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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
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Consolidation of customers and payers
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Acceleration of generic approvals by FDA
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Aggressive competition and pricing activities impacting the generic market
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Accelerated price deflation being reported by US generic peers
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High single - mid teen digits
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Industry experiencing declining generic revenue and gross profit margins
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─ -5% to -15% revenue declines
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─ 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)
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FY17 revenue increased by 292% to A$419m
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FY17 gross profit increased by 259% to A$218m
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Dofetilide became largest selling generic product
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Teva acquired products delivered revenue of US$180m and EBITDA of US$90m
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Accelerated price deflation in the second half impacting gross profit margin
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Specialty Brands Division (SBD)
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FY17 revenue down 20% to A$62m
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FY17 gross profit down 20% to A$59m
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Impacted by loss of exclusivity on Doryx® 50mg and 200mg tablets in May 2016
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Stronger performance in 2H17 driven by launch of Fabior® and Sorilux® in January 2017
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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
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FY17 gross profit up 22% to A$32m
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Growing customer demand for end to end solutions
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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)
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FY17 revenue up 2% to A$34m
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FY17 gross profit down 13% to A$7m
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Australian sales benefited from sales growth in Lozanoc® and oxycodone; offset by softer Kapanol® and injectable sales
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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
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Revenue down 12% to A$151m impacted by generic competitive pricing pressures, abnormal Doryx® returns and lower SBD trade volumes
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Gross profit impacted by abnormal Doryx® returns and also one-off extraordinary stock obsolescence in GPD
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─ Gross profit margin 41%
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─ Adjusted gross profit margin 50%[1]
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GPD revenue down 10% on pcp to US$88m
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MCS revenue up 7% on pcp to US$15m
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MPI revenue up 12% on pcp to A$13m
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SBD revenue down 48% on pcp to US$6m
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─ 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
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Approved in Australia, Spain, Germany, UK, Italy, Portugal, Belgium and Austria
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Marketed by Mayne Pharma in Australia and ISDIN in Germany and Spain
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Partnered with the US listed HedgePath Pharmaceuticals Inc. (OTCQX: HPPI) to pursue the clinical development, registration and commercialisation of SUBA®-Itraconazole in anticancer applications
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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
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Mayne Pharma owns 50%+ of HPPI
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FDA and EMA granted Orphan Drug Designation for BCCNS
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Expected to file in the US in FY18
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Ongoing US Phase IIb multi-centre clinical trial
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US market potential: US$200m
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US market potential: US$300m for BCCNS
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Phase IIb study in BCCNS patients
● 38 patients treated to date
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─ 10 patients in active treatment
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─ 10 patients in follow up
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─ 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
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─ Serious TLs (N=90) 55.6%
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─ 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.)
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Median time on study 38 weeks
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Up to 90 weeks on study for some patients
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Very good safety profile with
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only 11% of patients discontinued due to adverse events
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No hair loss
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No loss of taste
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No severe muscle spasms
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Durable response for 256 responding target lesions with limited side-effects
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