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MAYNE PHARMA GROUP LIMITED AGM Information 2019

Nov 21, 2019

65396_rns_2019-11-21_362165cf-79d0-4a99-becd-6df1fcc02ccd.pdf

AGM Information

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Mayne Pharma Group Limited

Annual General Meeting 22 November 2019

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Disclaimer

This material is not intended to be relied upon as advice to investors or potential investors.

Forward looking statements

  • This presentation contains forward-looking statements that involve subjective judgement and analysis and are subject to significant uncertainties, risks and contingencies, many of which are outside the control of, and are unknown to the Company. These forward looking statements use words such as ‘potential’, ‘expect’, ‘anticipate’, ‘intend’, ‘plan’ and ‘may’, and other words of similar meaning. No representation, warranty or assurance (express or implied) is given or made in relation to any forward looking statement by any person (including the Company). Actual future events may vary materially from the forward looking statements and the assumptions on which the forward looking statements are based. Given these uncertainties, readers are cautioned not to place undue reliance on such forward looking statements. Subject to the Company’s continuing disclosure obligations at law and under the listing rules of the Australian Securities Exchange, the Company disclaims any obligation to update or revise any forward looking statements. The factors that may affect the Company’s future performance include, among others: changes in economic conditions, changes in the legal and regulatory regimes in which the Company operates, litigation or government investigations, decisions by regulatory authorities, changes in behaviour of major customers, suppliers and competitors, interruptions to manufacturing or distribution, the success of research and development activities and research collaborations and the Company’s ability to protect its intellectual property.

Other

  • A glossary of industry terminology is contained in the Mayne Pharma Annual Report which can be accessed at maynepharma.com/investorrelations/results-reports and product descriptions are detailed at maynepharma.com/us-products and maynepharma.com/australianproducts.

  • NUVARING®, LO LOESTRIN® FE, XULANE® and TAYTULLA® are registered trademarks of third parties

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CHAIRMAN’S ADDRESS

US peer share price performance

Relative share price performance
0%
20%
40%
60%
80%
100%
120%
Nov-18
Jan-19 Mar-19 May-19
Jul-19
Sep-19
Mayne Pharma
US peers
Share price change
Company
1-Year
2-Year
5-Year
(46%)
(11%)
(27%)
(53%)
(22%)
(82%)
(48%)
(54%)
(69%)
(83%)
Na
Na
(63%)
(38%)
(93%)
50%
(64%)
(80%)
(45%)
(88%)
(89%)

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  1. Based on share prices as at 20 Nov 2019. US generic peers comprises Teva, Mylan, Amneal, Akorn, Endo and Lannett

FY19 overview

  • Reported sales of A$525.2m, down 1%

  • Reported EBITDA of A$111.6m and underlying EBITDA of A$130.9m

  • Reported net loss after tax of A$(280.8)m driven by asset impairments

  • Positive operating cash flow of A$106.6m

  • Net debt reduced by A$18.0m in 2HFY19 with bank leverage ratio 2.0x

  • Generic Products impacted by competitive pressure on key products

  • Strong growth from Specialty Brands with sales and gross profit doubling

  • Metrics Contract Services benefited from favourable market dynamics and the new Greenville manufacturing facility

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Actively rebalancing the portfolio to specialty products led by the commercialisation of E4/DRSP oral contraceptive

FY19 revenue by type FY24F revenue by type[1] (illustrative purposes only) <20% 34% 45% A$525m >60% US specialty products[1] US contract services US retail generics / other Rest of world

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Pipeline and business development activity targeting complementary specialty products in women’s health and dermatology

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  1. Specialty products includes dermatology, women’s health and infectious disease products (brand and generic)

