This pharma stock has surged 16% on Friday; zoomed over 100% so far in CY24

Shilpa Medicare hit a multi-year high of Rs 672.50, rallied 16% after the company's CDMO customer reported positive results from pivotal clinical trial & placed binding purchase order.

Shares of Shilpa Medicare (SML) hit a multi-year high of Rs 672.50, as they rallied 16 per cent on the BSE in Friday’s intra-day trade after the company’s contract development and manufacturing organization (CDMO) customer reported positive results from pivotal clinical trial & placed binding purchase order.

The stock of pharmaceutical company was trading at its highest level since August 2020. It had hit a record high of Rs 786.75 on December 21, 2016. Thus far in the calendar year 2024 (CY24), the market price of SML has more-than-doubled or zoomed 104 per cent. In comparison, the BSE Sensex was down 0.43 per cent at 11:22 am. Thus far in CY24, the benchmark index gained 10.4 per cent.

In an exchange filing, SML said the companys’ CDMO customer Unicycive Therapeutics, Inc. reported positive results from pivotal clinical trial of Oxylanthanum Carbonate (OLC), a NCE molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients which has several benefits for various patients in this chronic disease. Unicycive is expected to file the New Drug Application for OLC by mid-2024 with potential approval by mid-2025.

SML has partnered with Unicycive to provide end-to-end CDMO services right from development & supply of Active Pharmaceutical Ingredients (APIs) to finished dosage form.

Based on the outcome of the pivotal clinical studies, Unicycive has entered into long term manufacturing and supply agreement with SML and agreed to place a binding purchase order for supply of OLC tablets by June 30, 2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026, the company said.

Apart from the supply arrangement, SML is expected to receive $10 million as milestone income spanning over filing, approval and launch of the product. Additionally, in anticipation of increased product demand Unicycive will also fund the establishment of new manufacturing block at Shilpa’s site, it added.

Meanwhile, the rating agency India Ratings and Research (Ind-Ra) upgraded SML’s and its material subsidiary Shilpa Pharma Lifesciences’s (SPLL) instruments ratings with stable outlook.

Ind-Ra expects further improvement in the SML’s earnings before interest, taxes, depreciation, and amortization (EBITDA) performance from FY25, led by a stabilising pricing scenario in the formulations and API businesses, aided by lower raw material cost and other expenses. SML took various initiatives towards cost containment during FY23-FY24, which could improve the operating performance during FY25-FY26. CLICK HERE FOR MORE DETAILS