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Investor Presentation Peter Grant (CEO) Jefferies Conference: 19/20 November 2014

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Page 1: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Investor Presentation Peter Grant (CEO)

Jefferies Conference: 19/20 November 2014

Page 2: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

2

Disclaimer The contents of this presentation and the information which you are given at the time of 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 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 Skyepharma PLC (the “Company”) nor shall 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 this presentation and/or opinions therein. This presentation is 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 (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 does not constitute or form part of any offer or invitation or inducement to sell, issue, purchase or subscribe for (or any solicitation of any offer to purchase or

subscribe for) the Company’s securities in the UK, U.S. or any other jurisdiction and its distribution, does not form the basis of, and should not be relied on in connection with, any

contract or investment decision in relation thereto nor does it constitute a recommendation regarding the Company’s securities by the Company or its advisers and agents.

Nothing in the presentation shall form the basis of any contract or commitment whatsoever. The distribution of this presentation outside the UK may be restricted by law and

therefore persons outside the UK into whose possession this presentation comes should inform themselves about and observe any such restrictions as to the distribution of this

presentation. The Company has not registered, and does not intend to register, any securities under the US Securities Act of 1933, as amended or to conduct a public offering of

any securities in the US.

This presentation contains "forward-looking" statements, beliefs or opinions, including statements with respect to the business, financial condition, results of operations and plans

of the Company. These forward-looking statements involve known and unknown risks and uncertainties, many of which are beyond the Company’s control and all of which are

based on the current beliefs and expectations of the directors of the Company about future events. Recipients should note that past performance is not necessarily an indication

of future performance. Forward-looking statements are sometimes identified by the use of forward-looking terminology such as "believes", "expects", "may", "will", "could",

"should", "shall", "risk", "intends", "estimates", "aims", "plans", "predicts", "continues", "assumes", "positioned" or "anticipates" or the negative thereof, other variations thereon or

comparable terminology or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements may and often do differ materially

from actual results. 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. They appear in a number of places throughout this presentation and include

statements regarding the intentions, beliefs or current expectations of the directors of the Company with respect to future events and are subject to risks relating to future events

and other risks, uncertainties and assumptions relating to the Company's business, concerning, amongst other things, the results of operations, financial condition, prospects,

growth and strategies of the Company and the industry in which it operates. The Company will not publicly update or revise any forward-looking statements, either as a result of

new information, future events or otherwise.

In considering the performance information contained herein, recipients should bear in mind that past performance is not necessarily indicative of future results, and there can be

no assurance unrealised return projections will be met. Certain of the past performance information presented herein may not be representative of all transactions of a given type.

Actual events could differ materially from those projected herein and depend on a number of factors, including the success of the Company’s development strategies, the

successful and timely completion of clinical studies, securing satisfactory licensing agreements for products, the ability of the Company to obtain additional financing for its

operations and the market conditions affecting the availability and terms of such finances.

The Company reports under IFRS. Where foreign currency equivalents have been provided for convenience in this presentation, the exchange rates applied are those used in

the relevant financial statements from which the figures have been extracted.

Page 3: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

3

Business summary

• Scientific expertise plus proprietary technologies

• Track record of complex product development Oral & Inhalation drug development experts

• Long-term royalty and supply agreements

• 16 approved products, 8 recent Recurring revenues, positive momentum

• Strong cash flow from portfolio of approved products

• Multiple products recently launched in multiple countries Strong cash flow, earnings visibility

• Strengthening pipeline with new products and technologies

• Innovation through R&D, collaboration, in-licensing, M&A Investing for the next

phase of growth

Page 4: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Growth in sales from recently approved products

• Improving operational leverage in flutiform® supply chain

• Balance sheet transformed by capital raise - saved £25m in future payments

4

Financial highlights

£m H1 2014 FY 2013

Sales 34.4 62.6

Operating profit 13.2 13.6

EBITDA 14.6 17.9

Net finance costs 5.8 14.6

Operating cash flow 8.8 14.4

As at 30 Jun 2014 As at 31 Dec 2013

Cash 26.3 16.5

Net Debt (IFRS) 2.9 84.2

Page 5: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Proven credibility with multiple partners

5

Page 6: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Balance sheet transformed