CEO’S ADDRESS

Year to date trading update

A$million Jul - Oct 19
(4 months)
Jul - Oct 18
(4 months)
Jan - Apr 19
(4 months)
Change %
versus pcp
Jul - Oct 18
Change %
versus
Jan - Apr 19
Specialty Brands
Contract Services
Generic Products
Mayne Pharma International
Reported revenue
Reported gross profit
Group grossprofit %
26.3
26.4
28.0
25.5
22.0
24.9
88.6
120.3
88.9
13.3
14.3
12.3
153.6
183.0
154.1
(1%)
(6%)
16%
2%
(26%)
(0%)
(7%)
8%
(16%)
(0%)
72.3
107.8
78.6
47%
59%
51%
(33%)
(8%)
Average AUD/USD FX rate 0.684
0.726

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Dermatology products TRx performance

Foam weekly prescriptions (TRx)

DORYX® weekly prescriptions (TRx)

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3,000
2,500
2,000
1,500
1,000
500
0
FABIOR SORILUX LEXETTE
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4,500
4,000
3,500
3,000
2,500
2,000
1,500
1,000
500
-
DORYX 200mg generic DORYX other
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Source: IQVIA TRx, 8 November 2019

TOLSURA® establishes a new US infectious disease platform

  • TOLSURA® listed on 6 IDN[1] / hospital networks representing 11% of institutional itraconazole market volume

  • US addressable market: US$300m[2]

  • Expect to broaden the therapeutic use of TOLSURA® through further clinical programs

  • Targeting 25% itraconazole US prescription (TRx) market share by end of FY22

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  1. Integrated Delivery Network

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  1. Company estimate based on target patient population, gross pricing and current healthcare costs to treat patient population includes endemic mycoses and select other indications including chronic pulmonary aspergillosis

E4/DRSP oral contraceptive overview

  • 20-year exclusive license and supply agreement for E4/DRSP in the US

  • Novel, next generation combined hormonal contraceptive (CHC)

  • Two Phase 3 studies conducted in >3,700 patients with positive results

  • Expect to launch 1HCY21 subject to FDA approval

  • Total consideration of US$295 million paid if cumulative net sales exceed US$2.25 billion

  • Following regulatory approval, Mithra will own up to 9.6% of Mayne Pharma and hold a Board seat

  • Peak net sales potential in excess of US$200 million per annum

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E4 (Estetrol): a unique mode of action

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Antagonist on the membrane receptor E4 blocks the estrogen receptor in the breast and has a neutral effect on the liver

Agonist on the nuclear receptor E4 activates the nuclear estrogen receptor in bone, vagina, endometrium stability and heart to provide beneficial effects (as other estrogens)

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E4 acts differently compared to other estrogens depending on the tissue

Benefits of E4/DRSP oral contraceptive

✓ Studied in 4,400 women during Phase 2 and Phase 3 with low adverse events Phase 3 studies showed E4/DRSP was highly efficacious including in high BMI ✓ women and had neutral effect on lipids or glucose metabolism

✓ Minimal impact on hepatic function (liver cells), lipids and glucose metabolism Phase 2 clinical studies demonstrate less impact on coagulation factors which ✓ could result in improved Venous Thromboembolism (VTE) risk[1]

✓ Potentially improved safety on reproductive tissue due to unique mechanism of action[1] Clinical studies show no impact on weight ✓ Potential decreased drug-drug interactions ✓

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Safe and effective with a number of potential points of differentiation

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  1. Based on mechanism of E4/DRSP and may not be approved as part of US label

Combined hormonal contraceptive market

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CHC market
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IQVIA sales of key CHC brands

US$970m

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US$830m
Combined oral
7%
contraceptive
24%
US$4.0b Vaginal ring
US$290m
69%
US$170m
Patch
Ring Pill Patch Pill
% share of CHC
4.9% 4.4% 1.9% 0.7%
market by units
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US patient population of 10 million women using CHCs

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Source: IQVIA, Sales and NSP equivalent units, Sep 2019

Outlook

  • Generic Products performance will depend on many factors including timing of FDA approvals, competitor launches and withdrawals on key products

  • Specialty Brands expected to benefit from product launches of TOLSURA® and LEXETTE®, and from E4/DRSP in FY22

  • Contract Services expected to benefit from expansion of technical team and delivery of the pipeline of committed business

  • Group operating expenses expected to be lower in FY20 versus FY19 on a constant currency basis

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