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Xbrane Biopharma

Investor Presentation Aug 28, 2024

3128_ir_2024-08-28_6941e79b-4232-4353-b26e-acff622c0dae.pdf

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Science for high quality biosimilars

FIRST PAGE CEO'S LETTER PRODUCT CANDIDATE

PORTFOLIO

PATENT PROTECTION FINANCIAL

OVERVIEW

FINANCIAL INFORMATION SHAREHOLDERS INFORMATION

FINANCIAL SUMMARY FOR THE GROUP

2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Revenue (SEK 000) 52,034 51,116 66,103 112,945 238,729
Research and development expenses (SEK 000) –116,310 –87,327 –203,936 –145,254 –305,783
R&D expenses as percentage of total costs 90% 84% 89% 81% 82%
Operating profit/loss (SEK 000) –63,665 –88,646 –148,803 –145,920 –322,164
EBITDA (SEK 000) –54,711 –81,052 –130,750 –129,466 –288,428
Profit/loss for the period (SEK 000) –70,502 –91,011 –167,907 –149,408 –388,172
Cash and cash equivalents (SEK 000) 72,835 315,640 72,835 315,640 65,402
Equity ratio (%) 36% 40% 36% 40% 26%
Earnings per share before dilution (SEK) –0.05 –0.15 –0.18 –0.25 –0.63
Earnings per share after dilution (SEK) –0.05 –0.15 –0.18 –0.25 –0.63
Number of employees on balance sheet date 71 93 71 93 93

SIGNIFICANT EVENTS DURING THE SECOND QUARTER 20241)

  • In April, it was announced that the U.S. Food and Drug Administration (FDA) sent a Complete Response Letter (CRL) in response to Xbrane's application for market approval for its ranibizumab biosimilar candidate (under the development name Xlucane) for the treatment of eye diseases.
  • In May, it was announced that Xbrane and STADA had entered a partnership agreement with Valorum Biologics to commercialize the biosimilar candidate for Ranibizumab in the US. The three partners are committed to bringing the ranibizumab biosimilar candidate to the US market as quickly as possible, contributing to more treatment options that can reduce costs and increase patient access to biological drugs for serious eye diseases. Valorum will pay a license fee of up to USD 45 m, split between an upfront payment, regulatory and sales-related milestones, as well as royalties on net sales. The revenue shared equally by Xbrane and STADA.

SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER1)

  • In August, the company announced that it was regaining full rights to BIIB801. This followed a decision by Biogen Inc. to terminate the commercialization and license agreement between the companies. All rights to the product have therefore returned to Xbrane.
  • In August, Xbrane updated the continuing outlicensing of Xdivane™ (Opdivo® biosimilar candidate) and XB003 (Cimzia® biosimilar candidate) and its financial position. Given the delay in FDA approval for Ximluci® and the unforeseen termination of the licensing agreement with Biogen, Xbrane must successfully out-license both Xdivane™ and XB003 in the coming months. The company's Board and management believe that this is feasible as there is significant interest in XB003 due to the unique nature of the program, and that Xdivane™ is focused on markets outside the US with a reduced clinical program. The latter is based on positive feedback from the European Medicines Agency (EMA). The company's Board and management are fully committed and working hard to achieve this and are also investigating other possible avenues to ensure shareholder value.

1) See page 8 for more information.

Interim report January – June 2024

FINANCIAL OVERVIEW SECOND QUARTER 2024*

• Revenue amounted to SEK 52.0 m (51.1).

Q2

  • Other operating income was SEK 0.8 m (3.2).
  • EBITDA amounted to SEK −54.7 m (−81.1).
  • R&D costs amounted to SEK −116.3 m (−87.3), corresponding to 90 percent (84) of total operating costs.
  • The loss for the period was SEK 70.5 m (−91.0).
  • Earnings per share was SEK −0.05 (−0.15).
  • Cash and cash equivalents at the end of the period amounted to SEK 72.8 m (315.6).

FINANCIAL OVERVIEW FIRST HALF-YEAR 2024*

  • Revenue amounted to SEK 66.1 m (112.9).
  • Other operating income was SEK 6.1 m (7.3).
  • EBITDA amounted to SEK −130.8 m (−129.5).
  • R&D costs amounted to SEK −203.9 m (−145.3), corresponding to 89 percent (81) of total operating costs.
  • The loss for the period was SEK 167.9 m (−149.4).
  • Earnings per share was SEK −0.18 (−0.25).
  • Cash and cash equivalents at the end of the period amounted to SEK 72.8 m (315.6).

FIRST PAGE CEO'S LETTER PRODUCT CANDIDATE PORTFOLIO

PATENT PROTECTION FINANCIAL

OVERVIEW SHAREHOLDERS INFORMATION

FINANCIAL INFORMATION

"Focus on out-licensing processes."

CEO's letter

Dear shareholders

During Q2 we were pleased by the accelerated sales growth of Ximluci® and to have successfully upscaled the production processes for both XdivaneTM and XB003 with confirmed analytical similarity, which paves the way for out-licensing and taking the step into clinical development.

Ximluci®

As of July, Ximluci® had been launched in 18 European countries. In Q2 2024, the market share value well exceeded 1 percent1 of the ranibizumab market worth around EUR 300 m2 . We also saw a strong growth in revenue during Q2, close to 40 percent compared to Q1 2024. This was higher than expected compared to our new revised sales estimate and resulted in a greater than expected profit share for Xbrane, mainly driven by a favorable market mix. Overall, we generated revenues of SEK 52 m during Q2 2024, also including Xbranes share of the upfront from Valorum. The work towards re-submitting the BLA to FDA is progressing according to plan with re-submission envisioned in Q4 2024.

XB003 (Cimzia® biosimilar candidate)

Xbrane made significant progress with XB003 during Q2. The production process has been successfully upscaled together with Xbranes selected contract manufacturer with confirmed analytical similarity to the reference product. However, unexpectedly, the licensing agreement with Biogen Inc. was terminated due to a strategic revision by Biogen and Xbrane regained the full rights to the program. This was an unforeseen event, which will significantly impact the company´s expected income over the coming 6–12 months. Xbrane immediately initiated an out-licensing process of the biosimilar candidate with an accelerated timeline. Currently a handful of interested companies are conducting active due diligence alongside discussions on terms for a potential partnership. The out-licensing process is running according to a strict established timeline with an envisioned license agreement, which has to be signed by the end of October 2024 at the latest. The program is ready to initiate clinical trials in 2025.

