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2014 Interim Results Acquisition of AQTIS Medical BV · 2019. 2. 18. · Ellansé has clear benefits relative to Radiesse ® and Sculptra ® combining instant volumisation with an

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Page 1: 2014 Interim Results Acquisition of AQTIS Medical BV · 2019. 2. 18. · Ellansé has clear benefits relative to Radiesse ® and Sculptra ® combining instant volumisation with an

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2014 Interim Results Acquisition of AQTIS Medical BV

Page 2: 2014 Interim Results Acquisition of AQTIS Medical BV · 2019. 2. 18. · Ellansé has clear benefits relative to Radiesse ® and Sculptra ® combining instant volumisation with an

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Disclaimer

2

The contents of this presentation and the information which you are given at the time of these slides and the presentation have not been approved by an authorised person within the meaning of the Financial Services and Markets Act 2000 (the “Act”). Reliance on this presentation and its slides for the purpose of engaging in investment activity may expose an individual to a significant risk of losing all of the property or other assets invested. This presentation does not constitute or form part of any offer for sale or subscription or solicitation of any offer to buy or subscribe for any securities in Sinclair IS Pharma Plc (the “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein. These slides and the presentation are exempt from the general restriction (in section 21 of the Act) on the communication of invitations or inducements to engage in investment activity on the grounds that it is made to: (a) persons who have professional experience in matters relating to investments who fall within Article 19(1) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (b) high net worth entities and other persons to whom it may otherwise lawfully be communicated, falling within Article 49(1) of the Order (all such persons together being referred to as “relevant persons”). Any person who is not a relevant person should not rely on this presentation or any of its contents and all persons (whether relevant persons or otherwise) are recommended to

seek their own independent financial advice from a person authorised for the purposes of the Act before engaging in any investment activity involving the Company’s securities. This presentation includes certain forward-looking statements with respect to certain development projects, potential collaborative partnerships, results of operations and certain plans and objectives of the Company including, in particular and without limitation, the statements regarding potential sales revenues from products, both currently marketed and under development, possible launch dates for new products and line extensions, and any revenue and profit guidance. By their very nature forward-looking statements involve risk and uncertainty that could cause actual results and developments to differ materially from those expressed or implied. The significant risks related to the Company’s business which could cause the Company’s actual results and developments to differ materially from those forward-looking statements are discussed in the Company’s annual report and other filings. All forward-looking statements in this presentation are based on information known to the Company on the date hereof. The Company will not publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

3

Overview

• Acquisition of AQTIS Medical BV brings global rights to next generation collagen stimulator Ellansé™ and complements HA filler Perfectha®

• Aesthetics portfolio well positioned and with global rights, c.50% Group sales in FY15

• Both Ellansé™ and Perfectha® will be earnings accretive in FY15

• Flammacerium® US orphan drug designation provides major opportunity

• H1 sales hit by short term supply, regulatory and political factors but FY14 anticipated in-line with market expectations after strong H2

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

4

• Acquisition of global rights to Ellansé™ for an initial consideration of €16.6m funded by extension to Hayfin debt facility

• Ellansé™ revenues grew 100% to €5.0m in 2013

• Total consideration potentially up to €46.6m with contingent milestones linked to sales targets and FDA approval

• Ellansé™ uses distributor-only model with 90% sales from Emerging Markets. Sinclair will capture margin and improve direct sales force productivity in Europe

• Structured deal and Ellansé™ fast growth implies low acquisition multiples

Acquisition of Ellansé ™

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Financial Highlights

• Revenues of £24.5 million (H1 13: £23.0 million)

• 6.6% Growth helped by Sculptra acquisition

• -7.5% LFL1 performance due primarily to short-term supply, regulatory and political factors

• Adjusted EBITDA2 increased to £1.1 million (H1 13: £1.0 million)

• Loss before tax reduced to £2.5 million (H1 13: loss of £5.8 million)

• Net debt of £9.1 million 1.2x LTM EBITDA

1 Like-for-like revenues exclude product acquisitions and disposals, one-off licence income and currency fluctuations 2 Adjusted EBITDA is defined as earnings before interest, tax, depreciation, amortisation, share based payments and exceptional items

