TAKE A LOOK AT OUR 3D-PRINTED GRAPHS 2015 ANNUAL REPORT
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- Winfred Moody
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1 TAKE A LOOK AT OUR 3D-PRINTED GRAPHS 2015 ANNUAL REPORT
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3 INDEX CORPORATE OVERVIEW 5 1. INTRODUCTION 7 Ablynx at a glance achievements 10 Letter to our stakeholders 12 Company strategy and outlook for NANOBODIES POWERFUL PLATFORM GENERATING POTENTIALLY INNOVATIVE MEDICINES 19 Platform advantages 20 Product pipeline 22 Key clinical value drivers 24 Key pre-clinical value drivers SHAREHOLDERS INFORMATION 33 Key figures and performance indicators 34 Shareholder structure 36 The shares in Financial calendar 54 Analyst coverage 55 Contact the IR department GLOSSARY 57 CORPORATE GOVERNANCE AND FINANCIAL INFORMATION REPORT OF THE BOARD OF DIRECTORS RESPONSIBILITY STATEMENT FINANCIAL STATEMENTS NOTES TO THE FINANCIAL STATEMENTS 124 ANNUAL REPORT 2015 / ABLYNX 3. INDEX
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7 INTRODUCTION
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9 ABLYNX AT A GLANCE LATE-STAGE CLINICAL DEVELOPMENT COMPANY WITH POWERFUL PROPRIETARY TECHNOLOGY PLATFORM DEDICATED TO CREATING NEW MEDICINES WHICH WILL MAKE A REAL DIFFERENCE TO PATIENTS AND THEIR CAREGIVERS Ablynx is a clinical-stage biopharmaceutical company engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments. Due to their small size and unique structure, Nanobodies offer multiple advantages making them ideal building blocks for the generation of novel biological drugs. >40 PROGRAMMES in the R&D pipeline 9 PHARMA PARTNERS across the globe > 380 MILLION non-dilutive cash received to date from partners > 7 BILLION in potential milestones PLUS ROYALTIES UNIQUE AND POWERFUL technology platform 236 MILLION 2015 year-end cash position 350 EMPLOYEES 15 nationalities >1,000 PATIENTS treated with Nanobodies >500 PATENTS granted and pending 78 MILLION 2015 revenue (+57% vs. 2014) LISTED ON EURONEXT ticker: ABLX 6 PRODUCTS in clinical development ANNUAL REPORT 2015 / ABLYNX 9. CORPORATE OVERVIEW
10 2015 ACHIEVEMENTS EXCELLENT PROGRESS IN ALL AREAS R&D MILESTONES During the year we initiated one Phase III study and three Phase II studies which together will include a total of over 900 patients worldwide. In addition, we completed recruitment of 35 infants in the Phase I/IIa RSV study with ALX-0171 and 345 patients in the Phase IIb combination study with ALX-0061 in RA patients. Finally, 14 new discovery programmes have been initiated, both proprietary and as part of pharmaceutical collaborations. Caplacizumab (anti-vwf) Defined the commercial strategy whereby Ablynx will retain direct control over commercialisation in Europe and the United States (August) Initiated the confirmatory international Phase III HERCULES study in patients with acquired TTP (attp) (September) ALX-0061 (anti-il-6r) Initiated a Phase IIb study in RA patients in combination with methotrexate (March); recruitment of 345 patients was completed at year-end, on schedule Initiated a Phase IIb RA monotherapy study (April) and recruitment of 251 patients was completed on schedule post year-end, in February 2016 The first eligible patients from both Phase IIb RA studies rolled-over in the open-label extension study (July) Initiated a Phase II study in patients with systemic lupus erythematosus (SLE) (August) ALX-0171 (anti-rsv) The Phase I/IIa safety study with inhaled ALX-0171 completed recruitment in 35 infants, aged 3-24 months, who were hospitalised with an RSV infection (December) An independent data monitoring board gave approval to extend this Phase I/IIa study in younger infants, aged 1-5 months, to generate additional data (December) Immuno-oncology Pre-clinical proof-of-concept was achieved with a bi-specific Nanobody programme as part of the extensive immuno-oncology collaboration with Merck & Co., Inc., which triggered a 3.5 million milestone payment to Ablynx (October) BI (anti-vegf/ang2) Ablynx s partner Boehringer Ingelheim presented compelling pre-clinical proof-ofmechanism data with the bi-specific anti-vegf/ang2 Nanobody in multiple in vivo cancer models (November) ANNUAL REPORT 2015 / ABLYNX 10. CORPORATE OVERVIEW
11 STRATEGIC PARTNERSHIPS We signed three new pharmaceutical partnerships and extended two existing collaborations in 2015: In March, we announced an extension of our initial two-year research collaboration with Merck & Co., Inc. to develop and commercialise Nanobodies directed towards an undisclosed voltage-gated ion channel. Merck & Co., Inc. will extend their funding to the end of September FINANCIAL PERFORMANCE MILLION CASH, CASH EQUIVALENTS, RESTRICTED CASH AND OTHER SHORT TERM INVESTMENTS In May, a research and option agreement was signed with Genzyme to explore the potential of a Nanobody targeting an ion channel that plays a role in multiple sclerosis, triggering an undisclosed exclusivity payment to Ablynx MILLION CASH INCOME FROM COLLABORATIONS In June, we signed an exclusive license agreement with Taisho Pharmaceuticals to develop and commercialise the anti-tnfα Nanobody, ozoralizumab, in Japan. We received an upfront payment of US$3 million and we are entitled to receive development and commercial milestone payments plus royalties. 100 MILLION RAISED THROUGH 5-YEAR CONVERTIBLE BONDS WITH 3.25% COUPON RATE AND 26.5% CONVERSION PREMIUM In July, we significantly expanded our immuno-oncology partnership with Merck & Co., Inc., which was originally signed in February 2014, to include up to 17 programmes with focus on multi-specific Nanobodies. As part of both the original and expansion agreements, we received 33 million in upfront payments and are entitled to receive up to 5.7 billion in future milestone payments, plus royalties. In November, we entered into a drug discovery collaboration with Novo Nordisk to investigate multi-specific Nanobodies in an undisclosed indication. We received an upfront payment of 5 million early in 2016, and are entitled to receive 4 million in research funding during the initial three year research term of the collaboration and up to 182 million in potential milestones, plus royalties. 95% FREE FLOAT DIVERSIFIED SHAREHOLDER BASE WITH >60% OF INSTITUTIONAL SHAREHOLDING IN UK AND USA ANNUAL REPORT 2015 / ABLYNX 11. CORPORATE OVERVIEW
12 LETTER TO OUR STAKEHOLDERS ANNUAL REPORT 2015 / ABLYNX 12. CORPORATE OVERVIEW
