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MAYNE PHARMA GROUP LIMITED Interim / Quarterly Report 2017

Feb 23, 2017

65396_rns_2017-02-23_6f6a09d5-53fc-4171-8434-8aa4edb7336a.pdf

Interim / Quarterly Report

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Friday, 24 February 2017

Manager, Company Announcements ASX Limited Level 4 20 Bridge Street SYDNEY NSW 2000

Via E-Lodgement

Dear Sir/Madam

Mayne Pharma Group Limited Interim Results

Please find attached the Appendix 4D Half Year Report, Directors’ Report, the Financial Report and Auditor’s Independent Review Report relating to the results for the half-year ended 31 December 2016.

This information should be read in conjunction with Mayne Pharma Group Limited’s 2016 Annual Report.

This announcement comprises the information required by ASX Listing Rule 4.2A and the statement required by Rule 4.2C.2.

Yours faithfully, Mayne Pharma Group Limited

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Mark Cansdale Group CFO & Company Secretary

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Appendix 4D Interim Results Half Year Report

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RESULTS FOR ANNOUNCEMENT TO THE MARKET APPENDIX 4D – HALF YEAR REPORT

% Change Dec
2016
$’000
Dec
2015
$’000
Revenue from ordinary activities
up
132% 294,831 127,261
Profit from ordinary activities before income tax expense
up
237% 90,811 26,986
Profit from ordinary activities after income tax expense
up
298% 71,323 17,905
Attributable to:
Equity holders of the parent
Non-controlling interests
up
up
278%
6%
72,736
(1,413)
19,231
(1,326)
298% 71,323 17,905
Other comprehensive income after income tax expense 57,781 6,889
Total comprehensive income after income tax expense 129,104 24,794
Attributable to:
Equity holders of the parent
Non-controllinginterests
130,245
(1,141)
25,551
(757)
129,104 24,794
Net tangible assets per ordinary share $0.051 $0.040
2016
Cents
2015
Cents
Basic earnings per share
Diluted earnings per share
5.15
5.03
2.46
2.39
Final dividend in respect of the financial year ended 30 June per share
Interim dividend in respect of the period ended 31 December per share
Nil
Nil
Nil
Nil

No dividend has been declared in relation to the period ended 31 December 2016.

Refer to the Directors’ Report and the accompanying ASX announcement dated 24 February 2017 for a brief commentary on the results.

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Page 2

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MAYNE PHARMA GROUP LIMITED ABN 76 115 832 963

HALF-YEAR FINANCIAL REPORT

FOR THE HALF-YEAR ENDED 31 DECEMBER 2016

(Prior comparable period: Half-year ended 31 December 2015)

Appendix 4D Interim Results Half Year Report

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CONTENTS

CORPORATE INFORMATION ............................................................................................................................................... 3 DIRECTORS’ REPORT .......................................................................................................................................................... 4 AUDITOR’S INDEPENDENCE DECLARATION ......................................................................................................................... 8 CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME ................................................... 9 CONSOLIDATED STATEMENT OF FINANCIAL POSITION ...................................................................................................... 10 CONSOLIDATED STATEMENT OF CHANGES IN EQUITY ....................................................................................................... 11 CONSOLIDATED STATEMENT OF CASH FLOW .................................................................................................................... 12 NOTES TO THE FINANCIAL STATEMENTS ........................................................................................................................... 13 DIRECTORS’ DECLARATION ............................................................................................................................................... 26 AUDITOR’S INDEPENDENT REVIEW REPORT ...................................................................................................................... 27

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Page 2

Appendix 4D Interim Results Half Year Report

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CORPORATE INFORMATION

DIRECTORS: Mr Roger Corbett, AO (Chairman)
Mr Scott Richards (Managing Director and CEO)
Hon. Ron Best
Ms Nancy Dolan
Mr William (Phil) Hodges
Mr Bruce Mathieson
Prof Bruce Robinson, AM
Mr Ian Scholes
COMPANY SECRETARY: Mr Mark Cansdale
REGISTERED OFFICE 1538 Main North Road,
Salisbury South
South Australia 5106
PRINCIPAL PLACES OF 1538 Main North Road,
BUSINESS: Salisbury South
South Australia 5106
1240 Sugg Parkway
Greenville
North Carolina 27834 USA
AUDITORS: Ernst & Young
8 Exhibition Street
Melbourne VIC 3000
SOLICITORS: Minter Ellison Lawyers
Rialto Towers
525 Collins Street
Melbourne VIC 3000
SHARE REGISTRY: Computershare Investor Services Pty Ltd
Yarra Falls
452 Johnston Street
Abbotsford VIC 3067
Telephone:
(03) 9415 4184
Facsimile:
(03) 9473 2500
BANKER: Westpac
150 Collins Street
Melbourne VIC 3000
ABN: 76 115 832 963
DOMICILE AND COUNTRY
OF INCORPORATION: Australia
LEGAL FORM OF ENTITY: Public company listed on the Australian Securities Exchange (MYX)

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Page 3

Appendix 4D Interim Results Half Year Report

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DIRECTORS’ REPORT

The Directors of Mayne Pharma Group Limited (“the Company” or “Mayne Pharma”) submit their report for the half-year ended 31 December 2016.

DIRECTORS

The names of the Company’s Directors in office during the half-year and until the date of this report are set out below. Directors were in office for this entire period unless otherwise noted.

Mr Roger Corbett, AO, Chairman Mr Scott Richards, Managing Director and CEO The Hon Ron Best Ms Nancy Dolan (appointed 21 September 2016) Mr William (Phil) Hodges Mr Bruce Mathieson Prof Bruce Robinson, AM Mr Ian Scholes

REVIEW OF RESULTS

The Consolidated Entity’s net profit attributable to members of the Company for the half-year ended 31 December 2016 was a profit of $72,736,000 (half-year ended 31 December 2015: profit of $19,231,000).

The Company announced on 28 June 2016 that it had entered into an agreement to acquire 37 approved and 5 FDA filed products from Teva Pharmaceutical Industries Limited (“Teva”) and Allergan plc (“Allergan”). The Teva and Allergan products acquisition was completed 3 August 2016 and significantly transformed the scope and breadth of the Generic Products Division diversifying Mayne Pharma’s earnings across more products, therapeutic areas, dosage forms and complex technologies. The acquisition created new opportunities for further growth through the launch of pipeline products, expanding channels to market and optimising the supply chain through transferring products in-house or to contract manufacturing organisations.

