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Novartis Q1 Kisqali Sales Jump 74 Percent; Drugmaker Addressing Pluvicto Supply Challenges


NEW YORK – Novartis on Tuesday reported that sales of its CDK4/6 inhibitor Kisqali (ribociclib) climbed 74 percent during the first quarter of 2023, while overall net sales increased a more modest 3 percent versus the prior year's quarter.

In a call to discuss its financial performance, Novartis executives also detailed how they are addressing manufacturing issues that have hampered patients' access to its prostate cancer radioligand therapy Pluvicto (177Lu-PSMA-617).

During the three months ending March 31, Basel, Switzerland-based Novartis brought in $12.95 billion in revenues, up from $12.53 billion during Q1 2022, and above the $12.64 billion that analysts had forecast on average. On a constant currency basis, Novartis' revenues increased 8 percent versus the prior year's first quarter.

"Kisqali had an outstanding quarter, gaining momentum globally," Novartis CEO Vas Narasimhan said on a conference call Tuesday morning to discuss first-quarter financials. The breast cancer drug brought in $415 million during Q1, up from $239 million in Q1 2022. According to Narasimhan, this reflects Kisqali's growing uptake in the metastatic breast cancer setting in the US and European Union. Additionally, the National Comprehensive Cancer Network (NCCN) guidelines now list Kisqali plus an aromatase inhibitor as a category 1-level treatment for newly diagnosed metastatic breast cancer patients, and this also likely helped bolster sales, he said, adding, "We expect continued momentum for Kisqali as it achieves its multibillion-dollar potential in the metastatic setting."

Last month, Novartis announced that adjuvant Kisqali plus endocrine therapy had met its primary endpoint by improving invasive disease-free survival compared to just endocrine therapy in the Phase III NATALEE trial of high-risk early-stage hormone receptor-positive HER2-negative breast cancer patients. The drugmaker will present the findings at a future medical meeting but is already in the process of submitting the data to regulators around the world. The firm expects the final NATALEE analysis to read out during the second half of this year. 

"The benefit was consistent in a broad population of stage II and III early breast cancer patients at risk of recurrence," Narasimhan said, adding that the patient population enrolled in NATALEE is approximately two-to-three times the size of the patient population enrolled in the Phase III monarchE study of Kisqali's main competitor, Eli Lilly's Verzenio (abemaciclib), in the equivalent early breast cancer adjuvant treatment setting.

Pluvicto gains ground as Novartis shores up supply issues

Earlier this quarter, Novartis announced it was halting new patient starts on its radioligand therapy Pluvicto because its manufacturing capacity was insufficient to meet patient demand for the prostate-specific membrane antigen (PSMA)-positive metastatic castrate resistant prostate cancer (mCRPC) therapy.

Pluvicto, which gained US Food and Drug Administration approval last March, brought in $211 million in Q1 2023 sales. While it's not possible to quantify demand for the drug compared to sales in the year-ago quarter, in an earnings call last year, Narasimhan acknowledged the firm may have underestimated Pluvicto's demand in preparing for the therapy's launch.

When Novartis announced it was halting new patient starts last month, it noted it hadn't yet received FDA approval for its US-based manufacturing facility in Millburn, New Jersey. In the absence of that facility, Novartis had to ship all Pluvicto doses from a site in northern Italy to the US. As of late last week, however, Novartis has officially secured the FDA approval to begin manufacturing Pluvicto in New Jersey.

With this additional facility, Novartis expects to gradually ramp up Pluvicto production, the company said, but did not provide a precise timeline for when new patients will gain access to the treatment. A Novartis spokesperson said in an email that the firm "is actively engaging with healthcare providers and treatment centers to help them understand how the gradual increase of Pluvicto supply will impact existing and new orders, as well as our expectations for scheduling into the second half of the year."

According to the spokesperson, the Millburn site approval is a "first step" to ensuring reliable Pluvicto capacity in the long run. Once it's fully up and running, Narasimhan said the Millburn facility could produce twice as much Pluvicto as the site in Ivrea, Italy. The drugmaker has also opened another manufacturing site in Zaragoza, Spain, to supply Pluvicto to the EU patient population.

In the US, Novartis is bringing an additional manufacturing site online in Indianapolis, which Narasimhan said could ideally score FDA approval by the end of 2023. Looking further ahead, he said, "the last element of our story on [radioligand therapy production] is the building of automated production lines, which allows substantial capacity."

In the short term, however, Narasimhan expects second quarter 2023 Pluvicto sales to be about the same as Q1. The drugmaker continues to target a production capacity of at least 250,000 doses annually in 2024.

As Novartis addresses its supply challenges, the firm is pushing ahead with expanding Pluvicto and its broader radioligand therapy pipeline in new indications. Novartis will present data from the Phase III PSMAfore trial of Pluvicto in mCRPC patients who haven't received prior chemo during the second half of 2023, at which time the drugmaker also plans to file for regulatory approval in this indication. That trial had a positive top-line data readout, and Narasimhan expects the trial to meet its overall survival endpoints this coming summer. Beyond castration-resistant prostate cancer, Novartis is also trying to move Pluvicto into the hormone-sensitive prostate cancer setting and is targeting 2024 for what it believes will be a positive data readout supporting regulatory submission.

Beyond Pluvicto, Novartis is focused on strengthening and broadening its radioligand therapy pipeline. The drugmaker inked several recent deals toward this end, including a discovery collaboration with Bicycle Therapeutics and a deal with Clovis Oncology to acquire 177Lu-FAP-2286, a fibroblast activation protein (FAP)-targeting radioligand therapy currently being evaluated in a Phase I/II solid tumor trial. Novartis believes FAP represents a promising radioligand therapy target in pancreatic, colorectal, breast, and non-small cell lung cancer.

Sales of the drugmaker's other marketed radioligand therapy, the neuroendocrine cancer theranostic Lutathera (lutetium Lu 177 dotatate), jumped 19 percent to $149 million in Q1 2023. The firm is studying Lutathera in other settings, including glioblastoma and certain small-cell lung cancers.

During Q1 2023, Scemblix (asciminib), which is sold for various molecularly defined leukemia indications, brought in $76 million, up more than threefold from $24 million in Q1 2022. Novartis' BRAF-MEK inhibitor combo, Tafinlar and Mekinist (dabrafenib and trametinib), brought in $458 million in Q1 2023, up 14 percent from $403 million in Q1 2022. Last month, the targeted treatment combination garnered FDA approval for pediatric patients with low-grade glioma harboring BRAF V600E mutations.

Novartis recorded Q1 net income of $2.29 billion, or $1.09 per share, compared to $2.22 billion, or $1.00 per share in Q1 2022. Its core EPS was $1.71, which exceeded analysts' average expectation of $1.55 per share.

Despite the strong quarter, Novartis CFO Harry Kirsch cautioned against several ongoing headwinds, including the negative impact of inflation; continued generics competition; and the costs associated with transitioning Novartis' generics business division Sandoz into a standalone company.

Still, Novartis is raising its full-year 2023 guidance based on the momentum it saw this quarter. It now expects group sales to grow in the mid-single digits, whereas previously it expected growth in the low-to-mid single digits for the full year.