Business Development & Commercialization Plan
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Business Development & Commercialization Plan
- 1. 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
- 2. 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.
- 3. 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.
- 4. Management Team: Chief Executive Officer Finance Director Who are we? Experience: 25 years Experience: 20 years Early stage biotech Company in Research and Development Stage of the Project SAPHVIDTM Vinie Varkey Helena Gwani DOMAIN EXPERTISE • Diagnostic Technology General Manager • Pregnancy Disorders Experience: 15 years • Product DevelopmentOperating Manager Experience: 18 years PRODUCT PIPELINE Srishti • Saphvid™ Jain Priyesh Waghmare • PROM Chief Scientific officer Marketing Manager Experience: 35 years STRATEGIC PARTNERSHIP Experience: 21 years • Raupack Limited (Strip manufacturing) • Millipore Corporation (Raw materials) Ayotunde Awosusi • Universal Biologicals (Raw materials) Igwe Daniel G7 Diagnostics. Save the mother. Save the child.
- 5. Higher risks: PROBLEM (Pre-eclampsia) Younger <20 years • Pregnancy Disorder women • Damage to the blood vessels Older >35 years • Hypertension & Proteinuria women 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.
- 6. Sample Port Blood Filter Biochemical Marker Plasma Concentration ManifestCells are Pre- eclampsia separated from Reaction Chamber Trimester 1 Trimester 2 plasma A small fraction of the Plasma sample mixes with Soluble fms- like tyrosine -- high Timegate Early increase thekinase dried reagents Hydrophobic (Sflt-1) surface –ensures Three Internal reaction time Controls Independent Positive High – and Endoglin Soluble low – -- high Early increase Assay Zones control zones and a (sEng) nonspecific binding Fluorescent control tagged Waste Reservoir Placental Growth Factor low low Further decrease on antibodies Excess sample (PlGF) nano particles collected in the are captured on periphery separate zones G7 Diagnostics. Save the mother. Save the child.
- 7. Reaction Chamber PlGF sEng sflt Array of Antibodies G7 Diagnostics. Save the mother. Save the child.
- 8. Priority Features Sensitivity 94.5% Specificity 95% Time to result 15 minutes Heat stability 15°C- 30°C Storage conditions 20°C • Week No. of 12 Test 1patient Req. 2 Strips test • Week 19 G7 Diagnostics. Save the mother. Save the child.
- 9. Licensed Patents Patent number Claims Patentee GB 2464222. Analysis method and device Bolbot, J. A. (2010) (Inverness Medical) EP 1175940 Diagnostic devices and Beuchler, K. A (2002) apparatus for controlled (Biosite Diagnotics Inc.) movement of reagents without membranes Filed Patent EP 1 175 940 A1 An assay device utilizing G7 Diagnostics three biomarkers Regulatory approvals • Product classified as annex II (Non self test) • CE marking • ISO:13485 G7 Diagnostics. Save the mother. Save the child.
- 10. Method Limitations Companies • Doppler Ultra • Time consuming • Perkin Elmer Inc Sonography • Complex • DRG Diagnostic Inc • Urine Test • Low reliability • Alere Inc • ELISA (Enzyme linked Immunosorbent Assay) • Late diagnosis • Summit Doppler Systems • RIA (Radio Immuno • Rate of false positive is Assay) high • Roche Inc. • FIA (Fluroscent Immunoassay) • Blood pressure G7 Diagnostics. Save the mother. Save the child.
- 11. • Consumer relationships • Financial policies (feedbacks, • Funding (Grants, customer PROFIT charity) support) • Cost Structure • Value • Shareholder propositions CUSTOMER REVENUE & INVESTMENT Strategic SALES Alliances MARKETING OPERATIONS • Brand development • USPs • Key suppliers • Marketing strategies • Manufacturer Medical journals • International Medical awards distributors press releases internet G7 Diagnostics. Save the mother. Save the child.