Xdivane™ (Opdivo® biosimilar candidate)

Xbrane also made significant progress with the XdivaneTM program during Q2. The production process was successfully upscaled together with Xbranes selected contract manufacturer with confirmed analytical similarity to the reference product. Based on this, Xbrane received positive feedback in a Scientific Advice meeting with the EMA where the agency endorsed the analytical similarity shown and agreed to the proposed reduced clinical development plan. Out-licensing efforts for XdivaneTM are now focused outside the US territories with reduced clinical development plan as agreed with the EMA. The focus territory is expected to represent USD 5 b of reference product sales upon patent expiry, and hence a meaningful opportunity. Following the positive news from the EMA we recognized an increased interest from potential partners and we are working on a plan to conclude an out-licensing agreement by the end of October.

Financial position

Xbrane had a cash-position of SEK 73 m at the end of Q2. A positive operating cash flow is expected to be achieved, assuming FDA approval of Ximluci® (Lucentis® biosimilar candidate) in Q2 2025. Given the delay in the FDAs approval for Ximluci® and the unforeseen termination of the licensing agreement with Biogen, Xbrane must successfully out-license both Xdivane™ and XB003 in the coming months. It is essential that the company can maintain the

timelines of the out licensing to ensure financing of the company from November and onwards. The company's Board of Directors and senior management believe this is feasible given the level of interest and that multiple stakeholders evaluate the programs. The Board and management are working closely with a highly regarded external biopharma outlicensing consultant to close the out-licensing program in the coming months and to fulfill Xbranes' working capital requirements from November 2024 onwards.

Thank you for your continued support!

Solna, August 28, 2024

Martin Åmark, CEO

1) Source: Xbrane estimate based on reported sales from respective product

2) The market for VEGF inhibitors including both vial and pre-filled syringes for ophthalmic use

FINANCIAL INFORMATION

Biosimilar candidate portfolio

Xbrane has a portfolio of four biosimilar candidates for a range of treatment areas. This includes a number of serious eye diseases, several different types of cancer and, among others, rheumatoid arthritis, psoriasis and Crohn's disease.

Ximluci®

Ximluci® is a biosimilar candidate to ranibizumab, the original drug Lucentis®, a VEGFa inhibitor used to treat a number of serious eye diseases. Ximluci® addresses a market of around EUR 13 bn1) per year.

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

Xbrane has received a Complete Response Letter (CRL) in response to Xbrane's application for market approval for

Ximluci® in the US market. Xbrane is aiming to, and planning for, a resubmission of the BLA in Q4 2024. If successful, it would result in a BsUFA date in Q2 2025. It anticipates a standardized review process of six months. STADA is also actively working to take Ximluci® to other regions such as the Middle East, Latin America and Southeast Asia, where the application for market approval has been submitted to various regulatory authorities in these regions. In May, STADA and Xbrane signed a collaboration agreement with Valorum Biologics, 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 injection into the eye. Xbrane also plans to launch a prefilled syringe for Ximluci® in Europe in 2025.

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

PORTFOLIO

PATENT PROTECTION FINANCIAL

OVERVIEW FINANCIAL INFORMATION SHAREHOLDERS INFORMATION

XB003

XB003 (formerly BIIB801) is a biosimilar candidate to certolizumab pegol, the original drug Cimzia®, a TNF alpha inhibitor, mainly used in the treatment of rheumatoid arthritis and psoriasis. Cimizia® has sales of over EUR 2 bn2) and will lose its patent protection in 2024 in the US and 2025 in Europe.

Xbrane signed a licensing agreement with Biogen Inc. for XB003, in February 2022. In August 2024, it was announced that Biogen had decided to terminate the agreement. Biogen notified Xbrane that the termination relates to a recent strategic review. All rights granted to Biogen under the agreement will be terminated and the full rights to the program will thus revert to Xbrane. XB003 is currently, to Xbrane's knowledge, one of the few, or the only, biosimilar candidate for Cimzia® globally, being developed. The production process for the biosimilar candidate has been upscaled successfully together with Xbrane's selected contract manufacturers. Production of clinical material will take place in 2024, enabling the initiation of a clinical study in 2025. Analytical similarity compared to the reference product has been shown and initial scientific advice from both the EMA and FDA has been obtained. The production process that enables high productivity is patented by Xbrane. Xbrane has started a structured out-licensing process with the aim of finding a new development and commercialization partner as soon as possible. Given the program's unique nature, Xbrane is optimistic about the prospects of closing a deal in an accelerated timeline.

Xdivane™

Xdivane™ is a biosimilar candidate to nivolumab, original drug Opdivo®, a PD1 inhibitor for the treatment of various types of cancer. Opdivo® is expected to generate sales of EUR 13 billion1) and lose its patent protection in 2026–2031, depending on the country. Upscaling of Xdivane™, has been successfully completed with contract manufacturers and Xbrane has successfully sought acceptance from regulatory authorities for a reduced clinical development program. Positive feedback regarding this has been received from the EMA on the basis of a high analytical similarity shown against a comprehensive panel of analytical methods compared to the reference product. This will affect the program's

out-licensing timeline, and Xbrane is therefore currently focusing on partnership discussions with companies interested in Europe and other key markets outside the US. Xbrane assesses that the business case of a reduced clinical development plan with a focus outside the USA is positive and where the company is in talks with a number of commercialization partners about outlicensing the product.

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.

Xdarzane™ is at the preclinical development stage with a focus on developing a cost-effective production process and demonstrating a biochemical similarity to the original drug.

Product portfolio

Product Original drug Primary indication Estimated annual
sales of original drug1)
Patent expiry
of original drug
Development phase
Ximluci® Ranibizumab
(Lucentis®)
Wet age-related macular degeneration,
diabetes-related eye damage and retinal
vein occlusion.
EUR 2 bn3) 2022 (Europe)
2020 (USA)
Launch phase
XB003 Certolizumab pegol
(Cimzia®)
Rheumatoid arthritis, axial spondyloarthritis,
psoriatic arthritis and psoriasis.
EUR 2 bn2) 2024 (USA)
2025 (Europe)
Preclinical phase
XdivaneTM, Nivolumab
(Opdivo®)
Melanoma, lung cancer, kidney cell cancer,
head and neck cancer and bladder and
urinary tract cancer.
EUR 13 bn1) 2026–2031
depending on country
Preclinical phase
XdarzaneTM, Daratumumab
(Darzalex®)
Multiple melanoma. EUR 9 bn1) 2029–2031
depending on country
Preclinical phase
EUR 26 bn1)

Source:

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

2) UCB 2023 Integrated Annual report.

