proactive investors forum...atopiclair indication atopic dermatitis (eczema) competitive positioning...
TRANSCRIPT
Proactive Investors
Forum
25th June 2009
Disclaimer
This presentation has been organised by Sinclair Pharma plc (the Company) in order to provide general information on the Company. This material has been prepared solely by the Company and is (i) for your private information, and the Company is not soliciting any action based upon it; (ii) not to be construed as an offer to sell or a solicitation of an offer to buy any security and (iii) based upon information that the Company considers reliable. The Company does not represent that the information contained in this material is accurate or complete, and it should not be relied upon as such. No representation, warranty or undertaking, express or implied, is or will be made with respect to the fairness, accuracy or completeness of any of the information or statement of opinion or expectation contained herein or stated in the presentation or any other such information nor shall you be entitled to rely upon it. In furnishing you with this information no obligation is undertaken to provide you with any further information, to update this information nor any other information nor to correct any information contained herein orany omission therefrom.
The Company's securities have not been registered under the U.S. Securities Act of 1933 (as amended), and may not be offered or The Company's securities have not been registered under the U.S. Securities Act of 1933 (as amended), and may not be offered or sold in the United States or to U.S. persons unless they have been registered under such Act, or except in compliance with anexemption from the registration requirements of such Act.
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In relation to information about the price at which securities in the Company have been bought or sold in the past, note that past performance cannot be relied upon as a guide to future performance. In addition, the occurrence of some of the events described in this document and the presentation that will be made, and the achievement of the intended results, are subject to the future occurrence of many events, some or all of which are not predictable or within the Company's control; therefore, actual results may differ materially from those anticipated in any forward looking statements. The Company disclaims any obligation to update these forward looking statements.
� Overview
� Product Portfolio
� Globalisation
� Pipeline
� Financial Overview
Agenda
� Financial Overview
� Operational focus
� Milestones
� Investment Summary
� Appendix
1
Sinclair Pharma is a pan European
specialty pharma company with
global reach, providing solutions to
treat
dermatological, oral care and
Introduction
Revenue and Profit since IPO
25
30
35
dermatological, oral care and
gynecological diseases
through advanced surface technology
and innovative delivery system.
Sinclair Pharma is listed on LSE and Euronext
Products registered in EU & US
Products launched in over 40 countries
0
5
10
15
20
2004 2005 2006 2007 2008
FY
£m
Revenue
GP
Our Products
� Patented*
� Clear USP’s
� Substantial Markets
� Market need
� Commercially Viable
19
*Patents owned by SPH
dermatology oral health non-core
Product Portfolio
Sebclair Atopiclair
B.Derm &
B.Lift
Aloclair
Range
Decapinol
Range SST T-Go Herpclair Sinlice
20
Dermatology
In dermatology, Sinclair provides
specific solutions
to dermatologists and pharmacists
for patients with skin damage and
skin injuries
Three product groups:
•Prescription
•OTC
•Dermo-cosmetics
Built on patented technologies
through its own operations in France,
Italy and Spain
and through its global network of
marketing partners
In 2012, the dermatological market
will generate $19.4bn with a 3%
CAGR from 2006 to 2012
Dermo-cosmetics are growing:
estimated market size of $6.9bn
Product Focus:Dermo-cosmetics
Indication Corrective Dermatology: Anti-ageing, Acne
Competitive
positioning
Efficacious products supported by scientific data
Target audience Dermatologists /Pharmacists/ consumers
22
Product Focus :
Atopiclair
Indication Atopic dermatitis (eczema)
Competitive
positioning
Proven efficacy and safety: steroid-
free, TIM-free, ‘steroid-sparing
Target
audience
Dermatologists, Paediatricians
Registered EU, US
Atopic dermatitis/eczema:
•one of most common skin conditions
•50% of cases identified in infants under 12
months1
•15-24% school aged children2
•2-10% adults3
•8th most common disease in under 25s4
1. C Ellis et al. International Consensus on Atopic Dermatitis II (ICCAS II) br J Dermatol 2003; 148 (supp 63): 3-10
2. Yura et al, Br J Dermatol 2001; 145 (6) 966-73/ Tay et al Br J Dermatol 2002; 146 (1): 101-6 / Mortz. Br J Dermatol 2001; 144 (3) 523-32
