Corporate Report 2014

Xellia 2014 1 CONTENTS

Contents

2 Xellia at a glance

3 2014 highlights

5 Spotlight on growth

9 Business overview

15 Corporate responsibility

24 Corporate governance

Forward-looking statement This report contains certain projections and other forward-looking statements with respect to the fi nancial condition, results of operations, businesses and prospects of New Xellia Group A/S (“Xellia”). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future.

Xellia 2014 1 Headquartered Owned by in Copenhagen, Novo A/S since XelliaXellia atat aa glanceglance July 2013

Xellia is a specialty pharmaceutical company

focused on providing important anti-infective A GLANCE XELLIA AT treatments against serious and often life-threatening infections

Xellia is developing novel effective against resistant species in partnership with SINTEF Materials and Chemistry and the Statens Serum Institut supported by a grant from the Research Council of Norway

Oslo, Norway Our new state-of–the-art R&D Center of Excellence focused on APIs and discovery of novel anti-infectives opened in November 2014

Copenhagen, Denmark Xellia’s headquarters. Our biggest operation, manufactures both sterile APIs and FDFs, provides lyophilized vials and dry powder Budapest, Hungary Manufactures several unique products and fill vials, stability testing and packaging provides additional capacity for . This facility houses fermentation pilot plants, and is our site for introducing and scaling-up new APIs

Chicago, USA Commercial Shanghai, China organization in Commercial and back-office Xellia’s major market organization supporting the work with partners in the Chinese market

Tokyo, Japan Commercial organization handling the challenging Japanese market

Raleigh, USA Acquired from Fresenius Kabi in July 2014, our first US manufacturing facility significantly expands our capacity for the production of Taizhou, China Established in 2008 as a injectable pharmaceutical products partnership with Zhejiang Hisun Pharmaceutical Company, Ltd. Bangalore, India CMO and commercial group established to manage growing network of CMOs Key: and to capitalize on emerging market opportunities including India Manufacturing Zagreb, Croatia R&D Our Product and Innovation R&D Center Sales of Excellence focused on innovative Other formulation technologies and FDFs

1000 500 100 Xellia has over 1,000 We supply our anti-infective Over 100 years’ experience in employees in eight countries products to more than 500 the development, manufacture around the world pharmaceutical companies and supply of generic in over 70 countries fermented and semi-synthetic 1 APIs and FDFs

Xellia is the leading supplier of important anti-infectives Vancomycin and Colistimethate Sodium (CMS) Xellia 2014 2 be abletomeet customerdemand. new facility in facilities inCopenhagen aswell asthe expanding ourvialmanufacturing the year we continuedtofocuson a key part in thisrespect,andduring vials manufacturing facility played Copenhagen, approvals fromtheUS to customersintheUSfollowing of several injectableanti-infectives D for ourUScustomers. service ofsupplying this market andtoprovide abetter opportunity forustoexpand in first facility intheUS.Itwasagreat supply agreement. a continuousmanuf A a preferred,trustedsupplierof F W North Carolinafrom manufacturing facility in lyophilized (freeze-dried)vial In Julywe acquiredadedicated for usthisyear. innovation were significantobjectives to increaseourfocuson to betterserve ourcustomersand challenges. strategically despitesomeoperational In 2014we madeexcellent progress Operations 2014 business inordertoprioritizeoureffortswithininnovative anti-infectives. certain activitiesinadjacenttherapeutic areasthatwere notcoretoour produce genericanti-infectives; however duringtheyear we discontinued of moreinnovative andproprietaryanti-infective products. We continueto to increaseandrefocusourresourcesondeveloping abalancedportfolio products, we areprogressively re-shapingourbusiness.During2014we decided pharmaceutical ingredients(API)andinjectablefinisheddosageform(FDF) manufacture andsupplyofimportantgenericanti-infective active While Xellia’s businesshasalwaysbeengroundedinthedevelopment, and governance by ourindependentBoardofDirectors. Novo A/S,acommittedlong-terminvestor withlifesciencesectorinsights, It wasalsoourfirstentire year ofoperations underthe ownership of 2014 wasanimportantyear ofstrategic investment andgrowth forXellia. resenius Kabiformanyy P uring 2014w e have beeninpartnershipwith Is andtheacquisitionincludes E xpansion ofthebusiness D R e commenced supply e commencedsupply enmark ly aleigh, NCinorderto R acturing and aleigh isXellia’ FDF F resenius Kabi. FD R highlights ophilized ophilized products R A. Our A. Our & ears as aleigh, D and

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selected forinclusioninthe visit. one ofonlythree a StatevisittoCroatia.Xelliawas from Center washonoredtoreceiv Inno doubled capacityatour Oslo, Norway,andhave extended and art relocation ofournew state-of-the- D for ourproducts. efficiencies andcarbonfootprint sites aimedatimproving energy in 2013acrossourmanufacturing sustainability program initiated we have continuedtobuildonthe pharmaceutical industry.In2014, a challengingenvironmentforthe facilities, inwhatcontinuestobe regulators acrossallmanufacturing compliance track recordwiththe year we maintainedourimpeccable I would alsolike tohighlightthatthis was discussed. heritage inantimicrobialproducts infectious diseasesandXellia’s has played inthebattle against the importanceofroleXellia D F M Consort, togetherwiththe D Croatia. InOctober isheries, enmark and uring atourofthelabor uring they inister for R vation & HM D Centerof

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2014 HIACCOUNTSGHLIGHTS 2013 2014 highlights continued...

