Biocon Ltd. share price target

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.

ICICI Securities Ltd | Retail Equity Research Revenues declined 6% YoY to | 934 crore (I-direct estimate: | 955 crore) due to sluggish API sales, adverse currency movement, GST impact, fire incident at Syngene and lower licensing income EBITDA margins contracted 595 bps YoY to 20.6% (I-direct estimate: 21.2%) mainly due to commissioning of the Malaysian plant Net profit fell 51% YoY to | 81 crore (I-direct estimate: | 88 crore) due to below expected operational performance, higher depreciation...

Revenue grew by 0.23% to Rs. 927.4 Cr in Q1FY18 when compared to the previous quarter Revenue grew by 0.23% to Rs. 927.4 Cr in Q1FY18 when compared to the previous quarter

USFDA's Advisory Committee (ODAC) unanimously voted 16-0 in favor of approval of Biocon/ Mylan's MYL-1401O, biosimilar Trastuzumab (Herceptin) for all indications. It determined MYL-1401O is highly similar to Herceptin. We believe positive ODAC ruling paves way for the approval in US (albeit GMP..

In a significant development that can be termed as a precursor for biosimilar launch in the US, the USFDA Oncologic Drugs Advisory Committee (ODAC) has strongly recommended approval of Biocon/Mylan's proposed biosimilar Trastuzumab, a biologically similar version of Roche's breast-cancer drug Herceptin. Herceptin is indicated to treat certain HER2-positive breast and gastric cancers. The committee voted 16-0 in support of eligible indications of the reference product. During the discussion, ODAC determined that no clinically meaningful...

Revenue fell by 10.1% to Rs. 919.2 Cr in Q4FY17 when compared to the previous quarter. Also it decreased by 1.53% when compared with Q4FY16.