Orexo Ab · OMXSTO:ORX
Orexo Ab — Investor Day (March 2026)
65 slides from Orexo Ab's investor day presentation, Mar 24, 2026
Slide 1: R&D Day March 24 2026
Roote R&D Day march 24 2026 in science, proven in amorph market’. > -.
Slide 2: Management team leading a streamlined organization with presence in Sweden and the US
R&D DAY – LEADERSHIP TEAM 2 Management team leading a streamlined organization with presence in Sweden and the US Employees after Zubsolv® US transition: ~55 5 Nikolaj Sørensen President and CEO Fredrik Järrsten Cecilia Coupland Ed Kim Lisa Moore EVP CFO & Business Robert Rönn SVP Product & Develo
Slide 3: Agenda
R&D DAY 2026 – AGENDA 3 Agenda 9.00-9.30 9.30-9.45 Strategy & value creation Nikolaj Sørensen, President and CEO Registration & Breakfast 9.45-10.00 AmorphOX® platform insights Robert Rönn, SVP Head of R&D/ Cecilia Coupland, SVP Head of Operations 10.00-10.15 AmorphOX® expansion & partnerships Lis
Slide 4: Legal disclaimer
R & D D AY 2 0 2 6 – D I S C L A I M E R 4 Legal disclaimer • This presentation, which is personal to the recipient, has been prepared and produced by Orexo AB (publ) (“Orexo”) solely for the benefit of investment analysis and may not be used for any purpose other than assessment of investments co
Slide 5: Shaping Orexo's future: Strategic priorities and value creation
5 Shaping Orexo’s future: Strategic priorities and value creation Nikolaj Sørensen President and CEO Rooted in science, proven in market
Slide 6: Sale of Zubsolv enables a transformation of Orexo
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 6 Sale of Zubsolv enables a transformation of Orexo Divestment of Streamlining the Transformation Zubsolv® US rights operations Zubsolv US rights sold to Dexcel Restructure organization Drive global leadership in amorphous • USD 91 m • Stepwise
Slide 7: Building a new company on a strong heritage
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 7 Building a new company on a strong heritage… 4 drugs developed Heritage in numbers Markets with approval Long experience from partnering from idea to market¹ > 25 1. Of which three are develop based on the first-generation drug dilivery platf
Slide 8: A promising development pipeline and established commercial products
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 8 …and a promising development pipeline and established commercial products Technology Partnership Preclinical Clinical Registration Approved Development program Exploratory/ OX472 GLP-1 agonist, semaglutide Large molecules Vaccine, influenza O
Slide 9: With 8 years of research the AmorphOX technology is the foundation of Orexo
With 8 years of research the AmorphOX® technology is today the foundation of Orexo
Slide 10: 3 strategic focus areas to maximize value of the AmorphOX technology
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 10 3 strategic focus areas to maximize value of the AmorphOX technology New applications of the AmorphOX® technology are EXPLORE key to unlocking substantial future value creation DEVELOP Proprietary projects drive greater value capture and ren
Slide 11: New applications of AmorphOX key to unlock substantial future value
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 11 New applications of AmorphOX key to unlock EXPLORE substantial future value Explore new AmorphOX® applications • From incremental gains to transformative drug delivery Status: promising start • New applications driving projects, partnerships
Slide 12: Proprietary projects with greater value capture and renewed commercialization opportunities
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 12 Proprietary projects with greater value DEVELOP capture and renewed commercialization opportunities Zubsolv® transaction supports funding to key value inflection points Status: Approaching FDA filings in • Izipry progressed to approval to re
