Annual report 2020 Allergy solutions for life Table of content
Management’s review • Annual report 2020 • ALK 2 Table of contents p8 Letter from the Management’s review Financial statements Chairman and CEO "2020 represented the final year of ALK's strategic transformation, Introduction Statements and our focus remained on the relentless execution of our goals." 4 2020 highlights 48 Statement by Management on the annual report 5 ALK at a glance 49 Independent auditor’s reports 8 Letter from the Chairman and CEO Consolidated financial statements 10 2021 outlook 54 Income statement p10 Performance 54 Statement of comprehensive income 2021 outlook 13 Financial highlights and key ratios 55 Cash flow statement ALK expects growth across all 14 Sales and market trends 56 Balance sheet sales regions in 2021. 16 COVID-19: The defining challenge of 2020 57 Statement of changes in equity 17 Financial review of 2020 58 Notes 19 Q4 review Parent company financial statements Strategic transformation 88 Income statement 22 Strategy update 89 Balance sheet 26 Succeed in North America 90 Statement of changes in equity p14 27 Complete and commercialise the tablet 91 Notes Tablet sales up strongly Tablet sales grew by 42% in portfolio for all relevant ages 2020 with ITULAZAX® leading 29 Consumer engagement and new horizons 97 Financial highlights by quarter the way. 30 Optimise for excellence 31 Lead the way – people and planet 32 Medium-term financial ambitions
Corporate matters 34 Sustainability p22 37 Governance and ownership Delivering sustainable 40 Risk management growth and profitability 43 Remuneration With the transformation complete, ALK is now entering 44 Board of Directors Cover picture: Collection of catkins from ALK's birch tree the next phase of its strategic orchard in Post Falls, Idaho. Allergenic source materials are the development. 46 Board of Management main ingredients of ALK's allergy immunotherapy products Intro - COVER
Management’s review • Annual report 2020 • ALK 3
After collection, the catkins are dried in special areas with carefully controlled environments
Introduction
4 2020 highlights 5 ALK at a glance 8 Letter from the Chairman and CEO 10 2021 outlook Intro - 2020 highlights
Management’s review • Annual report 2020 • ALK 4 2020 highlights
Succeed in North America Complete and commercialise the tablet portfolio for all relevant ages Consumer engagement and new horizons Optimise for excellence Other
ALK launches ITULATEK™ Annual general meeting tablet for tree pollen elects Anders Hedegaard as allergy in Canada new Chairman of ALK’s Board RAGWIZAX® for ALK launches klarify digital ALK launches klarify ragweed allergy platform in Denmark digital platform in is approved for Ireland COVID begins to children in Europe New clinical Phase III trial impact business ALK secures rights to for ALK’s house dust mite operations and market OTIPRIO™ in tablet initiated in China clinical activities the USA
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
ALK announces drug ALK launches klarify Q2 report: Revenue RAGWITEK® for ragweed discovery partnership digital platform in Slovakia unchanged with tablet allergy is approved for with American biotech sales up 25% and children in Canada Q1 report: Revenue up company X-Chem EBITDA up 213% 10% with tablet sales up Full-year 2020 financial 38% and EBITDA up 49% results: Revenue up 8% with tablet sales up 42% and EBITDA up 64%
ALK launches klarify ALK updates its full-year financial digital platform in outlook to reflect improved earnings the USA and cash flow as well as growth at the lower end of the guidance range
Q3 report: Revenue up 7% with tablet sales up 52% and EBITDA up 61% Intro - ALK at a glance
Management’s review • Annual report 2020 • ALK 5 ALK at a glance
ALK key figures Global presence
ALK is a global allergy solutions company with a wide range of treatments, products and services to meet the unique needs of allergy sufferers, their families and doctors. Headquartered in Hørsholm, Denmark, the company is listed on Nasdaq Copenhagen (ALKB:DC /OMX: ALK B) International markets North America Revenue Revenue 11% 16% Europe Established: Employees: Revenue 1923 ~2,500 73%
Patients in treatment Development in revenue Markets: with ALK products*: SLIT-tablets (% growth in local currencies)** SCIT/SLIT-drops Other Production sites ALK’s unique manufacturing 41 ~2m DKK bn processes ensure its products meet required quality standards 0 2 2 2 and represent a significant 2 2 2 2 2 2 2 barrier to potential competitors, making them an important factor in maintaining ALK’s The number of the most common market position global respiratory allergies Participated in clinical covered by ALK's tablet portfolio: trials for the tablets: 5 >23,000 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
* Covering AIT and anaphylaxis ** Includes certain milestone payments from partnerships in the period 2011 to 2016 Intro - ALKs business model
Management’s review • Annual report 2020 • ALK 6 ALK's business model
As a global allergy solutions company with a century of knowledge and expertise, ALK helps people to take control of their allergies and their lives.
