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Swedish Orphan Biovitrum

Quarterly Report Oct 20, 2025

2974_10-q_2025-10-20_1ec0a9cd-c051-47e0-90de-f1850db5831b.pdf

Quarterly Report

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Q3 2025 report

Accelerated growth and portfolio momentum

"For the quarter, our business accelerated and achieved 21 per cent growth at CER demonstrating the strength of our portfolio. We also advanced our pipeline with the US filing acceptance for NASP in uncontrolled gout and the preparations for a new opportunity for olezarsen in severe hypertriglyceridemia, both expected to contribute significantly to long-term growth."

  • Guido Oelkers, President & CEO

Third Quarter 2025

  • Total revenue increased 13 per cent, 21 per cent at constant exchange rates, (CER)1 , to SEK 7,776 M (6,894)
  • Haematology revenue increased 26 per cent at CER to SEK 4,771 M (4,000), mainly driven by Altuvoct of SEK 769 M (129), strong sales of Doptelet of SEK 1,408 M (1,039) and sales of Aspaveli/Empaveli of SEK 317 M (270), somewhat offset by low Vonjo sales of SEK 307 M (379)
  • Immunology revenue increased 12 per cent at CER to SEK 2,658 M (2,583), driven by strong sales of Gamifant of SEK 733 M (405) and Kineret sales of SEK 769 M (699), somewhat offset by lower Beyfortus royalty of SEK 1,166 M (1,478)
  • Revenue from the strategic portfolio1* grew by 39 per cent at CER to SEK 5,001 M (3,830)
  • The product and marketing right Vonjo was impaired by SEK 6,612 M before tax. The impairment has not affected cash flow and is reported as items affecting comparability (IAC2 ). See Note 4 for more information
  • The adjusted EBITA margin1,2 was 47 per cent (43), excluding IAC2 of SEK -6,664 M. EBITA1 was SEK 3,620 M (2,923), corresponding to a margin of 47 per cent (42). EBIT was SEK -3,858 M (2,038) including the impairment of Vonjo by SEK 6,612 M
  • Earnings per share (EPS) before dilution was SEK -8.40 (4.27) and EPS after dilution was SEK -8.32 (4.22). Adjusted EPS before dilution1 was SEK 6.11 (4.36) and adjusted EPS after dilution1 was SEK 6.05 (4.31). Cash flow from operating activities was SEK 1,840 M (1,201)

Outlook 2025 - updated

  • Revenue is anticipated to grow at low double-digit percentage at CER (previously high-single-digit)
  • Adjusted EBITA margin is anticipated to be at mid-to-high 30s percentage of revenue (previously mid-30s)

Financial summary

Q3 Q3 Jan-Sep Jan-Sep FY
SEK M 2025 2024 Change 2025 2024 Change 2024
Total revenue 7,776 6,894 13% 20,417 18,592 10% 26,027
Gross profit 6,162 5,563 11% 15,788 14,407 10% 20,242
Gross margin1 79% 81% 77% 77% 78%
Adjusted gross margin1,2 80% 81% 78% 78% 78%
EBITA1 3,620 2,923 24% 7,743 6,585 18% 9,158
Adjusted EBITA1,2 3,672 2,965 24% 8,124 6,811 19% 9,368
EBITA margin1 47% 42% 38% 35% 35%
Adjusted EBITA margin1,2 47% 43% 40% 37% 36%
Profit/loss for the period -2,895 1,464 >-200% -1,386 2,488 -156% 3,879
EPS before dilution, SEK -8.40 4.27 >-200% -4.02 7.29 -155% 11.37
Adjusted EPS before dilution, SEK1,2 6.11 4.36 40% 11.25 7.80 44% 11.83
EPS after dilution, SEK -8.32 4.22 >-200% -3.99 7.21 -155% 11.24
Adjusted EPS after dilution, SEK1,2 6.05 4.31 40% 11.14 7.71 45% 11.69

1. Alternative Performance Measures (APMs), see section APM for further information.

2. Items affecting comparability (IAC), see page 3 for further information.

* The strategic portfolio includes Sobi's medicines Altuvoct, Aspaveli/Empaveli, Doptelet, Gamifant, Vonjo and Zynlonta, and royalty on Sanofi's sales of Altuviiio and Beyfortus.

CEO statement

We accelerated our growth trajectory in the third quarter, with 21 per cent growth at CER and year to date growth at 15 per cent at CER. The Sobi portfolio excluding seasonal RSV revenue grew 30 per cent at CER highlighting the strength of our on-market medicines. The adjusted EBITA margin in the quarter was 47 per cent. As a result of our strong performance we have upgraded the full year outlook for 2025.

Our strategic portfolio grew 39 per cent at CER, from 56 per cent of total revenue in Q3 2024 to 64 per cent in the quarter. We expect to extend the growth of our strategic products by the forthcoming launches of Gamifant in HLH/MAS, Aspaveli in C3G and IC-MPGN, NASP in uncontrolled gout, and Tryngolza first in FSG and later in MCS.

Haematology revenue increased by 26 per cent at CER in the quarter. Revenue was driven by the launch of Altuvoct, the continued strong growth of Doptelet and growth of Aspaveli/Empaveli.

Altuvoct continues to demonstrate robust growth following its launch, with patients continuing to transition from Elocta as well as from competing products. Having established itself as a market leader in Germany, Altuvoct is expanding its market share across additional territories as the launch progresses. During the quarter, our combined haemophilia A sales increased by 31 per cent at CER. We remain committed to providing this important therapy to an increasing number of patients.

Vonjo experienced demand growth in the quarter, but it was not enough to compensate negative gross to net effects. Given its deferred uptake we have recognised an impairment charge of SEK 6,612 M. Vonjo is still projected to be a long-term growth driver, following the expected completion of the PACIFICA Phase 3 study, securing a broader label authorisation in the US and expanding into additional international markets. Efforts are ongoing to accelerate the completion of enrolment in the

PACIFICA study, and we continue with the development of potential new indications where there is a high unmet medical need.

Immunology revenue increased by 12 per cent at CER in the quarter, primarily driven by a strong performance of Gamifant and Kineret.

During the quarter, Gamifant was launched in the US for HLH/MAS in Still's disease and grew 98 per cent at CER with new patient demand and launch in MAS in the US. Additionally, Sobi disclosed that the US FDA accepted the biologics licence application (BLA) for NASP for the treatment of uncontrolled gout setting up a potential launch in the US in H2 2026. We look forward to bringing this important potential treatment to patients.

In Specialty Care Sobi received EU approval for Tryngolza (olezarsen) for the treatment of familial chylomicronaemia syndrome (FCS). Additionally, our partner Ionis Pharmaceuticals announced the topline positive data for the CORE clinical program in severe hypertriglyceridemia (sHTG). Tryngolza is the first and only medicine to significantly reduce acute pancreatitis events in people with sHTG. This new indication represents a significant growth opportunity for Sobi and filing is planned in Europe in 2026. We look forward to supporting patients suffering form multifactorial chylomicronemia syndroms (MCS), a subgroup of sHTG patients with a potential launch in this area anticipated in 2027.

We are very pleased with the strong performance and continued progress across our pipeline. Our portfolio presents meaningful opportunities for growth, and we are encouraged by the momentum we are building. We remain focused on maintaining this positive trajectory and delivering on our strategic goals.

Stockholm, Sweden, 20 October 2025 Guido Oelkers, President & CEO

Financial performance

Total revenue

Total revenue for July to September ('the quarter') was SEK 7,776 M (6,894) and increased by 13 per cent compared with the same period a year ago and by 21 per cent at CER. Strong growth from Altuvoct, Doptelet, Gamifant, and Kineret and royalty on Altuviiio was partially offset by lower sales for Elocta and lower royalty on Beyfortus.

Total revenue for January to September ('the year-to-date period') was SEK 20,417 M (18,592), which increased by 10 per cent compared with the same period a year ago and by 15 per cent at CER.

SEK M Q3
2025
Q3
2024
Change Change
at CER
Jan-Sep
2025
Jan-Sep
2024
Change Change
at CER
FY
2024
Haematology 4,771 4,000 19% 26% 13,974 11,942 17 % 22 % 16,429
Immunology 2,658 2,583 3% 12% 5,472 5,768 -5 % 1 % 8,332
Specialty Care 347 311 11% 17% 971 882 10 % 14 % 1,267
Total 7,776 6,894 13% 21% 20,417 18,592 10 % 15 % 26,027

Items affecting comparability (IAC)

Items affecting comparability (IAC) are outlined in the table below. During the quarter, Sobi recognised an impairment charge of SEK 6,612 M related to Vonjo, following a reassessment of its commercial potential. The quarter also includes the dissolvement of the fair value adjustment originating from the purchase price allocation (PPA) related to the acquired inventory from CTI. Furthermore, it includes a write-down of pre-launch inventory related to NASP, pending FDA approval.

Q3
2025
IAC Q3 2025
adjusted
Jan-Sep
2025
IAC Jan-Sep
adjusted
7,776 7,776 20,417 20,417
-1,614 -53 -1,562 -4,629 -176 -4,453
6,162 -53 6,214 15,788 -176 15,964
79% 80% 77% 78%
-9,241 -6,612 -2,629 -14,793 -6,749 -8,044
-754 -754 -2,438 -68 -2,370
-9,995 -6,612 -3,383 -17,231 -6,817 -10,414
-26 -26 -48 -48
-3,858 -6,664 2,806 -1,491 -6,993 5,502
7,478 6,612 866 9,234 6,612 2,622
3,620 -53 3,672 7,743 -381 8,124
47% 47% 38% 40%

The table is non-IFRS financial information, refer to the APM section for further details. See the Consolidated statement of comprehensive income for an IFRS income statement.

1. Refers to the dissolvement of the fair value adjustment originating from the PPA related to the acquired inventory from CTI of SEK -37 M in the quarter and SEK -169 M year-to-date (YTD). The YTD period also included a release of provisions of SEK 11 M linked to the discontinuation of contract manufacturing for Pfizer, due to final severance payments.

2. The quarter refers to a write-down of pre-launch inventory intended for commercial use of SEK -15 M, related to NASP, pending FDA approval.

3. The YTD period refers to restructuring costs of SEK -208 M, of which SEK -3 M allocated to cost of goods sold, following the organisational changes primarily in the US operations and the R&D functions made to enhance efficiencies and ensure prioritisation in line with Sobi's strategy.

4. The quarter refers to impairment of the product- and marketing right Vonjo of SEK -6,612 M as a consequence of prevailing competition in the US Myelofibrosis market, constrained growth potential in our label for patients with <50k platelets and recent negative gross-to-net adjustments that have caused a weaker than expected sales development. See also Note 4.

