Swedish Orphan Biovitrum — Earnings Release 2021

Oct 22, 2021

Growth and pipeline progress

July – September 2021

• Total revenue SEK 3,761 M (2,970), +27 per cent, +29 per cent at constant exchange rates (CER)
• Haematology revenue SEK 2,291 M (2,147), +9 per cent at CER of which Elocta® SEK 1,035 M (1,115), -6 per cent at CER, Alprolix® SEK 430 M (435), unchanged at CER, and Doptelet® SEK 400 M (145), +187 per cent at CER
• Immunology revenue SEK 1,144 M (619), +89 per cent at CER of which Kineret® SEK 516 M (463), +13 per cent at CER, Synagis® SEK 374 M (46), +769 per cent at CER, and Gamifant® SEK 255 M (110), +139 per cent at CER
• EBITA¹ SEK 1,166 M (933), EBITA margin¹ 31 per cent (31)
• Earnings per share (EPS) before dilution SEK 1.60 (0.94)
• Cash flow from operating activities SEK 257 M (381)

January – September 2021

• Total revenue SEK 10,633 M (10,680), unchanged, +7 per cent at CER
• Haematology revenue SEK 6,294 M (6,578), +1 per cent at CER of which Elocta SEK 2,896 M (3,514), -14 per cent at CER, Alprolix SEK 1,281 M (1,286), +4 per cent at CER, and Doptelet SEK 810 M (396), +126 per cent at CER
• Immunology revenue SEK 3,450 M (3,133), +21 per cent at CER of which Kineret SEK 1,608 M (1,493), +16 per cent at CER, Synagis SEK 1,286 M (1,294), +13 per cent at CER, and Gamifant SEK 556 M (346), +78 per cent at CER
• EBITA¹ SEK 3,572 M (4,124), EBITA margin¹ 34 per cent (39)
• EPS before dilution SEK 4.87 (5.92)
• Cash flow from operating activities SEK 3,349 M (4,209)

Significant events after the reporting period

• Aspaveli® (pegcetacoplan) for PNH: positive CHMP opinion in the EU

2021 outlook – refined

• Revenue for the full year 2021 is expected to be in the range of SEK 14,500-15,000 M
• EBITA margin is expected to be in the range of 33-35 per cent of revenue

Financial summary

	Q3	Q3		Jan-Sep	Jan-Sep		Full-year
SEK M	2021	2020	Change	2021	2020	Change	2020
Total revenue	3,761	2,970	27%	10,633	10,680	0%	15,261
Gross profit	2,802	2,339	20%	8,165	8,318	-2%	12,036
Gross margin1	75%	79%		77%	78%		79%
EBITA1	1,166	933	25%	3,572	4,124	-13%	6,700
EBITA adjusted1,2	1,166	933	25%	3,572	4,124	-13%	6,301
EBITA margin1	31%	31%		34%	39%		44%
EBITA margin adjusted1,2	31%	31%		34%	39%		41%
Profit for the period	473	278	70%	1,438	1,743	-18%	3,245
Earnings per share, before dilution, SEK	1.60	0.94	70%	4.87	5.92	-18%	11.01
Earnings per share, before dilution, SEK adjusted1,2,3	1.60	0.94	70%	4.87	5.92	-18%	9.66

1 Alternative Performance Measures (APMs), see page 20 for further information.

²EBITA in 2020 excluding non-recurring items; other operating income related to the reversal of the CVR liability of SEK 399 M.

3 EPS in full-year 2020 excluding the reversal of the CVR liability of SEK 399 M.

Q3 2021 report

Total revenue Q3, SEK M

3,761

Total revenue growth Q3, CER

29%

EBITA margin¹ Q3

31%

CEO statement

We saw continued growth and pipeline progress in the third quarter of 2021, and it is satisfying to see that results are confirming our strategic direction.

Overall, our two main business areas are in solid shape and they progressed as expected. In Haematology, growth in Doptelet sales more than compensated for lower sales of Elocta and Alprolix, where Elocta in particular was impacted by a negative price effect. In Immunology, strong sales growth was driven by Synagis due to an early RSV season as well as strong Gamifant sales, while Kineret continued to show solid double-digit growth.

While the mix of business had a negative impact on the gross margin, the EBITA margin also reflected continued investment in research and development as well as sales and marketing support for ongoing and future launches.

With the above taken together, we refined the financial outlook for 2021 in the preliminary headline announcement on 11 October 2021.

Last week, we were pleased to receive a positive regulatory opinion from the CHMP in the EU for the new medicine Aspaveli for the treatment of adults with PNH. This is a significant pipeline milestone for Sobi and for people living with PNH across Europe.

In early September, Agnafit Bidco AB announced a public cash offer to Sobi's shareholders, of which the outcome is not certain at the time of publishing this report. We continue to focus on our business, to further advancing our pipeline and fulfilling our commitment to provide innovative treatments to patients.

I would like to take this opportunity to thank every colleague in Sobi for their dedication over the past months.

Solna, Sweden, 22 October 2021

Guido Oelkers, President & CEO

Financial performance

Total revenue

Total revenue for July to September ('the quarter') amounted to SEK 3,761 M (2,970), an increase of 27 per cent compared with the same period a year ago and 29 per cent at CER. Growth reflected the benefit of an early start to the respiratory syncytial virus (RSV) season for the use of Synagis in the US as well as advanced deliveries of Doptelet to the Chinese partner Fosun following the inclusion of Doptelet on the national reimbursement drug list in China. Gamifant and recently in-licensed Tegsedi® and Waylivra®, under the agreement with Akcea Therapeutics, also contributed.

Revenue for January to September ('the year-to-date period') was SEK 10,633 M (10,680), unchanged, with an increase of 7 per cent at CER.

	Q3	Q3		Change	Jan-Sep	Jan-Sep		Change	Full-year
SEK M	2021	2020	Change	at CER	2021	2020	Change	at CER	2020
Haematology	2,291	2,147	7%	9%	6,294	6,578	-4%	1%	8,660
Immunology	1,144	619	85%	89%	3,450	3,133	10%	21%	5,415
Specialty Care	326	204	59%	63%	890	968	-8%	-1%	1,186
Total	3,761	2,970	27%	29%	10,633	10,680	0%	7%	15,261

Gross profit

Gross profit for the quarter was SEK 2,802 M (2,339), representing a gross margin of 75 per cent (79). The margin decrease was driven mainly by a mandatory price reduction for Elocta in Germany, high share of low-margin Doptelet sales to China and the new partner medicines Tegsedi and Waylivra. Year-to-date gross profit was SEK 8,165 M (8,318), representing a gross margin of 77 per cent (78).

