Quarterly Report • May 6, 2021
Quarterly Report
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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."
Detailed information about the above events can be found on page 6.
• There have been no significant events after the end of the quarter.
| 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 |
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®)
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.
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.
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.
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.
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.
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.
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
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 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 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 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.
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
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.
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 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.
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.
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 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 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 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.
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 amounted to SEK 49.3m (43.7). The increase is due to a growth in business and activities.
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.
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).
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.
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 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.
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 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.
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.
There have been no significant events after the end of the quarter.
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.
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.
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.
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.
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.
The 2021 Annual General Meeting will take place on May 6, 2021 in Baker McKenzie's premises at Vasagatan 7, Stockholm.
This interim report has not been subject to review by the company's auditor.
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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 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.
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 | – | – | – | – |
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.
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.
| 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 | – |
| Total financial liabilities | – | 101 | – |
|---|---|---|---|
| Whereof currency derivatives | – | 101 | – |
| Other current payables | – | 101 | – |
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
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.
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 |
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 |
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 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
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
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:
| 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 |
| 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 |
| 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.
| 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 |
| 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 |
| 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.
| 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 |
| 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.
| 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 |
| 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 |
| 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.
| 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 |
| 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.
| 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 |
| 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 |
| 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.
| 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 |
| 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.
| 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 |
| 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 |
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
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.
| 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.
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