|KIRAN MAZUMDAR SHAW, CMD|
Monday, January 28, 2013
BIOCON LIMITED - RESULTS FOR - Q3 FY 2012-13 - Q/E DEC,2012 - good progress - future promising
RESULTS FOR Q3 FY 2012-13
MAIN HIGH LIGHTS
Biocon’s Nine Months Revenue Continues to Deliver Steady Growth in FY13
Revenues at Rs.1,889 Crores; EBITDA at Rs.472 Crores;
PAT at Rs.260 Crores
Commenting on the results, CMD,Kiran Mazumdar-Shaw stated, “Our 9M performance has seen a 23% YoY increase in revenues and an 11% EBITDA growth attributable to a combination of volume expansions , price increases and improved export realizations. We have performed well across all our business verticals. We continue to gain market share for Biosimilar Insulins in ROW markets which now accounts for a significant part of our business.
I am also pleased to announce that we have received approval from the DCGI for our novel Monoclonal antibody, Itolizumab indicated for Psoriasis. This is a significant milestone that enhances the value of this late stage asset.”
9M FY13 financials reflect the continued momentum across verticals :
Biopharma Business: 17%YoY
Branded Formulations: 35% YoY
Research Services (Syngene and Clinigene): 34% YoY
EBITDA and PAT margins at 25 % and 14% respectively
Marketing Authorization received from DCGI for AlzumabTM, the novel anti-CD6 biologic (Itolizumab) indicated for psoriasis
Option Agreement with Bristol Myers Squibb for the novel oral Insulin program: IN 105
Phase I trial initiated for BVX 20, The Novel Anti CD -20 molecule for Non-Hodgkin’s Lymphoma
Completion of the second part of the EU Phase III trials for biosimilar rh-Insulin
Initiation of Global Phase III clinical study for Biosimilar Trastuzumab
Quarterly Business Performance (In Crs)
Revenue : 660
EBITDA: 167 (EBITDA Margin:25%)
PAT: 92 (PAT Margin: 14%)
• Biopharma: 409
• Research Services: 140
• Branded Formulations: 86
Biopharma: Small Molecules & Biosimilars
The biopharma business delivered a strong performance of 22 % YoY growth this quarter, led by an improved product mix.
Small Molecules sales to US and Europe remain robust and emerging markets delivered strong sales in Insulins and Immunosuppressants . The formulations business in the Middle East , through the joint venture NeoBiocon , has begun to gain critical mass recording sales of $5 Mn.
Biocon has initiated patient enrollment for the global phase III clinical trials for biosimilar trastuzumab, post the successful completion of global phase I study.
The ongoing phase III trial being conducted in India continues to make good progress .
Biocon has recently concluded the second part of its EU Phase III trial for biosimilar rh-Insulin, aimed at establishing comparable immunogenicity & safety with the innovator products, over a 12 month evaluation period.
This data is being compiled along with the efficacy data obtained in the first part of the study. This will enable the dossier submission with the regulatory authorities , thus paving the way for marketing authorization.
The 3rd Quarter of FY13 witnessed major advancements in Biocon’s novel molecules program with significant progress across all lead programs. It received Marketing Authorization from the Drugs Controller General of India (DCGI) for the Novel Biologic Itolizumab, an anti CD6 molecule, for the treatment of chronic plaque Psoriasis.
Itolizumab is a first -in-class therapy with a unique mechanism of action and an excellent safety profile as indicated during the 52 week Phase III study conducted in India.
It will introduce this product under the brand name, AlzumabTM in India in FY 14 .
It has signed an option agreement with Bristol Myers Squibb (BMS) for the global clinical development of its oral Insulin program: IN-105.
This alliance with BMS is a strategic partnership which will help us undertake targeted global trials under a US IND. BMS has the right to exercise an option for exclusive worldwide license post the completion of these trials.
BVX 20, the novel anti CD-20 therapy , has entered the clinic in India for a Phase I trial in Non-Hodgkins Lymphoma (blood cancer).
The branded formulations business delivered a growth of 35% in 9MFY13,outpacing the Indian Pharmaceutical Market which grew at 13 % for the same period . Several product introductions were made in this quarter, across Cardiology, Immunology and Comprehensive Care.
The research services arm continues to grow robustly, delivering 34%YoY growth for 9M FY13. We expect the recent partnership with GE to leverage novel platform technologies, thereby creating further value differentiators.
Commenting on this performance, Peter Bains, Director Syngene International , said, “....The order book position has been further strengthened with retention of existing business as well as expansion with existing clients, and acquisition of new customers. We are well positioned to see momentum continue through Q4 and into the next fiscal”
The business outlook remains positive as it is fully geared to accelerate growth of all the business verticals. Going forward it aims aim to have higher contribution from Biosimilars, Research Services and Branded Formulations to the overall revenue. The increasing R&D investments are reflective of the progress being made in this direction with all the research assets of novel molecules and biosimilars progressing well on the development pathway. It continues discussions with potential partners for taking the insulins & novel portfolio to the global markets.
9 M CONSOLIDATED P&L ACCOUNT (9m FY13 vs 9m FY12)
TOTAL SALES : Rs.1797 Cr ( 1461 cr) (+23%)
Other Income : 92 Cr (76 Cr) (20%)
Total Income : 1889 cr (1537 cr )(23%)
Manufacturing, staff & other exopenses : 1417 cr ( 114 cr) (27%)
PBDIT / EBITDA : 472 (423)(11%)
PBT 331 (283) (17%)
TAXES 69 (42) (65%)
Net profit after tax : 262 (241) (8%)
Minority Interest : 2(-) (-)
Consolidated NPT : 260 (241) (8%)
EPS :Rs.13.3 (12.3)
3 M CONSOLIDATED P&L ACCOUNT (3m FY13 vs 3m FY12)
TOTAL SALES : Rs.635 Cr ( 517 cr) (+23%)
Other Income : 25 Cr (19 Cr) (36%)
Total Income : 660 cr (536 cr )(23%)
Manufacturing, staff & other exopenses : 493 cr ( 394 cr) (25%)
PBDIT / EBITDA : 167 (142)(18%)
PBT : 167 (142) (18%)
TAXES : 25 (11) (124%)
Net profit after tax : 93 (85) (9%)
Minority Interest : 1(-) (-)
Consolidated NPT : 92 (85) (8%)
EPS :Rs.4.7 (4.3)
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