US prospects, new drugs make Glenmark look better

Synopsis

Glenmark's marketing portfolio as of December 2024 had 201 generic products authorised for distribution in the US. The company has 51 applications pending at various stages in the approval process.

ET Intelligence Group: The stock of Glenmark Pharmaceuticals has shown marginal improvement of 2% in a month, amid higher market volatility, compared with a 7% loss incurred in the prior three months. The positive sentiment follows expectations of a strong growth trajectory in FY26 led by the US market and its respiratory and injectable portfolio. It has launched key drugs, expanded its global footprint, and advanced its oncology pipeline. Analysts have revised the target price upwards by over 10%.

Glenmark's marketing portfolio as of December 2024 had 201 generic products authorised for distribution in the US. The company has 51 applications pending at various stages in the approval process. The company stated that its subsidiary, Ichnos Glenmark Innovation (IGI), has a robust pipeline of oncology molecules. Two of these molecules have received orphan drug designation from the USFDA. The designation provides incentives like market exclusivity and fee waivers as it is assigned to medicines developed for rare diseases.

Agencies

In January 2024, the company obtained an exclusive licence for Envafolimab, a cancer drug. Glenmark plans to file for regulatory approval in over 20 markets with commercial launches expected from FY26. In an analyst conference call, the company stated that $600 million-$700 million of franchise will be coming to market in FY27. In addition, it has three sole 180-day exclusivities coming up in FY27 and FY28, which will be another $800 million market. The company has also received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to market WINLEVI in the United Kingdom. It is awaiting approval in its other licensed markets and plans to launch it in FY26.

As of December 2024, Glenmark has submitted marketing applications for RYALTRIS, a nasal spray for allergies and runny nose, in more than 90 countries, and the product has been commercialised in 43 markets. It expects that this drug would achieve $200-$300 million of peak sales over time.

ISB 2001, a trispecific antibody, which aims to treat multiple myeloma, a type of blood cancer, may arise as another major opportunity for Glenmark. "We assume there is a high likelihood of ISB 2001 securing an out-licensing deal based on its data and rising market optimism for tri-specific antibodies," stated HSBC Global Research in a report citing potential sales worth upwards of $500 million.

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