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BioArctic

Interim / Quarterly Report Jul 9, 2021

3012_ir_2021-07-09_a6771d37-652e-448b-b14a-702adcf2eb05.pdf

Interim / Quarterly Report

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INTERIM REPORT

April – June 2021

FDA grants Breakthrough Therapy designation for lecanemab

EVENTS DURING THE SECOND QUARTER 2021

• The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for lecanemab in Alzheimer's disease, which is a program intended to facilitate and accelerate the development and review of drugs for serious or lifethreatening conditions.

FINANCIAL SUMMARY APRIL – JUNE 2021

  • Net revenues for the period amounted to MSEK 7.3 (7.0)
  • Operating profit amounted to MSEK -33.8 (-37.9)
  • Profit for the period amounted to MSEK -34.2 (-38.2) and earnings per share before and after dilution were SEK -0.39 (-0.43)
  • Cash flow from operating activities amounted to MSEK -28.9 (-19.8)
  • Cash and cash equivalents at the end of the period amounted to MSEK 929.6 (1,049.9)

FINANCIAL SUMMARY JANUARY – JUNE 2021

  • Net revenues for the period amounted to MSEK 14.5 (43.4)
  • Operating profit amounted to MSEK -63.0 (-34.1)
  • Profit for the period amounted to MSEK -63.3 (-34.7) and earnings per share before and after dilution were SEK -0.72 (-0.39)
  • Cash flow from operating activities amounted to MSEK -66.4 (-56.1)
  • Cash and cash equivalents at the end of the period amounted to MSEK 929.6 (1,049.9)

KEY FINANCIAL PERFORMANCE INDICATORS

Q2
Jan-Jun
Jan-Dec
MSEK 2021 2020 2021 2020 2020
Net revenues 7.3 7.0 14.5 43.4 62.3
Other operating income 0.5 -2.1 2.2 1.3 3.6
Operating profit/loss -33.8 -37.9 -63.0 -34.1 -85.0
Operating margin, % neg neg neg neg neg
Profit/loss for the period -34.2 -38.2 -63.3 -34.7 -68.5
Earnings per share before dilution, SEK -0.39 -0.43 -0.72 -0.39 -0.78
Earnings per share after dilution, SEK -0.39 -0.43 -0.72 -0.39 -0.78
Equity per share, SEK 9.59 10.68 9.59 10.68 10.30
Cash flow from operating activities -28.9 -19.8 -66.4 -56.1 -92.3
Cash flow from operating activities per share, SEK -0.33 -0.22 -0.75 -0.64 -1.05
Equity/assets ratio, % 86.7 85.5 86.7 85.5 86.4
Return on equity, % -3.97 -3.98 -7.22 -3.62 -7.28
Share price at the end of the period, SEK 137.80 73.35 137.80 73.35 95.40

Unless otherwise stated, this Interim report refers to the Group. Figures in parentheses refer to the corresponding period last year. The amounts stated are rounded, which sometimes leads to some totals not being exact.

Comments from the CEO

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This is a time of hope for the 30 million patients around the world – and their families – who are living with Alzheimer's disease. In the latest quarter, BioArctic and its industry colleagues from around the world have announced positive news, and developments in both diagnostics as well as treatment are proceeding rapidly. In the near future, early diagnosis using blood tests will be much easier thanks to new biomarkers. Later, when early diagnosis is paired with new disease-modifying treatments, the much-anticipated paradigm shift in the care of Alzheimer's patients can finally take place. In the US, the first antibody against amyloid beta, aducanumab, has obtained an accelerated approval with requirements from the FDA in early June. The decision was not based on clinical effect but on biomarkers that are reasonably likely to predict a clinical effect.

The pivotal Phase 3 study in early Alzheimer disease (Clarity AD) is now in progress with lecanemab, the antibody developed by BioArctic against amyloid beta, designed to demonstrate an effect on both biomarkers and symptoms of the disease. The need for new treatments is enormous, and analyses of the findings from both our own and others' studies we see indications of lecanemab demonstrating a more rapid clinical effect on several relevant parameters and a better tolerability profile than other antibodies in late development. In March, our partner Eisai finished recruitment for Clarity AD and the readout of the primary endpoint is expected by the end of September 2022. However, the results of the Phase 2b study, which encompassed 856 patients with early Alzheimer's disease, provide evidence of effects on several clinical endpoints and biomarkers:

• Phase 2 data demonstrated a rapid, dose-dependent, and robust decrease of amyloid plaques in the brain. After 18 months, more than 90 percent of the patients had decreased plaque levels corresponding to those seen in healthy individuals • A positive impact on several other biomarkers in the brain was also noted, which indicates that the progress of the disease had been affected and that the improvements observed were due to lecanemab

• In addition to the positive biomarker findings, the study also demonstrated a rapid, dose-dependent clinical effect as measured by ADCOMS, ADAS-cog and CDR-Sum of Boxes Based on these results, the FDA granted lecanemab a Breakthrough Therapy designation in late June, which means

that the agency can contribute to and accelerate the development and review of the drug candidate. This decision demonstrates the strength and potential in the data we and our partner have generated to date.

A further advantage for lecanemab is its tolerability profile. All other antibodies in late development must be administered to patients in gradually increasing doses owing to the risk of side effects, whereas the effective dose of lecanemab can be administered immediately. The side effect ARIA-E, a form of cerebral edema, under particular observation. Treatments with other antibodies in late development have in various studies shown ARIA-E in approximately 30 percent of patients treated, and approximately 5–10 percent of patients display symptoms despite carefully increased doses. Whereas in treatment with lecanemab we observed ARIA-E in less than 10 percent of patients and only approximately 1 percent developed symptoms.

If the Phase 2 results are confirmed in the ongoing Phase 3 study, we are convinced that lecanemab will be a major breakthrough in care for patients with Alzheimer's disease. This is only the beginning, however. More treatment options are needed. We will continue to dedicate ourselves to and focus on our research with our other antibody projects against Alzheimer's disease. Moreover, we have connected two of them – AD-BT2802 and AD-BT2803 – to our new Brain Transporter technology, which aims to facilitates transport across the blood-brain barrier. The difficulty in transporting antibodies across the blood-brain barrier has long held development back. The fact that we have now begun to find safe methods for circumventing this problem opens the way to a future with many effective therapies.

As stated, it is a time of hope. There are now selective antibodies as disease-modifying treatments and increasingly effective diagnoses using blood-biomarkers in late-stage development. Society and healthcare have everything to gain from preparing for a paradigm shift in the care of patients with Alzheimer's disease, and we are proud of the fact that our research is enabling this development.

Gunilla Osswald CEO, BioArctic AB

BioArctic in short

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BioArctic AB (publ) is a Swedish biopharma company developing new drugs based on groundbreaking research for patients with central nervous system disorders. For a global market, the aim is to generate transformative medicines that can stop or slow down the progression of Alzheimer's disease, Parkinson's disease and other neurological diseases. BioArctic was founded in 2003 based on innovative research from Uppsala University, Sweden. BioArctic's B-share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B).