• Rejuvenated product portfolio driving growth in revenues and EBITDA

• flutiform® launched in major markets including Japan and France

• New inhalation therapy platform in development for COPD

• Developing novel concept for a gastro-retentive drug delivery platform

6

Substantial progress over last 12 months

EXPAREL® flutiform®

€m

Share Price*

* 12 months to 13 November 2014

Page 7: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

0

20

40

60

80

100

120

2009 2010 2011 2012 2013 H1 2014

EBITDA* Net Debt

• Strong EBITDA over the years – previously servicing debt

• Net debt largely eliminated in 2014:

− All outstanding bonds repaid in April following over-subscribed capital raise

− Final Paul Capital amortisation payment made in June

− €12.7m (£10.6m) CRC Finance repaid in October out of general cash resources

• Substantial reduction in finance charges

• Additional debt retirement opportunities under review

7

Transformed balance sheet

£m

Page 8: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Rejuvenated product portfolio

Sales

Time

Approved Introduction Growth Maturity Decline

Incruse® (Eur, U.S.)

flutiform® (Spain)

flutiform® (France)

Relvar®Ellipta® (Japan)

flutiform® (Japan)

flutiform®

(Italy)

flutiform® (Germany)

flutiform®

(UK)

EXPAREL® (U.S)

RAYOS® (U.S.)

PAXIL CR® (Japan)

Requip® Once-a-Day (Japan)

Solaraze® (Europe)

Solaraze® (U.S.)

Xatral®

Paxil CR® (Ex-Japan)

Requip® Once-a-Day (Ex-Japan)

Breo® Ellipta® (U.S.)

Coruno®

Lodotra® (RoW)

Anoro® Ellipta ® (U.S.)

flutiform®

(South Korea) Relvar®Ellipta® (UK, Germany)

flutiform® (Singapore)

Anoro® Ellipta ® (Europe – first launches)

flutiform® (Austria)

flutiform® 120-puff (Japan)

8

Page 9: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Revenues from 7 products launched since March 2012 have grown £20.4m

since H1 2012, significantly ahead of growth in total revenues

• These represented 63% of total revenues in H1 2014 (H1 2013: 48%)

9

Revenues rejuvenated by new products

£m

Page 10: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Inhalation Products Primary Indication Licensee / Partner

flutiform® – EU & other / Japan Asthma Mundipharma / Kyorin

†Relvar® / Breo® Ellipta® COPD (U.S.) / Asthma (Japan) / COPD & Asthma (Europe) GlaxoSmithKline

†Anoro® Ellipta® COPD (U.S., Europe & Japan) GlaxoSmithKline

†Incruse® COPD (U.S. & Europe) GlaxoSmithKline

10

Revenues from 16 approved products

Oral Products Primary Indication Licensee / Partner

Xatral® OD / Uroxatral® BPH (urinary symptoms) Sanofi

Requip® Once-a-day Parkinson’s disease GlaxoSmithKline

Paxil CR® Depression GlaxoSmithKline

Sular® Hypertension Shionogi

ZYFLO CR® Asthma Cornerstone Therapeutics

Coruno® Angina Therabel

Lodotra® / RAYOS® RA pain & stiffness Horizon Pharma

Triglide® Lipid disorders Shionogi

Madopar DR® Parkinson’s disease Roche

Diclofenac-ratiopharm® uno Pain / inflammation Teva

† Technology licence, product not developed by Skyepharma *A product of Skyepharma’s former Injectable Business now Pacira Pharmaceuticals

Other Products Primary Indication Licensee / Partner

Solaraze® Actinic keratosis Sandoz / Almirall

*EXPAREL® Pain management Pacira Pharmaceuticals

Page 11: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

8 recent product approvals driving growth

flutiform®

23 European Countries

RAYOS®

U.S.

EXPAREL®

U.S.

Breo® Ellipta®

U.S.

flutiform®

Australia

flutiform®

RoW - Israel, HK, S Korea, Taiwan

flutiform®

Japan & Singapore

Paxil CR ®

Japan

Requip® Once-a-day

Japan

Relvar® Ellipta®

Japan

Relvar® Ellipta®

Europe

Anoro® Ellipta ®

U.S.

Incruse®

Europe

Incruse®

U.S.

Anoro® Ellipta®

Europe

flutiform®

Argentina

Key

Inhalation

Oral

Other

Relvar® Ellipta®

Japan

Anoro® Ellipta®

Japan

Products launched since March 2012 contributed 63% of H1 2014 Group revenues

Anoro® Ellipta®

Australia

11

Page 12: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

12

Continuing wave of product launches

2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

flu

tifo

rm®

O

the

rs

UK Germany

Netherlands Cyprus

Sweden Norway

Denmark Italy Finland

Ireland Japan

Belgium Slovakia

Australia Hong Kong

Czech Rep.