3) "Novartis Full year 2023 product sales" and "Roche's Full-Year Results 2023"

OVERVIEW SHAREHOLDERS INFORMATION

FINANCIAL INFORMATION

Xbrane is an innovative company that invests significantly in research and development, which is why strategic patents to protect our technologies and products are essential. A growing patent portfolio strengthens the company's brand. Xbrane's most important regions for the protection of intellectual property rights (IP) are Europe and the US, but applications may also be made in other countries.

Expanding patent portfolio

The expanding patent portfolio will facilitate the implementation of commercially important initiatives such as licensing and strategic business partnerships or alliances for commercializing biosimilars and biosimilar production platforms.

Xbrane plans to file patent applications that protect a wide range of technologies, from protein production and protein purification to novel formulations of biosimilars.

The most important regions for patents are Europe and the US, but patent applications may also be filed in Canada, China, South Korea, India, Japan and Australia if the company's products and methods are thought to have a market there. Other international patent applications may also be involved.

Xbrane's LEMO™ technology platform is protected by two patents in Europe and the US until 2029. Between 2020 and 2023, these two patents, originally filed in 2009, have been complemented with 16 further patents as well as 59 applications "harvested" from four different development programs.

Strengthen the Xbrane brand

The Swedish Intellectual Property Office (PRV) granted eight patents in 2021. Of these, three related to DNA constructs for the regulation of protein production and were co-filed with CloneOpt AB. Five of the patents resulted from the development of XdivaneTM and enables a broadening of the technology platform for highyield antibody production in mammalian cells. A large part of the upcoming development of the biosimilar candidate XdarzaneTM based on this platform.

The five Swedish patents were followed up, via an international patent application, with applications in the US, Canada, Europe, India, China, South Korea, Singapore, Australia and Japan in autumn 2022. Patents were granted in Australia and South Korea in Q1 2023 and divisional applications were filed in these two countries before the patents were granted. The patent applications protect new DNA sequences in genes that are introduced into host cells and instruct the cells to express the protein of interest. These DNA sequences have resulted in a significant increase in yield and can also be applied to future biosimilar candidates to be expressed in mammalian cells. In addition, three patent applications were filed in February 2024 to protect Xdivane™ formulations.

A large portion of the rest of the patent applications relate to DNA constructs, host cells and/or methods for producing Ximluci® and XB003.

The patent applications to protect Ximluci® were filed during March–May 2023 together with STADA Arzneimittel AG in thirty-two different countries and regions such as the US, Europe, Canada, China, South Korea, India, Japan and Australia as well as MENA and some Latin American countries. In December 2023, PRV granted three patents in the XB003 program. During Q1 and Q2 2024, another 13 patent applications for XB003 were filed in Australia, Brazil, Canada, China, Europe, India, Indonesia, Japan, Mexico, Singapore, South Africa, South Korea and the US.

The expanding patent portfolio will strengthen Xbrane's brand, protect the company's products and enables more out-licensing of IP in the future.

Number of patents and patent applications (accumulated)

FIRST PAGE CEO'S LETTER PRODUCT CANDIDATE

PORTFOLIO

PATENT PROTECTION FINANCIAL

OVERVIEW

Shareholders

As of June 30, 2024, Xbrane had around 11,300 shareholders. The number of outstanding shares was 1,529,483,397. The ten largest shareholders at the end of the period are shown in the table below1).

Name Number of shares Shareholding, %
Systematic Growth AB 181,709,252 11.9
Håkan Stödberg 71,750,000 4.7
Handelsbanken Fonder 51,935,440 3.4
Avanza Pension 36,846,130 2.4
Nordnet Pensionsförsäkring 35,695,255 2.3
Bengt Göran Westman 33,081,649 2.2
Nordea Liv & Pension 20,842,983 1.4
Souverain AB 20,407,854 1.3
Swedbank Försäkring 15,274,465 1.0
Joakim Ek 13,600,000 0.9
Total ten largest shareholders 481,143,028 31.5
Other Swedish shareholders 644,709,701 42.2
Other foreign shareholders 403,630,668 26.4
Total outstanding shares 1,529,483,397 100

1) Modular Finance. Based on complete list of owners including directly registered and nominee registered shareholders. Ownership is verified at various times.

Why invest in Xbrane?

Xbrane – a world-leading developer of biosimilars

Platform-based developer of biosimilars with low production costs

FINANCIAL INFORMATION

  • A patented development platform to ensure a low production cost.
  • Business concept to commercialize biosimilars in partnership with major global pharmaceutical companies, for the benefit of patients and payers.

The first product, Ximluci® was launched in Europe in Q1 2023 and is now available in 18 countries

Ximluci® (biosimilar to Lucentis®) was launched in Q1 2023 and competes in a market worth around EUR 5 bn in Europe.

Attractive portfolio with more candidates to be launched when the patents expire on the original drugs.

  • XB003 (previously BIIB801) is, as far as we know, the only biosimilar candidate in development for the TNF inhibitor Cimizia®, which has annual sales of more than EUR 2 bn.
  • Portfolio of two biosimilar candidates in oncology addressing a combined annual peak sales of the reference products totaling EUR 22 bn for which we are discussing outlicensing.

SHAREHOLDERS INFORMATION

FINANCIAL INFORMATION

Financial overview

Group results for April – June 2024

The Group's revenue amounted to SEK 52.0 m (51.1). During Q2, together with STADA, a license agreement was entered into with Valorum Biologics, which resulted in upfront remuneration of SEK 27.2 m. Revenue for product sales of Ximluci® amounted to SEK 21.7 m (37.0). The Group did not deliver additional products to STADA during the first half of the year. Sales to STADA vary over the quarters because they are made in larger individual deliveries. Revenue from product sales during Q2 was made up entirely of a positive effect on profit sharing, due to a positive marketmix. Last year, the Group received income from out-licensing, mainly through the licensing agreement with Biogen Inc. regarding XB003 (previously BIIB801).

The cost of goods sold regarding Ximluci® amounted to SEK 13.4 m (–39.6). The positive effect is mainly due to the company receiving a retroactive adjustment of the price from a contract manufacturer, which gave a net effect of around SEK 13 m. In addition, positive production deviations had a certain effect on the reduced cost in Q2.

Other operating income amounted to SEK 0.8 m (3.2) and consisted of exchange rate gains on operating receivables and liabilities.

Research and development costs amounted to SEK –116.3 m (–87.3). The XB003 program made up about 45 percent of the R&D costs for the quarter, and Xdivane™ and Ximluci® made up about 35 and 19 percent, respectively. During the period, XB003 produced the first scale-up batch. Xdivane™ has produced the first upscaling batches and production of clinical material will follow during the year. Administration costs amounted to SEK –9.3 m (–11.3). The cost reduction is an effect of the savings scheme that was introduced in Q4 2023.