13 DEAR SHAREHOLDERS, COLLEAGUES AND BUSINESS PARTNERS, 2015 WAS A YEAR OF EXCELLENT PROGRESS ACROSS OUR ENTIRE BUSINESS. OUR NANOBODY-BASED DRUGS ADVANCED SUCCESSFULLY INTO THE LATER STAGES OF DEVELOPMENT AS WE STARTED A PHASE III STUDY AND THREE PHASE II STUDIES WHICH TOGETHER WILL INCLUDE A TOTAL OF OVER 900 PATIENTS WORLDWIDE. COLLABORATIONS TO EXPLOIT THE FULL POTENTIAL OF OUR NANOBODY TECHNOLOGY CONTINUE TO FORM A CRUCIAL PART OF OUR HYBRID BUSINESS MODEL AS WE SIGNED THREE NEW PHARMACEUTICAL PARTNERSHIPS AND EXTENDED TWO EXISTING COLLABORATIONS, FURTHER FUELLING OUR BROAD PRODUCT PIPELINE, WHICH NOW INCLUDES OVER 40 PROPRIETARY AND PARTNERED PROGRAMMES. WE ALSO SUCCESSFULLY PLACED 100 MILLION OF FIVE-YEAR CONVERTIBLE BONDS A PARTICULARLY NOTEWORTHY ACHIEVEMENT IN THE EUROPEAN BIOTECH SECTOR STRENGTHENING OUR BALANCE SHEET TO FACILITATE THE FINANCING AND EXECUTION OF OUR BUSINESS PLAN. ANNUAL REPORT 2015 / ABLYNX
14 MATURING PRODUCT PIPELINE 2015 was a year of outstanding execution with six Nanobodies now in late-stage clinical development. We significantly expanded our clinical pipeline with the start of a Phase III study with caplacizumab, our first-in-class wholly-owned bivalent Nanobody to treat acquired TTP, as well as three Phase II studies with the anti-il-6r Nanobody, ALX-0061, in RA and SLE, for which AbbVie has an option for an exclusive global license. In less than 10 months, we completed recruitment of 345 patients in the Phase IIb RA combination study of ALX-0061 and we completed recruitment of 35 infants in the Phase I/IIa study of our wholly-owned, first-in-class trivalent Nanobody, ALX-0171, to treat RSV, a serious viral respiratory infection. This was the first trial in which a Nanobody was administered to infants by inhalation and could prove to be a very important validation for the platform as a whole, in the general area of inhaled therapeutics, as well as in this particularly challenging indication. PREPARING FOR OUR FIRST PRODUCT LAUNCH 2015 was also the year in which we expanded our expertise beyond R&D, as we began preparing for our first product launch. Following compelling Phase II TITAN results with caplacizumab, our anti-vwf Nanobody to treat acquired TTP, we are on track to file for conditional approval of caplacizumab in Europe in early 2017 with the first European launch possible in In parallel with the European regulatory filing preparations, the confirmatory, international Phase III HERCULES study with caplacizumab has been initiated to support a BLA filing in the United States in The publication of the Phase II TITAN study in The New England Journal of Medicine on 11 February 2016 was a major accomplishment and is another endorsement of the potential of caplacizumab in the treatment of acquired TTP. We are now defining the commercial infrastructure required to lead the commercialisation of caplacizumab ourselves in Europe and the United States and we will announce further details when these plans are finalised. HYBRID BUSINESS MODEL CONTINUES TO FUEL THE PIPELINE It is our ambition to ensure that the unique advantages of our Nanobodies are widely exploited to develop differentiated and innovative medicines which have the potential to make a real difference to patients suffering from severe diseases. To achieve this goal, we are committed to a hybrid business model where we invest directly in our own programmes in specific areas as well as collaborating with pharmaceutical partners at all ANNUAL REPORT 2015 / ABLYNX 14. CORPORATE OVERVIEW
15 stages of discovery and development. These partners are selected for their expertise and experience in certain therapeutic indications as well as having resources which help us advance programmes rapidly. During the past year we have again successfully delivered on this business strategy and initiated four new internal discovery programmes and some 10 new partnered programmes. We broadened our disease scope through partnering with Genzyme (in multiple sclerosis) and Novo Nordisk (in a disease indication that is of strategic importance to them). We significantly expanded our immuno-oncology agreement with Merck & Co., Inc., so that it now includes up to 17 Nanobody programmes for which the first bi-specific Nanobody has already achieved pre-clinical proof-of-concept in in vivo cancer models. We also delivered a breakthrough in our ion channel collaboration with Merck & Co., Inc., resulting in an extension of the research term to September anticipate top line results from two Phase IIb studies with ALX-0061 in patients with RA and then we will await the decision by AbbVie on whether they wish to exercise their option to license this product in this indication. We also expect the initiation of up to four clinical studies by our collaborators (one of which already started early in 2016) which would trigger milestone payments to Ablynx. THANK YOU To conclude, we would like to thank all of our talented employees for their dedication to achieving our goals, our business partners for their enthusiasm and commitment, and our shareholders for supporting us in the creation of a unique European biotech company with, we believe, very significant potential. Sincerely yours, AN EXCITING YEAR AHEAD As we continue to develop and mature, our priorities and objectives remain focused on delivering new hope for patients and sustainable value to all our stakeholders. We look forward to an exciting year with multiple potentially value-creating catalysts, including the results from the Phase I/IIa study with ALX-0171 in 53 infants who were hospitalised with an RSV infection. We also Dr Peter Fellner Chairman Dr Edwin Moses CEO ANNUAL REPORT 2015 / ABLYNX 15. CORPORATE OVERVIEW