The combination of the operational Innovation In 2010 we formed Pharmaero ApS, 2014 HIGHLIGHTS challenges and the increase in With the continued investment in a joint venture with Scandinavian resources spent on expanding innovation, we are extending our Health Ltd, a significant player in the our injectable vial manufacturing R&D to focus on improving the injectable device space, to address facilities in Copenhagen and efficacy, safety profile and reducing unmet medical needs in providing Raleigh to meet customer demand the side effects of existing anti- anti-infective treatments localized to negatively impacted the Company’s infectives and developing new drugs the lung and respiratory tract. In 2014 profitability for the year and will to help tackle the global crisis of we continued the development of also have an impact in 2015. Despite antimicrobial resistance. We have drug-device combination products this we were able to achieve our embarked on an ambitious path to providing liquid anti-infective overall performance indicators and develop a pipeline of unique and formulations for inhalation used meet customer requirements and proprietary anti-infective products for the treatment of Pseudomonas expectations at a satisfactory level. starting with line extensions based aeruginosa infections in cystic fibrosis Products and markets on improved formulations, drug- patients. Further clinical studies are Our generic anti-infective business device combinations and in the long planned for 2015, and beyond. is built to meet the immediate and term new anti-infective compounds. Outlook for 2015 long-term requirements of our We appointed an eminent Scientific As we look ahead we will continue customers comprising branded, Advisory Board in 2014 to support to build on the strong platform specialty and generic pharmaceutical us as we increase the breadth of for growth that we established in companies in more than 70 countries our science beyond manufacturing 2014. Going the extra distance to around the world. Our vertical of anti-infective generics to place our customers at the center integration strategy enables us to support more innovative product of everything we do, and innovation supply our customers with multiple developments. The Board, which in R&D will continue to drive the product forms, supply security from is chaired by Professor George Group’s progress, maintaining and multiple sites and provide a ‘one- E Griffin, Emeritus Professor of extending our leadership position in stop-shop’, offering both the API Infectious Disease and Medicine at the development, manufacture and and the FDF. St George’s, University of London, supply of critical and life-saving The ratio of API and FDF products UK had its inaugural meeting in anti-infectives. sold in 2014 was 66.7% to 33.3% December. It brings together leading In closing, I would like to take this respectively, moving towards our international scientific advisors with opportunity to thank all of our longer-term strategic aim for a more expertise in infectious diseases, customers for their support, the balanced figure with 50% of sales clinical microbiology, respiratory originating from APIs and 50% from Board for their counsel and every medicines and pharmaceutical FDFs. The transition to the supply of member of the Xellia team for research and development. FDFs allows us to help simplify and their dedication which has made streamline the supply chain for our In February 2013 we announced 2014 such a pivotal year. We have customers by providing a final product. a four year collaboration with developed an ambitious strategy for further development and growth, We are constantly extending the prestigious research groups at and we are excited about the future range of products that we offer SINTEF Materials and Chemistry, potential for the Group in 2015, our customers, completing 13 filings based in Trondheim, Norway, and and beyond. in 2014. In 2015, we are expecting the Statens Serum Institut in this momentum to continue with Copenhagen, to identify and develop approximately 10 planned new antibiotics effective against applications. In the medium term the multi-drug resistant, Gram-negative number of filings will be reduced bacteria. The project is supported by as a consequence of our refocused a 3 MUSD grant from the Research strategy to develop more proprietary Council of Norway and incorporates products. Underpinning this strategy contributions from other laboratories is our commitment to provide across Europe. Research continues to excellent quality and service to progress well and we hope to be able Carl-Åke Carlsson our customers and continuing to achieve the project aim with the CEO improvements to our manufacturing identification of new anti-infective processes and capacity. drug candidates. Xellia 2014 4 Spotlight on growth... LIGHT ON GROWTH LIGHT A closer look at three key SP OT investments of 2014

Xellia 2014 5 Spotlight on... Raleigh Raleigh, NC, USA

First US manufacturing facility ON RALEIGH SPOTLIGHT

In July we acquired our fi rst US manufacturing site. The facility provided a great opportunity for us to expand our manufacturing capabilities into the US, a key market for Xellia, and to better serve our US customers. The Raleigh site is located close to Research Triangle Park, a world famous biotech and pharmaceutical hub. 90 Employees Capabilities Manufacture of lyophilized injectable anti-infective products

Xellia is committed to increasing its employees at the site by almost 50%.

Xellia 2014 6 Oslo Spotlight on... Oslo, Norway R&D Center of Excellence for APIs ONSPOTLIGHT OSLO

We opened a new active pharmaceutical ingredients (API) R&D Center of Excellence in Oslo, Norway in November. The new 1,900m2 state-of-the-art facilities are being used to develop new products, and to improve the manufacture and continuity of supply of existing products used in treatments of serious, life threatening infections.

Capabilities • Development of new fermentation and semi-synthetic based APIs • Development of novel and improvement of 50 existing producing microbial strains • Identifi cation and implementation of process Employees improvement opportunities in the upstream and downstream manufacturing process • Discovery of new hit and lead compounds to target multi-drug resistant Gram-negative bacteria

The research team is working with scientists at SINTEF Materials and Chemistry (Trondheim, Norway) and the Statens Serum Institute (Copenhagen, Denmark) on the projects to discover new chemical entities supported in part by a grant from the Research Council of Norway.

Xellia 2014 7 Spotlight on... Zagreb Zagreb, Croatia

Product and Innovation Center of Excellence for FDFs ON ZAGREB SPOTLIGHT

In June we completed work to signifi cantly expand our Product and Innovation R&D Centre in Zagreb to a footprint of more than 1,250m2 including 650m2 of state-of-the-art laboratories. The team in Zagreb focuses on the development of new generic and innovative proprietary anti-infective products and formulation technologies to combat serious bacterial and fungal infections, including resistant varieties.

Capabilities • Development of new generic and innovative proprietary anti-infective products • Identifi cation and implementation of process improvement 40 opportunities focusing on advanced formulation technologies • Development of proprietary line extensions based on Employees innovative improved formulations, novel drug-device combinations, new drug comibations and novel indications for existing products (New Therapeutic Entities, NTEs) • Enhancements to and revival of the use of existing important last-line anti-infective treatments for multi-drug resistant bacteria

HM The Queen Margrethe II of Denmark and HRH The Prince Consort together with the Danish Minister for Food, Agriculture and Fisheries, Mr. Dan Jørgensen visited the site on Wednesday 22 October during a State visit to Croatia. Xellia was one of only three Danish companies selected for inclusion in the visit.

Xellia 2014 8 Business overview BUSINESS OVERVIEW

Xellia 2014 9 Customer focus MER FOCUS CUSTO

Xellia aims to be the preferred partner for global supply of fermented and semi-synthetic anti-infectives for critical care to the pharmaceutical industry and continues to focus strongly on its customers. We believe in building strong and lasting relationships with our broad customer base through our commitment to providing first-class products, excellent quality and service.