Operating expenses

Selling and administrative expenses, excluding amortisation and write-downs, amounted to SEK 1,112 M (947) for the quarter, and year to date to SEK 3,106 M (3,007). For the quarter, expenses increased by 18 per cent at CER, reflecting launch preparations for Aspaveli/Empaveli™, increased activities related to Doptelet, Tegsedi and Waylivra.

Research and development expenses amounted to SEK 485 M (405) for the quarter, and year to date to SEK 1,440 M (1,108). The increase for the quarter reflected spending related to development programmes for Aspaveli/Empaveli and SEL-212.

Operating profit

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
SEK M	2021	2020	2021	2020	2020
Total revenue	3,761	2,970	10,633	10,680	15,261
Cost of goods sold	-959	-632	-2,468	-2,362	-3,225
Gross profit	2,802	2,339	8,165	8,318	12,036
Gross margin	75%	79%	77%	78%	79%
Selling and administrative expenses before amortisation and write-downs	-1,112	-947	-3,106	-3,007	-4,099
Research and development expenses	-485	-405	-1,440	-1,108	-1,594
Total operating expenses less amortisation and write-downs	-1,597	-1,351	-4,546	-4,115	-5,693
Other operating income/expenses	-38	-54	-47	-78	357
EBITA	1,166	933	3,572	4,124	6,700
Non-recurring items	–	–	–	–	-399
EBITA adjusted 1	1,166	933	3,572	4,124	6,301
Amortisation and write-downs related to Selling and administrative expenses	-459	-469	-1,364	-1,422	-1,882
EBIT (Operating profit)	708	464	2,208	2,702	4,818

This is non-IFRS financial information. For an IFRS income statement, please refer to the Consolidated statement of comprehensive income.

1 EBITA in full-year 2020 excluding non-recurring items; other operating income related to the reversal of the CVR liability of SEK 399 M.

Operating profit

EBITA for the quarter was SEK 1,166 M (933) and year to date SEK 3,572 M (4,124), corresponding to a margin of 31 per cent (31) and 34 per cent (39), respectively. Amortisation of intangible assets for the quarter amounted to SEK 459 M (469) and year to date to SEK 1,364 M (1,422). EBIT for the quarter amounted to SEK 708 M (464) and year to date to SEK 2,208 M (2,702). EBIT includes a loss of SEK 53 M following the decision not to opt in to the early-stage projects NI-1701 and NI-1801, originally a part of the Novimmune Gamifant acquisition in 2019.

Net financial items

Net financial items amounted to SEK -109 M (-98) for the quarter and year to date to SEK -336 M (-421). The year-to-date improvement reflected lower debt in 2021 and negative exchange rate effects in 2020.

Tax

Income tax amounted to SEK -125 M (-88) for the quarter, corresponding to an effective tax rate of 20.9 per cent (24.0), and year to date to SEK -434 M (-538), corresponding to an effective tax rate of 23.2 per cent (23.6). The lower tax rate was mainly due to capitalisation of losses from prior years.

Profit

Profit totalled SEK 473 M (278) for the quarter and year to date SEK 1,438 M (1,743).

Cash flow

Cash flow from operating activities before changes in working capital amounted to SEK 978 M (884) for the quarter and year to date to SEK 2,500 M (3,319). Changes in working capital for the quarter affected cash flow by SEK -721 M (-503), reflecting increased receivables following the early start of the RSV season. Year-to-date changes in working capital affected cash flow by SEK 849 M (890).

Cash flow from investing activities was SEK -17 M (-1,289) for the quarter and year to date SEK -122 M (-1,436). The 2020 figures include the investment in SEL-212.

Cash and net debt

On 30 September 2021, cash and cash equivalents amounted to SEK 212 M (SEK 404 M on 31 December 2020) with undrawn committed credit facilities totalling SEK 5,583 M (SEK 4,320 M on 31 December 2020) and drawn credit facilities totalling SEK 11,403 M (SEK 14,234 M on 31 December 2020). Net debt at the end of September 2021 amounted to SEK 11,131 M (SEK 13,748 M on 31 December 2020). The decrease in net debt was mainly driven by operating cash flow generated in the period.

Equity

On 30 September 2021, consolidated shareholders' equity was SEK 21,743 M (SEK 20,206 M on 31 December 2020).

Personnel

On 30 September 2021, the number of full-time equivalents was 1,532 (1,509 on 31 December 2020).

Parent company

In the quarter, total revenue for the Parent Company, Swedish Orphan Biovitrum AB (publ), amounted to SEK 2,627 M (2,951), of which Group companies accounted for SEK 1,654 M (1,982). Total revenue year to date amounted to SEK 7,370 M (10,403) of which SEK 4,161 M (5,796) referred to Group companies' sales. The decrease reflected the transfer of the Synagis sales to the US subsidiary during 2020.

Profit amounted to SEK 761 M (1,477) for the quarter and to SEK 1,886 M (4,178) for the year to date. Investing activities affecting cash flow amounted to SEK 16 M (1,296) for the quarter and year to date to SEK 55 M (1,412).

Haematology

Revenue is generated from sales of the medicines Elocta, Alprolix and Doptelet. Revenue is also derived from manufacturing of the drug substance for ReFacto AF®/Xyntha® for Pfizer and royalty from Sanofi's sales of Eloctate® and Alprolix.

Revenue Haematology

	Q3	Q3		Change	Jan-Sep	Jan-Sep		Change	Full-year
SEK M	2021	2020	Change	at CER	2021	2020	Change	at CER	2020
Elocta	1,035	1,115	-7%	-6%	2,896	3,514	-18%	-14%	4,585
Alprolix	430	435	-1%	0%	1,281	1,286	0%	4%	1,705
Royalty	315	314	0%	3%	934	985	-5%	5%	1,301
Doptelet	400	145	176%	187%	810	396	105%	126%	587
Manufacturing	110	138	-20%	-20%	373	398	-6%	-6%	481
Total	2,291	2,147	7%	9%	6,294	6,578	-4%	1%	8,660

Haematology revenue amounted to SEK 2,291 M (2,147) for the quarter, an increase of 7 per cent and 9 per cent at CER. Year-to-date revenue amounted to SEK 6,294 M (6,578), -4 per cent and up 1 per cent at CER.

