investor meeting - ergomed · 7/4/2017 · continuing to out-pace the market with global solutions...
TRANSCRIPT
www.ergomedplc.comwww.ergomedplc.com
TRANSFORMING DRUG DEVELOPMENT
1
INVESTOR MEETING
Guildford
4 July 2017
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
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AGENDA
| 3
1. Introductions Miroslav Reljanović, MD
2. Ergomed Overview Miroslav Reljanović, MD
3. PrimeVigilance Jan Petracek, MD
4. BREAK
5. PrimeVigilance CONTD. Jan Petracek, MD
6. Co-development Andrew Mackie
7. Haemostatix Andrew Mackie
8. Summary Financials Stephen Stamp
9. LUNCH
10. Futura Medical
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
DAN WENG M.D.
| 4
EDUCATION:
Tongji Medical University (MD)
Leeds University (MA, Health Planning, Policy and Management)
Strathclyde University (PhD, Bio-engineering)
Psychology Institute of Sino-Academy of Sciences (Diploma, Human Psychology)
PROFESSIONAL:
85-88 Ministry of Health, PRC
91-93 Massachusetts General, Harvard Medical School
93-94 University of California
94-96 Institute of Pharmaceutics, Beijing
97-99 Quintiles, PRC
99-02 PharmaNet
02-09 ICON Clinical Research
10-11 MedPace
11-17 EPS Holding Inc.
Jul 17 CEO of Ergomed PLC
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Building a profitable services business
combined with
sustainable product development
for significant shareholder value.
OUR MISSION
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com | 6
Organic Growth combined with targeted acquisitions
20 YEARS OF GROWTH AND PROFITABILITY
1997
Ergomed CRO
formed
2006
First
Co-development deal
2008
PrimeVigilance
formed
2014
Ergomed Plc
IPO
Haemostatix
acquired
2015 2016
O+P, GASD
acquired
Sound Opinion
acquired
2017
PharmInvent
acquired
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Balanced downside protection and upside potential
HYBRID BUSINESS MODEL
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PROFITABLE, FAST GROWING,
PREDICTABLE
BREAK-OUT UPSIDE
POTENTIAL
SERVICES PRODUCTS
Global platform
Full range of services
EBITDA accretive acquisition opportunities
Diversified portfolio
Multiple shots on goal
Managed risk approach
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
All clinical phases and post-approval
SERVICES – COMPREHENSIVE RANGE
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SERVICES
CRO ServicesPharmacovigilance /
Medical Information
Phases I – III Phase IV Drug SafetyMedical
Information
Project management
Patient recruitment
Medical writing
Data management / statistics
Regulatory affairs
Quality assurance
Adverse event case processing
Medical safety review / reports
Consulting / audit
Medical information
QPPV / Qualified person
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Continuing to out-pace the market with global solutions
SERVICES – FAST-GROWING
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* Source: Transparency Market Research
**Source: Global Data
£39.2m
2016 Revenue
£13.4m
£25.8m
+18% GROWTH
Clinical Research
ServicesDrug Safety &
Medical Information+63% GROWTH
CRO Services
Industry Growth
+7.5%**
PV Industry Growth
+17%*
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Efficient management and control of complex trial protocols
ERGOMED CRO SERVICES: KEY DIFFERENTIATORS
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ALL CROs
STUDY PHYSICIAN
TEAM
SITE MANAGEMENT
TEAM
PROJECT MANAGER
STUDY MONITOR(S)
HOSPITAL
INVESTIGATOR
NURSES/ SITE STAFF
• Peer-to-peer support
• Develops best practice across treating centres
• Provides expertise for particular study designs
• Enhanced recruitment
• Increased retention
• More evaluable patients
www.ergomedplc.comwww.ergomedplc.com
RESULTS VALIDATE OUR STRATEGY
11
UNIQUE SITE MANAGEMENT MODEL
ENHANCED RECRUITMENT
INCREASED RETENTION
600
400
200
02
month4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
762 patients recruited 5 months prior
to scheduled end of recruitment
571 patients included through
Site Management Model
Ergomed start Ergomed12 sites
CRO ´X´15 sites
Enrolled
Withdrawn
60
40
20
0
MS Study 1
Patients
120
80
40
0
MS Study 2
Patients
Drop out rate:
Ergomed 3.4%
Global 8.9%
Drop out rate:
Ergomed 4.1%
Global 6.0%
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
20 year track record of performance and execution
PROFITABLE SERVICES – GLOBAL PLATFORM
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65,000+adverse event
cases p.a.
