Biocon's Nine Months Revenue Continues to Deliver Steady Growth

Bengaluru, Karnataka, India, Thursday, January 24, 2013 -- (Business Wire India) 
Commenting on the results, Chairman and Managing Director, 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.” 
Highlights: 
-- 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 
-- Novel Programs: 
-- Marketing Authorization received from DCGI for AlzumabTM, our 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, our Novel Anti CD-20 molecule for
Non-Hodgkin's Lymphoma 
-- Biosimilars: 
-- 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 
Financial Highlights: Q3 FY13 
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. Our formulations business in the Middle East, through our
joint venture NeoBiocon, has begun to gain critical mass recording sales of $ 5
Mn. 
We have 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.  
We have recently concluded the second part of our 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 our dossier submission with the regulatory authorities,
thus paving the way for marketing authorization. 
Novel Molecules 
The 3rd Quarter of FY13 witnessed major advancements in our novel molecules
program with significant progress across all lead programs. We received
Marketing Authorization from the Drugs Controller General of India (DCGI) for
our 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. We will introduce this product under
the brand name, AlzumabTM in India in FY 14. 
We have signed an option agreement with Bristol Myers Squibb (BMS) for the
global clinical development of our 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, our novel anti CD-20 therapy, has entered the clinic in India for a
Phase I trial in Non-Hodgkins Lymphoma (blood cancer). 
Branded Formulations  
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. 
Research Services  
Our 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, “We are pleased with Syngene and Clinigene's Q3 results and the
maintenance of the strong momentum we have seen in the first half of the year.
This performance is clearly underpinned by our ongoing strategy of building a
broader and strengthened platform of discovery and development service
capabilities to support our customers' evolving needs. We are particularly
encouraged to see strong performances coming from Syngene's Manufacturing and
Formulation services and Clinigene's Large Molecule Bio-analytical services. Our
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” 
Outlook 
The business outlook remains positive as we are fully geared to accelerate
growth of all our business verticals. Going forward we aim to have higher
contribution from Biosimilars, Research Services and Branded Formulations to the
overall revenue. Our increasing R&D investments are reflective of the progress
being made in this direction with all our research assets of novel molecules and
biosimilars progressing well on the development pathway. We continue discussions
with potential partners for taking our insulins & novel portfolio to the global
markets. 
About Biocon 
Biocon Limited (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is
India's premier biotechnology company with a strategic focus on
biopharmaceuticals and research services. Established in 1978 by Dr. Kiran
Mazumdar-Shaw, the Group is an integrated, innovation-driven healthcare
enterprise with offerings that traverse the entire drug development value chain.
Balancing its novel molecule research pipeline with a diversified product
portfolio, Biocon delivers affordable solutions to partners and customers in
over 75 countries across the globe. Many of these products have USFDA and EMA
acceptance. Stellar products from Biocon' s stable include the world's first
Pichia-based recombinant human insulin, INSUGEN® and glargine, BASALOG®
coupled with a state of the art insulin pen device, INSUPen® and India's first
indigenously produced monoclonal antibody BioMAb-EGFR®. www.biocon.com 
Disclaimer  
Certain statements in this release concerning our future growth prospects are
forward-looking statements, which are subject to a number of risks,
uncertainties and assumptions that could cause actual results to differ
materially from those contemplated in such forward-looking statements. Important
factors that could cause actual results to differ materially from our
expectations include, amongst others general economic and business conditions in
India, our ability to successfully implement our strategy, our research and
development efforts, our growth and expansion plans and technological changes,
changes in the value of the Rupee and other currency changes, changes in the
Indian and international interest rates, change in laws and regulations that
apply to the Indian and global biotechnology and pharmaceuticals industries,
increasing competition in and the conditions of the Indian biotechnology and
pharmaceuticals industries, changes in political conditions in India and changes
in the foreign exchange control regulations in India. Neither our company, our
directors, nor any of our affiliates, have any obligation to update or otherwise
revise any statements reflecting circumstances arising after this date or to
reflect the occurrence of underlying events, even if the underlying assumptions
do not come to fruition.  
Earnings Call 
The company will conduct an hour long call at 03:15 pm IST on January 25, 2013
where the senior management will discuss the company's performance and answer
questions from participants. To participate in this conference call, please dial
the numbers provided below five to ten minutes ahead of the scheduled start
time. The dial-in number for this call is +91-22-6629 5889/ 3065 2542. Other
toll numbers are listed in the conference call invite which is posted on the
company website www.biocon.com. The operator will provide instructions on asking
questions before the start of the call. A replay of this call will also be
available from January 25, 2013 – February 1, 2013 on the same dial-in numbers
provided above. The transcript of the conference call will be posted on the
company website.  
To view the fact sheet, please click on the link mentioned below: 
Fact Sheet - Q3 FY13 Crs 
Media contact details 
Sweta Pachlangiya, Investor Relations,
+91 9686509372,
sweta.pachlangiya@biocon.com 
Seema Ahuja, Media Relations,
+91 9972317792,
seema.ahuja@biocon.com 
Varija Beliappa, Media Relations,
+91 (80) 28082808,
varija.beliappa@biocon.com 
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-0- Jan/25/2013 05:28 GMT
 
 
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