Quarterly Report • Oct 24, 2025
Quarterly Report
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| 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 |
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).
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
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.
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.
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.
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.
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
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® 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 | 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™ 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™ 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 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.
A strong debut with continual growth potential.
Xbrane collaborates with global drug companies to:
Low risk – high potential returns.
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).
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 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 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 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 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.
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).
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.
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.
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).
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.
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.
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.
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
This interim report has not been subject to review by the company's auditor.
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
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.
| 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.
| 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 |
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.
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.
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..
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."
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.
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 |
| 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 REPORTS

NOTE 6 Assets held for sale and classification of divested operations
| 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 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.
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.
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.
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
To the Board of directors in Xbrane Biopharma AB (publ), corporate identity number 556749-2375
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.
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.
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.
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.
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.
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 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 |
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% |
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% |

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 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.
| 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 |
Martin Åmark,
CEO
Jane Benyamin,
CFO
[email protected] +46 73-360 37 33
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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