£39m+revenue
50,000+patients studied
Ergomed Offices Longstanding Partners
500+employees
300+studies
150+active clients
Clinical trials
in 56 countries
Supporting
products in
100+countries
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
QUESTIONS?
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www.ergomedplc.comwww.ergomedplc.com
JAN PETRACEK M.D.
CHIEF EXECUTIVE OFFICER, PRIMEVIGILANCE
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
EMERGING PATIENT SAFETY SCIENCE HAS CHANGED PHARMACOVIGILANCE
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ORIGINS OF MODERN PHARMACOVIGILANCE
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Withdrawal of cerivastatin
(August 2001)
HMA WG G10 InitiativeEMEA
RM strategy
FDA
RM strategy
European Risk
Management Strategy
New legislationStrengthening
EudraVigilanceENCePPICH E2E
CHMP Guideline on RMS
In force since November 2005
Withdrawal of rofecoxib
(September 2004)
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EU GOOD PHARMACOVIGILANCE PRACTICE (SINCE JUNE 2012)
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PHARMACOVIGILANCE IN A LIFECYCLE OF A MEDICINAL PRODUCT
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Authorisation
Market Surveillance
Research Development
New
effects
Post-authorisation
lessons
Withdrawal
Reference
Information
Updates
Pre-authorisation PV
Post-authorisation PV
Medical Information
Audits
Risk Management
Plan
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
ESSENTIAL PHARMACOVIGILANCE PROCESSALL COVERED BY PRIMEVIGILANCE
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COMPREHENSIVE PHARMACOVIGILANCE SYSTEM
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Extremely sensitive and regulated area
• High barrier to changes => stable long term contracts
• Long term relationship => stable cashflow
• Highly demanding 24/7 job and quickly changing environment => limited
competition
• Restructuring of Pharma and Biotech => growing outsourcing approach
• Increasingly demanding => growing market – both existing and new
clients, as well as new territories with stronger regulation
WHY IS PHARMACOVIGILANCE COMMERCIALLY ATTRACTIVE?
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Year 2015 $2.2 BnForecast for 2022 $5.9 BnCAGR (2016 – 2022) 15.8 %
GLOBAL PHARMACOVIGILANCE MARKET GROWTH
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Forecast for 2022 over $8.2 Bn
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Established 2008, Pharmacovigilance and Medical Information Specialists
PRIMEVIGILANCE
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High customer retention leads to strong
backlog of contracts
Queens Award for Enterprise in 2014
Offices in 6 countries (Guildford, Zagreb, Prague,
Waltham, Belgrade and Frankfurt)
300+ employees supporting 100+ customers with
products marketed in 100+ countries
www.ergomedplc.comwww.ergomedplc.com
PRIMEVIGILANCE KEY STATISTICS
• Process over 65,800 per year
• Review over 380,000 per year
• Review over 9,000 per year
• Write over 800 PSURs, DSURs, PADERs, ACOs per year
• Over 140 written per year • 22 managed in-house, 30 developed
MI Enquiries
• Enquiries handled across all therapeutic areas for over 1,500 products across 20+ companies
• Prepare over 500 signal reports each year
Periodic Safety Reports
RMPs
Full Articles
PSMFs
Signal Evaluations
Periodic Safety Reports
RMPs
ICSRs/SAEs Full Articles
Literature Abstracts
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
PRIMEVIGILANCE ORGANIC GROWTH
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5,59
8,27
13,46
0,65
2,10
3,59
-
2,00
4,00
6,00
8,00
10,00
12,00
14,00
16,00
2014 2015 2016
GB
P M
n
Revenue
EBITDA
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
PHARMINVENT ORGANIC GROWTH
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1,87
2,71
3,92
0,550,66
0,94
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
4,5
2014 2015 2016
GB
P M
n(E
x.
