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MAYNE PHARMA GROUP LIMITED — Annual Report 2016
Oct 6, 2016
65396_rns_2016-10-06_02c06ef2-4e8d-436a-93b9-3fa192310bdf.pdf
Annual Report
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Annual Report 2016 maynepharma.com
What’s inside
Overview
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|About Mayne Pharma|4|
|Mayne Pharma Performance|5|
|FY16 Business Highlights|6|
|Growth Strategy|7|
|Chairman’s Letter|8|
|Chief Executive Officer’s Review|10|
|Global Leadership Group|12|
|Investing for growth|14|
|Financial Report|
|Directors’ Report|16|
|Remuneration Report|27|
|Auditor’s Independence Declaration|35|
|Corporate Governance Statement|36|
|Consolidated Statement of Profit and Loss and|
|other Comprehensive Income|37|
|Consolidated Statement of Financial Position|38|
|Consolidated Statement of Cash Flows|39|
|Consolidated Statement of Changes in Equity|40|
|Notes to the Consolidated Financial|
|Statements|41|
|Directors’ Declaration|81|
|Independent Auditor’s Report|82|
|ASX Additional Information|84|
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2 Mayne Pharma Annual Report 2016
Our international footprint
Direct commercial presence Indirect presence through distribution partners for current and pipeline products
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US Commercial Office
Raleigh, North Carolina
Product development
and manufacturing facility,
Greenville, North Carolina
36.1 acre facility; 99,200 square foot
of manufacturing space.
FDA approved. Technologies:
• High potency drug handling
• SOD matrix modified-release
tablets Head office, product development and
manufacturing facility, Salisbury, South Australia
• Controlled substances (CII-CV)
32.1 acre facility; 129,000 square foot of Global
• Multi-particulate modified-
manufacturing space. FDA, MHRA and TGA approved. Commercial
release (via capex expansion)
Technologies: Office
• Multi-particulate modified-release beads Melbourne,
• Multi-particulate modified-release tablets Victoria
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- Microencapsulation utilising spray drying process
Our Business Units
UNITED STATES
REST OF WORLD
Generic Products
Specialty Brands
- Develops, manufactures, Markets and distributes markets and distributes generic specialty branded products products in the US in the US
Contract Services
Provides contract pharmaceutical development and analytical services to third party customers globally
Mayne Pharma International
Develops, manufactures, markets and distributes branded and generic products globally (excl. US)
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Butalbital / APAP / Caffeine • Doryx®
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• Carbidopa / Levodopa • Doryx® MPC • Clonidine • Fabior®
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Dextroamphetamine • Sorilux®
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Dofetilide
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• Liothyronine • Methamphetamine • Methylphenidate • Oxycodone • Range of oral contraceptives
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Analytical services (method development and validation, drug substance and drug product release, stability, and trace metals analysis)
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• Formulation Development (incl. clinical trials manufacturing)
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Astrix®
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• Doryx® • Eryc® • Lozanoc® / Itragerm® • Kapanol® / Kadian® • Luxiq® • Magnoplasm® • Olux-E® • Range of injectable products
Mayne Pharma Annual Report 2016
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About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals, providing patients with access to better and more affordable medicines. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that have been marketed around the world.
Key business facts
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700+ staff
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200+ scientists employed globally
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A$267 million in sales revenue in FY16
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A$1.5 billion market capitalisation at 30 June 2016
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A$29 million invested in research and development in FY16
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A$30 million strategic investment in Australian and US facilities in FY16
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40+ US pipeline products and 10+ Australian pipeline products
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100+ contract service customers
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Products sold in 10+ countries
Mayne Pharma has two product development and manufacturing facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral dose forms including highly potent compounds, controlled substances, modified-release products and inherently unstable compounds.
Mayne Pharma Annual Report 2016
Mayne Pharma Performance
Strong track record of growth since 2012
Mayne Pharma share price (A$)
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$2.00
$1.50
$1.00
$0.50
0
Jan 12 Mar 12 May 12 Jul 12 Sep 12 Nov 12 Jan 13 Mar 13 May 13 Jul 13 Sep 13 Nov 13 Jan 14 Mar 14 May 14 Jul 14 Sep 14 Nov 14 Jan 15 Mar 15 May 15 Jul 15 Sep 15 Nov 15 Jan 16 Mar 16 May 16 Jul 16 Sep 16
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Key Financials
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Revenue (A$m) 267.3
143.3 141.4 51%
83.4 Compound
51.9 annual growth
rate since 2012
FY12 FY14 FY14 FY15 FY16
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Key organic initiatives
Jul 2013
Launched doxycycline DR tablets and erythromycin DR capsules in the US
Jun 2014
Launched Lozanoc in Australia and Spain and received FDA approval for oxycodone solution
M&A activity
Oct 2012
Announced acquisition of Metrics, Inc. for up to US$120m
Dec 2012
Announced A$14m acquisition of Kapanol
Jul 2013
Announced acquisition of US based generic company Libertas Pharma Inc.
May 2015
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EBITDA – adjusted (A$m) [1] 88.5
40.4
36.4 67%
Compound
18.4 annual growth
11.5
rate since 2012
FY12 FY14 FY14 FY15 FY16
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Research & development
cash investment (A$m) 28.6
19.8
17.0
64%
10.9
Compound
annual growth
4.0
rate since 2012
FY12 FY14 FY14 FY15 FY16
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Re-launched Doryx 200mg tablet as part of Mayne Pharma’s new US Specialty Brands Division
Aug 2015
Announced expansion of US and Australian facilities to support projected growth
Aug 2015
In-licensed generic butalbital/ APAP/caffeine (BAC) tablet and launched in the US
May 2016
Announced FDA approval of Doryx MPC tablets
Jun 2016
Launched dofetilide capsules in the US, first generic approval to Pfizer’s Tikosyn™
Feb 2014
Announced acquisition of select brands from Forest Laboratories for up to US$12m
Feb 2015
Announced acquisition of Doryx for US$50m and methamphetamine tablets and BAC capsules for US$15.7m
May 2015
Acquired oxycodone franchise from Mylan
Aug 2016
Completed US$652m acquisition of US product portfolio from Teva and Allergan
- Adjusted EBITDA excludes certain one-off items. Refer to reconciliation table in our earnings releases dated 26 August 2016, 28 August 2015, 27 August 2014, 27 August 2013 and 21 August 2012 for adjustment details
Mayne Pharma Annual Report 2016
FY16 Business Highlights
AUGUST 2015
MARCH 2016
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50mg Doryx tablet launched in the US
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Recipient of a A$4m grant from the Federal Government as part of the Next Generation Manufacturing Investment Programme to support investment in a new fluid bed coater at the Salisbury site
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Announced US$65m investment in new oral dose manufacturing facility in Greenville, North Carolina
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Launched noradrenaline injectable in Australia – first generic source
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Acquired 100% of liothyronine ANDA from Perrigo Company plc
APRIL 2016
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Lozanoc capsules listed on the PBS in Australia for systemic fungal infections
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Launched BAC tablet in the US
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HedgePath Pharmaceuticals commenced Phase IIb multi-centre, open label, non-placebo controlled trial in Basal Cell Carcinoma Nevus Syndrome using Mayne Pharma’s SUBA®-itraconazole capsules
OCTOBER 2015
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Oxycodone immediate-release tablet launched in Australia; first independent generic source
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In-licensed a specialty branded product to launch in Australia
MAY 2016
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Itraisdin™ (SUBA-itraconazole capsule) launched in Germany by marketing and distribution partner ISDIN
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Approval of Doryx MPC tablets in the US
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Launched generic doxycycline hyclate delayed-release 50mg and 200mg tablets in the US
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Invested US$2.8m in HedgePath Pharmaceuticals to support ongoing clinical program using Mayne Pharma’s patented oral formulation of itraconazole to treat certain cancers
NOVEMBER 2015
- Out-licensed Lozanoc to ISDIN in Brazil
DECEMBER 2015
- Out-licensed Kapanol to Spirig HealthCare in Switzerland
JUNE 2016
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Approval and launch of dofetilide capsules – first generic alternative to Pfizer’s Tikosyn™
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Announced US$652m acquisition of 42 generic products from Teva Pharmaceutical Industries Limited (“Teva”) and Allergan plc (“Allergan”)
FEBRUARY 2016
- Mayne Pharma USA announced as Pitt County’s Industry of the Year Award for 2015-16 which recognises a manufacturer or distributor that best represents the community as a model corporate citizen
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Growth strategy
| KEY GROWTH DRIVER US retail generics maximisation Expand US branded specialty franchise portfolio Research and development maximisation Strategic acquisitions, licensing and partnerships Optimise and grow Metrics Contract Services |
ACTIVITIES |
|---|---|
| • Optimise market penetration of product portfolio • Commercialise filed FDA products • Eficient and reliable product sourcing, manufacturing and supply • Leverage product portfolio in non-retail segments (e.g. government, universities and institutional) • Extract synergies from recent product acquisitions • Portfolio expansion through growing product pipeline |
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| • Develop US specialty dermatology franchise by leveraging Doryx, Fabior and Sorilux and pipeline of future products • Build new specialty therapeutic platforms that leverage the Company’s development and manufacturing capabilities |
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| • Portfolio selection that leverages drug delivery expertise in complex generics and specialty products • Selective paragraph IV2filings in the US • Development of SUBA-itraconazole in cancer through the alliance with HedgePath Pharmaceuticals |
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| • In-licensing niche generic or specialty products in Australia and the US • Commercialisation of specialty products such as Lozanoc through out-licensing arrangements in key markets to broaden global footprint • Product and enterprise acquisitions with strong growth potential, complementary assets and technologies • Build an injectable portfolio and branded specialty franchise in Australia |
|
| • Enhance operational eficiencies and client experience • Globalise customer base • Introduce high value manufacturing services following Greenville site expansion |
- A product may be filed with the FDA before the relevant patent has expired as a paragraph IV certification either because the filer believes the patent is not infringed; is invalid, or both.
Mayne Pharma Annual Report 2016
Chairman’s Letter
Dear Fellow Shareholders,
On behalf of the Mayne Pharma Board and Management, I am pleased to present the 2016 annual report.
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Roger Corbett AO, Chairman
Over the last twelve months, your Board and Management have focused on delivering on our objective of becoming a leading global specialty pharmaceutical company. The 2016 financial year has been another successful period for Mayne Pharma as new product launches, product acquisitions and increased market penetration of key product franchises contributed to the strong financial result.
Financial performance
The Company reported FY16 revenue of A$267.3m up 89% on the prior corresponding period (pcp), underlying EBITDA of A$88.5m[3] up 143% on pcp and reported NPAT of A$37.4m up 379% on pcp. These results were driven by inclusion of the full year of earnings from the Doryx acquisition and strong growth in the generics and contract service businesses. Doryx achieved the EBITDA guidance, which the Company provided at the time of the Doryx acquisition in February 2015. The approval and launch of dofetilide capsule, the Company’s first generic product to be awarded 180-days of market exclusivity achieved 100% return on investment in its first week following regulatory approval.
Sales by region (%)
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87% 10%
3%
USA Australia Rest of world
Sales by division (%)
40% 29% 18% 13%
Generic Products Specialty Brands
Metrics Contract Services Mayne Pharma International
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Investing for growth
We also continued to strengthen the organisation through significant investment in research and development to advance our product pipeline, expansion of our facilities, strategic M&A as well as the strengthening of our team and capabilities.
During FY16 A$29m was invested in research and development, an increase of more than 70% from the prior year. Most of this investment was directed towards generic programs that leverage the Company’s capabilities in modified-release, potent compounds and controlled substances.
Acquisitions remain a key driver of growth with the business announcing in June 2016 a transformational US$652m acquisition of 42 generic products from Teva and Allergan. This acquisition was completed in August 2016 and transforms the scope and breadth of the US Generic Products Division, diversifying Mayne Pharma’s earnings across more products, therapeutic areas, dosage forms and complex technologies. Up to eleven of the acquired products will be transferred into our manufacturing facilities in Salisbury, South Australia and Greenville, North Carolina. This will accelerate utilisation of manufacturing capacity and enable additional margin to be captured over time, improving overhead recovery and the return on capital invested in expanding these two facilities.
In August 2016, we announced the US$50.1m acquisition of a portfolio of dermatology foam products from GlaxoSmithKline (GSK). The key acquired products were Fabior and Sorilux, which are complementary dermatology products to Doryx and will be marketed through Mayne Pharma’s established Specialty Brands Division. These products will strengthen Mayne Pharma’s position in the US dermatology market, diversify future branded earnings and create new opportunities for growth.
- Underlying result excludes certain specified expenses as outlined in the FY16 Results Presentation dated 26 August 2016.
Mayne Pharma Annual Report 2016
Chairman’s Letter
Outlook
Acquisitions remain a key driver of growth with the business announcing a transformational US$652m acquisition of 42 generic products from Teva and Allergan.
In terms of our facilities, I am pleased to report the investment we announced twelve months ago to transform our global manufacturing footprint is well underway and on track to be completed by early 2018. These investments will bring new capacity and capability on line. The dual-site expansion programs will support the mid to long-term growth we are forecasting across our products and pipeline. We see significant strategic value in controlling the supply chain where possible to reduce business continuity risk, service our customers better, protect our IP and reduce cost.
To support the growth of the Company, we also expanded our global workforce to over 700 employees with at least 100 new roles added in the last year across all key functions.
The outlook remains very positive with growth to be driven by recent product acquisitions, new product launches and growth of our existing products.
The Company will also continue to identify further business development opportunities to in-license or acquire complementary assets to expand the on-market portfolio and pipeline, or introduce new manufacturing or technology platforms.
On behalf of the Board, I would like to thank all of our dedicated team at Mayne Pharma for their continued commitment and hard work over the last year to deliver our strategic goals.
The Board is grateful to you, our shareholders, for your continued support and in particular for the support we received during the equity raising this year. I am confident that Mayne Pharma will continue to deliver shareholder value into the future.
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Roger Corbett, AO Chairman
Financial position
The Company ended the year in a solid financial position with cash of A$47.5m and outstanding borrowings of A$76.8m. As a result of the recent product acquisitions, the Company successfully raised an additional A$888m in equity and expanded existing debt facilities to fund these transactions. Following the acquisitions, the Company’s new capital structure has retained flexibility to pursue further growth initiatives with significant undrawn debt capacity.
Mayne Pharma Annual Report 2016
Chief Executive Officer’s Review
Dear Fellow Investors
It is a pleasure to present the Chief Executive Officer’s Review for 2016.
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Scott Richards, CEO
FY16 has been a strong year for Mayne Pharma with the business reporting growth across all operating segments and group revenue, adjusted EBITDA, NPAT and cashflow were all up significantly on the prior year. The Generic Products Division and Metrics Contract Services delivered especially strong growth in US dollar terms and the Specialty Brands Division which incorporates Doryx achieved the guidance we announced to the market in February 2015 when we acquired the rights to the product.
Our key achievements in FY16 include:
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Revenue up 89% on pcp to A$267m
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Reported NPAT up 379% on pcp to A$37m and growth in earnings per share of more than 300% to 4.6c
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Material improvement in Gross Profit and adjusted EBITDA margins reflecting the full year contribution of the high margin Doryx franchise
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Launch of dofetilide capsules, the first generic approval to Pfizer’s Tikosyn™ capsules
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FDA approval of patent-protected Doryx MPC tablets
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Launched BAC tablet and authorised generics to the 50mg and 200mg Doryx tablets in the US
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Commenced construction of a new oral dose manufacturing facility in Greenville, North Carolina
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Announced the transformational acquisition of 42 products from Teva and Allergan for US$652m
Mayne Pharma’s strength lies in its integrated operations from product development, through to manufacturing and marketing of our products and services around the world. With three US-facing business segments and 87% of revenue generated in this market, Mayne Pharma’s key focus and attention over the medium term is to continue to drive and optimise performance in this strategically important market.
Having both branded and generic product platforms diversifies our business model and enables the Company to fully leverage growth opportunities. Future branded products can be marketed by the Specialty Brands Division and as these products lose exclusivity, the Company can participate in a new generic market that may form. A very recent example of this was the introduction of generic competition on the 50mg and 200mg Doryx franchise in May 2016 which led to Mayne Pharma also launching its own authorised generic variants. Pleasingly, the combined brand and generic franchise held onto more than 80% of the prescriptions written for those dose strengths across June and July.
Operating performance
In terms of the operating performance at a segment level, the Specialty Brands Division reported sales of A$77.8m and gross profit of A$73.4m. In USD terms the division met the guidance target of US$2.7m adjusted EBITDA per month on average over FY16.
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Acquired 100% of liothyronine ANDA from Perrigo
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Launched oxycodone tablets in Australia, an original Metrics, Inc. product and the first independent generic alternative to Endone™
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Completed further out-licensing deals for Lozanoc and Kapanol around the world
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HedgePath Pharmaceuticals commenced Phase IIb study in Gorlin’s Syndrome (a rare form of skin cancer) using Mayne Pharma’s patented oral formulation of itraconazole
The Generic Products Division grew sales 84% to A$106.8m and gross profit grew 58% to A$60.8m driven by new product launches and growth in the key product franchises with eight of the top ten molecules growing sales year on year.
Metrics Contract Services revenue was A$48.9m, an increase of 45% and gross profit was A$26.4m, up 55% on pcp reflecting the continued focus on operational efficiencies, price optimisation and improvement in service mix.
The fourth segment, Mayne Pharma International grew sales 6% to A$33.7m and gross profit grew 7% to A$7.8m.
Mayne Pharma Annual Report 2016
Chief Executive Officer’s Review
Pipeline
The Company increased its investment in research and development this year to expand and accelerate the product pipeline. The US pipeline contains over 40 products in various stages of development targeting markets with sales greater than US$7bn[4] and in Australia there are 10 pipeline products targeting markets with sales greater than A$100m[4] . During the year, the Company introduced eight new US pipeline products into development targeting markets with sales greater than US$1bn[4] and filed five products with the FDA.
Commercialisation of Lozanoc, the Company’s patented formulation of itraconazole is advancing with the product recently launched in Germany. Lozanoc is now out-licensed in 15 countries and on-market in Spain, Germany and Australia. Further countries are expected to launch in 2017 including Italy, the largest itraconazole market in Europe. Also during the period, the Company invested US$2.8m in HedgePath Pharmaceuticals Inc to support the repurposing of Mayne Pharma’s itraconazole to treat certain cancers. A Phase IIb study in Gorlin’s Syndrome (a rare form of skin cancer) is currently underway with encouraging interim results.
Mayne Pharma’s strength lies in its integrated operations from product development, through to manufacturing and marketing of our products and services around the world.
operating infrastructure with material synergies to come from leveraging relationships with customers, bringing in-house manufacture of select products and optimising our expanded network of suppliers and contract manufacturing organisations.
The year ahead
I am looking forward to the coming year and integrating the recent product acquisitions, launching many new products and continuing the growth we are delivering across all business segments.
Management changes
Senior leadership changes during FY16 included the appointment of Mr Andrew Van Breugel as Executive Vice President of Operations who brings over 30 years of industry experience and strengthens our leadership in this critical area as we embark on a phase of material product and capacity expansion. Mr Craig Boyd joined as Executive Vice President of Generic Products bringing more than 20 years’ of industry experience across generic, branded and biosimilar product offerings.
I would like to take this opportunity to thank our 700 staff who are responsible for the Company’s current success. I am confident we have the right team of people to lead and execute on the various growth opportunities we have around the world.
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Scott Richards, Chief Executive Officer
Recent acquisitions
The recent product acquisitions from Teva and GSK will enhance the generic and specialty platforms and provide a stable base of revenue and earnings with growth to come from a combination of the launch of pipeline products, the re-launch of Fabior and Sorilux, and the delivery of revenue and cost synergies over time. Both acquisitions will leverage existing
- IMS Health, MAT June 2016.
Mayne Pharma Annual Report 2016
Global Leadership Group
Mayne Pharma has an established and experienced leadership team
Scott Richards
Chief Executive Officer and Managing Director Mr Richards has more than 27 years’ international experience in the pharmaceutical industry and has worked in Europe, the US and Asia. Prior to joining Mayne Pharma, Mr Richards spent ten years in Europe in a variety of leadership roles including President, Europe Middle East and Africa and President, Global Commercial Operations for Mayne Pharma Limited (acquired by Hospira in 2007). He also served on the Group Management Board of Actavis for four years where he was responsible for the firm’s global injectable/hospital business operations. Prior to working in Europe, Mr Richards spent 14 years with FH Faulding and Co (acquired by Mayne Nickless in 2001) in a variety of roles including leading Faulding Pharmaceuticals Asia Pacific operations together with spending five years with Faulding in the United States leading business development and portfolio management operations.
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Mark Cansdale
Group CFO and Company Secretary
Mr Cansdale is a Chartered Accountant and Company Secretary with more than 25 years’ experience in
the accounting and finance profession. Mr Cansdale was formerly the CFO and Company Secretary at McMillan Shakespeare Limited and prior to that, Vision Systems Limited. He has extensive experience in the areas of business development, mergers and acquisitions, corporate strategy, tax, financial planning and analysis, risk management, treasury and investor relations. Prior to joining Vision Systems in 2002, Mr Cansdale held senior finance positions in the insurance and financial services industry at Norwich Union Australia and KPMG.
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Stefan Cross
President, Mayne Pharma USA
Mr Cross brings more than 25 years’ of pharmaceutical industry experience to his role.
Prior to joining Mayne Pharma, Mr Cross was Head of Marketing (Asia Pacific) for Hospira Inc., a leading global provider of pharmaceuticals and medical devices, where he was responsible for expansion of the new product portfolio and on-market product growth across all markets in the region. Prior to joining Hospira, Mr Cross worked for six years with Mayne Pharma Limited in Europe and Australia and eight years with F H Faulding & Co across strategy, business development/M&A, sales and marketing, HR and finance/IT.
Ilana Stancovski
Executive Vice President and Chief Scientific Officer Dr Stancovski has over 20 years’ of international experience in the pharmaceutical industry and academia. She has been instrumental in driving Mayne Pharma’s pipeline selection, the global development of branded and generic products and the regulatory approval of NDAs, ANDAs and 505(b)2 dossiers. Prior to joining Mayne Pharma, Dr Stancovski was Vice President of Research & Development for Actavis Group’s global Hospital Division where she made a significant contribution to advancing that company’s injectable pipeline. Prior to Actavis, Dr Stancovski was the Vice President Scientific Affairs at Intas Pharmaceuticals Limited and also held senior management roles at other multinational pharmaceutical and biotech companies. She holds a Ph.D. in Life Sciences from the Weizmann Institute, Israel and worked as a post-doctoral scholar at Caltech and MIT in the United States.
Mayne Pharma Annual Report 2016
Global Leadership Group
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Kate Rintoul
Executive Vice President and General Counsel Ms Rintoul has over 15 years’ of varied legal experience in corporate, commercial, intellectual
property (IP) and litigation law, spanning multiple jurisdictions. She is responsible for worldwide legal operations, including IP. Prior to joining Mayne Pharma, Ms Rintoul spent much of her career in private practice at Minter Ellison Lawyers, one of the largest Australian-based international law firms, where she worked closely with Mayne Pharma on various agreements and transactions. Ms Rintoul has also worked for Shell International in The Hague as IP Counsel and for the University of British Columbia’s technology transfer office in Vancouver as a consultant.
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Peter Paltoglou
Chief Development Officer, Head of M&A Mr Paltoglou has over 15 years’ of experience in executing public and private mergers and
acquisitions, capital management and providing strategic advice across a range of contexts and market sectors. He was previously Managing Director of Investment Banking at Credit Suisse Emerging Companies in Australia. Prior to Credit Suisse, Mr Paltoglou was a Director of Hindal Group, a boutique M&A advisory business.
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Eric Evans
Chief Financial Officer, Mayne Pharma USA Mr Evans has 30 years’ of experience in financial leadership roles across both the pharmaceutical
Andy McClenaghan
Executive Vice President, Specialty Brands Mr McClenaghan has more than 25 years’ of pharmaceutical industry experience across general management, marketing, sales, managed care, operations and regulatory affairs. Prior to leading Mayne Pharma’s new Specialty Brands Division in 2015, Mr McClenaghan was the Vice President of Commercial Operations for North America at Warner Chilcott and responsible for US$2 billion in sales, a 700 member sales team and key brands including Doryx until its acquisition by Actavis in October 2013. He was also General Manager at Procter & Gamble Pharmaceuticals, responsible for its Canadian business.
Craig Boyd
Executive Vice President, Generic Products
Mr Boyd has more than 20 years’ of experience in the pharmaceutical industry across generic, branded, biosimilar and device businesses and has worked extensively in the US, Europe and Australia. Prior to joining Mayne Pharma he was the Head of Sales for Pfizer’s US generic injectables division with revenue of over US$4 billion and more than 300 staff. Mr Boyd was also previously the Vice President of Global Sales at Mylan, leading sales teams across all international markets. He also spent ten years in a number of senior commercial and sales and marketing roles at Novartis.
John Ross
Executive Vice President, Metrics Contract Services Mr Ross has more than 20 years’ of experience in the pharmaceutical industry across finance, sales, operations and supply chain. Prior to joining Mayne Pharma, Mr Ross was a Principal at Tunnell Consulting, a leading US biotech and pharmaceutical consulting organisation. He has also held a number of leadership roles including Chief Operating Officer of Contract Pharmaceuticals Limited, a provider of outsourced third-party contract development, manufacturing and testing of pharmaceuticals.
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Andrew Van Breugel
Executive Vice President, Operations
Mr Van Breugel has more than 30 years’ experience in the pharmaceutical industry across Europe
and Asia Pacific. Prior to joining Mayne Pharma, he was Chief Operating Officer for Medochemie with responsibility for 11 manufacturing plants. He was also Operations Director at Douglas Pharmaceuticals and Schering Plough/Merck with responsibility for key functions such as quality, manufacturing, engineering, finance and IT.
and contract services sectors. He was previously the CFO of AAIPharma Services, a leading global provider of contract services with over 800 employees across seven sites in the US and Europe. Prior to AAIPharma, he was CFO and EVP at Patheon, Inc. and VP and Controller for Novartis Pharmaceuticals’ US branded business with sales in excess of US$8 billion. He was also CFO for Sandoz US, one of the world’s largest generic pharma companies.
Mayne Pharma Annual Report 2016
Investing for growth
Research and development
Mayne Pharma continues to invest in the development of new generic and branded products focusing on higher value and niche product opportunities in the US. The Company has invested more than A$75m in research and development over the last four years.
During FY16, the Company received two significant US FDA product approvals - dofetilide capsules, the first generic alternative to Pfizer’s Tikosyn™ brand and Doryx MPC, a new product in the Doryx family.
doxycycline in the acidic environment of the stomach. The new polymer coat further delays absorption of Doryx MPC into the GI tract by approximately 15 minutes. Doryx MPC was launched in August 2016 and is expected to become a material part of the Doryx franchise. Mayne Pharma has been granted two patents by the US Patent and Trademark Office relating to this formulation with expiry dates in 2034 and one further patent has received a Notice of Allowances.
Dofetilide capsule
Dofetilide capsules are an antiarrhythmic agent used to prevent irregular heartbeats such as atrial fibrillation and atrial flutter. In early 2013, Mayne Pharma began working on the generic dofetilide program and filed the ANDA with the FDA in May 2014 certifying Paragraph IV. In November 2014, Pfizer announced its intention to sue Mayne Pharma in connection with the filing of the ANDA, however, in February 2015, Pfizer withdrew its lawsuit.
Doryx MPC tablet
In June 2016, Mayne Pharma received FDA approval for dofetilide capsules and was awarded 180-days of market exclusivity as the first company to file a substantially complete ANDA containing a Paragraph IV certification.
Doryx is a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne. Doryx incorporates Mayne Pharma’s drug delivery IP and contains enteric-coated delayedrelease pellets designed to minimise upper gastro intestinal (GI) tract exposure to doxycycline.
Launch of Mayne Pharma’s dofetilide began immediately following approval with 19 batches of product or more than 50,000 bottles dispatched to customers. Mayne Pharma achieved 100% return on the investment of all development and related litigation costs in the first week and after ten weeks held 44% unit share of the total dofetilide market and 75% share of the generic market[[5]] .
In May 2016, Mayne Pharma received approval for a new formulation of doxycycline - Doryx MPC, which incorporates a modified polymer coat designed to further retard the release of
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the generic market [[5]] .
A variety of
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- IMS Health, US Weekly dofetilide prescription volume, data up to week ending 12 August 2016.
Mayne Pharma Annual Report 2016
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Greenville
facilities
expansion
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Facilities Expansion
In August 2015, Mayne Pharma announced the construction of a new 125,000 square foot solid oral dose manufacturing facility in Greenville, North Carolina. The investment will more than double the operational footprint to 225,000 square foot and creates new capacity and capability to accelerate growth.
Current commercial production is expected to migrate to the new building following completion in early 2018. The facility adds multi-particulate layering, bead coating fluid bed technology, organic solvent coating capacities and commercial scale handling of potent compounds, increasing dose capacity from 250m to 1bn units / year.
In Australia, Mayne Pharma announced strategic investments at the company’s manufacturing facility in Salisbury, South Australia, to expand fluid bed processing capacity and add new potent handling capability to support the pipeline of products under development and the transfer in-house of three products from the Teva portfolio. The construction of new and refurbished production spaces and the installation of new equipment is expected to be completed by early 2018.
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Greenville construction site status as at September 2016
Mayne Pharma Annual Report 2016
DIRECTORS’ REPORT
The Directors of Mayne Pharma Group Limited (‘the Company’) present their report together with the financial report of the Company and its controlled entities (collectively the ‘Group’ or ‘Consolidated Entity’ or ‘Mayne Pharma’) for the year ended 30 June 2016 and the Auditor’s Report thereon. The information set out below is to be read in conjunction with the Remuneration Report set out on pages 27 to 34, which forms part of this Directors’ Report.
DIRECTORS
The Directors of the Company during the financial year and up to the date of this report are:
Mr Roger Corbett, AO (Chairman) Mr Scott Richards (Managing Director and Chief Executive Officer) Hon Ron Best Mr William (Phil) Hodges Mr Bruce Mathieson Prof Bruce Robinson, AM Mr Ian Scholes
Particulars of the Directors’ qualifications, other listed company directorships, experience and special responsibilities are detailed on pages 23 and 24 of this report. Particulars of the qualifications and experience of the Company Secretary are detailed on page 24 of this report.
DIRECTORS’ MEETINGS
The number of Directors’ meetings (including meetings of committees of directors) and number of meetings attended by each of the Directors of the Company during the 2016 financial year are:
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||||||||||
|---|---|---|---|---|---|---|---|---|
|BOARD|AUDIT & RISK COMMITTEE|NOMINATION|REMUNERATION AND PEOPLE|
|COMMITTEE|COMMITTEE|
|HELD1|ATTENDED2|HELD1|ATTENDED2|HELD1|ATTENDED2|HELD1|ATTENDED2|
|Mr R Corbett|15|15|-|-|-|-|1|1|
|3|
|Mr S Richards|15|15|-|-|-|-|1|1|
|Mr I Scholes|15|14|3|3|-|-|1|1|
|Hon R Best|15|15|3|3|-|-|1|1|
|Mr B Mathieson|15|14|3|3|-|-|-|-|
|Mr P Hodges|15|13|-|-|-|-|-|-|
|Prof Bruce Robinson|15|15|-|-|-|-|-|-|
----- End of picture text -----
-
This column shows the number of meetings held during the period the Director was a member of the Board or Committee.