SEK M Q3
2024
IAC Q3 2024
adjusted
Jan-Sep
2024
IAC Jan-Sep
adjusted
FY
2024
IAC FY 2024 adjusted
Total revenue 6,894 _ 6,894 18,592 _ 18,592 26,027 _ 26,027
Cost of goods sold 1 -1,331 -41 -1,289 -4,185 -99 -4,087 -5,785 -83 -5,702
Gross profit 5,563 -41 5,604 14,407 -99 14,505 20,242 -83 20,326
Gross margin 81% 81% 77% 78% 78% 78%
Selling and administrative -2,694 _ -2,694 -7,896 -118 -7,778 -11,085 -118 -10,967
Research and development expenses -845 _ -845 -2,557 -9 -2,549 -3,538 -9 -3,529
Operating expenses -3,540 _ -3,540 -10,453 -127 -10,326 -14,623 -127 -14,497
Other operating income/expenses 15 _ 15 10 _ 10 6 _ 6
Operating profit (EBIT) 2,038 -41 2,080 3,963 -226 4,189 5,625 -210 5,836
Plus amortisation and impairment of intangible assets 885 _ 885 2,622 _ 2,622 3,532 _ 3,532
EBITA 2,923 -41 2,965 6,585 -226 6,811 9,158 -210 9,368
EBITA margin 42% 43% 35% 37% 35% 36%

The table is non-IFRS financial information, refer to the APM section for further details. See the Consolidated statement of comprehensive income for an IFRS income statement.

Gross profit

Gross profit was SEK 6,162 M (5,563) in the quarter, and the gross margin was 79 per cent (81). Gross profit for the quarter included IAC of SEK -53 M (-41), excluding these, the gross margin was 80 per cent (81). The positive effect from the new Aspaveli royalty agreement announced in July was offset by a lower Beyfortus royalty.

In the year-to-date period, gross profit was SEK 15,788 M (14,407), including IAC of SEK -176 M (-99). The gross margin excluding IAC was 78 per cent (78).

Operating expenses

Selling and administrative expenses were SEK 9,241 M (2,694) in the quarter, including amortisation and impairment of SEK 7,478 M (885). IAC amounted to SEK $-6,612^2$ M (-). Excluding these costs, amortisation and impairment, the selling and administrative expenses increased by 3 per cent at CER. The increase was due to launch and pre-launch activities for Altuvoct, the Aspaveli nephrology indication and NASP, as well as a higher activity level for Gamifant. This was partially offset by lower costs for Vonjo, Doptelet, Synagis and Elocta. In the year-to-date period, expenses were SEK 14,793 M (7,896) and included IAC of SEK -6,749 M (-118) and amortisation and impairment of SEK 9,234 M (2,622). Excluding IAC and amortisation and impairment, the increase was 9 per cent at CER.

R&D expenses were SEK 754 M (845) in the quarter. The decrease was mainly due to NASP related programs completed in 2024, partially offset by development programs for Gamifant and Vonjo. In the year-to-date period, expenses were SEK 2,438 M (2,557) and included IAC of SEK -68 M (-9). Excluding IAC, the decrease was 4 per cent at CER.

Operating profit

EBITA was SEK 3,620 M (2,923) in the quarter, corresponding to a margin of 47 per cent (42). Adjusted EBITA was SEK 3,672 M (2,965), corresponding to an adjusted margin of 47 per cent (43). In the year-to-date period, EBITA was SEK 7,743 M (6,585), corresponding to a margin of 38 per cent (35). Adjusted EBITA was SEK 8,124 M (6,811) corresponding to an adjusted margin of 40 per cent (37). Operating profit/loss was SEK -3,858 M (2,038) in the quarter and SEK -1,491 M (3,963) in the year-to-date period.

1. The full year refers to the dissolvement of the fair value adjustment originating from the PPA related to the acquired inventory from CTI of SEK -159 M. This was partially offset by the release of provisions of SEK 76 M linked to the discontinuation of contract manufacturing for Pfizer, due to early exit of the manufacturing facility.

2. The full year refers to restructuring costs of SEK -85 M related to the restructuring of the commercial team for Synagis and restructuring and integration costs related to CTI of SEK -42 M. Integration costs refers to external expenses related to structural efficiency programmes to enable synergies and structure the combined business to appropriately support the business in the future.

&lt;sup>1 For more information see section Other information.

&lt;sup>2 For more information see Note 4

Net financial items

Net financial items were SEK -168 M (-326) in the quarter and SEK -646 M (-994) in the year-to-date period. The decrease was mainly driven by lower borrowings and interest rates.

Income tax

Income tax was SEK 1,132 M (-248) in the quarter and SEK 752 M (-481) in the year-to-date period, corresponding to an effective tax rate (ETR) of 28.1 per cent (14.5) and 35.2 per cent (16.2), respectively. The higher ETR was mainly driven by a one-time deferred tax effect related to the impairment of Vonjo. The quarter and year-to date period ETR excluding one-off effects was 20.1 per cent.

Profit/loss

Profit/loss in the quarter totalled SEK -2,895 M (1,464) and SEK -1,386 M (2,488) in the year-to-date period.

Cash flow

Cash flow from operating activities were SEK 1,840 M (1,201) in the quarter and SEK 5,584 M (5,591) in the year-to-date period. The increase in the quarter mainly reflects improved operations. Cash flow from investing activities was SEK -2,699 M (-2,202) in the quarter and SEK -3,217 M (-2,990) in the yearto-date period. The quarter included an upfront payment of SEK 2,621 M linked to the new royalty purchase agreement for Aspaveli.

Cash and net debt

On 30 September 2025, cash and cash equivalents were SEK 1,039 M (1,140 on 31 December 2024) and net available committed credit facilities totalled SEK 9,671 M (8,039 on 31 December 2024). Utilised credit facilities, issued bonds and commercial papers totalled SEK 13,224 M (16,375 on 31 December 2024). Net debt was SEK 12,177 M (15,194 on 31 December 2024).

Total equity

On 30 September 2025, total equity was SEK 35,983 M (40,295 on 31 December 2024).

Personnel

On 30 September 2025, the number of full-time equivalent employees was 1,890 (1,840 on 31 December 2024).

Parent Company

Revenue for the Parent Company, Swedish Orphan Biovitrum AB (publ), was SEK 4,521 M (3,356) in the quarter, of which Group companies accounted for SEK 2,799 M (1,950). In the year-to-date period, revenue was SEK 12,017 M (11,473) of which Group companies accounted for SEK 6,685 M (6,791).

The loss in the quarter totalled SEK -4,348 M (-79) and SEK -3,327 M (1,285) in the year-to-date period, including a write-down of the shares in US Holding Corp. of SEK 4,981 M following the impairment of Vonjo. Investing activities affecting cash flow were SEK -2,690 M (-2,199) in the quarter and SEK -2,886 M (-2,338) in the year-to-date period. The quarter included an upfront payment of SEK 2,621 M for Aspaveli.

Haematology

Revenue

SEK M Q3
2025
Q3
2024
Change Change
at CER
Jan-Sep
2025
Jan-Sep
2024
Change Change
at CER
FY
2024
Altuvoct 769 129 >200% >200% 1,851 134 >200% >200% 436
Elocta 812 1,119 -27% -24% 3,075 3,753 -18% -15% 4,891
Alprolix 601 575 4% 9% 1,748 1,736 1% 4% 2,372
Royalty1 518 459 13% 23% 1,548 1,347 15% 22% 1,889
Doptelet 1,408 1,039 35% 46% 3,757 2,723 38% 45% 3,870
Aspaveli/Empaveli 317 270 18% 23% 953 760 25% 30% 1,030
Vonjo 307 379 -19% -11% 915 1,046 -13% -7% 1,462
Zynlonta 40 29 38% 43% 128 68 89% 94% 103
Manufacturing n/a n/a 375 -100% -100% 375
Total 4,771 4,000 19% 26% 13,974 11,942 17% 22% 16,429

1. Royalty from Sanofi's sales of Eloctate, Alprolix and Altuviiio.

Haematology revenue was SEK 4,771 M (4,000) in the quarter and increased by 19 per cent, 26 per cent at CER. In the year-to-date period, revenue was SEK 13,974 M (11,942) and increased by 17 per cent, 22 per cent at CER.

Altuvoct sales were SEK 769 M (129) in the quarter, following strong launches and initial sales in 20 countries led by Germany, Spain and Switzerland. During the quarter, Altuvoct was launched in the UK. In the year-to-date period, revenue was SEK 1,851 M (134).

Elocta sales were SEK 812 M (1,119) in the quarter and decreased by 24 per cent at CER. Sales of Elocta in the quarter were negatively impacted by switch of patients to Altuvoct in launched markets. In the year-to-date period, revenue was SEK 3,075 M (3,753) and decreased by 15 per cent at CER. The combined haemophilia A sales (Altuvoct and Elocta) increased by 31 per cent at CER in the quarter.

Alprolix sales were SEK 601 M (575) in the quarter and increased by 9 per cent at CER. The performance in the quarter was driven by continued growth in the number of patients. In the year-to-date period, revenue was SEK 1,748 M (1,736) and increased by 4 per cent at CER.

In the quarter, Doptelet sales was SEK 1,408 M (1,039) and increased by 46 per cent at CER. The strong performance was driven by increased uptake across markets. Excluding a milestone revenue from the partner in China in 2024, growth was 54 per cent at CER. In the year-to-date period, revenue was SEK 3,757 M (2,723) and increased by 45 per cent at CER.

Aspaveli/Empaveli sales were SEK 317 M (270) in the quarter and increased by 23 per cent at CER, reflecting continued growth in number of patients across most markets, partially offset by negative impact in Europe due to increased competition. In the year-to-date period, revenue was SEK 953 M (760) and increased by 30 per cent at CER.

Vonjo sales were SEK 307 M (379) in the quarter and decreased by 11 per cent at CER. Increase in demand was outweighed by negative gross-to-net adjustments. In the year-to-date period, revenue was SEK 915 M (1,046) and decreased by 7 per cent at CER.

Immunology

Revenue

Q3 Q3 Change Jan-Sep Jan-Sep Change FY
SEK M 2025 2024 Change at CER 2025 2024 Change at CER 2024
Kineret 769 699 10% 20% 2,253 2,077 8% 15% 2,854
Gamifant 733 405 81% 98% 1,947 1,365 43% 52% 1,876
Synagis -11 0 n/a n/a -90 523 -117% -120% 591
Beyfortus royalty 1,166 1,478 -21% -14% 1,362 1,803 -24% -19% 3,010
Total 2,658 2,583 3% 12% 5,472 5,768 -5% 1% 8,332

Immunology revenue was SEK 2,658 M (2,583) in the quarter and increased by 3 per cent and 12 per cent at CER. In the year-to-date period, revenue was SEK 5,472 M (5,768) and decreased by 5 per cent and increased by 1 per cent at CER.

