Biocon Ltd. share price target

5 June 2018 Neulasta biosimilar version) was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to Neulasta. Because of non-interchangability clause, BIOS/MYL would have to invest marketing efforts to garner business from this product. Other than BIOS/MYL, leading companies vying for approval in regulated markets are Apotex, Sandoz, Coherus, Pfizer and Dr Reddys. However, Apotex has not yet received approval for its BLA (biologic license application) version from USFDA. Coherus would be submitting the day-180 responses by the end of May and expects further opinion from advisory group CHMP (Committee for Medicinal Products for Human Use) on day-210, which is around end of June 2018. EU regulators are reviewing marketing authorization applications filed by BIOS/MYL, Sandoz and Cinfa Biotech. Specifically, BIOS/MYLs MAA was accepted in November 2017, Cinfa Biotechs in October 2017, and Sandoz filed in October 2017.

ICICI Securities Ltd | Retail Equity Research Revenues increased 26% YoY to | 1170 crore (I-direct estimate: | 1098 crore) mainly due to 48% YoY growth in Biologics to | 241 crore (I-direct estimate: | 179 crore) and 45% YoY growth in Syngene to | 409 crore (I-direct estimate: | 359 crore). EBITDA margins remained at 20%, however lower than I-direct estimates of 22.0% mainly due to lower gross margins led by change in product mix. EBITDA increased 24% YoY to | 233 crore...

Subdued revenue (up 1% YoY) and EBITDA (down 20% YoY on higher staff costs) were in line with estimates. Higher depreciation and lower other income pulled PAT down 46% YoY (11% lower than our estimate).

ICICI Securities Ltd | Retail Equity Research Biocon reported flat YoY revenues at | 1058 crore (I-direct estimate: | 1073 crore). Biopharmaceutical segment declined 9% YoY to 369...

We believe sharing responsibilities for end-to-end development, manufacturing and global regulatory approvals for a number of products will ensure higher control and ownership. This also allows to develop higher number of molecules by leveraging on their talent pools and existing capabilities

First biosimilar approval for Herceptin (Trastuzumab; ~USD 2.5 bn in US) for the treatment of cancer establishes Biocon as a global biosimilar player'. While Mylan-Biocon has settled with Roche for launch on a certain date.

ICICI Securities Ltd | Retail Equity Research In a positive development for Biocon, the USFDA has approved Mylan's Ogivri, a biosimilar of Herceptin (Trastuzumab-dkst) co-developed with Biocon. The approval comes on the heels of a strong recommendation for approval of Biocon/Mylan's biosimilar Trastuzumab by the USFDA Oncologic Drugs Advisory Committee (ODAC) by a 16-0 vote in support of eligible indications of the reference product, on July 13, 2017. Herceptin, manufactured by Roche, is used to treat certain breast cancers...

Mylan/ Biocon announced on Friday that US FDA approved Mylan's Ogivr (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon. Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US. Notably, Mylan is the only player which has settled for a launch date with innovator Roche. Mylan anticipates to be the first player to launch biosimilar version of Herceptin. Patent for Herceptin is expiring in mid-2019. Since Biocon has not filed this product through interchangeable route, it will not receive exclusivity...

BIOS reported weak 2QFY18 results. Revenue declined 2% YoY to INR9.6b (est. of INR10.9b). The muted performance can primarily be ascribed to disruption at the Bangalore facility, pricing pressure in the US and delays in tenders in the emerging market. EBITDA declined 24.1% YoY (-5% QoQ) to INR1.8b (est. of INR2.6b). EBITDA margin came in at 18.8% (-630bp YoY and -176bp QoQ). PAT declined ~53% YoY to INR687m (est. of INR1.4b), primarily due to an increase in depreciation and interest expense relating to the Malaysian facility. Uptick in branded formulation biz post GST; expect pick-up in biologics in 2H:...

EMA's Committee for Medicinal Products for Human use (CHMP) has asked Biocon to withdraw its Peg-filgrastim and Trastuzumab filings in EU post the recent inspections by European Regulatory authorities.