-
This column shows the number of meetings attended.
-
Mr Scott Richards is not a member of the Remuneration and People Committee however he attended a meeting at the Chairman’s invitation.
The Nomination Committee did not meet during the year.
SIGNIFICANT CHANGES IN THE STATE OF AFFAIRS
On 28 June 2016, the Company announced 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”) for cash consideration of US$652m (“the Teva transaction”).
The Teva transaction significantly transforms the scope and breadth of the Company’s Generic Products Division and is expected to propel Mayne Pharma into the top 25 retail generic pharmaceutical companies and the top 2 in the generic oral contraceptives market in the United States. The acquisition also increases and diversifies Mayne Pharma’s earnings across more products, therapeutic areas, dosage forms and complex technologies, and builds upon the Company’s expertise in modified-release, potent compounds and controlled substances. This asset purchase was completed 3 August 2016.
The Company funded the acquisition via an extension of its existing debt facility, and a fully underwritten A$601m 1-for-1.725 accelerated non-renounceable entitlement offer and A$287m placement which was completed in July 2016.
On 18 August 2016 the Company acquired a portfolio of on-market dermatology Foam Assets from GlaxoSmithKline (GSK) for US$50.1m. The Foam Assets include US rights to Fabior® and Sorilux®, Canadian rights to Luxiq® and Olux-E® and Mexican rights to betamethasone foam. Under the terms of the agreement Mayne Pharma will acquire the approved regulatory filings, trademarks, marketing materials, select product inventory, related medical and technical data and will acquire or obtain licenses for related patents.
Both Fabior and Sorilux will be marketed through Mayne Pharma’s Specialty Brands Division and existing sales team. Re-launch for both products is expected in FY17. During the intervening period GSK will continue to distribute Fabior and Sorilux under a transition services arrangement.
The non-US dermatology Foam Assets will continue to be distributed by GSK in the short term and Mayne Pharma will seek to out-license these products to new partners.
These changes are discussed in the Principal Activities, Results of Operations and Likely Developments section of this report.
16 Mayne Pharma Annual Report 2016
PRINCIPAL ACTIVITIES
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that have been marketed around the world.
Mayne Pharma has two product development and manufacturing facilities based in Salisbury, South Australia and Greenville, North Carolina USA with expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds.
REVIEW OF OPERATIONS AND LIKELY DEVELOPMENTS
Summary of financial performance
Set out below is a summary of the financial performance attributable to Mayne Pharma shareholders for the 2016 financial year (FY16) compared to the prior corresponding period (pcp). This summary includes non-IFRS financial information that is stated excluding certain non-operating income and expense items. The results are set out this way as the Directors consider them to be a meaningful comparison from period to period. Earnings before interest tax, depreciation and amortisation (EBITDA) is used as a key measure of the earnings considered by Management in operating the business and assessing performance.
| SALES AND PROFIT NOTES |
CHANGE ON PCP 2016 $M 2015 $M $M % |
|---|---|
| Revenue Gross profit Gross profit % Adjusted EBITDA Adjustments 1 Reported EBITDA Depreciation / Amortisation Reported PBIT Net Interest 2 Income tax expense Reported NPAT attributable to Mayne Pharma shareholders |
267.3 141.4 125.9 89% 168.4 80.0 88.4 111% 63.0% 56.6% 88.5 36.4 52.1 143% (11.6) (5.1) (6.5) |
| 76.9 31.3 45.6 146% (20.9) (13.5) (7.4) 55% 56.0 17.6 38.4 218% (3.2) (6.4) 3.2 (50%) (15.5) (3.7) (11.8) (219%) |
|
| 37.4 7.8 29.6 379% |
1. Adjustments in FY16 include a $5.2m non-cash credit arising from the decrease in the fair value of earn-out liabilities, a $6.7m payment to settle a dispute with a former distributor, $6.8m of transaction and other related costs in relation to the recent product acquisitions, $1.3m of legal costs relating to the Department of Justice investigation, $2.5m to exclude HedgePath Pharmaceuticals losses attributable to members of the Company and a non-cash credit of $0.5m relating to the fair value increment of the HPPI warrants.
2. Includes finance expenses of $2.5m plus the notional non-cash interest expense of $1.1m (representing the charge for the unwinding of the discount on earn-out liabilities) less interest revenue $0.5m.
The non IFRS financial information is unaudited.
Review of operations
The following information is provided on a total group basis, rather than that attributable to Mayne Pharma’s members and hence includes 100% of the revenues (2016: nil; 2015: nil) and expenses incurred by Hedgepath Pharmaceuticals Inc (HPPI) where applicable.
The Group recorded revenue of $267.3m, up 89% on pcp and gross profit was $168.4m up 111% on pcp.
Gross profit margin as a percentage of revenue was 63.0% up from 56.6% driven by inclusion of earnings from the Doryx acquisition for the full year.
Reported EBITDA attributable to members of Mayne Pharma was $76.9m and adjusted EBITDA (i.e. the reported result excluding certain specified non-operating items) was $88.5m, up 143% on pcp. The reported profit before tax attributable to the members of Mayne Pharma was $52.8m and the net profit after tax was $37.4m, up 379% on pcp.
Expenses
Gross research and development costs increased by $12.2m to $31.3m. Development expenditure of $22.6m (2015: $13.5m) was capitalised during the period as it related to qualifying products under development in accordance with Australian Accounting Standards, leaving net R&D expenses of $8.7m compared to $5.6m in the pcp.
Marketing and distribution expenses increased by $20.5m to $38.0m with the majority of the increase relating to the inclusion of the Speciality Brands Division sales force for the entire period.
Finance costs of $2.5m represent interest and line fees on the USD loan facility established in June 2015 and the amortisation of related borrowing costs.
Administration and other expenses increased by $31.2m. This category includes amortisation of intangible assets which was $16.3m for the year, an increase of $7.8m on the prior year. The increase in the current year is due to the fact that FY16 includes a full year charge of $7.4m (2015:$2.9m) relating to the amortisation of intangible assets recognised following the Doryx acquisition. The balance of the increase in administration and other expenses relates to the settlement with a former distributor ($6.7m), transaction, set up other costs relating to the Teva transaction $6.8m and increased legal and corporate costs.
Mayne Pharma Annual Report 2016 17
Tax
The tax expense of $15.3m comprised:
-
Current period income tax expense for the year to 30 June 2016 of $33.4m;
-
A reduction in current year tax in respect of prior years of $0.2m; and
-
A reduction in income tax expense of $17.8m relating to the movement in deferred tax assets and liabilities.
Financial position
Set out below is a summary of the financial position as at 30 June 2016 compared to the position as at 30 June 2015.
| BALANCE SHEET EXTRACT NOTES |
CHANGE ON PCP 2016 $M 2015 $M $M % |
|---|---|
| Cash Inventory & receivables PP&E Intangibles Teva/Allergan product acquisition asset rights Other assets Total assets Interest-bearing debt Other financial liabilities Other liabilities Teva/Allergan product acquisition asset obligation Total liabilities Equity |
47.5 59.2 (11.7) (20%) 162.7 87.1 75.6 87% 84.4 59.6 24.8 42% 332.5 303.0 29.5 10% 876.1 - 876.1 54.2 20.0 34.2 171% |
| 1,557.4 528.9 1,028.5 194% |
|
| 76.8 61.8 15.0 24% 19.0 34.1 (15.1) (44%) 209.1 110.8 98.3 89% 876.1 - 876.1 |
|
| 1,181.2 206.7 974.5 471% |
|
| 376.2 322.2 54.0 17% |
The material changes to the operating assets and liabilities of the business were as follows:
Cash
Cash decreased by $11.7m compared to 30 June 2015. Refer below for further commentary.
Inventory, receivables and other liabilities
Inventory, receivables and payables increases reflect the full year impact of US Doryx and the launch of Dofetilide in June 2016.
Intangible assets and goodwill
Intangible assets increased by $29.5m compared to the balance at 30 June 2015. The movement comprised of:
-
An increase of $22.6m for capitalised development costs;
-
An increase of $19.1m for several product ANDAs and marketing and distribution rights acquired;
-
A decrease of $16.3m for amortisation;
-
A decrease of $1.8m for impairments; and
-
An increase of $5.9m due to foreign currency translation as a result of the weaker Australian dollar against the US dollar.
The tangible and intangible assets relating to the Teva transaction will be recognised next financial year as the transaction had not closed at 30 June 2016.
Other financial liabilities
Other liabilities as at 30 June 2016 include the earn-out liabilities and deferred consideration for the Liothyronine acquisition, the oxycodone distribution rights, and the Zebutal™, Esgic™ and Lorcet™ branded products, as well as the Libertas and various other product acquisitions.
Other financial liabilities decreased by $15.0m from 30 June 2015 as a result of:
-
A decrease of $5.2m relating to re-assessment of the underlying assumptions for the Hospira and Methamphetamine earn-out liabilities;
-
An increase of $1.1m due to the non-cash unwinding of the discount for the various earn-out liabilities;
-
An increase of $8.9m resulting from new asset acquisitions relating to ANDAs;
-
Payments of $20.9m; and
-
An increase relating to foreign currency translation of $0.9m.
The equity movements include current year profit and loss and other comprehensive income of $37.1m.
Cash flow
Net operating cash flow before interest, tax, transaction and other costs was $95.7m up $56.6m. Total net cash flows from operating activities was an inflow of $53.5m after including supplier dispute costs ($6.7m) transaction, set-up and other costs ($8.1m), $26.5m of tax payments and $1.0m of net interest payments.
18 Mayne Pharma Annual Report 2016
Cash on hand at 30 June 2016 was $47.5m representing a decrease of $11.7m from 30 June 2015.
The Company had bank debt of $77.0m at 30 June 2016, with significant headroom against the facility’s financial covenants.
Notable cash flows during the period included:
-
An inflow of $13.7m representing the net proceeds from new borrowings;
-
$28.6m in payments for research and development (includes expensed and capitalised);
-
Earn-out and deferred settlement payments totalling $20.9m relating to the 2009 acquisition of Mayne Pharma International Pty Ltd from Hospira ($5.4m), the Methamphetamine acquisition ($5.5m), the Oxycodone acquisition ($4.7m) and various other acquisitions ($5.3m);
-
An outflow of $10.7m for the acquisition of various intangible assets;
-
An outflow of $3.4m for acquisition related expenses;
-
$29.6m in capital expenditure across the Group.
Research and development
The Company continues to commit substantial resources in terms of people and research and development spend to developing and advancing its pipeline globally. In FY16, the Company spent, in cash terms, $28.6m in research and development of which 79% was capitalised over the period to be amortised in the future in accordance with Accounting Standards.
The Company now has more than 40 pipeline products in the US, of which 19 are pending FDA approval. In Australia, the Company has more than ten pipeline products of which four products are pending approval at the TGA.
In June 2016, Mayne Pharma launched dofetilide capsules, the first generic approval to Pfizer’s Tikosyn™. Mayne Pharma was the first company to file a substantially complete ANDA containing a Paragraph IV certification for dofetilide capsules and as a result was awarded 180-days of market exclusivity.
The Company also continues to advance the pipeline of branded products, which are an important part of the strategy to diversify the business across both branded and generic products. During the period, the Company received FDA approval for Doryx® MPC which is a new formulation that incorporates a modified polymer coat designed to further retard the release of doxycycline in the acidic environment of the stomach.
Operating Segments
The Consolidated Entity operates in four operating segments being, Generic Products (GPD), Specialty Brands (SBD), Metrics Contract Services (MCS), and Mayne Pharma International (MPI). In the prior comparative period, the Consolidated Entity reported three operating segments being GPD (formerly called US Products), MCS and MPI.
Following the acquisition of the Doryx assets in February 2015, the Company separated the US Products segment into GPD which markets and distributes generic products and SBD which markets and distributes specialty branded products. The June 2015 comparative information has been restated, including re-allocations between segments, to reflect the new operating segment structure.
Refer to Note 2 for further information about the operating segments
GPD
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|||||
|---|---|---|---|
|$MILLION|2016|2015|CHANGE %|
|Revenue|106.8|58.2|83.6|
|Gross profit|60.8|38.5|57.9|
|Gross profit %|57%|66%|
----- End of picture text -----
Nature of operations
GPD’s revenues and gross profit are derived principally from the manufacture and distribution of generic pharmaceutical products in the US.
FY16 performance
GDP performed strongly with sales at $106.8m, up $48.6m or 84% on FY15 and gross profit was $60.8m up 58% on FY15.
In US dollar terms, sales were up 60% to US$77.8m driven by the launch of BAC tablet and dofetilide and further market penetration of oxycodone, hydrocodone and methamphetamine. Nystatin and the legacy doxycycline generic product strengths were impacted by more competitive market dynamics.
Gross profit margin was down from 66% to 57% reflecting the changing portfolio with stronger contribution from profit share products including dofetilide, and oxycodone and hydrocodone that participate in more competitive markets.
SBD
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|||||
|---|---|---|---|
|$MILLION|2016|2015|CHANGE %|
|Revenue|77.8|17.6|342.3%|
|Gross profit|73.4|17.1|328.4%|
|Gross profit %|94%|97%|
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Nature of operations
The SBD operating segment markets and distributes specialty branded pharmaceutical products in the US.
Mayne Pharma Annual Report 2016 19
FY16 performance
The SBD operating segment’s sales were $77.8m and gross profit was $73.4m in FY16. This segment operated for the whole period for the first time this reporting period.
In the last quarter of FY16, Doryx faced generic competition on the 50mg and 200mg dose strengths, which impacted sales in that period. In May 2016, SBD launched authorised generic 50mg and 200mg products to compete in the newly formed generic market.
MCS
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|||||
|---|---|---|---|
|$MILLION|2016|2015|CHANGE %|
|Revenue|48.9|33.8|44.7|
|Gross profit|26.4|17.0|55.0|
|Gross profit %|54%|50%|
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Nature of operations
MCS’ revenue and gross profit are derived from the provision of contract analytical and pharmaceutical development services to thirdparty customers principally in the US.
FY16 performance
MCS outperformed industry growth with revenue of $48.9m up $15.1m or 45% on FY15 and gross profit was $26.2m up 54% on FY15. In US dollar terms, sales were up 26% to US$35.6m. Revenue and gross profit margin increases were the result of an increase in higher margin, later stage formulation development work, improved pricing and lab operating efficiencies.
Key performance measures continued to improve over the period with the committed business pipeline growing 30%. Continued investment in new state-of-the-art laboratory and production equipment has helped contribute to an increase in the average number of quotes signed which were up 44% on the prior year.
MPI
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|||||
|---|---|---|---|
|$MILLION|2016|2015|CHANGE %|
|Revenue|33.7|31.8|6.0|
|Gross profit|7.8|7.3|6.9|
|Gross profit %|23%|23%|
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Nature of operations
MPI’s revenues and gross profit are derived principally from the Australian manufacture and sale of branded and generic pharmaceutical product globally (ex-US) and provision of contract manufacturing services to third party customers within Australia.
FY16 performance
MPI’s revenue was $33.7m up $1.9m or 6% on FY15 and gross profit improved 7% to $7.8m. Australian sales grew 11% driven by the launch of a number of new products including noradrenaline injectable the first generic competitor in this market and oxycodone tablets, which is a product, originally developed in Greenville. The rest of world sales declined 10% driven by softer sales of Astrix in Korea in the first half, which then rebounded in the second half.
20 Mayne Pharma Annual Report 2016
Strategy and material business risks
Mayne Pharma is using its world-class oral drug delivery expertise to build a global speciality pharmaceutical company. The Company is focused on increasing the breadth of its product portfolio, technologies and footprint.
The Company’s core strategic priorities include the following:
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||||
|---|---|---|
|KEY GROWTH DRIVER|ACTIVITIES|
|US retail generics maximisation|•|Optimise market penetration of product portfolio|
|•|Commercialise filed FDA products|
|•|Efficient and reliable product sourcing, manufacturing and supply|
|•|Leverage product portfolio in non-retail segments (e.g. government, universities and|
|institutional)|
|•|Extract synergies from recent product acquisitions|
|•|Portfolio expansion through growing product pipeline|
|Expand US branded specialty franchise portfolio|•|Develop US specialty dermatology franchise by leveraging Doryx, Fabior and Sorilux and|
|pipeline of future products|
|•|Build new specialty therapeutic platforms that leverage the Company’s development and|
|manufacturing capabilities|
|Research and development maximisation|•|Portfolio selection that leverages drug delivery expertise in complex generics and specialty|
|products|
|•|Selective paragraph IV1 filings in the US|
|•|Development of SUBA-Itraconazole in cancer through the alliance with HedgePath|
|Pharmaceuticals|
|Strategic acquisitions, licensing and partnerships|•|In-licensing niche generic or specialty products in Australia and the US|
|•|Commercialisation of specialty products such as Lozanoc through out-licensing|
|arrangements in key markets to broaden global footprint|
|•|Product and enterprise acquisitions with strong growth potential, complementary assets|
|and technologies|
|•|Build an injectable portfolio and branded specialty franchise in Australia|
|Optimise and grow MCS|•|Enhance operational efficiencies and client experience|
|•|Globalise customer base|
|•|Introduce high value manufacturing services following Greenville site expansion|
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- A product may be filed with the FDA before the relevant patent has expired as a paragraph IV certification either because the filer believes the patent is not infringed; is invalid, or both.
Material business risks
The Company maintains a risk register and the material business risks are regularly reported on and discussed with the Audit & Risk Committee. The material business risks faced by the Group that could have an effect on the financial prospects of the Group include:
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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|RISK|NATURE OF THE RISK|ACTIONS / PLANS TO MITIGATE|
|Internal product|•|Failure to establish bioequivalence and meet end points in|•|Recruitment|of|experienced|product|development|
|development|clinical trials|personnel|
|•|Development of new intellectual property and products|•|Disciplined and risk-balanced product selection process|
|takes longer and is more expensive than forecast|•|Robust business cases developed for selected products|
|•|Product development projects may not be commercialised,|•|Regular monitoring of product development progress|
|requiring capitalised spend to be written off|•|Input from regulatory authorities before and during the|
|The balance of capitalised development costs at 30 June|development process|
|2016 was $72m covering 46 projects for products in-market|
|and under development|
|Other product|•|Application of SUBA®-itraconazole in Gorlin’s Syndrome|•|Recruitment of experienced regulatory personnel|
|development - HPPI|cancer fails to meet underlying valuation assumptions,|•|Input from US FDA before and during the development|
|including risk-adjusted assessments of expected clinical|process|
|trial program outcomes, resulting in full or partial write-off of investment in HPPI|•|Active engagement with Gorlin’s Syndrome Patient|
|Association|
|•|The carrying value of the investment in HPPI plus the value of warrants held at 30 June 2016 was $16.5m.|•|Engagement with independent regulatory and quality|
|experts|
|In-market pricing and|•|Competitive dynamics for a product become unfavourable|•|Recruitment of experienced sales and marketing personnel|
|competitive intensity|•|New competitors enter a market or competitors increase|•|Disciplined and risk balanced product selection process|
|market share|•|Strong systems and processes to monitor and manage the|
|•|Inability to obtain or delays in obtaining satisfactory pricing|performance of each product and customer relationship|
|and reimbursement from government bodies, national|
|health authorities and other third parties|
|Customer|•|Loss of a key customer|•|Recruitment of experienced sales and marketing and|
|relationships|•|Inability to renew contracts on similar terms|business development personnel|
|•|Inability to attract new customers|•|Management of customer pricing, economics and contract|
|•|Customers fail to honour payment obligations|•|compliance Strong systems and processes to manage and monitor|
|collections|
|Regulatory|•|Loss of regulatory compliance certification for production|•|Recruitment|of|experienced|quality|and|production|
|compliance|facilities|personnel|
|•|Strong systems and processes to manage and monitor|
|compliance|
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Mayne Pharma Annual Report 2016 21
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||||||||||
|---|---|---|---|---|---|---|---|---|
|RISK|NATURE OF THE RISK|ACTIONS / PLANS TO MITIGATE|
|Product cost inflation|•|Increasing cost of active pharmaceutical ingredients and|•|Exclusive supply arrangements|
|other components|•|Distribution arrangements with partners allow for rising|
|input costs to be passed through|
|Foreign exchange|•|Adverse movements in exchange rates|•|Hedging of net receipts in accordance with Company policy|
|movements|
|Product liability|•|Serious adverse event with consumers and potential|•|Medical|information,|pharmacovigilance|and|quality|
|product liability risks in marketing and use of products|systems established and maintained|
|•|Allocate or share risk with distribution partners where|
|appropriate|
|•|Appropriate insurance cover|
|Intellectual property|•|Infringement of third party intellectual property rights|•|Disciplined product selection process taking into account|
|•|Loss or infringement of owned intellectual property|possible intellectual property infringement|
|•|Implementation of a robust intellectual property strategy|
|•|Allocate or share risks with manufacturing partners where|
|appropriate|
|Legal|•|Litigation and other proceedings taken against the|•|Recruitment of experienced legal personnel|
|Company|•|Limit liability in contractual relationships where possible|
|•|Provide for resolution of international disputes through|
|mediation and arbitration where possible|
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The above list does not represent an exhaustive list and it may be subject to change based on underlying market events and developments in the Company’s operations.
Outlook
The outlook remains very positive and the Company has significant growth opportunities across multiple channels and all US business segments in the world’s largest pharmaceutical market. Growth in FY17 will be driven by the recent product acquisitions, new product launches and further market penetration of the on-market portfolio globally.
The recently announced product acquisitions from Teva and GSK will significantly enhance the GPD and SBD platforms and provide a stable base of revenue and earnings with growth to come from a combination of the launch of pipeline products, the re-launch of Fabior® and Sorilux®, and the delivery of revenue and cost synergies over time.
The Company will also continue to identify further business development opportunities to in-license or acquire complementary assets to expand the on-market portfolio and pipeline or introduce new manufacturing or technology platforms
DIVIDENDS
The Directors have not declared an interim or final dividend for the 2016 financial year.
EVENTS SUBSEQUENT TO THE REPORTING PERIOD
On 28 June 2016, the Company announced 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”) for cash consideration of US$652m.
This asset purchase was completed on 3 August 2016.
The Company funded the acquisition via an extension of its existing debt facility (increasing limit to US$400m), and a fully underwritten A$601m 1-for-1.725 accelerated non-renounceable entitlement offer and A$287m placement.
Prior to settling the Teva transaction, the Company drew down the syndicated loan facility to an amount of US$150m which included rolling over the existing loan balance.
On 29 July 2016, the Company announced it had entered into a settlement agreement with Forest Laboratories, LLC (“Forest”) relating to Mayne Pharma’s US Patent No. 6,194,000. In December 2013, Mayne Pharma filed a patent infringement lawsuit against Forest over Forest’s Namenda XR product, which was launched in the USA in June 2013.The settlement is expected to result in Mayne Pharma recording additional income of up to US$19.5m in FY17.
On 18 August 2016 the Company acquired a portfolio of on-market dermatology Foam Assets from GSK for US$50.1 million. Under the terms of the agreement Mayne Pharma will acquire the approved regulatory filings, trademarks, marketing materials, select product inventory, related medical and technical data and will acquire or obtain licenses for related patents.
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.
22 Mayne Pharma Annual Report 2016
DIRECTORS’ EXPERIENCE AND SPECIAL RESPONSIBILITIES
MR ROGER CORBETT AO, BCom, FAIM
Independent Chairman Appointed 17 November 2010
Mr Corbett joined the Board of Mayne Pharma Group Limited in November 2010 and was appointed Chairman in January 2011. Mr Corbett has been involved in the retail industry for more than 40 years. In 1984, Mr Corbett joined the board of David Jones Australia as a Director of Operations and in 1990 was appointed to the board of Woolworths Limited and to the position of Managing Director of BigW. In 1999, Mr Corbett was appointed Chief Executive Officer of Woolworths Limited, from which he retired in 2006. Mr Corbett was Chairman of Fairfax Media Limited, one of Australia’s largest diversified media companies from October 2009 until 31 August 2015. Mr Corbett was a Director of the Reserve Bank of Australia until 1 December 2015, and was a director of Wal-Mart Stores until May 2016.
In addition to being Chairman of the Board, Mr Corbett is Chair of the Remuneration and People Committee and is a member of the Nomination Committee.
MR SCOTT RICHARDS
Executive Director and Chief Executive Officer Appointed 13 February 2012
Mr Richards has more than 27 years’ international experience in the pharmaceutical industry and has worked in Europe, the US and Asia. Prior to joining Mayne Pharma, Mr Richards spent 10 years in Europe in a variety of leadership roles including President, Europe Middle East and Africa and President, Global Commercial Operations for Mayne Pharma Limited (acquired by Hospira in 2007). He also served on the Group Management Board of Actavis for 4 years where he was responsible for the firm’s global injectable/hospital business operations. Prior to working in Europe, Mr Richards spent 14 years with FH Faulding and Co (acquired by Mayne Nickless in 2001) in a variety of roles including leading Faulding Pharmaceuticals Asia Pacific operations together with spending 5 years with Faulding in the United States leading business development and portfolio management operations. Mr Richards’ experience spans sales and marketing, regulatory/medical affairs, supply chain, business development, mergers and acquisitions, finance, intellectual property and manufacturing.
HON RON BEST
Independent Non-Executive Director Appointed 26 July 2006
The Hon Ron Best is a highly respected former member of the Victorian Parliament (1988 to 2002), having held a number of senior positions in the National Party of Australia (Victoria) including Parliamentary Secretary, Shadow Minister for Housing and Spokesman for Health, Housing, Racing, Sport and Recreation. Mr Best has also been a member of various Parliamentary Committees including the Public Accounts and Estimates Committee, the Environmental and Natural Resources Committee and a Board Member of the Victorian Health Promotion Foundation. Prior to his political career, Mr Best was the owner of a successful food distribution business and General Manager of the Glacier Food Group. Since retiring from politics in 2002 Mr Best has consulted for privately-owned companies in the food services industry.
Mr Best is Chairman of the Nomination Committee and a member of the Audit & Risk Committee.
MR BRUCE MATHIESON
Independent Non-Executive Director Appointed 16 February 2007
Mr Mathieson is currently a Director and was the former Chief Executive Officer of Australian Leisure and Hospitality Group Pty Limited, a joint venture between Woolworths Limited and the Mathieson Family. The ALH Group owns approximately 325 hotels and 520 retail outlets across Australia, and employs more than 15,000 staff. Mr Mathieson has operated in the hotel, leisure and hospitality industry since 1974 and is a well-respected member of the Australian business community. He has previously served as a Director of the Carlton Football Club. He is trained as an engineer, and brings management and transactional experience from across a number of industries to the Board. Mr Mathieson is a director of Western Desert Resources Limited and was a director of Isonea Limited (resigned 28 November 2014).
Mr Mathieson is a member of the Audit & Risk and Nomination Committees.
MR IAN SCHOLES BCom, CA
Independent Non-Executive Director Appointed 17 October 2007
Mr Scholes has extensive financial and corporate advisory experience, both in Australia and internationally. Mr Scholes has held senior roles within Merrill Lynch Australia, most recently as Vice Chairman of Investment Banking. Previously Mr Scholes held the position of Executive General Manager at National Australia Bank Limited, running the corporate and institutional banking division. Mr Scholes is currently a Partner and Chief Executive Officer of Chord Capital Pty Ltd. Mr Scholes has previously held positions on the Board of St Vincent’s Health as Chairman of the St Vincent’s Foundation and was a former Director of SDI Limited.
Mr Scholes is Chairman of the Audit & Risk Committee and a member of the Remuneration and People Committee.
MR WILLIAM (PHIL) HODGES
Non-Executive Director Appointed 15 November 2012
Mr Hodges has been involved in the pharmaceutical industry for over 30 years and founded the Metrics business in 1994. Since 1994, Mr Hodges oversaw the transition of Metrics from a start-up analytical laboratory with four employees to a specialty pharmaceutical company with a portfolio of niche generic products. Prior to starting Metrics, Mr Hodges spent 11 years at Burroughs Wellcome Co. (which became part of GlaxoSmithKline) in the development and validation of analytical methods. Mr Hodges ceased his executive role as President of Metrics on 31 December 2013 but continues as a Non-Executive Director of Mayne Pharma Group Limited.
Mayne Pharma Annual Report 2016 23
PROF BRUCE ROBINSON, AM
Non-Executive Director Appointed 26 August 2014
Professor Robinson is Dean of Sydney Medical School at the University of Sydney, a position he has held since 2007. As Dean, he leads one of the largest medical schools in Australia. Professor Robinson is an Endocrinologist and practices at Sydney’s Royal North Shore Hospital. Professor Robinson has been the head of the Cancer Genetics Unit at the Kolling Institute of Medical Research, Royal North Shore Hospital since 1989. Since 2001, Professor Robinson has been Chairman of Hoc Mai Foundation, a major program in medical and health education and exchange with Vietnam. He is a Board Member of the Woolcock Institute, the ANZAC Research Institute for Cancer Research, the Centenary Institute for Cancer Research, the Royal Flying Doctor Service (South-Eastern Division) and is Chair of RFDS Medical Advisory Committee.
COMPANY SECRETARY
Mr Mark Cansdale, BEc, CA (Group CFO and Company Secretary) was appointed as the Company Secretary on 27 January 2011. Mr Cansdale is a Chartered Accountant with 25 years’ experience in the accounting and finance profession. Mr Cansdale has extensive experience in the areas of business development, mergers and acquisitions, corporate strategy, tax, financial planning and analysis, risk management, treasury and investor relations.
DIRECTORS’ INTERESTS IN SHARE CAPITAL AND OPTIONS
The relevant interest of each Director in the share capital and options of the Company as at the date of this report is as follows:
==> picture [495 x 118] intentionally omitted <==
----- Start of picture text -----
|||||
|---|---|---|---|
|FULLY PAID ORDINARY|RESTRICTED ORDINARY|NUMBER OF OPTIONS|
|SHARES|SHARES ISSUED UNDER|OVER ORDINARY SHARES|
|LONG TERM INCENTIVE|
|PLAN WITH NON|
|RECOURSE LOANS|
|Mr R Corbett|10,284,769|-|-|
|Mr S Richards|9,368,564|6,377,025|7,500,000|
|Hon R Best|1,568,506|-|-|
|Mr B Mathieson|90,269,499|-|-|
|Mr I Scholes|2,058,636|-|-|
|Mr P Hodges|8,406,554|-|-|
|Prof B Robinson|407,519|-|-|
----- End of picture text -----
UNISSUED SHARES UNDER OPTION
As at the date of this Directors’ Report there were 29,874,000 unissued ordinary shares under option (31,460,000 at the reporting date). Details of these options are as follows:
==> picture [497 x 214] intentionally omitted <==
----- Start of picture text -----
|||||
|---|---|---|---|
|DATE OPTIONS GRANTED|EXPIRY DATE|EXERCISE PRICE|NUMBER UNDER OPTION|
|13 February 2012|13 February 2019|$0.1492|7,500,000|
|11 January 2013|12 January 2019|$0.2184|7,220,0001|
|25 January 2013|26 January 2019|$0.2184|4,634,000|
|1 July 2013|1 July 2019|$0.3184|1,000,000|
|2 July 2013|7 March 2019|$0.2984|500,000|
|21 April 2014|11 November 2019|$0.6647|1,000,000|
|1 May 2014|21 October 2019|$0.5923|320,000|
|1 May 2014|30 November 2019|$0.6754|1,000,000|
|19 August 2014|28 March 2019|$0.8003|600,000|
|19 August 2014|19 June 2019|$0.7701|600,000|
|19 August 2014|30 June 2019|$0.8188|1,000,000|
|19 August 2014|2 July 2019|$0.8109|400,000|
|19 August 2014|1 August 2019|$0.7437|200,000|
|19 August 2014|28 August 2019|$0.7682|600,000|
|29 January 2015|17 December 2019|$0.6447|600,000|
|29 January 2015|1 February 2020|$0.5347|2,700,000|
|Total|29,874,000|
----- End of picture text -----
- 1,110,000 options were forfeited prior to year-end and are excluded from the outstanding options.
