Mayne Pharma Group Limited

Transcription

1 Mayne Pharma Group Limited Company Presentation Rodman & Renshaw Annual Investment Conference September 9 th, 2015 Stefan Cross, President, Mayne Pharma USA

2 Mayne Pharma is a diverse global pharma company Mayne Pharma is an Australian-listed specialty pharmaceutical company, headquartered in Adelaide Develops and manufactures generic and proprietary pharmaceuticals which are distributed globally either directly or through distribution partners Fully-integrated US operations across contract services, generic and branded products Product portfolio and pipeline characterised by high barriers to entry DEA regulated molecules, high potent and modified-release - 30 molecules marketed globally across 100 different presentations pipeline products targeting US markets >US$7bn FY15 revenue of A$141m and EBITDA of A$36m 1 12% By geography 5% 17% USA A$141m By division 23% US Generic Products A$141m 24% By channel Australia Rest of World 78% 41% Metrics Contract Services US Specialty Brands (Doryx) Mayne Pharma International Market capitalization >A$850m Products sold in 10+ countries 125+ contract service clients 31% A$141m 27% 42% Generic products Branded products Contract services & manufacturing 600+ staff (1) Refer to reconciliation table in earnings release dated 28 August 2015 for adjustments to EBITDA 2

3 FH Faulding & Co Company history s Leading Australian healthcare company with over 150 years of history Development of enteric coated erythromycin (Eryc ) FDA approval and first US sales of Eryc by Warner Lambert (Warner Chilcott) 1980s Salisbury site acquired in 1983 Development of delayed-release doxycycline capsules (Doryx ) and enteric-coated aspirin (Astrix ) 1990s Development of sustained-release morphine (Kadian / Kapanol ) Metrics founded as a contract testing company in Greenville, North Carolina s Development of improved bioavailability technology (SUBA ) Development of pellet-in-a-tablet technology (Doryx 75/100/150mg tablet) Development of Lozanoc, improved formulation of itraconazole 2004 Metrics moved to new purpose built facility in Greenville and began development of its own generic products 2009 Hospira sold Mayne Pharma International to ASX listed Halcygen Pharmaceuticals (which later changed its name to Mayne Pharma Group Limited) 2011 Metrics acquired its own US distribution capabilities - Midlothian Laboratories 2012 Mayne Pharma acquired Metrics, Inc. Mayne Pharma acquired Kapanol and related assets in Australia Mayne Pharma acquired Libertas, Inc US based generic business Mayne Pharma acquired Zebutal from Shionogi and Lorcet and Esgic from Forest Laboratories Mayne Pharma acquired methamphetamine tablet and butalbital/apap/caffeine capsule ANDA Mayne Pharma acquired Doryx brand and related assets from Actavis 3

4 Mayne Pharma s international footprint Commercial office Raleigh, North Carolina Direct commercial presence Product development and manufacturing facility space. FDA approved. US$ hectare facility at Greenville, North Carolina has 99,200ft 2 of manufacturing m strategic investment in new greenfield oral dose commercial manufacturing facility (Announced Aug 15) to double footprint to 225,000ft 2 Technologies: - High potency drug handling - Matrix tablets - Controlled substances (CII-CV) - Modified-release (capex expansion) Indirect presence through distribution partners for current and pipeline products Head office and manufacturing facility 13 hectare facility at Salisbury, South Australia has 129,000ft 2 of manufacturing space. FDA, MHRA and TGA approval. A$11m investment in additional fluid bed spray coater (Announced Aug 15). Technologies: - Modified release beads - Modified release tablets - Microencapsulation utilizing spray drying process Commercial office Melbourne, Victoria 4

5 Mayne Pharma s business structure United States Rest of world US Generic Products (GPD) US Specialty Brands (SBD) Metrics Contract Services (MCS) Mayne Pharma International (MPI) Overview Develops, manufactures, markets and distributes generic products in the US Responsible for the marketing and distribution of branded pharmaceuticals in the US Provides contract pharmaceutical development services to 3rd parties globally Develops, manufactures, markets and distributes branded and generic products globally Key current products and services Dermatology / antiinfectives - Doxycycline Hyclate, Erythromycin, Nystatin Pain Butalbital/APAP/ Caffeine, Hydrocodone/APAP, Oxycodone, Oxycodone/APAP, Oxycodone/Aspirin Other Dermatology - Doryx Analytical services Formulation development Clinical trial batch manufacture Potent and cytotoxic services Commercial contract manufacturing Dermatology / antiinfectives Doryx, Eryc, Lozanoc Pain Kapanol, Percutane Other Licener, Magnoplasm, range of injectable products Amiodarone, Bromfenac, Liothyronine, Methamphetamine 5