Other operating expenses amounted to SEK –4.3 m (–5.0) and consisted of exchange rate losses on operating receivables and liabilities.

The operating loss was SEK 63.7 m (–88.6). The loss before tax was SEK 70.2 m (–90.6). During Q2, there was no taxable profit and thus no tax expense (0.0). The quarter's loss after tax from continuing operations therefore amounted to SEK 70.2 million (–90.6). The loss for the period amounted to SEK 70.5 m (–91.0). Earnings per share for continuing operations amounted to SEK –0.05 (–0.15) and earnings per share amounted to SEK –0.05 (–0.15).

The Group's cash flow for April – June 2024

Cash flow from operating activities amounted to SEK –99.5 m (–143.5), of which SEK -0.1 m (-0.3) was from discontinued operations (Primm Pharma). Q2's negative cash flow was driven, among other things, by the production of commercial batches for Ximluci® and upscaling batches for Xdivane™. Cash flow from investment activities amounted to SEK –10.5 m (–0.5) and refers to capitalized costs for Ximluci® attributable to the development of the pre-filled syringe and the work with FDA approval.

Cash flow from financing activities amounted to SEK –86.0 m (338.5). During Q2, a repayment of the bond was made amounting to SEK 62.5 m. No further repayments will be made during the year. Issuance costs, primarily remuneration to guarantors of the rights issue, burdened the cash flow with SEK –19.9 m. Amortization of leasing liabilities amounted to SEK –3.5 m (–2.5).

Group results for January – June 2024 The Group's revenue amounted to SEK 66.1 m (112.9). Revenue from product sales of Ximluci® amounted to SEK 35.7 m (84.6). The Group has not delivered any additional products to STADA during the first half of the year. Sales to STADA vary over the year because they are made in larger individual deliveries. The revenue from product sales for the first half of the year consisted entirely of a positive effect on profit sharing, as the margin has improved in line with increased sales volumes as well as a positive market mix. During Q2, together with STADA, a license agreement was entered into with Valorum Biologics, which entailed an upfront payment of SEK 27.2 million. Last year, the Group received licensing revenue of SEK 28.2 million, mainly through the agreement with Biogen Inc. regarding XB003 (previously BIIB801).

The cost of goods sold regarding Ximluci® amounted to SEK 8.6 m (–85.9). The positive effect for cost of goods sold is due to a retroactive adjustment of the raw material price from a contract manufacturer, which gave a net effect of around SEK 13 m. Otherwise, the cost was affected by obsolescence and production deviations.

Other operating income amounted to SEK 6.1 m (7.3) and consisted of exchange rate gains on operating receivables and liabilities.

Research and development costs amounted to SEK –203.9 m (–145.3). For the first half-year, Xdivane™ made up about 42 percent of the R&D costs, and XB003 and Ximluci® made up about 31 and 27 percent, respectively. Xdivane™ is working with upscaling production volumes together with contract manufacturers. Ximluci® has produced validation batches at contract manufacturers for the

pre-filled syringe and XB003 has produced a first upscaled batch. Administration costs amounted to SEK –20.3 m (–23.3). The cost reduction is primarily due to consulting and salary costs, which is an effect of the savings scheme that was introduced in Q4 2023.

Other operating expenses amounted to SEK –5.4 m (–11.6) and consisted of exchange rate losses on operating receivables and liabilities.

The operating loss was SEK148.8 m (–145.9). The loss before tax was SEK 167.3 m (–148.4). During the first half-year, there was no taxable profit and thus no tax cost (0.0). The period's loss after tax from continuing operations therefore amounted to SEK 167.3 m (–148.4). The loss for the period amounted to SEK 167.9 m (–149.4). Earnings per share for continuing operations amounted to SEK –0.18 (–0.25) and earnings per share amounted to SEK –0.18 (–0.25).

The Group's cash flow for January – June 2024

Cash flow from operating activities amounted to SEK –212.7 m (–200.1), of which SEK –0.3 m (–0.5) came from discontinued operations (Primm Pharma). The period's negative cash flow is due, among other things, to greater tied-up capital in inventory. Furthermore, cash flow was driven by intensified development work with Ximluci® and Xdivane™. The cash flow from investment activities was SEK –11.0 m (–16.4), which is mainly attributable to capitalized development expenses regarding Ximluci®.

Cash flow from financing activities was SEK 230.1 m (336.1). During the first half of the year, a rights issue was carried out, which brought in SEK 299.8 m net after issue costs. A bridging loan of a nominal SEK 50 m was taken out during Q1, which was then repaid in connection with the issue. Also, in connection with the issue, a repayment of the bond was made amounting to SEK 62.5 m. No further repayments of the bond will be made during the year. Amortization of leasing liabilities amounted to SEK –7.2 m (–4.9).

The Group's financial position and continued operations As of the end of June, the Group's cash and cash equivalents amounted to SEK 72.8 m (315.6).

The Board and Senior Management are assessing the Companys cash position closely on a regular basis. A positive operating cash flow is expected to be achieved, assuming FDA approval of Ximluci® (Lucentis® biosimilar candidate) in Q2 2025. Given the delay in FDA approval for Ximluci® and the unforeseen termination of the licensing agreement with Biogen, Xbrane must successfully out-license both Xdivane™ and XB003 in the coming months to ensure funding until the expected positive operating cash flow. The company's board and management believe that this should

be feasible as interest in XB003 is high given the unique nature of the program and Xdivane™ is focused on markets outside the US with a reduced clinical program based on positive feedback from the EMA. The timing of when exactly the out-licensing can take place is uncertain, which is why additional financing needs may arise. The company's ability to obtain additional financing depends on a number of factors, including the general situation on the financial markets, the company's creditworthiness and the company's ability to increase its indebtedness. The Board and management deems that the revised plan should be feasible and that the group should thus be able to ensure necessary liquidity for continued operation of the business for at least the next twelve months.

The company's Board and management are fully committed and working hard to achieve this and are also investigating other possible avenues to ensure shareholder value.

Fixed assets

Fixed assets amounted to SEK 185.2 m (182.9). Fixed assets consist primarily of capitalized expenditures for Ximluci®, right-of-use assets, and laboratory equipment, machinery, fixtures for office premises and customary monthly depreciation.

