Mayne Pharma Group Limited

Transcription

1 Mayne Pharma Group Limited Company Presentation Rodman & Renshaw Annual Investment Conference September 9, 2014 Stefan Cross, President Mayne Pharma USA

2 Mayne Pharma is a diverse global pharma company Mayne Pharma is an Australian-listed specialty pharmaceutical company Develops and manufactures branded and generic products which are distributed globally either directly or through distribution partners FY14 Revenue Breakdown By geography 5% 16% 79% USA Australia Rest of World Vertical contract services platform offering analytical services, formulation and commercial manufacturing FY14 revenue of US$131m and underlying EBITDA of US$37.1m 1 By product type 26% 41% Generic products Branded products Contract services & manufacturing Market capitalization of US$410m 30 year history in drug delivery 500+ employees 33% By segment 42% 39% US Products Metrics Contract Services MPI (1) USD:AUD FX rate of Refer to reconciliation table in earnings release dated 27 August 2014 for adjustments to EBITDA 19% 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 taste-masking technology (Cleantaste ), sustained-release morphine (Kadian / Kapanol ), pulsereleased diltiazem HCI (US equivalent to Cardizem CD) and transfer of drug delivery technology and products to Faulding US site (Purepac Pharmaceutical Co) 2001 Metrics founded as a contract testing company in Greenville, North Carolina 2000s 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 2008 Metrics invested in a highly potent / cytotoxic suite to add to its development and manufacturing capabilities 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 2013 Mayne Pharma acquired Libertas, Inc US based generic business Mayne Pharma acquired ZEBUTAL from Shionogi 2014 Mayne Pharma acquired LORCET and ESGIC from Forest Laboratories 3

4 Mayne Pharma s international footprint Warehouse 23,000ft 2 commercial and distribution facility in Montgomery, Alabama Direct commercial presence R&D and manufacturing facility 14.6 hectare facility at Greenville, North Carolina 99,200ft 2 of manufacturing space. FDA inspected and cgmp compliant. Annual production capacity of: ~1 billion capsules Segregated potent drug development facility Indirect presence through distribution partners for current and planned 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. Annual production capacity of: ~2.5 billion capsules/tablets 100 tonnes of bulk product 16 million units of liquids and creams Corporate registered office Melbourne, Victoria 4

5 Operating facilities Facility location Greenville, NC, USA Salisbury, Australia Montgomery, AL, USA Location Inspections Technologies Scale FDA, MHRA inspected and cgmp compliant Last FDA inspection May 2014 High potency drug handling Matrix tablets Controlled substances (CII-CV) FDA, TGA, MHRA inspected and cgmp compliant Last FDA inspection August 2013 Modified release beads Modified release tablets Microencapsulation utilizing spray drying process FDA inspected and cgmp compliant Last FDA inspection May 2012 Distribute controlled substances (CIII-CV) 99,200ft 2 facility 129,000ft 2 manufacturing space 23,600ft 2 commercial and distribution facility Key capabilities Research and development Manufacturing Quality control and assurance Sales and marketing Commercial Corporate headquarters Research and development Manufacturing Quality control and assurance Sales and marketing Distribution Commercial Commercial operations Distribution Sales and marketing Customer service 5

6 Mayne Pharma s business segments Mayne Pharma International (MPI) US Products (USP) Metrics Contract Services (MCS) Overview Develops, manufactures, markets and distributes branded and generic products globally (principally Australian-manufactured product) Develops, manufactures, markets and distributes branded and generic products in the US (principally USmanufactured product) Provides contract pharmaceutical development services to 3rd parties globally FY14 financials Revenue US$56.2m Gross profit margin 51.2% Revenue US$52.2m Gross profit margin 56.3% Revenue US$26m Gross profit margin 45.6% Key current products and services Branded specialty Doryx, Eryc, Kapanol, Lozanoc, Urocarb Branded OTC/Pharmacy Astrix, Licener, Magnoplasm, Percutane Generic Aspirin, Doxorubicin, Doxycycline, Erythromycin, Ondansetron Commercial contract manufacturing Branded ESGIC, LORCET, ZEBUTAL Generic Amiodarone, Bromfenac, Butalbital/APAP/Caffeine, Doxycycline Hyclate, Erythromycin, Hydrocodone/APAP, Liothyronine, Methamphetamine, Nystatin, Oxycodone, Oxycodone/APAP Analytical services Formulation development Clinical trial batch manufacture Potent and cytotoxic services Commercial contract manufacturing Pipeline products 30+ products in pipeline 16 products pending with the TGA 30+ products in pipeline 17 products pending with the FDA n/a 6