Value created
Patients: ALK’s tablet portfolio is helping to democratise AIT by covering the most common respiratory allergies, and bringing new treatment Raw materials Active Pharmaceutical Ingredient (API ) production options to people without easy access to allergy Allergenic source materials, such as grass Allergens undergo thorough analysis, standardisation specialists. pollen and house dust mites, are the main and quality control, so that naturally occuring ingredients of our products. Every year variations are minimised, ensuring quality and Doctors: ALK helps allergists to drive better access and the company grows, collects or harvests consistency in the finished products. outcomes for all AIT-eligible patients, reaching out with several tonnes of allergens. support, disease information and treatment options.
Our people: ALK is committed to a sustainable working life and keeps a constant focus on being a safe place to Key resources work for motivated and satisfied employees.
Our people and culture: Around 2,500 highly-skilled Society: ALK addresses profound societal challenges employees live our cultural beliefs every day in their by producing medicines for the leading cause of work to help more people with allergy. lost productivity and lost work days. The company partners with payers and health authorities to Production/natural allergens: ALK’s biological Finished production advance registered, documented AIT products and is a medicines are derived from natural resources, such APIs are purified, then formulated for signatory of the United Nations Global compact. as pollen, which it harvests, standardises and quality subcutaneous injections, sublingual drops or controls at its own facilities. sublingual tablets. Our investors: ALK works to create long-term value for its shareholders. Scientific knowledge: ALK continuously applies its scientific knowledge to help people take control of their allergies and their lives. Allergy solutions for life Sales and partnerships: In addition to its own sales organisation, ALK partners for growth with leading specialty pharma companies worldwide. ALK is present in 41 markets, either directly or via partnerships.
R&D: The completion of the tablet portfolio remains the primary focus of ALK’s R&D efforts. In addition, Packaging and distribution Through information resources, services People with allergies the company is conducting research into innovative Following careful quality control, and products, ALK is working to support often endure a decade solutions for high-impact allergic conditions – such as the finished products are labelled, people with allergy early in their disease or more of symptoms food allergies. packaged and distributed. journey, smoothing the path to treatment. before turning to AIT. Intro - Megatrends shaping allergy
Management’s review • Annual report 2020 • ALK 7 Megatrends shaping allergy
Most common chronic Shift towards Food allergy disease in the world evidence-based medicine If you are allergic to a specific food, exposure may trigger an acute allergic reaction - In Europe, authorities, prescribers and anaphylaxis - for which adrenaline auto-injectors ~500m payers are increasingly turning to registered are an effective rescue medication. In addition, people around the world are affected and and documented products to treat allergies. recent advances in food AIT hold promise of a consume products and services worth more better life for people with food allergy. than DKK 100 billion annually.
