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Bavarian Nordic Annual Report 2018 Management Commentary | Financial Statements

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Bavarian Nordic Annual Report 2018 Management Commentary | Financial Statements Unlocking the power of the ANNUAL immune system REPORT 2018 199425 2019 YEARS OF GREAT ACHIEVEMENTS IN THE VACCINE SPACE STIMULATING THE IMMUNE SYSTEM GIVING HOPE TO MILLIONS Management commentary | Financial statements CONTENTS MANAGEMENT FINANCIAL COMMENTARY STATEMENTS INTRODUCTION BUSINESS AND PIPELINE CONSOLIDATED FINANCIAL STATEMENTS Letter from the CEO & chairman .................... 4 Product pipeline.................................. 20 Consolidated income statements .................. 68 At a glance ....................................... 6 Infectious disease ................................ 22 Consolidated statements of comprehensive 25 years of great achievements .................... 8 Our partnership with Janssen ...................... 28 income .......................................... 68 Key developments................................ 10 Cancer immunotherapy ........................... 36 Consolidated statements of cash flow.............. 69 A word from the new CFO......................... 12 Chordoma........................................ 38 Consolidated statements of financial position Strategy track ................................... .16 – assets ......................................... 70 Financial results for 2018 ......................... .18 CORPORATE INFORMATION Consolidated statements of financial position The Bavarian Nordic share ........................ .46 – equity/liabilities ............................... 71 Corporate social responsibility .................... .48 Consolidated statements of changes in equity ...... 72 Corporate governance ............................ .50 Notes ........................................... 74 Risk management ................................ 51 Remuneration report ............................. 54 FINANCIAL STATEMENTS OF THE PARENT COMPANY Management of Bavarian Nordic .................. 60 Income statements ............................. .114 Financial review 2018 ............................ .64 Statements of financial position – assets .......... 115 Statements of financial position – equity/liabilities 116 Statements of changes in equity.................. 117 Notes .......................................... 118 Statement by management on the annual report .. 129 Independent auditor’s reports .................... 130 3 Bavarian Nordic Annual Report 2018 Management commentary | Financial statements LETTER FROM THE CEO AND CHAIRMAN Last year we confirmed our global leadership for small- pox vaccines suitable for the general population. On the back of positive Phase 3 efficacy data we filed a BLA that was accepted and granted priority review status. We are on track in supporting the FDA review process and 2018 IN remain confident that MVA-BN® will be approved along with the receipt of a priority review voucher in 2019. Last year’s cases of monkeypox in the UK and Israel, REVIEW including a health care worker looking after one of the infected patients, highlight the need for a better prepar- edness for emerging diseases, or biological threats like smallpox. When licensed, there will be new opportuni- ties to assist the U.S. Government preparedness plans beyond the stockpiling of smallpox vaccines, such as the vaccination of military and other first line responders. 2018 was another year that saw important progress of our pipeline assets towards licensure and fulfilling of our Bavarian Nordic remains at the forefront of RSV vaccine mission to unlock the power of the immune system to development and has the most progressed vaccine improve public health. We reported positive clinical data, initiated four proof of concept Phase 2 studies, and filed the company’s first ever Biological License Application (BLA) for our smallpox vaccine with the FDA. To secure the future revenue streams we are expanding our manu- Bavarian“ Nordic remains facturing capabilities to include a state-of-the-art fill and at the forefront of RSV finish facility and we announced new immunotherapy vaccine development concepts that will further expand and enrich our pipeline assets. These and other important strategic events (page and has the most 17) will transform the company in the years to come, progressed vaccine in on the path towards fulfilling our vision of becoming a development leading and profitable biotech company, developing, manufacturing and commercializing products for infec- — Paul Chaplin tious disease and cancer. President & CEO 4 Bavarian Nordic Annual Report 2018 Management commentary | Financial statements in development. We rarely follow the crowd and our With a solid year’s operational performance behind us, vaccine candidate has a unique and completely differen- we have an exciting year ahead. 