Kineret sales were SEK 769 M (699) in the quarter and increased by 20 per cent at CER, driven by increased demand across regions. In the year-to-date period, sales were SEK 2,253 M (2,077) and increased by 15 per cent at CER.

Gamifant sales were SEK 733 M (405) in the quarter and increased by 98 per cent at CER. The increase was driven by an increase in the number of patients on treatment, positive patient mix and new patients treated for MAS in Still's disease in the US. This was further supported by strong sales in the International region. In the year-to-date period, sales were SEK 1,947 M (1,365) and increased by 52 per cent at CER.

Synagis sales amounted to SEK -11 M (0) in the quarter, reflecting product returns. In the year-to-date period sales were SEK -90 M (523).

Royalty from Sanofi's sales of Beyfortus was SEK 1,166 M (1,478) in the quarter and SEK 1,362 M (1,803) in the year-to-date period.

Specialty Care

Revenue

SEK M Q3
2025
Q3
2024
Change Change
at CER
Jan-Sep
2025
Jan-Sep
2024
Change Change
at CER
FY
2024
Orfadin 109 128 -15% -9% 339 353 -4% 0% 481
Tegsedi 12 32 -63% -62% 65 123 -47% -45% 180
Waylivra 88 61 45% 51% 220 186 18% 22% 273
Other Specialty Care 138 91 52% 59% 347 221 57% 62% 333
Total 347 311 11% 17% 971 882 10% 14% 1,267

Specialty Care revenue was SEK 347 M (311) in the quarter and increased by 11 per cent and 17 per cent at CER, mainly reflecting growth of partner products Fetcroja, Jyseleca and Waylivra. In the year-todate period, sales were SEK 971 M (882) and increased by 10 per cent, 14 per cent at CER.

Pipeline

For more information, please visit sobi.com/en/pipeline.

Pipeline milestones since the previous report

(Abbreviations used in the table are explained in the text below)

Significant milestones Doptelet approved in US for paediatric ITP Doptelet approved in Japan for ITP NASP – Uncontrolled gout: BLA accepted by FDA Tryngolza (olezarsen) – European Union approved for FCS Tryngolza (olezarsen) – positive topline data from CORE pivotal program in sHTG

Haematology

Doptelet approved in US for paediatric ITP, including a new formulation

In July, the US FDA approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in paediatric patients one year and older. The approval also includes a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for use in children ages one to less than six years.

Doptelet approved in Japan for ITP

In August, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in patients with persistent and chronic immune thrombocytopenia (ITP). This extends its indication beyond chronic liver disease (CLD) for which it was approved in Japan in 2023.

Immunology

BLA accepted by the US FDA for NASP in uncontrolled gout

In September, Sobi announced the US FDA accepted the biologics licence application (BLA) for NASP for the treatment of uncontrolled gout. The submission is based on the results of the DISSOLVE I and II pivotal studies.The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date of 27 June 2026.

Kineret submitted in Japan

In July, Sobi submitted the marketing authorisation application to the Japanese PMDA for Kineret in Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD). The application is based on the Sobi ANAKIN-303 pivotal Phase 3 study conducted in Japanese patients, and a regulatory decision is expected in about a year.

Specialty Care

European Union approved Tryngolza (olezarsen) for FCS

In September, Tryngolza (olezarsen) was approved in the European Union as an adjunct to diet in adult patients for the treatment of familial chylomicronemia syndrome (FCS). The approval is based on positive data from the Phase 3 Balance study, in which Tryngolza 80 mg demonstrated a statistically significant reduction in fasting triglyceride levels at six months that was sustained through 12 months. Additionally, Tryngolza demonstrated a substantial and clinically meaningful reduction in acute pancreatitis events over 12 months.

Additionally, during the quarter, Sobi's partner Ionis Pharmaceuticals announced positive topline data for olezarsen in the CORE clinical program in severe hypertriglyceridemia (sHTG).

Olezarsen significantly reduced triglycerides and acute pancreatitis events in the pivotal studies for people with sHTG. Multifactorial Chylomicronemia Syndrome (MCS), is a subgroup of sHTG patients, in Europe defined as blood triglycerides >880mg/dl. Across the major EU countries—France, Germany, Italy, and Spain—as well as the United Kingdom, it is estimated that approximately 700,000 individuals are affected by MCS. Given the significant number of cases, Sobi believes this condition could offer a market potential exceeding SEK 5 billion within these countries. Sobi holds the commercial rights to olezarsen for both FCS and MCS in all countries except in the United States, Canada, and China. Sobi plans regulatory filing in MCS in Europe based on the CORE clinical program data.

Pipeline news flow

Anticipated upcoming pipeline news flow

Aspaveli – Nephrology: Japan regulatory submission
Aspaveli – Nephrology: CHMP opinion (EU)
Q4 2025 Gamifant – HLH/MAS in Still's disease: Japan regulatory submission
Gamifant – Interferon gamma driven sepsis Phase 2a data (Proof of concept research collaboration)
Altuvoct – Haemophilia A: FREEDOM Phase 3b initial study data
Aspaveli – Nephrology: EU regulatory decision
Aspaveli – Nephrology: Japan regulatory decision
Gamifant – HLH/MAS in Still's disease: Japan regulatory decision
2026 Gamifant – HLH/MAS in Still's disease: EU submission
NASP – Uncontrolled gout: US regulatory decision
Tryngolza – MCS: EU regulatory submission
Zynlonta – DLBCL 2L; LOTIS-5 data readout

Other information

Significant events

In the quarter

Aspaveli agreement with Apellis amended

In July, Sobi announced a defined caps royalty purchase agreement with Apellis Pharmaceuticals, Inc. under which Sobi will reduce its ex-US royalty obligations to Apellis by 90 per cent for Aspaveli in exchange for USD 275 M upfront and up to USD 25 M in additional milestone payments dependent on regulatory approvals in the EU for C3G and primary IC-MPGN. After defined caps are achieved, royalties will revert to the terms of the original licence agreement.

Expanded agreement with Pint Pharma to further strengthen the presence in Latin America

In September, Sobi agreed to expand its agreement with Pharma Investments S.A. ("Pint Pharma") to acquire 19.9 per cent of the voting rights and 60 per cent of the economic rights in Pint Pharma for USD 105 M. The acquisition is expected to be completed subject to customary closing conditions, and the investment will be reported as an investment in an associated company. The new agreement will allow Sobi to strengthen the strategic partnership with Pint Pharma as a launch platform for Sobi's medicines in Brazil and the broader LATAM countries. Further, the parties have an intention to establish a joint venture for the Brazilian market, in which Sobi will be the majority owner.

Pint Pharma is specialised in the commercialisation of rare disease and speciality care medicines across Latin America. Through the current agreement established in 2021, Pint Pharma commercialises several key Sobi products, including Empaveli/Aspaveli, Doptelet, Vonjo, Zynlonta, Gamifant and Kineret.

Outlook - updated

At the publication of the Q4 2024 report on 5 February 2025 Sobi stated the outlook for the FY 2025 to be: Revenue was anticipated to grow by a high single digit percentage at CER and adjusted EBITA margin was anticipated to be in the mid-30s per cent of revenue.

Sobi has updated its full-year revenue outlook based on year-to-date performance and strong momentum in Q3. Group revenue grew 15 per cent at CER year-to-date and 21 per cent at CER in Q3. This was driven by higher-than-expected in-market performance particularly for Doptelet and Gamifant, but also other areas contributed.

• Revenue is anticipated to grow at low-double-digit percentage at CER (previously high-single-digit)

Sobi has also updated its adjusted EBITA margin outlook. Adjusted EBITA margin reached 40 per cent year-to-date and 47 per cent in Q3. The strong performance is driven primarily by lower-thananticipated R&D spend, demonstrating disciplined cost control and accelerated effects from organisational changes implemented in Q2. Realigned SG&A and R&D activities following the confirmation from the FDA on a mid-2026 review decision on the NASP biologics licence application (BLA) also contributed.

Importantly, the SEK 6,612 M impairment on Vonjo is non-cash, sits in items affecting comparability, and does not impact adjusted EBITA or cash flow, preserving the underlying margin quality.

• Adjusted EBITA margin is anticipated to be at mid-to-high 30s percentage of revenue (previously mid-30s)

Sustainability

Sobi's sustainability efforts support the overall mission of working together with stakeholders to find and make available medicines that transform the lives of people with rare and debilitating diseases and are based on two priorities:

  • Maintain commitment to patients
  • Always act responsibly

During the quarter, Sobi reached further milestones in the strive to expand access to medicine. Details on approvals and presentation of new data are provided in the Pipeline section.

In September, Sobi announced that it had been ranked number one out of 31 global pharma companies by patient groups in 'The Corporate Reputation of Pharma — Rare-Disease Edition 2024'.

Sobi helped advocate for improved access for people living with rare disease by participating in the 2025 edition of the Nordic Rare Disease Summit together with patient representatives and European policy makers.

Sobi shared knowledge on the most recent progress in the field of haemostasis and inherited bleeding disorders in the 13th BIC Conference, held in Padua, Italy and hosted a meeting in Tokyo of top regional haematology experts from Japan, Korea and Taiwan on Paroxysmal Nocturnal Hemoglobinuria (PNH).

New digital platforms to share knowledge and best practice around the rare kidney disease C3 Glomerulopathy (C3G) were also launched in September.

Financial calendar

Q4 2025 report 5 February 2026 Annual and Sustainability report 31 March 2026 Q1 2026 report 28 April 2026 AGM 6 May 2026 Q2 2026 report 16 July 2026 Q3 2026 report 27 October 2026

For a full calendar, please visit sobi.com.

Forward-looking statements

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

This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out in the press release concerning this report, on 20 October 2025 at 08:00 CEST.