Slide 13: AmorphOX with potential beyond Orexo's capacity and access to molecules
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 13 AmorphOX with potential beyond Orexo’s PARTNER capacity and access to molecules Partner the AmorphOX® technology • Rapid feasibility testing enabled by a broad, validated molecule library Status: expanding the reach • Applicable to both prop
Slide 14: Several value opportunities short, medium and long term
R&D DAY - STRATEGY & VALUE CREATION 14 Several value opportunities short, medium and long term 2026 2027 2028 2029 and beyond Launched • Zubsolv® EU • Zubsolv US earn-out • Zubsolv US earn-out • Q3 FDA filing • Q1 FDA approval IzipryTM • Partnering OX640 • Q4 pivotal trial start • H1 trial results
Slide 15: Building global leadership in amorphous drug delivery
R & D D AY - S T R AT E G Y & VA L U E C R E AT I O N 15 Ideasleadership Global For Vision And Mission Ppt Presentations and growth Company key Building global leadership in amorphous drug delivery objectives Strategic pillars to reach key objectives Drive global leadership in amorphous Advance pr
Slide 16: AmorphOX: A unique opportunity to transform drug delivery of biomolecules
16 AmorphOX: A unique opportunity to transform drug delivery of biomolecules in an established scalable commercial supply chain. Robert Rönn SVP Head of R&D Rooted in science, proven in market Cecilia Coupland SVP Head of Operations
Slide 17: From product idea to next-generation drug delivery technology
R & D D AY - A M O R P H OX ® P L AT F O R M I N S I G H T S 17 From product idea to next-generation drug delivery technology – AmorphOX Rapid onset and Highly stable formulation IZIPRY high bioavailability 100% (amount of API) Medical Hypothesis: development Technology need: Nasal Naloxone Spray-
Slide 18: The foundation of AmorphOX: Structure, process and IP
R & D D AY - A M O R P H OX ® P L AT F O R M I N S I G H T S 18 The foundation of AmorphOX: Structure, process and IP Powder consisting of Manufactured by spray- Extensive IP protection amorphous composite drying particles Control of particle size Numerous patents and patent Unique combinati
Slide 19: Differentiating attributes of the AmorphOX platform
R & D D AY - A M O R P H OX ® P L AT F O R M I N S I G H T S 19 Differentiating attributes of the AmorphOX® platform A versatile, modality-agnostic drug Rapid absorption and high delivery platform bioavailablity Small molecules, peptides, proteins and vaccines Supersaturation at site of absorp
Slide 20: Enabling tailored formulation and product development with AmorphOX
R&D DAY - AMORPHOX® PLATFORM INSIGHTS 20 Enabling tailored formulation and product development with AmorphOX Leveraging the AmorphOX® design space to tailor formulations for each API Final Medical Formulation Final API commercial need / TPP candidate formulation product Analysis of In-vivo Process
Slide 21: Spray-drying manufacturing built for scale
R & D D AY - A M O R P H OX ® P L AT F O R M I N S I G H T S 21 Rapid early development enabled by in-house lab-scale spray-drying for clinical materials Robust, scalable spray-drying process with established commercial design space at Orexo’s CMO Proprietary Orexo know-how used to design pl
Slide 22: AmorphOX: Moving beyond nasal delivery in GLP-1s and expanding into new areas
22 AmorphOX: Moving beyond nasal delivery in GLP-1s and expanding into new areas with significant market needs through preclinical innovation, and strategic partnerships. Lisa Moore SVP Product and Portfolio Strategy Rooted in science, proven in market Robert Rönn SVP Head of R&D
Slide 23: AmorphOX technology applications advance when four key requirements are met
R&D DAY 2026 – AMORPHOX® EXPANSION & PARTNERSHIPS 23 AmorphOX® technology applications advance when four key requirements are met • Fulfill a commercial imperative for a manufacturer • Fulfill a strong unmet need for a patient, healthcare professional, or payer • Allow for differentiated enablemen
