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ALK-Abelló

Annual Report Feb 8, 2022

3351_10-k_2022-02-08_83a1edf4-3e08-45b6-9edc-d8d007fd104c.pdf

Annual Report

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Annual report 2021: ALK delivers strong sales growth of 12% with tablet sales up 29% and EBITDA up 35%

ALK's (ALKB:DC / OMX: ALK B / AKABY / AKBLF) Board of Directors has approved the company's annual report (ESEF-version ALK-2021-12-31-en attached): Following a solid Q4, ALK ended 2021 at top of its most recent revenue guidance, with double-digit sales growth in all regions with tablets as the main driver of growth. For 2022, ALK expects revenue growth of 8-12% and a further improvement in profitability.

ALK's President and CEO, Carsten Hellmann said: "2021 represented another important stepping stone towards fulfilling ALK's goals of continuous growth and improved profitability, and we expect to build on this progress with 8-12% revenue growth in 2022, as we continue to pursue our targets for 2025. At the same time, we are also investing in a number of potential sales- and profit growth accelerators which look to the longer term."

(Revenue growth rates are stated in local currencies. Comparative figures for 2020 are shown in brackets.)

Q4 2021 highlights

  • Revenue in Q4 increased 9% in local currencies to DKK 1,099 million (991), driven by tablet sales growth of 23%. This was despite a Q4 in 2020 that saw extraordinarily high revenue growth, in part fuelled by a high number of product shipments to Japan.
  • EBITDA more than doubled to DKK 136 million (64), reflecting higher sales, improved gross margins and a modest increase in capacity costs.

Full-year 2021 highlights

  • Full-year revenue increased by 12% to an all-time high of DKK 3,916 million (3,491), based on double-digit growth in all sales regions.
  • Tablet sales grew 29% on market expansion and market share gains and now represent 45% of total revenue (39). Sales of SCIT and SLIT-drops were largely unchanged, while sales of other products increased 10%.
  • EBITDA was up 35% to DKK 534 million (395), driven by higher sales and an improving gross margin. Earnings improved despite a planned 23% increase in R&D expenses to support clinical trials.
  • Free cash flow was positive at DKK 202 million (56), mainly on higher earnings.
  • ALK made further progress on its long-term strategy, despite the ongoing impact of COVID, most notably on certain clinical trials.

2022 financial outlook

ALK expects sales growth across all regions in 2022 and improved earnings, in line with its longterm ambitions.

  • Revenue is expected to grow 8-12% in local currencies. Tablets will remain key to overall growth with sales estimated to grow by around 20%.
  • EBITDA is expected to increase to DKK 625-725 million (2021: DKK 534 million), benefiting from higher sales, an improved gross margin and efficiencies. R&D costs are expected to increase to DKK 650-700 million (2021: DKK 631 million). Sales and marketing costs are also expected to increase, reflecting investments in current and future growth drivers, including China.

ALK-Abelló A/S

For further information please contact:

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Jeppe Ilkjær, mobile +45 3050 2014

Audio cast

Today, ALK is hosting a conference call for analysts and investors at 12.00 noon (CET) at which Management will review the financial results and the outlook. The conference call will be audio cast on https://ir.alk.net where the relevant presentation is available shortly before the call begins. Participants are kindly requested to call in before11.55am (CET). Danish participants should call in on tel. +45 3544 5577 and international participants should call in on tel. +44 333 300 0804 or +1 631 913 1422. Please use the Participant Pin Code: 58470902#.

This information is information that ALK-Abelló A/S is obliged to make public pursuant to the EU Market Abuse Regulation.

About ALK

ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,600 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

Annual report 2021

Allergy solutions for life

ALK-Abelló A/S Bøge Allé 6-8 DK-2970 Hørsholm Denmark CVR no. 63 71 79 16

Table of contents

Management's review

Introduction

  • 4 Letter from the Chairman and CEO
  • 7 ALK at a glance
  • 8 2021: Highlights of the year
  • 9 2022 outlook

Performance

  • 13 Financial highlights and key ratios
  • 14 Sales and market trends
  • 16 Financial review of 2021
  • 18 Q4 review
  • 20 Sustainability

Strategy

24 Strategy progress 30 ALK's business model

Corporate matters

  • 32 Governance and ownership
  • 40 Risk management
  • 42 Board of Directors
  • 44 Board of Management

Tablet sales up

Tablet sales grew by 29% in 2021

Revenue up

12%

Revenue grew by 12% to DKKm 3,916 in 2021

Financial statements

Statements

46 Statement by Management on the annual report

47 Independent auditor's report

Consolidated financial statements

  • 52 Income statement
  • 52 Statement of comprehensive income
  • 53 Cash flow statement
  • 54 Balance sheet
  • 55 Statement of changes in equity
  • 56 Notes

Parent company financial statements

  • 92 Income statement
  • 93 Balance sheet
  • 94 Statement of changes in equity
  • 95 Notes

Financial highlights by quarter Cover picture: ALK has begun 103

developing an allergy immunotherapy tablet for potentially life-threatening peanut allergy.

At the start of a complex manufacturing process, ALK turns peanut kernels into a powder to be used as a source material for the peanut tablets.

Introduction

4 Letter from the Chairman and CEO

  • 7 ALK at a glance
  • 8 2021: Highlights of the year
  • 9 2022 outlook

Letter from the Chairman and CEO

ALK is growing fast and is on course to deliver longterm, continuous growth with improving profitability, while also investing in, and executing, new projects and activities to deliver an EBIT in the range of 25% while safeguarding, and potentially accelerating growth, from 2025 onwards.

In 2021, ALK maintained its progress towards continuous growth and improved profitability as we successfully executed on our strategic priorities. Revenue grew by 12% on broad-based growth across all three sales regions, with tablets being the key driver of growth. Operating profit (EBITDA) increased by 35% in reported

currency to DKK 534 million, driven by higher sales, margin improvements, and efficiencies.

Throughout the year, COVID still impacted the lives of millions around the world, and ALK continued to prioritise the safety and well-being of its staff, as well as the supply of products for doctors and their patients. Despite some challenges – for example, schedules for certain clinical trials had to be revised – the pandemic proved manageable for ALK, not least due to the hard work of our employees and their flexibility in accommodating changes in working practices. Thanks in part to these efforts, our supply chain, inventories and distribution remained resilient to the raw materials and logistical challenges reported by multiple industries.

In 2022, we expect continued progress with full-year revenue forecast to grow

8-12% organically, and increased operating profit (EBITDA). This is expected despite extraordinarily high R&D costs, and the support for new, short-term growth initiatives, such as ramping up in China and digital consumer activities, plus longer-term growth initiatives such as an entry into food allergy, developing a new adrenaline auto-injector, and the pursuit of paediatric indications for the tablets. COVID, unfortunately, will most likely remain a factor in the year ahead, and may cause short-term fluctuations in sales in some markets, but overall, we expect to continue to withstand this ongoing challenge.

Employee engagement and retention remain important areas of focus for us. Over the past year, ALK has implemented programmes to support engagement and retention, promote talent identification and development, and to develop our

"ALK maintained its progress towards continuous growth and improved profitability as we successfully executed on our strategic priorities.

Anders Hedegaard, Chairman of the Board

"The pandemic proved manageable for ALK, not least due to the hard work of our employees.

Carsten Hellmann, President & CEO

leaders. The 2021 employee engagement survey registered scores that were above the healthcare industry average and we are striving to further improve the attractiveness of working at ALK, using the valuable input from our employees, so we can continue to recruit and retain skilled employees.

In addition, we continued to take steps on our sustainability journey, by ensuring that this priority becomes an integrated part of our overall business strategy.

Maintaining growth and improving profitability

Our ambition remains to deliver organic growth of 10% or more annually, and to ramp up profitability to an EBIT-margin of around 25% in 2025. We believe that these are realistic ambitions given the market potential, the business transformation we have delivered, and the unwavering commitment of everyone at ALK to deliver on the promises we have made.

Tablets, which already account for 45% of ALK's total revenue, will still be the main growth engine, and we aim to continue their momentum by expanding prescriber

depth and breadth in existing and new markets – via consumer engagement and new digital models, new channels, market share gains and additional registrations. At the same time, we will manage our legacy portfolio of SCIT and SLIT-drops products to further support overall growth.

In the process, we expect gross margins to gradually improve, while capacity costs relative to revenue will decrease from 2023, once we have completed largescale clinical development work on the respiratory tablets.

Safeguarding and, potentially, accelerating growth

While we remain committed to delivering on our promises, we are also, as previously mentioned, investing to accelerate growth beyond 2025. That's why we are already funding a number of high potential growth accelerators, which look many years beyond 2025.

The first of these is children. In 2023, we expect to complete our paediatric clinical trials in house dust mite and tree pollen allergic rhinitis, which should open the door to full paediatric coverage in

Europe and North America. To illustrate the importance of this, the vast majority of SLIT-tablet patients in the fast-growing market of Japan are currently under 18 years. That's probably because parents, who may play down their own allergies and suffer in silence, are much more proactive when it comes to seeking treatment for their children.

The second opportunity is China, which is already one of the world's largest markets for house dust mite allergy immunotherapy (AIT) and has the potential to become significantly larger. Right now, we are expanding our salesforce and strengthening market access activities with the aim of speeding up the adoption of our existing AIT offering. This is so we can build the allergy treatment market ahead of a planned introduction of ACARIZAX® which, subject to approval, is targeted for 2025. Meanwhile, our new Jext® partnership with Grandpharma will further widen our footprint in China.

Thirdly, we want to enter the market for adrenaline auto-injectors in the USA with an affordable, competitive, next-Continues generation product. To achieve this, we have two development programmes – an external project with Windgap Medical and an in-house project, with the aim of submitting a regulatory filing to the FDA by 2024.

Finally, we want to develop a new, mainstream treatment for food allergy. In 2021, we completed a feasibility study confirming that ALK's current tablet technology is suitable for this project, and we plan to start Phase I clinical development in 2022 with an initial project for peanut allergy. With very limited treatment options available for this potentially life-threatening allergic condition, we believe this move is an important step towards fulfilling our promise of becoming the allergy company.

Each of these potential accelerators is being pursued at full speed and, if we can repeat our recent successes, they will help to establish a much larger and stronger ALK, capable of continuously generating attractive shareholder returns for many years to come.

Dedicated to allergy solutions for life

In closing, we would like to thank ALK's employees for their continuing efforts and their tireless commitment to providing allergy solutions for life. Their dedication and discipline are what allow us to deliver on the ambitious targets we have set, and to help as many allergy sufferers as possible. Special thanks are also due to our partners, without whom we could not succeed, and to the patients and prescribers who place their trust in us – a trust we never take for granted and work hard every day to maintain.

Last, but not least, we would like to thank our shareholders. As ALK's financial performance continues to improve towards our targets, we look forward to rewarding them through continued, longterm value creation.

Anders Hedegaard

Chairman of the Board

Carsten Hellmann President & CEO

Peanut drug substance samples are analysed in our state-of-the-art laboratories using highperformance liquid chromatography, whereby chromatograms show visualisations of the peanut drug substance alongside other allergens.

ALK at a glance

ALK key figures

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)

Established:

1923

Markets with ALK presence:

Number of most common respiratory allergies covered by ALK's tablets:

Patients in treatment with ALK products*: ~2.1m

Employees: ~2,600

Participated in clinical trials for the tablets: >24,000

* Covering AIT and/or adrenaline

3.9

Development in revenue (DKKbn)

  • SLIT-tablets (% growth in local currencies)
  • SCIT/SLIT-drops

Other

Production sites

ALK's unique manufacturing processes ensure its products meet required quality standards and represent a significant barrier to potential competitors, making them an important factor in maintaining ALK's market position

Sustainability

2021: Highlights of the year

2022 outlook

ALK expects growth across all sales regions in 2022, with revenue projected to increase by 8-12% organically in local currencies, and the tablet portfolio expected to remain the key growth driver.

(Revenue growth rates are stated in local currencies, unless otherwise indicated)

Operating profit (EBITDA) is expected to increase to DKK 625-725 million

(2021: 534), reflecting revenue growth and an improved gross margin, both attributable to tablet sales growth, as well as efficiencies.

The COVID pandemic continues to cause a degree of uncertainty regarding capacity at allergy clinics and patients' behaviour, which may lead to some volatility in the quarterly results.

Revenue

The growth, projected at 8-12% in local currencies, is expected to be broad-based across all sales regions. The mid-point of the projected revenue range assumes that

sales in Europe will increase in single digits whereas sales growth in North America is expected at around 10% and growth in International markets is expected to exceed 10%. However, in absolute terms, the majority of growth is expected to come from Europe.

Tablets, ALK's single largest product category, will remain key to growth in 2022. ALK plans for strong tablet sales growth across its regions and estimates global tablet sales growth of around 20% in 2022, with double-digit growth across all three sales regions, led by market share

Continues

2022 targets

Revenue 8-12% growth

Growth across all sales regions

(2021: DKK 3,916 million)

EBITDA DKK 625-725 million

Operating profit (EBITDA)

DKK ~50 million increase in R&D costs

(2021: DKK 534 million)

Forward-looking statements

This report contains forward-looking statements, including forecasts of future revenue, operating profit and cash flow, as well as expected business-related events. Such statements are, by their very nature, subject to risks and uncertainties, as various factors, some of which are beyond the control of ALK, may cause actual results and performance to differ materially from the forecasts made in this report. Without being exhaustive, such factors include, e.g., consequences of the global COVID pandemic, general economic and business-related conditions, including: legal issues, uncertainty relating to demand, pricing, reimbursement rules, partners' plans and forecasts, fluctuations in exchange rates, competitive factors and reliance on suppliers. Additional factors include the risks associated with the sourcing and manufacturing of ALK's products, as well as the potential for side effects from the use of ALK's existing and future products, as allergy immunotherapy may be associated with allergic reactions of differing extents, durations and severities.

gains and market expansion, particularly in central and northern Europe, and Japan.

In addition, ALK expects low single-digit sales growth from the remaining, nontablet portfolio, mainly driven by SCIT products and the adrenaline auto-injector, Jext®.

The higher end of the projected revenue range assumes accelerated sales growth across all regions with tablets leading the way and faster market share gains, supported by continuing regulatory impetus towards evidence-based allergy immunotherapy (AIT) products in key markets. The lower end of the revenue range incorporates pricing pressures, particularly in selected markets in Europe, and/or more pronounced, negative effects from COVID.

Margins

The gross margin is expected to improve by 1-2 percentage points on 61% in 2021, driven by efficiencies and higher sales – especially from tablets, with higher volumes absorbed by existing capacity. ALK will continue to allocate resources to the execution of its product and site strategy. These activities – in combination with the increased sales and efficiencies that come from utilising higher-volume production lines – are expected to lead to long-term margin improvements.

Operating profit

As previously stated, capacity costs will be influenced by a planned increase in R&D expenses in order to complete the clinical development of the respiratory tablet portfolio, gather further evidence for the tablets' use in children, secure tablet registrations in new geographies and progress the food AIT programme into clinical development. R&D costs for 2022 are estimated at around DKK 650-700 million, roughly a DKK 50 million increase over 2021. The increase mainly relates to activities that were originally scheduled for 2020-21 but were postponed due to the impact of COVID on patient recruitment for clinical trials.

Sales and marketing costs are expected to increase, although the ratio to revenue is expected to improve slightly versus 2021. The expected increase reflects investments in current and future growth drivers, including additional investments to expand in China, further consumer-to-

Our industry-leading project teams meet regularly to brainstorm, share ideas, and discuss results – an essential part of the peanut tablet development project.

patient initiatives and early preparations for future paediatric tablet launches. ALK will continue to seek to leverage its existing sales and marketing platforms to drive underlying margin improvement.

On this basis, ALK expects the operating profit (EBITDA) to be in the range of DKK 625-725 million, exceeding the level of 2021 and in line with ALK's long-term earnings ambitions of achieving a ~25% EBIT margin in 2025.

Assumptions

  • The outlook assumes that COVID will not affect home-based tablet treatments, and that patients in general will remain able and willing to visit healthcare professionals without significant limitations, although fluctuations may occur in some markets.
  • The outlook assumes that COVID will not significantly impact planned clinical activities, sales and marketing activities or investments. CAPEX is

projected at around DKK 400 million, with investments focused on supporting long-term growth ambitions relating to tablets and adrenaline autoinjectors, the further streamlining and specialisation of production facilities, as well as IT upgrades. Free cash flow is expected to be negative, mainly due to changes in working capital, including a one-off repayment of up to DKK 175 million in accrued rebates, originally anticipated as due for payment in 2021.

  • The outlook does not include any revenue from acquisitions, new partnerships or the in-licensing of adjacent products and services, nor does it include any sizeable payments related to M&As or in-licensing activities.
  • The outlook is based on current exchange rates, resulting in a positive effect of approximately 1 percentage point on reported revenue growth and an immaterial effect on reported EBITDA.

Ramping up in China

ALK has had a presence in China's rapidly growing allergy treatment market for nearly 20 years. New allergy immunotherapy products must be documented and registered before they can be sold in China, and there are just three players in the market, including ALK, with a competitor's SLIT-drops products the current leaders in a market worth around DKK 800 million annually.

ALK enjoys a strong reputation locally for offering high-quality products which are prescribed via selected hospital-based clinics in key locations. The current range is focused on the SCIT product Alutard® for the treatment of house dust mite allergy, plus an associated diagnostic product, and these are building ALK's reputation and market presence ahead of the introduction of ALK's house dust mite tablet which, subject to approval, could be on the market from 2025 onwards.

In anticipation of this, ALK will ramp up its local presence over the next three years, increasing the size of its salesforce significantly, supporting education and training for allergy specialists, and recruiting back-office staff for essential disciplines such as management, medical and legal affairs, compliance, and sales and marketing.

Alongside this build-up, ALK has teamed up with local partner Grandpharma in an exclusive licensing agreement that will see ALK's adrenaline autoinjector Jext® registered and launched in China. In addition, it is in the process of establishing a partner-based digitalisation strategy, to ensure an engagement platform for its future ambitions.

The peanut drug substance is carefully analysed via the electrophoretic SDS-PAGE method. The blue bands reveal proteins of different molecular weights.

Performance

Financial highlights and key ratios Sales and market trends Financial review of 2021 Q4 review

20 Sustainability

Financial highlights and key ratios for the ALK Group*

Amounts in DKKm/EURm** DKK
2021
DKK
2020
DKK
2019
DKK
2018
DKK
2017
EUR
2021
EUR
2020
Income statement
Revenue 3,916 3,491 3,274 2,915 2,910 527 469
EBITDA 534 395 241 136 253 72 53
Operating profit (EBIT) 292 150 (14) (96) (80) 39 20
Net financial items (13) (49) (17) (7) (42) (2) (7)
Profit before tax (EBT) 279 101 (31) (103) (122) 38 14
Net profit 219 25 (50) (170) (158) 29 3
Average number of employees (FTE) 2,492 2,419 2,385 2,341 2,213 2,492 2,419
Balance sheet
Total assets 5,830 5,563 5,495 4,865 4,958 784 748
Invested capital 2,931 2,807 2,759 2,968 2,864 394 377
Equity 3,480 3,153 3,176 3,179 3,290 468 424
Cash flow and investments
Depreciation, amortisation
and impairment 242 245 255 232 333 33 33
Cash flow from operating activities 468 301 132 (95) (387) 63 40
Cash flow from investing activities (266) (245) (157) (199) (358) (36) (33)
– of which investment in intangible assets (45) (26) (20) (52) (27) (6) (3)
– of which investment in tangible assetss (218) (196) (147) (126) (240) (29) (26)
– of which acquisitions of
companies and operations - - (20) (21) (94) - -
Free cash flow 202 56 (25) (294) (745) 27 8

* Management's review comprises pages 1-44 as well as 'Financial highlights and key ratios by quarter for the ALK Group' on page 103

** 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 2021 (EUR 100 = DKK 744) (31 December 2020: EUR 100 = DKK 744)

For definitions and reconciliation of alternative performance measures, see page 90

Amounts in DKKm/EURm** DKK
2021
DKK
2020
DKK
2019
DKK
2018
DKK
2017
EUR
2021
EUR
2020
Information on shares
Proposed dividend - - - - - - -
Share capital 111 111 111 111 111 14.9 14.9
Shares in thousands of DKK 10 each 11,141 11,141 11,141 11,141 11,141 11,141 11,141
Share price, at year end 3,430 2,500 1,635 960 740 461.2 336.1
Net asset value per share 312 283 285 285 295 42.0 38.0
Key figures
Gross margin – % 61.2 58.1 57.8 56.0 56.4 61.2 58.1
EBITDA margin – % 13.6 11.3 7.4 4.7 8.7 13.6 11.3
Return on equity (ROE) – % 6.6 0.8 (1.6) (5.3) (5.1) 6.6 0.8
ROIC incl. goodwill – % 10.2 5.5 (0.5) (3.3) (3.1) 10.2 5.5
Pay-out ratio – % - - - - - - -
Earnings per share (EPS) 20.0 2.3 (4.6) (15.6) (15.9) 2.7 0.3
Earnings per share (DEPS), diluted 19.8 2.3 (4.6) (15.6) (15.9) 2.7 0.3
Cash flow per share (CFPS) 42.7 27.6 12.1 (8.7) (39.0) 5.7 3.7
Price earnings ratio (PE) 172 1,092 (356) (61) (46) 172 1,092
Share price/Net asset value 11.0 8.8 5.7 3.4 2.5 11.0 8.8
Revenue growth – %
Organic growth 12 8 11 1 (6) 12 8
Exchange rate differences - (1) 1 (1) (1) - (1)
Acquisitions/divestments - - - - 4 - -
Total growth revenue 12 7 12 - (3) 12 7

Read the ESG key figures overview here

Sales and market trends

ALK's full-year revenue for 2021 increased 12% to DKK 3,916 million (3,491), in line with the improved outlook, issued on 11 November 2021, and reflecting strong performances in all sales regions.

(Comparative figures for 2020 are shown in brackets. Revenue growth rates are stated in local currencies, unless otherwise indicated)

Revenue growth was driven by ALK's tablet portfolio, sales of which grew 29% overall, continuing the strong positive trajectory of recent years. Sales of legacy products were largely unchanged as sales mostly recovered for SCIT products previously impacted by COVID, which had prevented or discouraged visits to allergy clinics. Meanwhile, sales of SLIT-drops declined on planned product discontinuations and

the shift of patients to SLIT-tablets. Sales of other products increased 10% as lower Jext® sales were outweighed by a recovery in sales for the wider portfolio.

Europe

European revenue was up 10% at DKK 2,809 million (2,550), despite occasional constraints caused by resurgences of COVID.

Sales growth was largely fuelled by tablets, revenue from which increased by 31% on market share gains and market expansion – predominantly on the takeup of ITULAZAX® and the halo effect this created for GRAZAX®. Furthermore, the convenience of tablets as a home-based treatment made them a useful option for patients unable to continue with their usual treatments due to COVID-related constraints. Sales of legacy allergy immunotherapy (AIT) products declined 4%, influenced by planned product discontinuations which reduced growth

Continues

Revenue by geography Revenue by product line
Growth Growth
DKKm 2021 (l.c.) 2020 DKKm 2021 (l.c.) 2020
Europe 2,809 10% 2,550 SCIT/SLIT-drops 1,655 (1)% 1,673
North America 683 23% 573 SLIT-tablets 1,774 29% 1,370
Int'l markets 424 15% 368 Other products 487 10% 448
Overall revenue 3,916 12% 3,491 Overall revenue 3,916 12% 3,491

Revenue by geography

Europe North America International markets

2021 (2020) 72% (73%) 17% (16%) 11% (11%)

Revenue by product line

SCIT/SLIT-drops SLIT-tablets Other

5-year total revenue by geography

Europe
International markets
North America
DKKm
4,000
3,000
2,000
1,000
0 2017 2018 2019 2020 2021

5-year total revenue by product line

by 3 percentage points, however, this effect is expected to be negligible from 2022 onwards. Sales of other products fell back 8% due to lower Jext® sales, mainly influenced by fewer prescription renewals because of COVID. These figures reflect the fact that, at an individual market level, the European picture differs from country to country.

