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Novartis Reports 10 Percent Sales Growth in Q1; Discusses Upcoming Regulatory Filings

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Novartis

NEW YORK – Novartis is gearing up to file regulatory applications for several key precision cancer therapies in the coming months.

Novartis executives discussed these upcoming regulatory plans during a call Tuesday on its financial performance in Q1 2024, during which the firm reported 10 percent revenue growth compared to the year-ago period. 

For the three months ending March 31, Basel, Switzerland-based Novartis' overall revenue rose to $11.83 billion from $10.80 billion in Q1 2023, beating analysts' average estimate of $11.26 billion. On a constant currency basis, Novartis' revenue was up 11 percent versus Q1 the prior year.

"It's been a strong start to the year," Novartis CEO Vas Narasimhan said during the call. "We saw this momentum across all of our key growth brands and across geographies, indicating the high quality of the performance that we're seeing in the company."

During Q1 2024, Novartis recorded $136 million in revenue for its STAMP inhibitor Scemblix (asciminib), up 83 percent on a constant currency basis from Q1 2023. In the US, Europe, and other regions, the firm markets Scemblix for patients with previously treated Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph-positive CML-CP). In the US, the drug is also approved for Ph-positive CML patients whose cancers harbor a T315I mutation.

In the coming months, Novartis plans to seek regulatory approval for the treatment in first-line Ph-positive CML-CP based on results from the Phase III ASC4FIRST study, which met its primary endpoint by showing that Scemblix improved patients' major molecular response rates versus Novartis' Gleevec (imatinib) and other standard-of-care tyrosine kinase inhibitors. The firm will present the study data at the American Society of Clinical Oncology's annual meeting in June and seek regulatory approval in the first-line setting during the first half of this year.

"Our goal, over time, is to make this the leading CML treatment in the world," Narasimhan said, citing as a positive that Scemblix is not included on the list of drugs subject to price-setting by the US Centers for Medicare & Medicaid Services (CMS) under the Inflation Reduction Act (IRA).

"We have here a medicine that can drive growth through this decade and well into the next decade, both in the US and around the globe," he said. At the same time, Narasimhan noted that many CML patients who currently take Gleevec or generic imatinib are treated in the community oncology setting, where physicians with a long history of using the drug might be resistant to change. For this reason, he said Scemblix uptake could be initially slow in some US healthcare settings.

Meanwhile, sales of Novartis' radioligand therapy Pluvicto (lutetium vipivotide tetraxetan) were $310 million during Q1 2024, a 47 percent increase versus Q1 2023 on a constant currency basis. Pluvicto has been commercially available since early 2022 for prostate-specific membrane antigen (PSMA)-positive, previously treated, metastatic castration-resistant prostate cancer patients. Although Novartis faced supply issues for this therapy last year, Narasimhan doubled down on the message that the firm has resolved these issues and is able to consistently supply the agent "at a very high level." Novartis is making "steady progress" toward its goal of having more than 500 treatment sites certified to administer Pluvicto, according to Narasimhan.

Based on the results of the Phase III PSMAfore clinical trial, including an updated overall survival data readout, Novartis will seek regulatory approval for Pluvicto in an earlier-line, pre-chemotherapy advanced prostate cancer setting during the second half of this year.

Novartis is also trying to bring Pluvicto to prostate cancer patients in Japan and China, where it plans to build facilities for manufacturing Pluvicto and its other targeted radioligand therapy for neuroendocrine cancer, Lutathera (lutetium Lu 177 dotatate).

Sales of Lutathera climbed to $169 million during Q1 2024, up 14 percent on a constant currency basis versus the prior year's first quarter. The treatment is approved for adult patients with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. On Tuesday, shortly after Novartis reported its Q1 earnings, the US Food and Drug Administration approved Lutathera as a treatment for pediatric patients with SSTR-positive GEP-NETs.

The firm's BRAF/MEK inhibitor combination, Tafinlar plus Mekinist (dabrafenib plus trametinib), brought in $474 million in Q1 2024, up 5 percent on a constant currency basis compared to Q1 2023. 

Novartis' CDK4/6 inhibitor Kisqali (ribociclib), a treatment for hormone receptor-positive, HER2-negative metastatic breast cancer, recorded sales of $627 million in Q1 2024, up 54 percent on a constant currency basis from Q1 2023. Based on data from the Phase III NATALEE trial, Novartis is seeking approval in the US, Europe, and China for Kisqali as an adjuvant treatment for intermediate- and high-risk breast cancer patients. Narasimhan said the firm expects to hear from regulators about these applications by the end of the second quarter this year.

"There's increasing recognition of the unique profile that Kisqali offers, given its broad dataset on [overall survival] across three different studies in metastatic breast cancer," Narasimhan said, noting that Kisqali accounts for 45 percent of new-to-brand prescriptions in the HR-positive, HER2-negative metastatic breast cancer setting in the US.

Novartis' net income in Q1 2024 was $2.69 billion, or $1.31 per share, compared to $2.15 billion, or $1.02 per share, in Q1 2023. The core EPS for the quarter, $1.80, beat analysts' average estimate of $1.69.

In 2024, Novartis expects full-year sales to grow in the high-single to low double-digit percentage range, and its core operating income to grow in the low double-digit to mid-teens range.