The exercise price of all options was reduced by 9.43 cents effective 22 July 2016 under ASX Listing Rule 6.22 following the 1:1.725 nonrenounceable rights issue announced in June 2016.
In the prior year, the exercise price of all options granted prior to March 2015 were reduced by 1.73 cents under ASX Listing Rule 6.22 following the 1:3.45 rights issue announced in February 2015.
Option holders do not have any right, by virtue of the option, to participate in any share issue of the Company.
24 Mayne Pharma Annual Report 2016
SHARE OPTIONS GRANTED
No share options were granted during the financial year.
Further details of options are contained in Note 27 of the financial statements.
SHARES ISSUED AS A RESULT OF THE EXERCISE OF OPTIONS
During the financial year options have been exercised to acquire a total of 3,450,000 fully paid ordinary shares in Mayne Pharma Group Limited at a weighted average exercise price of $0.2895 per share.
NON-AUDIT SERVICES
The Company’s auditor, EY Australia (EY), provided the non-audit services listed below. The Directors are satisfied that the provision of these non-audit services is compatible with the general standard of independence for auditors imposed by the Corporations Act 2001.
The nature and scope of each type of non-audit service provided means that auditor independence was not compromised.
EY received or are due to receive the following amounts for the provision of non-audit services:
| 2016 $ 2015 $ |
|
|---|---|
| Taxation services Acquisition accounting services Other assurance Total |
140,930 61,367 49,600 30,750 31,025 31,000 |
| 221,555 123,117 |
INDEMNIFICATION AND INSURANCE OF OFFICERS AND INDEMNIFICATION OF AUDITORS
The Company’s constitution (rule 11.1(a)) requires the Company to indemnify every officer of the Company and its wholly owned subsidiaries against liabilities incurred in their role as officer, only to the extent permitted by the Corporations Act 2001. In addition, the indemnity will not apply to liabilities arising out of conduct involving a lack of good faith. The Company has entered into an Access, Indemnity and Insurance Deed with each of the Directors and Officers of the Company. Each Access, Indemnity and Insurance Deed indemnifies the relevant officer, to the extent permitted by law, against any liability incurred by the relevant officer as an officer of the Company or as an officer of a subsidiary, including legal costs (for an unspecified amount). The Access, Indemnity and Insurance Deeds also require the Company to (subject to the Corporations Act 2001) use its best efforts to effect and maintain a D&O policy covering the relevant officers during each officer’s term of office and for seven years thereafter.
During the financial year, the Company maintained an insurance policy which indemnifies the Directors and Officers of Mayne Pharma Group Limited in respect of any liability incurred in connection with the performance of their duties as Directors or Officers of the Company, other than for matters involving a wilful breach of duty or a contravention of sections 182 or 183 of the Corporations Act 2001 as permitted by section 199B of the Corporations Act 2001. The Company’s insurers have prohibited disclosure of the amount of the premium payable and the level of indemnification under the insurance contract.
To the extent permitted by law, the Company has agreed to indemnify its auditors, EY, as part of the terms of its audit engagement agreement against claims by third parties arising from the audit (for an unspecified amount). No payment has been made to indemnify EY during or since the financial year. Such an indemnity is permitted under rule 11.1(a) of the Company’s constitution.
ENVIRONMENT, HEALTH AND SAFETY (EHS) REGULATION AND PERFORMANCE
The Group’s operations are subject to various EHS laws and regulations and where required the Group maintains EHS licenses and registrations in compliance with applicable regulatory requirements. The Group has mechanisms in place to monitor for changes to regulatory requirements and ensure ongoing compliance with any new requirements.
The Group has EHS policies and procedures in place designed to ensure compliance with all EHS regulatory requirements and to continuously improve the health and safety of our workplaces and environmental sustainability of our operations.
The EHS function continues to refine and improve our standards, processes and performance through the ongoing development and maintenance of an EHS management system focussed on the identification and assessment of EHS hazards and effective management of EHS risks by applying sound risk management principles.
The Group monitors EHS outcomes on a regular basis and provides reports including but not limited to performance data such as injury rates, utilities consumption, waste discharges and emissions to various internal and external stakeholders. The operating sites in Salisbury and Greenville are subject to periodic inspections by EHS regulators; several inspections occurred during the year by the relevant authorities with no violations or citations recorded.
The Directors are not aware of any material breaches of EHS regulations by the Group.
Mayne Pharma Annual Report 2016 25
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 the 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 has been received from the Auditor and is included on page 35 of this report.
26 Mayne Pharma Annual Report 2016
REMUNERATION REPORT (AUDITED)
This report outlines the specific remuneration arrangements in place for the key management personnel (“KMP”) and the broader remuneration policies and philosophy adopted by the Board. KMP are those persons in the Group having authority and responsibility for planning, directing and controlling the major activities of the Company and the Group, directly or indirectly, including any director (whether executive or otherwise) of the Company.
Changes from the prior year include an expanded number of KMP due to the recruitment of additional senior executives and the establishment of the Corporate Executive Committee (CEC - all members of which are considered to be KMP) and a revision of TSR hurdles for the LTI share plan as recommended by independent remuneration consultants 3 Degrees Consulting Pty Limited (3dc) and as outlined in the 2015 Remuneration Report were implemented effective 1 July 2015.
1. KEY MANAGEMENT PERSONNEL DETAILS
Non-Executive Directors:
-
Mr Roger Corbett, AO – Independent Chairman
-
Hon Ron Best – Independent Non-Executive Director
-
Mr Phil Hodges – Non-Executive Director
-
Mr Bruce Mathieson – Independent Non-Executive Director
-
Prof Bruce Robinson, AM – Independent Non-Executive Director
-
Mr Ian Scholes – Independent Non-Executive Director
Executive Directors:
- Mr Scott Richards – Managing Director and Chief Executive Officer
Other executive KMPs:
-
Mr Mark Cansdale – Group CFO and Company Secretary
-
Mr Stefan Cross – President of Mayne Pharma USA
-
Dr Ilana Stancovski – Chief Scientific Officer
-
Ms Kate Rintoul – Executive Vice President and General Counsel
-
Mr Eric Evans – Chief Financial Officer of Mayne Pharma USA (appointed 3 August 2015)
-
Mr Peter Paltoglou – Chief Development Officer and Head of M&A (appointed 22 August 2015)
-
Ms Lisa Pendlebury – Vice President Investor Relations and Communications (appointed 11 November 2015)
-
Mr Andrew Van Breugel – Executive Vice President Operations (appointed 11 January 2016)
The CEC monitors business strategy and performance, guides strategic allocation of resources and capital, assesses and mitigates material business risks and sets the framework for interaction and management of external stakeholders and influencers.
2. REMUNERATION GOVERNANCE
The Board of Directors has delegated the responsibility for determining and reviewing compensation arrangements for the Directors, other members of the KMP and the balance of the CEO’s direct reports to the Remuneration and People Committee (“RPC”).
The RPC is made up of three Non-Executive Directors and the CEO, Group CFO and the Director of People and Culture attend meetings as required at the invitation of the Committee Chair.
The RPC assesses the appropriateness of the nature and amount of emoluments of such officers on a periodic basis by reference to relevant employment market conditions with the overall objective of ensuring maximum stakeholder benefit from the retention of a high quality Board and executive team. Such officers are paid their base emolument in cash only.
To ensure the RPC is fully informed when making remuneration decisions it seeks advice from the Company’s Director of People and Culture as well as specialist advice from external remuneration consultants. The RPC continued to engage 3dc during the year.
The fees paid to 3dc for the remuneration advice were $85,000 (2015: $99,000) which included remuneration recommendations as defined under the Corporations Act 2001 .
The RPC is satisfied that the advice received from 3dc was free from undue influence from the KMP to whom the recommendations may have related as 3dc were engaged by, and reported directly to, the Chair of the RPC.
Remuneration Report approval at the 2015 Annual General Meeting
The FY15 Remuneration Report received strong shareholder support at the 2015 AGM with a vote of 96% in favour. Additional remuneration-related resolutions covering the issue of shares under the LTI share loan scheme to the Managing Director and an increase in the fee pool for Non-Executive Directors also received strong support.
3. REMUNERATION POLICY
In general, the Board links the nature and amount of KMP and other senior executives’ emoluments to the Company’s financial and operational performance. Given the nature of the industry in which the Company operates and the position it is in regarding the on-going development of new products, the review of performance can also give regard to elements such as the scientific progress and commercialisation of the Company’s projects, results of trials, progress with the development of relationships with sales and marketing partners, research institutions, and other collaborations.
Mayne Pharma Annual Report 2016 27
Remuneration paid to the Company’s Directors and senior executives is also determined with reference to the market level of remuneration for other listed development, pharmaceutical and manufacturing companies in Australia and the US. Specific roles are also benchmarked against similar roles in other listed companies in the ASX 151-200. This assessment is undertaken with reference to published information provided by various executive search firms operating in the sector.
4. ELEMENTS OF KMP REMUNERATION
Remuneration packages may contain the following key fixed and performance-based elements:
-
Short-term benefit – salary/fees, annual leave, bonuses and other benefits such as novated lease payments;
-
Post-employment benefits – superannuation;
-
Share-based payments – share options granted under the Company’s approved option plans and LTI shares granted under the non-recourse loan arrangements as disclosed in Note 27 to the financial statements;
-
Long-term benefits – long service leave; and
-
Termination payments
Fixed remuneration
Managing Director and Officers
Fixed remuneration consists of a base remuneration package, which generally includes salary and employer contributions to superannuation funds.
Fixed remuneration levels for KMP and other senior executives are reviewed annually by the Board through a process that considers personal development, achievement of key performance objectives for the year, internal relativities, and industry benchmarks wherever possible and CPI data.
In assessing fixed remuneration, the Board has considered the increasing scale and complexity of the operations of Mayne Pharma, and the remuneration paid to comparable roles amongst the companies comprising the ASX151-200. As a result, the Board resolved to increase the fixed remuneration of the CEO from $800,000 to $900,000 effective 13 February 2016 (being the anniversary of his commencement). The Board is very comfortable that this increase is appropriate having regard to Mayne Pharma’s continued growth and strong performance during the year under Mr Richards’ leadership.
Non-executive directors
Total remuneration for non-executive directors is determined by resolution of shareholders. The maximum available aggregate cash remuneration approved for non-executive directors at the 2015 Annual General Meeting is $1,200,000. Non-executive directors do not receive retirement benefits other than a superannuation guarantee contribution required by government regulation, which is currently 9.5% of their fees, except where a non-executive director elects to have their fees paid as contributions to a superannuation fund.
The current annual fees for the Chairman and other non-executive directors were reviewed effective 1 July 2015 and reflect the market competitiveness review conducted by 3dc.
Non-executive directors may provide specific consulting advice to the Group upon direction from the Board. Remuneration for this work is made at market rates. No such consulting advice was provided to the Company during the year.
Performance-linked remuneration
Remuneration packages for KMP and senior executives have traditionally included the entitlement to short-term incentives (STI) in the form of cash bonuses, and the entitlement to long-term incentives (LTI) through the award of options over ordinary shares under the Chief Executive Share Option Plan, and to other executives under the Employee Share Option Plan.
Effective 1 July 2014, and as approved by shareholders at the 2014 Annual General Meeting, the Board removed the entitlement to an STI for the CEO and Group CFO & Company Secretary and replaced it with an amended LTI based on annual grants under the new Executive Share Loan Scheme (ESLS). Following a further review (from the perspective of both the Company and senior executives), the Board decided to expand the ESLS to all KMP and other select senior executives effective 1 July 2015, to ensure that these executives are focussed on the long term growth of shareholder value.
The ESLS allows the issue of shares to participants based on a percentage of fixed remuneration funded by a non-recourse loan. Issues will be made annually to KMP and other senior executives who have foregone their STI entitlement.
Under the ESLS, eligible senior management are provided with non-recourse loans from the Group for the sole purpose of acquiring the shares. The shares are granted upfront based on the five day volume weighted average price, and remain restricted and subject to risk of forfeiture until the end of the vesting/performance period and while the loan remains outstanding, with any unvested/unexercised shares lapsing 49 months after the first test date.
Any dividends paid on the shares are applied (on a notional after tax basis) towards repaying the loan. The shares generally vest over three years with 20% vesting after the first test date, 30% after the second test date and 50% vesting after the third test date, other than those issued to the CEO during FY15, of which 100% only vest after 36 months if the hurdles are met.
The test dates for the LTI loan scheme issues made since 1 July 2015 have been set as 1 July each year. For previous issues the testing dates were based on the anniversary of the grant date. This provides a rolling benefit to senior executives over the three year period in the absence of a short term incentive.
The number/proportion of shares (granted prior to reporting date) that vest is based on the absolute Total Shareholder Return (TSR) over the period, with 50% vesting if a TSR of 5% (10% for pre 1 July 2015 issues) Compound Annual Growth (CAGR) is achieved, rising to 100% vesting for achievement of a TSR CAGR of 10% (15% for pre 1 July 2015 issues). If the hurdles are not met at the date of the initial test, the unvested shares are re-tested at the next test date. If any shares remain unvested after the third test date, they are able to be retested six monthly for a further two years, at which point they will lapse if unvested. The Board has determined that the opportunity for retesting of the absolute TSR hurdle is appropriate at this time given the uncertain timing of product approvals. The Board took advice from
28 Mayne Pharma Annual Report 2016
3d on the appropriate TSR targets for the issues made since 1 July 2015 considering the significant growth in the Company’s share price. Given this, the Board set the TSR target range at a CAGR of 5% to 10% for LTI issues made since 1 July 2015.
The Board considered performance measures other than TSR however concluded these were not appropriate at this time. The Board will continue to consider whether an earnings or returns based measure is more appropriate for future grants. The Board considers that an absolute TSR target aligns managements reward (via the share based loan plan) with that of shareholders.
Hedging of equity awards
The Company prohibits KMP from entering into arrangements to protect the value of unvested equity awards. The prohibition includes entering into contracts to hedge their exposure to options or ESLS shares awarded as part of their remuneration package.
5. KMP REMUNERATION TABLES
The following table discloses KMP remuneration during the year ended 30 June 2016:
| SHORT-TERM BENEFITS POST- EMPLOYMENT BENEFITS LONG TERM BENEFITS |
|
|---|---|
| DIRECTORS’ FEES $ SALARY $ ANNUAL LEAVE $ BONUS 1 $ OTHER BENEFITS 2 $ SUPER- ANNUATION $ OTHER 3 $ OPTIONS $ LTI SHARES $ TOTAL $ PROPORTION RELATED TO PERFORMANCE % |
|
| Non-Executive Directors |
|
| Mr R Corbett | 250,000 - - - - 23,750 - - - 273,750 - |
| Hon R Best | 95,583 - - - - 46,767 - - - 142,350 - |
| Mr B Mathieson | 130,000 - - - - 12,350 - - - 142,350 - |
| Mr I Scholes | 140,000 - - - - 13,300 - - - 153,300 - |
| Mr P Hodges | 120,000 - - - - - - - - 120,000 - |
| Prof B Robinson | 120,000 - - - - 11,400 - - - 131,400 - |
| Executive Directors |
|
| Mr S Richards | - 803,127 60,052 - 19,308 19,517 403,257 443,875 1,749,136 48.4 |
| Other KMP | |
| Mr M Cansdale | - 387,435 35,053 - 26,194 19,308 7,449 - 227,432 702,871 32.4 - 535,383 32,968 - 119,395 36,744 4,275 131,258 169,914 1,029,937 29.2 - 332,992 27,730 - - - 9,012 - 149,017 518,751 28.7 - 295,301 23,343 53,560 - 19,308 4,960 38,131 90,087 524,690 34.6 - 421,860 33,120 - 16,162 5,652 - - 131,487 608,281 21.6 - 337,658 26,923 - 9,111 17,011 - - 187,505 578,208 32.4 - 140,000 12,307 - - 14,102 - - 48,155 214,564 22.4 - 129,164 10,577 - 29,991 10,836 - - - 180,568 - |
| Mr S Cross | |
| Dr I Stancovski | |
| Ms K Rintoul 4 |
|
| Mr E Evans 5 |
|
| Mr P Paltoglou 6 |
|
| Ms L Pendlebury 7 |
|
| Mr A Van Breugel 8 |
|
| Total | 855,583 3,382,920 262,073 53,560 200,853 249,836 45,213 572,645 1,447,472 7,070,156 |
-
Bonuses are accrued when specified personal and/or corporate parameters are met.
-
Other benefits include car lease payments, rental allowances and medical related payments. Mr Cross also receives return flights to Australia and other typical expat benefits.
-
Other long-term benefits represent accruals for long service leave entitlements that may arise should the relevant key management personnel meet the eligibility requirements in the future.
-
Ms Rintoul was considered to be KMP from 1 July 2015.
-
Mr Evans commenced with the Group on 5 August 2015
-
Mr Paltoglou commenced with the Group 22 August 2015
-
Ms Pendlebury commenced with the Group (as a full time employee) 11 November 2015
-
Mr Van Breugel commenced with the Group 15 January 2016.
Mayne Pharma Annual Report 2016 29
The following table discloses KMP remuneration during the year ended 30 June 2015:
| The following table | discloses KMP remuneration during the year ended 30 June 2015: |
|---|---|
| SHORT-TERM BENEFITS POST- EMPLOYMENT BENEFITS LONG-TERM BENEFITS |
|
| DIRECTORS’ FEES $ SALARY $ ANNUAL LEAVE $ BONUS 1 $ OTHER BENEFITS 2 $ SUPER- ANNUATION $ OTHER 3 $ OPTIONS $ LTI SHARES $ TOTAL $ PROPORTION RELATED TO PERFORMANCE % |
|
| Non-Executive | |
| Directors | |
| Mr R Corbett | 140,000 - - - - 13,300 - - - 153,300 - |
| Hon R Best | 77,500 - - - - 7,362 - - - 84,862 - |
| Mr B Mathieson | 77,500 - - - - 7,362 - - - 84,862 - |
| Mr I Scholes | 77,500 - - - - 7,362 - - - 84,862 - |
| Mr P Hodges | 77,500 - - - - - - - - 77,500 - |
| Prof B Robinson 4 |
64,583 - - - - 6,135 - - - 70,718 - |
| Executive Directors | |
| Mr S Richards | - 626,673 52,367 - 18,783 17,026 461,540 96,770 1,273,179 43.9 |
| Other KMP | |
| Mr M Cansdale | - 345,507 31,631 - 29,334 18,783 6,722 16,435 55,794 504,206 14.3 - 369,132 20,989 92,283 233,146 37,527 4,275 162,466 - 919,820 27.7 - 298,371 21,231 - 20,324 15,653 - - 17,145 372,724 4.6 |
| Mr S Cross | |
| Dr I Stancovski 5 |
|
| Total | 514,583 1,639,683 126,238 92,283 282,806 132,267 28,023 640,441 169,709 3,626,033 |
-
Bonuses are accrued when specified personal and/or corporate parameters are met.
-
Other benefits include car lease payments, rental allowances and medical related payments. Mr Cross also receives return flights to Australia and other typical expat benefits.
-
Other long-term benefits represent accruals for long service leave entitlements that may arise should the relevant key management personnel meet the eligibility requirements in the future.
-
Prof Robinson was appointed 26 August 2014.
-
Dr Stancovski commenced with the Group 1 September 2014.
6. VALUE OF EQUITY INTRUMENTS GRANTED TO KMP
Options
The number and value of options granted to KMP is set out below:
NUMBER HELD AT 1 JULY 2015 NUMBER GRANTED DURING YEAR NUMBER EXERCISED DURING YEAR NUMBER LAPSED DURING THE YEAR NUMBER HELD AT 30 JUNE 2016 NUMBER VESTED AT 30 JUNE 2016 VALUE OF OPTIONS AT GRANT DATE $ VALUE OF OPTIONS INCLUDED IN COMPENSATION FOR THE YEAR $ |
||
|---|---|---|
| GRANT DATE | ||
| Year ended 30 June 2016 Mr R Corbett Mr S Richards Hon R Best Mr B Mathieson Mr I Scholes Mr P Hodges Prof B Robinson Mr M Cansdale Mr S Cross Mr S Cross Dr I Stancovski Ms K Rintoul Mr E Evans Mr P Paltoglou Ms L Pendlebury Mr A Van Breugel |
- - - - - - - 7,500,000 - - - 7,500,000 7,500,000 1,842,300 1 403,257 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 800,000 - - - 800,000 300,000 110,800 2 27,197 1,000,000 - - - 1,000,000 200,000 336,850 2 104,061 - - - - - - - - 800,000 - - - 800,000 300,000 164,090 38,131 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
|
| 13 Feb 12 | ||
| 25 Jan 13 | ||
| 21 Apr 14 | ||
| 2 Jul 13 | ||
| 10,100,000 - - - 10,100,000 8,300,000 2,454,040 572,645 |
-
As a result of the underwritten pro-rata accelerated non-renounceable entitlement offer announced on 10 February 2015 to fund the US Doryx acquisition, the exercise price changed in accordance with ASX Listing Rule 6.22 and the hurdle prices of unquoted options issued to the Chief Executive Officer were reduced in accordance with a resolution passed at the 2013 AGM. The fair value of the options prior to the change were as follows: tranche one $0.560, tranche two $0.537, tranche three $0.506 per option and the fair value of the options after the change were as follows: tranche one $0.577, tranche two $0.554, tranche three $0.533 per option. At grant date the total value of the options was $940,000. This value was increased by $740,000 as a result of the previous hurdle price changes. The value further increased as a result of the 2015 exercise price and hurdle changes by $162,300.
-
As a result of the underwritten pro-rata accelerated non-renounceable entitlement offer announced on 10 February 2015 to fund the US Doryx acquisition, the exercise price of unquoted options issued to Stefan Cross were reduced by $0.0173 on 11 March 2015 in accordance with ASX Listing Rule 6.22. At the grant dates the total value of the options was $434,100. This value was increased by $13,550 as a result of the exercise price change in March 2015.
30 Mayne Pharma Annual Report 2016
NUMBER HELD AT 1 JULY 2014 NUMBER GRANTED DURING YEAR NUMBER EXERCISED DURING YEAR NUMBER LAPSED DURING THE YEAR NUMBER HELD AT 30 JUNE 2015 NUMBER VESTED AT 30 JUNE 2015 VALUE OF OPTIONS AT GRANT DATE $ VALUE OF OPTIONS INCLUDED IN COMPENSATION FOR THE YEAR $ |
||
|---|---|---|
| GRANT DATE | ||
| Year ended 30 June 2015 Mr R Corbett Mr S Richards Hon R Best Mr B Mathieson Mr I Scholes Mr P Hodges Prof B Robinson Mr M Cansdale Mr S Cross Mr S Cross Dr I Stancovski |
- - - - - - - - 7,500,000 - - - 7,500,000 4,000,000 1,842,300 1 461,540 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 950,000 - 950,000 - - - 295,129 2 16,435 1,000,000 - 200,000 - 800,000 - 110,800 3 32,886 1,000,000 - - - 1,000,000 - 336,850 3 129,580 - - - - - - - - |
|
| 13 Feb 12 | ||
| 25 Jul 11 | ||
| 25 Jan 13 | ||
| 21 Apr 14 | ||
| 10,450,000 - 1,150,000 - 9,300,000 4,000,000 2,585,079 640,441 |
-
As a result of the underwritten pro-rata accelerated non-renounceable entitlement offer announced on 10 February 2015 to fund the US Doryx acquisition, the exercise price changed in accordance with ASX Listing Rule 6.22 and the hurdle prices of unquoted options issued to the Managing Director and Chief Executive Officer were reduced in accordance with a resolution passed at the 2013 AGM. The fair value of the options prior to the change were as follows: tranche one $0.560, tranche two $0.537, tranche three $0.506 per option and the fair value of the options after the change were as follows: tranche one $0.577, tranche two $0.554, tranche three $0.533 per option. At grant date the total value of the options was $940,000. This value was increased by $740,000 as a result of the previous hurdle price changes. The value further increased as a result of the 2015 exercise price and hurdle changes by $162,300.
-
As a result of the underwritten pro-rata accelerated non-renounceable entitlement offer announced on 10 February 2015 to fund the US Doryx acquisition, the exercise price of unquoted options issued to the Group CFO and Company Secretary was reduced by $0.0173 on 11 March 2015 in accordance with ASX Listing Rule 6.22. At grant date the total value of the options was $152,994. This value was increased by $125,700 as a result of the exercise price change in November 2013 and by $16,435 as a result of the exercise price change in March 2015.
-
As a result of the underwritten pro-rata accelerated non-renounceable entitlement offer announced on 10 February 2015 to fund the US Doryx acquisition, the exercise price of unquoted options issued to Stefan Cross were reduced by $0.0173 on 11 March 2015 in accordance with ASX Listing Rule 6.22. At the grant dates the total value of the options was $434,100. This value was increased by $13,550 as a result of the exercise price change in March 2015.
Chief Executive Officer Share Option Plan (CEOSOP)
As noted above, a share option plan was used historically where the CEO could be issued with options over the ordinary shares of Mayne Pharma Group Limited. Shareholders approved the plan at the Extraordinary General Meeting held on 27 January 2012. The options, issued for nil consideration, were issued in accordance with guidelines established by the Directors.
Each CEO share option converts to one ordinary share in Mayne Pharma Group Limited upon exercise. The options carry neither rights to dividends nor voting. Options may be exercised at any time from the date of vesting to seven years after the Grant Date (13 February 2019) subject to the terms and conditions outlined in the plan, including Share Price hurdles ranging from $0.74 to $1.19 (2015: share price hurdles were $0.74 to $1.19), Share Gateway conditions apply.
The options were issued in three tranches:
| The options were issued in three tranches: | |
|---|---|
| NUMBER OF OPTIONS GRANT DATE VESTING DATE |
|
| Tranche 1 Tranche 2 Tranche 3 |
1,500,000 13 February 2012 13 February 2015 2,500,000 13 February 2012 13 February 2015 3,500,000 13 February 2012 13 February 2016 2016 NUMBER OF OPTIONS 2016 WEIGHTED AVERAGE EXERCISE PRICE $ 2015 NUMBER OF OPTIONS 2015 WEIGHTED AVERAGE ERERCISE PRICE $ |
| Balance at beginning of year Granted during the year Balance at end of year |
7,500,000 0.2435 1,2 7,500,000 0.2435 1 - - - - |
| 7,500,000 7,500,000 |
-
The weighted average exercise price of the CEOSOP options changed during the previous year as a result of the application of ASX Listing Rule 6.22 following the Company’s entitlement offer announced in February 2015.
-
The exercise price of the CEOSOP options were reduced by 9.43 cents each to $0.1492 subsequent to the reporting period (effective 22 July 2016) as a result the application of ASX Listing Rule 6.22 following the Company’s entitlement offer announced in June 2016.
The Tranche 3 options vested during the reporting period.
There were no option issues under the CEOSOP during the year (2015: nil).
Option modification
The terms of the options issued in February 2012 under the CEOSOP were modified during the previous year. Following the issue of shares under an underwritten pro-rata accelerated non-renounceable entitlement offer of new ordinary shares, as announced in February 2015, the exercise price was changed in accordance with ASX Listing Rule 6.22 and the hurdle price of the options was subsequently adjusted in accordance with the special resolution passed at the Company’s 2013 AGM. The exercise price was reduced by 1.73 cents and the hurdle prices were changed such that the tranche two hurdle changed from $0.98 to $0.92 and the tranche three hurdle changed from $1.29 to $1.19.
As tranche 1 and tranche 2 options had vested and were exercisable at the time of the exercise price change, the change in the intrinsic value was considered to be equal to the change in the exercise price (i.e. change $0.0173 cents per option).
Mayne Pharma Annual Report 2016 31
The modification resulted in an expense value greater than the pre-modification expense value of $93,100 for the unvested options and as such the expense amount was changed with this additional amount to be expensed over the remaining life of the options. The modification of the vested options resulted in additional expense of $69,200 which was expensed in the prior year.
Following the issue of shares under an underwritten pro-rata accelerated non-renounceable entitlement offer of new ordinary shares, as announced in June 2016, the exercise price was reduced by 9.43 cents in accordance with ASX Listing Rule 6.22 effective 22 July 2016. The expense impact had not been assessed at the date of this report. Any adjustment to the expense will be reflected in the FY17 reporting period.
LTI Shares
As noted above, under the new LTI program (“Executive Share Loan Scheme” or “ESLS”), eligible KMP (and other select senior management) are invited to acquire shares in the Company funded by a non-recourse loan from the Group. Although the shares are acquired under the plan for legal and taxation purposes, Australian Accounting Standards require the shares be treated as options for accounting purposes. As a result, the amounts receivable from KMP in relation to these loans are not recognized in the financial statements.
