Natco Pharma rises 4% after filing ANDA for generic lung cancer drug

Natco Pharma is the first company to have filed a substantially complete ANDA for a generic cancer drug

Natco Pharma shares advanced 4.6 per cent on Friday, August 30, to register an intra-day high of Rs 1,569 per share on BSE. 

Buying interest in the stock came after the company submitted an Abbreviated New Drug Application (ANDA) for the generic version of lung cancer drug TABRECTA (Capmatinib hydrochloride).

The pharmaceutical company had announced the submission in the late hours of trading on August 29.

"Natco Pharma Limited is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of TABRECTA (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets," the filing read.

At around 10:46 AM, shares of Natco Pharma were down 3.51 per cent, or Rs 52.6 lower, at Rs 1552.15 per share. The market capitalisation of the company at around the same time stood at Rs 27,822.93 crore.

As per the company's filing, Natco Pharma is the first company to have filed a substantially complete ANDA for this product and expects to be eligible for 180 days.

TABRECTA or Capmatinib Hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation. It has recorded sales of $126 million in the US market for the year 2023.

Natco Pharma Q1FY25 result

The company's consolidated profit after tax (PAT) in the quarter ended June stood at Rs 668.5 crore, compared to Rs 420.3 crore in the year-ago period. 

Consolidated revenue for the quarter stood at Rs 1410.7 crore, compared to Rs 1,160.2 crore, in the corresponding quarter the previous year.

Natco's earnings before interest tax, depreciation, and amortisation (Ebitda) margin stood at 60.5 per cent in Q1FY25, compared to 47.2 per cent in the year-ago period, as per its FY24 investor's presentation. Meanwhile, Ebitda for the quarter stood at Rs 852.9 crore , compared to Rs 547.7 crore in the corresponding quarter last year.

Headquartered in Hyderabad, India, Natco Pharma operates in the US, Canada and Europe. The company is involved in the discovery, development, manufacturing and commercialization of finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs).

It sells active pharmaceutical ingredients (APIs) in the domestic and international markets.

Natco Pharma's share price history

In the past one year, shares of Natco Pharma have gained 67.1 per cent, compared to the BSE Sensex's gain of 26.2 per cent during the same period.