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MAYNE PHARMA GROUP LIMITED Annual Report 2012

Aug 20, 2012

65396_rns_2012-08-20_844d2552-ba30-4569-8d95-d6dcf70497b4.pdf

Annual Report

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

21 August 2012

Via E-Lodgement

Dear Sir/Madam

Mayne Pharma Group Preliminary Final Report and accompanying announcement

Please find attached the Appendix 4E Preliminary Final Report relating to the results for the year ended 30 June 2012.

This announcement comprises the information required by ASX Listing Rule 4.3A.

Yours faithfully, Mayne Pharma Group Limited

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Mark Cansdale

Chief Financial Officer and Company Secretary

Mayne Pharma Group Limited ACN | 115 832 963 a | Level 9, 470 Collins St, Melbourne, VIC, 3000 t | +61 3 8614 7777 f | +61 3 9614 7022 | www.maynepharma.com

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MAYNE PHARMA GROUP LIMITED

ABN 76 115 832 963

APPENDIX 4E PRELIMINARY FINAL REPORT

FOR THE YEAR ENDED 30 JUNE 2012

1

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

RESULTS FOR ANNOUNCEMENT TO THE MARKET

%
Change
Current period
2012
$’000
Previous
corresponding
period
2011
$’000
Revenue from ordinary activities Up 5 % 52,546 50,101
Profit from ordinary activities before income tax
expense
NM1 7,751 (1,504)
Profit from ordinary activities after income tax
expense
Up 266 % 6,153 1,679
Net profit attributable to members Up 266 % 6,153 1,679
Current period
2012
Previous
corresponding
period
2011
Net tangible asset backing per ordinary share 17.4 cents 10.5 cents
Net asset backing per ordinary share 20.1 cents 15.9 cents
Basic earnings per share
Diluted earnings per share
4.05 cents
4.02 cents
1.12 cents
1.10 cents
Special dividend in respect of the period ended 30 December
2010 per share
- 1.0 cent

The Board has not declared a final dividend in relation to the year ended 30 June 2012.

All dividends were fully franked at the corporate income tax rate (2010: 30%). No dividend reinvestment plan has operated for any dividends paid.

  1. NM – not measurable

2

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

COMMENTARY ON OPERATING PERFORMANCE

The consolidated entity‟s net profit attributable to members of the Company for the year ended 30 June 2012 was $6,153,000 (year ended 30 June 2011: $1,679,000).

Review of operations

Mayne Pharma Australia (MPA)

Mayne Pharma Australia (MPA) manufactures, markets and distributes proprietary and generic products in the Australian market. The products in the MPA portfolio include Doryx®, Astrix®, Eryc®, Magnoplasm® and Mayne-Pharma branded generic products (doxycycline, aspirin and erythromycin). Sales were $9,837,000 for FY12, up 5.6% on the prior comparable period (pcp) driven by the sale of increased volumes of Astrix® capsules. A new pricing programme was implemented in the last quarter of FY12 for key products, which had a positive impact on margins.

Mayne Pharma Global (MP Global)

MP Global manufactures and out-licences proprietary pharmaceuticals to international marketing and distribution partners including Warner Chilcott, Pfizer, Abbott Laboratories, GlaxoSmithKline and Boryung and provides contract manufacturing services. In FY12, sales revenue was $42,067,000, up 11.5% on pcp reflecting solid growth across the portfolio including proprietary pharmaceuticals (Doryx®, Astrix®, Eryc®) and contract manufacturing.

Out-licensed sales were $30,645,000, up 13.0% on pcp. Expanded marketing efforts by Boryung for Astrix® low-dose aspirin capsules in Korea drove sales up $545,000 or 17.9% to $3,597,000. In Europe, Teva Pharmaceutical Industries and Meda AB, the marketing and distribution partners for Eryc® drove European sales up $529,000 or 94.3% to $1,092,000.

Doryx®

Sales of US Doryx® were up 10.7% to $20,450,000 on pcp. This was a strong result notwithstanding a 6% increase in the average AUD/USD rate settled in FY12 versus pcp and a reduction in manufacturing volumes following the launch of a generic Doryx® 150mg tablet late in the period.

In September 2011, a dual-scored formulation of Doryx® 150mg tablet was approved by the US Food and Drug Administration (FDA) and launched by Warner Chilcott. In May 2012, Mylan Pharmaceuticals Inc. (Mylan) launched a single-scored generic version of the Doryx® 150mg tablet following a US District Court decision that its generic product did not infringe the Doryx® „161 patent.