Auditor's review report

Introduction

We have reviewed the condensed interim report for Swedish Orphan Biovitrum AB (publ) as of 30 September, 2025, and for the nine months period then ended. The Board of Directors and the CEO 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, 20 October 2025

Ernst & Young AB

Jonatan Hansson Authorised Public Accountant

Financial statements – condensed

Consolidated statement of profit or loss

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Total revenue 7,776 6,894 20,417 18,592 26,027
Cost of goods sold -1,614 -1,331 -4,629 -4,185 -5,785
Gross profit 6,162 5,563 15,788 14,407 20,242
Selling and administrative expenses1, 2 -9,241 -2,694 -14,793 -7,896 -11,085
Research and development expenses -754 -845 -2,438 -2,557 -3,538
Other operating income/expenses -26 15 -48 10 6
Operating profit -3,858 2,038 -1,491 3,963 5,625
Net financial items -168 -326 -646 -994 -1,219
Profit before tax -4,027 1,712 -2,137 2,969 4,407
Income tax 1,132 -248 752 -481 -528
Profit/loss for the period -2,895 1,464 -1,386 2,488 3,879
Profit/loss for the period attributable to:
Owners of the parent company -2,894 1,464 -1,384 2,488 3,885
Non-controlling interests 0 0 -2 0 -6
Earnings per share (EPS), SEK
EPS before dilution -8.40 4.27 -4.02 7.29 11.37
EPS after dilution -8.32 4.22 -3.99 7.21 11.24
1. Amortisation and impairment of intangible assets included in
Selling and administrative expenses.
7,478 885 9,234 2,622 3,532

2. Includes impairment of Vonjo by SEK 6,612 M, see Note 4 for further information.

Consolidated statement of comprehensive income

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Profit/loss for the period -2,895 1,464 -1,386 2,488 3,879
Other comprehensive income
Items that will not be reclassified into profit or loss
Remeasurements on defined-benefit pension plans and
similar plans (net of tax)
0 0 10 0 -81
Remeasurement of equity instruments (net of tax) 0 -22 -18 -8 -2
Total 0 -22 -8 -8 -83
Items that may be reclassified into profit or loss
Translation differences -292 -988 -3,438 171 2,136
Net investment hedges (net of tax) 18 93 286 -17 -180
Cash flow hedges (net of tax) 3 3
Total -271 -895 -3,148 154 1,956
Other comprehensive income -271 -918 -3,156 146 1,874
Total comprehensive income for the period -3,166 546 -4,542 2,634 5,753
Total comprehensive income for the period attributable
to:
Owners of the parent company -3,166 546 -4,539 2,635 5,759
Non-controlling interests -1 0 -3 0 -6

Consolidated balance sheet

SEK M Sep
2025
Dec
2024
Sep
2024
ASSETS
Non-current assets
Intangible assets1,2 49,725 58,971 57,338
Tangible assets3 1,639 1,584 1,435
Financial assets 176 166 175
Prepaid production costs 209 268 203
Deferred tax assets 981 1,293 909
Total non-current assets 52,731 62,282 60,059
Current assets
Inventories 4,637 4,159 3,994
Accounts receivable 5,769 5,195 4,675
Other receivables 2,789 2,667 2,873
Cash and cash equivalents 1,039 1,140 594
Total current assets 14,234 13,162 12,136
Total assets 66,964 75,444 72,195
EQUITY AND LIABILITIES
Equity
Share capital 196 195 195
Other contributed capital 17,410 17,186 17,118
Other reserves -2,174 981 -746
Retained earnings 21,928 18,039 18,038
Profit for the period -1,384 3,885 2,488
Equity attributable to the owners of the parent company 35,977 40,286 37,094
Non-controlling interests 6 9 15
Total equity 35,983 40,295 37,109
Non-current liabilities
Borrowings 8,776 12,407 11,473
Deferred tax liabilities 4,502 6,702 6,517
Lease liabilities 265 268 254
Other liabilities 3,458 3,171 2,941
Total non-current liabilities 17,001 22,549 21,185
Current liabilities
Borrowings 4,439 3,926 6,001
Accounts payable 841 944 1,366
Lease liabilities 109 134 139
Other liabilities 8,591 7,596 6,395
Total current liabilities 13,981 12,600 13,901
Total equity and liabilities 66,964 75,444 72,195

1. Including goodwill of SEK 9,206 M (10,456 on 31 December 2024).

2. Information about impairment of Vonjo, see Note 4.

3. Including right-of-use assets of SEK 368 M (322 on 31 December 2024).

Consolidated statement of changes in equity

SEK M Equity related to
owners of the
parent company
Non-controlling
interests
Total equity
Opening equity, 1 January 2025 40,286 9 40,295
Share-based compensation to employees 229 229
Stock options exercised by employees 1 1
Tax adjustments for share programmes1 0 0
Equity swap for hedging of share programmes2 1 1
Total comprehensive income for the period3 -4,539 -3 -4,542
Closing equity, 30 September 2025 35,977 6 35,983
Opening equity, 1 January 2024 33,867 33,867
Share-based compensation to employees 579 579
Stock options exercised by employees 2 2
Tax adjustments for share programmes1 28 28
Equity swap for hedging of share programmes2 -16 -16
Changes in non-controlling interests 15 15
Total comprehensive income for the period 2,635 0 2,634
Closing equity, 30 September 2024 37,094 15 37,109
Opening equity, 1 January 2024 33,867 33,867
Share-based compensation to employees 645 645
Stock options exercised by employees 2 2
Tax adjustments for share programmes1 30 30
Equity swap for hedging of share programmes2 -16 -16
Changes in non-controlling interests 15 15
Total comprehensive income for the period3 5,759 -6 5,753
Closing equity, 31 December 2024 40,286 9 40,295

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

2. Refers to equity swap agreement entered into by Sobi to meet its obligations to deliver shares under the share programmes.

3. Whereof changes in cash flow hedges (net of tax) amounted to SEK 3 M (— on 31 December 2024) and investment hedges (net of tax) amounted to SEK 286 M (-180 on 31 December 2024).

Consolidated cash flow statement

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Cash flow from operating activities
Profit/loss before tax -4,027 1,712 -2,137 2,969 4,407
Non-cash items
Depreciation/amortisation and impairment 7,515 924 9,342 2,747 3,679
Other, non-cash items1 223 467 742 1,161 903
Cash items
Interest received 4 7 16 25 34
Interest paid -120 -201 -420 -852 -1,091
Payment to pension funds -18 -8 -33 -18 -58
Income tax paid -164 -49 -1,186 -388 -307
Cash flow from operating activities before change
in working capital
3,413 2,852 6,322 5,644 7,567
Changes in working capital -1,573 -1,652 -739 -53 -179
Cash flow from operating activities 1,840 1,201 5,584 5,591 7,388
Investment in intangible assets -2,676 -2,159 -3,082 -2,787 -2,835
Investment in tangible assets -8 -21 -35 -158 -170
Investment in productions -6 -22 -64 -45 -85
Investment in financial assets -9 -39
Other investing activities 2
Cash flow from investing activities -2,699 -2,202 -3,217 -2,990 -3,091
Borrowings/repayments of borrowings 802 698 -2,876 -3,092 -4,436
Hedging arrangement for financing 81 69 565 -77 163
Repayment of leasing -36 -43 -160 -123 -170
Proceeds from exercise of share options 10 136 46 426 427
Transactions with non-controlling interests 15 15
Cash flow from financing activities 857 860 -2,424 -2,851 -4,001
Change in cash and cash equivalents -2 -141 -58 -250 296
Cash and cash equivalents at the beginning of the
period
1,058 779 1,140 904 904
Translation difference in cash flow and cash and
cash equivalents
-17 -45 -42 -60 -61
Cash and cash equivalents at the end of the period 1,039 594 1,039 594 1,140
1Specification other, non-cash items
Interest expenses 123 223 417 890 1,114
IFRS 2 costs on share-based compensation to employees 58 59 182 153 218
FX 91 199 36 216 -219
Other -48 -15 107 -98 -209
Total 223 467 742 1,161 903

Key ratios and other information

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Profit measures
Gross profit 6,162 5,563 15,788 14,407 20,242
Adjusted gross profit1,2 6,214 5,604 15,964 14,505 20,326
EBITDA1 3,656 2,962 7,851 6,711 9,305
Adjusted EBITDA1,2 3,709 3,003 8,232 6,937 9,529
EBITA1 3,620 2,923 7,743 6,585 9,158
Adjusted EBITA1,2 3,672 2,965 8,124 6,811 9,368
EBIT -3,858 2,038 -1,491 3,963 5,625
Adjusted EBIT1,2 2,806 2,080 5,502 4,189 5,836
Profit/loss for the period -2,895 1,464 -1,386 2,488 3,879
Adjusted profit/loss for the period1,2 2,105 1,495 3,866 2,660 4,035
Per share data (SEK)
EPS before dilution -8.40 4.27 -4.02 7.29 11.37
Adjusted EPS before dilution1,2 6.11 4.36 11.25 7.80 11.83
EPS after dilution -8.32 4.22 -3.99 7.21 11.24
Adjusted EPS after dilution1,2 6.05 4.31 11.14 7.71 11.69
Equity per share1 100.7 104.2 100.7 104.2 113.2
Equity per share after dilution1 99.8 103.1 99.8 103.1 112.0
Other information
Gross margin1 79% 81% 77% 77% 78%
Adjusted gross margin1,2 80% 81% 78% 78% 78%
EBITA margin1 47% 42% 38% 35% 35%
Adjusted EBITA margin1,2 47% 43% 40% 37% 36%
Equity ratio1 54% 51% 54% 51% 53%
Net debt1 12,177 16,880 12,177 16,880 15,194
Number of ordinary shares 357,412,837 356,000,049 357,412,837 356,000,049 356,000,049
Number of ordinary shares (in treasury)3 12,756,537 12,564,213 12,756,537 12,564,213 12,557,222
Number of ordinary shares (ex shares in treasury) 344,656,300 343,435,836 344,656,300 343,435,836 343,442,827
Number of ordinary shares after dilution 360,635,341 359,829,096 360,635,341 359,829,096 359,835,405
Average number of ordinary shares (ex shares in
treasury)
344,648,852 343,013,416 343,947,311 341,151,567 341,726,901
Average number of ordinary shares after dilution (ex
shares in treasury)
347,871,356 346,842,463 347,169,815 344,980,614 345,562,257

1. See section APM for further information.

2. IAC, see page 3 for further information.

3. The decrease in the number of shares in treasury since year-end results from allotment of shares for the programmes expired.

Financial statements – condensed

Parent Company statement of profit and loss

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Revenue 4,521 3,356 12,017 11,473 16,464
Cost of goods sold -1,629 -1,158 -4,200 -3,480 -4,917
Gross profit 2,892 2,198 7,817 7,993 11,547
Selling and administrative expenses1 -1,405 -1,271 -4,294 -3,937 -5,405
Research and development expenses -421 -507 -1,377 -1,595 -2,170
Other operating income/expenses 61 -17 182 88 211
Operating profit 1,127 404 2,328 2,548 4,183
Result from participation in Group companies2 -4,981 -4,981
Net financial items -82 -95 -11 -683 -1,062
Profit after financial items -3,936 309 -2,663 1,865 3,121
Appropriations3 6,439
Profit before tax -3,936 309 -2,663 1,865 9,560
Income tax -412 -388 -664 -580 -1,979
Profit/loss for the period -4,348 -79 -3,327 1,285 7,581
1. Amortisation and impairment of intangible assets included
in Selling and administrative expenses.
-205 -151 -526 -411 -573

2. Includes a write-down of the value of the shares in Sobi US Holding Corp. by SEK 4,981 M followed by the impairment of Vonjo, see Note 4.

