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Orexo : Q1 2026 Interim Report MASTER
Orexo : Q1 2026 Interim Report
About this update from Orexo Ab
Q1 2026 Interim report April 28, 2026 Well positioned to advance pipeline to value inflection points Well positioned to advance pipeline to value inflection points The sale of Zubsolv® US continues to impact the balance sheet and P&L Redemption of the corporate bond Payment of rebates and returns related to 2025 and earlier sale of Zubsolv Restructuring of the organization Transaction related fees and costs Cash: SEK 334 m excl. SEK 52 m attributable to Dexcel Successful transition after Zubsolv US divestment Development programs making steady progress Exploring new applications of AmorphOX® 3 >30 yrs of experience developing improved pharmaceuticals based on proprietary drug delivery technologies. - largest shareholder at 26 % SEK 334 m Cash position March. 31 2026 3 strategic focus areas to maximize value of the Amorph OX technology EXPLORE New applications of the AmorphOX® technology are key to unlocking substantial future value creation and partnership generation DEVELOP Proprietary projects drive greater value capture and renewed commercialization opportunities for Orexo, either standalone or together with a partner PARTNER Power partners' proprietary projects with the AmorphOX technology 4 Preclinical PK study : Intranasal semaglutide formulated by AmorphOX vs oral formulation Expanding the nasal semaglutide program to incl. oral delivery GLP-1 semaglutide (nasal delivery): Exploratory formulation work progressed to improve bioavailablilty, supporting continued in-vivo evaluation AmorphOX® - oral semaglutide delivery : Initiated formulation development of an oral semaglutide tablet ahead of a planned preclinical in-vivo proof-of-concept study in H2 2026. In addition, multiple patent applications filed. Vaccine project (nasal delivery): Focused on expanding the evidence base through potential collaboration with Abera Bioscience and additional industry and academic partners. AmorphOX formulations Oral tablet 1 Semaglutide stability at 40°C/75% RH Semaglutide content (%) 100 80 60 40 20 Note: Rybelsus® is a registered trademark of Novo Nordisk A/S 1. Exposure of AmorphOX formulations were lower than injectable reference. 0 0 1 3 6 Months EXPLORE 5 DEVELOP Proprietary programs advanced to potential inflection points Izipry continued to progress stability and reliability studies. NDA resubmission to the FDA is planned for Q3 2026. OX640 accelerated its commercial-scale manufacturing readiness ahead of entering pivotal clinical studies. Also Human Factors studies were initiated. First in-vivo study conducted for OX390 , with data read-out in Q2 2026. Type C meeting planned with BARDA 1 for in 2026 with focus on non-clinical plan. 1 BARDA contributes with the majority of the financing of the project and is valued up to USD 51 m. Upon a potential approval Orexo owns all rights to the product. 6 IZIPRY approaching FDA resubmission in Q3 2026 IZIPRY is based on AmorphOX ® and designed to treat overdoses caused by synthetic opioids, such as fentanyl and fentanyl analogues Orexo will seek partnership for US commercialization PARTNER 7 Scale and commercialize through strategic collaborations The AmorphOX technology has applications beyond what Orexo can pursue independently. Significant opportunities exist in development-stage products facing challenges with stability and/or bioavailability. Orexo collaborates with both smaller and larger companies to assess the feasibility of applying AmorphOX® to their products or APIs. The ambition is to expand this project portfolio beyond early-stage feasibility studies. Income statement Income statement SEK m Q1 2026 Q1 2025 Jan - Dec 2025 Comments Q1 Net revenues 5.0 13.2 26.0 Cost of goods sold (COGS) -0.5 -4.7 -14.5 Gross Profit 4.6 8.5 11.5 Operating Costs -79.5 -84.7 -364.3 EBIT -75.0 -76.3 -352.7 Net financial items -29.2 -14.1 -50.3 EBT -104.2 -90.3 -403.0 Net revenues SEK 5 m (13.2) Lower Abstral ROW royalties due to expiring markets in line with the license agreement Higher Edluar royalties mainly due to higher partner sales in Canada. Lower Zubsolv ex-US revenues reflecting the absence of tablet sales to Orexo's partner Accord Healthcare while finalizing their Zubsolv manufacturing setup OPEX SEK -79.5 m (-84.7): Lower Selling expenses due to lower marketing related costs for Izipry , DMHP activities and for positive adjustment for long-term incentive programs Higher Admin expenses explained by higher expenses for DOJ investigation Higher R&D costs due to higher costs for OX640 and OX390 partly offset by lower internal costs Tax -1.0 -0.3 -0.3 Net profit/loss for continued