Contract manufacturing

Sales revenue from contract services was $11,422,000, up 9.0% on pcp driven by growth in new product lines introduced by customers. A major contract was renegotiated for a further three years during the second half.

Research and development

Research and development income decreased by $2,411,000 in the period to $306,000 as the prior period included development activity on new formulations of Doryx®. Going forward, the internal R&D resources will be focussed on the development of new pipeline products for the Group.

3

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

Gross margin

Manufacturing gross margin (ie gross margin excluding the impact of “Other revenue”) as a percentage of sales revenue improved slightly year on year: FY12: 43.5%, FY11: 42.9%.

Expenses

Research and development expenses decreased by $1,956,000 during the period to $4,018,000 as a result of reduced clinical and development work on Doryx® and SUBACAP® as the development work has been completed.

The decrease in other expenses of $799,000 reflects reduced net foreign exchange losses in the current period.

The majority of the restructure and redundancy costs in the current period reflect the termination payment made to the former CEO. The costs in the prior period were incurred when a restructuring program was undertaken at the Salisbury production site to improve efficiencies and increase capacity utilisation.

The reduction in finance costs in FY12 of $313,000 is due to the interest expense being lower as the USD loan was repaid.

Amortisation of the intangible assets that were recognised on the acquisition of Mayne Pharma International Pty Ltd (MPI) amounted to $3,836,000 for the period compared to $6,098,000 in the previous period. The intangible assets are amortised on a diminishing value basis that delivers higher amortisation charges in the earlier years of the assets‟ useful lives.

The share-based payments expense of $272,000 represents the cost of options issued to the CEO and CFO during the year and the shares issued to employees under the Company‟s tax exempt share plan.

A charge has been recognised for the Impairment of the customer relationships intangible asset in relation to the Company‟s relationship with Warner Chilcott. The charge of $181,000 reflects an adjustment for the Company‟s long-term forecasts for Doryx® following the launch of the generic to Doryx®.

Earn-out liability

The carrying value of the earn-out liability has decreased by $5,732,000 to $9,331,000 as a result of:

  • an increase of $1,006,000 recognised as a notional non-cash interest charge;

  • a decrease of $3,856,000 due to a change in the fair value of the earn-out liability over the year following the reassessment of the underlying assumptions used in the calculation; and

  • a payment of $2,881,000 in February 2012 representing the instalment for the 2011 calendar year.

Tax

The consolidated tax group has unutilised tax losses of $226,000 as at 30 June 2012 that are recognised as a Deferred Tax Asset. Losses of approximately $3,148,000 have been offset against the taxable income of the Group during the period.

4

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

Cash flow

Net operating cash generated during the period was $13,387,000, up 227.6%. Cash on hand at 30 June 2012 was $11,596,000, representing an increase of $5,789,000 from 30 June 2011. During the period, the following key payments were made:

  • $2,881,000 in earn-out payments to Hospira for the acquisition of MPI,

  • $2,315,000 in loan repayments to retire the US$10m loan facility in full, and

  • $2,547,000 in capital expenditure for a new itraconazole spray dryer (for the production of SUBACAP®) and other tablet manufacturing equipment including an aspirin tablet press required for the transfer of the manufacturing of the aspirin tablets in-house.

Dividend

The Directors have not declared a dividend in the year ending 30 June 2012.

SUBSEQUENT EVENTS

Doryx® litigation

In July 2012, Warner Chilcott and Mayne Pharma filed an appeal against the non-fringement determinations on the Doryx® „161 Patent in the US Court of Appeals for the Federal Circuit. Furthermore, the Company together with Warner Chilcott received notification of four anti-trust lawsuits from Mylan, Rochester Drug Co-operative, Meijer Inc. and American Sales Company LLC, alleging that Warner Chilcott and Mayne Pharma have engaged in conduct that constrains generic competition for Doryx®. At the date of this report, no certainty exists as to the outcome of these actions, however Mayne Pharma does not foresee incurring any material financial liabilities in relation to these actions based on pre-existing contractual rights with Warner Chilcott and current legal advice received by the Company.

ROUNDING

The amounts contained in this report and in the financial report have been rounded to the nearest $1,000 (unless otherwise stated) under the option available to the Company under ASIC Class Order 98/0100. The Company is an entity to which the Class Order applies.

