An Expert Drug Delivery Company Skyepharma PLC Peter Grant, CEO
An Expert Drug Delivery Company
2 June 2014
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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.
2
Disclaimer
3
Business summary
• Proven scientific expertise + validated proprietary technologies
• Track record of diverse and complex inhalation and oral pharmaceutical product development
• Independent partner for companies worldwide
Drug delivery experts
with global reach
• Long-term royalty and supply agreements
• Include 16 approved products
• Momentum from multiple recent product approvals
Recurring revenues and strong growth
potential
• flutiform® - up to €45m+ of further* milestones and royalties from Europe, Japan, RoW, plus product supply
• GSK’s Relvar®/Breo®, Anoro® - royalties up to £9m a year
• Pacira’s EXPAREL® - up to $52m of further milestones plus 3% share of relevant net sales
New revenue streams
Listed on LSE (SKP.L), HQ: London, UK, R&D: Muttenz, Switzerland * Post 31 December 2013
• 2013 revenues and operating profits ahead of market expectations
• Substantial progress with flutiform®, now approved in 29 countries
• Significant revenue-generating potential from other recent approvals
• Strong share price momentum – market cap ~ $437m*
4
Operating highlights
* As at 29 May 2014
April 2014 Capital Raise
• £112m capital raise used to pay off bond debt and increase capacity to
strengthen the product pipeline
• Net debt at 30 April 2014 reduced to £4.8m, significantly lower finance costs
5
Financial highlights 2013
* Comparative amounts for 2012 are pre-exceptional and for continuing operations
2013 % Change 2012
£m(Increase/
Decrease)£m
Sales 62.6 25% 49.9
Operating profit* 13.6 8% 12.6
EBITDA* 17.9 15% 15.6
Net finance costs* 14.6 21% 12.1
Cash 16.5 1% 16.4
Net Debt (IFRS) 84.2 4% 80.7
Global potential from 8 recent product approvals
flutiform®
23 European Countries
RAYOS®
U.S.
EXPAREL®
U.S.
Breo® Ellipta®
U.S.
flutiform®
Australia
flutiform®
RoW - Israel, HK, S Korea
flutiform®
Japan
Paxil CR™
Japan
Requip® Once-a-day
Japan
Relvar® Ellipta®
Japan
Relvar® Ellipta®
Europe
Anoro™ Ellipta ®
U.S.
NASDAQ:PCRX NASDAQ:HZNP LSE:GSK TOKYO:4569
7
Incruse®
Europe
Incruse® Ellipta™
U.S.
Anoro® Ellipta®
Europe
flutiform®
Argentina
Key
Inhalation
Oral
Other
Inhalation Product 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® - U.S., Europe COPD (U.S., Canada, Europe) GlaxoSmithKline
†Incruse® - U.S., Europe COPD (U.S.,Canada & Europe) GlaxoSmithKline
Revenues from 16 approved products
Oral Product 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
Other Products Primary Indication Licensee / Partner
Solaraze® Actinic keratosis Sandoz / Almirall
*EXPAREL® Pain management Pacira Pharmaceuticals
8
† Technology license, product not developed by Skyepharma *A product of Skyepharma’s former Injectable Business now Pacira Pharmaceuticals
Key product lifecycles – significant potential
Sales
Time
Approved Introduction Growth Maturity Decline
Anoro™ (Eur)
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®
9
Lodotra® (RoW)
Anoro™ Ellipta ® (U.S.)
