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Xbrane Biopharma

Quarterly Report Oct 24, 2025

3128_10-q_2025-10-24_120b44db-4617-41b3-bb35-50aa9548b997.pdf

Quarterly Report

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Interim report January – September 2025

FINANCIAL SUMMARY FOR THE GROUP

2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Revenue, (SEK 000) 10,119 16,187 143,267 82,290 148,098
Research and development costs, (SEK 000) -9,843 -7,810 -58,995 -143,311 -162,014
R&D costs as percentage of total costs 59% 39% 58% 79% 68%
Operating profit/loss, (SEK 000) -23,532 -25,356 -3,586 -106,140 -97,224
EBITDA, (SEK 000) -20,745 -20,371 8,246 -91,120 -77,335
Profit/loss for the period, (SEK 000) -24,030 -45,115 153,722 -213,022 -266,220
Cash and cash equivalents, (SEK 000) 93,563 30,591 93,563 30,591 124,330
Equity ratio, % 84% 31% 84% 31% 25%
Earnings per share before dilution, SEK -0.02 -0.03 0.10 -0.19 -0.22
Earnings per share after dilution, SEK -0.02 -0.03 0.10 -0.19 -0.22
Number of employees on balance sheet date 26 65 26 65 65

FINANCIAL OVERVIEW THIRD QUARTER 2025*

  • Revenue amounted to SEK 10.1 m (16.2).
  • Other operating income was SEK –1.9 m (0.8).
  • EBITDA amounted to SEK –20.7 m (–20.4).
  • R&D costs amounted to SEK -9.8 m (-7.8), corresponding to 59 percent (39) of total operating costs
  • The loss for the period was SEK 24.0 m (-45.1).
  • Earnings per share was SEK -0.02 (-0.03).
  • · Cash and cash equivalents at the end of the period amounted to SEK 93.6 m (30.6).

FINANCIAL OVERVIEW JANUARY - SEPTEMBER 2025

  • Revenue amounted to SEK 143.3 m (82.3).
  • Other operating income was SEK 10.0 m (6.8).
  • FBITDA amounted to SFK 8.2 m (91.1)
  • R&D costs amounted to SEK -59.0 m (-143.3), corresponding to 58 percent (79) of total operating costs

  • The profit for the period was SEK 153.7 m (-213.0).

  • Earnings per share was SEK 0.10 (-0.19).
  • · Cash and cash equivalents at the end of the period amounted to SEK 93.6 m (30.6).
  • On June 2, Xbrane completed its transaction with Alvotech, and in connection with this, a post-tax gain from the disposal of operations amounting to SEK 168.9 m was reported.1)

SIGNIFICANT EVENTS DURING THE THIRD QUARTER 2025

On July 3, an extraordinary general meeting (EGM) decided, in accordance with the Board's proposal, to approve the board's decision on a new share issue. The new share issue raised approximately SEK 240 m before issue costs for the Company.

On September 10, the Board of Directors called an EGM to decide on amendments to the articles of association, including a decision to merge the Company's shares in a ratio of 1:125, whereby 125 existing shares shall be merged into 1 new share. The total number of shares in the Company will, through the merger, decrease from 2.575.668.555 shares to 20.605.348 shares (rounded down). A decision will be made regarding the adjustment of the limits for the number of shares and the adjustment of the limits for share capital. An EGM will also decide on a reduction of the share capital to cover losses from previous years and a reduction of share capital for allocation to unrestricted equity. Furthermore, an EGM will decide on the authorization for the Board of Directors to issue shares, warrants and/or convertibles

SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER

  • On October 13, an EGM decided, in accordance with the Board's proposal, to approve the Board's proposal from September 10, 2025 in its entirety.
  • · On October 17, the Board of Directors and management of Xbrane resolved to strengthen the company's financing in order to meet its working capital requirements. As a proactive measure. Xbrane has therefore secured a loan of SEK 60 million
  • On October 19. Xbrane announced that the company had received a Complete Response Letter (CRL) from the FDA, outlining unresolved observations following the inspection of one of the manufacturing facilities. Xbrane is now awaiting further communication from the FDA in order to plan the next steps together with the contract manufacturer.

This document is a translation of the original Swedish version. In the event of any inconsistency or discrepancy between this translation and the Swedish original, the Swedish version shall be deemed the legally binding and prevailing document.

* Figures in parentheses refer to the corresponding period in the previous year. 1 For more information, see page 5.

During the third quarter of 2025, the clinical study for Xdivane was initiated.

CEO's letter

Dear shareholders.

Over the past few months, Xbrane has faced significant challenges. The divestment of parts of our business to Alvotech marks an important strategic step, while the FDA's Complete Response Letter (CRL) regarding our ranibizumab biosimilar application delays our planned launch. This experience highlights the challenges inherent in the biotech industry and the importance of maintaining focus on our leading products and long-term strategy.

Continued strong growth for Ximluci® in Europe and ongoing regulatory process in the US

Ximluci® has now been launched in 24 countries, 20 of which are in Europe. Overall, volume growth in Q3 2025 more or less compared to Q2 2025. Ximluci®'s market share in Europe by volume within the ranibizumab market (Lucentis and Lucentis biosimilars) remained at 8%. We continue to see significant potential for Ximluci® togain additional market share, but price pressure remains substantial and together with our partner STADA, we are currently undertaking several initiatives to reduce production costs..Regarding the U.S. market. Xbrane received a so-called 'Complete Response Letter' related to the marketing authorization application for Ximluci from the FDA. The agency stated that certain actions in response to observations from the inspection of one of the manufacturing facilities must be completed before approval can be granted. We are now awaiting further information from the FDA to determine the timing for resubmission of the application. We are, of course, disappointed by this outcome but are now working with our contract manufacturer to resolve the outstanding issues as quickly as possible.

