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ERGOMED PLC January 2016 www.ergomedplc.com www.ergomedplc.com - - PowerPoint PPT Presentation
ERGOMED PLC January 2016 www.ergomedplc.com www.ergomedplc.com - - PowerPoint PPT Presentation
ERGOMED PLC January 2016 www.ergomedplc.com www.ergomedplc.com www.ergomedplc.com DISCLAIMER The information contained in this confidential document ( Presentation ) has been prepared by Ergomed plc (the Company ). It has not been
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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
- perations, 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
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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.
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THREE BUSINESS SEGMENTS, HIGHLY EXPERIENCED TEAM, UNIQUE BUSINESS MODEL
AT A GLANCE
- Founded in 1997 and profitable since
- IPO on LSE in 2014
- Strong order backlog of c.£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 Stephen Stamp, CFO Ex-Group FD of Shire, > 30 years experience Andrew Mackie, CBO Industry experience in clinical development and business development Neil Clark, CEO of PrimeVigilance Private/listed life science companies Peter George – Non-Executive Director CEO of Clinigen Group plc., > 20 years experience Christopher Collins – Non-Executive Director Ex-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
*Pro forma
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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
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OVER 60 CURRENT CLIENTS INCLUDING TOP TEN PHARMA TO SMALL BIOTECHS
ERGOMED AND PRIMEVIGILANCE CLIENTS
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ERGOMED WELL POSITIONED TO EXPLOIT PHARMACEUTICAL INDUSTRY TRENDS
ERGOMED’S BUSINESS MODEL
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- 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-DEVELOPMENT
with 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
MARKET
with strong dynamics
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LEVERAGING STABLE PROFITABLE GROWTH WITH REDUCED RISK CO- DEVELOPMENT
STRATEGY
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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
- 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
- utsource drug development
CO- DEVELOPMENT
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COMPOUND PARTNER PHASE I PHASE II PHASE III RESULTS Lorediplon Ferrer H1 2016 AEZS 108 Aeterna Zentaris H2 2016 Multikine Cel-Sci 2018 Multikine Cel-Sci TBC Sevuparin Dilaforette TBC Ganetespib Synta Pharma
PhIII in NSCLC terminated, clinical trials ongoing in AML,
- varian and breast cancer,
- ther tumor types
Indicates Ergomed co-development investment phase
RESULTS FROM LATE STAGE TRIALS AHEAD
GROWING CO-DEVELOPMENT PIPELINE
Head & Neck Cancer Endometrial Cancer Sickle-Cell Disease Insomnia Perianal warts in HIV / HPV Targeting two new deals per year NSLC 10 NSLC
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LEVERAGING CLINICAL EXPERIENCE
CO-DEVELOPMENT BUSINESS
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- Assets are targeted where
Ergomed brings
- perational/therapeutic
expertise to a partnership
- Experienced due diligence
team reviews 100 potential
- pportunities per annum
- Partner’s expertise in
manufacture and discovery merged with Ergomed’s capabilities in Clinical and Regulatory development
- Provides services to a value
- f 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
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100
Reviews CDA/ Due Diligence Advanced Negotiations
DEALS
50 12 2
STRUCTURED DUE DILIGENCE PROCESS
ERGOMED CO-DEVELOPMENT MODEL
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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
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US BILLION DOLLAR EXITS FOR CRO-DRIVEN CO-DEVELOPMENT BUSINESSES
CO-DEVELOPMENT OFFERS SIGNIFICANT VALUE CREATION
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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
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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 15
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OUR RESULTS VALIDATE OUR STRATEGY
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UNIQUE SITE MANAGEMENT MODEL
ENHANCED RECRUITMENT INCREASED RETENTION
600 400 200 2 month 4 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 Ergomed
12 sites
CRO ´X´
15 sites
Enrolled Withdrawn 60 40 20 MS Study 1 Patients 120 80 40 MS Study 2 Patients
Drop out rate Ergomed 3.4% Global 8.9% Drop out rate Ergomed 4.1% Global 6.0%
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OUR SUBSIDIARY PRIMEVIGILANCE PROVIDES SUSTAINABLE STRONG GROWTH
