Slides
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Presenters
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Ximluci® launched by STADA in 24 countriesXimluci® – Launched across 24 countries Global generics and biosimilar specialist with sales in over 100 countriesSales: EUR 4,059m (2024)Employees: 11,649 (2024)Partnership with STADA signed in 2018. STADA are granted the commercial rights to Ximluci® globally including Europe, the US, several countries in the Middle East and North Africa and selected markets in Asia Pacific. Xbrane retains responsibility for development. Economics & Mechanics1.Xbrane produce Ximluci® basis STADA forecasts (12-month binding / semi-binding)2.Xbrane sells Ximluci® to STADA at cost as per forecast3.STADA sells Ximluci® in launched markets4.Xbrane receives its share of profit contribution after production and S&M expenses every quarterSTADA Activities & CommitmentDedicated biosimilars team within STADA global speciality careDedicated KAMs to target KOLs / compoundersDedicated ophthalmology field force for specific marketsExperienced local tender teams in all countries for bidding and participation in key tendersXimluci® is the sixth approved biosimilar in STADA’s specialty care portfolio. Strong track record of commercializing biosimilars: Co-Development & Commercialization Partnership with STADAUp-frontEUR 7.5mMilestones / cost-coverageEUR 40-50mProfit Sharing50% of EBITDAAdditionally launched in Bahrain, UAE, Uzbekistan and Iraq
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Ximluci® addressable market in Europe is €5 billion Europe retinal anti VEGF: EUR 5 billion marketCommentaryEurope retinal anti VEGF market at €5 billion in 2024 with approx. 7 million units (excl off label Avastin) shippedVolume growth of 7% p.a. and value growth of 5.5% p.a. last 3 yearsParticularly Vabysmo take market share in the overall retinal anti VEGF market as perceived as more durable treatment option compared to ranibizumab and afliberceptEylea biosimilars to be launched Nov 2025Significant usage of off-label Avastin, at lower cost. First Avastin biosimilar, Lytenava (Outlook), launched in select countriesRanibizumab market approx. €0.8 billion and 1.3 million units shipped annuallyXimluci one out of four Lucentis (ranibizumab) biosimilars launched in Europe Source: GM Insights – Anti-VEGF Therapeutics Market 2025; Samsung Bioepis Biosimilar Market Report; Company estimates. Note: (*) Average Sales Price, calculated as the revenue for units sold per quarter divided by the units sold per quarter. RanibizumabVabysmoAvastin (off-label)0%20%40%60%80%100% Europe retinal anti VEGF market 2024 € 5 billionEylea
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Ximluci® – Currently at 8% volume market share in Europe Note: (*) Average quarterly growth over last four quarters.; (**) Scenario table assumes average NSP and profitability on Ximluci® during 2024. Profit split to Xbrane and growth in vials sold by STADACommentary Volume constant Q3 2025 vs. Q2 2025. Ximluci® share of ranibizumab market across launched countries in Europe was 8.0% by volume in August 2025, i.e. constant market share since May 2025. Ximluci market leader amongst biosimilars in Italy and Germany.Total profit generation by Xbrane since launch of SEK 115 m (SEK 85m paid in cash). Variability in quarterly profit generation dependent on if shipment of finished goods to Stada took place during quarter or not, as revenue recognition done on shipment Current inventory with value of SEK 170m to be converted into cash during H2 2025-2027 as more product is delivered to STADA
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Xbrane & STADA partner with ValorumLucamzi – delay in FDA approval Biosimilar commercialization specialist founded by several industry veterans Johnson & Johnson, Merck and Roche. Xbrane and STADA license US commercial rights to Valorum Biologics. Valorum will be responsible for sales, marketing and commercial efforts in the US after approval. STADA are responsible for completing the regulatory approval process. Xbrane are responsible for commercial manufacturing and supply. Economics & Mechanics1.Xbrane produce Lucamzi on basis of Valorum forecast (2 years binding/semi-binding)2.Xbrane sell Lucamzi to Valorum with double-digit mark-up as per forecast3.Valorum sells Lucamzi in US4.Xbrane receives its share of royalty in line with agreement on quarterly basisValorum Activities & CommitmentCurrent activities that Valorum are engaging in for swift launch upon approval:Set up commercialisation teamMarket Lucamzi to key accounts (mainly larger PE owned retinal chains)Apply for Q-code (post approval)Contract distributors and list product with Medicare and private insurance companies CRL received on October 17thdue to unresolved observations at one of the manufacturing sitesFurther communication expected from FDA directly to the site with more clarity on which specific actions required prior to approvalBest case re-submission Q1 2026 with expected BsUFA date Q3 2026 US Commercialization PartnershipFDA statusMilestones Upon regulatory approval & launchRoyaltieson net sales of Lucamzi , shared equally by STADA & XbraneSupplyXbrane to supply Lucamzi at a double-digit mark-up to COGS