S Korea

PAXIL CR® (Japan)

Requip® Once-a-Day (Japan)

EXPAREL® (U.S.)

Breo® Ellipta® (U.S.)

Relvar® Ellipta® (Japan)

RAYOS® (U.S.)

France Iceland Israel

Anoro® Ellipta® (U.S.)

Relvar® Ellipta® (UK, Germany)

Luxembourg Switzerland

Bulgaria

Anoro® Ellipta® (First launches

in Europe)

Anoro® Ellipta® (Japan)

Austria Singapore

Page 13: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Proven development capabilities to address c.U.S.$30bn* global asthma and COPD

market – covering both pMDI and DPI

• Cover full development cycle from pre-clinical R&D to post approval supply and support

• Product approvals in more than 50 countries including U.S., Europe and Japan

• Supporting Mundipharma in the development of a breath-activated version of flutiform®

• 2014 commenced development of SKP-2075, a potential novel treatment for COPD

Expert developers of inhalation products

13

* Source: Company analysis: i) Datamonitor COPD report, DMKC0047510, Publication Date: 19/08/2013 ii) Datamonitor Asthma report, DMKC0082148, Publication Date: 07/09/2012 iii) Extrapolation of main market sales to global numbers with a factor of 25%

Metered Dose (pMDI) Dry Powder (DPI)

Approvals in more than 50 countries Approvals in 31 countries, incl. U.S.

Products developed by SKP have included flutiform® and Pulmicort pMDI

Products developed by SKP have included Foradil® Certihaler®

New developments for RespiVert (Janssen Biotech)

Technologies: SkyeDry™, SkyeStabe™, SkyeFine™, IDD®- P

Technologies: SkyeProtect™ Device: Skyehaler

Page 14: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Support long-term revenues of established products (e.g. flutiform®)

• Focus on product development areas which play to our strengths and

balance risk with potential revenue

− Identify new product and technology opportunities where careful appraisal of

investment could add significant value – self-generated, by collaboration, and by

acquisition (e.g. SKP-2075)

• Undertake additional contract development work, especially where likely to

generate IP and/or royalties

Inhalation strategy

14

Page 15: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• flutiform® combines most commonly prescribed ICS1 with fast onset LABA2

flutiform - novel asthma treatment

15

Product Developer ICS LABA Inhaler

flutiform® Skyepharma3 fluticasone propionate formoterol pMDI

Seretide/Advair4 GSK fluticasone propionate salmeterol DPI/pMDI

Symbicort4 AZ budesonide formoterol DPI/pMDI

Foster/Fostair Chiesi beclametasone formoterol pMDI/DPI

Dulera (U.S. only) Merck & Co mometasone formoterol pMDI

Breo/Relvar GSK5 fluticasone furoate vilanterol DPI

3 and licensees

1 Inhaled corticosteroid (anti-inflammatory) 2 Long acting beta2 agonist (bronchodilator)

4 plus generics in certain markets 5 includes technology under license from Skyepharma

Page 16: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

flutiform® - launched in 25 countries

Launched in 19 European countries, plus Japan, Australia, HK, Israel, South Korea, Singapore Approved in Argentina, Poland, Portugal, Romania, Spain, Taiwan

Latin America (Sanofi) First regional approval in Argentina; NDA under review in Colombia; joint review of impact of currency weakness

United States Renewed efforts to find a partner

Japan (Kyorin) 56-puff version launched 2013 120-puff version launch planned Dec. 2014

Europe & RoW (Mundipharma) 2014: launched in France, S. Korea, Israel, Singapore & 6 other European countries Planned launches: Spain, Italy (as Abriff®)

16

Page 17: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Country-specific marketing

17

Page 18: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

fluticasone and formoterol…

18

Page 19: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

…together at last

19

Page 20: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

flutiform® - H1 sales growth

20

€m

Source: Internal calculations using IMS Health data, Q2 2014, based on sales to pharmacies excluding Cyprus , Iceland and Belgium Hospitals

“We are delighted with the successful launch of flutiform® for the treatment of bronchial asthma. In Europe, sales are growing in line with our expectations and we look forward to the further roll-out of flutiform ® and its continued growth.” Antony Mattessich, Regional Director, Europe, Mundipharma, 20th August 2014