16 STRATEGY AND OUTLOOK CORPORATE STRATEGY Ablynx s strategy is to use the Company s unique Nanobody technology to develop therapeutics in areas of high unmet medical need where Nanobodies offer a clear advantage over existing products and technologies. The Company employs a hybrid business model where it invests directly in its own development programmes as well as collaborating with pharmaceutical partners at all stages of discovery and development, selected for their expertise and experience in key areas. In addition, Ablynx will retain some or all rights to commercialise its products, with the first launch of a wholly-owned Nanobody expected in Ablynx s ambition is to develop differentiated and innovative medicines which have the potential to make a real difference to society, as well as creating sustainable value for all its stakeholders. OUTLOOK 2016 AN EXCITING YEAR AHEAD Ablynx remains focused on creating sustainable value, and is well positioned for further growth during the course of 2016 with multiple significant pre-clinical, clinical and commercial catalysts: Expected clinical study results ALX-0171 (anti-rsv) Phase I/IIa safety results with inhaled ALX-0171 in 53 infants aged 1-24 months who were hospitalised with an RSV infection (Q2 2016) ALX-0061 (anti-il-6r) Top line results from the Phase IIb RA monotherapy and combination therapy studies (AbbVie has an option for global exclusive license) (Q3 2016) ALX-0761 (anti-il-17a/f) Phase Ib results in 40 patients with psoriasis (exclusively licensed to Merck KGaA) (H1 2016) ANNUAL REPORT 2015 / ABLYNX 16. CORPORATE OVERVIEW
17 Building the pipeline Caplacizumab (anti-vwf) Recruitment of patients with acquired TTP in the Phase III HERCULES study will continue and a three -year follow-up study will be initiated in Q ALX-0171 (anti-rsv) Initiation of a worldwide Phase II dose-ranging study in approximately 120 infants, aged 1-24 months, who are hospitalised with an RSV infection in Q Various Start of up to four Phase I studies with partners and multiple pre-clinical data points with partners, triggering milestone payments to Ablynx. Initiate and continue about 40 internal and partnered discovery and pre-clinical programmes Regulatory & Commercial Caplacizumab (anti-vwf) Continue preparations for the commercialisation of caplacizumab in Europe and the United States, and proceed with the preparations to file the dossier, in early 2017, for conditional approval of caplacizumab in Europe ALX-0061 (anti-il-6r) Licensing decision in Q by AbbVie for ALX-0061 in RA which, in the case of optin, would trigger a US$75 million license payment to Ablynx Various Expand existing collaborations and/or initiate new partnerships ANNUAL REPORT 2015 / ABLYNX 17. CORPORATE OVERVIEW
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19 NANOBODIES POWERFUL PLATFORM GENERATING POTENTIALLY INNOVATIVE MEDICINES
20 ABLYNX S NANOBODIES PLATFORM ADVANTAGES Nanobodies are a novel class of proprietary therapeutic proteins based on singledomain antibody fragments that contain the unique structural and functional properties of naturally-occurring heavy chain only antibodies. Due to their small size and unique structure, Nanobodies are ideal building blocks for the generation of novel biological drugs with multiple advantages: Mix and match Multi-specific/multivalent Nanobodies that address multiple targets in a single drug molecule flexible GS* linker lengths Ability to bind multiple targets with one therapeutic Nanobody molecule. These therapeutic molecules may contain Nanobody building blocks combined with each other (up to 7), combined with other protein domains, or with other molecules or drugs. Multi-specific (binding different targets; currently 2 bi-specific Nanobodies in the clinic), multivalent (binding identical targets; currently 2 Nanobodies in the clinic) and bi-paratopic (binding 2 different epitopes on the same target) Nanobody molecules have been successfully produced and their potential therapeutic effect demonstrated. Multiple delivery routes Inhalation Ocular Oral-to topical The robust nature and stability of Nanobodies allows administration through multiple delivery routes, including intravenous and subcutaneous injection (currently 5 Nanobodies in the clinic) and nebulisation directly into the respiratory tract (currently 1 Nanobody in the clinic), as well as potentially through the ocular route and orally for local treatment in the gut. Able to bind and block challenging targets * glycine-serine linker Nanobodies against ion channels and GPCRs Nanobodies can interact with epitopes on targets which are hidden or shielded from the much larger conventional antibodies. Functional selective Nanobodies have been generated against GPCRs as well as against ion-gated, ligand-gate and voltage-gated ion channels (multiple programmes on-going, both internally and with partners including Merck & Co., Inc., Novartis and Genzyme). ANNUAL REPORT 2015 / ABLYNX 20. CORPORATE OVERVIEW
21 Customised half-life Hours/days/weeks Albumin-binding Nanobody Fc Ability to customise the in vivo half-life of a Nanobody from a few hours to over 3 weeks to achieve the desired properties, such as the use in chronic versus acute indications. Ablynx s proprietary half-life extension technology is based on a Nanobody that binds to human serum albumin, thereby increasing the in vivo serum half-life of the therapeutic molecule. Two clinical proof-of-concepts have been achieved in patients with rheumatoid arthritis with two Nanobodies that incorporate this proprietary half-life extension technology. Manufacturing High-yield high-concentration, low-viscosity, microbial production Nanobodies (including multi-specific, multivalent and bi-paratopic constructs) are encoded by single genes and are efficiently produced with high-yields in prokaryotic and eukaryotic hosts, including bacteria, yeast, and mammalian cells. They can be formulated at high concentrations and maintain low viscosity, enabling multiple routes of administration, including low volume injectables. ANNUAL REPORT 2015 / ABLYNX 21. CORPORATE OVERVIEW
22 THE PRODUCT PIPELINE MULTIPLE SHOTS ON GOAL >40 R&D PROGRAMMES 6 NANOBODIES IN CLINICAL DEVELOPMENT Ablynx s product pipeline currently includes over 40 wholly-owned and partnered programmes across various stages of development. At the date of this report, six Nanobodies were in clinical development in a wide range of diseases, including haematology, inflammation, respiratory disease and oncology. Product Indication Target Pre-clinical caplacizumab attp vwf ALX-0061 RA RA SLE IL-6R IL-6R IL-6R ALX-0171 RSV RSV Up to 17 programmes Immuno-oncology Various BI Oncology VEGF/Ang2 ozoralizumab RA RA TNFa TNFa ALX-0141 Bone disorders RANKL ALX-0761 Psoriasis IL-17A/IL-17F ~ 15 wholly-owned and partnered programmes Various The current status and upcoming near term milestones of the Company s major pre clinical and clinical value drivers are described in the following sections. More detailed information is also available on the Ablynx website ANNUAL REPORT 2015 / ABLYNX 22. CORPORATE OVERVIEW