operations -105.2 -90.6 -403.3 Higher Other operating income and expenses explained by higher BARDA reimbursement of OX390 related costs of SEK 7.1 m (0.0), higher fx gains partly offset by lower insurance reimbursement of DOJ investigation related legal expenses. EBIT SEK -75.0 m (-76.3) Net financial items operations SEK -29.2 m (-14.1): Net profit/loss for discontinued operations -28.7 74.7 1,042.6 Net profit/loss -133.9 -15.9 639.3 EBITDA continued operations -66.1 -65.2 -285.7 Higher bond loan costs of SEK -32.9 m (-11.5) following the early redemption of the outstanding senior secured social bond and by lower negative unrealized fx impact partly offset by higher interest income from bank accounts Net profit/loss SEK -105.2 m (-90.6) Net profit/loss discontinued operations SEK -28.7 m (74.7): Mainly explained by post transaction related restructuring costs 8 Cash position Cash flow SEK m Q1 2026 Q1 2025 Jan - Dec 2025 Cash flow from operating activities -33.3 -41.6 -195.4 Comments Q1 Investment activities -0.2 -19.2 -19.2 Financing activities -494.3 -5.9 -2.3 Cash flow (excl. exchange rate differences) continued operations -527.9 -66.7 -216.9 Cash flow (excl. exchange rate differences) discontinued operations -7.5 73.4 1,023.5 Exchange-rate differences in cash and cash equivalents 9.2 -10.8 -17.5 Cash and cash equivalents at the beginning of the period 912.4 123.3 123.3 Cash and cash equivalents at the end of period 386.2 119.1 912.4 Cash and cash equivalents Orexo 333.8 119.1 912.4 Cash and cash equivalents payable to Dexcel 52.3 - - Net cash position 386.2 -341.7 429.7 Cash and cash equivalents decreased with SEK 526 m from Q4 2025 (SEK 912 m) to SEK 386 m SEK 490 m negative impact on financing activities from amortization of the outstanding bond SEK 33.3 m negative contribution from operating activities primarily impacted by: Operating earnings of SEK -75.0 m Interest and other financial expenses paid of SEK -26.9 m mainly due to early redemption of the bond loan Adjustments for non-cash items of SEK -96.0 m mainly due to change in provisions -109.1 m from paid Zubsolv payer rebates Positive changes in working capital of SEK 161.5 m positively impacted by receivables SEK +164.9 m from collected Zubsolv sales related 2025 receivables partly offset by current liabilities SEK -3.4 m Cash flow SEK from continued operations SEK -527.9 m Cash flow from discontinued operations SEK -7.5 m (73.4) for the period mainly including post transaction related restructuring costs 9 Legal update Subpoena issued by the US authorities in 2020 On July 14, 2020, Orexo became aware of an investigation by the US authorities which is ongoing Based on communications from the US authorities, the company believes it refers to certain historic marketing messaging campaigns Orexo, as of this date, is not aware of any filed civil or criminal case related to the investigation Orexo´s position is that Zubsolv® has been promoted in a compliant and responsible manner, but Orexo is also seeking to negotiate a resolutions to this matter Change in administration may slow down process due to US process of politically appointed US prosecutors. 10 Value opportunities short, medium and long term 2026 2027 2028 2029 and beyond Launched products Izipry TM OX640 Zubsolv® EU • Zubsolv US earn-out Q3 FDA refiling • Q1 FDA approval Partnering Q4 pivotal trial start • H1 trial results Start final pivotal trials Zubsolv US earn-out Outcome final pivotal trials FDA / EMA submission 2029 FDA / EMA approval OX390 Q2 in-vivo study results BARDA financing stage 2 Conclusion of non-clinical program Continued clinical studies, FDA review process, submission and approval Explore GLP-1 Partnering is a continuous process for all projects without specific target dates agonist / vaccines Additional in-vivo studies First human studies (if in-vivo are successful) Development plan • Continued clinical studies, FDA review process, submission and approval 11 12 Q&A Financial Calendar May 7, 2026, 4 pm July 16, 2026, 7 am Oct. 22, 2026, 7 am Feb. 4, 2027, 7 am Annual General Meeting Interim Report Q2 2026 Interim Report Q3 2026 Interim Report Q4 2026, incl. Full Year Report BD & Scientific Conferences May 10, 2026 June 22-25, 2026 Sep. 16 -17, 2026 D. RDD 2026, Phoenix, AZ BIO International San Diego, CA IPAC-RS 2026 Nasal Innovation Forum Orexo is headquartered in Uppsala, Sweden, with a US subsidiary in New Jersey. The company has been listed on Nasdaq Stockholm's main market since 2005 (STO: ORX) and trades as ADRs on the OTCQX market in the US (OTCQX: ORXOY). Thanks https://www.orexo.com [email protected] Attention : This is an excerpt of the original content. To continue reading it, access the original document here .