7 MPI and USP revenue breakdown MPI revenue breakdown USP revenue breakdown 3% 8% 16% 3% US$56.2m 45% 2% 4% 5% 6% 7% 9% US$52.2m 20% 18% 12% 7% 13% 8% 14% Doxycycline Morphine Erythromycin Other Aspirin Itraconazole Contract manufacturing Nystatin Oxycodone Bromfenac Oxycodone/APAP Methamphetamine Other Liothyronine Butalbital/APAP/Caffeine Doxycycline Amiodarone Erythromycin 7

8 Recent financial and operational highlights Revenue (A$m) Strong growth in revenue and gross profit across all segments Successful integration of Libertas and US product acquisitions Margin expansion from changing sales mix and increased sales of key branded products New products launched in the US, Australia and Spain FDA approval of Oxycodone HCl Oral Solution and TGA approval of Lozanoc and Doxorubicin HCl IV 17 products now pending at the FDA and 16 products pending at the TGA Appointed licensing partners for Lozanoc in Spain, Italy, Portugal, Austria, China and South Korea 0 FY10 FY11 FY12 FY13 FY14 EBITDA underlying (A$m) FY10 FY11 FY12 FY13 FY14 EBITDA EBITDA margin R&D cash investment (A$m) 30% 20% 10% 0% Agreement finalised with HedgePath Pharmaceuticals to exploit SUBA -Itraconazole in various cancer indications in the US Management team strengthened across the organization FY10 FY11 FY12 FY13 FY14 8

9 Pipeline update >30 filings under review today with the FDA and TGA R&D increased significantly over last 2 years to expand US generic product portfolio 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 US Pipeline statistics IMS market size (US$bn) 1 August AU Pipeline statistics IMS market size (A$m) 1 August Filed To be filed Total Number of products products with poor bioequivalence Variety of formulation and formats including oral, topical, ointments, tablets and capsules Expect to file ~6 products with the FDA annually Filed To be filed Total Number of products (1) IMS Health MAT Jun

10 Specialty product and business development focus Expanding our specialty platform Dermatology Maximize value from Lozanoc anti-fungal application Pain Oncology Expand global footprint through out-licensing key branded products - Kapanol rest of world rights acquired back from GSK Exploit repurposing of existing products in new therapeutic areas - SUBA - Itraconazole in cancer Infectious disease Leverage and expand US and Australian commercial infrastructure to exploit new specialty brand opportunities Continued development of new specialty products employing drug delivery technology New patents filed/approved that strengthen protection of key products e.g. Doryx, Lozanoc 10

11 Future catalysts for value Growth strategy US retail generics maximisation Doxycycline franchise optimisation R&D execution Strategic acquisitions, licensing and partnerships Approval and launch of filed FDA products Optimise market penetration of product portfolio Portfolio expansion through growing product pipeline Efficient and reliable product sourcing, manufacturing and supply Leverage patent and data exclusivity Optimise market penetration of US product portfolio Portfolio selection that leverages drug delivery expertise in complex generics and specialty products Selective paragraph IV filings in the US Development of SUBA - Itraconazole in cancer in alliance with HedgePath Pharmaceuticals Licensing niche generic or specialty products in Australia and US Commercialise specialty products such as Lozanoc through licensing arrangements in key markets to broaden global footprint Product and enterprise acquisitions with strong growth potential, complementary assets and technologies Build an injectable and pain portfolio in Australia 11

12 A specialty pharmaceutical company with an increasingly diversified portfolio of products, technologies and footprint 12