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TiGenix, from IP to IPO Leuven 20 November 2008 Gil Beyen Co-founder & CEO TiGenix NV Michael van Eeno Director ING Corporate Finance.

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Presentation on theme: "TiGenix, from IP to IPO Leuven 20 November 2008 Gil Beyen Co-founder & CEO TiGenix NV Michael van Eeno Director ING Corporate Finance."— Presentation transcript:

1 TiGenix, from IP to IPO Leuven 20 November 2008 Gil Beyen Co-founder & CEO TiGenix NV Michael van Eeno Director ING Corporate Finance

2 2 2000, spin-off K.U.Leuven and U.Gent Regenerating motion. Innovative local treatments for damaged and osteoarthritic joints. ChondroCelect ®, autologous cell-based medicinal product for cartilage regeneration; Phase III trial successfully completed; in registration phase in EU Biological Implants: next generation products for repair of musculoskeletal tissues Leuven (Belgium), New York & Memphis (US) 2000-2006: 29 million EUR venture capital March 22, 2007: 46 million EUR via IPO TiGenix Founded Focus Lead product Pipeline Locations Finance

3 3 Cartilage defects  > 2 million articular cartilage defects diagnosed per year*  Ca. 130.000 grade 3-4 full thickness defects* Meniscus trauma  2.2 million menisci removed or partially removed per year* Osteoarthritis 2.5 to 5% of adult population in Western world has symptomatic knee osteoarthritis * Europe and US femur articular cartilage tibia inner meniscus outer meniscus Clear focus: joint function

4 4 Lead product: ChondroCelect

5 5 Proprietary molecular profile of stable cartilage forming cells F. Dell’Accio, C. De Bari and F.P. Luyten., Arthritis & Rheumatism, 2001

6 6 Interaction science - IP

7 7 Proof: clinical trials Prospective Randomized Controlled Trial of ChondroCelect versus Microfracture in the Repair of Symptomatic Cartilage Defects of the Knee  Study objective: demonstrate superiority on structural repair at 12 months as precursor of long term clinical benefit  118 patients treated in nine Belgian and three international centers  5 year patient follow-up to confirm long term clinical benefit  State-of-the-art trial management and monitoring

8 8 Superior structural repair at 12 m ChondroCelect Microfracture

9 9 Superior clinical outcome at 36m * Average of all KOOS domains, except Sports ** FAS without imputation for missing data or failures

10 10 Regulatory approvals  EU-EMEA:  MAA filed in 2007  First cell-based product to go for central approval at EMEA as somatic cell therapy/advanced therapy medicinal product (ATMP)  CHMP opinion: H1 09  US-FDA:  BLA filing targeted H1 09

11 11 GMP Production

12 12 Adult stem cells Meniscus repair (TGX003) Pipeline development Increase ease of use and patient friendliness Broaden indication Next Generation-3D (TGX002-TGXFAB002) Combination product (TIG-FAB) ChondroCelect (TGX001)

13 13 Adequate financial means needed Long time to market Clinical trial GMP facility R&D and IP Marketing & sales

14 14 Seed financing (2000-2001)  Initial seed funding: EUR 1.000.000  Gemma Frisius Fonds  Founders  K.U.Leuven R&D & UZ Leuven  Research grant: EUR 1.000.000  IWT  Bridge loan: EUR 800.000  Use of proceeds:  Research & validation of patents  Preparation of clinical trial

15 15 Series A round (2003)  EUR 12,000,000  Investors  ING Private Equity, Capricorn Venture Partners, Auriga Partners, Fagus (Fortis)  Conversion of bridge loan (GFF, U Gent)  Use of proceeds:  clinical development of lead product  development and expansion of product pipeline and IP position  setting up of in-house research laboratory  strengthening the team

16 Financing life cycle Knowledge-Based Companies CASH-IN TIME VCs & Strategic Alliances Angels, FFF Seed CapitalEarly Stage Later Stage Mezzanine 3rd 2nd 1st IPO Public Market Secondary Offerings Public Company Operating Cash Flow

17 Later stage financing – pre-IPO Key investor view ( Venture Capital, Cross-over investors, Private and public equity funds, hedge funds,…) Strong scientific foundation/ strong IP Leader in it’s market Access to a global market Validation of the product / commercialisation Management team Progress after last round Valuation Too early, too late stage (risk, return)

18 Later stage financing – pre-IPO Preparation of the next steps -Appointment of further professional management -Corporate Governance – professional/independent board members -IFRS figures -Work on business plan and equity story -Commercial role out of product -Increase corporate communication - professional marketing -…

