AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Xbrane Biopharma

Quarterly Report May 6, 2021

3128_10-q_2021-05-06_919b3fc7-1af2-48b8-a6e9-24ce2cb7f412.pdf

Quarterly Report

Open in Viewer

Opens in native device viewer

Interim report January – March 2021

"During the first quarter of the year, a new Biotech lab was established which enables a faster and broader supply of clinical development programs in the future. Xbrane will have the capacity to initiate a new development program every year."

Financial summary first quarter 2021

  • Revenue amounted to SEK 0.0m (0.0).
  • Other operating income amounted to SEK 4.1m (4.9).
  • EBITDA was SEK -49.0m (-50.0*).
  • R&D expenses amounted to SEK 46.0m (-47.5*) representing 83% (84*) of total operating expenses.
  • The loss for the period was SEK 51.3m (-51.8*).
  • Earnings per share amounted to SEK -2.31 (-3.36*).
  • Cash and cash equivalents at the end of the period amounted to SEK 239.2m (84.5).

Significant events during the first quarter 2021

  • In early January 2021, Xbrane renegotiated an existing intellectual property license agreement with Vaxiion Therapeutics.
  • Xbrane signed a non-binding letter of intent with New FaDem in February 2021, regarding the divestment of the subsidiary Primm Pharma.
  • Anette Lindqvist took over as Chief Financial Officer & Head of Investor Relations in early January 2021 and Erik Domines took over as General Counsel in March 2021.
  • Xbrane established a new development laboratory for biosimilars at Campus Solna outside Stockholm in March 2021.

Detailed information about the above events can be found on page 6.

Significant events after the end of the quarter

• There have been no significant events after the end of the quarter.

Financial summary for the Group

2021 Q1 2020 Q1 2021 Full year
Revenue (SEK 000)
Research and development expenses (SEK 000) –46,020 –47,543* –203,301
R&D expenses as percentage of total costs 83 84* 83
Operating profit/loss (SEK 000) –51,410 –51,628* –225,257
EBITDA (SEK 000) –48,993 –49,976* –218,691
Profit/loss for the period (SEK 000) –51,267 –51,833* –226,026
Cash and cash equivalents (SEK 000) 239,244 84,470 243,139
Equity ratio (%) 44 36* 56
Number of shares at the end of period 22,200,415 15,415,199 22,200,415
Number of shares at the end of period after dilution 22,200,415 15,415,199 22,200,415
Average number of shares 22,200,415 15,415,199 18,113,313
Average number of shares after dilution 22,200,415 15,415,199 18,113,313
Earnings per share before dilution (SEK) –2.31 –3.36* –12.48
Earnings per share after dilution (SEK) –2.31 –3.36* –12.48
Number of employees on balance sheet date 45 38 42

About the operations

Xbrane Biopharma AB develops high-quality biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane's leading product candidate XlucaneTM is a biosimilar to the original drug Lucentis®. The market for ophthalmic VEGFa-inhibitors amounts to around SEK 106bn1,2,3. XlucaneTM is in phase III and an application for marketing authorization is expected to be submitted in the latter part 2021. Xbrane has a further 3 biosimilars in the pipeline where sales of the original products are estimated at around SEK 100bn.

This report is a translation of the Swedish version. When in doubt, the Swedish version should prevail.

1) Novartis Annual Report 2020 (Lucentis® and Beovu®)

2) Roche Annual Report 2020 (Lucentis®)

*) This period has been recalculated due to restatement, see Appendix 1 for the effects

This information is information that Xbrane Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the CEO, for publication on 05-06-2021, 08:00 CEST.

3) Regeneron Annual Report 2020 (Eylea®)

CEO's letter

Dear Shareholders,

The first quarter of 2021 was characterized by activities related to the application for marketing authorization of XlucaneTM and the establishment of Xbrane's new Biotech lab for the development of biosimilars on Campus Solna. We are now looking forward to meeting the key milestones for 2021, which includes Phase III top-line data, expected in the middle of the year, followed by an application for marketing authorization to EMA and FDA during Q3 and Q4 2021 respectively.

XlucaneTM phase III top-line data is expected in the middle of 2021

The pivotal phase III study Xplore, which aims to demonstrate equivalent efficacy and safety of XlucaneTM compared to Lucentis®, includes a total of 583 patients with age-related macular degeneration globally. Patients undergo 12 months of treatment as per the study protocol. An interim read-out is made when all patients have reached month 6 in the treatment schedule. We expect to be able to announce the results from the interim read-out in the middle of the year. The read-out will include results on the primary endpoint, improved vision relative to the reference drug Lucentis® 2 months after starting treatment, and data on adverse events and immunogenicity.

XlucaneTM, application for marketing authorization to EMA and FDA scheduled for Q3 and Q4 2021 respectively

We will, in agreement with both the EMA and FDA, submit an application for marketing authorization based on the interim read-out. Therefore, the marketing authorization application to both the EMA and FDA is expected to take place during Q3 and Q4 respecitvely 2021. With an expected regulatory process of 12 months, marketing authorization could be obtained in the second half of 2022 and enable our partners STADA and Bausch + Lomb to launch the product thereafter.

Preparations for the commercialization of XlucaneTM

In 2021, Xbrane will sign binding supply agreements with its most important contract manufacturers for XlucaneTM, thereby ensuring production capacity for forecast sales for the next three years. This capacity is sufficient to achieve Xbrane's

ambition of reaching EUR +100m in annual net revenue in the third year after launch, after deduction of costs and profit sharing.

Establishment of a new expanded development lab

During Q1, Xbrane established a new expanded biotech lab for biosimilars on Campus Solna next to the Karolinska Institute. The lab is 2,000 m2 and has the capacity to develop biological drugs expressed in both E.coli and mammalian host cells and has advanced equipment for detailed, comprehensive biochemical analysis, a requirement for biosimilars. In the expanded lab, Xbrane will have the capacity to initiate a new development program every year.

Xbrane is arranging a virtual capital markets day on 17 May

At the capital markets day, held between 14-15.30 (CET), members of the company's management will highlight and describe Xbrane's strategic direction to develop into a world-leading biosimilar developer in the coming years. This will include an in-depth presentation of Xbrane's platform technology and development portfolio. There will also be a virtual tour of the expanded development lab on the new premises at Campus Solna.

Key milestones in the coming 12-month period

  • Capital markets day where we will present how Xbrane will achieve its goal of starting a new development program every year and how the selection of the next clinical candidate will take place
  • Announce the top-line results from the phase III study Xplore
  • Application for marketing authorization in Europe and the USA for XlucaneTM
  • Agreements with additional partners for the sales and marketing of XlucaneTM in China, Latin America and Japan.
  • Upscaling the production process for XcimzaneTM and preparing for the start of clinical trials
  • Establish partners for the commercialization of XcimzaneTM in Europe and/or the US

A big thank you to my employees and the shareholders who have made it possible for Xbrane to take these important steps in its development. We are all very enthusiastic about Xbrane's next step in our journey towards becoming a global leading biosimilar developer. I feel the support of and security from our unique patented platform technology, to achieve our vision of developing cost-effective biosimilars for the benefit of patients around the world.