5

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME for the year ended 30 June 2012

Revenues from continuing operations
Sale of goods
Royalties revenue
Other revenue
Total revenue
Cost of sales
Gross profit
Other income
Other expenses
Research and development expenses
Distribution expenses
Marketing expenses
Regulatory affairs expenses
Share-based payments
Amortisation expense
Administrative expenses
Finance costs
Fair value movement in earn-out liability
Restructure & redundancy costs
Impairment of customer relationship intangible asset
Inventory write down
Profit before income tax
Income tax (expense)/benefit
Net profit for the period
Other comprehensive income
Total comprehensive income for the period
Current Period
Previous
Corresponding
Period
2012
2011
$’000
$’000
50,436
45,700
1,468
1,333
642
3,068
52,546
50,101
(29,342)
(26,861)
23,204
23,240
15
-
-
(799)
(4,018)
(5,974)
(600)
(614)
(675)
(709)
(872)
(641)
(272)
-
(3,836)
(6,098)
(6,985)
(6,771)
(28)
(341)
2,850
(677)
(851)
(1,005)
(181)
-
-
(1,115)
7,751
(1,504)
(1,598)
3,183
6,153
1,679
-
-
6,153
1,679

6

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

CONSOLIDATED STATEMENT OF FINANCIAL POSITION as at 30 June 2012

Current assets
Cash and cash equivalents
Trade and other receivables
Inventories
Income tax receivable
Other current assets
Total current assets
Non-current assets
Property, plant and equipment
Deferred tax assets
Intangible assets and goodwill
Total non-current assets
Total assets
Current liabilities
Trade and other payables
Interest-bearing loans and borrowings
Income tax payable
Other financial liabilities
Provisions
Total current liabilities
Non-current liabilities
Other financial liabilities
Deferred tax liabilities
Provisions
Total non-current liabilities
Total liabilities
Net assets
Equity
Contributed equity
Reserves
Accumulated losses
Total equity
Current Period
Previous
Corresponding
Period
30 June 2012
30 June 2011
$’000
$’000
11,596
5,807
3,821
5,697
7,244
6,423
-
630
594
281
23,255
18,838
22,224
21,457
4,260
5,199
4,194
8,183
30,678
34,839
53,933
53,677
4,234
3,848
-
2,339
1,456
-
2,782
5,837
3,832
2,915
12,304
14,939
6,549
9,283
3,730
4,478
750
803
11,029
**14,564 **
23,333
29,503
30,600
24,174
32,016
31,870
1,087
960
(2,503)
(8,656)
30,600
24,174

7

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

CONSOLIDATED STATEMENT OF CASH FLOWS for the year ended 30 June 2012

Cash flows from operating activities
Cash receipts from customers
Cash payments for R&D expenditure
Cash payments to suppliers and employees
Interest received
Interest paid
Tax received / (paid)
Net cash flows from operating activities
Cash flows from investing activities
Payments for property, plant and equipment
Payments for acquisition of operating licenses
Net cash flows used in investing activities
Cash flows from financing activities
Proceeds from issue of shares
Repayment of borrowings
Payment of earn-out liability instalment
Payment of dividend
Net cash flows used in financing activities
Net increase /(decrease) in cash held
Cash and cash equivalents at the beginning of the period
Effect of foreign exchange changes on cash held in
foreign currencies
Cash and cash equivalents at the end of the period
Current Period
Previous
Corresponding
Period
2012
2011
$’000
$’000
56,464
52,441
(4,018)
(6,482)
(40,009)
(39,000)
181
264
(8)
(220)
777
(2,917)
13,387
4,086
(2,547)
(2,063)
-
(41)
(2,547)
(2,104)
-
1,467
(2,315)
(5,057)
(2,881)
(6,556)
-
(4,521)
(5,196)
(14,667)
5,644
(12,685)

5,807
19,709
145
(1,217)
11,596
5,807

8

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY for the year ended 30 June 2012