19 19 Series B (pre-IPO) round (2005)  EUR 16.000.000  Use of proceeds:  Drive regulatory process for ChondroCelect at FDA and EMEA  Set up network of key opinion leaders in EU and US  Develop pipeline & next generation ChondroCelect products  Prepare TiGenix’ entry in the US  Investors  Existing investors  Broader base: HSS Ventures (US), ITX (Japan), BIP, SRIW, Partners@Venture, e.a

20 20 End 2006: important achievements…  ChondroCelect Phase III trial results positive  Deal on second generation product in the making  Strong technology base in major indication areas (OA, meniscus)  Experienced management team  Strong and broad shareholder base  US presence (TiGenix Inc & NY office)  Network of key opinion leaders in EU and US

21 21  File for market authorizations  Set up manufacturing capability  Prepare and execute the launch of ChondroCelect ®  Launch clinical study next generation product  Broaden indication to osteoarthritis  Develop product for meniscus repair  Prepare for next financing… … and important milestones to come

22 Next steps Company IPOSale of the Company Private Placement existing investors Private Placement new investors Public market Broader investor base Industrial party Financial party

23 Strategic options available Strategic rationalePossible issues IPO Longer term exit for financial shareholders Continue to benefit from longer term potential upside Ongoing control of company’s destiny Acquisition currency Management incentive Visibility Funding and future access to markets Specialist business Unproven long term growth prospects for the business No listed comparables Likely to suffer an important initial discount on valuation compared to a sale of whole business Delays full exit of the founders Realise whole value immediately Complex business will be understood by buyers with sector knowledge Identified interest of some industrial players Future role and ambitions of management Future upside Premium valuation to earlier rounds Specialised investors Track record Further delays exit of the founders Valuation discussion Dilution for initial investors M&A Sales Process Private Placement

24 When is a company a feasible IPO candidate? Timing Commitment Management Growth prospects Strong and clear investment case Earnings Characteristic Good visibility of earnings or future earnings Proven track record Focused business strategy Strong IP portfolio/technology Market position Growth opportunities Increasing market share Product diversification and innovation Solid track record in achieving growth strategy Management composition and commitment going forward IPO window Criteria

25 Advantages of an IPO vs Private placement Possibility for existing shareholders to trade shares at market / objective value Opportunity for existing shareholders with immediate liquidity needs Enhanced confidence for all existing shareholders who have the option to exit Feeling of increased wealth as share price evolves from ‘potential & subjective’ to ‘realisable & ascertain’ Liquidity Use of equity incentives such as stock (option) plans in order to align the interests of employees and shareholders Stock plans Shares can be used to pay acquisitions: valuation is less subject to discussion, liquid shares are more easily accepted by the sellers, notoriety enhances M&A opportunities, limits use of cash. Valuation of listed companies usually higher than non-listed companies: improved negotiation power Valuation and acquisition currency Increased brand awareness and exposure Increased ability to attract and retain employees Ability to strengthen Board of Directors or management Increased visibility and prestige Ability to increase funds (at moment of IPO and thereafter) to support organic and external growth A listing could improve financing terms from suppliers/banks as credit risk is often perceived as lower Increased future access to public markets Funding An IPO process stimulates a wide, in-depth strategic thinking in terms of internal organisation, strategic targets, communication, financial reporting, company culture, motivation of employees Momentum created Initial shareholders partly remain in control of company strategy with broad international investor base and analysts serving as a sanity check on company’s strategy and transactions Shareholders’ diversification

26 26 Key decision factors  Partnering or alone?  Added value of partner for business (or part of business)  Importance of independence for value creation  Exit considerations  Private or public financing?  Access to capital & cost of capital  Exit & liquidity  Timing  Image & visibility

27 27 IPO: Offering Summary  Base deal of up to €40 million new shares plus 15% greenshoe of new shares  Public offer in Belgium, institutional private placement in Europe  Listing on Eurolist by Euronext Brussels  Joint-Lead managers: ING and Piper Jaffray – Petercam is Co-lead manager  12 month lock-up for the pre-IPO security holders and standstill for the company Offering Listing Syndicate Lock-up & standstill

28 28 Last 12 months as a public company

29 29 Business Highlights – Q3 Update  Further data analysis confirms clinical superiority of ChondroCelect  ChondroCelect registration procedure progressing  European cell expansion facility obtained GMP status  TiGenix’ core patent granted in the US  Cash position of EUR 29 million on September 30, 2008

30 30 Business Highlights – Outlook  CHMP opinion and EU approval of ChondroCelect  Launch of ChondroCelect in selected EU countries  Submission of the Biological License Application at the US FDA  Start of clinical trial with TGX002

31 31 Concluding  Exciting journey  Innovation and entrepreneurship  Thanks to excellent interaction & support  Pre-start  At initial stages  At later stages  And continuing…


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