Strategy for sustainable growth

BioArctic's vision is to generate innovative medicines that improve life for patients with disorders in the central nervous system. Our work is based on groundbreaking scientific discoveries, and the company's researchers collaborate with strategic partners such as research groups at universities and major pharmaceutical companies.

The company has scientific excellence and vast experience in developing drugs from idea to market. Under BioArctic's business model, the company at an early stage itself pursues project development and then, at an appropriate juncture, licenses commercial rights and late phase development to global pharmaceutical companies. In recent years, BioArctic has successfully delivered high quality drug projects that have resulted in significant strategic license and partnership agreements in two major disease areas with high unmet medical need.

Three important cornerstones of BioArctic's strategy are:

  • CONTINUE supporting the partnered projects with great market potential
  • DEVELOP our own projects further, up to an appropriate time for partnership or exit
  • EXPAND the portfolio with new projects and indications with high unmet medical need

Operations

BioArctic conducts its research in five focus areas:

  • Alzheimer's disease
  • Parkinson's disease
  • Other CNS disorders
  • Blood-brain barrier technology
  • Diagnostics

Neurodegenerative disorders are conditions in which cells in the brain degenerate and die. Normally the neurodegenerative processes begin long before any symptoms appear. Neurodegenerative disorders affect the lives of millions of people and constitute a growing global health care problem.

A key cause of Alzheimer's disease and Parkinson's disease is believed to be misfolding and aggregation of proteins. The spreading of aggregated soluble forms of proteins leads to neuronal dysfunction, cell death, brain damage and symptoms of disease. Each neurodegenerative disorder is characterized by different aggregated proteins. The protein amyloid beta (Aβ) is involved in Alzheimer's disease, while the protein alpha-synuclein (α-synuclein) is involved in Parkinson's disease. BioArctic's aim with the antibodies currently in clinical phase, is to achieve a disease-modifying effect through the selectivity of antibodies, binding, and elimination of the harmful soluble aggregated forms of the amyloid beta protein (oligomers/protofibrils) in the brain.

Project portfolio

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BioArctic has a balanced, competitive portfolio consisting of unique product candidates, technology platforms and methods for diagnostics. All projects are focused on disorders of the central nervous system. The projects are a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential. The projects are in various phases: from discovery to late clinical phase.

As of June 30, 2021, the project portfolio consisted of:

Project Partner Discovery Preclinical Phase 1 Phase 2 Phase 3
ALZHEIMER'S DISEASE Lecanemab (BAN2401)
Clarity AD
Eisai1 Early Alzheimer's disease3
Lecanemab (BAN2401)
AHEAD 3-45
Eisai1 Preclinical (asymptomatic) Alzheimer's disease4
BAN2401 back-up Eisai
AD1801
AD1502
AD1503
AD-BT2802
AD-BT2803
AD2603
PARKINSON'S DISEASE ABBV-08052 AbbVie
PD1601 AbbVie
PD1602 AbbVie
OTHER CNS DISORDERS Lecanemab (BAN2401) Down's syndrome5
Traumatic brain injury5
ND3014
BLOOD-BRAIN BARRIER Brain Transporter (BT)
technology platform
DIAGNOSTICS Imaging and biochemical
biomarkers – Alzheimer's
disease
Imaging and biochemical
biomarkers – Parkinson´s
disease
AbbVie

1) Partnered with Eisai for lecanemab for treatment of Alzheimer's disease. Eisai entered partnership with Biogen regarding BAN2401 (lecanemab) in 2014

2) AbbVie in-licensed BAN0805 in late 2018 and develops the antibody with the designation ABBV-0805

3) Mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease

4) Normal cognitive function with intermediate or elevated levels of amyloid in the brain

5) Dementia and cognitive impairment associated with Down´s syndrome and with traumatic brain injury

ALZHEIMER'S DISEASE

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BioArctic has developed several unique and selective antibodies with the potential to slow the progress of Alzheimer's disease. The most advanced drug candidate, lecanemab (BAN2401) is currently being evaluated in two Phase 3 studies: Clarity AD for early Alzheimer's disease and AHEAD 3-45 for preclinical (asymptomatic) Alzheimer's disease. Lecanemab previously showed convincing results in a large Phase 2b study in patients with early Alzheimer's disease. The development of lecanemab against Alzheimer's disease is being financed and pursued by BioArctic's partner Eisai, which also co-owns the rights to the lecanemab back-up in Alzheimer's disease. BioArctic has six additional antibodies projects against Alzheimer's disease in its project portfolio.

Drug candidate lecanemab (collaboration with Eisai)

In Alzheimer's disease, the amyloid beta protein clumps together into increasingly larger aggregates in the brain – from the harmless form with a normal function (monomers) to larger forms such as oligomers, protofibrils, fibrils and finally amyloid plaques containing fibrils. Oligomers and protofibrils are considered the most harmful forms of amyloid beta that initiate the process of Alzheimer's disease. Lecanemab is a drug candidate which functions by eliminating these forms of amyloid from the brain and thereby has the potential to slow down the progression of disease. BioArctic's partner Eisai is responsible for the clinical development of lecanemab in Alzheimer's disease and the project is based on research from Uppsala University, Sweden.

Eisai is conducting two global Phase 3 studies with lecanemab, one in patients with early Alzheimer's disease (Clarity AD) and one in cognitively unimpaired individuals with intermediate or elevated amyloid levels in the brain who have not yet developed symptoms of Alzheimer's disease (AHEAD 3-45).

Clarity AD is the pivotal and confirmatory Phase 3 study. It is based on the Phase 2b study with lecanemab in 856 patients with early Alzheimer's disease which demonstrated dose dependent, clinically meaningful, and statistically significant effects of lecanemab on several clinical endpoints and on biomarkers and showed good tolerability.

This Phase 3 study is a global placebo-controlled, doubleblind, parallel-group, randomized study in 1,795 patients with early Alzheimer's disease i.e. mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease. Patients are allocated in a 1:1 ratio to receive intravenous infusion twice a month, either with placebo or with lecanemab 10 mg/kg. The primary endpoint is the change from baseline in the cognition and function scale Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment. Changes in the clinical scales AD composite score (ADCOMS) and AD Assessment Scale-Cognitive Subscale (ADAS-Cog) are key secondary endpoints together with brain amyloid levels as measured by amyloid-PET. According to Eisai, the goal is to be able to obtain the results from the primary endpoints from the study by the end of September 2022 and thereafter submit an application for marketing approval.

An open-label extension study, without placebo control, with continued treatment with lecanemab with the highest study dose for all the participants in the Phase 2b study is in progress. During 2020 Eisai presented data from the study showing that the patients who had previously received placebo in the Phase 2b study had rapidly and continually decreasing amyloid levels in the brain after three, six and twelve months of treatment with lecanemab. Additionally, with treatment with lecanemab less than 10 percent of patients experienced ARIA-E side effects, consistent with previously reported data. This picture was further strengthened in March 2021 when Eisai at the 15th International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders, AD/PD, presented results showing that the effects of lecanemab on reducing amyloid in the brain on average persist for at least two years following discontinuation of treatment. At the same time, it was verified that when lecanemab is administered in a dose of 10 mg/kg every other week, amyloid levels in the brains of more than 80 percent of patients decreased to levels under those that define Alzheimer's disease. These results were achieved in both the primary study and in the open-label extension study.

