Post on 06-Apr-2018
8/2/2019 Presentatie TiGenix
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At the Forefront of Regenerative Medicine
Frank HazevoetsCFO and Company secretary
Luc Van de SteenMember of the Board
BrusselsJanuary 14, 2010
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This document does not constitute or form part of any offer or invitation to sell or issue,
or any solicitation of any offer to purchase or subscribe for, any shares in the Company,nor shall any part of it nor the fact of its distribution form part of or be relied on inconnection with any contract or investment decision relating thereto, nor does itconstitute a recommendation regarding the securities of the Company.This document may contain forward-looking statements and estimates made by theCompany, including with respect to the anticipated future performance of TiGenix andthe market in which it operates. They include all matters that are not historical facts.Such statements, forecasts and estimates are based on various assumptions and
assessments of known and unknown risks, uncertainties and other factors, which weredeemed reasonable when made but may or may not prove to be correct. Actual eventsare difficult to predict and may depend upon factors that are beyond the Company'scontrol. Therefore, actual results, the financial condition, performance or achievementsof TiGenix, or industry results, may turn out to be materially different from any futureresults, performance or achievements expressed or implied by such statements,forecasts and estimates. Forward-looking statements, forecasts and estimates onlyspeak as of the date of this document and no representations are made as to theaccuracy or fairness of such forward-looking statements, forecasts and estimates.TiGenix disclaims any obligation to update any such forward-looking statement,forecast or estimates to reflect any change in the Companys expectations with regardthereto, or any change in events, conditions or circumstances on which any suchstatement, forecast or estimate is based.
Notice
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The next 30 minutes
TiGenix at a glance
The strategy and the execution
10 years of building the company
Why an IPO and listing on Euronext Brussels? Corporate governance at TiGenix
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Focus
Products
Pipeline
Locations
Finance
Regenerative medicine - Innovative local treatments
for damaged and diseased joints
ChondroCelect, autologous cell-based product forcartilage repair. First approved ATMP in Europe.ChondromimeticTM, resorbable implant for treatmentof osteochondral defects. Approved in Europe (CE)
Complementary regenerative medicine products,integrating biomaterials and adult stem cells
HQ in Leuven (Belgium); Manufacturing in Belgium,the Netherlands & Memphis (US); Cambridge (UK)
Listed on Euronext Brussels since March 07
Raised in total mEUR 88
TiGenix at a glance
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Regenerative Medicine
Regenerative Medicine
Cells Biomaterials Growth factors
Cell Therapy Tissue Engineering
Products to regenerate tissues and cure patients
Regenerative medicine replaces or regenerates human cells,tissue or organs, to restore or establish normal function
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Cells Biomaterials Growth factors
Technology
scope
TiGenix strategy
Indication scope
Other
Cardio
Skin
Muscle
Spine
Bone
Ligaments
Meniscus
Cartilage
TiGenix aims to be a global leaderin regenerative medicine solutions
for patients with damagedand arthritic joints
femur
articular cartilage
tibia
inner meniscus
outer meniscus
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Indication scope
Other
Cardio
Skin
Muscle
Spine
Bone
Tendon
Meniscus
Cartilage
Cells Biomaterials Growth factors
Technology
scope
Acquisition of Orthomimetics
UK based; spin-out from MIT and University ofCambridge
Regenerative Medicine for a mobile, active life
Lead product for osteochondral repair CE-marked,complementary to ChondroCelect: distinctindication, same point of sale
Leading collagen-based biomaterials platform
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Complementary market-ready product portfolio
Small lesions Large Lesions
CartilageDamage
Only
Cartilage andSubchondralBone Damage
ChondromimeticOsteochondral Plug
ChondroCelect
+
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GMP Manufacturing
Europe GMP approved cleanroom
facility
EU capacity secured forproduct launch
New site and financingsecured; Constructionstarted upon approval
U.S.A (Memphis) Operational cell expansion facility