Our customers consist of branded, outstanding technical services evolve This approach is now central to specialty and generic pharmaceutical to meet the challenges our customers our business as it provides major companies in more than 70 countries face in the ever-changing healthcare benefits to our customers through who rely on us to ensure continued landscape. We work closely with convenience and streamlining of the supply thereby protecting their customers to help them in developing supply chain, reducing logistical reputation and patients. The success their products for their markets costs, while enabling them to meet of our business is based on and needs. their market needs. The majority of customer satisfaction and loyalty, FDFs in Xellia’s portfolio are While the origins of our business injectables; however we also develop demonstrated by longstanding and started with the supply of quality other forms when they are important often multi-product repeat orders. fermented difficult-to-manufacture for our key products. Other delivery We ensure that our industry-leading APIs, we are now strongly focused on forms include creams, ointments and supply capability for our core anti- adding value for our customers by inhalation devices. We are continually infective products, as well as our providing the final dosage form. expanding our FDF product portfolio.

Gram-Negative Gram-Positive Antibacterials Antifungals Antibacterials

Vancomycin Base Sulfate Caspofungin Polymyxin Vancomycin HCl

APIs CMS Teicoplanin Amphotericin B Bacitracin Zinc

Tigecycline Vancomycin Tobramycin Voriconazole FDFs Polymyxin Vancomycin Daptomycin Caspofungin CMS Teicoplanin Bacitracin

Attractive FDF Pipeline in Development

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement. Key Capsules Vials

Xellia 2014 10 Anti-infectives: Our core product offering ANTI-INFECTIVES

Anti-infectives are a cornerstone of modern medicine. Xellia’s anti-infective treatments are generics that combat serious bacterial and antibiotic- resistant infections and certain fungal diseases. As “tried and tested” medicines generics are typically available at signifi cantly lower costs than their brand equivalents. As a result of the need to control rapidly rising healthcare costs in developed countries, and the inability of patients in developing countries to afford live-saving medicines, Xellia’s anti-infective products are becoming increasingly important for global health.

An example of the relevance of an in diffi cult-to-manufacture and OF REVENUE IS “old” drug which is still providing a develop anti-infectives. >10% INVESTED IN R&D meaningful solution is Vancomycin, Our core capabilities support the In June we completed work to of which we are the leading global discovery, development, signifi cantly expand our Product and industry supplier. This drug is still manufacture and continuity of supply Innovation R&D Centre in Zagreb, considered the gold standard of treatments for serious and life- Croatia. (page 8). We also relocated treatment for certain Gram-positive threatening diseases. Our R&D and opened a new API R&D Center of bacteria, including methicillin- teams are constantly evaluating and Excellence for APIs in Oslo, Norway resistant strains of Staphylococcus in November (page 7). developing technologies that aureus (MRSA), Streptococci spp. enhance our processes and products, To guide us in this extension of and Clostridium diffi cile. Despite the and optimize manufacturing. our scientifi c capabilities we availability of newer compounds, appointed a Scientifi c Advisory In addition to the manufacture and Vancomycin remains the “last resort” Board (page 13-14). The Board antibiotic in the treatment of severe supply of generic anti-infectives brings together leading international staphylococcal infections where other we decided to increase and scientists and clinicians with antibiotics cannot be used due to refocus our resources in 2014 to expertise in infectious diseases, patient intolerance or drug resistance. develop a balanced portfolio of clinical microbiology, respiratory Xellia is renowned for its expertise more innovative and proprietary medicines and pharmaceutical and innovative approach, specializing anti-infective products. research and development.

Xellia’s production process – built on core capabilities

1. Strain and MANY COMMON fermentation development INFECTIONS WILL NO 2. LONGER HAVE A CURE Purification AND, ONCE AGAIN,

3. COULD KILL UNABATED.

Final World Health Organisation handling (WHO) 2013

4.

Formulation development. 5. Standard forms and delivery devices

Delivery to customers

Xellia 2014 11 Anti-infectives: Innovation ANTI-INFECTIVES

Developing improved drugs innovative Drug Delivery Systems Certain drugs in our portfolio which with proprietary drug-device are effective against Gram-negative combinations. As an example, to DRUG-RESISTANT address unmet medical needs in the bacteria such as the polymyxin class INFECTIONS ALREADY which consists of and treatment of respiratory infections Colistimethate Sodium (CMS), a we founded Pharmaero in 2010. KILL HUNDREDS OF derivative of colistin (polymyxin E) Pharmaero is a 50:50 joint venture THOUSANDS A YEAR with Scandinavian Health Ltd to have been used for over 60 years GLOBALLY, AND BY 2050 without developing a significant develop novel aqueous droplet inhalation (ADI) devices to provide microbial resistance. However, THAT FIGURE COULD BE anti-infective treatments localized they are often a last-line treatment to the lung and respiratory tract for MORE THAN 10 MILLION. due to elevated nephrotoxicity out-patient use. which affects kidney function and THE ECONOMIC is therefore not ideal for systemic Building an anti-infective pipeline COST WILL ALSO BE treatment of multi-drug resistant Over the past 30 years, no major SIGNIFICANT, WITH infections. Xellia’s innovative R&D new class of antibiotics has been team is working in partnership with discovered with very few antibiotics THE WORLD ECONOMY scientists at SINTEF Materials and from existing classes being approved BEING HIT BY UP TO Chemistry, Norway and Statens by the regulatory agencies. With this $100 TRILLION BY 2050 Serum Institut, Denmark to extend in mind we announced a four year the use of this class of polymyxin collaboration in 2013 with SINTEF IF WE DO NOT TAKE drugs by reducing the toxicity Materials and Chemistry, the ACTION. and side effects, thereby making Statens Serum Institut with Jim O’Neill, them safer and more suitable for contributions from other laboratories Chairman of the Review on AMR 2014 intravenous use. across Europe to identify and In addition, through in-house discover new antibiotics effective programs and partnerships against multi-drug resistant, we are developing unique and Gram-negative bacteria.

The fight against antimicrobial resistance While anti-infectives have saved millions of lives worldwide, some of these drugs are losing their effectiveness due to antimicrobial resistance, caused by a microbe’s natural ability to evolve genetically and thereby counter the effects of these drugs. Antimicrobial resistance is now recognized as one of the world’s most serious threats to human health. Infections from resistant bacteria are becoming increasingly common, and some pathogens also known as “superbugs” have even become resistant to multiple types or classes of antibiotics. This means there are fewer, or sometimes no effective treatments available for infections caused by these multidrug resistant (MDR) microbes. The loss of effective antibiotics will reduce our ability to fight infectious diseases and manage the complications or secondary infections common in vulnerable patients such as immunosuppressed patients or ageing populations.