In ALK's largest market, Germany, sales grew strongly on increased market share, and ALK's market position strengthened as updated national prescription

guidelines reinforced recommendations that only documented, registered AIT products should be prescribed for new allergy patients. Meanwhile, in the Nordic countries, ALK saw solid growth resulting from its work to expand the overall AIT market. In France, sales were down slightly as tablet sales growth was counterbalanced by lost sales from patients shifting from legacy products to tablets. Continuing concerns and restrictions related to COVID impacted selected allergy markets somewhat towards the end of the year.

COVID-aside, market conditions were largely stable across Europe in 2021, and there were no notable changes affecting the pricing and reimbursement of AIT products, although the risk of pressure in selected markets remains.

North America

Revenue in North America recovered from the 2020 impact of COVID, growing by 23% in local currencies to DKK 683 million (573). Tablet sales increased 42% in the region to DKK 120 million (85) on increased uptake among key prescribers, improved sales margins in the USA, and easing of COVID-related restrictions, allowing patients to visit clinics more freely once again. Growth was further supported by the strong early performance of ITULATEKTM in Canada.

Sales of bulk allergen extracts and other products – particularly those that are primarily used in hospital settings – also recovered well, up 14% at DKK 302 million (275), and up 27% at DKK 261 million (213), respectively.

International markets

Revenue from International markets increased 15% in local currencies to DKK 424 million (368). Growth was largely attributable to a strong performance from ALK's largest market in the region – Japan – although there was sales growth in almost all International markets.

Quarterly revenue figures for Japan and China continued to be distorted by the phasing of shipments to these markets. However, in both cases, in-market sales growth remained very strong throughout the year.

Financial review of 2021

ALK's full-year operating profit (EBITDA) increased 35% in reported currency to DKK 534 million (395), in line with the improved outlook, issued on 11 November 2021, and reflected higher sales and improved gross margin.

(Comparative figures for 2020 are shown in brackets)

2021 revenue increased by 12% in local currencies to DKK 3,916 million (3,491). Exchange rate fluctuations did not materially impact reported revenue growth. Planned product discontinuations, which mostly involved SCIT/SLIT-drops products in Europe during Q1, impacted overall growth negatively by ~1 percentage point. The effect was negligible in the remaining nine months of the year.

Cost of sales increased 5% in local currencies to DKK 1,520 million (1,463). The gross profit of DKK 2,396 million (2,028) yielded a gross margin of 61% (58%) which exceeded the orginal goal of a 1-2 percentage point improvement and mainly reflected increased sales – especially from tablets in Europe – although this was somewhat reduced by increased shipments to Torii in Japan, which yield lower gross margins. ALK continues to see significant costs for compliance efforts to secure robustness in product supply, as well as the implementation of the product and site strategy.

Capacity costs increased 13% in local currencies to DKK 2,105 million (1,877). R&D expenses increased by 23% in local currencies to DKK 631 million (515) in support of a planned increase in clinical trial activities. Sales and marketing expenses increased by 10% in local currencies, reflecting a gradual Continues

2021 guidance history

DKK 2021E
5 Feb. outlook
2021E
5 May outlook
2021E
9 Aug. outlook
2021E
11 Nov. outlook
2021
Actual
Revenue +8-12% (l.c) +9-12% (l.c.) +10-12% (l.c.) +11-12% (l.c.) +12% (l.c.)
EBITDA 325-425m 375-425m 450-500m 500-550m 534m
Free cash flow ~(200-300)m ~(200)m ~(100)m ~ +200m +202m

Revenue

Revenue

Revenue growth

normalisation of activity levels following the 2020 impact of COVID on business activities, but also operational leverage of ALK's commercial activities. Administrative expenses increased 3% in local currencies.

EBITDA (operating profit before depreciation and amortisation)

increased 35% in reported currency to DKK 534 million (395) and was better than originally expected, driven by the higher sales and improving gross margin. Exchange rates had only a minor effect on operating profit.

Net financials were a loss of DKK 13 million (loss of 49) mainly relating to interest payments and loan fees. Tax on the profit totalled DKK 60 million (76) and net profit was DKK 219 million (25).

Cash flow from operating activities improved to DKK 468 million (301) driven by higher earnings and receipt of a milestone payment related to the recently established Jext® partnership for China.

Cash flow from investment activities was DKK minus 266 million (minus 245), mainly on upgrades to legacy production and the build-up of capacity for SLITtablets production.

Free cash flow was positive at DKK 202 million (56), which was better than originally expected due to higher earnings and the timing of repayment of accrued rebates. This result was in line with the improved outlook issued on 11 November 2021.

Cash flow from financing activities was DKK minus 311 million (minus 62), relating

to the settlement of incentive programmes and a refinancing of ALK's loan and credit facilities. Currently, ALK has DKK 1.5 billion in credit facilities running until the end of 2024, of which, DKK 1.3 billion is currently unused.

Equity totalled DKK 3,480 million (3,153) at the end of the year, and the equity ratio was 60% (57%).

At the end of 2021, ALK held 148,528 of its own shares or 1.3% (1.9%) of the share capital.

Research and development

  • Research and development expenses
  • Percentage of revenue

Sales, marketing and administration

  • Administrative expenses
  • Sales and marketing expenses
  • Percentage of revenue

EBITDA

  • EBITDA
  • EBITDA margin

Q4 review

(Comparative figures for 2020 are shown in brackets. Revenue growth rates are stated in local currencies, unless otherwise indicated)

Strong Q4 delivers results in line with latest outlook

ALK delivered 2021 full-year results in line with expectations following a Q4 which saw revenue growth of 9%. Growth was fuelled by continued strong tablet sales growth of 23%, during what is traditionally the peak season for allergy immunotherapy (AIT) treatment initiations. This compares with a Q4 2020 that saw extraordinarily high revenue growth of 16%, with tablet sales growth of 55% which was, in part, fuelled by a high number of shipments to ALK's partner in Japan.

Q4 highlights

• Total revenue was up 9% in local currencies at DKK 1,099 million (991). Reported growth was positively

influenced by 2 percentage points due to exchange rate fluctuations.

  • Tablet sales grew by 23% to DKK 509 million (409), with double-digit growth in Europe and North America, whereas sales in International markets were impacted by the phasing of shipments to ALK's partner in Japan.
  • Combined SCIT and SLIT-drops sales were largely unchanged at DKK 483 million (477).
  • Sales of other products declined 2% to DKK 107 million (105).
  • The overall impact of COVID on ALK's business continued to be modest and ALK's supply chain, inventory levels and distribution channels remained robust.

In Europe, revenue was up 7%, driven by strong uptake of the tablets. Tablet sales increased 31%, fuelled in particular

Revenue by geography Revenue by product line
DKKm Q4
Growth
Q4
2021
(l.c.)
2020
DKKm
Q4
2021
Growth
(l.c.)
Q4
2020
Europe 795 7% 734 SCIT/SLIT-drops 483 0% 477
North America 193 20% 155 SLIT-tablets 509 23% 409
Int'l markets 111 6% 102 Other products 107 (2)% 105
Overall revenue 1,099 9% 991 Overall revenue 1,099 9% 991

Revenue by geography

Europe North America International markets

Revenue by product line

SCIT/SLIT-drops SLIT-tablets Other

in central and northern Europe by the uptake of ITULAZAX® and the halo effect this had on GRAZAX®. Combined sales of SCIT and SLIT-drops were down 7%, reflecting COVID-related constraints in some countries and the ongoing transition of patients to tablets, while sales of other products declined 33% on low sales of the Jext® adrenaline auto-injector, influenced by fewer prescription renewals because of COVID and a Q4 2020 extension to its shelf life. Another factor was an industrywide adjustment of rebates in the UK under the agreed rebate scheme, announced in December. Also in Q4, ALK downsized its commercial activities in Spain and Turkey to reflect the current market conditions for evidence-based AIT treatments.

In North America, revenue increased 20%, driven by the ongoing recovery in sales across the portfolio after the very challenging market conditions resulting from COVID in 2020. Tablet sales in the region were up 40%, while sales of bulk allergen extracts (SCIT) increased 11%. Sales of other products and services increased 24%.

Revenue from International markets grew by 6%, fuelled by product shipments to China. Revenue from Japan was, as planned, slightly below the high level of 2020, and impacted by fluctuations in the timing of shipments.

Gross margin improved to 64% (58%), reflecting higher sales – especially from tablets in Europe – but also the cost of compliance efforts to solidify robustness in product supply, as well as the implementation of the product and site strategy.

Capacity costs increased 5% to DKK 622 million (588), largely due to higher sales and marketing expenses, related to restructuring costs for changes to ALK's setup in Spain and Turkey. R&D expenses were level with 2020.

EBITDA of DKK 136 million (64) was in line with the most recent outlook, reflecting higher sales, as well as improved gross margins.

Income statement

Amounts in DKKm Q4 2021 Q4 2020
Revenue 1,099 991
Cost of sales 398 412
Gross profit 701 579
Gross margin 64% 58%
Research and development expenses 179 178
Sales and marketing expenses 372 338
Administrative expenses 71 72
Operating profit/(loss) (EBIT) 79 (9)
Net financial items (5) (5)
Profit/(loss) before tax (EBT) 74 (14)
Tax on profit (2) 17
Net profit/(loss) 76 (31)
Operating profit before depreciation
and amortisation (EBITDA) 136 64

"Growth was fuelled by continued strong tablet sales growth of 23%, during what is traditionally the peak season for AIT treatment initiations.

Sustainability

After forming a new, internal Sustainability Committee in 2021, ALK continued integrating sustainability into its overall business strategy. ALK remains a committed signatory of the UN Global Compact Principles and supports the UN Sustainable Development Goals.

The driving force behind ALK's sustainability efforts is ensuring 'Access to Allergy Care for All'. This strategy includes expanding ALK products into new geographical markets directly or through partnerships, and into new segments such as children and adolescents. ALK ensures a comprehensive portfolio of quality allergy solutions through innovative research and development. ALK's sustainability strategy

also considers employee diversity and inclusion, responsible business practices, and environmental impact across the company's value chain.

Expanding 'Access to Allergy Care for All'

'Access to Allergy Care for All' aims to make ALK products and solutions universally accessible, while growing an ethical and sustainable business. In 2021, ALK made allergy diagnosis, allergy immunotherapy (AIT) treatment, and adrenaline products available to more than 100,000 additional patients, bringing the total number of patients served to approximately 2.1 million.

ALK introduced tablet-based AIT to two new countries, while extending the children and adolescent indications of the existing tablet portfolio to 10 additional countries. ALK also ran clinical trials with

the ambition of securing registrations in new geographies and patient segments. In addition, ALK entered a partnership with Grandpharma, a Chinese pharmaceutical company, to expand the availability of its adrenaline auto-injector, Jext®, which is used for the emergency treatment of acute allergic reactions.

Furthermore, ALK's digital channels mobilised more than 375,000 people to take action on their allergies and ALK tested several concepts in various countries to eliminate friction points on the path to prescriptions for the many untreated patients eligible for AIT treatment.

The availability of medicines is just one factor in broadening access to allergy care. A significant barrier to allergy treatment is the lack of access to specialist doctors. Therefore, ALK is partnering with Find out more

healthcare systems to train healthcare professionals on how to diagnose and treat allergies. In 2021, this initiative resulted in approximately 3,800 healthcare professionals being educated.

Diverse and engaged employees

A skilled, diverse and engaged workforce is essential to ALK's success. ALK invests significantly to ensure all employees have equal opportunities to realise their full potential, regardless of age, gender, race, ethnicity, religion, disability, sexual orientation, or any other unique characteristic. In addition, ALK's Cultural Beliefs: Do the right thing, Pursue growth, and Build bridges, are designed to inspire and empower employees to reach their

Continues

in ALK's sustainability report, https://www.alk.net/ sustainability

full potential, in the pursuit of advancing allergy care for all.

In 2021, ALK continued to take all necessary measures to protect employees from the various resurgences of COVID, while maintaining the pursuit of its strategic growth ambitions. This required a degree of flexibility to accommodate new ways of working. Nevertheless, ALK's 2021 employee engagement survey confirmed that employees felt the company had prioritised their well-being and communicated effectively throughout this period. The survey had a participation rate of 93% and resulted in an overall engagement score of 8.2, which was 0.6 above the benchmark for the healthcare industry.

In 2021, the company took further steps towards increasing gender diversity among its senior leadership. At the end of the year, 29% of vice president and senior director positions were held by women, which was on track for ALK's 2025 goal of at least 35%. The gender balance at manager and director levels remained

on track for approximately 50%, with 53% women and 47% men. The number of women at vice president and senior director levels is expected to increase over the coming years, supported by ALK's talent, mentoring and sponsorship programmes.

At the end of 2021, ALK's Board of Directors consisted of nine members. Of the six shareholder-elected members, two were women, meeting the target of 30%. Furthermore, women accounted for 67% of employee-elected Board members.

Addressing environmental impact

ALK's journey towards reducing its environmental impact includes the optimisation of waste management, reduction of energy consumption, and elimination of CO2 emissions across the value chain. This will involve an increase in recycling, a transition to renewable energy sources, and a more circular life-cycle for ALK's products and materials. In 2021, ALK improved waste management and recycling. The share of waste that was reused or recycled increased to 50%, up

Continues

ESG key figures overview

Unit 2021 2020 2019
Environmental data
Total CO2 emissions
(Scope 1, Scope 2, refrigerants) Tonnes 11,258 11,263 12,2131
CO2 emissions (less renewables) Tonnes 7,130 7,391 9,644
Energy consumption MWh 45,686 45,441 46,7621
Energy intensity Ratio 30 31 33
Renewable energy share % 45 38 20
Water consumption m3 127,520 110,530 122,4611
Waste recycled from production sites % 50 38 381
Social data
Workforce Headcount 2,593 2,486 2,406
Gender diversity (total)
Gender diversity (all management levels)
% female
% female
63
49
63
46
62
47
Gender pay ratio (men to women) Times 1.18 1.14 1.13
Employee turnover ratio, % 13 10 11
Lost time injury frequency LTIF 0.32 2.9 3.5
Absence due to sickness % 3.1 3.1 2.7
Governance data
Gender diversity (Board) % 33 20 17
Board meeting attendance rate % 94 98 97
CEO pay ratio Times 34 34 29

1 Baseline for improvement target

2 LTIF includes all work-related injuries resulting in an individual being physically or mentally unable to work. In 2021, injuries were only included if diagnosed by a competent medical professional.

Find out more

Please see further information on the reporting practices for ESG key figures in ALK's sustainability report, https://www.alk.net/sustainability

Read the Financial highlights and key figures overview here

from 38% in 2020. In France, switching to biodegradable packaging materials and converting to 100% renewable energy at ALK's production site in Varennes were just some of the intiatives taken to reduce ALK's impact on climate.

As a result of the company's efforts, energy consumption remained at 2019 levels, despite a significant increase in production output, while CO2 emissions from manufacturing operations fell by 42% compared to the 2019 baseline of total emissions from non-renewable sources.

Preparing for Scope 3

ALK set a target to reduce its CO2 emissions by 60% in 2025, which includes emissions from Scope 1, Scope 2, transport, business travel, and company cars.

In addition, ALK will work to secure valid and robust Scope 3 data as well as investigate potential material categories to include in its Scope 3 reporting by 2025.

Policies and guidelines

ALK's sustainability efforts are supported by a wide range of policies and guidelines designed to ensure everyday activities are aligned with the company's long-term ambitions. Topics covered by specific policies include: sustainability as well as the environment, health and safety (EHS), diversity, remuneration, data ethics, tax, stakeholder communications, investor relations, anti-corruption and bribery, and whistleblowing. Additionally, ALK's Code of Conduct details the company's expectations on professionalism, honesty and integrity. In 2021, 97% of employees completed and signed off on the annual online training exercise covering the Code of Conduct.

For more information, ALK's statutory annual report on sustainability, data ethics and gender diversity (as required by §99a, §99b, §99d and §107d of the Danish Financial Statements Act as well as Article 8 of the EU Taxonomy) is available at https://www.alk.net/sustainability

Switching from plastic to recyclable cardboard packaging

With an increase in awareness and concern from its patients and healthcare professionals, ALK developed a new packaging solution in 2021 for its OSIRIS® products in France. Stringent testing ensured the quality of the medicines would remain uncompromised with this new packaging solution.

The total carbon footprint of the OSIRIS® packaging is now 19 times lower than before, potentially reducing plastic consumption by up to 60 tonnes annually. In addition to the sustainability benefits, the new packaging is also more user-friendly with its colour-coded design, which makes it easier to read, especially for patients who take multiple treatments. ALK intends to evaluate similar packaging solutions across the entire supply chain.

ALK's precision extraction processes used to make the peanut allergy tablets is made possible by a Dia-Ultra Filtration machine.

Strategy

24 Strategy progress 30 ALK's business model

Strategy progress ALK's strategic focus areas

A year ago, ALK updated its strategy following the conclusion of a three-year strategic transformation programme designed to stimulate a new period of continued growth.

The priority for the immediate future is to build upon that successful transformation by targeting continuous growth and profitability, as ALK seeks to become ever more relevant to people with allergy.

This will be achieved by extending the company's leadership in respiratory allergy, expanding its position in anaphylaxis, establishing a presence in food allergy, and pursuing new innovations through research. The steps towards fulfilling these ambitions fall into four key focus areas: succeed in North America, complete and commercialise the tablet portfolio, consumer engagement and new horizons, and optimise for excellence.

All of this is underpinned by a companywide ambition to lead the way on sustainability, through ALK's 'people and planet' commitments.

These strategic priorities map a path towards ALK's financial ambitions for 2025 and beyond – and will shape an ALK capable of delivering continuous, high revenue and earnings growth, with annual revenue growth of 10% or more, and will improve the company's EBIT margin towards around 25% in 2025.

The strategy is further supported by selected longer-term initiatives, which are designed to safeguard and potentially accelerate ALK's longer-term growth trajectory towards 2030 and beyond.

Progress on the strategic priorities

ALK continued the execution of its strategy in 2021, making progress in each of the four focus areas despite the impact

Continues

of COVID, particularly on the clinical development programme:

In North America, ALK continued its efforts to mobilise allergy patients, accelerate tablet sales, and to secure paediatric and adolescent indications for ACARIZAX®/ODACTRA® and RAGWITEK®, as well as introducing other prescription allergy solutions. Overall, tablets sales in the region grew by 42% on increased uptake among key prescribers, improved sales margins in the USA, and reduced COVID-related restrictions, allowing patients to visit clinics more freely once again. Growth was further supported by the strong early performance of ITULATEKTM in Canada. Even so, the long-established market barriers to the adoption of the tablets in the USA remained a challenge.

Work to increase traction in the USA for the tablet portfolio included the introduction and expansion of a telehealth partnership giving patients direct access to an allergy health professional, which saw patients mobilised to take action on their allergies, albeit still in small numbers.

In 2022, ALK's goal is to further grow its tablets business by increasing

Towards '25 in 25' and growth beyond

Relentless focus on strategy execution in pursuit of 'allergy care for all'

development of peanut AIT, 2024 US filing of next-generation adrenline

• Strong growth foundations

• Maintain focus on people and planet activities

product, expand in China

  • paediatric use
  • Late-stage clinical development of food AIT
  • 60% reduction in CO2 emissions versus baseline
  • and other markets
  • Expand in anaphylaxis
  • Commercialise food AIT

prescriber depth among key specialists and continuing to pursue partnerships in digital health. ALK also aims to drive growth in its legacy product sales and to obtain approval for the use of ACARIZAX®/ ODACTRA® in adolescents.

Efforts to complete and commercialise the tablet portfolio advanced, with the aim of securing their use in new geographies and additional patient groups. In April, ALK received approval from the FDA for the use of RAGWITEK® in US paediatric patients, while December saw the filing of a US application covering the use of ODACTRA® in adolescents. Also in 2021, ACARIZAX® was approved for adult and adolescent use in the UK, and for adolescent use in an additional nine countries. There were also approvals for GRAZAX® in eight countries and RAGWIZAX® in two countries, the majority of which were in eastern Europe. There was also a first UK approval for ITULATEKTM for adults and in Russia for adults and adolescents.

ALK's two paediatric Phase III trials in allergic rhinitis – in Europe and North America for the house dust mite tablet, and in Europe and Canada for the tree pollen

tablet – progressed as planned, and patient recruitment will continue in 2022, with both trials expected to complete in 2023. The trials represent some of the final steps towards full paediatric coverage for the tablets in Europe and North America, which will be an important driver of continued double-digit revenue growth for ALK.

COVID continued to impact ALK's paediatric trial in house dust mite-induced allergic asthma, in line with previous updates. The trial was initiated before the start of the pandemic as a regulatory commitment to the European Medicines Agency's Paediatric Development Committee, to expand the current adult asthma indication in Europe by gathering equivalent paediatric data. During the pandemic, ALK has observed a significant reduction in the frequency of asthma exacerbations of almost 66% versus prepandemic levels among patient cohorts included in the trial. A reduction of asthma exacerbations has also been reported for society in general and is believed to be the result of virus containment measures, such as face masks and social distancing. Due to the low number of asthma exacerbations observed in the

Building evidence on AIT in allergy and asthma

ALK's REWEAL programme is designed to supplement the current clinical evidence base for allergy immunotherapy (AIT) by collating 'real-world' patient data from independent sources in multiple countries. In 2021, results from the ALKsponsored REACT study were published by The Lancet Regional Health – Europe.

REACT gathered data from more than 92,000 patients with both allergic rhinitis and asthma. It showed that AIT treatment was associated with long-term sustained reductions in the use of their existing medication for up to nine years after AIT treatment initiation. Patients with preexisting asthma who were treated with AIT were also more likely to step down their asthma treatment regimens, while AIT was also associated with a preventative

effect on severe asthma exacerbations over the nine years. Finally, patients treated with AIT had fewer in-patient stays and shorter stays if admitted to hospital.

REACT is just one example of how our understanding of the role of AIT in allergy and asthma has advanced significantly over recent years. In Europe, ALK's ACARIZAX® is already approved for the treatment of both allergic rhinitis and allergic asthma, and the Global Initiative for Asthma, GINA, now recommends sublingual AIT as a treatment option in patients with house dust mite-induced allergic asthma. ALK will continue to invest in generating new data with the aim of building on these successes and expanding the knowledge base still further.

trial, ALK now believes it is unlikely to fulfil its objective of demonstrating an effect on asthma exacerbations, and the company will begin a dialogue with authorities on possible next steps. Since house dust miteinduced allergic asthma is a comorbidity of allergic rhinitis, ALK nevertheless expects to gain full paediatric coverage via the abovementioned Phase III trials in allergic rhinitis. This development is not expected to impact ALK's long-term financial ambitions and ALK remains committed to exploring the full potential of AIT in the treatment of allergic disease.

Elsewhere, the Phase III registration trial in China of the house dust mite tablet in adult allergic rhinitis remains paused due to COVID, and ALK is in discussions with the relevant authorities on possible next steps.

In 2022, ALK's goal is to further grow global tablet sales by approximately 20%, with double-digit growth across its three sales regions.

