Professional Documents
Culture Documents
March 2007
This presentation and any material distributed in connection with this presentation do not constitute an offer or
invitation, or solicitation of an offer, to subscribe for or purchase any securities, and neither this presentation nor any
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This presentation and any accompanying material are for distribution in the United Kingdom only to (i) persons who
have professional experience in matters relating to investments falling within article 19(5) of the Financial Services
and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the “Order”) or (ii) high net worth entities
falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons").
This presentation and any accompanying material are directed only at Relevant Persons and may not be acted on or
relied on by persons who are not Relevant Persons. Any investment or investment activity to which this presentation
and any accompanying material relate is available only to Relevant Persons and will be engaged in only with
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restricted by law and persons into whose possession this presentation and any accompanying material come should
inform themselves about, and observe, any such restrictions. By accepting this presentation and any accompanying
material , you agree to be bound by the foregoing limitations.
Neither TiGenix, nor any of its officers, employees, advisers, or agents, nor Piper Jaffray and ING make any
representation or warranty, express or implied, as to any matter or as to the truth, accuracy, or completeness of any
statement made in this presentation, made in conjunction therewith or in any accompanying materials or made at
any time, orally or otherwise, in connection with the matters referred to herein and all liability (in negligence or
otherwise) in respect of any such matter or statements is expressly excluded (except only in the case of fraud).
Piper Jaffray and ING are acting as lead managers in relation to the proposed equity fund raising and are not acting
for any other person and will not regard any other person (whether or not such person is present at the presentation)
as their customer in relation to the offering and will not be responsible to anyone other than TiGenix for providing the
protections afforded to their customers or for providing advice in relation to the proposed offering.
2
Prospectus
If you intend to participate in the proposed offering, you are reminded that any such participation is to be made solely
on the basis of the information contained in the final prospectus of TiGenix (and any addenda thereto, as the case
may be). Before making an investment in the shares, you should carefully read the entire prospectus and should
give particular attention to the risk factors set forth therein.
When making any application or acceptance to acquire any shares or other securities in TiGenix, no reliance is to be
placed on the information contained in this presentation and any material distributed in connection with this
presentation (other than the prospectus), which in itself is not to be construed as an offer or invitation, or solicitation
of an offer, to subscribe for or purchase any securities and shall not form the basis of any contract or commitment
whatsoever.
The Dutch and English version of the prospectus and the French summary of the prospectus are available to
investors at no cost at the registered office of TiGenix, at the counters of ING Belgium NV/SA, Marnixlaan 24, 1000
Brussels, telephone numbers +32 (0)2 464 60 01 (Dutch), +32 (0)2 464 60 02 (French) or +32 (0)2 464 60 03
(English) and Petercam NV/SA, Sint-Goedeleplein 19, 1000 Brussels, telephone number +32 (0)2 229 64 46, and at
the following websites: www.tigenix.com, www.ing.be, www.petercam.be and on the websites of Euronext.
3
Introduction
4
Investment case
5
Experienced team
Founded 2000, spin-off of Universities of Leuven & Gent
Founders Prof. Frank Luyten, MD, PhD & Gil Beyen, MBA
6
Market
7
Clear focus: joint function
Cartilage defects
Tibia
2.5 to 5% of
adult population in
Western world has
symptomatic knee OA
Outer
meniscus
* Europe and US 8
Current treatments
Joint revision
Joint replacement
Severity of symptoms
9
Regenerative solutions to bridge the gap
1. Biopsy
2. Cell culture
Stable cartilage
? 3. Implantation
11
Primary addressable market(1)
Cartilage damage
(in otherwise healthy knee)
Other
24%
11%
Clinical validation
13
ChondroCelect
14
From ACI to CCI
ACI = CCI =
Autologous Chondrocyte Characterised Chondrocyte
Implantation Implantation
®
ChondroCelect
Cell Culture Service
Validated medicinal product
First of a new class!