2019 is the company’s tiated approach that has never previously been evaluat- 25th anniversary and on a solid financial base we expect ed. We reported additional positive data supporting an to report proof-of-concept data, and the path forward annual booster vaccination to induce broad and durable for RSV; to initiate new programs; celebrate our first U.S. immune responses in elderly adults and remain on track approval and seek new smallpox vaccine orders. to enter a Phase 3 efficacy trial in 2020. We would like to thank all our dedicated and skilled em- In collaboration with pharmaceutical companies and ployees, our partners, and investors for their support in the investigators, we have moved CV301 into three sepa- continued development and success of Bavarian Nordic. rate Phase 2 studies to investigate whether our cancer vaccine can enhance the efficacy of checkpoint inhibitors in several different cancer indications. BN-Brachyury also entered a pivotal study in patients with chordoma, an extremely rare cancer that once it has progressed post-surgery has few, if any, treatment options. Paul Chaplin Gerard van Odijk Utilizing adaptive designs, or investigator-sponsored stud- President & CEO Chairman of the Board of Directors ies, has allowed for a balanced investment with a rapid proof of concept, with data already expected in 2019. While we have many exciting pipeline opportunities we cannot rest on our laurels, because in drug development “ not all concepts will succeed. However, to ensure we With a solid year’s bring the best treatments for patients we must evolve operational performance our strategies and bring fresh new ideas forward. Last behind us, 2019 will be year we announced new immunotherapy strategies, which were developed in our own research laboratories an exciting year and that harness other parts of the immune system to fight the company’s 25th and kill cancer. These exciting new approaches will also anniversary move forward into clinical studies in 2019. — Gerard van Odijk Chairman of the Board of Directors 5 Bavarian Nordic Annual Report 2018 Management commentary | Financial statements BAVARIAN NORDIC AT A GLANCE FOUNDED IN 1994 UNLOCKING THE POWER IPO 1998 OF THE IMMUNE SYSTEM 400+ – TO IMPROVE PUBLIC HEALTH WITH FOCUS EMPLOYEES ON HIGH UNMET MEDICAL NEEDS FIRST PRODUCT APPROVED IN 2013 (MVA-BN AS SMALLPOX VACCINE) VISION STRATEGY 5 YEAR VISION TRACK PRIORITIES MILESTONES OBJECTIVES By 2023 we aspire to be a leading and profitable MAINTAIN GLOBAL LEADERSHIP OF OUR biotech company that SMALLPOX VACCINE BUSINESS through harnessing the EXPAND AND RAPIDLY ADVANCE THE PIPELINE power of the immune OF INFECTIOUS DISEASE PROGRAMS system will develop, ESTABLISH A BROAD AND DEEP CANCER manufacture and IMMUNOTHERAPY PORTFOLIO commercialize products for infectious disease EXPAND THE COMMERCIAL FOOTPRINT and cancer AND CAPABILITIES 6 Bavarian Nordic Annual Report 2018 Management commentary | Financial statements OUR Chordoma HIV & HBV VACCINES Improving Seeking a Bavarian Nordic focuses on survial functional cure developing product candi- dates to address cancer Solid tumors RSV and infectious diseases. CANCER INFECTIOUS Potentially MVA-BN A large unmet curing cancer IMMUNOTHERAPY DISEASES medical need HPV Smallpox & Ebola Preventing Strengthen global cancer preparedness CORE CAPABILITIES Proven vaccine Commercial scale Strong relationships Strong financial development vaccine manufacturing with USG and major position expertise capabilities pharma companies 25 30+ 15+ DKK 2.3 YEARS MILLION YEARS BILLION IN-HOUSE R&D EXPERTISE VACCINE DOSES PRODUCED STRONG RELATIONSHIPS WITH CASH PREPAREDNESS APPROVED PLATFORM COMMERCIAL SCALE FILL AND FINISH THE U.S. GOVERNMENT AND MAJOR BY END OF 2018 TECHNOLOGY FACILITY UNDER CONSTRUCTION PHARMA COMPANIES, INCLUDING BRISTOL-MYERS SQUIBB, ROCHE AND A STRATEGIC PARTNERSHIP WITH JANSSEN 7 Bavarian Nordic Annual Report 2018 Management commentary | Financial statements 25 YEARS OF GREAT ACHIEVEMENTS IN THE VACCINE SPACE! Employees: 3 43 87 145 264 1994 1998 2003 2004 2007 Founded Listed on the Copenhagen Entered the first smallpox Acquisition of First smallpox supply Stock Exchange development contract with manufacturing facility contract for 20 million the U.S. Government doses to the U.S. Government Founded in 1994, Bavarian Nordic has been a pioneer in Vaccine development is challenging and not all attempts go where others are afraid to tread. These bold decisions the biotechnology sector and have celebrated many suc- will obviously work, however we have never been afraid have often resulted in industry firsts; such as being the cesses over the last 25 years. Our activities have expand- of making tough decisions in our endeavors to revolution- first to develop a safer non-replicating smallpox vaccine ed, and we are today an international
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