5

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Income Statement

• Revenue growth of 6% from Sculptra acquisition offset by deliveries delayed to H2 and small disposals

• H1 Gross margin reduction due to sales mix effects, expected to pick up in H2

• Sales and marketing costs reducing as proportion of total revenue as anticipated

• EBITDA increased to £1.1m but strong H2 bias remains

• Exceptional and discontinued operation costs reduced to £0.8m from £3.1m

6

H1 FY14 H1 FY13£’m % Rev £’m % Rev

Revenue 24.5 23.0Gross profit 13.9 57% 14.2 62%

Selling, marketing and distribution (7.7) 31% (7.8) 34%

Development & Reg affairs (1.4) 6% (1.4) 6%

Manufacturing support (0.9) 4% (1.0) 4%

G&A/FX (2.8) 11% (3.0) 13%

EBITDA 1.1 4% 1.0 4%

Exceptional items 0.2 (3.1)Depreciation & amortisation (2.6) (2.5)Share based payments (1.0) (0.4)Operating loss (2.3) (5.0)

Net interest expense (0.2) (0.7)Loss before tax (2.5) (5.7)

Tax 0.1 0.6Loss after tax (2.4) (5.1)

Discontinued operations (1.0) - Net loss for the period (3.4) (5.1)

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

H1 Revenues

7

• Country operations (LFL -1.6%) improved performance compared with FY13 -5% LFL

• France back to growth +3% LFL with aesthetics strategy and more focused pharmacy selling

• UK focus on aesthetics with 60+ Sculptra training workshops and Variquel growing again, solution to be launched in H2

• Germany, Variquel back to growth following decline over FY13 • Italy strong growth +16% LFL, Menarini launch of Atopiclair

• International operations (LFL -17.6%) hurt badly by supply issues, regulatory delays and political factors

• Strong H2 bias anticipated as in previous years

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Second Half Weighting

• Sinclair retains a strong second half weighting to trading, expected to repeat again for FY14

• H1 Result held back by £1.6m delayed orders

• Even spread of overhead spend results in low EBITDA margin in H1 followed by much stronger contribution for H2

8

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Cash Flow

9

• Cash outflow from operations increased due to factory closure payments and settlement of other FY13 exceptional costs

• Strong improvement in cash flow anticipated in H2 when exceptional costs settled and following trading bias

• Tax payments eliminated

• Disposal proceeds from sale of Effederm, further focusing of portfolio on key dermatology assets with growth potential

• Net debt of £9.1m at 31 December, 1.2x LTM EBITDA

H1 FY14 H1 FY13£’m £’m

Loss before tax (2.5) (5.8)Non-cash items 2.5 6.0Working capital (1.8) (0.4)Discontinued operations (1.3) (0.3)Cash flow from operations (3.1) (0.5)

Interest paid (0.3) (0.4)Tax paid - (0.5)Operating cash flow (3.4) (1.4)

Disposal proceeds 1.0 0.4Acquisition of Sculptra - (7.6)Acquisition of other intangibles (0.2) - Cash flow pre financing (2.6) (8.6)

Net decrease in borrowings (1.7) (1.4)Proceeds from equity issue - 8.8 Net cash out flow (4.3) (1.2)

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Balance Sheet

10

• Goodwill/intangibles decreased from amortisation of £2.6m and FX variances of £4.5m

• Inventory increased slightly from June

• Net working capital at £6.5m

• Provisions reducing as factory redundancies paid

• Deferred tax liabilities are linked to IFRS3 valuations on acquired intangibles (ISP/ABT), these are non cash liabilities

Dec-13 Jun-13£'m £'m

Goodwill/Intangibles 114.3 121.3 Property, plant & equipment 0.6 0.5 Deferred tax assets 3.9 4.2 Other non current assets 0.2 0.2 Non-current assets 119.0 126.2 Inventories 5.2 4.8 Trade and other receivables 19.6 19.9 Cash and cash equivalents 0.8 5.1 Current assets 25.6 29.8 Borrowings (3.4) (3.4)Trade and other payables (18.3) (18.4)Current tax liabilities (0.3) (0.3)Deferred consideration (0.4) (0.5)Provisions (0.9) (1.4)Current liabilities (23.3) (24.0)Borrowings (6.5) (8.5)Deferred consideration (1.5) (1.5)Deferred tax liabilities (10.6) (10.9)Other non-current liabilities (0.2) (0.6)Non-current liabilities (18.8) (21.5)Net assets 102.5 110.5

