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MAYNE PHARMA GROUP LIMITED AGM Information 2017

Nov 27, 2017

65396_rns_2017-11-27_20554729-34e0-45fa-92b6-b11ac4449688.pdf

AGM Information

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Mayne Pharma Group Limited Annual General Meeting 28 November 2017

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US generic industry dynamics

  • Consolidation of customers and payers

  • Acceleration of generic approvals by FDA

  • Aggressive competition and pricing activities impacting the generic market

  • Accelerated price deflation being reported by US generic peers

  • High single - mid teen digits

  • Industry experiencing declining generic revenue and gross profit margins

  • ─ -5% to -15% revenue declines

  • ─ Some peers reporting 1,000 basis point reduction in gross margins

Share Price Performance (% change) Performance (% change) Performance (% change)
Company 1-Year 2-Year 3-Year 5-Year
(60%) (45%) (9%) +150%
(64%) (78%) (77%) (66%)
+3% (28%) (33%) +41%
+23% (61%) (45%) (17%)
(53%) (87%) (89%) (72%)
+20% (32%) (44%) +462%

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Sources. Bloomberg data as at 22 November 2017.

FY17 key financial metrics[1]

Reported basis Revenue A$572.6m,

+114%

Reported basis EBITDA

  • A$204.0m, +165%

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Underlying basis
EBITDA [2]
 A$206.5m, +133%
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Reported basis
NPAT
 A$88.6m, +137%
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Reported basis
EPS
 6.2 cents, +30%
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  • (1) EBITDA and NPAT is profit attributable to members of the Company.

(1) (2) Adjustments to reported EBITDA include A$22.4m net patent litigation gains (A$26.2m of patent settlement income less A$3.8m of litigation expenses relating to Mayne Pharma’s allegation that Merck’s Noxafil® product infringes a Mayne Pharma patent); A$20.2m intangible asset impairment; A$5.6m of transaction and other related costs; A$5.3m credit for the revaluation of HPPI warrants; A$1.5m of legal costs associated with the US Department of Justice investigation and A$2.9m to remove the HedgePath Pharmaceuticals Inc. (HPPI) losses attributable to members of the Company.

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Generic Products Division (GPD)

  • FY17 revenue increased by 292% to A$419m

  • FY17 gross profit increased by 259% to A$218m

  • Dofetilide became largest selling generic product

  • Teva acquired products delivered revenue of US$180m and EBITDA of US$90m

  • Accelerated price deflation in the second half impacting gross profit margin

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Specialty Brands Division (SBD)

  • FY17 revenue down 20% to A$62m

  • FY17 gross profit down 20% to A$59m

  • Impacted by loss of exclusivity on Doryx® 50mg and 200mg tablets in May 2016

  • Stronger performance in 2H17 driven by launch of Fabior® and Sorilux® in January 2017

  • Both Fabior® and Sorilux® exceeded the previous peak prescription volumes under the former brand owner

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  • Doubling dermatology field sales force in FY18

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Metrics Contract Services (MCS)

  • FY17 revenue up 18% to A$58m

New fluid bed spray coater and stability centre

  • FY17 gross profit up 22% to A$32m

  • Growing customer demand for end to end solutions

  • Greenville facility expansions and investment in new technical equipment attracting higher value and commercial contract manufacturing business

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Mayne Pharma International (MPI)

  • FY17 revenue up 2% to A$34m

  • FY17 gross profit down 13% to A$7m

  • Australian sales benefited from sales growth in Lozanoc® and oxycodone; offset by softer Kapanol® and injectable sales

  • Gross profit decline reflects reduced one-off licensing fee income and international Kapanol® royalties

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  • Australia - Urorec® launched and Monurol® launching in FY18

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Greenville campus – nearing completion

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Year to date October trading

  • Revenue down 12% to A$151m impacted by generic competitive pricing pressures, abnormal Doryx® returns and lower SBD trade volumes

  • Gross profit impacted by abnormal Doryx® returns and also one-off extraordinary stock obsolescence in GPD

  • ─ Gross profit margin 41%

  • ─ Adjusted gross profit margin 50%[1]

  • GPD revenue down 10% on pcp to US$88m

  • MCS revenue up 7% on pcp to US$15m

  • MPI revenue up 12% on pcp to A$13m

  • SBD revenue down 48% on pcp to US$6m

  • ─ Adjusted revenue up 8% excluding abnormal Doryx® returns

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(1) Adjusted gross profit excludes one-off items of (i) A$8.9m abnormal stock obsolescence which is calculated as the amount above standard industry rates of obsolescence and (ii) A$7.6m of Doryx® returns emanating from the generic event on legacy Doryx 50mg and 200mg tablets

SUBA-Itraconazole franchise has multiple opportunities for growth

Anti-fungal

Oncology

  • Approved in Australia, Spain, Germany, UK, Italy, Portugal, Belgium and Austria

  • Marketed by Mayne Pharma in Australia and ISDIN in Germany and Spain

  • Partnered with the US listed HedgePath Pharmaceuticals Inc. (OTCQX: HPPI) to pursue the clinical development, registration and commercialisation of SUBA®-Itraconazole in anticancer applications

  • Out-licensed in 15 countries around the world and expect to launch in Argentina, Austria, Belgium, Columbia, Italy, Mexico and Portugal over the coming year

  • Mayne Pharma owns 50%+ of HPPI

  • FDA and EMA granted Orphan Drug Designation for BCCNS

  • Expected to file in the US in FY18

  • Ongoing US Phase IIb multi-centre clinical trial

  • US market potential: US$200m

  • US market potential: US$300m for BCCNS

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Phase IIb study in BCCNS patients

● 38 patients treated to date

  • ─ 10 patients in active treatment

  • ─ 10 patients in follow up

  • ─ 18 patients off study

● 195 BCC excisions per patient prior to the study

  • Only one surgery for a BCC target lesion while on study

● Target lesion (TL) response rates[1]

  • ─ All target lesions (N=477) 53.7%

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100%
75%
50%
25%
0%
-25%
-50%
-75%
-100%
% change from BL
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Target lesions

  • ─ Serious TLs (N=90) 55.6%

  • ─ Other TLs (N=387) 53.2%

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(1) Response defined as ≥ 30% size reduction from baseline (BL). Serious TLs defined as ≥ 6mm on the face or >20mm elsewhere

Phase IIb study in BCCNS patients (cont.)

  • Median time on study 38 weeks

  • Up to 90 weeks on study for some patients

  • Very good safety profile with

  • only 11% of patients discontinued due to adverse events

  • No hair loss

  • No loss of taste

  • No severe muscle spasms

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Durable response for 256 responding target lesions with limited side-effects

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