Progress on increasing consumer engagement continued, and Q2 saw the launch of ALK's klarify digital engagement platform in Canada, bringing the total Continues

SLIT-tablet portfolio covers five of the most common respiratory allergies

ALK's SLIT-tablet pipeline Phase I Phase II Phase III Filing Marketed
GRAZAX® Europe Adults and children – Allergic rhinitis (grass) 2007
GRASTEK® North America Adults and children – Allergic rhinitis (grass) 2014
GRAZAX® International markets* Adults and children – Allergic rhinitis (grass) 2017
RAGWITEK® North America Adults and children – Allergic rhinitis (ragweed) 2014/21
RAGWIZAX® Europe & Int'l markets Adults and children – Allergic rhinitis (ragweed) 2020
ACARIZAX® Europe Adults – Allergic rhinitis and allergic asthma (HDM)
Adolescents – Allergic rhinitis (HDM)
2016/17
ACARIZAX®/ODACTRA®
North America
Adults – Allergic rhinitis (HDM) 2017/18
MITICURE™ Japan** Adults and children – Allergic rhinitis (HDM) 2015/18
ACARIZAX® International markets* Adults - Allergic rhinitis and allergic asthma (HDM) ***
ACARIZAX® China Adults – Allergic rhinitis (HDM)
ACARIZAX®/ODACTRA®
Europe & North America
Children – Allergic asthma (HDM)
ACARIZAX®/ODACTRA®
Europe & North America
Children – Allergic rhinitis (HDM)
ODACTRA® North America Adolescents – Allergic rhinitis (HDM)
CEDARCURE™ Japan** Adults and children – Allergic rhinitis
(Japanese cedar)
2018
ITULAZAX®/ITULATEK™
Europe & Canada
Adults – Allergic rhinitis (tree: birch family) 2019/20
ITULAZAX®/ITULATEK™
Europe & Canada
Children – Allergic rhinitis (tree: birch family)

number of klarify countries to six. Metrics on the success of this platform remain encouraging and, during 2021, ALK mobilised more than 375,000 consumers worldwide via klarify, including more than 40,000 in the USA, versus targets of 250,000 and 20,000, respectively. ALK will continue this work in 2022 with a focus on converting mobilised consumers into allergy immunotherapy patients, so that this truly becomes an 'end-to-end' journey for people with allergy.

ALK's 'new horizons' priority covers initiatives with the ability to accelerate the company's long-term growth, including an expanded offering in anaphylaxis and an entry into food allergy treatment. On the first of these, ALK continued to advance two parallel adrenaline auto-injector (AAI) projects – one in-house, and one in partnership with Windgap – with the aim of a submission to the US FDA in 2024. In 2022, these programmes will progress further with the device development and chemistry, manufacturing and controls (CMC) work needed to produce initial batches for use in stability and reliability testing. These steps will generate essential data for the planned regulatory submissions.

Also in 2021, ALK signed an exclusive agreement with the China-based pharmaceutical company, Grandpharma, that will see its existing AAI, Jext®, become the first to be registered and launched in China.

Work on the food allergy treatment initiative progressed well. In Q2, ALK concluded a development and licensing agreement with Catalent for the use of its ZydisTM fast-dissolving tablet technology – the same technology used in ALK's existing respiratory tablet portfolio – for use in future food allergy products. This was followed, in Q4, by the successful completion of a formulation feasibility study confirming the suitability of ZydisTM for use in a peanut allergy product, and supporting ALK's 2022 goal of initiating Phase I development in the first half of the year.

The priority 'optimise for excellence' covers ALK's product and site strategy programme (PASS), amongst other initiatives. This aims to safeguard ALK's core portfolio of legacy products by ensuring it remains viable in the longterm, which, in part, means upgrading Continues

An entry into food allergy treatment

Food allergies can be life-threatening, and are often detected in early childhood. They affect around 2.5% of people worldwide and are on the increase. In early 2021, ALK announced its intention to establish a presence in this area, initially covering allergy to peanut, which is one of the most common food allergies, and can last a lifetime.

Since that initial announcement, progress has been both swift and encouraging. ALK's approach is to adapt the fastdissolving sublingual tablet technology already used in its respiratory tablet portfolio.

In Q2, ALK finalised a development and licensing agreement with Catalent on the use of this technology in the food allergy programme, and in Q4 completed a feasibility study confirming its suitability for use in the clinical development of a peanut allergy product. This paves the way for the initiation of Phase I clinical development in the first half of 2022, which will draw upon ALK's extensive knowledge and experience from the development of the respiratory tablets. It will also build upon evidence from earlier, clinical proof of concept work, by leading academic researchers, which has demonstrated that peanut sublingual AIT is efficacious, and may provide a safe and practical treatment for people living with peanut allergy.

legacy production processes so that they continue to meet the very latest regulatory standards. A key element in this programme is the simplification of ALK's production setup by reducing the number of different drug substances used for similar products. In October, this work took another important step towards completion when ALK received an EU regulatory approval opening the door to the necessary changes for its SCIT product line ALUTARD SQ®. In 2021, as part of this ongoing work, ALK submitted a total of 1,859 regulatory variations covering 129 products to 40 authorities around the world.

In 2022, ALK's goal is to further progress the PASS programme as well as ensuring there are no quality-related major interruptions to product supply.

People and planet

Underpinning ALK's efforts in each of the four focus areas is a business-wide commitment to people and planet, which addresses ALK's future organisational

agility, employee engagement and retention, and its sustainability agenda.

Through a series of organisational agility initiatives, ALK aims to ensure its future growth ambitions can be delivered by the necessary range and depth of engaged and motivated employees, each of whom benefits from a strong framework and culture of support when it comes to both talent and leadership development. ALK's approach is rooted in its cultural values, which encourage open dialogue, honest feedback, and strong cross-organisational cooperation.

In 2022, ALK's goal is to maintain or improve upon the high engagement score achieved in the previous year. In addition, ALK will continue to take steps to prioritise sustainability within its business model with the aim of improving access to allergy care and addressing environmental impact across the value chain. A more in-depth summary of progress to date on the people and planet platform, as well as future goals, can be found in ALK's sustainability report.

Market expansion by activating doctors and patients

Market expansion is a key part of ALK's growth strategy, especially in more mature allergy immunotherapy markets. The tablet portfolio is particularly important here because, in many cases, it brings growth that is additional to sales from the legacy portfolio.

ALK's experience, especially in the Nordic countries, has shown that existing prescribers of the tablets can become powerful advocates for their use, helping to expand the prescriber base among their peers and, in turn, driving increased prescription rates. In addition, the tablets are an attractive proposition to healthcare professionals in specialisms adjacent to allergy, such as paediatrics, ear, nose and throat, and to selected general practitioners.

Further impetus can come from patients themselves, and ALK's digital engagement strategy is designed to motivate new patients to take action on their allergies by connecting them with specialist doctors who can understand their needs, diagnose their condition and prescribe a relevant treatment that can improve their quality of life.

This model – of registering new products, building advocacy and market access, expanding the prescriber base, and mobilising patients – while predominantly applicable to Europe today, has shown increasing success each time ALK has launched a new tablet, from grass, to house dust mite, and most recently, to tree.

company with a century of

ALK's business model

Becoming relevant for more people with allergy

A profound understanding of allergy Expertise from academic institutions Diverse talent Raw materials, water and energy 2.1 million patients in treatment with ALK products >24,000 participants in clinical trials* for the tablets ~2,600 employees, a net addition of 100 employees ALK share price up 364% since 31 December 2017 Resources Value created Global commercial reach and leader in severe allergy care Efficient large-scale production of AIT Deep understanding of natural allergens Standardising, formulating, developing and documenting AIT treatments in large-scale clinical programmes "As a global allergy solutions scientific knowledge and expertise, ALK's business model is designed to help people to take control of their allergies and their lives.

* 22 Phase III trials

Corporate matters

Governance and ownership Risk management Board of Directors Board of Management

High-performance liquid chromatography (HPLC) is just one of the pharmaceutical-grade analytical processes used to monitor the quality and consistency of ALK's peanut product.

Management's review • Annual report 2021 • ALK 31

Governance and ownership

Corporate governance

ALK's statutory corporate governance statement for 2021, pursuant to section 107b of the Danish Financial Statements Act, is available at https://ir.alk.net/ financial-reporting/risk-management

The statement provides a detailed account of ALK's two-tier management structure, including the Board of Directors' composition, competencies, activities, self-assessment process, and remuneration. The statement also describes key elements of ALK's internal control and risk management systems related to financial reporting processes.

Board composition

At the Annual General Meeting (AGM) in 2021, Anders Hedegaard (Chairman), Lene Skole (Vice Chairman), Lars Holmqvist, Jakob Riis, and Vincent Warnery were all re-elected to the Board of Directors. Furthermore, Gitte Aabo, CEO of GN Hearing, and Bertil Lindmark, Chief

Continues

Board of Director's annual cycle

  • Board meetings
  • Monthly reports
  • Annual General Meeting
  • Strategy work
  • Review of finacial performance
  • Evaluation of collaboration between the Board of Directors and Board of Management
  • Organisational performance review and succession planning
  • Next year's budget

Attendance at meetings

Attended Absent

Name (male/female) Board
meetings
Audit Committee
meetings
Remuneration & Nomination
Committee meetings
Scientific Committee
meetings
Anders Hedegaard (m)
Lene Skole (f)
Gitte Aabo (f)*
Lars Holmqvist (m)
Bertil Lindmark (m)*
Jakob Riis (m)
Vincent Warnery (m)**
Katja Barnkob (f)***
Nanna Rassov Carlson (f)***
Johan Smedsrud (m)***
* elected at the AGM on 18 March 2021 ** stepped down on 5 August 2021 *** employee-elected

Medical Officer of Galecto, were elected as new, independent members of the Board.

At the next AGM on 16 March 2022, the Board of Directors will propose the election as a new Board member of Alan Main, previously head of Consumer Healthcare and Executive Committee member at Sanofi. His nomination follows the decision of Vincent Warnery to step down in August 2021 after his appointment as CEO of Beiersdorf.

If the nomination of Alan Main is approved at the AGM, four out of seven shareholder-elected members will again be independent, according to the definitions set by the Danish Committee on Corporate Governance. This reflects the Board's efforts to provide an adequate balance between independent and nonindependent members.

No other changes to the Board of Directors will be proposed at the next AGM, as the Board's annual self-evaluation process validated the skills and competencies of the current Board. As such, the Board is considered to have the right competencies

Competency matrix for the Board of Directors

Based on its long-term strategy, ALK has identified the core competencies which must be represented in the Board of Directors for the Board to be able to support the strategy. To assess whether all core competencies are adequately represented, each shareholderelected member of the Board has been

asked to identify a maximum of four primary competencies they bring to the Board, considering ALK's long-term strategy. They may also have knowledge or experience in areas other than the four primary competencies. The matrix shows the responses to the self-assessment process.

Employee-elected members are not part of the competency self-assessment. For the Chairman and Vice Chairman, two additional competencies, specific to these roles, have been identified.

Core competencies Role competencies:
Chairman &
Vice
Chairman
Executive
experience
in a global
company
Life
science
industry
Consumer
healthcare /
OTC
Financial
/ Risk
Commer
cial
Digitalisa
tion
Experience
with
US market
Research
& Devel
opment
Experience
at CEO level
Board
experience
from other
companies
Anders Hedegaard
Chairman
Lene Skole
Vice Chairman
Gitte Aabo
Member
Lars Holmqvist
Member
Bertil Lindmark
Member
Jakob Riis
Member

to support ALK's long-term value creation and strategic progress.

All shareholder-elected Board members are elected for a term of one year. In addition, the Board includes three employee-elected members, all elected for a term of four years. All Board members are presented on pages 42-43 of this annual report, with details of their specific competencies, directorships, and other relevant background information. The Board of Management is presented on page 44. There were no changes to the Board of Management in 2021. Continues

Governance recommendations

The Danish Committee on Corporate Governance has set out a series of recommendations on corporate governance which has been adopted by Nasdaq Copenhagen. ALK's Board of Directors actively applies these recommendations as inspiration for setting up structures, tasks and procedures, and ALK accounts for its compliance with the recommendations in an annual 'complyor-explain' review.

The most recent update to the Danish Committee on Corporate Governance's recommendations took place in 2020 and came into effect from 2021. To ensure its continued compliance, ALK has made the following amendments to procedures and policies:

  • The election of new independent Board members in 2021-22 to achieve an overweight of independent members on the Board of Directors and its three subcommittees: The Audit Committee, the Remuneration & Nomination Committee, as well as the Scientific Committee.
  • New policies were adopted covering stakeholder communications and investor relations.
  • New guidelines were introduced to govern the principles and procedures in the event of a proposed takeover.

The review of all updated 40 guidelines is available at https://ir.alk.net/corporategovernance

Remuneration

Remuneration for the Board of Directors and the Board of Management is determined in accordance with ALK's remuneration policy as adopted by the AGM. The policy is prepared in accordance with sections 139 and 139a of the Danish Companies Act as well as items 4.1.1- 4.1.6 of the latest Danish Corporate Governance Recommendations.

The policy outlines the overall framework for remuneration. The objectives of the policy are to:

  • Attract, motivate, and retain qualified members of the Board of Directors and Board of Management.
  • Align the remuneration components to the interests of shareholders.
  • Contribute to promoting value creation at ALK and support ALK's business strategy.
  • Ensure that the remuneration of individual members of the Board of Management reflects the overall performance as well as individual results.

The remuneration policy was approved by the AGM in March 2021.

Summary of remuneration report

Remuneration for the Board of Directors and Board of Management is reported separately in ALK's remuneration report. The report is prepared in accordance with section 139b of the Danish Companies Act.

The report provides an overview of the components in the remuneration for the Board of Directors and Board of Management, including an overview of the actual remuneration in 2021, its development during the past three years, as well as the shareholdings of Board of Directors and Board of Management members.

All remuneration for the Board of Directors and Board of Management followed the principles and framework outlined in ALK's remuneration policy.

Members of the Board of Directors each received a fixed annual fee for serving on the Board, with the Vice Chairman and Chairman receiving double and triple the annual fee, respectively. In addition, members received an additional fee for

Remuneration 2017-21

DKKt 2021 2020 2019 2018 2017
Board of Directors
Base fees 3,650 3,359 3,245 3,080 3,300
Committee fees 998 885 850 850 850
Total 4,648 4,244 4,095 3,930 4,150
Board of Management
Base salary 17,276 16,804 15,104 14,229 16,775
Short-term incentives (cash bonus) 11,924 9,906 8,535 7,342 7,835
Sign-on bonus (cash) - - - 686 1,500
Pension incl. social security 1,396 1,345 1,298 1,151 1,584
Other benefits 703 741 803 814 932
Termination benefits - - - - 2,332
Long-term incentives (grant value) 6,371 6,204 6,863 12,376 13,228
Total 37,670 35,000 32,603 36,598 44,186

serving on the Board's committees. The Board and committee fees remained unchanged from 2020 to 2021. For members serving on the Scientific Committee, a fee was set as outlined in ALK's remuneration policy. Members of the Board are not offered share options, performance shares or other incentives as payment for their work on the Board or committees.

The remuneration of the Board of Management reflects a good year with strong financial results and solid progress on ALK's strategic agenda. Both the shortterm and long-term incentive plans were settled above target, while the base salary for members of the Board of Management was increased by 1.75%, in line with the general increase for ALK employees Continues

Find out more The remuneration policy is available at https://ir.alk. net/corporate-governance in Denmark – except for the CFO, who received an increase above the general level to bring his base salary closer to the market level.

The remuneration report for 2021 will be presented for an advisory vote at the AGM on 16 March 2022. The remuneration report is available at https://ir.alk.net/ corporate-governance

Investor relations objectives

It is ALK's objective to have a diversified shareholder base in terms of geography, investment profile and time horizon that shares the company's vision and supports its long-term strategy. Accordingly, ALK's investor relations (IR) activities aim to support the perception of ALK as an accessible, trustworthy, and professional company that provides relevant, accurate, balanced, and timely information to capital markets in order to enable both a fair valuation and regular trading of its shares.

Growing shareholder base

ALK's share capital is divided into A shares, AA shares and B shares. The A and AA shares are not listed and are predominantly held by the Lundbeck

Foundation, while all B shares are listed on Nasdaq Copenhagen and freely negotiable.

On 31 December 2021, ALK had 20,434 registered shareholders versus 17,697 at the end of 2020. The registered shareholders owned 98% of the share capital (98%).

Two shareholders have reported to ALK that they held 5% or more of the shares on 31 December 2021:

  • The Lundbeck Foundation (Denmark): 40.3% incl. A and AA shares
  • ATP (Denmark): 5.8%

Of the largest registered shareholders, the vast majority were institutional investors, particularly from Europe and North America. The international registered ownership was estimated at approximately 31% (23%), representing 52% of the free float of the B share capital, excluding the Lundbeck Foundation's holding and treasury shares.

To meet obligations to deliver shares under management incentive programmes, ALK held 148,528 of its own shares, or 1.3% of the share capital, versus 1.9% at the end of 2020. The holding was reduced during the year following the settlement of share option and performance share programmes. The

Continues

Core data for the share

Share capital DKK 111,411,960
Nominal value 10 DKK per share
No of A shares 920,760 units with
10 votes per share
No of AA shares 92,760 units with
10 votes per share
No of B shares 10,128,360 units with
1 vote per share
Stock exchange Nasdaq Copenhagen
Ticker symbol ALK B
Indices X4500 (healthcare),
OMXCLCPI (LargeCap)
and OMXCPI (all)
ISIN DK0060027142
Blomberg code ALKB.DC
Reuters code ALKB_CO
ADR ticker symbol AKABY
LEI code 529900SGCREUZCZ7P020

Major shareholders' and treasury shares

Shareholder Registered office No of shares Interest Votes
Lundbeck Foundation Copenhagen,
Denmark
920,720 A shares
92,072 AA shares
3,474,827 B shares
40.3% 67.2%
ATP Hillerød,
Denmark
642,314 B shares 5.8% 3.2%
ALK (treasury shares) Hørsholm,
Denmark
148,528 B shares 1.3% -

current holding is considered sufficient to cover current obligations under long-term incentive programmes.

The Board of Directors and Board of Management held a total of 12,963 shares at year-end, corresponding to 0.1% of the share capital (0.1%).

Liquidity

The daily trading liquidity during 2021 was largely unchanged and averaged DKK 30 million (31) per day in value.

Return to shareholders

At year-end, the closing price of ALK B shares on Nasdaq Copenhagen was DKK 3,430, up 37% since 31 December 2020. During the same period, the Danish OMXC25 increased by 17% and the Nasdaq Biotechnology Index decreased by 1%.

The total market value of ALK's B shares, excluding treasury shares, was DKK 34 billion at year-end versus DKK 25 billion at the end of 2020. Since end of 2017, shortly after the announcement of ALK's new strategy, share price increases have yielded an average, annual return of 47% to shareholders.

Dividend and capital structure

The Board of Directors considers that ALK's financial resources, including credit facilities, continue to form a sufficient basis for executing ALK's strategy and to fund investments. At the end of 2021, net interest-bearing debt amounted to DKK 516 million and leverage stood at 1.0 EBITDA (1.6).

In support of ALK's growth strategy, the Board of Directors is extending its recommendation that dividend payments be suspended until ALK's profitability further improves. Accordingly, the Board of Directors will propose to the AGM, that no dividends are declared for 2021. The Board of Directors revisits the dividend policy and ALK's capital structure on an ongoing basis.

Up to and including 11 March 2023, the Board of Directors is authorised to increase the share capital by up to DKK 11,141,196 (AA shares with a nominal value of up to DKK 1,012,836, and B shares with a nominal value of up to DKK

Shareholders as at 31 December 2021

The ALK share in 2021

ALK OMXC25 (indexed) Pharma, biotech and life sciences (NBI-NAS, indexed)

10,128,360). Capital increases may either be at a price below market price with preemption rights for existing shareholders, or at market price without pre-emption rights for B shareholders.

The Board of Directors is authorised for the period until 12 March 2024 to let the company acquire own B shares on a regular basis for a nominal value of up to DKK 11,141,196 (equivalent to 10% of the share capital). Such shares may only be acquired for an amount that, together with the treasury shares already held by the company, at no time exceeds a nominal value of 10% of the share capital. The consideration for such shares may not deviate by more than 10% from the official quoted price of the B shares on Nasdaq Copenhagen on the date of acquisition.

Investor relations

According to ALK's IR policy, the IR department is committed to:

• Providing information on strategy, operations, performance, expectations, goals, pipeline, market development, and other matters of importance to the assessment of the share.

  • Working to strengthen its dialogue with all financial stakeholders, in accordance with good IR practice and the applicable rules and regulations for companies listed on Nasdaq Copenhagen, by providing equal and sufficient access to potentially price-sensitive information.
  • Sharing key feedback from investors and analysts with the Board of Management and Board of Directors; and facilitating the ability of all shareholders to easily exercise their voting rights.

During 2021, besides hosting regular telephone conferences, ALK representatives participated in many individual meetings and briefing calls with analysts and investors. ALK also presented at investor conferences and seminars targeting various audiences. As in-person meetings continued to be limited due to COVID, the engagement with investors and analysts was predominantly virtual.

A total of 26 announcements were published in 2021 (2020: 17), including investor news and reports on transactions by managerial staff. All announcements

are available on ALK's main corporate website, together with reports, presentations, recordings of telephone conferences, share price information, analysts' estimates, and related information. Registered shareholders are encouraged to sign up at the InvestorPortal.

Find out more Visit Investor Relations at https://ir.alk.net/investors

Contact Investor Relations

Per Plotnikof, Head of IR Tel. +45 4574 7527

Financial calendar for 2022

Annual General Meeting 16 March
Three-month interim report (Q1) 12 May
Six-month interim report (Q2) 11 August
Nine-month interim report (Q3) 10 November

Ownership structure

The Lundbeck Foundation

Institutional and private investors (20,433)

59.7% of capital

32.8% of votes

40.3% of capital

67.2% of votes

A + AA shares
(The Lundbeck Foundation):
A + AA shares (Other):
1,012,792
44
A + AA shares total: 1,012,836
B-shares
(The Lundbeck Foundation):
3,474,827
B-shares (ATP): 642,314
B-shares (Other): 5,862,691
B-shares total: 10,128,360

The Lundbeck Foundation

The Lundbeck Foundation, one of Denmark's largest commercial foundations, is the controlling shareholder of ALK, owning 67% of the votes and 40% of the capital. The Foundation grants a minimum of DKK 500 million each year to public biomedical and health science research with a particular focus on neuroscience. Its business activities encompass majority shareholdings in two other healthcare companies, H. Lundbeck and Falck, an international portfolio of life science venture companies, a portfolio of biotech start-ups based on research from primarily Danish universities, as well as management of securities of around DKK 24 billion.

Risk management

ALK's Board of Management is responsible for the ongoing management of risks throughout the value chain, including risk mapping, the assessment of probabilities and potential consequences, and the introduction of risk-reducing measures.

The Board of Management has established a risk committee to assist it in meeting its overall responsibility for risk management. The Risk Committee comprises representatives from each functional area

relevant to ALK's risk profile. It meets twice a year or more, as required, to perform its tasks. Risks are systematically assessed according to a two-dimensional matrix, rating the impact and probability of each risk. A risk management report with key enterprise risks and recommended mitigation plans is presented to Board of Management before it is submitted to the Board of Directors on an annual basis for their review and approval.

The following is a description of ALK's key enterprise risks, and the main initiatives taken to mitigate these risks. The risk movements compared to the previous year are indicated.

2021 movement

  • The impact of the risk has increased compared to the year before
  • The impact of the risk is stable and has not changed from the year before
  • The impact of the risk has decreased compared to the year before 2021 movement:

Commercial risks

Description

The degree of market acceptance for a new product or drug candidate depends on several factors, including the demonstration of clinical efficacy and safety, cost-effectiveness, convenience and ease of administration, potential advantages over alternative treatment methods, competition, and marketing and distribution support. If ALK's new products, primarily tablets, fail to achieve market acceptance, this could have a significant influence on the company's ability to generate revenue. Even if market acceptance of the tablets is successfully achieved, the extent of their acceptance could influence the company's ability to fully deliver on its sales-growth targets for these products. While acceptance of tablets continues to increase in most markets, market acceptance remains a risk for ALK primarily in the USA.

Price pressures mandated by authorities can have a significant impact on the company's earnings capacity. In most of the countries in which ALK operates, prescription drugs are subject to reimbursement from, and price controls by, national authorities and healthcare providers. This often results in significant price differences between individual markets. Exceptionally, governments and national authorities may introduce economic measures that also affect the pricing and reimbursement of medicines, for example, because of the impact of COVID on healthcare budgets or because of a major economic downturn.