Rate
30 J
une 2
017)
Revenue
EBITDA
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
PV Providers: ProPharma, PharmaLex, PV Ashfield, PharSafer, Xendo, Sciformix…
• PrimeVigilance has full PV services, expanding geographical presence and
access to resources for a quick scale up
Full service CROs with add on PV: Quintiles, Parexel, PPD, PRA, ICON…
PrimeVigilance offers value for money, specialised services, and personal
long-term relationship with customers
Business process outsourcing: Accenture, IBM, Deloitte, Oracle, Aris Global…
PrimeVigilance can offer the same tools used with higher PV expertise
COMPETITORS
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Best People• PrimeVigilance employs some of the best people in industry• Leadership in understanding and influencing regulations and standards• High proportion of physicians and pharmacists
Best Tools• PrimeVigilance is platform independent, adopting the best tools available
Access to Resources• Quick scale up and deployment of new teams• Investment to the best technology – intelligent automation• Growth through M&A
Established Brand
• Early entry to the market, well known experts in leadership
Unique QPPV Coverage
• Ahead of all competitors
UNIQUE SELLING POINTS OF PRIMEVIGILANCE
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UNIQUE PHARMACOVIGILANCE QP COVERAGE
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Call centre
• Pharmacists answer any queries about medicinal products of our clients
coming from healthcare professionals/(patients)
• They cover medical queries, product quality complaints, as well as
reports of suspected adverse drug reactions
• Multilingual and Multichannel Call Handling services
• Includes phones, emails, fax, letters, and social media
• Development of FQA and Standard Response Documents
• Design of systems, validation, audits
MEDICAL INFORMATION LINE OF BUSINESS
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
MEDICAL INFORMATION IN PRIMEVIGILANCE
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• PrimeVigilance Medical Information has 25+ customers already
• Acquisition of Sound Opinion in 2015 strengthened the position
• PrimeVigilance has won a milestone contract in the UK for medical
information recently
• Scale-up for technology, space and people is ongoing to meet the new
demand
• Medical Information is the usual entry point for pharmacovigilance
services
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
• PrimeVigilance is ready for any outcome of Brexit negotiation in our
lines of business (press statement released)
• We can move EU QPPVs to our offices in Frankfurt, Prague and Zagreb
• We can ensure continuous support in UK as well as remaining 28
Member States
• There should be no negative impact on PrimeVigilance business
BREXIT UNCERTAINTY
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www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com | 33
THANK YOU
FOR YOUR
ATTENTION
QUESTIONS?
www.ergomedplc.comwww.ergomedplc.com
ANDREW MACKIECHIEF BUSINESS OFFICER
| 34
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Full and Partial Ownership of Products to generate SHV
PRODUCT DEVELOPMENT @ ERGOMED
Objective
Building Higher Shareholder Return with
limited risk
Balance of Product
Reward and risk
Ownership and exposure
Stage of development
Field of medicine
Technology
Risk
Reward
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www.ergomedplc.comwww.ergomedplc.com
Rationale for Partners
CO DEVELOPMENT
Operational Skills
Funding
Development Strategy
Commercial Skills or Partner
http://www.biopharmadive.com/news/3-major-trends-driving-layoffs-in-biotech-and-pharma/399484/
https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
www.ergomedplc.comwww.ergomedplc.com
Rationale for Ergomed and How it works
CO DEVELOPMENT
30-50%
Clinical Costs
50-70%
Clinical Costs
Non Clinical
CMC & PC
Leveraging our knowledge of 20 years drug
development
Overall division stays cost neutral to the company
Forego profit on some projects in exchange for
the chance of turning it into LT revenue
Illustrative Numbers:
Discount of 30% to 50%
Share of revenue 5-15%
Investment cycle 2 years, Product launch 3 years
Probability of Success 10-20%
Returns could be >£3m per year
Ten projects will give us one or two successes with a
positive NPV for the division
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
100Reviews
CDA / Due Diligence
Advanced Negotiations
DEALS
50
12
2
Co-development leverages services expertise
FINDING OPPORTUNITIES
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Desktop review by BD analysts annually