6 FY15 operational and financial highlights Transformational US$50m Doryx acquisition completed which has diversified and transformed the earnings profile US Specialty Brands Division created with a 60+ person sales team to market specialty brands in the US Expanded marketed product portfolio and pipeline internationally Brought distribution of Doryx, Methamphetamine and Oxycodone franchise in-house in the second half Launched 3 new products in the US and 7 in Australia FDA approval of 50mg Doryx tablet and TGA approval of 12 products Out-licensed Lozanoc into 9 further countries in Europe, Asia and Sth America 30+ pipeline products targeting US markets >US$7bn of which 17 pending US FDA approval 20+ pipeline products targeting AU markets >US$100m of which 7 pending Australian TGA approval First-to-file opportunity for Tikosyn generic capsules; settled litigation with Pfizer and free to launch following FDA approval 2H15 underlying EBITDA performance up 49% to $22m on 1H15 with Doryx, directly distributed generic products and Metrics Contract Services driving this growth Solid financial position with alternate sources of capital to fund growth - net debt of $2.6m at 30 June 2015 Investing for growth through strategic investment in Australian and US facilities Material earnings growth to come in FY16 from recent product acquisitions, new product launches, increased market penetration of existing products and accelerated growth in contract services 6

7 Doryx - the game changer for Mayne Pharma 1 Transformed earnings base following Doryx acquisition Attractive market fundamentals in US dermatology space Optimize Doryx sales through: Mayne Pharma s sales force, which will be focused and dedicated to marketing Doryx Further product pricing improvements Continued product innovations to enhance product characteristics Line extensions Mayne Pharma has an intimate knowledge of Doryx having developed the product and manufactured it for 30 years and having employed new US leadership who successfully managed the brand in the past Provided platform for Mayne Pharma to build a US specialty brands franchise through targeted in-licensing / product acquisitions and fully leveraging own development pipeline 7

8 Development pipeline expected to drive long-term sustainable growth Team of 60+ professionals in R&D with particular expertise in formulating complex oral dose forms including - highly potent compounds - schedule II-V controlled substances - inherently unstable compounds - modified release - products with poor bioequivalence Focus on higher value and high barrier to entry product opportunities in the US Active in-licensing program to supplement organic development targeting niche generic and specialty products 30+ pipeline products in the US targeting markets >US$7bn1-17 products pending with FDA targeting markets >US$1.8b1 US Pipeline statistics IMS market size (US$bn) 1 August Number of products Filed To be filed Total pipeline products in Australia targeting markets >A$150m1 Selective paragraph IV filings - First to file opportunity with Tikosyn (1) IMS Health, MAT June

9 5 pillars of our corporate strategy 1. US retail generics maximization 3. R&D maximization 4. Strategic acquisitions, licensing and partnerships 2. Establish a US branded specialty franchise 5. Optimize and grow US contract services 9

10 Outlook US Specialty Brands Division (SBD) US Generic Products Division (GPD) Metrics Contract Services (MCS) Mayne Pharma International (MPI) New segment will capture full year contribution from Doryx Recent launch of 50mg Doryx tablet is expected to grow the franchise Expected monthly EBITDA contribution of US$2.7m on average in FY16 from US Doryx franchise US generic market grew 7% in FY15 to US$66bn 1 Growth in GPD is expected to accelerate with Methamphetamine, Oxycodone, BAC, Hydrocodone and Erythromycin being the key drivers In-licensed FDA-approved generic BAC tablet with launch in FY16 (Market size >US$100m 1 ) Upsides include timing of FDA product approvals (including Dofetilide), price optimisation and more rapid market share gains Key performance indicators such as the number and value of quotes written and signed as well as committed business pipeline trending strongly indicating a positive outlook for MCS in the coming year Expect further growth in later stage projects Knowledge of the Greenville site expansion will help secure additional business as able to promote one-stop shop Excluding US Doryx, MPI sales and gross profit are expected to be up driven by stronger contributions from injectable portfolio, OTC products and the launch of oxycodone immediaterelease tablets in Australia. Morphine and Itraconazole are expected to drive international sales Mayne Pharma is now set for a period of strong growth in the world s largest pharmaceutical market (1) IMS Health, MAT June

11 A specialty pharmaceutical company with an increasingly diversified portfolio of products, technologies and footprint 11