Xellia 2014 12 RD B OA

Scientific Advisory Board Y SCIENTIFIC ADVISOR The Scientific Advisory Board is crucial to ensuring the success of our new focus in innovative anti-infectives. The Board brings together leading international experts in infectious diseases, clinical microbiology, respiratory medicines and drug research and development. The insight and guidance provided by the Board will combine with Xellia’s specialist expertise to support innovations in anti-infective discovery and development.

Professor George E Griffin Emeritus Professor of Infectious Disease XELLIA HAS ATTRACTED and Medicine at St George’s, University of London, UK AN IMPRESSIVE BOARD OF Professor Griffin is a world renowned expert SCIENTIFIC AND CLINICAL in infectious diseases. His work has involved ADVISORS WHICH I AM developing cellular, molecular and whole body research aimed at defining how humans adapt PROUD TO CHAIR. to infection with TB and HIV. In addition he has ANTIMICROBIAL RESISTANCE used vaccination in humans to define normal IS A HUGE AREA OF UNMET and perturbed immune response. MEDICAL NEED AND Professor Griffin has held a number of appointments on the Wellcome Trust and MRC ONE OF THE GREATEST grants committees and was part of the Gates THREATS TO HUMAN Grand Challenge grant awarding committee. HEALTH. BY WORKING He is Chairman of the Advisory Committee in Dangerous Pathogens, responsible for advising TOGETHER, WE CAN FOCUS the British Government. ON OVERCOMING THE CHALLENGES ASSOCIATED WITH DEVELOPING IMPROVED, AND NEW DRUGS TO COMBAT THESE SERIOUS Dr Andreas Rummelt Professor Gerhard Winter BACTERIAL AND FUNGAL Member of Xellia Board of Directors Department of Pharmacy, Ludwig INFECTIONS. supporting R&D. Also CEO and Maximilian University of Munich, Germany Partner at InterPharmaLink AG, Professor Winter is an expert in Basel, Switzerland Professor George Griffin formulation development and delivery of Chairman of the Scientific Advisory Board Dr Rummelt’s international career biopharmaceutical drugs, colloidal drug in pharmaceuticals has focused carriers, parenteral process technologies in the areas of pharmaceutical and lyophilization. development, generics, Before moving to academia, he spent manufacturing and quality. more than 12 years working in the He has served more than twenty pharmaceutical industry. During this time years in executive management he was responsible for market formulations positions in the industry. of erythropoietin, ibandronate and reteplase and led a formulations research team on parenteral drugs, focusing on biotech products.

Xellia 2014 13 RD B OA

Scientific Advisory Board continued... Y SCIENTIFIC ADVISOR

Professor Christoph Tang Dr Tania Pressler Professor Anne O’Donnell The Sir William Dunn School of Chief Attending Physician, Rigshospitalet, Professor and Chief, Division of Pathology, University of Oxford, Copenhagen, Denmark Pulmonary, Critical Care, and Sleep Oxford, UK Dr Pressler has been working in Medicine, Georgetown University Professor Tang leads a research Cystic Fibrosis since 1982 and is the Hospital, Washington DC, USA group which is focused on defining the Consultant Physician at the Julianes Professor O’Donnell has particular mechanisms of important bacterial Maries Center, Outpatient Clinic for Cystic interests pulmonary diseases, with pathogens that cause disease in humans, Fibrosis and other chronic lung diseases in special focus in bronchiectasis, and applying these findings to the children at the Copenhagen University respiratory infections including development of vaccines and Hospital, and Director of the Copenhagen nontuberculous mycobacterium, therapeutics. Cystic Fibrosis Centre for both children sleep apnea and sleep disorders, cystic His research group has a number and adults. fibrosis and non-invasive ventilation. of prestigious collaborations with In addition to clinical responsibilities, institutes in the UK, Europe and the US Dr Pressler holds a research position at and Professor Tang has published over the Department of Clinical Microbiology 100 papers in peer-reviewed journals. where she is involved in a number of research projects and international collaborations.

Professor Arjana Tambić Professor Keith S Kaye Andrašević Division of Infectious Diseases Head of the Department of Clinical and Department of Medicine at Wayne Microbiology at the University Hospital State University and Detroit Medical for Infectious Diseases, Zagreb, Croatia Center, Detroit, USA. Professor Andrašević is active in many He is also the Corporate Medical national and international organizations Director of Hospital Epidemiology and committees. and Antimicrobial Stewardship for She is President of the Croatian Society both institutions. for Clinical Microbiology, the Croatian Professor Kaye’s academic interests Committee for Antibiotic Resistance are the epidemiology of and outcomes Surveillance and the Interdisciplinary associated with multi-drug resistant Section for Antibiotic Resistance Control bacteria; infections in the elderly; surgical at the Croatian Ministry of Health. site infection; device-related infections She is also the national representative for and antimicrobial stewardship. He is a number of prominent European antibiotic currently a Principal Investigator on a and antimicrobial resistance initiatives. multi-center NIH-funded contract studying colistin-based therapy for infections due to extremely drug resistant Gram-negative bacilli. Professor Kaye has authored over 100 peer-reviewed articles and 15 book chapters.

Xellia 2014 14 Corporate responsibility E RESPONSIBILITY CORPOR AT

Xellia 2014 15 Xellia and corporate responsibility E RESPONSIBILITY CORPOR AT

At Xellia we value integrity and openness, and are committed to a high level of compliance in all aspects of our work. As a global business with international customers it is vital that we have a uniform set of standards that can be applied to our business regardless of the country in which we operate. Over the following pages we have provided an overview of our corporate responsibility activities and performance, focusing on economic, environmental and social areas. Our corporate responsibility program is at an early phase. We are actively working to expand our corporate responsibility policies across the entire business and to update or introduce systems and platforms that will progress our corporate responsibility practices further. In future reports, we aim to report more measurable goals to track our performance over the coming years. We also continue to work on alignment of the content in this report with the relevant standards on sustainability reporting produced by the Global Reporting Initiative (GRI). In 2014 we established a Corporate Social Responsibility (CSR) steering group headed by our CEO and with participation of senior management representatives from functions including Operations, Human Resources, EHS (Environment, Health and Safety), Communication and Legal. The role of the group is to monitor and follow up on the progress of corporate responsibility initiatives across different areas of our business. The following part of this report meets the requirements in Section 99a of the Danish Financial Statements Act (Årsregnskabsloven) with respect to CSR reporting and constitutes part of the annual report of New Xellia Group A/S and Xellia Pharmaceuticals ApS (our Danish operating subsidiary).