• Medically led
• Therapeutic expert
reviews
Comprehensive review covering:
• IP
• Legal
• Finance
Deals per year
• Regulation
• Clinical
• CMC
• Confidential package
• Focus on clinical need
• Commercialisation
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Building a portfolio with significant upside potential
OUR DIVERSIFIED PRODUCT PIPELINE
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COMPOUND PARTNERNEXT
MILESTONE
PRE-
CLINICALPHASE I PHASE II PHASE III
Partnership
Multikine Cel-Sci TBD
Lorediplon Ferrer TBD
SevuparinModus
Therapeutics1H 2018
SepranoloneAsarina
Pharma EoY 2017
Multikine Cel-Sci TBD
Ownership
PeproStat 1H 2018
ReadyFlow 2H 2017
Evaluate 100+ deal opportunities per year, aim to sign two per year
Head & Neck Cancer
Insomnia
Sickle-Cell Disease
Premenstrual Dysphoric Disorder
Haemostasis
Haemostasis
Perianal warts
www.ergomedplc.comwww.ergomedplc.com
Lorediplon with Ferrer
CO DEVELOPMENT
Phase II POC vs
Comparator
145 patients included
Share of Revenue
Low double digit share
Study Positive
Partnership with US development
partner and Phase II
$500m Peak Sales
Revenues from milestones,
royalties and sales
• Sleeping Tablet
• Market 2bn but many
patients dissatisfied with
current treatments, need
something to maintain
sleep longer
• New chemical with longer
duration of effect
www.ergomedplc.comwww.ergomedplc.com
Sevuparin with Modus
CO DEVELOPMENT
Phase II POC vs
Comparator
120 evaluable patients
EquityHigh single digit share of company
Study ongoing
Recruitment Target H1
2018
>$1bn Peak Sales
Previous Pfizer Deal
>$300m
• Cardiac crises in Sickle
Cell Anaemia
• Orphan Disease in high
unmet need population
• Modified heparin
www.ergomedplc.comwww.ergomedplc.com
Sepranalone with Asarina
CO DEVELOPMENT
Phase II POC Protocol
under development
EquityHigh single
digit share of company
Study in planning
Recruitment to begin H2
2017
>$500m Peak Sales
No disease addressing treatments
• PMDD – an extreme form
of PMT
• 3% of women believed to
suffer
• Modified natural steroid
which modifies the
woman’s response to
GABAa
www.ergomedplc.comwww.ergomedplc.com
Multikine with Cel-Sci
CO DEVELOPMENT
Phase III 928 patients included
Share of revenue
Single digit share; capped
Recruitment completed
In follow up; FDA
discussion
>$2bn Peak Sales
Revenue across several
indications
• Immuno-oncology
therapy for multiple
cancer types and viral
infections
• Potential for a large
number of cancers and
patients
• Combination of
chemokines and
cytokines (natural small
proteins naturally
involved in the immune
system)
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
THE SURGICAL BLEEDING MARKET AND LIMITATIONSOF THROMBIN HAEMOSTATS
| 44
THROMBIN ON SPONGES GELS
LIQUIDS
multiple preparation -slow mode of action-
needs to be
re-constituted- Animal Blood
Human Blood
$2.5bn
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Mode of Action and Advantages
OUR NEW GENERATION OF HAEMOSTAT PRODUCTS
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PATENTED FIBRINOGEN-BINDING
PEPTIDE TECHNOLOGY
PeprostatAccessible
wounds
Uneven
wounds,
puncture
wounds
Readyflow
Blood-free source
Ready-to-use liquid
Rapid, effective action
PRODUCT USP´S
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
The Opportunity
OUR NEW GENERATION OF HAEMOSTAT PRODUCTS
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SALES POTENTIAL
Mix up fronts and LT Royalties
Control supply chain
Hospital Products are regional
COMMERCIALISATION STRATEGY
PEPROSTAT $150-200M
• Competes with liquid
haemostats that sell up to
$100m each in the US and
has additional potential in EU
and Asia
• Analysts suggest $150m
potential
READYFLOW >$300M
• Compete with the flowables,
market predicted to exceed
$1.0 Bn in 2025
• Strong competitive
advantage
TIMING AT END OF PHASE II
Capture value inflection
FAST TO SECURE MARKET
Potential launch in 2020
Strong IP position up to 2036
Study to report H2 2017
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
PROGRAMME UPDATE
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PEPROSTAT PHASE I COMPLETED IN 20 LIVER
SURGERY PATIENTS• Faster, no safety concerns and easy to use
PEPROSTAT PHASE II IN 4 SURGICAL INDICATIONS• Recruitment ahead of schedule – Results in Q4 2017
• 126 evaluable patients
READYFLOW• Pre Clinical – peptide in HA gel formulation being tested
• Phase I in 2018
1.4 min(PeprostatTM)
3 to 6 min (Competitors)
vs
3 years
2020 market
entry
Combined
$500m peak
sales potential
PEPROSTAT PHASE III• Repeat of phase II design in more patients (600)
• Planned for 2018
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
QUESTIONS?
