The go to European specialist pharma company

The ‘go to’ European specialist pharma company Annual Report 2015 Norgine is a leading European specialist pharmaceutical company that has been esta...
Author: Emily Ray
44 downloads 2 Views 2MB Size
The ‘go to’ European specialist pharma company Annual Report 2015

Norgine is a leading European specialist pharmaceutical company that has been established for 110 years and has a presence in all major European markets.

New commercial partnerships to acquire assets

Divestment to focus on EU infrastructure

Product milestones

Major infrastructure investment

Agreement with

Divested Norgine’s

Obtained

Opened a new

Navidea for the

rights in the UK

reimbursement

£4.5 million

commercialisation

for NORGALAX

for XIFAXAN

temperature

and distribution of

(docusate sodium)

LYMPHOSEEK

®

®

Vision 2020:

Norgine is the ‘go to’ European specialist pharma company Norgine believes that high quality health

In 2015, Norgine made inroads towards

outcomes are best achieved through

achieving that vision and showed that its flexible

constructive partnerships with health services,

and agile approach to partnerships is the

health professionals and patients.

right one to win opportunities and to integrate,

In 2014, Norgine outlined its vision to be the ‘go to’ European specialist pharma company and the organisation that other companies

in Europe

Divested South

®

in England and

controlled

Wales

warehouse in Hengoed, Wales

African operations

Launched

and product rights

ENDOCUFF

Invested

Apharm for the

VISION in the

to increase

distribution of

UK, Austria,

manufacturing

Agreement with

®

ZIVEREL in

Germany, Spain,

capacity for

Spain, Australia

Switzerland,

MOVICOL®,

and New Zealand

Australia and

MOVIPREP®

New Zealand

and NER1006

®

Acquisition of a 70% stake

NER1006

in Arc Medical

achieved primary

Design Ltd and

endpoints in all

its ENDOCUFF

three Phase III

products

clinical trials

Norgine is a patient-centric organisation

develop and commercialise new products quickly for the benefit of patients in Europe

In keeping with its long term strategy, Norgine’s focus continued to be upon the development

and across the globe.

and marketing of products that address significant unmet clinical needs in gastroenterology, hepatology, critical and supportive care.

come to, in order to develop and market their products in Europe.

In 2015, Norgine’s key products MOVICOL®, MOVIPREP® and XIFAXAN® were used by 11.3 million patients.1 As a patient-centric company, Norgine continued to provide support to patient and professional groups through grants and sponsorship. In 2015, Norgine supported 23 patient groups in Europe, Australia and New Zealand.

1

1. XIFAXAN® 550: COGNOS sales, (calculated assuming 130 day duration of therapy) / MOVICOL®: 2015 actual sales, (calculated assuming 100 days of treatment on average per year and per patient) / MOVIPREP®: number of procedures assuming that one patient would have one procedure per year.

2

Norgine’s total operating charges for the year, excluding extraordinary impairments, were €307 million, an increase of 5% from 2014 (2014: €293 million).

Key Financial Figures for 2015

€320M

Despite the continuing difficulties in the European pharmaceutical

Net financial income for the year was €32 million (2014: €4 million) and includes €27 million

market, Norgine has maintained respectable sales growth and

net proceeds with respect to the sale of Norgine’s business in South Africa.

increased product sales by more than the overall market.

Norgine’s result after income tax was a profit of €21.1 million (2014: €4.3 million).

In 2015, Norgine achieved a total consolidated net product revenue

Total revenue

of €300 million, an increase of 6% from 2014 (2014: €284 million). The revenue increase was primarily due to an increase in the sales

€300M

of Norgine’s three flagship products MOVICOL®, MOVIPREP® and XIFAXAN® in Norgine’s core markets.

Product sales

During the year, Norgine received payments of €4.1 million (2014:

6% Growth

€2.8 million) related to the achievement of contractual milestones by Norgine’s partners and generated revenue of €7.1 million (2014:

Annual growth

€2.5 million) from the disposal of non-strategic products.

