ERGOMED PLC - Proactiveinvestors NA€¦ · Ganetespib Synta Pharma H2 2016 AEZS 108 Aeterna...
Transcript of ERGOMED PLC - Proactiveinvestors NA€¦ · Ganetespib Synta Pharma H2 2016 AEZS 108 Aeterna...
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
ERGOMED PLC A fast growing, global, profitable
services and co-development business
September 17th 2015
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com 2
DISCLAIMER
The information contained in this confidential document (“Presentation”) has been prepared by Ergomed plc (the “Company”). It has not been fully verified and is subject to material updating, revision
and further amendment. This Presentation has not been approved by an authorised person in accordance with Section 21 of the Financial Services and Markets Act 2000 (“FSMA”) and therefore it is
being delivered for information purposes only to a very limited number of persons and companies who are persons who have professional experience in matters relating to investments and who fall within
the category of person set out in Article 19 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or are high net worth companies within the meaning set out in
Article 49 of the Order or are otherwise permitted to receive it. Any other person who receives this Presentation should not rely or act upon it. By accepting this Presentation and not immediately returning
it, the recipient represents and warrants that they are a person who falls within the above description of persons entitled to receive the Presentation. This Presentation is not to be disclosed to any other
person or used for any other purpose.
Stifel Nicolaus Europe Limited (“Stifel”) is acting in the provision of corporate finance business to the Company, within the meaning of the Financial Conduct Authority’s Conduct of Business Sourcebook
(“COBS”), and no-one else in connection with the proposals contained in this Presentation. Accordingly, recipients should note that Stifel is neither advising nor treating as a client any other person and
will not be responsible to anyone other than the Company for providing the protections afforded to clients of Stifel under the COBS nor for providing advice in relation to the proposals contained in this
Presentation.
While the information contained herein has been prepared in good faith, neither the Company nor any of its shareholders, directors, officers, agents, employees or advisers give, have given or have
authority to give, any representations or warranties (express or implied) as to, or in relation to, the accuracy, reliability or completeness of the information in this Presentation, or any revision thereof, or of
any other written or oral information made or to be made available to any interested party or its advisers (all such information being referred to as “Information”) and liability therefore is expressly
disclaimed. Accordingly, neither the Company nor any of its shareholders, directors, officers, agents, employees or advisers take any responsibility for, or will accept any liability whether direct or indirect,
express or implied, contractual, tortious, statutory or otherwise, in respect of, the accuracy or completeness of the Information or for any of the opinions contained herein or for any errors, omissions or
misstatements or for any loss, howsoever arising, from the use of this Presentation.
This Presentation may contain forward-looking statements that involve substantial risks and uncertainties, and actual results and developments may differ materially from those expressed or implied by
these statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the Company's results of
operations, financial condition, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve risks and uncertainties because they
relate to events and depend on circumstances that may or may not occur in the future. These forward-looking statements speak only as of the date of this Presentation and the Company does not
undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date of this Presentation.
Neither the issue of this Presentation nor any part of its contents is to be taken as any form of commitment on the part of the Company to proceed with any transaction and the right is reserved to
terminate any discussions or negotiations with any prospective investors. In no circumstances will the Company be responsible for any costs, losses or expenses incurred in connection with any appraisal
or investigation of the Company. In furnishing this Presentation, the Company does not undertake or agree to any obligation to provide the recipient with access to any additional information or to update
this Presentation or to correct any inaccuracies in, or omissions from, this Presentation which may become apparent.
This Presentation should not be considered as the giving of investment advice by the Company or any of its shareholders, directors, officers, agents, employees or advisers. In particular, this
Presentation does not constitute an offer or invitation to subscribe for or purchase any securities and neither this Presentation nor anything contained herein shall form the basis of any contract or
commitment whatsoever. Any decision to subscribe for the Company’s securities must be made only on the basis of the information contained in the admission document in its final form relating to the
Company, which may be different to the information contained in this Presentation. Each party to whom this Presentation is made available must make its own independent assessment of the Company
after making such investigations and taking such advice as may be deemed necessary. In particular, any estimates or projections or opinions contained herein necessarily involve significant elements of
subjective judgment, analysis and assumptions and each recipient should satisfy itself in relation to such matters.
Neither this Presentation nor any copy of it may be (a) taken or transmitted into Australia, Canada, Japan, the Republic of Ireland, the Republic of South Africa or the United States of America (each a
“Restricted Territory”), their territories or possessions; (b) distributed to any U.S. person (as defined in Regulation S under the United States Securities Act of 1933 (as amended)) or (c) distributed to
any individual outside a Restricted Territory who is a resident thereof in any such case for the purpose of offer for sale or solicitation or invitation to buy or subscribe any securities or in the context where
its distribution may be construed as such offer, solicitation or invitation, in any such case except in compliance with any applicable exemption. The distribution of this document in or to persons subject to
other jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. Any failure to comply with these
restrictions may constitute a violation of the laws of the relevant jurisdiction.
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
ERGOMED has a growing portfolio of
co-development partnerships with several products
already in Phase II / III trials.