Risk mitigation

ALK closely monitors economic, market and regulatory developments as they relate to product pricing, along with the competitive situation and initiatives in all important markets, with the aim of appropriate risk mitigation.

ALK regularly conducts extensive surveys of market conditions and similar factors and commits significant resources to providing information on its products to doctors and patients. Sales growth targets are set with a full understanding of the potential risks involved in successfully marketing any product and these are anticipated and managed so far as is possible. ALK continues its focus on market access strategy, especially in the USA, to make tablets a more attractive alternative for patients.

ALK is strongly committed to evidenced-based medicine, based on strong clinical and health economic evidence as the basis for pricing and reimbursement. ALK actively engages in dialogue with authorities with the aim of securing fair pricing and reimbursement agreements and maintains a strong focus on its market access strategy.

Production and quality issues impacting product supply and patient safety

Description

ALK's products are subject to many statutory and regulatory requirements with respect to issues such as safety, efficacy, and production. The products may, in unexpected situations, be associated with allergic reactions of varying extents, durations and severities. Meeting high product quality standards is a prerequisite for the company's ability to supply products and hence its competitive strength, and for the company's earnings and sales.

ALK has concentrated its key in-house production capacity at plants in Denmark, France, Spain and the USA. Although the plants are in areas that have not historically been hit by natural disasters, this geographical spread calls for risk planning to avoid emergencies, such as lack of, or poor access to, raw materials: for instance, pollen.

As ALK works to rationalise its product portfolio, there may be risks associated with the discontinuation of its products. Among others, these may include potential disruption at manufacturing sites during decommissioning work, the loss of sales from products for which no suitable ALK substitute product exists, or the inability to meet sudden spikes in demand for other products due to patients switching from discontinued products. Dependency on third parties for supplying input for key production processes and commercialising the company's products in several markets entails risks that ALK would not be subject to if the company possessed the necessary in-house capabilities.

Risk mitigation

ALK stringently monitors product quality and safety, both in clinical development and in sales and marketing activities. If, despite the high levels of quality and safety, a situation should occur in which it is necessary to recall a product, ALK has procedures in place to ensure that this can be managed swiftly and effectively and in accordance with regulatory requirements. Production and manufacturing processes are subject to periodic and routine inspections by regulatory authorities as a regular part of their monitoring processes to ensure that ALK observes the prescribed requirements and standards.

ALK's production processes and quality standards have been developed and optimised over many years. ALK has invested significantly to increase the robustness and compliance of the legacy business by reducing manufacturing complexity, and all possible steps are taken during portfolio rationalisation work to mitigate any potential impact on other areas of manufacturing or the wider business. ALK conducts risk planning including for the prevention of unwanted events, and preventative inventory management. ALK manages third party dependency risks through contractual stipulations, planning, monitoring, and joint steering committees.

Description

The future success of ALK depends on the company's ability to maintain current products and to successfully identify, develop and market new, innovative drugs, which involves significant risks.

Failures or delays in product development

A pharmaceutical drug must be subjected to extensive and lengthy clinical trials to document qualities such as safety and efficacy before it can be approved for marketing. During the development process, the outcomes of these trials are subject to significant risks. Even though substantial resources are invested in the development process, the trials may produce negative results.

Failures or delays in the development process or in obtaining regulatory approvals may have a major impact for the patients not able to benefit from the products, and on the ability of ALK to achieve its long-term goals.

Risk mitigation

ALK and its collaborative partners perform thorough risk assessments of their research and development programmes throughout the development and registration processes with the objective of risk mitigation to optimise the likelihood of the products reaching the market.

ALK's Scientific Committee is responsible for other patient-/product-related innovation activities. The committee advises on matters relating to R&D activities and other patient-/product-related innovation activities, including reviewing R&D programmes and the overall R&D pipeline.

Description

Non-compliance with applicable regulations, legislation, or ALK's Code of Conduct could negatively impact the company's good reputation which is essential for operating within the pharmaceutical industry.

Breaches of legal or ethical standards

Patents and other intellectual property rights are important for developing and retaining ALK's competitive strength.

Risk mitigation

ALK strives to act professionally, honestly, and with high integrity throughout the company in relation to stakeholders. ALK's Code of Conduct defines ALK's high standard of ethical behaviour in relation to customers, employees, shareholders, society, suppliers, and partners. Immediate action is taken on substantiated non-compliance. Annually, all employees are asked to sign and confirm their knowledge of the Code of Conduct and to take an online test.

Internal controls and policies are in place to safeguard ALK's intellectual property rights. The risk that ALK might infringe patents or trademark rights held by other companies, as well as the risk that other companies may attempt to infringe the patents and/or trademark rights of ALK are monitored and, if necessary, suitable measures are taken.

Severe IT security breaches impacting business continuity

Description

The threat of cyberattacks continues to grow significantly for ALK, as it does for most major companies. Disruption to IT systems, such as severe breaches of data security, may occur across the global value chain, where well-functioning IT systems and infrastructure are critical for the company's ability to operate effectively.

Risk mitigation

ALK continuously manages this risk, among other ways, by having a security strategy in place to prevent intruders from causing damage to systems or gaining access to critical data and systems. Awareness campaigns, access controls, intrusion detection and prevention systems have all been implemented, further initiatives are planned, and systems are regularly upgraded to increase network security.

2021 movement:

Board of Directors

Anders Hedegaard (1960, Danish)

Rodenstock Group, CEO

Chairman Board member since 20202

Member of the Audit Committee Chairman of the Remuneration & Nomination Committee Member of the Scientific Committee

Competencies

Specific expertise within management and sales & marketing in international life science and consumer care companies.

Lene Skole1 (1959, Danish)

The Lundbeck Foundation, CEO and directorships at two other subsidiaries Vice Chairman Board member since 20142 Member of the Remuneration & Nomination Committee

Member of the Scientific Committee

Competencies

Experience in management, financial and economic expertise, experience in strategy and communication in international companies.

Directorships3

Falck A/S, Vice Chairman H. Lundbeck A/S, Vice Chairman Tryg Forsikring A/S Tryg A/S Ørsted A/S, Vice Chairman

Gitte Aabo (1967, Danish)

GN Hearing, CEO Board member since 20212 Member of the Audit Committee

Lars Holmqvist1 (1959, Swedish)

Professional board member Board member since 20152

Competencies

Extensive global leadership experience and deep understanding of international management, finance, IT, and sales & marketing, as well as considerable insights into building digital communities.

Directorships3

Danmarks Nationalbank HIMPP A/S (Hearing Instrument Manufacturers Patent Partnership) UNION therapeutics A/S The Danish Chamber of Commerce

Competencies

Experience in management, finance and sales & marketing in international life science companies, including med-tech and pharmaceutical companies.

Directorships3

Biovica International AB, Chairman H. Lundbeck A/S The Lundbeck Foundation Naga UK Topco Limited, UK Vitrolife AB, Sweden

1 These board members are not regarded as independent in the sense of the definition contained in the Danish Corporate Governance Recommendations due to their affiliations with the Lundbeck Foundation, which owns 40.3% of ALK's shares.

2 Members elected by the Annual General Meeting are up for re-election each year.

3 Directorships do not include those for companies that are privately owned, in whole or in part, by members of the Board of Directors.

Bertil Lindmark (1955, Swedish)

Galecto A/S, Chief Medical Officer Board member since 20212 Chairman of the Scientific Committee

Competencies

More than 30 years' experience of global R&D leadership in pharmaceuticals and biotech. Brings board-level experience from Almirall and Medicon Valley Alliance, and served on the Research Board of AstraZeneca. Has also participated in a range of IPOs, acquisitions and debt-financing activities.

Jakob Riis1 (1966, Danish)

Falck A/S, President & CEO Board member since 20132 Chairman of the Audit Committee

Competencies

Experience in management and sales & marketing in the international healthcare industry.

Katja Barnkob (1969, Danish)

Project Director, Global CMC Development, ALK-Abello A/S

Board member since 2011 Employee-elected

Competencies

Experience in project management of global drug development projects in the pharmaceutical industry.

Nanna Rassov Carlson (1976, Danish)

Manager, QA Release, ALK-Abelló A/S Board member since 2019

Employee-elected

Competencies

Expertise in production and release of ALK's active pharmaceutical ingredients for sublingual immunotherapy products.

Johan Smedsrud (1972, Danish)

Maintenance Supporter, Process & Production Support, ALK-Abelló A/S

Board member since 2019

Employee-elected

Competencies

Experience in HVAC systems, cleanroom testing, utensil washing and sterilisation for the pharmaceutical industry.

Directorships3

Danish Board of Business Development, Chairman

1 These board members are not regarded as independent in the sense of the definition contained in the Danish Corporate Governance Recommendations due to their affiliations with the Lundbeck Foundation, which owns 40.3% of ALK's shares.

2 Members elected by the Annual General Meeting are up for re-election each year.

3 Directorships do not include those for companies that are privately owned, in whole or in part, by members of the Board of Directors.

Board of Management

Competencies

Executive management experience in global healthcare and biopharmaceutical companies.

Henrik Jacobi (1965)

President & CEO Executive Vice President, Research & Development

Competencies Experience in management, innovation, and research & development in the pharmaceutical industry.

Henrik Jacobi holds a degree in Medicine from 1993.

Søren Jelert (1972)

Executive Vice President & CFO Executive Vice President,

Competencies

Experience in management, financial and economic expertise in the pharmaceutical industry and other sectors.

Søren Niegel (1971)

Commercial Operations

Competencies

Experience in management as well as global production and sales & marketing within the pharmaceutical industry.

Directorships1

Coloplast A/S Copenhagen Capacity The Danish Chamber of Commerce

1 Directorships do not include those for companies that are privately owned, in whole or in part, by members of the Board of Management.

Financial statements

Statements

  • 46 Statement by Management on the annual report
  • 47 Independent Auditor's reports

Consolidated financial statements

  • 52 Income statement
  • 52 Statement of comprehensive income
  • 53 Cash flow statement
  • 54 Balance sheet
  • 55 Statement of changes in equity
  • 56 Notes

Parent company financial statements

  • 92 Income statement
  • 93 Balance sheet
  • 94 Statement of changes in equity
  • 95 Notes

Financial statements • Annual report 2021 • ALK 45

The peanut drug substance is processed into a lyophilised tablet as the drug product that is visually inspected for e.g. colour.

Statement by Management on the annual report

The Board of Directors and the Board of Management have today considered and adopted the annual report of ALK-Abelló A/S for the financial year 1 January to 31 December 2021.

The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as adopted by the EU and further requirements in the Danish Financial Statements Act. The parent company financial statements have been prepared in accordance with the Danish Financial Statements Act. Management's review has been prepared in accordance with the Danish Financial Statements Act.

In our opinion, the consolidated financial statements and the parent company financial statements give a true and fair view of the financial position at 31 December 2021 of the group and the parent company and of the results of the group and parent company operations and consolidated cash flows for the financial year 1 January to 31 December 2021.

In our opinion, Management's review includes a true and fair account of the development in the operations and financial circumstances of the group and the parent company, of the results for the year and of the financial position of the group and the parent company as well as a description of the most significant risks and elements of uncertainty facing the group and the parent company.

In our opinion, the annual report of ALK-Abelló A/S for the financial year 1 January to 31 December 2021 identified as "ALK-2021-12-31-en.zip" is prepared, in all material respects, in compliance with the ESEF Regulation.

We recommend that the annual report be adopted at the annual general meeting.

Hørsholm, 8 February 2022

Board of Management

Carsten Hellmann President & CEO

Henrik Jacobi Søren Jelert Søren Daniel Niegel Executive Vice President, Executive Vice President Executive Vice President,

Research & Development & CFO Commercial Operations

Board of Directors

Independent Auditor's Reports

To the shareholders of ALK-Abelló A/S

Report on the audit of the Financial Statements

Our opinion

In our opinion, the Consolidated Financial Statements give a true and fair view of the Group's financial position at 31 December 2021 and of the results of the Group's operations and cash flows for the financial year 1 January to 31 December 2021 in accordance with International Financial Reporting Standards as adopted by the EU and further requirements in the Danish Financial Statements Act.

Moreover, in our opinion, the Parent Company Financial Statements give a true and fair view of the Parent Company's financial position at 31 December 2021 and of the results of the Parent Company's operations for the financial year 1 January to 31 December 2021 in accordance with the Danish Financial Statements Act.

Our opinion is consistent with our Auditor's Long-form Report to the Audit Committee and the Board of Directors.

What we have audited

The Consolidated Financial Statements (pp 51-90) and the Parent Company Financial Statements (pp 91-102) of ALK-Abelló A/S for the financial year 1 January to 31 December 2021 comprise income statement, balance sheet, statement of changes in equity and notes, including summary of significant accounting policies for the Group as well as for the Parent Company and statement of comprehensive income and cash flow statement for the Group.

Collectively referred to as the "Financial Statements".

Basis for opinion

We conducted our audit in accordance with International Standards on Auditing (ISAs) and the additional requirements applicable in Denmark. Our responsibilities under those standards and requirements are further described in the Auditor's responsibilities for the audit of the Financial Statements section of our report.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.

Independence

We are independent of the Group in accordance with the International Ethics Standards Board for Accountants' International Code of Ethics for Professional Accountants (IESBA Code) and the additional ethical requirements applicable in Denmark. We have also fulfilled our other ethical responsibilities in accordance with these requirements and the IESBA Code.

To the best of our knowledge and belief, prohibited non-audit services referred to in Article 5(1) of Regulation (EU) No 537/2014 were not provided.

Appointment

We were first appointed auditors of ALK-Abelló A/S on 11 March 2020 for the financial year 2020. We have been reappointed annually by shareholder resolution for a total period of uninterrupted engagement of two years including the financial year 2021.

Key audit matters

Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the Financial Statements for 2021. These matters were addressed in the context of our audit of the Financial Statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.

Denmark.

Valuation of deferred tax assets

Key audit matter How our audit addressed the key audit matter

A significant part of the recognised deferred tax assets relates to tax losses carried forward in assessing their valuation.

Utilisation of the recognised deferred tax assets is depending on the expected future taxable income within the Danish joint taxation group with the Lundbeck Foundation and its other subsidiaries.

We focused on this area as the amounts involved are material and as the valuation of deferred tax assets is associated with significant accounting estimates and judgements. This includes the estimation uncertainty regarding assessing the future taxable profits of ALK-Abelló A/S and within the Danish joint taxation group.

We refer to note 2.8 in the consolidated financial statements.

We assessed the method applied by Management for calculating the deferred tax assets and

We tested the calculation of the deferred tax assets prepared by Management and involved our internal tax specialist in assessing the tax calculation to ensure compliance with relevant tax legislation.

We evaluated and challenged the documentation prepared by Management regarding the deferred tax assets, including Management's best estimate of the probability of realising the future taxable profits in Denmark and within the Danish joint taxation group. We furthermore evaluated Management's sensitivity and risk analysis.

We assessed the appropriateness of the related disclosure provided in the consolidated financial statements.

Statement on Management's Review

Management is responsible for Management's Review (pp 1-44 and p 103).

Our opinion on the Financial Statements does not cover Management's Review, and we do not express any form of assurance conclusion thereon.

In connection with our audit of the Financial Statements, our responsibility is to read Management's Review and, in doing so, consider whether Management's Review is materially inconsistent with the Financial Statements or our knowledge obtained in the audit, or otherwise appears to be materially misstated.

Moreover, we considered whether Management's Review includes the disclosures required by the Danish Financial Statements Act.

Based on the work we have performed, in our view, Management's Review is in accordance with the Consolidated Financial Statements and the Parent Company Financial Statements and has been prepared in accordance with the requirements of the Danish Financial

Statements Act. We did not identify any material misstatement in Management's Review.

Management's responsibilities for the Financial Statements

Management is responsible for the preparation of consolidated financial statements that give a true and fair view in accordance with International Financial Reporting Standards as adopted by the EU and further requirements in the Danish Financial Statements Act and for the preparation of parent company financial statements that give a true and fair view in accordance with the Danish Financial Statements Act, and for such internal control as Management determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the Financial Statements, Management is responsible for assessing the Group's and the Parent Company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless Management either intends to liquidate

the Group or the Parent Company or to cease operations, or has no realistic alternative but to do so.

Auditor's responsibilities for the audit of the Financial Statements

Our objectives are to obtain reasonable assurance about whether the Financial Statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and the additional requirements applicable in Denmark will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these Financial Statements.

As part of an audit in accordance with ISAs and the additional requirements applicable in Denmark, we exercise professional judgement and maintain professional scepticism throughout the audit. We also:

  • Identify and assess the risks of material misstatement of the Financial Statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.
  • Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group's and the Parent Company's internal control.
  • Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by Management.
  • Conclude on the appropriateness of Management's use of the going concern

basis of accounting and based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's and the Parent Company's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor's report to the related disclosures in the Financial Statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group or the Parent Company to cease to continue as a going concern.

  • Evaluate the overall presentation, structure and content of the Financial Statements, including the disclosures, and whether the Financial Statements represent the underlying transactions and events in a manner that gives a true and fair view.
  • Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an

opinion on the Consolidated Financial Statements. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our audit opinion.

We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.

We also provide those charged with governance with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied.

From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the Financial Statements of the current period and are therefore the key audit matters. We

describe these matters in our auditor's report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication.

Report on compliance with the ESEF Regulation

As part of our audit of the Financial Statements we performed procedures to express an opinion on whether the annual report of ALK-Abelló A/S for the financial year 1 January to 31 December 2021 with the filename ALK-2021-12-31-en. zip is prepared, in all material respects, in compliance with the Commission Delegated Regulation (EU) 2019/815 on the European Single Electronic Format (ESEF Regulation) which includes requirements related to the preparation of the annual report in XHTML format and iXBRL tagging of the Consolidated Financial Statements.

Management is responsible for preparing an annual report that complies with the ESEF Regulation. This responsibility includes:

  • The preparing of the annual report in XHTML format;
  • The selection and application of appropriate iXBRL tags, including extensions to the ESEF taxonomy and the anchoring thereof to elements in the taxonomy, for all financial information required to be tagged using judgement where necessary;
  • Ensuring consistency between iXBRL tagged data and the Consolidated Financial Statements presented in human-readable format; and
  • For such internal control as Management determines necessary to enable the preparation of an annual report that is compliant with the ESEF Regulation.

Our responsibility is to obtain reasonable assurance on whether the annual report is prepared, in all material respects, in compliance with the ESEF Regulation based on the evidence we have obtained, and to issue a report that includes our opinion. The nature, timing and extent of procedures selected depend on the auditor's judgement, including the assessment of the risks of material departures from the requirements set out in the ESEF Regulation, whether due to fraud or error. The procedures include:

  • Testing whether the annual report is prepared in XHTML format;
  • Obtaining an understanding of the company's iXBRL tagging process and of internal control over the tagging process;
  • Evaluating the completeness of the iXBRL tagging of the Consolidated Financial Statements;
  • Evaluating the appropriateness of the company's use of iXBRL elements selected from the ESEF taxonomy and the creation of extension elements where no suitable element in the ESEF taxonomy has been identified;
  • Evaluating the use of anchoring of extension elements to elements in the ESEF taxonomy; and

• Reconciling the iXBRL tagged data with the audited Consolidated Financial Statements.

In our opinion, the annual report of ALK-Abelló A/S for the financial year 1 January to 31 December 2021 with the file name ALK-2021-12-31-en.zip is prepared, in all material respects, in compliance with the ESEF Regulation.

Hellerup, 8 February 2022

PricewaterhouseCoopers

Statsautoriseret Revisionspartnerselskab CVR No 3377 1231

Lars Baungaard

State Authorised Public Accountant mne23331

Kim Tromholt

State Authorised Public Accountant mne33251

Consolidated financial statements

Financial statements

Income statement 52
Statement of comprehensive income 52
Cash flow statement 53
Balance sheet 54
Statement of changes in equity 55
Notes 56

Definitions 90

Notes

Section 1 Basis of reporting

1.1 General accounting policies 56

1.2 Significant accounting estimates and judgements 58

Section 2

  • Results for the year
  • 2.1 Revenue and segment information 59
  • 2.2 Expenses 60
  • 2.3 Depreciation, amortisation and impairment 61
  • 2.4 Staff costs 61
  • 2.5 Fees to the ALK Group's auditors 62
  • 2.6 Other operating items, net 62
  • 2.7 Financial income and expenses 62
  • 2.8 Income taxes and deferred tax 63

Section 3 Operating assets and liabilities

3.1 Intangible assets 66
3.2 Property, plant and equipment 68
3.3 Leases 70
3.4 Inventories 72
3.5 Trade receivables 73
3.6 Prepayments 73
3.7 Pensions and similar liabilities 74
3.8 Provisions 76
3.9 Other payables 76
3.10 Contingent liabilities
and commitments
77

Section 4

Capital structure and financing

4.1 Share capital and earnings per share 78 4.2 Financial risks and financial instruments 79

Section 5 Other disclosures

5.1 Share-based payments 84
5.2 Cash flow 87
5.3 Related parties 88
5.4 Events after the reporting period 88
5.5 Approval of financial statements 88
5.6 List of companies in
the ALK Group
89
Amounts in DKKm Note 2021 2020
Revenue 2.1 3,916 3,491
Cost of sales 2.2-2.4, 3.4, 5.1 1,520 1,463
Gross profit 2,396 2,028
Research and development expenses 2.2-2.4, 5.1 631 515
Sales and marketing expenses 2.2-2.4, 5.1 1,234 1,125
Administrative expenses 2.2-2.4, 5.1 240 237
Other operating items, net 2.6 1 (1)
Operating profit (EBIT) 292 150
Financial income 2.7 10 5
Financial expenses 2.7 23 54
Profit before tax (EBT) 279 101
Tax on profit/(loss) 2.8 60 76
Net profit 219 25
Earnings per share (EPS) 4.1
Earnings per share (EPS) 19.96 2.29
Earnings per share (DEPS), diluted 19.82 2.27

Income statement Statement of comprehensive income

Amounts in DKKm Note 2021 2020
Net profit 219 25
Items
that
will
subsequently
be
reclassified
not
the
to
income
statement:
Actuarial gains/(losses) on pension plans
Tax related to actuarial gains/(losses) on pension plans
3.7
2.8
16
(5)
(3)
1
11 (2)
Items
that
will
subsequently
be
reclassified
to
the
when
specific
conditions
income
statement,
are met:
Foreign currency translation adjustment of foreign affiliates
84 (106)
Tax related to other comprehensive income, that will
subsequently be reclassified to the income statement
2.8 (4) 1
80 (105)
Other comprehensive income/(loss) 91 (107)
Total comprehensive income/(loss) 310 (82)

Cash flow statement

Amounts in DKKm Note 2021 2020
Net profit 219 25
Adjustments
Adjustments for non-cash items 5.2 400 462
Changes in working capital 5.2 (28) (154)
Financial income, received - 4
Financial expenses, paid (23) (22)
Income taxes, paid (net) (100) (14)
Cash flow from operating activities 468 301
Investments in intangible assets 3.1 (45) (26)
Investments in tangible assets 3.2 (218) (196)
Investments in other financial assets* (3) (23)
Cash flow from investing activities (266) (245)
Free cash flow 202 56
Sale of treasury shares 31 11
Exercised share options, paid 5.1 (72) (24)
Proceeds from borrowings 5.2 226 -
Repayment of lease liabilities 5.2 (32) (30)
Repayment of borrowings 5.2 (464) (19)
Cash flow from financing activities (311) (62)
Net cash flow (109) (6)
Cash beginning of year 298 316
Unrealised gain/(loss) on cash held in foreign currency and
financial assets carried as cash 5 (12)
Net cash flow (109) (6)
Cash year end 194 298

The consolidated statement of cash flow is compiled using the indirect method. As a result, the individual figures in the cash flow statement cannot be reconciled directly to the income statement and the balance sheet.

