Clinigen Group - Peter George (CEO) Right Drug Right Patient Right Time

Transcription

1 Clinigen Group - Peter George (CEO) Right Drug Right Patient Right Time

2 Group overview Global specialty pharmaceuticals and services business, supplying clinical trial, licensed and unlicensed critical, life saving drugs Three distinct operating businesses which benefit from important synergies between them: Clinigen CTS Specialist global supply of drugs for use in clinical trials (comparator & co-meds) Clinigen GAP Global supply of unlicensed or yet to be licensed drugs for unmet patient need in orphan diseases and difficult to treat oncology's, infectious, orphan and other diseases Clinigen SP A portfolio of oncology support and infectious disease medicines. Selectively acquiring further niche, hospital-based or emergency medicines which can be revitalised Global distribution network serving c.75+ countries and a broad, blue chip customer base of global pharmaceutical/biotech companies and contract research organisations Highly profitable, cash-generative business with impressive continuous growth over the past five years Good visibility of earnings with significant growth opportunities, both organically and through acquisition Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 1

3 Income statement 2014 m year ended 30 June Growth Sales %/7.5% 2014 Revenue ( 126.6m) Gross profit % Gross profit margin (%) 28.6% 32.5% Overheads % EBITDA 1 (underlying) % Margin (%) 18.3% 21.2% Pre tax profit (underlying) % 2014 Gross profit ( 41.2m) Earnings per share (underlying) p 24.5p 22% Total dividend 2.6p 3.1p 19% 1: Overheads, EBITDA & underlying PBT represent underlying performance and 2014 excludes a non cash share based payment charge of 1.2m and associated NI of 0.6m excludes 4.0m exceptional costs and a non-cash share based payment charge of 1.9m both arising wholly as a result of the companies IPO 2: Adjusted earnings per share is based on underlying PAT adjusted to exclude amortisation Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 2

4 FY14 results - key highlights Like for like revenues* up 7.5% Underlying EBITDA** up 19.8% to 26.8m Underlying earnings per share** up 22% to 24.5 pence Final dividend of 2.1 pence per share proposed, bringing the total dividend to 3.1 pence per share (FY13: 2.6 pence per share) Specialty Pharmaceuticals (SP) two further oncology acquisitions, Savene and Ethyol, bringing the total number of products to five Lifting of Marketing Authorization suspension achieved for Vibativ and product launched Clinical Trial Supply (CTS) gross margins returned to 15% with deeper penetration of customer base Global Access Programs (GAP) 58,000 units of drugs shipped to more than 75 countries, an 87% increase * Copyright Like for like Clinigen at CER Group represents plc. All revenues rights reserved adjusted for stock fill ( 3m) in FY13,and FY14 stated at FY13 exchange rates ** Underlying EBITDA & EPS excludes share based payments and amortisation Right Drug Right Patient Right Time 3

5 Operating Businesses Cancer cells (Campath) Right Drug Right Patient Right Time 4

6 Acquiring hospital only or emergency medicines and revitalising them Oncology Support Portfolio Dexrazoxane - Cardioxane acquired from Novartis in 2013, used for as a cardioprotective drug against anthracycline toxicity and Savene acquired from Norgine in 2014, used to treat extravasation caused by anthracycline treatment - Both started to contribute in FY14 but will complete transition during FY15 - Strong academic and KOL support for Clinigen s strategy of challenging Article 31 restrictions Ethyol - Acquired from AstraZeneca August 2014, it is a cytoprotective drug indicated to reduce the incidence of xerostomia (dry mouth) in patients undergoing radiation treatment for head and neck cancer and to reduce renal toxicity associated with cisplatin in patients with advanced ovarian cancer - Ethyol will start to contribute during FY15 Copyright Clinigen Group plc. All rights reserved Right Drug Right Right DrugPatient Right Patient Right Right Time 15 5

7 Infectious Disease Portfolio Foscavir - Acquired global rights from AZ in Anti-viral last line treatment predominantly used for CMV in bone marrow transplant patients - Sales beginning to plateau and going forward will reflect the growth of underlying disease it treats will see full effect of key market price increases and launch in South Korea - In-market sales up 4.2% - Foscavir GAP program accounts for 8% of volume and 10.3% of sales from 18 countries Vibativ - In-licensed Vibativ from Theravance in 2013, used to treat hospital acquired pneumonia of an MRSA cause - Product launched in European market 19 th September - etest is currently research only, but will be sufficient for launch patient population Copyright Clinigen Group plc. All rights reserved Right Drug Right Right DrugPatient Right Patient Right Right Time 15 6