Economic sustainability Continuing sustainable growth and development, and the protection of our employees is paramount to our future success. Many internal and external stakeholders rely on us to maintain a consistent supply of high quality products and to invest and borrow wisely to create a strong and stable business.

Continuity of production The sustainable production of We also invested in significant anti-infectives for critical care expansion of our Product and forms the foundation of Xellia. Innovation R&D Centre of Excellence We ensure consistent and in Zagreb, Croatia as well as new continuous manufacture and supply state-of-the-art facilities for our API of the products that our customers R&D Centre of Excellence in Oslo, rely on from our global production Norway which replaced the R&D sites through: center at the former manufacturing • Rigorous monitoring of quality site in Oslo. and manufacturing systems In addition, in 2014 we acquired THE SUSTAINABLE • Investment in new capacity a dedicated lyophilized PRODUCTION OF and equipment (freeze-dried) vial manufacturing facility in Raleigh, North Carolina from ANTI-INFECTIVES FOR • Improvement of existing products Fresenius Kabi. The manufacturing CRITICAL CARE FORMS and processes site is our first facility in the US THE FOUNDATION and significantly expands our In the full year of 2014, we invested OF XELLIA 17 MUSD in tangible assets to increase manufacturing capacity for injectable and improve our production capacity. pharmaceutical products.

Xellia 2014 16 continued... Xellia completed thefi rstcertifi cation. Copenhagen, Denmarkfacility under OHSAS 18001andour Taizhou, Chinaremained certifi ed our Budapest,Hungaryfacility and and controlassociatedrisks.In2014, implement effective management and safetyframework fromwhich to which provides anoccupationalhealth recognized OHSAS 18001standard We applytheinternationally responsibility fortheirsafety. employees take personal recognized andmitigated, where theserisksareclearly inherent risks. We promoteaculture our operations involve certain company producinganti-infectives As apharmaceuticalmanufacturing manufacturing sites. standards thatwe applyacrossour management anddetailedEHS sets outourkey principlesforEHS Health andSafety(EHS)policywhich We have adoptedanEnvironment, safety acrossallofourlocations. standards ofoccupationalhealthand committed tomaintaininghigh than 1,000employees andare working environmentforourmore create ahealthy,safeandsecure At Xellia,we constantlystrive to occupational safety High level ofhealthprotectionand create long-termvalue. us toinvest infuturegrowth plansto a strongfi nancialposition;enabling repaid infull,whichhasplacedus enabled allmajorloanfacilities tobe Xellia by Novo A/SinJuly2013 sustainability. The acquisitionof and we work hardtoensurefi nancial sustainable businessbenefi tsusall We believe thatastableand Financial stability and corporate responsibility accidents to5.0in2020. maximum frequencyofwork-related a long-termtargettoreducethe achieved. In2014we alsoestablished 1,000,000 working hours,whichwas accidents atalloursitesbelow 8.0per the frequencyofwork-related corporate KPIsin2014wastokeep occupational accidents.Oneofour to measurethefrequencyof We usetheOHSAS standard take actiontoprevent reoccurrence. reporting andinensuringthatwe We areresponsive inaccident 1000 1100 6.0% 7.0% 8.0% 9.0% 100 800 900 20 40 50 60 70 80 10 (accident frequencyrate per1,000,000working hours) 0 0 5 Employee turnover rate (voluntary resignations) 2011 855 8.1% 2011 2011 8 2010 Employee survey (engagement) Total numberofemployees O Recordable injuryrate verall index 0221 2014 2013 2012 907 2012 0221 2014 2013 2012 6 7.1% 2012 E 7.1% 929 ngagement 2013 3.5 2014 1067 2014 7.8% 4.5

Xellia 2014 17 2014

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sites. did notreceive anycomplaintsat from ourlocalcommunity;in2014we complaints regardingodorandnoise proximity tous. impact onthepeoplelivinginclose we work tominimizeanynegative sites arelocatedinurbanareasand internally andexternally. M matters withallstakeholders both communication onenvironmental encourage open,reliable R&D sitesaroundtheworld and boundaries ofourproductionand business canstretchbeyond the W Stakeholders which we arebased. good neighborstothecommunitiesin measures toensurethatwe remain seriously andhave implemented before they cantake place. environment by preventing incidents standards andpoliciestoprotectthe these riskswe have implemented B an inherentrisktotheenvironment. and processesfromwhichthereis the useofcertainhazardousmaterials development of anti-infectives involve The manufacture, qualitycontroland to minimizeincidents Identifying environmentalrisks wherever possible. and take stepstolimitnoiseandodor monitor noiselevels frommachinery y understanding and identifying y understandingandidentifying e know thattheimpactofour W e take complaintsvery W W e receive very few ith carefulmanagementwe cangrow our W e constantly e constantly ost of our ost ofour is minimized. the localcommunityandourbusiness that anyimpactontheenvironment, they areeffectively managedand ensure thatifincidentsdooccur management plans. These programs management programs into emergency responseandcrisis incidents. Allsitesincorporate responsibility towards preventing and encourage asenseofpersonal culture amongstouremployees W prevent reoccurrence. in 2014aswell asactionplansto causes oftheincidentthatoccurred performed thoroughanalysisofthe environmental incidentsandwe have It isourambitiontoprevent any environment duetotheseincidents. H Copenhagen, D incidents atourproductionsitesin a totalofsixminorenvironmental achieved. global productionsiteswhichwe environmental incidentsacrossour a corporate KP As inprevious years, in2014itwas potential environmentalaccidents. identification andprevention of W ungary. There wasnoimpacttothe e are building a risk-aware e arebuildingarisk-aware e arecommittedtothe