Amounts in DKKm Note 31 Dec.
2021
31 Dec.
2020
Non-current assets
Intangible assets
Goodwill 3.1 457 452
Other intangible assets 3.1 165 172
622 624
Tangible assets
Land and buildings 3.2-3.3 958 921
Plant and machinery 3.2 451 442
Other fixtures and equipment 3.2-3.3 80 72
Property, plant and equipment in progress 3.2 325 269
1,814 1,704
Other non-current assets
Receivables 29 30
Deferred tax assets 2.8 790 697
Income tax receivables 172 168
991 895
Total non-current assets 3,427 3,223
Current assets
Inventories 3.4 1,204 1,093
Trade receivables 3.5 583 544
Receivables from group companies 5.3 12 20
Income tax receivables 14 24
Other receivables 82 96
Prepayments 3.6 314 265
Cash 194 298
Total current assets 2,403 2,340
Total assets 5,830 5,563

Balance sheet – Assets Balance sheet – Equity and liabilities

Amounts in DKKm Note 31 Dec.
2021
31 Dec.
2020
Equity
Share capital 4.1 111 111
Currency translation adjustment (41) (125)
Retained earnings 3,410 3,167
Total equity 3,480 3,153
Liabilities
Non-current liabilities
Mortgage debt 4.2 222 240
Bank loans 4.2 - 446
Pensions and similar liabilities 3.7 324 345
Lease liabilities 4.2 207 207
Deferred income 42 -
Deferred tax liabilities 2.8 1 -
Income tax payables 169 143
965 1,381
Current liabilities
Mortgage debt 4.2 18 18
Bank loans 4.2 226 -
Trade payables 115 74
Lease liabilities 4.2 37 32
Deferred income 4 1
Provisions 3.8 12 3
Income tax payables 23 21
Other payables 3.9 950 880
1,385 1,029
Total liabilities 2,350 2,410
Total equity and liabilities 5,830 5,563

Statement of changes in equity

Currency
translation
Amounts in DKKm Share
capital
adjust-
ment
Retained
earnings
Total
equity
2021
Equity at 1 January 111 (125) 3,167 3,153
Net profit - - 219 219
Other comprehensive income - 84 7 91
Total comprehensive income - 84 226 310
Share-based payments - - 36 36
Share options settled - - (72) (72)
Sale of treasury shares - - 31 31
Tax related to items recognised
directly in equity - - 10 10
Other adjustments - - 12 12
Other transactions - - 17 17
Equity at 31 December 111 (41) 3,410 3,480
Currency
translation
Share adjust- Retained Total
Amounts in DKKm capital ment earnings equity
2020
Equity at 1 January 111 (19) 3,084 3,176
Net profit - - 25 25
Other comprehensive income/(loss) - (106) (1) (107)
Total comprehensive income/(loss) - (106) 24 (82)
Share-based payments - - 29 29
Share options settled - - (24) (24)
Sale of treasury shares - - 11 11
Tax related to items recognised
directly in equity - - 43 43
Other transactions - - 59 59
Equity at 31 December 111 (125) 3,167 3,153

Section 1 – Basis of reporting

1.1 General accounting policies

The consolidated financial statements for the period 1 January to 31 December 2021 have been prepared in accordance with the International Financial Reporting Standards (IFRS) as adopted by the EU and in accordance with Danish disclosure requirements for listed companies. Additional Danish disclosure requirements for annual reports are imposed by the Statutory Order on Adoption of IFRS issued under the Danish Financial Statements Act.

The consolidated financial statements are presented in Danish kroner (DKK), which is considered the primary currency of the ALK Group's activities and the functional currency of the parent company.

The consolidated financial statements are presented on a historical cost basis, apart from certain financial instruments, which are measured at fair value.

The general accounting policies described below apply to the consolidated financial statements as a whole. To enhance understanding, specific accounting policies are described in the notes to which they relate. The description of accounting policies in the notes form part of the

overall description of accounting policies.

The accounting policies are unchanged from last year except for the below mentioned impacts of new standards.

New standards effective from 1 January 2021

The ALK Group has implemented all new and amended standards and interpretations (IFRIC) which are effective for the financial year 2021. This has not resulted in any changes to the accounting policies of the ALK Group.

New standards effective on or after 1 January 2022

A number of IFRS standards, amended standards and IFRIC interpretations, which are effective on or after 1 January 2022, have not been implemented. Based on a preliminary assessment it is estimated that these standards and interpretations will have no material impact on the consolidated financial statements.

The consolidated financial statements

The consolidated financial statements comprise the financial statements of ALK-Abelló A/S (the parent company)

and companies (subsidiaries) controlled by the parent company. The parent company is considered to control a subsidiary when it holds, directly or indirectly, more than 50% of the voting rights, or is otherwise able to exercise or actually exercises a controlling influence and has the right to variable returns from the entity.

Basis of consolidation

The consolidated financial statements are prepared based on the financial statements of ALK-Abelló A/S and its subsidiaries. The consolidated financial statements are prepared as a consolidation of items of a uniform nature. The financial statements used for consolidation are prepared in accordance with the ALK Group's accounting policies.

On consolidation, intra-group income and expenses, intra-group balances and dividends, and gains and losses arising on intra-group transactions are eliminated.

Foreign currency translation

On initial recognition, transactions denominated in currencies other than DKK are translated at average exchange rates, which are an approximation of the exchange rates at the transaction date. Receivables and debt and other monetary items not settled at the balance sheet date are translated at the closing rate.

Exchange rate differences between the exchange rate at the date of the transaction and the exchange rate at the date of payment or the balance sheet date, respectively, are recognised in the income statement under financial items. Tangible assets and intangible assets, inventories and other nonmonetary assets acquired in foreign currency and measured based on historical cost are translated at the exchange rates at the transaction date.

On recognition in the consolidated financial statements of subsidiaries whose financial statements are presented in a functional currency other than DKK, the income statements are translated at average exchange rates for the respective months, unless these deviate materially from the actual exchange rates at the transaction dates. In that case, the actual exchange rates are used. Balance sheet items are translated at the exchange rates at the balance sheet date. Goodwill is considered to belong to the acquired company in question and is translated

at the exchange rate at the balance sheet date.

Exchange rate differences arising on the translation of foreign subsidiaries' opening balance sheet items to the exchange rates at the balance sheet date and on the translation of the income statements from average exchange rates to exchange rates at the balance sheet date are recognised in other comprehensive income.

Foreign exchange rate adjustment of receivables or debt to subsidiaries which are considered part of the parent company's overall investment in the subsidiary in question are also recognised in other comprehensive income in the consolidated financial statements.

Definitions and ratios

The key ratios have been calculated in accordance with generally accepted financial ratios applied by financial analysts. Definitions are shown on page 90.

Reporting under the ESEF regulation

The Commission Delegated Regulation (EU) 2019/815 on the European Single Electronic Format (ESEF) (ESEF Regulation) has introduced a single

Section 1 – Basis of reporting

1.1 Accounting policies – continued

electronic reporting format for the annual financial reports of issuers with securities listed on the EU regulated markets.

The ESEF Regulation sets out the following main requirements: (1) Issuers shall draw up and disclose their annual financial reports using the XHTML format; and (2) issuers that draw-up their primary consolidated financial statements in accordance with IFRS as endorsed by the EU shall tag those consolidated financial statements using inline eXtensible Business Reporting Language (iXBRL) and with effect from the 2022 annual report block-tag the notes to the consolidated financial statements.

The combination of the XHTML format with the iXBRL tags makes the annual financial reports both humanreadable and machine-readable, thus enhancing accessibility, analysis and comparability of the information included in the annual financial reports.

iXBRL tags shall comply with the ESEF taxonomy, which is included in the ESEF Regulation and developed based on the IFRS taxonomy published by the IFRS Foundation.

As part of the tagging process financial statement line items are marked up to elements in the ESEF taxonomy. If a financial statement line item is not defined in the ESEF taxonomy, an extension to the taxonomy is created. Extensions have to be anchored to elements in the ESEF taxonomy, except for elements corresponding to subtotals.

The annual report 2021 for the ALK Group submitted to the Danish Financial Supervisory Authority (The Officially Appointed Mechanisms) consists of the XHTML document together with some technical files all included in a ZIP file named "ALK-2021-12-31-en.zip".

Key definitions

XHTML (eXtensible HyperText Markup Language) is a text-based markup language used to structure and mark up content such as text, images, and hyperlinks in documents that are displayed as Web pages in an updated standard Web browser like Chrome, Internet Explorer or Safari.

iXBRL tags (or Inline XBRL tags) are hidden meta-information embedded in the source code of an XHTML document in accordance with the Inline XBRL 1.1 specification, which enables the conversion of XHTML-formatted information into a machine-readable XBRL data record by appropriate software.

The tagging process is a process where iXBRL tags are applied to financial statement line items, etc.

Taxonomy is an electronic dictionary of business reporting elements used to report business data. A taxonomy element is an element defined in a taxonomy that is used for the machinereadable labeling of information in an XBRL data record.

ESEF data

Name of reporting entity or other means of identification ALK-Abelló A/S

Domicile of entity Denmark

Legal form of entity A/S

Country of incorporation Denmark

Address of entity's registered office Bøge Allé 6-8, DK-2970 Hørsholm

Principal place of business Global

Description of nature of entity's operations and principal activities ALK is a global allergy solutions company

Name of parent entity

Lundbeck Foundation (Lundbeckfond Invest A/S)

Name of ultimate parent of group Lundbeck Foundation (Lundbeckfond Invest A/S)

Section 1 – Basis of reporting

1.2 Significant accounting estimates and judgements

In the preparation of the consolidated financial statements according to IFRS, Management is required to make certain estimates as many financial statement items cannot be reliably measured, but must be estimated. Such estimates comprise judgements made on the basis of the most recent information available at the reporting date.

were based or due to supplementary information, additional experience or subsequent events. Similarly, the value of assets and liabilities often depends on future events that are somewhat uncertain. In that connection, it is necessary to set out e.g. a course of events that reflects Management's assessment of the most probable course of events.

It may be necessary to change previous estimates as a result of changes to the assumptions on which the estimates

Management considers those listed below as the key accounting estimates and related judgements used in

the preparation of the consolidated financial statements.

A description of significant accounting estimates and judgements as well as assumptions applied is included in the relevant notes.

Note Key accounting estimates and judgements Estimate/
judgement
2.2 Expenses Recognition of costs for outsourced clinical trials Estimate
2.8
Income taxes and deferred tax
Provision for uncertain tax positions and measurement of
deferred tax assets
Estimate/
judgement
3.1 Intangible assets Recoverable amount of goodwill Estimate
3.4 Inventories Valuation of inventories and capitalisation of indirect
production costs
Estimate

2.1 Revenue and segment information

Europe North America International markets Total
Amounts in DKKm 2021 2020 2021 2020 2021 2020 2021 2020
SCIT/SLIT-drops 1,273 1,320 302 275 80 78 1,655 1,673
SLIT-tablets 1,340 1,019 120 85 314 266 1,774 1,370
Other products and services 196 211 261 213 30 24 487 448
Total revenue 2,809 2,550 683 573 424 368 3,916 3,491
Sale of goods 3,835 3,429
Royalties 81 58
Services - 4
Total revenue 3,916 3,491

Of total revenue, DKK 101 million (2020: DKK 83 million) is derived from Denmark.

The ALK Group's non-current tangible and intangible assets are distributed among the following geographical markets:

Europe North America International markets Total
Amounts in DKKm 2021 2020 2021 2020 2021 2020 2021 2020
Non-current tangible and
intangible assets 1,671 1,629 763 695 2 4 2,436 2,328

Of total non-current tangible and intangible assets, DKK 1,283 million relates to assets in Denmark (2020: DKK 1,257 million).

Accounting policies

Segment information

Based on the internal reporting used by the Board of Management to assess the results of operations and allocation of resources, the ALK Group has identified one operating segment 'Allergy treatment', which is in accordance with the way the activities are organised and managed. Even though revenue within the operating segment "Allergy treatment" can be divided by product lines and market, the main part of the activities within production, research and development, sales and marketing and administration are shared by the ALK Group as a whole. The disclosures in the financial statements include a breakdown of revenue by product line and a geographical breakdown of revenue and non-current assets. The geographical information on markets is based on customer and asset location.

Revenue

The primary performance obligation of the ALK Group is the sale and delivery of ownmanufactured goods and goods for resale for allergy treatment. Revenue from the sale of goods is recognised in the income statement upon the control of the goods being transferred to the customer, i.e. when goods are delivered. Revenue is recognised by the ALK Group at a point in time.

2.1 Revenue and segment information – continued

The ALK Group's customers have payment terms that reflect the customer type and the market in which sales take place, which typically varies from 0 to 180 days.

Revenue is measured as the fair value of the consideration received or receivable.

Revenue is measured exclusive of VAT, taxes etc. charged on behalf of third parties and less any commissions and discounts in connection with sales.

Furthermore, revenue includes licence income and royalties from outlicensed products as well as upfront payments, milestone payments and services in connection with partnerships. These revenues are recognised in the income statement in accordance with the agreements and when the ALK Group obtains the right to the payments, which is when services have been delivered to the customer or at the point in time the subsequent sales occur.

When combined contracts are entered, the elements of the contracts are identified and assessed separately for accounting purposes.

2.2 Expenses

Accounting policies

Cost of sales

The item comprises cost of sales and production costs incurred in generating the revenue for the year. Costs for raw materials, consumables, goods for resale, production staff and a proportion of production overheads, including maintenance and depreciation, amortisation and impairment of tangible assets and intangible assets used in production as well as operation, administration and management of factories are recognised in cost of sales and production costs. In addition, the costs and write-down to net realisable value of obsolete and slow-moving goods are recognised.

Research and development expenses

The item comprises research and development expenses, including expenses incurred for wages and salaries, amortisation, impairment of capitalised development projects in progress, and other overheads as well as costs relating to research partnerships. Research expenses are recognised in the

2.2 Expenses – continued

income statement when incurred. Due to the long development periods and significant uncertainties in relation to the development of new products, including risks regarding clinical trials and regulatory approvals, it is the assessment that most of the ALK Group's development expenses do not meet the capitalisation criteria in IAS 38, Intangible Assets. Consequently, development expenses are generally recognised in the income statement when incurred. Development expenses relating to individual minor development projects running for short-term periods and subject to limited risk are capitalised under other intangible assets.

Sales and marketing expenses

The item comprises selling and marketing expenses, including salaries and expenses relating to sales staff, advertising and exhibitions, depreciation, amortisation and impairment losses on tangible assets and intangible assets used in the sales and marketing process as well as other indirect costs.

Administrative expenses

The item comprises expenses incurred for management and administration, including expenses for administrative staff and management, office expenses and depreciation, amortisation and impairment losses on tangible assets and intangible assets used in administration.

Significant accounting estimates and judgements

Clinical trials, which are outsourced to Clinical Research Organisations ("CROs"), take several years to complete. As such, Management is required to make estimates based on the progress and costs incurred to-date for the ongoing trials. Estimates are made in determining the amount of costs to be expensed during the period or recognised as prepayments or accruals on the balance sheet.

At 31 December 2021, DKK 179 million is recognised as accrued expenses (2020: DKK 135 million) and DKK 240 million as prepayments in the balance sheet (2020: DKK 218 million). In 2021, clinical trials expenses of DKK 242 million have been recognised in the income statement (2020: DKK 154 million).

2.3 Depreciation, amortisation and impairment

Amounts in DKKm 2021 2020
Depreciation, amortisation and impairment allocation:
Cost of sales 158 152
Research and development expenses 8 26
Sales and marketing expenses 36 29
Administrative expenses 40 38
Total 242 245

Impairment amounts to DKK 20 million (2020: DKK 38 million), of which DKK 8 million relate to tangible assets (2020: DKK 16 million) and DKK 12 million relate to intangible assets (2020: DKK 22 million).

The impairment of tangible assets is related to impairment of equipment with no recoverable amount after impairment of which DKK 7 million relate to production equipment and DKK 1 million relate to research and development equipment. The impairment is recognised as cost of sales and research and development expenses, respectively.

The impairment of intangible assets is related to impairment of acquired intellectual property rights of DKK 1 million and to impairment of sales and marketing software solution of DKK 11 million with no recoverable amount after impairment. The impairment is recognised as sales and marketing expenses.

2.4 Staff costs

Amounts in DKKm 2021 2020
Wages and salaries 1,425 1,342
Pensions, cf. note 3.7 115 110
Other social security costs, etc. 193 197
Share-based payments, cf. note 5.1 35 28
Total 1,768 1,677
Staff costs are allocated as follows:
Cost of sales 682 668
Research and development expenses 254 233
Sales and marketing expenses 604 557
Administrative expenses 170 164
Included in the cost of assets 58 55
Total 1,768 1,677
Remuneration to Management:
Remuneration to Board of Management:*
Salaries 18 18
Short-term incentive (cash bonus) 12 10
Pensions 1 1
Long-term incentives (share-based) based on
expensed accounting value, cf. note 5.1 11 11
Total remuneration to Board of Management 42 40
Remuneration to Board of Directors** 5 4
Total remuneration to Board of Management and Board of Directors 47 44
Employees
Average number (FTE) 2,492 2,419
Number year end (FTE) 2,537 2,447

* The expensed costs include DKK 5 million (2020: DKK 3 million) related to adjustment in the share options and performance share units expected to vest.

** The total remuneration to the Board of Directors includes remuneration for participation in the Audit Committee DKK 385,000 (2020: DKK 385,000), the Remuneration and Nomination Committee DKK 310,000 (2020: DKK 350,000) and the Scientific Committee DKK 303,000 (2020: DKK 150,000). The remaining remuneration relates to regular Board of Directors activities.

2.5 Fees to the ALK Group's auditors

Amounts in DKKm 2021 2020
Fees to the auditors appointed at the annual general meeting:
Audit services 3 3
Other opinions - -
Tax advisory services 1 -
Other services - -
Total 4 3

The fee for non-audit services provided by PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab (Denmark) of DKK 1 million (2020: DKK 0.4 million) relates to tax advisory and other general financial accounting matters.

For information on ALK entities intended to be exempt from local audits of the 2021 accounts, see note 5.6.

2.6 Other operating items, net

In 2021, other operating items, net includes other operating income of DKK 1 million related to numerous minor components.

In 2020, other operating items, net included other operating expenses of DKK 1 million related to sale of production equipment.

Accounting policies

Other operating items comprise income and expenses of a secondary nature relative to the principal activities of the ALK Group.

2.7 Financial income and expenses

Amounts in DKKm 2021 2020
Interest income 1 5
Financial income from financial assets measured at amortised cost 1 5
Currency gains, net 9 -
Total financial income 10 5
Interest expenses* 23 30
Financial expenses from financial liabilities measured
at amortised cost
23 30
Interest expenses on uncertain tax positions, net
Currency losses, net
-
-
4
20
Total financial expenses 23 54

* Includes interest expenses related to leasing of DKK 7 million (2020: DKK 8 million).

Accounting policies

Financial items comprise interest receivable and interest payable, the interest element of lease payments, realised and unrealised gains and losses on securities, cash, liabilities and foreign currency transactions, mortgage amortisation premium/allowance etc. and provisions for uncertain tax positions.

Interest expenses and income related to uncertain tax positions are recognised on the balance sheet as tax liabilities and tax assets respectively upon the receipt of ruling from the tax authorities and correspondingly reflected in the income statement as financial items net.

Interest income and expenses are accrued based on the principal and the effective rate of interest. The effective rate of interest is the discount rate to be used on discounting expected future payments in relation to the financial asset or the financial liability so that their present value corresponds to the carrying amount of the asset or liability, respectively.

2.8 Income taxes and deferred tax

Amounts in DKKm 2021 2020
Tax on profit
Current income tax 154 117
Adjustment of deferred tax (97) (38)
Prior year adjustments, income tax 3 (3)
Tax on profit for the year 60 76
Profit before tax 279 101
Income tax, tax rate of 22% (2020: 22%) 61 22
Effect of deviation of foreign subsidiaries' tax rate
relative to Danish tax rate 11 15
Permanent differences (14) (2)
Other taxes and adjustments 1 46
Change in valuation of net tax assets (2) (2)
Prior year adjustments, income tax 3 (3)
Tax on profit for the year 60 76

Tax related to equity comprises an income of DKK 10 million (2020: income of DKK 43 million) and other comprehensive income comprises an expense of DKK 9 million (2020: income of DKK 2 million).

2.8 Income taxes and deferred tax – continued

Amounts in DKKm Intangible
assets
Tangible
assets
Current and
other assets
Liabilities Tax losses
carried forward
Total
2021
Deferred tax
Carrying amount beginning of year (7) (103) 340 135 332 697
Adjustment to prior years' deferred tax 3 1 (4) - - -
Adjustment of receivables from group companies - - - - (6) (6)
Currency adjustments - (2) - 1 1 -
Recognised in the income statement, net (16) 6 125 (4) (16) 95
Change in valuation of net tax assets - - - 2 - 2
Recognised in other comprehensive income, net - - - (5) (4) (9)
Recognised in equity, net (share-based payments) - - (23) - 33 10
Carrying amount year end (20) (98) 438 129 340 789
2020
Deferred tax
Carrying amount beginning of year 11 (100) 206 117 382 616
Adjustment to prior years' deferred tax - (1) (17) 19 (1) -
Adjustment of receivables from group companies - - - - (2) (2)
Currency adjustments 1 3 (1) (2) (1) -
Recognised in the income statement, net (19) (5) 117 (2) (55) 36
Change in valuation of net tax assets - - - 2 - 2
Recognised in other comprehensive income, net - - - 1 1 2
Recognised in equity, net (share-based payments) - - 35 - 8 43
Carrying amount year end (7) (103) 340 135 332 697

Deferred tax consists of deferred tax assets of DKK 790 million (2020: DKK 697 million) and deferred tax liabilities of DKK 1 million (2020: DKK 0).

Unrecognised deferred tax assets comprising tax losses carried forward amount to DKK 14 million and primarily relate to US entities (2020: DKK 16 million). The tax losses have no expiry date.

2.8 Income taxes and deferred tax – continued

Accounting policies

Tax on the profit for the year comprises the year's current tax and changes in deferred tax. The tax expense relating to the profit/loss for the year is recognised in the income statement, and the tax expense relating to items recognised in other comprehensive income and directly in equity, respectively, is recognised in other comprehensive income or directly in equity. Exchange rate adjustments of deferred tax are recognised as part of the adjustment of deferred tax for the year.

Current tax payable and receivable is recognised in the balance sheet as the expected tax on the taxable income for the year, adjusted for tax paid on account.

The current tax charge for the year is calculated based on the tax rates and rules enacted at the balance sheet date.

Uncertain tax position is recognised for those matters for which the tax determination is uncertain but it is considered probable that there will be a future outflow of funds to a tax authority (and a future inflow of funds from a tax authority). The uncertain tax positions are measured at the best estimate of the amount expected to become payable (and receivable).

Deferred tax is measured using the balance sheet liability method on all temporary differences between the carrying amount and the tax base of assets and liabilities. However, deferred tax is not recognised on temporary differences relating to the initial recognition of goodwill or the initial recognition of a transaction, apart from business combinations, and where the temporary difference existing at the date of initial recognition affects neither profit/loss for the year nor taxable income.

Deferred tax is calculated based on the planned use of each asset and settlement of each liability, respectively. Deferred tax is measured using the tax rates and tax rules that, based on legislation enacted or in reality enacted at the balance sheet date, are expected to apply in the respective countries when the deferred tax is expected to crystallise as current tax. Changes in deferred tax as a result of changed tax rates or rules are recognised in the income statement, in other comprehensive income or in equity, depending on where the deferred tax was originally recognised. Deferred tax related to equity transactions is recognised in equity.

Deferred tax assets, including the tax value of tax loss carry-forwards, are recognised in the balance sheet at the value at which the asset is expected to be realised, either through a set-off against deferred tax liabilities or as net assets to be offset against future positive taxable income. Deferred tax assets including the tax value of tax losses are recognised if it is probable that it can be utilised against future taxable

income within a foreseeable future. This includes an assessment of the possibilities to utilise tax losses in the joint Danish taxation scheme with the Lundbeck Foundation (Lundbeckfond Invest A/S).