3. Verboom et al Br J Dermatol 2002; 147 (4) 716-24
4. Frequence of atopic dermatitis. Postgraduate medicine June 2001 p119
Corrective Dermatology:SPHR913
� Topical anti-ageing product containing Telmesteine developed by Sinclair
� Multiple mode of action to reduce the appearance of fine lines and wrinkles
� Reduce Collagen destruction
� Reduce Elastin destruction
� Inhibition of hyaluronidase: maintains skin’s natural hydration� Inhibition of hyaluronidase: maintains skin’s natural hydration
� N=30, 6 week study
� Objective results supported by positive results for
subjective criteria
� Objective outcomes:
� Skin elasticity
� Increased elastic component
Before
SPHR913:Initial Clinical Study
� Increased elastic component
� Decreased plastic component
� Profilometry
� Skin compactness, smoothness, roughness
� Decreased micro-roughness
� Tensor “lifting effect”
� Subjective outcomes:
� Acceptability
� Efficacy
After
In oral care, Sinclair provides
oral care solutions
for mouth & gum diseases
to specialists and pharmacists
Oral Health
� Two flagship brands:
�Decapinol®, for gum disease (gingivitis) and plaque
�Aloclair® for mouth ulcers
� Both approved in the US & EU to specialists and pharmacists
marketed
through its global network of
marketing partners
� Both approved in the US & EU and in some additional territories
Product Focus: Aloclair Plus
Indication: Mouth ulcers
Mode of Action:
29
Before: exposed nerve endings over-stimulated After: exposed nerve endings protected from
over-stimulation
Product Focus: Decapinol
Indication Gingivitis (gum disease), dental
plaque
Competitive
positioning
First new product class in gingivitis
for decades. ‘Intelligent’ mode of
action, targeting ‘bad’ bacteria. Lack
of tooth staining.
Target
audience
Dentists
Registration EU, US
Next Steps: � Expand geographic coverage
� US launch
� Further toothpaste and line
extension launches
In gynaecology, Sinclair is developing
gynaecological solutions
for gynaecologists and pharmacists
to be marketed
Gynaecology
to be marketed
through its global network of marketing
partners,
outside Americas
New Market EntriesNew Market Entries
2
TGo: Teething
symptoms
SINLICE: Head lice HERPCLAIR: Herpes simplex
cold sores30% of population infected
with HSV
Competitive
positioning:
barrier-based pain
relief aimed at
paediatricians and
Novel, safe and
effective
treatment to kill
reduces the
symptoms and
accelerates the
New Market Entries
paediatricians and
consumers
treatment to kill
head lice and their
eggs
accelerates the
healing process
Next Steps: �Establish partners
�Expand geographic coverage
Global Reach
18
Marketing Partner Network
High quality, targeted alliances
Decapinol
Papulex
B.Lift &
B.DermSinlice
Herpclair
T-Go
Sebclair
Geographical
Expansion
Commercialisation Drivers
Fadiamone
Optys
Effadiane
Keren
AloclairBio-
Taches
Gen-
Ongles
Tridesonit
Affina-
Lift
Atopiclair
28
Financial OverviewFinancial Overview
2
Revenue Growth
Revenue growth since IPO (UK £m)
23.2
30.3
2007
2008
2.6
7.0
11.6
23.2
2004
2005
2006
2007
7
Financial Highlights H1 09
�Total revenues up 56% to £16.2m £10.4m
�Gross profit up 77% to £11.8m £6.7m
�Operating profit of £4.1m (£0.9m)
H1 08
�Operating profit of £4.1m (£0.9m)
�EBITDA profit of £2.2m (£1.6m)
�Earnings per share of 4.0p (1.1p)
�Cash balance on 31st December 2008 of £2.4m
6
� Address current marketplace challenges
� Continue organic growth
� Build sustainable brands
� Pursue M&A opportunities
Operational Focus
� Pursue M&A opportunities
31
FY2010 Milestones
� Sebclair US Launch
� Decapinol US launch � Decapinol US launch
� Approval of Decapinol in Japan
� Robust business model
� Profitable
� Experienced management team
Investment Summary
� Experienced management team
� Innovative portfolio
� Rich pipeline
32
AppendixAppendix
Generate substantial and sustainable profits
Become a world class specialty pharma companyVision
Strategic Objective
Core
•Reinforce internal sales & marketing capabilities
•Increase sales of existing products
Strategy
•Increase organic growth
•Build & leverage Brand Equity
•Expand into new therapeutic areas
•Utilise existing technology
Identify & manage issues and challenges -•Secure cash flow
-Conserve cash
- Build cash cushion
•Monitor financial strength of partners
•Secure new partners & alternative suppliers
•Effective Contingency planning
Core
Tactics
Long Term
Focus
Short Term
Focus
•Increase sales of existing products
•New Product Launches
•Opportunistic M&A
•Product acquisition
5
Development of Sinclair
Phase 1: Building a portfolio
� Acquired and developed technologies
� Sold products only through partners
2000 Acquisition of Salix Pharma (Swedish) bringing SST for
xerostomia. Consideration £120k.