The acquisition was funded by a fully underwritten A$601m 1-for-1.725 entitlement offer, a A$287m placement and an extension of existing debt facilities.

A more detailed analysis of the operating performance is included in the accompanying Investor Presentation dated 24 February 2017.

Operating performance

The Consolidated Entity operates in four operating segments being, Generic Products (GPD), Metrics Contract Services (MCS), Specialty Brands (SBD) and Mayne Pharma International (MPI).

Generic Products Division (GPD)

The Generic Products Division distributes generic pharmaceutical products in the United States of America (USA). Revenue increased by 399% to $222,634,000 ($44,633,000 prior comparative period or “pcp”) and gross profit increased by 377% to $125,838,000 ($26,377,000 pcp) for the period. In US dollar terms, sales were up 420% to US$167.8m driven by the acquisition of the Teva product portfolio, the launch of dofetilide in June 2016 and the strong performance of the underlying business.

Metrics Contract Services (MCS)

The Metrics Contract Services segment provides contract pharmaceutical development services to third party customers principally in the USA. Revenue increased by 20% to $28,105,000 ($23,501,000 pcp) and gross profit increased by 25% to $15,445,000 ($12,363,000 pcp) for the period. In US dollar terms, MCS’ sales were well ahead of industry growth rates with sales up 25% to US$21.2m. The growth was driven by increased repeat business from existing customers and an increase in late stage development work.

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Page 4

Appendix 4D Interim Results Half Year Report

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Specialty Brands Division (SBD)

The Specialty Brands Division distributes branded pharmaceutical products in the USA. Revenue decreased by 38% to $26,829,000 ($43,372,000 pcp) and gross profit decreased by 31% to $26,141,000 ($38,128,000 pcp) for the period. In US dollar terms, SBD’s revenue was US$20.2m down 36%. The decrease in performance on pcp was driven by the entry of generic competition on the Doryx 50mg and 200mg products.

Mayne Pharma International (MPI)

The MPI operating segment’s revenues and gross profit are derived principally from the Australian manufacture and sale of branded and generic pharmaceutical products globally and the provision of contract manufacturing services to third party customers within Australia. Revenue increased by 10% to $17,263,000 ($15,755,000 pcp) and gross profit increased by 6% to $3,750,000 ($3,532,000 pcp) for the period, driven by increased sales of several products around the world.

Gross margin

Gross margin as a percentage of sales revenue was 58%, compared to 63% in the pcp. This decrease was driven by product mix with the decline in SBD sales and the increase of generic sales for Dofetilide which has a profit share arrangement and the Teva portfolio of products all contributing factors.

Expenses

Net research and development expense after qualifying capitalisation (of $10,997,000) was $5,169,000, an increase in the expense of $725,000 (16%) on the pcp. This category includes HPPI research and development expense of $1,303,000 ($1,086,000 pcp).

Marketing and distribution expense was $20,378,000, an increase of $2,505,000 (14%) on the pcp. The major increase was due to the expansion of the GPD portfolio and scaling up for the launch of the SBD foam products.

Administration and other expenses were $75,982,000, an increase of $43,758,000 (136%) on the pcp. This includes amortisation of intangible assets which was $28,815,000, an increase of $20,335,000 on the pcp largely due to the Teva products acquisition in August 2016. Increased head count and insurance costs contributed to the increase to support the expansion and growth of the business. Administration and other expenses includes legal costs (including the US Department of Justice matter) and transaction costs for the Teva/Allegan product portfolio acquisition.

Finance expenses were $5,312,000, an increase of $3,634,000 (217%) on the pcp as a result of increased borrowings supporting the Teva portfolio acquisition.

Tax

The tax expense of $19,488,000 comprised:

  • Current period income tax for the six months to 31 December 2016 of $67,367,000; and

  • A reduction of $47,879,000 relating to the movement in net tax deferred tax assets and liabilities.

The split between current and deferred tax has been influenced by the timing of assessable income compared to accounting income, particularly the treatment of gross to net sales adjustments and rebates in GPD and SBD.

REVIEW OF BALANCE SHEET

There were a number of significant changes to the Company’s balance sheet since 30 June 2016 with the major changes related to Teva portfolio acquisition.

At 30 June 2016, the Company recognised “Contract rights relating to the Teva transaction settled post year-end” (as an Other Current Asset) and a “Settlement obligation in relation to the Teva transaction” (as a Current Payable) as the Company had entered into an agreement to acquire 37 approved and 5 FDA filed products from Teva Pharmaceutical Industries Limited (“Teva”) and Allergan plc (“Allergan”) for cash consideration of US$652m.

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Page 5

Appendix 4D Interim Results Half Year Report

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At 30 June 2016, the contract was subject to conditions which were subsequently met and settlement occurred on 3 August 2016. As a result of contract completion, the contract obligation was extinguished (by paying the cash amount due) and the Company de-recognised the Contracts rights asset and recognised the intangible assets acquired (A$866m), the inventory acquired (A$15.9m) and an amount for capital equipment (A$0.7m) acquired.

On 18 August 2016 the Company acquired a portfolio of on-market dermatology Foam Assets from GSK for A$65.3m. This amount has been recognised as intangible assets.

Total Intangible additions were $946m for the period. Currency movements added $46.7m to the value of intangible assets in AUD terms for US assets due to the AUD / USD exchange rate declining from 0.7442 at June to 0.7226 at December. Amortisation of intangible assets was $28.8m for the period.

The Company funded these acquisitions (and part of the resulting working capital investment) via an extension of its existing debt facility, and a fully underwritten equity raise of A$601m, in the form of a 1-for-1.725 accelerated non-renounceable entitlement offer and a A$287m placement.

As a result of the Teva portfolio acquisition and GPD base business growth, the Company invested approximately A$66m in additional inventory (which includes the $15.9m acquired directly as part of the Teva portfolio acquisition noted above). Additional levels of safety stock were purchased to ensure that no stock-outs occurred in the transition to Mayne Pharma distribution.