At each balance sheet date, it is reassessed whether it is likely that there will be sufficient future taxable income for the deferred tax asset to be utilised.

The parent company is included in a joint Danish taxation scheme with the Lundbeck Foundation (Lundbeckfond Invest A/S) and its Danish subsidiaries. The tax charge for the year is allocated among the jointly taxed companies in proportion to the taxable incomes of individual companies, taking into account taxes paid.

Significant accounting estimates and judgements

Management is required to make an estimate in the recognition of deferred tax assets. This assessment includes estimates of future taxable income in ALK and other members of the joint Danish taxation scheme with the Lundbeck Foundation. The forecasts for ALK-Abelló A/S with increased positive results (EBT) is based on growth in revenue and earnings driven by SLIT-tablets.

At 31 December 2021, the value of the total net deferred tax asset is DKK 789 million (2020: DKK 697 million). It includes a net deferred tax asset in Denmark related to tax losses carried forward of DKK 328 million (2020: DKK 322 million).

Complying with tax rules, when conducting business globally, can be complex as the interpretation of legislation and case law may change over time or may not always be clear. Management's judgements are applied to assess the possible effect of exposures and the possible outcome of disputes or interpretational uncertainties when transfer pricing disputes with local tax authorities may occur. Dialogue with local tax authorities, tax advisors, business plans and knowledge of the business are key parameters for Management to estimate the tax assets and liabilities.

At 31 December 2021, the ALK Group recognises uncertain tax positions as part of non-current tax and deferred tax. The actual outcome may deviate and depends on the result of litigation and settlements with the relevant local tax authorities.

3.1 Intangible assets

Amounts in DKKm Goodwill Software Patents,
trademarks
and rights
Other Total
2021
Cost beginning of year 475 396 231 245 1,347
Currency adjustments 4 1 5 1 11
Additions - 8 1 36 45
Disposals - (17) (1) (1) (19)
Transfer to/from other groups - 32 - (32) -
Cost year end 479 420 236 249 1,384
Amortisation and impairment
beginning of year 23 313 214 173 723
Currency adjustments (1) - 4 1 4
Amortisation for the year - 25 7 9 41
Amortisation on disposals - (17) (1) - (18)
Impairment for the year, cf. note 2.3 - 11 1 - 12
Amortisation and impairment
year end 22 332 225 183 762
Carrying amount year end 457 88 11 66 622
Amounts in DKKm Goodwill Software and rights Other Total
2020
Cost beginning of year 483 400 240 251 1,374
Currency adjustments (8) (1) (9) (2) (20)
Additions - 3 - 23 26
Disposals - (7) - (26) (33)
Transfer to/from other groups - 1 - (1) -
Cost year end 475 396 231 245 1,347
Amortisation and impairment
beginning of year 22 299 208 163 692
Currency adjustments 1 (2) (7) (1) (9)
Amortisation for the year - 23 13 11 47
Amortisation on disposals - (7) - (22) (29)
Impairment for the year, cf. note 2.3 - - - 22 22
Amortisation and impairment
year end 23 313 214 173 723
Carrying amount year end 452 83 17 72 624

3.1 Intangible assets – continued

Goodwill

Goodwill is related to acquisition of companies in previous years and has been subject to an impairment test, which has been submitted to the Audit Committee for subsequent approval by the Board of Directors. The impairment test performed in 2021 revealed no need for impairment of goodwill.

Goodwill has been tested at an aggregated level for ALK as one cash-generating unit. In the calculation of the value in use of the cash-generating unit, future free net cash flow is estimated based on Board of Directors-approved budget (2022) and financial forecasts (2023-2025) in line with the ALK Group's strategy.

The budget and the forecast plans are based on specific future business initiatives for which the risks relating to key parameters have been assessed and recognised in estimated future free cash flows. The key parameters in the calculation of the value in use are revenue, earnings, working capital, capital expenditure, discount rate and the preconditions for the terminal value. Estimates are based on historical data and expectations on future changes in the markets and products. These expectations are based on a number of assumptions including expected product launches, volume forecasts, price information and profitability of both the ALK Group's business as well as geographical expansions.

For financial years after the four year budget and forecast period (2022-2025), the cash flows in the most recent period have been extrapolated adjusted for a growth factor of 1.5% (2020: 1.5%) during the terminal period. The discount rate used is 9% pre-tax and 7% after tax (2020: 10% pre-tax and 7.5% after tax).

The calculated value in use shows that future earnings and cash flows fully support the carrying amount of total net assets, including goodwill.

Accounting policies

Goodwill

On initial recognition, goodwill is measured and recognised as the excess of the cost of the acquired company over the fair value of the acquired assets, liabilities and contingent liabilities.

On recognition of goodwill, the goodwill amount is allocated to the ALK Group's cash-generating unit. The ALK Group is considered as one cash-generating unit as the individual companies and business units in the ALK Group cannot be evaluated separately due to the value-adding processes are generated across corporations and entities.

Goodwill is not amortised, but is tested for impairment at least once a year. To the extent that the carrying amount of goodwill exceeds the recoverable amount, goodwill is written down to this lower amount. Impairment of goodwill is not reversed.

Acquired intellectual property rights

Acquired intellectual property rights in the form of patents, brands, licenses, software, customer base and similar rights are measured at cost less accumulated amortisation and impairment.

The cost of software includes costs of instalment and direct salaries.

Intangible assets with determinable useful lives are amortised on a straight-line basis over the expected useful lives of the assets, typically not exceeding 10 years. If the actual useful life is shorter than either the remaining life or the contract period, the asset is amortised over this shorter useful life. The carrying amounts are reviewed at the balance sheet date to determine whether there are any indications of impairment. If such indications are found, the recoverable amount of the asset is calculated to determine any need for an impairment write-down and, if so, the amount of the writedown.

Intangible assets with indeterminable useful lives are not amortised, but are tested for impairment at least once a year. To the extent that the carrying amount of the assets exceeds the recoverable amount, the assets are written down to this lower amount.

See note 3.2 for moreinformation on assessment, recognition and reversal of impairment.

Other intangible assets

Other intangible assets includes individual minor development projects running for short-term periods, including software development projects, which fulfil the requirements in IFRS. The measurement follows the same rules as described above for acquired intellectual property rights.

Significant accounting estimates and judgements

The assessment of whether goodwill is impaired requires a determination of the value in use of the cash-generating unit. The determination of the value in use requires estimates of the expected future cash flow of the cash-generating unit and a reasonable discount rate.

At 31 December 2021, the carrying amount of goodwill is DKK 457 million (2020: DKK 452 million).

3.2 Property, plant and equipment

Amounts in DKKm Land and
buildings*
Plant and
machinery
Other
fixtures and
equipment
Property,
plant and
equipment
in progress
Total
2021
Cost beginning of year 1,493 942 256 360 3,051
Currency adjustments 41 21 2 7 71
Additions 46 18 12 176 252
Disposals (1) (25) (13) (1) (40)
Transfer to/from other groups 44 67 15 (126) -
Cost year end 1,623 1,023 272 416 3,334
Depreciation and impairment
beginning of year 572 500 184 91 1,347
Currency adjustments 9 12 2 - 23
Depreciation for the year 85 77 19 - 181
Depreciation of disposals (1) (24) (13) (1) (39)
Impairment for the year, cf. note 2.3 - 7 - 1 8
Depreciation and impairment
year end 665 572 192 91 1,520
Carrying amount year end 958 451 80 325 1,814
of which financing costs -
Value of land and buildings
subject to mortgages 186

* Land and buildings include buildings on land leased from Scion DTU A/S, Hørsholm in Denmark. The leases are open-ended and the estimated lease terms are 15 years. See also note 3.3.

Other Property,
plant and
Amounts in DKKm Land and
buildings*
Plant and
machinery
fixtures and
equipment
equipment
in progress
Total
2020
Cost beginning of year 1,533 807 244 421 3,005
Currency adjustments (58) (23) (4) (9) (94)
Additions 15 15 9 167 206
Lease contract modifications 1 - - - 1
Disposals (1) (34) (14) (18) (67)
Transfer to/from other groups 3 177 21 (201) -
Cost year end 1,493 942 256 360 3,051
Depreciation and impairment
beginning of year 510 482 183 91 1,266
Currency adjustments (13) (15) (3) - (31)
Depreciation for the year 76 66 18 - 160
Depreciation of disposals (1) (33) (14) (16) (64)
Impairment for the year, cf. note 2.3 - - - 16 16
Depreciation and impairment
year end 572 500 184 91 1,347
Carrying amount year end 921 442 72 269 1,704
of which financing costs -
Value of land and buildings
subject to mortgages 197

* Land and buildings include buildings on land leased from Scion DTU A/S, Hørsholm in Denmark. The leases are open-ended and the estimated lease terms are 15 years. See also note 3.3.

3.2 Property, plant and equipment – continued

Accounting policies

Land and buildings, plant and machinery and other fixtures and equipment are measured at cost less accumulated depreciation and impairment. Land is not depreciated.

Cost comprises the purchase price and any costs directly attributable to the acquisition and any preparation costs incurred until the date when the asset is available for use.

The depreciation base is cost less the estimated residual value at the end of the useful life. The residual value is determined as the amount the company expects to obtain for the asset less costs of disposal.

The cost of an asset is divided into smaller components that are depreciated separately if such components have different useful lives.

Tangible assets are depreciated on a straight-line basis over their estimated useful lives as follows: Buildings 25-50 years Plant and machinery 5-10 years Other fixtures and equipment 5-10 years

Depreciation methods, useful lives and residual values are reassessed once a year.

Impairment

The carrying amounts of tangible assets are reviewed at the balance sheet date to determine whether there are any indications of impairment. If such indications are found, the recoverable amount of the asset is calculated to determine any need for an impairment write-down and, if so, the amount of the write-down.

If the asset does not generate any cash flows independently of other assets, the recoverable amount is calculated for the smallest cash-generating unit that includes the asset.

The recoverable amount is calculated as the higher of the fair value less costs to sell and the value in use of the asset or the cash-generating unit, respectively. In determining the value in use, the estimated future cash flows are discounted to their present value, using a discount rate reflecting current market assessments of the time value of money as well as risks that are specific to the asset or the cashgenerating unit and which have not been taken into account in the estimated future cash flows.

If the recoverable amount of the asset or the cash-generating unit is lower than the carrying amount, the carrying amount is written down to the recoverable amount. For the cash-generating unit, the writedown is allocated in such a way that goodwill amounts are written down first, and any remaining need for write-down is allocated to other assets in the unit, although no individual assets are written down to a value lower than their fair value less costs to sell.

Impairment write-downs are recognised in the income statement. If write-downs are subsequently reversed as a result of changes in the assumptions on which the calculation of the recoverable amount is based, the carrying amount of the asset or the cash-generating unit is increased to the adjusted recoverable amount, not, however, exceeding the carrying amount that the asset or cash-generating unit would have had, had the write-down not been made.

3.3 Leases

Specification of right-of-use assets:

Amounts in DKKm Land and
buildings*
Other
fixtures and
equipment
Total
2021
Cost beginning of year 295 2 297
Currency adjustments 6 - 6
Additions 34 - 34
Cost year end 335 2 337
-
Depreciation beginning of year 69 1 70
Currency adjustments 2 - 2
Depreciation for the year 38 - 38
Depreciation year end 109 1 110
Carrying amount year end 226 1 227

* Land and buildings include buildings on land leased from Scion DTU A/S, Hørsholm in Denmark. The leases are open-ended and the estimated lease terms are 15 years.

Specification of right-of-use assets:

Other
Amounts in DKKm Land and
buildings*
fixtures and
equipment
Total
2020
Cost beginning of year 293 2 295
Currency adjustments (9) - (9)
Additions 10 - 10
Lease contract modifications 1 - 1
Cost year end 295 2 297
Depreciation beginning of year 35 1 36
Currency adjustments (2) - (2)
Depreciation for the year 36 - 36
Depreciation year end 69 1 70
Carrying amount year end 226 1 227

* Land and buildings include buildings on land leased from Scion DTU A/S, Hørsholm in Denmark. The leases are open-ended and the estimated lease terms are 15 years.

3.3 Leases – continued

Leases in the income statement

Amounts in DKKm 2021 2020
Expenses from short-term leases 1 1
Expenses from low-value assets (including cars) 19 19
Depreciation of right-of-use assets 38 36
Interest expenses on lease liabilities 7 8
Total 65 64

Cash outflow related to lease agreements was DKK 41 million (2020: DKK 38 million).

Lease liabilities

Lease assets are recognised at the commencement date of the contract if it is or contains a lease. Lease assets are recognised at cost less accumulated depreciation and impairment. Cost is defined as the lease liability adjusted for any lease payments made at or before the commencement date. Lease assets are depreciated on a straight-line basis over the lease term.

On initial recognition, lease liabilities are measured as the present value of future payments. The lease payments contain fixed payments less any lease incentives receivable and variable lease payments that depend on an index or a rate.

On subsequent recognition, lease liabilities are measured at amortised cost. The difference between the present value and the nominal value of lease payments is recognised in the income statement over the term of the lease as a finance charge.

If the interest rate cannot be determined in the agreement, the lease payments are discounted using the ALK Group's incremental borrowing rate adjusted for the functional currency and length of the lease term. The lease liability is remeasured if or when the future payment or lease term changes.

Short term lease expenses and low value assets are not recognised as part of lease liabilities. They are recognised in the income statement when incurred as an operating expense.

3.4 Inventories

Amounts in DKKm 2021 2020
Raw materials 245 209
Work in progress 432 438
Manufactured goods and goods for resale 527 446
Total 1,204 1,093
Amount of write-down of inventories during the year 40 45
Amount of reversal of write-down of inventories during the year* 15 10
Total cost of materials included in cost of sales 396 357
Net carrying amount of inventory not expected to be sold in following year 209 225
* Reversal of provision for slow moving items, sold in 2021.

Accounting policies

Inventories are measured at cost determined under the FIFO method or net realisable value where this is lower.

Cost comprises raw materials, goods for resale, and direct payroll costs as well as fixed and variable production overheads. Variable production overheads comprise indirect materials and payroll costs and are allocated based on predetermined costs of the goods actually produced. Fixed production overheads comprise maintenance of and depreciation on the machines, factory buildings and equipment used in the manufacturing process as well as the cost of factory management and administration. Fixed production overheads are allocated based on the normal capacity of the production plant.

The net realisable value of inventories is calculated as the expected selling price less completion costs and costs incurred in making the sale.

A minor part of ALK's raw materials inventory contains biological assets from agricultural activities. Due to missing market on which a fair value can be established these products are not valuated.

Significant accounting estimates and judgements

The valuation of inventories includes Management's assessment of the saleability of the finished goods, and the quality of raw materials to be used in the production process. If the expected sales price less any completion costs and costs to execute sales (net realisable value) of inventories is lower than the carrying amount, the inventories are written down to net realisable value. When assessing salability and net realisable value, Management uses estimates for future sales and related costs.

End of 2021, the write-down of inventories to net realisable value amounted to DKK 97 million (2020: DKK 70 million).

Further, work in progress and manufactured goods and goods for resale are measured at cost including indirect production costs. The indirect production costs are measured using a standard cost method. This is reviewed regularly to ensure reliable measurement of employee costs, capacity utilisation, cost drivers and other relevant factors. When including the indirect productions costs for capitalisation, Management makes estimates about cost of production, standard cost variances, cost drivers and capacity utilisation. Changes in these parameters may have a significant impact on the gross margin and the overall valuation of work in progress and manufactured goods and goods for resale.

End of 2021, the indirect production costs capitalised under inventories amounted to DKK 406 million (2020: DKK 377 million).

3.5 Trade receivables

Amounts in DKKm Not due <180 days 180-360 >360 days Total
2021
Average expected credit loss rate 1% 6% 20% 50%
Trade receivables (gross) 519 68 5 2 594
Loss allowance 5 4 1 1 11
Trade receivables (net) 514 64 4 1 583
Loss allowance:
Balance beginning of year
Change in allowances during the year
Realised losses during the year
15
(1)
(3)
Loss allowance, year end 11
2020
Average expected credit loss rate 1% 8% 14% 50%
Trade receivables (gross) 475 71 7 6 559
Loss allowance 5 6 1 3 15
Trade receivables (net) 470 65 6 3 544
Loss allowance:
Balance beginning of year
12
Change in allowances during the year 6
Realised losses during the year (3)

Loss allowance, year end 15

Accounting policies

On initial recognition, receivables are measured at fair value, subsequently at amortised cost.

Expected credit losses are measured based on historical data adjusted by forward-looking information. Forward-looking information includes assessment of the probability of default as well as consideration of various external sources of actual and economic information that is reasonable and supportable without undue cost or effort.

ALK recognises expected credit losses that result from default events possible within the whole asset life. Risk related to trade receivables is managed in ALK locally by entities, based on an individual assessment. Loss allowance for doubtful trade receivables is also based on an individual assessment of the receivables. ALK has not implemented a global provision matrix due to different characteristics related to receivables across the ALK Group. Loss allowance are calculated based on variables, e.g. probability-weighted amount (based on historical realised losses), the time value of money, additional supportable information, including an individual assessment of each customer/customer group.

An impairment gain or loss is recognised in the income statement.

Receivables are written down when information indicates severe financial difficulties and that there is no reasonable expectation of recovery. Financial assets written off may still be subject to enforcement activities. Any recoveries made are recognised in the income statement.

3.6 Prepayments

Amounts in DKKm 2021 2020
Clinical trials, cf. note 2.2
Other
240
74
218
47
Total 314 265

Accounting policies

Prepayments are recognised as an asset and comprise incurred costs relating to subsequent financial years. Prepayments are measured at cost.

3.7 Pensions and similar liabilities

The ALK Group has entered into defined contribution plans as well as defined benefit plans.

In defined contribution plans, the ALK Group is obliged to pay a certain contribution to a pension fund or the like but bears no risks regarding the future development in interest, inflation, mortality, disability rates etc. regarding the amount to be paid to the employee.

The ALK Group sponsors defined benefit plans for qualifying employees of its subsidiaries in Germany, France and Switzerland. The defined benefit plans guarantee employees a certain level of pension benefits for life. The pension is based on seniority and salary at the time of retirement. The ALK Group bears the risks regarding the future development in interest, inflation, mortality, disability rates etc. regarding the amount to be paid to the employee.

Amounts in DKKm 2021 2020
Costs related to defined contribution plans 91 86
Costs related to defined benefit plans 24 24
Total 115 110
Present value of funded pension obligations 25 20
Fair value of plan assets (17) (13)
Funded pension obligations, net 8 7
Present value of unfunded pension obligations 246 268
Pension obligations 254 275
Anniversary liabilities 11 12
Other liabilities* 59 58
Pension obligations and similar liabilities, year end 324 345

* Other liabilities include liability related to the transition period for the Danish Holiday Act of DKK 59 million (2020: DKK 58 million).

Plan assets consist of assets placed in pension companies. Assets are placed in investments classified as other assets than shares, bonds and property by the pension companies, and are not measured at quoted prices.

The weighted average duration of the pension obligations is 19.24 years (2020: 19.64 years).

Amounts in DKKm 2021 2020
The principal assumptions used for the actuarial valuations
Discount rate range of 0.4% - 1.1% (weighted average rate)
Expected future rate of salary increase range of 1% - 2.5%
1.0% 0.7%
(weighted average rate) 2.4% 2.4%
Assumed life expectations on retirement age for current pensioners
(years based on weighted average)*:
Males 21.1 21.1
Females 24.4 24.8
Assumed life expectations on retirement age for current employees
(future pensioners) (years based on weighted average)*:
Males 22.4 22.3
Females 26.3 26.2
Sensitivity analysis:
Significant actuarial assumptions for determining the
defined benefit obligation
Discount rate, effect in case of increase in range of 0.25% - 1%**
(42) (43)
Discount rate, effect in case of decrease in range of 0.25% - 1%** 50 56
Salary, effect in case of 0.25% - 0.5% increase** 4 5
Salary, effect in case of 0.25% - 0.5% decrease** (4) (5)
Life expectancy, effect in case of increase by 1 year* 11 12
Life expectancy, effect in case of decrease by 1 year* (11) (12)
Movements in the present value of the defined benefit obligation
in the current year
Opening defined benefit obligation 20 20
Current service costs 2 2
Actuarial (gains)/losses arising from experience adjustments - (1)
Benefits paid 2 (1)
Currency translation adjustment 1 -
Closing defined benefit obligation 25 20

* Based on national statistics for mortality.

**Based on actuarial reports with different rates.

3.7 Pensions and similar liabilities – continued

Amounts in DKKm 2021 2020
Movements in the fair value of the plan assets in the current year
Opening fair value of plan assets 13 13
Contribution from plan participants 2 1
Benefits paid 2 (1)
Closing fair value of plan assets (fully invested in insurance contracts) 17 13
Movements in present value of unfunded pension obligations
in the current year
Opening present value of unfunded pension obligations 268 257
Other adjustments (12) -
Current service costs 7 8
Interest costs 2 2
Actuarial (gains)/losses from changes in financial assumptions (15) 7
Actuarial (gains)/losses arising from experience adjustments (1) (1)
Actuarial (gains)/losses arising from demographic adjustments
Benefits paid
-
(3)
(2)
(3)
Closing present value of unfunded pension obligations 246 268
Amount recognised as staff expenses in the income statement
Current service costs 10 10
Net interest expense 2 2
Total 12 12
Amount recognised in comprehensive income in respect
of defined benefit plans
Actuarial (gains)/losses (16) 3
Total (16) 3

The expected contribution for 2022 for the defined benefit plans is DKK 12 million (2021: DKK 12 million).

The most recent actuarial valuations of the defined benefit liability were carried out by external independent actuary agents at 31 December 2021.

Accounting policies

The ALK Group has entered into pension agreements and similar agreements with some of the ALK Group's employees.

In respect of defined contribution plans, the ALK Group pays in fixed contributions to independent pension funds etc. The contributions are recognised in the income statement during the period in which the employee renders the related service. Payments due are recognised as a liability in the balance sheet.

In respect of defined benefit plans, the ALK Group is required to pay an agreed benefit in connection with the retirement of the employees covered by the plan, e.g. in the form of a fixed amount or a percentage of the salary at retirement.

For defined benefit plans, an annual actuarial assessment is made of the net present value of future benefits to which the employees have earned the right through their past service for the ALK Group and which will have to be paid under the plan. The Projected Unit Credit Method is applied to determine net present value.

The net present value is calculated based on assumptions of the future development of salary, interest, inflation, mortality and disability rates.

The net present value of pension liabilities is recognised in the balance sheet, after deduction of the fair value of any assets attached to the plan, as either plan assets or pension liabilities, depending on whether the net amount is an asset or a liability, as described below.

If the assumptions made with respect to discount factor, inflation, mortality and disability are changed, or if there is a discrepancy between the expected and realised return on plan assets, actuarial gains or losses occur. These gains and losses concerning previous financial years are recognised in other comprehensive income.

3.8 Provisions

Amounts in DKKm Restructuring
programs*
Other
provisions**
Total
2021
Provisions beginning of year - 3 3
Provisions made during the year 10 - 10
Used during the year - (1) (1)
Provisions, year end 10 2 12
Provisions are recognised as follows:
Current liabilities 10 2 12
Provisions, year end 10 2 12
2020
Provisions beginning of year 19 4 23
Used during the year (19) (1) (20)
Provisions, year end - 3 3
Provisions are recognised as follows:
Current liabilities - 3 3
Provisions, year end - 3 3
* Provision made during 2021 for restructuring programs of DKK 10 million relates to restructuring of ALK's Spanish entity ALK

Abelló S.A. Provision for restructuring programs of DKK 19 million used during 2020 related to restructuring of ALK's Italian entity ALK-Abelló S.p.A (DKK 16 million) and restructuring of production in Denmark (DKK 3 million).