8 Financial Year % of revenue, 56% of GP Foscavir currently accounts for 86% (98%) of sales, with the dexrazoxane products accounting for 14% Continued sales growth; total sales up 10.4% with GP up 16.7% In-market Foscavir sales up 4.2% In-market Cardioxane sales as expected First Savene sales recorded May 2014 First Ethyol sales recorded September 2014 New Foscavir prices agreed Spain & Italy and general price increase applied for 2015 New MA approved in South Korea Vibativ license suspension lifted, EU grade product manufactured, MA reinstated and EU launch 19 th Sept Ethyol fifth product acquired August 2014 m 12 months ended 30 June Clinigen CTS Clinigen GAP Clinigen SP Sales Sales YoY SP Growth (%) 124% 12% 10.4% Clinigen CTS Clinigen GAP Clinigen SP GP Gross profit YoY SP Growth (%) 123% 8% 16.7% Gross Profit Margin (%) 84.4% 81.5% 86.1% Copyright Clinigen Group plc. All rights reserved Right Drug Right Right DrugPatient Right Patient Right Right Time 7

9 % Sales The main revenue generator in the group, but lowest GM% at 15% A successful entry into the US market has generated strong revenue growth Addressable outsourced market c. $ bn, estimated to grow at 8% over next 3 years 55% of purchased clinical trial drugs are estimated to be leftover, unused or wasted, due to poor purchasing decisions Clinigen CTS has sourced more than 3,000 products for circa 1,750 clinical trials in the last four years Exclusive clinical trial sourcing and supply arrangements with AstraZeneca UK, Accord Generics, Napp and a direct manufacturing relationship with Roche Blue chip customer base Clinigen CTS top 15 Customers (2011, 2012, 2013 and 2014) Top 15 customers represent c. 90% of sales Top 15 Customers Right Right Drug Drug Right Right Patient Right Time Copyright Clinigen Group plc. All rights reserved 8

10 Top 18 customers have greater than 1m in sales each Top 19 products have greater than 1m in sales and account for 77% of total sales and 69% of GM Of these 19, 16 are comparators and 3 co-therapies; 14 are oncology, 2 Hep C, 2 RA and 1 COPD Drug Indication Sales FY14 Drug Indication Sales FY13 1 MabThera 1 Oncology 14.4 Copegus Hep C Tarceva Oncology 5.8 Arzerra Oncology Glivec 2 Oncology 5.4 Incivo Hep C Solvadi Hep C 5.5 Nexavar Oncology Humira RA 5.4 Glivec 2 Oncology Folotyn Oncology 3.7 Folotyn Oncology Copegus Hep C 3.6 Pegasys Hep C Nexavar Oncology 2.5 MabThera 1 Oncology Enbrel RA 2.5 Faslodex Oncology Levact 3 Oncology 4.6 Ribavirin Hep C 2.4 * Glivec, Gemcitibine & Imatinib ** MabThera Copyright & Rituxan Clinigen Group plc. All rights reserved Right Right Drug Drug Right Right Patient Right Time 9 *** Levact & Treanda

11 66% of sales and 31% of GP Deeper customer presentation Top 18 customers and top 19 products have greater than 1m in sales Exclusive supply agreements now account for 7.5% of sales with addition of Levact to AZ and Accord agreements Financial Year 2014 Sales down (- 4.2m) due to prior year one-off anti-viral sales ( 24m) not repeated Gross profit performance, up 10.9% at 15.1% Underlying activity up, with requests up 44% and medicines supplied up 28% Sales pipeline c. 160m m 12 months ended 30 June Clinigen CTS Sales Clinigen GAP Clinigen SP Sales YoY CTS Growth (%) 151% 49% -5% Clinigen CTS GP Clinigen GAP Clinigen SP Gross profit YoY CTS Growth (%) 64% 14% 11% Gross Profit Margin (%) 17.0% 13.0% 15.1% Right Right Drug Drug Right Right Patient Right Time Copyright Clinigen Group plc. All rights reserved 10

12 Clinigen is an early entrant into this new market sector and shows continued strong sales and profit growth Compassionate use Early access to drugs before regulatory approval Treatment Investigational New Drug programs (US) Non-launch market access (commercial access) Mature product access programs to licensed drugs in process of being withdrawn from market Often run in orphan or infectious diseases or oncology programs. Exclusive programs under management for clients including, Pfizer, Sanofi, AZ, Boehringer Ingleheim, Astellas and Eisai Enable companies to provide market access to medicines before obtaining regulatory approval, in non-launch markets or continue to provide a drug after discontinuation or withdrawal Global logistical network, relationships with Key Opinion Leaders, and regulatory expertise key to provide a comprehensive solution to program management Growth opportunities in pharmerging markets for on-demand unlicensed supply Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 15 11

