G7 Diagnostics Business Plan

Helena Gwani Ayotunde Awosusi Daniel Igwe Priyesh Waghmare Srishti Jain
G7 Diagnostics. Save the mother. Save the child.

Vinie Varkey T

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. Save the mother. Save the child.

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

G7 Diagnostics. Save the mother. Save the child.

Management Team:

Who are we? Experience: 25 years Early stage biotech Company in Research and Development Stage of the Project SAPHVIDTM

Chief Executive Officer

Finance Director Experience: 20 years

Vinie Varkey General Manager Experience: 15 years

PRODUCT PIPELINE

Helena Gwani DOMAIN EXPERTISE

Diagnostic Technology Pregnancy Disorders Product Development Operating Manager

Experience: 18 years
Priyesh Waghmare

Srishti Saphvid Jain

PROM

Chief Scientific officer Experience: 35 years

Marketing Manager STRATEGIC PARTNERSHIP Experience: 21 years

Raupack Limited (Strip manufacturing) Millipore Corporation (Raw materials) Universal Biologicals (Raw materials) Ayotunde Awosusi

Igwe Daniel

G7 Diagnostics. Save the mother. Save the child.

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

Higher risks: Younger women Older women <20 years >35 years

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 G7 Diagnostics.
Save themother. Save the child.

Sample Port

Biochemical Marker
Reaction Chamber
A small fraction of the Plasma sample mixes with Soluble fms- like tyrosine thekinase dried reagents

Plasma Concentration
Trimester 1 -Trimester 2 high

Blood Filter ManifestCells are Preeclampsia separated from plasma Timegate Early increase Hydrophobic surface ensures reaction time

(Sflt-1) Three Internal Controls

Independent Positive High and Endoglin Soluble low control zones and a (sEng) nonspecific binding control

--

high

Early increase Assay Zones

Waste Reservoir Placental Growth Factor Excess sample (PlGF)

collected in the periphery

low

low

Fluorescent tagged antibodies Further decrease on nano particles are captured on separate zones

G7 Diagnostics. Save the mother. Save the child.

Reaction Chamber

PlGF sEng

sflt
Array of Antibodies

G7 Diagnostics. Save the mother. Save the child.

Priority Features

Sensitivity
Specificity

94.5%
95%

Time to result
Heat stability Storage conditions

15 minutes
15C- 30C 20C

Test

1patient

Week 12 No. of test Week 19

G7 Diagnostics. Save the mother. Save the child.

Req.

2 Strips

Licensed Patents Patent number GB 2464222. EP 1175940 Claims Analysis method and device Diagnostic devices and apparatus for controlled movement of reagents without membranes An assay device utilizing three biomarkers Patentee Bolbot, J. A. (2010) (Inverness Medical) Beuchler, K. A (2002) (Biosite Diagnotics Inc.)

Filed Patent EP 1 175 940 A1 G7 Diagnostics

Regulatory approvals Product classified as annex II (Non self test) CE marking ISO:13485
G7 Diagnostics. Save the mother. Save the child.

Method
Doppler Ultra Sonography Urine Test

Limitations Time consuming Complex Low reliability

Companies Perkin Elmer Inc DRG Diagnostic Inc Alere Inc Summit Doppler Systems Roche Inc.

ELISA (Enzyme linked Immunosorbent Assay)

RIA (Radio Immuno Assay) FIA (Fluroscent Immunoassay) Blood pressure

Late diagnosis Rate of false positive is high

G7 Diagnostics. Save the mother. Save the child.

 Consumer relationships (feedbacks, customer support) Value propositions

PROFIT
CUSTOMER

REVENUE & INVESTMENT

Financial policies Funding (Grants, charity) Cost Structure Shareholder

SALES
MARKETING
Brand development USPs Marketing strategies Medical journals Medical awards press releases internet
G7 Diagnostics. Save the mother. Save the child.

Strategic Alliances
OPERATIONS
Key suppliers Manufacturer International distributors

Customer value Proposition Target customer: (Cost-benefit) General Better management of the health of Practitioner pregnant women Gynecologist Health economics: Cost Obstetrician GBP (000) per Mid Preeclampsia
Pre-term births
Pre- term survivor (up to 18 years)

Customer Relationship
Personnel Relationship Early Delivery Feedback forms Consistency Report Any problems Improvements

year 300
23

wife

3,000,000

End User/ Consumer: Birth: <33 weeks 60 Pregnant women

Birth: <28 weeks 95
Source: Ferring Pharmaceuticals,2010

G7 Diagnostics. Save the mother. Save the child.

