456, Road #3, Industrial Area, Jigani, Bangalore South, 562 105

1

Stellence Pharmscience Pvt Ltd

Stellence Background

•Stellence Pharmscience Pvt Limited (SPPL) is promoted by RamachandranRadhakrishnan (Ram) and Dr. Francis Pinto – managers with extensive experienceand proven track record in both Indian and International pharmaceutical industry

•The SPPL opportunity was established in 2006 through a cost effective purchase ofassets and turnaround of a distressed company in BIFR (bankruptcy restructuring)•The first phase of development, financed by the promoters, has been completed -SPPL currently operates a state of the art manufacturing and research facility inBangalore•The next phase of the project focuses on the cost effective development andmanufacture of niche, high value pharmaceutical products and intermediates

2

Historical background and milestones

• Commenced operations as Karnataka Chemsyn Ltd (KCL) to manufacture ibuprofen;

• Ibuprofen strategy unsuccessful;

• Diversifies into herbal extracts

• Turns sick and referred to BIFR;

• Avigna Chemitech, promoted by Mr. R. Ramachandran and Dr. Francis J. Pinto identifies strategic opportunity to acquire KCL;

• Negotiates with KCL per BIFR norms;

• Acquires KCL and commences operations in 2006;

• Avigna invests heavily in KCL; Builds state of the art manufacturing, process research and development facility;

• Emerges from BIFR;

• Conducts extensive development and testing to overcome technical barriers in manufacture of contrast media agents;

• KCL is renamed Stellence Pharmscience Private Limited;

• Establishes processes and growing product portfolio;

• Multiple orders with strong revenue growth;

• In 2012, received strategic interest from an experienced overseas company with strong credentials in Latam and emerging markets; Deal does not go through because of regulatory changes and delays;

• Poised to grow rapidly by taking advantage of huge opportunities in core areas of interest –Contrast media products, niche APIs and contract manufacturing;

• Expanding new product portfolio;

• Raising capital for expansion of Contrast media manufacturing, scaling up APIs, further development of APIs, DMFs and retiring high cost debt;

▪

▪

▪

▪▪

▪

19921994

To1998

2006 2009-12 2012-15 2015-18

3

SPPL Sales Strategy - Market Opportunity

Niche High Value Specialty API (SAPI)

- Diagnostic imaging agents - Global market worth over $5 billion- Complexity in manufacturing process (Quality)- Rapid growth in emerging markets- Market controlled by a few players: Bracco, Bayer- Opportunity to source Iodine from Latam directly

Contrast Media Products(CMP)

High End Intermediates

(HEIN)

- Overall Indian Pharma market ~ $11 billion, 20% CAGR. API market is ~$4Bn- Broad range of products in space- SPPL target niche, low volume high value products- SPPL focus on ‘off radar’, and complex manufacturing

- Contract manufacturing of intermediaries for MNC- Opportunity market worth ~$3 billion- Leverage high quality facility, cost effective process- Utilise capacity - QC validated by International Partners

4

SWOT Analysis

Strengths Very experienced promoter/directors in the

area of pharmaceutical manufacturing Contrast Media market space with limited

competition and pioneer advantage State of art manufacturing facilities for

catering to regulated and other markets. Well equipped Quality Control systems and

experienced Quality Assurance team Proven Process Research and Development

capabilities India Strong relationship and network in Pharma

sector for assured opportunities.

Challenges Ensuring and maintaining relationship

with partners – integrity, IPR management etc.

Ensuring cost and timely delivery especially as most are long term contracts.

Retention of talent is critical factor.Margin pressures and changing

government policies.Working Capital and financial needs

Threats Spate of M&A activities by MNC Pharma

may strain established relations Growing presence of MNCs in India in

the Pharma sector as Capex is easier/affordable

As result increase in competition and margins can come under pressure.