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Xdivane is one out of four biosimilars in clinic addressing $14 billion of originator sales with US patent expiry late 2028 8,19140510152022 2023 2028USD, billionOpdivo® expected to generate net-sales of $14b globally in 2028Landscape & Commentary Opdivo is an immuno-oncology drug (PD1 inhibitor) used in treatment of several cancers including melanoma and lung cancerThe total global market for PD1/PDL1 inhibitors is estimated to €40bnOpdivo is the first PD1 inhibitor to lose exclusivity (Dec 2028 in US/June 2030 in Europe) creating an opportunity for Opdivo biosimilars to take market share from other novel PD1/PDL1sXdivane is one out of 4 biosimilars to Opdivo in in clinic targeting US and day one launchSandoz, Amgen and Boan Biotech have biosimilar candidates currently undergoing clinical trialExpected uptake by BMS Opdivo follow on product Opdualag(combination of nivolumab and relatlimab) reduced due to recently failed Phase 3 in stage III-IV melanoma Source: BMS annual reports, Global Data
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2030202920282027202620252024Xdivane – Clinical trial initiated and program on track towards day 1 launchLoE USLoE EuropeSuccessful scale-up to commercial scaleConformed analytical similarity at scaleScientific advice meetings with EMA and FDACMC development for the intravenous formulation (ongoing) Commercialization Production of clinical materialPivotal clinical trialSingle pivotal trial with ~340 patientsPrimary end-point: Comparative pharmacokineticsSecondary end-points: safety and immunogenicityNo confirmatory efficacy analysis needed (as required in traditional Phase 3 for a biosimilar)EMA and FDA endorsed clinical development planSupported by comparative analytical assessment with minimal residual uncertaintyMAA / BLAIntas overall responsible for regulatory processPositive indications from EMA/FDA on comparative analytical assessmentManufacturing partner for both drug substance and product a global top 3 CMO with production sites already approved by FDA Intas have 5 biologics approved in EU and 2 in the USXdivane is positioned to launch at patent expiration of Opdivo® (US – December 2028, EU – June 2030) Milestone payment to XbraneMilestone payment to Xbrane
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Xdivane – +1 billion SEK annual profit sharing potential for Xbrane US biosimilar volume market share vs. reference productProfit share scenario table basis claimed Opdivo market share*13%15%19%Claimedmarket shareby volume70%55%40%Discount to orignator1,0002,0003,000Estimatedprofit share to Xbrane (SEK, million) ASP trend by moleculeSource: Samsung Bioepis Biosimilar Market Report. Note (*): Assumptions include annual Opdivo sales of USD 14 billion at time of patent expiry, with biosimilars taking 75% of Opdivo volume at year 3. COGS are assumed basis current manufacturing partner and maximum sales and marketing allowances, as per agreement with Accord. Commentary Oncology biosimilars have been well received with average penetration of 75% at year 3 post launch in US Sold via hospital channel in US under Medicare Part B reimbursement scheme with strong incentive to select biosimilar (e.g. +8% originator ASP vs. 6% for originator) Accord has strong track record in oncology biosimilars: 39% market share in US peg-filgrastim market (via acquired franchise from Coherus)30% market share across oncology injectables in Europe
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* In accordance with the payment agreement between Xbrane and its three biggest suppliers the accounts payable accumulated during 2024 were finally settled in July 20256240-19-22-91-49-11-27-51894Cash flow chart Q3-25
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Cash and Cash Equivalents Operating Cash Flow
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