Parent Company statement of comprehensive income

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Profit/loss for the period -4,348 -79 -3,327 1,285 7,581
Other comprehensive income
Items that will not be reclassified into profit or loss
Remeasurement of equity instruments (net of tax) 0 -22 -18 -8 -2
Items that may be reclassified into profit or loss
Cash flow hedges (net of tax) 3 3
Other comprehensive income 2 -22 -15 -8 -2
Total comprehensive income for the period -4,346 -102 -3,343 1,277 7,579

3. The increase 2024 was mainly attributable to a reversal of accumulated excess depreciation upon transition to the residual value method, having a positive impact of SEK 4,279 M.

Parent Company balance sheet

SEK M Sep
2025
Dec
2024
Sep
2024
ASSETS
Non-current assets
Intangible assets 14,606 10,825 10,996
Tangible assets 585 591 591
Financial assets1 29,590 35,880 36,809
Prepaid production costs 795 816 684
Deferred tax assets 102
Total non-current assets 45,576 48,112 49,181
Current assets
Inventories 3,448 2,924 2,847
Accounts receivable 1,526 1,366 1,246
Receivables Group companies 7,874 12,125 7,835
Other receivables 943 836 917
Cash and cash equivalents 524 745 180
Total current assets 14,316 17,996 13,025
Total assets 59,892 66,109 62,206
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 196 195 195
Statutory reserve 800 800 800
Total restricted equity 996 996 996
Non-restricted equity
Retained earnings 36,579 28,784 28,710
Profit for the period -3,327 7,581 1,285
Total non-restricted equity 33,252 36,366 29,995
Shareholder's equity 34,248 37,361 30,991
Untaxed reserves 4,279
Non-current liabilities
Borrowings 8,776 12,407 11,473
Deferred tax liabilities 1,057 999
Other liabilities 3,034 2,569 2,457
Total non-current liabilities 12,867 15,975 13,930
Current liabilities
Borrowings 4,439 3,926 6,001
Accounts payable 649 714 1,143
Liabilities Group companies 3,774 5,004 3,281
Other liabilities 3,913 3,128 2,582
Total current liabilities 12,776 12,772 13,005
Total equity and liabilities 59,892 66,109 62,206

1. For information of write-down of shares in Sobi US Holding Corp., see Note 4.

Parent Company statement of changes in equity

SEK M Jan-Sep
2025
FY
2024
Jan-Sep
2024
Opening balance 37,361 29,121 29,121
Share-based compensation to employees 229 645 579
Stock options exercised by employees 1 2 2
Tax adjustments for share programmes1 0 30 28
Equity swap for hedging of share programmes2 1 -16 -16
Total comprehensive income for the period3 -3,343 7,579 1,277
Closing balance 34,248 37,361 30,991

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

2. Refers to equity swap agreement entered into by Sobi to meet its obligations to deliver shares under the share programmes.

3. Whereof changes in cash flow hedges (net of tax) amounted to SEK 3 M (— on 31 December 2024).

Notes

Note 1 | Accounting policies and measurement bases and other information

Accounting policies

This report has been prepared in accordance with IAS 34 and the Swedish Annual Accounts Act. The Parent Company applies the Annual Accounts Act and the Swedish Corporate Reporting Board's Recommendation RFR 2 Accounting for Legal Entities.

The accounting policies is consistent with those described in the Annual and sustainability report 2024. IASB has published amendments of standards that were effective as of 1 January 2025 or later. These have not had any material impact on the consolidated financial statements. Amounts are stated in SEK M (million krona), rounded to the nearest SEK M and values in parentheses refer to the same period a year ago unless otherwise stated.

There were no significant related-party transactions during the period. More detailed information about the Group's accounting policies and measurement bases can be found in the Annual and sustainability report 2024, available at sobi.com.

In 2024, Sobi reclassified several agreements in the balance sheet linked to prepaid production costs. In the comparative period at the end of the quarter in the Group, intangible assets have therefore decreased by SEK 540 M, tangible assets increased by SEK 1,051 M, other receivables decreased by SEK 511 M and other long-term assets of SEK 203 M have been reclassified to prepaid production costs. In the Parent company, intangible assets of SEK 540 M have been reclassified to tangible assets and other long-term assets of SEK 173 M and other receivables of SEK 511 M have been reclassified to prepaid production costs for the corresponding comparative period. The change has not affected the income statement in either the Group or the Parent Company for the corresponding comparative period. In the cash flow statement, investments attributable to prepaid production costs are reported within investing activities, whereby the reclassification has only occurred within investing activities for the corresponding comparative period. See Note 2 in the Annual and sustainability report for 2024 for further information.

Risks and uncertainties

A comprehensive enterprise risk management process runs annually to identify and evaluate existing and emerging risks affecting Sobi's ability to achieve its targets and provide the Executive committee and the Board with information to support their governance of Sobi. Principal risk areas are:

  • Pipeline and commercialisation, including but not limited to key medicines, approval and marketing authorisation, pricing
  • Business execution, including but not limited to supply chain, third party, information security, patient and product safety, workforce
  • Finance, including but not limited to financial, reporting, taxation
  • Legal, regulatory and compliance, including but not limited to patent, litigation

The current global situation with geopolitical uncertainties, war and potential international tariffs is closely monitored and any potential impact is continuously assessed, including actions to limit any impact on Sobi. The recently imposed tariffs in the US is not expected to have a material impact on the costs in 2025. Sobi is currently assessing different options to manage specific production flows.

More details about risk exposure and risk management are included in the Annual and sustainability report 2024.

Note 2 | Segment reporting

Revenue and EBITA by segment

Q3 2025 Haematology Immunology Specialty Care Group – other6 Total
Total revenue 4,771 2,658 347 7,776
EBITA1 2,010 1,660 124 -175 3,620
Adjusted EBITA1,2,3 2,047 1,675 124 -175 3,672
Amortisation and impairment4 -7,174 -285 -5 -14 -7,478
Net financial items -168 -168
Profit before tax -5,164 1,375 119 -357 -4,027
Q3 2024 Haematology Immunology Specialty Care Group – other6 Total
Total revenue 4,000 2,583 311 6,894
EBITA1 1,398 1,594 132 -201 2,923
Adjusted EBITA1,2,5 1,440 1,594 132 -201 2,965
Amortisation and impairment -547 -287 -40 -12 -885
Net financial items -326 -326
Profit before tax 852 1,307 92 -539 1,712
Jan-Sep 2025 Haematology Immunology Specialty Care Group – other6 Total
Total revenue 13,974 5,472 971 20,417
EBITA1 5,354 2,519 387 -516 7,743
Adjusted EBITA1,2,3 5,682 2,569 390 -516 8,124
Amortisation and impairment4 -8,258 -854 -77 -45 -9,234
Net financial items -646 -646
Profit before tax -2,904 1,665 310 -1,207 -2,137
Jan-Sep 2024 Haematology Immunology Specialty Care Group – other6 Total
Total revenue 11,942 5,768 882 18,592
EBITA1 4,205 2,606 355 -581 6,585
Adjusted EBITA1,2,5 4,346 2,691 355 -581 6,811
Amortisation and impairment -1,595 -870 -120 -38 -2,622
Net financial items -994 -994
Profit before tax 2,610 1,736 235 -1,613 2,969
FY 2024 Haematology Immunology Specialty Care Group – other6 Total
Total revenue 16,429 8,332 1,267 26,027
EBITA1 5,437 4,019 493 -792 9,158
Adjusted EBITA1,2,5 5,563 4,104 493 -792 9,368
Amortisation and impairment -2,163 -1,160 -160 -50 -3,532
Net financial items -1,219 -1,219
Profit before tax 3,302 2,835 329 -2,061 4,407

There are no intersegment transactions.

    1. See section APM for further information.
    1. Items affecting comparability, see page 3 for further information.
    1. Includes impairment of Vonjo by SEK -6,612 M, see also Note 4.
    1. Adjusted EBITA FY 2024; Haematology refers to inventory fair value adjustment originating from the PPA of SEK -159 M and restructuring and integration costs of SEK -42 M, all related to CTI. This was partially offset by release of restructuring costs of SEK 76 M linked to the discontinuation of contract manufacturing for Pfizer, due to early exit of the manufacturing facility. Immunology refers to restructuring costs of SEK -85 M related to the restructuring of the commercial team for Synagis.
    1. The category Group other mainly refers to costs for central functions such as finance, legal, communication, human resources and other items that cannot be allocated by segment.

3. Adjusted EBITA Q3 and Jan-Sep 2025; Haematology refers to the inventory fair value adjustment originating from the PPA of SEK -37 M in the quarter and SEK -169 M in the YTD period. It also includes restructuring costs of SEK -171 M in the YTD period followed by the organisational changes primarily in the US operations and the R&D functions made to enhance efficiencies and ensure prioritisation in line with Sobi´s strategy. This was partially offset by release of restructuring costs of SEK 11 M in the YTD period linked to the discontinuation of contract manufacturing for Pfizer, due to final severance payments. Immunology, in the quarter, refers to a write-down of pre-launch inventory intended for commercial use of SEK -15 M related to NASP, pending FDA approval. The YTD period for Immunology and Speciality Care refer also to restructuring costs of SEK -37 M related to the organisational changes.

Revenue - Gross to net

Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Product sales, gross 8,674 6,752 25,108 21,228 29,049
Discounts -2,583 -1,849 -7,600 -6,219 -8,353
Product sales, net 6,092 4,903 17,508 15,009 20,696
Manufacturing 375 375
Royalty 1,684 1,938 2,910 3,151 4,899
Milestone payments 52 52 52
Service fees 1 -1 6 6
Total revenue1 7,776 6,894 20,417 18,592 26,027

1. For revenue by product see pages 6-7.

Revenue by segment and geographic area

Q3 2025 Haematology Immunology Specialty Care Total
Europe 2,345 207 164 2,715
North America 1,298 1,121 72 2,491
International 611 164 111 886
Other1 518 1,166 1,684
Total 4,771 2,658 347 7,776
Q3 2024 Haematology Immunology Specialty Care Total
Europe 1,966 198 155 2,319
North America 1,072 826 71 1,969
International 502 81 85 668
Other1 459 1,478 1,938
Total 4,000 2,583 311 6,894
Jan-Sep 2025 Haematology Immunology Specialty Care Total
Europe 6,746 646 468 7,860
North America 3,576 2,992 209 6,776
International 2,104 472 295 2,872
Other1 1,548 1,362 2,910
Total 13,974 5,472 971 20,417
Jan-Sep 2024 Haematology Immunology Specialty Care Total
Europe 5,967 656 450 7,072
North America 2,921 3,075 237 6,233
International 1,707 234 195 2,136
Other1 1,347 1,803 3,151
Total 11,942 5,768 882 18,592
FY 2024 Haematology Immunology Specialty Care Total
Europe 8,170 900 619 9,690
North America 4,163 4,038 313 8,513
International 2,207 383 335 2,925
Other1 1,889 3,010 4,899
Total 16,429 8,332 1,267 26,027

1. Refers to royalty and the majority of royalties received are attributable to North America.

Note 3 | Fair value of financial instruments

The table below shows financial instruments measured at fair value, based on their classification in the fair value hierarchy. The breakdown of how fair value is determined is made based on the following three levels.