13 Company Product Disease Area Astrazeneca CAZ-AVI Complicated intra-abdominal infections Metreleptin Lipodystrophy Astellas Enzalutimide Prostate Cancer Xtandi Advagraf Modigraf Dificlir Prostate Cancer Transplant Immunosuppressant Transplant Immunosuppressant Antibacterial Boehringer Ingleheim Nintedanib Idiopathic pulmonary fibrosis BTG Digifab Digoxin Toxicity Voraxase UTA Methotrexate Toxicity 5-FU Toxicity Pfizer Mylotarg Acute Myloid Leukaemia Valeant Demser Malignant Phaeochromocytoma Cuprimine Edecrin Ethacrynate Sodium Mephyton Lacrisert Wilson's Disease Nephrotic Syndrome Oedema Blood Clotting Factors Dry Eye Therapy Cubist Ceftolozane Novel Cephlosporin for cutis Abiogen Nerixia Osteogenesis Imperfecta (OI) Raptor Procysbi Nephropathic Cystinosis Viropharma Plenadren Addisons Disease Zogenix Sumavel Neurology Pharmaxis Bronchitol Cystic Fibrosis Sucampo Amitiza Oncology Support Sanofi Campath Chronic Lymphatic Leukaemia Brabant Brabafen Dravet Syndrome (Epilepsy) Taiho TAS-102 Colorectal Cancer Iron Tx ST10 Iron Deficient Anaemia Eisai Fycompa Epilepsy Clinigen Cardioxane Oncology Support Ethyol Oncology Support Foscavir BMT Vibativ HAP Savene Oncology Support Index Pharmaceuticals Kapaproct Dravet Syndrome (Epilepsy) Copyright Clinigen Group plc. All rights reserved GAP delivered 58,000 units in FY14 (31,000 FY13) Extended Access/Non-launch markets Early Access Mature Access Right Drug Right Patient Right Time 12 Source: GAP Business unit 5 th July

14 Continued growth in activity with units supplied up 87% Good growth from long-term programs, Campath (+100%) and BTG (+60%) New client wins; AZ, BI, Taiho and Cubist Wind-down of a large early access program (enzalutimide) Financial Year 2014 Significant sales growth, up 54% Strong gross profit performance, up 33% Cliniport an on-line management support tool live for all programs m 12 months ended 30 June Clinigen CTS Clinigen GAP Sales Clinigen SP Sales YoY GAP Growth (%) -16% 559% 54% Clinigen CTS Clinigen GAP GP Clinigen SP Gross profit YoY GAP Growth (%) -42% 467% 39% Gross Profit Margin (%) 43.3% 37.3% 33.4% Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 13

15 Key Strategic Objectives MRSA (Vibativ) Right Drug Right Patient Right Time 14

16 Key Strategic Objectives SO 1: Acquisition of product opportunities from top 50 pharma SO 2: Revitalize acquired assets SO 3: Extend global capabilities SO 4: #1 Global CTS Company SO 5: #1 Global GAP Company SO 6: Corporate Acquisitions Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 15

17 SO 2: Revitalize acquired assets Foscavir is an example of what can be achieved (five-fold growth), the dexrazoxane assets have similar opportunities for revitalization Article 31 PSUR & ANSM meetings Cardioxane US launch Dexrazoxane Broader indication Combipack? Savene Pricing Central vs decentralized license Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 16

18 SO 3: Extend global capabilities Clinigen currently controls its global product supply through a complex network of partners. Strengthening our market presence and directly serving key growth markets for all three operational businesses is a key strategy Partner Hospira CPDN Technofarma IMS Medical Proreo Pharma MegaPharm BL&H Zuellig Nobel Pharma Clinect Senaru Country USA Canada South & Latin America Russia Switzerland Israel South Korea Singapore & Asia Japan Australia & NZ India Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 17

19 Key investment highlights Unique business model, supplying critical life saving, hospital-based and emergency medicines, both licensed and unlicensed, into c. 75+ countries via a global distribution (hub and spoke) network Highly profitable and cash generative business with a impressive track record of significant growth Good visibility of earnings with significant growth opportunities, both organically and through acquisition Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 18

