Alkem Lab's Taloja facility clears UK MHRA inspection

The drug maker's Bioequivalence Center at Taloja successfully completed UK drug regulator's inspection.

The UK Medicines and Healthcare products Regulatory Agency (UK MHRA) conducted an online inspection at Alkem Laboratories' Bioequivalence Center located at Taloja, Maharashtra from 31st January 2022 to 4th February 2022 and 8th February 2022 to 10th February 2022.

As per the Good Clinical Practice (GCP) Inspection Statement dated 12th May 2022 there were no critical or major observations identified and the said inspection stands closed, Alkem Laboratories said in a statement on 13 May 2022.

Separately, the drug maker announced its Q4 results on 13 May 2022. The company reported 52.4% decrease in consolidated net profit to Rs 114.25 crore in Q4 FY22 as against Rs 239.99 crore in Q4 FY21. Net sales stood at Rs 2,483.86 crore for the quarter ended 31 March 2022 as against Rs 2,192.16 crore during the same period in the previous year, registering a growth of 13.3%.

Profit before tax stood at Rs 242.68 crore in the fourth quarter, down by 6% from Rs 258.16 crore during the period under review. Profitability was dented after the company reported a 13.7% spike in total expenditure to Rs 2,161.59 crore in Q4 FY22 over Q4 FY21.

Consolidated EBITDA rose 15.8% to Rs 337.2 crore in Q4 March 2022, from Rs 291.1 crore in Q4 March 2021. EBITDA margin stood at 13.6% in Q4 FY22 from 13.3% in Q4 FY21.

R&D expenses for the quarter was Rs 163.4 crore, or 6.6% of total revenue from operations compared to Rs 140.8 crore in Q4FY21 at 6.4% of total revenue from operations.

The company's India sales were at Rs 1,718.7 crore (up 16.7% YoY) while International sales were at Rs 741.1 crore (up 7.3% YoY) in the fourth quarter.

As per secondary sales data by IQVIA for the quarter ended 31 March 2022, the company's domestic business grew ahead of Indian Pharmaceutical Market (IPM) with growth of 15.3% YoY compared to IPM growth of 9.6% YoY. Even for the full year FY22, the company outperformed the IPM with growth of 27.6% YoY compared to IPM growth of 18.2% YoY. This outperformance was largely driven by acute therapies like anti-infectives, gastro intestinal, vitamins/minerals/nutrients and pain management which witnessed a good growth during the financial year partly helped by COVID-19 tailwinds.

During the quarter, the company filed 6 abbreviated new drug applications (ANDAs) with the US FDA and received 3 final approvals. For FY22, the company filed 14 ANDAs with the US FDA and received 21 approvals (including 3 tentative approvals).

On full year basis, the company reported a 4.6% increase in net profit to Rs 1,657.64 crore on a 20% rise in net sales to Rs 10,634.19 crore in FY22 over FY21.

Meanwhile, the board recommended a final dividend of Rs 4 per share for the financial year ended 31 March 2022. The record date for the said dividend is fixed on Wednesday, 10 August 2022.

Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals, which it markets in India and International markets.

Shares of Alkem Laboratories fell 1.94% to close at Rs 2903 on Friday, 13 May 2022.

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