1,500 m fully equipped cell cultureand 2,000m expansion space
Team in place
Process & Tech transfer Ensuring transfer between
R&D and manufacturingand between sites
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EU market launch
Commercial core team in place
Key reference centers trained
Ease of use supported
Communication campaign ready
Pricing and reimbursement on track
First (commercial) patients treated
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Innovative products in the pipeline
Further improvements to ChondroCelect E.g. Cryopreservation
Development of enhanced delivery systems E.g. for minimal invasive implantation
Development of products for meniscus repair Cell free scaffold Cell-based combination products
Development of an adult stem cell platform For treatment of other tissues
In view of allogeneic treatments
Leveraging of Orthomimetics biomaterials platform
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Executing the strategy in 2009
ChondroCelect approved in EU by EMEA as first ATMP New EU manufacturing site secured and financed
Acquisition of Orthomimetics
A second approved product in EU
Biomaterials platform
Building the commercial core team for the launch
Cash use financed through private placements
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10 years of building the company
2000 2001 : Seed money / Grants / Bridge loan
Initial seed funding: EUR 1.000.000
Gemma Frisius Fonds
Founders
K.U.Leuven R&D
Research grant: EUR 1.000.000
IWT
Bridge loan: EUR 800.000
Use of proceeds
Research & validation of patents
Preparation of clinical trial
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10 years of building the company
2003 : series A round - VCs and Private equity entered
EUR 12,000,000
Investors
ING Private Equity, Capricorn Venture Partners, Auriga Partners,Fagus (Fortis)
Conversion of bridge loan
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
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10 years of building the company
2005 : Series B round
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 of knowledgable investors
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Role & contribution from VCs and Private Equity
Challenger
Pre-investment
Post-investment
Support (e.g. in recruiting)
Sounding board & sparring partner : strategic direction
Industry expertise & contacts
More formality in corporate governance
Financial reporting/communication Milestone driven
ROI : exit opportunities / dilution
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Why an IPO and listing on Euronext Brussels?
Additional source of funding
Potential exit for VCs
Creating visibility and awareness
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Stepping out of the comfort zone
Underwriters Legal Counsel Issuers Legal Counsel
Auditors
V4GStrategic consultant
CITYGATEPR Advisors
45 persons
IPO Project ToscaIndicative timetable
Action / Event Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 Week 17
M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F M T W T F
Kick-off meeting
Determine offer structure
Data room preparation
Due diligence
Comfort Letters, legal opinions
Business Plan/Valuation
Equity story
Audited accounts IFRS
Preparation of legal documents- Underwriting agreement
- Agreement among managers
- Legalopinions
Signing- Underwriting agreement
- Agreement among managers
Prospectus drafting
Present project to authorities
Filling CBFA
Review CBFA
Approval CBFA
Filing Euronext
Board meeting
Prospectus translation
Appointment of printers
Prospectus printing
Prospectus availability
Preparation of Management presentation
Syndicate Analyst meeting - availability research guidelines
Research preparation
Research distribution
Research black-out period Listing + 40 days
Sales force briefing
Investor education
Preparation of Roadshow presentation
Presse conference
Roadshow
Launch
Price range
Bookbuilding
Pricing/allocation
Listing
Payment date
2/apr
Week 21
9/apr
Week 22
19/mrt
Week 19
26/mrt
Week 20
A.Legal,Financialandbusinessduediligence
Marketing/Research
Offering/Pricing
22/jan
Documentation
13/nov 20/nov 11/dec27/nov 19/feb5/feb 12/feb29/jan 12/mrt
Week 18
26/feb 5/mrt4/dec 8/jan 15/jan18/dec 25/dec 1/jan
Researc
h/
Marketin
g
Legal/Finance
Preparation
Prospectus
Offering
Pricing
Roadshow overview with institutional investors
Retail meetings in Leuven and Gent
Press meetings, Kanaal Z, VFB
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New shareholder structure
Class A
Class B
Class C
Class D
Class E
Class A : Gemma Frisius Fund
Class B : Founders (Gil Beyen and Frank Luyten)
Class C : Universities
Class D : Personnel
Class E : VCs and private equity
