Bengaluru, India: October 21, 2014

Commenting on the quarterly performance and highlights, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, “The growth of our core biopharma business this quarter has been muted largely due to capacity constraints and geo-political challenges in the Middle East. However, clinical progress in our key global programs for generic Insulin Glargine and Trastuzumab is indicative of the value accretion that is realizable in the foreseeable future. The strategic investment by Silver Leaf Oak in Syngene validates the strength of our research services business and sets a good valuation benchmark. Whilst we continue to invest in R&D and capacity building for our insulins and antibodies portfolio, we expect Branded Formulations and Research Services businesses to drive growth in the interim.”

Highlights:

• Biocon’s partner Mylan begins multicenter phase III clinical trials for insulin glargine in the United States.
• Biocon, through its subsidiary Biocon Research Limited (BRL), buys back GE Equity International Mauritius’s 7.69% stake in Syngene for Rs. 215.38 Crore. Subsequently, it enters into an agreement to sell 10% to Silver Leaf Oak (Mauritius) Limited, valuing Syngene at Rs. 3800 Crore. The transaction is subject to standard condition precedents including regulatory approvals in India.
• Syngene successfully completes USFDA pre-approval inspection of one of its manufacturing facilities.
• Biocon Foundation Receives 'Asia Best CSR Practices Award 2014' for 'Cervical Cancer Screening Program' by the World CSR Congress. The foundation also initiated Project One, a clean drinking water initiative for rural communities in the villages its serves currently.

Business Performance

Financial Highlights: Q2 FY15 (In Crore)

Revenue : 773
R&D Expenses: 35 (6 % of Biopharmaceutical sales)
EBITDA: 188         (EBITDA Margin: 24 %)
PAT:  102              (PAT Margin: 13 %)

Revenue Breakup:

• Biopharmaceuticals: 558
• Research Services: 192
• Other Income: 23

Biopharmaceuticals

Biopharma
The biopharma segment recorded revenues of Rs. 442 Crore in Q2FY15.

The biopharma business continues to be impacted by various factors like geo-political challenges in terms of credit risk in the MENA region, reduced offtake of specialty API, and capacity constraints, affecting the growth of this business. The outlook for the biopharma business remains challenging for the remaining part of this fiscal.

We continue to work towards further optimization of our product portfolio in the small molecules vertical. During the quarter, we further added to our list of ANDA filings, targeting the US generics market.

Our partner Mylan initiated multicenter phase III trials for our insulin glargine in the United States. Two trials, both for 24 weeks, comprising a total of 1100 patients (500 type-1 diabetes mellitus patients & 600 type-2 diabetes mellitus patients) are expected to be completed by June 2016.

The Malaysia insulin facility remains on track to be commissioned in H2 FY15. The commercialization of products from Malaysia will commence post validation and regulatory approvals from respective countries.

Branded Formulations
The Branded formulations business recorded revenues of Rs. 116 Crore in Q2 FY15.

The vertical grew ahead of the industry reporting a robust growth of 17% YoY.  Our key brands CANMAb™ BIOMAb EGFR™ ALZUMAb ™ INSUGEN® and BASALOG® continue to benefit a large patient pool in India. The growth this quarter was driven by Oncotherapeutics, Metabolics and Nephrology divisions. The vertical continues with the strategy to drive synergies and profitable growth around key anchor brands and optimization of product portfolios.  

Research Services
The research services segment recorded revenues of Rs. 192 Crore.

Commenting on this performance, Peter Bains, Director Syngene International, said, "Research Services delivered a sequential revenue growth of 11% in Q2 FY15 reflecting steady business traction for our services. Our recent capacity additions have come online and we have a strong order book to support these in the near term. We continue to invest further across new and existing service platforms to sustain our growth curve and support the developing pipelines of our clients. A key highlight this quarter was the successful completion of a USFDA pre-approval inspection of one of our manufacturing facilities. We have, in the past 12 months, cleared two successive FDA audits with no 483s, underpinning the quality of our systems and processes”

This quarter, Biocon, through its wholly owned subsidiary Biocon Research Limited (BRL), purchased the 7.69% stake held by GE Equity International Mauritius in Syngene International Limited (Syngene) for an agreed consideration of Rs. 215.38 Cr.

About Us
Biocon Limited, publically listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 85 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of novel biologics, biosimilars, differentiated small molecules and affordable recombinant human insulin and analogs from ‘Lab to Market’. Some of its key brands are INSUGEN®(rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and ALZUMAb ™(Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of biosimilars and novel biologics at various stages of development including a high potential oral insulin. Visit: archive.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 3:30 PM IST on October 22, 2014 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 ten minutes ahead of the scheduled start time. The dial-in number for this call is +91-22-3938 1081/ 6746 5891.  Other toll numbers are listed in the conference call invite which is posted on the company website archive.biocon.com. The operator will provide instructions on asking questions before the start of the call. To receive reminders for the earnings call, you can register here. A replay of this call will also be available from till October 30, 2014 on +91 22 6181 3322, Playback ID: 311121.  We will aim to post the transcript of the conference call on the company website within 7 working days of the investor conference call.


For further information, please contact:

Media Relations

Seema Ahuja
Phone: +91 080 2808 2808
Email: seema.ahuja@biocon.com

Rumman Ahamed
Phone: +91 080 2808 2808
Email: rumman.ahmed@biocon.com


Investor Relations

Saurabh Paliwal
Phone: +91 95383 80801
Email: saurabh.paliwal@biocon.com