Mayne Pharma Group Ltd. · ASX:MYX
Mayne Pharma — Shareholder Meeting (November 2011)
18 slides from Mayne Pharma's shareholder meeting presentation, Nov 23, 2011
Slide 1: FY11 Annual General Meeting
For personal use only Mayne Pharma Group Limited FY11 Annual General Meeting 23rd November 2011 Mr Roger Corbett Chairman Dr Roger Aston Chief Executive Officer www.maynepharma.com
Slide 2: Agenda
Agenda For personal use only • Chairman’s address • Chief Executive Officer’s presentation • Formal business – Financial report – Re‐election of Directors – Remuneration report 2
Slide 3: Executive Summary
Executive Summary For personal use only • Challenging 12months for Doryx® with US sales down 46%* Doryx® • New dual‐scored Doryx® 150mg tablet launched in US • Doryx® has maintained marketing exclusivity in the US post expiry of 30 month stay • SUBACAP® on track for approval in the EU during FY12 SU
Slide 4: FY11 group results
FY11 group results For personal use only • Sales and earnings down on annualised FY10 result FY10 Reported 8 month contribution MPI – Total revenue $50.1m $36.7m – Gross profit $23.2m $18.5m – Reported EBITDA $7.9m $8.5m – Reported NPAT $1.7m $3.3m – Reported EPS 1.1cps 2.6cps – Underlying EBITDA $9
Slide 5: Balance sheet and cash flow stable
Balance sheet and cash flow stable For personal use only • Total assets of $53.7m (30 June 2011), including $5.8m cash, $21.5m property, plant & equipment and $12.8m inventory & receivables • US$ debt completely paid down in October • Carrying value of the earn‐out to Hospira is $15.1m with 5 remain
Slide 6: Business strategy for growth
Business strategy for growth For personal use only Existing products • Maintain a product life-cycle management program to stay ahead of Improve potential competition formulations • New dose strengths and improved formulations of many existing products under development Defend & • Vigorous defense a
Slide 7: Agenda
Agenda For personal use only • Chairman’s address • Chief Executive Officer’s presentation • Formal business – Financial report – Re‐election of Directors – Remuneration report 7
Slide 8: Key milestones
Key milestones For personal use only Achieved • SUBACAP® dossier lodged in the EU • Successful Phase II trial of SUBACAP® in the US • Doryx® maintaining marketing exclusivity in the US • Maiden dividend and special dividend paid • Debt paid down • Restructured business to deliver ongoing savings Ong
Slide 9: Proprietary drug development program
Proprietary drug development program For personal use only Extended IP Protection Controlled Release New Markets Simplified Regulatory Path Taste Masked Proven Drugs SuperGeneric Drugs Improved Bioavailibility Reduced Safety/ Efficacy Development Proprietary Drug Delivery Technologies Improvements T
Slide 10: SUBACAP®
SUBACAP® For personal use only • Super‐bioavailable itraconazole – Significant improved formulation of itraconazole (Sporanox®) based on SUBA® technology – Sporanox® hampered by erratic/unpredicatble clinical response (poorly controlled absorption) and safety issues – SUBACAP® formulation provides f
Slide 11: SUBACAP® broad-spectrum antifungal
SUBACAP® broad‐spectrum antifungal For personal use only FUNGAL INFECTIONS Histoplasmosis Aspergillosis Onychomycosis Candidiasis Cryptococcus Itraconazole 9 9 9 9 x Fluconazole x x x 9 9 Posaconazole x 9 x 9 x Voriconazole x 9 x 9 x Terbinafine x x 9 x x Itraconazole’s broad‐spectrum makes it a goo
Slide 12: SUBACAP® – Phase II study
SUBACAP® – Phase II study For personal use only All cures at Week 24 * Significantly superior to placebo 18% • Significantly improved 16% formulation of itraconazole 14% based on SUBA® technology 12% % of patients 10% • SUBACAP® significantly 8% superior to placebo at both 6% efficacy endpoints 4% •
Slide 13: SUBACAP® – Regulatory update
SUBACAP® – Regulatory update For personal use only Europe • Collaborating with MHRA to address its evaluation questions, with approval anticipated in FY12 • Launch FY12 subject to approval and appointment of marketing and distribution partner US • Pre‐phase III meeting requested with the FDA to conf
Slide 14: SUBACAP® – Development update
SUBACAP® – Development update For personal use only • New dose forms in development • Line extensions under review • Manufacturing equipment for commercial supply currently being installed at Salisbury facility 14
Slide 15: Doryx®
Doryx® For personal use only • Dual‐scored Doryx® 150mg tablet approved and launched in the US • Injunction against Mylan prevented launch of a generic Doryx® following the expiry of 30 month stay in September – US District court found a reasonable likelihood that the Doryx® 161 patent is valid and
Slide 16: Other products
Other products For personal use only • New Astrix® formulations under development to expand the product offering to patients • New business development resource appointed to expand the contract manufacturing client base • New product opportunities under review – Specialised generics for the US marke
Slide 17: Trading update
Trading update For personal use only • Our year to date performance is up on last year for both sales and EBITDA • Company expects 1H12 EBITDA to be up on last year • Business now debt free • US$5m 3‐year interest only bill facility negotiated, but not drawn • Cash on hand (31/10/11) $5.0m – Net cas
Slide 18: Agenda
Agenda For personal use only • Chairman’s address • Chief Executive Officer’s presentation • Formal business – Financial report – Re‐election of Directors – Remuneration report 18
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