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Novartis' Pluvicto Sales Grew 53 Percent in Q4, Closing in on Blockbuster Status in 2023

Novartis HQ

NEW YORK – Novartis' radioligand therapy Pluvicto (lutetium vipivotide tetraxetan) achieved near-blockbuster status during 2023, further bolstering the Swiss drugmaker's resolve to pursue new indications for this treatment class.

In 2023, Pluvicto — which was approved in the US in March 2022 as a treatment for prostate specific membrane antigen (PSMA)-positive, previously treated, metastatic castration-resistant prostate cancer patients — brought in $980 million, up 262 percent from 2022. In the fourth quarter of 2023, Pluvicto contributed $273 million in sales, up 53 percent from Q4 2022.

For the three months ending Dec. 31, Basel, Switzerland-based Novartis' overall revenue increased 8 percent to $11.42 billion from $10.58 billion in the Q4 of 2022, but fell short of analysts' average estimate of $11.75 billion. On a constant currency basis, Novartis' revenue was up 10 percent versus Q4 the prior year.

"Importantly, now we see unconstrained supply for this brand," Novartis CEO Vas Narasimhan said about Pluvicto's uptake during a call to discuss the firm's financial results on Wednesday morning. However, Novartis did struggle to meet patient demand for the therapy in early 2023, reaching a point where it had to pause new patient starts. Now, Narasimhan said Novartis has fully resumed new patient starts on the radioligand therapy, and he added that there are more than 300 sites currently treating patients with Pluvicto, a number the company hopes to increase to 500 during 2024.

According to Narasimhan, 99.9 percent of Pluvicto doses are being injected on the intended day. Novartis began manufacturing the treatment at a site in Indianapolis this year, which helped ease supply constraints. Novartis expects to administer 250,000 radioligand therapy doses during 2024, and Narasimhan said the firm is investing in building out Pluvicto manufacturing capabilities in Asian regions, including in China and Japan.

In the second half of 2024, Narasimhan said Novartis hopes to file a regulatory application in the US seeking Pluvicto's approval in an earlier-line prostate cancer setting. That application will contain data from the Phase III PSMAfore trial. Data from that study raised a few eyebrows when they were presented during the European Society for Medical Oncology conference in October, since patients crossing over to the control arm once their cancers progressed on Pluvicto may have muddied the overall survival analysis. However, Narasimhan said on Wednesday that he is "hopeful that patient benefit is ultimately what rules out over some of the pure statistical considerations, given that [drugmakers and investigators] are encouraged to utilize crossover in our studies to be patient-friendly and appropriate."

"It's very important that we start to look at adjusted analyses," he said of trials that are designed to allow crossover to the investigational treatment arm. "Otherwise, this puts the industry overall in a very challenging position."

Novartis also has other ongoing clinical trials that it hopes will help move Pluvicto into even broader patient populations and into earlier lines of therapy. These include the Phase III PSMAddition trial, in which Novartis is evaluating Pluvicto as a treatment for metastatic hormone-sensitive prostate cancer, and the Phase III PSMA-DC trial, in which Novartis is evaluating Pluvicto as a treatment for patients with localized oligometastatic prostate cancer. Novartis expects to officially kick off the latter in the first half of 2024.

Beyond Pluvicto, Novartis said that its CDK4/6 inhibitor Kisqali (ribociclib) brought in $610 million for the firm in Q4 2023, up 71 percent from Q4 2022. Kisqali is marketed for treating hormone receptor-positive, HER2-negative metastatic breast cancer. Based on data from the Phase III NATALEE trial, Novartis is seeking approval in the US, Europe, and China for adjuvant use of Kisqali across intermediate and high-risk breast cancer patients. Narasimhan said he is hoping to receive these approvals this year, as regulatory decisions in the US and EU are expected in the second half of 2024.

Novartis recorded $125 million in revenue for the STAMP inhibitor Scemblix (asciminib) in Q4 2023, up 143 percent on a constant currency basis from Q4 2022. The drug is sold in the US, Europe, and other regions for patients with previously treated Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) and in the US for Philadelphia chromosome-positive CML patients whose cancers harbor a T315I mutation.

"The global rollout in the third-line setting is ongoing," Narasimhan said, pointing out that Scemblix has garnered "very positive feedback from payors regarding its clinical benefit."

Recently, Novartis said that the Phase III ASC4FIRST trial pitting first-line Scemblix against investigator's choice of tyrosine kinase inhibitor in Ph+ CML-CP met its primary endpoints. In that trial, Scemblix improved major molecular responses versus tyrosine kinase inhibitors in the comparator arm, which Narasimhan called a "reasonable predictor" of progression-free survival and overall survival. Novartis will present those data at an upcoming medical congress, and according to Narasimhan, the drugmaker is "moving rapidly toward a [regulatory] submission" in that indication in the US during the first half of 2024.

The firm is also planning a regulatory submission in Japan for Scemblix in the first-line setting for Ph+ CML-CP during the second half of 2024. Ultimately, Narasimhan believes Scemblix has the potential to be a multibillion-dollar asset.

The firm's BRAF/MEK inhibitor combination, Tafinlar plus Mekinist (dabrafenib plus trametinib) brought in $486 million in Q4 2023, up 5 percent from the prior year's fourth quarter. Additionally, Novartis' neuroendocrine cancer radioligand therapy Lutathera (lutetium Lu 177 dotatate) brought in $147 million in Q4 2023, up 15 percent from Q4 2022. Earlier this month during the American Society of Clinical Oncology Gastrointestinal Cancers Symposium, Novartis presented data showing Lutathera's benefit in the first-line treatment setting for gastroenteropancreatic neuroendocrine tumors.

Novartis's net income in Q4 2023 was $2.64 billion, or $1.29 per share, compared to $1.32 billion, or $.62 per share in Q4 2022. The core EPS, $1.53, underdelivered relative to the Wall Street consensus estimate of $1.68 per share.

Full-year financials

During 2023, Novartis' total revenue was $45.44 billion, up 8 percent from $42.21 billion in 2022, and under the Wall Street average estimate of $47.18 billion. On a constant currency basis, the drugmaker's total revenue increased 10 percent year over year.

Lutathera brought Novartis $605 million, up 28 percent from 2022, while Kisqali brought in $2.10 billion, up 69 percent from the prior year. Tafinlar-Mekinist, meanwhile, brought in $1.92 billion, up 9 percent from 2022. Scemblix recorded $413 million in revenue during 2023, which, on a constant currency basis, increased 179 percent versus 2022.

Novartis recorded net income of $8.57 billion in 2023, or $4.13 per share, compared to $6.05 billion, or $2.77 per share in 2022. The core EPS, $6.47, fell just short of analysts' average estimate of $6.66 per share. For 2024, Novartis is expecting sales to grow in the mid-single digits and core operating income to grow in the high-single digits.