Level 1: Consist of equity instruments and refers to Sobi's holding of quoted shares in Cartesian Therapeutics, Inc. Fair value measurement is based on quoted prices in active markets.

Level 2: Consist of derivatives held for trading and refers t currency derivatives forward contracts. Fair value measurement is based on published forward prices.

Level 3: Consist of shares in investment fund, CVR:s and endowment policies.

Sobi entered into a partnership with 4BIO Capital during the year as an investor in their fund, 4BIO Ventures III. The fund invests in the pharmaceutical, biotechnology, advanced therapies, life sciences and other emerging technologies sectors. Sobis investment in the fund is recognised as shares in investment fund. Through the partnership, Sobi will gain access to scientific advice from 4BIO's team and introductions to companies under management. Sobi's commitment in the fund amounts to USD 10 M, of which approximately USD 6 M remained at the end of the quarter. The reported value of Sobi's holding in the fund is based on the fair value provided by the fund administrator.

Due to the merger of Selecta Biosciences with Cartesian Therapeutics Sobi received transferable CVRs which entitles Sobi to receive future royalty and milestone payments related to NASP and all other legacy Selecta assets. Fair value measurement for the CVRs are based on a discounted cash flow analysis (DCF) which uses a number of estimates regarding amount and timing of future cash flows. The key assumptions in cash flows are probability of success for regulatory approval of NASP in the US and estimated sales.

Endowment policies are reported gross with the corresponding liability, which is reported as other liabilities. No transfers have been made between the levels during the period.

Liabilities linked to contingent considerations attributable to intangible assets acquired and fixed rate bond loans were SEK 4,429 M (3,437 on 31 December 2024). These are measured at amortised cost using the effective interest method. Fair value for these liabilities was SEK 4,030 M (3,088 on 31 December 2024 ). All other financial instruments on the balance sheet had reported values that are in all material aspects equivalent to fair value on 30 September 2025.

Financial assets and liabilities measured at fair value

Sep 2025 Level 1 Level 2 Level 3 Total
Financial assets and liabilities measured at fair value
through profit or loss
Currency derivatives held for trading 12 12
Shares in investment fund 29 29
Contingent value rights (CVR) 53 53
Endowment policies 43 43
Financial assets measured at fair value through other
comprehensive income
Equity instruments 17 17
Total 17 12 125 154
Sep 2024 Level 1 Level 2 Level 3 Total
Financial assets and liabilities measured at fair value
through profit or loss
Currency derivatives held for trading 8 8
Interest derivatives held for trading 20 20
Contingent value rights (CVR) 42 42
Endowment policies 47 47
Financial assets measured at fair value through other
comprehensive income
Equity instruments 29 29
Total 29 28 90 147
Dec 2024 Level 1 Level 2 Level 3 Total
Financial assets and liabilities measured at fair value
through profit or loss
Currency derivatives held for trading
-52 -52
Contingent value rights (CVR) 46 46
Endowment policies 43 43
Financial assets measured at fair value through other
comprehensive income
Equity instruments 36 36
Total 36 -52 90 74

The tables below show the periods changes for financial instruments in level 3.

Fair value of financial assets, Level 3

Sep 2025 Shares in
investment fund
Contingent value
rights (CVR)
Endowment
policies
Total
Opening balance 46 43 90
Remeasurement recognised in statement of profit or
loss
-4 15 -1 10
Investments 39 39
Translation differences -5 -9 -14
Closing balance 29 53 43 125
Sep 2024 Shares in
investment fund
Contingent value
rights (CVR)
Endowment
policies
Total
Opening balance 46 46
Remeasurement recognised in statement of profit or
loss
5 1 6
Investments 38 38
Translation differences -1 -1
Closing balance 42 47 90
Dec 2024 Shares in
investment fund
Contingent value
rights (CVR)
Endowment
policies
Total
Opening balance 46 46
Remeasurement recognised in statement of profit or
loss
6 1 7
Investments 38 2 40
Divestments/payments -6 -6
Translation differences 2 2
Closing balance 46 43 90

Note 4 | Intangible assets - impairment

Vonjo

In the quarter, Sobi impaired the product and marketing right Vonjo by SEK 6,612 M. At the end of the quarter, the carrying amount of Vonjo was SEK 6,263 M, which corresponds to its value in use adjusted for working capital. The updated amortisation per year is expected to amount to USD 52 M corresponding to SEK 0.5 billion (previously USD 109 M, SEK 1 billion) and the asset is expected to be fully amortised during 2038. The impairment is reported as an item affecting comparability in Selling and administrative expenses within the Haematology segment and has not affected cash flow. The annual impairment test for Haematology showed significant headroom for the segment's goodwill.

The impairment is a consequence of prevailing competition in the US Myelofibrosis market, constrained growth potential in our label for patients with <50k platelets and recent negative gross-to-net adjustments that have caused a weaker than expected sales development. The development work continues with the confirmatory Phase 3 study PACIFICA in order to achieve full approval in the US, to expand its use in myelofibrosis and allow regulatory filing outside of the US. Additionally, clinical trials to investigate the potential of Vonjo in new indications are under way. When calculating the recoverable amount, a discount rate of 8.4 per cent after tax has been used (10.6 per cent before tax). The most important assumption for the estimated recoverable amount for Vonjo is a positive outcome of the PACIFICA confirmatory trial and an expanded label of Vonjo in Myelofibrosis. The PACIFICA study is expected to be completed in 2027.

Followed by the impairment of Vonjo the Parent Company recognised a SEK 4,981 M write-down of its shares in Sobi US Holding Corp.

Alternative performance measures – financial measures not defined according to IFRS

Sobi uses certain financial measures, Alternative performance measures (APM) in this report that are not defined according to IFRS. Sobi considers these measures to provide valuable supplementary information for stakeholders 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. The alternative performance measures should not, therefore, be regarded as substitutes for measures defined according to IFRS. Sobi has updated its definition of items affecting comparability (IAC) during the quarter to include a new type of cost, write-down of pre-launch inventory, incurred in the quarter. These costs are considered as IAC to better reflect the performance of the ordinary operations. See below metrics not defined according to IFRS and definitions used, referred to and presented in this report. Numbers are presented in SEK M unless otherwise stated.

Change at CER

Definition: Change at CER (constant exchanges rates) on total revenue excludes the effect of exchange rates by recalculating total revenue for the relevant period using the exchanges rates that were used for the comparable period.

Reason for use: The measure is important in order to understand the underlying performance of the operations and increases the comparability between periods.

Q3 2025 Total revenue FX impact Total revenue,
adjusted for FX
impact
Total revenue,
comparable
period
Change at CER
Haematology
Altuvoct 769 23 792 129 >200 %
Elocta 812 33 845 1,119 -24%
Alprolix 601 27 627 575 9%
Royalty 518 47 565 459 23%
Whereof Eloctate/Alprolix 258 24 281 307 -6 %
Whereof Altuviiio 260 24 284 152 29 %
Doptelet 1,408 111 1,519 1,039 46%
Aspaveli/Empaveli 317 15 333 270 23%
Vonjo 307 29 336 379 -11%
Zynlonta 40 1 42 29 43%
Total 4,771 287 5,058 4,000 26%
Immunology
Kineret 769 69 838 699 20%
Gamifant 733 68 801 405 98%
Synagis -11 -1 -12 0 n/a
Beyfortus royalty 1,166 106 1,272 1,478 -14%
Total 2,658 241 2,899 2,583 12%
Specialty Care 347 17 364 311 17%
Total 7,776 545 8,321 6,894 21%
Q3 2024 Total revenue FX impact Total revenue,
adjusted for FX
impact
Total revenue,
comparable
period
Change at CER
Haematology
Altuvoct 129 4 133 n/a
Elocta 1,119 9 1,128 1,245 -9%
Alprolix 575 12 587 545 8%
Royalty 459 22 481 417 16%
Whereof Eloctate/Alprolix 307 15 322 374 -13%
Whereof Altuviiio 152 7 160 42 28%
Doptelet 1,039 34 1,073 650 65%
Aspaveli/Empaveli 270 10 280 169 66%
Vonjo 379 14 393 347 13%
Zynlonta 29 1 30 15 96%
Manufacturing 96 -100%
Total 4,000 106 4,106 3,484 18%
Immunology
Kineret 699 26 725 600 21%
Gamifant 405 21 425 438 -3%
Synagis 0 0 0 100 -100%
Beyfortus royalty 1,478 121 1,600 263 >200 %
Total 2,583 168 2,750 1,400 96%
Specialty Care 311 9 321 284 13%
Total 6,894 283 7,177 5,168 39%
Total revenue,
adjusted for FX
Total revenue,
comparable
Jan-Sep 2025 Total revenue FX impact impact period Change at CER
Haematology
Altuvoct 1,851 54 1,905 134 >200%
Elocta 3,075 103 3,178 3,753 -15%
Alprolix 1,748 53 1,801 1,736 4%
Royalty 1,548 98 1,646 1,347 22%
Whereof Eloctate/Alprolix 820 49 870 947 -6%
Whereof Altuviiio 727 49 777 400 28%
Doptelet 3,757 200 3,957 2,723 45%
Aspaveli/Empaveli 953 34 987 760 30%
Vonjo 915 54 969 1,046 -7%
Zynlonta 128 4 132 68 94%
Manufacturing 375 -100%
Total 13,974 601 14,574 11,942 22%
Immunology
Kineret 2,253 135 2,388 2,077 15%
Gamifant 1,947 121 2,068 1,365 52%
Synagis -90 -12 -102 523 -120%
Beyfortus royalty 1,362 102 1,464 1,803 -19%
Total 5,472 346 5,818 5,768 1%
Specialty Care 971 36 1,007 882 14%
Total 20,417 983 21,399 18,592 15%
Jan-Sep 2024 Total revenue FX impact Total revenue,
adjusted for FX
impact
Total revenue,
comparable
period
Change at CER
Haematology
Altuvoct 134 4 138 n/a
Elocta 3,753 60 3,812 3,592 6%
Alprolix 1,736 4 1,740 1,570 11%
Royalty 1,347 13 1,361 1,149 18%
Whereof Eloctate/Alprolix 947 9 956 1,091 -12%
Whereof Altuviiio 400 5 405 58 30%
Doptelet 2,723 23 2,746 2,270 21%
Aspaveli/Empaveli 760 17 777 408 91%
Vonjo 1,046 10 1,056 383 176%
Zynlonta 68 1 68 24 191%
Manufacturing 375 375 333 13%
Total 11,942 132 12,073 9,729 24%
Immunology
Kineret 2,077 17 2,094 1,794 17%
Gamifant 1,365 12 1,377 1,148 20%
Synagis 523 1 524 1,526 -66%
Beyfortus royalty 1,803 121 1,924 263 >200%
Total 5,768 151 5,919 4,730 25%
Specialty Care 882 5 887 821 8%
Total 18,592 287 18,879 15,280 24%
FY 2024 Total revenue FX impact Total revenue,
adjusted for FX
impact
Total revenue,
comparable
period
Change at CER
Haematology
Altuvoct 439
436 2 2
Elocta 4,891 60 4,951 4,916
Alprolix 2,372 -2 2,370 2,125
Royalty 1,889 2 1,890 1,565
Whereof Eloctate/Alprolix 1,279 2 1,281 1,421
Whereof Altuviiio 610 0 609 145
Doptelet 3,870 13 3,883 2,997
Aspaveli/Empaveli 1,030 16 1,046 594
Vonjo 1,462 4 1,466 706
Zynlonta 103 0 103 33
Manufacturing 375 375 431
Total 16,429 95 16,523 13,370 >200%
1%
12%
21%
-9%
30%
30%
76%
108%
>200%
-13%
24%
Immunology
Kineret 2,854 13 2,867 2,415
Gamifant 1,876 6 1,882 1,645
Synagis 591 3 594 2,422
Beyfortus royalty 3,010 131 3,142 1,153
Total 8,332 153 8,484 7,635 19%
14%
-75%
172%
11%
Specialty Care 1,267 2 1,269 1,119 13%