20 Appendices Right Drug Right Patient Right Time 19

21 Operating business overviews focuses on acquiring global rights to niche hospital only drugs or emergency medicines SP has had strong growth with good margins which makes it the largest contributor to Gross Profit SP currently has five products in its portfolio; two anti-infective products, Foscavir and Vibativ and three oncology support products, Cardioxane, Savene and Ethyol New product identification and in-licensing or acquisition of new products is an important strategic element for Clinigen, with the goal of 10 products by end 2018 has an 11 year history in clinical and comparator trial drug sourcing. CTS is the largest sales contributor with strong historical growth. The market is c.$2bn per annum and Clinigen is the number two ranked specialist company globally for outsourced clinical trial drug supply The strategic goal is to be the leading global company by 2018 Clinigen SP uses the relationships and insights gained from late stage product withdrawals and non-launch market access programs run by GAP to identify potential candidates for acquisition or in-licensing Clinigen CTS and GAP benefit from Clinigen SP s experience of regulatory, pharmacovigilance and quality systems required as a specialty pharmaceutical company plays an important role in linking the three businesses and ensuring synergies are realised across the Group due to its role in pre-launch, unlicensed supply and withdrawal medicines GAP has successfully transformed from a UK Specials business to a provider of exclusive Global Access Programs GAP has been instrumental in identifying product acquisition candidates GAPs focus is on extending its global supply and distribution network Copyright Clinigen Group plc. All rights reserved Clinigen GAP provides on-going patient access to comparator drugs following their clinical trial. GAP benefits from relationships in the clinical trial market gained by Clinigen CTS Right Drug Right Patient Right Time 20

22 Operating businesses overview Discovery & Pre-Clinical Clinical Development Regulatory & Marketing Supply Services Products Lead selection & optimization followed by development formulation and pre-clinical studies Phase I Clinical Trials Phase II Clinical Trials Phase III/IV clinical trials & post marketing surveillance Pre marketing launch & support Post marketing supply Patent expiry Mature & discontinued products Global Access Programs (GAP) Global Trials Supply (CTS) Specialty Pharmaceuticals (SP) Global supply of medicines for use in phase II to IV clinical trials Diversified, blue chip customer base with many of the global top 20 pharmaceutical companies and CRO s as its customers Has sourced more than 3,750 products for circa 2,500 clinical trials in the last four years Relationships developed through Clinical Trials Supply underpin product sourcing for Global Access Programs and distribution for Specialty Pharmaceuticals Global Access Programs allow critically ill patients access to unlicensed but potentially life saving treatments Enable companies to provide market access to medicines before obtaining regulatory approval and/or in non-launch markets or continue to provide a drug after discontinuation or withdrawal Most often run in orphan or infectious diseases or oncology programs Exclusive programs under management for clients including Pfizer, Sanofi, GSK, Boehringer-Ingelheim, Eisai, BTG and Astellas Relationships and insights from late stage product withdrawals support identification of potential product acquisitions for Specialty Pharmaceuticals Acquiring or in-license niche, hospitalbased drugs divested by large pharmaceutical companies with potential to revitalize with respect to price, geography and/or other indications Five products in existing portfolio Active pipeline of potential product acquisitions from global top 50 pharmaceutical companies High profitability with FY2014 gross profit margin of 86% Strong in-house experience of regulatory, pharmacoviligance and quality systems Benefits from Clinical Trials Supply relationships with major pharmaceutical companies and insights gained from GAP late stage product withdrawals Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 21

23 Senior Management Peter George Chief Executive Officer Joined Clinigen when it formed in June 2010 Former CEO at Penn Pharma, having led a GBP67m management buy-out (2007) Previously executive VP for Wolters Kluwer Health with responsibility for Europe/Asia Pacific regions Former Chief Operating Officer of Unilabs Clinical Trials International Limited Robin Sibson Chief Financial Officer Joined ADL Healthcare Limited, a company owned by Clinigen s former Executive Chairman (2003) Over 30 years experience in the pharmaceutical industry, including 15 years as Finance Director Formerly Finance Director of BASF s UK Pharmaceuticals, sales and R&D divisions Previously Finance Director at Boots UK Pharmaceutical business, leading the integration following its sale to BASF Shaun Chilton Chief Operating Officer Joined Clinigen in January 2012 Previously President within KnowledgePoint360 Group, a global pharmaceutical information and services operation 20 years commercial, strategic and operational experience, including sales and marketing in Pfizer and Sanofi-Aventis (now Sanofi) Paul Thomas Chief Technical Officer Joined Clinigen as consultant in early 2011, permanently appointed in April 2012 Previously Chief Scientific Officer at Penn Pharma More than 25 years experience in the pharmaceutical industry, having held senior quality assurance and manufacturing posts at Parke-Davis/Warner Lambert and Nycomed-Amersham (GE Healthcare) Copyright Clinigen Group plc. All rights reserved Right Drug Right Patient Right Time 22