Elocta sales were SEK 1,035 M (1,115) for the quarter, -7 per cent and -6 per cent at CER. Sales declined due to a mandatory price reduction in Germany, partly offset by patient growth. Patient growth was in low single-digit percentages compared with the same period previous year and patient factor consumption continued the recent positive trend. Year-to-date sales amounted to SEK 2,896 M (3,514), -18 per cent and -14 per cent at CER.

Alprolix sales were SEK 430 M (435) for the quarter, -1 per cent and unchanged at CER. While patient growth continued, sales were offset by de-stocking effects. Year-to-date sales amounted to SEK 1,281 M (1,286), up 4 per cent at CER.

Doptelet sales were SEK 400 M (145) for the quarter, up 176 per cent and 187 per cent at CER. Growth was driven by continued launch progress in the US as well as sales of SEK 214 M to the partner in China. Year-to-date sales amounted to SEK 810 M (396).

Royalty revenue was SEK 315 M (314) for the quarter and SEK 934 M (985) year to date.

ReFacto AF/Xyntha manufacturing revenue totalled SEK 110 M (138) for the quarter and SEK 373 M (398) year to date.

Immunology

Revenue is generated from sales of the medicines Kineret, Synagis and Gamifant.

Revenue Immunology

	Q3	Q3		Change	Jan-Sep	Jan-Sep		Change	Full-year
SEK M	2021	2020	Change	at CER	2021	2020	Change	at CER	2020
Kineret	516	463	11%	13%	1,608	1,493	8%	16%	2,079
Synagis	374	46	705%	769%	1,286	1,294	-1%	13%	2,726
Gamifant	255	110	132%	139%	556	346	61%	78%	609
Total	1,144	619	85%	89%	3,450	3,133	10%	21%	5,415

Immunology revenue for the quarter amounted to SEK 1,144 M (619), an increase of 85 per cent and 89 per cent at CER. Year-to-date revenue was SEK 3,450 M (3,133), +10 per cent and +21 per cent at CER.

Kineret sales for the quarter were SEK 516 M (463), up 11 per cent and 13 per cent at CER. Kineret continued to perform well, driven by new uses and patient growth. Year-to-date sales were SEK 1,608 M (1,493), +8 per cent and +16 per cent at CER.

Synagis sales for the quarter were SEK 374 M (46), up 705 per cent and 769 per cent at CER. The strong sales were driven by the early start of the RSV season and stocking effects. Year-to-date sales were SEK 1,286 M (1,294).

Gamifant sales for the quarter amounted to SEK 255 M (110), up 132 per cent and 139 per cent at CER, reflecting continued patient growth, increased volume per patient and longer duration of therapy. Year-to-date sales of Gamifant were SEK 556 M (346).

Specialty Care

Revenue is generated from sales of Orfadin®, Tegsedi and other medicines in the Specialty Care portfolio.

Revenue Specialty Care

	Q3	Q3		Change	Jan-Sep	Jan-Sep		Change	Full-year
SEK M	2021	2020	Change	at CER	2021	2020	Change	at CER	2020
Orfadin	116	156	-25%	-24%	338	519	-35%	-30%	665
Tegsedi	112	–	n/a	n/a	304	–	n/a	n/a	–
Other Specialty Care	98	49	100%	102%	247	449	-45%	-41%	521
Total	326	204	59%	63%	890	968	-8%	-1%	1,186

Specialty Care revenue for the quarter was SEK 326 M (204), an increase of 59 per cent and 63 per cent at CER. Year-to-date sales were SEK 890 M (968), -8 per cent and -1 per cent at CER.

Orfadin sales for the quarter were SEK 116 M (156), -25 per cent and -24 per cent at CER, impacted by generic competition and associated price erosion. Year-to-date sales were SEK 338 M (519), -35 per cent and -30 per cent at CER. Tegsedi sales for the quarter were SEK 112 M (-) and year-todate sales were SEK 304 M (-).

Sales in the quarter for Other Specialty Care were SEK 98 M (49), up 100 per cent and 102 per cent at CER driven by Waylivra. Year-to-date sales were SEK 247 M (449), -45 per cent and -41 per cent at CER.

Research and Development

R&D milestones since the previous quarterly report

Regulatory approval	Elocta - haemophilia A: approval Algeria Doptelet - ITP and CLD: approval Saudi Arabia Gamifant - pHLH: approval United Arab Emirates
Regulatory opinion	Aspaveli (pegcetacoplan) - PNH: positive CHMP opinion in the EU
Other significant R&D milestones	Kineret - COVID-19: publication of the SAVE-MORE phase 3 data

Haematology

Aspaveli/Empaveli

On 15 October 2021, Aspaveli, the trade name for pegcetacoplan in the EU, obtained a positive regulatory opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months. The positive opinion was referred to the European Commission for an anticipated approval decision in due course. If approved, Aspaveli will become the first new medicine in the EU since 2007 for the treatment of PNH with a novel mechanism of action, providing expanded choice to treating physicians and patients.

Sobi and its US collaborator Apellis are developing Aspaveli/Empaveli for potential use in several new indications, including outside of haematology. Sobi-sponsored studies in cold agglutinin disease (CAD, phase 3) and haematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA, phase 2) are anticipated to start in 2021. Apellis is advancing the medicine in immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G) with a phase 3 study planned to initiate in 2021 and has an ongoing study in amyotrophic lateral sclerosis (ALS, MERIDIAN phase 2).

Efanesoctocog alfa

Sobi and its collaborator Sanofi are on track for the first phase 3 data readout during the first half of 2022 for efanesoctocog alfa (formerly BIVV001) for the treatment of haemophilia A. If positive, this potential new medicine for the most common form of haemophilia could deliver high sustained factor VIII levels with less-frequent once-weekly dosing and near-normal factor levels for the majority of the week.

Immunology

Kineret

In September 2021, the Kineret SAVE-MORE phase 3 study was published in Nature Medicine. It was conducted by the Hellenic Institute for the Study of Sepsis and was the first large, randomised and controlled study to specifically evaluate a patient population at risk of progressing to a critical state of COVID-19 infection. The study demonstrated considerable benefit of earlier intervention against interleukin-1 (IL-1), the target of Kineret, for the prevention of disease progression and death. IL-1 is present in patients because of the inflammatory disease that can develop after a COVID-19 infection.