Strategic portfolio

Definition: Includes Sobi's medicines Altuvoct, Aspaveli/Empaveli, Doptelet, Gamifant, Vonjo and Zynlonta, and royalty on Sanofi's sales on Altuviiio and Beyfortus.

Reason for use: Focused list of medicines in the launch phase and key royalty income which contribute significantly to growth and the Sobi strategy: lead in Haematology, grow in Immunology, go global and capture the value of the pipeline. The development of the strategic portfolio is an important measure in order to understand the underlying performance and potential of the portfolio separate from matured medicines with lower growth.

SEK M Q3
2025
Q3
2024
Change Change
at CER
Jan-Sep
2025
Jan-Sep
2024
Change Change
at CER
FY
2024
Altuvoct 769 129 >200% >200% 1,851 134 >200% >200% 436
Aspaveli/Empaveli 317 270 18% 23% 953 760 25% 30% 1,030
Doptelet1 1,408 987 43% 46% 3,757 2,671 41% 45% 3,818
Gamifant 733 405 81% 98% 1,947 1,365 43% 52% 1,876
Vonjo 307 379 -19% -11% 915 1,046 -13% -7% 1,462
Zynlonta 40 29 38% 43% 128 68 89% 94% 103
Altuviiio royalty 260 152 71% 86% 727 400 82% 94% 610
Beyfortus royalty 1,166 1,478 -21% -14% 1,362 1,803 -24% -19% 3,010
Strategic portfolio 5,001 3,830 31% 39% 11,640 8,247 41% 48% 12,346

1. Doptelet excluding China

Gross margin

Definition: Gross profit as a percentage of total revenue.

Reason for use: Gross margin is an important measure which provides a better understanding of the business development. Gross margin is impacted by several factors such as business, product and region mix and price developments.

Items affecting comparability

Definition: Items that are of significant value, have no clear connection to recurring, ordinary operations and are of such a type that they cannot be expected to occur often. This may, for example, refer to capital gains/losses from divestments, restructuring, impairments, write-down of inventory related to production of inventory pre-approval and reversal of these costs at approval, other unusual one-time income/expenses and fair value adjustments. Restructuring refers to structural efficiency programmes that impact the scope of the business or other changes to business operations. Costs for carrying out restructuring are identified on a project basis and may be incurred over more than one year.

Reason for use: Provides a better understanding of the company's underlying operating activities.

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Total revenue 7,776 6,894 20,417 18,592 26,027
Total cost of goods sold -1,614 -1,331 -4,629 -4,185 -5,785
Gross profit 6,162 5,563 15,788 14,407 20,242
Gross margin 79% 81% 77% 77% 78%
Items affecting comparability
-Restructuring costs:
-Discontinuation of contract manufacturing 11 76
-Acquisition of business, fair value adjustment of acquired
inventory -37 -41 -169 -99 -159
-Organisational change -3
-Inventory NASP -15 -15
Items affecting comparability -53 -41 -176 -99 -83
Adjusted gross profit 6,214 5,604 15,964 14,505 20,326
Adjusted gross margin 80% 81% 78% 78% 78%
EBIT1 -3,858 2,038 -1,491 3,963 5,625
Items affecting comparability
-Restructuring costs:
-Discontinuation of contract manufacturing 11 76
-Acquisition of business -37 -41 -169 -141 -201
-Impairment Vonjo -6,612 -6,612
-Organisational change -208
-Inventory NASP -15 -15
-Commercial team for Synagis -85 -85
Items affecting comparability2 -6,664 -41 -6,993 -226 -210
Adjusted EBIT 2,806 2,080 5,502 4,189 5,836

1. For EBIT and EBITA per segment, see Note 2.

2. Items affecting comparability, see page 3 for further information.

EBITA and EBITA margin

Definition: Earnings before interest, tax, amortisation and impairment of intangible assets. EBITA margin; EBITA as a percentage of total revenue.

Reason for use: EBITA is a key performance measure and gives a fair view of the profitability of the ongoing business.

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
EBIT1 -3,858 2,038 -1,491 3,963 5,625
Plus amortisation and impairment of intangible assets 7,478 885 9,234 2,622 3,532
EBITA1 3,620 2,923 7,743 6,585 9,158
EBITA margin 47% 42% 38% 35% 35%
  1. For EBIT and EBITA per segment, see Note 2.
Items affecting comparability
-Restructuring costs:
-Discontinuation of contract manufacturing 11 76
-Acquisition of business -37 -41 -169 -141 -201
-Impairment Vonjo -6,612 -6,612
-Organisational change -208
-Inventory NASP -15 -15
-Commercial team for Synagis -85 -85
Items affecting comparability -6,664 -41 -6,993 -226 -210
Adjusted EBITA 3,672 2,965 8,124 6,811 9,368
Adjusted EBITA margin 47% 43% 40% 37% 36%

EBITDA

Definition: Earnings before interest, taxes, depreciation, amortisation and impairment of intangible and tangible assets. Reason for use: It is a relevant measure to present profitability aligned with industry standard.

EBITA 3,620 2,923 7,743 6,585 9,158
Plus depreciation and impairment of tangible assets 36 39 108 126 147
EBITDA 3,656 2,962 7,851 6,711 9,305
Items affecting comparability
-Restructuring costs:
-Discontinuation of contract manufacturing 11 61
-Acquisition of business -37 -41 -169 -141 -201
-Impairment Vonjo -6,612 -6,612
-Organisational change -208
-Inventory NASP -15 -15
-Commercial team for Synagis -85 -85
Items affecting comparability -6,664 -41 -6,993 -226 -225
Adjusted EBITDA 3,709 3,003 8,232 6,937 9,529

Adjusted earnings per share

Definition: Adjusted profit attributable to equity holders of the parent company divided by the average number of ordinary shares. Reason for use: Adjusted earnings per share is a good measure of the company's profitability and is used to determine the value of the company's outstanding shares.

SEK M Q3
2025
Q3
2024
Jan-Sep
2025
Jan-Sep
2024
FY
2024
Profit for the period attributable to the holders of the parent
company -2,894 1,464 -1,384 2,488 3,885
Items affecting comparability -6,664 -41 -6,993 -226 -210
Tax on items affecting comparability
-Restructuring costs:
-Discontinuation of contract manufacturing -2 -16
-Acquisition of business 9 10 42 35 50
-Impairment Vonjo 1,653 1,653
-Organisational change 46
-Inventory NASP 3 3
-Commercial team for Synagis 19 19
Tax on items affecting comparability 1,665 10 1,742 54 54
Items affecting comparability (net of tax) -4,999 -31 -5,251 -171 -156
Adjusted profit for the period attributable to the holders
of the parent company
2,105 1,495 3,868 2,660 4,041
Average number of ordinary shares (excluding shares in
treasury)
344,648,852 343,013,416 343,947,311 341,151,567 341,726,901
Average number of ordinary shares after dilution
(excluding shares in treasury)
347,871,356 346,842,463 347,169,815 344,980,614 345,562,257
Adjusted EPS before dilution, SEK 6.11 4.36 11.25 7.80 11.83
Adjusted EPS after dilution, SEK 6.05 4.31 11.14 7.71 11.69

Net debt

Definition: Borrowings to banks and other credit institutions and commercial papers less cash and cash equivalents.

Reason for use: Net debt is relevant to present as it is useful to illustrate the indebtedness, financial flexibility and capital structure.

Borrowings 13,216 17,474 13,216 17,474 16,333
Cash and cash equivalents 1,039 594 1,039 594 1,140
Net debt 12,177 16,880 12,177 16,880 15,194

Equity ratio

Definition: Total equity as a proportion of total assets.

Reason for use: A measure for showing financial risk, expressing the percentage of total assets that is financed by the owners.

Equity per share

Definition: Equity attributable to the holders of the parent company divided by the number of ordinary shares.

Reason for use: A measure of the amount of equity that exists per outstanding share and is used for measuring the share against the share price.