2015

2014

Net product sales

300

284

6%

Milestones & other income

20

14

43%

€320M

€298M

Building strong partnerships is key to Norgine’s business strategy to become the ‘go to’

Balance Sheet

European specialist pharma company.

ASSETS €M

2015

2014

Non-current assets

 

 

Intangible fixed assets

23

20

Tangible fixed assets

43

39

Financial fixed assets

38

40

Current assets

 

 

Inventories

39

41

Receivables

75

75

 

What sets Norgine apart from other companies is its flexible and agile approach to collaboration. Norgine has a number of ways of working with partners, whether it’s through a joint venture, a profit share or as an investor or conventional licensee.

Norgine licenses in or acquires a partially developed product:

Cash and cash equivalents     TOTAL ASSETS   Equity and Liability €M

69

19

78.9

98.4

 

 

€287M

€233M

 

 

 

 

Equity

186

156

Provisions

16

19

Non-current liabilities

25

3

Current liabilities

60

56

  TOTAL EQUITY AND LIABILITIES

3

Growth

Norgine in 2015: continuing to deliver Vision 2020

 

 

€287M

€233M

Norgine owns the asset outright and controls all future development

or

Norgine shares responsibility for future development in collaboration with the licensor

Norgine and a partner create a special purpose vehicle (SPV) to own and develop specified product assets in which the partner wishes to retain an interest: Norgine manages the SPV

or

Norgine acts as an investor and service provider for a company that has its own management

4

New partnership deals signed in 2015

Divestment of non-core assets

With Norgine’s established infrastructure and extensive history of working in Europe

In 2015, Norgine divested some of its non-core assets and activities to reinforce its strategic focus on Europe.

(and Australia and New Zealand), Norgine continued to make significant headway in

Norgine sold its rights in the UK for NORGALAX® (docusate sodium) and, in September 2015, Norgine divested its South

identifying new partners and signing new partnership deals in 2015.

African operations and product rights Pharmacare Limited, a wholly owned subsidiary of Aspen Pharmacare Holdings.

Navidea Biopharmaceuticals Inc. (NYSE MKT: NAVB)

Hengoed

Manufacturing Part of Norgine’s strength as a partner lies in its high quality

In March 2015, Norgine and its affiliate SpePharm AG, entered into an

manufacturing and distribution facilities in Hengoed, Wales

agreement with Navidea Biopharmaceuticals for the commercialisation

and Dreux, France.

and distribution, in Europe and other key markets, of LYMPHOSEEK® (technetium Tc 99m tilmanocept).

Hengoed

Hengoed

In November 2015, Norgine opened its new £4.5 million temperature controlled warehouse in Hengoed, Wales, as part of a programme

Radiolabelled LYMPHOSEEK® is approved in the US and Europe for

of investments to substantially increase the manufacturing capacity

imaging and intraoperative detection of sentinel lymph nodes draining

of powder products.

a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.

Arc Medical Ltd

Dreux

In April 2015, Norgine acquired a 70% stake in Arc Medical Design Ltd. Arc Medical Design’s existing management remained in position and retained a 30% ownership stake in the business. Prior to acquiring the majority stake in Arc Medical Design Ltd, Norgine entered into an agreement with Arc Medical Design Ltd to commercialise and distribute ENDOCUFF VISION®, a Class 1 sterile medical device used in colonoscopy, across a number of major European markets, Australia and New Zealand.

Apharm s.r.l. In June 2015, Norgine entered into an agreement with Apharm s.r.l. to distribute ZIVEREL® in Spain, Australia and New Zealand. ZIVEREL® is a Class III medical device used to maintain the integrity of the oesophageal mucosa to avoid the irritation of the oesophagus caused by stomach acid, amongst other causes.