Initiation of clinical trial for Xdivane™

In October, the first patient in the registration-enabling clinical study for Xdivane™ is expected to be enrolled. We currently estimate that all patients will be recruited within the next 12 months, and that an application to the FDA can be submitted in Q4 2027. Xbrane is now leading the work, together with the selected contract manufacturer, to validate the production process and generate all production-related data for the marketing authorization application. For Xdivane™, Xbrane and Intas are working with a major contract manufacturer whose two production sites that make the substance (DS) as well as fill the substance into vials (DP) have long been approved by the FDA and manufacture the product commercially for the USA.

Strengthened financial position in connection with the completed directed share issue

In July, Xbrane completed a directed share issue of SEK 240 m before transaction costs. A significant portion of the proceeds were used to repay the last outstanding liabilities. At the end of Q3, Xbrane had SEK 93 m in cash. In connection with the current delay

in FDA approval for Ximluci®, Xbrane has received an opportunity financing from Fenja SEK 60 m to secure the company's working capital requirements during the delay.

We look forward to continuing our journey as a focused and financially stronger company, with the goal of providing cost-effective biological drugs to patients worldwide through partnerships.

Solna, October 24 2025

Martin Åmark

Portfolio of biosimilar candidates

PRODUCT

PORTFOLIO

Xbrane has a portfolio of three biosimilar candidates, for different treatment areas. These include a number of serious eye diseases and several different types of cancer.

Ximluci®

Ximluci® is a biosimilar candidate to ranibizumab, the original drug Lucentis®, a VEGFa inhibitor used to treat a number of serious eve diseases. Ximluci® addresses a market of around EUR 14 bn¹) per

The European Medicines Agency (EMA) approved Ximluci® for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in 27 member states in Europe in 2022. Ximluci® was launched by Xbrane's partner STADA Arzneimittel AG (STADA) in Q1 2023 and by the end of the quarter, Ximluci® was available in twenty markets in Europe and four markets outside Europe.

On October 19. Xbrane announced that it had received a Complete Response Letter (CRL) regarding the company's Biologics License Application (BLA). Xbrane and its contract manufacturer

are now awaiting further communication from the FDA to better understand the obstacles to approval. Xbrane will collaborate with the manufacturing facility to address the identified issues and enable a resubmission of the BLA as soon as possible.

STADA is also working actively to bring Ximluci® to other regions such as the Middle East, Latin America, and Southeast Asia, where applications for market approval have been submitted to various regulatory authorities. In May 2024, STADA and Xbrane signed a collaboration agreement with Valorum, which will commercialize Ximluci® in the US

Ximluci® is approved in Europe in a vial containing the active substance, from which the ophthalmologist extracts the product into a syringe for injecting into the eye. Xbrane also plans to submit an application for approval of a pre-filled syringe in 2026.

1) Evaluate Pharma: "Originator Peak Sales Estimate 2026".

Product portfolio

Product Original drug Primary indication Estimated annual sales of original drug 1) Patent expiration for original drug Development stage
Ximluci® Ranibizumab
(Lucentis®)
Wet age-related macular degeneration,
diabetes-related eye damage and retinal
vein occlusion.
EUR 1 bn 2) 2022 (Europe)
2020 (US)
Launch phase
Xdivane™ Nivolumab
(Opdivo®)
Skin cancer, lung cancer, kidney cell cancer, head and neck cancer and bladder and urinary tract cancer. EUR 12 bn 3) 2026–2031
depending on country
Clinical phase
Xdarzane™ Daratumumab
(Darzalex ®)
Multiple Myeloma. EUR 9 nb 1) 2029–2031
depending on country
Preclinical phase
EUR 23 bn¹)

Source: 1) Evaluate Pharma; "Originator Peak Sales Estimate 2026". 2) Novartis Annual Report 2024, Roche Annual Report 2024 3) BMS Annual Report, Global Data

Xdivane™

Xdivane™ is the first product on Xbrane's mammalian cell-based technology platform. Xdivane™ is a biosimilar to the programmed cell death protein 1 (PD1) inhibitor nivolumab (Opdivo®), a renowned immuno-oncology product. Opdivo® is expected to generate sales of EUR 12 bn1) and lose its patent protection in December 2028 in the US and June 2030 in Europe. Xbrane's clear ambition for Xdivane™ is to become the leading biosimilar to Opdivo®, both in terms of cost-effectiveness and the time of launch. Xbrane expects that Xdivane can be launched in conjunction with the expiration of the Opdivo® patent, which will occur between 2028 and 2031 depending on the country. In November 2024, Xbrane entered into a strategic partnership with Intas for the development and commercialization of Xdivane™. The Company has sought approval from the regulatory authorities for a reduced clinical development program and received positive feedback from both the EMA and the FDA. This affects the program's timeline and increases the value of the business case, as a reduced clinical development plan entails significant cost savings. For Xdivane™. development is proceeding according to plan, with the production process scaled up at contract manufacturers and demonstrating scalability, which minimizes the risks for the Company's future production of clinical material. The next step in the development is to initiate the clinical study, which the Company's partner INTAS will run and has also started

Xdarzane™

Xdarzane™ is a biosimilar candidate to daratumumab, original drug Darzalex®, an antibody that binds to CD38 for the treatment of multiple myeloma (around EUR 9 bn1 in estimated sales). The patent protection for Darzalex® is expected to expire in 2029–2031 depending on the country.

The development of Xdarzane™ is proceeding according to plan and is undergoing continued preclinical development with a focus on developing a cost-effective production process and demonstrating biochemical similarity to the original drug.

Xbrane – An investment in the future of drugs

World-leading in biosimilars

Xbrane Biopharma combines ground-breaking technology with global reach to revolutionize access to biologic drugs. Through smart partnerships and patented platform technology, Xbrane develops biosimilars that are both cost-effective and lifechanging.