6.4M (3.84M) 27

1.5M (0.9M) 32

AVAILABLE MARKET G7 TARGET MARKET PRODUCT PRICING

18.5M (11.1M) 24

6.1M (3.66M) 10

27.5M (16.5M) 12

 Health economics.

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

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

Pregnant women

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

NICE:National insititute for health & Clinical Execellence G7 Diagnostics. NHS: National Health Service Save the mother. Save the child.

ACTIVITY

Year 1

Year 2

Year 3

Year 4

Year 5

Year 6

Year 7

Year 8

Year 9 Year 10

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 schedule Patent 1 File PCT National Europe USA

G7 Diagnostics. Save the mother. Save the child.

SALES REVENUE
250,000

CUMMULATIVE CASHFLOW
600,000

200,000

500,000

GBP (000)

400,000 150,000 UK GBP (000)

China
100,000 USA India Nigeria 50,000

300,000

200,000
BREAK-EVEN POINT

100,000 0 5 6 7 8 YEAR 9 10 0

1
(100,000)

9 10

YEAR

G7 Diagnostics. Save the mother. Save the child.

300,000.0 285,231.4 250,000.0 235,887.3

Retained profit 000's GBP

200,000.0 186,543.1

150,000.0

100,000.0

50,000.0

1.0 (50,000.0) 2.0 3.0 4.0 5.0 Year 6.0 7.0 8.0 9.0 10.0

Normal sales

20% above projected sales

G7 Diagnostics. Save the mother. Save the child.

20% below projected sales

S.NO.

RISKS

MITIGATION

Product supply interruptions

Continuous monitoring
Dual sourcing when possible

2 3

Patents- validity and infringement Non- compliance to regulations

Internal and external experts Educate employees on the Standard operating procedures in place Short- term hedging transactions based on economic forecasts

Currency and treasury effects

G7 Diagnostics. Save the mother. Save the child.

YEAR
1 2 3 4 5 6 7

CASHFLOW 000s GBP

(780.4) (580.4) (928.4) (553.0) 344.4 10,404.3 29,420.3

CUMMULATIVE CASHFLOW 000s GBP

(780.4) (1,360.8) (2,289.2) (2,842.2) (2,497.8) 7,906.5 37,326.8

Pay back period:

5 years+ (344/10404)
Approx 5 years and 1 month

8
9 10

92,598.9
167,327.2 235,884.6

129,925.7
297,252.9 533,137.5
G7 Diagnostics. Save the mother. Save the child.

 Total funding required: 2.7 million GBP Rate of return on investment (compounded): 30%
Investment period 1 2 3 4 5 6 7 8 9 10 Investment (GBP) 2,700,000 3,510,000 4,563,000 5,931,900 7,711,470 10,024,911 13,032,384.3 16,942,099.59 22,024,729.47 28,632,148.31 Rate of return (%) 30 30 30 30 30 30 30 30 30 30 Cash returns (GBP) 3,510,000 4,563,000 5,931,900 7,711,470 10,024,911 13,032,384.3 16,942,099.59 22,024,729.47 28,632,148.31 37,221,792.8

G7 Diagnostics. Save the mother. Save the child.

Research & development

Clinical trials

1.3 million
Year 1 & 2

560,000
Year 3&4

Pilot scale manufacture

Regulatory approvals

850,000
Year 3
G7 Diagnostics. Save the mother. Save the child.

250,000
Year 4

G 7 Diagnostics
Valuation at the end of 10th Year: NPV: 224.0 million Research and Profit: 235 million Retained

Development Year 4 High Product Value Exit

Clinical trials and Regulatory Approval Year 10 Prospective buyers: Alere, Roche, Perkin Elmer

Full Manufacturing and Sales

G7 Diagnostics. Save the mother. Save the child.

Exit

Regulatory approval in process

Patent Protection

Huge global market opportunities for preeclampsia

Reliable, innovative strip technology

G7 Diagnostics. Save the mother. Save the child.

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

G7 Diagnostics. Save the mother. Save the child.

G7 Diagnostics Inc. Contact info.:

Coventry Building Society, Oakfield House, PO Box 600, Binley Business Park, Coventry CV3 2YR. Ph.no.: 0845 766 5522 Web: www.G7 diagnostics.co.uk E-mail: contactus@G7diagnostics.co.uk