Slide 24: A disciplined triage engine drives identification of top priority AmorphOX use cases
R & D D AY 2 0 2 6 – A M O R P H OX ® E X PA N S I O N & PA R T N E R S H I P S 24 A disciplined triage engine drives identification of top priority AmorphOX use cases Use cases tested in interviews with experts and industry representatives 1 Use case prioritization approach Long list of potential
Slide 25: AmorphOX-formulated GLP-1s unlock new possibilities for patients and customers
R & D D AY 2 0 2 6 – A M O R P H OX ® E X PA N S I O N & PA R T N E R S H I P S 25 AmorphOX-formulated GLP-1s unlock new possibilities for patients and customers ~2.5 b Adults globally who are overweight1 • Provides a more convenient RoA than injectables with ~890 m Adults globally living with obe
Slide 26: Preclinical PK study: Intranasal semaglutide formulated by AmorphOX vs oral
R & D D AY 2 0 2 6 – A M O R P H OX ® E X PA N S I O N & PA R T N E R S H I P S 26 Preclinical PK study: Intranasal semaglutide formulated by AmorphOX vs oral Promising first data on formulation 10 Orexo’s nasal semaglutide OX472-1 7 mg 5, 5,9.165 9.16 8, 8.505 AmorphOX OX472-2 7 mg 3, 8.08 8 form
Slide 27: Moving beyond nasal GLP-1: Exploring AmorphOX in oral peptide delivery
R&D DAY 2026 – AMORPHOX® EXPANSION & PARTNERSHIPS 27 Moving beyond nasal GLP-1: Exploring the potential of AmorphOX in oral peptide delivery Scientific rationale for AmorphOX® Potential benefits and value • Amorphous supersaturation at site of absorption • Higher bioavailability reduced dose
Slide 28: AmorphOX-formulated thermostable vaccines create new opportunities to transform care
R & D D AY 2 0 2 6 – A M O R P H OX ® E X PA N S I O N & PA R T N E R S H I P S 28 AmorphOX-formulated thermostable vaccines create new opportunities to transform care • Creates a thermostable vaccine for administration as a nasal AmorphOX vaccine: Nasal powder or powder for reconstitution powder
Slide 29: Advancing a new generation of vaccines
R&D DAY 2026 – AMORPHOX® EXPANSION & PARTNERSHIPS 29 Advancing a new generation of vaccines • AmorphOX® is a highly stable delivery platform enabling formulation of sensitive APIs, including vaccines • Eliminating cold chain requirements may improve accessibility and reduce COGS 1 SARS-CoV-2 Spike
Slide 30: OMV Vaccine: Nasal powder vaccine demonstrates potential advantages over liquid
R & D D AY 2 0 2 6 – A M O R P H OX ® E X PA N S I O N & PA R T N E R S H I P S 30 Systemic immune response 3OMV Vaccine: Nasal powder 1,5 IgG Serum vaccine demonstrates potential Absorbance (450 nm) advantages over liquid 1 nasal spray 0,5 0 Formulation Liquid Liquid Powder Powder • Collaboration
Slide 31: Building the evidence base to advance vaccine partnerships
R & D D AY 2 0 2 6 – A M O R P H OX ® E X PA N S I O N & PA R T N E R S H I P S 31 Building the evidence base to advance vaccine partnerships Data generated so far Next steps • Succesful formulation of three different vaccine • Advance ongoing collaboration with Abera types in the AmorphOX platfor
Slide 32: OX640: Advancing a best-in-class nasal epinephrine product
32 OX640: Advancing a best-in-class nasal epinephrine product with improved stability, bioavailability, and patient convenience, supported by accelerated development and scalable manufacturing to meet the needs of severe allergy patients. Lisa Moore SVP Product and Portfolio Strategy Rooted in scien
Slide 33: Large global epinephrine market, growing steadily; strong momentum for needle-free delivery
R&D DAY 2026 – OX640: BEST-IN-CLASS EPINEPHRINE 33 Large global epinephrine market, growing steadily; strong momentum for needle-free delivery systems • 200M+ people globally have life-threatening food allergies1 • ~40M people in US experience Type I allergic reactions2 • Global epinephrine market