Lecanemab has a unique binding profile that distinguishes it from other amyloid beta antibodies and its unique binding profile has been confirmed in laboratory analyses, which are ongoing in parallel with the clinical development program. BioArctic has an ongoing research collaboration with Eisai in order to further deepen the knowledge about the drug candidate lecanemab's unique binding profile.

Lecanemab was selected by the Alzheimer's Clinical Trials Consortium (ACTC) and Eisai to be evaluated in a second clinical Phase 3 program which aims to evaluate the effects of lecanemab on preclinical asymptomatic Alzheimer's disease (AHEAD 3-45). The clinical program, that was started 2020, include individuals that are at a very early stages of Alzheimer's disease with a high risk of developing the disease. The program that is being conducted with funding from the United States National Institute on Aging (NIA) and Eisai, consists of two clinical sub-studies: A3 and A45. After a joint screening process, the participants are included in one of the randomized, double-blind and placebo-controlled sub-studies based on amyloid levels in the brains of the specific individuals. AHEAD 3-45 is a global program that is expected to include approximately 1,400 individuals.

In June 2021, the US Food and Drug Administration (FDA) granted lecanemab Breakthrough Therapy designation. This is an FDA program intended to facilitate and accelerate the development and review of drugs for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance from the FDA on an efficient development program as well as eligibility for rolling review and potentially priority review.

Back-up candidate to lecanemab (collaboration with Eisai)

The antibody is a refined version of lecanemab for the treatment of Alzheimer's disease. The antibody was developed by BioArctic in collaboration with Eisai, which resulted in a

new license agreement in 2015. The project is driven and financed by Eisai and is in the preclinical phase.

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Projects AD1801, AD1502, AD1503 and AD2603 (owned by BioArctic)

BioArctic has four additional antibody projects against Alzheimer's disease in its project portfolio, all of which are in the research phase. These antibodies have different targets, and each has the potential to become a disease-modifying treatment for Alzheimer's disease. All of them are being developed to treat early Alzheimer's disease. AD1801 is an antibody project where the mechanism of action is linked to ApoE, which is the most common genetic risk factor for Alzheimer's disease. AD1503 is an antibody project against a shorter (truncated) form of amyloid beta, which has a pronounced ability to aggregate and create toxic forms that could cause Alzheimer's disease.

Drug projects AD-BT2802 and AD-BT2803 (blood-brain barrier technology owned by BioArctic)

BioArctic has two antibody projects against Alzheimer's disease that are being combined with our blood-brain barrier technology — Brain Transporter, or BT — to facilitate uptake of antibodies in the brain.

PARKINSON'S DISEASE

In the Parkinson's disease treatment area, BioArctic has been collaborating with AbbVie since 2016. In 2018, AbbVie acquired a license to develop and commercialize BioArctic's portfolio of antibodies against alpha-synuclein for Parkinson's disease and other potential indications.

Drug candidate ABBV-0805 (collaboration with AbbVie)

The drug candidate ABBV-0805 is a monoclonal antibody that selectively binds to and eliminates oligomers and protofibrils of alpha-synuclein. The goal is to develop a disease modifying treatment that stops or slows down disease progression.

In February 2019, the U.S. Food and Drug Administration, FDA, approved the application to conduct a clinical study with ABBV-0805 and the Phase 1 study started in March 2019. In July 2020, AbbVie decided to develop a detailed plan to accelerate ABBV-0805 into a Phase 2 study in Parkinson's disease patients. AbbVie drives and finances the continued clinical development of ABBV-0805.

The scope of the drug candidate ABBV-0805 may be expanded to include, for example, Lewy body dementia and multiple system atrophy.

The project is based on research from Uppsala University.

Projects PD1601 and PD1602 (collaboration with AbbVie)

The antibody projects PD1601 and PD1602 target alphasynuclein for treatment of Parkinson's disease. The goal is to develop a disease modifying treatment that stops or slows down disease progression. The projects are included in the collaboration with AbbVie.

OTHER CNS DISORDERS

BioArctic aims to improve the treatment of a number of central nervous system disorders. The company is evaluating the

possibility of developing its existing as well as new antibodies against other diseases in the central nervous system.

Drug candidate lecanemab (indications other than Alzheimer's disease, owned by BioArctic)

Lecanemab, which is currently being clinically evaluated for Alzheimer's disease, can potentially also be used for other indications. BioArctic owns the rights for all such indications. The antibody lecanemab is in the preclinical phase as a potential treatment of cognitive disorders in conjunction with Down's syndrome and traumatic brain injury. BioArctic and Eisai presented at the AD/PD conference findings suggesting that lecanemab also could be developed into a disease modifying treatment benefiting individuals with Down's syndrome with dementia.

Project ND3014 (owned by BioArctic)

Research to develop new antibodies for treating neurodegenerative disorders is ongoing at BioArctic. ND3014 is intended to be a disease modifying treatment with potential to address various neurodegenerative disorders. The project is in an early research phase.

BLOOD-BRAIN BARRIER TECHNOLOGY (BRAIN TRANSPORTER) (owned by BioArctic)

The blood-brain barrier controls the passage of substances between the blood and the brain. It protects the brain from harmful substances, but at the same time it can make the delivery of therapeutic agents to the brain more difficult. BioArctic and researchers at Uppsala University are collaborating on developing technology that facilitates the passage of antibodies across the blood-brain barrier. Together with Uppsala University, BioArctic received grants from Sweden's Innovation Agency, Vinnova, for continued research in the blood-brain barrier project. The technology, which is at an early stage, has shown highly encouraging results and has significant potential for many different treatments for various diseases of the brain.

DIAGNOSTICS

Alzheimer's disease diagnostics (owned by BioArctic) and Parkinson's disease diagnostics (in collaboration with AbbVie)

BioArctic is engaged in the development of new diagnostic methods that improve the ability to diagnose and monitor the treatment of Alzheimer's and Parkinson's disease. The company conducts a number of projects in collaboration with commercial and academic partners. Among other things, BioArctic is developing biochemical methods based on the company's antibodies to be applied to cerebral spinal fluid (CSF) testing. Beyond this, the company is exploring the possibilities to measure biomarkers with a simple blood test. BioArctic is also active in projects to improve the diagnostic imaging (PET) of the brain of patients. The goal is to create tools to better diagnose the disease, follow the disease progression and objectively measure the effect of drug treatment.

Comments to the financial development

REVENUES AND RESULT

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Revenues consist of milestone payments, payments from research agreements and research grants. Because of the nature of the business operations, there may be large fluctuations in revenues for different periods, as revenues from milestone payments are recognized at the point in time when performance obligations are fulfilled.

