BIOPHORE We Focus on Niche APIs For Generic Industry

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1 BIOPHORE We Focus on Niche APIs For Generic Industry

2 ABOUT US What We Do Overview R&D driven company Focus on creating superior value proposition Providing end to end solutions Specialists Development for Regulated markets- US & EU Development for PIV challenges Core capabilities in complex Injectables Novel process and polymorph development Manufacturing Products and Pipeline Two world class facilities Both USFDA approved Wide range of therapeutic areas Over 40 DMFs filed Over 80 APIs developed Filed over 30 patents 2

3 ABOUT US Inception and Growth Beginnings Growth New Clients Awards R&D center setup in 2007 First Manufacturing facility started in 2010 Second Manufacturing facility started in 2014 First USDMF filed in 2010 Sionc USFDA approved in 2013 Azico-Biophore USFDA approved in DMFs filed by 2016 Currently catering to over 85 customers Several in top 20 pharma companies as clients Third most USDMFs filed worldwide in 2015 Recognized as one of the fastest growing pharma companies by Silicon Review 3

4 ABOUT US Vision and Mission Vision Our aim is to place Biophore in the midst of most reliable knowledge based firms in the API sector in the immediate nearfuture through customer-focused approach Mission To be the most trusted R & D company in the complex and niche pharmaceutical molecule segments and achieve superior customer satisfaction through continuous innovation; and providing an inclusive work culture that helps our employees excel and grow 4

5 OUR PRESENCE Global 5 Locations Including USA, Hyderabad, Vishakhapatnam 220 R&D Staff In synthesis, analytical, formulation, IP and regulatory 600 People In manufacturing and Research 10 Member CQA team To monitor manufacturing and compliance in two sites Over 25 Projects In development stage at any point of time US NJ Office For front end marketing and Regulatory submissions in USA 5

6 OUR STRENGTHS Our Accomplishments Over 80 products developed and several complex barrier to entry products successfully completed Over 30 patents filed in the last 8 years and for a few key products patents have been filed globally Synthesis and Analytical Intellectual Property and Management 40 DMFs Filed Over 40 DMFs filed in US, EU and a few DMFs filed in Canada, China, and Turkey Regulatory and DMF filings Execution and Project Management 30 Patents Filed Over 50 product validations executed in the manufacturing facilities 6

7 DMFs Filing Growth 25 USDMFs EUDMFs Planned Canada DMFs Other DMFs 7

8 OUR MANAGEMENT Directors Dr. Jagadeesh Rangisetty CEO and Managing Director Biophore Dr. Manik Reddy Chief Scientific Officer Biophore M. Pharm. - BITS, Pilani Ph.D. - BITS, Pilani Post-Doc - VCU, Virginia, US Over 25 years of research experience More than 70 patents and publications B. Pharm. - BITS, Pilani Ph.D. - VCU, Virginia, USA Post-Doc - VCU, Virginia and UGA, Georgia Over 17 years of research experience More than 45 patents and publications Director of lab at VCU Was Vice-President and co-founder of Navinta LLC, New Jersey Worked at Navinta LLC, New Jersey Worked at Hospira, Colorado 8

9 OUR TEAM Key People K. Ramesh COO Dr. M. Nandakumar VP R&D K. Kalyan VP ARD and Compliance More than 30 years experience in the industry. Was head of Supply Chain at DRL and was CEO of Vijayasri Organics previously Ph.D in organic chemistry with post-doc experience from US and Germany. Has about 18 years of research experience. Is a post graduate in analytical chemistry. Has about 20 years experience in Pharma and was previously with Actavis and Cipla. 9

10 OUR FACILITIES R&D Corporate Office Central R&D Center Vizag R&D Center ARD Center Located in Jubilee State of the Art Located in Vizag GMP analytical Hills, Hyderabad R&D center of in Pharma city validation Functions of about 80,000 Sft. and focusses on activities are finance, IT and will be operational process performed at this Business in July 2016 development and center and is development located in optimization located in operate from here Pashamylaram, activities Balanagar, Hyderabad Hyderabad 10

11 OUR FACILITIES Sionc Pharmaceuticals Location and details Regulatory Status Located in Pharmacity Vizag 100% EOU unit Operational since 2010 USFDA approved in 2013 EU approved in 2015 CDSCO Written confirmation from 2014 Capabilities and Setup 5 clean rooms in facility Setup for both very small volume and medium volume products Also has Oncology manufacturing suite DMFs Over 30 DMFs filed from the facility About 40 products manufactured in the facility Supplying products commercially to US and EU 11

12 OUR FACILITIES Azico-Biophore Pharma Location and details Regulatory Status Located in Pharmacity Vizag Operational since 2014 USFDA approved in 2015 EU inspection in 2015 for Microbiology lab Capabilities and Setup 7 clean rooms in facility Lyophilization and dialyzer capability Peptide manufacturing facility Dedicated hormonal products manufacturing facility DMFs 9 USDMFs filed from the facility in 2 years About 18 products manufactured in the facility 12

13 Our Products

14 COMPLEX CHARACTERIZATION Iron Products PRODUCT STATUS Ferric citrate Validations Complete Sucroferric Oxyhydroxide Under Validations Iron Sucrose Developed Sodium Ferricgluconate Developed Ferric Carboxymaltose Under Development 14

15 LYOPHILIZED PRODUCTS Peptides and Excipients PRODUCT STATUS SBECD DMF Ready Icatibant Acetate DMF Filed Sincalide Developed Pasireotide Under Development 15

16 COLORED PRODUCTS Dyes For Human Use PRODUCT STATUS Isosulfan Blue DMF Filed Indigo Carmine Under Validations Methylene Blue Developed Indocyanine Green Under Development 16

17 HORMONAL PRODUCTS Synthetic APIs PRODUCT STATUS Levothyroxine Sodium DMF Filed Liothyronine Sodium Validations Complete Esterified Estrogens Developed Conjugated Estrogens Under Development 17

18 ONCOLOGY APIs Orals and Injectables DESCRIPTION DMF Bendamustine Melphalan HCl and Free Base Decitabine Bortezomib Clofarabine Chlorambucil Nilutamide Carfilzomib Under Validations 18

19 CONTRAST AGENTS MRI and Radio-contrast PRODUCT DOTA STATUS DMF Filed DTPA Validations Complete Gadobutrol Developed Gadoxetate Under Development Diatrizoate Sodium DMF Filed Diatrizoate Meglumine DMF Filed 19

20 NCE-1 PIPELINE PRODUCT STATUS Tavabarole Belinostat Palbociclib Pasireotide Pirfenidone Ferric citrate Developed Developed Under Development Under Development Developed DMF Ready 20

21 Thank you