Alembic Pharmaceuticals Ltd. announced on tentative approval for dronedarone tablets, 400 mg, should add to the earnings outlook for the company. According to IQVIA, the product has an estimated market size of $500 million for the twelve months ending September 2021.
Alembic has settled the matter with Sanofi-Aventis and will launch its generic as per the terms of the settlement.
The company’s US sales outlook is gradually improving as the company has received several approvals for its US launch. The company has received 19 approvals (13 final approvals and 6 provisional approvals) during the financial year and the launch may help improve the company’s US sales trajectory. Alembic’s US sales remain under pressure for some time. The company, which had benefited from strong product launch momentum and drug shortages in the US during FY 2011, saw increased competitive intensity for key products. Although the company’s US pipeline remained strong, it still managed Sartans (hypertension treatment). drugs) had pricing pressure which put pressure on US sales.
Alembic’s revenue from the international generic segment grew at an impressive 35% CAGR (compounded annual growth) in FY2018-21, helped by US sales growth of 33% CAGR as per analyst data, however, as of FY12. Came under pressure during the first half. , Q1FY22 and Q2FY22 exports declined by 30.0% and 12.6%, year-on-year, respectively. However, analysts remain optimistic about increased product approvals and expected launch growth.
Analysts at Sharekhan said, “Going forward, Alembic expects US sales to bottom out and improve, driven by growth in base business and a strong new product launch pipeline including products that have yet to be commercialized. has not been done.”
The company was also investing in niche products in the form of injectables that should support the company’s tide of high competition in the base business. In this regard, the approval of the company’s F3 facility by the USFDA (US drug regulator) for export of ophthalmic products, generic injections, remains important. Analysts at Sharekhan say the USFDA’s comments for the F3 plant are procedural in nature and the management is confident of a solution. Analysts say that while the receipt of the comments could delay development plans, a resolution could be a potential growth driver.
The stock is down 27% from the 52-week high seen in January last year.
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