Total equity 35,983 37,109 35,983 37,109 40,295
Total assets 66,964 72,195 66,964 72,195 75,444
Equity ratio 54% 51% 54% 51% 53%
Equity attributable to Parent Company shareholders 35,977 37,094 35,977 37,094 40,286
Number of ordinary share 357,412,837 356,000,049 357,412,837 356,000,049 356,000,049
Number of ordinary shares after dilution 360,635,341 359,829,096 360,635,341 359,829,096 359,835,405
Equity per share, SEK 100.7 104.2 100.7 104.2 113.2
Equity per share after dilution, SEK 99.8 103.1 99.8 103.1 112.0

Definitions

Alprolix® (eftrenonacog alfa) A recombinant, extended half-life (EHL) clotting factor IX medicine for the treatment of
haemophilia B.
Altuvoct® (efanesoctocog alfa) The first high-sustained FVIII replacement therapy with the potential to maintain near
normal factor activity levels for a significant portion of the week, providing improved bleed
protection with a once-weekly dose for people with haemophilia A. It is marketed as
Altuvoct by Sobi in Europe and as Altuviiio® by Sanofi in the US, Japan, and Taiwan.
Aspaveli®/Empaveli® (pegcetacoplan) A targeted C3 therapy designed to regulate the excessive activation of the complement
cascade, which is part of the body's immune system. It is approved for the treatment of a
rare blood disorder called paroxysmal nocturnal haemoglobinuria (PNH). By targeting C3, a
protein in the immune system, it helps regulate excessive activation that can lead to the
onset and progression of serious and rare diseases. It is marketed as Aspaveli in Europe and
as Empaveli in Canada, the Middle East, South America, and certain countries in Asia by
Sobi. In the US, Empaveli is marketed by Apellis.
Beyfortus® (nirsevimab) A single-dose, long-acting antibody developed and commercialised in partnership by
AstraZeneca and Sanofi. It is designed to protect newborns and infants from RSV during
their first RSV season, as well as children up to 24 months who are still at risk of severe
disease in their second RSV season.
Biologics Licence Application, BLA A submission to the US Food and Drug Administration (FDA) requesting permission to
market a biological product in the US. A BLA is similar to a New Drug Application (NDA) but
specifically for biologics.
Chronic liver disease, CLD A liver disease becomes chronic when it has been present for more than 6-12 months
without signs of resolution. Chronic liver disease can be inherited (genetic) or caused by a
variety of factors such as viruses, auto-immunity, obesity and alcohol use.
Gout One of the most common forms of inflammatory arthritis, caused by high levels of uric acid
in the body that accumulate around the joints and other tissues, resulting in flares that cause
intense pain.
Cold agglutinin disease, CAD A rare autoimmune disorder characterised by the premature destruction of red blood cells
(haemolysis). More specifically, CAD is a subtype of autoimmune haemolytic anaemia. The
disease is termed "cold" because the disease is active and cause haemolysis at cold
temperatures, usually 3 to 4⁰C.
Cryopyrin-associated periodic syndromes,
CAPS
CAPS are a group of rare, autoinflammatory disorders, including familial cold
autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and neonatal-onset
multisystem inflammatory disease (NOMID).
Diffuse large B-cell lymphoma, DLBCL A form of non-Hodgkin lymphoma and the most common blood cancer. Lymphomas occur
when cells of the immune system, known as B-lymphocytes, grow and multiply
uncontrollably. DLBCL occurs mostly in adults and is a fast-growing (aggressive) lymphoma.
Doptelet® (avatrombopag) An orally administrated thrombopoietin receptor agonist that increases platelet count for
the treatment of thrombocytopenia.
Elocta® (efmoroctocog alfa) A recombinant, extended half-life (EHL) clotting factor VIII medicine for the treatment of
haemophilia A. It is also known as Eloctate in some countries.
Familial chylomicronemia syndrome, FCS A rare, genetic form of sHTG caused by the body's inability to properly break down
triglycerides (blood fats). This leads to extremely high triglycerides levels, which increase the
risk of acute pancreatitis and chronic symptoms such as fatigue and severe, recurrent
abdominal pain.
Familial mediterranean fever, FMF An autoinflammatory genetic disorder that mainly affects people of Mediterranean or Middle
Eastern origin, characterised by recurrent episodes of fever and serositis (an inflammation in
chest, abdomen, joints), leading to painful attacks early during childhood.
Full-time equivalent A unit that indicates the workload of an employee in a way that makes it comparable.
Gamifant® (emapalumab) A monoclonal antibody medicine that binds to and neutralises interferon gamma for the
treatment of ultra-rare syndromes of hyperinflammation.
Haemophilia A genetic bleeding disorder caused by insufficient levels of blood proteins, including factor
VIII (haemophilia A) and factor IX (haemophilia B). Clotting factors are essential for proper
clotting, the process by which blood clumps together to plug the site of a wound to stop
bleeding. 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.
Haemophilia business Sobi's haemophilia business consists of Altuvoct, Altuviiio royalties, Elocta, Alprolix, Eloctate
and Alprolix royalties.
Haemophilia A business Sobi's haemophilia A business consists of sales of Altuvoct and Elocta.
Immune-complex membranoproliferative
glomerulonephritis, IC-MPGN and C3
glomerulopathy, C3G
C3G and primary IC-MPGN are ultra-rare kidney diseases caused by an overactive C3
protein in the immune system, which mistakenly damages the kidneys. Both conditions are
characterised by deposits of C3 protein in the kidneys, with additional deposits of
immunoglobulins in the case of primary IC-MPGN.
Immune thrombocytopenia, ITP An autoimmune disorder caused by low platelet count in the blood, leading to bruising and
an increased risk of bleeding.
Investigational New Drug application, IND A request to obtain authorisation from the US Food and Drug Administration (FDA) to
administer an investigational drug or biological product to humans in the US.
Kineret® (anakinra) A recombinant protein medicine that blocks interleukin-1α and β by binding to interleukin-1
type 1 receptors. Interleukin-1 is a key mediator of inflammation and a significant
contributor to autoinflammatory diseases, including several rare diseases.
Macrophage activation syndrome, MAS A severe complication of rheumatic diseases, causing symptoms such as fever, enlarged
organs, blood and liver issues, and, in severe cases, organ failure or death.
Multifactorial chylomicronemia syndrome,
MCS
A severe form of sHTG where chylomicrons (fat particles in the blood) build up to extremely
high levels, causing symptoms such as fatigue, severe, recurrent abdominal pain and an
increased risk of acute pancreatitis.
Myelofibrosis A rare type of blood cancer that causes scar tissue to form in the bone marrow. As the scar
tissue builds up, it disrupts the body's normal production of blood cells.
Nanoencapsulated sirolimus plus
pegadricase, NASP (formerly SEL-212)
A novel investigational combination medicine designed to reduce serum urate levels in
people with uncontrolled gout, potentially reducing harmful tissue urate deposits that can
cause gout flares and joint deformities if left untreated.
New Drug Application, NDA A submission to the US Food and Drug Administration (FDA) seeking approval to market a
new pharmaceutical drug in the US.
Orfadin® (nitisinone) A medicine used to treat hereditary tyrosinaemia type 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 can also be used for alkaptonuria.
Paroxysmal nocturnal haemoglobinuria, PNH A rare, acquired disorder in which red blood cells break apart prematurely. Some stem cells
in individuals with PNH have mutated and produce defective blood cells. These defective
red blood cells are extremely susceptible to premature destruction by a part of the immune
system called the complement system.
Prescription Drug User Fee Act date, PDUFA
date
The target date set by the US Food and Drug Administration (FDA) for a decision on whether
to approve a new drug application (NDA) or biologics licence application (BLA).
Primary haemophagocytic
lymphohistiocytosis, pHLH
A rare, life-threatening condition caused by an overactive, abnormal response of the
immune system. In heamophagocytic lymphohistiocytosis, the immune system responds to
a stimulus or 'trigger', often an infection, but the response is ineffective and abnormal. Some
affected individuals may have a genetic predisposition to developing haemophagocytic
lymphohistiocytosis. This is known as the primary or familial form.
Respiratory syncytial virus, RSV A common virus and the most common cause of lower respiratory tract infections in young
children. The RSV season usually occurs from early autumn until late spring and peaks
during the winter.
Science Based Targets initiative, SBTi SBTi is a partnership between the Worldwide Fund for Nature (WWF), World Resources
Institute (WRI), the United Nations Global Compact (UNGC) and CDP. The SBTi defines and
promotes best practice in CO2-emission reductions and net-zero targets.
Second-line treatment Treatment for a disease or condition after the initial treatment (first-line treatment) has
failed, stopped working, or has side effects that aren't tolerated.
Severe hypertriglyceridemia, sHTG A condition with very high triglyceride (blood fat) levels, increasing the risk of acute
pancreatitis and other complications.
Still's disease A rare systemic autoinflammatory disease characterized by fevers, rash, and joint pain. Still's
disease includes Systemic juvenile idiopathic arthritis (SJIA) and Adult-Onset Still's disease
(AOSD) which share symptoms but vary in frequency and presentation. A potentially fatal
complication is macrophage activation syndrome (MAS).
Strategic portfolio Includes Sobi's medicines Altuvoct, Aspaveli/Empaveli, Doptelet, Gamifant, Vonjo and
Zynlonta, and royalty on Sanofi's sales on Altuviiio and Beyfortus.
Synagis® (palivizumab) A monoclonal antibody that helps neutralise RSV activity and inhibiting RSV replication.
Approved for the prevention of serious lower respiratory tract infections caused by RSV in
infants and young children at high risk of RSV disease.
Synovitis Synovitis is the major and most common complication of haemophilia. It is caused by
bleeding inside a joint (haemarthrosis) which irritates the membrane lining the joints
(synovium), leading to inflammation and thickening of the synovium (synovitis). Untreated
synovitis invariably evolves into arthropathy which is irreversible.
Tegsedi® (inotersen) A medicine for the treatment of polyneuropathy caused by hereditary transthyretin
mediated amyloidosis in adults.
Tryngolza® (olezarsen) A medicine approved for the treatment of adults with familial chylomicronemia syndrome
(FCS) to reduce very high triglyceride (blood fat) levels. Under a licence agreement with Ionis
Pharmaceuticals, Sobi holds exclusive rights to commercialise Tryngolza outside the US,
Canada, and China. Tryngolza is currently approved in the US and the European Union.
Vonjo® (pacritinib) An oral medicine approved in the US for the treatment of adults with certain types of
myelofibrosis and low platelet counts. It is a targeted kinase inhibitor, which works by
blocking the activity of specific kinases responsible for blood cell formation and immune
system function.
Vacuoles, E1 enzyme, X-linked,
autoinflammatory, somatic, VEXAS
A rare, chronic autoinflammatory syndrome with currently no approved treatments.
Waylivra® (volanesorsen) A medication used to reduce triglyceride blood levels in patients with familial
chylomicronaemia syndrome (FCS) that has been confirmed by genetic testing.
Zynlonta® (loncastuximab tesirine) A medication used to treat adults with certain types of diffuse large B-cell lymphoma

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden Visiting address: Norra Stationsgatan 93A, Stockholm, Sweden

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