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2014 18 2014

CORPORATE RESPONSIBILITYACCOUNTS 2013 Xellia and corporate responsibility continued... E RESPONSIBILITY CORPOR AT

Carbon footprint and sustainability We take a collective approach to sustainability and encourage our employees to take an active interest in minimizing the impact of our operation on the environment. In 2014, we continued the sustainability program that we commenced in 2013 which includes publishing regular “Xellia Green Info” newsletters. This updates the team on what is being done to meet our environmental targets and how employees can help. We welcome input, feedback and suggestions from all staff as to how we can further improve our commitment to the environment. All our sites employ a specialist team In previous years we have focused on focusing solely on energy use and the carbon footprint of our largest how to improve energy consumption API, Vancomycin. In 2014 we worked efficiencies. Our energy consumption with external consultants to calculate strategy is defined in close and evaluate the total carbon collaboration with each site’s EHS footprint of all products produced teams, purchasing departments and at each of our manufacturing sites. engineering departments (energy We completed this work in 2014 and management specialists). During on that basis will set short and long 2014 there were ongoing energy term targets for improving the carbon projects at each of our sites based footprint of both our API and FDF on new techniques and technologies production over the coming years. to reduce energy consumption. Energy and water efficiency Our sustainable water management We understand the importance of process is focused both on creating managing the use of energy and water efficiencies in the use of water at our sustainably and take our responsibility manufacturing sites and on improving to protect this precious resource very our discharge treatment systems and seriously. We have established short implementing systematic quality and long term targets for improving controls for effluents to help preserve our efficiency with respect to energy the availability of drinking water and and water consumption. to prevent any risk of contamination.

Xellia 2014 19 Xellia and corporate responsibility continued... E RESPONSIBILITY

Social responsibility Our people make us what we are. We aim to attract the most talented, productive employees in our CORPOR AT industry and to earn their loyalty and commitment. We support and protect our employees through comprehensive human resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

Improving human resources processes Business Conduct Guidelines Anti-bribery program The Xellia Business Conduct We adopted an improved anti-bribery Guidelines, established in 2008, program in 2012 which aimed to set out the principles that must reduce the risk of non-compliance. be adhered to by all employees. The anti-bribery program includes The guidelines cover key areas annual risk assessments, due that are essential to our business diligence procedures for agents and including compliance and fair other business partners and adoption dealings in relevant areas and a of corporate guidelines for gifts, copy is presented to each employee hospitality and entertainment. on joining Xellia. In addition, all We believe that a successful employees at manager level and anti-bribery program is spearheaded above are required to certify annually by informed, aware employees that they have acted in compliance and during 2012, 2013 and 2014 with the guidelines. Any alleged ensured that all relevant parts of or suspected cases where the the organization received training in guidelines may have been violated are the program. investigated by selected members of our corporate functions. In 2014 there were no cases of alleged or suspected violations of the guidelines. Conflict of interest It is imperative to the maintenance of our good reputation that business decisions are made independently from conflicts of interest and on an objective basis. These decisions must not be influenced by any personal interests which employees may have, wherever in the world they work, and at whatever level of seniority they operate. We have established procedures including the pre-approval of any ‘related party’ transactions by the Board of Directors as well as an annual certification of compliance by all senior employees.

Xellia 2014 20 Xellia and corporate responsibility continued...

Employee surveys

We ask all employees to participate RESPONSIBILITY CORPORATE in employee surveys at regular intervals, usually on a biannual basis. 10 8 These surveys address a number

6 of areas such as motivation,

5 4.5 satisfaction and communication. 3.5 The survey is followed up both at a All affected employees received senior management level and in each 0 2011 2012 2013 outplacement2014 support to help them function and department. The 2014 Recordable injury rate fi nd jobs elsewhere or training grants employee survey showed the overall (accident frequency rate per 1,000,000 workingto enter hours) a new profession. We were index to be at the same level as in also able to offer alternative roles 2012. One area that showed a strong within Xellia to some employees. improvement was the “engagement” Change, diversity and Of the employees affected by category. This included: redundancies in 2013 and 2014, employee turnover • 78% of employees responding 1100 by the end of 2014 more than 1067 favorably to the statement “I am Managing change 70% had either found a new job, proud of working at Xellia and would Our1000 business exists in a highly are in education or retired. gladly tell people about it” (up from competitive, dynamic environment.929 907 Employee relations 73% in 2012 and 62% in 2010) Our commitment900 to open communication 855 and engagement remains strong as We operate across diverse social • 82% responding favorably to we support800 employees through the backgrounds and locations where “I am committed to Xellia and what 2011 2012 2013 2014 internal and external changes that continued and constructive dialogue it stands for” (up from 74% in 2012 infl uence us. Total number of employees with our employees is important. and 64% in 2010) Without this interchange, labor Following the transition of the We also use the surveys to identify disputes can occur which are manufacture of two of our anti-infective potential areas for improvement. disruptive to our business, and affect APIs from our Oslo, Norway site to a wide range of stakeholders beyond In the 2014 survey it was revealed our Taizhou, China site in 2013 we that “organizational effi ciency” and 9.0% the working site. closed our manufacturing site in “responsibility and initiatives” had Oslo which resulted8.1% in a total of We aim to foster a culture based less favorable responses compared 8.0% 7.8% 74 redundancies in 2013 and the fi rst on trust, mutual respect and to previous years. quarter of 2014. We understand7.1% 7.1% the communication. Our employee Diversity emotional7.0% impact of losing a job and relations strategy encourages open the anxiety around fi nding a new one dialogue with employees and external As a truly international company, and 6.0%we have worked hard to support stakeholders. We support collective we benefi t from a diverse, our people through2011 these2012 changes. 2013 2014dialogue and negotiations with multicultural workforce. Across our CommunicatingEmployee clearly turnover and rate regularly (voluntary resignations)employment unions and other sites in eight countries we employ with employees was a priority representative associations within more than 25 nationalities. Although throughout the restructuring process. the local legal framework. We have located around the world we have an maintained good integrated, open and transparent relationships with the culture built on mutual respect, trust 100 Overall index Engagement unions and in 2014 and accountability. We aim to recruit 80 there were no major competent and motivated people 70 incidents or industrial who respect our values, and we in turn 60 actions resulting in lost provide equal opportunities for their 50 working time except development, and protect their 40 for a minor occurrence privacy. We do not tolerate any 20 at our facility in form of harassment or discrimination 0 2010 2012 2014 Copenhagen resulting for any reason and strive to Employee survey (engagement) in a total of 85 lost maintain a culture that provides working hours. equal opportunities for all.