Proven growth – Ximluci®

  • First product: Ximluci® (biosimilar to Lucentis®)
  • Launched Q1 2023 available today in 24 countries
  • In a market worth EUR 5 bn

A strong debut with continual growth potential.

World-class strategic partnerships

Xbrane collaborates with global drug companies to:

  • Upscale development
  • Maximize market penetration
  • Accelerate launches

Low risk – high potential returns.

Unique technology = competitive advantage

  • Proprietary and patented platform technology
  • Ensures low costs and high scalability
  • Enables development of world-class biosimilars

Why invest in Xbrane?

  • Proven commercial success
  • Clear route to more market launches
  • Strong partners
  • Significant market potential
  • Solution to a global health problem

Financial overview

Group results

Revenue

The Group's net revenue for the quarter amounted to SEK 10.1 m (16.2) including an adjustment of expected profit share amounting to SEK –10.0 m. During the period January through September, net revenue amounted to SEK 143.3 m (82.3).

Gross profit

The cost of goods sold for the quarter amounted to SEK –15.1 m (–22.2) and SEK –55.4 m (–13.5) for the period January through September. The gross loss for the quarter was, due to the adjustment of the net revenue, SEK 5.0 m (–6.0) and the gross profit for January through September was SEK 87.9 m (68.8).

Operating expenses

Operating expenses for the quarter, excluding cost of goods sold, amounted to SEK –16.7 m (–20.1) and SEK –101.5 m (–181.7) for January through September.

Administrative costs

Administrative costs for the quarter amounted to SEK –8.0 m (–9.8) and SEK –37.2 m (–30.5) for January through September.

Research and development costs.

Research and development costs for the quarter amounted to SEK –9.8 m (–7.8) and SEK –59.0 m (–143.3) for January through September. R&D costs including capitalized development expenditure amounted to SEK –81.3 m (–31.7) for the quarter and SEK –203.4 m (–177.76) for January through September.

Other operating expenses

Other operating expenses for the quarter amounted to SEK 1.1 m (–2.5) and for SEK –5.2 m (–7.9) for January through September. The expenses consist primarily of exchange rate losses on receivables and operating liabilities.

Profit/loss and tax

The operating loss for the quarter was SEK 23.5 m (–25.4) and SEK –3.6 m (–106.1) for January through September. EBITDA for continuing operations amounted to SEK –20.7 m (–20.4) for the quarter and SEK 8.2 million (–91.1) for January through September. The loss before tax for the quarter was SEK 23.7 m (–32.0) and SEK –17.7 million (–129.7) for January through September. The tax cost for the quarter was SEK 0.0 (0.0) and SEK –2.2 m (0.0) for January through September. The tax expense is attributable to the milestone income from the agreement with Intas. The loss after tax from continuing operations for the quarter thus amounted to SEK 23.7 m (–32.0) and SEK 20.0 m (–129.7) for January through September. The loss from discontinued operations for the quarter was SEK 0.3 m (–13.1) and was a profit of SEK 173.7 m (–83.3) for January through September. In connection with Xbrane entering into an agreement with Alvotech to divest XB003 and parts of the organization, items attributable to the divestment are reported as Profit/loss from discontinued operations in the income statement. The comparative figure for the previous year has also been adjusted for discontinued operations. The loss for the quarter was SEK 24.0 m (–45.1) and there was a profit of SEK 153.7 m (–213.0) for January through September. Earnings per share for continuing operations for the quarter amounted to SEK –0.02 (–0.02) and earnings per share amounted to SEK –0.02 (–0.03). During the period January through September, earnings per share for continuing operations amounted to SEK –0.01 (–0.11) and earnings per share amounted to SEK 0.10 (–0.19).

The Group's cash flow

Cash flow from operating activities amounted to SEK –49.4 m (–14.9) for the quarter and SEK –183.1 m (–227.6) for January through September. Cash flow from investment activities amounted to SEK –66.5 m (–23.9) for the quarter and SEK –41.9 m (–34.9) for January through September. This is mainly attributable to the divested part of the business.

Cash flow from financing activities amounted to SEK 206.0 m (–3.2) for the quarter and SEK 198.2 m (226.9) for January through September. A rights issue was carried out during the quarter, which raised net proceeds of SEK 226.0 m. Cash flow amounted to SEK 90.1 m (–42.0) for the quarter and SEK –26.9 m (–35.7) for January through September.

Divestment of Discontinued Operations

In the first quarter of 2025, the company entered into an agreement with Alvotech hf regarding the divestment of the drug candidate XB003 and parts of the organization, including associated assets. In connection with the resolution at the general meeting, related assets and liabilities were reclassified in accordance with IFRS 5. The results from the discontinued operations are reported separately in the income statement, and comparative figures have been adjusted accordingly.

At the time of the divestment, the assets amounted to SEK 124.3 m, including fixed assets amounting to SEK 55.4 m. Total liabilities amounted to SEK 38.5 m. The total profit from the divestment of the discontinued operations after taxes amounted to SEK 168.9 m.

The Group's financial position and continued operations The Board of Directors and the CEO continuously monitor the Group's liquidity and financial resources in both the short and long term. As of September 30, the company's cash and cash equivalents amounted to SEK 93.6 m (30.6).

After the end of the reporting period, the company secured a loan facility amounting to SEK 60 million as part of its liquidity strategy. In addition, discussions are ongoing with stakeholders regarding the capital requirements for the ongoing Xdivane project.

The Board of Directors and the CEO therefore believe that there are alternatives with good opportunities to ensure the company's financing for at least the coming twelve-month period. If key assumptions about these options change or prove not to be feasible, there is a risk to the company's ability to continue operations, which could cast significant doubt on the company's ability to continue as a going concern.

