Strides Pharma hits fresh 52-week high after tentative US FDA nod for Dolutegravir tablets

Strides Pharma stock: The shares of pharmaceutical company Strides Pharma on Friday surged as much as 11.50 per cent to hit an intraday high of Rs 522.20 per share after its step down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, secured tentative approval for Dolutegravir 50 mg tablets from the United States Food & Drug Administration (US FDA).

In an exchange filing, the Bengaluru-headquartered said, “The product (Dolutegravir 50 mg) is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tivicay Tablets of ViiV Healthcare Company. The approval adds to a list of products that Strides has approved under the PEPFAR pathway taking the total to 13 products.”

Dolutegravir is used with other HIV medications to help control HIV infection. It helps in decreasing the amount of HIV in the body so that the immune system can work better.

The company highlighted that the Dolutegravir 50mg tablet has a market opportunity in the US of approximately $1,345 million, as per IQVIA. The products will be manufactured at the company’s facility in Bengaluru, Strides Pharma added.

Earlier this week, the company received US FDA approval for Sevelamer carbonate for oral suspension. Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children six years of age and older with chronic kidney disease (CKD) on dialysis.

Financial performance 

The company reported a quarterly sales of Rs 932 crore in the June quarter (Q1 FY24). Its gross margins came in at 58.7 per cent. The company's consolidated EBITDA soared over 100 per cent annualy to Rs 168.6 crore.

On the company’s June quarter performance, Arun Kumar, Founder, Managing Director, and Executive Chairperson of Strides Pharma said, “Our focus on profitability and efficiency is clearly witnessed in the results as we expanded EBITDA margins by 200 bps QoQ and generated strong operating cash flows. We are on track to achieve the targets we set out for FY24 at the beginning of this year on all financial parameters. The regulated markets grew by 25 per cent YoY with the US growing by 32 per cent YoY and other regulated markets growing by 15 per cent YoY. The growth is driven by a disciplined approach on product launches and sustainable market share on existing products. The emerging markets performance had a slow start and expected to gain traction during the year.” 

The market capitalisation of Strides Pharma is Rs 4,629.11 crore. The stock’s 52-week high is Rs 522.20 per share while its 52-week low is Rs 268.40 per share.

The stocks of the company were trading over 9.50 per cent higher at Rs 513 per share, as of 11:23 am, on BSE.