flutiform® (South Korea)
Relvar®Ellipta® (UK, Germany)
flutiform® (Argentina)
Proven oral platform
Oral drug delivery solutions and technologies used in 10 marketed products
Oral products incorporating Skyepharma technology achieved in-market sales of
approx. U.S.$3bn in past 5 years
Developing new drug delivery technologies to serve unmet needs
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 drug delivery with
pre-determined release delay LODOTRA® / RAYOS®, SKP-1041, SKP-1052
Gastroretention “Parachute” technology Xatral® OD / Uroxatral®
Improved
bioavailability
Several particle engineering
technologies Triglide®
11
Inhalation platform covering pMDI and DPI
• Global Asthma and COPD market U.S.$29.4bn*
• Broad range of R&D and clinical regulatory capabilities from pre-clinical
development through to post-approval supply and product support
• Proven formulation and device expertise
− Pressurised Metered Dose Inhaler (“pMDI”) approvals in more than 50
countries
− Dry Powder Inhaler (“DPI”) approvals in 31 countries including the U.S.
• pMDI flutiform®, conceived and developed by Skyepharma, already
approved in 29 countries
• DPI formulation, analytical and process development of new classes of
molecules for COPD and severe asthma for Janssen Biotech
(RespiVert)
* 2012 Market 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% 12
flutiform - novel asthma treatment
flutiform® combines most commonly prescribed ICS† with fast onset LABA††
Product Developer ICS LABA Inhaler
flutiform® Skyepharma* fluticasone formoterol pMDI
Seretide/Advair♯ GSK fluticasone salmeterol DPI/pMDI
Symbicort♯ AZ budesonide formoterol DPI/pMDI
Foster/Fostair Chiesi beclametasone formoterol pMDI/DPI
Dulera (U.S. only) Merck & Co mometasone formoterol MDI
* and licensees
† Inhaled corticosteroid (anti-inflammatory) † † Long acting beta2 agonist (bronchodilator)
♯ plus generics in certain markets 13
As needed rapid-acting β2 agonist
Treatment guidelines for asthma
Source: Global Strategy for Asthma Management and Prevention (updated 2013) – www.ginasthma.org http://www.ginasthma.org/uploads/users/files/GINA_Pocket2013_May15.pdf
Controller options
Low-dose inhaled ICS
Leukotriene
modifier
Low-dose ICS plus LABA
Medium-or high
dose ICS
Low-dose ICS plus leukotriene modifier
Low-dose ICS plus sustained release
theophylline
Medium-or high dose ICS plus LABA
Leukotriene modifier
Sustained release theophylline
Oral glucocorticosteroid
(lowest dose)
Anti-IgE treatment
Step 1
Select one Select one To Step 3 treatment select one or more
To Step 4 treatment add either
Step 2 Step 3 Step 4 Step 5
flutiform ® market
14
flutiform® - key partnerships Partner
ICS/LABA combination
market size*
Strengths Potential Future Revenues
Post 31 December 2013
Mundipharma Europe, rest of world
outside Japan and the
Americas
EU & RoW (excl Americas
& Japan): U.S.$6.4bn*
Mundipharma network: 2,400
employees in 33 countries in Europe,
growing presence in RoW.
Strongly growing with >20% year-on-
year growth rate‡ in each of Italy,
Spain and France
Royalties: 10%+ of net sales (subject to
certain caps and recoveries)
Sales milestones: Up to €40m (subject to
certain recoveries)
Launch milestones: France €3m†, Spain €2m
Product supply
Kyorin Japan
U.S.$0.7bn*
A leading respiratory company in
Japan
Products include Kipres® (Merck & Co:
Singulair®); Mucodyne®; Ketas®
Royalties: high-mid single digit % of net
sales
Product supply
Sanofi Latin America
U.S.$0.3bn*
Major pharmaceutical company in
Latin America
Direct presence in 18 countries in
Latin America
Royalties: high-single digit % of net sales
Milestones: several million U.S. dollars
(approval and sales)
Components’ supply
* Source:Internal calculations based on IMS Health data, Q4 2013 † Milestone received Q1 2014
15 ‡ Mundipharma analysis based on IMS Health data (April 2013)
flutiform® - progress and potential
Market Progress Future Potential
Europe Marketing authorised for asthma in 23
European countries
Launched in 17 European countries:
Germany, UK, Italy, France, Belgium, Cyprus,
the Czech Republic, Denmark, Finland,
Iceland, Ireland, Luxembourg, Netherlands,
Norway, Slovakia, Sweden and Switzerland
Launch in remaining countries expected when
pricing has been agreed
International clinical trials of flutiform® for
potential treatment of COPD initiated by
Mundipharma, September 2013 (1,530
patients)
Paediatric study report being prepared ready
for filing in Europe
Japan
Marketing authorised for asthma in
September 2013
14-day product launched November 2013
30-day product to be launched late 2014
Rest of the World
Marketing authorised for asthma in 5
countries.