ALK’s allergy solutions Allergy can Internet lead to asthma 1 in 10 AIT candidates The internet is the principal source of Asthma is one of the world’s most common SLIT-tablets are receives treatment disease information for people with allergy: chronic childhood diseases. Preventing the allergy is googled >100 million times a year. the best documented progression of allergy into asthma would AIT treatments ~50m represent a major health breakthrough for Since 2001, 23,000 people have taken part people with allergy are so seriously affected millions of children. in ALK’s clinical programmes. Its tablets are that they are potential candidates The COVID effect now the best documented AIT products in for treatment with AIT, but fewer than 5m the world and are approved to the highest people receive treatment today. In 2020, the coronavirus pandemic and associated containment measures restricted the regulatory standards Symptoms of ability of people with allergy to visit clinics in many (FDA, EMA, PMDA etc). respiratory allergies countries, increasing interest in telemedicine and home-based treatment options. Respiratory allergies can affect both the upper and lower Climate change may respiratory tract. Biological products increase number of people ALK's SLIT-tablets have been developed with severe allergy Digital engagement from natural ingredients and are Through ALK’s klarify digital platform, people with strongly protected thanks to unique Climate change means longer pollen Upper respiratory allergy are able to get information about their biological manufacturing processes and seasons and more people suffering from tract – allergic condition and seek treatment in greater numbers. standardisation procedures. severe allergies. Warmer weather is also rhinitis Eyes causing ragweed to spread to new regions. Runny or blocked Nose nose, itchy eyes, Mouth sneezing. Throat Included in Complete tablet portfolio Lower respiratory asthma guidelines tract – allergic Trachea Urbanisation asthma The Global Initiative for Asthma, >80% Bronchus Shortness of GINA, recommends sublingual Increasing migration to cities - especially Lungs of adults with respiratory allergic disease breath, narrowed AIT as a treatment option in in Asia - will further drive the prevalence of airways, coughing, requiring AIT are now covered by ALK's patients with house dust mite- allergies such that ALK expects it to reach wheezing. portfolio of five SLIT-tablets which can be similar levels to Europe and the USA. induced allergic asthma. taken at home. Intro - Letter from the CEO
Management’s review • Annual report 2020 • ALK 8
Letter from the Chairman and CEO
2020 represented the final year of ALK’s strategic transformation, and our focus remained on the relentless execution of our goals. When we first announced this transformation, we said that we wanted to ‘fix and grow’ ALK by cleaning up past issues and establishing strong foundations to support growth. What 2020 clearly demonstrated is that we have been able to deliver on both of those promises, as a refocused ALK delivered 8% revenue growth while also proving resilient to an unprecedented global challenge, without which, growth would have been even stronger. Everyone at ALK Revenue growth was fuelled in the large part by a further spectacular increase in sales from our can feel justifiably ® tablet portfolio of 42%, with the newly launched ITULAZAX leading the way. proud of the cultural and “organisational transformation Throughout the transformation period, we have consistently ODACTRA®, although long-standing financial disincentives that they have contributed to overperformed relative to our promises, exceeding the for prescribers, and the impact of COVID, have challenged over the past three years. cumulative sales forecast for 2018-20 by more than DKK commercial progress there. We have invested significantly to
700 million, delivering EBITDA that was ahead of target, and improve our patient engagement capabilities by developing Anders Hedegaard, registering significantly improved cash flow that was more our klarify digital ecosystem, which offers help and resources Chairman of the Board than DKK 700 million ahead of plan. The positive results are to the millions of people living with allergy so they can better also there to see across our four areas of strategic focus: understand and manage their condition. Importantly, klarify also enables us to mobilise patients to seek diagnosis Tablets are now the undisputed growth engine of ALK, and treatment in greater numbers. In addition to all of the delivering an average growth of 37% over three years above, we have advanced our site specialisation strategy (CAGR). Meanwhile, the addition of ITULAZAX® to our range and significantly pruned our portfolio, while also enhancing completed our mission to cover the five major most important manufacturing efficiency, quality, and robustness. Together, respiratory allergies. In North America, we have established these initiatives will secure long-term margin improvements. a new sales infrastructure and launched ACARIZAX®/
Continues Management’s review • Annual report 2020 • ALK 9