Xellia 2014 21 Xellia and corporate responsibility continued...

Gender diversity RESPONSIBILITY CORPORATE Xellia is committed to building a workforce represented equally by both genders across both our management team and other management positions (directors, managers, and team-managers), 10 and the wider Group. In 2014, for 8 all companies in the Group there 6 was an average of 60% male and 5 4.5 3.5 40% female employees. At manager level the average was 67% male managers and 33% female managers. 0 Information pursuant to Danish 2011 2012 2013 2014 legislation on gender diversity Recordable injury rate (accident frequency rate per 1,000,000 working hours) Pursuant to Danish regulations, Xellia included the addition of close to has adopted a policy which is aimed 90 employees. The employee turnover at accomplishing a more equal in 2014 was 7.8%. This fi gure covers composition between the genders at the rate of voluntary resignations through performance reviews, feedback management level, such that female and, therefore, does not include the and leadership training. In 2014, the managers represent at least 40% 1100 employees affected by redundancies 10 Danish companies in the Group had 1067 before the end8 of 2017. The policy following the closing of our Oslo, an average of 55% male and 45% includes initiatives, such as Norway production site. The employee 6 female employees. At manager1000 level encouraging qualifi ed women to turnover rates vary between countries. 5 the average4.5 was 59% male managers 929 apply for managerial positions within3.5 The907 increased turnover in 2013 was and 41% female managers.900 the Group, as well as development 855 mainly related to our new production and succession planning initiatives, Employee Turnover facility in Raleigh and a signifi cant such as0 retention of qualifi ed female In 2014, the number of employees800 in increase in the turnover at our facility 2011 2012 2013 2014 2011 2012 2013 2014 employees, focus on work/life balance Xellia increased by 138 to 1,067. in Copenhagen compared to 2013. in order to create an Recordableattractive injury rateThe main reason for the increase was TotalA portfolionumber of of employees retention projects working(accident environment, frequency and rate personal per 1,000,000 the working acquisition hours) of the Raleigh, North has been initiated to address the development of female employees Carolina production facility which increased turnover rate.

9.0% 1100 1067 8.1% 8.0% 7.8% 1000

929 7.1% 7.1% 907 900 7.0% 855

800 6.0% 2011 2012 2013 2014 2011 2012 2013 2014 Total number of employees Employee turnover rate (voluntary resignations)

9.0% 100 Xellia 2014 22 Overall index Engagement 80

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2014 23 2014

CORPORATE RESPONSIBILITY Corporate governance ERNANCE E G OV CORPOR AT

Xellia 2014 24 Corporate governance ERNANCE E G OV

New Xellia Group A/S has adopted a governance and management structure that allows the Group to manage its business successfully and mitigate risk on an on-going basis. CORPOR AT In accordance with Danish company law, Xellia has a two-tier management system comprising the Board of Directors and a Managing Director (CEO). As outlined in the Group’s Articles of Association, the Board of Directors should consist of between three and six independent directors. Currently, the Board has five members; a Chairman and four independent directors. Directors are appointed for one year at a time, and can be re-elected at the annual shareholders meeting. The CEO is not a member of the Board of Directors.

The Board of Directors has adopted the Rules of Procedure for the Board of Directors which sets out the responsibilities of the Board of Directors in a number of areas. These include determining Xellia’s overall strategy and actively contributing to developing the Group as a focused, sustainable, global speciality pharmaceutical company and supervising Executive Management in its decisions and operations. The Board of Directors has also adopted an annual meeting framework consisting of six meetings annually comprising of four regular Board meetings, one end-of-year meeting to review the annual operating plan and budget for the following year and one Company and their compensation meeting focused on the long-term is not dependent on Xellia’s strategy of the Group. In 2014 a total performance or results. In 2014 of nine Board meetings were held. management and other employees received, in addition to basic salary, The Board has established a Finance variable compensation dependent on and Audit Committee, consisting of the achievement of operational and members of the Board of Directors strategic targets in addition to the The B-Shares are owned by members and Management, which assists the financial targets. of management and other senior Board in areas relating to accounting, employees of the Group. In connection audit, internal control and financial Share capital with the acquisition of Xellia in July reporting. Chaired by Benny Loft, a Share capital of the New Xellia 2013 a Management Investment member of the Board, the Finance and Group A/S is divided into A and B Program was established. At the end Audit Committee held six meetings shares. These two share classes have of 2014 a total of 1,148,605 B-shares during 2014. identical rights, with the exception were subscribed by 48 managers and that A-Shares hold 10 votes per share Compensation for the Chairman senior employees. In addition to the and B-Shares hold 1 vote per share. of the Board of Directors, other B-shares, managers and senior members of the Board and the The A-Shares, which total employees have subscribed warrants CEO is based on market terms and 100,500,000, are held by Xellia in the Company with a right to conditions. Members of the Board of Holdco A/S, which is owned subscribe by up to 6,153,991 Directors do not own shares in the by Novo A/S. additional B-Shares.

Xellia 2014 25 Board of Directors RS RD OF DIRE CTO

Steen Riisgaard B OA Chairman of the Board Born: 1951 Steen is the former President and CEO of Denmark-based biotech company Novozymes A/S. He has also held senior level positions at Novo Nordisk A/S and Novo Industri A/S. Other Board positions: Chairman of the Boards of COWI Holding A/S, ALK-Abelló A/S, Egmont International Holding A/S and the World Wildlife Fund (WWF), Denmark. Vice Chairman of the Novo Nordisk Foundation and the Villum Foundation. Member of the Boards of Novo A/S, Corbion and the University of Aarhus, Denmark. Education: MSc in Microbiology, University of Copenhagen, Denmark.