Thank you for your continued support,

Solna, May 6, 2021

Martin Åmark, CEO

Product candidate portfolio

XlucaneTM

XlucaneTM is a biosimilar to ranibizumab (original drug Lucentis®), known as a VEGFa-inhibitor, and it is used to treat a number of serious eye diseases: wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR) and retinal vein occlusion (RVO). The VEGFainhibitors market saw sales of over SEK 106bn1,2,3 in 2019 and has grown by over 10% annually in recent years1,2,3, although a marginal decline was noted in 2020 due to Covid-19.

In April 2019, Xbrane started its pivotal phase III study, Xplore, comprising 583 patients with the wet age-related macular degeneration. The purpose of the Phase III clinical trial is to demonstrate equivalence to Lucentis®. To date, Xplore is progressing without any safety concerns being reported. At the end of 2020, the Xplore study was fully recruited. Xbrane will, in agreement with the EMA and FDA, apply for marketing authorization for XlucaneTM in Europe and the US, based on six months of Xplore treatment data.

Xbrane has a collaboration agreement with STADA GmbH for the development, sales and marketing of XlucaneTM in Europe and a number of markets in the Middle East and Asia-Pacific region. Last year, Xbrane and STADA signed an agreement with Bausch + Lomb, which will commercialize XlucaneTM in North America.

XcimzaneTM

XcimzaneTM is a biosimilar to certolizumab pegol (original drug Cimzia®), a so-called TNF-inhibitor particularly used in the treatment of rheumatoid arthritis, psoriasis and Crohn's disease. The patent protection of Cimzia® is expected to expire in 2024 in the US and 2025 in Europe. XcimzaneTM is

undergoing pre-clinical development and a cost-effective production process has been established. Then, upscaling and planning with a production partner will follow, after which the product can commence clinical trials.

XdivaneTM

XdivaneTM is a biosimilar to nivolumab (original drug Opdivo®), a PD1-inhibitor for the treatment of different types of cancer with a turnover of around SEK 64bn in 20206 . Opdivo® is expected to lose its patent protection between 2026 and 2031, depending on the country. XdivaneTM is at the pre-clinical development stage, with a focus on developing a cost-effective production process and demonstrating a biochemical similarity to the original drug. Then, upscaling with a production partner will follow, after which the product can be taken into clinical trials.

XoncaneTM

XoncaneTM is a biosimilar to pegaspargase (original drug Oncaspar®), used in the treatment of acute lymphocytic leukemia. In 2018, sales of Oncaspar® were around SEK 2bn7 . XoncaneTM is now undergoing pre-clinical development.

Spherotide

Xbrane has agreed on a non-binding letter of intent with New FaDem regarding the divestment of the subsidiary Primm Pharma. The purchase price will amount to €14.0m and must be paid upon signing and at various development and sales milestones. The parties intend to complete the transaction in 2021.

Product Original drug Primary indication Estimated sales
of originator drug
Patent expiry
of original drug
Development phase
XlucaneTM Ranibizumab
(Lucentis®)
Wet age-related macular
degeneration, diabetes-related
eye damage and retinal vein
occlusion.
SEK 32bn1,2 2022 (Europe)
2020 (USA)
Phase III
XcimzaneTM Certolizumab
pegol (Cimzia®)
Rheumatoid arthritis,
axial spondylarthrosis, psoriatic
arthritis, psoriasis and Crohn's
disease.
SEK 19bn5 2024 (USA)
20259
(Europe)
Pre-clinical phase
XdivaneTM Nivolumab
(Opdivo®)
Melanoma, lung cancer, kidney
cell cancer, head and neck
cancer and bladder and urinary
tract cancer.
SEK 64bn6 2026–2031
depending on
country
Pre-clinical phase
XoncaneTM Pegaspargase
(Oncaspar®)
Acute lymphocytic leukemia. SEK 2bn7 Expired Pre-clinical phase
Spherotide Triptorelin
(Decapeptyl®)
Prostate cancer, breast cancer,
endometriosis and fibroids.
SEK 4bn8 Expired Pre-clinical phase

1) Novartis Annual report 2020

2) Roche Annual report 2020

3) Regeneron Annual report 2020

4) Research and markets Global Tumor Necrosis Factor (TNF) Inhibitors Market 2018–2026: A \$181.13 Billion Market Opportunity by 2026

5) UCB Annual report 2020

6) BMS Annual report 2020

7) Evaluate Pharma 2018 8) IQVIA 2018

9) Includes six months patent extension due to pediatric indication

Shareholders

As of March 31, 2021, Xbrane had around 5,300 shareholders. The number of outstanding shares totaled 22,200,415. The ten largest shareholders at the end of the period are shown in the table below1 .

Number of
Name shares Ownership, %
Serendipity Group 2,819,967 12.7
Swedbank Robur Fonder 2,147,972 9.7
Bengt Göran Westman 1,790,173 8.1
STADA Arzneimittel AG 1,570,989 7.1
TIN Fonder 1,200,000 5.4
Futur Pension 1,179,556 5.3
Avanza Pension 814,953 3.7
Nordnet Pensionsförsäkring 393,210 1.8
Swedbank Försäkring 371,188 1.7
Paolo Sarmientos 296,939 1.3
Ten largest shareholders in total 12,584,947 56.7
Other Swedish shareholders 7,548,635 34.0
Other foreign shareholders 2,066,833 9.3
Total outstanding shareholders 22,200,415 100.0

1) Modular Finance. Based on complete list of shareholders comprising directly registered and nominee registered shareholders.

Financial overview

The Group's results for January – March 2021

In Q1, there were no sales (0.0), and thus no cost of goods sold was reported (0.0).

Other operating income amounted to SEK 4.1m (4.9) and relates mainly to the licensing of the American and Canadian rights for XlucaneTM to Bausch + Lomb, which will accrue over two years. Other operating income also includes license income from non-core operations as well as exchange rate gains on operating receivables and liabilities.

Administrative expenses amounted to SEK -8.8m (-7.0) and the change is largely explained by personnel costs that have increased due to a growing organization and non-recurring costs related to the move to new premises.

Research and development costs amounted to SEK -46.0m (-47.5*), of which SEK -45.2m (-45.5*) relates to biosimilars, primarily XlucaneTM and SEK -0.9m (-2.1) relates to the long-acting injectable drug Spherotide. The majority of the R&D costs relates to the ongoing Xplore study for XlucaneTM, the parallel regulatory work and the establishment of a production chain. The Xplore study was fully-recruited by the end of 2020 and we expect to be able to announce top-line data from interim read-outs in July 2021.

Other operating expenses amounted to SEK -0.1m (-2.0) and consisted of exchange rate losses on operating receivables and liabilities. The operating loss was SEK -51.4m (-51.6*). The loss before tax was SEK 51.3m (51.8*). During the quarter, there was no taxable profit and thus no tax expense (0.0). The loss after tax for the quarter was SEK -51.3m (-51.8*) and the earnings per share was SEK -2.31 (-3.36*).

The Group's cash flow for January – March 2021

The cash flow from operating activities amounted to SEK 7.9m (-83.3). Changes in operating receivables and operating liabilities amounted to SEK 38.0m (-49.2) and SEK 19.1m (20.3*) respectively. The change in operating receivables is a result of re-invoicing to STADA regarding the development work for XlucaneTM and costs for the clinical study.

The cash flow from investment activities amounted to SEK -8.7m (0.0) and consisted of investments in tangible assets in R&D.

The cash flow from financing activities amounted to SEK -1.1m (-0.8), of which the largest part is the amortization of lease liabilities.

