MAYNE PHARMA GROUP LIMITED — AGM Information 2013

Nov 25, 2013

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ASX Announcement

ANNUAL GENERAL MEETING

MINTER ELLISON LEVEL 23, 525 COLLINS ST, MELBOURNE VIC 3000 AT 10.30 AM ON 26 NOVEMBER, 2013

CEO’S ADDRESS

Thank you Roger, Good morning Ladies and Gentlemen.

It is a pleasure to be speaking to you today at my second Mayne Pharma AGM. I am very excited about where we are heading with this business and the outlook for the future.

I believe our company has enormous potential and I and the leadership team in Australia and the United States are very committed to pursuing both organic and inorganic growth opportunities and leveraging off our established product base, people, manufacturing facilities and technologies.

Roger has taken you through the highlights over the past year. I would now like to give you an update on how each of the 4 segments are performing.

In summary, sales in all 4 segments have shown growth over the first 4 months of this financial year versus the prior corresponding period. Total Group sales for this period were $45m, up 230% over the prior period driven largely by the acquisition of Metrics and strong rebound in the performance of Doryx®.

Firstly, our domestic sales operations here in Australia, which we call Mayne Pharma Australia or MPA.

Mayne Pharma is committed to building its domestic business in Australia through not only improving the sales and marketing of its existing proprietary products but also by in-licensing and acquiring attractive niche products in channels and therapeutic areas with limited competition.

We now have marketing rights to sell 8 products in Australia today, up from just 5 products in FY12. Over the last 12 months we have launched Percutane® – a pain relief cream, and our pain product Kapanol®. Licener®, a plant based natural head lice treatment, will be launched in early 2014. In the coming year, we expect to more than double the number of marketed products in our Australian portfolio with the addition of SUBACAP®, which is on track for approval by the TGA in the first half of next year, and a range of injectable molecules that we in-licensed from Intas Pharmaceuticals. The first wave of injectables will be launched from mid 2014.

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As most of you know, we acquired the Kapanol® franchise in Australia in February this year which enabled us to recruit a national sales force. This sales team has been out in the field for almost 6 months and made over 2,000 visits to GPs and other prescribers. Kapanol® is a long acting oral opioid used to treat moderate to severe pain, and the product has some key advantages over other drugs in the class. Under its previous owners, the product was not actively marketed and had been in steady decline for more than 5 years. I am pleased to report that we have now stabilised the sales of this product and we are starting to see some positive upward trends. It does take time to change the prescribing habits of physicians, and I remain convinced we can grow this franchise materially in the coming years.

Turning now to Mayne Pharma Global which includes our sales to international marketing partners.

The most significant product in this segment is Doryx® which is sold in the US through our marketing and distribution partner, Warner Chilcott which has just been acquired by Actavis for over US$8 billion to create one of the world’s leading specialty pharmaceutical companies. I know the Actavis leadership and I believe they will continue to support Doryx® with the same level of commitment shown by Warner Chilcott over many years.

In FY13, Doryx® faced a challenging first half due to the launch of a competing 150mg generic product which negatively impacted our manufacturing volumes. The second half performance of Doryx® rebounded strongly with sales more than double the first half and we also received FDA approval for a 200mg strength tablet during that period.

The launch of the 200mg tablet occurred in July this year and sales are tracking above expectations. During the month of September, the 200mg tablet represented 60% of Doryx® prescriptions, indicating strong market response to this new formulation. With 3 years of exclusivity granted by the FDA, we are confident that we will see solid growth in our Doryx® branded franchise in FY14.

The other major near term event in this segment is the launch of SUBACAP® in Europe which is on track for launch in the UK in early 2014 and mid 2014 in Spain. The Company has manufactured launch stocks with bulk capsules shipped to Eastern Europe for packaging.

In terms of other markets, the Company continues to progress the commercialisation of SUBACAP® globally and is in discussions with potential marketing partners in many other markets around the world including Canada, China, Japan and Korea. In the US, we are close to finalising the regulatory path and remain confident that we will submit a New Drug Application (NDA) for this product with the FDA in 2014.

Moving to the US businesses.

Our US Generic Products segment continues to perform strongly in FY14 with the approval and launch of several new products. As Roger mentioned earlier, the generic doxycycline hyclate and erythromycin products are both performing well in the US with multiple contracts signed with the key drug store chains. Libertas, which we acquired on the 2[nd] of July is also tracking ahead of our expectations.

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Since we reported our full year results in August, the Company has filed a further 3 ANDAs with the FDA and now has 10 generic products filed. These products are targeting markets with sales of US$800m per year. Of the 10 filed products, 3 have been granted expedited review, which should see those products approved in a more timely manner. The FDA grants an expedited review process in certain circumstances such as when there is a nationwide shortage of the drug or when a filing is the first generic filed and there are no blocking patents or exclusivity periods for the reference listed drug.

In terms of approval times for these filed products, we are still confident that some of these will be approved and launched in this financial year, but as we mentioned back in August the timing of this remains uncertain due to the backlog of applications that the FDA has and the recent US public service shutdown which has also caused minor delays.

In addition to the filed products we also have another 10 products in various stages of development and we will continue to add more products into the development pipeline each year.

In order to support the R&D pipeline, the company is in the process of expanding its development laboratories in the US to provide additional capacity to absorb a broader array of new development programs. The expanded development facility will be in operation early in 2014.

The last business I will discuss is Contract Services, our fee for service business based in the US

Metrics Contract Services segment is a fee for service business with approximately 100 clients ranging from big pharma through to smaller biotechnology and specialty pharma companies. This business operates in the US CDMO industry which is valued at over US$20bn. The industry is highly fragmented with the top 10 firms accounting for less than 40% of the market. Favourable industry dynamics are supporting increased outsourcing trends by pharmaceutical companies to lower costs and increase efficiencies.

This segment remains very important to the overall business and has been a key enabler of the development of our US generic platform as it provides capability and know-how for the products business.

We have recently strengthened the management team in this segment with the appointment of Mr John Ross as EVP, Contract Services. John will be a great addition to this business as he brings an extensive track record and capability in developing and growing contract development and manufacturing organisations and also brings functional expertise in marketing and sales, manufacturing and distribution, global sourcing and supply chain. I believe we can accelerate the growth of the fee for service business under John’s leadership.

Other staffing changes in the US business include the appointment of Stefan Cross as President of Mayne Pharma USA. Stefan is now based in the US as of two weeks ago and is responsible for all our US business operations.

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In Australia, we have also added two senior executives to our management team this year:

• Danny Dragovic has joined as Director of Business Development. Danny joins us from Fresenius-Kabi where he’s led numerous global in-licensing programs for their pharmaceutical business.

• Kate Rintoul has joined us from Minter Ellison as VP and General Counsel. Kate is responsible for all our worldwide legal operations.

That concludes my update on the business. In closing, I would like to thank you all for your ongoing support of our Company and I look forward to reporting to you on our progress in the coming year. I will now hand back to Roger to complete the formal part of the meeting.

For further information contact: Scott Richards +61 8 8209 2410 Lisa Pendlebury +61 419 548 434, lisa.pendlebury@maynepharma.com

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