Novartis Drops TIM-3 Blood Cancer Asset After Flop, Posts Disappointing Q4 Results

2024-01-31

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Pictured: Novartis' building in Basel, Switzerland/iStock, Michael Derrer Fuchs Novartis on Wednesday posted fourth-quarter and full-year 2023 financial results, which fell short of analysts’ estimates, while also revealing that it has dropped a late-stage blood cancer hopeful following a Phase III failure. After failing to significantly improve overall survival in the Phase III STIMULUS-MDS2 study, Novartis decided to pull the plug on the TIM-3 targeting monoclonal antibody sabatolimab, which was originally being developed as a combination regimen with azacitidine for patients with high- or very high-risk myelodysplastic syndrome (MDS) who are ineligible for intensive chemotherapy or hematopoietic stem cell transplantation. In its third-quarter 2023 earnings report, Novartis still listed its Phase I study of sabatolimab in low-risk MDS, as well as Phase II studies in unfit and acute myeloid leukemia. All three trials have been left out of its pipeline update in its Wednesday presentation. Novartis’ discontinuation of sabatolimab’s development comes as it weathers disappointing fourth-quarter revenues. The pharma reported overall net sales of $11.4 billion in the most recent quarter, which represents a strong 10% year-on-year growth at constant currencies but it fell short of the $11.56 billion analysts expected, according to Seeking Alpha. Fourth-quarter 2023 core net income also jumped 11% to nearly $3.13 billion versus the same period the prior year. However, this also missed analysts' estimates of around $3.3 billion, according to Reuters. Novartis' stock price dipped 3.6% in premarket trading on Wednesday morning after it released its earnings report. Despite falling short of analysts' estimates, Novartis CEO Vas Narasimhan in a statement touted the “very strong performance” of its key growth drivers. The company’s heart failure drug Entresto (sacubitril/valsartan) earned $1.635 billion in the fourth quarter, demonstrating a 26% year-on-year growth at constant currencies. The psoriasis treatment Cosentyx (secukinumab) was another top-seller for Novartis in the fourth quarter, bringing in $1.3 billion. The multiple sclerosis therapy Kesimpta (ofatumumab) and the breast cancer drug Kisqali (ribociclib) nabbed $641 million and $610 million in sales, respectively. The Swiss pharma also reported a net income of $5.8 billion from the discontinued operations connected with the spinoff of its generics business Sandoz. Looking ahead to the rest of the year, Novartis expects mid-single-digit growth in net sales versus 2023, barring unforeseen events and assuming that there will be no generic competition to Entresto in the U.S. in 2024. During the fourth quarter of 2023, generics took three percentage points away from Novartis’ growth. To hit this growth target, Novartis is eyeing several key regulatory submissions this year, including for the endothelin A receptor agonist endothelin A receptor agonist atrasentan in IgA nephropathy (IgAN), the oral BTK inhibitor remibrutinib in chronic spontaneous urticaria and the oral factor B inhibitor iptacopan—both in IgAN and C3 glomerulopathy. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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