Key Highlights of this Quarter
- Marketing authorization applications for Biosimilars – Pegfilgrastim, Trastuzumab and Insulin Glargine have been reviewed and approved by the European Medicines Agency
- Applications for proposed Biosimilars of Tastuzumab and Pegfilgratim are under US FDA review with target action dates for September and October respectively
- Biocon’s Malaysian Insulin Plant started commercial sales where Biocon subsidiary Biocon SDN. BHD. has been awarded a 3 year contract of 300 Million for the supply of Human insulin catridges and reusable insulin pens under Malaysian government’s offtake agreement
- Commercial launch of biosimilar insulin glargine in Japan through FUJIFILM Pharma as a partner on 15th July,2016
- Received FDA approval for Rosuvastatin Calcium from USFDA, first ANDA approval for Biocon
- Ranked amongst the top 10 biotech employers, the only Asian company to feature in 2016 Rankings released by Science Career magazine.
Financial Highlights Q4 FY17
- Consolidated Revenues for Q4 FY17 were Rs. 974 Crores, which is flat compared to last year
- Biocon sales amounted to Rs. 653 Crores which represents a growth of 4%
- Group EBITDA was at Rs.231 Crores for Q4 FY17 reflecting a growth of 5%
- EBITDA margin was at 24%
- Core margins, i.e. EBITDA margins net of licensing, impact of forex and R&D expenses, stood at 31%.
- Forex Loss of Rs.17 Crores, on account of restatement of foreign currency denominated assets due to appreciation of rupee against the dollar
- Total R&D Expenses accounted to 98 Crores, of which 65 Cr in P&L corresponding to 10% of sales excluding Syngene
- Capitalized Rs.33 crores related to trastuzumab and glargine development expenses.
- Reported net profit was at Rs.127 Crores representing a net margin of 13%.
- Adjusting for exceptional items, the net profit is at Rs.135 crores reflecting a growth of 75% over Q4 of last year
Financial Highlights of FY17
- Consolidated revenues grew 18% over FY16 to 4,079 crores
- Biocon sales were at 2,738 crores, representing a strong 20% growth
- Small Molecule sales were 1,587 crores, a growth of 14%.
- Biologics grew 34% to 458 crores
- Branded Formulations clocked sales of 549 crores which is a growth of 24%.
- Licensing income for the year was 144 crores as compared to 108 crores last year.
- Research Services (Syngene) sales grew 7% over FY16 to 1,138 crores on a consolidated basis
- On a standalone basis, Syngene reported sustained revenues of 1,272 crores, EBITDA of 478 crores and a net profit of 287 crores
- Gross R&D spends at Biocon for the year were 402 crores compared to Rs.427 crores last year
- 267 crores R&D spend is reported in the P&L representing approximately 10% of Biocon sales excluding Syngene. Rs.135 crores was capitalized during the year.
- Gross projected R&D spend to remain in the 12%-15% range in FY18.
- Group EBITDA was at 1,137 crores with EBITDA margins at a very strong 28%.Core margins for the full year stood at 32%.
- Reported Net Profit for the year was Rs.612 crores with net profit margin of 15%. Adjusting for exceptional items, net profit was Rs.620 crores reflecting a growth of 54% over FY16
Bonus Shares Issue
- Board of Directors decided to issue Bonus Shares at a ratio of 2:1 i.e., for 2 bonus shares for every one share held by an individual on the record date.
- A final dividend of Rs 3 per share pre-bonus for FY 2016- 17.
- On a standalone basis, Syngene reported revenues of 315 Crores, EBITDA of 124 crores and Net Profit of 78 crores
- Small Molecules sales were Rs.387 crores for Q4, marginally down from Q4 pf last year
- Biologics sales were at flat at 119 crores
- Branded Formulations were at Rs.131 crores , growing by 25% from last year’s Q4
- Licensing income were at Rs.16 Crores as compared to Rs.10 Crores of last year’s Q4
- Syngene contributed a sales of Rs.272 crores in Q4, down 14% as compared to Q4 16
Growth in Small Molecules:
- Growth down marginally in Q4, but showed a robust 14% growth for the full year
- Growth was largely led by rosuvastatin, pravastatin and immunosuppressant API sales
- Focus on certain niche API and generic formulation opportunities to sustain long-term growth
- Biologics continued its strong performance in FY17.
- Insulin sales for the Malaysian OTA and trastuzumab sales in certain emerging markets drove growth in this segment.
- Strong licensing income, bulk of it was as a result of partnerships for trastuzumab in emerging markets
- The performance has been flat on alike-to-like basis
- Increased competition from low price biosimilar mAbs
- Introduction of price caps in some key brands by the government in India along with the loss of key in-licensed oncology brand Abraxane, which was withdrawn by the licensor from India and UAE market impacted growth
- Increase in prescription shares for both our insulin brands Insugen and Basalog in FY17
Syngene Research and Development:
- Standalone revenue was at a sustained growth of 14%
- Operational performance - EBITDA and PAT margins at 38% and 23% respectively for FY17
- Revenue growth this quarter and for the full year has been impacted by the fire incident that happened in December
- First phase of the Syngene Research Center has been commissioned
- A strategic deal has been signed for setting up a dedicated R&D center for Amgen which represents Syngene's fourth dedicated R&D center
- Syngene added new capabilities in Bioinformatics
- A strategic partnership with Herbalife Nutrition was also announced as the fifth dedicated center for SyngeneAt
- Syngene continues its investments to expand its service offerings and building capacities which among others include the commercial manufacturing API facility at Mangalore and a new biologics plant in Bangalore.
- In diabetes, Biocon's lead program is Insulin Tregopil, a first-in-class oral prandial insulin molecule for post-prandial glycemic control
- A clinical trial application for Insulin Tregopil has been filed with DCGI, the Indian regulator
- Clinical developments of novel anti-CD6 monoclonal antibody, Itolizumab, continues in Australia
- Stage 2 of a Phase I clinical study using a subcutaneous form of Itolizumab is scheduled to start very shortly
- QPI-1007, a novel SiRNA molecule to treat non-arteritic ischemic optic neuropathy or NAION, which is based on Quark Pharma's SiRNA technology platform continues to make progress
- Five regulatory filings across the U.S. and EU for a few of products by various Biosimilar programs
- Completed the ROW-focused Phase III trial in metastatic colorectal cancer for our proposed biosimilar bevacizumab.
- Submitted a Marketing Authorization Application for the same with DCGI in India
- Additional Phase III global trial has also commenced in non-small cell lung cancer.
- As part of insulins portfolio, Marketing Authorization Application for Insulin Glargine with the US FDA is expected very shortly.
- Other molecules from our insulin analogs portfolio, Insulin Aspart and Insulin Lispro are also advancing.