The Group's financial position and continued operations

On the balance sheet date, cash and cash equivalents amounted to SEK 239.2m (84.5).

The capital raising exercise carried out in 2020 totaled SEK 346,4m before transaction costs and thus significantly strengthened the company's financial position and is expected to provide capital to complete the application for marketing authorization for XlucaneTM, ensures production capacity and start upscaling the production process for XcimzaneTM. In addition to additional income that partnerships and transactions may bring in the near future, Xbrane is expected to need additional capital during the second half of 2021. Beyond this, additional financing of the business may be needed until 2023 when the company is expected to achieve a positive cash flow based on sales revenue from XlucaneTM. The company is continuing to evaluate various financing alternatives together with its financial advisers and dialogs with investors.

Assets held for sale

During Q1 2021, a non-binding letter of intent was signed with New FaDem regarding the divestment of the subsidiary Primm Pharma. As a result of the non-binding letter of intent, Primm Pharma is considered to be in divestment and therefore the company's assets and liabilites have been reclassified to Assets held for sale in the Group's balance sheet. The reclassification has created some minor effects on a number of items in the balance sheet and the significant change seen relates to the item goodwill as described below. Other balance sheet items for the Group show a smaller effect from the reclassification, which is expected as Primm Pharma is a minor part of the Group and its composition.

Goodwill

Goodwill amounted to SEK 0.0m (64.5) on the balance sheet date and the decrease compared with the previous year is entirely attributable to the reclassification to Assets held for sale described above.

Accounts receivable

Accounts receivable amounted to SEK 0.6m (42.9). Compared with the previous year, the receivable, which relates to the receivable from our partner STADA, was settled before the end of the balance sheet date.

Prepaid expenses and accrued income

Prepaid expenses and accrued income amounted to SEK 79.4m (84.8), of which SEK 8.1m (45.1) relates to the purchase and packaging costs of reference medicines for the ongoing phase III study, which will be used on an ongoing basis, SEK 42.1m (17.9) relates to an advance payment to the CRO (Contract Research Organization) which is carrying out the clinical study and the remaining SEK 29.2m (21.8) relates to other prepaid expenses and accrued income.

Changes in equity

Equity amounted to SEK 5.0m (3.5) on the balance sheet date. Other capital contributions amounted to SEK 774.4m (448.3) and were affected by share-based payments to employees of SEK 0.7m (0.2) during the year. Total equity amounted to SEK 208.4m (111.6). The equity ratio was 44% (56).

Accounts payable

Accounts payable amounted to SEK 49.3m (43.7). The increase is due to a growth in business and activities.

Accrued expenses and prepaid income

Accrued expenses and prepaid income amounted to SEK 150.8m (136.6) and primarily relates to advance payments of SEK 107.0m (84.4) from STADA for XlucaneTM.

*) This period has been recalculated due to a correction. See Appendix 1 for the effects of the recalculation.

Impact of the cooperation agreement with STADA on the income statement and balance sheet

Since the cooperation agreement with STADA for XlucaneTM started in July 2018, Xbrane's net costs for the research and development of XlucaneTM have been reported in the results, i.e. 50% of the total cost of the project. With regard to the balance sheet, assets and liabilities attributable to the development of XlucaneTM are reported in their entirety, i.e. 100%, and then STADA's share of these, i.e. 50% is reported additionally as the receivable or liability arising between Xbrane and STADA. This applies to both the Group and parent company. On the balance sheet date, Xbrane had a non-current non-interest-bearing liability to STADA amounting to SEK 4.2m (0.0) as well as deferred income from STADA amounting to SEK 107.0m (84.4).

Parent company

Xbrane's core business, which is the development of biosimilars, is run by the parent company. As announced, the Group has begun the sale of the subsidiary Primm Pharma, which is expected to be completed shortly. As a result, shares in subsidiaries have been written down by SEK 43.0m.

As the Parent Company constitutes such a large part of the Group, an account in text format of the Parent Company's earnings, financial position and cash flow does not lead to any further information than that described in the report on the Group. Therefore, this is only presented in report format on pages 13–15.

Significant events during the first quarter Xbrane renegotiates existing patent license agreement with Vaxiion Therapeutics

At the beginning of January 2021, Xbrane renegotiated an existing intellectual property license agreement, mainly patent US7871815B2, with Vaxiion Therapeutics. The renegotiated license agreement gives Xbrane full non-exclusive rights to the said intellectual property rights and entitles Vaxiion to a low single-digit SEKm payment upon signing and a low singledigit royalty on sales revenue generated by Xbrane from pharmaceutical products in which the intellectual property rights are used for production, up to February 2024. After February 2024, Xbrane may continue to use Vaxiion's intellectual property rights for all of its products without any additional royalty payments to Vaxiion.

Anette Lindqvist new CFO and Head of IR

Anette Lindqvist took over as Chief Financial Officer & Head of Investor Relations at the start of January 2021.

Anette has extensive experience from senior Finance & Business roles within the Life Science sector, with companies including AstraZeneca, Mölnlycke Healthcare and Getinge Infection Control. Anette replaced Margareta Hagman, the interim CFO since August 2020.

Intention to sell Primm Pharma subsidiary

Xbrane has signed a non-binding letter of intent for the sale of the subsidiary Primm Pharma, which owns the rights to Spherotide, to the Italian pharmaceutical company New FaDem. The purchase price in the letter of intent is set at €14.0m, to be paid over time as the company achieves certain research and development goals. The parties intend to sign a binding agreement during 2021.

Erik Domines takes over as General Counsel

Erik was previously at legal operations where, among other things, he worked with training and business development. His qualifications include a law degree from the University of Stockholm, General Counsel mini-MBA.

New premises

Xbrane moved to new premises in March 2021, which includes a new development laboratory for biosimilaries with greatly increased capacity compared to before. The company will therefore be able to broaden its product portfolio further and initiate the development of more biosimilar candidates.

Significant events after the first quarter

There have been no significant events after the end of the quarter.

Risks and uncertainties

Risks and uncertainties are described on pages 26–28 of the Annual Report of 2020, which is available on the company's website. At the time of publication of this interim report, these have not changed significantly.

Impact of Covid-19

Xbrane has adapted its operations to comply with local government health guidelines. This has led to travel being cancelled, a switch to digital meetings and the majority of employees working from home. The company continues to follow local health guidelines from authorities at the places where Xbrane operates. For the employees, the company has offered those who need access to the lab safe travel options and scheduled the work so that guidelines regarding social distancing could be complied with. Sick leave has been relatively low. Overall, the company has found effective ways of working and an even stronger cohesion that allows the company to be sustainable in this situation and continue to put the health and safety of staff, partners and patients first.

Share information

Xbrane's share capital at the end of the period was SEK 5.0m (3.5) divided into 22,200,415 shares (22,200,415). The quota value of all shares is SEK 0.224, and all the shares have equal rights to the Company's assets and earnings. Since September 23, 2019, Xbrane's shares have been listed on the Nasdaq OMX main list and Xbrane had around 5,300 shareholders on the balance sheet date. The closing price for the share on the balance sheet date was SEK 91.0 generating a market capitalization of SEK 2,020m.

Organization and employees

Xbrane is headquartered in Solna, outside of Stockholm, Sweden, where the Company also has a laboratory for the research and development of biosimilars. Xbrane has one wholly-owned subsidiary, Primm Pharma, located in Milan, Italy. As mentioned above, the sale of the subsidiary is ongoing. On the balance sheet date, the Group had 51 (40) employees, 45 (31) of whom were employed by the parent company and 6 (9) by the subsidiary.