2001 Acquisition of ProPharma (Italian), bringing dermatology
range including Atopiclair. Consideration £3.6m.
2002 Acquisition of Biosurface (Swedish), bringing Decapinol for
gingivitis. Consideration £10m.
Phase 2: Building a commercial presence
� Acquisition of European marketing
2003 IPO on AIM, raising £8.9m
� Acquisition of European marketing
operations
� Continue portfolio growth - acquire
and develop technologies
2004
2005 Acquisition of Euroderm, establishing sales presence in
Italy. Consideration £4m.
2006 Acquisition of CS Dermatologie, establishing sales presence
in France, Spain, Portugal. Consideration £38m.
Acquisition of Ashbourne (British), establishing sales
presence in UK. Consideration £1.2m.
Phase 3: Building critical mass
Goal: Become a sustainably profitable,
international pharma company with an
integrated specialty salesforce
2007 H2: first profitable half year since IPO
2008
2009
FY08: first profitable full year since IPO
H1: first profitable H1 at EBITDA level since IPO
4
PipelinePipeline
Driving organic growth
through portfolio expansion
29
Therapeutic
areas
FY2010
(Jul09–Jun10)
FY2011
(Jul10–Jun11)
FY20102
(Jul11–Jun12)
Market Opportunity
MAS011
1st & 2nd degree burns
Dermatology Under development Target filing EU, USA $ 1.9bn *****
SPHD600
Psoriasis
Dermatology Under development Target filing EU, USA 18 m patients ww (7.7 only in
USA)
$ 921 m ($ 764 topical)
SPHR910-1-2-3-4-5-6-7-8
anti-aging
Dermatology Target filing EU Target filing USA $ 3.6bn only in USA
($ 855m Hyaluronic acid based)
SPHD652
Dermatitis
Dermatology Target filing EU Target filing USA 46m patients** (17m only in
USA)
Pipeline:New Products
Dermatitis USA)
SPHD 654
Dry skin
Dermatology Target filing EU, USA
SPHD 653
Dry skin
Dermatology Target filing EU, USA
MAS054D
Dry skin
Dermatology Target filing EU, USA
Therapeutic areas FY2010
(Jul09–Jun10)
FY2011
(Jul10–Jun11)
FY20102
(Jul11–Jun12)
Market Opportunity
SPHD427
Acne
Dermatology Under Development Target filing EU 150m patients*(60m only in
USA)
$ 2.6bn ($1.8 topical and $0.8
oral treatments)
SPHD428
Acne & Sunscreen
Dermatology Under Development Target filing EU 150m patients*(60m only in
USA)
$ 2.6bn ($1.8 topical and $0.8
oral treatments)
SPHD487
Hyperpigmentation
Dermatology Under Development Target filing EU Target Filing USA
Pipeline:Line Extensions
SPHD785
Hyperpigmentation
Dermatology Under Development Target filing EU Target Filing USA
SPHD752
Anti-ageing
Dermatology Under Development Target filing EU $ 3.6bn only in USA
($ 855m Hyaluronic acid based)
Therapeutic
Areas
FY2010
(Jul09–Jun10)
FY2011
(Jul10–Jun11)
FY2012
(Jul11–Jun12)
BMG1601
Iron deficiency
OBGYN Target filing EU, US
BMG1301
Breast Tension
OBGYN Target filing US
Registered EU
BMG1001
Genital Warts
OBGYN In development In development Target filing EU, USA
BMG0905
Vaginal lubricant
OBGYN In development Target filing EU, USA
Pipeline:Gynaecology
Vaginal lubricant
BMG0501
Interstitial Cystitis
OBGYN In development In development Target filing EU, USA
SPHG820
BRAND N.A.