Launched in South Korea, Australia, Hong
Kong, Israel
Filed in multiple territories in AsiaPac, Middle
East and Africa by Mundipharma
Filing initiated in Latin America by Sanofi,
marketing authorised in Argentina
* Source: Internal calculations using IMS Health data, Q4 2013, based on sales to pharmacies excluding sales in Cyprus
16
flutiform® sales growth
17
€m
Source: Internal calculations using IMS Health data, Q4 2013, based on sales to pharmacies excluding Cyprus
“We are delighted with the successful launch of flutiform® for the treatment of bronchial asthma. 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, March 2014
GSK licences worth up to £9m annually
• A dry powder inhalation formulation technology licensed to GSK
• Skyepharma entitled to low single-digit royalty on net sales of all products
incorporating the technology - capped at maximum £3m annually per
chemical entity
• Potential of up to £9m annually (3 chemical entities) for life of patents
(granted patent earliest expiry in U.S., Europe, Japan – Nov 2019)
18
Product Type Actives US Europe Japan
Breo®/Relvar® Ellipta® ICS/LABAFluticasone furoate/
vilanterol
Launched (COPD,
Oct 2013)
Launched (COPD &
Asthma, from Jan 2014)
Launched (Asthma,
Dec 2013)
Anoro™ Ellipta® LAMA/LABAUmeclidinium bromide/
vilanterol
Launched (COPD,
April 2014)
Approved (COPD,
May 2014)Filed (COPD)
Incruse® LAMA Umeclidinium bromideApproved (COPD,
April 2014)
Approved (COPD,
April 2014)
Region
• EXPAREL® developed by Skyepharma’s former Injectable Business,
now Pacira Pharmaceuticals†
− Long-acting bupivacaine for post-surgical pain management
− Studies show analgesia delivered for up to 72 hours post-surgery
− sNDA filed for nerve block indication in May 2014
EXPAREL® - milestones plus 3% share of net sales
* On a cash-received basis † NASDAQ:PCRX Market Cap $2.8bn at 29 May 2014
• Launched in U.S. April 2012; 2013 sales
$76.2m; Q1 2014 $34.4m
• Skyepharma eligible for 3% of net sales* in
U.S., Japan and major European countries
until patents expire (anticipated Nov 2018)
• Further contingent milestones of up to $52m
• $8m when annual net sales reach $100m
• $8m when annual net sales reach $250m
• $32m when annual net sales reach $500m
• $4m on launch in major EU country
19
0
5
10
15
20
25
30
35
40
Q2 '12 Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14
Quarterly Sales, $ Millions
Pipeline product candidates (disclosed)
Oral Product Primary Indication Feasibility Phase
I
Phase
II
Phase
III Filed Licensee / Partner
SKP-1041 Sleep
maintenance Somnus
SKP-1052 Nocturnal
hypoglycaemia Available
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
Anoro (Japan) COPD GlaxoSmithKline
flutiform (U.S.) Asthma † Available
flutiform (Canada) Asthma 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 20
• Growing momentum from recent launches and approvals
• Transactions significantly reduce debt and enhance future earnings
• Increased capacity to invest in product and technology development and
corporate opportunities
• Strategy is to:
− Maximise revenue from approved products and pipeline product candidates
− Strengthen product pipeline by developing new products and technologies
− The development opportunities may be from own development, collaborations
with partners, targeted in-licensing or acquisition
21
Summary
Peter Grant
Chief Executive Officer
Andrew Derodra
Chief Financial Officer
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 22