With the increased level of sales from the Teva portfolio and growth in the GPD base business, the level of trade receivables increased from $89.9m to $209.5m. The level of accrued rebates and allowances (included in Trade and Other Payables) also increased as a result of the increased sales values.

The capital works program, as previously announced, continued during the period with $6.5m of additions capitalised relating to the Salisbury site in South Australia and $41.4m of additions capitalised in relation the Greenville site in North Carolina.

REVIEW OF CASH FLOWS

A summary of the net operating cash flows is as follows –

Operating cash flows before working capital movements
Less Working capital investment
Net Operating cash flows
A$000’s
103,462
(170,573)
(67,111)

The Teva/Allergan portfolio acquisition was the main reason for increased working capital investment. This represents the net impact of increased receivables, increased inventory and increased trade payables and accruals.

Cash on hand at 31 December 2016 (net of restricted cash held as security for letters of credit on issue) was $80,820,000, representing an increase of $33,339,000 from 30 June 2016. Notable cash flows during the period included:

  • $47,886,000 in capital expenditure across the Group mainly relating to the facilities upgrades;

  • $10,997,000 in capitalised development expenditure;

  • Earn-out and deferred settlement payments totalling $4,481,000;

  • Payment of $865,984,000 to Teva/Allergan for the acquisition of the product portfolio;

  • Payment of $65,288,000 to GSK for the acquisition of the foam products;

  • Payments of $4,071,000 relating to the purchase and development of other intangible assets;

  • Receipt of $26,175,000 as a result of the litigation settlement (included in operating cash flows);

  • Equity raised of $860,487,000 (net of equity raising costs) to fund the Teva products acquisition; and

  • Proceeds from borrowings of $234,282,000 (net of fees) to partially fund the Teva and GSK asset acquisitions and the incremental working capital requirements to support these product acquisitions.

Dividend

The Directors have not declared an interim dividend in relation to the period ended 31 December 2016.

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Page 6

Appendix 4D Interim Results Half Year Report

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ROUNDING

The Company is of a kind referred to in ASIC Legislative Instrument 2016/191 issued by the Australian Securities and Investments Commission, relating to the “rounding off” of amounts in this report and in the financial report. Amounts in this report and in the financial report have been rounded off in accordance with that Legislative Instrument to the nearest hundred thousand dollars or, in certain cases, to the nearest dollar.

AUDITOR’S INDEPENDENCE DECLARATION

The Auditor’s independence declaration is included on page 7 of the Financial Report.

EVENTS SUBSEQUENT TO REPORTING DATE

No other matter or circumstance has arisen since the reporting date which is not otherwise reflected in this report that significantly affected or may significantly affect the operations of the consolidated entity.

Signed in accordance with a resolution of the Directors.

Dated at Melbourne, this 24th day of February 2017.

Scott Richards Director

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Page 7

Appendix 4D Interim Results Half Year Report

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AUDITOR’S INDEPENDENCE DECLARATION

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Auditor’s Independence Declaration to the Directors of Mayne Pharma Group Limited

As lead auditor for the review of Mayne Pharma Group Limited for the half-year ended 31 December 2016, I declare to the best of my knowledge and belief, there have been:

  • a) no contraventions of the auditor independence requirements of the Corporations Act 2001 relation to the review; and

  • b) no contraventions of any applicable code of professional conduct in relation to the review.

This declaration is in respect of Mayne Pharma Group Limited and the entities it controlled during the financial period.

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Ernst & Young

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Ashley Butler Partner Melbourne 24 February 2017

A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards

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Page 8

Appendix 4D Interim Results Half Year Report

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CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

FOR THE HALF-YEAR ENDED 31 DECEMBER 2016

Notes 31 December
2016
$’000
31 December
2015
$’000
Sale of goods
Services revenue
License fee revenue
Royalties revenue
Revenue
Cost of sales
Gross profit
Other income
3
Research and development expenses
Marketing and distribution expenses
Administrative and other expenses
4
Finance expenses
4
Profit before income tax
Income tax expense
5
Net profit for the period
Attributable to:
Equity holders of the Parent
Non-controlling interests
Other comprehensive income for the period, net of tax
Items which may be reclassified to profit/loss
Unrealised gain on cash flow hedges
Income tax effect
Exchange differences on translation
Income tax effect
Items that will not be reclassified to profit or loss in future periods
Exchange differences on translation
Income tax effect
Total comprehensive income for the period
Attributable to:
Equity holders of the Parent
Non-controlling interests
Basic earnings per share
Diluted earnings per share
261,335
98,420
32,966
28,182
81
142
449
517
294,831
127,261
(123,657)
(46,861)
171,174
80,400
26,478
2,805
(5,169)
(4,444)
(20,378)
(17,873)
(75,982)
(32,224)
(5,312)
(1,678)
90,811
26,986
(19,488)
(9,081)
71,323
17,905
72,736
19,231
(1,413)
(1,326)
71,323
17,905
3,741
-
-
-
53,768
6,320
-
-
272
569
-
-
129,104
24,794
130,245
25,551
(1,141)
(757)
129,104
24,794
5.15 cents
2.46 cents
5.03 cents
2.39 cents

This statement should be read in conjunction with the accompanying notes to the financial statements.

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Page 9

Appendix 4D Interim Results Half Year Report

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CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2016

Notes 31 December
2016
$’000
30 June
2016
$’000
Current assets
Cash and cash equivalents
6
Trade and other receivables
7
Inventories
8
Income tax receivable
Other financial assets
Other current assets
9
Total current assets
Non-current assets
Property, plant and equipment
Deferred tax assets
5
Intangible assets and goodwill
10
Total non-current assets
Total assets
Current liabilities
Trade and other payables
11
Interest-bearing loans and borrowings
12
Income tax payable
Other financial liabilities
13
Provisions
Total current liabilities
Non-current liabilities
Interest-bearing loans and borrowings
12
Other financial liabilities
13
Deferred tax liabilities
5
Provisions
Total non-current liabilities
Total liabilities
Net assets
Equity
Contributed equity
14
Reserves
Retained Earnings
Equity attributable to equity holders of the Parent
Non-controlling interests
Total equity
80,820
47,481
215,028
92,117
108,851
38,943
-
7,399
5,074
3,458
16,862
887,653
426,635
1,077,051
142,336
84,449
82,278
31,799
1,296,692
332,483
1,521,306
448,731
1,947,941
1,525,782
141,709
988,954
372
503
47,791
12,308
10,209
13,273
9,516
9,287
209,596
1,024,325
313,075
76,331
5,352
5,814
48,188
41,640
1,069
1,451
367,684
125,236
577,280
1,149,561
1,370,661
376,221
1,125,331
263,161
98,463
39,058
134,266
61,530
1,358,060
363,749
12,601
12,472
1,370,661
376,221

This statement should be read in conjunction with the accompanying notes to the financial statements.