** Other provisions include a provision for sales in Italy of DKK 2 million (2020: DKK 3 million).

Accounting policies

Provisions are recognised when, as a consequence of a past event during the financial year or previous years, the ALK Group has a legal or constructive obligation, and it is likely that settlement of the obligation will require an outflow of the ALK Group's financial resources. Provisions are measured as the best estimate of the costs required to settle the obligations at the balance sheet date. Provisions with an expected term of more than a year after the balance sheet date are measured at present value.

3.9 Other payables

Amounts in DKKm 2021 2020
Rebates and commissions 294 243
Salaries, holiday payments etc. 239 242
Clinical trials, cf. note 2.2 179 135
VAT and other taxes 85 109
Other 153 151
Total 950 880

Accounting policies

Other payables are recognised as a current liability and comprise costs due in the subsequent financial year. Other payables are measured at amortised cost.

3.10 Contingent liabilities and commitments

Contingent liabilities

In the ordinary course of business, the ALK Group is involved in certain claims, disputes etc. In the opinion of Management, settlement or continuation of pending claims and other disputes will have no material impact on the ALK Group's financial position.

The ALK Group operates in a wide variety of jurisdictions, in some of which the tax law is subject to varying interpretations and potentially inconsistent enforcement. As a result, there can be practical uncertainties in applying tax legislation to the ALK Group's activities. Whilst the ALK Group considers that it operates in accordance with applicable tax law, there are potential tax exposures in respect of its operations, the impact of which cannot be reliably estimated, but could be material.

Joint taxation scheme

ALK-Abelló A/S is included in a joint Danish taxation scheme with the Lundbeck Foundation (Lundbeckfond Invest A/S) and its Danish subsidiaries. The Danish companies are joint and several liable for the joint taxation liability. The joint taxation liability covers income taxes and withholding taxes on dividends, royalties and interest. The joint taxation liability is capped at an amount equal to the share of the capital of the company directly or indirectly owned by the ultimate parent company. The total tax obligation under the joint Danish taxation scheme is shown in the financial statements of the Lundbeck Foundation (Lundbeckfond Invest A/S).

Commitments

Land and buildings provided as security vis-à-vis for mortgage debt amount to DKK 186 million (2020: DKK 197 million) out of mortgage debt of DKK 240 million (2020: DKK 258 million).

Change of control

The ALK Group's credit facilities are subject to standard change of control clauses according to which the lender has the right to cancel the commitment and demand repayment of outstandings.

Section 4 – Capital structure and financing

4.1 Share capital and earnings per share

2021
Units Nominal
value
(DKKm)
Units Nominal
value
(DKKm)
Share capital
The share capital consists of:
A shares (nominal value of DKK 10)
920,760 9 920,760 9
AA shares (nominal value of DKK 10) 92,076 1 92,076 1
B shares (nominal value of DKK 10) 10,128,360 101 10,128,360 101
Total 11,141,196 111 11,141,196 111

Each A and AA share carries 10 votes, whereas each B share carries 1 vote. AA shares no longer held by individuals or legal entities other than the Lundbeck Foundation (Lundbeckfond Invest A/S) or companies which are group affiliated with the Lundbeck Foundation, cf. the definition of groups in section 6 of the Danish Companies Act, or in the event that a company which holds AA shares is no longer group affiliated with the Lundbeck Foundation, such AA shares shall be transferred to the B share capital.

According to a resolution passed by the parent company at the annual general meeting, the parent company is allowed to purchase treasury shares, up to 10% of the share capital. The parent company has purchased treasury shares in connection with the issuance of share-based incentive plans. All shares are paid in.

2021 2020
Treasury shares
Treasury shares beginning of year (B-shares), units 212,873 240,694
Sale of treasury shares, units (64,345) (27,821)
Treasury shares year end (B-shares), units 148,528 212,873
Proportion of share capital year end 1.3% 1.9%
Nominal value year end 1.5 2.1
Market value year end 509 532
Earnings per share
The calculation of earnings per share is based on the following:
Net profit (DKKm) 219 25
Number in units:
Average number of issued shares 11,141,196 11,141,196
Average number of treasury shares (171,509) (225,139)
Average number of shares used for calculation of
earnings per share 10,969,687 10,916,057
Average dilutive effect of outstanding share options 79,810 78,328
Average number of shares used for calculation
of diluted earnings per share 11,049,497 10,994,385
Earnings per share (EPS) (DKK) 19.96 2.29
Earnings per share, diluted (DEPS) (DKK) 19.82 2.27

Accounting policies

Acquisition and sales sums arising on the purchase and sale of treasury shares and dividends on treasury shares are recognised directly in retained earnings under equity.

Section 4 – Capital structure and financing

4.2 Financial risks and financial instruments

Financial risk management policy

As a result of operations, investments and financing, the ALK Group is exposed to exchange and interest rate changes. ALK-Abelló A/S manages the ALK Group's financial risks centrally and coordinates the ALK Group's cash management, including the raising of capital and investment of excess cash. The ALK Group complies with a policy, approved by the Board of Directors, to maintain a low risk profile, ensuring that the ALK Group is only exposed to foreign exchange rate risk, liquidity risk, interest rate risk, and credit risk in connection with its commercial activities.

Capital structure

The ALK Group manages its capital to ensure that all entities will be able to continue as going concern while maximising the return to stakeholders through the optimisation of the debt and equity balances. The capital structure of the ALK Group consists of net debt and equity. The dividend policy of the ALK Group is to distribute maximum possible dividend to ALK-Abelló A/S.

The ALK Group's Risk Committee reviews the capital structure annually. As a part of this review, the committee considers the cost of capital and the risks associated with each class of capital.

Foreign exchange rate risk

Foreign exchange rate risk arises due to imbalances between revenue and expenses in each individual currency. Foreign exchange rate exposure relating to future transactions and assets and liabilities is evaluated and hedged through matching of payments received and paid in the same currency. This serves to limit the impact on the financial results of any exchange rate fluctuations. The exchange rate exposure relating to net investments in foreign subsidiaries is not hedged by forward exchange contracts. In case it is evaluated to be relevant, the ALK Group hedges significant exchange rate exposures regarding future sales and purchase of goods in the coming six months in accordance with the ALK Group's policy.

The general objective of the ALK Group's foreign exchange risk management is to limit and delay any adverse impact of exchange rate fluctuations on earnings and cash flows and thus increase the predictability of the financial results. The most significant financial risk relates to exchange rate fluctuations. The greatest exposure is to USD and in 2021, 15% (2020: 15%) of the revenue was denominated in USD. The sales are not deemed to be exposed to EUR due to Denmark's participation in the European Exchange Rate Mechanism.

The ALK Group is exposed to exchange rate risks when intercompany balances and net assets of foreign subsidiaries are translated into DKK. In accordance with the ALK Group's accounting policies, such currency translation adjustments are recognised in the income statement and in other comprehensive income, respectively.

No exchange rate hedge contracts were open at 31 December 2021 or 31 December 2020.

Sensitivity to a 10% increase in USD exchange rate

The table below shows the estimated effect of a 10% increase in the USD exchange rate on revenue, EBITDA and equity levels, respectively. A decrease in the exchange rates will have a corresponding adverse effect. In the sensitivity analysis, data for revenue and EBITDA are based on current short-term expectations and data for equity are based on actual equity at 31 December 2021.

Amounts in DKKm Revenue EBITDA Equity
31
December 2021
USD approx. +65 approx.
0
approx. +110
31
December 2020
USD approx.
+60
approx.
0
approx.
+90

4.2 Financial risks and financial instruments – continued

Net positions

Amounts in DKKm Cash Receivables Liabilities Amount
hedged
Net
position
31
December 2021
DKK (9) 69 (957) - (897)
USD 67 123 (176) - 14
EUR 75 342 (1,093) - (676)
GBP 4 12 (21) - (5)
SEK 3 39 (19) - 23
Other 54 135 (84) - 105
Total 194 720 (2,350) - (1,436)
31
December 2020
DKK 18 124 (936) - (794)
USD 65 88 (144) - 9
EUR 150 345 (1,243) - (748)
GBP 5 20 (16) - 9
SEK 7 28 (14) - 21
Other 53 109 (57) - 105
Total 298 714 (2,410) - (1,398)

Liquidity risk

In connection with the ALK Group's ongoing financing of operations, including refinancing, efforts are made to ensure adequate and flexible liquidity. This is guaranteed by placing free funds in creditworthy, liquid, interest bearing instruments of relatively short durations in accordance with the ALK Group's policy.

The liquidity risk is considered to be minimal due to the ALK Group's current capital structure.

Liquidity exposure

Revaluation/payment date
Amounts in DKKm Carrying
amount
Total
cash flow*
Within
1 year
From
1-5 years
After
5 years
31
December 2021
Mortgage debt and bank loans 466 472 245 76 151
Trade payables 115 115 115 - -
Lease liabilities 244 269 43 134 92
Other financial liabilities 973 973 973 - -
Financial liabilities 1,798 1,829 1,376 210 243
31
December 2020
Mortgage debt and bank loans 704 746 29 535 182
Trade payables 74 74 74 - -
Lease liabilities 239 270 38 126 106
Other financial liabilities 901 901 901 - -
Financial liabilities 1,918 1,991 1,042 661 288

* Total cash flow includes interests.

Section 4 – Capital structure and financing

4.2 Financial risks and financial instruments – continued

Interest rate risk

The ALK Group does not hedge its interest rate exposure, as this is not considered to be financially viable.

Concerning the ALK Group's financial assets and financial liabilities, the earlier of the contractual revaluation and redemption date is applied. Effective interest rates are stated on the basis of the current level of interest rates on the balance sheet date.

Interest rate exposure

Amounts in DKKm Carrying
amount
Currency Expiry date Fixed/ Effective
floatinginterest rate
31
December 2021
Cash 194 Various Floating (1.09)-(0.10)
Interestbearing assets 194
Mortgage debt
Lease liabilities
Bank loans
240
244
226
DKK
Various
EUR
2035
2022-2033
2022
Floating
Fixed
Fixed
0.2
2.0
0.4-0.5
Interestbearing liabilities 710

31 December 2020

Cash 298 Various Floating (1.40)-(0.05)
Interestbearing assets 298
Mortgage debt 258 DKK 2035 Floating 0.2
Lease liabilities 239 Various 2021-2033 Fixed 2.0
Bank loans 446 EUR 2022 Fixed 1.8
Interestbearing liabilities 943

An increase in the interest rate of 1 percentage point on mortgage debt and bank loans would decrease net profit and equity by approximately DKK 4 million (2020: decrease of DKK 5 million). An increase in the interest of 1 percentage point on cash would increase net profit and equity by approximately DKK 2 million (2020: increase of DKK 3 million).

Credit risk

The ALK Group's primary credit exposure is related to trade receivables and cash. The ALK Group has no major exposure relating to one single customer or business partner. According to the ALK Group's policy for assuming credit exposure, all customers and business partners are credit rated regularly. Trade receivables are monitored at the local level and are distributed across a number of markets and customers. Therefore, the credit risk is considered to be low. For more information, see note 3.5.

Embedded derivative financial instruments

The ALK Group has made a systematic review of contracts that might contain terms that would make the contract or parts thereof a derivative financial instrument. The review did not lead to recognition of derivative financial instruments relating to the contracts.

4.2 Financial risks and financial instruments – continued

Categories of financial instruments

Amounts in DKKm 2021 2020
Financial assets
Financial assets measured
at amortised cost Impairment method
Receivables from group companies 12m ECL 12 20
Receivables 12m ECL 29 30
Trade receivables Lifetime ECL (simplified approach) 583 544
Other receivables 12m ECL 82 96
Cash 194 298
Total 900 988
Financial liabilities
Financial liabilities measured at amortised cost
Mortgage debt 240 258
Bank loans 226 446
Lease liabilities 244 239
Trade payables 115 74
Other payables 950 880
Total 1,775 1,897

Measurement and fair value hierarchy

Revaluation/payment date
Fair Within From After
Amounts in DKKm value 1 year 1-5 years 5 years
31
December 2021
Mortgage debt 243 18 73 152
Bank loans 226 226 - -
Total 469 244 73 152
31
December 2020
Mortgage debt 263 18 73 172
Bank loans 446 - 446 -
Total 709 18 519 172

All financial assets and liabilities are measured at cost or amortised cost. The carrying amounts for these approximate fair value.

Fair value for mortgage debt is measured by level 1 input (quoted prices in active markets) from the fair value hierarchy and fair value for bank loans is measured by level 2 input (inputs other than quoted markets that are observable) from the fair value hierarchy.

No financial derivatives were used in 2021 or 2020.

Financial resources

In 2021, the ALK Group extended its financial resources with a DKK 1,500 million credit facility which runs until the end of 2024. By the end of 2021, DKK 223 million was drawn.

Section 4 – Capital structure and financing

4.2 Financial risks and financial instruments – continued

Financial assets

On initial recognition, investments and other financial assets are measured at cost, corresponding to fair value. They are subsequently measured at fair value either through the income statement or through comprehensive income.

Financial liabilities

Other financial liabilities, including bank loans and trade and other payables, are on initial recognition measured at fair value. The liabilities are subsequently measured at amortised cost.

Debt

Trade payables, other payables, including sales discounts and rebates as well as debt to public authorities etc., are measured at amortised cost.

Mortgage debt

Mortgage debt is recognised on the raising of a loan at cost, equalling fair value of the proceeds received, and net of transaction costs incurred. Subsequently, mortgage debt is measured at amortised cost.

5.1 Share-based payments

The ALK Group has established long-term equity-based incentive plans linked to the creation of shareholder value and the fulfilment of strategic goals. The plans are established for the members of Board of Management and other key employees, reward long-term value creation and align to interests of the shareholders.

The incentive plans consist of share options and performance share units that are considered sufficiently covered by treasury shares.

Ordinary incentive plans

The share options entitle the holder to acquire one existing B share of DKK 10 nominal value in the company per share option and the performance share units entitle the holder to receive one existing B share per performance share unit free of charge.

The vesting period for both share options and performance share units is three years after grant. Vesting is conditional upon certain targets being met and upon the participant not having resigned. Target achievement is met upon fulfilment of strategic key performance indicators. In case performance is below the threshold there will be no units vesting, and if above target, a multiplier is applied that can increase the vesting by up to 100%.

The exercise of share options is possible in the trading windows following the release of annual and interim reports conditional upon the share option holder not having resigned at the time of exercise. For performance share units, the final transfer of ownership takes place at vesting three years after the grant.

Special incentive plan 2018

ALK's special incentive plan was a one-time scheme designed to implement ALK's growth strategy and consisted of both share options and performance share units with a vesting period of three years.

The special incentive plan was adopted at the annual general meeting in March 2018 and vested in March 2021. The grant value of the plan did not exceed 50% of the Executive's 2018 annual base salary on the grant date. The plan was conditional upon strategic key performance indicators being attained. Based on the financial results for 2020, the KPI achievements exceeded their targets increasing the granted number of performance shares and share options by 100%. However, the overall payout of the plan on the vesting date for the performance shares and on the exercise date for the share options can never exceed a total value of 300% of the recipient's 2018 annual base salary.

Expensed in the income statement:

Amounts in DKKm 2021 2020
Cost for the year regarding share-based payments is recognised as follows:
Cost of sales 5 3
Research and development expenses 7 6
Sales and marketing expenses 11 9
Administrative expenses 12 10
Financial expenses 1 1
Total 36 29

In 2021, the total cost of share-based payments included a financial expense of DKK 1 million due to the exercise and cash settlement of share options (2020: DKK 1 million). The total cost included DKK 11 million related to adjustment in the share options and performance share units expected to vest (2020: DKK 5 million).

5.1 Share-based payments – continued

Specification of outstanding share options and performance share units:

Share options Performance share units
Board of
Management
units
Other key
employees
units
Total
units
Weighted average
exercise price
DKK
Board of
Management
units
Other key
employees
units
Total
units
2021
Outstanding at 1 January
Additions
Exercised/settled
Expired
89,758
29,811
(55,279)
0
59,338
25,494
(46,323)
(100)
149,096
55,305
(101,602)
(100)
972
1,129
844
795
13,444
6,250
(13,183)
0
35,426
10,799
(20,316)
0
48,870
17,049
(33,499)
0
Outstanding at 31 December 64,290 38,409 102,699 1,187 6,511 25,909 32,420
Total number of vested share options
Average remaining life at year end (years)
Exercise prices at year end (DKK)
49,247
2.1
802-2,320
2020
Outstanding at 1 January
Additions
Exercised/settled
Cancellations
98,263
13,253
(21,758)
-
62,293
12,130
(15,085)
-
160,556
25,383
(36,843)
-
904
1,332
954
-
13,569
3,024
(3,149)
-
36,257
12,528
(12,774)
(585)
49,826
15,552
(15,923)
(585)
Outstanding at 31 December 89,758 59,338 149,096 972 13,444 35,426 48,870
Total number of vested share options
Average remaining life at year end (years)
Exercise prices at year end (DKK)
32,467
2.6
783-1,372

The Board of Directors decided for one trading window in 2021 to settle share options by cash and a total of 66,986 share options were exercised and total cash payments amounted to DKK 62 million. For three trading windows the Board of Directors decided to settle share options by shares and a total of 34,616 share options were exercised.

The Board of Directors decided for two trading windows in 2020 to settle share options by cash and a total of 24,945 share options were exercised and total cash payments amounted to DKK 24 million. For two trading windows the Board of Directors decided to settle share options by shares and a total of 11,898 share options were exercised.

5.1 Share-based payments – continued

Outstanding share options and performance share units have the following characteristics:

Share options Performance share units
Plan Units Average
exercise
price
DKK
Vested
as per
Exercise
period
(years)
Units Vested
as per
2016 Plan 3,660 1,113 1 Mar 2019 4
2018 Plan 5,789 802 1 Mar 2021 2
2018 Plan – special plan* 39,798 802 1 Mar 2021 2
2019 Plan 23,738 1,141 1 Mar 2022 2 13,241 1 Mar 2022
2020 Plan 18,677 1,460 1 Mar 2023 2 11,314 1 Mar 2023
2021 Plan 11,037 2,439 1 Mar 2024 2 7,865 1 Mar 2024
Outstanding at
31 December 102,699 32,420

* The payout upon exercise of the outstanding options cannot exceed DKK 18 million according to the conditions of the plan.

Fair value of share options and performance share units granted:

Share options

Fair value at grant date is measured in accordance with the Black & Scholes model for valuation of share options, using the following assumptions:

2021
Plan
2020
Plan
Average share price (DKK) 2,320 1,372
Expected exercise price (DKK) 2,498 1,477
Expected volatility rate, based on the historical volatility 36% p.a. 34% p.a.
Expected option life 4 years 4 years
Expected dividend per share - -
Risk-free interest rate -0.49% p.a. -0.01% p.a.
Calculated fair value of granted share options (DKK) 576 328

Performance share units

Performance share units have been granted at DKK 2,320 per share (2020: DKK 1,372 per share).

Accounting policies

Share-based incentive plans (equity-settled share-based payments), which comprise share options and performance share units, are measured at the grant date at fair value and recognised in the income statement under the respective functions over the vesting period and offset in equity.

The fair value of share options is determined using the Black & Scholes model. The exercise price is equivalent to the average market price of the share for the five trading days immediately preceeding the date of grant and is increased by 2.5% p.a. and reduced by dividends paid. The fair value of performance share units is determined using the average share price (closing) five days after annual general meeting.

The ALK Group settles the equity-settled share-based incentive plans in shares. However, the share option agreement entitles the ALK Group to demand cash settlement of the options. The ALK Group recognises share options, in case of cash settlement, as other liabilities and adjusts to fair value as from the time when the ALK Group has an obligation to settle in cash. The ALK Group recognises subsequent adjustment to fair value in the income statement under financial income or financial expenses.

5.2 Cash flow

Adjustment for non-cash items

Amounts in DKKm 2021 2020
Tax on profit 60 76
Financial income and expenses 13 49
Share-based payments 36 29
Depreciation, amortisation and impairment 242 245
Other adjustments* 49 63
Total 400 462

* Other adjustments include non-cash transactions related to the divestment of ALK's part-share of a formulation production line for tablets to production partner Catalent of DKK 33 million (2020: DKK 37 million). In 2020, other adjustments further included provision for transition period for the Danish Holiday Act of DKK 39 million.

Changes in working capital

Amounts in DKKm 2021 2020
Change in inventories (84) (69)
Change in receivables and prepayments (5) (159)
Change in short-term payables 61 74
Total (28) (154)

Reconciliation of liabilities arising from financing activities

Amounts in DKKm 2021 2020
Liabilities from financing activities at 1 January 943 990
Proceeds from borrowings 226 -
Repayment of borrowings (464) (19)
New leases 34 11
Installments of lease liabilities (32) (30)
Exchange rate adjustments 3 (9)
Total 710 943
Financial reserves
Amounts in DKKm 2021 2020
Cash 194 298
Undrawn facilities 1,277 600
Total 1,471 898

In 2021 the ALK Group extended its financial resources with a DKK 1,500 million credit facility which runs until the end of 2024. By the end of 2021, DKK 223 million was drawn.

Accounting policies

Cash flow

The cash flow statement of the ALK Group is presented using the indirect method and shows cash flows from operating, investing and financing activities as well as cash at the beginning and at the end of the financial year.

The cash effect of acquisitions and divestments is shown separately under cash flows from investing activities. In the cash flow statement, cash flows concerning acquired companies are recognised from the date of acquisition, while cash flows concerning divested companies are recognised until the date of divestment.

Cash flows from operating activities are stated as net profit, adjusted for non-cash operating items and changes in working capital, less the income tax paid and plus net financial items.

Cash flows from investing activities comprise payments in connection with acquisition and divestment of companies and financial assets as well as purchase, development, improvement and sale of intangible and tangible assets.

Cash flows from financing activities comprise changes to the parent company's share capital and related costs as well as the raising and repayment of loans, instalments on interest-bearing debt, lease liabilities, purchase of treasury shares, and settlement of share options and payment of dividends.

5.2 Cash flow – continued

Cash flows in currencies other than the functional currency are recognised in the cash flow statement using average exchange rates for the individual months if these are a reasonable approximation of the actual exchange rates at the transaction dates. If this is not the case, the actual exchange rates for the specific days in questions are used.

Cash comprise cash subject to an insignificant risk of changes in value less any overdraft facilities that are an integral part of the ALK Group's cash management.

5.3 Related parties

Related party exercising control

ALK-Abelló A/S is controlled by the Lundbeck Foundation (Lundbeckfond Invest A/S) domiciled in Copenhagen, Denmark, which holds 67.2% of the total number of votes in ALK Abelló A/S. The remaining shares are widely held. ALK-Abelló A/S is parent company, and ultimate parent for the ALK Group is the Lundbeck Foundation (Lundbeckfond Invest A/S, incorporated in Denmark).

Other related parties comprise ALK's Board of Management and Board of Directors, companies in which the majority shareholder exercises control, and such companies' subsidiaries, in this case H. Lundbeck A/S and Falck A/S and their subsidiaries.

Transactions and balances

Transactions and balances with the parent company's majority shareholder:

  • ALK-Abelló A/S received DKK 26 million (2020: DKK 121 million) concerning outstanding company tax from the Lundbeck Foundation (Lundbeckfond Invest A/S). The company tax relates to ALK-Abelló A/S, ALK-Abelló Nordic A/S, and ALK e-com A/S.
  • Receivables from group companies to ALK-Abelló A/S relate to outstanding company tax of DKK 12 million (2020: DKK 20 million) covering ALK-Abelló A/S, ALK-Abelló Nordic A/S, and ALK e-com A/S.

Transactions with key management personnel consist of remuneration and exercise of share options, see notes 2.4 and 5.1 of the consolidated financial statements.

No other transactions have taken place during the year with Board of Directors, Board of Management, major shareholders or other related parties.

5.4 Events after the reporting period

No events have occured after the reporting period, that influence the evaluation of the consolidated financial statements.

5.5 Approval of financial statements

The financial statements were approved by the Board of Directors and authorised for issue on 8 February 2022.