In the EU and the UK, Kineret is under regulatory review for the potential treatment of COVID-19 with anticipated regulatory opinion/decision in due course. Additionally, Sobi is in dialogue with the US Food and Drug Administration on a potential regulatory submission in 2021 for a COVID-19 emergency use authorisation.

Gamifant

During the third quarter, Gamifant obtained regulatory approval in the United Arab Emirates for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH), a severe systemic inflammatory syndrome which can be fatal. Regulatory review is ongoing in China with a regulatory decision anticipated in 2021.

Gamifant also has potential utility in secondary HLH (sHLH), an umbrella indication for several underlying diseases, including rheumatologic HLH. Sobi anticipates starting a phase 3 study in this new indication in 2021.

Nirsevimab

On 2 October 2021, the detailed nirsevimab MELODY phase 3 data were presented at IDWeek 2021, a US medical meeting. The top-line data were initially released in April 2021 and showed that nirsevimab met its primary endpoint of a statistically significant reduction in the incidence of medically attended lower respiratory tract infections caused by respiratory syncytial virus compared to placebo in healthy late preterm and term infants (35 weeks or more) during their first RSV season. Collaborators AstraZeneca and Sanofi intend to make regulatory submissions for nirsevimab in the first half of 2022 based on the MELODY and MEDLEY studies. Sobi has the right to AstraZeneca's full share of US profits for nirsevimab.

SEL-212

SEL-212, a potential new medicine for the treatment of chronic refractory gout, is advancing in clinical development with data readout anticipated during the second half of 2022 from the phase 3 studies DISSOLVE I and DISSOLVE II. If positive, the studies will facilitate regulatory submissions globally during the course of 2023.

Research and Development expenses

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
SEK M	2021	2020	2021	2020	2020
Research and development expenses	-485	-405	-1,440	-1,108	-1,594
Total revenue	3,761	2,970	10,633	10,680	15,261
Research and development expenses in relation to total revenues	13%	14%	14%	10%	10%

Other information

Significant events after the reporting period

On 15 October 2021, Aspaveli obtained a positive regulatory opinion from the CHMP of the EMA. For more details, please refer to the Research and Development section.

The acceptance period of the public offer to the shareholders of Sobi to tender all shares in Sobi to Agnafit Bidco AB ended on 21 October 2021.

Sustainability

Sobi's sustainability efforts are closely linked to the business and are based on two priorities:

• Commitment to patients
• Responsible behaviour

During the third quarter, efforts to increase public awareness and knowledge of rare diseases were intensified on occasions such as International FMF Day for familial Mediterranean fever, Still's Disease Awareness Day and World Patient Safety Day.

To improve sustainability performance, a new data platform to better monitor and track progress on all main sustainability key performance indicators is being implemented. The alignment of suppliers and partners with Sobi's sustainability commitments, as part of the responsible sourcing programme that integrates sustainability performance in business follow-ups, is on track.

2021 outlook refined

On 11 October 2021, Sobi announced preliminary headline numbers for the third quarter and the period January to September 2021 and refined the financial outlook for 2021:

• Revenue for the full year 2021 is expected to be in the range of SEK 14,500-15,000 M (previously SEK 14,000-15,000 M)
• EBITA margin is expected to be in the range of 33-35 per cent (previously 30-35 per cent) of revenue

Forward-looking statements

This report includes forward-looking statements. Actual results may differ from those stated. Internal factors such as the successful management of research programmes and intellectual property rights may affect future results. There are also external conditions such as the economic climate, political changes and competing research programmes that may affect Sobi's results.

Financial calendar

Q4 2021 10 February 2022

Solna, Sweden, 22 October 2021

Guido Oelkers, President & CEO

Auditor´s review report

Introduction

We have reviewed the condensed interim report for Swedish Orphan Biovitrum AB (publ) as of 30 September 2021, and for the nine-month period then ended. The Board of Directors and the Chief Executive Officer are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.

Scope of review

We conducted our review in accordance with the International Standard on Review Engagements, ISRE 2410 Review of Interim Financial Statements Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing standards in Sweden.

The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act regarding the Group, and in accordance with the Swedish Annual Accounts Act regarding the Parent Company.

Stockholm, 22 October 2021 Ernst & Young AB

Jonatan Hansson Authorised Public Accountant

Financial statements – Group

Consolidated statements of comprehensive income

	Q3	Q3	Jan-Sep	Jan-Sep	Full-Year
SEK M	2021	2020	2021	2020	2020
Total revenue1	3,761	2,970	10,633	10,680	15,261
Cost of goods sold	-959	-632	-2,468	-2,362	-3,225
Gross profit	2,802	2,339	8,165	8,318	12,036
Selling and administrative expenses2	-1,571	-1,416	-4,470	-4,429	-5,981
Research and development expenses	-485	-405	-1,440	-1,108	-1,594
Other operating income/expenses	-38	-54	-47	-78	357
Operating profit	708	464	2,208	2,702	4,818
Net financial items3	-109	-98	-336	-421	-601
Profit before tax	598	366	1,872	2,281	4,217
Income tax	-125	-88	-434	-538	-972
Profit for the period	473	278	1,438	1,743	3,245
All earnings are attributable to Parent Company shareholders
Other comprehensive income
Items that cannot be reclassified into profit or loss
Remeasurements on defined-benefit plans (net of tax)	-2	-5	6	1	-3
Fair value of equity instruments (net of tax)	4	–	8	–	9
Total	1	-5	14	1	6
Items that can be reclassified into profit or loss
Translation differences	145	-133	211	17	-434
Net investment hedges (net of tax)	-78	10	-167	48	246
Cash flow hedges (net of tax)	-22	15	-56	-13	130
Total	45	-108	-11	52	-58
Other comprehensive income	46	-113	2	53	-52
Comprehensive income for the period	519	165	1,440	1,796	3,193
All comprehensive income are attributable to Parent Company shareholders
Earnings per share, SEK	1.60	0.94	4.87	5.92	11.01
Earnings per share, SEK, adjusted4	1.60	0.94	4.87	5.92	9.66
Earnings per share after dilution, SEK	1.59	0.93	4.85	5.87	10.90
Earnings per share after dilution, SEK, adjusted4	1.59	0.93	4.85	5.87	9.56
1 See page 3 for split by business area.
2 Amortisation and write-downs of intangible assets included in Selling and administrative expenses.	-459	-469	-1,364	-1,422	-1,882
3 Including financing costs.	-9	-8	-27	-22	-32

