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TRANSCRIPT
Investor Presentation Peter Grant (CEO)
Jefferies Conference: 19/20 November 2014
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
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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
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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
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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.
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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
• 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
Proven credibility with multiple partners
5
• 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
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
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
• 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
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
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
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
• 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
• 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
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• 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
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
Country-specific marketing
17
fluticasone and formoterol…
18
…together at last
19
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
• 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
• 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
• 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
• 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®
• 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
• 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
• 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
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
• 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
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)
• 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
31
• 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™
32
• 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
33
Theoretical scheme
Group strategy and summary
34
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
35
Group strategy
• 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
36
Potential news flow 2014/15
• 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
37
Summary
London Stock Exchange, as at market close 13 November 2014
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
LSE:SKP
www.skyepharma.com
38
Appendices
39
40
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
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
41
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%
42
Major Investors (disclosed)
* As publicly disclosed at 11 November 2014