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Page 10

Appendix 4D Interim Results Half Year Report

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CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE HALF-YEAR ENDED 31 DECEMBER 2016

Balance at 1 July 2016
Profit for the period
Other comprehensive
income
Foreign exchange
translation
Cash flow hedge
Total comprehensive income
Transactions with owners in
capacity as owners
Shares issued (net of issue
costs)
Change in equity investment
in subsidiary
Equity contributions by non-
controlling interests
Share options exercised
Tax effect of employee share
options
Share-based payments
Balance at 31 December
2016
Balance at 1 July 2015
Profit for the period
Other comprehensive
income
Foreign exchange
translation
Total comprehensive income
Transactions with owners in
capacity as owners
Shares issued (net of issue
costs)
Share options exercised
Tax effect of employee share
options
Share-based payments
Balance at 31 December
2015
Contributed
Equity
Share-
Based
Payment
Reserve
$’000
$’000
Foreign
Currency
Translation
Reserve
Cash
Flow
Hedge
Reserve
$’000
Other
Reserve
Retained
Earnings
Total
Non-
Controlling
Interests
Total
Equity
$’000
$’000
$000’s
$000’s
$’000
1,180
61,530
363,749
12,472
376,221
-
72,736
72,736
(1,413)
71,323
-
-
53,768
272
54,040
-
-
3,741
-
3,741
$’000
263,161
7,950
-
-
-
-
-
-
30,792 (864)
-
-
3,741
-
53,768
-
-
-
861,895
-
-
-
--
-
1,785
(1,785)
(1,510)
-
-
6,194
53,768 3,741
-
-
-
-
-
-
-
72,736
130,245
(1,141)
129,104
-
-
861,895
-
861,895
(2,513)
-
(2,513)
490
(2,023)
-
-
-
780
780
-
-
-
-
-
-
-
(1,510)
-
(1,510)
-
-
6,194
-
6,194
-
-
-
-
-
-
1,125,331
12,359
84,560 2,877 (1,333)
134,266
1,358,060
12,601
1,370,661
255,834
3,230
-
-
-
-
-
-
-
-
24,175
310,870
11,332
322,202
-
19,231
19,231
(1,326)
17,905
-
-
6,320
569
6,889
27,631
-
6,320
-
-
156
-
62
(62)
2,660
-
-
2,341
6,320 -
-
-
-
-
-
19,231
25,551
(757)
24,794
-
-
156
-
156
-
-
-
-
-
-
-
2,660
-
2,660
-
-
2,341
-
2,341
-
-
-
-
258,712
5,509
33,951 - -
43,406
341,578
10,575
352,153

This statement should be read in conjunction with the accompanying notes to the financial statements.

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Page 11

Appendix 4D Interim Results Half Year Report

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CONSOLIDATED STATEMENT OF CASH FLOW

FOR THE HALF-YEAR ENDED 31 DECEMBER 2016

CONSOLIDATED STATEMENT OF CASH FLOW
FOR THE HALF-YEAR ENDED 31 DECEMBER 2016
Notes 31 December
2016
$’000
31 December
2015
$’000
Cash flows from operating activities
Receipts from customers
Payments to suppliers and employees
Interest received
Interest paid
Tax paid
Patent infringement settlement
Payments for research and non-capitalised development expenditure
Transaction and DOJ costs
Net cash flows (used in) / from operating activities
6
Cash flows from investing activities
Payments for plant and equipment
Payments for intangible assets
Payments for capitalised development costs
Earn-out payments
Net cash flows used in investing activities
Cash flows from financing activities
Proceeds from issue of shares
Equity raising costs
Equity contributions from non-controlling interests
Repayment of borrowings
Proceeds from borrowings (net of fees)
Net cash flows from financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Effect of foreign exchange changes on cash held in foreign currencies
Cash and cash equivalents at end of period
6
201,483
94,109
(259,771)
(46,822)
221
253
(4,318)
(1,101)
(22,733)
(13,137)
(85,118)
33,302
26,175
-
(4,591)
(2,782)
(3,577)
-
(67,111)
30,520
(47,886)
(6,603)
(935,343)
(5,186)
(10,997)
(11,447)
(4,481)
(17,712)
(998,706)
(40,948)
890,252
156
(28,357)
-
780
-
(183)
(103)
234,282
(47)
1,096,773
6
30,956
(10,422)
47,481
59,201
2,383
956
80,820
49,735

This statement should be read in conjunction with the accompanying notes to the financial statements.

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Page 12

Appendix 4D Interim Results Half Year Report

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NOTES TO THE FINANCIAL STATEMENTS

FOR THE HALF-YEAR ENDED 31 DECEMBER 2016

1. BASIS OF PREPARATION AND ACCOUNTING POLICIES

Basis of preparation

The financial report for the half-year ended 31 December 2016 has been prepared in accordance with AASB 134 Interim Financial Reporting and the Corporations Act 2001 .

The half-year financial report does not include all notes of the type normally included within the annual financial report and therefore cannot be expected to provide as full an understanding of the financial performance, financial position and financing and investing activities of the consolidated entity as the annual financial report.

Under AASB 134 Interim Financial Reporting, measurement is generally made on an annual reporting period to date basis. However, it is recognised that the interim period is part of a larger annual reporting period not an independent reporting period. Accordingly, interim period income tax expense can be accrued using the estimated average annual effective income tax rate that would be applicable to expected total annual earnings.