- 12. Customer value Proposition • Target customer: Customer Relationship (Cost-benefit) – General •Better management of the health of Practitioner pregnant women •Personnel Relationship – Gynecologist Health economics: •Early Delivery – Obstetrician GBP (000) per Cost •Feedback forms year •Consistency – Mid Preeclampsia wife 3,000,000 Pre-term births 300 •Report Any Pre- term survivor (up 23 problems to 18 years) • End User/ Consumer: Birth: <33 weeks 60 •Improvements – Pregnant women Birth: <28 weeks 95 Source: Ferring Pharmaceuticals,2010 G7 Diagnostics. Save the mother. Save the child.
- 13. 1.5M AVAILABLE MARKET 6.4M (0.9M) G7 TARGET MARKET (3.84M) PRODUCT PRICING £ 32 £ 27 18.5M (11.1M) £ 24 27.5M (16.5M) £ 12 6.1M (3.66M) £ 10
- 14. • 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 • Articles in magazines • Campaigns awareness (pre-eclampsia) Pregnant women • Ante-natal fitness routine G7 Diagnostics. NICE:National insititute for health & Clinical Execellence NHS: National Health Service Save the mother. Save the child.
- 15. 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.
- 16. SALES REVENUE CUMMULATIVE CASHFLOW 600,000 250,000 500,000 200,000 400,000 GBP (000) 150,000 UK China GBP (000) 300,000 100,000 USA India Nigeria 200,000 50,000 BREAK-EVEN POINT 100,000 0 5 6 7 8 9 10 YEAR 0 1 2 3 4 5 6 7 8 9 10 (100,000) YEAR G7 Diagnostics. Save the mother. Save the child.
- 17. 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 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 (50,000.0) Year Normal sales 20% above projected sales 20% below projected sales G7 Diagnostics. Save the mother. Save the child.
- 18. 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 G7 Diagnostics. Save the mother. Save the child.
- 19. CASHFLOW CUMMULATIVE CASHFLOW YEAR 000’s GBP 000’s GBP 1 (780.4) (780.4) 2 (580.4) (1,360.8) 3 (928.4) (2,289.2) Pay back period: 4 (553.0) (2,842.2) 5 years+ (344/10404) 5 344.4 (2,497.8) 10,404.3 7,906.5 Approx 5 years and 1 6 month 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 G7 Diagnostics. Save the mother. Save the child.
- 20. • Total funding required: 2.7 million GBP • Rate of return on investment (compounded): 30% Investment Investment (GBP) Rate of return (%) Cash returns period (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 G7 Diagnostics. Save the mother. Save the child.
- 21. Research & development Clinical trials £1.3 £560,000 million Year 3&4 Year 1 & 2 Pilot scale Regulatory manufacture approvals £850,000 £250,000 Year 3 Year 4 G7 Diagnostics. Save the mother. Save the child.
- 22. G 7 Diagnostics Valuation at the end of 10th Year: NPV: £ 224.0 million Research and Profit: £ 235 million Retained Development Year 4 Exit High Clinical trials Product and Regulatory Value Approval Year 10 Full Exit Prospective Manufacturing buyers: and Sales Alere, Roche, G7 Diagnostics. Perkin Elmer Save the mother. Save the child.
- 23. Regulatory approval in Patent Protection process Huge global market Reliable, innovative strip opportunities for pre- technology eclampsia G7 Diagnostics. Save the mother. Save the child.
- 24. • 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.
- 25. 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
Notes de l'éditeur
- Of the estimated 211 million pregnancies that occur each year, 46 end in induced labour. This leaves only 165 million. 10% of this number gives 16.5 million: http://www.who.int/whr/2005/chapter3/en/index3.htmlhttp://www.who.int/bulletin/volumes/88/1/08-062554-table-T3.htmlhttp://www.who.int/bulletin/volumes/88/1/08-062554/en/Maternal deathshttp://www.childinfo.org/maternal_mortality.htmlhttp://www.childinfo.org/files/Trends_in_Maternal_Mortality_1990_to_2008.pdf
- How do we intend to sell this product?How will the company generate revenue?Sales cycle?
- Go-to market startegyPricing modelGross marginDistributionCustomer support
- We can see that the cumulative cash flow becomes positive in the 6th year. We have assumed that the cash flows evenly over the year, the precise payback period becomes: (Refer to slide)
- We can see that the cumulative cash flow becomes positive in the 6th year. We have assumed that the cash flows evenly over the year, the precise payback period becomes: (Refer to slide)