Net revenues in the second quarter amounted to MSEK 7.3 (7.0). Net revenues for the half-year period amounted to 14.5 MSEK (43.4). The decrease for the period compared to last year relates to lower revenue from the Parkinson's program, which was according to plan. Further a lump sum of MSEK 22.8 was recorded attributable to a remeasurement of the total costs of the Parkinson's program during the first quarter last year.

Other operating income relates to research grants and operating exchange rate gains. Other operating income amounted to MSEK 0.5 (-2.1) and for the half-year period January-June to MSEK 2.2 (1.3). The increase is mainly attributable to exchange rate gains.

Total operating expenses for the second quarter amounted to MSEK -41.7 (-42.9) and for the half-year period January-June to MSEK -79.7 (-78.9). Project expenses for projects fully owned by BioArctic increased due to a higher activity within those projects. The expenses for personnel in the second quarter and for the period increased as a result of an increase in the number of employees. Other external costs was unchanged both in the quarter as well as for the period. Other operating expenses mainly consist of realized operating exchange rate losses.

Since BioArctic's own projects are in an early research phase they did not meet all the conditions for R&D costs to be capitalized and thus, all such costs have been charged to the income statement. The external projects are owned by our partners and BioArctic has no costs for the clinical programs.

Operating profit before financial items (EBIT) amounted to MSEK -33.8 (-37.9) for the second quarter and to MSEK -63.0 (-34.1) for the half-year. The decrease in operating profit was primarily attributable to lower revenue from the Parkinson's program, which was according to plan.

Net financial items totaled MSEK -0.4 (-1.4) for the second quarter and to MSEK -0.3 (-0.6) for the half-year period. Financial income consists of financial exchange rate gains and financial expenses consists of negative interest on cash and cash equivalents and interest on leasing liabilities according to IFRS 16 Leases.

Profit (loss) amounted to MSEK -34.2 (-38.2) for the second quarter and to MSEK -63.3 (-34.7) for the half-year period.

Earnings per share before and after dilution amounted to SEK -0.39 (-0.43) for the second quarter and to SEK -0.72 (-0.39) for the half-year.

Net revenues (MSEK)

Operating expenses (MSEK)

Operating profit/loss (MSEK)

Profit/loss for the period (MSEK)

LIQUIDITY AND FINANCIAL POSITION

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Equity amounted to MSEK 844.3 as of June 30, 2021 compared with MSEK 907.3 as of December 31, 2020. This corresponds to equity per outstanding share of SEK 9.59 (10.30). The equity/asset ratio increased from 86.4 percent as of December 31, 2020 to 86.7 percent as of June 30, 2021. Compared with the second quarter last year, the equity/asset ratio increased from 85.5 percent to 86.7 percent.

The Group's cash and cash equivalents consist of bank balances that at the end of the period amounted to MSEK 929.6 compared with MSEK 999.9 as of December 31, 2020.

The decrease in right of use assets is attributable to depreciation in accordance with IFRS 16, which is mainly related to the head office's lease. The leasing liabilities is related to the above described right of use assets. There were no loans as of June 30, 2021 and no loans have been taken since this date. The Group has no other credit facility or loan commitments.

In order to neutralize foreign exchange rate exposure some liquid funds are held in foreign currency. This has reporting effects in connection with the recalculation of currency to the current rate. These effects are recognized in the operating profit and in financial income and expenses.

CASH FLOW AND INVESTMENTS

Cash flow from operating activities for the second quarter amounted to MSEK -28.9 (-19.8) and to MSEK -66.4 (-56.1) for the half-year period.

For the second quarter investments amounted to MSEK 0.0 (1.5). For the half-year period the investments amounted to MSEK 1.0 (1.7). The investments were mainly related to laboratory equipment.

Cash flow from financing activities amounted to MSEK -1.7 (-1.6) for the second quarter and to MSEK -3.5 (-4.4) for January - June and relates to the amortization of leasing liabilities.

PARENT COMPANY

All of the Group's business operations are conducted in the Parent Company.

EVENTS DURING THE PERIOD JANUARY – JUNE 2021

  • The US Food and Drug Administration (FDA) granted breakthrough therapy designation for lecanemab in Alzheimer's disease.
  • BioArctic will support research into physical activity and brain health in an eightyear research project being conducted by the Swedish School of Sport and Health Sciences, in partnership with several other companies and non-profit organizations.
  • BioArctic received a Japanese patent for new antibodies against Alzheimer's disease.
  • Lecanemab Phase 2b study results in early Alzheimer's disease published in peerreviewed journal, Alzheimer's Research and Therapy, and lecanemab confirmatory Phase 3 Clarity AD clinical trial completed enrollment with 1,795 patients.
  • BioArctic presented findings at the AD/PD conference suggesting that lecanemab also could be developed into a disease modifying treatment benefiting individuals with Down's syndrome with dementia.
  • New preliminary results that Eisai presented at the AD/PD conference from the ongoing open-label extension of the Phase 2b study in early Alzheimer's disease continued to support the effect of lecanemab on brain amyloid levels.
  • Eisai increased the number of participants in Clarity AD with 200 patients to ensure a robust dataset. Eisai still expects readout by end of September 2021.
  • BioArctic received patent approval from the European Patent Office for antibodies against truncated amyloid beta, which are linked to the AD1503 project.

Cash and cash equivalents (MSEK)

Financial position (MSEK)

30 Jun 31 dec
2021 2020
Non-current lease liabilities 11.3 13.6
Current lease liabilities 7.9 7.1
Cash and cash equivalents 929.6 999.9
Net cash position 910.4 979.2

Cash flow from operating activities (MSEK)

Other information

PATENTS

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Patents are crucial to the company's future commercial opportunities. BioArctic has therefore an active patent strategy covering all major pharmaceutical markets including the US, EU, Japan and China. At the end of the quarter, BioArctic's patent portfolio consisted of 14 patent families with more than 230 granted patents and more than 60 ongoing patent applications.

PARTNERSHIPS, COLLABORATIONS AND MAJOR AGREEMENTS

Collaborations and license agreements with leading pharma and biopharma companies are an important part of BioArctic's strategy. In addition to financial compensation, BioArctic benefits from the expertise the company's partners contribute in drug development, manufacturing and commercialization. BioArctic has entered into a number of such agreements with the Japanese global pharma company Eisai and the American global biopharma company AbbVie. These strategic partnerships with leading global companies confirm that BioArctic's research is of very high quality. In the future BioArctic may enter into additional agreements that can contribute further funding and research and development competence for BioArctic's product candidates in preclinical and clinical phase, manufacturing and marketing competence, geographic coverage and other resources.

BioArctic has been collaborating with Eisai in the field of Alzheimer's disease since 2005. The company has signed research and licensing agreements concerning the lecanemab and BAN2401 back-up antibodies. The total value of these agreements may amount to MEUR 222 in addition to royalties. To date, approximately MEUR 66 has been received and recognized.