Changes in equity

Share capital on the balance sheet date amounted to SEK 577.4 m (342.9). Other contributed capital amounted to SEK 1,386.0 m (1,394.1). Total equity amounted to SEK 587.0 m (260.1), and the equity ratio was 84 percent (31).

Parent Company

The core business of Xbrane, i.e., the development of biosimilars, is conducted in the parent company. As the parent company constitutes such a large part of the Group, a statement of the company's current results, financial position and cash flow does not

provide any additional information beyond what is described in the Group report. Therefore, this is presented only in report format on pages 11–12. The effects of assets held for sale and profit/loss from discontinued operations have not been separated in the income statement or the balance sheet for the parent company. See note 6 for further information.

Share information

Xbrane's share capital at the end of the period was SEK 577.4 m (342.9), divided into 2,575,668,555 registered shares (1,529,483,397). The quota value of all shares per 30 September was SEK 0.224, and all the shares have equal rights to the company's assets and earnings. Since September 23, 2019, Xbrane's shares have been listed on the Nasdaq OMX main list under the XBRANE ticker. Xbrane had around 14,000 shareholders on the balance sheet date. The closing price of the share on the balance sheet date was SEK 0.2606, generating a market capitalization of around SEK 671 m.

Organization and employees

Xbrane is headquartered at Campus Solna, outside of Stockholm, Sweden. On the balance sheet date, the Group had a total of 23 employees (71), of which 23 (71) in the parent company.

Annual General Meeting

The Annual General Meeting for 2025 was held on May 5, 2025. The minutes and communiqué from the AGM are available on Xbrane's website, www.xbrane.com

Auditor's review

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

Presentation of the interim report

The presentation of the interim report for January to September 2025 will take place virtually on October 24 at 9:00, where CEO Martin Åmark and CFO Jane Benyamin will present the interim report. The presentation will be held in English and is expected to last about 20 minutes, after which there will be the opportunity for questions. To participate in the presentation, follow the link below: https://xbrane-biopharma.events.inderes.com/q3-report-2025

Consolidated income statement

Amounts in SEK thousand Notes 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Revenues
2
10,119 16,187 143,267 82,290 148,098
Cost of goods sold –15,102 –22,160 –55,402 –13,528 –18,225
Gross profit –4,983 –5,973 87,865 68,762 129,873
Other operating income –1,878 758 10,021 6,805 11,659
Administrative expenses –7,953 –9,836 –37,242 –30,530 –40,805
Research and development
expenses
–9,843 –7,810 –58,995 –143,311 –162,014
Other operating expenses 1,126 –2,495 –5,235 –7,865 –35,936
Operating profit/loss –23,532 –25,356 –3,586 –106,140 –97,224
Net financial costs –196 –6,673 –14,151 –23,566 −32,498
Profit/loss before tax –23,728 –32,029 –17,737 –129,706 –129 ,723
Tax –6 –2,234 –11,589
Profit/loss for the period
from continuing operations
–23,734 –32,029 –19,971 –129,706 –141,311
Profit/loss from discontinued
operations
6
–296 –13,086 173,693 –83,316 –124 ,908
Profit/loss for the period –24,030 –45,115 153,722 –213,022 –266,220
Profit/loss for the period attributable to:
– Owners of the Company –24,030 –45,115 153,722 –213,022 –266,220
– Non-controlling interests
Total comprehensive income
for the period
–24,030 –45,115 153,722 –213,022 –266,220
Earnings per share from
continuing operations
– Before dilution (SEK) –0.02 –0.02 –0.01 –0.11 –0.11
– After dilution (SEK) –0.02 –0.02 –0.01 –0.11 –0.11
Earnings per share
– Before dilution (SEK) –0.02 –0.03 0.10 –0.19 –0.22
– After dilution (SEK) –0.02 –0.03 0.10 –0.19 –0.22
Amounts in SEK thousand Notes 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Number of outstanding shares
at the end of the reporting period
– Before dilution 2 575 668 555 1,529,483,397 2 575 668 555 1,529,483,397 1,529,483,397
– After dilution 2 577 895 273 1,529,483,397 2 577 895 273 1,529,483,397 1,532,162,295
Average number of
outstanding shares
– Before dilution 2 577 895 273 1,529,483,397 2 577 895 273 1,129,325,938 1,229,911,966
– After dilution 2 577 895 273 1,529,483,397 2 577 895 273 1,129,325,938 1,230,021,757

Consolidated income statement and other comprehensive income

Amounts in SEK thousand 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Profit/loss for the period –24,030 –45,115 153,722 –213,022 −266,220
Other comprehensive income
Items that have been transferred to,
or can be transferred to
the profit/loss for the year
Reclassification of foreign currency
translation differences
–8 –23 –79 59 111
Comprehensive income
for the period
–8 –23 –79 59 111
Total comprehensive profit/loss
attributable to:
– Owners of the Company –24,037 –45,138 153,643 –212,964 –266,109
– Non-controlling interests 0
Total comprehensive income
for the period
–24,037 –45,138 153,643 –212,964 –266,109