Inventory

Inventory amounted to SEK 214.3 m (95.2), consisting primarily of drug substance, ready to be packaged and then shipped directly to customers. Drug substance has a shelf life of five years, and no impairment is deemed necessary.

Prepaid costs and accrued income

Prepaid costs and accrued income amounted to SEK 248.5 m (254.2). Essential items consisted of advance payments for production, SEK 26.8 m (79.6), and advance payments to contract manufacturers for development and upscaling amounting to SEK 129.0 m (149.3). In addition, accrued income amounted to SEK 82.7 m (0.0), which is mainly attributable to product sales of Ximluci®.

Changes in equity

The share capital on the balance sheet date was SEK 342.9 m (6.6). Other contributed capital amounted to SEK 1,393.4 m (1,414.1). Total equity amounted to SEK 304.5 m (400.0) and the equity ratio was 36 percent (40). During the year, a rights issue was carried out, which increased equity by SEK 300.2 m net, of which SEK 336.7 million increased the share capital and the remainder was reported under other contributed capital.

Accrued expenses and prepaid income

Accrued expenses and prepaid income amounted to SEK 267.9 m (300.5), consisting of advance payments from STADA amounting to SEK 121.9 m (153.1), of which SEK 74.8 million (88.5) was attributable to commercialization. In addition, the item was mainly affected by accrued production costs of SEK 8.9 m (42.7) and accrued development costs for projects of SEK 123.1 m (75.0).

Significant events during the second quarter

  • In April, it was announced that the FDA had sent a CRL in response to Xbrane's application for marketing approval for its ranibizumab biosimilar candidate (under the development name Xlucane) for the treatment of eye diseases. Xbrane will work closely with the FDA to submit answers as quickly as possible to the questions raised, which mainly relate to the reference standard, and completed inspections, of Xbrane's partner's production facilities. The FDA has not requested any additional clinical trials or any additional studies to demonstrate biosimilarity.
  • In May, it was announced that Xbrane and STADA had entered into a licensing agreement for the American commercial rights to the biosimilar candidate for ranibizumab with Valorum, a specialist in the commercialization of biosimilars founded by renowned industry individuals with a solid track record of selling and marketing biosimilars in the US. Valorum will bring invaluable experience and well-established networks in the US pharmaceutical market. Valorum will be responsible for sales, marketing and all other commercialization efforts in the US following regulatory approval of the product, which is expected to be marketed under the brand name Lucamzi™. Valorum will pay a licensing fee of up to USD 45 m, split between an upfront payment, regulatory and sales-related milestones, as well as royalties on net sales. The remuneration will be shared equally by STADA and Xbrane. The three partners are committed to bringing the ranibizumab biosimilar candidate to the US market as quickly as possible, thereby contributing to more treatment options that can reduce costs and increase patient access to biologics for serious eye diseases.
  • Significant events after the end of the quarter
  • In August, the company announced that it has regained full rights to BIIB801. This follows a decision by Biogen Inc. to terminate the commercialization and licensing agreement between the companies. All rights to the product have therefore been returned to Xbrane.
  • In August, Xbrane updated the continuing out-licensing of Xdivane™ (Opdivo® biosimilar candidate) and XB003 (Cimzia® biosimilar candidate) and its financial position. Given the delay

in FDA approval for Ximluci® and the unforeseen termination of the licensing agreement with Biogen, Xbrane must successfully out-license both Xdivane™ and XB003 in the coming months. The company's Board and management believe that this is feasible as there is significant interest in XB003 due to the unique nature of the program, and that Xdivane™ is focused on markets outside the US with a reduced clinical program. The latter is based on positive feedback from the EMA. The company's Board and management are fully committed and working hard to achieve this and are also investigating other possible avenues to ensure shareholder value.

The effects of the collaboration with STADA

The collaboration agreement which began in July 2018 with STADA AG regarding projects for research and development of Ximluci® meant that STADA AG and Xbrane would equally share (50/50) research and development costs attributable to the project. Receivables and liabilities attributable to the project are reported in full in Xbrane's balance sheet with a settlement of 50 percent for STADA AG's share. This applies to both the Group and the parent company.

In connection with the first delivery of Ximluci® in 2023, Xbrane also signed a supply agreement with STADA. The agreement means that Xbrane will provide the product for commercialization to STADA and will be reimbursed in accordance with the actual production cost. In accordance with the agreement, Xbrane also has the option of pre-invoicing STADA for future product deliveries.

On the balance sheet date, Xbrane had accounts receivable from STADA of SEK 15.9 m (0.0), other receivables amounting to SEK 33.2 m (55.0) and accrued costs and prepaid income from STADA amounting to SEK 121.9 m (153.1) of which SEK 74.8 m (88.5) is pre-invoicing of future product deliveries.

Effects of the planned sale of Primm Pharma Assets held for sale

Xbrane's intention, in accordance with its previous decision, is to continue to work towards a divestment of the subsidiary Primm Pharma. In the Q1 interim report for 2021, Primm Pharma's assets and liabilities were reclassified to "Assets held for sale" and

"Liabilities attributable to assets held for sale" respectively, in the consolidated balance sheet in the income statement, Primm Pharma's results are reported separately as "Profit/loss from discontinued operations Primm Pharma's share of each business is reported in the cash flow under "Of which from discontinued operations". In December 2023, Xbrane chose to write-down access to its reported net assets, in this case Primm Pharma's equity.

Parent company

The core business of Xbrane, i.e. the development of biosimilars, is conducted in the parent company. As the parent company forms such a large part of the Group, an account of the parent company's results, financial position and cash flow would not provide any additional information to that described in the report on the Group. Therefore, this is only presented in report format on pages 14–15.

Risks and uncertainty factors

Risks and uncertainty factors are described in the Annual Report 2023 on pages 60–61, available on the company's website, www.xbrane.com. At the time of publication of this interim report, these have not changed significantly.

Share information

Xbrane's share capital at the end of the period was SEK 342.9 m (6.6) divided into 1,529,483,397 shares (29,216,004). The quota value of all shares is SEK 0.224, and all the shares have equal rights to the company's assets and earnings. Since September 23, 2019, Xbrane's shares have been listed on the Nasdaq OMX main list under the XBRANE ticker. Xbrane had around 11,300 shareholders on the balance sheet date. The closing price of the share on the balance sheet date was SEK 0.26 generating a market capitalization of around SEK 402 m.

Organization and employees

Xbrane is headquartered at Campus Solna, outside of Stockholm, Sweden, where the company also has a laboratory for the research and development of biosimilars. On the balance sheet date, the Group had a total of 71 employees (93) of which 71 (93) in the parent company.