BioArctic has been collaborating with AbbVie in the field of Parkinson's disease since 2016, when a research agreement was signed that included products such as the antibody BAN0805, now designated ABBV-0805. At the end of 2018, AbbVie exercised its option to license BioArctic's alphasynuclein antibody portfolio for Parkinson's disease and other potential indications. BioArctic has had primary responsibility for the preclinical development work and AbbVie is responsible for the clinical development. The total value of the agreement could amount to MUSD 755 in addition to royalty payments. To date, MUSD 130 has been received. For more information regarding BioArctic's two large collaboration partners, please see the Annual Report 2020 on pages 22, 29, 43 and 44.

Collaborating with universities is also of great importance to BioArctic. The company has ongoing collaborations with academic research groups at a number of universities.

RISKS AND UNCERTAINTY FACTORS

The management makes assumptions, judgments and estimates that affect the content of the financial statements. Actual results may differ from these assumptions and estimates, as is also stated in the accounting principles. The objective of the Group's risk management is to identify, mitigate, measure, control and limit the risks of the business. Significant risks are the same for the Parent Company and the Group.

BioArctic's operational and external risks mainly consist of risks related to research and development, clinical trials and dependence on key employees.

A detailed description of exposure and risk management is presented in the Annual Report 2020 on pages 50 - 53.

FLUCTUATIONS IN REVENUE GENERATION

Currently, BioArctic does not have any drugs on the market. The company develops a number of drug candidates and diagnostics for Alzheimer's and Parkinson's diseases in collaboration with global pharmaceutical companies. The company also conducts research for wholly owned projects including new potential antibody treatments, diagnostics, as well as a blood-brain barrier technology platform. The company signs research and licensing agreements with partners and then receives remuneration for research as well as milestone payments and royalties, which the company uses to finance current and new projects. Milestone payments are normally received when the project reaches predetermined development targets – the start of clinical trials, for example – or when clinical trials move from one phase to a later phase. Thus, these payments arise unevenly over time.

FUTURE PROSPECTS

The company enjoys a strong financial position and has a business model in which its revenue and earnings are currently primarily based on non-recurring revenue from research and licensing agreements the company signed. The company's liquidity facilitates continued development of the projects covered by strategic partnership agreements as well as financing of the company's own projects in early phase and therefore are less costly. BioArctic's focus areas comprise unique drug candidates, innovative blood-brain barrier technology and diagnostics, areas with high unmet medical need. All projects are focused on disorders of the central nervous system and have great market potential. BioArctic's ambition is to generate the medicines of the future for patients with central nervous system disorders.

EXPECTED DEVELOPMENT OF OPERATING EXPENSES

Operating expenses are expected to be in the range of MSEK 170 – 200 for the fiscal year January – December 2021 (previously expectation MSEK 180 – 220). During 2020 operating expenses were MSEK 151 and during the last three years the average annual level of the operating expenses has been approximately MSEK 190.

EMPLOYEES

At the end of the period, the number of employees was 47 (45) of which 18 (17) are men and 29 (28) women. Just over 80 percent work in R&D and approximately 70 percent are PhDs.

A cost-efficient organization at BioArctic is achieved by hiring consultants for specific assignments and tasks in competence areas that the company lacks or only has need for periodically. As of June 30, 2021, these corresponded to 11 (10) full-time positions.

THE SHARE AND SHAREHOLDINGS

repr

The share capital in BioArctic amounts to SEK 1,761,200 divided by 88,059,985 shares which is split between 14,399,996 A-shares and 73,659,989 B-shares. The quotient value for both A- and B-shares is SEK 0.02. The A-share has 10 votes per share and the B-share has 1 vote per share.

LARGEST SHAREHOLDERS AS OF JUNE 31, 20211

Number Share of (%)
A-shares B-shares capital votes,
Demban AB (Lars Lannfelt) 8,639,998 22,628,052 , %
35.5
%
50.1
Ackelsta AB (Pär Gellerfors) 5,759,998 15,086,301 23.7 33.4
Fourth AP-Fund - 4,300,000 4.9 2.0
Third AP-Fund - 3,400,075 3.9 1.6
Gladiator - 2,733,164 3.1 1.3
Unionen - 2,391,835 2.7 1.1
Swedbank Robur Funds - 1,895,515 2.2 0.9
Wellington Management - 1,348,256 1.5 0.6
Investment AB Öresund - 1,330,000 1.5 0.6
Handelsbanken Funds - 1,187,795 1.3 0.5
Tot. 10 largest shareholders 14,399,996 56,300,993 80.3 92.1
Other - 17,358,996 19.7 7.9
Total 14,399,996 73,659,989 100.0 100.0

1) Source: Monitor by Modular Finance AB. Compiled and processed data from various sources, including Euroclear, Morningstar and Swedish Financial Supervisory Authority (Finansinspektionen).

ANNUAL GENERAL MEETING 2021

The Annual General Meeting (AGM) for BioArctic was held on 6 May through advance voting using the postal voting method. Lotta Ljungqvist was elected new member of the board. Hans Ekelund had declined re-election and resigned as board member. The company's chairman, vice deputy chairman and its other board members were re-elected.

LONG-TERM INCENTIVE PROGRAMS

The Annual General Meeting 2019 approved the Board of Directors' proposal for resolution concerning an employee warrant program for the company's management, researchers and other staff, a directed issue of warrants and the transfer of warrants or shares in the company to the participants in the employee warrant program.

The employee warrant program 2019/2028 include not more than 1,000,000 warrants. To enable the company's delivery of shares under the employee warrant program 2019/2028, the Annual General Meeting approved a directed issue of a maximum of 1,000,000 warrants.

The dilutive effect of the employee warrant program 2019/2028 is estimated to be a maximum of 1.1 percent of the share capital and 0.5 percent of the votes in the company (calculated on the number of existing shares in the company), assuming full exercise of all employee warrants. The employee warrants can be exercised three years after allocation at the earliest. As of the end of the period, 550,000 employee warrants were allocated. No warrants were allocated in the second quarter 2021. The allocation of employee warrants had a dilutive effect corresponding to 500,000 shares, or 0.57 percent, at the end of the period. More information is available on www.bioarctic.com

This information is information that BioArctic AB (publ) is obligated to make public pursuant to the Swedish Securities Market Act (Swe. VpmL). The information was submitted for publication, though the agency of the named contact persons, at 08:00 a.m. CET on July 9, 2021.

This interim report has not been subject to review by BioArctic´s auditors.

Stockholm, Sweden, July 9, 2021

Wenche Rolfsen Ivar Verner Håkan Englund Chairman Deputy Chairman Board member

Board member Board member CEO

Board member Board member Board member

Pär Gellerfors Lars Lannfelt Lotta Ljungqvist

Mikael Smedeby Eugen Steiner Gunilla Osswald

INVITATION TO PRESENTATION OF INTERIM REPORT FOR THE PERIOD JANUARY – JUNE 2021

BioArctic invites investors, analysts, and media to an audiocast with teleconference (in English) today, July 9, at 9:30–10:30 a.m. CET. CEO Gunilla Osswald and CFO Jan Mattsson will present BioArctic, comment on the interim report and answer questions.

