While we expect China and global injectable business to scale up in two-three years, US sales would improve with new launches (15 in FY19).
Mr Erez Israeli, new COO, in our meeting underscored focus on (1) six key areas — US, India, Russia, China, API & global injectable business (vs. US earlier) and (2) improving profitability by making self-sustainable businesses (Biosimilar, PP) and cost optimisation (R&D, staff, processes). Target is to have 20% EBITDA across products & markets. While we expect China and global injectable business to scale up in two-three years, US sales would improve with new launches (15 in FY19).
Approval/launch momentum to improve: Ex-injectables from Duvvada facility, expects 15-20 product launches per year (7 in H1’19, over 10 in H2’19 with few interesting products including Suboxone; already launched 4 in Oct’18).85 products are in the market and 110 are pending as of FY18, 100 products are under development including some high-value assets to support future pipeline.
The company would resume the launch soon after withdrawal of district court’s preliminary injunction prohibiting DRL to sell (while final outcome on patent litigation is still pending). We expect it to be limited competition product with AG and Mylan as other players in CY19.Submitted response to CRL received in Oct’18; could have some queries from USFDA, but expects approval by H1CY19.
Submitted response to USFDA post Form 483 observations in Oct’18; does not expect to escalate as the observations despite being repeat are not risking human life or infrastructure related, (b) to de-risk, have transferred most key products to third party site; also constructing new injectable facility in Vizag expected to be functional in 1-2 years. Data integrity related issues and USFDA had asked 15 years of retrospective data for all the products; expects response from USFDA in few weeks.