Nomination committee

According to the principles for the nomination committee in Xbrane Biopharma AB ("the Company" or "Xbrane") which were adopted at the annual general meeting on May 2, 2024, the nomination committee shall consist of three members, appointed by the Company's three largest shareholders as of September 30, 2023. if a shareholder ceases to be one of the Company's three largest shareholders before three months before the general meeting, the member must resign from the nomination committee and a new member must be appointed.

Based on the above, Oscar Bergman, appointed by Swedbank Robur Fonder, the company's third largest shareholder as of September 30, 2023, has resigned from the nomination committee. Xbrane's Chairman of the Board, Anders Tullgren, has been in contact with the company's largest shareholders, but at the time of this report's publication, no new member has been appointed. For the time being, the nomination committee consists of

  • Saeid Esmaeilzadeh, appointed by Systematic Growth AB, the company's largest shareholder
  • Bengt Göran Westman, the company's second largest shareholder
  • Anders Tullgren, Xbrane's Chairman of the Board, deputy member if necessary.

Saeid Esmaeilzadeh has been appointed as the nomination committee's Chairman.

Annual General Meeting

The Annual General Meeting for 2024 was held on May 2, 2024. The minutes and report from the Annual General Meeting 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.

PORTFOLIO

OVERVIEW SHAREHOLDERS INFORMATION

FINANCIAL INFORMATION

Consolidated income statement

Amounts in SEK thousand Notes 2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Revenues
2
52,034 51,116 66,103 112,945 238,729
Cost of goods sold 13,385 –39,362 8,632 –85,945 –203,341
Gross profit 65,419 11,754 74,735 27,000 35,388
Other operating income 814 3,249 6,051 7,269 13,707
Administrative expenses –9,318 –11,308 –20,283 –23,297 –40,031
Research and
development expenses
–116,310 –87,327 –203,936 –145,254 –305,783
Other operating expenses –4,271 –5,012 –5,370 –11,637 –25,445
Operating profit/loss –63,665 –88,646 –148,803 –145,920 –322,164
Net financial costs –6,534 −1,934 –18,503 −2,521 137
Profit/loss before tax –70,200 –90,580 –167,306 –148,440 –322,028
Tax
Profit/loss for the period
from continuing operations
–70,200 –90,580 –167,306 –148,440 –322,028
Profit/loss from discontinued
operations
–302 –432 –601 –968 –66,144
Profit/loss for the period –70,502 –91,011 –167,907 –149,408 –388,172
Profit/loss for the period
attributable to:
– Owners of the Company –70,502 –91,011 –167,907 –149,408 –388,172
– Non-controlling interests
Total comprehensive income
for the period
–70,502 –91,011 –167,907 –149,408 –388,172
Earnings per share from
continuing operations
– Before dilution (SEK) –0.05 –0.15 –0.18 –0.25 –0.53
– After dilution (SEK) –0.05 –0.15 –0.18 –0.25 –0.53
Earnings per share
– Before dilution (SEK) –0.05 –0.15 –0.18 –0.25 –0.63
– After dilution (SEK) –0.05 –0.15 –0.18 –0.25 –0.63
Amounts in SEK thousand Notes 2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Number of outstanding
shares at the end of the
reporting period
– Before dilution 1,529,483,397 29,216,004 1,529,483,397 29,216,004 29,810,364
– After dilution 1,529,483,397 29,216,004 1,529,483,397 29,216,004 29,810,364
Average number of
outstanding shares
– Before dilution 1,529,483,397 28,238,869 927,048,541 27,874,468 28,705,554
– After dilution 1,529,483,397 28,238,869 927,048,541 27,874,468 28,705,554

Consolidated income statement and other comprehensive income

Amounts in SEK thousand 2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Profit/loss for the period –70,502 –91,011 –167,907 –149,408 –388,172
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
–57 3,284 82 4,211 –201
Comprehensive income
for the period
–57 3,284 82 4,211 –201
Total comprehensive profit/loss
attributable to:
– Owners of the Company –70,559 –87,727 –167,825 –145,197 –388,373
– Non-controlling interests
Total comprehensive income
for the period
–70,559 –87,727 –167,825 –145,197 –388,373

FINANCIAL INFORMATION

Consolidated statement of financial position

Amounts in SEK thousand Notes 06-30-2024 06-30-2023 12-31-2023
ASSETS
Intangible assets 104,781 106,496 99,670
Property, plant and equipment 28,361 36,792 32,537
Right of use assets 48,068 35,653 55,663
Long-term receivables 3,945 3,945 3,945
Non-current assets 185,155 182,887 191,815
Inventory 4 214,324 95,209 106,856
Accounts receivables 15,902
Other receivables 97,801 77,824 34,213
Prepaid expenses and accrued income 248,522 254,187 251,907
Cash and cash equivalents 72,835 315,640 65,402
Assets held for sale 2,647 72,964 3,314
Current assets 652,030 815,823 461,693
TOTAL ASSETS 837,185 998,710 653,508
Amounts in SEK thousand Notes 06-30-2024 06-30-2023 12-31-2023
EQUITY
Share capital 342,889 6,550 6,683
Other contributed capital 1,393,350 1,414,140 1,428,530
Reserves 10,202 14,533 10,121
Retained earnings including profit/loss for the year –1,441,906 –1,035,235 –1,273,999
Equity attributable to parent company's owners 304,536 399,988 171,335
Non-controlling interests
TOTAL EQUITY 304,536 399,988 171,335
LIABILITIES
Long-term interest-bearing liabilities 5 88,572 145,452 112,897
Leasing liabilities 36,589 28,099 42,711
Long-term non interest-bearing liabilities 5 14,982 8
Total long-term liabilities 125,161 188,533 155,616
Short-term interest- bearing liabilities 5 31,250 62,012 62,500
Accounts payable 93,183 34,247 30,974
Other liabilities 2,083 2,933 2,810
Leasing liabilities 12,635 9,782 13,371
Accrued expenses and prepaid income 267,855 300,482 216,296
Liabilities attributable to assets held for sale 482 732 606
Total short-term liabilities 407,488 410,189 326,557
TOTAL LIABILITIES 532,649 598,722 482,173
TOTAL LIABILITIES AND EQUITY 837,185 998,710 653,508