An Expert Drug Delivery Company
Financials Andrew Derodra, CFO
An Expert Drug Delivery Company
2 June 2014
Capital Raise
• Raised c. £112.1m at 191 pence per share (10-day mid-market average to 25 March 2014)
Use of Proceeds
• Repaid Bonds in full for £95.6m, at £25.2m discount
• c. £8.4m of additional funding for general corporate purposes
Rationale
• Significantly reduced gearing and cost of debt
• Eliminated £120.8m of future payments to bondholders (net saving £25.2m)
• Increased capacity to invest in product and technology development and corporate
opportunities
24
April 2014 Capital Transactions
£m 2013 Pro-forma* 2013
Revenue 62.6 62.6
Gross profit 29.4 29.4
Operating costs (15.8) (15.8)
Operating profit 13.6 13.6
Finance costs 14.6 4.6
(Loss)/profit before tax before expectionals
(1.0) 9.0
Pro-forma P&L
All amounts are shown in accordance with IFRS
25
* As if Transactions had occurred on 31 December 2012
£m As at 31 Dec 2013
Firm Placing, Placing and Open
Offer
Repayment of bonds
Pro forma as at 31 Dec 2013
2024 bonds 66.8 - (66.8) -
Property Mortgage 7.3 - 7.3
CRC Finance 24.5 - 24.5
Other Borrowings 2.1 - 2.1
Total Debt 100.7 - (66.8) 33.9
Less cash and cash equivalents
(16.5) (104.4)† 96.0* (24.9)
Net Debt 84.2 (104.4) † 29.2 9.0
Pro-forma net debt
All amounts are shown in accordance with IFRS
26
† This figure assumes a Capital Raise of £112m less transaction costs of £7.6m
* This figure includes bond repayment of £95.6m plus related costs of £0.4m
• Revenues up 25%
• Gross profit up 5%
• Operating profit* up 8%
• EBITDA up 15%
2013 results
† Re-stated * Pre-exceptional
27
2013
£m
2012†
£m
Continuing operations
Revenue 62.6 49.9
Cost of sales (33.2) (21.9)
Gross profit 29.4 28.0
Selling, marketing and distribution (1.5) (1.5)
Research and development (10.8) (11.9)
Corporate costs (2.7) (2.0)
Amortisation (0.9) (0.7)
Share-based payment charge (0.3)
Other income 0.4 0.7
Operating profit* 13.6 12.6
EBITDA* 17.9 15.6
Profit/ (loss) for the period 0.8 (4.4)
EPS (pence) 1.8 (14.9)
Diluted EPS (pence) 1.7 (14.9)
Revenues*: substantial growth
• Product supply £28.1m
− Increased flutiform® supply reflecting launches
• Royalties £16.8m
− Recent launches - flutiform® and others
− Reduction in Solaraze® due to generic competition
• Contract development £10.3m
− Continued development for Janssen Biotech
− Further flutiform®-related development for Kyorin
and Mundipharma
• Milestones £5.7m
− 2013 launch for flutiform® - Italy and Japan
• Other revenues £1.7m
− Lyon rent
− EXPAREL® share of net sales
0.8
1.7
28 * Revenues from continuing operations
• Gross R&D costs £10.8m - largely
recharged to partners
− Increase in contract development
services provided for Janssen
Biotech
− Completion of process validation of
56-puff version of flutiform® for Japan
− flutiform® lifecycle development with
Mundipharma
• Guidance: £3m to £6m net
investment in 2014
Investment in R&D 2013 2012
£m £m
Contract R&D revenue 10.3 9.5
R&D costs (10.8) (11.9)
Net investment (0.5) (2.4)
29
• As expected, progression towards positive gross profit driven by:
− Increased volumes
− Supplier price breaks
• Substantial growth anticipated as in-market sales increase
• Supply chain is anticipated to move into positive gross profit during 2014
flutiform® supply chain – substantial growth
30
2013 2012
£m £m
Supply revenue 20.6 4.8
Cost of sales (23.4) (10.4)
Gross profit/(loss) (2.8) (5.6)
• Operating cash inflow £14.4m