Capital Markets Day

Xbrane is holding a virtual capital markets day for investors, analysts and journalists on May 17, 2021 at 14.00–15.30 CET, where Xbrane will expand upon its strategy and the next step in its ambition to become a leading global biosimilar developer.

Annual General Meeting

The 2021 Annual General Meeting will take place on May 6, 2021 in Baker McKenzie's premises at Vasagatan 7, Stockholm.

Auditor's review

This interim report has not been subject to review by the company's auditor.

Consolidated income statement

Amounts in SEK thousand Notes 2021
Q1
2020
Q1*
2020
Full year
Revenues 2,3
Cost of goods sold
Gross profit
Other income 2,3 4,082 4,902 20,652
Selling and distribution expenses
Administrative expenses –8,840 –7,035 –31,189
Research and development expenses –46,020 –47,543 –203,301
Other expenses –631 –1,952 –11,419
Operating profit/loss 2 –51,410 –51,628 –225,257
Financial income 512
Financial costs –370 –206 –769
Net financial costs 2 142 –206 –769
Profit/loss before tax –51,267 –51,833 –226,026
Income tax expense
Profit/loss for the period –51,267 –51,833 –226,026
Profit/loss attributable to:
– Owners of the Company –51,267 –51,833 –226,026
– Non-controlling interests
Total comprehensive income for the period –51,267 –51,833 –226,026
Earnings per share
– Basic earnings per share (SEK) –2.31 –3.36 –12.48
– Diluted earnings per share (SEK) –2.31 –3.36 –12.48
Number of outstanding shares at the end of the reporting period
– Before dilution 22,200,415 15,415,199 22,200,415
– After dilution 22,200,415 15,415,199 22,200,415
Average number of outstanding shares
– Before dilution 22,200,415 15,415,199 18,113,313
– After dilution 22,200,415 15,415,199 18,113,313

Consolidated income statement and other comprehensive income

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Total comprehensive income for the period –51,267 –51,833 –226,026
Other comprehensive income
Items that have been transferred and can be transferred to profit/loss for the period
Reclassification of foreign currency translation differences 1,259 3,820 –2,774
Comprehensive income for the period 1,259 3,820 –2,774
Total comprehensive profit/loss attributable to:
– Owners of the Company –50,009 –48,013 -228,801
– Non-controlling interests
Total comprehensive income for the period –50,009 –48,013 –228,801

Consolidated statement of financial position

Amounts in SEK thousand 03-31-2021 03-31-2020* 12-31-2020
ASSETS
Goodwill 64,543 58,453
Intangible assets 5,153 4,083
Property, plant and equipment 13,375 6,612 8,166
Right of use assets 47,421 8,471 5,969
Trade and other receivables 12,770 9,501 12,610
Non-current assets 73,566 94,280 89,281
Trade receivables 611 42,886 51,384
Other receivables 8,417 4,893 6,981
Prepaid expenses and accrued income 79,415 84,825 72,978
Cash and cash equivalents 239,244 84,470 243,139
Assets held for sale 72,501
Current assets 400,187 217,074 374,482
TOTAL ASSETS 473,754 311,354 463,763
EQUITY
Share capital
4,977 3,456 4,977
Share premium 774,395 448,331 773,724
Reserves 5,203 10,539 3,945
Retained earnings including the loss of the period –576,205 –350,744 –524,938
Equity attributable to owners of the Company 208,370 111,582 257,708
Non-controlling interests
Total equity 208,370 111,582 257,708
LIABILITIES
Leasing liability 40,793 5,644 3,995
Non-current non-interest-bearing liabilities 8,337 4,433 8,257
Provisions 5,021 4,810
Non-current liabilities 49,130 15,098 17,062
Trade and other payables 49,339 43,650 29,546
Other current liabilities 1,573 1,321 1,328
Leasing liability 6,995 3,063 2,265
Deferred income/revenue 150,764 136,641 155,853
Assets held for sale 7,583
Current liabilities 216,254 184,675 188,993
TOTAL LIABILITIES 265,384 199,773 206,055
TOTAL EQUITY AND LIABILITIES 473,754 311,354 463,763

Consolidated cash flow statement

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Cash flow from operating activities
Profit/loss before tax –51,267 –51,833 –226,026
Adjustments for items not included in cash flow 2,086 –2,471 6,247
Paid income taxes
Total –49,181 –54,304 –219,779
Increase (–)/Decrease (+) of trade and other receivables 38,029 –49,227 –51,325
Increase (+)/Decrease (–) of trade and other payables 19,098 20,254 32,697
Cash flow from current operations 7,946 –83,277 –238,407
Cash flow from investing activities
Acquisition of property, plant and equipment –8,747 –42 –3,855
Cash flow from investing activities –8,747 –42 –3,855
Cash flow from financing activities
Proceeds from exercise of share options 3
New share issue 346,444
Transaction expense –20,584
Amortization of loan –12 –12
Amortization of lease liability –1,144 –798 –3,127
Cash flow from financing activities –1,144 –810 322,724
Cash flow for the period –1,945 –84,129 80,461
Cash and cash equivalents in assets held for sale –896
Cash and cash equivalents at beginning of period 243,139 164,197 164,197
Exchange rate differences in cash and cash equivalents –1,054 4,402 –1,520
Cash and cash equivalents at end of period 239,244 84,470 243,139

Consolidated statement of changes in equity

Amounts in SEK thousand Share
capital
Share
premium
Translation
reserve
Retained
earnings
Total
equity
Balance at January 1, 2021 4,997 773,724 3,945 –524,938 257,708
Total comprehensive income for the period
Profit/loss for the period –51,267 –51,267
Other comprehensive income for the period 1,259 1,259
Total comprehensive income for the period 1,259 –51,267 –50,009
Transactions with group shareholder
Share savings program 671 671
Total contributions from and distributions to shareholders 671 671
Balance at March 31, 2021 4,997 774,395 5,203 –576,205 208,370
Amounts in SEK thousand Share
capital
Share
premium
Translation
reserve
Retained
earnings
Total
equity
Balance at January 1, 2020 3,456 448,089 6,719 –273,941 184,323
Recalculation* –24,970 –24,970
Balance at January 1, 2020 after recalculation 3,456 448,089 6,719 –298,911 159,352
Total comprehensive income for the period
Profit/loss for the period –51,833 –51,833
Other comprehensive income for the period 3,820 3,820
Total comprehensive income for the period 3,820 –51,833 –48,013
Transactions with group shareholder
Share savings program 242 242
Total contributions from and distributions to shareholders 242 242
Balance at March 31, 2020 3,456 448,331 10,539 –350,744 111,582
Amounts in SEK thousand Share
capital
Share
premium
Translation
reserve
Retained
earnings
Total
equity
Balance at January 1, 2020 3,456 448,089 6,719 –273,941 184,323
Recalculation* –24,970 –24,970
Balance at January 1, 2020 after recalculation 3,456 448,089 6,719 –298,911 159,352
Total comprehensive income for the period
Profit/loss for the period –226,026 –226,026
Other comprehensive income for the period –2,774 –2,774
Total comprehensive income for the period –2,774 –226,202 –228,801
Transactions with group shareholder
New share issue 1,519 324,342 325,860
– New share issue 1,519 344,926 346,444
– Transaction expenses –20,584 –20,584
Share savings program 3 1,293 1,296
Total contributions from and distributions to shareholders 1,521 325,635 327,156
Balance at December 31, 2020 4,997 773,724 3,945 –524,938 257,708