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

11

• Acquisition of global rights to Perfectha™ for an initial consideration of €10.0m funded by new debt facility from Hayfin

• Perfectha™ revenues grew 75% to €9.3m in 2013

• Total consideration up to €32.2m including contingent milestones linked to Lidocaine version approval and future sales target

• Perfectha™ uses distributor only model with 90% sales from Emerging Markets. Sinclair will capture margin and improve direct sales force productivity in Europe

• Hayfin agreed initial £35m credit facility plus £3m RCF extended by £15m for AQTIS acquisition • Pro forma Net debt : EBITDA expected to reduce rapidly from 3.5x at June 14 to 3.0x by Dec 14

Acquisition of Perfectha™ and Hayfin facility

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Sinclair’s Aesthetic Strategy

• Facial rejuvenation through the use of fast acting, long lasting, subtle, collagen stimulation treatments Ellansé™ and Sculptra® augmented by HA filler Perfectha®

• Global presence. Ellansé™ and Perfectha® to be launched in Europe but opportunities for further growth in Asia/Japan, MEA, Russia, LATAM and US

• Further acquisition and license opportunities under consideration with ambition to create unique patient lifecycle approach to non-invasive facial and body rejuvenation

12

6

8

10

12

14

75

100

125

150

175

200

2011 2012 2013 2014 2015 2016 2017

% G

row

th

US$

m

AsiaPac Dermal Filler Market 2011 - 2017

HA Other % GrowthSource: Millennium Research Group Dec 2012

2

4

6

8

10

12

50

100

150

200

250

2011 2012 2013 2014 2015 2016 2017

% G

row

th

US$

m

European Dermal Filler Market 2011 - 2017

HA Other GrowthSource: Millennium Research Group Dec 2012

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Ellansé™ Next Generation Collagen Stimulation

• AQTIS acquisition brings global rights to Ellansé™. Sales doubled in 2013 despite limited infrastructure and marketing resources

• Rapid uptake in Asia and other key emerging markets driven by marketing authorisations. Limited presence in Western Europe. US launch expected in 2017

• Ellansé™ has clear benefits relative to Radiesse® and Sculptra® combining instant volumisation with an unrivalled lifespan up to 4 years

• Ellansé™ is made from PCL microspheres. PCL used in CE and FDA approved medical devices for over 20 years and is fully bioresorbable

• Collagen stimulation is the key to sustained growth for Sinclair’s broad aesthetic product offer. Ellansé™ advances that strategy materially

13

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Sinclair has Critical Mass in Aesthetics

14

• Aesthetics expected to be around 50% of Sinclair's revenues in FY15

• Kelo franchise will grow c.20% in FY14 following short term factors in H1

• Global rights to HA five product range Perfectha® acquired in January for c.2x sales with further new product and sales related milestones

• Dynamic performance of Ellansé™ in fast uptake markets (Korea, Russia) augurs well for broader growth in Europe and elsewhere

• Increasing operational leverage as 70 strong sales and marketing team maximise Perfectha® and Ellansé™ sales in broader portfolio

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Aesthetics Enable Europe to Return to Growth

15

• Aesthetics franchise in the largest countries (UK and France) grew 17% LFL in H1

• European salesforces now largely focused on Aesthetics • Perfectha® European roll-out ongoing with Ellansé™ to follow • Cross-sell benefits including Kelo-Cote® • Significant operational leverage

• Co-marketing and partnership deals support direct sales. New partnerships include the successful launch of Atopiclair® by Menarini in Italy and OTC partnership with Fannin in the UK for multiple products

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

16

Aesthetics Enhances International Growth Prospects

• Aesthetics expected to be around two-thirds of International revenues in FY15. Over 50% from Asia

• Fast Asian growth for Perfectha® and Ellansé™. South Korea currently accounts for 55% of dermal filler procedures in the region but strong prospects elsewhere too

• Kelo franchise will continue to experience strong growth with the added benefit of multiple International product launches