Our backbone is a well established, fast growing
and profitable drug development and post-marketing
services business.
3www.ergomedplc.com
www.ergomedplc.comwww.ergomedplc.com
THREE BUSINESS SEGMENTS, HIGHLY EXPERIENCED TEAM, UNIQUE BUSINESS MODEL
AT A GLANCE
Founded in 1997 and profitable since
IPO on LSE in 2014: £11m (gross proceeds)
Revenues 2014*: £23.7m (from £19.2m)
Operating income 2014*: £2.7m (from £1.4m)
Strong order backlog of £60m, good visibility
Sound Opinion acquisition in May 2015
Rolf Stahel, Chairman: Ex-CEO of Shire, industry veteran > 40 years experience
Miroslav Reljanovic M.D., CEO Founder of Ergomed, Neurologist
Neil Clark, CFO Private/listed life science companies
Andrew Mackie, CBOIndustry experience in clinical development and business development
Peter George – Non-Executive DirectorCEO of Clinigen Group plc., > 20 years experience
Christopher Collins – Non-Executive DirectorEx-CEO and a founding partner of Code Securities
Profitable growth through core business in combination with
potential upside via co-development
Specialised in high growth post-marketing services
Innovative site management and study physicians model in
clinical research
BUSINESS SEGMENTS BOARD
FACTS & FIGURES USPS
Co-development
CRO
Post-
marketing
*proforma4
www.ergomedplc.comwww.ergomedplc.com
WORLDWIDE EXPERIENCE
OUR PRESENCE
Over 60 current clients including top ten pharma and
generics to small biotechs
Operations in 40 countries across five continents
Over 300 employees, 85 of whom are medically qualified
Managed the clinical development programmes of over
80 products and product candidates
Frankfurt
Zagreb
Geneva
Guildford
Cambridge
San Antonio
Madrid
Novi Sad
Krakow
Moskow
Kiev
Mumbai
Taiwan
Dubai
Pisa
Sarajevo
Riyadh
Ankara
Brasov
Ergomed Offices
Longstanding Partners
5
www.ergomedplc.comwww.ergomedplc.com
ERGOMED WELL POSITIONED TO EXPLOIT PHARMACEUTICAL INDUSTRY TRENDS
ERGOMED’S BUSINESS MODEL
6
Clinical research & development from
Phase I to IV trials
Clinical and post-marketing – drug safety
(PrimeVigilance) and medical information
Specialists in oncology, neurology, immunology and
rare diseases
SERVICES as strong backbone
Leveraging the 15 years of clinical development track
record
Diversified pipeline: Five current active partnerships
Flexible deal structuring
Focus on compounds in late stage clinical phases
CO-DEVELOPMENTwith low-risk / high upside
Global drug development outsourcing market is estimated at US$ 24bn per annum and expected to grow at 5%-10%
CAGR over the next five years
Rare disease/orphan drug development requires specialist provider to manage complex clinical trials
Global pharmacovigilance market growing and expected to reach US$5bn in the next five years
Continued need for alternative sources of funding drug development
MARKETwith strong dynamics
www.ergomedplc.comwww.ergomedplc.com
LEVERAGING STABLE PROFITABLE GROWTH WITH REDUCED RISK CO-
DEVELOPMENT
STRATEGY
7
OUR AIM IS TO
BECOME ONE OF THE
LEADING GLOBAL
PROVIDERS FOR:
Co-development partnerships
Post marketing services e.g. drug safety and medical information
Rare disease / orphan drug development services
Co-development
Very significant potential returns from current and
future agreements / upside USD >100m for 3
ongoing Phase III products
Important results in 2016
Targeting two new deals per year
Services
Stable growth driver in drug development/fast growth
in post-marketing
Well established, profitable business
Well positioned to capitalise on industry trends to
outsource drug development
CO-DEVELOPMENT
www.ergomedplc.com
COMPOUND PARTNER PHASE I PHASE II PHASE III RESULTS
Lorediplon Ferrer H12016
Ganetespib Synta Pharma H2 2016
AEZS 108 Aeterna Zentaris H2 2016
Multikine Cel-Sci 2018
Multikine Cel-Sci TBC
Sevuparin Dilaforette TBC
Indicates Ergomed co-development investment phase
RESULTS FROM LATE STAGE TRIALS AHEAD
GROWING CO-DEVELOPMENT PIPELINE
Head & Neck
Cancer
Endometrial
Cancer
NSLC
Sickle-Cell
Disease
Insomnia
Perianal warts
in HIV / HPV
Targeting two new deals per year
NSLC
9
www.ergomedplc.comwww.ergomedplc.com
LEVERAGING CLINICAL EXPERIENCE
CO-DEVELOPMENT BUSINESS
10
Assets are targeted where
Ergomed brings
operational/therapeutic
expertise to a partnership
Experienced due diligence
team reviews 100 potential
opportunities per annum