23 Phase I Phase II Phase III Filing + Greater China Japan Greater China ANNUAL REPORT 2015 / ABLYNX 23. CORPORATE OVERVIEW
24 KEY CLINICAL VALUE DRIVERS CAPLACIZUMAB (ANTI-VON WILLEBRAND FACTOR; vwf) FIRST-IN-CLASS BIVALENT NANOBODY FOR THE TREATMENT OF ACQUIRED TTP Wholly-owned Nanobody with Orphan Drug Status in the United States and Europe Potential to become a critical new component in the current standard of care Filing for conditional approval in Europe in early 2017, based on Phase II study results Worldwide Phase III HERCULES study on-going to support BLA submission in the USA in 2018 Ablynx to lead commercialisation in Europe and in the United States Market potential of approx. 300 million with first potential launch in Europe in 2018 Acquired thrombotic thrombocytopenic purpura Life-threatening, ultra-rare, acute blood clotting disorder Auto-immune disorder characterised by impaired activity of ADAMTS13 (<10% of that in normal plasma) Impaired ADAMTS13 activity leaves ultra-large vwf multimers (UL-vWF) uncleaved UL-vWFs bind to platelets, resulting in severe thrombocytopenia (very low platelet count), and micro-clot formation in the small blood vessels of vital organs Leads to small blood vessel occlusion, tissue ischaemia and organ damage Incidence rate Up to 11 patients per 1 million people Current standard of care Daily plasma exchange plus immunosuppressive treatments High unmet need with no drug specifically approved for this indication Mortality high (10-20%), with vast majority within 2 weeks post diagnosis Approximately 36% of patients have a recurrence Major morbidities after TTP episode, including vital organ damage Impacts life expectancy and quality of life There remains a high need for a therapeutic that immediately inhibits micro-clot formation in the acute phase of the disease. Caplacizumab has been developed to address that need. It has a unique mode of action by inhibiting the interaction between ultra-large vwf and platelets through binding with the A1 domain of vwf. It thereby immediately prevents platelet aggregation and the formation of micro-clots in the acute, critical phase of acquired TTP. ANNUAL REPORT 2015 / ABLYNX 24. CORPORATE OVERVIEW
25 Caplacizumab s effect has been demonstrated in a worldwide, Phase II TITAN study in 75 patients with acquired TTP. Recently published in The New England Journal of Medicine: Treatment with caplacizumab resulted in a nearly 40% reduction in median time to platelet count normalisation (p=0.005), reduced the use of daily plasma exchange, and prevented further consumption of platelets in the microclots and small blood vessel occlusion. Caplacizumab s clinical effect has been shown by a low number of recurrences requiring re-initiation of daily plasma exchange during treatment with caplacizumab (N=3) versus placebo (N=11). Caplacizumab had an acceptable safety profile: manageable mild bleeding tendency; with no requirement for substitution therapy. Three attp experts describe the impact of the NEJM publication: Despite the advances in immunosuppressive therapy, better plasma exchange, better supportive care, the 10% to 15% acute mortality in acquired TTP in an acute episode has not been impacted. I think caplacizumab has the potential to do that. Dr Spero Cataland Ohio State University, Columbus, USA With this drug I can quickly control the patient s symptoms. I can detach the platelet from the ultralarge von Willebrand Factor and not have the consequences or damage due to microthrombosis, giving me more time to treat the patient. That is fantastic. This is the reason why this paper is very much appreciated by the physician and the patient. Dr Flora Peyvandi University of Milan, Italy The importance of this paper is twofold. Firstly, it s the method of action of the compound, which is really quite unique. It s not associated with significant side effects. It doesn t appear to be immunogenic. The second important and probably the most important reason for this trial is that we ve always been stuck in the acute scenario of trying to achieve a rapid increase in the platelet count, which in itself is associated with a better outcome for patients, and that s exactly what s been demonstrated in this paper. Dr Marie Scully University College Hospital, London, UK 2015 achievements In August, the commercial strategy was defined whereby Ablynx retains full control over the commercialisation in Europe and the United States. In September, a confirmatory, international, Phase III HERCULES study of caplacizumab was initiated in patients with acquired TTP. Ablynx plans to recruit 92 patients into this study by Potential near term milestones 2016 Prepare filing for conditional approval in Europe Continue recruitment in Phase III HERCULES study Define full commercialisation plan Initiate a three-year follow-up study 2017 Filing of caplacizumab for conditional approval in Europe Phase III HERCULES top line results 2018 First launch in Europe BLA submission in the United States ANNUAL REPORT 2015 / ABLYNX 25. CORPORATE OVERVIEW
26 ALX-0171 (ANTI-RSV) FIRST-IN-CLASS TRIVALENT INHALED NANOBODY FOR THE TREATMENT OF RESPIRATORY SYNCYTIAL VIRUS (RSV) INFECTION Wholly-owned Nanobody delivered through inhalation Potential breakthrough for the treatment of RSV infections Recruitment of first-in-infant Phase I/IIa safety study completed with results expected in Q Phase II dose-ranging study to start by end 2016 Opportunity in a multi-billion dollar market Respiratory syncytial virus infection Major cause of acute upper (colds) and lower (pneumonia and bronchiolitis) respiratory tract infections in infants, young children, and the elderly Leading cause of infant hospitalisation >3 million children (<5 years) hospitalised worldwide each year High incidence rate 60%-70% of children will have been infected by the age of 1 year Current standard of care Only symptomatic treatments available, including corticosteroids and bronchodilators Monoclonal antibody (Synagis ) used as prophylaxis and only approved in high-risk, pre-term infants High unmet need 3,000-8,500 deaths in infants <2 years globally, each year Long-term disease burden (prolonged wheezing and increased risk for asthma development later in life) No specific treatment option available ANNUAL REPORT 2015 / ABLYNX 26. CORPORATE OVERVIEW