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 01-01-2024 6,683 1,428,530 10,121 –1,273,999 171,335
Total comprehensive income for the period
Profit/loss for the period –167,907 –167,907
Other comprehensive income for the period 82 82
Total comprehensive income for the period 82 –167,907 –167,825
Transactions with group shareholder
New share issue 336,206 8,719 344,925
Issue expenses –45,161 –45,161
Share savings program 1,263 1,263
Total contributions from and distributions to shareholders 336,206 –35,180 301,026
Closing balance 06-30-2024 342,889 1,393,350 10,202 –1,441,906 304,536
Amounts in SEK thousand Share Capital Other contributed
capital
Translation
reserve
Retained earnings incl.
profit/loss for the period
Total
Opening balance 01-01-2023 6,166 1,294,227 10,322 –885,827 424,888
Total comprehensive income for the period
Profit/loss for the period –388,172 –388,172
Other comprehensive income for the period –201 –201
Total comprehensive income for the period –201 –388,172 –388,373
Transactions with group shareholder
New share issue 517 134,545 135,062
Issue expenses –962 –962
Share savings program 720 720
Total contributions from and distributions to shareholders 517 134,303 134,820
Closing balance 12-31- 2023 6,683 1,428,530 10,121 –1,273,999 171,335

PATENT PROTECTION FINANCIAL

OVERVIEW

FINANCIAL INFORMATION

Consolidated cash flow statement

Amounts in SEK thousand 2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Cash flow from operating activities
Profit/loss for the period before tax –70,502 –91,011 –167,907 –149,408 –388,172
Adjustments for items not included
in cash flow
–968 8,565 13,243 18,462 100,650
Paid income taxes
Total –71,470 –82,446 –154,664 –130,947 –287,522
Increase (–)/Decrease (+)
of inventory
–52,535 –41,474 –132,963 –44,949 –56,596
Increase (–)/Decrease (+)
of trade and other receivables
–89,355 –112,852 –60,869 –133,034 –85,132
Increase (+)/Decrease (–)
of trade and other payables
113,829 93,292 135,758 108,787 22,572
Cash flow from current operations –99,531 –143,479 –212,738 –200,143 –406,678
Of which discontinued operations −109 –254 –289 –489 –645
Cash flow from investing activities
Acquisition of property,
plant and equipment
–544 –501 –6,428 –6,791
Acquisition of intangible assets –10,547 –10,547 −9,978 –9,978
Cash flow from investing activities –10,547 –544 –11,048 −16,406 –16,769
Of which discontinued operations
2024 2023 2024 2023 2023
Amounts in SEK thousand Apr – Jun Apr – Jun Jan – Jun Jan – Jun Full year
Cash flow from financing activities
Stock options redeemed by staff 18
New share issue 120,000 337,242 120,000 120,000
Issue expenses –19,930 –962 –37,479 –962 –962
Loans taken out 225,000 50,000 225,000 225,000
Costs of loans taken out –3,075 –3,075 –10,617
Amortization of loans –62,499 –112,499 –20,833
Amortization of lease liability –3,539 –2,466 –7,204 –4,895 –13,909
Cash flow from financing activities –85,967 338,498 230,060 336,068 298,696
Of which discontinued operations
Cash flow for the period –196,045 194,474 6,275 119,519 –124,752
Cash and cash equivalents
reported in assets held for sale
–877 –1,405 –877 –1,405 –1,166
Cash and cash equivalents at
beginning of period
269,757 118,746 65,402 193,994 193,994
Cash and cash equivalents at
beginning of period (reported
in assets held for sale)
1,062 1,597 1,166 1,811 1,811
Exchange rate differences
in cash and cash equivalents
–1,062 2,228 869 1,721 –4,485
Cash and cash equivalents
at end of period
72,835 315,640 72,835 315,640 65,402

FINANCIAL INFORMATION

Income statement, Parent company

PORTFOLIO

Income statement and other comprehensive income, Parent company

Amounts in SEK thousand 2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Revenues 52,034 51,116 66,103 112,945 238,729
Cost of goods sold 13,385 –39,362 8,632 –85,945 –203,341
Gross profit 65,419 11,754 74,735 27,000 35,388
Other operating income 814 3,249 6,051 7,269 13,707
Administrative expenses –9,824 –11,675 –21,296 –24,030 –41,684
Research and development
expenses
–116,444 –87,425 –204,229 –145,482 –306,299
Other operating expenses –4,271 –5,012 –5,370 –11,637 –25,445
Operating profit/loss –64,306 –89,109 –150,109 –146,881 –324,332
Financial items
Impairment loss on shares in
subsidiary
–70,300
Financial expenses –5,756 –1,357 –16,894 −1,332 2,887
Net finance costs –5,756 –1,357 –16,894 –1,332 –67,413
Profit/loss before tax –70,061 −90,467 –167,003 –148,212 –391,745
Tax
Profit/loss for the period –70,061 −90,467 –167,003 −148,212 –391,745
Amounts in SEK thousand 2024
Apr – Jun
2023
Apr – Jun
2024
Jan – Jun
2023
Jan – Jun
2023
Full year
Profit/loss for the period –70,061 –90,467 –167,003 –148,212 –391,745
Other comprehensive income
Comprehensive income
for the period
–70,061, –90,467 –167,003, –148,212 –391,745

PORTFOLIO

OVERVIEW

FINANCIAL INFORMATION

Balance sheet, Parent company

Amounts in SEK thousand 06-30-2024 06-30-2023 12-31-2023
ASSETS
Fixed assets
Intangible assets 104,781 106,496 99,670
Property, plant and equipment 28,361 36,792 32,537
Financial assets
Shares in group companies 3,766 74,066 3,766
Other non-current receivables 3,945 3,945 3,945
Total financial assets 7,711 78,011 7,711
Total non-current assets 140,853 221,300 139,919
Current assets
Current receivables
Inventory 214,324 95,209 106,856
Accounts receivables 15,902
Other receivables 97,801 77,824 34,213
Prepaid expenses and accrued income 250,252 254,187 254,069
Total current receivables 578,278 427,220 395,139
Cash and bank 72,835 315,640 65,402
Current assets 651,113 742,860 460,541
TOTAL ASSETS 791,966 964,159 600,459
Amounts in SEK thousand 06-30-2024 06-30-2023 12-31-2023
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 342,889 6,550 6,683
Reserve for development expenditure 104,781 105,107 99,670
Unrestricted equity
Share premium 1,393,350 1,414,140 1,428,530
Retained earnings –1,366,047 –974,628 –969,191
Profit/loss for the period –167,003 –148,212 –391,745
TOTAL EQUITY 307,970 402,956 173,947
Long-term liabilities
Long-term interest-bearing liabilities 88,572 145,452 112,897
Long-term non interest-bearing liabilities 14,982 8
Total long-term liabilities 88,572 160,434 112,905
Current liabilities
Short-term interest-bearing liabilities 31,250 62,012 62,500
Liabilities to subsidiaries 1,052 1,094 1,032
Accounts payables 93,183 34,247 30,974
Other current liabilities 2,083 2,933 2,807
Deferred income and prepaid revenue 267,855 300,482 216,296
Current liabilities 395,423 400,769 313,608
TOTAL LIABILITIES 483,995 561,203 426,512
TOTAL EQUITY AND LIABILITIES 791,966 964,159 600,459

FIRST PAGE CEO'S LETTER PRODUCT CANDIDATE PORTFOLIO

PATENT PROTECTION FINANCIAL

OVERVIEW SHAREHOLDERS INFORMATION

FINANCIAL INFORMATION

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 in other parts of this interim report.