It is recommended that the half-year financial report be read in conjunction with the annual report for the year ended 30 June 2016 and considered together with any public announcements made by Mayne Pharma Group Limited during the half-year ended 31 December 2016 in accordance with the continuous disclosure obligations of the ASX Listing Rules .

Where required, items in the June 2016 comparatives have been reclassified to reflect the current presentation and enable better comparison between periods.

The accounting policies and methods of computation are the same as those adopted in the most recent annual financial report.

Changes in accounting policy

From 1 July 2016 the Group has adopted the relevant standards and interpretations mandatory for annual reports beginning on or after 1 July 2016. Adoption of the standards and interpretations did not have any effect on the financial position or performance of the Group.

Change in functional currency

During the period, a subsidiary – Mayne Pharma LLC changed its functional currency from AUD to USD. The change of functional currency was due to the settlement of the Teva products acquisition.

New accounting standards and interpretations

The list of standards issued not yet effective includes three issued standards which are likely to have some impact on future financial reports – AASB 9 Financial Instruments (effective 1 July 2018), AASB 15 Revenue from Contracts with Customers (effective 1 July 2018) and AASB 16 Leases (effective 1 July 2019). Management has not yet completed a full assessment of the impact of these standards and are therefore unable to comment on the impact on future financial reports.

2. SEGMENT REPORTING

The Group has identified its operating segments based on the internal reports that are reviewed and used by the CEO (as the chief operating decision maker) in assessing performance and in determining the allocation of resources.

The operating segments are identified by management based on the nature of revenue flows and responsibility for those revenues. Discrete financial information about each of these operating segments is reported to the chief operating decision maker on at least a monthly basis.

The Consolidated Entity operates in four operating segments being, Generic Products Division (GPD), Metrics Contract Services (MCS), Specialty Brands Division (SBD) and Mayne Pharma International (MPI).

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Generic Products Division

The Generic Products operating segment’s revenues and gross profit are derived principally from the distribution of generic pharmaceutical products in the US.

Metrics Contract Services

The Metrics Contract Services segment’s revenue and gross profit are derived from providing contract pharmaceutical development services to third-party customers principally in the United States.

Specialty Brands Division

The Specialty Brands operating segment’s revenues and gross profit are derived principally from the distribution of branded pharmaceutical products in the US.

MPI

The MPI operating segment’s revenues and gross profit are derived principally from the Australian manufacture and sale of branded and generic pharmaceutical product globally and provision of contract manufacturing services to third party customers within Australia.

The Consolidated Entity reports the following information on the operations of its identified segments:

Generic
Products
Metrics
Contract
Services
Specialty
Brands
MPI
$’000
$’000
$’000
$’000
Total
Consolidated
$’000
Half Year ended
31 December 2016
Sale of goods
Services income
License fee income
Royalty income
Revenue
Cost of sales
Gross profit
Other income
Amortisation of intangible assets
Fair value movement in earn-out
liability
Other expenses (refer Statement
of Profit or Loss and Other
Comprehensive Income)
Profit before income tax
Income tax expense
Net profit for the period
222,634
-
26,829
11,872
-
28,105
-
4,861
-
-
-
81
-
-
-
449
261,335
32,966
81
449
222,634
28,105
26,829
17,263
(96,796)
(12,660)
(688)
(13,513)
294,831
(123,657)
125,838
15,445
26,141
3,750
171,174
26,478
(28,815)
(536)
(77,490)
90,811
(19,488)
71,323

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Generic
Products
Metrics
Contract
Services
Specialty
Brands
MPI
$’000
$’000
$’000
$’000
Total
Consolidated
$’000
Half Year ended
31 December 2015
Sale of goods
Services income
License fee income
Royalty income
Revenue
Cost of sales
Gross profit
Other income
Amortisation of intangible assets
Fair value movement in earn-out
liability
Other expenses (refer Statement
of Profit or Loss and Other
Comprehensive Income)
Profit before income tax
Income tax expense
Net profit for the period
44,633
-
43,372
10,415
-
23,501
-
4,681
-
-
-
142
-
-
-
517
98,420
28,182
142
517
44,633
23,501
43,372
15,755
(18,256)
(11,138)
(5,244)
(12,223)
127,261
(46,861)
26,377
12,363
38,128
3,532
80,400
2,805
(8,480)
4,759
(52,498)
26,986
(9,081)
17,905

Geographical segment information

eographical segment information
Revenue from external customers 31 December
2016
$’000
31 December
2015
$’000
Australia
United States
Korea
Other
Total external revenue
12,692
12,930
277,570
111,506
1,872
381
2,697
2,444
294,831
127,261

Product information

roduct information
Revenue by product group / service 31 December
2016
$’000
31 December
2015
$’000
Contract manufacturing
Analytical and formulation
Oral and other pharmaceuticals
Other revenue
Total external revenue
4,861
4,681
28,105
23,501
261,416
98,562
449
517
294,831
127,261

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3. OTHER INCOME

THER INCOME
31 December
2016
$’000
31 December
2015
$’000
Interest income
Patent infringement settlement
Net gain on foreign exchange
Other income
221
253
26,175
-
-
2,462
82
90
26,478
2,805

The Patent infringement income relates to the settlement agreement reached during the period with Forest Laboratories LLC (“Forest”) following the Company’s patent infringement lawsuit against Forest.

4. EXPENSES

XPENSES
31 December
2016
$’000
31 December
2015
$’000
Finance expenses
Interest expense
Unused line fees
Amortisation of borrowing costs
Change in fair value attributable to the unwinding of the discounting of the
earn-out liabilities
Total finance expense
Depreciation(1)
Employee benefits expense(2)
Wages and salaries
Superannuation expense
Share-based payments(3)
Other employee benefits expense
Total employee benefits expense
Administration and other expenses
Administration and other expenses include the following:
Foreign exchange loss
Settlement costs relating to a distributor dispute
Transaction and DOJ related costs
Share-based payments additional expense due to the rights issue(3)
Amortisation of intangible assets
Fair value movement in earn-out liability
Movement in undiscounted fair value of earn-out liabilities
3,065
705
1,238
396
605
104
404
473
5,312
1,678
3,169
2,616
39,856
29,458
1,794
1,382
6,194
2,340
4,093
4,254
51,937
37,434
2,123
-
-
6,668
3,577
-
1,971
-
28,815
8,480
132
(5,232)

The movement in the undiscounted fair value of earn-out liabilities relates to the re-assessment of the final payment to the former shareholder of Libertas.