Sustainable growth and profitability opportunities over the next five-to-10 years – such as an Having made the necessary, significant investments to expanded offering in anaphylaxis, an entry into food allergy transform ALK, we are now entering the next phase of the treatment, and research into innovative new treatments company’s development, where we must carefully work for high-impact allergic conditions. If we repeat our recent to sustain long-term growth, while also returning ALK to success in each of these areas over the coming years, we profitability. will establish a much larger ALK capable of continuously generating attractive shareholder returns. Our overall trajectory remains unchanged, because we are still convinced that the four priorities we established three The commitment of our employees has been instrumental years ago are the most critical to delivering future growth. to delivering on the very ambitious targets we set when Moreover, maintaining this continuity of focus will allow us to the strategy was first announced, and everyone at ALK build on the foundations that we have now established, using can feel justifiably proud of the cultural and organisational our progress in each of these areas as a springboard from transformation that they have contributed to over the past which to drive further growth. three years. Moreover, the work we have done together to strengthen ALK’s foundations has been critical to our ability Tablets will remain our primary growth driver for the to withstand the challenge of COVID, in response to which, not foreseeable future, and effective life-cycle management only did our employees swiftly implement our contingency will be important to supporting their continued strong plans and keep each other safe, but they also enabled ALK to Having made the performance. This means expanding into new countries maintain an uninterrupted supply of medicines for those who necessary, significant – such as China, and extending coverage to new patient rely upon them. investments to transform groups – including children. Clearly, the US market still has “ALK, we are now entering the largely untapped potential for ALK and will require much We continue to value the trust placed in us by patients, creativity and persistence before it fulfils our expectations prescribers, and investors, and we will maintain our efforts next phase of the company’s but, as in other parts of the world, if we support our efforts to sustain and strengthen that trust wherever possible. By development, where we must with an effective commercial strategy by expanding the reach successfully executing the next phase of our development, carefully work to sustain of klarify and establishing a broader, scalable sales model, which is designed to deliver sustainable growth and and we back that up with excellence and robustness within profitability, we can continue our progress towards becoming long-term growth, while also our organisation, there is much more that we can achieve with the 'go-to' allergy company. returning ALK to profitability. the assets already at our disposal. Carsten Hellmann, Nevertheless, we have also taken care to incorporate President & CEO initiatives that have the ability to accelerate our long-term Anders Hedegaard Carsten Hellmann development. Projects that may not make a significant Chairman of the Board President & CEO contribution immediately, but which offer even further growth Intro - 2021 outlook
Management’s review • Annual report 2020 • ALK 10 2021 outlook
ALK expects growth across all sales regions growth negatively by approximately 1 in 2021, and revenue is projected to increase percentage point. 2021 expectations by 8-12% organically in local currencies, with the tablet portfolio expected to remain the key ALK expects broad-based growth across growth driver. all sales regions. The mid-point of the Revenue projected revenue range assumes that As a consequence of significant R&D cost sales in Europe will increase by around 8-12% organic growth delays from 2020 to 2021 due to the impact 10%. Sales in North America are expected – in local currencies of COVID, and a gradual normalisation of to recover from the impact of COVID during capacity costs, operating profit (EBITDA) is 2021, growing in double digits, while Growth across all sales regions expected to be close to that seen in 2020, sales growth in International markets is despite revenue growth and an improved projected to temporarily slow to high single gross margin, attributable to tablet sales digits. This is mainly due to growth in Japan growth, and efficiencies. becoming more incremental following the extraordinarily high rates seen when Torii EBITDA ALK’s working assumption is that the first half converted patients from an outgoing legacy of 2021, and especially Q1, will continue to product to the CEDARCURE™ tablet, and DKK 325-425 million be impacted by COVID, especially in relation built up its inventories of CEDARCURE™ and Operating profit (EBITDA) – close to that seen in 2020, mainly due to to allergy patients’ ability and willingness to MITICURE™. COVID-related delays in R&D activities visit healthcare professionals. This is likely Substantial, DKK ~150 million increase in R&D costs to continue to impact the sales of treatments Tablets, ALK’s single largest product that rely on more frequent clinic visits, while category, will remain key to growth in 2021. sales of tablets are expected to remain ALK plans for strong, double-digit tablet sales resilient. growth in Europe and North America, while growth in Japan will be slower for the reasons Free cash flow Consequently, and as a result of the quarterly stated above. Taking these factors together, variations in 2020, fluctuations in revenue ALK estimates that global tablet sales growth DKK minus 200-300 million growth and earnings are likely from quarter to will exceed 20% in 2021, continuing their vs. DKK +56 million in 2020 quarter during 2021. strong positive trajectory. Impacted by payments postponed from 2020
Revenue In addition, ALK expects low single-digit Organic growth is projected at 8-12% in sales growth from the remaining, non-tablet local currencies. Discontinuations of legacy product portfolio, mainly driven by SCIT products are estimated to impact projected products, and double-digit sales growth from the Jext® adrenaline auto-injector.