27 There remains a high need for an effective and specific therapeutic to treat RSV infections. ALX-0171 has been developed to address this unmet need and has firstin-class potential for the treatment of RSV infection. It is administered via nebulisation directly to the site of infection, i.e. the respiratory tract including the lungs, where it inhibits RSV replication and neutralises RSV activity by blocking virus uptake into cells. ALX-0171 has shown a potent anti-viral effect against a broad range of RSV strains and it demonstrated to have a strong therapeutic effect following administration via nebulisation in a neonatal animal model for infant RSV infection. Repeated daily inhalation of ALX-0171 was proven to be well-tolerated in multiple Phase I clinical studies in adult volunteers, including a study in subjects with hyper-reactive airways achievements In December, the Phase I/IIa safety study of inhaled ALX-0171 completed recruitment in 35 infants, aged 3-24 months, who were hospitalised with an RSV infection. Also in December, an independent Data Monitoring Committee reviewed safety data available for the first 15 infants from the placebo-controlled part of this Phase I/IIa study and confirmed that the inclusion age for recruitment could be lowered to 1 month of age. Post year-end, in January 2016, the Phase I/IIa study was expanded to include an expansion cohort of 18 additional infants, aged 1-5 months. Recruitment of this expansion cohort was completed ahead of schedule post year-end, in February Potential near term milestones 2016 Top line Phase I/IIa results in 53 hospitalised RSV infected infants Start Phase II dose-ranging study in approximately 120 hospitalised RSV infected infants, aged 1-24 months 2017 Complete recruitment of the Phase II dose-ranging study 2018 Top line results from the Phase II dose ranging study References: Nair et al, Lancet 2010; Byington et al, Pediatrics 2014; Shi et al, J Med Econ 2011; Sigurs et al, Thorax 2010; Beckman et al, Acta Pediatr 2014 ANNUAL REPORT 2015 / ABLYNX 27. CORPORATE OVERVIEW
28 ALX-0061 (ANTI-IL-6R) HALF-LIFE EXTENDED NANOBODY FOR THE TREATMENT OF AUTO-IMMUNE DISORDERS Compelling Phase IIa results, demonstrating best-in-class potential Results from Phase IIb RA monotherapy and combination therapy studies expected in Q Decision by AbbVie for an exclusive, global license in RA expected by the end of 2016 Phase II study in SLE on-going with results anticipated in 2018 Opportunity in multi-billion dollar markets Rheumatoid arthritis (RA) Chronic, progressive, inflammatory disease of the joints and surrounding tissues RA is an inflammatory disease that occurs when a person s immune system mistakenly starts attacking healthy joints, causing symptoms that may range in severity from patient to patient. These symptoms may include pain, swelling, stiffness, and loss of physical function Patients with RA may also experience systemic symptoms, such as low-grade fever, fatigue, or weight loss Over time, rheumatoid arthritis symptoms can worsen, everyday tasks may become difficult, and permanent joint damage may occur High incidence rate 1.5 million patients in the United States Approximately 6 million people expected to suffer from RA by 2021 in the 7 major markets Current treatment options Two broad categories: 1) symptomatic treatments (e.g. corticosteroids); 2) disease modifying agents (DMARDs) to halt the destructive course of RA and prevent debilitating joint damage Market-leading drugs include anti-tnfα biological DMARDs RA drugs had >US$500 million in sales in 2014 Unmet need Many patients respond initially to their treatment but relapse between 10 and 13 months >30% of patients do not respond to TNFα inhibitors, the market leading biological DMARDs Need for new, differentiating treatments with fewer treatment failures and fewer inadequate responders Need for disease modifying therapies with substantial efficacy, particularly on higherdemanding measures such as remission, ACR50 and ACR70 ANNUAL REPORT 2015 / ABLYNX 28. CORPORATE OVERVIEW
29 There remains a high need for new, differentiating treatment options with substantial efficacy. ALX-0061 has been developed to address this unmet need and the results from the Phase IIa study in 37 patients with RA demonstrated that ALX-0061 has best-in-class potential: Highly efficacious: treatment with ALX-0061 showed ACR20, ACR50 and ACR70 scores of up to 100%, 75% and 63% respectively, with first onset of activity as of week 2. Convenient dosing: wide therapeutic window with potential to dose subcutaneously once a month. Favourable safety profile: no dose dependent increase in frequency or severity of adverse events achievements In March, Ablynx initiated a Phase IIb study of ALX-0061, in combination with methotrexate, in patients with RA. Recruitment of 345 patients was completed on schedule in December. In April, Ablynx initiated a Phase IIb monotherapy study of ALX-0061 in RA patients. Recruitment of 251 patients was completed on schedule post year-end, in February In July, the first eligible patients from the Phase IIb RA studies with ALX-0061 rolled-over into the open-label extension study. In August, Ablynx initiated a Phase II study of ALX-0061 in patients with SLE. The Company plans to recruit 300 patients into this study by Potential near term milestones 2016 Results Phase IIb RA monotherapy study (251 patients) Results Phase IIb RA combination therapy study (345 patients) AbbVie s opt-in decision to license ALX-0061 in RA 2017 Potential start Phase III RA study 2018 Top line results RA open-label extension study Top line results Phase II SLE study AbbVie s opt-in decision to license ALX-0061 in SLE Global exclusive licensing option deal with AbbVie In September 2013, Ablynx and AbbVie entered into a global license agreement worth up to US$840 million plus double-digit royalties, to develop and commercialise ALX-0061 in RA and SLE. Ablynx received an US$175 million upfront payment and is responsible for Phase II clinical development of ALX-0061 in both RA and SLE. AbbVie will pay a fee for each indication if they exercise the right to license ALX-0061 after completion of the Phase II studies. AbbVie will then be responsible for Phase III development, registration and commercialisation in each indication. References: Datamonitor Healthcare; Sagient Research/BioMedTracker; Decision Resources ANNUAL REPORT 2015 / ABLYNX 29. CORPORATE OVERVIEW