  • Notes: 1. Depreciation expense is included in R&D expenses and cost of sales 2. Employee benefit expense is included in various expense categories and cost of sales.

  • Share-based payments includes $1,971,000 expense relating to the additional expense incurred due to the change in the exercise price of employee options (9.43 cents each) due to the 1 for 1.725 rights issue to fund the Teva products acquisition in accordance with ASX Listing Rule 6.22.

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5. INCOME TAX

  • (a) The major components of income tax expense are:
31 December
2016
$’000
31 December
2015
$’000
Current income tax
Current income tax
Adjustment in respect of current income tax of previous years
Deferred income tax
Relating to movement in net tax deferred tax assets and liabilities
Income tax expense in the consolidated statement of profit or loss and other
comprehensive income
(68,162)
(18,949)
795
-
47,879
9,868
(19,488)
(9,081)
  • (b) Numerical reconciliation between aggregate tax expense recognised in the consolidated statement of profit or loss and other comprehensive income and tax expense calculated per the statutory income tax rate
31 December
2016
$’000
31 December
2015
$’000
The prima facie tax on operating profit differs from the income tax provided in
the accounts as follows:
Profit before income tax
Prima facie tax (expense) at 30%
Effect of R&D concessions
Over provision in respect of prior years
Non-assessable items
Non-deductible expenses for tax purposes
Amortisation
Share-based payments
Other non-deductible expenses
Effect of higher tax rate in USA
US State taxes
US Domestic Production Activity Deduction
Tax loss of HPPI not recognised
Restatement of DTA & DTL re US state tax rate changes
Income tax expense
90,811
26,986
(27,243)
(8,096)
367
174
795
-
12,790
1,192
(926)
(1,291)
(493)
(219)
(1,816)
(57)
(2,000)
323
(2,097)
(431)
2,726
-
(805)
(701)
(786)
25
(19,488)
(9,081)

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C. Recognised deferred tax assets and liabilities

31 December
2016
$’000
30 June
2016
$’000
Deferred tax assets
Intangible assets
Provisions
Payables
Inventory
Receivables
Employee share options
US state taxes
Earn-out liability
Equity raising costs
Other
Reconciliation to the Statement of Financial Position
Total Deferred Tax Assets
Set off of Deferred Tax Liabilities
Net Deferred Tax Assets1
Deferred tax liabilities
Property, plant and equipment
Intangible assets
US State taxes
Other receivables and prepayments
Unrealised foreign exchange gains
Other
Reconciliation to the Statement of Financial Position
Total Deferred Tax Liabilities
Set off against Deferred Tax Assets
Net Deferred Tax Liabilities2
3,911
1,883
2,509
2,542
7,141
6,624
14,613
14,497
58,768
12,320
4,453
7,296
5,561
2,789
496
496
867
1,145
1,534
55
99,853
49,647
99,853
49,647
(17,575)
(17,848)
82,278
31,799
5,177
4,468
52,967
46,805
5,455
5,286
1,998
-
-
663
166
2,266
65,763
59,488
65,763
59,488
(17,575)
(17,848)
48,188
41,640

Notes: 1. Represents Australian and US Deferred Tax Assets that cannot be offset against US Deferred Tax Liabilities.

  1. Represent US Deferred Tax Liabilities that cannot be offset against Australian Deferred Tax Assets.

Deferred tax assets and deferred tax liabilities are presented based on their respective tax jurisdictions.

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6. CASH AND CASH EQUIVALENTS

(a) For the purpose of the consolidated statement of cash flows, cash and cash equivalents are comprised of the following:

31 December
2016
$’000
30 June
2016
$’000
Cash at bank and in hand 80,820
47,481

(b) Reconciliation of net profit after income tax to net cash flow from operating activities

31 December
2016
$’000
31 December
2015
$’000
Net profit after income tax
Adjustments for:
Depreciation and amortisation
Share-based payments
Movement in earn-out liabilities
Asset impairments
Net unrealised foreign exchange differences
Changes in tax balances:
(Increase) in deferred tax assets
Decrease in current and deferred tax liabilities
Operating cash flows before working capital movements
Changes in working capital:
(Increase in receivables
(Increase) in inventories
(Increase) in other assets
Increase in creditors
(Decrease) in provisions
Total working capital movements
Net cash flow (used in) / from operating activities
71,323
17,905
32,592
11,153
6,194
2,340
536
(4,759)
-
1,137
(3,938)
(1,402)
(49,512)
(12,073)
46,267
8,055
103,462
22,356
(115,377)
(33,152)
(65,696)
(5,215)
(5,535)
(2,790)
16,362
49,384
(327)
(62)
(170,573)
8,164
(67,111)
30,520

7. TRADE AND OTHER RECEIVABLES

31 December 30 June
2016 2016
$’000 $’000
Trade receivables (net of charge-backs) 209,472 89,895
Trade receivables – profit share 1,066 1,670
Provision for impairment (24) (23)
Other receivables 4,514 575
215,028 92,117

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8. INVENTORIES

31 December
2016
$’000
30 June
2016
$’000
Raw materials and stores at cost
Work in progress at cost
Finished goods at lower of cost and net realisable value
28,268
11,301
11,754
11,525
68,829
16,117
108,851
38,943

9. OTHER ASSETS

31 December
2016
$’000
30 June
2016
$’000
Prepayments
Contract rights relating to the Teva transaction settled post year-end
16,862
11,509
-
876,144
16,862
887,653