Continues Management’s review • Annual report 2020 • ALK 11
The higher end of the projected revenue Operating profit Free cash flow range assumes accelerated sales growth Capacity costs will be influenced by a Free cash flow is expected to be negative, in Forward-looking statements across all regions with tablets leading significant increase in R&D expenses in the region of DKK 200-300 million. Free cash This report contains forward-looking the way and faster market share gains, order to complete the clinical development flow will be impacted by changes in working statements, including forecasts of future supported by a continuing regulatory of the tablet portfolio and gather further capital, including a one-off repayment of up revenue, operating profit and cash transition towards evidence-based AIT evidence for the tablets’ use in children, to DKK 175 million in accrued rebates, which flow, as well as expected business- related events. Such statements are, products in key markets. The lower end of the adolescents and to secure registrations was originally scheduled for 2020, as well by their very nature, subject to risks revenue range incorporates pricing pressure, in new geographies. R&D costs for 2021 as a deadline extension for the settlement and uncertainties, as various factors, particularly in southern Europe, and/or more are estimated at around DKK 650 million, of around DKK 50 million related to 2020 tax some of which are beyond the control pronounced, ongoing negative effects from a significant increase over 2020, of which, payments for employees in Denmark. CAPEX of ALK, may cause actual results and COVID. approximately DKK 100 million relates to is projected at approximately DKK 300 million performance to differ materially from the forecasts made in this report. Without activities that were originally scheduled for with investments focused on streamlining being exhaustive, such factors include, Margins 2020 but were postponed due to the impact of the manufacturing footprint and further e.g., consequences of the global COVID The gross margin is expected to increase by COVID on patient recruitment for clinical trials. specialisation at ALK’s production facilities. pandemic, general economic and 1-2 percentage points versus 2020, driven business-related conditions, including: by efficiencies and higher sales – especially Sales and marketing activities are expected Other assumptions legal issues, uncertainty relating to demand, pricing, reimbursement from tablets, with higher volumes absorbed to gradually return to normal as the impact of The outlook does not include any revenue rules, partners’ plans and forecasts, by existing capacity. ALK will continue COVID eases, particularly in the second half of from acquisitions, new partnerships or the in- fluctuations in exchange rates, to allocate significant resources to the the year. For the full year, costs are expected licensing of adjacent products and services, competitive factors and reliance on execution of its portfolio and site strategy, to rise in line with support for growth nor does it include any sizeable payments suppliers. Additional factors include which designates each production facility initiatives, although ALK will continue to seek related to M&As or in-licensing activities. The the risks associated with the sourcing and manufacturing of ALK’s products as a centre of manufacturing excellence to leverage its existing sales and marketing outlook is based on current exchange rates, as well as the potential for side effects and is consolidating the number of active platforms to drive margin improvement. resulting in a negative effect of approximately from the use of ALK’s existing and future pharmaceutical ingredients used across the 1 percentage point on reported revenue products, as allergy immunotherapy portfolio. These activities – in combination On this basis, ALK expects the operating profit growth and an immaterial effect on reported may be associated with allergic with increased sales and efficiencies that (EBITDA) to be in the range of DKK 325-425 EBITDA. reactions of differing extents, durations and severities. come from utilising higher-volume production million, which is largely level with 2020's lines – are expected to lead to substantial, EBITDA of DKK 395 million. long-term margin improvements. Perform - COVER
Management’s review • Annual report 2020 • ALK 12
Performance
13 Financial highlights and key ratios 14 Sales and market trends 16 COVID-19: The defining challenge of 2020 17 Financial review of 2020 19 Q4 review Perform - Financial highlights Group