Webcast: https://tv.streamfabriken.com/bioarctic-q2-2021

To participate in the conference, please call: +46 8 505 583 68 (Sweden), +45 781 501 10 (Denmark), +31 107 129 163 (Netherlands), +47 239 636 88 (Norway), +41 225 805 976 (Switzerland), +44 333 300 92 62 (UK), +49 692 222 203 80 (Germany) or +1 833 249 8406 (USA)

CALENDAR 2021 Full Year Report Jan-Dec 2021 Feb 3, 2022, at 08:00 a.m. CET

Interim report Jan-Sep 2021 Oct 21, 2021, at 08:00 a.m. CET

FOR FURTHER INFORMATION, PLEASE CONTACT

Gunilla Osswald, CEO, [email protected], phone +46 8 695 69 30 Jan Mattsson, CFO, [email protected], phone + 46 70 352 27 72 Oskar Bosson, VP Communications & Investor Relations, [email protected], phone +46 70 410 71 80

BioArctic AB (publ)

Swedish Corporate Identity Number 556601-2679 Warfvinges väg 35, SE-112 51, Stockholm, Sweden Telephone +46 (0)8 695 69 30 www.bioarctic.com

This report has been prepared in a Swedish original version and translated into English. In the event of any inconsistency between the two versions, the Swedish language version applies.

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Financial statements, Group

CONSOLIDATED INCOME STATEMENT

Q2 Jan-Jun Jan-Dec
kSEK 2021 2020 2021 2020 2020
Net revenues (note 4) 7,312 7,007 14,489 43,438 62,347
Other operating income 549 -2,051 2,236 1,334 3,597
Operating revenues 7,861 4,956 16,724 44,772 65,943
Operating expenses
Project related expenses -13,355 -15,716 -24,654 -26,203 -50,242
Other external expenses -6,642 -6,147 -12,650 -12,903 -23,370
Personnel expenses -18,261 -16,529 -35,525 -32,496 -62,977
Depreciations of tangible assets -3,261 -2,566 -6,536 -5,088 -11,013
Other operating expenses -154 -1,937 -315 -2,228 -3,353
Operating profit/loss -33,812 -37,940 -62,956 -34,146 -85,012
Financial income -152 -1,097 117 - 7
Financial expenses -234 -309 -465 -599 -1,686
Profit/loss before tax -34,198 -39,347 -63,304 -34,744 -86,691
Tax 21 1,124 41 76 18,174
Profit/loss for the period -34,177 -38,222 -63,263 -34,668 -68,517
Earnings per share
Earnings per share before dilution, SEK -0.39 -0.43 -0.72 -0.39 -0.78
Earnings per share after dilution, SEK -0.39 -0.43 -0.72 -0.39 -0.78

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

Q2 Jan-Jun Jan-Dec
kSEK 2021 2020 2021 2020 2020
Profit/loss for the period -34,177 -38,222 -63,263 -34,668 -68,517
Other comprehensive income - - - - -
Comprehensive income for the period -34,177 -38,222 -63,263 -34,668 -68,517

CONSOLIDATED BALANCE SHEET

kSEK 30 Jun 2021 30 Jun 2020 31 dec 2020
ASSETS
Tangible fixed assets 16,276 9,467 18,120
Right-to-use assets 20,079 24,072 21,820
Deferred tax assets 592 374 452
Other financial assets 1,579 1,524 1,562
Current assets excluding cash and cash equivalents 5,393 14,486 8,420
Cash and cash equivalents 929,570 1,049,934 999,940
TOTAL ASSETS 973,489 1,099,856 1,050,313
EQUITY AND LIABILITIES
Equity 844,324 940,475 907,299
Deferred tax liabilities 20,666 38,685 20,666
Non-current lease liabilities 11,347 16,461 13,627
Current lease liabilities 7,890 6,475 7,141
Other current liabilities 10,266 9,232 17,887
Accrued expenses and deferred income 78,996 88,528 83,692
EQUITY AND LIABILITIES 973,489 1,099,856 1,050,313

CONSOLIDATED STATEMENT OF CHANGE IN EQUITY (CONDENSED) 1

kSEK 30 Jun 2021 30 Jun 2020 31 dec 2020
Opening balance at 1 January 907,299 974,497 974,497
Correction of opening balance -402 - -
Comprehensive income for the period -63,263 -34,668 -68,517
Share-based payments 690 646 1,319
Paid dividend - - -
Closing balance 844,324 940,475 907,299

CONSOLIDATED STATEMENT OF CASH FLOW (CONDENSED)2

Q2 Jan-Jun Jan-Dec
kSEK 2021 2020 2021 2020 2020
Operating profit -33,812 -37,940 -62,956 -34,146 -85,012
Adjustment for non-cash items 1,446 4,546 1,957 -23,341 -19,991
Interest received/paid -386 -309 -347 -599 -1,679
Income tax paid 525 -367 541 -11,483 -12,217
Cash flow from operating activities before changes in working
capital -32,227 -34,071 -60,806 -69,569 -118,899
Change in working capital 3,296 14,279 -5,625 13,428 26,558
Cash flow from operating activities after changes in working capital -28,931 -19,792 -66,431 -56,141 -92,341
Cash flow from investing activities -45 -1,489 -994 -1,746 -12,524
Cash flow from financing activities -1,644 -3,536 -4,399 -6,598
Cash flow for the period -30,699 -22,925 -70,960 -62,286 -111,463
Cash and cash equivalents at beginning of period 960,466 1,077,255 999,940 1,112,770 1,112,770
Exchange rate differences in cash and cash equivalents -197 -4,396 591 -550 -1,367
Cash and cash equivalents at end of period 929,570 1,049,934 929,570 1,049,934 999,940

1) A minor error was discovered during the transition to a new system for translation in accordance with IFRS 16, which affects the opening balance for equity by MSEK 0.4, corresponding to 0.05%.

2) For the comparison period Jan-Dec 2020, an adjustment of kSEK 1,460 has been made between the lines Change in working capital and Cash flow from investing activities compared with the Full Year Report 2020.