10. INTANGIBLE ASSETS AND GOODWILL

Goodwill
Customer
Contracts,
Customer
Relationships
Product Rights
& Intellectual
Property
$’000
$’000
Development
Expenditure
$’000
Marketing &
Distribution
Rights
Trade Names
Total
$’000
$’000
$’000
Six months ended 31
December 2016
Balance at beginning of
the period net of
accumulated
amortisation
Additions
Amortisation
Exchange differences
Balance at end of period
net of accumulated
amortisation
As at 31 December 2016
Cost
Accumulated
amortisation
Accumulated
impairments
Net carrying amount
60,115
85,312
-
934,393
-
(23,262)
1,782
41,534
72,048
10,997
(1,282)
2,056
57,402
57,606
332,483
950
-
946,340
(1,056)
(3,215)
(28,815)
1,195
117
46,684
61,897
1,037,977
83,819 58,491
54,508
1,296,692
61,897
1,098,133
-
(60,156)
-
-
90,412
(3,397)
(3,196)
61,840
69,007
1,381,289
(3,349)
(14,444)
(81,346)
-
(55)
(3,251)
61,897
1,037,977
83,819 58,491
54,508
1,296,692

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11. TRADE AND OTHER PAYABLES

31 December
2016
$’000
30 June
2016
$’000
Trade payables
Accruals and rebates
Other payables
Settlement obligation in relation to the Teva transaction
72,730
64,050
61,665
39,859
7,314
8,901
-
876,144
141,709
988,954

12. INTEREST-BEARING LOANS AND BORROWINGS

31 December
2016
$’000
30 June
2016
$’000
Current
Lease liabilities
372
503
372
503
31 December
2016
$’000
30 June
2016
$’000
Non-current
Syndicated loan
Borrowing costs (net of amortisation)
Lease liabilities
318,291
76,999
(5,344)
(836)
128
168
313,075
76,331

Syndicated loan

The syndicated loan facility was restated and amended in July 2016. The loan facility is now supported by nine individual banks. The loan facility limit was increased to US$400m with working capital facilities of A$10m and U$20m also available. The loan facility can be drawn down in either USD or AUD with USD expected to be the major currency drawn down. The amount drawn at 31 December 2016 was U$230m.

The facility is unsecured and incurs interest based on either LIBOR (for USD) with no floor, or BBSY (for AUD) plus an agreed fixed margin. The loan is subject to certain covenants and has an unused line fee payable based on the undrawn amount.

The Group is in compliance with the covenants at reporting date. The Directors believe there is no risk of default at reporting date.

At 31 December 2016, the variable interest rate was 2.98% (2015: 1.94%). During the period, the Group entered into additional interest rate swap contracts to hedge the interest rate risk exposure with 48% of the outstanding loan amount hedged at 31 December 2016 (30 June 2016: 41%). The interest rate risk is managed using interest rate swaps in which the Group agrees to exchange, at specific intervals, the difference between fixed and variable rate interest amounts calculated by reference to an agreed-upon notional principal amount.

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13. OTHER FINANCIAL LIABILITIES

31 December
2016
$’000
30 June
2016
$’000
Current
Earn-out liability – Libertas’ former shareholder
Earn-out liability – Oxycodone
Earn-out liability – Liothyronine
Earn-out liability – various other products/distribution rights
Deferred consideration - Liothyronine
-
1,343
4,832
5,230
2,020
3,252
1,281
1,432
2,076
2,016
10,209
13,273
31 December
2016
$’000
30 June
2016
$’000
Non-current
Earn-out liability – Liothyronine
Earn-out liability – various products/distribution rights
Deferred consideration – Liothyronine
650
1,314
2,773
2,829
1,929
1,671
5,352
5,814

Earn-out liabilities represent the net present value of estimated future payments. Any changes in fair value in the net present value of estimated future payments are recognised in the statement of profit or loss. The earn-out liabilities at reporting date include a charge representing the unwinding of the discounting of the earn-out liabilities of $404,000 (31/12/15: $473,000) for the period representing the change in fair value as a result of the unwinding of the discounting.

The value of the earn-outs has been determined based on expected future cash flows required to be paid for the balance of the earn-out period.

14. CONTRIBUTED EQUITY

(a) Issued capital

31 December
2016
$’000
30 June
2016
$’000
Ordinary shares, fully paid 1,125,331
263,161

(b) Movements in share capital

31 December 2016
Number
$’000
Balance at beginning of period
Teva products acquisition funding1
Exercise of employee options
Tax effect of employee share options
Shares issued to employees under the LTI non-recourse loan funded
arrangement (subject to risk of forfeiture)
LTI shares exercised (and loan repaid)
Balance at end of period
810,046,346
263,161
661,048,634
860,487
6,671,000
3,067
-
(1,510)
21,164,820
-
-
126
1,498,930,800
1,125,331

Notes: 1. Shares issued are net of $28,357,000 equity raising costs.

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15. DIVIDENDS

The Board has decided to preserve the Company’s capital and no interim dividend has been declared.

16. COMMITMENTS AND CONTINGENCIES

There were no material changes in commitments.

Mayne Pharma is one of numerous generic pharmaceutical companies to receive a subpoena from the Antitrust Division of the US Department of Justice (“DOJ”) in the past few years seeking information relating to the marketing, pricing and sales of select generic products. Mayne Pharma has also received a subpoena from the Office of the Attorney General in the State of Connecticut seeking similar information. These investigations are ongoing. Civil complaints have been filed in the past few months by a number of US states and purchasers alleging anticompetitive conduct in the doxycycline hyclate delayed-release market. External counsel has been engaged and the Directors’ current assessment remains that these investigations will not have a material impact on Mayne Pharma’s future earnings.

17. FINANCIAL INSTRUMENTS

Set out below is an overview of financial instruments, other than cash and short term deposits, held by the Group as at 31 December 2016:

$’000
Financial assets
Current
Warrants
Derivatives designated as hedges
Financial liabilities
Current
Earn-out liabilities
Non-current
Earn-out liabilities
Syndicated loan
900
2,877
3,777
10,209
10,209
5,352
312,947
318,299

Trade and other receivables, trade and other payables, other financial assets and other liabilities are considered short term and their fair values approximates the carrying values.