The number of notional shares granted to KMP under the ESLS is set out below:
NUMBER HELD AT 1 JULY 2015 NUMBER GRANTED DURING YEAR NUMBER EXERCISED DURING YEAR NUMBER LAPSED DURING THE YEAR NUMBER HELD AT 30 JUNE 2016 NUMBER VESTED AT 30 JUNE 2016 VALUE OF OPTIONS AT GRANT DATE $ VALUE OF OPTIONS INCLUDED IN COMPENSATION FOR THE YEAR $ |
||
|---|---|---|
| GRANT DATE | ||
| Year ended 30 June 2016 Mr R Corbett Mr S Richards Mr S Richards Hon R Best Mr B Mathieson Mr I Scholes Mr P Hodges Prof B Robinson Mr M Cansdale Mr M Cansdale Mr S Cross Dr I Stancovski Dr I Stancovski Ms K Rintoul Mr E Evans Mr P Paltoglou Ms L Pendlebury Mr A Van Breugel |
- - - - - - - - 3,823,529 - - - 3,823,529 - 845,000 169,000 - 2,553,496 - - 2,553,496 - 1,237,169 274,875 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1,092,063 - - - 1,092,063 218,413 344,000 68,800 1,173,682 - - 1,173,682 - 518,885 158,632 - 1,257,153 - - 1,257,153 - 555,787 169,914 833,003 - - - 833,003 166,601 210,000 42,000 - 791,789 - - 791,789 - 350,050 107,017 - 666,533 - - 666,533 - 294,674 90,087 - 974,997 - - 974,997 - 432,996 131,487 - 2,231,344 - - 2,231,344 - 633,032 187,505 - 524,070 - - 524,070 - 200,771 48,155 - - - - - - - - |
|
| - | ||
| 4 Dec 14 | ||
| 4 Dec 15 | ||
| - | ||
| - | ||
| - | ||
| - | ||
| - | ||
| 8 Sep 14 | ||
| 3 Aug 15 | ||
| 3 Aug 15 | ||
| 2 Feb 15 | ||
| 3 Aug 15 | ||
| 3 Aug 15 | ||
| 5 Aug 15 | ||
| 24 Aug 15 | ||
| 11 Nov 15 | ||
| - | ||
| 5,748,595 10,173,064 - - 15,921,659 385,014 5,622,364 1,447,472 |
||
NUMBER HELD AT 1 JULY 2014 NUMBER GRANTED DURING YEAR NUMBER EXERCISED DURING YEAR NUMBER LAPSED DURING THE YEAR NUMBER HELD AT 30 JUNE 2015 NUMBER VESTED AT 30 JUNE 2015 VALUE OF OPTIONS AT GRANT DATE $ VALUE OF OPTIONS INCLUDED IN COMPENSATION FOR THE YEAR $ |
||
| GRANT DATE | ||
| Year ended 30 June 2015 Mr R Corbett Mr S Richards Hon R Best Mr B Mathieson Mr I Scholes Mr P Hodges Prof B Robinson Mr M Cansdale Mr S Cross Dr I Stancovski |
- - - - - - - - - 3,823,529 - - 3,823,529 - 845,000 96,770 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1,092,063 - - 1,092,063 - 344,000 55,794 - - - - - - - - - 833,003 - - 833,003 - 210,000 17,145 |
|
| - | ||
| 4 Dec 14 | ||
| - | ||
| - | ||
| 8 Sep 14 | ||
| - | ||
| 2 Feb 15 | ||
| - 5,748,595 - - 5,748,595 - 1,399,000 169,709 |
32 Mayne Pharma Annual Report 2016
7. OPTIONS AND SHARES GRANTED SUBSEQUENT TO REPORTING DATE
No options were issued to KMP subsequent to report date.
The following restricted shares were issued subsequent to report date to KMP in accordance with the terms of the ESLS:
==> picture [491 x 139] intentionally omitted <==
----- Start of picture text -----
||||||
|---|---|---|---|---|
|Number of shares|Exercise Price / loan|
|NAME|Date granted|issued|value $|Expiry date|
|Mr M Cansdale|11 August 2016|676,119|2.01|31 July 2021|
|Mr S Cross|11 August 2016|715,418|2.01|31 July 2021|
|Dr I Stancovski|11 August 2016|584,979|2.01|31 July 2021|
|Ms K Rintoul|11 August 2016|516,017|2.01|31 July 2021|
|Mr E Evans|11 August 2016|556,600|2.01|31 July 2021|
|Mr P Paltoglou|11 August 2016|719,413|2.01|31 July 2021|
|Ms L Pendlebury|11 August 2016|298,291|2.01|31 July 2021|
|Mr A Van Breugel|11 August 2016|370,617|2.01|31 July 2021|
----- End of picture text -----
8. SHARES ISSUED ON EXERCISE OF OPTIONS BY KMP
No shares were issued to KMP on the exercise of options during the year ended 30 June 2016.
==> picture [490 x 68] intentionally omitted <==
----- Start of picture text -----
|||||
|---|---|---|---|
|SHARES ISSUED|PAID PER SHARE|UNPAID PER SHARE|
|NUMBER|$|$|
|30 June 2015|
|Mr S Cross|200,000|0.3127|-|
|Mr M Cansdale|950,000|0.2505|
|Total|1,150,000|-|
----- End of picture text -----
9. SHARES HELD BY KMP
Movements in shares
The movement during the year in the number of ordinary shares in the Company held, directly, indirectly or beneficially, by each KMP including their related parties at reporting date, is as follows:
==> picture [497 x 295] intentionally omitted <==
----- Start of picture text -----
|||||||||
|---|---|---|---|---|---|---|---|
|RECEIVED DURING|RECEIVED DURING|
|THE YEAR ON|THE YEAR ON|
|EXERCISE OF|EXERCISE OF|
|OPTIONS AND / OR|OPTIONS AND / OR|
|HELD AT|LTI SHARES|OTHER CHANGES|HELD AT|LTI SHARES|OTHER CHANGES|HELD AT|
|30 JUNE 2014|GRANTED|DURING THE YEAR|30 JUNE 2015|GRANTED|DURING THE YEAR|30 JUNE 2016|
|Directors|NUMBER|NUMBER|NUMBER|NUMBER|NUMBER|NUMBER|NUMBER|
|Mr R Corbett|5,047,499|-|1,463,043|6,510,542|-|-|6,510,542|
|Mr S Richards|2,500,000|3,823,529|1,090,367|7,413,896|2,553,496|-|9,967,392|
|Hon R Best|2,173,244|-|319,094|2,492,338|-|68,000|2,560,338|
|Mr B Mathieson|43,774,748|-|12,688,332|56,463,080|-|680,000|57,143,080|
|Mr I Scholes|1,010,328|-|292,846|1,303,174|-|-|1,303,174|
|Mr P Hodges|5,302,738|-|1,536,929|6,839,667|-|-|6,839,667|
|Prof B Robinson|-|-|257,971|257,971|-|-|257,971|
|59,808,557|3,823,529|17,648,582|81,280,668|2,553,496|748,000|84,582,164|
|Other KMP|
|Mr M Cansdale|230,710|2,042,063|(566,588)|1,706,185|1,173,682|-|2,879,867|
|Mr S Cross|-|200,000|-|200,000|1,257,153|-|1,457,153|
|Dr I Stancovski|-|833,003|40,000|873,003|791,789|-|1,664,792|
|Ms K Rintoul|-|-|-|-|666,533|-|666,533|
|Mr E Evans|-|-|-|-|974,997|-|974,997|
|Mr P Paltoglou|-|-|-|-|2,231,344|374,000|2,605,344|
|Ms L Pendlebury|-|-|-|287,697|524,070|-|811,767|
|Mr A Van Breugel|-|-|-|-|-|-|-|
|230,710|3,075,066|(526,588)|3,066,885|7,619,568|374,000|11,060,453|
|60,039,267|6,898,595|17,121,994|84,347,553|10,173,064|1,122,000|95,642,617|
----- End of picture text -----
Mayne Pharma Annual Report 2016 33
10. EMPLOYMENT CONTRACTS
Remuneration and other key terms of employment for the Chief Executive Officer other KMP are formalised in service agreements. The service agreements specify the components of remuneration, benefits, notice periods and termination provisions.
The table below provides details on the CEO’s service agreement:
==> picture [491 x 85] intentionally omitted <==
----- Start of picture text -----
|||||||
|---|---|---|---|---|---|
|BASE SALARY|
|INCLUDING|
|NAME|TERM OF AGREEMENT|SUPERANNUATION1|NOTICE PERIOD|INCENTIVE ARRANGEMENTS|TERMINATION BENEFITS|
|Mr S Richards|On-going commencing|$900,000|12 months|Entitlement to participate in|Nil if for serious mis-conduct.|
|Chief Executive Officer|13 February 2012|LTI option plan. The value|Otherwise, up to 12 months’|
|of the LTI is based on|pay in lieu of notice.|
|130% of fixed|If employment is terminated|
|remuneration.|within six months of a change of|
|control, entitled to a payment|
|equal to 12 months’ pay.|
----- End of picture text -----
- Base salary quoted is for a 12 month period and is current and is reviewed annually by the Remuneration and People Committee.
Other executive KMP are subject to service agreements with notice periods from 3 months to 6 months. Other KMP participate in the LTI plan receiving an annual allocation of shares under the plan. LTI participation is between 70% and 90% of fixed remuneration. These executives no longer participate in the STI plan.
In order to align the executive KMP interests with shareholder interests, all executive KMP are required to build and hold a specified minimum shareholding in the Company over time.
11. GROUP PERFORMANCE
In considering the Group’s performance and its effect on shareholder wealth, the Board has regard to a broad range of factors, primarily related to financial and operational performance, the scientific progress and commercialisation of the Company’s projects, results of trials, relationship building with sales and marketing partners, research institutions, and collaborations.
As part of the Board’s commitment to align remuneration with Company performance, employee performance is reviewed annually against agreed performance objectives set prior to the commencement of the financial year. The Company’s performance review system involves employees completing a self-assessment template, as well as their manager completing an assessment document. These written assessments form the basis of a performance review discussion between the employee and their manager.
The Board (through the RPC) agrees objectives for the evaluation of the CEO. The performance of the CEO against the agreed objectives is reviewed by the Chairman on behalf of the Board. The performance of the other KMP and other senior executives is reviewed by the CEO and reported to, and discussed by, the Board. Performance reviews take place shortly after the end of the financial year.
As outlined in this report, the Company has implemented a broader based long-term incentive (LTI) plan for senior management. This plan places a significant percentage of remuneration at risk and more closely aligns employee remuneration with the earnings growth of the Company.
The Company now has 132 senior members of staff participating in the LTI programme, either though previous option issues, or more recently through the share loan scheme, including 14 senior executives who have agreed to forgo STI entitlements. The Board considers this a strong indication of the alignment of the shareholders’ and employees’ interests.
The following table outlines key statistics reported by the Company over the last five years to 30 June 2016:
==> picture [490 x 91] intentionally omitted <==
----- Start of picture text -----
|||||||
|---|---|---|---|---|---|
|2016|2015|2014|2013|2012|
|$000’S|$000’S|$000’S|$000’S|$000’S|
|Total revenue ($000)|267,280|141,420|143,254|83,431|51,904|
|NPAT ($000) attributable to Mayne Pharma|
|shareholders|37,355|7,759|21,290|(2,843)|6,153|
|Basic EPS (cents)|4.77|1.18|3.72|(0.70)|4.05|
|Share price (30 June)|$1.905|$0.985|$0.850|$0.430|$0.350|
|Dividends per share (cents)|-|-|-|-|-|
----- End of picture text -----
This Directors’ Report is signed in accordance with a resolution of the Directors.
Dated at Melbourne, Australia this 25th day of August 2016.
Mr Scott Richards Managing Director and CEO
34 Mayne Pharma Annual Report 2016
AUDIT INDEPENDENCE DECLARATION
==> picture [61 x 46] intentionally omitted <==
Ernst & Young Tel: +61 3 9288 8000 8 Exhibition Street Fax: +61 3 8650 7777 Melbourne VIC 3000 Australia ey.com/au GPO Box 67 Melbourne VIC 3001
Auditor’s Independence Declaration to the Directors of Mayne Pharma Group Limited
As lead auditor for the audit of Mayne Pharma Group Limited for the financial year ended 30 June 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 in relation to the audit ; and
-
b) no contraventions of any applicable code of professional conduct in relation to the audit.
This declaration is in respect of Mayne Pharma Group Limited and the entities it controlled during the financial year.
==> picture [102 x 39] intentionally omitted <==
Ernst & Young
==> picture [89 x 60] intentionally omitted <==
Ashley C Butler Partner Melbourne 25 August 2016
A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation
Mayne Pharma Annual Report 2016 35
CORPORATE GOVERNANCE WEBSITE
Important information relating to the Company’s corporate governance policies and practices are set out on the Company’s website at http://www.maynepharma.com/investor-relations/corporate-governance.
The Company has adopted the ASX Corporate Governance Council 3rd Edition Corporate Governance Principles and Recommendations. The recommendations allow companies to publish Corporate Governance information on their websites rather than include the information in the Annual Report.
The following documents are available on the Mayne Pharma website:
-
Corporate Governance Statement;
-
Board Charter;
-
Audit & Risk Committee, RPC and Nomination Committee Charters;
-
Code of Conduct;
-
Communications Policy;
-
Continuous Disclosure Policy,
-
Risk Management Framework;
-
Workplace Gender Equality Agency Annual Compliance Report; and
-
Securities Trading Policy.
36 Mayne Pharma Annual Report 2016
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
For the year ended 30 June 2016
| NOTE | CONSOLIDATED 2016 $’000 2015 $’000 |
|---|---|
| Continuing operations Sale of goods Services revenue License fee revenue Royalties revenue Revenue Cost of sales Gross profit Other income 4 Research and development expenses Marketing and distribution expenses Administration expenses and other expenses 6 Finance expenses 6 Share of associate loss 14 Profit before income tax Income tax expense 7 Net profit from continuing operations after income tax Attributable to: Equity holders of the Parent Non-controlling interests Other comprehensive income/(loss) for the period, net of tax Items that may be reclassified to profit or loss in future periods Unrealised loss on cash flow hedges Income tax effect Exchange differences on translation Income tax effect Share of associate exchange differences on translation 14 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 8 Diluted earnings per share 8 |
206,629 96,316 59,170 43,514 391 494 1,090 1,096 |
| 267,280 141,420 (98,914) (61,433) |
|
| 168,366 79,987 7,491 6,920 (8,731) (5,588) (38,029) (17,549) (76,766) (45,592) (2,494) (5,945) - (990) |
|
| 49,837 11,243 (15,314) (3,706) |
|
| 34,523 7,537 |
|
| 37,355 7,759 (2,832) (222) |
|
| 34,523 7,537 |
|
| (864) - - - 3,161 22,665 - - - 1,528 310 515 - - |
|
| 37,130 32,245 |
|
| 39,652 31,952 (2,522) 293 |
|
| 37,130 32,245 |
|
4.77 cents 1.18 cents 4.62 cents 1.15 cents |
This statement is to be read in conjunction with the accompanying notes.
Mayne Pharma Annual Report 2016 37
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
As at 30 June 2016
| NOTE | CONSOLIDATED 2016 $’000 2015 $’000 |
|---|---|
| Current assets Cash and cash equivalents 23 Trade and other receivables 9 Inventories 10 Income tax receivable Other financial assets 11 Other current assets 12 Total current assets Non-current assets Property, plant and equipment 13 Deferred tax assets 7 Intangible assets and goodwill 15 Total non-current assets Total assets Current liabilities Trade and other payables 16 Interest-bearing loans and borrowings 17 Income tax payable Other financial liabilities 18 Provisions 19 Total current liabilities Non-current liabilities Interest-bearing loans and borrowings 17 Other financial liabilities 18 Deferred tax liabilities 7 Provisions 19 Total non-current liabilities Total liabilities Net assets Equity Contributed equity 20 Reserves 21 Retained earnings 22 Equity attributable to equity holders of the Parent Non-controlling interests Total equity |
47,481 59,201 123,716 64,657 38,943 22,444 7,399 2,956 3,458 2,229 887,653 5,333 |
| 1,108,650 156,820 |
|
84,449 59,597 31,799 9,569 332,483 302,960 |
|
| 448,731 372,126 |
|
| 1,557,381 528,946 |
|
1,020,553 59,980 503 - 12,308 1,764 13,273 26,811 9,287 6,523 |
|
| 1,055,924 95,078 |
|
76,331 61,756 5,814 7,312 41,640 41,353 1,451 1,245 |
|
| 125,236 111,666 |
|
| 1,181,160 206,744 |
|
| 376,221 322,202 |
|
263,161 255,834 39,058 30,861 61,530 24,175 |
|
| 363,749 310,870 12,472 11,332 |
|
| 376,221 322,202 |
This statement is to be read in conjunction with the accompanying notes.
38 Mayne Pharma Annual Report 2016
CONSOLIDATED STATEMENT OF CASH FLOWS
For the year ended 30 June 2016
| NOTE | CONSOLIDATED 2016 $’000 2015 $’000 |
|---|---|
| Cash flows from operating activities Receipts from customers Payments to suppliers and employees Interest received Interest paid Tax paid Net operating cash flows before research and non-capitalised development expenditure, set-up and transaction costs Payments for research and non-capitalised development expenditure Settlement costs relating to a distributor dispute Set-up, transaction and other costs Net cash flows from operating activities 23 Cash flows from investing activities Payments for property, plant and equipment Payments for intangible assets Acquisition of subsidiary (net of cash acquired) 31 Acquisition of warrants Payments for capitalised development costs Earn-out payments Net cash flows used in investing activities Cash flows from financing activities Proceeds from issues of shares Transaction costs on issue of shares 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 the beginning of the period Effect of exchange rate fluctuations on cash held Cash at the end of the period Less restricted cash 11 Cash at the end of the period (unrestricted) 23 |
208,745 111,156 (107,024) (68,898) 461 355 (1,422) (4,264) (26,496) (7,587) |
| 74,264 30,762 (6,014) (3,174) (6,668) - (8,079) (5,168) |
|
| 53,504 22,420 |
|
| (29,590) (4,174) (10,665) (65,917) - 996 - (966) (22,593) (13,512) (20,950) (11,931) |
|
| (83,798) (95,504) |
|
| 995 118,596 - (4,581) 3,658 - (344) (59,682) 13,681 60,776 |
|
| 17,990 115,109 |
|
| (12,304) 42,025 |
|
| 59,567 15,110 595 2,432 |
|
| 47,858 59,567 |
|
(377) (366) |
|
| 47,481 59,201 |
This statement is to be read in conjunction with the accompanying notes.
Mayne Pharma Annual Report 2016 39
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
For the year ended 30 June 2016
| CONTRIBUTED EQUITY SHARE-BASED PAYMENTS RESERVE FOREIGN CURRENCY TRANSLATION RESERVE CASH FLOW HEDGE RESERVE OTHER RESERVE RETAINED EARNINGS / ACCUMULATED LOSSES TOTAL NON- CONTROLLING INTERESTS TOTAL EQUITY $’000 $’000 $’000 $’000 $’000 $’000 $’000 $’000 $’000 |
|
|---|---|
| Balance at 1 July 2015 Profit/(loss) for the period Other comprehensive income Cash flow hedge Foreign exchange differences Total comprehensive income for the period Transactions with owners in their capacity as owners Shares issued Share issue costs (net of tax) Change equity investment in subsidiary Equity contributions by non- controlling interests Tax effect of employee share options Share-based payments Share options exercised Balance at 30 June 2016 Balance at 1 July 2014 Profit/(loss) for the period Other comprehensive income Foreign exchange differences Total comprehensive income for the period Transactions with owners in their capacity as owners Shares issued Share issue costs (net of tax) Tax effect of employee share options Share-based payments Share options exercised Non-controlling interest arising on a business combination (note 3) Balance at 30 June 2015 |
255,834 3,230 27,631 - - 24,175 310,870 11,332 322,202 - - - - - 37,355 37,355 (2,832) 34,523 - - - (864) - - (864) - (864) - - 3,161 - - - 3,161 310 3,471 |
| - - 3,161 (864) - 37,355 39,652 (2,522) 37,130 995 - - - - - 995 - 995 - - - - - - - - - - - - - 1,180 - 1,180 - 1,180 - - - - - - - 3,662 3,662 5,943 - - - - - 5,943 - 5,943 - 5,109 - - - - 5,109 - 5,109 389 (389) - - - - - - - |
|
| 263,161 7,950 30,792 (864) 1,180 61,530 363,749 12,472 376,221 |
|
| 137,498 1,922 3,438 - - 16,416 159,274 - 159,274 - - - - - 7,759 7,759 (222) 7,537 - - 24,193 - - - 24,193 515 24,708 |
|
| - - 24,193 - - 7,759 31,952 293 32,245 119,768 - - - - - 119,768 - 119,768 (3,207) - - - - - (3,207) - (3,207) 1,261 - - - - - 1,261 - 1,261 - 1,822 - - - - 1,822 1,822 514 (514) - - - - - - - |
|
| - - - - - - - 11,039 11,039 |
|
| 255,834 3,230 27,631 - - 24,175 310,870 11,332 322,202 |
This statement is to be read in conjunction with the accompanying notes.
40 Mayne Pharma Annual Report 2016
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
For the year ended 30 June 2016
==> picture [489 x 655] intentionally omitted <==
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|||
|---|---|
|CONSOLIDATED!STATEMENT!OF!PROFIT!OR!LOSS!AND!OTHER!COMPREHENSIVE!INCOME!|37!|
|CONSOLIDATED!STATEMENT!OF!FINANCIAL!POSITION!|38!|
|CONSOLIDATED!STATEMENT!OF!CASH!FLOWS!|39!|
|CONSOLIDATED!STATEMENT!OF!CHANGES!IN!EQUITY!|40!|
|NOTES!TO!THE!CONSOLIDATED!FINANCIAL!STATEMENTS!|41!|
|NOTE!1!–!ABOUT!THIS!REPORT!|42!|
|NOTE!2!–!OPERATING!SEGMENTS!|43!|
|NOTE!3!–!FINANCIAL!RISK!MANAGEMENT!OBJECTIVES!AND!POLICIES!|46!|
|NOTE!4!–!OTHER!INCOME!|48!|
|NOTE!5!–!FAIR!VALUE!MEASUREMENT!|49!|
|NOTE!6!–!EXPENSES!|51!|
|NOTE!7!–!INCOME!TAX!|51!|
|NOTE!8!–!EARNINGS!PER!SHARE!|54!|
|NOTE!9!–!TRADE!AND!OTHER!RECEIVABLES!|55!|
|NOTE!10!–!INVENTORIES!|56!|
|NOTE!11!–!OTHER!FINANCIAL!ASSETS!|56!|
|NOTE!12!–!OTHER!ASSETS!|57!|
|NOTE!13!–!PROPERTY,!PLANT!AND!EQUIPMENT!|58!|
|NOTE!14!–!INVESTMENT!IN!ASSOCIATE!|59!|
|NOTE!15!–!INTANGIBLE!ASSETS!AND!GOODWILL!|60!|
|NOTE!16!–!TRADE!AND!OTHER!PAYABLES!|62!|
|NOTE!17!–!INTERESTGBEARING!LOANS!AND!BORROWINGS!|63!|
|NOTE!18!–!OTHER!FINANCIAL!LIABILITIES!|64!|
|NOTE!19!–!PROVISIONS!|65!|
|NOTE!20!–!CONTRIBUTED!EQUITY!|65!|
|NOTE!21!–!RESERVES!|66!|
|NOTE!22!–!RETAINED!EARNINGS!|67!|
|NOTE!23!–!NOTES!TO!THE!CONSOLIDATED!STATEMENT!OF!CASH!FLOWS!|67!|
|NOTE!24!–!RELATED!PARTY!DISCLOSURES!|68!|
|NOTE!25!–!KMP!DISCLOSURES!|69!|
|NOTE!26!–!AUDITOR’S!REMUNERATION!|70!|
|NOTE!27!G!SHAREGBASED!PAYMENT!PLANS!|70!|
|NOTE!28!–!PARENT!ENTITY!DISCLOSURES!|75!|
|NOTE!29!–!COMMITMENTS!AND!CONTINGENCIES!|75!|
|NOTE!30!–!DIVIDENDS!|76!|
|NOTE!31!–!BUSINESS!COMBINATIONS!|76!|
|NOTE!32!–!DEED!OF!CROSS!GUARANTEE!|77!|
|NOTE!33!–!EVENTS!SUBSEQUENT!TO!THE!REPORTING!PERIOD!|80!|
|NOTE!34!–!NEW!AND!REVISED!ACCOUNTING!STANDARDS!|80!|
|DIRECTORS’!DECLARATION!|81!|
|INDEPENDENT!AUDITOR’S!REPORT!|82!|
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Mayne Pharma Annual Report 2016 41
NOTE 1 – ABOUT THIS REPORT
Mayne Pharma Group Limited is a company limited by shares incorporated and domiciled in Australia, whose shares are publicly traded on the Australian Securities Exchange. The financial report for the year ended 30 June 2016 was authorised for issue by the Directors on 25 August 2016.
The nature of the operations and principal activities of the Group are described in the Directors’ Report.
A. Basis of preparation
These financial statements are a general purpose financial report which has been prepared for a “for-profit” enterprise and in accordance with the requirements of the Corporations Act 2001, Australian Accounting Standards and other authoritative pronouncements of the Australian Accounting Standards Board. The financial report has been prepared on a historical cost basis except for financial instruments which have been measured at the fair value.
The financial report complies with Australian Accounting Standards as issued by the Australian Accounting Standards Board and International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board
The financial report is presented in Australian dollars and rounded to the nearest thousand dollars ($’000) unless otherwise stated.
B. Basis of consolidation
The consolidated financial statements comprise the financial statements of the Group and its subsidiaries as at 30 June 2016. Control is achieved when the Group is exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. Specifically, the Group controls an investee if and only if the Group has:
-
Power over the investee (i.e. existing rights that give it the current ability to direct the relevant activities of the investee)
-
Exposure, or rights, to variable returns from its involvement with the investee, and
-
The ability to use its power over the investee to affect its returns
When the Group has less than a majority of the voting or similar rights of an investee, the Group considers all relevant facts and circumstances in assessing whether it has power over an investee, including:
-
The contractual arrangement with the other vote holders of the investee
-
Rights arising from other contractual arrangements
-
The Group’s voting rights and potential voting rights
The Group re-assesses whether or not it controls an investee if facts and circumstances indicate that there are changes to one or more of the three elements of control. Consolidation of a subsidiary begins when the Group obtains control over the subsidiary and ceases when the Group loses control of the subsidiary. Assets, liabilities, income and expenses of a subsidiary acquired or disposed of during the year are included in the statement of comprehensive income from the date the Group gains control until the date the Group ceases to control the subsidiary.
Profit or loss and each component of other comprehensive income (OCI) are attributed to the equity holders of the parent of the Group and to the non-controlling interests, even if this results in the non-controlling interests having a deficit balance. When necessary, adjustments are made to the financial statements of subsidiaries to bring their accounting policies into line with the Group’s accounting policies. All intra-group assets and liabilities, equity, income, expenses and cash flows relating to transactions between members of the Group are eliminated in full on consolidation.
A change in the ownership interest of a subsidiary, without a loss of control, is accounted for as an equity transaction. If the Group loses control over a subsidiary, it:
-
De-recognises the assets (including goodwill) and liabilities of the subsidiary
-
De-recognises the carrying amount of any non-controlling interests
-
De-recognises the cumulative translation differences recorded in equity
-
Recognises the fair value of the consideration received
-
Recognises the fair value of any investment retained
-
Recognises any surplus or deficit in profit or loss
-
Reclassifies the parent’s share of components previously recognised in OCI to profit or loss or retained earnings, as appropriate, as would be required if the Group had directly disposed of the related assets or liabilities.
C. Foreign currency
The Group’s consolidated financial statements are presented in Australian dollars, which is also the Parent’s functional currency. The Group determines the functional currency for each entity and items included in the financial statements of each entity are measured using that functional currency. The functional currency for the US subsidiaries is US dollars. The Group uses the direct method of consolidation and has elected to recycle the gain or loss that arises from using this method.
On consolidation, the assets and liabilities of foreign operations are translated into Australian dollars at the rate of exchange prevailing at the reporting date and their income statements are translated at exchange rates prevailing at the dates of the transactions. The exchange differences arising on translation for consolidation are recognised in Other Comprehensive Income. On disposal of a foreign operation, the component of other comprehensive income relating to that particular foreign operation is reclassified to profit or loss as part of the gain or loss on sale.
Transactions in foreign currencies are initially recorded by the Group’s entities at their respective functional currency spot rates at the date the transaction first qualifies for recognition.
Monetary assets and liabilities denominated in foreign currencies are translated at the functional currency spot rates of exchange at the reporting date.
42 Mayne Pharma Annual Report 2016
Differences arising on settlement or translation of monetary items are recognised in profit or loss with the exception of monetary items that are designated as part of the hedge of the Group’s net investment of a foreign operation. These are recognised in other comprehensive income until the net investment is disposed of, at which time, the cumulative amount is reclassified to profit or loss. Tax charges and credits attributable to exchange differences on those monetary items are also recorded in other comprehensive income.
In substance, the Group’s net investment in a foreign operation includes loans advanced by the parent entity to the foreign operation where settlement of which is neither planned nor likely to occur within the foreseeable future. Exchange differences arising on such monetary items that form part of a reporting entity’s net investment in a foreign operation are recognised in profit or loss in the separate financial statements of the reporting entity. In the Group’s financial statements which include the foreign operation and the reporting entity, such exchange differences are recognised initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the net investment.
Non-monetary items that are measured in terms of historical cost in a foreign currency are translated using the exchange rates at the dates of the initial transactions. Non-monetary items measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value is determined. The gain or loss arising on translation of non-monetary items measured at fair value is treated in line with the recognition of gain or loss on change in fair value of the item (i.e., translation differences on items whose fair value gain or loss is recognised in other comprehensive income or profit or loss are also recognised in other comprehensive income or profit or loss, respectively).
Any goodwill arising on the acquisition of a foreign operation and any fair value adjustments to the carrying amounts of assets and liabilities arising on the acquisition are treated as assets and liabilities of the foreign operation and translated at the spot rate of exchange at the reporting date.
D. Other accounting policies
Significant accounting policies that outline the measurement basis used and are relevant to the understanding of the financial statements are provided throughout the notes to the financial statements.
E. Key judgements and estimates
The preparation of the financial statements requires Management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates these judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases these judgements and estimates on historical experience and on other various factors it believes to be reasonable under the circumstances, the result of which form the basis of the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions. Material judgements and estimates are found in the following notes:
-
Note 7 - Income tax
-
Note 15 - Intangible assets
-
Note 16 - Trade and Other Payables
-
Note 18 - Other Financial Liabilities
-
Note 19 - Provisions
-
Note 27 - Share-Based Payments
F. Significant changes in the current reporting period
There were no changes in accounting policy during the year ended 30 June 2016, nor did the introduction of new accounting standards lead to any change in measurement or disclosure in these financial statements. See note 35 for details on new accounting standards introduced this financial year.
G. Reclassification of comparatives
Where required, items in the 2015 comparative period have been reclassified to reflect the current presentation and enable better comparison between periods.
NOTE 2 – OPERATING SEGMENTS
An operating segment is a component of the Group:
-
that engages in business activities from which it may earn revenues and incur expenses (including revenues and expenses relating to transactions with other components of the Group);
-
whose operating results are regularly reviewed by the Group’s chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance; and
-
for which discrete financial information is available.
Operating segments that meet the quantitative criteria as prescribed by AASB 8 are reported separately. However, an operating segment that does not meet the quantitative criteria is still reported separately where information about the segment would be useful to users of the financial statements.
The Consolidated Entity has identified its operating segments based on the internal reports that are reviewed and used by the CEO (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 (GPD), Specialty Brands (SBD), Metrics Contract Services (MCS), and Mayne Pharma International (MPI). In the prior comparable period, the Consolidated Entity reported three operating segments being GPD (formerly called US Products), MCS and MPI. Following the acquisition of the Doryx assets in February 2015, the
Mayne Pharma Annual Report 2016 43
Company separated the US Products segment into GPD which markets and distributes generic products and SBD which markets and distributes specialty branded products. The June 2015 comparative information has been restated, including re-allocations between segments, to reflect the new operating segments structure.