Pre-IPO
One class of shares
Free float
Specialtyfunds
Beneluxfunds
Otherfunds
Retail
Post-IPO
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Advantages/inconveniences of a listing
Regular reporting
Business update
Financial update (IFRS)
Transparancy
Corporate governance
Short term stock performance vs long term strategy
Open communication and corporate governance structures in placeto contribute to the creation of long-term stakeholder value
Additional source of funding
Listed shares as financing tool
+/- 13 M
Orthomimetics acquisition +/- 16 M
Creating visibility and awareness
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Governance structure at TiGenix
"one-tier" governance structure
The Board of Directors is the ultimate decision-making body
The Board appointed a Chairman (who must always bedifferent from the CEO) and a Company Secretary
The Board has delegated the Companys daily management
to a managing director
The Board has established
an Audit Committee, a Nomination and Remuneration Committee
Corporate Governance code
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Shareholding structure
Important early stage investors still reference shareholders
ING Group, BNP-Paribas Fortis Group, Gemma-Frisius
Key management
Have brought Tigenix to where it is today
Ensured stability
Institutional investors
Important new sources of funding
Not represented in the Board
Stable: show confidence in long term goals
Other Investors
Market actors
Shorter term investors, variable and unknown
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Role, powers and responsibilities of the Board
Develop a clear vision and strategy about the overallcorporate goals
Take, manage and control risks
Control
TiGenix aims to be a global leader inregenerative medicine solutions for patients
with damaged and arthritic joints
femur
articular cartilage
tibia
inner meniscus
outer meniscus
- Review reporting (Audit committee)- Business and financial update
- Supervise Corporate communication
Accountability - Reliable information to all stakeholders
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Composition of the Board
Representation of key investors
Important role of independent Board Members (Chairman,majority in committees)
Chaired by strong and experienced person (W. Duron)
Close and intensive cooperation with CEO / Top management
Steering together with CEO
Composition
Diversity in knowledge and experience (scientific, processes,financial, legal, market(ing)
Acting in the interest of the company
Medium-Long term mindset
Room for discussion
Adapt composition to Corporate needs throughout evolution
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Individual requirements of the directors
Particular professional experience, knowledge and skills
Very active and engaged Board: Sufficient time to exercise
their duties 2009: 14 meetings :
Board involved soon in important decisions
Important decisions regularly require second meeting
Not purely Go/ No go decisions
Responsible for acquiring and maintaining skills andknowledge
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Chairman and secretary
Chairman of the Board
Can not be the CEO
Independent
The leadership of the Board Drive decisions in the Board
Support and advice to the CEO
one on one meetings
Company Secretary
Advise the Board on all governance matters
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Key to good corporate governance
Transparency and reliable information to all the stakeholders
It is not just about the rules, it is about how you live
Corporate Governance in your company
It is not just about the Board of Directors, it is about all levelsin a company
Control is necessary, but lets not forget about strategy and
entrepreneurship
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Key to good corporate governance
Is all about Is not so much aboutMeans Goal
Guidance Compliance
Spirit Written rules
Entrepreneurship Abuse
Risk taking Recklessness
Assurance Guarantees
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More legislation required?
Will this lead to better governance?What do we want to reach?
Different types of companies have different needs
There is a need for flexibility and common sense Common ground: accountability and transparency
The balance is essential
More rules will not prevent abuse or fraud
Procedures or disciplinary action
Corporate Governance is a building block for successin the long run but no guarantee for success
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TiGenix NVRomeinse straat 12 bus 23001 Leuven, BelgiumT: +32 (0)16 39 60 60
Thank you for your attention