− £5m Pulmicort settlement in 2012
• Capex
− Primarily related to flutiform®
supply chain
• Interest and scheduled debt
repayments £10.7m
− Capital repayments mainly Paul
Capital Note
− Interest payments primarily CRC
• Cash at 31 December 2013 £16.5m
(31 December 2012 - £16.4m)
Cash flow £m
Cash Flows 2013 2012
Operating cash flow 14.4 18.5
Discontinued operations - 6.2
Capex (3.5) (1.1)
Net interest (3.6) (7.3)
Debt repaid (7.1) (12.7)
Refinancing cost - (2.5)
Exchange - (0.1)
Other (0.1) 0.2
Total cash flow 0.1 1.2
Cash at 31 December 16.5 16.4
31
• Board expects further substantial growth in revenues in 2014:
− €3m (£2.5m) received on launch of flutiform® in France plus potential milestone U.S.$8m
(£4.9m) related to sales of EXPAREL®
− Growth of royalties from recently launched products likely to offset decline in royalties from
products which are off patent or facing generic competition
− Full years’ rental income for Lyon Facility and growing EXPAREL® sales
− Product supply growing to support increasing market penetration of flutiform® - anticipate
moving into positive gross profit during 2014
− Increased demand for contract development work (recruitment in progress)
• Operating costs to increase to support the customer-funded work and the Group’s
own expenditure on developing technologies and products
• Guidance: net expenditure in 2014 on R&D between £3m and £6m. Board will
consider uplifting this in future years as the Group’s net income rises, subject to
suitable opportunities being available
• Exceptional charge related to paying off the bonds estimated at £25.5m*
Outlook (31 March 2014)
32 * Being the difference between the expected book value of the Bonds at 30 April 2014 and cost of redemption
Skyepharma’s business model
Expertise
Track record Resources Networks
Capabilities Technologies
Patents
Know-how
Products
Partner-initiated Skyepharma-initiated
Licence
fees
Royalties
Milestones
Contract research &
development revenues
Supply income
Revenues
34
Recent launches
2012 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
flu
tifo
rm®
O
the
rs
UK Germany
Netherlands Cyprus
Sweden Norway
Denmark Iceland 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.)
35
France
Israel
Anoro™ Ellipta® (U.S.)
Relvar®Ellipta® (UK, Germany)
Locations
R&D Muttenz, Switzerland
Leased to Aenova: Manufacturing
Lyon, France
Corporate Headquarters London, UK
FTEs: 69* (Aenova FTEs: approx. 100) FTEs: 11*
* as at 31 December 2013 36
• Pharmaceutical manufacturing site (22,000m² operational buildings), which
makes a number of the Group’s oral products
− Plant approved according to FDA (U.S.); EMA (EU); ANVISA (Brazil) and KFDA
(South Korea)
− Approximately 100 employees
• Entire operation was leased to Aenova in July 2011 for up to 5 years
− Aenova bears operating risks and profits and losses during lease period
− Aenova sought to terminate in July 2013, but expert determination resolved in
Skyepharma’s favour
− Lease renewed December 2013 at a rent of €2m per annum to June 2016
− On expiry in June 2016 the operations come back to Skyepharma
• Process underway to see if there is a third party interested in taking over the
facility
Lyon manufacturing facility
37
The Board Frank Condella Non-Executive Chairman
• Joined 2006
• CEO 2006 - 2008
• President/CEO Columbia Labs
• NED: Prosonix
• 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
38
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