Income statement, Parent company

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Revenues
Cost of goods sold
Gross profit
Other income 4,647 4,884 17,730
Selling and distribution expenses
Administrative expenses –8,146 –5,769 –26,567
Research and development expenses –45,391 –45,804 –197,690
Other expenses –545 –1,899 –11,203
Operating profit/loss –49,435 –48,588 –217,730
Financial items
Financial income 512 11 11
Impairment loss on shares in subsidiary –4,554 –38,400
Financial expenses –71 –70 –296
Net finance costs –4,113 –59 –38,685
Profit/loss before tax –53,547 –48,647 –256,415
Income tax expense
Total comprehensive income for the period –53,547 –48,647 –256,415

Parent company statement of comprehensive income

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Profit/loss for the period –53,547 –48,647 –256,415
Other comprehensive income
Total comprehensive income for the period –53,547 –48,647 –256,415

Balance Sheet, Parent company

Amounts in SEK thousand 03-31-2021 03-31-2020* 12-31-2020
ASSETS
Fixed assets
Non-current assets Property, plant and equipment 13,375 3,254 5,212
Financial non-current assets
Shares in group companies 74,066 105,638 74,066
Other non-current receivables 12,770 9,501 12,610
Total financial non-current assets 86,836 115,139 86,676
Total non-current assets 100,211 118,393 91,888
Current assets
Current receivables
Trade receivables 611 42,886 51,384
Other receivables 8,417 2,881 5,148
Prepaid expenses and accrued income 79,415 84,710 72,935
Total current receivables 88,443 130,476 129,467
Cash and bank 239,244 83,701 242,247
Current assets 327,687 214,177 371,715
TOTAL ASSETS 427,898 332,570 463,603
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 4,977 3,456 4,977
Unrestricted equity
Share premium 775,081 449,017 774,410
Retained earnings –508,889 –252,474 -252,474
Profit/loss for the period –53,547 –48,647 -256,415
Total equity 217,622 151,353 270,498
Non-current liabilities
Non-current interest-bearing liabilities 8,337 4,433 8,257
Non-current non-interest-bearing liabilities 8,337 4,433 8,257
Current liabilities
Liabilities to subsidiaries 263 160 285
Trade and other payables 49,339 42,981 29,421
Other current liabilities 1,573 1,194 1,192
Deferred income/revenue 150,764 132,449 153,949
Current liabilities 201,939 176,784 184,847
TOTAL LIABILITIES 210,276 181,217 193,104
TOTAL EQUITY AND LIABILITIES 427,898 332,570 463,603

Cash flow statement, Parent company

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Cash flows from operating activities
Earnings before income and tax –53,547 –48,647 –256,415
Adjustments for items not included in cash flow 2,950 –3,829 39,601
Paid income taxes
Total –50,597 –52,476 –216,814
Increase (–)/Decrease (+) of trade and other receivables 40,866 –50,282 –52,381
Increase (+)/Decrease (–) of trade and other payables 19,193 21,757 36,709
Cash flow from current operations 9,462 –81,001 –232,486
Cash flow from investing activities
Investments in subsidiaries –4,554 –3,318 –10,148
Acquisition of property, plant and equipment –8,747 –42 –3,503
Cash flow from investing activities –13,301 –3,360 –13,651
Cash flow from financing activities
Exercised share options by employees 3
New share issue 346,444
Transaction expense –20,584
Cash flow from financing activities 325,863
Cash flow for the period –3,839 –84,360 79,726
Cash and cash equivalents at beginning of period 242,247 163,601 163,601
Exchange rate differences in cash and cash equivalents 835 4,460 –1,079
Cash and cash equivalents at end of period 239,244 83,701 242,247

Notes

NOTE 1 Accounting principles

This interim report has been prepared in accordance with IAS 34, Interim Financial Reporting, as well as applicable regulations from the annual accounts act. The interim report for the parent company has been prepared according to the Annual Accounts Act, chapter 9, Interim Report. For the Group and the parent company the same accounting principles and calculation bases as the previous annual report has been applied with the exception of the additional applications principles for accounting for license revenues described below on the new license agreements which is different in nature to licensing agreements previously reported. Information according to IAS 34.16A is included in these financial statements and related notes as well in other parts of this interim report.

Assets and liabilities held for sale and discontinued operations

Assets are classified as held for sale if their value, within one year, will be recovered through sale and not through continued use in the business. At the time of reclassification, assets and liabilities are valued at the lower of fair value, after deduction of selling expenses and the carrying amount. The assets are no longer depreciated after reclassification. The profit is limited to an amount corresponding to previously made write-downs. Gains and losses reported on revaluation and divestment are reported in the profit for the period.

When an independent line of business or a significant activity within a geographical area is divested, it is classified as a discontinued operation. The sale, or the time when the business meets the criteria for being classified as held for sale, determines when the business is to be classified as a discontinued business. The profit/loss after tax from discontinued operations is reported as a separate item in the income statement.

NOTE 2 Segment reporting

Report of revenue, operating profit/loss and profit/loss before tax per segment.

Amounts in SEK thousand 2021
Q1
2020
Q1
2020
Full year
Other revenues per segment
Biosimilars 2,642 6,787
Long-acting injectable drugs
Unallocated revenue 1,440 4,902 13,865
Total 4,082 4,902 20,652
Operating profit or loss
per segment
Biosimilars -42,520 –45,484 –190,497
Long-acting injectable drugs -858 –2,060 –6,017
Unallocated revenue -8,031 –4,084 –28,743
Operating profit/loss -51,410 –51,628 –225,257
Net finance costs
Biosimilars -290 –114 –406
Long-acting injectable drugs -8 –33 –90
Unallocated revenue 441 –59 –274
Total 142 –206 –769
Profit/loss before tax –51,267 –51,833 –226,026
Depreciation, amortization
and write downs
Biosimilars 1,888 1,071 4,337
Long-acting injectable drugs 452 470 1,799
Unallocated revenue 76 113 430
Total 2,416 1,654 6,566

NOTE 3 Distribution of Income

Q1 2021
Amounts in
SEK thousand
Biosimilars Long-acting
injectable
drugs
Unallocated/
administration
Group
Income per region
Middle East
Asia
Europe 1,199 1,199
United States 2,642 241 2,883
Total 2,642 1,440 4,082
Income per category
Pharmaceuticals
Milestone payments
from partners
2,642 2,642
Services and other 1,440 1,440
Total 2,642 1,440 4,082
Q1 2020
Amounts in
SEK thousand
Biosimilars Long-acting
injectable
drugs
Unallocated/
administration
Group
Income per region
Middle East
Asia
Europe 4,848 4,848
United States 54 54
Total 4,902 4,902
Income per category
Pharmaceuticals
Milestone payments
from partners
Services and other 4,902 4,902
Total 4,902 4,902
Full year 2020
Amounts in
SEK thousand
Biosimilars Long-acting
injectable
drugs
Unallocated/
administration
Group
Income per region
Middle East
Asia
Europe 13,693 13,693
United States 6,787 171 6,958
Total 6,787 13,865 20,652
Income per category
Total 6,787 13,865 20,652
Services and other 13,865 13,865
from partners 6,787 6,787
Milestone payments
Pharmaceuticals

NOTE 4 Transactions with related parties

Since 2019, STADA Arnzeimittel AG has been a shareholder in Xbrane (see the list of owners on page 4). Transactions with STADA relate to shared costs for the collaboration agreement with Xlucane.