Consolidated statement of financial position

Amounts in SEK thousand Notes 09-30-2025 09-30-2024 12-31-2024
ASSETS
Intangible assets 303,940 125,960 167,687
Property, plant and equipment 86 26,058 23,855
Right of use assets 44,671 41,044
Long-term receivables 3,945 3,945
Non-current assets 304,026 200,634 236,532
Inventory 3 201,728 212,968 246,902
Accounts receivables 3,900 79,692 16,854
Other receivables 5,465 61,129 16,973
Prepaid expenses and accrued income 91,932 252,355 198,851
Cash and cash equivalents 93,563 30,591 124,330
Assets held for sale 863 2,299 1,988
Current assets 397,450 639,033 605,898
TOTAL ASSETS 701,476 839,667 842,429
Amounts in SEK thousand Notes 09-30-2025 09-30-2024 12-31-2024
EQUITY
Share capital 577,429 342,889 343,496
Other contributed capital 1,385,962 1,394,101 1,395,030
Reserves 10,152 10,179 10,231
Retained earnings including profit/loss for the year –1,386,496 –1,487,021 –1,540,218
Equity attributable to parent company's owners 587,048 260,148 208,539
Non-controlling interests
TOTAL EQUITY 587,048 260,148 208,539
LIABILITIES
Long-term interest-bearing liabilities 5 72,097 66,371
Leasing liabilities 33,264 29,580
Long-term non interest-bearing liabilities
Total long-term liabilities 105,360 95,950
Short-term interest- bearing liabilities 4, 5 52,083 82,500
Accounts payable 39,667 194,719 242,570
Other liabilities 1,177 2,446 10,748
Leasing liabilities 12,913 13,267
Accrued expenses and prepaid income 73,364 211,551 188,449
Liabilities attributable to assets held for sale 220 446 407
Total short-term liabilities 114,429 474,159 537,940
TOTAL LIABILITIES 114,429 579,519 633,890
TOTAL LIABILITIES AND EQUITY 701,476 839,667 842,429

Consolidated statement of changes in equity

Amounts in SEK thousand Share Capital Other contributed
capital
Translation
reserve
Retained earnings
incl. profit/loss for the period
Total
Opening balance 01-01-2025 343,496 1,395,030 10,231 –1,540,218 208,539
Total comprehensive income for the period
Profit/loss for the period 153,722 153,722
Other comprehensive income for the period –79 –79
Total comprehensive income for the period –79 153,722 153,643
Transactions with group shareholder
New share issue 233,933 6,067 240,000
Issue expenses –14,043 –14,043
Share savings program –1,092 –1,092
Total contributions from and distributions to shareholders 233,933 –9,068 224,865
Closing balance 09-30-2025 577,429 1,385,962 10,152 –1,386,496 587,048
Amounts in SEK thousand Share Capital Other contributed
capital
Translation
reserve
Retained earnings
incl. profit/loss for the period
Total
Opening balance 01-01-2024 6,683 1,428,530 10,121 –1,273,999 171,335
Total comprehensive income for the period
Profit/loss for the period –266,220 –266,220
Other comprehensive income for the period 111 111
Total comprehensive income for the period 111 –266,220 –266,109
Transactions with group shareholder
New issue, net 336,813 –36,264 300,548
New share issue 336,206 8,719 344,925
Ongoing share issue 607 178 785
Issue expenses –45,161 –45,161
Share savings program 2,765 2,765
Total contributions from and distributions to shareholders 336,813 –33,500 303,313
Closing balance 12-31-2024 343,496 1,395,030 10,231 –1,540,218 208,539

Consolidated cash flow statement

Amounts in SEK thousand 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Cash flow from operating activities
Profit/loss for the period before tax –23,728 –45,115 –17,737 –213,022 –129,723,
Profit/loss from discontinued
operations
–296 173,693 –124,908,
Adjustments for items not included in
cash flow
11,699 15,372 –138,451 28,615 90,225
Paid income taxes –2,234 –2,234 –11,589
Total –14,558 –29,743 15,271 –184,407 –175,995
Increase (–)/Decrease (+) of
inventory
10,332 1,394 45,952 –131,569 –166,002
Increase (–)/Decrease (+) of trade
and other receivables
29,597 –35,171 62,586 –96,040 –4,555
Increase (+)/Decrease (–) of trade
and other payables
–74,805 48,618 –306,941 184,376 212,824
Cash flow from current operations –49,434 –14,902 –183,132 –227,640 –133,728
Cash flow from investing activities
Acquisition of property, plant and
equipment
–501 –501
Acquisition of property, plant and
equipment*
–71,458 –23,898 –144,408 –34,445 –51,745
Disposal of discontinued operations,
net cash effect
5,000 102,500
Cash flow from investing activities –66,458 –23,898 –41,908 –34,946 –52,246
Amounts in SEK thousand 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Cash flow from financing activities
Stock options redeemed by staff
New share issue 240,000 240,000 337,242 337,242
Issue expenses –14,000 –14,043 –37,479 –37,479
Loans taken out 20,000 50,000 70,000
Amortization of loans –20,000 –43,500 –112,499 –112,500
Amortization of lease liability –3,192 –4,280 –10,396 –13,640
Cash flow from financing activities 206,000 –3,192 198,177 226,868 243,623
Cash flow for the period 90,108 –41,993 –26,863 –35,718 57,650
Cash and cash equivalents reported
in assets held for sale
–341 –817 –341 –817 –727
Cash and cash equivalents at
beginning of period
7,134 72,835 124,330 65,402 65,402
Cash and cash equivalents at
beginning of period
(reported in assets held for sale)
483 877 727 1,166 1,166
Exchange rate differences in cash
and cash equivalents
–3,821 –311 –4,291 558 839
Cash and cash equivalents
at end of period
93,563 30,591 93,563 30,591 124,330

Income statement, Parent company

Amounts in SEK thousand 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Revenues 10,119 66,811 143,267 132,913 198,721
Cost of goods sold –15,102 –22,160 –55,402 –13,528 –18,225
Gross profit –4,983 44,650 87,865 119,385 180,496
Other operating income –1,878 2,721 187,846 8,772 15,827
Administrative expenses –7,953 –10,217 –37,819 –31,514 –42,133
Research and development
expenses
–9,843 –72,673 –64,751 –276,902 –313,359
Other operating expenses 1,126 –2,495 –5,235 –7,865 –61,246
Operating profit/loss –23,532 –38,014 167,906 –188,123 –220,414
Financial items
Impairment loss on shares in
subsidiary
Financial expenses –196 –6,673 –14,151 –23,566 −32,498
Net finance costs –196 –6,673 –14,151 –23,566 −32,498
Profit/loss before tax –23,728 –44,687 153,755 –211,690 –252,912
Tax –6 –2,234 –11,589
Profit/loss for the period –23,734 –44,687 151,521 –211,690 –264,501

