rumored target that Novartis has reportedly circled is Alnlyam Pharmaceuticals, a pioneer in RNA interference technology and the originator of Leqvio. But given Alnylam’s market cap of more than $20 billion, a buyout of that drugmaker would constitute a large transaction.
Narasimhan is known for his strategy of building Novartis around cutting-edge platforms that can be applied to various disease areas. During Thursday’s presentation, the chief executive highlighted RNA therapy—alongside cell and gene therapy and radioligand therapy—as an advanced platform that could drive Novartis’ growth beyond 2030.
Novartis has had in-house RNAi R&D capability for more than a decade, despite a significant reduction in the field in 2014, Narasimhan noted. With Leqvio being the first marketed siRNA therapy for a common disease, Novartis is set to become the largest siRNA manufacturer in the world as it brings manufacturing for the medicine in-house, he added.
“Because of that expertise we already have, partnerships that we’ve made, and the ability we think to be able to hopefully direct siRNAs beyond the liver to other parts of the body, [Novartis has] an opportunity to build a portfolio using our internal capabilities,” Narasimhan said.
The complexity of those advanced technologies, including the manufacturing processes, mean that the products resulting from the work will be hard to replicate, the CEO said.
“Our expectation is that will enable us to have a longer lifecyle on these brands and over time hopefully have a significantly growing proportion of Novartis sales which are less exposed to typical [loss of exclusivity] lifecycle,” Narasimhan said.