Through this investment, Norgine will continue to meet the needs of patients worldwide by delivering high quality products, while continuing to adhere to stringent compliance requirements that regulate the pharmaceutical sector. In addition, a number of significant efficiency improvements were introduced at Hengoed, which further contributed a substantial increase in its output of MOVICOL® and MOVIPREP®. Of note, in 2015, the Hengoed site was awarded the RoSPA Health and Safety Award in recognition of excellence in safety performance.  Norgine also introduced new supply chain systems in the Dreux facility in France, on top of other measures to improve manufacturing capacity and to prepare for the manufacture of a new product scheduled for launch in 2016.

5

6

Patient and professional organisations supported by Norgine in 2015

Patient engagement Over the years, Norgine has established relationships with key opinion leaders, professional

Alianza para la prevención del Cáncer de colon, Spain

Conseil National Professionnel d’Hépato-Gastroentérologie, France

Beating Bowel Cancer, UK

Asociación de pacientes con síndrome de Lynch, Spain

Deutschland gegen Darmkrebs, Germany

Selbsthilfgruppe Darmkrebs, Austria

Stop Darmkanker, Belgium

Dutch Digestive Foundation, The Netherlands

Stiftung LebensBlicke, Germany

Bowel Cancer, UK

Felix Burda Foundation, Germany

Spanish Digestive Society Foundation, Spain

organisations and health services to help navigate complex systems and ensure that patients gain access to its effective products. Norgine has a long history of actively working with patient groups, academics and other organisations and in 2015, Norgine supported 23 such organisations.

Governance In 2015, Norgine continued to operate and meet the strict regulatory requirements which govern the

Raising the profile of hepatic encephalopathy and liver disease

pharmaceutical sector. Norgine seeks to always remain compliant with relevant laws, regulations and the Norgine Business Code. All Norgine employees are expected to conduct their duties according to the highest ethical and professional business standards.

Norgine provided several educational grants and sponsorships to the European liver community to help raise the profile and awareness of hepatic encephalopathy and liver disease among clinicians and policy makers. Hepatic encephalopathy is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis. Norgine supported the European Liver Patients Association to launch a new call to action report ‘Time to DeLiver: Getting a Grip on HE’ at the European Parliament in Brussels.

This was the first report at a European level to highlight the significant burden of hepatic encephalopathy on patients, their carers, families and society as a whole. In Denmark, Norgine made a donation to a liver patient group, Leverforeningen, to organise a health debate regarding liver diseases. In the UK, Norgine supported the Foundation for Liver Research in their work to raise the awareness of liver disease with UK parliamentarians and drive forward the implementation of the recommendations of the Lancet Commission on liver disease.

Continuing to support detection of colorectal cancer As a leader in bowel cleansing and colonoscopy, Norgine continued to collaborate with key European patient organisations to increase the detection of colorectal cancer and to help improve patients’ quality of life. Colorectal cancer is the second most common cause of cancerrelated mortality in the world,1 with nearly 1.4 million new cases diagnosed worldwide and 412,000 people in Europe.3,4

7

2. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J et al.  Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. Eur J Cancer 2013;49:1374-1403. 3. Colorectal Cancer Statistics, World Cancer Research Fund International, http://www.wcrf.org/int/cancer-facts-figures/ data-specific-cancers/colorectal-cancer-statistics [Accessed 3 March 2016]. 4. Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915.

8

MACROGOL 3350, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE

MOVICOL® continued to reinforce its leading position in Europe,

Priority 1:

generating more than €159 million in sales (a 2% decrease in sales compared to 2014). Although MOVICOL® was launched 20 years ago and is subject to generic competition in many markets, it continues to

Achieve double digit growth

be the market leader in Europe in its class. Norgine remains focused on providing a product that is trusted by patients and prescribers.

