Novartis' Q4 earnings clouded by regulatory setbacks on inclisiran, Zolgensma
When Novartis CEO Vas Narasimhan hops on the phone with investors at 8 a.m. Tuesday, he will do so with his company already 4 points in the red.
The culprit? Regulatory delays and setbacks that have impeded two of the Swiss pharma’s major new drugs and made for a rocky Q4 report.
Novartis had planned to enter 2021 with an approval in the bag for inclisiran, the RNAi heart drug they purchased for $9.7 billion in 2019. In December, though, the FDA issued a surprising complete response letter, which Novartis chalked up to “unresolved facility inspection-related conditions.” They emphasized that there were no safety or efficacy issues, casting the rejection as another casualty of the FDA’s inability to conduct on-site inspections in Europe during the pandemic.
Still, the company has little of line of sight on when those issues might be resolved, said Narasimhan, who also declined to provide details on the FDA’s facility concerns.
“Largely the timelines are out of our control,” Narasimhan told reporters, per Reuters.
The drug, branded as Leqvio, has been approved in Europe, however, where the Big Pharma saw significant sales growth on another one of its new potential blockbusters, the SMA gene therapy Zolgensma. Sales on the continent eclipsed US sales through the second half of last year. Overall, the gene therapy collected $567 million in Europe and $459 million in the US.
Novartis, though, has yet to steer Zolgensma from the long-running regulatory issues that emerged in the fall of 2019, when the company, still operating under a cloud of an FDA investigation, reported that the drug led to a form of neural toxicity in animal models. The FDA halted the Zolgensma trial for older adults.
Narasimhan said they expect new animal data to be ready between the middle and second half of this year. But the company will still face a longer road to approval than they initially anticipated. In September, the agency requested a new pivotal study, pushing Novartis further behind Roche and Biogen in a closely-contested SMA field.