CONSOLIDATED QUARTERLY DATA

2021 2021 2020 2020 2020 2020 2019 2019
MSEK Q2 Q1 Q4 Q3 Q2 Q1 Q4 Q3
Income statement
Net revenues 7 7 8 11 7 36 26 21
Other operating income 1 2 1 1 -2 3 0 9
Operating expenses -42 -38 -40 -32 -43 -36 -48 -40
Operating profit/loss -34 -29 -30 -21 -38 4 -21 -11
Operating margin, % neg neg neg neg neg 10.4 neg neg
Profit/loss for the period -34 -29 -13 -21 -38 4 -17 -8
Balance sheet
Fixed assets 39 40 42 36 35 37 39 40
Current assets 5 5 8 4 14 29 32 29
Cash and cash equivalents 930 960 1,000 1,036 1,050 1,077 1,113 1,170
Equity 844 879 907 920 940 978 974 991
Deferred tax liabilities 21 21 21 39 39 39 39 33
Lease liabilities 19 19 21 22 23 25 27 28
Current liabilities 89 87 102 95 98 101 143 187
Cash flow
From operating activities -29 -38 -27 -9 -20 -36 -54 -49
From investing activities -0 -1 -7 -3 -1 -0 -0 -2
From financing activities -2 -2 -1 -1 -2 -3 -2 -2
Cash flow for the period -31 -40 -35 -14 -23 -39 -56 -53
Key ratios
Equity/asset ratio, % 86.7 87.3 86.4 85.5 85.5 85.6 82.4 80.0
Return on equity, % -4.0 -3.3 -1.4 -2.2 -4.0 0.4 -1.7 -0.8
Data per share
Earnings per share before dilution, SEK -0.39 -0.33 -0.15 -0.23 -0.43 0.04 -0.19 -0.09
Earnings per share after dilution, SEK -0.39 -0.33 -0.15 -0.23 -0.43 0.04 -0.19 -0.09
Equity per share, SEK 9.59 9.98 10.30 10.45 10.68 11.11 11.07 11.26
Cash flow operating activities per share, SEK -0.33 -0.43 -0.30 -0.11 -0.22 -0.41 -0.62 -0.56
Share price at the end of the period, SEK 137.80 91.00 95.40 88.95 73.35 61.50 94.90 61.75
Number of shares outstanding at the end of the period,
thousands 88,060 88,060 88,060 88,060 88,060 88,060 88,060 88,060
Average number of shares outstanding before dilution,
thousands
Average number of shares outstanding after dilution,
88,060 88,060 88,060 88,060 88,060 88,060 88,060 88,060
thousands 89,105 88,855 88,355 88,082 88,060 88,060 88,060 88,060

Financial statements, Parent company

PARENT COMPANY INCOME STATEMENT

Q2 Jan-Jun Jan-Dec
kSEK 2021 2020 2021 2020 2020
Net revenues 7,312 7,007 14,489 43,438 62,347
Other operating income 549 -2,051 2,236 1,334 3,597
Operating revenues 7,861 4,956 16,724 44,772 65,943
Operating expenses
Project related expenses -13,356 -15,716 -24,655 -26,203 -50,242
Other external expenses -8,730 -8,025 -16,794 -16,657 -31,161
Personnel expenses -18,261 -16,529 -35,525 -32,496 -62,977
Depreciations of tangible assets -1,421 -845 -2,820 -1,647 -3,829
Other operating expenses -154 -1,937 -315 -2,228 -3,353
Operating profit/loss -34,061 -38,097 -63,384 -34,458 -85,618
Financial income -152 -1,097 117 - 7
Financial expenses -1 -63 -15 -91 -707
Profit/loss after financial items -34,214 -39,258 -63,282 -34,549 -86,318
Change in tax allocation reserves - - - - 81,865
Profit/loss before tax -34,214 -39,258 -63,282 -34,549 -4,453
Tax 24 1,105 36 35 75
Profit/loss for the period -34,190 -38,152 -63,246 -34,514 -4,378

There are no items recognized as other comprehensive income in the Parent Company. Accordingly, total comprehensive income matches profit for the year.

PARENT COMPANY BALANCE SHEET (CONDENSED)

30 Jun 2021 30 Jun 2020 31 dec 2020
ASSETS
Tangible fixed assets 16,276 9,467 18,120
Deferred tax assets 361 284 325
Other financial assets 1,629 1,624 1,612
Current assets excluding cash and cash equivalents 7,352 15,843 9,882
Cash and cash equivalents 929,523 1,049,839 999,892
TOTAL ASSETS 955,141 1,077,057 1,029,831
EQUITY AND LIABILITIES
Equity 771,071 802,819 833,628
Tax allocation reserve 94,809 176,674 94,809
Other current liabilities 10,266 9,036 17,702
Accrued expenses and deferred income 78,995 88,528 83,692
EQUITY AND LIABILITIES 955,141 1,077,057 1,029,831

Notes

NOTE 1 GENERAL INFORMATION

This Interim Report for the period January – June 2021 covers the Swedish Parent Company BioArctic AB (publ), Swedish Corporate Identity Number 556601-2679, and the fully owned subsidiary LPB Sweden AB, Swedish Corporate Identity Number 559035-9112. All the Group's business operations are conducted in the Parent Company. BioArctic is a Swedish limited liability company registered in and with its registered office in Stockholm. The head office is located at Warfvinges väg 35, SE-112 51, Stockholm, Sweden.

NOTE 2 ACCOUNTING PRINCIPLES

The consolidated financial statements for BioArctic AB (publ) have been prepared in accordance with IFRS (International Financial Reporting Standards) as adopted by the EU, the Annual Accounts Act and the Swedish Financial Reporting Board's RFR 1 Supplementary Accounting Rules for Groups. The Parent Company's financial statements are presented in accordance with the Swedish Annual Accounts Act and RFR 2 Accounting for Legal Entities.

The Interim Report for the period January – June 2021 is presented in accordance with IAS 34 Interim Financial Reporting and the Swedish Annual Accounts Act. Disclosures in accordance with IAS 34 are presented both in notes and

elsewhere in interim report. The accounting principles and calculation methods applied are in accordance with those described in the Annual Report 2020. New and amended IFRS standards and interpretations applied from 2021 have not had a material impact on the financial statements.

The guidelines of the European Securities and Markets Authority (ESMA) on alternative performance measures have been applied. This involves disclosure requirements for financial measures that are not defined by IFRS. For performance measures not defined by IFRS, see the Calculations of key figures section.

NOTE 3 SEGMENT INFORMATION

An operating segment is a part of the Group that conducts operations from which it can generate income and incur costs and for which independent financial information is available. The highest executive decision-maker in the Group follows up the operations on aggregated level, which means that the operations constitute one and the same segment and thus no separate segment information is presented. The Board of Directors is identified as the highest executive decision maker in the Group.

