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Informist, Tuesday, Aug. 12, 2025

By Sunil Raghu and Gopika Balasubramanium

AHMEDABAD/MUMBAI – Zydus Lifesciences Ltd. continues to maintain guidance of a single-digit growth in the US market during 2025-26 (Apr-Mar), company management said at an analysts conference call Tuesday. The company plans to launch over 30 new products in the US markets in FY26, the management said, adding that with the potential clearance of its injectable facility, there could be some more launches.

The company said that while its 505(b)(2) drugs would scale up by the end of FY26, it would spill over more into FY27 and substantially add to its business. A 505(b)(2) drug is developed based on data from published literature or the drug regulator's findings on a reference drug to support safety and effectiveness, rather than conducting a new study in-house. This enables companies to bring differentiated variations of the approved drugs to market faster and more cost-effectively.

The Zydus Life management sees a major ramp-up in the 505(b)(2) portfolio after FY27, with a product pipeline of almost 25 products available for launch. Of these, 15 products have already been filed with the regulator for approvals. The launch of these products would be in addition to 20 or 30 products Zydus Life launches on an annual basis in the US market, the management said.

The company, however, is still not clear of the tariff overhang in the US market. "We don't know the extent of the tariff on pharmaceuticals or generics. So as and when we are clear on that, we can give a better understanding," the management said. "But as I said, the US is an important market for us."

The sales of US formulations, which contributed to 49% of the company's top line in the June quarter, rose nearly 3% on year to INR 31.82 billion in the June quarter.

Other than 505(b)(2) drugs, the company is also hoping to get regulatory nod from China in 12 months. It hopes to be able to sell its Desidustat in this "multi-million dollar" market, as China is one of the largest markets for hip inhibitors, the management said. "... we have completed the clinical trials in China with our partner. The data right now is already published. We have mostly answered all our queries with the Chinese authorities," the company management said.

Zydus Life reported better-than-expected June quarter earnings, aided by India formulations and International market sales. The company reported a 3.3% on-year increase in its consolidated net profit to INR 14.67 billion in Apr-Jun against the analysts' estimate of INR 13.6 billion. The drugmaker's net sales rose nearly 6% on year to INR 65.74 billion in the June quarter. Analysts had expected the revenue at INR 65.3 billion.

The company's India formulations sales rose 8% on year to INR 15.20 billion, backed by growth in its chronic segment, pillar brands and innovation portfolio. India formulations business accounted for around 24% of the consolidated revenues of the company in Apr-Jun. The management believes that it has seen a steady start to FY26.

Zydus is also actively preparing to launch a generic version of semaglutide — the active ingredient in Novo Nordisk's blockbuster drug Ozempic for Type 2 diabetes and Wegovy for weight loss, once the patent expires in India. It is investing INR 1 billion to build specialised manufacturing facilities, thereby building enough capacity for launch and meeting demand that may emanate from India.

The company has received approval from the Indian regulator to proceed with the phase III clinical trial for semaglutide injection aimed at treating type 2 diabetes. It is working on launching a new formulation for semaglutide and its administration in patients. It also plans to take this new novel formulation to other markets such as Brazil and Canada in the future. The company is hoping to begin seeing the results of the trial by the end of this year.

On Tuesday, shares of Zydus Lifesciences closed almost flat at INR 955.65 on the National Stock Exchange. The company announced the earnings during market hours.  End

Edited by Saji George Titus

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