GPD
GPD’s revenue and gross profit are derived from the manufacturing and distribution of generic and branded pharmaceutical products in the United States.
MCS
MCS’ revenue and gross profit are derived from providing contract pharmaceutical development services to third-party customers principally in the United States.
SBD
SBD’s revenues and gross profit are derived principally from the distribution of branded pharmaceutical products in the US.
MPI
MPI’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 $’000 METRICS CONTRACT SERVICES $’000 SPECIALTY BRANDS $’000 MPI $’000 |
TOTAL | |
|---|---|---|
| CONSOLIDATED | ||
| $’000 | ||
| Year ended 30 June 2016 Sale of goods Services income License fee revenue 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 Profit or Loss and Other Comprehensive Income) Profit before income tax Income tax expense Net Profit for the period |
106,824 - 77,835 21,970 - 48,886 - 10,284 - - - 391 - - - 1,090 |
|
206,629 |
||
59,170 |
||
391 |
||
1,090 |
||
| 106,824 48,886 77,835 33,735 (46,048) (22,492) (4,436) (25,938) |
267,280 |
|
(98,914) |
||
| 60,776 26,394 73,399 7,797 |
168,366 |
|
| 7,491 | ||
| (16,335) | ||
| 4,086 | ||
| (113,771) | ||
| 49,837 | ||
| (15,314) | ||
| 34,523 |
The combined revenue from the largest customer from each segment was $71,418,000 for the year ended 30 June 2016. Revenue from two individual customers was 23% and 15% of the Group’s total revenue. Both customers trade with both the GPD and SBD segments.
| GENERIC PRODUCTS $’000 METRICS CONTRACT SERVICES $’000 SPECIALTY BRANDS $’000 MPI $’000 |
TOTAL | |
|---|---|---|
| CONSOLIDATED | ||
| $’000 | ||
| Year ended 30 June 2015 Sale of goods Services income License fee revenue 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 Profit or Loss and Other Comprehensive Income) Profit before income tax Income tax expense Net Profit for the period |
58,199 - 17,601 20,516 - 33,793 - 9,721 - - - 494 - - - 1,096 |
|
96,316 |
||
43,514 |
||
494 |
||
1,096 |
||
| 58,199 33,793 17,601 31,827 (19,676) (16,760) (467) (24,530) |
141,420 |
|
(61,433) |
||
| 38,523 17,033 17,134 7,297 |
79,987 |
|
| 6,920 | ||
| (8,527) | ||
| (3,023) | ||
| (64,114) | ||
| 11,243 | ||
| (3,706) | ||
| 7,537 |
44 Mayne Pharma Annual Report 2016
Geographical information
| Geographical information | |
|---|---|
| Revenue from external customers | 2016 $’000 2015 $’000 |
| Australia United States Korea Europe Other Total external revenue Non-current assets |
26,021 23,369 233,654 109,632 2,465 4,014 2,319 1,837 2,821 2,568 |
| 267,280 141,420 |
|
| 2016 $’000 2015 $’000 |
|
| Australia United States Total non-current assets |
111,736 111,671 305,196 250,886 |
| 416,932 362,557 |
Non-current assets for this purpose consist of property, plant and equipment and intangible assets.
Product information
| Revenue by product group/service | 2016 $’000 2015 $’000 |
|---|---|
| Contract services Analytical & formulation Oral & other pharmaceuticals Other revenue Total external revenue |
10,284 9,721 48,886 33,793 207,020 96,810 1,090 1,096 |
| 267,280 141,420 |
Revenue recognition and measurement
Sale of goods
Revenue is recognised when the significant risks and rewards of ownership of the goods have passed to the buyer and the costs incurred or to be incurred in respect of the transaction can be measured reliably. Risks and rewards of ownership are considered passed to the buyer at the time of delivery of the goods to the customer or wholesalers.
US distribution sales are typically subject to agreement with customers allowing for chargebacks, rebates, rights of returns and other pricing adjustments. These amounts are recorded as reductions to revenue and accounts receivable and as such revenue is recognised on a net basis. The distribution receivables are included in trade receivables. Chargebacks and rebates for pharmaceutical products sold by the Group to its wholesalers but estimated to be unsold by the wholesalers at year end are recorded as accrued chargebacks and rebates. The Group may incur chargebacks and rebates that differ from the original estimate.
US Doryx sales are subject to customer loyalty programs, wholesaler fees, rebates, rights of returns and other pricing adjustments. These amounts are recorded as reductions to revenue and as such revenue is recognised on a net basis. Accruals for customer loyalty programs, rebates and returns are made based on historical trends. The Group may incur charges that differ from the original estimate.
Profit-sharing revenue represents the Group’s share of the net profit from the sale of generic pharmaceutical products based on agreements with distribution partners. Amounts are based on calculated profits net of cost of goods sold, distribution expenses, chargebacks, returns and related accruals as reported by the distribution partners. Product return allowances are calculated for products that may be returned due to expiration dates or recalls. The Group and its distribution partners do not expect any significant product returns that are not adequately covered by the reserve amounts calculated and recorded by the distribution partners.
Services revenue
Services revenue relates to manufacturing and analysis for third parties. Revenue is recognised when the work is completed and the work is billed or billable to the client.
Royalties revenue
Royalties arising from the manufacturing rights are recognised when earned in accordance with the substance of the agreement.
Research and development income
Research and development income is recognised when its recoverability can be regarded as assured when the specific milestones of the projects are met.
License fee revenue
Some of the Group’s revenues are generated on the basis of licensing agreements under which third parties have been granted rights to products and technologies. Consideration received, or expected to be received, that relates to the sale or out licensing of technologies or technological expertise is recognised in profit or loss as of the effective date of the agreement if all rights relating to the technologies and all obligations resulting from them have been relinquished under the contract terms. However, if rights to the technologies continue to exist or obligations resulting from them have yet to be fulfilled, the consideration received is deferred accordingly. Any consideration deferred is recorded as other liabilities and recognised in profit or loss over the estimated performance period stipulated in the agreement.
Mayne Pharma Annual Report 2016 45
NOTE 3 – FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES
The Group’s principal financial instruments comprise cash, short-term deposits, receivables, payables and bank loans.
The Group manages its exposure to key financial risks, including credit risk, interest rate risk, currency risk and liquidity risk in accordance with the Group’s financial risk management framework. The objective of the framework is to support the delivery of the Group’s financial targets whilst protecting future financial security.
The main risks arising from the Group’s financial instruments are interest rate risk, foreign currency risk and liquidity risk. The Group uses different methods to measure and manage different types of risks to which it is exposed. These include monitoring levels of exposure to interest rate and foreign exchange risk and assessments of market forecasts for interest rate and foreign exchange rates. Liquidity risk is monitored through the development of future rolling cash flow forecasts.
Primary responsibility for identification and control of financial risks rests with the Board. The Board reviews and agrees policies for managing each of the risks identified below.
Risk exposures and responses
Interest rate risk
The Group’s main interest rate risk arises from long term borrowings. Borrowings issued at variable rates expose the Group to cash flow interest rate risk. During the year the Group’s borrowings at variable rates were denoted in US dollars. At reporting date, approximately 41% of the Group’s borrowings were swapped to fixed interest.
As at the end of the reporting period, the Group had the following variable rate borrowings outstanding:
==> picture [490 x 85] intentionally omitted <==
----- Start of picture text -----
||||
|---|---|---|
|2016|2015|
|$’000|$’000|
|Interest bearing loans and borrowings|76,999|61,756|
|The variable interest rate risk on borrowings is partially off-set by the variable interest rate risk of cash at bank and on hand.|
|2016|2015|
|$’000|$’000|
|Cash at bank and in hand|47,481|59,201|
----- End of picture text -----
The following sensitivity analysis is based on the interest rate risk exposures in existence at reporting date. At reporting date, if interest rates had moved, as illustrated in the table below, with all other variables held constant, net profit and equity would have been affected as follows:
==> picture [490 x 66] intentionally omitted <==
----- Start of picture text -----
||||||
|---|---|---|---|---|
|NET PROFIT/(LOSS)|EQUITY|
|HIGHER/(LOWER)|HIGHER/(LOWER)|
|2016|2015|2016|2015|
|$’000|$’000|$’000|$’000|
|US interest rates +0.5% (50 basis points)|(158)|(161)|-|-|
|AUD interest rates +0.5% (50 basis points)|47|166|-|-|
----- End of picture text -----
The movements are due to higher/lower interest expense on borrowings less lower/higher interest revenue from cash balances. Possible movements in interest rates were determined based on the current observable market environment.
Foreign currency risk
The Group has significant transactional currency exposures arising from sales and purchases in currencies other than the functional currency. Approximately 89% of the Group’s revenues and 70% of the Group’s costs are denominated in currencies other than the functional currency.
It is the Group’s general policy to enter into simple Forward Exchange Contracts or Participating Forward Exchange Contracts over a set percentage of the forecast net receipts of US dollars. The percentages used vary depending on the length of the forecast period (0-3 months and 4-6 months). The Group has not applied the hedge accounting rules and no mark-to-market valuation for the contracts has been recognised in the Statement of Profit or Loss and Other Comprehensive Income at 30 June 2016 (2015: $nil).
The Company enters into FX contracts to manage the FX exposure of the Australian parent company relating to loans advanced to US subsidiaries denoted in USD. No FX contracts were outstanding at reporting date relating to intra-group loans.
The Group also holds assets and liabilities in US dollars (USD), British pounds (GBP), Japanese yen (JPY), Canadian dollars (CAD) and Euro (EUR). The existence of both assets and liabilities denominated in USD provides a limited natural hedge against adverse currency movements for USD denoted exposures.
Prior to year-end and in preparation to settle the purchase price for the Teva / Allergan assets, the Company entered into forward exchange contracts to exchange AUD860m for USD639.9m (average exchange rate 0.7441).
46 Mayne Pharma Annual Report 2016
At balance date the Group’s only significant foreign exchange exposure was to US dollar monetary assets and US dollar monetary liabilities:
| A$’000 30 JUNE 2016 A$’000 30 JUNE 2015 |
|
|---|---|
| Cash at bank Other financial assets Intra Group receivables Trade and other payables Other financial liabilities Interest-bearing borrowings Net exposure |
13,602 208 2,918 1,267 121,707 61,088 (673) (983) (1,343) (2,496) (76,163) (61,744) |
| 60,049 (2,452) |
The following table demonstrates the sensitivity to a reasonably possible change in the USD exchange rate, with all other variables held constant. The impact on the Group’s profit before tax is due to changes in the fair value of monetary assets and liabilities including nondesignated foreign currency derivatives and embedded derivatives. The pre-tax impact on the Group’s equity is due to changes in the fair value of forward exchange contracts designated as cash flow hedges and net investment hedges. The Group’s exposure to foreign currency changes for all other currencies is not material.
| NET PROFIT/(LOSS) EQUITY |
|
|---|---|
| HIGHER/(LOWER) HIGHER/(LOWER) |
|
| 2016 $’000 2015 $’000 2016 $’000 2015 $’000 |
|
| AUD/USD +5% AUD/USD -5% |
(4,903) (2,130) - - 5,467 2,354 - - |
The movements are due to foreign currency gains or losses as a result of changes in the balances of cash, borrowings, and the net of receivables and payables.
Credit risk
Credit risk arises from the financial assets of the Group, which comprise cash and cash equivalents and trade and other receivables. The Group’s exposure to credit risk arises from potential default of the counter party, with a maximum exposure equal to the carrying amount of the financial assets.
The Group does not hold any credit derivatives to offset its credit exposure. The Group trades only with recognised, creditworthy third parties, and as such collateral is not requested nor is it the Group’s policy to securitise its trade and other receivables.
Management of credit risk
It is the Group’s policy that all customers who wish to trade on credit terms are subject to credit verification procedures including an assessment of their independent credit rating, financial position, past experience and industry reputation.
Approximately 50% of the Group’s 2016 revenue was derived from the three largest customers which is not unusual for operations in the US pharmaceutical market where the majority of both branded and generic sales are made to a small number of key wholesale and retail organisations. The Group had three customers who comprised approximately 72% of the total trade receivables balance at reporting date. All of these customers were operating within agreed trading terms at the end of the 2016 period.
The Group believes that there is no credit risk on the above key customer concentration as there has never been any default on their obligations and they are major US pharmaceutical wholesale/retail organisations.
The collectability of debts is assessed on an ongoing basis. A provision for impairment loss is raised when there is objective evidence that the Group will not be able to collect the debt. Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial reorganisation, and default or delinquency in payments are considered indicators that the trade receivable is impaired. Bad debts are written off when identified. Receivables are monitored on an ongoing basis and the incidence of bad debt write off has been extremely low.
Financial assets included on the Consolidated Statement of Financial Position that potentially subject the Group to concentration of credit risk consist principally of cash and cash equivalents and trade receivables. The Group minimises this concentration of risk by placing its cash and cash equivalents with financial institutions that maintain superior independent credit ratings in order to limit the degree of credit exposure. The maximum exposures to credit risk as at 30 June 2016 in relation to each class of recognised financial assets is the carrying amount of those assets, as indicated in the Consolidated Statement of Financial Position.
Credit quality of financial assets:
| 2016 $’000 2015 $’000 |
|
|---|---|
| Cash and cash equivalents 1 Trade and other receivables 2 Notes: 1. Minimum of S&P AA rated counterparty with which deposits are held 2. At period end 2016 trade receivables were $123,164,000, with 96% of trade receivables within trading terms. |
47,481 59,201 123,716 64,657 |
| 171,197 123,858 |
|
Mayne Pharma Annual Report 2016 47
Liquidity risk
Liquidity risk arises from the financial liabilities of the Group and the Group’s subsequent ability to meet its obligations to repay its financial liabilities as and when they fall due.
The Group’s objective is to maintain a balance between continuity of funding and flexibility through the use of bank loans and cash and short-term deposits sufficient to meet the Group’s current cash requirements.
The Board manages liquidity risk by monitoring, on a monthly basis, the total cash inflows and outflows expected forecast on a rolling 18month basis.
The following table discloses the remaining contractual maturities for the Group’s financial assets and liabilities based on undiscounted cash flows. The timing of cash flows for liabilities is based on the contractual terms of the underlying contract.
| LESS THAN 6 MONTHS $’000 6 TO 12 MONTHS $’000 1 TO 5 YEARS $’000 GREATER THAN 5 YEARS $’000 TOTAL $’000 |
|
|---|---|
| 30 June 2016 Liquid financial assets Cash and cash equivalents Trade and other receivables Financial liabilities Trade and other payables Settlement obligation in relation to the Teva transaction 1 Interest-bearing loans and borrowings Other financial liabilities Net inflow/(outflow) Note: 1. The Teva transaction was settled on 3 August 2016 using f |
47,481 - - - 47,481 123,716 - - - 123,716 |
| 171,197 - - - 171,197 |
|
| (144,409) - - - (144,409) (876,144) - - - (876,144) - - (76,834) - (76,834) (6,436) (6,837) (7,306) - (20,579) |
|
| (1,026,989) (6,837) (84,140) - (1,117,966) |
|
| (855,792) (6,837) (84,140) - (946,769) |
|
| unds from the share issue (A$865m) completed in July 2016 as well as additional borrowings. Less THAN 6 MONTHS $’000 6 TO 12 MONTHS $’000 1 TO 5 YEARS $’000 GREATER THAN 5 YEARS $’000 TOTAL $’000 |
|
| 30 June 2015 Liquid financial assets Cash and cash equivalents Trade and other receivables Financial liabilities Trade and other payables Interest-bearing loans and borrowings Other financial liabilities Net inflow/(outflow) |
59,201 - - - 59,201 64,657 - - - 64,657 |
| 123,858 - - - 123,858 |
|
| (59,980) - - - (59,980) - - (61,774) - (61,774) (13,861) (12,966) (8,473) - (35,300) |
|
| (73,841) (12,966) (70,247) - (157,054) |
|
| 50,017 (12,966) (70,247) - (33,196) |
The Group has undrawn loan facilities of US$67.7m plus the undrawn working capital facility of A$10m available at reporting date. Refer note 17.
NOTE 4 – OTHER INCOME
| NOTE 4 – OTHER INCOME | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Interest received Rental from excess office space Gain on restatement of HPPI investment and warrants Net gain on foreign exchange Other |
461 355 185 174 470 3,951 4,462 2,257 1,913 183 |
| 7,491 6,920 |
Interest revenue
Revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest revenue over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.
48 Mayne Pharma Annual Report 2016
Lease revenue
Rental income arising from the operating lease on the building at Salisbury is accounted for on a straight-line basis over the lease term and included in other income due to its operating nature.
NOTE 5 – FAIR VALUE MEASUREMENT
Fair value measurement
The Group measures financial instruments, such as, derivatives, and non-financial assets, at fair value at each reporting date.
Fair value is the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. The fair value measurement is based on the presumption that the transaction to sell the asset or transfer the liability takes place either:
-
in the principal market for the asset or liability, or
-
in the absence of a principal market, in the most advantageous market for the asset or liability.
The principal or the most advantageous market must be accessible by the Group. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest.
A fair value measurement of a non-financial asset takes into account a market participant's ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use.
The Group uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximising the use of relevant observable inputs and minimising the use of unobservable inputs.
All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorised within the fair value hierarchy, described as follows, based on the lowest level input that is significant to the fair value measurement as a whole:
-
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
For assets and liabilities that are recognised in the financial statements on a recurring basis, the Group determines whether transfers have occurred between levels in the hierarchy by re-assessing categorisation (based on the lowest level input that is significant to the fair value measurement as a whole) at the end of each reporting period.
The Group determines the policies and procedures for fair value measurement.
External valuers are involved for valuation of significant assets and significant liabilities, such as contingent consideration. Involvement of external valuers is decided upon annually. Selection criteria include market knowledge, reputation, independence and whether professional standards are maintained.
At each reporting date, the Group analyses the movements in the values of assets and liabilities which are required to be re-measured or re-assessed as per the Group’s accounting policies. For this analysis, the Group verifies the significant inputs applied in the latest valuation by agreeing the information in the valuation computation to contracts and other relevant documents.
The Group also compares each of the changes in the fair value of each asset and liability with relevant external sources to determine whether the change is reasonable.
The Group’s external valuers provide the valuation results. The results and underlying assumptions are discussed with the Audit & Risk Committee and/or the Group’s independent auditors.
For the purpose of fair value disclosures, the Group has determined classes of assets and liabilities on the basis of the nature, characteristics and risks of the asset or liability and the level of the fair value hierarchy as explained above.
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.
Mayne Pharma Annual Report 2016 49
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||||||
|---|---|---|---|---|
|CARRYING AMOUNT|FAIR VALUE|
|2016|2015|2016|2015|
|$’000|$’000|$’000|$’000|
|Assets|
|Warrants (options) - HPPI|2,918|1,267|2,918|1,267|
|Liabilities|
|Earn-out liability - Hospira|-|6,500|-|6,500|
|Earn-out liability - Libertas’ former shareholder|1,343|2,402|1,343|2,402|
|Earn-out liability - Oxycodone|5,230|9,479|5,230|9,479|
|Earn-out liability - various other products/distribution rights|8,826|4,131|8,826|4,131|
|Mark to market valuation - interest rate swap contracts|864|-|864|-|
|Interest bearing syndicated loan|76,163|60,776|76,999|61,774|
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Cash and short-term deposits approximate their carrying amounts largely due to the short-term maturities of these instruments.
Warrants represent options to purchase shares in HPPI. A summary of the number of warrants and exercise prices are included in note 11. The warrants have been recognised at fair value using the Black-Scholes method. A key input in determining the fair value of the warrants is share price volatility. The share price volatility used in the valuation was 62% and was based on the Nasdaq Bio-tech index over 5 years. A change in the share price volatility to 72% would increase the warrants value by approximately 13% in US dollar terms.
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 DCF method using the discount rate 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
Assets and liabilities measured at fair value
As at 30 June 2016, the Group held the following financial instruments carried at fair value in the Statement of Financial Position:
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||||||
|---|---|---|---|---|
|LEVEL 2|LEVEL 3|
|2016|2015|2016|2015|
|$’000|$’000|$’000|$’000|
|Financial Assets|
|Warrants (options)|-|-|2,918|1,267|
|Financial Liabilities|
|Earn-out liability – Hospira|-|-|-|6,500|
|Earn-out liability – Libertas’ former shareholder|-|-|1,343|2,402|
|Earn-out liability – Oxycodone|-|-|5,230|9,479|
|Earn-out liabilities – various other products / distribution rights|-|-|8,826|4,131|
|Deferred consideration – Methamphetamine ANDA and distribution|
|rights|-|-|-|9,142|
|Mark to market valuation - interest rate swap contracts|864|-|
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Reconciliation of fair value measurements of Level 3 financial instruments
The Group carries earn-out liabilities classified as Level 3 within the fair value hierarchy.
A reconciliation of the beginning and closing balances including movements is summarised below:
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||||||
|---|---|---|---|---|
|2016|2015|2016|2015|
|$’000|$’000|$’000|$’000|
|WARRANTS|WARRANTS|EARN-OUTS|EARN-OUTS|
|Opening balance|1,267|392|31,654|11,259|
|Additions recognised for acquisitions made during current year|1,181|966|5,292|27,053|
|Fair value movement (refer Note 5)|470|(91)|(4,086)|3,023|
|Amounts settled|-|-|(18,089)|(13,076)|
|Restatement of foreign currency balances|-|-|629|3,395|
|Closing Balance|2,918|1,267|15,400|31,654|
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50 Mayne Pharma Annual Report 2016
NOTE 6 – EXPENSES
| NOTE 6 – EXPENSES | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Finance costs Interest expense – loan Unused line fees Amortisation of borrowing costs Interest expense – finance leases Write-off of unamortised borrowing costs related to borrowing facilities repaid during the period Depreciation 1 Employee benefits expense 2 Wages and salaries Superannuation expense Other employee benefits expense Share-based payments (refer note 27) Total employee benefits Administration and other expenses Settlement costs relating to a distributor dispute Department of Justice legal costs Acquisition costs Set-up costs re Teva/Allergan products acquisition Establishment costs for Speciality Brands Division Amortisation of intangible assets Movement in undiscounted fair value of earn-out liabilities 3 Change in fair value attributable to the unwinding of the discounting of the earn-out liabilities 4 |
1,504 3,936 725 - 209 411 56 - - 1,598 |
| 2,494 5,945 |
|
| 5,042 4,975 |
|
| 64,135 46,015 3,080 2,564 9,065 6,528 5,109 1,822 |
|
| 81,389 56,929 |
|
| 6,668 - 1,255 - 3,382 658 3,442 - - 4,510 16,335 8,527 (5,202) 2,235 1,116 788 |
Notes:
-
Depreciation expense is included in R&D expenses and cost of sales.
-
Employee benefit expense is included in various expense categories and cost of sales.
-
The movement in the undiscounted fair value of earn-out liabilities of $5,202,000 is a non-cash (credit)/charge relating to re-assessment of the underlying assumptions for the Hospira and Methamphetamine earn-out liabilities.
-
The non-cash unwinding of the discount relates to all earn-out liabilities
Acquisition costs
In the current financial period acquisition costs relating to the Teva/Allergan transaction of $3,382,000 were expensed.
In the prior period $658,000 of acquisition costs relating to the US Doryx™ and HPPI acquisitions were expensed.
NOTE 7 – INCOME TAX
A. The major components of income tax expense are:
| 2016 $‘000 2015 $‘000 |
|
|---|---|
| Income tax expense Current income tax Adjustment in respect of current income tax of previous years Deferred income tax Income tax expense in the consolidated statement of profit or loss and other comprehensive income Deferred income tax benefit/(expense) included in income tax expense comprises Increase in deferred tax assets (Increase) in deferred tax liabilities |
(33,359) (7,130) 232 235 17,813 3,189 |
| (15,314) (3,706) |
|
| 25,684 6,358 (7,871) (3,169) |
|
| 17,813 3,189 |
Mayne Pharma Annual Report 2016 51
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
| 2016 $‘000 2015 $’000 |
|
|---|---|
| The prima facie tax on operating profit differs from the income tax provided in the accounts as follows: Profit/(loss) before income tax Prima facie tax benefit/(expense) at 30% Effect of R&D concessions Over/(under) provision in respect of prior years Recognition of DTA for share-based payments Non-deductible expenses for tax purposes Share-based payments Acquisition costs Adjustments relating to earn-out liabilities Share of associate loss Amortisation intangibles Other non-deductible expenses Non assessable income Tax loss not recognised Restatement of deferred tax balances due to change in US tax rate Effect of higher tax rate in USA US State taxes US Domestic production activity deduction Income tax expense |
49,837 11,243 |
| (14,952) (3,373) 803 401 232 (141) - 377 (546) (51) (44) (176) 957 (121) - (297) (2,217) (861) (172) (64) 141 312 (1,511) (113) - 39 449 477 275 (138) 1,271 23 |
|
| (15,314) (3,706) |
C. Recognised deferred tax assets and liabilities
| C. Recognised deferred tax assets and liabilities |
|
|---|---|
| 2016 $‘000 2015 $‘000 |
|
| Deferred tax assets Intangible assets Provisions Other Payables Inventory Employee share options Equity raising costs US state taxes Earn-out liability Other |
1,883 2,023 2,542 2,138 18,944 5,344 14,497 3,466 7,296 1,952 1,145 1,699 2,789 731 496 766 55 1 |
| 45,222 13,958 |
|
| 49,647 18,119 |
|
| 2016 $‘000 2015 $‘000 |
|
| Reconciliation to the Statement of Financial Position Total Deferred Tax Assets Set off of Deferred Tax Liabilities that are expected to reverse in the same period Net Deferred Tax Assets 1 |
49,647 18,119 (17,848) (8,550) |
| 31,799 9,569 |
Note: 1. Represent Australian and US Deferred Tax Assets that cannot be offset.
52 Mayne Pharma Annual Report 2016
| INTANGIBILE ASSETS $’000 PROVISIONS $’000 |
OTHER $’000 TOTAL $’000 |
|
|---|---|---|
| Deferred tax asset movements Balance at 1 July 2014 Credit/(charge) to profit/loss Credit direct to equity Restatement of foreign currency balances Balance at 30 June 2015 Credit/(charge) to profit/loss Credit direct to equity Restatement of foreign currency balances Balance at 30 June 2016 |
2,164 2,096 (141) (183) - - - 225 |
4,011 8,271 6,682 6,358 2,635 2,635 630 855 |
| 2,023 2,138 (140) 371 - - - 33 |
13,958 18,119 25,453 25,684 5,943 5,943 (132) (99) |
|
| 1,883 2,542 |
45,222 49,647 |
|
| 2016 $‘000 2015 ‘000 |
||
| Deferred tax liabilities Property, plant and equipment Intangible assets Other Unrealised foreign exchange gains US State taxes Other Reconciliation to the Statement of Financial Position Total Deferred Tax Liabilities Set off of Deferred Tax Assets that are expected to reverse in the same period Net Deferred Tax Liabilities 1 |
4,468 4,680 46,805 40,340 663 601 5,286 4,171 2,266 111 |
|
| 8,215 4,883 |
||
| 59,488 49,903 |
||
| 59,488 49,903 (17,848) (8,550) |
||
| 41,640 41,353 |
| PROPERTY PLANT EQUIPMENT $’000 INTANGIBLE ASSETS $’000 OTHER $’000 TOTAL $’000 |
|
|---|---|
| Deferred tax liability movements Balance at 1 July 2014 Charge to profit/loss Restatement of foreign currency balances Acquisition of subsidiary Balance at 30 June 2015 Charge/(credit) to profit/loss Restatement of foreign currency balances Balance at 30 June 2016 |
4,309 22,252 2,170 28,731 (103) 1,138 2,133 3,169 474 5,123 580 6,177 - 11,827 - 11,827 |
| 4,680 40,340 4,883 49,903 (283) 4,977 3,177 7,871 71 1,488 155 1,714 |
|
| 4,468 46,805 8,215 59,488 |
Note: 1. Represent US Deferred Tax Liabilities that cannot be offset.
Deferred tax assets and deferred tax liabilities are presented based on their respective tax jurisdictions.
Income tax and other taxes
Current tax assets and liabilities for the current and prior periods are measured at the amount expected to be recovered from or paid to the taxation authorities based on the current period’s taxable income. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted by the reporting date.
Deferred income tax is provided on all temporary differences at the reporting date between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.
Deferred income tax assets are recognised for all deductible temporary differences, carry-forward of unused tax credits and unused tax losses, to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and the carry-forward of unused tax credits and unused tax losses can be utilised.
The carrying amount of deferred income tax assets is reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available to allow all or part of the deferred income tax asset to be utilised.
Unrecognised deferred income tax assets are reassessed at each reporting date and are recognised to the extent that it has become probable that future taxable profit will allow the deferred tax asset to be recovered.
Deferred income tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realised or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted at the reporting date.
Income taxes relating to items recognised directly in equity are recognised in equity and not in profit or loss.
Mayne Pharma Annual Report 2016 53
Deferred tax assets and deferred tax liabilities are offset only if a legally enforceable right exists to set off current tax assets against current tax liabilities and the deferred tax assets and liabilities relate to the same taxable entity and the same taxation authority.
Mayne Pharma Group Limited and its wholly-owned Australian controlled entities have implemented the tax consolidation legislation. As a consequence, these entities are taxed as a single entity and the deferred tax assets and liabilities of these entities are set off in the consolidated financial statements.
Tax consolidation legislation
Mayne Pharma Group Limited and its wholly-owned Australian controlled entities are part of an income tax consolidated group.
The head entity, Mayne Pharma Group Limited, and the controlled entities in the income tax consolidated group continue to account for their own current and deferred tax amounts. The Group has applied the “separate taxpayer within group” approach in determining the appropriate amount of current taxes and deferred taxes to allocate to the members of the income tax consolidated group.
In addition to its own current and deferred tax amounts, Mayne Pharma Group Limited also recognises the current tax liabilities (or assets) and the deferred tax assets arising from unused tax losses and unused tax credits assumed from controlled entities in the income tax consolidated group.
Each company in the Group contributes to the income tax payable by the Group in proportion to their contribution to the Group’s taxable income.
Assets or liabilities arising under the tax funding agreement with the income tax consolidated entities are recognised as amounts receivable from or payable to other entities in the Group.
Any difference between the amounts assumed and amounts receivable or payable under the tax funding agreement are recognised as a contribution to (or distribution from) wholly-owned income tax consolidation entities.
Significant accounting judgements
Deferred tax assets
The Group’s accounting policy for taxation requires Management’s judgement in assessing whether deferred tax assets are recognised in the Consolidated Statement of Financial Position. Deferred tax assets, including those arising from un-recouped tax losses, capital losses and temporary differences, are recognised only where it is considered more likely than not that they will be recovered, which is dependent on the generation of sufficient future taxable profits.
Assumptions about the generation of future taxable profits depend on Management’s estimates of future cash flows. These depend on estimates of future revenues, operating costs, capital expenditure and other capital management transactions. Judgements are also required about the application of income tax legislation. These judgements and assumptions are subject to risk and uncertainty, hence there is a possibility that changes in circumstances will alter expectations, which may impact the amount of other tax losses and temporary differences not yet recognised.