Changing export and import policies Foreign exchange risk

Opportunity The size of the global market for Contrast

Media is growing Great opportunity for generic API and

intermediates exports Big Pharma and others looking for reliable

manufacturers for their off patented products India offers high quality and cost competitive

production facility for bulk drugs and intermediates

5

Key Products Portfolio

6

Category Production Line

Non criticalraw materials

Multiproduct line

Key starting materials Multiproduct line

RegisteredIntermediates

Dedicated line – environmentcontrolled – 5 micron filtered air

APIs Dedicated line – Class 100,000specifically designed formanufacture of APIs

Facilities

Lab Capacity : Small Volumes 100 Gms to 5 Kgs

GMP Intermediate / API: Pilot Capacities (2 plants) :5 Kgs to 50 Kgs

7

Fume Cupboards 15 nos

Vessel Capacities 50 ml to 20 lts

Nutsche Filters 50 Gms to 5 Kgs

Driers Fluid Bed and Vacuum Tray Driers

Hydrogenator 10 lts – 100 Kgs/cm2

SS Reactors 300 to 500 lts 2.2m3

Nutsche Filters 24 inches 2 Numbers

Centrifuges 24 inches 2 Numbers

Driers Tray driers,RCVD

Each one

Facilities…continued.

GMP Intermediate/ Fine Chemicals Manufacturing.Large Scale Capacities (2 plants) : 50 Kgs to 500 Kgs

8

Glass Lined Reactors 300 to 8000 lts 22.8m3

SS Reactors 300 to 7000 lts 62.0m3

Nutsche Filters (NF) & ANF

100 to 400 Kgs

2 KL

NF - 3 Numbers

ANF – 1 numberCentrifuges 36 and 48 inches 2 & 3 Numbers

Driers RCVD, TrayDriers

2 RCVD1 Tray drier

Hydrogenator 2000 lts- 40Kgs/cm2pressure

1 Number

Facilities…continued.

Large Scale Manufacture of APIs under cGMPconditions : Capacity : 100 to 500 Kgs

9

Glass Lined Reactors 5000 lts 5m3

SS Reactors 2000 to 4000 lts 8m3

Centrifuges 48 inches 2 Numbers

Driers RCVD

FBD

2 Numbers

1 NumberBlender 2500 lts 1 Number

Reaction capabilities

10

Hydrogenation

Friedel Crafts reaction

Alkylation

Chlorination

Nitration

Bromination

Diazotization

Esterification

Oxidation

Reduction

Resolution

Grignard reaction

Regulatory Affairs, Quality Assurance and Control

Manufacturing Systems and Documentation complying to cGMP, ICH

Q7 guidelines

Regular Internal Audits

Stringent change control systems

Validation Master Plans :

Tech pack / Drug Master Files for APIs in CTD format

Stability Data Support

Analytical Method Validation

Extensive Product Release Controls

11

• Sophisticated Analytical Lab with:

• HPLCs, GCs , FTIR & UV Spectrometers, Auto-titrators

– Validated and calibrated systems

– Methods Development, Standardisation and Validation

• Analytical Development, Specification Development

• API / API Intermediate specifications complying to ICH

• CMC guidelines

• Method Validation as per ICH guidelines

• Qualified and Experienced Technical Personnel

Regulatory Affairs, Quality Assurance and Control

12

Key Differentiators

• Driven by a team of dedicated scientists and approved by Department of Science andIndustrial Research, Govt of India.

• Enhancing customer satisfaction by providing quality products is one of the basic principlesthat energizes the SPPL team in this current competitive market.

• A major portion of the investments made in manufacturing have been to achieve thehighest level of process compliance and product quality

• In house technical expertise in the field of hydrogenation

13

Custom Synthesis and Contract Manufacturing

• Full fledged R&D lab suitable for development activities

• Pilot facility for scale-up

• Analytical method development and related functions form an integral partof the process leading to commercial process development and potentiallymanufacture of final molecule.

• The compamy’s track record of development of various molecules isinterestingly different and has contributed to customer delight!

• Integrated approach to partnering with our customers

14

Process development

Pilot Plant & Validation

Commercial Manufacturing

R&D and Manufacturing Manufacturing

Safety Health and Environment

◦ Environmental Safety :

◦ Specific EHS officer to monitor and scientifically dispose effluents to authorized agencies :

Pai and Pai Chemicals – Liquid Effluents

Ramky Incinerators– Solid waste

◦ Closed systems

◦ Containment kits and bunding in specific areas

◦ On site emergency plan approved by the Inspectorate of Factories and Boilers

15

Safety Health and Environment

SHE programs

• Personnel Safety• Personnel protective equipment

• Fire alarm systems

• Mock Drills

• Evacuation plans

• Annual medical checkup

• Process Safety• Risk Analysis

• MSDS training and inclusion of critical aspects in batch records

16

Thank You !

17