Buzzing Stock: Alembic Pharmaceuticals rises after securing two approvals from USFDA

Shares of Alembic Pharma were trading 2% higher intraday on Tuesday
 

Shares of Alembic Pharmaceuticals were trading 2% higher intraday on Tuesday after the drug firm secured two approvals from the United States Food and Drug Administration (USFDA).

Alembic Pharmaceuticals received USFDA tentative approval for Dabigatran Etexilate Capsules in the strength of 150 mg. The drug is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the treatment of deep venous thrombosis (DVTY and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days.

The tentatively-approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim. The drug has an estimated market size of US$ 410 million for twelve months ending September 2021, according to IMS Health (IQVIA).

In a separate filing, the company also announced that it secured approval from USFDA for its ANDA for Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial. The ANDA has been co-developed with Orbicular Pharmaceutical Technologies Private Limited. According to IQVIA, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of USD 310 million for twelve months ending September 2021.

Alembic Pharma has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval.

The company has been witnessing heightened competition in the US market. Due to a fall in the US sales, Alembic Pharma has experienced a 680 bps decline in EBITDA margins to 19.9% and a 650 bps decline in net profit margin to 13.1% since Q4FY21. However, management believes that the US sales decline has bottomed out, although the market situation (excess supply) is expected to continue for another 6 months.
 

At 1.50 pm on Tuesday, the stock of Alembic Pharmaceuticals was seen trading at Rs 748.35, up by 1.73% or Rs 12.70 per share on BSE. The 52-week high of the scrip is recorded at Rs 1,150 and the 52-week low at Rs 720.80 on the BSE.