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Fair Value

Set out below is a comparison by class of the carrying amounts and fair value of the Group’s financial instruments that are carried in the financial statements.

hat are carried in the financial statements.
Carrying Amount Fair Value
31 Dec 2016 30 June 2016 31 Dec 2016 30 June 2016
$’000 $’000 $’000 $’000
Assets
Warrants (options) - HPPI 900 2,918 900 2,918
Market to market valuation – interest rate
swaps 2,877 - 2,877 -
Liabilities
Earn-out liability - Libertas’ former shareholder - 1,343 - 1,343
Earn-out liability – Oxycodone 4,832 5,230 4,832 5,230
Earn-out liability – various products 6,724 8,826 6,724 8,826
Market to market valuation – interest rate
swaps - 864 - 864
Interest-bearingsyndicated loan 312,947 76,163 318,291 76,999

Warrants, as at reporting date, represent options to purchase an additional 23,504,236 shares (30 June 2016 71,957,138) in HPPI at an exercise price of 12.0 US cents per share. As at 30 June 2016 the warrants available had various exercise prices – 8.78 US cents, 7.5 US cents and 12 US cents per share. During the period, the Company exercised 10,250,569 warrants at 8.78 US cents each, 33,333,333 warrants at 7.5 US cents each and 4,860,000 warrants at 12 US cents each.

Interest rate swaps represent the Mark to Market value of open contracts at reporting date.

The earn-out liabilities payable utilise present value calculation techniques that are not based on observable market data. The key inputs are forecast sales. Based on current data and normal market variations, no reasonable possible change in inputs is expected to have a material impact on earn-out liabilities.

Fair values of the Group’s interest-bearing borrowings and loans are determined by using the DCF method using the discount rates applying at the end of the reporting period. The own non-performance risk at reporting date was assessed as insignificant.

Fair value hierarchy

The Group uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique:

  • Level 1: Quoted (unadjusted) market prices in active markets for identical assets or liabilities.

  • Level 2: Valuation techniques for which the lowest level input that is significant to the fair value measurement is directly or indirectly observable.

  • Level 3: Valuation techniques for which the lowest level input that is significant to the fair value measurement is unobservable.

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Assets and liabilities measured at fair value

As at 31 December 2016, the Group held the following financial instruments carried at fair value in the Statement of Financial Position:

Level 2 Level 3
31 December 30 June 31 December 30 June
2016 2016 2016 2016
$’000 $’000 $’000 $’000
Financial Assets
Warrants (options) - HPPI - - 900 2,918
Market to market valuation – interest rate
swaps 2,877 - - -
Financial Liabilities
Earn-out liability - Libertas’ former
shareholder - - - 1,343
Earn-out liability – Oxycodone - - 4,832 5,230
Earn-out liability – various products - - 6,724 8,826
Market to market valuation – interest rate
swaps - 864 - -

Reconciliation of fair value measurements of Level 3 financial instruments

The Group carries earn-out liability classified as Level 3 within the fair value hierarchy.

A reconciliation of the beginning and closing balances including movements is summarised below:

2016
Warrants
$’000
2016
Earn-outs
$’000
Opening balance
Fair value movement
Warrants exercised
Currency fluctuations
Payments
Closing Balance
2,918
15,400
-
336
(2,018)
-
-
301
-
(4,481)
900
11,556

During the six-month period ended 31 December 2016, there were no transfers between Level 1 and Level 2 fair value measurements. The fair value increase of $336,000 was recorded in determining profit before tax.

18. EVENTS SUBSEQUENT TO REPORTING DATE

No other matter or circumstance has arisen since the reporting date which is not otherwise reflected in this report that significantly affected or may significantly affect the operations of the consolidated entity.

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DIRECTORS’ DECLARATION

In accordance with a resolution of the directors of Mayne Pharma Group Limited, I state that:

In the opinion of the directors:

  • (a) the financial statements and notes of the consolidated entity are in accordance with the Corporations Act 2001 , including:

  • (i) giving a true and fair view of the financial position as at 31 December 2016 and the performance for the halfyear ended on that date of the consolidated entity; and

  • (ii) complying with Accounting Standard AASB 134 Interim Financial Reporting and Corporations Regulations 2001;

  • (b) there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due and payable.

On behalf of the Board

Scott Richards Director

Melbourne, 24 February 2017

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AUDITOR’S INDEPENDENT REVIEW REPORT

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To the members of Mayne Pharma Group Limited

Report on the Half-Year Financial Report

We have reviewed the accompanying half-year financial report of Mayne Pharma Group Limited, which comprises the consolidated statement of financial position as at 31 December 2016, the consolidated statement of profit or loss and other comprehensive income, consolidated statement of changes in equity and consolidated statement of cash flows for the half-year ended on that date, notes comprising a summary of significant accounting policies and other explanatory information, and the directors’ declaration of the consolidated entity comprising the company and the entities it controlled at the halfyear end or from time to time during the half-year.

Directors’ Responsibility for the Half-Year Financial Report

The directors of the company are responsible for the preparation of the half-year financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal controls as the directors determine are necessary to enable the preparation of the half-year financial report that is free from material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express a conclusion on the half-year financial report based on our review. We conducted our review in accordance with Auditing Standard on Review Engagements ASRE 2410 Review of a Financial Report Performed by the Independent Auditor of the Entity , in order to state whether, on the basis of the procedures described, we have become aware of any matter that makes us believe that the half-year financial report is not in accordance with the Corporations Act 2001 including: giving a true and fair view of the consolidated entity’s financial position as at 31 December 2016 and its performance for the half-year ended on that date; and complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001 . As the auditor of Mayne Pharma Group Limited and the entities it controlled during the half-year, ASRE 2410 requires that we comply with the ethical requirements relevant to the audit of the annual financial report.

A review of a half-year financial report consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Independence

In conducting our review, we have complied with the independence requirements of the Corporations Act 2001 . We have given to the directors of the company a written Auditor’s Independence Declaration, a copy of which is included in the Directors’ Report.

A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation

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Appendix 4D Interim Results Half Year Report

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Conclusion

Based on our review, which is not an audit, we have not become aware of any matter that makes us believe that the half-year financial report of Mayne Pharma Group Limited is not in accordance with the Corporations Act 2001, including:

  • a) giving a true and fair view of the consolidated entity’s financial position as at 31 December 2016 and of its performance for the half-year ended on that date; and

  • b) complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001.

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Ernst & Young

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Ashley Butler Partner Melbourne 24 February 2017

A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation

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