Business Development & Commercialization Plan

G7 Diagnostics Business Plan

SaphvidTM

In early detection of Pre-eclampsia

Helena Gwani

Ayotunde Awosusi

Daniel Igwe

Priyesh Waghmare

Srishti Jain

Vinie Varkey TG7 Diagnostics.

Save the mother. Save the child.

G7 Diagnostics. Save the mother. Save the child.

Objectives of the Business Plan

• To introduce G7 Diagnostics:– Company– Management team

• The need of SaphvidTM and market potential to be a BIG success

• Define the G7 business model

• Acknowledge the competition

• Present G7 exit strategy

• Why invest in G7 Diagnostics?


G7 DIAGNOSTICS

Vision:

To become the leading experts for providing diagnostic solutions in the field of

obstetrics

Mission:

To provide innovative point of care diagnostic products for early detection of

pregnancy related disorders

Management Team:Who are we?Early stage biotech Company in Research and Development Stage of the Project SAPHVIDTM

COMPANY STATUS

PRODUCT PIPELINE• Saphvid™• PROM

DOMAIN EXPERTISE• Diagnostic Technology• Pregnancy Disorders• Product Development

STRATEGIC PARTNERSHIP• Raupack Limited (Strip manufacturing)• Millipore Corporation (Raw materials)• Universal Biologicals (Raw materials)


Chief Executive OfficerExperience: 25 years

Finance DirectorExperience: 20 years

Vinie Varkey Helena Gwani

Srishti Jain

General ManagerExperience: 15 years Operating Manager

Experience: 18 years

Priyesh Waghmare

Chief Scientific officerExperience: 35 years

Igwe Daniel

Marketing ManagerExperience: 21 years

Ayotunde Awosusi

BACKGROUND

PROBLEM (Pre-eclampsia)• Pregnancy Disorder• Damage to the blood vessels• Hypertension & Proteinuria

CURRENT GLOBAL STATISTICS*• 10% of all pregnancies: 16.5 million• 1/3rd of pre mature births: 4.3 million• 12% of maternal deaths *SOURCE: World Health Organization

NEED FOR BETTER DIAGNOSIS?• No effective Diagnosis • Current diagnostic method is inaccurate • If not detected early, may lead to critical condition

Higher risks:

Younger women

<20 years

Older women

>35 years

G7 Diagnostics. Save themother. Save the child.


Biochemical Marker Plasma Concentration Manifest Pre-eclampsia

Trimester 1 Trimester 2

Soluble fms- like tyrosine kinase(Sflt-1)

-- high Early increase

Soluble Endoglin (sEng)

-- high Early increase

Placental Growth Factor (PlGF)

low low Further decrease

SaphvidTM

Sample Port

Reaction ChamberA small fraction of the Plasma sample mixes

withthe dried reagents

Three Internal Controls

Independent Positive High – and low –

control zones and a nonspecific binding

control

Waste ReservoirExcess sample collected in the

periphery

Blood FilterCells are

separated from plasma

TimegateHydrophobic

surface –ensures reaction time

Assay Zones Fluorescent

tagged antibodies on nano particles

are captured on separate zones


Reaction Chamber

Array of Antibodies

PlGF

sEng

sflt

SaphvidTM : WORKING PRINCIPLE


FEATURES OF SaphvidTM

Priority Features

Sensitivity 94.5%

Specificity 95%

Time to result 15 minutes

Heat stability 15°C- 30°C

Storage conditions 20°C

1patientTest• Week 12• Week 19

No. of test 2 StripsReq.

Licensed PatentsPatent number Claims PatenteeGB 2464222. Analysis method and device Bolbot, J. A. (2010)

(Inverness Medical)EP 1175940 Diagnostic devices and

apparatus for controlled movement of reagents without membranes

Beuchler, K. A (2002)(Biosite Diagnotics Inc.)

Filed PatentEP 1 175 940 A1 An assay device utilizing

three biomarkersG7 Diagnostics

Regulatory approvals • Product classified as annex II (Non self test)• CE marking• ISO:13485

PRODUCT’S LEGAL STATUS



COMPETITION Method

• Doppler Ultra Sonography

• Urine Test

• ELISA (Enzyme linked Immunosorbent Assay)

• RIA (Radio Immuno Assay)

• FIA (Fluroscent Immunoassay)

• Blood pressure

Companies

• Perkin Elmer Inc

• DRG Diagnostic Inc

• Alere Inc

• Summit Doppler Systems

• Roche Inc.

Limitations

• Time consuming

• Complex

• Low reliability

• Late diagnosis

• Rate of false positive is high

BUSINESS MODEL

• Key suppliers• Manufacturer• International

distributors

• Brand development• USPs• Marketing strategies

Medical journals Medical awards press releases internet

• Financial policies• Funding (Grants,

charity)• Cost Structure• Shareholder

• Consumer relationships (feedbacks, customer support)

• Value propositions

CUSTOMER REVENUE &

INVESTMENT

OPERATIONS

MARKETING


SALES

PROFIT

Strategic Alliances

MANAGEMENT

TECHNOLOGY

CUSTOMER


• Target customer:– General

Practitioner– Gynecologist– Obstetrician– Mid wife

• End User/ Consumer:– Pregnant women

Customer value Proposition (Cost-benefit)

Cost GBP (000) per year

Preeclampsia 3,000,000

Pre-term births 300

Pre- term survivor (up to 18 years)

23

Birth: <33 weeks 60

Birth: <28 weeks 95

•Better management of the health of pregnant womenHealth economics:

Customer Relationship

Source: Ferring Pharmaceuticals,2010

•Personnel Relationship•Early Delivery•Feedback forms

• Consistency

• Report Any problems

• Improvements

TARGET MARKET6.4M

(3.84M)£ 27

18.5M(11.1M)

£ 24

27.5M(16.5M)

£ 126.1M(3.66M)

£ 10

1.5M(0.9M)

£ 32

AVAILABLE MARKETG7 TARGET MARKETPRODUCT PRICING

MARKETING STRATEGY

NHS/ Government

• Health economics.NICE/

APPROVALS

• Proof NICE approval• Press Release indicating clinical trial success.• Publication in Journals

Obstetricians

• Networking• Public & professional relations• Clinical Conferences, symposiums• Sponsoring of Medical awards

Pregnant women

• Articles in magazines• Campaigns awareness (pre-eclampsia)• Ante-natal fitness routine


NICE:National insititute for health & Clinical ExecellenceNHS: National Health Service


ACTIVITY

Development (internal)

GMP manufacture pilot scale (subcontracted)

Clinical trials (subcontracted)

Regulatory approval (subcontracted)

Full scale GMP manufacture (subcontracted)

Internal Quality Control and Customer Support (internal)

Patent filing schedulePatent 1

File PCT NationalEuropeUSA

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10

GANTT CHART

1 2 3 4 5 6 7 8 9 10

(100,000)

0

100,000

200,000

300,000

400,000

500,000

600,000

CUMMULATIVE CASHFLOW

YEAR

GB

P (

00

0)

BREAK-EVEN POINT

SALES REVENUE AND CUMMULATIVE CASHFLOW

5 6 7 8 9 100

50,000

100,000

150,000

200,000

250,000

SALES REVENUE

UKChinaUSAIndiaNigeria

YEAR

GB

P (

00

0)

G7 Diagnostics. Save the mother. Save the

child.

•Sales Revenue Year 1: 1,536,000 GBP•Total Sales Revenue Year 10: 722,991,000 GBP


SENSITIVITY ANALYSIS

1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0

(50,000.0)

-

50,000.0

100,000.0

150,000.0

200,000.0

250,000.0

300,000.0

350,000.0

235,887.3

285,231.4

186,543.1

Normal sales 20% above projected sales 20% below projected sales

Year

Re

tain

ed

pro

fit

00

0's

GB

P


RISK MANAGEMENT

S.NO. RISKS MITIGATION

1 Product supply interruptions •Continuous monitoring

•Dual sourcing when possible

2 Patents- validity and infringement •Internal and external experts

3 Non- compliance to regulations •Educate employees on the Standard operating procedures in place

4 Currency and treasury effects •Short- term hedging transactions based on economic forecasts

YEAR CASHFLOW000’s GBP

CUMMULATIVE CASHFLOW000’s GBP

1 (780.4) (780.4)

2 (580.4) (1,360.8)

3 (928.4) (2,289.2)

4 (553.0) (2,842.2)

5 344.4 (2,497.8)

6 10,404.3 7,906.5

7 29,420.3 37,326.8

8 92,598.9 129,925.7

9 167,327.2 297,252.9

10 235,884.6 533,137.5

PAY-BACK PERIOD


Pay back period:

5 years+ (344/10404)

Approx 5 years and 1 month

• Total funding required: 2.7 million GBP• Rate of return on investment (compounded): 30%

Investment period

Investment (GBP) Rate of return (%) Cash returns(GBP)

1 2,700,000 30 3,510,000

2 3,510,000 30 4,563,000

3 4,563,000 30 5,931,900

4 5,931,900 30 7,711,470

5 7,711,470 30 10,024,911

6 10,024,911 30 13,032,384.3

7 13,032,384.3 30 16,942,099.59

8 16,942,099.59 30 22,024,729.47

9 22,024,729.47 30 28,632,148.31

10 28,632,148.31 30 37,221,792.8

WHAT IS G7 DIAGNOSTICS ASKING FOR?


DISTRIBUTION OF FUNDS


Research & development

£1.3 million

Year 1 & 2

Pilot scale manufacture

£850,000

Year 3

Clinical trials

£560,000

Year 3&4

Regulatory approvals

£250,000

Year 4


Valuation at the end of 10th Year:NPV: £ 224.0 million

Retained Profit: £ 235 million

G 7 Diagnostics

Research and Development

Clinical trials and

Regulatory Approval

Full Manufacturing

and Sales

ExitYear 4 High

Product Value

Exit Year 10 Prospective

buyers: Alere, Roche, Perkin Elmer

COMPANY VALUATION & EXIT STRATEGY


WHY INVEST IN Us?

Regulatory

approval in

process

Patent Protection

Huge global market opportunities for pre-

eclampsia Reliable, innovative

strip technolog

y

SAPHVIDTM

• G7 Diagnostics Company status• SaphvidTM : Features, Intended use, Legal status, Market• Our Customer and Competition• Business model• Marketing and financial Projections• Exit strategy• Net present value: £ 224 million• Amount required: £ 2.7 million• Personal contribution: £ 300,000

SUMMARY


Thank you!

G7 Diagnostics Inc.Contact info.:Coventry Building Society, Oakfield House, PO Box 600, Binley Business Park, Coventry CV3 2YR.Ph.no.: 0845 766 5522Web: www.G7 diagnostics.co.ukE-mail: [email protected]

Save the Mother. Save the Child!

Business Development & Commercialization Plan

Health & Medicine

Transcript of Business Development & Commercialization Plan