Management’s review • Annual report 2020 • ALK 13 Financial highlights and key ratios for the ALK Group*
DKK DKK DKK DKK DKK EUR EUR DKK DKK DKK DKK DKK EUR EUR Amounts in DKKm/EURm** 2020 2019 2018 2017 2016 2020 2019 Amounts in DKKm/EURm** 2020 2019 2018 2017 2016 2020 2019
Income statement Information on shares Revenue 3,491 3,274 2,915 2,910 3,005 469 438 Proposed dividend - - - - 51 - - EBITDA 395 241 136 253 642 53 32 Share capital 111 111 111 111 101 14.9 14.9 Operating profit/(loss) (EBIT) 150 (14) (96) (80) 479 20 (2) Shares in thousands of DKK 10 each 11,141 11,141 11,141 11,141 10,128 11,141 11,141 Net financial items (49) (17) (7) (42) 8 (7) (2) Share price, at year end 2,500 1,635 960 740 920 336.1 218.9 Profit/(loss) before tax (EBT) 101 (31) (103) (122) 487 14 (4) Net asset value per share 283 285 285 295 284 38.0 38.2 Net profit/(loss) 25 (50) (170) (158) 270 3 (7) Average number of employees (FTE) 2,419 2,385 2,341 2,213 2,010 2,419 2,385 Key figures Gross margin – % 58.1 57.8 56.0 56.4 66.9 58.1 57.8 Balance sheet EBITDA margin – % 11.3 7.4 4.7 8.7 21.4 11.3 7.4 Total assets 5,563 5,495 4,865 4,958 4,799 748 736 Return on equity (ROE) – % 0.8 (1.6) (5.3) (5.1) 9.7 0.8 (1.6) Invested capital 2,664 2,759 2,968 2,864 2,353 358 369 ROIC incl. goodwill – % 5.5 (0.5) (3.3) (3.1) 20.0 5.5 (0.5) Equity 3,153 3,176 3,179 3,290 2,875 424 425 Pay-out ratio – % - - - - 18.9 - - Earnings/(loss) per share (EPS) 2.3 (4.6) (15.6) (15.9) 27.5 0.3 (0.6) Cash flow and investments Earnings/(loss) per share (DEPS), diluted 2.3 (4.6) (15.6) (15.9) 27.2 0.3 (0.6) Cash flow per share (CFPS) 27.6 12.1 (8.7) (39.0) 41.3 3.7 1.6 Depreciation, amortisation Price earnings ratio (PE) 1,092 (356) (61) (46) 33 1,092 (356) and impairment 245 255 232 333 163 33 34 Share price/Net asset value 8.8 5.7 3.4 2.5 3.2 8.8 5.7 Cash flow from operating activities 301 132 (95) (387) 405 40 18 Cash flow from investing activities (245) (157) (199) (358) (204) (33) (21) – of which investment in intangible assets (26) (20) (52) (27) (46) (3) (3) Revenue growth – % – of which investment in tangible assetss (196) (147) (126) (240) (179) (26) (20) Organic growth 8 11 1 (6) 19 8 11 – of which acquisitions of Exchange rate differences (1) 1 (1) (1) (2) (1) 1 companies and operations - (20) (21) (94) - - (3) Acquisitions/divestments - - - 4 - - - Free cash flow 56 (25) (294) (745) 201 8 (3) Total growth revenue 7 12 - (3) 17 7 12
* Management’s review comprises pages 1-46 as well as ‘Financial highlights and key ratios by quarter for the ALK Group’ on page 97 ** Financial highlights and key ratios stated in EUR constitute supplementary information to the Management’s review. The exchange rate used in translating from DKK to EUR is the exchange rate prevailing on 31 December 2020 (EUR 100 = DKK 744) (31 December Read the ESG key figures overview here 2019: EUR 100 = DKK 747)
For definitions and reconciliation of alternative performance measures, see page 86 Perform - Sales and market trends
Management’s review • Annual report 2020 • ALK 14 Sales and market trends
Revenue grew 8% organically in Overall revenue was DKK 3,491 million continuing constraints caused by COVID. SCIT treatments rely on more frequent clinic local currencies, and was in line (3,274), which equates to organic growth of Planned product discontinuations reduced visits, and were disproportionately affected 8% in local currencies. Growth was driven by growth by 4 percentage points, as numerous by COVID since patients were either unable with the most recent outlook, tablets, which is ALK’s largest single product older SCIT and SLIT-drops products or unwilling to visit clinics and, in any case, issued in November 2020. Planned category, and which proved resilient to the continued to be phased out in favour of capacity at many clinics – particularly in portfolio rationalisations reduced effects of COVID – in part due to its suitability documented, registered products. southern Europe – was significantly reduced. growth by around 3 percentage as an alternative option for patients who were unable to continue with their usual Revenue growth was largely fuelled by sales Sales of other products were up 18% at DKK points in 2020. ALK also saw an treatments. Tablet sales grew by 42% with of SLIT-tablets, which were up 40% at DKK 211 million (179), driven by strong demand impact on sales from COVID, ITULAZAX® leading the way, while SCIT 1,019 million (735). Sales benefited from the for the adrenaline auto-injector Jext®, which particularly in the USA, where products were negatively affected by the confluence of several factors: resilience to the registered 42% sales growth