NOTE 8 – EARNINGS PER SHARE
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||||
|---|---|---|
|2016|2015|
|Earnings per share for profit attributable to the ordinary equity holders of the Parent:|
|Basic earnings per share|4.77 cents|1.18 cents|
|Diluted earnings per share|4.62 cents|1.15 cents|
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Basic earnings per share is calculated by dividing the profit for the year attributable to ordinary equity holders of the Parent by the weighted average number of ordinary shares outstanding during the year.
Diluted earnings per share is calculated by dividing the profit for the year attributable to ordinary equity holders of the Parent by the weighted average number of ordinary shares outstanding during the year plus the weighted average number of shares that would be issued on conversion of all the dilutive potential ordinary shares into ordinary shares.
The following reflects the income and share data used in the basic and diluted EPS calculations:
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||||
|---|---|---|
|2016|2015|
|$’000|$’000|
|For basic earnings per share|
|Net profit attributable to equity holders of Mayne Pharma|37,355|7,759|
|For diluted earnings per share|
|Net profit attributable to equity holders of Mayne|
|Pharma|37,355|7,759|
|2016|2015|
|‘000|‘000|
|Weighted average number of ordinary shares for|
|basic earnings/(loss) per share|782,397|655,016|
|Effect of dilution:|
|Share options and LTI shares|26,950|19,465|
|Weighted average number of ordinary shares|
|adjusted for the effect of dilution|809,347|674,887|
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54 Mayne Pharma Annual Report 2016
The calculation of weighted average number of ordinary shares adjusted for the effect of dilution does not include the following options which could potentially dilute basic earnings per share in the future, but were not dilutive in the periods presented:
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||||||
|---|---|---|---|---|
|2016|2015|
|‘000|‘000|
|Number of potential ordinary shares|-|3,200|
|Subsequent to reporting date, the Company issued the following shares to part-fund the Teva acquisition:|
|NUMBER OF SHARES|VALUE|
|PRICE PER SHARE|DATE ISSUED|‘000|$‘000|
|Institutional placement|$1.50|7 July 2016|191,300|286,950|
|Institutional – take-up of shortfalls|$1.50|7 July 2016|2,797|4,195|
|Institutional entitlement offer|$1.28|7 July 2016|227,892|291,701|
|Directors accelerated entitlement offer|$1.28|7 July 2016|40,793|52,215|
|Retail entitlement offer|$1.28|22 July 2016|198,111|253,582|
|660,892|888,643|
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The Teva acquisition is expected to be significantly EPS accretive.
There have been no other subsequent transactions involving ordinary shares or potential ordinary shares that would significantly change the number of ordinary shares or potential ordinary shares outstanding at the end of the reporting period.
NOTE 9 – TRADE AND OTHER RECEIVABLES
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||||
|---|---|---|
|2016|2015|
|$’000|$’000|
|Current|
|Trade receivables|121,494|60,993|
|Trade receivables – profit share|1,670|1,544|
|Provision for impairment|(23)|(22)|
|Other receivables|575|2,143|
|123,716|64,657|
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At 30 June, the ageing analysis of trade receivables is as follows:
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||||||
|---|---|---|---|---|
|NOT PAST DUE NOR|OVERDUE AND NOT|OVERDUE AND NOT|
|IMPAIRED|IMPAIRED 0-30 DAYS|IMPAIRED 30+ DAYS|
|WITHIN TERMS|OVERDUE|OVERDUE|TOTAL|
|$’000|$’000|$’000|$’000|
|Trade receivables 30 June 2016|117,990|1,021|4,130|123,141|
|Trade receivables 30 June 2015|54,135|8,025|355|62,515|
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Trade receivables are non-interest bearing and are generally on 30 to 60-day terms. A provision for impairment loss is raised when there is objective evidence that the Group will not be able to collect the debt. Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial reorganisation, and default or delinquency in payments are considered indicators that the trade receivable is impaired. As at reporting date, $23,000 (2015: $22,000) of receivables were considered to be impaired.
Trade receivables – profit share are due on 90 day terms. None of these receivables are considered to be impaired at reporting date.
Other receivables include amounts outstanding for goods and services tax (GST). These amounts are non-interest bearing and have repayment terms applicable under the relevant government authority. Other balances within trade and other receivables do not contain impaired assets and are not past due. It is expected that these other balances will be received when due.
Due to the short-term nature of these receivables, their carrying value is equal to their fair value.
Trade and other receivables
Trade receivables are recognised initially at fair value and subsequently measured at amortised cost using the effective interest method, less an allowance for any uncollectible amounts.
Collectability of trade receivables is reviewed on an ongoing basis. Debts that are known to be uncollectible are written off when identified. A provision for impairment loss is raised when there is objective evidence that the Group will not be able to collect the debt. Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial reorganisation, and default or delinquency in payments are considered indicators that the trade receivable is impaired.
Mayne Pharma Annual Report 2016 55
NOTE 10 – INVENTORIES
| NOTE 10 – INVENTORIES | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Raw materials and stores at cost Work in progress at cost Finished goods at lower of cost and net realisable value |
11,301 6,512 11,525 2,901 16,117 13,031 |
| 38,943 22,444 |
Recognition and measurement
Inventories
Inventories are valued at the lower of cost and net realisable value. Costs incurred in bringing each product to its present location and conditions are accounted for as follows:
Raw materials – purchase cost on a first-in, first-out basis.
Finished goods and work-in-progress – cost of direct materials and labour and a proportion of manufacturing overheads based on normal operating capacity.
Net realisable value is the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs necessary to make the sale.
NOTE 11 – OTHER FINANCIAL ASSETS
| NOTE 11 – OTHER FINANCIAL ASSETS | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Current Restricted cash Unbilled client service fees Warrants |
377 366 163 596 2,918 1,267 |
| 3,458 2,229 |
Restricted cash represents cash held as security for letters of credit.
The warrants represent options to acquire shares in HPPI as follows:
| The warrants represent options to acquire shares in | HPPI as follows: |
|---|---|
| EXERCISE EXPIRY |
BALANCE AT BEGINNING OF GRANTED DURING EXERCISED DURING THE BALANCE AT END 2016 2015 |
PRICE (US CENTS) DATE |
YEAR THE YEAR YEAR OF YEAR $’000 $’000 |
| Number Number Number Number |
|
| Unlisted options 8.78 24/06/19 |
10,259,569 - - 10,259,569 350 245 |
| Unlisted options 7.50 15/05/20 |
33,333,333 - - 33,333,333 1,481 1,022 |
| Unlisted options 12.00 27/05/21 |
- 28,364,236 - 28,364,236 1,087 - |
| 43,592,902 28,364,236 - 71,957,138 2,918 1,267 |
The warrants have been recognised at fair value using the Black-Scholes method.
Financial Instruments
Initial recognition and subsequent measurement
A financial instrument is any contract that gives rise to a financial asset of one entity and a financial liability or equity instrument of another entity.
Financial assets are classified, at initial recognition, as financial assets at fair value through profit or loss, loans and receivables, held-tomaturity investments, available-for-sale financial assets, or as derivatives designated as hedging instruments in an effective hedge, as appropriate.
All financial assets are recognised initially at fair value plus, in the case of financial assets not recorded at fair value through profit or loss, transaction costs that are attributable to the acquisition of the financial asset.
Financial assets at fair value through profit or loss
Financial assets at fair value through profit or loss include financial assets held for trading and financial assets designated upon initial recognition at fair value through profit or loss. Financial assets are classified as held for trading if they are acquired for the purpose of selling or repurchasing in the near term. Derivatives, including separated embedded derivatives are also classified as held for trading unless they are designated as effective hedging instruments as defined by AASB 139.
The Group holds warrants which are derivatives and are not hedging instruments and hence are held at fair value through profit or loss. Financial assets at fair value through profit or loss are carried in the statement of financial position at fair value with net changes in fair value presented as finance costs (negative net changes in fair value) or finance income (positive net changes in fair value) in the statement of profit or loss.
56 Mayne Pharma Annual Report 2016
Impairment of financial assets
The Group assesses, at each reporting date, whether there is objective evidence that a financial asset or a group of financial assets is impaired. An impairment exists if one or more events that has occurred since the initial recognition of the asset (an incurred ‘loss event’) has an impact on the estimated future cash flows of the financial asset or the group of financial assets that can be reliably estimated.
Forward exchange contracts
The Group uses derivative financial instruments (forward currency contracts) to hedge its risks associated with foreign currency, and interest rate fluctuations. These derivatives do not qualify for hedge accounting and mark to market valuation adjustments are recognised in profit or loss in income or expenses.
NOTE 12 – OTHER ASSETS
| NOTE 12 – OTHER ASSETS | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Current Pre-payments Contract rights relating to the Teva transaction settled post year-end |
11,509 5,333 876,144 - |
| 887,653 5,333 |
On 28 June 2016, the Company announced 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”) for cash consideration of US$652m. As the Company had a contractual obligation at 30 June 2016, the Company has recognised both the rights and obligations under the contract at reporting date.
This asset purchase was completed on 3 August 2016.
The Company funded the acquisition via an extension of its existing debt facility, and a fully underwritten A$601m, 1-for-1.725 accelerated non-renounceable entitlement offer and A$287m placement.
After the completion of the transaction, the assets acquired will be recognised in the appropriate asset categories on the balance sheet with the majority relating to product rights intangible assets.
Mayne Pharma Annual Report 2016 57
NOTE 13 – PROPERTY, PLANT AND EQUIPMENT
==> picture [490 x 391] intentionally omitted <==
----- Start of picture text -----
|||||||
|---|---|---|---|---|---|
|PLANT AND|CAPITAL UNDER|
|LAND|BUILDINGS|EQUIPMENT|CONSTRUCTION|TOTAL|
|$’000|$’000|$’000|$’000|$’000|
|Year ended 30 June 2016|
|Balance at beginning of year net of|
|accumulated depreciation|9,150|26,913|21,559|1,974|59,597|
|Additions|-|596|4,134|24,529|29,259|
|Disposals|-|-|-|-|-|
|Depreciation charge for year|-|(998)|(4,044)|-|(5,042)|
|Foreign currency restatement|133|581|364|(442)|636|
|Balance at end of year net of accumulated|
|depreciation|9,283|27,092|22,013|26,061|84,449|
|At 30 June 2016|
|At cost|9,283|31,462|42,602|26,061|109,408|
|Accumulated depreciation|-|(4,370)|(20,589)|-|(24,959)|
|Net carrying amount|9,283|27,092|22,013|26,061|84,449|
|Year ended 30 June 2015|
|Balance at beginning of year net of|
|accumulated depreciation|8,280|23,758|20,157|1,214|53,409|
|Additions|-|291|3,143|713|4,147|
|Disposals|-|-|(66)|-|(66)|
|Depreciation charge for year|-|(898)|(4,078)|-|(4,976)|
|Foreign currency restatement|870|3,762|2,403|47|7,083|
|Balance at end of year net of accumulated|
|depreciation|9,150|26,913|21,559|1,974|59,597|
|At 30 June 2015|
|At cost|9,150|30,247|37,943|1,974|79,314|
|Accumulated depreciation|-|(3,333)|(16,384)|-|(19,717)|
|Net carrying amount|9,150|26,914|21,559|1,974|59,597|
----- End of picture text -----
Property, plant and equipment
Plant and equipment is stated at historical cost less accumulated depreciation and any accumulated impairment losses. Land and buildings are measured at cost less accumulated depreciation on buildings and less any impairment losses.
Depreciation is calculated on a straight-line basis over the estimated useful life of the assets as follows:
==> picture [204 x 27] intentionally omitted <==
----- Start of picture text -----
|||
|---|---|
|Land|Not depreciated|
|Buildings|Over 40 years|
|Plant and equipment|Between 1.5 and 20 years|
----- End of picture text -----
The assets’ residual values, useful lives and amortisation methods are reviewed, and adjusted if appropriate, at each financial year-end. Gains and losses on disposals are determined by comparing proceeds with the carrying amount. These are included in the Consolidated Statement of Profit or Loss and Other Comprehensive Income.
Significant accounting estimates and assumptions
Estimation of useful lives of assets
The estimation of the useful lives of assets has been based on historical experience as well as manufacturers’ warranties and lease terms. In addition, the condition of the assets is assessed at least once per year and considered against the remaining useful life. Adjustments to useful lives are made when considered necessary.
58 Mayne Pharma Annual Report 2016
NOTE 14 – INVESTMENT IN ASSOCIATE
In the prior year (up to 15 May 2015), the Group held a 41.5% interest in HedgePath Pharmaceuticals Inc (“HPPI”) which is pursuing clinical development, registration and commercialisation of Mayne Pharma’s patented formulation of itraconazole, known as SUBA™-Itraconazole, for treatment of a variety of cancers in the United States. Mayne Pharma acquired this initial interest in HPPI in June 2014. HPPI shares held by certain shareholders may be traded on the OTC market in the US although trading volumes are very limited. The Group’s interest in HPPI was accounted for using the equity method in the consolidated financial statements in the prior year.
The Group gained control of HPPI effective 15 May 2015. The results from operations in the prior period below reflect the period from the beginning of the prior period up to the date control was gained. Results post gaining control are included in the appropriate line items in the Consolidated Statement of Profit or Loss and Other Comprehensive Income.
| the Consolidated Statement of Profit or Loss and Other Comprehensive Income. | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Revenue Expenses Loss before income tax Income tax Net Loss after tax Group’s share of profit/(loss) for the period 41.5% Group’s share of other comprehensive income/(loss) for the period |
- - - (2,384) |
| - (2,384) - - |
|
| - (2,384) |
|
| - (990) |
|
| - 1,528 |
Investment in associates
An associate is an entity over which the Group has significant influence. Significant influence is the power to participate in the financial and operating policy decisions of the investee, but is not control or joint control over those policies. At 30 June 2014, HPPI was considered to be an associate of the Company. As a result of changes which occurred during the prior year, HPPI became a controlled entity effective 15 May 2015 and hence the Group has consolidated HPPI from that date and ceased equity accounting its investment in HPPI.
The considerations made in determining significant influence are similar to those necessary to determine control over subsidiaries.
The Group’s investments in its associate are accounted for using the equity method. Under the equity method, the investment in an associate is initially recognised at cost. The carrying amount of the investment is adjusted to recognise changes in the Group’s share of net assets of the associate since the acquisition date. Goodwill relating to the associate is included in the carrying amount of the investment and is neither amortised nor individually tested for impairment.
The statement of profit or loss and other comprehensive income reflects the Group’s share of the results of operations of the associate. Any change in Other Comprehensive Income of those investees is presented as part of the Group’s Other Comprehensive Income. In addition, when there has been a change recognised directly in the equity of the associate, the Group recognises its share of any changes, when applicable, in the statement of changes in equity. Unrealised gains and losses resulting from transactions between the Group and the associate are eliminated to the extent of the interest in the associate or joint venture. The aggregate of the Group’s share of profit or loss of an associate is shown on the face of the statement of profit or loss outside operating profit and represents profit or loss after tax and non-controlling interests in the subsidiaries of the associate.
The annual financial statements of the associate (HPPI) are prepared on a December year-end basis. The associate prepares quarterly unaudited financial statements which have been utilised by the Group to prepare these financial statements. When necessary, adjustments are made to bring the accounting policies in line with those of the Group.
After application of the equity method, the Group determines whether it is necessary to recognise an impairment loss on its investment in its associate. At each reporting date, the Group determines whether there is objective evidence that the investment in the associate is impaired. If there is such evidence, the Group calculates the amount of impairment as the difference between the recoverable amount of the associate and its carrying value, then recognises the loss as ‘Share of profit of an associate and a joint venture’ in the statement of profit or loss.
Upon loss of significant influence over the associate, the Group measures and recognises any retained investment at its fair value. Any difference between the carrying amount of the associate upon loss of significant influence and the fair value of the retained investment and proceeds from disposal is recognised in profit or loss.
Mayne Pharma Annual Report 2016 59
NOTE 15 – INTANGIBLE ASSETS AND GOODWILL
| GOODWILL CUSTOMER CONTRACTS, CUSTOMER RELATIONSHIPS, PRODUCT RIGHTS AND INTELLECTUAL PROPERTY DEVELOPMENT EXPENDITURE MARKETING & DISTRIBUTION RIGHTS TRADE NAMES OTHER TOTAL $'000 $'000 $'000 $'000 $'000 $'000 $'000 |
|
|---|---|
| Year ended 30 June 2016 Balance at beginning of year net of accumulated amortisation Transfers (1) Additions Amortisation Impairments (2) Foreign currency restatement Balance at end of year net of accumulated amortisation As at 30 June 2016 Cost Accumulated amortisation Accumulated impairments Net carrying amount Year ended 30 June 2015 Balance at beginning of year net of accumulated amortisation Additions Acquisition of subsidiary Amortisation Impairments (2) Foreign currency restatement Balance at end of year net of accumulated amortisation As at 30 June 2014 Cost Accumulated amortisation Accumulated impairments Net carrying amount |
58,436 38,609 51,562 56,646 65,183 32,523 302,960 - 32,523 - - - (32,523) - - 17,886 22,593 1,196 - - 41,675 - (5,500) (1,189) (1,992) (7,654) - (16,335) - - (1,701) - (54) - (1,755) 1,679 1,794 783 1,551 131 - 5,938 |
| 60,115 85,312 72,048 57,402 57,606 - 332,483 |
|
| 60,115 120,725 77,180 59,677 68,855 - 386,552 - (35,413) (2,028) (2,275) (11,195) - (50,911) - - (3,104) - (54) - (3,158) |
|
| 60,115 85,312 72,048 57,402 57,606 - 332,483 |
|
| 47,476 29,450 33,438 27,078 3,673 - 141,115 - 6,824 13,461 25,497 63,775 - 109,557 - - - - - 31,122 31,122 - (4,602) (442) (289) (3,098) (98) (8,529) - - (1,278) - - - (1,278) 10,960 6,937 6,383 4,360 834 1,499 30,973 |
|
| 58,436 38,609 51,562 56,646 65,183 32,523 302,960 |
|
| 58,436 68,226 53,712 56,962 68,711 32,630 338,677 - (29,617) (832) (316) (3,527) (107) (34,399) - - (1,318) - - - (1,318) |
|
| 58,436 38,609 51,562 56,646 65,184 32,523 302,960 |
Notes: 1. Additions relating to HPPI temporarily classified as Other Intangibles for the year ended 30 June 2015 have been reviewed and reclassified to the appropriate category in the current period
- Development expenditure impairments are included in research and development expenses in the Statement of Profit or Loss and Other Comprehensive Income.
Goodwill and intangibles
Goodwill
Goodwill on acquisition is initially measured at cost, being the excess of the cost of the business combination over the acquirer’s interest in the net fair value of the identifiable assets, liabilities and contingent liabilities. Following its initial recognition, goodwill is measured at cost less any accumulated impairment losses. Goodwill is not amortised.
Goodwill is reviewed for impairment at each reporting date, or more frequently if events or changes in circumstances indicate that the carrying value may be impaired. Impairment is determined by assessing the recoverable amount of the cash-generating unit (CGU) to which the goodwill relates. Where the recoverable amount of the cash-generating unit is less than the carrying amount, an impairment loss is recognised.
Where goodwill forms part of a cash-generating unit and part of the operation within that unit is disposed of, the goodwill associated with the operation disposed of is included in the carrying amount of the operation when determining the gain or loss on disposal of the
60 Mayne Pharma Annual Report 2016
operation. Goodwill disposed of in this circumstance is measured on the basis of the relative values of the operation disposed of and the portion of the cash-generating unit retained.
For the purpose of impairment testing, goodwill acquired in a business combination is, from the acquisition date, allocated to each of the Group’s cash-generating units, or groups of cash-generating units, that are expected to benefit from the synergies of the combination, irrespective of whether other assets or liabilities of the Group are assigned to those units or groups of units. Each unit or group of units to which the goodwill is so allocated represents the lowest level within the Group at which the goodwill is monitored for internal management purposes and is not larger than an operating segment in accordance with AASB 8 Operating Segments.
The aggregate carrying amounts of goodwill are allocated to the Group’s cash-generating units as follows:
| 2016 $’000 2015 $’000 |
|
|---|---|
| GPD MCS Closing goodwill balance at 30 June |
39,986 38,869 20,129 19,567 |
| 60,115 58,436 |
Goodwill arising from the acquisition of Metrics, has been allocated between two CGUs operating in the USA, namely the GPD and MCS segments. The allocation split was 65% to GPD and the balance to MCS. Goodwill arising on the acquisition of Libertas has been allocated to the GPD CGU.
The Directors have used the following key assumptions in determining the value-in-use calculations:
-
Gross margin
-
The basis used to determine the value assigned to the budgeted gross margin is the average gross margin achieved in the year immediately before the first budgeted year adjusted for the budgeted growth for the next two years.
-
Budgeted overheads
-
The basis used to determine the value assigned to the budgeted overheads is the average overhead achieved in the year immediately before the budgeted year adjusted for the budgeted increase for the following two years.
-
Discount rates
Discount rates reflect Management’s estimate of time value of money and the risks specific to the CGU. In determining appropriate discount rates, regard has been given to the weighted average cost of capital of the entity as a whole and adjusted for business risk specific to the CGU. The discount rates used were 10.2% for MCS and 11% for GPD.
-
Growth rate estimate
-
The basis used reflects Management’s estimates, determined by future forecasts in sales generation methods and by growth rates achieved within previous periods:
-
The average growth rate used for the MPI CGU for the first three years was 5%, for the next two years 5.0% and the longterm rate of 2.5% for future periods.
-
The average growth rate used for the GPD was 42% for the first three years, 6% for the next three years and a long-term rate of 3% for future periods. The growth rates reflect new product approvals.
-
The average growth rate used for the MCS CGU was 8% for the first three years 12% for the next three years and a longterm rate of 1% for future periods.
Sensitivity to changes in assumptions
Management believe that, based on currently available information, there are no reasonably possible changes to any of the above key assumptions that would result in the carrying value of the CGUs materially exceeding its recoverable amount.
Intangibles
Intangible assets acquired separately or in a business combination are initially measured at cost. The cost of an intangible asset acquired in a business combination is its fair value as at the date of acquisition. Following initial recognition, intangible assets are carried at cost less any accumulated amortisation and any accumulated impairment losses. Internally generated intangible assets, excluding capitalised development costs, are not capitalised and expenditure is recognised in profit or loss in the year in which the expenditure is incurred.
Intangibles are reviewed for impairment at each reporting date, or more frequently if events or changes in circumstances indicate that the carrying value may be impaired.
Intangible assets with finite lives are amortised over their useful life, which range from ten to twenty years, and tested for impairment whenever there is an indication that the intangible asset may be impaired. The amortisation period and amortisation method for an intangible asset with a finite useful life is reviewed at least at each financial year-end. Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are accounted for prospectively by changing the amortisation period or method, as appropriate, which is a change in accounting estimate. The amortisation expense on intangible assets with finite lives is recognised in profit or loss in the expense category consistent with the function of the intangible asset.
Certain intangible assets other than goodwill (i.e., customer contracts, relationships, intellectual property and trade marks) have been assessed as having finite useful lives and as such are amortised over their useful lives. Intangible assets relating to the Metrics, Libertas and HPPI acquisitions are amortised on a straight line basis. Marketing and distribution rights are considered to have an infinite life and hence are not amortised. The assets’ residual values, useful lives and bases of amortisation are reviewed annually and adjusted if appropriate.
Research and development expenditure
Research costs are expensed as incurred. Development expenditures on an individual project are recognised as an intangible asset when the Group can demonstrate:
• the technical feasibility of completing the intangible asset so that the asset will be available for use or sale;
Mayne Pharma Annual Report 2016 61
-
its intention to complete and its ability to use or sell the asset;
-
how the asset will generate future economic benefits;
-
the availability of resources to complete the asset; and
-
the ability to measure reliably the expenditure during development.
Following initial recognition of the development expenditure as an asset, the asset is carried at cost less any accumulated amortisation and accumulated impairment losses. Amortisation of the asset begins when development is complete and the asset is available for use. It is amortised over the period of expected future benefit. During the period of development, the asset is tested for impairment annually.
Significant accounting judgements
Research and development costs
Expenditure on research activities is recognised as an expense in the period in which it is incurred. An intangible asset arising from development expenditure on an internal project is recognised only when the Group can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale, its intention to complete and its ability to use or sell the asset, how the asset will generate future economic benefits, the availability of resources to complete the development and the ability to measure reliably the expenditure attributable to the intangible asset during its development. During the year ended 30 June 2016, 46 development projects met the requirements for capitalisation (2015: 43 development projects).
Significant accounting estimates and assumptions
Impairment of intangible assets
The Group determines whether intangible assets are impaired in accordance with the accounting policies stated. This process requires an estimation to be made of the recoverable amount of future cash flows of the assets.
Estimation of useful lives of assets
The estimation of the useful lives of intangible assets has been based on the assets’ contractual lives for the expected period of the future cash flows. In addition, the valuation assumptions used are assessed at least annually and considered against the useful life and adjustments to useful lives are made when considered necessary.
NOTE 16 – TRADE AND OTHER PAYABLES
| NOTE 16 – TRADE AND OTHER PAYABLES | |
|---|---|
| 2016 $‘000 2015 $’000 |
|
| Current Trade payables Other payables Settlement obligation in relation to the Teva transaction |
135,508 51,572 8,901 8,408 876,144 - |
| 1,020,553 59,980 |
On 28 June 2016, the Company announced 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”) for cash consideration of US$652m.
This asset purchase was completed and the above liability was settled on 3 August 2016.
The Company funded the acquisition via an extension of its existing debt facility, and a fully underwritten A$601m, 1-for-1.725 accelerated non-renounceable entitlement offer and A$287m placement.
Information regarding liquidity risk exposure is set out in Note 3.
Trade and other payables
Trade payables and other payables are carried at amortised cost. They represent liabilities for goods and services provided to the Group prior to the end of the financial year that are unpaid and arise when the Group becomes obliged to make future payments in respect of the purchase of these goods and services. The amounts are unsecured and are usually paid within 30 days of recognition.
Significant accounting judgements
Chargebacks, rebates, returns and customer loyalty programs
Accruals are made for customer rebates, rebates, chargebacks and loyalty programs. The Group may incur costs that differ from its original estimate.
62 Mayne Pharma Annual Report 2016
NOTE 17 – INTEREST-BEARING LOANS AND BORROWINGS
| NOTE 17 – INTEREST-BEARING LOANS AND BORROWINGS | |
|---|---|
| 2016 $‘000 2015 $’000 |
|
| Current Lease liabilities |
503 - |
| 503 - |
|
| 2016 $‘000 2015 $’000 |
|
| Non-current Syndicated loan Borrowing costs (net of amortisation) Lease liabilities |
76,999 61,774 (836) (998) 168 980 |
| 76,331 61,756 |
The syndicated loan facility provided by Westpac and National Australia Bank (NAB) is a five year loan effective from 24 June 2015. The amount drawn at 30 June 2016 was US$57.3m (30 June 2015 US$47.32m). This facility has a limit of US$125 million and can be drawn down in either USD or AUD with USD expected to be the major currency drawn down.
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 was in compliance with the covenants at reporting date and the Directors believe there is no risk of default at reporting date.
At 30 June 2016, the average variable interest rate was 1.943% (30 June 2015: 1.944%).
NAB has also provided a working capital facility of A$10m. The facility is subject to interest based on BBSY plus a margin. The facility is subject to the same financial covenants as the syndicated loan facility and also has an unused line fee payable based on the undrawn amount.
Loan maturities are summarised as follows:
| Loan maturities are summarised as follows: | |
|---|---|
| 2016 $‘000 2015 ‘000 |
|
| Current Non-current Due by 30 June 2017 Due by 30 June 2018 Due by 30 June 2019 Due by 30 June 2020 |
- - 76,999 61,774 |
| 76,999 61,774 |
|
| - - - - - - 76,999 61,774 |
|
| 76,999 61,774 |
There were no defaults or breaches on any loans during the year ended 30 June 2016.
Subsequent to the reporting period, the Company increased the syndicated loan facility to US$400m to partially fund the acquisition of the Teva/Allergan products. The revised facility has two tranches with US$150m maturing in three years and US$250m maturing in five years from the effective date (29 July 2016). Other material aspects of the syndicated facility remain similar to the facility as at 30 June 2016.
Recognition and measurement
Interest-bearing loans and borrowings
Borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the reporting date. After initial recognition, interest-bearing loans and borrowings are subsequently measured at amortised cost using the effective interest method. Fees paid on the establishment of loan facilities that are yield related are included as part of the carrying amount of the loans and borrowings.
Leases
The determination of whether an arrangement is or contains a lease is based on the substance of the arrangement and requires an assessment of whether the fulfilment of the arrangement is dependent on the use of a specific asset or asset and the arrangement conveys a right to use the asset.
Finance leases, which transfer to the Group substantially all the risks and benefits incidental to ownership of the lease item are capitalised at the inception of the lease at the fair value of the leased asset or, if lower, at the present value of the minimum lease payments. Lease payments are apportioned between the finance charges and reduction of the lease liability so as to achieve a constant rate of interest on the remaining balance of the liability. Finance charges are recognised as an expense in profit or loss.
Mayne Pharma Annual Report 2016 63
NOTE 18 – OTHER FINANCIAL LIABILITIES
| NOTE 18 – OTHER FINANCIAL LIABILITIES | |
|---|---|
| 2016 $‘000 2015 $’000 |
|
| Current Earn-out liability – Hospira 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 Deferred consideration – BAC ANDA Deferred consideration – Methamphetamine ANDA and distribution rights Non-current Earn-out liability – Libertas’ former shareholder Earn-out liability – Oxycodone Earn-out liability – Liothyronine Earn-out liability – various products/distribution rights Deferred consideration – Liothyronine |
- 6,500 1,343 1,159 5,230 6,095 3,252 - 1,432 1,444 2,016 - - 2,471 - 9,142 |
| 13,273 26,811 |
|
| - 1,244 - 3,381 1,314 - 2,829 2,687 1,671 - |
|
| 5,814 7,312 |
The consolidated entity has recognised various earn-out liabilities relating to various asset purchases. The majority of the earn-outs are based on a percentage of net sales and typically payable on a quarterly basis for a period of between two and five years.
Deferred consideration recognised includes amounts which are contingent on market conditions (e.g. no entry of a new competitor into the relevant market). At balance date the Group expects to pay all contingent amounts outlined in the asset purchase agreements and has therefore recognised such liabilities in full.
During the period, a decrease in the liabilities of $5,202,000 was recognised relating to re-assessment of the underlying assumptions for the Hospira and Methamphetamine earn-out liabilities. Refer note 6.
Earn-out liabilities
Recognition and derecognition
Earn-out liabilities of the Group are initially recognised on the consolidated statement of financial position as part of business combinations and intangible asset acquisitions at fair value. Financial liabilities are derecognised when they are extinguished.
Subsequent measurement
After initial recognition, earn-out liabilities are recognised at fair value through profit or loss and are remeasured each reporting period. Movements in the liability from these changes are reported in the consolidated statement of profit or loss and other comprehensive income.
