At Novartis these days, immunology therapy Cosentyx and heart drug Entresto are without a doubt the major growth drivers. But as the company continues its search for new star meds, it’s betting on recently launched multiple sclerosis injection Kesimpta and cholesterol fighter Leqvio, aka inclisiran.
Novartis is “not leaving any stone unturned when it comes to Kesimpta and inclisiran,” Novartis pharma President Marie-France Tschudin told reporters during a Tuesday conference call.
Kesimpta has the potential to be a real first-line choice for MS patients, she said. And on the Leqvio side, the company plans to work with healthcare systems to tackle some of the “nonclinical barriers” other cholesterol drugs in and outside the PCSK9 class have come up against, including ensuring patient adherence.
A CD20-targeting drug, Kesimpta got its FDA go-ahead in August as a direct competitor to Roche’s fast-growing Ocrevus. So far, the marketing team has beat all its internal goals for gaining access, Tschudin told investors on a separate call Tuesday.
That includes reaching all the potential prescribers Novartis has targeted. Plus, about 73% of people with commercial insurance in the U.S. now have unrestricted coverage or must try just one other treatment before turning to Kesimpta. In its first four months on the market, about 1,000 patients have been treated with the drug, according to a Novartis presentation.
But Tschudin admitted that the COVID-19 pandemic has caused some setbacks; in the fourth quarter, the drug brought in just $14 million. “We cannot move as fast as we would like due to the limited face-to-face [interactions] with physicians,” she said. “And we’re also seeing a hesitance to switch as physicians and patients prefer to wait.”
Nevertheless, Tschudin believes this road bump doesn’t change Kesimpta’s prospects. In fact, she expects the B cell drug class could take 40% of MS market share.
“Once we’re out of this pandemic and we can put our full commercial power behind Kesimpta, we will really see the potential of this product,” she added. For that, she expects to see an uptick in Kesimpta sales mainly in the second half of 2021, on the premise that the pandemic-related slowdown eases up by then.
As for Leqvio, the drug just snagged its EU go-ahead last month, and Tschudin’s projecting a “slow and steady start” as it secures reimbursement in different countries.
The drug recently suffered a manufacturing-related complete response letter at the FDA. Novartis plans to respond to the agency’s concerns by the third quarter, though CEO Vas Narasimhan, M.D., said the approval timeline after that is unpredictable.
Tschudin and Narasimhan spun the delay as a potential positive—it saved Novartis from launching amidst a pandemic. During the lag time, the company can beef up its launch preparations and spend more time working with healthcare systems on reimbursement.
Before these two launches gain traction, Entresto and Cosentyx will continue to be Novartis’ main growth engine for some time. In 2020, the two blockbusters together reeled in $6.49 billion, about 13.3% of Novartis’ total top-line haul.
Both continued double-digit sales growth, too. In the fourth quarter, Entresto’s sales increased by 35% year over year at constant currencies to $716 million, 4% ahead of industry watchers’ expectations. Cosentyx’s $1.11 billion in Q4 sales marked 13% year-over-year growth at unchanged exchange rates, despite marketwide slowdowns in dermatology and rheumatology patient starts, thanks to COVID-19.
Both drugs have some new developments fueling growth. For Cosentyx, it’s fleshing out a new FDA nod in non-radiographic axial spondyloarthritis (nr-axSpA) since June 2020, and it's expecting phase 3 results in the inflammatory skin disease hidradenitis suppurativa in time to support an approval filing next year. The drug recently won China’s national reimbursement in plaque psoriasis and ankylosing spondylitis ahead of its biologics competitors.
Entresto’s looking at a likely FDA nod to expand into heart failure with preserved ejection fraction (HFpEF) after winning backing from an FDA advisory panel, despite questions about the exact patient population that might be covered by the drug's final label. Tsuchdin said about 3 million HFpEF patients live in the U.S., with about 2 million below normal ejection fraction—a subgroup that some FDA advisers have proposed for a potential go-ahead.
Overall, Novartis’ full-year 2020 sales came in at $48.7 billion, representing a 3% year-over-year growth, in line with analyst expectations. Moving into 2021, the company expects sales to grow in the low- to mid-single digits on the condition that the pandemic eases up in the second half of the year.