30 KEY PRE-CLINICAL VALUE DRIVERS IMMUNO-ONCOLOGY CHANGING THE CANCER TREATMENT PARADIGM Extensive early-stage pipeline with Merck & Co., Inc., which includes up to 17 fullyfunded programmes Multiple wholly-owned programmes in early development WHY NANOBODIES? Ideally suited to bind simultaneously to multiple different epitopes or targets with a single Nanobody construct Mix and match approach allows for the rapid generation of multi-specific Nanobody constructs Rapid exploration of combinations: in vivo proof-of-concept in months Multi-specific Nanobody combinations have the potential to increase efficacy and avoid escape mechanisms Ease and cost-effective manufacturing Further formatting flexibility: choice of half-life and potential to combine with Fc receptor Extensive immuno-oncology collaboration with Merck & Co., Inc. In February 2014, Ablynx entered into a research collaboration and licensing agreement with a subsidiary of Merck & Co., Inc., focused on the discovery and development of 5 predefined Nanobody candidates (including multi-specific Nanobody combinations) directed toward so-called immune checkpoint modulators. In July 2015, Ablynx and Merck & Co., Inc. significantly expanded their collaboration to include up to 12 additional Nanobody programmes against individual protein targets and target combinations (mono-specific and multi-specific Nanobodies). Under the terms of both the original and expansion agreements, Ablynx received 33 million in upfront payments and is potentially entitled to receive up to 5.7 billion in future development, regulatory and sales milestone payments, plus royalties. Merck & Co., Inc. will be responsible for clinical development, manufacturing and commercialisation of any products resulting from the collaboration. ANNUAL REPORT 2015 / ABLYNX 30. CORPORATE OVERVIEW
31 Immuno-oncology Immuno in immuno-oncology refers to a person s own immune system. Immuno-oncology drugs, known as immunotherapies, target the patient s own immune system to help fight cancer Cancer is the most common cause of death globally Each year, approximately 14 million people are diagnosed with cancer Approximately 8 million patients die of cancer each year It is expected that in the next 2 decades the number of cancer cases will increase by 70% to approximately 22 million per year Current immuno-oncology treatment options Immunotherapies have a proven substantial survival impact and are expected to treat 60% of cancers First antibody drugs that hit the market target the immune checkpoint modulators CTLA4 and PD1 Next generation The number of targets in immuno-oncology is increasing Combination therapies are the next generation immunotherapies Market in immuno-oncology drugs expected to grow to >US$43 billion by achievements In July, Ablynx significantly expanded its immuno-oncology collaboration with Merck & Co., Inc., which was originally signed in February 2014, to include up to 12 additional programmes with focus on multi-specific Nanobodies. The expansion agreement triggered a 13 million upfront payment to Ablynx, comprising exclusivity fees and FTE payments. In October, pre-clinical proof-of-concept was achieved with a bi-specific Nanobody programme as part of the immuno-oncology collaboration with Merck & Co., Inc. This Nanobody construct is a selective bi-specific molecule that potently binds to two different immune modulators. The results from the pre-clinical study in relevant tumour models demonstrated that this bi-specific Nanobody construct potently inhibits tumour growth. Potential near term milestones Pre-clinical milestones (wholly-owned and with Merck & Co., Inc.) Start of clinical development with the first programme(s) both internally and as part of the collaboration Merck & Co., Inc. References: BofA Merrill Lynch, July 2015; MSD Belgium & Luxembourg ANNUAL REPORT 2015 / ABLYNX 31. CORPORATE OVERVIEW
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33 SHAREHOLDERS INFORMATION
34
35 KEY FIGURES AND PERFORMANCE INDICATORS (EUR'000) R&D income 28,068 29,196 19,861 25,645 33,181 47,710 76,761 Grants 1,615 2,263 2,008 1,082 2,761 1, Total revenue and grant income 29,683 31,432 21,869 26,727 35,942 49,297 77,540 R&D expenses (42,800) (48,512) (56,307) (46,868) (43,699) (54,488) (83,084) G&A expenses (9,044) (8,882) (10,423) (9,409) (10,044) (11,052) (11,405) Total expenses (51,844) (57,394) (66,730) (56,277) (53,743) (65,540) (94,495) Other operating income/(expense) 1 97 (668) (222) Operating result (22,160) (25,865) (45,529) (29,772) (17,673) (16,238) (16,955) Net financial result 2,165 1,395 1,634 1,264 1,797 3,508 (37,592) Result before taxes Income tax expense Net result of the year Basic and diluted loss per share (19,995) (24,470) (43,895) (28,508) (19,470) (12,730) (54,547) (19,995) (24,470) (43,895) (28,508) (19,470) (12,730) (54,547) (0.54) (0.58) (1.01) (0.65) (0.41) (0.24) (1.00) ANNUAL REPORT 2015 / ABLYNX 35. CORPORATE OVERVIEW
36 TOTAL REVENUE AND GRANT INCOME ( MILLION) YEAR
37 78 TOTAL REVENUE AND GRAND INCOME 30 MILLION MILLION MILLION MILLION MILLION MILLION MILLION
38 NUMBER OF EMPLOYEES YEAR
39 NUMBER OF EMPLOYEES G&A + R&D = TOTAL... YEAR = = = = DIFFERENT NATIONALITIES WORKING TOGETHER: AMERICAN, BELGIAN, BRITISH, CANADIAN, DANISH, DUTCH, FRENCH, GERMAN, HUNGARIAN, INDIAN, IRISH, ITALIAN, POLISH, PORTUGUESE AND SENEGALESE G&A R&D TOTAL
40 PRODUCTS IN THE CLINIC * 4 3 YEAR
41 P R O D U C T S IN THE CLINIC * 2015 * Not including anti-rankl Nanobody (ALX-0141) licensed to Eddingpharm in Greater China (in pre-clinical development in China but completed Phase I study in Europe before it was licensed to Eddingpharm)
42 CASH-INCOME, OPERATING EXPENSES AND YEAR-END CASH POSITION ( MILLION) OPERATING EXPENSES & CASH INCOME YEAR CASH POSITION OPERATING EXPENSES CASH INCOME
43 CASH POSITION CASH INCOME, OPERATING EXPENSES AND YEAR-END CASH POSITION CASH & EXPENSES ( MILLION) IN 2015, TOTAL CASH INCOME FROM COLLABORA- TIONS CAME IN AT 24.8 MILLION ( 30.1 MILLION IN 2014). TOTAL OPERATING EXPENSES INCREASED TO 94.5 MILLION ( 65.5 MILLION IN 2014), MAINLY AS A RESULT OF HIGHER R&D EXPENSES WHICH ARE IN LINE WITH GROWTH IN EXTERNAL DEVELOPMENT COSTS RELATED TO CLINICAL TRIALS EXPENDITURE FOR CAPLACIZUMAB, ALX-0061 AND ALX ABLYNX ENDED THE YEAR 2015 WITH MILLION IN CASH, CASH EQUIVALENTS, RE- STRICTED CASH AND OTHER SHORT TERM INVEST- MENTS ( MILLION IN 2014). Note: 2013 cash income includes US$175 million upfront payment received from AbbVie.