NOTE 5 Financial instruments

The below table shows the different valuation levels of the financial assets and liabilities that are reported at fair value in the consolidated balance sheet. For a description of how fair value has been calculated, see Note 25 in the 2020 Annual Report. All entries assessed at fair value are defined as being Level 2. The fair value of financial assets and liabilities to acquisition value or accrued acquisition value is estimated to correspond to book values in all material aspects.

The total value of the currency derivatives held shows a neutral value at the balance sheet date. During the first quarter, no transfers were made between the different valuation levels.

Group

Amounts in SEK thousand 03-31-2021
Level 2
03-31-2020
Level 2
12-31-2020
Level 2
Financial assets
Other current receivables 101
Whereof currency derivatives 101
Total financial assets 101

Financial liabilities

Total financial liabilities 101
Whereof currency derivatives 101
Other current payables 101

Certification

The Board of Directors and the CEO hereby certify that this Interim report provides a true and fair view of the Parent Company and the Group's operations, position and results and describes significant risks and uncertainties faced by the Company and the companies that are part of the Group.

Stockholm, May 6, 2021

Anders Tullgren Chairman of the Board

Eva Nilsagård Board member

Peter Edman Board member

Mats Thorén Board member Karin Wingstrand Board member

Giorgio Chivirí Board member

Ivan Cohen-Tanugi Board member

Martin Åmark CEO

Alternative performance measures

The Company presents certain financial measures in the interim report that are not defined in accordance with IFRS. The Company believes that these measures provide valuable supplementary information to investors and the Company's management as they enable evaluation of the Company's performance. Since not all companies calculate financial measurements in the same way, these are not always comparable to measurements used by other companies. These financial measures should therefore not be seen as replace- ment for measures that are defined in accordance with IFRS. The tables below show measurements that are not defined in accordance with IFRS.

Gross margin

The gross margin is calculated as gross result in relation to the net sales. The gross margin is net sales minus cost of goods sold.

2021
Q1
2020
Q1*
2020
Full year
N/A N/A N/A

EBITDA

Shows the business's earning ability from current operations without regard to capital structure and tax situation and is intended to facilitate comparisons with other companies in the same industry.

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Operating profit or loss –51,410 –51,628 –225,257
Depreciation, amortization and
write downs
–2,416 –1,653 –6,566
EBITDA –48,993 –49,975 –218,691

Research and development expenses as a percentage of operating expenses

The company's direct costs for research and development relate to personnel, materials and external services costs. Research an development expenses as a percentage of operating expenses show the proportion of operating expenses relating to research and development. This is calculated by dividing research and development expenses by total operating expenses. Total operating expen- ses comprise of selling and distribution expenses, administrative expenses, research and development expenses and other operating expenses.

Amounts in SEK thousand 2021
Q1
2020
Q1*
2020
Full year
Research and development expenses –46,020 –47,543 –203,301
Total operating expenses –55,491 –56,530 –245,909
R&D expenses as a percentage
of operating expenses
83% 84% 83%

Equity ratio

Equity ratio is the proportion of assets funded by equity to show the company's long-term ability to pay, i.e. equity through total assets.

Amounts in SEK thousand 03-31-2021 03-31-2020* 12-31-2020
Total equity 208,370 111,582 257,708
Total assets 473,754 311,354 463,763
Equity ratio 44% 36% 56%

For further information: Martin Åmark, CEO [email protected] +46 76-309 37 77

Anette Lindqvist CFO/IR [email protected] +46 76-325 60 90

www.xbrane.com

Financial calendar

Annual General Meeting 2021 May 6, 2021 Interim report January–June 2021 August 13, 2021 Interim report January–September 2021 October 29, 2021 Year end report 2021 February 16, 2022

Appendix 1 Adjustment Retroactive adjustment of revenue recognition of STADA's share of research and development costs

In 2018, Xbrane signed a cooperation agreement with STA-DA for Xlucane where both parties share costs equally for the development of Xlucane. Prior to the registration-based phase III study Xplore, the original drug Lucentis® was purchased for use in the study and for research and development purposes. The costs for Lucentis® will be charged to the results as it is used in the ongoing Xplore-studie. The recognition of STADA's share of the cost has been done too early, which has resulted in lower research and development expenses, due to the recognition of STADA's share, and advance payments from STADA, which are reported under accrued costs and prepaid income, have also been deducted too early. The correction is an adjustment of when in time the revenues are to be recognized. All advances from STADA are estimated to be recognized as revenues within twelve months.

In connection with the interim report for January-June 2020, a correction has been made for this, which runs from the third quarter of 2018 to the first quarter of 2020. The correction leads to an increase in research and development expenses for the last seven quarters, a reduction in equity and an increase in accrued income and prepaid expenses.

Advance payments from STADA will be recognized as revenue against research and development expenses for the remainder of the Xplore study and thus the advance will not be refunded to STADA.

The reports listed below are shown in following order to demonstrate the quantifiable effects:

  • The consolidated income statement and report on comprehensive income for Q1 2020, Q 1–4 2019 and full year 2019.
  • The consolidated balance sheet on the balance sheet date for March 31, 2020, December 31, 2019, September 30, 2019, June 30, 2019, and March 31, 2019.
  • The parent company's income statement for Q1 2020, Q 1–4 2019 and full year 2019.
  • The parent company's balance sheet on the balance sheet date for March 31, 2020, December 31, 2019, September 30, 2019, June 30, 2019, and March 31, 2019.

Group – January–March 2020

Consolidated income statement

Amounts in SEK thousand After correction
Q1 2020
Correction Before correction
Q1 2020
Research and development expenses -47,543 -2,947 -44,597
Operating profit/loss -51,628 -2,947 -48,681
Profit/loss before tax -51,833 -2,947 -48,887
Total comprehensive income for the period -51,833 -2,947 -48,887
Earnings per share
- Basic earnings per share (SEK) -3.36 -0.19 -3.17
- Diluted earnings per share (SEK) -3.36 -0.19 -3.17

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q1 2020
Correction Before correction
Q1 2020
Total comprehensive income for the period -51,833 -2,947 -48,887
Other comprehensive income 3,820 - 3,820
Total comprehensive income for the period -48,013 -2,947 -45,067

Consolidated statement of financial position

Amounts in SEK thousand After correction
03-31-2020
Correction Before correction
03-31-2020
TOTAL ASSETS 311,354 - 311,354
Retained earnings -350,744 -27,917 -322,827
Equity attributable to owners of the Company 111,582 -27,917 139,499
Deferred income/revenue 136,641 27,917 108,724
Current liabilities 184,675 27,917 156,758
Total liabilities 199,773 27,917 171,856
TOTAL EQUITY AND LIABILITIES 311,354 - 311,354

In the Group's cash flow for Q1 2020, profit before tax has decreased by SEK 2,947 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – January–December 2019

Consolidated income statement

Amounts in SEK thousand After correction
2019
Correction Before correction
2019
Research and development expenses -137,665 -21,952 -115,713
Operating profit/loss -186,572 -21,952 -164,620
Profit/loss before tax -187,989 -21,952 -166,037
Total comprehensive income for the period -187,989 -21,952 -166,037
Earnings per share
- Basic earnings per share (SEK) -16,80 -1,96 -14,84
- Diluted earnings per share (SEK) -16,80 -1,96 -14,84