NOTE 2 Revenue from contracts with customers
-------- -- -- ---------------------------------------
Amounts in SEK
thousand
2024
Apr–Jun
2023
Apr–Jun
2024
Jan–Jun
2023
Jan–Jun
2023
Full year
Net sales
Outlicensed
products
27.2 14.1 27.2 28.2 28.4
Product sales 21.7 37.0 35.7 84.6 209.5
Contract
manufacturing
0.0
Other 3.1 0.0 3.2 0.1 0.9
Total 52.0 51.1 66.1 112.9 238.7
Of which
North America
14.1 28.2 28.7

The Group's revenue consisted primarily of revenue from product sales from Ximluci®.

NOTE 3 Transactions with related parties

STADA Arnzeimittel AG has been a shareholder in Xbrane since 2019 (see list of owners on page 6). Related party transactions with STADA refer to cost sharing for the cooperation agreement with Ximluci®.

NOTE 4 Inventory

Amounts in SEK thousand 2024-06-30 2023-06-30 2023-12-31
Goods in progress 214,324 95,209 106,856
Finished goods
Total inventory 214,324 95,209 106,856

Determination of acquisition value of inventory

The acquisition value of assets in inventory is determined, among other things, by using contract prices. Volume discounts or other discounts are included in the cost of inventory when it is probable that they have been earned and will accrue to the Company.

See Note 1 for the Group's other accounting principles regarding inventories.

Reported amounts in the income statement

During the 2024 financial year, the cost of goods sold has been reported in the income statement as SEK 8,632 thousand (2023 SEK –85,945 thousand). The inventory includes a reserve for obsolete goods of SEK –3,195 thousand (2023 SEK –1,025 thousand). The inventory has not been written down.

NOTE 5 Convertible debentures

On May 26, 2023, Xbrane issued convertible bonds with a nominal value of SEK 250 m. The debentures mature on May 26, 2027, if they have not been amortized or converted to shares at the holder's request before then. The debt is amortized in twenty-four equal installments during the term of the debenture. Xbrane can choose to settle the amortization with cash payments or in shares at 90% of the market price (lowest VWAP during the six trading days before the payment date). The holder of the debenture has the right to advance up to two amortization payments per interest period. The interest rate amounts to 6% until formal approval by the United States Food and Drug Administration (FDA) of the company's application in connection with its biosimilar candidate for trial to Lucentis® (ranibizumab), thereafter the interest rate is 0%. The conversion rate amounts to 125% of the offer price at the time of issue. The conversion rate may be adjusted in the event of capital restructuring. In the balance sheet as of June 30, 2024, the convertible debentures are reported as interest-bearing loans amounting to SEK 119.8 m and SEK 0.0 million as derivatives in the item long-term non-interest-bearing liabilities. The nominal value of the liability amounted to SEK 156.2 m as of June 30, 2024.

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 August 28, 2024

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

Alternative performance measures

The Company presents certain financial measures in the interim report that are not defined in accordance with IFRS. The Company believes that these measures provide valuable supplementary information to investors and the Company's management as they enable evaluation of the Company's performance. Since not all companies calculate financial measurements in the same way, these are not always comparable to measurements used by other companies. These financial measures should therefore not be seen as replacement for measures that are defined in accordance with IFRS. The tables below show measurements 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
2024
Apr–Jun
2023
Apr–Jun
2024
Jan–Jun
2023
Jan–Jun
2023
Full year
Gross profit 65,419 11,754 74,735 27,000 35,388
Gross margin 126% 23% 113% 24% 15%

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
2024
Apr–Jun
2023
Apr–Jun
2024
Jan–Jun
2023
Jan–Jun
2023
Full year
Operating
profit/loss
–63,665 –88,646 –148,803 –145,920 –322,164
Depreciation
and impairment
8,954 7,594 18,053 16,454 33,736
EBITDA –54,711 –81,052 –130,750 –129,466 –288,428

Research and development expenses

as a percentage of operating expenses

The company's direct costs for research and development relate to personnel, materials and external services costs. Research and development expenses as a percentage of operating expenses show the proportion of operating expenses relating to research and development. This is calculated by dividing research and development expenses by total operating expenses. Total operating expenses comprise of selling and distribution expenses, administrative expenses, research and development expenses and other operating expenses.

Amounts in
SEK thousand
2024
Apr–Jun
2023
Apr–Jun
2024
Jan–Jun
2023
Jan–Jun
2023
Full year
Research and
development
expenses
–116,310 –87,327 –203,936 –145,254 –305,783
Operating
expenses
–129,899 –103,648 –229,589 –180,188 –371,259
Research and
development
expenses as a
percentage of
operating
expenses
90% 84% 89% 81% 82%

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 ability to pay, i.e., equity through total assets.

Amounts in SEK thousand 06-30-2024 06-30-2023 12-31-2023
Total equity 304,536 399,988 171,335
Divided by total assets 837,185 998,710 653,508
Equity ratio 36% 40% 26%

INFORMATION

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.

FINANCIAL CALENDAR

Interim report January–September 2024 October 24, 2024
Interim report January–December 2024 February 21, 2025
Annual Report 2024 March 31, 2025
Annual General Meeting May 2, 2025

FOR FURTHER INFORMATION

Martin Åmark,

CEO [email protected] + 46 76-309 37 77

Anette Lindqvist,

CFO/IR [email protected] +46 76-325 60 90

www.xbrane.com

FIRST PAGE CEO'S LETTER PRODUCT CANDIDATE

PORTFOLIO

PATENT PROTECTION FINANCIAL

OVERVIEW SHAREHOLDERS FINANCIAL INFORMATION

INFORMATION

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.

Xbrane Biopharma AB Retzius väg 8, 171 65 Solna, Sweden | www.xbrane.com

This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the CEO, at 08-28-2024 08.00 CET.

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