and market ALK estimates the total value of impact of COVID as they are administered impact of COVID versus alternative treatment share gains in key markets. during visits to allergy clinics. The COVID- options, the ongoing market shift in favour of missed sales exceeded DKK 100 effect impacted sales in the USA in particular, evidence-based medicines, the benefits of Overall revenue increased in most markets, million. where conditions were challenging, with an ALK sales excellence programme, and the especially Germany, which delivered double- significantly fewer patients visiting allergy ongoing roll-out of ITULAZAX®. digit growth following a significant increase specialists. in tablet sales with a promising performance (Comparative figures for 2019 are shown Combined SCIT and SLIT-drops sales were by ITULAZAX®. Furthermore, ALK became the in brackets. Revenue growth rates are Europe down 9% at DKK 1,320 million (1,454). Of first company in Germany to offer a complete organic and stated in local currencies, unless European revenue increased by 8% to this, 6 percentage points related to product product range for major allergens comprised otherwise indicated) DKK 2,550 million (2,368) despite some discontinuations, as well as the fact that solely of registered AIT treatments, reflecting
Continues
Revenue by geography Revenue by geography Revenue by product line Revenue by product line
Growth Europe North America Growth SCIT/SLIT-drops SLIT-tablets DKKm 2020 (l.c.) 2019 International markets DKKm 2020 (l.c.) 2019 Other
11% (7%) Europe 2,550 8% 2,368 SCIT/SLIT-drops 1,673 -7% 1,818 13% (15%) North America 573 -10% 669 SLIT-tablets 1,370 42% 973 16% (20%) 73% (73%) 48% (55%) Int'l markets 368 58% 237 Other products 448 -4% 483 Overall revenue 3,491 8% 3,274 Overall revenue 3,491 8% 3,274 2020 2020 (2019) (2019) 39% (30%) Management’s review • Annual report 2020 • ALK 15
an ongoing market shift in favour of North America Full-year sales of tablets in the region grew ALK became the first registered, evidence-based products, which The fallout from the COVID pandemic by 4% to DKK 85 million (85), driven by company in Germany was further facilitated by a change to the fee made market conditions in North America Canada as US sales stagnated. In volume model, mitigating unintended disincentives challenging, especially in the USA, and terms, tablet uptake in North America to offer a complete product for doctors to prescribe tablets. In France, suppressed sales across the portfolio. A increased by 28%, but market-building “range for major allergens overall sales were unchanged as growth in major influence on this was patients’ ability tactics such as rebates and coupons – comprised solely of tablet sales was offset by lower SLIT-drops and willingness to visit allergy clinics, while essential to establishing any new medicine in registered AIT treatments. sales. However, ALK remains the market a further challenge came from the fact that this region – reduced effective sales prices. leader in terms of the number of patients many clinics were running at a reduced Sales of bulk allergen extracts were down receiving treatment. Meanwhile, sales in capacity. At one point, during Q2, ALK 5% at DKK 275 million (306), while sales of Spain were also impacted by COVID, while the estimated that up to half of US allergy clinics diagnostics and other products decreased challenging conditions in Italy were further were fully or partially closed, while those that 19% to DKK 213 million (278) – mainly due exacerbated. were open were seeing significantly fewer to COVID reducing sales of non-allergy patients. related life science products and the use of Overall, market conditions were largely PRE‑PEN® in hospitals. stable, and there were no notable changes In consequence, revenue in North America affecting the pricing and reimbursement of was down 10% organically in local currencies International markets AIT products, although the risk of pressure in to DKK 573 million (669). This was despite Revenue from International markets was up southern Europe remains. some improvements in H2, particularly in 58% in local currencies at DKK 368 million sales of tablets and bulk SCIT products. (237) as ALK’s largest markets in the region, Japan and China, resisted and rebounded from COVID, respectively.
Revenue in Japan from product supply and 5-year total revenue by geography 5-year total revenue by product line sales royalties grew by 80%. ALK’s partner
Europe North America SCIT/SLIT-drops SLIT-tablets Torii continued to successfully build the International markets Other market for tablets and MITICURE™ sales were