Balance at 1 July 2011
Profit for the year
Other comprehensive income
Total comprehensive income
Transactions with owners in
capacity as owners
Shares issued
Share-based payments
Dividends paid
Balance at 30 June 2012
Balance at 1 July 2010
Profit for the year
Other comprehensive income
Total comprehensive income
Transactions with owners in
capacity as owners
Shares issued
Share options exercised
Dividends paid
Balance at 30 June 2011
Contributed
equity
Share-
based
payments
reserve
Accumulated
losses
$’000
$’000
$’000
31,870
960
(8,656)
-
-
6,153
-
-
-
Total
$’000
24,174
6,153
-
-
-
6,153
146
-
-
-
127
-
-
-
-
6,153
146
127
-
32,016
1,087
(2,503)
30,600
29,649
1,714
(5,814)
-
-
1,679
-
-
-
25,549
1,679
-
-
-
1,679
1,467
-
-
754
(754)
-
-
-
(4,521)
1,679
1,467
-
(4,521)
31,870
960
(8,656)
24,174

9

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

1. BASIS OF PREPARATION

This preliminary final report has been prepared in accordance with ASX Listing Rule 4.3A and the disclosure requirements of ASX Appendix 4E.

The preliminary final report has been prepared in accordance with Australian Accounting Standards, including Australian Accounting Interpretations, other authoritative pronouncements of the Australian Accounting Standards Board and the Corporations Act 2001.

The preliminary final report covers the consolidated group of Mayne Pharma Group Limited and its controlled entities (economic entity). Mayne Pharma Group Limited is a listed public company, incorporated and domiciled in Australia.

The preliminary final 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.

It is recommended that the preliminary final report be read in conjunction with the annual report for the year ended 30 June 2011 and considered together with any public announcements made by Mayne Pharma Group Limited during the reporting period in accordance with the continuous disclosure obligations of the ASX Listing Rules.

Reporting basis and conventions

The preliminary final report has been prepared on an accruals basis and is based on historical costs.

2. DIVIDENDS

Amount per security

Amount per
security
Franked
amount per
security at
% tax
Amount per
security of
foreign
source
dividend
Final dividend:
Current year
Previous year
Nil
Nil
N/A
N/A
Nil
Nil
Interim/special dividend:
Current year
Previous year
Nil
1.0 cent
N/A
100%
N/A
Nil

10

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

2. DIVIDENDS (cont)

Total dividend per security (interim plus final)

Ordinary securities
Preference securities
. CONSOLIDATED RETAINED PROFITS
Accumulated losses at the beginning of the period
Net profit attributable to members
Dividends paid
Accumulated losses at the end of the period
Current Period
2012
Previous
Corresponding
Period
2011
N/A
N/A
1.0 cent
N/A
Current Period
2012
$’000
(8,656)
6,153
-
Previous
Corresponding
Period
2011
$’000
(5,814)
1,678
(4,521)
(8,656)
(2,503)

3. CONSOLIDATED RETAINED PROFITS

4. SEGMENT INFORMATION

The Group has identified its operating segments based on the internal reports that are reviewed and used by the key management personnel (the chief operating decision makers) 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 key management personnel on at least a monthly basis. The segments identified in this report are different from previous reports where data was presented for two segments on an entity basis, namely Mayne Pharma International (MPI) and Mayne Pharma Group (MPG). This change in reportable segments has arisen as the newly appointed CEO and key management personnel have changed the way they manage and review the business‟ operations.

The consolidated entity operates in two operating segments, being Mayne Pharma Australia (MPA) and Mayne Pharma Global (MP Global).

MPA revenues and gross profit are derived from the manufacturing, distribution and marketing of proprietary and generic products within Australia.

MP Global revenues and gross profit are derived from the manufacturing and out-licensing of proprietary pharmaceutical products to international marketing and distribution partners and provision of contract manufacturing services to third party customers within Australia.

11

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

4. SEGMENT INFORMATION (cont)

Year ended 30
Mayne
Mayne Total Eliminations Total
June 2012
Pharma
Pharma Segments and
$’000
Australia
Global adjustments
Sale of goods and
services
9,837
40,599 50,436 - 50,436
Royalty income
-
1,468 1,468 - 1,468
R&D income
-
- - 306 306
Other
-
- - 336 336
Total revenue
**9,837 **
**42,067 ** **51,904 ** 642 52,546
Gross profit
3,088
19,474 **22,562 ** 642 **23,204 **
$’000
Gross profit per segment report 22,562
Plus:
R&D income
306
Interest received on funds 181
Administrative buildingrental 155
Gross Profit per Statement of Comprehensive Income **23,204 **
Reconciliation between Gross Profit and Profit after income tax
$’000
Gross profit per segment analysis 23,204
Other income 15
Research and development expenses (4,018)
Distribution expenses (600)
Marketing expenses (675)
Regulatory affairs expenses (872)
Share-based payments (272)
Amortisation expense (3,836)
Administrative expenses (6,985)
Finance costs (28)
Fair value movement in earn-out liability 2,850
Restructure and redundancy costs (851)
Impairment ofcustomer relationshipintangible asset (181)
Profit before income tax 7,751
Income tax(expense) (1,598)
Profit after income tax per Statement of Comprehensive Income 6,153