Page 21: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Mundipharma making substantial investment in the flutiform® franchise

flutiform® - major line extension progress

21

European paediatric asthma indication Phase III endpoints met, filing being

prepared

COPD (Europe) >1,500 patients, recruitment

commenced Sept 2013

Novel breath-actuated version flutiform® canister coupled with

Mundipharma’s breath-actuated device

China / Asia Pacific - COPD Clinical trials commenced 2014

China - Asthma Clinical trials being planned

Page 22: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Dry powder inhalation formulation technology licensed to GSK

• Potential royalties of up to £9m per annum for life of patents (earliest expiry

in U.S., Europe, Japan, Nov 2019) related to Breo® / Relvar® Ellipta®,

Anoro® Ellipta® and Incruse®

• Breo® / Relvar® Ellipta® approved in over 50 markets

− Launched in 30 markets including U.S. (for COPD only), Japan (asthma only),

UK, Germany, Brazil.

− Filed in U.S. for asthma June 2014 (PDUFA anticipated Q2 2015)

• Anoro® Ellipta® approved in 42 markets

− Launched in 9 including U.S., Canada, UK, Germany & Japan

• Incruse® approved in U.S. and Europe

− Launch anticipated by end of 2014

GSK products - up to £9m per annum royalties

22

Source: Theravance Q3 Financial Results, 30 October 2014

Page 23: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Product of Skyepharma’s former Injectable Business, now Pacira Pharmaceuticals,

Inc.†

− Indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia

− Skyepharma eligible for 3% of net sales* in U.S., Japan and major EU countries until

patents expire (September 2018) plus sales-related* milestones (see table)

• SNDA under review for nerve block indication (PDUFA action date: 5 March 2015)

• Pacira in “active discussions” and “look forward to resolving [FDA] concerns” raised in

a warning letter, received in September 2014, related to certain promotional material

23

EXPAREL® - growing revenues

† NASDAQ:PCRX market cap $3.21bn at 13 November 2014

* On a cash-received basis

Q3 sales $50.2m, up 12% on Q2; up 151% on Q2 2013 EXPAREL® annual worldwide net sales*

Skyepharma milestone

$100m $8m rec’d 2014

$250m $8m

$500m $32m

First major EU country sale

$4m

Page 24: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Oral products incorporating Skyepharma technology achieved in-market

sales of approx. U.S.$3bn in past 5 years

• Proven expertise and technologies for oral drug delivery

• Excellent industry reputation and connections built up over many years

• Oral drug delivery solutions and technologies used in 10 marketed products

Oral drug delivery experts

24

Technology Delivery solution Product examples

Geomatrix™ Family of 8 controlled

release mechanisms

Paxil CR®, Requip® Once-a-day, ZYFLO CR,

Coruno, Sular®,

Diclofenac-ratiopharm-uno, Madopar DR

Geoclock™ Customised release

delay for chronotherapy LODOTRA® / RAYOS®, SKP-1041, SKP-1052

“Parachute” technology Gastroretention Xatral® OD / Uroxatral®

Particle engineering Improved bioavailability Triglide®

Page 25: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Focus on classic drug delivery model – early licensing, with partner funding

development

• Refresh portfolio of oral drug delivery technologies, targeting unmet delivery

needs

− 3 novel oral drug delivery platform technologies in development, including

Soctec™ a gastro-retentive platform

− Seek out potential infill acquisitions/in-licensing of other oral drug delivery

technologies

• SKP-1052 (nocturnal hypoglycaemia) – seek funding partner(s) for further

development

Oral strategy

25

Page 26: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Owned by Skyepharma, leased to Aenova* from July 2011 to June 2016

− 2014 rental €2.0m (£1.6m at current rates) per annum

− Facility has current good manufacturing practice (cGMP) status, approved by the

EMA (Europe), FDA (U.S.), Anvisa (Brazil) and KFDA (South Korea)

− Capabilities include multi-layer tablets and DPI filling

• Aenova currently responsible for management and financial performance

− Negotiations in progress with works council on site restructuring plan

− If implemented, some of the costs of restructuring may be borne by Skyepharma

• In anticipation of return to Skyepharma in July 2016

− Seeking opportunities to add additional work into the facility

− Investing to improve operating efficiency and capabilities

Lyon manufacturing facility update

26

*Aenova is a contract manufacturing organisation

Page 27: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Planned mix of self-funded and customer-funded development

