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The US Food and Drugs Administration (FDA)’s approval to Lupin for launch of new dosage strengths (54 mg and 160 mg) of cholesterol lowering drug was cheered by the market, as the stock surged over eight per cent intra-day before closing 5.4 per cent up at Rs 1,892. The reason is understandable. Lupin had been seeing a soft patch where the approval rate in the US had slowed and, hence, on a high base the US sales declined in the June 2015 quarter. Further, the USFDA inspected Lupin’s Goa facility in July and subsequent observations left the Street guessing. Though the management had said the observations were not serious, the Street remained nervous. With the latest approval of a filing from the Goa plant, these concerns are laid to rest and validate the management’s commentary after June quarter results that there would not be supply disruption. This is a big positive and should boost to Street’s sentiment, given that the Goa facility manufactures oral solid dosages that contributed about 50 per cent to Lupin’s FY15 US sales.
For now, Finofibrate, an interesting cholesterol lowering product, will strengthen Lupin’s lipid control portfolio in the US. The new dosage strengths have been approved, given the fact that the company already has a Finofibrate portfolio that is being sold currently in the market. It has brands like Antara (fenofibrate in the capsule form) and had also launched authorised generics to stay ahead of competition. Lupin had launched Tricor generics (fenofibrate in the tablet form) too. Further, its lipid control portfolio strengthened after launch of Triplix generics (Fenofibric Acid Delayed·Release Capsule) and Niaspan (niacin, another cholesterol control drug) generics last year. The new strengths now strengthen the portfolio
Though analysts as Sarabjit Kour Nangra at Angel Broking believe the drug is highly competitive and hence unlikely to contribute significantly to the company, nevertheless, the approval has boosted confidence on the Goa plant besides hopes of approval rate picking up. The boost is expected to come from second half of FY16. Analysts at Citi say Lupin has meaningful leverage to a pickup in pace of approvals with close to 170 ANDAs pending approvals and see a bounce back in earnings growth over next few quarters.
What's more, Lupin had acquired generic company Gavis Pharmaceuticals recently, which brings in 66 products pending approvals and another 65 under development. Gavis markets 19 products, has a manufacturing and R&D facility in the US and is the only generic company marketing methylergonovin, a drug for treating Uterus bleeding that contributes $37 million, as per analysts at Ambit. Lupin expects Gavis' revenues to grow by about 3x by FY18 from $96 million in 2014. Analysts at Ambit say Gavis is a good strategic fit for Lupin and expands the company's US product pipeline.