Income statement and other comprehensive income, Parent company

Amounts in SEK thousand 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full year
Profit/loss for the period –23,734 –44,687 151,521 –211,690 –264,501
Other comprehensive income
Comprehensive income for the period –23,734 –44,687 151,521 –211,690 –264,501

Balance sheet, Parent company

Amounts in SEK thousand 09-30-2025 09-30-2024 12-31-2024
ASSETS
Fixed assets
Intangible assets 303,940 125,960 167,687
Property, plant and equipment 86 26,058 23,855
Financial assets
Shares in group companies 3,766 3,766 3,766
Other non-current receivables 3,945 3,945
Total financial assets 3,766 7,711 7,711
Total non-current assets 307,792 159,729 199,253
Current assets
Current receivables
Inventory 201,728 212,968 246,902
Accounts receivables 3,900 79,692 16,854
Other receivables 5,465 61,129 16,973
Prepaid expenses and accrued income 91,932 253,869 200,148
Total current receivables 303,025 607,657 480,877
Cash and bank 93,563 30,591 124,330
Current assets 396,588 638,248 605,207
TOTAL ASSETS 704,380 797,977 804,461
Amounts in SEK thousand 09-30-2025 09-30-2024 12-31-2024
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 577,429 342,889 343,496
Reserve for development expenditure 303,940 125,960 167,687
Unrestricted equity
Share premium 1,385,962 1,394,101 1,395,030
Retained earnings –1,829,707 –1,387,226 –1,428,954
Profit/loss for the period 151,521 –211,690 –264,501
TOTAL EQUITY 589,145 264,034 212,759
Long-term liabilities
Long-term interest-bearing liabilities 72,097 66,371
Long-term non interest-bearing liabilities
Total long-term liabilities 72,097 66,371
Current liabilities
Short-term interest-bearing liabilities 52,083 82,500
Liabilities to subsidiaries 1,026 1,047 1,062
Accounts payables 39,667 194,719 242,570
Other current liabilities 1,177 2,446 10,751
Deferred income and prepaid revenue 73,364 211,551 188,449
Current liabilities 115,235 461,846 525,331
TOTAL LIABILITIES 115,235 533,943 591,702
TOTAL EQUITY AND LIABILITIES 704,380 797,977 804,461

Notes

NOTE 1 Accounting principles

This consolidated interim report for the Group has been prepared in accordance with IAS 34, Interim Financial Reporting, as well as applicable regulations from the Annual Accounts Act. The interim report for the parent company has been prepared according to the Annual Accounts Act, chapter 9, Interim Reports. For the Group and the parent company the same accounting principles and calculation bases as the previous annual report have been applied except for the changed or additional accounting principles described below. Information according to IAS 34.16A is included in these financial statements and related notes as well as in other parts of this interim report.

NOTE 2 Revenue from contracts with customers

Amounts in SEK m 2025
Jul – Sep
2024
Jul – Sep
2025
Jan – Sep
2024
Jan – Sep
2024
Full
year
Revenue
License revenue 0.2 –0.1 84.7 27.1 81.4
Product sales 9.9 16.2 58.6 51.9 63.4
Contract
manufacturing
0.0 0.0 0.0 0.0 0.0
Other 0.0 0.0 0.0 3.2 3.3
Total 10.1 16.2 143.3 82.3 148.1
Of which North
America
0.0 -0.1 0.1 0.7 26.4
Of which Germany 9.9 16.2 58.6 81.4 66.5
Of which India 0.0 84.3 54.1
Of which Other 0.2 0.4 1.1

For the year, there are two individual customers that account for more than 10 percent of revenue. These account for SEK 58.6 m (81.4) and SEK 84.1 m (0.0) of revenue, respectively. See NOTE 1 in the 2024 Annual Report for information on Xbrane's accounting principles regarding revenue recognition.

NOTE 3 Inventory

Amounts in SEK 000 09-30-2025 09-30-2024 12-31-2024
Products in progress 201,728 212,968 246,902
Finished goods
Total inventory 201,728 212,968 246,902

NOTE 3 Inventory

Reported amounts in the income statement

During the 2025 financial year, the cost of goods sold has been reported in the income statement as SEK −55.4 m (SEK −13.5 m). Inventory includes a reserve for obsolete goods of SEK −2.9 m (SEK −3.2 m). The inventory has not been written down.

NOTE 4 Transactions with related parties

During the Q1 2025, Xbrane took out a short-term loan from Systematic Group AB amounting to SEK 20 m with an interest rate of 1 percent for the first quarter and 3 percent thereafter. The transaction was made on market terms. The loan was repaid in July 2025.

NOTE 5 Convertible bonds

In June 2025, the convertible bond was taken over in its entirety by Alvotech as part of the divestment. As of June 30, 2025, there is no value attributable to the convertible bond in the balance sheet..

NOTE 6 Assets held for sale and classification of divested operations

Effects of planned sale of Primm Pharma

Xbrane's continues to work towards a sale of the subsidiary Primm Pharma, in accordance with previously taken decisions. In the interim report January–March 2021, Primm Pharma's assets and liabilities were reclassified to "Assets held for sale" and "Liabilities attributable to assets held for sale" in the consolidated balance sheet. In the income statement, Primm Pharma's results are reported separately as "Profit/loss from discontinued operations."

