Drug Development and Manufacturing
On July 18, Novartis announced its 2023H1 performance, becoming the first multinational pharmaceutical company to release its 2023 half-year results. According to the financial report, Novartis' net sales in the first half of the year reached $26.575 billion, a year-on-year increase of 5%, or 8% growth at constant exchange rates. The net profit was $4.611 billion, a year-on-year increase of 32%. * Drug sales figures in the report are calculated based on constant currencies.
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Innovative Drug Revenue: Net Sales in the First Half of the Year Reached US$21.813 Billion (+8%), Mainly Driven by Strong Growth from Products Such as Entresto (Sacubitril/Valsartan), Kesimpta (Ofatumumab), Kisqali (Ribociclib), and Pluvicto. Sandoz Net Sales Were US$4.762 Billion (+8%), with Its Spin-off IPO Expected to Be Completed in Q4 This Year.
Novartis TOP20 Best-Selling Drugs in the First Half of 2023
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In the autoimmune field, Novartis has heavyweight products such as Cosentyx (secukinumab), Xolair (omalizumab), and Ilaris (canakinumab), collectively generating revenue of $3.708 billion (+2%). Secukinumab is a key pillar product of Novartis, with nine autoimmune indications launched since its market debut. Despite facing competition from many products in the same field and biosimilars, secukinumab maintained a stable performance in H1 2023.
In the cardiovascular field, Entresto has become Novartis' best-selling drug, with all regions achieving strong double-digit growth. The total sales for the first half of the year reached $2.915 billion (+35%).
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PCSK9 siRNA lipid-lowering drug Leqvio's sales in the first half of the year increased nearly 3 times (+293%), reaching 142 million US dollars.
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In July this year, Leqvio received an updated label from the FDA, expanding its applicable population from patients with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) to patients with primary hyperlipidemia. With the continuous expansion of indications and ongoing market penetration, Leqvio is also expected to maintain its growth momentum.
In the field of oncology, the CDK4/6 inhibitor Kisqali (ribociclib) showed significant volume growth in H1 2023 compared to the same period, with sales revenue reaching $9.08 billion (+73%).
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Currently, clinical studies on Ribociclib show that patients can benefit equally regardless of combination with endocrine therapy, menopausal status, metastatic sites, and the number of metastases. In March this year, the Phase III NATALEE study of Ribociclib combined with endocrine therapy as adjuvant treatment for HR+/HER2- early breast cancer (EBC) also achieved positive results, reducing the risk of cancer recurrence by 25.2%. Novartis stated that these study results are expected to more than double the number of patients who benefit.
Novartis plans to submit this research data to regulatory authorities in the United States and Europe in the second half of this year. It can be foreseen that the coverage of an earlier patient population with HR+/HER2- breast cancer will inevitably foster a new growth point for ribociclib tablets.
CD20 Fully Human Monoclonal Antibody Kesimpta (Ofatumumab) is one of the products with the highest growth in Novartis' H1 this year (+103%), generating revenue of $873 million. This drug was first launched in the U.S. in 2009 for the treatment of chronic lymphocytic leukemia. In 2020, a new autoimmune indication for the treatment of multiple sclerosis was approved, after which the product's sales continued to soar, nearly doubling in 2022.
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Notably, Ofatumumab can be self-administered by patients using the Sensoready® auto-injector pen. Therefore, with the advantage of high convenience, Ofatumumab has also attracted more patients to use it and is expected to become another significant growth point for Novartis' innovative drugs.
Pluvicto, a nuclear medicine, is one of Novartis' recent standout innovative products. In March 2022, Pluvicto received FDA approval for marketing as a third-line treatment for PSMA-positive metastatic castration-resistant prostate cancer and is the world's first radioactive ligand therapy targeting PSMA.
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Despite production shortages and the suspension of new patient initiations, Pluvicto achieved $451 million in revenue in the first half of the year. In April this year, Novartis received FDA approval to add a production base and expand capacity to address supply constraints.
Nuclear medicine has always been a key investment area for Novartis. To consolidate its leading position in this field, Novartis also entered into a strategic collaboration agreement with Bicycle Therapeutics, founded by a Nobel laureate, in March this year to jointly develop bicyclic peptide radiopharmaceutical conjugates (BRCs).
In the first half of 2023, to focus on the development of core areas, Novartis continued its "slimming down" strategy from 2022. Not only did it terminate the development cooperation projects for the NASH therapy PLN-1474 and the sickle cell disease (SCD) drug OTQ923/HIX763, but it also divested its dry eye disease assets to Bausch+Lomb for a total transaction value of $2.5 billion.
At the same time, Novartis is actively seeking high-quality external assets. In mid-June, it acquired Chinook Therapeutics, a Canadian company, for a total amount of $3.5 billion, gaining two high-value chronic kidney disease drugs in late-stage clinical trials and expanding its renal product portfolio.
Due to better-than-expected Q2 results, Novartis has raised its overall outlook for 2023 and announced a $15 billion share buyback.
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