12

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

4. SEGMENT INFORMATION (cont)

Year ended 30
Mayne
Mayne Total Eliminations Total
June 2011
Pharma
Pharma Segments and
$’000
Australia
Global adjustments
Sale of goods and
services
9,316
36,384 45,700 - 45,700
Royalty income
-
1,333 1,333 - 1,333
R&D income
-
- - 2,655 2,655
Other
-
- - 413 413
Total revenue
9,316
37,717 47,033 3,068 **50,101 **
Gross profit
**2,754 **
17,418 20,172 3,068 23,240
$’000
Gross profit per segment report 20,172
Plus:
R&D income
2,655
Interest received on funds 264
Administrative buildingrental 149
Gross Profit per Statement of Comprehensive Income 23,240
Reconciliation between Gross Profit and Profit after income tax
$’000
Gross profit per segment analysis 23,240
Research and development expenses (5,974)
Distribution expenses (614)
Marketing expenses (709)
Regulatory affairs expenses (641)
Amortisation expense (6,098)
Administrative expenses (6,771)
Finance costs (341)
Fair value movement in earn-out liability (677)
Restructure and redundancy costs (1,005)
Other expenses (foreign exchange) (799)
Inventorywrite down (1,115)
Loss before income tax (1,504)
Income taxbenefit 3,183
Profit after income tax per Statement of Comprehensive Income 1,679

13

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

5. EARNINGS PER SHARE (EPS)

Economic entity Economic entity
Previous
Current Corresponding
Period Period
2012 2011
‘000 ‘000
Net profit $6,153 $1,679
Earnings used to calculate basic and diluted EPS $6,153 $1,679
Weighted average number of ordinary shares
outstanding during the year used in the calculation 152,041 150,385
of basic EPS
Weighted average number of options on issue
outstanding net of lapses 848 2,840
Weighted average number of ordinary shares
outstanding during the year used in calculation of 152,889 152,255
diluted EPS

6. INCOME TAX

The prima facie tax on profit from ordinary activities before income tax is reconciled to the income tax benefit as follows:

Accounting profit/(loss) before income tax
Prima facie tax (expense)/benefit at 30%
Effect of R&D tax concession
Adjustment relating to earn-out liability
Overprovision for tax in respect of prior years
Deferred tax assets not previously brought to
account – losses
Tax effect of amounts which are not deductible
Restatement of deferred tax balances upon
entry into tax consolidation
Share-based payments
Income tax (expense)/benefit
Current Period
2012
$‘000
Previous
Corresponding
Period
2011
$‘000
7,751
(1,504)
(2,325)
451
289
440
855
217
31
461
-
979
(3)
(2)
(363)
637
(82)
-
(1,598)
3,183

14

Mayne Pharma Group Limited Appendix 4E Preliminary final report Year ended 30 June 2012

7. CONTINGENT LIABILITIES

Doryx® litigation

In July 2012, Warner Chilcott and Mayne Pharma filed an appeal against the non-fringement determinations on the Doryx® „161 Patent in the US Court of Appeals for the Federal Circuit. Furthermore, the Company together with Warner Chilcott received notification of four anti-trust lawsuits from Mylan, Rochester Drug Co-operative, Meijer Inc. and American Sales Company LLC, alleging that Warner Chilcott and Mayne Pharma have engaged in conduct that constrains generic competition for Doryx®. At the date of this report, no certainty exists as to the outcome of these actions, however Mayne Pharma does not foresee incurring any material financial liabilities in relation to these actions based on pre-existing contractual rights with Warner Chilcott and current legal advice received by the Company.

8. COMPLIANCE STATEMENT

This report is based on accounts that are in the process of being audited.

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............................................................... 21 August 2012 Mark Cansdale, Company Secretary

15