Significant accounting estimates and assumptions
Earn-out liabilities
The earn-out liabilities have been determined based on contracted royalty rates payable on expected future cash flows. The estimation of the cash flows over a significant period, combined with the impact of currency movements and interest rates may result in substantial movements in the value of the liabilities recognised between reporting periods. The cash flows, assumed discount rate and forecast exchange rates are reviewed every six months to ensure the most accurate fair value of the liabilities is reported. Movements in the liabilities from changes in these assumptions and forecasts are reported in the consolidated statement of profit of loss and other comprehensive income.
Earn-out liabilities represent the net present value of estimated future payments. Any changes in fair value for changes in the net present value of estimated future payments are recognised in the statement of profit or loss and other comprehensive income. The earn-out liabilities at reporting date include a charge representing the unwinding of the discounting of the earn-out liabilities of $1,116,000 (2015: $789,000) for the period representing the change in fair value as a result of the unwinding of the discounting.
Deferred consideration liabilities
Deferred consideration liabilities represent the net present value of future predetermined payments. In the prior year, one of the accrued amounts was subject to market conditions. Conditions in the current period resulted in the amount accrued being re-assessed (refer note 6). At 30 June 2016 all deferred consideration amounts reflect fixed contract amounts and are not subject to market conditions.
64 Mayne Pharma Annual Report 2016
NOTE 19 – PROVISIONS
| NOTE 19 – PROVISIONS | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Current Employee benefits Non-Current Employee benefits Restoration |
9,287 6,523 |
| 1,075 815 376 430 |
|
| 1,451 1,245 |
Provisions and employee benefits
Provisions are recognised when the Group has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation.
Provisions are measured at the present value of Management’s best estimate of the expenditure required to settle the present obligation at the reporting date. If the effect of the time value of money is material, provisions are discounted using a current pre-tax rate that reflects the time value of money and the risks specific to the liability.
Employee leave benefits
Liabilities for wages and salaries, including non-monetary benefits and annual leave expected to be settled within 12 months of the reporting date are recognised in respect of employees’ services up to the reporting date. They are measured at the amounts expected to be paid when the liabilities are settled. Liabilities for non-accumulating sick leave are recognised when the leave is taken and are measured at the rates paid or payable.
Long service leave
The liability for long service leave is recognised in the provision for employee benefits and measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures, and periods of service. Expected future payments are discounted using market yields at the reporting date on high quality corporate bonds with terms to maturity and currencies that match, as closely as possible, the estimated future cash outflows.
Restoration provision
The restoration provision represents the present value of anticipated costs for the future restoration of the Salisbury site. The outflows are expected to occur over 20 years.
Significant accounting estimates and assumptions
Restoration provision
Since the acquisition of Mayne Pharma International Pty Ltd from Hospira, a provision has been reflected in the statement of financial position for the present value of anticipated costs for future restoration of the Salisbury site. The calculation of this provision requires assumptions such as application of environmental legislation, timing of restoration and cost estimates. These uncertainties may result in future actual expenditure differing from the amounts currently provided.
NOTE 20 – CONTRIBUTED EQUITY
A. Movements in contributed equity
| A. Movements in contributed equity |
|
|---|---|
| 2016 NUMBER 2015 NUMBER 2016 $’000 2015 $’000 |
|
| Balance at beginning of year Issued during the year: US Doryx ™and selected generic product acquisition funding 1 Libertas earn-out consideration Product rights acquisition consideration Tax effect of employee share options Options exercised Shares issued to KMP (restricted) 2 Balance at end of year |
786,754,531 586,651,477 255,834 137,498 - 188,890,338 - 114,352 - 314,002 - 227 - 1,420,119 - 918 - - 5,943 1,261 3,450,000 3,730,000 1,384 1,578 19,841,815 5,748,595 - - |
| 810,046,346 786,754,531 263,161 255,834 |
Notes: 1. Shares issued are net of $3,207,000 of equity raising costs (net of income tax). 2. The shares were granted under the LTI arrangement (and are subject to risk of forfeiture)
Refer note 8 for details of contributed equity changes subsequent to the reporting period.
Mayne Pharma Annual Report 2016 65
Contributed equity
Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction from the proceeds.
B. Terms and conditions of contributed equity
Holders of ordinary shares are entitled to receive dividends as declared from time to time and are entitled to one vote per share at shareholders’ meetings.
In the event of winding up of the Company, ordinary shareholders rank after all other shareholders and creditors and are fully entitled to any proceeds of liquidation.
C. Capital management
The primary objective of the Group in relation to capital management is to ensure that it maintains a strong credit rating and healthy capital ratios in order to support its business objectives and maximise shareholder value.
The Group manages its capital structure and makes adjustments to it, in light of changes in economic conditions and the Company’s strategy. To maintain or adjust the capital structure, the Company may return capital to shareholders or issue new shares. During the year ended 30 June 2015 the Company issued new shares and refinanced the available debt facilities. No changes were made in the objectives, policies or processes during the years ended 30 June 2015 and 30 June 2014.
Management monitors capital with reference to the net debt position. The Group includes within net debt, interest-bearing loans and borrowings, trade and other payables, less cash and cash equivalents. The Group’s current policy is to maintain a net debt position that the Directors are comfortable with and that can be serviced by the Group’s cash flows.
| 2016 $’000 2015 $’000 |
|
|---|---|
| Trade and other payables Interest-bearing borrowings Less cash and cash equivalents Net debt |
144,410 59,980 76,834 61,756 (47,481) (59,201) |
| 173,763 62,535 |
The Group is subject to capital requirements under the terms of the syndicated loan facility.
NOTE 21 – RESERVES
| 2016 $’000 2015 $’000 |
|
|---|---|
| Share-based payments reserve Cash flow hedge reserve Other reserve Foreign currency translation reserve |
7,950 3,230 (864) - 1,180 - 30,792 27,631 |
| 39,058 30,861 |
Share-based payments reserve
The share-based payments reserve records the value of share-based payments provided to employees, including KMP, as part of their remuneration.
| 2016 $’000 2015 $’000 |
|
|---|---|
| Balance at beginning of year Share-based payments expense Transfer to contributed equity on exercise of options Balance at end of year |
3,230 1,922 5,109 1,822 (389) (514) |
| 7,950 3,230 |
Cash flow hedge reserve
The cash flow hedge reserve records the portion of the gain or loss on a hedging instrument in a cash flow hedge that is determined to be an effective hedge relationship.
| an effective hedge relationship. | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Balance at beginning of year Mark to Market unrealised loss on interest rate swap contracts Balance at end of year |
- - (864) - |
| (864) - |
66 Mayne Pharma Annual Report 2016
Other equity reserve
The Other equity reserve records movements in the Group’s equity in partly-owned subsidiaries after recognising changes to noncontrolling interests.
| controlling interests. | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Balance at beginning of year Change to equity investment in HPPI Balance at end of year |
- - 1,180 - |
| 1,180 - |
Foreign currency translation reserve
Exchange differences arising on translation of the foreign controlled entities are recognised in Other Comprehensive Income as described in Note 1C and accumulated in a separate reserve within equity. Exchange differences arising on monetary items that form part of the reporting entity’s net investment in a foreign operation are recognised in profit or loss in the separate financial statements of the reporting entity. In the Group’s financial statements that include the foreign operation and the reporting entity, such exchange differences are recognised initially in other comprehensive income. The cumulative amount is reclassified to profit and loss when the net investment is disposed of with the exception of cumulative exchange differences relating to non-controlling interests.
| 2016 $’000 2015 $’000 |
|
|---|---|
| Balance at beginning of year Foreign exchange translation differences Balance at end of year |
27,631 3,438 3,161 24,193 |
| 30,792 27,631 |
NOTE 22 – RETAINED EARNINGS
| NOTE 22 – RETAINED EARNINGS | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Retained earnings at the beginning of the period Net profit attributable to members Retained earnings at the end of the period |
24,175 16,416 37,355 7,759 |
| 61,530 24,175 |
NOTE 23 – NOTES TO THE CONSOLIDATED STATEMENT OF CASH FLOWS
A. Cash and cash equivalents
Cash and cash equivalents in the Statement of Financial Position and the for the purposes of the Statement of Cash Flows comprise cash at bank and in hand (excluding restricted cash) and short-term deposits with an original maturity of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.
Cash and cash equivalents at the end of the year as shown in the Statement of Financial Position and the Statement of Cash Flows comprise the following:
| 2016 $’000 2015 $’000 |
|
|---|---|
| Cash at bank and in hand | 47,481 59,201 |
Cash at bank attracts floating interest at current market rates.
Mayne Pharma Annual Report 2016 67
B. Reconciliation of net profit after income tax to net cash used in operating activities
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||||
|---|---|---|
|2016|2015|
|$’000|$’000|
|Net profit after income tax|34,525|7,537|
|Adjustments for:|
|Depreciation|5,042|4,975|
|Amortisation of intangibles and borrowing costs|16,544|10,536|
|Share-based payments|5,109|1,822|
|Movement in earn-out liability|(4,086)|3,023|
|Asset impairments|1,756|1,278|
|Book value of intangible product rights disposed|563|-|
|Gain on restatement of HPPI investment and/or warrants|(470)|(3,951)|
|Share of associate loss|-|990|
|Net foreign exchange differences|(5)|(2,254)|
|Changes in assets and liabilities|
|(Increase in receivables|(58,595)|(30,265)|
|(Increase) in inventories|(16,680)|(2,458)|
|(Increase) in prepayments|(5,697)|(3,244)|
|(Increase) in deferred tax assets|(25,684)|(6,358)|
|Increase in creditors|83,761|38,955|
|Increase/(decrease) in provisions|2,919|(657)|
|Increase in current and deferred tax liabilities|14,502|2,491|
|Net cash from operating activities|53,504|22,420|
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NOTE 24 – RELATED PARTY DISCLOSURES
A. Subsidiaries
The consolidated financial statements include the financial statements of Mayne Pharma Group Limited and the subsidiaries listed in the following table:
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|||||||
|---|---|---|---|---|---|
|% EQUITY INTEREST|INVESTMENT $’000|
|COUNTRY OF|
|INCORPORATION|2016|2015|2016|2015|
|Mayne Pharma International Pty Ltd|Australia|100|100|39,205|39,205|
|1|
|Mayne Products Pty Ltd|Australia|100|100|-|-|
|1|
|Mayne Pharma UK Limited|United Kingdom|100|100|-|-|
|Mayne Pharma, Inc2|United States|100|100|68,802|63,585|
|2|
|Libertas Pharma, Inc|United States|-|100|-|3,528|
|Mayne Pharma Ventures Pty Ltd|Australia|100|100|-|-|
|1|
|Mayne Pharma Ventures LLC|United States|100|100|-|-|
|1|
|Swan Pharmaceuticals LLC|United States|100|100|-|-|
|1|
|Tiger Pharmaceuticals LLC|United States|100|100|-|-|
|HedgePath Pharmaceuticals Inc|United States|49.4|49.4|13,567|10,778|
|3|
|Mayne Pharma SIP Pty Ltd|Australia|100|-|-|-|
|3|
|Mayne Pharma LLC|United States|100|-|-|-|
|121,574|117,096|
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Notes:
-
Dormant subsidiaries
-
Metrics Inc and Libertas Pharma Inc merged effective 31 October 2015 and the surviving entity changed its name to Mayne Pharma Inc
-
Mayne Pharma SIP Pty Ltd and Mayne Pharma LLC were incorporated during the period.
Financial information of a subsidiary which has a material non-controlling interest is as follows:
Portion of equity interest held by non-controlling interest:
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|||||
|---|---|---|---|
|% EQUITY INTEREST|
|COUNTRY OF|
|INCORPORATION|2016|2015|
|HedgePath Pharmaceuticals LLC|United States|50.6|50.6|
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68 Mayne Pharma Annual Report 2016
Summarised statement of profit or loss for period ended 30 June 2016
| Summarised statement of profit or loss for period ended 30 June 2016 | |
|---|---|
| HPPI 2016 $’000 HPPI 2015 $’000 |
|
| Revenue Cost of sales Interest income Research and development expenses Administration expenses Depreciation and amortisation Share-based payments expenses Loss before tax Income tax benefit Loss after tax Other Comprehensive income Total Comprehensive income Attributable to non-controlling interests |
- - - - 1 - (2,222) (168) (1,872) (127) (904) (98) (944) (82) |
| (5,941) (475) 344 37 |
|
| (5,597) (438) 613 1,024 |
|
| (4,984) 586 |
|
| (2,522) 293 |
The comparative period in the above statement of profit and loss is for the period from 15 May 2015 to 30 June 2015.
Summarised statement of financial position as at 30 June 2016
| Summarised statement of financial position as at 30 June 2016 | |
|---|---|
| 2016 $’000 PROVISIONAL HPPI 2015 $’000 |
|
| Cash at bank Other current assets Intangible assets Trade and other payables Deferred tax liabilities Total equity Attributable to equity holders of Mayne Pharma Attributable to non-controlling interests |
6,202 2,473 403 387 32,579 32,523 (831) (539) (12,380) (12,359) |
| 25,973 22,485 |
|
| 12,008 11,153 12,472 11,332 |
B. Ultimate parent
Mayne Pharma Group Limited is the ultimate parent entity.
C. KMP
Details relating to KMP, including remuneration paid, are included in Note 27.
D. Transactions with related parties
The Company had no other transactions with KMP or other related parties during the financial years ended 30 June 2016 or 30 June 2015.
Amounts owing to Directors, Director-related parties and other related parties at 30 June 2016 and 30 June 2015 were nil.
NOTE 25 – KMP DISCLOSURES
A. Directors and other KMP
The Directors of Mayne Pharma Group Limited during the financial year were:
-
Mr Roger Corbett, AO – Chairman
-
Mr Scott Richards – Managing Director and Chief Executive Officer
-
Hon Ron Best – Non-Executive Director
-
Mr William (Phil) Hodges – Non-Executive Director
-
Mr Bruce Mathieson – Non-Executive Director
-
Mr Ian Scholes – Non-Executive Director
-
Prof Bruce Robinson, AM - Non-Executive Director
Other KMP consisted of:
-
Mr Mark Cansdale – Group Chief Financial Officer and Company Secretary
-
Mr Stefan Cross – President Mayne Pharma USA
-
Dr Ilana Stancovski – Chief Scientific Officer
-
Ms Kate Rintoul – Executive Vice President and General Counsel (considered to be KMP from 1 July 2015)
-
Mr Eric Evans – Chief Financial Officer Mayne Pharma USA (appointed 3 August 2015)
-
Mr Peter Paltoglou – Chief Development Officer and Head of M&A (appointed 22 August 2015)
-
Ms Lisa Pendlebury – Vice President Investor Relations and Communications (appointed 11 November 2015)
-
Mr Andrew Van Breugel – Executive Vice President Operations (appointed 11 January 2016)
Mayne Pharma Annual Report 2016 69
B. Compensation of KMP
| B. Compensation of KMP |
|
|---|---|
| 2016 $’000 2015 $’000 |
|
| Short-term employee benefits Post-employment benefits Long-term benefits Share-based payments |
4,755 2,656 250 132 45 28 2,020 810 |
| 7,070 3,626 |
NOTE 26 – AUDITOR’S REMUNERATION
| NOTE 26 – AUDITOR’S REMUNERATION | |
|---|---|
| 2016 $ 2015 $ |
|
| Amounts received or due and receivable by EY Australia for Audit and review of financial statements Non-audit services Tax compliance services Tax advisory services Acquisition and other services Other Assurance |
372,500 372,800 140,930 61,367 - 49,600 30,750 31,025 31,000 |
| 221,555 123,117 |
|
| 594,045 495,917 |
|
| 2016 $ 2015 $ |
|
| Non-audit services amounts received or due and receivable from member firms related to EY Australia Tax compliance and advisory services Acquisition and other services |
253,746 129,017 164,531 - |
The above non-audit services are invoiced in USD to Mayne Pharma Inc, and are subject to foreign currency translation.
| 2016 $ 2015 $ |
|
|---|---|
| Non EY Auditors Audit and review of financial statements Other assurance |
339,810 215,625 - 27,775 |
| 339,810 243,400 |
The above non EY auditor services are invoiced in USD to Mayne Pharma Inc, and are subject to foreign currency translation.
NOTE 27 - SHARE-BASED PAYMENT PLANS
The expense recognised for employee services received during the year is shown in the table below:
| 2016 $’000 2015 $’000 |
|
|---|---|
| Expense arising from equity-settled share-based payment transactions Option modifications |
5,109 1,626 - 196 |
| 5,109 1,822 |
Share-based payment transactions – recognition and measurement
The Group provides benefits to its employees (including KMP) in the form of share-based payments, whereby employees render services in exchange for shares or rights over shares (equity-settled transactions). In the event that an employee leaves the Group prior to the vesting of any share-based payment previously granted to the employee, the share-based payment will normally be forfeited (subject to the discretion of the Board) . Where an employee leaves the Group subsequent to the vesting but prior to the expiry of sharebased payments granted, the Board has absolute discretion to determine whether or not such share-based payments will lapse. In the event that the Company’s Employee Share Option Plan was cancelled, this would not affect the rights of employees in relation to previously issued share-based payments.
The cost of these equity-settled transactions with employees is measured by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined using an appropriate option-pricing model, depending on the complexity of the exercise conditions. The cost is recognised, together with a corresponding increase in other capital reserves in equity, over the period in which the performance and/or service conditions are fulfilled in employee benefits expense.
The Group engaged an accredited independent valuer, to determine the fair value of options issued at the date at which they are granted.
The cost of equity-settled transactions is recognised, together with a corresponding increase in equity, over the vesting period.
70 Mayne Pharma Annual Report 2016
The dilutive effect, if any, of outstanding options is reflected as additional share dilution in the computation of diluted earnings per share (refer to Note 8).
Significant accounting estimates and assumptions
Share-based payment transactions
The Group measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined using an appropriate option-pricing model depending on the complexity of the exercise conditions with both the Black Scholes option-pricing model and the Monte Carlo Simulation option-pricing model utilised during the period. The specific assumptions applied to the options issued during the year are provided in this note. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but may impact expenses and equity.
Share Options granted to employees
| Share Options granted to employees | |
|---|---|
| BALANCE AT EXERCISED OTHER MOVEMENTS BALANCE OPTIONS |
|
| EXERCISE PRICE1 EXPIRY DATE |
BEGINNING OF YEAR GRANTED DURING THE YEAR DURING THE YEAR DURING THE YEAR AT END OF YEAR EXERCISABLE AT END OF YEAR |
| Year ended 30 June | |
2016 |
Number Number Number Number Number Number |
| Unlisted options $0.2435 13/02/19 |
7,500,000 - - - 7,500,000 7,500,000 |
| Unlisted options $0.2327 15/03/16 |
1,000,000 - (1,000,000) - - - |
| Unlisted options $0.3127 12/01/19 |
10,180,000 - (1,850,000) (1,110,000) 2 7,220,000 3,420,000 |
| Unlisted options $0.3127 26/01/19 |
6,440,000 - (600,000) - 5,840,000 2,040,000 |
| Unlisted options $0.3927 7/03/19 |
800,000 - - - 800,000 300,000 |
| Unlisted options $0.4127 1/07/19 |
1,000,000 - - - 1,000,000 200,000 |
| Unlisted options $0.6866 21/10/19 |
400,000 - - - 400,000 80,000 |
| Unlisted options $0.7590 11/11/19 |
1,000,000 - - - 1,000,000 200,000 |
| Unlisted options $0.7697 30/11/19 |
1,000,000 - - - 1,000,000 200,000 |
| Unlisted options $0.8946 28/03/19 |
600,000 - - - 600,000 300,000 |
| Unlisted options $0.8644 19/06/19 |
600,000 - - - 600,000 300,000 |
| Unlisted options $0.9131 30/06/19 |
1,000,000 - - - 1,000,000 500,000 |
| Unlisted options $0.9052 2/07/19 |
400,000 - - - 400,000 200,000 |
| Unlisted options $0.8380 1/08/19 |
200,000 - - - 200,000 - |
| Unlisted options $0.8625 28/08/19 |
600,000 - - - 600,000 120,000 |
| Unlisted options $0.7390 17/12/19 |
600,000 - - - 600,000 120,000 |
| Unlisted options $0.6290 1/02/20 |
2,700,000 - - - 2,700,000 540,000 |
| 36,020,000 - (3,450,000) (1,110,000) 31,460,000 16,020,000 |
Notes: 1. Original exercise price was adjusted down by $0.0173 under ASX Listing Rule 6.22 following the entitlement issue announced on 10 February 2015. The exercise prices for all outstanding options were subsequently reduced by 9.43 cents each effective 22 July 2016 under ASX Listing Rule 6.22 following the entitlement issue announced 28 June 2016. The above exercise price was the exercise price at 30 June 2016 and hence does not reflect the reduction. 2. Options were forfeited on the termination of employment.
No options were issued to executives under ESOP during the year ended 30 June 2016.
Mayne Pharma Annual Report 2016 71
| BALANCE AT EXERCISED OTHER MOVEMENTS BALANCE OPTIONS |
|
|---|---|
| EXERCISE PRICE1 EXPIRY DATE |
BEGINNING OF YEAR GRANTED DURING THE YEAR DURING THE YEAR DURING THE YEAR AT END OF YEAR EXERCISABLE AT END OF YEAR |
| Year ended 30 June | |
2015 |
Number Number Number Number Number Number |
| Unlisted options $0.2505 27/01/16 |
950,000 - (950,000) - - - |
| Unlisted options $0.2435 13/02/19 |
7,500,000 - - - 7,500,000 4,000,000 |
| Unlisted options $0.2327 15/03/16 |
2,000,000 - (1,000,000) - 1,000,000 1,000,000 |
| Unlisted options $0.3127 12/01/19 |
13,200,000 - (420,000) (2,600,000) 2 10,180,000 2,120,000 |
| Unlisted options $0.3127 26/01/19 |
7,600,000 - (1,160,000) - 6,440,000 360,000 |
| Unlisted options $0.3927 7/03/19 |
1,000,000 - (200,000) - 800,000 - |
| Unlisted options $0.4127 1/07/19 |
1,000,000 - - - 1,000,000 - |
| Unlisted options $0.6866 21/10/19 |
400,000 - - - 400,000 - |
| Unlisted options $0.7590 11/11/19 |
1,000,000 - - - 1,000,000 - |
| Unlisted options $0.7697 30/11/19 |
1,000,000 - - - 1,000,000 - |
| Unlisted options $0.8946 28/03/19 |
- 600,000 - - 600,000 - |
| Unlisted options $0.8644 19/06/19 |
- 600,000 - - 600,000 120,000 |
| Unlisted options $0.9131 30/06/19 |
- 1,000,000 - - 1,000,000 200,000 |
| Unlisted options $0.9052 2/07/19 |
- 400,000 - - 400,000 80,000 |
| Unlisted options $0.8380 1/08/19 |
- 200,000 - - 200,000 - |
| Unlisted options $0.8625 28/08/19 |
- 600,000 - - 600,000 - |
| Unlisted options $0.7390 17/12/19 |
- 600,000 - - 600,000 - |
| Unlisted options $0.6290 1/02/20 |
- 2,700,000 - - 2,700,000 - |
| 35,650,000 6,700,000 (3,730,000) (2,600,000) 36,020,000 7,880,000 |
Notes: 1. Original exercise price was adjusted down by $0.0173 under ASX Listing Rule 6.22 following the entitlement issue announced on 10 February 2015.
- Options were forfeited on the termination of employment.
Options issued to executives under the ESOP during the year ended 30 June 2015
-
600,000 granted on 19 August 2014 with an exercise price of $0.9119 and an expiry date of 28 March 2019.
-
600,000 granted on 19 August 2014 with an exercise price of $0.8817 and an expiry date of 19 June 2019.
-
1,000,000 granted on 19 August 2014 with an exercise price of $0.9304 and an expiry date of 30 June 2019.
-
400,000 granted on 19 August 2014 with an exercise price of $0.9225 and an expiry date of 2 July 2019.
-
200,000 granted on 19 August 2014 with an exercise price of $0.8553 and an expiry date of 1 August 2019.
-
600,000 granted on 19 August 2014 with an exercise price of $0.8798 and an expiry date of 28 August 2019.
-
600,000 granted on 29 January 2015 with an exercise price of $0.7563 and an expiry date of 17 December 2019.
-
2,700,000 granted on 29 January 2015 with an exercise price of $0.6463 and an expiry date of 1 February 2020.
Tax Exempt Share Plan (TESP)
374,344 shares were issued under the Tax Exempt Share Plan to long-term employees on 18 October 2011 for nil consideration at an effective issue price of $0.39 per share based on price at close of trade for that day. They were restricted for a period of three years but are now unrestricted.
There were no issues under the TESP during the year ended 30 June 2016 (2015: nil).
Employee share option plan (ESOP)
An employee share option plan is in place where Directors and employees of the Company may be issued with options over the ordinary shares of Mayne Pharma Group Limited. Shareholders last approved the plan at the AGM held on 9 November 2012. The options, issued for nil consideration, are issued in accordance with guidelines established by the Directors of Mayne Pharma Group Limited.
Each employee share option converts to one ordinary share in Mayne Pharma Group Limited upon exercise. The options carry neither rights to dividends nor voting rights. Options may be exercised at any time from the date of vesting to the date of their expiry. The exercise price is set by reference to the volume weighted average price at which the Company’s shares trade on the Australian Securities Exchange (ASX) across an agreed period. The contractual term varies across the various issues but generally ranges from three to six years and there are no cash settlement alternatives for employees.
No options were issued during the 2016 year under the ESOP and the plan is not expected to be utilised going forward. A total of 6,700,000 options were issued during the year ended 30 June 2015.
| 2016 NUMBER OF OPTIONS 2016 WEIGHTED AVERAGE EXERCISE VALUE $ 2015 NUMBER OF OPTIONS 2015 WEIGHTED AVERAGE EXERCISE VALUE $ |
|
|---|---|
| Balance at beginning of year Granted during the year Exercised during financial year Forfeitures Balance at end of year |
28,520,000 0.4599 28,150,000 0.3660 - - 6,700,000 0.7871 (3,450,000) 0.2895 (3,730,000) 0.2853 (1,110,000) 0.3127 (2,600,000) 0.3267 |
| 23,960,000 0.4127 28,520,000 0.4599 |
72 Mayne Pharma Annual Report 2016
Option modification
The exercise price for all options on issue under the ESOP were changed in accordance with ASX Listing Rule 6.22 following the Company’s pro-rata entitlement issue announced in June 2016. The exercise price change was effective 22 July 2016 and hence any adjustment the expense will be reflected is subsequent reporting periods. The accounting expense adjustment has not been determined at the date of this report.
Chief Executive Officer Share Option Plan (CEOSOP)
A share option plan is in place where the CEO of the Company may be issued with options over the ordinary shares of Mayne Pharma Group Limited. Shareholders approved the plan at the Extraordinary General Meeting held on 27 January 2012. The options, issued for nil consideration, were issued in accordance with guidelines established by the Directors of Mayne Pharma Group Limited.
Each CEO share option converts to one ordinary share in Mayne Pharma Group Limited upon exercise. The options carry neither rights to dividends nor voting rights. Options may be exercised at any time from the date of vesting to seven years after the Grant Date (13 February 2019) subject to the terms and conditions outlined in the plan, including Share Price hurdles ranging from $0.74 to $1.19 (previously share price hurdles were $0.74 to $1.29); Share Gateway conditions also apply.
The options were issued in three tranches:
| NUMBER OF OPTIONS GRANT DATE VESTING DATE |
|
|---|---|
| Tranche 1 Tranche 2 Tranche 3 |
1,500,000 13 February 2012 13 February 2015 2,500,000 13 February 2012 13 February 2015 3,500,000 13 February 2012 13 February 2016 2016 NUMBER OF OPTIONS 2016 WEIGHTED AVERAGE EXERCISE PRICE $ 2015 NUMBER OF OPTIONS 2015 WEIGHTED AVERAGE ERERCISE PRICE $ |
| Balance at beginning of year Granted during the year Exercised during the year Balance at end of year |
7,500,000 0.2435 1 7,500,000 0.2435 1 - - - - - - - - |
| 7,500,000 0.2435 7,500,000 0.2435 |
Note: 1. The exercise price of the CEOSOP options changed during the prior year as a result of the application of ASX Listing Rule 6.22 following the Company’s entitlement offer announced in February 2015. The exercise price for all outstanding options was subsequently reduced by 9.43 cents each effective 22 July 2016 under ASX Listing Rule 6.22 following the entitlement issue announced 28 June 2016. The above exercise price was the exercise price at 30 June 2016 and hence does not reflect the reduction.
There were no option issues under the CEOSOP during the year (2015: nil) and the CEOSOP is not expected to be utilised going forward.
Option modification
The exercise price for all options on issue under the CEOSOP were changed in accordance with ASX Listing Rule 6.22 following the Company’s pro-rata entitlements issue announced in June 2016. The exercise price change was effective 22 July 2016 and hence any adjustment the expense will be reflected is subsequent reporting periods. The accounting expense adjustment has not been determined at the date of this report.
Shares granted to employees
Under the LTI program, eligible employees acquire shares in Mayne Pharma funded by a non-recourse loan from the Group. While shares are acquired under the plan for legal and taxation purposes, Australian Accounting Standards require the shares be treated as options for accounting purposes. As a result the amounts receivable from employees in relation to these loans are not recognized in the financial statements.
The number of notional shares granted to employees under the LTI plan is set out below:
| GRANT DATE | EXPIRY DATE LOAN VALUE PER SHARE |
NUMBER HELD AT 1 JULY 2015 NUMBER GRANTED DURING YEAR NUMBER EXERCISED DURING YEAR NUMBER LAPSED OR FORFEITED DURING THE YEAR NUMBER HELD AT 30 JUNE 2016 VALUE OF OPTIONS AT GRANT DATE $ VALUE OF OPTIONS INCLUDED IN COMPENSATION FOR THE YEAR $ |
|---|---|---|
| Year ended 30 June 2016 Unlisted shares 8 Sep 14 Unlisted shares 4 Dec 14 Unlisted shares 2 Feb 15 Unlisted shares 3 Aug 15 Unlisted shares 5 Aug 15 Unlisted shares 24 Aug 15 Unlisted shares 11 Nov 15 Unlisted shares 11 Nov 15 Unlisted shares 4 Dec 15 |
8 Sep 19 $0.7636 4 Dec 19 $0.6815 2 Feb 20 $0.6163 31 Aug 20 $1.1000 31 Aug 20 $1.1538 31 Aug 20 $1.1297 31 Aug 20 $1.0200 31 Aug 20 $1.0460 31 Aug 20 $1.2300 |
1,092,063 - - - 1,092,063 344,000 68,800 3,823,529 - - - 3,823,529 845,000 169,000 833,003 - - - 833,003 210,000 42,000 - 12,578,136 - (100,000) 12,478,136 5,516,584 1,686,517 - 974,997 - - 974,997 432,996 131,487 - 2,231,344 - - 2,231,344 633,032 187,505 - 1,079,772 - - 1,079,772 423,811 91,662 - 524,070 - - 524,070 200,771 48,155 - 2,553,496 - - 2,553,496 1,237,169 274,875 |
| 5,748,595 19,941,815 - (100,000) 25,590,410 9,843,363 2,700,001 |
Mayne Pharma Annual Report 2016 73
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|---|---|---|---|---|---|---|---|---|---|---|
|VALUE OF|
|LOAN VALUE|OPTIONS|
|EXPIRY DATE|PER SHARE|NUMBER|NUMBER|NUMBER|VALUE OF|INCLUDED IN|
|NUMBER HELD|GRANTED|EXERCISED|LAPSED DURING|NUMBER HELD|OPTIONS AT|COMPENSATION|
|GRANT DATE|AT 1 JULY 2014|DURING YEAR|DURING YEAR|THE YEAR|AT 30 JUNE 2015|GRANT DATE $|FOR THE YEAR $|
|Year ended|
|30 June 2015|
|Unlisted shares|8 Sep 14|8 Sep 19|$0.7636|-|1,092,063|-|-|1,092,063|344,000|55,794|
|Unlisted shares|4 Dec 14|4 Dec 19|$0.6815|-|3,823,529|-|-|3,823,529|845,000|96,770|
|Unlisted shares|2 Feb 15|2 Feb 20|$0.6163|-|833,003|-|-|833,003|210,000|17,145|
|5,748,595|-|-|5,748,595|1,399,000|169,709|
----- End of picture text -----
Under the LTI plan, eligible senior management are provided with non-recourse loans from the Group for the sole purpose of acquiring shares in the Group. The shares are granted upfront based on the five day volume weighted average price, and remain restricted and subject to risk of forfeiture until the end of the vesting/performance period and while the loan remains outstanding, with any unvested/unexercised shares lapsing after 49 months after the initial testing date.