4 APMs, see page 20 for further information.

Consolidated balance sheet

SEK M	Sep 2021	Dec 2020	Sep 2020
ASSETS
Non-current assets
Intangible assets1	38,181	38,791	37,240
Tangible assets	481	534	564
Financial assets	189	179	170
Deferred tax assets	489	611	698
Total non-current assets	39,340	40,115	38,672
Current assets
Inventories	3,215	3,053	2,542
Accounts receivable	3,085	3,756	2,136
Other receivables, non-interest bearing	881	955	620
Cash and cash equivalents	212	404	164
Total current assets	7,392	8,168	5,462
Total assets	46,733	48,283	44,134
EQUITY AND LIABILITIES
Shareholders´ equity	21,743	20,206	18,784
Non-current liabilities
Borrowings	9,303	10,137	10,759
Deferred tax liabilities	3,448	3,464	3,476
Lease liabilities	260	308	336
Other liabilities, non-interest bearing	4,069	3,725	3,775
Total non-current liabilities	17,080	17,634	18,346
Current liabilities
Borrowings	2,040	4,015	2,108
Accounts payable	795	569	414
Lease liabilities	114	111	111
Other liabilities, non-interest bearing	4,962	5,748	4,370
Total current liabilities	7,910	10,443	7,004
Total equity and liabilities	46,733	48,283	44,134

1 Including goodwill of SEK 6,141 M (SEK 5,873 on 31 December 2020).

Changes in equity

	Jan-Sep	Full-year	Jan-Sep
SEK M	2021	2020	2020
Opening balance	20,206	16,930	16,930
Adjusted opening balance for post employment-benefits from prior years1	–	-38	-38
Share-based compensation to employees	93	114	85
Share-based compensation to employees tax effect2	4	7	12
Comprehensive income for the period3	1,440	3,193	1,796
Equity at end of period	21,743	20,206	18,784

1 Refers to post employment-benefits, mainly in Switzerland not previously included on December 2019 (net of tax).

2 The change relates to difference between the market value of vested shares and recognised IFRS 2 cost.

³Whereof changes in cash flow hedges (net of tax) amounted to SEK -56 M (SEK 130 M on 31 December 2020) and net investment hedges (net of tax) amounted to SEK -167 M (SEK 246 M on 31 December 2020).

Consolidated cash flow statement

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
SEK M	2021	2020	2021	2020	2020
Profit before tax1	598	366	1,872	2,281	4,217
Amortisation and depreciation	494	509	1,470	1,526	2,023
Other, including non-cash items	35	165	104	271	46
Income tax paid	-149	-155	-945	-758	-918
Cash flow from operating activities before change in working capital	978	884	2,500	3,319	5,367
Changes in working capital	-721	-503	849	890	-442
Cash flow from operating activities	257	381	3,349	4,209	4,926
Investment in intangible assets2 Investment in tangible assets	-15 -3	-1,164 -5	-110 -15	-1,288 -28	-3,811 -41
Investment in financial assets2	–	-120	–	-120	-120
Disposal of tangible assets	1	–	3	–	8
Cash flow from investing activities	-17	-1,289	-122	-1,436	-3,964
Borrowings/repayments of borrowings Hedging arrangement for financing	-226 -7	831 63	-3,105 -230	-3,407 147	-1,452 288
Repayment of leasing	-32	-29	-93	-88	-118
Cash flow from financing activities	-264	865	-3,427	-3,348	-1,282
Change in cash and cash equivalents	-24	-43	-200	-575	-320
Cash and cash equivalents at the beginning of the period	233	213	404	737	737
Translation difference in cash flow and cash and cash equivalents	3	-6	7	1	-13
Cash and cash equivalents at the end of the period	212	164	212	164	404

1 As of 2021, Sobi has changed the form of presentation for the cash flow statement, see Note 1 for more information.

2 2020 investments mainly refers to SEL-212 and pegcetacoplan.

Key ratios and other information

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
SEK M	2021	2020	2021	2020	2020
Profit measures
Gross profit	2,802	2,339	8,165	8,318	12,036
EBITDA1	1,202	971	3,678	4,228	6,830
EBITA1	1,166	933	3,572	4,124	6,700
EBITA adjusted1,2	1,166	933	3,572	4,124	6,301
EBIT (operating profit)	708	464	2,208	2,702	4,818
Profit for the period	473	278	1,438	1,743	3,245
Per share data (SEK)
Earnings per share	1.60	0.94	4.87	5.92	11.01
Earnings per share, adjusted2,3	1.60	0.94	4.87	5.92	9.66
Earnings per share after dilution	1.59	0.93	4.85	5.87	10.90
Earnings per share after dilution, adjusted2,3	1.59	0.93	4.85	5.87	9.56
Shareholders' equity per share1	70.8	61.8	70.8	61.8	66.5
Shareholders' equity per share after dilution1	70.5	61.3	70.5	61.3	65.9
Other information
Gross margin1	75%	79%	77%	78%	79%
EBITA margin1	31%	31%	34%	39%	44%
EBITA margin adjusted1,2	31%	31%	34%	39%	41%
Equity ratio1	47%	43%	47%	43%	42%
Net debt	11,131	12,703	11,131	12,703	13,748
Number of ordinary shares4	307,114,495	303,815,511	307,114,495	303,815,511	303,815,511
Number of ordinary shares (in treasury)	11,969,866	8,918,672	11,969,866	8,918,672	8,918,672
Number of ordinary shares (ex shares in treasury)	295,144,629	294,896,839	295,144,629	294,896,839	294,896,839
Number of ordinary shares after dilution	308,624,353	306,369,328	308,624,353	306,369,328	306,797,549
Average number of ordinary shares (ex shares in treasury)	295,144,629	294,896,839	295,017,887	294,577,987	294,658,136
Average number of ordinary shares after dilution (ex shares in treasury)	296,654,487	297,450,656	296,527,745	297,131,804	297,640,174

1 APMs, see page 20 for further information.

2 EBITA in full-year 2020 excluding non-recurring items; other operating income related to the reversal of the CVR liability of SEK 399 M.

3 EPS in full-year 2020 excluding the reversal of the CVR liability SEK 399 M.

4 The increase in the number of shares results from an issue of 3,298,984 shares for the purpose of ensuring fulfilment of commitments under incentive programmes, offset by allotment of shares for the programmes expired.