Andreas Rummelt Benny D. Loft Board Member Board Member Born: 1956 Born: 1965 Andreas is a Partner and CEO of Benny is EVP and CFO at Novozymes A/S. InterPharmaLink AG, Basle, Switzerland. His Since Novozymes’ launch in 2000, he has international career spans over twenty years also worked on acquisitions and negotiations in executive management positions at Novartis. and played an active role in steering groups Other Board positions: Member of the Boards for numerous corporate functions including of Directors of Alexion Pharmaceuticals, USA, ethics, sustainability and business and Member of the Advisory Board of several development. privately held international companies Other Board positions: Member of the Education: MSc and Ph.D. in Pharmaceutical Board of Directors of The Blue Planet, Sciences, University of Erlangen-Nuremberg, Denmark Aquarium, and DONG Energy A/S. Germany. Chairman of the Audit and Risk Committee, DONG Energy A/S. Education: MSc in Accounting, Tax and Auditing, Copenhagen Business School, Denmark and State Authorized Public Accountant.

Xellia 2014 26 Board of Directors continued... RS RD OF DIRE CTO B OA

Per Valstorp Julie McHugh Board Member Board Member Born: 1949 Born: 1964 Per Valstorp has a long track record Julie McHugh has a track record that attained from senior executive positions spans 27 years in the biopharmaceutical held at Novo Nordisk A/S within Pharma industry. Most recently, she was the Operation Management, Quality, COO at Endo Health Solutions, Inc., with Regulatory Affairs and Medical Devices. responsibilities for both the specialty Other Board positions: Member of the and generic pharmaceuticals businesses. Boards of DBI Plastics A/S, Mejerigården Other Board positions: Member of A/S, Orana A/S, Scarbur A/S, and EUDP the Board of Directors of Trevena Board, Danish Ministry of Climate, Pharmaceuticals, Inc., EPIRUS Energy and Building. Biopharmaceuticals, Inc., Ironwood Education: MSc in Operational Research & Pharmaceuticals, Inc. and Viropharma, Inc. Planning, Technical University of Denmark. (now Shire) and the Board of Visitors for the Smeal College of Business, Pennsylvania State University. Education: BSc in Finance, Pennsylvania State University, USA and an MBA Administration in International Management, St. Joseph’s University, USA.

Xellia 2014 27 Executive Management EXECUTIVE MANAGEMENT Carl-Åke Carlsson Chief Executive Officer and President

Carl-Åke has held various positions within the Company, where he started in the finance function in 1988. In 1995 he was appointed Vice President Finance, Business Development and IT, and in January 2000 he took on the role as President Alpharma Human Pharmaceuticals Division. From 2003 to December 2004 he was President of the US Branded Pharmaceuticals Division and he was appointed President of the Alpharma API Division in 2005. Today Carl-Åke is Chief Executive Officer and President of Xellia.

Mads Bodenhoff Gaël Bernard Aleksandar Danilovski Chief Financial Officer Vice President Chief Scientific Officer and and Vice President Sales and Marketing Vice President Global R&D Mads joined Xellia as CFO and Vice Gaël joined Xellia in 2008 from Aleksandar joined Xellia in 2009 President Finance in September Actavis where he was Vice President following an extensive career at 2014. He comes from Novozymes New Product Launches. Prior to PLIVA/Barr Group since 1994 where where he was Vice President for this, Gaël was at Alpharma where he held managerial positions within Corporate Finance. During his he held managerial roles including the R&D function. Most recently he 14 years with Novozymes he has Director Strategy and Marketing was a member of the Management held various financial managerial Development and Managing Board of PLIVA Croatia Ltd. with positions. Prior to this, Mads worked Director of Alpharma France. responsibility for leading the Global at Novo Nordisk and Arthur Andersen. API R&D and managing all R&D He has broad experience with in Croatia. finance and accounting, IT, legal, international business, sustainability, and mergers and acquisitions.

Xellia 2014 28 Executive Management continued... EXECUTIVE MANAGEMENT

Mikkel Lyager Olsen Anders B. Spohr Nora Elisabeth Håberg Hans Nielsen Chief Legal Officer and Vice President Vice President Vice President Vice President Global Product Supply Strategic Projects and IT Asia Operation Mikkel joined the Company Anders joined Xellia in July Nora joined the Company in Hans joined Xellia in 1981 in 2005 as Commercial 2014. Anders was previously 2003 and has worked in and has 26 years of industry Counsel and was appointed Executive Vice President different roles ranging from experience, first from Dumex Division Counsel for the API Global Supply Chain at process development and and later from Alpharma (now Division later that year. LEO Pharma, a global technology transfer, portfolio Xellia). He has held various Today Mikkel is General pharmaceutical leader within management, logistics and positions within quality and Counsel and Vice President dermatology and thrombosis sales and marketing. Nora compliance and since 2002 of Xellia. Prior to this, Mikkel headquartered in Denmark. was appointed Vice President has been the overall head of worked as an attorney with Prior to joining LEO Anders Strategic Projects in the API quality organization. one of Scandinavia’s largest spent 14 years at Novozymes September 2011. Prior to He has a broad background in commercial law firms. and Novo Nordisk in various Xellia, she was a consultant development, manufacturing managerial supply and with McKinsey & Company. and control of finished dosage production positions. forms as well as APIs.

Geelanie Briones Arnt Tore Valsvik Kristin Lund Myrdahl Vice President Quality Vice President Project Coordinator and Regulatory Affairs Human Resources Geelanie joined Xellia in May Arnt Tore joined the Company Kristin joined Xellia in 2014. She was previously in 2000 as HR Director, 1996 in the International Head of Quality Compliance Norway. He later assumed Pharmaceuticals Division of for the Oncology Injectable a more corporate role as Alpharma. From 2000 she business unit at Sandoz. Director Compensation and has been responsible for Prior to joining Sandoz Benefits Europe and Asia overseeing projects and Geelanie spent 12 years at before becoming HR Director activities initiated by the Novo Nordisk in various Alpharma API Division (new leadership team as well as senior quality control and Xellia) in 2005. Before joining driving internal and external compliance managerial Alpharma he was the HR communications. Prior to positions. She has considerable Manager of WorldFish (an Xellia, Kristin worked for experience in leading international research center Gemini Consulting where she operational and global matrix for living aquatic resources ran the program office for organisations and extensive management) in Manilla, major consulting projects. knowledge of Quality Philippines. Management Systems.

Xellia 2014 29 Contact [email protected] Tel +45 32645500Fax+4501 Denmark 2300 CopenhagenS Dalslandsgade 11 Xellia Pharmaceuticals www.xellia.com

CONTACT