5.6 List of companies in the ALK Group

Activity

Production

Sales & Distribution

Research & Development

Services

Entity Country Percentage of
shares owned
Activity
Parent company
ALK-Abelló A/S Denmark
Subsidiaries by geographical area
Europe
ALK-Abelló Allergie-Service GmbH Austria 100%
ALK-Abelló Nordic A/S Denmark 100%
ALK-Abelló Nordic A/S (branch) Finland 100%
ALK-Abelló Nordic A/S (branch) Norway 100%
ALK-Abelló Nordic A/S (branch) Sweden 100%
ALK e-com A/S Denmark 100%
ALK S.A.S. France 100%
ALK-Abelló Arzneimittel GmbH Germany 100%
ALK-Abelló B.V.* Netherlands 100%
ALK-Abelló Sp. z o.o. Poland 100%
ALK Slovakia s.r.o. Slovakia 100%
ALK Slovakia s.r.o. – od šteˇpny´ zavod (branch) Czech Republic 100%
ALK-Abelló S.A. Spain 100%
ALK-Abelló S.p.A. Italy 100%
ALK AG (In liquidation) Switzerland 100%
ALK-Abelló AG Switzerland 100%
ALK-Abelló Ltd. United Kingdom 100%

* Exemption for local audit of the 2021 accounts under the ruling of the Article 2:403 of the Dutch Civil Code is intended – Btw-nr. NL005302766B01

Percentage of
Country shares owned Activity
Canada 100%
USA 100%
USA 100%
100%
USA
USA
China
ALK (Shanghai) Medical Technology Company Limited (Dormant)
China
Turkey
100%
100%
100%
100%

Definitions

Term Definitions
Gross margin – % Gross profit x 100 / Revenue
EBITDA margin – % EBITDA x 100 / Revenue
Net asset value per share Net asset value / Number of shares end of period
Invested capital Intangible assets, tangible assets, inventories and current receivables
reduced by liabilities except for mortgage debt and bank loans
Return on equity (ROE) – % Net profit/(loss) for the period x 100 / Average equity
Pay-out ratio – % Proposed dividend x 100 / Net profit/(loss) for the year
Earnings/(loss) per share
(EPS)
Net profit/(loss) for the period / Average number of
outstanding shares
Earnings/(loss) per share
diluted
(DEPS)
Net profit/(loss) for the period / Average number of
outstanding shares diluted
Cash flow per share (CFPS) Cash flow from operating activities / Average number of outstanding
shares
ROIC incl. goodwill – % Operating profit x 100 / Average invested capital incl. goodwill
Price earnings ratio (PE) Share price / Earnings per share
Markets Geographical markets (based on customer location):

Europe comprises the EU, UK, Norway and Switzerland

North America comprises the USA and Canada
• International markets comprise Japan, China and all other countries

The definitions are aligned with generally accepted financial ratios applied by financial analysts. The definitions are part of the Management's review.

Alternative Performance Measures

Amounts in DKKm 2021 2020
EBITDA reconciliation to net profit
Net profit 219 25
Tax on profit/(loss) 60 76
Financial income (10) (5)
Financial expenses 23 54
Depreciation, amortisation and impairment 242 245
EBITDA 534 395
Net asset value
Equity 3,480 3,153
Net asset value 3,480 3,153
Invested capital reconciliation
Intangible assets 622 624
Tangible assets 1,814 1,704
Inventories 1,204 1,093
Trade receivables 583 544
Receivables from group companies 12 20
Income tax receivables 14 24
Other receivables 82 96
Prepayments 314 265
Pensions and similar liabilities (324) (345)
Lease liabilities (non-current) (207) (207)
Deferred income (non-current) (42) -
Trade payables (115) (74)
Lease liabilities (current) (37) (32)
Deferred income (current) (4) (1)
Provisions (current) (12) (3)
Income tax payables (current) (23) (21)
Other payables (950) (880)
Invested capital 2,931 2,807

Parent company financial statements

Financial statements

Income statement 92 Balance sheet 93 Statement of changes in equity 94 Notes 95

Notes

1 Accounting policies 95
2 Revenue and segment
information 96
3 Staff costs 96
4 Special items 97
5 Financial income and expenses 97
6 Income taxes 97
7 Intangible assets 98
8 Property, plant and equipment 98
9 Deferred tax 99
10 Investments in subsidiaries 100
11 Inventories 100
12 Mortgage debt and bank loans 100
13 Pensions and similar liabilities 101
14 Lease liabilities 101
15 Income tax payables to
group companies 101
16 Contingent liabilities and
commitments 101
17 Related parties 101
18 Fees to ALK-Abelló A/S' auditors 102
19 Proposed appropriation of
net profit 102
20 Events after the reporting period 102

Income statement

Amounts in DKKm Note 2021 2020
Revenue 2 2,296 2,015
Cost of sales 3,4 1,029 1,011
Gross profit 1,267 1,004
Research and development expenses 3,4 577 508
Sales and marketing expenses 3,4 248 195
Administrative expenses 3,18 113 101
Other operating items, net - (2)
Operating profit (EBIT) 329 198
Income from investments in subsidiaries 10 15 831
Financial income 5 22 14
Financial expenses 5 23 49
Profit before tax (EBT) 343 994
Tax on profit/(loss) 6 30 105
Net profit 19 313 889

Balance sheet – Assets

Amounts in DKKm Note 31 Dec.
2021
31 Dec.
2020
Non-current assets
Intangible assets
Intangible assets 7 127 119
127 119
Tangible assets
Land and buildings 8 312 324
Plant and machinery 8 244 263
Other fixtures and equipment 8 47 35
Property, plant and equipment in progress 8 194 151
797 773
Other non-current assets
Investments in subsidiaries 10 1,058 1,062
Receivables from group companies
Receivables
1,987
23
998
27
Deferred tax assets 9 298 326
Income tax receivables 122 109
3,488 2,522
Total non-current assets 4,412 3,414
Current assets
Inventories 11 420 361
Trade receivables 53 80
Receivables from group companies 338 770
Other receivables 56 71
Prepayments 271 233
1,138 1,515
Cash 42 162
Total current assets 1,180 1,677
Total assets 5,592 5,091

Balance sheet – Equity and liabilities

Amounts in DKKm Note 31 Dec.
2021
31 Dec.
2020
Equity
Share capital 111 111
Retained earnings 3,090 2,771
Capitalised development costs 3 4
Total equity 3,204 2,886
Liabilities
Mortgage debt 12 222 240
Bank loans 12 - 446
Pensions and similar liabilities 13 58 57
Lease liabilities 14 120 121
Deferred income 42 -
Income tax payables to group companies 15 115 111
Non-current liabilities 557 975
Mortgage debt 12 18 18
Bank loans 12 223 -
Trade payables 57 31
Payables to group companies 1,154 841
Lease liabilities 14 10 8
Deferred income 2 -
Other payables 367 332
Current liabilities 1,831 1,230
Total liabilities 2,388 2,205
Total equity and liabilities 5,592 5,091

Statement of changes in equity

Share Retained Reserve for
capitalised
development
Proposed Total
Amounts in DKKm capital earnings costs dividend equity
2021
Equity at 1 January 111 2,771 4 - 2,886
Appropriated from net profit - 313 - - 313
Share-based payments - 36 - - 36
Share options settled - (72) - - (72)
Sale of treasury shares - 31 - - 31
Transfer to/(from) legal reserves - 1 (1) - -
Tax related to items recognised directly in equity - 10 - - 10
Other transactions - 319 (1) - 318
Equity at 31 December 111 3,090 3 - 3,204

See note 4.1 in the consolidated financial statements for information on treasury shares.

1 Accounting policies

General

The financial statements of the parent company ALK-Abelló A/S for the period 1 January to 31 December 2021 have been prepared in accordance with the Danish Financial Statements Act for large reporting class D enterprises.

The financial statements are presented in Danish kroner (DKK), which is also the functional currency of the company.

The accounting policies are unchanged from last year.

The parent company's accounting policies for recognition and measurement are in accordance with the ALK Group's accounting policies with the following exceptions:

Income statement

Results of investments in subsidiaries

Dividends from investments in subsidiaries are recognised in the parent company's financial statements when the right to the dividend finally vests, typically at the date of the

company's approval in general meeting of the dividend of the company in question less any write-downs at the investments.

Balance sheet

Acquisition of activities from subsidiaries

Acquisition of activities from subsidiaries is accounted for using the purchase method. On initial recognition, goodwill is measured and recognised as the excess of the consideration transferred exceeding the fair value of the net assets acquired at the acquisition date.

Goodwill

Goodwill is measured at cost less accumulated amortisation and impairment. Amortisation is calculated using the straight-line method over the expected useful life, estimated at 10 years. This estimate was made on the basis of estimated useful lives of the assets acquired.

Investments in subsidiaries

Investments in subsidiaries are measured at cost.

Where the recoverable amount of the investments is lower than cost, the investments are written down to this lower value.

In addition, cost is written down to the extent that dividends distributed exceed the accumulated earnings in the company since the acquisition date. In the event of indications of impairment, an impairment test is performed of investments in subsidiaries.

Capitalisation of development costs

A reserve for capitalisation of development costs less deferred tax is recognised in the statement of equity. The reserve contains development costs, less amortisation/impairment losses, and less deferred tax, capitalised since 1 January 2016.

Other accounting information

Cash flow statement

As allowed under section 86 (4) of the Danish Financial Statements Act, no cash flow statement is presented, as this is included in the consolidated cash flow statement.

2 Revenue and segment information

Amounts in DKKm 2021 2020
Sale of goods 2,215 1,953
Royalties 81 58
Services - 4
Total revenue 2,296 2,015
Europe 1,969 1,735
International markets 327 280
Total revenue 2,296 2,015

3 Staff costs

Amounts in DKKm 2021 2020
Wages and salaries 654 609
Pensions 59 57
Other social security costs, etc. 12 22
Share-based payments 24 20
Total 749 708
Staff costs are allocated as follows:
Cost of sales 295 300
Research and development expenses 219 198
Sales and marketing expenses 94 77
Administrative expenses 96 89
Included in the cost of assets 45 44
Total 749 708
Remuneration to Board of Management and Board of Directors:
See note 2.4 and 5.1 in the consolidated financial statements
Employees
Average number (FTE) 913 855
Number year end (FTE) 954 873

4 Special items

Special items include impairment of assets of DKK 9 million (2020: DKK 24 million) of which DKK 2 million is related to intangible assets (2020: DKK 22 million) and DKK 7 million is related to tangible assets (2020: DKK 2 million). Further, special items include impairment of investments in subsidiaries of DKK 4 million (2020: DKK 0).

The impairment of intangible assets of DKK 2 million is related to impairment of software. In the income statement, the impairment of intangible assets is recognised as sales and marketing expenses. The impairment of tangible assets of DKK 7 million is related to impairment of plant and machinery. In the income statement, the impairment of tangible assets is recognised with DKK 6 million as cost of sales and DKK 1 million as research and development expenses. The impairment of investments in subsidiaries includes DKK 4 million impairment of ALK Abelló A/S' investment in its subsidiary in Turkey.

In 2020, the impairment of intangible assets included DKK 13 million relating to impairment of acquired intellectual property rights and DKK 9 million relating to impairment of software projects in progress. In the income statement, the impairment of intangible assets was recognised with DKK 19 million in research and development expenses and DKK 3 million as cost of sales. The impairment of tangible assets included DKK 2 million related to impairment of production equipment in progress. In the income statement, the impairment of tangible assets was recognised as cost of sales.

For the assets where ALK estimates that there is a recoverable amount, such amount was determined based on the fair value less cost to sell or the value in use of the respective asset.

5 Financial income and expenses

Amounts in DKKm 2021 2020
Interest on receivables from group companies 12 10
Other interest income 4 4
Currency gain, net 6 -
Total financial income 22 14
Other interest expenses*
Currency loss, net
23
-
29
20
Total financial expenses 23 49

* In 2021, other interest expenses include net interest related to uncertain tax positions of DKK 3 million (2020: income of DKK 7 million) and DKK 3 million related to lease interest expenses (2020: expense of DKK 3 million).

6 Income taxes

Amounts in DKKm 2021 2020
Current income tax (11) 28
Adjustment of deferred tax 41 79
Prior year adjustments, income tax 3 (2)
Prior year adjustments, deferred tax (3) -
Total 30 105
Profit before tax 343 994
Income tax, tax rate of 22% 75 219
Non-taxable income (22) (199)
Non-deductible expenses 9 9
Prior year adjustments, income tax 3 (2)
Prior year adjustments, deferred tax (3) -
Other taxes and adjustments (32) 78
Tax on profit for the year 30 105

7 Intangible assets

Amounts in DKKm Goodwill trademarks
and rights
Patents, Develop
ment
cost*
Software Assets in
progress
2021 2020
Cost beginning
of year 867 69 14 280 40 1,270 1,267
Additions - - 9 7 27 43 25
Disposals - - - (2) (9) (11) (22)
Transfer to/from
other groups - - - 23 (23) - -
Cost year end 867 69 23 308 35 1,302 1,270
Amortisation and
impairment
beginning of year
Amortisation
867 67 7 210 - 1,151 1,130
for the year
Amortisation
- 1 2 21 - 24 21
on disposals
Impairment for
- - - (2) - (2) (22)
the year - - - 2 - 2 22
Amortisation
and impairment
year end 867 68 9 231 - 1,175 1,151
Carrying amount
year end
- 1 14 77 35 127 119

* The capitalised development cost relates to development of medical device products where the individual minor development projects are running for short-term periods and are subject to limited risk. The development projects are generating economic benefits in the form of sale of goods. At 31 December 2021, the capitalised development cost relates to the historical development of the adrenaline auto-injector Jext® for the European market. Additions of DKK 9 million relate to development projects in progress.

8 Property, plant and equipment

Property,
Land and Plant and Other
fixtures and
plant and
equipment
Amounts in DKKm buildings machinery equipment in progress 2021 2020
Cost beginning of year 611 526 42 236 1,415 1,326
Additions 11 12 9 71 103 122
Disposals (1) (18) - - (19) (33)
Transfer to/from
other groups
1 16 11 (28) - -
Cost year end 622 536 62 279 1,499 1,415
Depreciation and
impairment beginning
of year 287 263 7 85 642 614
Depreciation for the year 24 40 8 - 72 57
Depreciation of disposals (1) (18) - - (19) (31)
Impairment for the year - 7 - - 7 2
Depreciation and
impairment year end 310 292 15 85 702 642
Carrying amount
year end 312 244 47 194 797 773
of which assets held
under leases* 125 - - - 125 127
Value of land and buildings subject to mortgages 186 197

* Land and buildings in Denmark include buildings on land leased from Scion DTU A/S, Hørsholm. The leases are open-ended and the estimated lease terms are 15 years.

9 Deferred tax

Amounts in DKKm Intangible
assets
Tangible
assets
Current and
other assets
Liabilities Tax losses
carried forward
Total
2021
Carrying amount beginning of year (3) (65) 60 30 304 326
Adjustment to prior years 3 - - - - 3
Recognised in the income statement, net (17) 1 (13) 10 (22) (41)
Recognised in equity, net (share-based payments) - - (23) - 33 10
Carrying amount year end (17) (64) 24 40 315 298
2020
Carrying amount beginning of year 16 (59) 17 31 351 356
Adjustment of receivables from group companies - - - - 6 6
Recognised in the income statement, net (19) (6) 8 (1) (61) (79)
Recognised in equity, net (share-based payments) - - 35 - 8 43
Carrying amount year end (3) (65) 60 30 304 326

ALK-Abelló A/S is included in a joint Danish taxation scheme with the Lundbeck Foundation (Lundbeckfond Invest A/S) and its Danish subsidiaries.

ALK-Abelló A/S recognises deferred tax assets including the tax value of tax losses if it is probable that it can be utilised against future taxable income within a foreseeable future. This includes an assessment of the possibilities to utilise tax losses in the joint Danish taxation scheme with the Lundbeck Foundation (Lundbeckfond Invest A/S).

10 Investments in subsidiaries

Amounts in DKKm 2021 2020
Cost beginning of year
Capital contribution in subsidiaries during the year
1,470
-
1,466
4
Cost year end 1,470 1,470
Write-down beginning of year 408 408
Write-down during the year, cf. note 4 4 -
Write-down year end 412 408
Carrying amount year end 1,058 1,062

In the income statement, income from investments in subsidiaries amounting to DKK 15 million (2020: DKK 831 million) is net amount of DKK 19 million dividends received (2020: DKK 831 million) and DKK 4 million write-down of investments in subsidiaries (2020: DKK 0).

For an overview of all subsidiaries see note 5.6 in the consolidated financial statements.

11 Inventories

Amounts in DKKm 2021 2020
Raw materials 102 75
Work in progress 284 255
Manufactured goods and goods for resale 34 31
Total 420 361
Amount of write-down of inventories during the year 13 4
Amount of reversal of write-down of inventories during the year 8 2

12 Mortgage debt and bank loans

Amounts in DKKm 2021 2020
Debt to mortgage credit institutions secured by real property
Mortgage debt is due as follows:
Within 1 year 18 18
From 1-5 years 73 72
After 5 years 149 168
Total 240 258
Bank loans
Bank loans are due as follows:
Within 1 year 223 -
From 1-5 years - 446
After 5 years - -
Total 223 446

13 Pensions and similar liabilities

Amounts in DKKm 2021 2020
Pensions and similar liabilities expire as follows:*
Within 1 year
- 1
From 1-5 years
After 5 years
3
55
2
55
Total 58 58

* Pensions and similiar liabilities relate to the provision for transition period for the Danish Holiday Act.

14 Lease liabilities

Amounts in DKKm 2021 2020
Lease liabilities expire as follows:
Within 1 year 10 8
From 1-5 years 41 35
After 5 years 79 86
Total 130 129

15 Income tax payables to group companies

Non-current income tax payables to group companies of DKK 115 million (2020: DKK 111 million) is expected to expire between 1 to 5 years.

16 Contingent liabilities and commitments

In December 2021, ALK-Abelló A/S issued a hold-harmless letter to ALK -Abelló Arzneimittel GmbH regarding costs under the ongoing tax audits in Germany (unlimited guarantee). The hold-harmless letter replaces the letter issued in December 2020.

In January 2022, ALK-Abelló A/S issued a letter of financial support to ALK e-com A/S. The Letter affirms Financial support for ALK e-com A/S for a period of at least 12 months from the date of approval of the 31 December 2021 financial statements.

Provisions recognised as debt to affiliates have been made to cover such exposures and the mentioned possible uncertainties are in addition to what is already provided for.

For more information on contingent liabilities and commitments, see note 3.10 in the consolidated financial statements.

17 Related parties

ALK-Abelló A/S is included in the consolidated financial statements of the Lundbeck Foundation (Lundbeckfond Invest A/S, incorporated in Denmark).

ALK-Abelló A/S has had transactions with susidiaries during 2021. All subsidiaries are owned 100%. The transactions are eliminated in the consolidated financial statements.

Transactions with the majority shareholder are disclosed in note 5.3 in the consolidated financial statements. Apart from remuneration, no other transactions have taken place during the year with Board of Directors, Board of Management, major shareholders or other related parties.

Remuneration etc. to Board of Directors and Board of Management

For information on remuneration and exercise of share options for the ALK Group's Board of Directors and Board of Management, see note 2.4 and 5.1 in the consolidated financial statements.

18 Fees to ALK-Abelló A/S' auditors

Amounts in DKKm 2021 2020
Fees to the auditors appointed at the annual general meeting:
Audit services 2 2
Tax advisory services 1 -
Other services - -
Total 3 2

19 Proposed appropriation of net profit

Amounts in DKKm 2021 2020
Proposed dividend - -
Retained earnings 313 889
Net profit 313 889

20 Events after the reporting period

No events have occured after the reporting period, that influence the evaluation of the parent company financial statements.

Financial highlights and key ratios by quarter for the ALK Group* (unaudited)

Q4 Q3 Q2 Q1
Amounts in DKKm 2021 unaudited unaudited unaudited unaudited
Income statement
Revenue 3,916 1,099 928 868 1,021
Cost of sales 1,520 398 369 362 391
Research and development expenses 631 179 147 172 133
Sales and marketing expenses 1,234 372 294 291 277
Administrative expenses 240 71 63 52 54
Other operating items, net 1 - - 1 -
Operating profit (EBIT) 292 79 55 (8) 166
Net financial items (13) (5) (1) (13) 6
Profit before tax (EBT) 279 74 54 (21) 172
Net profit 219 76 37 (21) 127
EBITDA 534 136 124 48 226
Average number of employees (FTE) 2,492 2,525 2,502 2,481 2,459
Revenue
(Growth in revenue in local currency %)
Europe 2,809
(10)
795
(7)
640
(15)
621
(14)
753
(5)
– SCIT/SLIT-drops 1,273
(-4)
366
(-7)
293
(4)
267
(3)
347
(-11)
– SLIT-tablets 1,340
(31)
400
(31)
278
(32)
302
(27)
360
(34)
– Other products and services 196
(-8)
29
(-33)
69
(5)
52
(12)
46
(-19)
North America 683
(23)
193
(20)
169
(23)
161
(33)
160
(16)
– SCIT/SLIT-drops 302
(14)
86
(11)
74
(11)
71
(34)
71
(4)
– SLIT-tablets 120
(42)
33
(40)
29
(67)
31
(59)
27
(12)
– Other products and services 261
(27)
74
(24)
66
(26)
59
(22)
62
(37)
International markets 424
(15)
111
(6)
119
(51)
86
(-15)
108
(29)
– SCIT/SLIT-drops 80
(1)
31
(153)
21
(7)
13
(-48)
15
(-29)
– SLIT-tablets 314
(18)
76
(-11)
91
(69)
68
(-1)
79
(35)
– Other products and services 30
(27)
4
(-28)
7
(22)
5
(-38)
14
(200)
Total revenue 3,916
(12)
1,099
(9)
928
(20)
868
(13)
1,021
(9)
– SCIT/SLIT-drops 1,655
(-1)
483
(0)
388
(5)
351
(4)
433
(-10)
– SLIT-tablets 1,774
(29)
509
(23)
398
(41)
401
(23)
466
(32)
– Other products and services 487
(10)
107
(-2)
142
(15)
116
(13)
122
(15)
Amounts in DKKm 2021 Q4
unaudited
Q3
unaudited
Q2
unaudited
Q1
unaudited
Balance sheet
Total assets 5,830 5,830 5,718 5,575 5,785
Invested capital 2,931 2,931 2,908 2,803 2,859
Equity 3,480 3,480 3,314 3,249 3,323
Cash flow and investments
Depreciation, amortisation and impairment 242 57 69 56 60
Cash flow from operating activities 468 158 99 84 127
Cash flow from investing activities (266) (105) (78) (42) (41)
– of which investment in intangible assets (45) (23) (11) (4) (7)
– of which investment in tangible assets (218) (82) (67) (38) (31)
Free cash flow 202 53 21 42 86
Information on shares
Dividend - - - - -
Share capital 111 111 111 111 111
Shares in thousands of DKK 10 each 11,141 11,141 11,141 11,141 11,141
Share price, end period – DKK 3,430 3,430 2,698 2,992 2,410
Net asset value per share – DKK 312 312 297 292 298
Key figures
Gross margin – % 61 64 60 58 62
EBITDA margin – % 14 12 13 6 22
Earnings per share (EPS) – DKK 20.0 6.9 3.4 (1.9) 11.6
Earnings per share diluted (DEPS) – DKK 19.8 6.9 3.4 (1.9) 11.5
Cash flow per share (CFPS)– DKK 42.7 14.4 9.0 7.7 11.6
Share price/Net asset value 11.0 11.0 9.1 10.3 8.1
* Management's review comprises this page as well as pages 1-44 and Financial highlights and key ratios for the ALK Group on

page 13.

Definitions: see page 90.

ALK-Abelló A/S

Bøge Allé 6-8 DK-2970 Hørsholm, Denmark

CVR no. 63 71 79 16 Tel. +45 45 74 75 76 www.alk.net

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