Financial statements - Parent Company

Income statement

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
SEK M	2021	2020	2021	2020	2020
Total revenue	2,627	2,951	7,370	10,403	13,968
Cost of goods sold	-720	-626	-1,969	-2,371	-3,134
Gross profit	1,907	2,325	5,401	8,032	10,834
Selling and administrative expenses1	-736	-531	-2,350	-2,631	-4,174
Research and development expenses	-319	-198	-908	-606	-923
Other operating income/expenses	118	13	246	20	96
Operating profit	970	1,608	2,389	4,815	5,833
Net financial items	-173	7	-291	9	194
Profit after financial items	797	1,616	2,098	4,824	6,027
Appropriations	–	–	–	–	-1,690
Profit before tax	797	1,616	2,098	4,824	4,337
Income tax expenses	-36	-138	-212	-646	-931
Profit for the period	761	1,477	1,886	4,178	3,406
1 Amortisation and write-downs of intangible assets included in Selling and administrative expenses.	-87	-86	-257	-246	-328

Statement of comprehensive income

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
SEK M	2021	2020	2021	2020	2020
Profit for the period	761	1,477	1,886	4,178	3,406
Items that cannot be reclassified into profit or loss
Fair value of equity instruments (net of tax)	4	–	8	–	9
Items that can be reclassified into profit or loss
Cash flow hedges (net of tax)	-22	20	-56	-13	130
Comprehensive income for the period	744	1,497	1,838	4,164	3,545

Balance sheet

	Sep	Dec	Sep
SEK M	2021	2020	2020
ASSETS
Non-current assets
Intangible assets	9,981	10,205	7,107
Tangible assets	55	64	68
Financial assets	23,248	23,164	25,254
Deferred tax assets	36	24	35
Total non-current assets	33,320	33,457	32,464
Current assets
Inventories	2,576	2,527	2,018
Accounts receivable	821	731	640
Receivables Group companies	3,330	3,947	2,868
Other receivables, non-interest bearing	757	835	484
Cash and cash equivalents	61	240	0
Total current assets	7,545	8,280	6,010
Total assets	40,865	41,737	38,474
EQUITY AND LIABILITIES
Shareholders´ equity	19,134	17,200	17,796
Untaxed reserves	3,091	3,091	2,984
Non-current liabilities
Borrowings	9,303	10,137	10,759
Liabilities Group companies	–	157	170
Other liabilities, non-interest bearing	2,800	2,557	2,281
Total non-current liabilities	12,103	12,851	13,210
Current liabilities
Borrowings	2,040	4,015	2,108
Accounts payable	335	398	327
Liabilities Group companies	2,408	1,674	161
Other liabilities, non-interest bearing	1,754	2,508	1,889
Total current liabilities	6,537	8,595	4,484
Total equity and liabilities	40,865	41,737	38,474

Change in shareholders' equity

	Jan-Sep	Full-year	Jan-Sep
SEK M	2021	2020	2020
Opening balance	17,200	13,534	13,534
Share-based compensation to employees	93	114	85
Share-based compensation to employees tax effect1	4	7	12
Comprehensive income for the period2	1,838	3,545	4,164
Equity at end of period	19,134	17,200	17,796

1 The change relates to difference between the market value of vested shares and recognised IFRS 2 cost.

²Whereof changes in cash flow hedges (net of tax) amounted to SEK -56 M (SEK 130 M on 31 December 2020).

Notes

Note 1 Accounting policies and measurement bases and other information

Accounting policies

This interim report has been prepared in accordance with IAS 34 and the Swedish Annual Accounts Act. The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) and the International Financial Reporting Interpretations Committee (IFRIC) as adopted by the EU. The Parent Company applies the Annual Accounts Act and the Swedish Financial Reporting Board's Recommendation RFR 2 Accounting for Legal Entities.

The accounting policies apply with those described in the 2020 Annual and Sustainability Report. IASB has published amendments of standards that are effective as of 1 January 2021 or later. The standards have not had any material impact on the consolidated financial statements.

More detailed information about the Group's accounting policies and measurement bases can be found in the 2020 Annual and Sustainability Report, available at www.sobi.com.

Cash flow statement

As of 2021, Sobi has changed the form of presentation for the cash flow statement and reclassified hedging arrangements for financing from cash flow from operating activities to cash flow from financing activities. Comparative figures for 2020 have been recalculated, whereby the cash flow from operating activities for the quarter July-September 2020 has been adjusted from SEK 443 M to SEK 381 M, the period January-September 2020 has been adjusted from SEK 4,356 M to SEK 4,209 M and the full year 2020 from SEK 5,214 M to SEK 4,926 M. Cash-flow from financing activities has been adjusted for the corresponding periods from SEK 802 M to SEK 865 M, SEK -3,495 M to SEK -3,348 M and from SEK -1,570 M to -1,282, respectively.

Risks and uncertainties

Sobi is exposed to a number of risks in its operations. Effective risk management aligns Sobi's business opportunities and profit with shareholders' and other stakeholders' demands for stable, long-term value growth and control. Key risk areas are summarised below:

• Pandemics and other external events
• Strategic and operational risk
• Commercialisation and business environment
• Financial and reporting risk
• Compliance risk

More information about risk exposure and risk management is included in Sobi's 2020 Annual and Sustainability Report.

Note 2 Segment reporting

SEK M

Q3 2021	Haematology	Immunology	Specialty Care	Group - other	Total
Total revenue	2,291	1,144	326	–	3,761
EBITA1	998	244	118	-194	1,166
Adjusted EBITA1,2	998	244	118	-194	1,166
Amortisation	-155	-252	-40	-12	-459
EBIT (Operating profit)	843	-8	78	-206	708

Q3 2020	Haematology	Immunology	Specialty Care	Group - other	Total
Total revenue	2,147	619	204	–	2,970
EBITA1	1,154	-139	82	-164	933
Adjusted EBITA1,2	1,154	-139	82	-164	933
Amortisation	-161	-251	-46	-11	-469
EBIT (Operating profit)	993	-390	36	-175	464

Jan-Sep 2021	Haematology	Immunology	Specialty Care	Group - other	Total
Total revenue	6,294	3,450	890	–	10,633
EBITA1	2,810	908	293	-438	3,572
Adjusted EBITA1,2	2,810	908	293	-438	3,572
Amortisation	-457	-754	-118	-35	-1,364
EBIT (Operating profit)	2,353	153	175	-473	2,208

Jan-Sep 2020	Haematology	Immunology	Specialty Care	Group - other	Total
Total revenue	6,578	3,133	968	–	10,680
EBITA1	3,397	637	505	-415	4,124
Adjusted EBITA1,2	3,397	637	505	-415	4,124
Amortisation	-492	-759	-138	-33	-1,422
EBIT (Operating profit)	2,905	-122	367	-448	2,702

Full-year 2020	Haematology	Immunology	Specialty Care	Group - other	Total
Total revenue	8,660	5,415	1,186	–	15,261
EBITA1	4,377	1,902	564	-143	6,700
Adjusted EBITA1,2	3,978	1,902	564	-142	6,301
Amortisation	-652	-1,009	-179	-42	-1,882
EBIT (Operating profit)	3,725	893	385	-185	4,818

There are no intersegment transactions.