Partner’s expertise in
manufacture and discovery
merged with Ergomed’s
capabilities in Clinical and
Regulatory development
Provides services to a value
of 30%-50% of total clinical
trial budget: co-development
partner funds balance
(genuine contribution
by BOTH partners)
Negotiated returns: between
5-17.5% of product revenues
earned by partner (including
royalties and milestones) or
equity stake
Joint Funding. Both parties
share the risk and participate
financially
Ergomed aims to enable its
partners to advance their
molecules while retaining
control for commercialization
OPERATIONAL FINANCIAL RATIONALE
www.ergomedplc.comwww.ergomedplc.com
100Reviews
CDA/ Due Diligence
Advanced Negotiations
DEALS
50
12
2
STRUCTURED DUE DILIGENCE PROCESS
ERGOMED CO-DEVELOPMENT MODEL
11
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.com
US BILLION DOLLAR EXITS FOR CRO-DRIVEN CO-DEVELOPMENT BUSINESSES
CO-DEVELOPMENT OFFERS SIGNIFICANT VALUE CREATION
12
Furiex Pharmaceuticals, the co-
development arm of PPD, sold in April
2014 for US$1.1bn to Forest
Ilex Oncology sold to Genzyme
for US$1.0bn in 2004
Ergomed is one of the leading operators globally of the co-development model
Opportunity to build significant value
CLINICAL DEVELOPMENT CAPABILITIES AND USPS
www.ergomedplc.comwww.ergomedplc.com
FOR FULL RANGE OF CLINICAL DEVELOPMENT SERVICES
ERGOMED –CLINICAL RESEARCH & DEVELOPMENT
MEDICAL
WRITING
CONSULTANCY
PROJECT
MANAGEMENT
& MONITORING
REGULATORY
AFFAIRS
CENTRAL
LABORATORY
ASSISTANCE
DATA
MANAGEMENT
& BIOSTATISTICS
QUALITY
ASSURANCE
14
www.ergomedplc.comwww.ergomedplc.com
OUR SUBSIDIARY PRIMEVIGILANCE PROVIDES SUSTAINABLE STRONG GROWTH
POST MARKETING SERVICES
15
PrimeVigilance is a leading provider of drug safety and medical information services
Fast growing profitable business: 34% CAGR since 2011
Over 150 employees
Supporting 30 customers in over 100 countries
Strong backlog of signed contracts
Increased regulation and trend to outsourcing driving rapid market growth
PrimeVigilance awarded 2014 Queen’s Award for Enterprise in International Trade
Grown into one of the leading European pharmacovigilance companies within 5 years of foundation. Expanding into
USA in 2015
Providing post-marketing support to US/Asian/EU pharma and generics
– Full pharmacovigilance services – case processing/reports/consultancy
– Sound Opinion acquisition in May 2015 – International Medical Information through multi-lingual call centre
www.ergomedplc.comwww.ergomedplc.com
OVER 60 CURRENT CLIENTS INCLUDING TOP TEN PHARMA TO SMALL BIOTECHS
ERGOMED AND PRIMEVIGILANCE CLIENTS
16
KEY FINANCIALS&OUTLOOK
www.ergomedplc.comwww.ergomedplc.comwww.ergomedplc.com
Stock code: ERGO
No of shares: 28,750,000/Market cap c.£50m
Date listed: 15.07.2014
Index market: AIM
UK Analyst coverage: Stifel, Peel Hunt, N+1 Singer
Shareholder structure: Freefloat 17%, Miroslav
Reljanovic 59.9%, Octopus Investments 9.5%, Slater
Investments Ltd 5.11%
KEY FIGURES / SHARE INFORMATION
18
SHAREFIGURES
£000s FY 2013 FY 2014
Revenues 19,232 23,694
EBITDA 2,799* 2,781
CHART
Total assets 6,715 21,728
Current liabilities (4,800) (5,808)
Net assets 1,907 15,339
Cash and equivalents 1,950 4,576
*Includes codev milestone of $2m in 2013
www.ergomedplc.comwww.ergomedplc.com 19
NEWS FLOW
Co-development partnerships
Aeterna Zentaris: Phase III first interim analysis H1 2015 and recruitment complete by mid 2015. Results
expected H2 2016
Dilaforette: Phase II study in sickle cell anaemia in final stage of study preparation. Aim to start recruitment
in H2 2015
Ferrer: Phase II study in insomnia started in H1 2015. Results expected H1 2016
Synta Pharmaceuticals: Phase III results expected in H2 2016
CEL-SCI:
− Phase III study in head and neck cancer recruitment ongoing. Completing 2015/16. Results expected 2018
− Phase I study in peri-anal warts in HIV/HPV co-infected patients underway
Management aims to sign new co-development deals in 2015/16
Andrew Mackie was appointed Chief Business Officer and member of the board
Continued contract wins for Ergomed and PrimeVigilance full service businesses
Potential acquisitions – a number of targets under review (Sound Opinion completed May 2015)
WHAT TO EXPECT 2015 / 2016
THANK YOU
HEADQUARTERS
The Surrey Research Park26 Frederick Sanger RoadGuildford, Surrey GU2 7YDUnited Kingdom