44 BREAKDOWN OF SHARE CAPITAL PERCEPTIVE ADVISORS BOEHRINGER INGELHEIM JP MORGAN ASSET MANAGEMENT T A U B E HODSON STONEX OPPENHEIMER FUNDS AVIVA INVESTORS POLAR CAPITAL FUNDS PLC F I D E L I T Y MANAGEMENT RESEARCH ABINGWORTH MANAGEMENT OTHER SHAREHOLDERS
45 BREAKDOWN OF SHARE CAPITAL 5% ABINGWORTH MANAGEMENT UK 5% FIDELITY MANAGEMENT RESEARCH USA 5% AVIVA INVESTORS UK 4% TAUBE HODSON STONEX UK 4% BOEHRINGER INGELHEIM DE 4% PERCEPTIVE ADVISORS USA 3% JP MORGAN ASSET MANAGEMENT UK 3% OPPENHEIMER FUNDS USA 3% POLAR CAPITAL FUNDS PLC UK 64% OTHER SHAREHOLDERS
46 % OF INSTITUTIONAL SHAREHOLDERS BY GEOGRAPHY (REPRESENTING 70% OF TOTAL SHARES OUTSTANDING) USA OTHER FRANCE UK SCANDINAVIA BENELUX
47 PERCENTAGE OF INSTITUTIONAL SHAREHOLDERS BY GEOGRAPHY 35% USA 28% BENELUX 27% UK 3% FRANCE 2% SCANDINAVIA 5% OTHER
48
49 THE SHARES IN 2015 On 31 December 2015, there were 54,812,374 shares representing a total share capital of the Company of 102,442,297. The total number of rights (warrants) to subscribe to not yet issued securities conferring voting rights currently was 2,675,031 at 31 December This number equals the total number of voting rights that may result from the exercise of these warrants. Currently 1,000 convertible bonds are outstanding entitling the holders thereof to 7,733,952 shares of the Company in the aggregate, upon conversion of such convertible bonds. The total number of fully diluted shares of the Company at 31 December 2015 was 65,221,357. Ablynx s shares are traded on Euronext Brussels, under the ticker symbol ABLX Average daily volume 69, , , , ,910 Average daily value 353, ,372 1,343,892 1,045,748 1,914,721 Total traded volume 17,975,216 29,771,718 48,686,030 30,795,240 42,472,998 Total traded value 90,972, ,863, ,692, ,619, ,168,666 ANNUAL REPORT 2015 / ABLYNX 49. CORPORATE OVERVIEW
50 ABSOLUTE PERFORMANCE IN % MONTH JANUARY JUNE DECEMBER
51 ABSOLUTE PERFORMANCE IN % 60% 40% 20% 0% 1.5M 1.0M 0.5M 0.0M
52 RELATIVE PERFORMANCE IN 2015 MONTH JANUARY JUNE DECEMBER BEL MID NEXT BIOTECH BEL PHARMA BIO ABLYNX
53 RELATIVE PERFORMANCE IN % 60% 40% 20% 0% % ABLYNX % NEXT BIOTECH % BEL PHARMA BIO % BEL MID
54 FINANCIAL CALENDAR March online publication annual report April annual general meeting May results Q August half year results November results Q SHAREHOLDERS CLUBS AT ABLYNX Ablynx organises frequent shareholders clubs at its headquarters in Ghent during which individual investors have the opportunity to meet with the CFO and IR, and to visit the laboratories. The events in 2016 will be held in the Dutch language and are scheduled on the following days: 18 May at 5.45pm 14 September at 5.45pm 7 December at 5.45pm To attend an event, please register via investors@ablynx.com, stating your name and preferred day. ANNUAL REPORT 2015 / ABLYNX 54. CORPORATE OVERVIEW
55 ANALYST COVERAGE At present, Ablynx is covered by six analysts: Broker Analyst Rating Berenberg Bank Alistair Campbell Buy Bryan Garnier Hugo Solvet Buy Jefferies Peter Welford Buy KBC Securities Jan De Kerpel Buy Kempen & Co Sachin Soni Buy Degroof Petercam Roderick Verhelst Buy INVESTOR RELATIONS CONTACT Marieke Vermeersch Associate Director Investor Relations Ablynx nv Technologiepark Zwijnaarde (Ghent) Belgium Tel: Website: ANNUAL REPORT 2015 / ABLYNX 55. CORPORATE OVERVIEW
56
57 GLOSSARY
58 Ang2 angiopoietin-2 (Ang2) - an important protein involved in the formation of new blood vessels from pre-existing vessels (angiogenesis), a vital mechanism in the growth of tumours Bi-specific Nanobody Nanobody construct which binds to two different targets Bivalent Nanobody Nanobody construct comprising two Nanobodies that bind with the same targets BLA Biologics License Application - request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce DMARDs disease modifying anti-rheumatic drugs (defined by their use in RA to slow down disease progression) Free float Free float is defined as the outstanding capital less shareholdings exceeding 5%, except where such interests are held by (a) collective investment schemes/ mutual funds or (b) pension funds. In addition, certain insider holdings (e.g. shares held by directors, employees, founders and family), government holdings and holdings of the company itself (including subsidiaries) are not considered free float, irrespective of the size IL-17A/F T Helper 17 (Th17) cells and interleukine-17 (IL-17) are associated with the pathology of many human inflammatory and autoimmune disorders like psoriasis, rheumatoid arthritis and multiple sclerosis and have proved to play an important role in animal models mimicking these and other auto-immune disorders. Although IL-17A is the most characterised family member, its closest relative IL-17F has similar biological activity and possibly even a non-redundant role in vivo. IL-6R receptor of interleukin-6 (IL-6R) - a cytokine involved in a wide range of biological activities Multi-specific Nanobody Nanobody construct which binds to multiple different targets Nanobody protein that is composed of one or more binding domains with the structural and functional characteristics of naturally occurring heavy chain variable domains (VHH s) from Camelidae. Nanobody is a registered trademark of Ablynx Orphan drug drug treating a rare disease - the grant of orphan drug status by the authorities provides certain privileges, intended to stimulate the research, development and commercialisation of orphan drugs including market exclusivity of ten years in Europe and seven years in the USA Phase I first stage of testing in human subjects. Normally, a small (20-100) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug Phase II once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger patient groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of patients Phase III Phase III studies are randomised controlled multi-centre trials on large patient groups (300-3,000 or more ANNUAL REPORT 2015 / ABLYNX 58. GLOSSARY