1 APMs, see page 20 for further information.

2 EBITA in 2020 excluding non-recurring items; other operating income related to the reversal of the CVR liability of SEK 399 M.

3 The category Group-other mainly refers to costs for central functions such as finance, legal, communication, human resources and other items that can not be allocated by segment.

Note 3 Fair value of financial instruments

The following table shows financial instruments measured at fair value, based on their classification in the fair value hierarchy. Sobi's financial instruments at fair value at the end of the quarter consist of equity instruments, derivatives held for trading and endowment policies.

Equity instruments are categorised within level 1 and consist of the Group's holding of quoted shares in Selecta Biosciences, Inc. Fair value measurement is based on quoted prices in active markets. Derivatives held for trading are categorised within level 2 and consist of currency derivatives forward contracts. Fair value measurement is based on published forward prices. Endowment insurances are categorised within level 3. No transfers have been made between the levels during the period.

On 30 September 2021, all other financial instruments on the balance sheet had reported values that are in all material aspects equivalent to fair value.

The contingent consideration in the third quarter of 2020 refers to the CVR which was reversed during the fourth quarter of 2020. See page 21 for more information.

Q3 2021	Level 1	Level 2	Level 3	Total
Financial assets and liabilities measured at fair value through profit or loss
Derivatives held for trading	–	-14	–	-14
Endowment policies	–	–	44	44
Financial assets measured at fair value through other comprehensive income
Equity instruments	141	–	–	141
Total	141	-14	44	171
Q3 2020	Level 1	Level 2	Level 3	Total
Financial assets and liabilities measured at fair value through profit or loss
Derivatives held for trading	–	-13	–	-13
Endowment policies	–	–	47	47
Contingent considerations	–	–	-389	-389
Financial assets measured at fair value through other comprehensive income
Equity instruments	120	–	–	120
Total	120	-13	-342	-235
Full-year 2020	Level 1	Level 2	Level 3	Total
Financial assets and liabilities measured at fair value through profit or loss
Derivatives held for trading	–	-151	–	-151
Endowment policies	–	–	44	44
Financial assets measured at fair value through other comprehensive income
Equity instruments	131	–	–	131
Total	131	-151	44	24

Alternative performance measures - financial measures not defined according to IFRS

Sobi uses certain financial measures (alternative performance measures, APM) in the interim report that are not defined according to IFRS. The company considers these measures to provide valuable supplementary information for investors and company management, as they enable an assessment and benchmarking of the company's reporting. Since not all companies calculate financial measures in the same way, these are not always comparable to measures used by other companies. These financial measures should not, therefore, be regarded as substitutes for measures defined according to IFRS. The following metrics are not defined according to IFRS:

SEK M unless otherwise stated.

	Q3	Q3	Jan-Sep	Jan-Sep	Full-year
	2021	2020	2021	2020	2020
Total revenue	3,761	2,970	10,633	10,680	15,261
Total cost of goods sold	-959	-632	-2,468	-2,362	-3,225
Gross profit	2,802	2,339	8,165	8,318	12,036
Gross margin	75%	79%	77%	78%	79%
EBIT (operating profit)1	708	464	2,208	2,702	4,818
Plus amortisation and write-downs of intangible assets	459	469	1,364	1,422	1,882
EBITA1	1,166	933	3,572	4,124	6,700
Plus depreciations and write-downs of tangible assets	35	38	106	104	130
EBITDA	1,202	971	3,678	4,228	6,830
EBITA margin	31%	31%	34%	39%	44%
Non-recurring items2	–	–	–	–	-399
EBITA adjusted	1,166	933	3,572	4,124	6,301
EBITA margin adjusted	31%	31%	34%	39%	41%
Profit for the period	473	278	1,438	1,743	3,245
Non-recurring items2	–	–	–	–	-399
Profit for the period, adjusted Average number of ordinary shares (excluding shares in treasury)	473 295,144,629	278 294,896,839	1,438 295,017,887	1,743 294,577,987	2,846 294,658,136
Average number of ordinary shares after dilution
(excluding shares in treasury)	296,654,487	297,450,656	296,527,745	297,131,804	297,640,174
EPS, SEK adjusted	1.60	0.94	4.87	5.92	9.66
EPS after dilution, SEK adjusted	1.59	0.93	4.85	5.87	9.56
Borrowings	11,343	12,867	11,343	12,867	14,152
Cash and cash equivalents	212	164	212	164	404
Net debt	11,131	12,703	11,131	12,703	13,748
Shareholders' equity	21,743	18,784	21,743	18,784	20,206
Total assets	46,733	44,134	46,733	44,134	48,283
Equity ratio	47%	43%	47%	43%	42%
Number of ordinary shares	307,114,495	303,815,511	307,114,495	303,815,511	303,815,511
Number of ordinary shares after dilution	308,624,353	306,369,328	308,624,353	306,369,328	306,797,549
Equity per share, SEK	70.8	61.8	70.8	61.8	66.5
Equity per share after dilution, SEK	70.5	61.3	70.5	61.3	65.9

¹For EBIT and EBITA per segment see Note 2.

2Relates to the reversal of the CVR liability of SEK 399 M in 2020, see page 21 for more information.