15
Forming stable cartilage: ChondroCelect®
ChondroCelect®
g2
Po 3
Ne 1
Po 2
s1
Ne 4
s
g
s
s
Po
Po
150 positive
Comparison of markers
populations that
pass and fail Stable cartilage
proprietary in- ChondroCelect®
vivo assay on score
gene
g2
Po 3
Ne 1
Po 2
s1
Ne 4
expression
g
s
s
Po
Po
profiles 60 negative
markers
Non-stable
17
ChondroCelect® cells characterised by in-vivo potency
3
Histology score
2
Differentiated,
hyaline-like cartilage
0 Fibrous or no tissue
-5 -3 -1 0 1 3 5
ChondroCelect score
Non-ChondroCelect ChondroCelect
18
Clinical validation: landmark trial
Prospective Randomized Controlled Trial of
ChondroCelect® versus Microfracture in the
Repair of Symptomatic Cartilage Defects of the Knee
19
Study Objectives/Hypothesis
Primary endpoints Secondary endpoints
40
Superiority on structural
35 repair parameters at 12
months as precursor of
L/T clinical benefit
Improvement from baseline
30
L/T Clinical
benefit
25
20
15
Non-inferiority on
S/T clinical
10
outcome
ChondroCelect
5
Microfracture
0
Months FU:BL Baseline
6m 12m Short-term
18m 24m 30m 36m 42m 48m Long-term
52m 60m
20
Primary Efficacy - Structural Outcome
CC is superior to MF on both primary efficacy parameters for structural repair
0.8
40
0.6
0.4
20
0.2
0 0
Microfracture CCI
ChondroCelect Microfracture CCI
ChondroCelect
* Sum of staining intensities for Collagen II and Safranin-O, ° Mean histological scores (ICRS2) of two blinded histopathologists
indicators of characteristics of hyaline-like cartilage
21
Primary Efficacy – Short-term Clinical Outcome
At 12 and 18 months, CC is as good as MF on all KOOS domains
30
ChondroCelect
Microfracture
25
Mean improvement from BL
20
15
10
0
Overall° Pain Symptoms ADL Sports QoL
Knee Injury and Osteoarthritis Outcome Score (KOOS)
°
Average of all KOOS domains , except Sports
22
Secondary Efficacy – Evolution Clinical Outcome
During first 18 months, the CC group showed stronger clinical improvement
Example: evolution of Quality of Life during the first 18 months post-surgery follow-up
% Improvement
65 from Baseline:
P = 0.0002
60 60% 88%
P < 0.0001
Quality of Life domain of the KOOS°
55
50
45
40
35
30
25
N= 61 51 59 51 55 51 51 44
20 ChondroCelect
Baseline 6 months 12 months 18 months Microfracture
°
Average of all KOOS domains , except Sports
23
Additional results
24
Trial conclusions
25
Regulatory approval
26
Reimbursement
27
Commercialisation strategy
EU strategy
Compassionate use at selected reference centres prior to launch
Reference centre approach
Direct sales team, complemented by local partners
Launch anticipated in 2008
US strategy
Manufacturing in JV with local partner
Reference centre approach
Direct sales team, complemented by local partners
A strategic alliance with a specialised orthobiologics player may be
considered for the launch of the next generation product
28
Key drivers for market success
ChondroCelect®
Clinical validation 5
Well designed, rigorous pre-clinical and clinical studies
Necessary to convince medical community, regulators and payers
30
Pipeline
Stem cell
therapies
Broaden indication
MeniscoCelect
ChondroCelect-3D
Combination product
®
ChondroCelect
Validated medicinal
product
Membrane 3D scaffold
32
Development portfolio
Product Development
Preclinical Clinical Registration &
character- of potency
Product Indication development development launch
isation assay
Articular cartilage
ChondroCelect
defects
Articular cartilage
1)
defects
ChondroCelect-3D1)
Cartilage defects
in (early) OA
Traumatic
MeniscoCelect
meniscus lesions
1) Combination of ChondroCelect with proven biomaterial (Hyalograft C) may allow faster start of pivotal clinical development
33
Financials
34
Cash provided and used pre-IPO
30 M cash provided :
Incorporated in February 2000 – Two seed rounds
Two financing rounds (A and B) – Venture backed
Exercise of warrants by founders and management, …
22 M cash used from incorporation to positive phase III results
€ 29.8 mio.
CASH 7.7 mio.
B Round
Seed Round
35
Cash flow statement*
Years ended December 31
Thousands of Euro 2006 2005 2004
36
Income statement*
Years ended December 31
Thousands of Euro 2006 2005 2004
Sales 0 0 0
Other revenues 416 784 567
Revenues 416 784 567
37
Outstanding financial instruments pre-IPO
Shares : 14,157,014
Outstanding warrants* : 1,226,084
38
Institutional shareholders
39
Cash provided and use of proceeds post-IPO
Up to € 69.8 mio.*
For our lead product ChondroCelect
Obtain the regulatory approvals and reimbursement
Pre-market and launch the product
40
Conclusions
41
Investment case
42
News flow
43
Details of Offering
44
Offering Summary
Offering Base deal of up to €40 million new shares plus 15%
greenshoe of new shares
Price range Price range: € 4.2 - € 5.5 or a pre-money valuation
between € 65 mln and € 85 mln
Offering Public offer in Belgium, institutional private placement
in Europe
Listing Listing on Eurolist by Euronext Brussels
45
Offering Summary
Key Dates March 9 : Press Conference
March 10 : Publication of the price range
in the press
March 12 - 23 : Bookbuilding
March 23 : End of bookbuilding
March 24 : Publication of final price
March 26 : Listing date
March 29 : Payment date
Early closing possible as of March 19
Syndicate
46
Thank you
More info:
Gil Beyen – CEO
Frank Hazevoets – CFO
investor@tigenix.com
TiGenix N.V.
Technologielaan 3
3001 Leuven
Belgium
+32 16 396060
www.tigenix.com