Any dividends paid on the shares are applied (on a notional after tax basis) towards repaying the loan.
The shares issued during the current period have a common testing/vest date with the testing/vesting date being 1 July each year. Shares issued in the prior period are tested on the anniversaries of the grant date.
The shares generally vest over three years with 20% vesting after the first testing date, 30% after the second testing date and 50% vesting after the third testing date, other than those issued to the CEO during the year ended 30 June 2015, of which 100% only vest after 36 months if the hurdles are met.
The number/proportion of shares that vest is based on the absolute Total Shareholder Return (TSR) over the period, with 50% vesting if a TSR of 5% Compound Annual Growth (CAGR) is achieved, rising to 100% vesting for achievement of a TSR CAGR of 10%. For shares issued under the plan during the year ended 30 June 2015, vesting is based on the absolute Total Shareholder Return (TSR) over the period, with 50% vesting if a TSR of 10% Compound Annual Growth (CAGR) is achieved, rising to 100% vesting for achievement of a TSR CAGR of 15%.If the hurdles are not met at the date of the initial test, the unvested shares are re-tested at the next test date. If any shares remain unvested after the 36-month period, they are able to be re-tested six monthly for a further two years, at which point they will lapse if unvested.
For share options granted during the financial year (these shares are treated as options for accounting purposes) the fair value of the options granted was determined by valuation specialists, using the Monte Carlo Simulation option pricing model (refer to Note 1R). The following inputs were used in the valuations:
==> picture [490 x 294] intentionally omitted <==
----- Start of picture text -----
|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|LTI SHARES GRANTED 3 AUG 2015|LTI SHARES GRANTED 5 AUG 2015|LTI SHARES GRANTED 24 AUG 2015|
|TRANCHE 1|TRANCHE 2|TRANCHE 3|TRANCHE 1|TRANCHE 2|TRANCHE 3|TRANCHE 1|TRANCHE 2|TRANCHE 3|
|Number of shares (treated|
|as options for|
|accounting)|2,495,627|3,743,441|6,239,068|194,999|292,499|487,499|446,269|669,403|1,115,672|
|Monte Carlo Simulation|
|model fair value|$0.3840|$0.4420|$0.4654|$0.3810|$0.4433|$0.4698|$0.2090|$0.2797|$0.3160|
|Share price at grant date|$1.20|$1.20|$1.20|$1.23|$1.23|$1.23|$0.995|$0.995|$0.995|
|Exercise price|$1.10|$1.10|$1.10|$1.1538|$1.1538|$1.1538|$1.13|$1.13|$1.13|
|Expected volatility|45%|45%|45%|45%|45%|45%|45%|45%|45%|
|Expected option life|2.5yrs|2.8yrs|3.3yrs|2.5yrs|2.8yrs|3.3yrs|2.3yrs|2.7yrs|3.2yrs|
|Dividend yield|0%|0%|0%|0%|0%|0%|0%|0%|0%|
|Risk-free rate|2.10%|2.10%|2.10%|2.19%|2.19%|2.19%|1.92%|1.92%|1.92%|
|LTI SHARES GRANTED 21 OCT 2015|LTI SHARES GRANTED 11 NOV 2015|LTI SHARES GRANTED 4 DEC 2015|
|TRANCHE 1|TRANCHE 2|TRANCHE 3|TRANCHE 1|TRANCHE 3|TRANCHE 3|TRANCHE 1|TRANCHE 2|TRANCHE 3|
|Number of shares (treated|
|as options for|
|accounting)|215,954|323,932|539,886|104,814|157,221|262,035|510,699|766,049|1,276,748|
|Monte Carlo Simulation|
|model fair value|$0.3355|$0.3917|$0.4158|$0.3230|$0.3817|$0.4080|$0.4165|$0.4833|$0.5124|
|Share price at grant date|$1.11|$1.11|$1.11|$1.11|$1.11|$1.11|$1.36|$1.36|$1.36|
|Exercise price|$1.02|$1.02|$1.02|$1.046|$1.046|$1.046|$1.23|$1.23|$1.23|
|Expected volatility|45%|45%|45%|45%|45%|45%|45%|45%|45%|
|Expected option life|2.1yrs|2.5yrs|3.0yrs|2.1yrs|2.5yrs|3.0yrs|2.0yrs|2.5yrs|2.9yrs|
|Dividend yield|0%|0%|0%|0%|0%|0%|0%|0%|0%|
|Risk-free rate|2.27%|2.27%|2.27%|2.27%|2.27%|2.27%|2.38%|2.38%|2.38%|
----- End of picture text -----
The expected volatility was determined based on historical volatility of the Company and of similar companies. The estimate reflects the likelihood that the volatility in financial markets over the next three to five years will be less extreme than that experienced during the global financial crisis, and also takes into account the likely stabilising impact of the capital raisings. The expected life of the share options is based on historical data and current expectations and is not necessarily reflective of exercise patterns that may eventuate.
74 Mayne Pharma Annual Report 2016
NOTE 28 – PARENT ENTITY DISCLOSURES
Financial position
| Financial position | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Assets Current assets Non-current assets Total assets Liabilities Current liabilities Non-current liabilities Total liabilities Net assets Equity Issued capital Reserves Accumulated losses Total equity Financial performance |
19,977 31,968 297,110 258,679 |
| 317,087 290,647 |
|
| 17,926 9,257 76,885 63,539 |
|
| 94,811 72,796 |
|
| 222,276 217,851 |
|
| 263,161 255,834 6,134 3,148 (47,019) (41,131) |
|
| 222,276 217,851 |
|
| 2016 $’000 2015 $’000 |
|
| Loss for the year Other comprehensive income Total comprehensive income |
(5,888) (3,832) (864) - |
| (6,752) (3,832) |
The parent entity has lease commitments of $1,280,000 at 30 June 2016 (2015: $1,415,000).
NOTE 29 – COMMITMENTS AND CONTINGENCIES
A. Commitments
Leasing commitments
The Group has entered into operating leases on warehouse and office space as well as equipment leases. Future minimum rentals payable under these operating leases are as follows:
| 2016 $’000 2015 $’000 |
|
|---|---|
| Within one year After one year but not more than five years After five years Total minimum lease payments |
982 800 1,860 1,446 235 337 |
| 3,077 2,583 |
Capital Commitments
The Group had $3,870,000 of contractual obligations for the purchase of capital equipment as at 30 June 2016 (2015: $158,000).
The Company announced plans to spend US$65m on the upgrade and expansion of its US manufacturing facilities. This work commenced in FY16 and will continue during FY17 and FY18.
B. Contingencies
The Company previously reported a contingency relating to a dispute with a former distributor who claimed loss of profits from an alleged breach of contract. The dispute went through a dispute resolution process as outlined in the contract and was finalised through arbitration in Hong Kong. The Company has reflected the outcome in this report (refer note 6).
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 last two years seeking information relating to the marketing, pricing and sales of select generic products. Mayne Pharma has more recently received a subpoena from the Office of the Attorney General in the State of Connecticut seeking similar information. The investigations are ongoing. External counsel have been engaged and the Directors’ current assessment is that, these investigations will not have a material impact on Mayne Pharma’s future earnings.
Based on currently available information, no reserves for costs associated with any anticipated litigation have been provided for in these financial statements, as management does not believe that such anticipated litigation meets the criteria for recognition.
Mayne Pharma Annual Report 2016 75
On 29 July 2016, Mayne announced it had entered into a settlement agreement with Forest Laboratories, LLC (“Forest”) relating to Mayne Pharma’s US Patent No. 6,194,000. In December 2013, Mayne Pharma filed a patent infringement lawsuit against Forest over Forest’s Namenda XR product, which was launched in the USA in June 2013. The settlement is expected to result in Mayne Pharma recording additional income of up to US$19.5m in FY17. This amount represented a contingent asset at 30 June 2016 however it did not meet the criteria to recognise as an asset at 30 June 2016.
NOTE 30 – DIVIDENDS
No dividends were paid or declared in the year ended 30 June 2016 (2015: nil).
Franking credit balance
| Franking credit balance | |
|---|---|
| 2016 $’000 2015 $’000 |
|
| Opening balance Franking credits arising from payments Franking credits that will arise from the payment of income tax as at the end of the financial year Franking credits available for future reporting periods |
3,384 2,769 4,846 615 12,319 1,811 |
| 20,549 5,195 |
NOTE 31 – BUSINESS COMBINATIONS
Business combinations are accounted for using the acquisition method. The cost of an acquisition is measured as the aggregate of the consideration transferred, measured at acquisition date fair value and the amount of any non-controlling interest in the acquiree.
For each business combination, the Group policy is to measure the non-controlling interest in the acquiree at the proportionate share of the acquiree’s identifiable net assets. Acquisition-related costs are expensed as incurred.
When the Group acquires a business, it assesses the financial assets and liabilities assumed for appropriate classification and designation in accordance with contractual terms, economic conditions, the Group’s operating or accounting policies and other pertinent conditions as at the acquisition date.
If the business combination is achieved in stages, any previously held equity interest is remeasured at its acquisition date fair value and any resulting gain or loss is recognised in profit or loss.
Any contingent consideration to be transferred by the acquirer will be recognised at fair value at the acquisition date. Subsequent changes to fair value of the contingent consideration which is deemed to be an asset or liability will be recognised in accordance with AASB 139; Financial Instruments Recognition and Measurement in profit or loss.
No business combinations were undertaken during FY16.
Control gained over entity during the prior year
Effective 15 May 2015, the Group gained control (for accounting purposes) of HPPI. The Group previously accounted for HPPI under the equity accounting rules (refer note 14). At reporting date the Group hold 49.4% of the issued capital of HPPI. The Group also hold warrants to acquire additional shares which potentially could increase Mayne Pharma’s interest to 57%.
As a result of gaining control, the Group consolidated HPPI from 15 May 2015.
The total cost of the acquisition included the following:
| The total cost of the acquisition included the following: | |
|---|---|
| $’000 | |
| Book value of the HPPI equity accounted investment Gain on restating the book value of the equity investment to fair value Additional capital invested Total value of consideration |
4,615 4,043 2,120 |
| 10,778 |
The Group recognised the fair values of the identifiable assets and liabilities acquired based on the information available at reporting date. The intangible assets include intellectual property.
76 Mayne Pharma Annual Report 2016
The provisional business combination accounting recognised in the prior year was as follows:
| PROVISIONAL RECOGNISED ON ACQUISITION $’000 |
|
|---|---|
| Cash and cash equivalents Other current assets Intangible assets Total identifiable assets acquired Payables – current Deferred tax liabilities Total identifiable liabilities assumed Fair value of identifiable net assets Non-controlling interests Total consideration Cost of the combination: Cash paid Net cash acquired with the subsidiary |
3,116 52 31,123 |
| 34,291 | |
| (647) (11,827) |
|
| (12,474) | |
| 21,817 (11,039) |
|
| 10,778 | |
| 2,120 (3,116) |
|
| (996) |
Note: The values above are based on the USD: AUD exchange rate applying at the date of acquisition.
The provisional accounting was subsequently finalised and no changes to the values above were made.
The value of the investment in HPPI at 30 June 2015 plus the value of the warrants held totalled $12,045,000. The value of the investment (and warrants) is dependent on the outcome of on-going clinical trials and subsequent FDA approvals.
From the date of gaining control to 30 June 2015, HPPI contributed nil revenue and $438,000 of expenses to continuing operations of the Group. If HPPI had been controlled for the whole of FY15, the contributed revenue would have been nil and the expenses would have been $3,548,000.
The strategic rationale for gaining control of HPPI was to accelerate HPPI’s clinical development program using Mayne Pharma’s patented oral formulation of Itraconazole, known as SUBA-itraconazole to treat certain cancers.
The Group gained control of HPPI (from an accounting perspective) by contributing cash in exchange for additional shares and by the Group having more influence (by agreement) over the operational activities of HPPI.
NOTE 32 – DEED OF CROSS GUARANTEE
As an entity subject to Class Order 98/1418, relief has been granted to Mayne Pharma International Pty Ltd (MPIPL) from the Corporations Act 2001 requirements for the preparation, audit and lodgement of their financial report.
As a condition of the Class Order, Mayne Pharma Group Limited and MPIPL entered into a Deed of Cross Guarantee on 28 June 2010. The effect of the deed is that the Company has guaranteed to pay any deficiency in the event of winding up of its controlled entity or if they do not meet their obligations under the terms of the liabilities subject to the guarantee. The controlled entity has also given a similar guarantee in the event that the Company is wound up or if it does not meet its obligations under the terms of loans or other liabilities subject to the guarantee.
Set out below are a Consolidated Statement of Profit or Loss and Other Comprehensive Income and a summary of movements in consolidated retained earnings/accumulated losses for the year ended 30 June 2016 of the closed group consisting of the Company and MPIPL.
Mayne Pharma Annual Report 2016 77
A. Consolidated Statement of Profit or Loss and Other Comprehensive Income and a summary of movements in retained earnings/(accumulated losses).
| CONSOLIDATED 2016 $’000 2015 $’000 |
|
|---|---|
| Continuing operations Sale of goods Services revenue License fee income Royalties revenue Revenue Cost of sales Gross profit Other income Research and development expenses Marketing expenses and distribution expenses Amortisation expenses Administration expenses and other expenses Finance costs Fair value movement in earn-out liability Acquisition costs Profit before income tax Income tax (expense)/benefit Net profit from continuing operations after income tax Other comprehensive income for the period, net of tax Total comprehensive income for the period attributable to owners of the parent |
103,242 49,353 10,284 9,721 391 494 1,090 1,096 |
| 115,007 60,664 (33,359) (26,468) |
|
| 81,648 34,196 14,511 6,822 (3,625) (2,199) (3,929) (5,465) (7,845) (3,865) (25,855) (10,491) (2,438) (68) |
|
| 1,001 (2,829) |
|
| (280) (658) |
|
| 53,189 15,455 |
|
| (18,312) (5,256) |
|
| 34,877 10,199 |
|
| (864) - |
|
| 34,013 10,199 |
|
| 2015 $’000 2014 $’000 |
|
| Retained earnings/(accumulated losses) at the beginning of the financial year Profit for the period Retained earnings at the end of the financial year |
13,149 2,950 |
| 34,877 10,199 |
|
| 48,026 13,149 |
78 Mayne Pharma Annual Report 2016
B. Consolidated Statement of Financial Position
Set out below is a Consolidated Statement of Financial Position as at 30 June 2016 of the closed group consisting of the Company and MPIPL.
| CONSOLIDATED 2016 $’000 2015 $’000 |
|
|---|---|
| Current assets Cash and cash equivalents Trade and other receivables Inventories Other current assets Total current assets Non-current assets Related party receivables Investment in subsidiaries Property, plant and equipment Deferred tax assets Intangible assets and goodwill Total non-current assets Total assets Current liabilities Trade and other payables Income tax payable Other financial liabilities Provisions Total current liabilities Non-current liabilities Interest-bearing loans and borrowings Other financial liabilities Provisions Total non-current liabilities Total liabilities Net assets Equity Contributed equity Reserves Retained earnings/(accumulated losses) Total equity |
27,036 39,043 7,100 5,187 12,406 9,684 660 409 |
| 47,202 54,323 |
|
| 188,556 120,666 68,790 67,112 26,149 22,595 3,465 508 85,978 89,467 |
|
| 372,938 300,348 |
|
| 420,140 354,671 |
|
| 9,325 6,833 12,308 1,978 1,344 7,659 3,273 2,985 |
|
| 26,250 19,275 |
|
| 76,163 60,776 - 1,244 1,451 1,245 |
|
| 77,814 63,265 |
|
| 103,864 82,540 |
|
| 316,276 272,131 |
|
| 262,191 255,834 6,059 3,148 48,026 13,149 |
|
| 316,276 272,131 |
Mayne Pharma Annual Report 2016 79
NOTE 33 – EVENTS SUBSEQUENT TO THE REPORTING PERIOD
On 28 June 2016, the Company announced 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”) for cash consideration of US$652m.
This asset purchase was completed on 3 August 2016.
The Company funded the acquisition via an extension of its existing debt facility (increased limit to US$400m), and a fully underwritten A$601m. 1-for-1.725 accelerated non-renounceable entitlement offer and A$287m placement. (Refer Note 8 for details of contributed equity changes).
Prior to settling the Teva transaction, the Company drew down the syndicated loan facility for an amount of US$150m which included rolling over the existing loan balance.
On 29 July 2016, the Company announced it had entered into a settlement agreement with Forest Laboratories, LLC (“Forest”) relating to Mayne Pharma’s US Patent No. 6,194,000. In December 2013, Mayne Pharma filed a patent infringement lawsuit against Forest over Forest’s Namenda XR product, which was launched in the USA in June 2013.The settlement is expected to result in Mayne Pharma recording additional income of up to US$19.5m in FY17. This amount represented a contingent asset at 30 June 2016 as it did not meet the criteria to be recognised as an asset at 30 June 2016.
On 18 August 2016 the Company acquired a portfolio of on-market dermatology Foam Assets from GSK for US$50.1m. Under the terms of the agreement Mayne Pharma will acquire the approved regulatory filings, trademarks, marketing materials, select product inventory, related medical and technical data and will acquire or obtain licenses for related patents.
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.
NOTE 34 – NEW AND REVISED ACCOUNTING STANDARDS
In the current year, the Group has adopted all new and revised Standards and Interpretations issued by the Australian Accounting Standards Board (the AASB) that are relevant to its operations and effective for the current annual reporting period:
The adoption of these new and revised Standards and Interpretations did not have any material financial impact on the amounts recognised in the financial statements of the Group, however they may have impacted the disclosures presented in the financial statements.
At the date of authorisation of the financial report, the following relevant Standards and Interpretations were issued but not yet effective:
-
(i) AASB 15 Revenue from Contracts with Customers (effective 1 January 2017).
-
(ii) AASB 9 Financial Instruments, AASB 2009-11 (effective 1 January 2018).
-
(iii) IAS 16, IAS 27 and IAS 38 amendments (effective 1 January 2016). These IFRS amendments have not yet been adopted by the AASB.
-
(iv) AASB 2014-3 Amendments to Australian Accounting Standards – Accounting for Acquisitions of Interests in Joint Operations (effective 1 January 2016).
-
(v) AASB 2014-4 Amendments to Australian Accounting Standards – Clarification of Acceptable Methods of Depreciation and Amortisation (effective 1 January 2016).
-
(vi) AASB 2014-10 Amendments to Australian Accounting Standards – Sale or Contribution of Assets between an Investor and its Associate or Joint Venture (effective 1 January 2016).
-
(vii) AASB 2015-1 Amendments to Australian Accounting Standards – Annual Improvements to Australian Accounting Standards 2012–2014 Cycle (effective 1 January 2016).
-
(viii) AASB 2015-2 Amendments to Australian Accounting Standards – Disclosure Initiative: Amendments to AASB 101 (effective 1 January 2016).
-
(ix) AASB 16 Leases (effective 1 January 2019)
With the exceptions of AASB 15 and AASB 16 which are yet to be assessed, it is anticipated that the adoption of these Standards and Interpretations in future periods will have no material financial impact on the financial statements of the Group.
80 Mayne Pharma Annual Report 2016
DIRECTORS’ DECLARATION
In accordance with a resolution of the Directors of Mayne Pharma Group Limited, we state that:
-
In the opinion of the Directors:
-
(a) The financial statements and notes of Mayne Pharma Group Limited for the financial year ended 30 June 2016 are in accordance with the Corporations Act 2001, including:
-
(i) Giving a true and fair view of its financial position as at 30 June 2016 and performance for the financial year ended on that date; and
-
(ii) Complying with Accounting Standards (including the Australian Accounting Interpretations) 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.
-
(c) There are reasonable grounds to believe that the members of the Closed Group identified in note 32 will be able to meet any obligations or liabilities to which they are or may become subject, by virtue of the Deed of Cross Guarantee.
-
(d) The financial statements and notes also comply with the International Financial Reporting Standards as disclosed in Note 1B.
This declaration has been made after receiving the declarations required to be made to the Directors in accordance with section 295A of the Corporations Act 2001 for the financial year ended 30 June 2016.
On behalf of the Board
Mr Scott Richards Managing Director and CEO
Dated at Melbourne, Australia this 25th day of August 2016.
Mayne Pharma Annual Report 2016 81
INDEPENDENT AUDITOR’S REPORT
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Ernst & Young Tel: +61 3 9288 8000 8 Exhibition Street Fax: +61 3 8650 7777 Melbourne VIC 3000 Australia ey.com/au GPO Box 67 Melbourne VIC 3001
Independent auditor's report to the members of Mayne Pharma Group Limited
Report on the financial report
We have audited the accompanying financial report of Mayne Pharma Group Limited, which comprises the consolidated statement of financial position as at 30 June 2016, the consolidated statement of profit and loss and other comprehensive income, the consolidated statement of changes in equity and the consolidated statement of cash flows for the year then ended, 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 year's end or from time to time during the financial year.
Directors' responsibility for the financial report
The directors of the company are responsible for the preparation of the 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 financial report that is free from material misstatement, whether due to fraud or error. In Note 1(a), the directors also state, in accordance with Accounting Standard AASB 101 Presentation of Financial Statements , that the financial statements comply with International Financial Reporting Standards .
Auditor's responsibility
Our responsibility is to express an opinion on the financial report based on our audit. We conducted our audit in accordance with Australian Auditing Standards. Those standards require that we comply with relevant ethical requirements relating to audit engagements and plan and perform the audit to obtain reasonable assurance about whether the financial report is free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial report. The procedures selected depend on the auditor's judgment, including the assessment of the risks of material misstatement of the financial report, whether due to fraud or error. In making those risk assessments, the auditor considers internal controls relevant to the entity's preparation and fair presentation of the financial report in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity's internal controls. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by the directors, as well as evaluating the overall presentation of the financial report.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.
Independence
In conducting our audit 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
82 Mayne Pharma Annual Report 2016
INDEPENDENT AUDITOR’S REPORT (CONT)
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Opinion
In our opinion:
-
a. the financial report of Mayne Pharma Group Limited is in accordance with the Corporations Act 2001, including:
-
i giving a true and fair view of the consolidated entity's financial position as at 30 June 2016 and of its performance for the year ended on that date; and
-
ii complying with Australian Accounting Standards and the Corporations Regulations 2001; and
-
b. the financial report also complies with International Financial Reporting Standards as disclosed in Note 1(a).
Report on the remuneration report
We have audited the Remuneration Report included in pages 27 to 34 of the directors' report for the year ended 30 June 2016. The directors of the company are responsible for the preparation and presentation of the Remuneration Report in accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards.
Opinion
In our opinion, the Remuneration Report of Mayne Pharma Group Limited for the year ended 30 June 2016, complies with section 300A of the Corporations Act 2001.
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Ernst & Young
==> picture [84 x 56] intentionally omitted <==
Ashley C Butler Partner Melbourne 25 August 2016
A member firm of Ernst & Young Global Limited Liability limited by a scheme approved under Professional Standards Legislation
Mayne Pharma Annual Report 2016 83
ASX ADDITIONAL INFORMATION
Additional information required by the Australian Stock Exchange Ltd and not shown elsewhere in this report is as follows. The information is current as at 7 September 2016.
DISTRIBUTION OF ORDINARY SHAREHOLDERS AND SHAREHOLDINGS
| SIZE OF HOLDING | NUMBER OF SHAREHOLDERS NUMBER OF SHARES NUMBER OF OPTION HOLDERS NUMBER OF OPTIONS |
|---|---|
| 1 to 1,000 1,001 to 5,000 5,001 to 10,000 10,001 to 100,000 100,001 and over Total |
1,332 13.77% 680,743 0.05% - - 2,633 27.21% 8,080,621 0.54% - - 1,715 17.72% 13,240,491 0.89% - - 3,209 33.16% 104,319,289 7.00% 18 1,619,000 787 8.13% 1,364,506,872 91.53% 45 28,155,000 |
| 9,676 100% 1,490,828,016 100% 63 29,774,000 |
Included in the above total are 427 shareholders holding less than a marketable parcel of 271 shares.
OPTIONS
There are 29,774,000 options on issue held by 63 individual option holders. Options do not carry a right to vote.
TWENTY LARGEST HOLDERS OF QUOTED ORDINARY SHARES
| SHARES % OF TOTAL |
|
|---|---|
| HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED 287,933,494 19.31 J P MORGAN NOMINEES AUSTRALIA LIMITED 204,549,657 13.72 CITICORP NOMINEES PTY LIMITED 113,979,058 7.65 NATIONAL NOMINEES LIMITED 113,002,163 7.58 MR BRUCE MATHIESON AND RELATED ENTITIES 90,269,499 6.05 INVESTMENT HOLDINGS PTY LTD 83,424,599 5.60 BNP PARIBAS NOMS PTY LTD 52,268,416 3.51 AUSTRALIAN FOUNDATION INVESTMENT COMPANY LIMITED 20,361,238 1.37 R & JS SMITH HOLDINGS PTY LTD 15,995,041 1.07 IVL GROUP PTY LTD 14,776,627 0.99 MR SCOTT RICHARDS AND RELATED ENTITIES 15,745,589 1.06 RBC INVESTOR SERVICES AUSTRALIA NOMINEES PTY LIMITED 12,886,957 0.86 CITICORP NOMINEES PTY LIMITED 11,239,403 0.75 MR ROGER CORBETT AND RELATED ENTITIES 10,284,769 0.69 HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED 9,861,006 0.66 WAL ASSETS PTY LTD 9,193,503 0.62 MR WILLIAM HODGES AND RELATED ENTITIES 8,406,554 0.56 AMP LIFE LIMITED 7,519,394 0.50 UBS NOMINEES PTY LTD 7,510,045 0.50 MIEKE INVESTMENTS PTY LTD 5,528,985 0.37 |
SUBSTANTIAL SHAREHOLDERS
The names of substantial shareholders in the Company who had notified the Company in accordance with Section 671B of the Corporations Act are:
Mr Bruce Mathieson and related entities Westpac Banking Corporation
6.1% 5.0%
84 Mayne Pharma Annual Report 2016
INTELLECTUAL PROPERTY & GLOSSARY
Astrix, Doryx, Eryc, Esgic, Kadian, Kapanol, Magnoplasm, Lozanoc, SUBAGItraconazole and Zebutal are registered trademarks of the Consolidated Entity.
For further information on Mayne Pharma’s products, refer to the product section of the Company’s website, http://www.maynepharma.com/products/us-products/ or http://www.maynepharma.com/products/australian-products/.
Itragerm™ is a registered trade mark of ISDIN, S.A.
Tikosyn™ is a registered trade mark of Pfizer Inc.
GLOSSARY
ANDA – Abbreviated New Drug Application. An application to market a generic drug in the USA. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
API - Active Pharmaceutical Ingredient. An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.
BA – Bioavailability. A measure of the fraction of a drug that enters the systemic blood circulation after oral administration.
BE – Bioequivalence. Two drug products are considered bioequivalent if they exhibit the "same" Cmax, Tmax and AUC in a properly powered pharmacokinetic study. In other words the two drug products have the plot of "drug concentration in plasma" against "time". The actual definition of "same" when applied to the pharmacokinetic parameters varies from country to country. If two drug products are bioequivalent then it is assumed that they are therapeutically equivalent. A bioequivalence study is the cornerstone of an ANDA or any generic drug application, because for the reasons given here, bioequivalence obviates the need to perform long and expensive clinical studies.
DR - Delayed Release. A drug product (typically oral) that is not intended to release the drug substance immediately after ingestion. The delay is commonly related to change of pH in the gastrointestinal tract ("enteric coating") or less commonly may relate to a specific time after ingestion when the drug is released. Enteric coating is achieved by coating with polymers that are poorly soluble in low pH media (for example gastric fluid), but are soluble in media with pH values typically found lower in the intestine.
FDA – US Food and Drug Administration. The US FDA is responsible for protecting public health by assuring the safety, efficacy and security of, amongst other things, human drugs.
NDA - New Drug Application. When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States.
OTC - Over-the-Counter Drugs. Drugs that are considered safe and effective by the FDA and TGA for use by the general public without a doctor's prescription.
PIV - Paragraph 4 filing. A type of ANDA submitted during the patent term of the originator product. The filing asserts that either the patents supporting the originator product are invalid or that they are not applicable to the product that is the subject of the ANDA.
PK – Pharmacokinetics. The study of the time course of the way the body handles drugs. There are four essential processes following a persons ingestion of a tablet or other oral dosage form, collectively known as ADME processes (Absorption of the drug from the gut; Distribution of the drug into other body tissues; Metabolism of the drug to other chemicals (metabolites) and Elimination of the drug from the body). This time course is typically followed by taking blood samples from volunteers at time intervals following swallowing a tablet, and measuring the amount of drug and / or metabolites in the plasma. A plot can be constructed of plasma concentration against time from which various PK parameters such as Cmax, Tmax and AUC can be derived.
TGA – Therapeutic Goods Administration. The TGA is Australia's regulatory authority for therapeutic goods.
Mayne Pharma Annual Report 2016 85
CORPORATE INFORMATION
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|---|---|
|DIRECTORS:|Mr Roger Corbett, AO (Chairman)|
|Mr Scott Richards (Managing Director and CEO)|
|Hon. Ron Best|
|Mr Bruce Mathieson|
|Mr Ian Scholes|
|Mr William (Phil) Hodges|
|Prof Bruce Robinson|
|Nancy Dolan|
|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:|EY Australia|
|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|
|BANKERS:|Westpac|
|150 Collins Street|
|Melbourne VIC 3000|
|National Australia Bank Limited|
|500 Bourke 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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86 Mayne Pharma Annual Report 2016
Mayne Pharma Group Limited ABN 76 115 832 963 maynepharma.com