Effects of sale of operations to Alvotech

During Q1 2025, an agreement was signed with Alvotech hf regarding the sale of XB003 and parts of the organization with its associated assets. In connection with the EGM voting in favor of the proposal, assets and liabilities attributable to the sold operations were reclassified to "Assets held for sale" and "Liabilities attributable to assets held for sale" in the consolidated balance sheet. In the income statement, the result of the discontinued operations is reported separately as "Profit/loss from discontinued operations." The reclassification has also been made to income and expenses for the comparative year, which means that comparative figures are no longer consistent with previous reports. The operation was divested on June 2, 2025 and is reported in the current period as a discontinued operation.

NOTE 6 Assets held for sale and classification of divested operations

Effects of the sale of operations to Alvotech

The financial information presented below refers to the time up to the divestment on June 2, 2025, as well as 2024.

Amounts in SEK 000 2025 Q3 2024 Q3 2025 Ack 2024 Ack 2024FY
Revenue 0 4 50,624
Other operating
profit/loss
12 061 –21,141
Expenses − –56,718 –5 360 –68,024 –150,180
Operating profit/loss − –56,718 6 701 –68,020 –120,697
Net financial items –779 –1 012 –1,609 –3,010
Profit/loss after
financial items
− –57,497 5 689 –69,629 –123,707
Tax 0
Profit/loss for
the period after tax,
discontinued
operations
− –57,497 5 689 –69,629 –123,707
Capital gains from
divestment of
operations
− 168 902
Profit/loss from
divested operations
− –57,497 174 591 –69,629 –123,707

Divestment of operations

Purchase price
received in SEK 000
2025
Cash and cash
equivalents
102,500
Fair value of
convertible bonds
132,233
Assumption of
liability, contract
manufacturers
20,000
Total purchase price 254,733
Divested net assets –85,831
Profit on divestment of
operations before tax
168,902
Tax expense on profit
from divestment of
operations
Profit from divestment
of operations after tax
168,902

FIRST PAGE CEO'S LETTER PRODUCT

FINANCIAL

FINANCIAL REPORTS

NOTE 6 Assets held for sale and classification of divested operations

Reported values for assets and liabilities divested as of June 2, 2025

Amounts in SEK 000 2025
Tangible fixed
assets¹
55,410
Total fixed assets 55,410
Prepaid expenses and
accrued income
68,929
Total assets 124,339
Leasing liabilities 38,508
Total liabilities 38,508
Net assets 85,831

1) Inkl. nyttjanderättstillgångar

NOTE 7 Risks and uncertainties

Risks and uncertainties

Risks and uncertainties are described in the 2024 Annual Report on pages 44–45, available on the company's website, www.xbrane.com. Despite the divestment of parts of the business to Alvotech, these have not changed in any material respect at the time of publication of this interim report.

NOTE 8 Pledged collateral

Redovisade belopp för tillgångar som ställts som säkerhet för kortfristiga och långfristiga skulder:

Amounts in SEK 000 09-30-2025 09-30-2024 12-31-2024
Tangible fixed assets 24,445
Inventory 155,824 43,777 156,697
Chattel mortgages 25,000
Total 155,824 43,777 206,142

The Group's pledged assets amounted to SEK 155.8 m (43.8) of which SEK 112.6 m is collateral pledged to contract manufacturers for the fulfillment of accounts receivable and future production. In addition, the Group has provided collateral for an advance payment from STADA of SEK 25.3 m (0.0).

In connection with entering into the license and development agreement with Intas Pharmaceuticals, Xbrane has pledged patents related to Xdivane™ as collateral for the fulfillment of obligations.

NOTE 9 Significant estimates and assessments

The management has discussed with the Audit Committee the development, selection and disclosure of the Group's significant accounting policies and estimates and the application of these policies and estimates.

Significant sources of uncertainty in estimates

The sources of uncertainty in estimates set out below are those that involve a significant risk that the value of assets or liabilities may need to be adjusted to a significant extent during the coming financial year.

The Group's financial position and continued operations The interim report has been prepared on the assumption that the company has the ability to continue operations during the coming 12 months, in accordance with the going concern principle.

Capitalization of development expenses

Capitalized expenses are attributable to the development of Ximluci® and Xdivane™.

According to Note 1, "Accounting principles" in the 2024 Annual Report, development expenses are recognized as an asset when the product or process is technically or commercially viable and the company has sufficient resources to complete the development and subsequently use or sell the intangible asset. The company has assessed that all criteria for capitalization of the development expenses of Ximluci® have been met from July 2021. From July 1, 2024, the Group has capitalized development expenses for Xdivane™, i.e., at the time when the criteria for capitalization in accordance with IFRS were deemed to be met. The technical risk in the program is considered limited as analytical similarity has been demonstrated on a commercial production scale and a reduced clinical program has been agreed with the EMA and FDA. In November 2024, the Group signed a global license and collaboration agreement with Intas Pharmaceuticals Ltd. Under the license and development agreement, Intas will finance and be responsible for clinical and regulatory development activities, as well as the global commercialization of the Nivolumab biosimilar candidate. This further strengthens the company's assessment that the opportunities for financing and continued development are good.

Certification

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

Stockholm, October 24, 2025

Anders Tullgren Chairman of the Board

Eva Nilsagård Board member

Mats Thorén Board member

Kirsti Gjellan Board member Kristoffer Bissessar Board member

Martin Åmark CEO

Revisorns granskningsrapport

To the Board of directors in Xbrane Biopharma AB (publ), corporate identity number 556749-2375

Introduction

We have conducted a limited review of the condensed interim financial information (interim report) for Xbrane Biopharma AB (publ)as of September 30, 2025, and the nine-month period ending on that date. The board of directors and the managing director are responsible for preparing and presenting 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 limited review.