− Reduces risk whilst driving next phase of growth

− Leverages Skyepharma capabilities

• Main focus for development

− Inhalation product development to proof of concept before out-licensing

(e.g. SKP-2075)

− Development of novel oral drug delivery platform technologies

− Collaborative developments – oral and inhalation

27

Investing in R&D to drive future growth

£m FY 2013

(Restated) H1 2014

Guidance

2014 (F)

Guidance

2015 onwards

Contract R&D revenue 10.3 3.5

R&D costs (10.8) (5.3)

Net investment (0.5) (1.8) £3 to £6m Consider increase in future

years as net income rises

Page 28: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

28

Pipeline product candidates (disclosed)

Inhalation Product Primary

Indication Feasibility

Phase

I

Phase

II

Phase

III Filed Licensee / Partner

flutiform (ROW) Asthma o o Mundipharma

flutiform (LATAM) Asthma o Sanofi

flutiform (Europe) COPD Mundipharma

flutiform (U.S.) Asthma † Available

flutiform (Canada) Asthma Available

SKP-2075 COPD Available

Various Asthma/COPD o o

Janssen Biotech (RespiVert)

Mundipharma has filed marketing authorisation applications in some Rest of World markets

† Complete response letter received January 2010 and additional studies are required

o Partial

Oral Product Primary

Indication Feasibility

Phase

I

Phase

II

Phase

III Filed Licensee / Partner

SKP-1041 Sleep

maintenance Somnus

SKP-1052 Nocturnal

hypoglycaemia Available

Page 29: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• COPD

− Affects an estimated 210m people worldwide; a major cause of death

− Market size: $8.3bn in U.S., Japan and top 5 EU countries

− Unmet medical need – inflammation not sufficiently treated with LABA/ICS, LABA,

LAMA or LABA/LAMA

• Pulmagen discovered that inhaling an ultra-low dose of theophylline together

with an inhaled corticosteroid (ICS) reactivates ICS as anti-inflammatory agent

for COPD

• Skyepharma acquired all global rights and IP including granted patents in

Europe, Japan and U.S.

• Skyepharma commenced development of lead product candidate, SKP-2075:

− Plan to conduct a phase II study sized to produce statistically significant data, then

partner for further development

− Investment estimated at c. £14m between 2014 and 2017

− Funded out of Skyepharma’s ongoing cash generation

− Uses known molecules in a novel way – lower risk than new chemical entities (NCE’s)

SKP-2075: novel therapy

29

Page 30: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

SKP-2075 potential therapy platform

30

Anti-inflammatory

(e.g. SKP-2075)

LABA, LAMA, LAMA/LABA

Long acting bronchodilators

LABA, LAMA, LAMA/LABA

ICS/LABA

combinations

possibly + LAMA

+

Current and currently emerging

Potential future

LABA, LAMA, LAMA/LABA

combinations with

anti-inflammatory

(e.g. SKP-2075)

Page 31: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

• Nocturnal hypoglycaemia is a side-effect of insulin treatment for patients with

diabetes mellitus

− Frequently unrecognised and often leads to poor metabolic control

− Up to 15% of diabetics with nocturnal hypoglycaemia require intensive assistance

− There are no drugs that address this condition

• SKP-1052 uses side effect of a known drug, with delayed release Geoclock™

technology

− Initial clinical study supportive of concept

− Patented concept

− Regulatory advice supportive

• Seeking partnering/funding for further development

SKP-1052: targeting nocturnal hypoglycaemia

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• Need for gastro-retention oral drug delivery platform

− Estimated that c.40% of compounds have poor absorption in the lower gastro-

intestinal (GI) tract - covers all therapeutic areas

− Absorption window for many drugs is limited to the upper GI tract

− The challenge is to retain the drug for as long as possible in the upper GI tract

• Skyepharma’s new concept – Soctec™ is designed to meet this challenge

− Initial technical feasibility completed, patent application filed

− Preliminary study in healthy volunteers carried out, initial data is supportive of the

concept

• Plan to carry out further work to optimise the technology and produce

additional data

• Seeking partners to work on potential applications with active ingredients

New oral technology: Soctec™

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• Easy to swallow capsule

• Floats immediately when it enters the

stomach

• Active ingredient released for:

− Delivery to an absorption window, or

− Local action in the stomach

• Potential release characteristics:

− Sustained release

− Multiple pulsed release

• Potential for both poorly and highly

soluble drugs

Soctec - Self Orienting Capsule Technology

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Theoretical scheme

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Group strategy and summary

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Page 35: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Existing projects and royalty streams • Continue to maximise value of existing agreements