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www.ergomedplc.comwww.ergomedplc.com
STEPHEN STAMPCHIEF FINANCIAL OFFICER
| 49
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Revenue and EBITDA (adjusted) ahead of expectations
2016 FINANCIAL HIGHLIGHTS
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2015 2016
Revenue (£m)
3,4 3,0
2015 2016
EBITDA (£m)
4.1
• Revenue up 30% to £39.2 million (2015: £30.2 million)• Excluding acquisitions, revenue up 27%
• Gross profit up 43% to £12.0 million (2015: £8.4 million)
• EBITDA (adjusted) before R&D £4.1 million (2015: £3.4 million)• After R&D (Haemostatix) £3.0 million
• Cash at bank £4.4 million at 31 December 2016 (2015: £4.0 million)
+30%
R&D
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Exceeded target revenue and EBITDA (adjusted)
PROFIT AND LOSS ACCOUNT
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£000s FY 2016 FY 2015
REVENUE 39,233 30,178
GROSS PROFIT 11,994 8,370
Administrative expenses (10,483) (6,379)
Other administrative expenses (8,323) (5,186)
Amortisation of acquired fair valued intangible assets (771) (596)
Share-based payment charge (398) (288)
Deferred consideration for acquisition (690) –
Write-back of deferred consideration for acquisition 460 –
Acquisition costs (584) (272)
Exceptional items (177) (37)
Research and development (1,040) –
Other operating income 127 81
OPERATING PROFIT 598 2,072
Finance costs (net) (272) –
PROFIT BEFORE TAXATION 326 2,072
Taxation 153 (520)
PROFIT FOR THE PERIOD 479 1,552
EBITDA (adjusted) 3,014 3,382
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
BALANCE SHEET
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£000s31 December
2016
31 December
2015
Goodwill 12,285 7,488
Intangibles 19,842 2,819
Other non-current assets 2,436 883
NON-CURRENT ASSETS 34,563 11,190
Trade and other receivables 14,958 9,528
Clinical trial inventory 450 –
Cash and cash equivalents 4,424 3,974
CURRENT ASSETS 19,832 13,502
TOTAL ASSETS 54,395 24,692
CURRENT LIABILITIES (8,592) (7,233)
NET CURRENT ASSETS 11,240 6,269
NON-CURRENT LIABILITIES (11,195) (523)
TOTAL LIABILITIES (19,787) (7,756)
NET ASSETS 34,608 16,936
£m
2015 7.5
Haemostatix 2.1
O+P / GASD 0.5
PharmInvent 2.2
2016 12.3
£m
2015 2.8
PeproStat 13.1
ReadyFlow 2.1
OPVERDI 0.4
GASD cust. lists 0.2
PharmInvent cust. lists 1.3
Software 0.7
20.6
Amortisation (0.8)
2016 19.8
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Multiple value inflection opportunities near term
NEWSFLOW
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Co-development deals – target two p.a.
Services acquisitions
PeproStat™ / ReadyFlow™ out- licensing opportunities
2017 2018
• Ferrer: Phase II insomnia results
• Haemostatix: PeproStat™
Phase IIb initiated
• Aeterna Zentaris: Zoptrex™
Phase III results
• Haemostatix: PeproStat™
Phase IIb completion
• Initiation of Asarina PMDD trial
• Haemostatix: PeproStat™
Phase III start
• Modus Therapeutics: Sevuparin
Phase II top line results
• Haemostatix: ReadyFlow™
Phase I ready
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Profitable Services with break-out potential from Product Portfolio
BUILDING SIGNIFICANT SHAREHOLDER VALUE
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5 Year Shareholder
value drivers
Services:
Stable profitable growth
Products:
Breakout potential
Commitment to remain overall EBITDA positive
E B
I T
D A
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STRATEGY FOR ACCELERATED GROWTH
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ACQUISITIONS
30% top line growth
STRATEGY
• Build on 20 years profitable
organic growth
• Continue to outpace the market
Pharmacovigilance
2016 DELIVERY
CRO • Build out global infrastructure
• Add specialist skills:
• Eg. orphan diseases, PMS
• Consolidate European leadership
• Establish global leadership:
• N. America
• Japan / China
• Monetize Haemostatix technology
• Expand development portfolio to
+/- 10 partnerships
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QUESTIONS?
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