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
2019
Correction Before correction
2019
Total comprehensive income for the period -187,989 -21,952 -166,037
Other comprehensive income 1,171 - 1,171
Total comprehensive income for the period -186,818 -21,952 -164,866

Consolidated statement of financial position

Amounts in SEK thousand After correction
12-31-2019
Correction Before correction
12-31-2019
TOTAL ASSETS 338,940 - 338,940
Retained earnings -298,912 -24,971 -273,941
Equity attributable to owners of the Company 159,352 -24,971 184,323
Deferred income/revenue 137,431 24,971 112,460
Current liabilities 164,587 24,971 139,616
Total liabilities 179,588 24,971 154,617
TOTAL EQUITY AND LIABILITIES 338,940 - 338,940

In the Group's cash flow for the full year 2019, profit before tax has decreased by SEK 21,952 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – October–December 2019

Consolidated income statement

Amounts in SEK thousand After correction
Q4 2019
Correction Before correction
Q4 2019
Research and development expenses -36,347 -10,749 -25,598
Operating profit/loss -66,322 -10,749 -55,573
Profit/loss before tax -66,675 -10,749 -55,926
Total comprehensive income for the period -66,675 -10,749 -55,926
Earnings per share
- Basic earnings per share (SEK) -5.96 -0.96 -5.00
- Diluted earnings per share (SEK) -5.96 -0.96 -5.00

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q4 2019
Correction Before correction
Q4 2019
Total comprehensive income for the period -66,675 -10,749 -55,926
Other comprehensive income -2,790 -2,790
Total comprehensive income for the period -69,465 -10,749 -58,716

In the Group's cash flow for Q4 2019, profit before tax has decreased by SEK 10,749 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – January–September 2019

Consolidated income statement

Amounts in SEK thousand After correction
Q1–3 2019
Correction Before correction
Q1–3 2019
Research and development expenses -101,318 -11,203 -90,115
Operating profit/loss -120,249 -11,203 -109,046
Profit/loss before tax -121,314 -11,203 -110,111
Total comprehensive income for the period -121,314 -11,203 -110,111
Earnings per share
- Basic earnings per share (SEK) -12.42 -1.15 -11.27
- Diluted earnings per share (SEK) -12.42 -1.15 -11.27

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q1–3 2019
Correction Before correction
Q1–3 2019
Total comprehensive income for the period -121,314 -11,203 -110,111
Other comprehensive income 3,815 - 3,815
Total comprehensive income for the period -117,499 -11,203 -106,296

Consolidated statement of financial position

Amounts in SEK thousand After correction
09-30-2019
Correction Before correction
09-30-2019
TOTAL ASSETS 406,410 - 406,410
Retained earnings -232,235 -14,221 -218,014
Equity attributable to owners of the Company 227,499 -14,221 241,720
Deferred income/revenue 139,617 14,221 125,396
Current liabilities 162,804 14,221 148,583
Total liabilities 178,911 14,221 164,690
TOTAL EQUITY AND LIABILITIES 406,410 - 406,410

In the Group's cash flow for Q1–3 2019, profit before tax has decreased by SEK 11,203 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – July–September 2019

Consolidated income statement

Amounts in SEK thousand After correction
Q3 2019
Correction Before correction
Q3 2019
Research and development expenses -31,354 -5,604 -25,750
Operating profit/loss -37,731 -5,604 -32,127
Profit/loss before tax -38,002 -5,604 -32,398
Total comprehensive income for the period -38,002 -5,604 -32,398
Earnings per share
- Basic earnings per share (SEK) -2.63 -0.39 -2.24
- Diluted earnings per share (SEK) -2.63 -0.39 -2.24

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q3 2019
Correction Before correction
Q3 2019
Total comprehensive income for the period -38,002 -5,604 -32,398
Other comprehensive income 1,382 - 1,382
Total comprehensive income for the period -36,620 -5,604 -31,016

In the Group's cash flow for Q3 2019, profit before tax has decreased by SEK 5,604 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – January–June 2019

Consolidated income statement

Amounts in SEK thousand After correction
Q1–2 2019
Correction Before correction
Q1–2 2019
Research and development expenses -69,964 -5,599 -64,365
Operating profit/loss -82,518 -5,599 -76,919
Profit/loss before tax -83,311 -5,599 -77,712
Total comprehensive income for the period -83,311 -5,599 -77,712
Earnings per share
- Basic earnings per share (SEK) -9.90 -0.67 -9.24
- Diluted earnings per share (SEK) -9.90 -0.67 -9.24

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q1–2 2019
Correction Before correction
Q1–2 2019
Total comprehensive income for the period -83,311 -5,599 -77,712
Other comprehensive income 2,433 - 2,433
Total comprehensive income for the period -80,878 -5,599 -75,279

Consolidated statement of financial position

Amounts in SEK thousand After correction
06-30-2019
Correction Before correction
06-30-2019
TOTAL ASSETS 455,189 - 455,189
Retained earnings -194,232 -8,617 -185,615
Equity attributable to owners of the Company 279,075 -8,617 287,692
Deferred income/revenue 123,788 8,617 115,171
Current liabilities 163,794 8,617 155,177
Total liabilities 176,114 8,617 167,497
TOTAL EQUITY AND LIABILITIES 455,189 - 455,189

In the Group's cash flow for Q1–2 2019, profit before tax has decreased by SEK 5,599 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – April–June 2019

Consolidated income statement

Amounts in SEK thousand After correction
Q2 2019
Correction Before correction
Q2 2019
Research and development expenses -40,804 -2,962 -37,842
Operating profit/loss -46,949 -2,962 -43,987
Profit/loss before tax -47,361 -2,962 -44,399
Total comprehensive income for the period -47,361 -2,962 -44,399
Earnings per share
- Basic earnings per share (SEK) -5.63 -0.35 -5.28
- Diluted earnings per share (SEK) -5.63 -0.35 -5.28

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q2 2019
Correction Before correction
Q2 2019
Total comprehensive income for the period -47,361 -2,962 -44,399
Other comprehensive income 1,144 - 1,144
Total comprehensive income for the period -46,217 -2,962 -43,255

In the Group's cash flow for Q2 2019, profit before tax has decreased by SEK 1,502 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Group – January–March 2019

Consolidated income statement

Amounts in SEK thousand After correction
Q1 2019
Correction Before correction
Q1 2019
Research and development expenses -29,160 -2,637 -26,523
Operating profit/loss -35,569 -2,637 -32,932
Profit/loss before tax -35,950 -2,637 -33,313
Total comprehensive income for the period -35,950 -2,637 -33,313
Earnings per share
- Basic earnings per share (SEK) -5.68 -0.42 -5.26
- Diluted earnings per share (SEK) -5.68 -0.42 -5.26

Consolidated income statement and other comprehensive income

Amounts in SEK thousand After correction
Q1 2019
Correction Before correction
Q1 2019
Total comprehensive income for the period -35,950 -2,637 -33,313
Other comprehensive income 1,289 - 1,289
Total comprehensive income for the period -34,661 -2,637 -32,024