POST MARKETING SERVICES
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PrimeVigilance is a leading provider of drug safety and medical information services Fast growing profitable business: 34% CAGR since 2011 Over 170 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
KEY HIGHLIGHTS/ FINANCIALS & OUTLOOK
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FINANCIAL AND CORPORATE – 2015 INTERIM RESULTS
KEY 2015/16 HIGHLIGHTS
- Strong first half trading performance – revenues up 85% and EBITDA up 66%
- Strong backlog of signed contracts
- Co-development projects on track
- New co-development deal signed with Dilaforette for orphan drug
- Expansion into post-marketing service sector through Sound Opinion acquisition
- Opened Asian office in Taipei
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OPERATIONAL AND CORPORATE HIGHLIGHTS
KEY 2015/16 HIGHLIGHTS
- Ergomed announced Board changes with the appointment of Neil Clark as Chief Executive Officer of
PrimeVigilance and Stephen Stamp as Chief Financial Officer of Ergomed
- Andrew Mackie also appointed as Chief Business Officer
- Placing of 3.96 million founder shares at 170p in July 2015 with institutional shareholders in London and
Europe and increasing free float to 37% from 27%
- Ergomed’s co-development partner Aeterna Zentaris obtained recommendation from Data Safety
Monitoring Board to continue ZoptEC Phase III trial in advanced endometrial cancer
- Ergomed and Dilaforette initiated Phase II trial with Dilaforette’s Sevuparin in Sickle-Cell Disease
- Ergomed shortlisted as a finalist for the ‘Best CRO’ award at the 11th Annual Scrip Awards 2015
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STRONG TRADING PERFORMANCE
£000s
H1 2015 H1 2014 FY 2014
Revenues
14,484 7,849 21,155
Cost of Sales
(10,292) (5,754) (15,385)
GROSS PROFIT
4,192 2,095 5,770
Administrative expenses
(2,606) (1,140) (3,677)
Amortisation
(286)
- (1,030)
Exceptional items (162)
- (584)
Share option charge
(133)
- (338)
Other operating income
52 10 54
OPERATING PROFIT
1,057 965 779
Finance costs
1 (2)
PROFIT BEFORE TAXATION
1,057 964 777
Taxation
(265) (218) (199)
PROFIT FOR THE PERIOD
792 746 578
EBITDA
1,500 900
PROFIT AND LOSS ACCOUNT
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£000s
H1 2015
H1 2014 FY 2014 Goodwill 7,656 1,332 7,282 Intangibles 2,733
- 2,927
Other non-current assets 737 136 547 NON-CURRENT ASSETS 11,126 1,468 10,756 Trade and other receivables 6,496 3,049 6,343 Cash and cash equivalents 4,947 1,601 4,576 CURRENT ASSETS 11,443 4,650 10,919 TOTAL ASSETS 22,569 6,118 21,675 CURRENT LIABILITIES (6,096) (3,517) (5,755) NET CURRENT ASSETS 5,347 1,133 5,164 NON-CURRENT LIABILITIES (536) (4) (581) TOTAL LIABILITIES (6,632) (3,521) (6,336) NET ASSETS 15,937 2,597 15,339
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BALANCE SHEET
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- 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, N+1 Singer
- Shareholder structure: Freefloat 37%, Miroslav Reljanovic 59.9%, Octopus Investments 9.5%, Slater Investments Ltd
7.5%
SHARE INFORMATION
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SHARE CHART
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NEWS FLOW
- Co-development partnerships
- Ferrer: Phase II study in insomnia started in H1 2015. Results expected 2016
- Aeterna Zentaris: ZoptEC Phase III results expected in H2 2016
- Dilaforette: Sevuparin Phase II 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
- Potential acquisitions – a number of targets under review (Sound Opinion completed May 2015)
WHAT TO EXPECT IN 2016
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- Ergomed is a market leader in co-development, leveraging our 15 years’ experience
- Four late stage co-development partnerships progressing
- Signed first orphan disease co-development deal signed in February 2015, first in orphan drug indication
- Several new co-development deals in due diligence
- Service contracts for clinical studies/pharmacovigilance with a value of £15 million signed in H1
2015
- Strong backlog of awarded contracts of approximately £60 million at the end of August 2015
- Financial numbers since IPO in line with analyst expectations
- Expanded presence in Asia with opening of office in Taiwan in line with the strategic growth plan
- Taipei base will be used as a first step for expansion into Asia
- Executing on clear growth strategy with the intention to become one of the leading global
providers for:
- Post marketing services e.g. drug safety and medical information
- Co-development partnerships
- Rare disease/orphan drug development services
SUMMARY
THANK YOU
HEADQUARTERS
The Surrey Research Park 26 Frederick Sanger Road Guildford, Surrey GU2 7YD United Kingdom info@ergomedplc.com