NEW YORK – Sales of Novartis' Pluvicto (lutetium vipivotide tetraxetan) soared 220 percent during the third quarter, and the firm is pointing to a data readout as a harbinger of continued commercial expansion for the new radiopharmaceutical.
For the three months ending Sept. 30, Basel, Switzerland-based Novartis' overall sales rose to $11.78 billion, up 12 percent from $10.49 billion during Q3 2022 and outperforming analysts' average estimate of $11.40 billion. On a constant currency basis, this revenue increase was also 12 percent versus last year's third quarter. These quarterly financial results are the first Novartis has shared since officially cutting ties with the generics drug company it used to own, Sandoz.
Pluvicto brought in $256 million during Q3 2023, up 220 percent from Q3 2022. The exponential growth reflects the fact that the drug netted US Food and Drug Administration approval for its first indication — previously treated, prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) — just last year, and the demand for the drug exploded following its commercial launch.
In a call to discuss the company's third-quarter earnings on Tuesday morning, however, Novartis CEO Vas Narasimhan said Pluvicto's revenue growth would have been even greater had Novartis not struggled with supply issues, which hindered patient access for much of 2023. According to Narasimhan, Novartis has since addressed those issues and Pluvicto supply is now "fully unconstrained." The firm expects Pluvicto to bring in $1 billion for the full year.
Following new data from the Phase III PSMAfore clinical trial presented during the European Society for Medical Oncology (ESMO) Congress on Monday, Novartis plans to file for Pluvicto regulatory approval in earlier-line PSMA-positive mCRPC in 2024. Previously, Novartis was eyeing the fourth quarter of 2023 for this filing, but a complicated study design, which confounded overall survival results, ended up shifting that anticipated milestone.
Meanwhile, Novartis' CDK4/6 inhibitor Kisqali (ribociclib) brought in $562 million during Q3 2023, up 72 percent versus Q3 2022. The drug is approved for hormone receptor-positive, HER2-negative metastatic breast cancer. Based on data from the Phase III NATALEE clinical trial, Novartis filed this past quarter for European regulatory approval for adjuvant Kisqali in early-stage breast cancer, and the firm said it plans to file an application with the FDA for this indication during the fourth quarter of this year.
Sales of the firm's BRAF/MEK inhibitor combination, Tafinlar plus Mekinist (dabrafenib plus trametinib) were $482 million in Q3 2023, up 7 percent from the prior year's third quarter. Its drug for molecularly defined leukemia, Scemblix (asciminib) brought in $106 million during Q3 2023, up 157 percent from Q3 2022.
Sales of the other radioligand therapy that Novartis markets beyond Pluvicto, Lutathera (lutetium Lu 177 dotatate), which is approved for certain neuroendocrine cancers, were $159 million during the third quarter of 2023, up 20 percent from Q3 2022.
In September, Novartis announced that based on the results of the Phase III NETTER-2 trial, it planned to move its radiopharmaceutical into an earlier-line treatment setting for gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
"This was a positive surprise that we had for the quarter," Narasimhan said. "This is consistent with what we [saw] with Pluvicto. It does appear as we move these radioligand therapies into earlier lines, we're seeing stronger results than we saw even in the later lines, where we also saw strong results."
In the US, Lutathera's current FDA label technically allows for this first-line GEP-NET use, so Narasimhan said the firm wouldn't need to pursue a regulatory label expansion here, but Novartis would focus on educating physicians about the benefit of using the radiopharmaceutical in this setting, where it's not typically the go-to treatment. In other countries, though, the firm does need to pursue expanded regulatory indications.
Narasimhan said that Novartis plans to present the NETTER-2 data to the medical community in early 2024.
Novartis recorded net income of $1.76 billion in Q2 2023, or $.85 per share, compared to $1.58 billion, or $.73 per share in Q2 2022. The core EPS, $1.83, beat analysts' average estimate of $1.70 per share.
The drugmaker said it is maintaining its full-year guidance, expecting to see revenue growth in the high-single digits in 2023. Novartis CFO Henry Kirsch raised the possibility that the growth could potentially hit 10 percent.