Consolidated statement of financial position

Amounts in SEK thousand After correction
03-31-2019
Correction Before correction
03-31-2019
TOTAL ASSETS 294,165 - 294,165
Retained earnings -146,871 -5,655 -141,216
Equity attributable to owners of the Company 95,463 -5,655 101,118
Deferred income/revenue 103,219 5,655 97,564
Current liabilities 142,597 5,655 136,942
Total liabilities 198,702 5,655 193,047
TOTAL EQUITY AND LIABILITIES 294,165 - 294,165

In the Group's cash flow for Q1 2019, profit before tax has decreased by SEK 2,637 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – January–March 2020

Income statement, parent company

Amounts in SEK thousand After correction
Q1 2020
Correction Before correction
Q1 2020
Research and development expenses -45,804 -2,947 -42,857
Operating profit/loss -48,588 -2,947 -45,641
Profit/loss before tax -48,647 -2,947 -45,700
Total comprehensive income for the period -48,647 -2,947 -45,700

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

Balance sheet, Parent company

Amounts in SEK thousand After correction
03-31-2020
Correction Before correction
03-31-2020
TOTAL ASSETS 332,570 - 332,570
Retained earnings -252,474 -24,971 -227,503
Profit/loss for the period -48,647 -2,947 -45,700
Total equity 151,353 -27,917 179,270
Deferred income/revenue 132,449 27,917 104,532
Current liabilities 176,784 27,917 148,867
TOTAL LIABILITIES 181,217 27,917 153,300
TOTAL EQUITY AND LIABILITIES 332,570 - 332,570

In the parent company's cash flow for Q1 2020, profit before tax has decreased by SEK 2,947 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – January–December 2019

Income statement, parent company

Amounts in SEK thousand After correction
2019
Correction Before correction
2019
Research and development expenses -126,509 -21,952 -104,557
Operating profit/loss -153,777 -21,952 -131,825
Profit/loss before tax -154,767 -21,952 -132,815
Total comprehensive income for the period -154,767 -21,952 -132,815

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

Balance sheet, Parent company

Amounts in SEK thousand After correction
12-31-2019
Correction Before correction
12-31-2019
TOTAL ASSETS 359,313 - 359,313
Retained earnings -97,707 -3,019 -94,688
Profit/loss for the period -154,767 -21,952 -132,815
Total equity 199,757 -24,971 224,728
Deferred income/revenue 132,298 24,971 107,327
Current liabilities 155,383 24,971 130,412
TOTAL LIABILITIES 159,556 24,971 134,585
TOTAL EQUITY AND LIABILITIES 359,313 - 359,313

In the parent company's cash flow for full year 2019, profit before tax has decreased by SEK 21,952 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – October–December 2019

Income statement, parent company

Amounts in SEK thousand After correction
Q4 2019
Correction Before correction
Q4 2019
Research and development expenses -34,653 -10,749 -23,904
Operating profit/loss -45,642 -10,749 -34,893
Profit/loss before tax -45,752 -10,749 -35,003
Total comprehensive income for the period -45,752 -10,749 -35,003

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

In the Parent company's cash flow for Q4 2019, profit before tax has decreased by SEK 10,749 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – January–September 2019

Income statement, parent company

Amounts in SEK thousand After correction
Q1–3 2019
Correction Before correction
Q1–3 2019
Research and development expenses -91,856 -11,203 -80,653
Operating profit/loss -108,135 -11,203 -96,932
Profit/loss before tax -109,015 -11,203 -97,812
Total comprehensive income for the period -109,015 -11,203 -97,812

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

Balance sheet, Parent company

Amounts in SEK thousand After correction
09-30-2019
Correction Before correction
09-30-2019
TOTAL ASSETS 402,192 - 402,192
Retained earnings -97,707 -3,019 -94,688
Profit/loss for the period -109,015 -11,203 -97,812
Total equity 244,336 -14,221 258,557
Deferred income/revenue 135,395 14,221 121,174
Current liabilities 153,565 14,221 139,344
TOTAL LIABILITIES 157,856 14,221 143,635
TOTAL EQUITY AND LIABILITIES 402,192 - 402,192

In the parent company's cash flow for Q1–3 2019, profit before tax has decreased by SEK 11,203 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – July–December 2019

Income statement, parent company

After correction Before correction
Amounts in SEK thousand Q3 2019 Correction Q3 2019
Research and development expenses -27,903 -5,604 -22,299
Operating profit/loss -33,668 -5,604 -28,064
Profit/loss before tax -33,778 -5,604 -28,174
Total comprehensive income for the period -33,778 -5,604 -28,174

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

In the Parent company's cash flow for Q3 2019, profit before tax has decreased by SEK 5,604 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – January–June 2019

Income statement, parent company

Amounts in SEK thousand After correction
Q1-2 2019
Correction Before correction
Q1–2 2019
Research and development expenses -63,953 -5,599 -58,354
Operating profit/loss -74,467 -5,599 -68,868
Profit/loss before tax -75,237 -5,599 -69,638
Total comprehensive income for the period -75,237 -5,599 -69,638

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

Balance sheet, Parent company

Amounts in SEK thousand After correction
06-30-2019
Correction Before correction
06-30-2019
TOTAL ASSETS 453,394 - 453,394
Retained earnings -97,707 -3,019 -94,688
Profit/loss for the period -75,237 -5,599 -69,638
Total equity 293,068 -8,617 301,686
Deferred income/revenue 119,472 8,617 110,854
Current liabilities 156,104 8,617 147,486
TOTAL LIABILITIES 160,328 8,617 151,709
TOTAL EQUITY AND LIABILITIES 453,394 - 453,394

In the Parent company's cash flow for Q1–2 2019, profit before tax has decreased by SEK 5,599 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – April–June 2019

Income statement, parent company

Amounts in SEK thousand After correction
Q2 2019
Correction Before correction
Q2 2019
Research and development expenses -38,234 -2,962 -35,272
Operating profit/loss -43,367 -2,962 -40,405
Profit/loss before tax -43,724 -2,962 -40,762
Total comprehensive income for the period -43,724 -2,962 -40,762

In the Parent company's cash flow for Q2 2019, profit before tax has decreased by SEK 2,962 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Parent company – January–March 2019

Income statement, parent company

Amounts in SEK thousand After correction
Q1 2019
Correction Before correction
Q1 2019
Research and development expenses -25,719 -2,637 -23,082
Operating profit/loss -31,107 -2,637 -28,470
Profit/loss before tax -31,521 -2,637 -28,884
Total comprehensive income for the period -31,521 -2,637 -28,884

The Parent Company has no transactions in other comprehensive income, which is why the profit for the year corresponds to the profit for the year above.

Balance sheet, Parent company

Amounts in SEK thousand After correction
03-31-2019
Correction Before correction
03-31-2019
TOTAL ASSETS 291,620 - 291,620
Retained earnings -97,707 -3,019 -94,688
Profit/loss for the period -31,521 -2,637 -28,884
Total equity 106,957 -5,655 112,612
Deferred income/revenue 99,962 5,655 94,307
Current liabilities 135,545 5,655 129,890
TOTAL LIABILITIES 184,663 5,655 179,008
TOTAL EQUITY AND LIABILITIES 291,620 - 291,620

In the Parent company's cash flow for Q1 2019, profit before tax has decreased by SEK 2,637 thousand and changes in operating liabilities have increased by the corresponding amount. The total cash flow has thus not been affected.

Talk to a Data Expert

Have a question? We'll get back to you promptly.