• Funded R&D, milestones and long-term royalties

Product supply • Run supply chain for strategic royalty-generating products

• Long-term source of recurring profitable revenues

Inhalation • Strengthen pipeline by developing products to value inflection points for outlicensing

• Mix of in-house innovation, collaborations, in-licensing, acquisitions

• Broaden technologies to support long-term royalty generation

Oral • Strengthen technology base via in-house innovation and in-licensing/small acquisitions

• Target unmet needs and hard to copy / genericise concepts

• SKP-1052 (nocturnal hypoglycaemia) – seek funding partner(s) for further development

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Group strategy

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• flutiform®

− Launch of Abriff ® in Italy

− Launch in Spain (€2m milestone receivable)

− Launch of 120-puff version in Japan

− Submission of paediatric MAA in Europe

− Partnering effort renewed for U.S. market

− Progress with COPD indication and breath-actuated version

− EXPAREL® – progress on sales and $8m milestone payable on $250m sales

• Inhalation – progress with SKP-2075

• Oral - progress with Soctec™; SKP-1052; oral drug delivery projects

• Additional licensing/development opportunities

• Further reduction of debt

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Potential news flow 2014/15

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• Growing momentum from rejuvenated product portfolio

• Robust financial platform underpins capacity to invest in product and

technology development and corporate opportunities

• Delivering strategy to invest in next phase of growth

− Acquisition of innovative inhaled therapy platform

− New oral technology platforms in development

• Committed to continue building shareholder value

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Summary

London Stock Exchange, as at market close 13 November 2014

Page 38: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Peter Grant

Chief Executive Officer

Andrew Derodra

Chief Financial Officer

Jonathan Birt

Investor Relations

Contact information

Head Office:

Skyepharma PLC

46-48 Grosvenor Gardens, London, SW1W 0EB, United Kingdom

Tel: (+44) 20 7881 0524

[email protected]

LSE:SKP

www.skyepharma.com

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Page 39: Peter Grant (CEO) Jefferies Conference: 19/20 November 2014 · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 orm ® Australia s UK Switzerland Germany Italy Netherlands Cyprus Sweden Norway

Appendices

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Locations

R&D Muttenz, Switzerland

Leased to Aenova: Manufacturing

Lyon, France

Corporate Headquarters London, UK

FTEs: 78* (Aenova FTEs: approx. 100) FTEs: 11*

* as at 30 June 2014

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The Board

Frank Condella Non-Executive Chairman

• Joined 2006

• CEO 2006 - 2008

• President/CEO Columbia Labs

• Previous Exec: IVAX; Faulding; Roche;

Lederle

Jean-Charles Tschudin Non-Executive Director

Senior Independent Director

Chairman Nomination Committee

• Joined 2007

• Non-Exec Director Sinclair IS Pharma

• Previous Exec: Astellas; Cardinal

Health; J&J; Schering-Plough

Thomas Werner Non-Executive Director

Chairman Remuneration Committee

• Joined 2009

• NED: Chairman 4SC; Board member:

Basilea; Blackfield; BSN; SuppreMol

• Previous Exec: GSK; BMS

Peter Grant Chief Executive Officer

• Joined 2006 as CFO

• Appointed CEO 2012

• Previous Exec: Voice Commerce;

Eurodis Electron; WorldPay;

Molins; General Electric; KPMG

John Murphy General Counsel,

Company Secretary

• Joined 2006

• Previous Exec: Medeva;

Celltech; Pharmagene

Andrew Derodra Chief Financial Officer

• Joined November 2013

• Previous Exec: Tate & Lyle;

SABMiller; Diageo; British Airways;

Reed Elsevier

No

n-E

xecu

tive

Ex

ecu

tive

C

o. S

ec

John Biles Non-Executive Director

Chairman Audit Committee

• Joined March 2014

• NED: Bodycote; HellermannTyton;

Sutton & E Surrey Water

• Previous Exec: FKI; Chubb Security;

Racal Electronics; PwC

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Fund Manager % Holding*

HBM Healthcare Investments 24.39%

Aviva Investors 7.51%

Legal & General Investment Management 5.96%

Standard Life 5.18%

BlackRock 5.01%

D E Shaw (held via contracts for difference) 4.90%

River & Mercantile Asset Management 4.51%

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Major Investors (disclosed)

* As publicly disclosed at 11 November 2014