Financial definitions

CER	Constant exchange rates
CVR	Following the completion of Sobi's acquisition of Dova Pharmaceuticals, Inc. (Dova) on 12 November 2019, Dova shareholders were provided one non-transferrable Contingent Value Right(CVR) to an additional USD 1.50 per share to be paid upon approval of Doptelet for use in chemotherapy-induced thrombocytopenia (CIT) by the FDA. On 9 October 2020, Sobi announced topline results for phase 3 CIT study of Doptelet. The primary endpoints were not met and Sobi estimates that the conditions of the CVR will not be met. Consequently, the corresponding liability on the balance sheet was reversed, positively impacting other operating income by SEK 399 M.
EPS	Earnings per share is the portion of a company's profit allocated to each outstanding share of common stock
EBIT	Earnings before interest and tax (operating profit)
EBITA	Earnings before interest, tax, and amortisation
EBITA margin in per cent	EBITA as a percentage of totalrevenue
EBITA adjusted	EBITA less non-recurring items
EBITA margin adjusted in per cent	EBITA adjusted as a percentage of totalrevenue
EBITDA	Earnings before interest, tax, depreciation, amortisation, and write-downs
EPS adjusted	Profit for the period, adjusted, divided by average number of ordinary shares
EPS after dilution adjusted	Profit for the period, adjusted, divided by average number of ordinary shares after dilution
Equity ratio	Shareholders' equity as a proportion of total assets
Equity per share	Equity divided by the number of ordinary shares
Equity per share after dilution	Equity divided by the number of ordinary shares after dilution
Full-time equivalents	Unit that indicates the workload of an employed person in a way that makes workloads comparable
Gross profit	Totalrevenue less cost of goodssold
Gross margin	Gross profit as a percentage of total revenue
IFRS	International Financial Reporting Standards
Net debt	Borrowings less Cash and cash equivalents

Non-recurring items Refers to items that have no clear connection with the ordinary operations and are of such a type that it cannot be expected to occur often or regularly and that it is an item of significant value. This may, for example, refer to capital gains/losses from divestments, restructuring initiatives, impairments and other unusual one-time income and expenses.

Other definitions

Alprolix (eftrenonacog alfa)	A recombinant, extended half-life (EHL) clotting factor IX medicine approved in the EU, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia, and Switzerland, as well asin Australia, Brazil, Canada,Japan, New Zealand, the United States and other countries, for the treatment of haemophilia B.
Aspaveli/Empaveli (pegcetacoplan)	A new medicine targeting complement component 3 (C3) designed to regulate excessive complement activation, which can lead to the onset and progression of many serious diseases. Aspaveli/Empaveli is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b.
COVID-19	An infectious disease caused by a coronavirus discovered in 2019, declared a pandemic by WHO.
Doptelet (avatrombopag)	A second-generation small molecule thrombopoietin (TPO) receptor agonist used in the treatmentof thrombocytopenia by increasing platelet count.
Efanesoctocog alfa (formerly BIVV001)	A novel factor VIII potential new medicine designed to extend protection from bleeds with prophylactic dosing of once weekly or longer intervals for people with haemophilia A. Builds on Fc-fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to potentially extend its time in circulation.
Elocta (efmoroctocog alfa)	A recombinant, EHL clotting factor VIII medicine approved in the EU, Algeria, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia, and Switzerland for the treatment of haemophilia A. It is also approved in Australia, Brazil, Canada, Japan, New Zealand, the United States and other countries, where it is known as Eloctate.
EMA	European Medicines Agency
FDA	The US Food and Drug Administration
Gamifant (emapalumab)	An anti-interferon-gamma (IFN-γ) monoclonal antibody (mAb), approved by the FDA and in the United Arab Emirates for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH), a life-threatening syndrome of immune activation.
Gout	An autoinflammatory disease that causes intensely painful flares and debilitating inflammatory arthritis due to deposition of pro-inflammatory monosodium urate (MSU) crystals in synovial fluid and other tissues.
Haemophagocytic lymphohistiocytosis, HLH	A rare and life-threatening syndrome of extreme immune activation. The primary form of the disease (pHLH, inherited) mainly occurs in infants and young children while the secondary form of the disease (sHLH, acquired) is acquired from or associated with infection, autoimmune diseases or malignancy.
Haemophilia	A rare, genetic disorder in which the ability of a person's blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male births annually, and haemophilia B occurs in about one in 25,000 male births annually. Both occur more rarely in females. People with haemophilia can experience bleeding episodes that may cause pain, limited mobility, irreversible joint damage, and life-threatening haemorrhages.
Kineret (anakinra)	A recombinant protein medicine that blocks the biological activity of interleukin-1α and β (IL-1α and IL-1β) by binding to IL-1 type 1 receptors (IL-R 1), expressed in a variety of tissues and organs, thereby blocking the IL-1 signalling. IL-1 is a key mediator of inflammation and a significant contributor to autoinflammatory diseases.
Orfadin (nitisinone)	A medicine used to treat hereditary tyrosinaemia type 1 (HT-1). It blocks the breakdown of tyrosine, thereby reducing the amount of toxic tyrosine by-products in the body. Patients must maintain a special diet in combination with Orfadin treatment as tyrosine is not adequately broken down. Orfadin was approved in the EU in 2020 for the treatment of adult patients with alkaptonuria.
Paroxysmal nocturnal haemoglobinuria, PNH	A rare, chronic, life-threatening blood disorder characterised by the destruction of oxygen-carrying red blood cells through extravascular and intravascular haemolysis. Persistently low haemoglobin can result in debilitating symptoms such as severe fatigue, haemoglobinuria, difficulty breathing (dyspnoea), and the need for frequent transfusions.

Respiratory syncytial virus, RSV A common virus and the most common cause of lower respiratory tract infections (LRTI) in young children. SEL-212 A novel combination therapy and potential new medicine designed to sustain control of serum uric acid levels in patients with chronic refractory gout. SEL-212 consists of pegadricase, co-administered with ImmTOR, designed to mitigate the formation of antidrug antibodies. Synagis (palivizumab) An immunisation treatment indicated for the prevention of serious lower respiratory tract infection (LRTI) caused by RSV in infants and young children at high risk of RSV disease. RSV is the most prevalent cause of LRTI among infants and young children. Synagis is an RSV F protein inhibitor monoclonal antibody that acts as a prophylaxis against serious RSV disease. Tegsedi (inotersen) A self-administered subcutaneous treatment for the treatment of polyneuropathy of hATTR amyloidosis in adults. Waylivra (volanesorsen) A treatment for the treatment of genetically confirmed familial chylomicronaemia syndrome (FCS).

Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology, and specialty indications. Today, Sobi employs approximately 1,500 people across Europe, North America, the Middle East, Russia, and Asia. In 2020, Sobi's revenue amounted to SEK 15.3 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at sobi.com.

Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden | Street address: Tomtebodavägen 23 A Telephone: +46 8-697 20 00 | Fax: +46 8-697 23 30 www.sobi.com