NOTE 4 NET REVENUES

Q2 Jan-Jun Jan-Dec
kSEK 2021 2020 2021 2020 2020
Geographic breakdown of net revnues
Europe 2,312 1,859 4,677 29,834 33,805
Asia 5,000 5,148 9,812 13,604 28,541
Total net revenues 7,312 7,007 14,489 43,438 62,347
Net revenues per revenue type
Milestone payments, recognized at a given point in time - - - -
Income from research collaborations, recognized over time 7,312 7,007 14,489 43,438 62,347
Total net revenues 7,007 14,489 43,438 62,347

BioArctic's net revenues essentially consist of income from the research collaborations concerning Parkinson's disease with AbbVie and Alzheimer's disease with Eisai. Under the collaboration agreement with AbbVie, BioArctic received an initial payment of MSEK 701.6, or MUSD 80, during the third quarter 2016. This payment is related to compensation for the preclinical development work that BioArctic will carry out under the agreement. Of the initial payment, MSEK 70.4 was reported as a one-time payment in 2016. The rest of the payment will be accrued based on the costs incurred up until the completion of the project. The project is continuously evaluated with the regard to status and remaining costs. In conjunction with a restatement of the total costs of the Parkinson's program in light of better performance than originally planned, a positive lump sum of MSEK 22.8 in revenue has been recorded during the first quarter 2020. As of June 30, 2021, MSEK 639.4 has been recognized as revenue and the remaining amount to be recognized as a revenue up until the completion of the project is MSEK 62.3. MSEK 2.3 was recognized as revenue in the period April–June 2021. A research collaboration agreement with Eisai began in January 2020. The revenue for this research collaboration was recognized over time based on the fulfillment of the performance obligation. The agreement ran until June 2021 and all income attributable to the agreement has thereby been recognized as income. At June 30, 2021, MSEK 38.4 had been recognized as revenue, of which MSEK 5.0 during the second quarter. A continuation of the research collaboration agreement with Eisai was agreed on end of June 2021.

Definition of key ratios

In this financial report BioArctic reports key financial ratios, some of which are not defined by IFRS. The Company's assesses that these key ratios are important additional information, since they enable investors, securities analysts, management of the company and other stakeholders to better analyze and evaluate the company's business and financial trends. These key ratios should not be analyzed separately or replace key ratios that have been calculated in accordance with IFRS. Neither should they be compared to other key

ratios with similar names applied by other companies, as key ratios cannot always be defined in the same way. Other companies may calculate them in a different way than BioArctic.

The key ratios "Net revenues", "Result for the period", "Earnings per share" and "Cash flow from operating activities" are defined according to IFRS.

Key ratios Definition
Other income Other income than net revenue
Operating profit Result before financial items
Operating margin, % Operating profit divided by net revenues
Cash flow from operating activities
per share, SEK
The cash flow from operating activities for the period divided by the weighted number of
shares
Equity/asset ratio, % Adjusted equity divided by total assets
Return on equity, % Net income divided by equity expressed as a percentage
Equity per share Adjusted equity divided by the number of shares at the end of the period

BioArctic – Interim report

Glossary

ADAS-Cog

ADAS-Cog (Alzheimer's Disease Assessment Scale cognitive subscale) is a well-established cognition scale whereof parts are included in ADCOMS.

ADCOMS

Alzheimer's Disease Composite Score – A cognition scale consisting of parts from three different scales (CDR-SB, ADAS-cog and MMSE) developed by Eisai. The cognition scale enables a sensitive detection of changes in clinical functions of symptoms in early Alzheimer's disease.

ADCS-ADL-MCI

ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild cognitive impairment) is a clinical scale focusing of activities of daily living particularly relevant in mild cognitive impairment.

Alfa-synuclein (α-synuclein)

A naturally occurring protein in the body that, in conjunction with Parkinson's disease, misfolds and forms harmful structures in brain cells.

Amyloid beta (Aβ)

A naturally occurring protein in the brain that, in conjunction with Alzheimer's disease, misfolds into harmful structures in brain cells. Amyloid beta form the plaque around brain cells visible in patients with Alzheimer's disease.

Antibody

A biological molecule originating in the immune system that binds to a target molecule with a high degree of accuracy.

ApoE (Apolipoprotein E)

ApoE transports fats in the blood. ApoE comes in three forms. Individuals expressing the ApoE4 form are at greater risk of developing Alzheimer's disease.

ARIA-E

A form of cerebral edema that occurs in some patients treated with anti-amyloid monoclonal antibodies for Alzheimer's disease.

Binding profile

A binding profile specifies in which way and to which forms of a protein (such as amyloid beta or alpha-synuclein) an antibody binds.

Biomarker

A measurable molecule, the levels of which can indicate a change in the body and enable diagnosis of a patient or measurement of the effect of a drug.

Blood-brain barrier

A structure of tightly bound cells that surround blood vessels in the brain. This barrier regulates the exchange of nutrients and waste and protects against bacteria and viruses.

Breaktrough therapy designation

The breakthrough therapy designation is an FDA program intended to facilitate and accelerate the development and review of drugs for serious or life-threatening conditions.

CDR-SB

CDR-SB (Clinical Dementia Rating Sum of Boxes) is a cognition and function scale which is part of ADCOMS.

Central nervous system (CNS)

The part of the body's nervous system comprising the brain and spinal cord.

Clinical studies

Drug trials performed in human subjects.

Disease modifying treatment

A treatment that interferes with the processes of the disease and changes it in a positive way.

Dose dependent

Increased effect at higher dose.

Drug candidate

A drug under development that has not yet gained marketing approval.

Early Alzheimer's disease

Mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease.

Interim analysis

A statistical analysis conducted during an ongoing clinical trial to evaluate preliminary findings.

Licensing

Agreement where a company that has invented a drug gives another company the right to further develop and sell the drug for certain payments.

Milestone payment

Financial remuneration received as part of a project or collaboration agreement once a specified goal has been achieved.

Monomer

An individual molecule with the ability to bind to other similar molecules to form larger structures such as oligomers and protofibrils.

Neurodegenerative disease

A disease that entails a gradual breakdown and degeneration in brain and nervous system function.

Oligomer

Molecules consisting of a number of monomers.

Open-label extension study

Clinical study conducted after a completed randomized and placebo-controlled study in which all patients receive active substance.

Pathology

The study of diseases and how they are diagnosed, through analysis of molecules, cells, tissues and organs.

PET

Positron emission tomography, an imaging method used to perform medical examinations.

Phase 1 studies

Studies the safety and tolerability of a drug. Performed in a limited number of healthy human volunteers or patients.

Phase 2 studies

Studies the safety and efficacy of a drug. Performed in a limited number of patients. Later stages of phase 2 studies can be called phase 2b and evaluate the optimal dose of the studied drug.

Phase 3 studies

Confirms the efficacy and safety of a drug. Performed in a large number of patients.

Placebo-controlled

A study design in research which means that some of the patients receive inactive compound to obtain a relevant control group.

Preclinical (asymptomatic) Alzheimer's disease

Normal cognitive function but with intermediate or elevated levels of amyloid in the brain.

Preclinical phase

Stage of development where preclinical studies of drug candidates are conducted to prepare for clinical studies.

Preclinical studies

Studies conducted in model systems in laboratories prior to conducting clinical trials in humans.

Product candidate

A product under development that has not yet gained marketing approval.

Protofibril

A harmful aggregation of amyloid beta formed in the brain, which gives rise to Alzheimer's disease, or a harmful aggregation of alpha-synuclein formed in the brain and gives rise to Parkinson's disease.

Research phase

Early research focused on studying and elucidating the underlying molecular disease mechanisms and generation of potential drug candidates.

Selective binding

The affinity of a molecule for binding to a specific receptor.

Tolerability

The degree of side effects from a drug that can be tolerated by a patient.

Truncated amyloid beta

Shortened (truncated) forms of the amyloid beta protein.

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