Bi-Phasic cannula
OBGYN In development Target filing EU, USA
SPHG800
Vulvitis cream
OBGYN Target filing EU Target filing USA
Therapeutic areas FY2008
(Jul07–Jun08)
FY2009
(Jul08–Jun09)
FY2010
(Jul09–Jun10)
Market Opportunity
SPHR972
Atopic dermatitis
Dermatology Under
development
SPHD440
Rosacea
Dermatology Under
development
44m patients ww (17m
only USA)
SPHO206
Lichen Planus
Oral Health Under
development
1-2% of general
population****
SPHD770 Dermatology Under
Pipeline:Early Stage
SPHD770
Skin infection
Dermatology Under
development
SPHD420
Acne
Dermatology Under
development
150m patients*(60m
only in USA)
$ 2.6bn ($1.8 topical and
$0.8 oral treatments)
Additional Clinical SupportAdditional Clinical Support
29
Product Focus:Fadiamone
� Fadiamone: for ageing skin
� Designed to stimulate collagen production
60
80
100
120
Effects of vehicle and
Fadiamone on the
quantity of collagen
+256%In vivo data :
•Statistically significant
increase in collagen
content in Fadiamone
0
20
40
60
Vehicle Fadiamone
Collagenic hydroxyproline
(micrograms/sample)
quantity of collagen
in the skincontent in Fadiamone
groups compared to
vehicle (p<0.01)
Clinical Data:Abramovits et al (2006)
Mean itch score
4050607080
itch
scor
e (1
00m
m V
AS
)
Atopiclair
•Design: N=218 adults, 50 day study, multicentre RCT
Mean EASI scores
4567
EA
SI
scor
e
Atopiclair
010203040
Baelin
e/da
y 1
Day 8
Day 22
Day 36
Day 50
itch
scor
e (1
00m
m V
AS
)
emollient
•Abramovits et al. “A multicenter, randomised, vehicle-controlled clinical study to examine the efficacy and safety of
Atopiclair in the management of mild to moderate atopic dermatitis in adults.” J Drugs Dermatol 2006; 5(3): 223-244
01234
Baelin
e/da
y 1
Day 8
Day 22
Day 36
Day 50
EA
SI
scor
e
emollient
EASI*: Atopiclair significantly more effective
than emollient at all time points (p<0.0001)
Itch: Atopiclair significantly better at all time
points (p<0.0001). Rapid reduction on VAS
scale
* EASI (Eczema Area and Severity Index)
� Multicentre, double-blind, US study in children and infants
� n=142, 43 days, Atopiclair vs emollient control
� Improved itch
� Steroid-sparing p<0.001
� Highly significant treatment success p<0.001
Clinical Data:Boguniewicz M et al (2008)
Boguniewicz M, Zeichner JA, Eichenfield LF, et al. MAS063DP is effective monotherapy for mild to moderate atopic dermatitis in infants and
children: A multicenter, randomized, vehicle-controlled study. J Pediatr 2008;152:854-859.
� Study to evaluate effect of product on wrinkles, skin luminosity and skin thickness
� 12 subjects: 2 month study
� Skin Hydration: statistically significant increase (22.1%) from baseline (p=0.01)
� Skin Elasticity: statistically significant decrease in deformation (22.2%) from baseline (p<0.01)
� Overall elasticity: statistically significant increase (14.8%) (p<0.05)
� Skin thickness: statistically significant increase (ultrasound) (4.2%) p<0.05
SPHR913: Further Clinical Data
� Skin thickness: statistically significant increase (ultrasound) (4.2%) p<0.05
� Skin roughness: highly statistically significant decrease in maximum roughness (-13.8%) (p<0.01)
Grahame Cook ACA
Non-executive Chairman
Dr Michael Flynn
Chief Executive Officer
Jerry Randall ACA
Chief Financial Officer
Board of Directors
Non-executive Chairman Chief Executive Officer Chief Financial Officer
Penny Freer Jean-Charles Tschudin
Non-executive Director Non-executive Director
Christophe Foucher Marco Mastrodonato Paul Phull Alan Olby
Senior Management
Christophe Foucher
Chief Operating Officer
Marco Mastrodonato
Executive Vice President
NPD
Paul Phull
Executive Vice President
International Operations
Alan Olby
Finance Director
Company Secretary
Mike Killeen
Executive Vice President,
North America
Vittorio Cavagnera
Vice President
Manufacturing & Logistics
Mariyam Rawat
Director of Communications
& Investor Relations
Steve Redman
Legal Director
For further information visit our website at http://www.sinclairpharma.com
or email: [email protected]