• Growing aesthetic presence in MEA, LATAM, Russia from a smaller base

• Key distribution partners (Menarini, Daewoong) critical to Sinclair’s International strategy with continuing investment in fast growing Skin Care brands

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Extending Global Distribution H1 2014

17

ARNEE Partnerships

Mexico - Farmapiel - Kelo-cote® / Atopiclair® Russia - Menarini - Atopiclair Plus® Launches Benelux - Multiple Brands Canada - Kelo-stretch® Russia - Papulex® MEA

Product Launches Algeria / Tunisia - Kelo-cote® Pakistan - Kelo-stretch ® Jordan - Bio-Taches / Papulex® Sub-Saharan Africa - Atopiclair®

ASIAPAC Product Launches

Japan - Kelo-cote® Philippines / Thailand - Kelo-stretch® Indonesia - Atopiclair® Multiple Countries - Papulex UV®

EUROPE UK - Kent OTC Partnership - Kelo-cote® / Aloclair Plus® / Flammasun® Italy - Menarini - Atopiclair® Launch

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Key Products and Pipeline

18

Dermatology Products Pipeline Indication

Aesthetics Ellansé™

Sculptra® New Fill®

Perfectha®

Kelo-cote® Kelo-stretch®

US clinical trials

Atlean®

Perfectha G®

Kelo-repair®

Eurograft-M®

Collagen Stimulator

HA Dermal Filler

Scar Management

Vitiligo

Wound Care Flammazine®

Flammacerium®

Aloclair Plus®

EU/MENA under registration

US Orphan Drug designation

Aloclair Plus 2x day

Burns

Severe Burns

Mouth Ulcers

Skin Care Atopiclair®

Bio-Taches®

Papulex®

Sebclair®

Papuduo®

Terbinafine Spray®

Atopic Dermatitis

Hyperpigmentation

Acne

Seborrheic Dermatitis

Athlete’s Foot

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Sinclair IS Pharma – A Low Risk Growth Strategy

19

Strategy

• Focus on Medicinal and Aesthetic Dermatology

• Drive operating leverage through volume growth using European infrastructure

• Create strong organic sales growth from Emerging Markets

Tactics • Create global Dermatology brands, organically and by acquisition from a

strong base in Europe • Medicinal quality and regulatory standards applied to aesthetics

• Grow proportion of revenues from non-reimbursed products

• Export Sinclair IS Pharma products and corporate brand image

• Fewer larger partners materially improve distribution capability

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● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Conclusion

• Strong overall growth outlook both in Europe and International

• Collagen stimulation is the key to sustained growth for Sinclair’s broad aesthetics portfolio

• Aesthetics expected to be around 50% of Sinclair revenues in FY15

• Further operating leverage expected through revenue growth and cost control

• Opportunities to accelerate growth through product acquisitions, pipeline and distribution deals

20

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Appendix

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Key brands

22

Product 2013 Sales Type Indication Ownership Rights Patent Protected

Kelo-cote® £9.1m Medical device Scar reduction Owned Worldwide ex US Yes

Flamma® Franchise £8.5m Drug Wound care Owned Substantially

Worldwide* No

Aloclair® £4.5m Medical device Mouth ulcers Owned Worldwide Yes

Perfectha® n/a Medical device Dermal filler Owned Worldwide Yes

Sculptra® £3.8m Medical device Collagen stimulator Licensee Western Europe No

Ellansé™ n/a Medical device Dermal filler Owned Worldwide Yes

Bio-Taches® £2.3m Cosmetic Hyper pigmentation Owned Worldwide No

Atopiclair® £2.1m Medical device Atopic dermatitis Owned Worldwide ex US Yes

Papulex® £1.9m Cosmetic Acne Owned Worldwide Yes

Sebclair® £1.8m Medical device Seborrheic dermatitis Owned Worldwide Yes

* Excludes UK and Italy in particular

Page 23: 2014 Interim Results Acquisition of AQTIS Medical BV · 2019. 2. 18. · Ellansé has clear benefits relative to Radiesse ® and Sculptra ® combining instant volumisation with an

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1st Floor Whitfield Court 30-32 Whitfield Street London W1T 2RQ United Kingdom Tel: +44 20 7467 6920 Fax: +44 20 7467 6930 www.sinclairispharma.com

23