The focus and scope of the limited review

We have conducted our limited review in accordance with the International Standard on Review Engagements ISRE 2410, "Review of Interim Financial Information Performed by the Independent Auditor of the Entity." A limited review consists of making inquiries, primarily of persons responsible for financial and accounting matters, performing analytical procedures, and other review procedures. A limited review has a different focus and a significantly

smaller scope compared to the focus and scope of an audit conducted in accordance with ISA and generally accepted auditing standards. The review procedures taken in a limited review do not enable us to obtain the assurance that we would become aware of all significant matters that might have been identified in an audit. Therefore, the conclusion expressed based on a limited review does not have the assurance that a conclusion expressed based on an audit has.

Emphasis of matter

We would like to draw attention to the section The group's financial position and continued operations on page 5-6, where it's stated that the company's financing for the next 12-month period is not secured. This indicates the existence of a material uncertainty that may cast significant doubt on the company's ability to continue as a going concern. Our statement is not modified in this regard.

Conclusion

Based on our limited review, nothing has come to our attention that causes us to believe that the interim report is not, in all material respects, prepared for the group in accordance with IAS 34 and the Annual Accounts Act and for the parent company in accordance with the Annual Accounts Act.

Stockholm, 24 October 2025

Öhrlings PricewaterhouseCoopers AB

Magnus Lagerberg Authorized Public Accountant

This is a translation of the Swedish language original. In the event of any differences between this translation and the Swedish language original, the latter shall prevail.

Alternative performance measures

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

Gross margin

The gross margin is a measure that the Group considers important for understanding the products' profitability. The gross margin is calculated as gross profit in relation to the revenue. The gross profit is revenue minus cost of goods sold.

Amounts in
SEK thousand
2025
Jul–Sep
2024
Jul–Sep
2025
Jan–Sep
2024
Jan–Sep
2024
Full year
Gross profit –4,983 44,650 87,865 119,385 129,873
Gross margin –49% 67% 61% 90% 88%

EBITDA

EBITDA is a measure that the Group considers relevant for an investor who wants to understand profit generation before investing in fixed assets. EBITDA shows the business's earning capacity from cash flow from operating activities without regard to capital structure and tax situation and is intended to facilitate comparisons with other companies in the same industry.

Amounts in
SEK thousand
2025
Jul–Sep
2024
Jul–Sep
2025
Jan–Sep
2024
Jan–Sep
2024
Full year
Operating
profit/loss
–23,532 –37,422 –3,586 –186,226 –97,224
Depreciation and
impairment
2,787 8,564 11,832 26,617 19,890
EBITDA –20,745 –28,858 8,246 –159,609 –77,335

Research and development expenses as a percentage of operating expenses

The company's direct expenses for research and development refer to costs for personnel, materials and external services. Research and development expenses as a percentage of operating expenses show how large a proportion of operating expenses are related to research and development. This is calculated by dividing research and development expenses by total operating expenses. Total operating expenses consist of selling expenses, administrative expenses, research and development costs and other operating expenses.

Amounts in
SEK thousand
2025
Jul–Sep
2024
Jul–Sep
2025
Jan–Sep
2024
Jan–Sep
2024
Full year
Research and
development
expenses
–9,843 –72,586 –58,995 –276,521 –162,014
Operating
expenses
–16,671 –84,794 –101,472 –314,383 –238,756
Research and
development
expenses as a
percentage of
operating
expenses
59% 86% 58% 88% 68%

Equity ratio

The equity ratio is a measure that the Group considers relevant for an investor who wants to understand the distribution between equity and liabilities. The equity ratio consists of the proportion of assets that are financed with equity to show the company's long-term solvency, i.e. equity divided by total assets.

Amounts in SEK thousand 09-30-2025 09-30-2024 12-31-2024
Total equity 587,048 260,148 208,539
Divided by total assets 701,476 839,667 842,429
Equity ratio 84% 31% 25%

Our objective – to contribute to health equality for everyone

Xbrane is a purpose-driven organization and our objective – to promote access to cost-effective drugs – is part of everything we do. Biological drugs are very effective in treating a number of serious medical conditions that affect many people. At the same time, biological drugs are expensive and only a fraction of the world's population has access to them.

Our purpose is clear – to be able to contribute to health equality for everyone. If there is a treatment, it should be available to everyone who needs it. By applying the latest science, Xbrane can develop cost-effective biological drugs at a lower price. This makes the treatment available to more people.

Xbrane in brief

Xbrane: a world-leading developer of biosimilars

Xbrane Biopharma AB is a biotechnology company that develops biosimilars, i.e. follow-up drugs on already approved biological drugs that can be introduced at a lower price after the patent expires on the original drug.

Xbrane has a patented platform technology that leads to a lower production cost of biological drugs compared to competing systems.

Xbrane has a team with expertise in taking biosimilars from cell-line to approval with long collective experience in drug development.

Xbrane has its headquarters and development lab at Campus Solna, just outside Stockholm. Since September 2019, Xbrane has been listed on Nasdaq Stockholm, with the ticker XBRANE.

FINANCIAL CALENDAR

Interim report January–December 2025 February 20, 2026
Annual Report 2025 March 31, 2026
Annual General Meeting May 5, 2026
Interim report January–March 2026 May 5, 2026

FOR FURTHER INFORMATION

Martin Åmark,

CEO

[email protected]

  • 46 76-309 37 77

Jane Benyamin,

CFO

[email protected] +46 73-360 37 33

www.xbrane.com

This is information which Xbrane Biopharma is required to publish in accordance with the EU's Market Abuse Regulation. The information was submitted for publication by the authority of the CEO on October 24, 2025 at 08:00 CET.

Xbrane Biopharma AB Scheeles väg 5, 171 65 Solna, Sweden | www.xbrane.com

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