59 depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is in comparison with current gold standard treatment. Because of their size and comparatively long duration Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions Pre-clinical involves in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information Proof-of-concept study clinical trial to demonstrate the product is effective in patients TTP thrombotic thrombocytopenic purpura - a rare thrombotic disorder UL-vWF ultra-large vwf multimers VEGF vascular endothelial growth factor (VEGF), an important protein involved in the formation of new blood vessels from pre-existing vessels (angiogenesis), a vital mechanism in the growth of tumours vwf von Willebrand factor - a blood glycoprotein involved in haemostasis RA rheumatoid arthritis - autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body RANKL Receptor Activator of Nuclear factor Kappa-B Ligand - a key regulator in bone remodelling RSV respiratory syncytial virus virus that infects the respiratory tract SLE systemic lupus erythematosus (SLE) - complex, multiorgan, autoimmune disorder characterised by the production of pathogenic autoantibodies and tissue deposition of immune complexes, which result in widespread tissue damage TNFα protein named Tumour Necrosis Factor-alpha - a cytokine involved in systemic inflammation ANNUAL REPORT 2015 / ABLYNX 59. GLOSSARY
60
61
62 TABLE OF CONTENTS 01. REPORT OF THE BOARD OF DIRECTORS Strategic Highlights 1.2. Analysis of Results of Operations 1.3. Balance Sheet Analysis 1.4. Cash Flow Analysis 1.5. Outlook Corporate Governance Statement 1.7. Transactions within the Authorised Capital 1.8. Acquisition of Own Securities 1.9. Use of Financial Instruments by the Company Circumstances that could considerably affect the Development of the Company Research and Development Conflicting Interests of Directors (Art. 523 of the Belgian Companies Code) Independence and Expertise of at least one Member of the Audit Committee Justification of the Valuation Rules Appropriation of Results Important Events subsequent to the Accounting Reference Date Grant of Discharge to the Directors and the Statutory Auditor 02. RESPONSIBILITY STATEMENT STATUTORY AUDITOR S REPORT BALANCE SHEET STATEMENT OF COMPREHENSIVE INCOME CASH FLOW STATEMENTS STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY NOTES TO THE FINANCIAL STATEMENTS General Information 8.2. Summary of Significant Accounting Policies 8.3. Financial Risk Management ANNUAL REPORT 2015 / ABLYNX 62. CORPORATE GOVERNANCE AND FINANCIAL INFORMATION
63 8.4. Critical Accounting Estimates and Judgements 8.5. Segment Information 8.6. Intangible Fixed Asset 8.7. Property, Plant and Equipment 8.8. Restricted Cash 8.9. Non-current R&D tax incentive receivables Trade Receivables and Other Current Assets Other Short-term Investments Cash and Cash Equivalents Financial Instruments by Category Share Capital Share-Based Payments Borrowings Trade Payables and Other Current Liabilities Deferred Income Tax Retirement Benefit Obligations Revenue Recognition Research and Development Expenses General and Administrative Expenses Other Income and Expenses Employee Benefit Expense Operating Leases Finance Income and Expenses Income Tax Expense Loss Per Share Contingencies and Arbitrations Commitments Related Party Transactions Events after the Balance Sheet Date 09. DISCLOSURE AUDIT FEES CONDENSED STATUTORY FINANCIAL STATEMENTS OF ABLYNX SUMMARY OF VALUATION RULES AND ADDITIONAL INFORMATION Principles Specific Rules ANNUAL REPORT 2015 / ABLYNX 63. CORPORATE GOVERNANCE AND FINANCIAL INFORMATION
64 01. REPORT OF THE BOARD OF DIRECTORS Dear Shareholders, We are pleased to present the financial statements for the fiscal year ended 31 December 2015 which have been prepared in accordance with the International Financial Reporting Standards (IFRS) as adopted by the EU STRATEGIC HIGHLIGHTS In 2015, total revenues and grant income increased by 57% to 77.5 million (2014: 49.3 million) driven by increased funding for full-time equivalents and increased recognised income, mainly from the upfront payment by AbbVie made in Total research and development costs increased to 83.1 million (2014: 54.5 million) in line with growth in external development costs, which are largely related to clinical trials expenditure for caplacizumab, ALX-0061 and ALX General and administrative costs remained broadly unchanged at 11.4 million (2014: 11.0 million). The operating loss increased to 17.0 million (2014: 16.2 million). The net loss for the period was 54.5 million (2014: 12.7 million). The net cash burn in 2015 (excluding the net proceeds of 97.2 million from the convertible bonds, announced on 20 May 2015) was 67.2 million. The Company ended the year with million in cash, cash equivalents, restricted cash and other short-term investments. Pipeline update At the end of 2015, there were five Nanobodies in clinical development, both internally and as part of collaborations. In March 2015, Ablynx initiated a Phase IIb study of the anti-il-6r Nanobody (ALX 0061), in combination with methotrexate, in patients with rheumatoid arthritis (RA). Recruitment of 345 patients was completed on schedule at year-end. In April 2015, Ablynx initiated a Phase IIb monotherapy study of ALX-0061 in RA patients. Recruitment of 251 patients was completed in February 2016, also on schedule. In July 2015, the first eligible patients from the Phase IIb RA studies with ALX-0061 rolled over into the open-label extension study. In August 2015, Ablynx initiated a Phase II study with ALX-0061 in patients with systemic lupus erythematosus (SLE). The Company plans to recruit 300 patients in this study by In September 2015, Ablynx initiated the confirmatory, international Phase III ANNUAL REPORT 2015 / ABLYNX 64. CORPORATE GOVERNANCE AND FINANCIAL INFORMATION
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