Indoco Remedies soars 19% on US FDA approval for Apixaban tablets

Apixaban is an anticoagulant, or blood thinner, used for patients with health problems caused by a blood clot

Shares of Indoco Remedies moved higher by 19 per cent to Rs 265 in the intra-day trade on the BSE on Monday after the company announced that it has received approval from the US health regulator for blood-thinning drug Apixaban tablets. The approved product is therapeutically equivalent to the reference listed drug Eliquis of Bristol-Myers Squibb.

"The company has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Apixaban tablets in the strengths of 2.5 mg and 5 mg," Indoco Remedies said in a press release.

Apixaban is an anticoagulant or blood thinner and is used for patients with health problems caused by a blood clot. As per IMS MAT June'20 data, the US market size of Apixaban tablets is $ 11,037 million.

Last month, rating agency ICRA, after due consideration, upgraded the long-term rating for the Line of Credit (LOC) to [ICRA]A+ from [ICRA]A. The outlook on the long-term rating has been revised to stable from negative.

"The upgrade of the rating factors in the improved financial profile of Indoco Remedies, driven by a pickup in its high-margin international formulations sales following the resolution of the regulatory non-compliances at two of its three affected plants. Coupled with limited capital expenditure (capex) and controlled working capital intensity of operations, this led to a reduction in the company's total debt to Rs 268 crore as on June 30, 2020 vis-a-vis Rs 296.3 crore as on March 31, 2019," ICRA said in rating rationale.

The company's revenue outlook for the international formulations segment remains strong. It reported a healthy 61 per cent year on year (YoY) growth in international formulations in Q1 FY2021 and is expected to continue to witness high revenue growth over the medium term. The company has launched five new products (including one solid oral and four injectables) in US in five months of FY2021 and plans to launch another three-four products in FY2021.

At 01:31 pm, Indoco Remedies was up 16 per cent to Rs 257 on the BSE, as compared to 0.35 per cent rise in the S&P BSE Sensex. The trading volumes on the counter jumped multiple-fold with a combined 1.09 million equity shares changing hands on the NSE and BSE so far. The stock of Indoco Remedies hit a 52-week high of Rs 285 on April 13, 2020.