Growing Norgine’s core products – MOVICOL®, MOVIPREP® and

Norgine continued to expand MOVICOL®’s uptake in new markets by

XIFAXAN and raising the profile and reach of its other products is

announcing a collaboration with its partner Modi-Mundipharma to sell

central to delivering Norgine’s goal to achieve double digit growth.

MOVICOL® Paediatric Plain and MOVICOL® Liquid in India.

®

While total sales growth, net of divestments, was short of the long

to its portfolio, Norgine strengthened its colon

term target of sustained double digit growth, the progress made with

cancer prevention and detection portfolio to

Norgine’s newer products sets the stage for attaining this objective

improve quality in colonoscopy, and ultimately

in the near future. MOVIPREP® Norgine’s second largest product generated sales of Product Sales (€ million) Product Maximising the growth of our flagship products

Indication

2014

2015

Growth in 2015

MOVICOL®

Constipation

161

159

-2%

MOVIPREP®

Bowel preparation

45

51

12%

XIFAXAN®

Traveller’s diarrhoea and hepatic encephalopathy

With the addition of ENDOCUFF VISION®

€51 million, representing 12% growth on 2014 sales. MOVIPREP® is currently available in Europe and Australia through Norgine’s own infrastructure and in Eastern Europe, the US, India, Japan and Canada via partners. Norgine continues to accelerate the launch of MOVIPREP® in new markets. In Japan, MOVIPREP® has become the largest product in its class.

to enhance health outcomes for patients. ENDOCUFF VISION®, a medical device, is a single-use endoscopic overtube which fits onto the distal end of an endoscope. The device can lead to a significant increase in lesion detection during colonoscopy which means patients avoid the need for repeat procedures.

22

34

52%

Through this acquisition, Norgine has demonstrated that it has the flexibility to The XIFAXAN® franchise (traveller’s diarrhoea and hepatic encephalopathy) continued to develop rapidly, with sales of €34 million, an increase of more than 52% over 2014. XIFAXAN® 550, which can reduce the risk of overt hepatic encephalopathy recurrence in patients aged 18 years and over, is a major growth driver for Norgine. XIFAXAN® 550 was granted reimbursement status in England and Wales by The National Institute for Health and Care Excellence (NICE) and in Switzerland by the Bundesamt für Gesundheit.

quickly integrate, develop and commercialise new products. ENDOCUFF VISION® was launched in April 2015 in the UK and subsequently in other European markets – Austria, Germany, Spain and Switzerland, and Australia and New Zealand. Since its launch, Norgine has been working with national and local healthcare systems to ensure that ENDOCUFF VISION® is used as part of the treatment pathway to improve the visualisation of the colon and detect adenomas, polyps and cancer. Norgine has high expectations for ENDOCUFF VISION® and sees it as one of the products that will drive Norgine’s sales in the future.

9

10

Acquiring and developing new high-quality products that will change medical care and add value to patients and payers is a priority for Norgine. In 2014, as part of our Vision 2020 strategy, Norgine redefined its priorities to focus on late stage development opportunities. In 2015, Norgine began to realise the benefit of this approach and made progress in the development of its pipeline, in particular for MOVICOL® Ready to Take and NER1006.

Priority 2:

Strengthen the late stage pipeline

NER1006 NER1006 is a novel, low volume polyethylene glycol (PEG) 3350-based bowel preparation that has been developed by Norgine to provide whole bowel cleansing, with a focus on the ascending colon. Norgine reported that NER1006 achieved both of the primary endpoints in each of the three phase III clinical trials carried out for the product.

MOVICOL® Ready to Take MOVICOL® Ready to Take is the latest addition to the MOVICOL® product range. It has been developed to enable patients to take their laxative at any time of the day to fit into their daily routine. MOVICOL® Ready to Take obtained Australian regulatory approval and Norgine initiated the European regulatory procedure with the view to launching the product in 2016.

LYMPHOSEEK® Norgine worked to develop a more suitable LYMPHOSEEK® formulation for the EU market. Norgine developed a revised single patient use vial formulation which is currently undergoing evaluation by the European Medicines Agency. Subject to successful review Norgine would anticipate approval in late 2016 with potential launches in multiple EU countries by early 2017.

Priority 3:

Be a dynamic place to work

Norgine employs over 1,100 staff across 14 sites. Of these people, 30% work in manufacturing and supply, 35% in commercial activities and 12% in development, medical and regulatory, with the remainder in general and administrative roles. Being a dynamic place to work is a strategic priority for Norgine. Norgine’s goal is to ensure that Norgine’s employees are always encouraged and able to challenge the status quo so they can find and test new and better ways of working and help meet Norgine’s overall objectives. Norgine believes that all of its employees contribute to its future success. In 2015, following the retirement of Jo Pillai, Vice President of Human Resources, Norgine welcomed the appointment of Tara Barry to the role of Vice President of Human Resources.

MUGARD® MUGARD® is a medical device for the prevention and management of the symptoms of oral mucositis, a painful mouth condition frequently seen in patients undergoing cancer therapy. Norgine proceeded with the development of MUGARD®. Registration remains on track with an anticipated approval in 2016. Launches are planned in selected markets towards the end of 2016.

CAMETOR®/OBLEAN® In Japan, our partner Takeda obtained approval for OBLEAN® by the Pharmaceuticals and Medical Devices Agency with a price recommended by the Ministry of Health, Labour, and Welfare. Takeda is currently waiting to obtain final approval for reimbursement. Norgine is still actively seeking collaboration partners for CAMETOR® in the rest of the world.

11

12

Executive Team

Looking forward to 2016 Norgine’s positive performance in 2015 has created a solid platform for the future. Norgine continued to deliver strong sales of its flagship

Peter Stein

Chief Executive Officer

Peter Martin

Chief Operating Officer

products despite challenging market conditions and progressed several drivers of future growth. In 2016, Norgine’s management will continue to work towards achieving Norgine’s strategic objectives and realising its long-term vision to be

Christopher Bath Chief Financial Officer

Paul Pay

Chief Business Development Officer

widely recognised by potential partners as the ‘go to’ European specialist pharma company. In order to fulfil this vision, Norgine’s management will continue to focus on using Norgine’s expertise and established infrastructure in Europe

Kenneth Scrimgeour Chief Commercial Officer

Sheila Hopkins Chief Legal Officer

(plus Australia and New Zealand) to ‘win’ global and local partnership opportunities that expand Norgine’s product portfolio in gastroenterology, hepatology, critical and supportive care, as well as other specialist areas that can be effectively accessed through its infrastructure.

Dr Donna McVey

Chief Development Officer

Dr Malcolm Taylor

Chief Manufacturing Officer

New asset acquisitions will remain a priority for Norgine and a number of registrations, launches and reimbursements are anticipated for 2016, including:

Jo Pillai

Vice President, Human Resources (Retired in November 2015)

Tara Barry

References All product names mentioned in this report are trademarks owned by or licensed to the Norgine group of companies, unless otherwise noted.

XIFAXAN® 550 is expected to be authorised for reimbursement in Belgium, the Netherlands and France

Vice President, Human Resources ENDOCUFF VISION® will be launched in Italy, Portugal, Belgium, France and the Netherlands LYMPHOSEEK® is expected to gain approval by the European Medicines Agency for a new formulation ZIVEREL® will be launched in Spain, Australia and New Zealand MOVIPREP® is expected to be launched in Russia, Armenia, Belarus, Uzbekistan and Kyrgyzstan through the Takeda partnership MOVICOL® Ready to Take is expected to be launched in key European markets NER1006 will be submitted for approval in the US with launch planned for late 2017 and soon thereafter in the EU MUGARD® which is expected to be approved and launched in selected markets

13

14

NORGINE and the sail logo are registered trademarks of the Norgine group of companies.