Slide 34: First nasal alternative with promising start and high expectations
R & D D AY 2 0 2 6 – OX 6 4 0 : B E S T - I N - C L A S S E P I N E P H R I N E 34 First nasal alternative with promising start and high expectations • Strong sales development in first year with USD 72.2 m net sales revenues in US1 • Ongoing rollout in several countries. Germany market share of c
Slide 35: OX640 aiming for best-in-class nasal epinephrine emergency treatment
R & D D AY 2 0 2 6 – OX 6 4 0 : B E S T - I N - C L A S S E P I N E P H R I N E 35 OX640 aiming for best-in-class nasal epinephrine emergency treatment of severe allergic reactions Differentiated OX640 target product profile vis-à-vis nasal competitors1: • Highly stable: Maintains potency at very l
Slide 36: Solid preliminary PK data from cross-study comparison
R & D D AY 2 0 2 6 – OX 6 4 0 : B E S T - I N - C L A S S E P I N E P H R I N E 36 Solid preliminary PK data1 from cross-study comparison OX640 2mg IM 0.3mg OX640 2mg NAC (dose-scaled) Autoinjector 0.3mg (cross-study comparison) 1. Orexo Data on File. OX640 is investigational and is not approved b
Slide 37: OX640 powered to transform anaphylactic rescue
R&D DAY 2026 – OX640: BEST-IN-CLASS EPINEPHRINE 37 OX640 powered to transform anaphylactic rescue Going from this… … to this Images are for illustrative purposes only.
Slide 38: OX640 uptake will be greatest with those who prioritize portability
R & D D AY 2 0 2 6 – OX 6 4 0 : B E S T - I N - C L A S S E P I N E P H R I N E 38 OX640 uptake will be greatest with those who prioritize portability and reducing patient burden Attribute Enthusiasm Perspectives “I hate needles; they give me so much anxiety. Route of If there was another option,
Slide 39: Next steps: Getting ready to start pivotal program
R&D DAY 2026 – OX640: BEST-IN-CLASS EPINEPHRINE 39 Next steps: Getting ready to start pivotal program Earlier stages CMC and • Finalize scale-up of manufacturing to commercial scale clinical work has been • Test product (incl Instruction for Use) in Human Factor Studies performed using earlier for
Slide 40: De-risking OX640 through proven learnings
R&D DAY 2026 – OX640: BEST-IN-CLASS EPINEPHRINE 40 De-risking OX640 through proven learnings • Final commercial product (FCP) • Izipry manufacturing platform reused produced on commercial lines for for OX640 reliability and verification studies • Izipry human factors inform OX640 • Importance of p
Slide 41: FDA/EMA market approval timeline for OX640
R & D D AY 2 0 2 6 – OX 6 4 0 : B E S T - I N - C L A S S E P I N E P H R I N E 41 FDA/EMA market approval timeline for OX640 FDA/EMA filing 2028 Clinical pediatric PK study1 Clinical Value PK studies - adults Human Factor studies Scale-up manufacturing and transfer to Final commercial site, formu
Slide 42: Orexo's own manufacturing capabilities create a competitive edge in nasal epinephrine
R & D D AY 2 0 2 6 – OX 6 4 0 : B E S T - I N - C L A S S E P I N E P H R I N E 42 Orexo´s own manufacturing capabilities create a competitive edge in nasal epinephrine Rescue products require 99.999% reliability (<1 failure per 100,000) Izipry FDA interactions, manufacturing and supply chain
Slide 43: Break
43 Break Rooted in science, proven in market
Slide 44: OX390: Developing the world's first medical countermeasure
44 OX390: Developing the world’s first medical countermeasure (MCM) to the rising threat from xylazine and medetomidine in collaboration with BARDA, a center within the US Department of Health and Human Services. Edward Kim Chief Medical Officer Rooted in science, proven in market
Slide 45: Xylazine – an emerging public health threat
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 45 Xylazine – an emerging public health threat Veterinary sedative known as “Tranq”, alpha-2 agonist added to illicit opioids: Produces profound sedation, “zombie-like” behavior, severe necrotic sores on sk
Slide 46: Xylazine adulteration of fentanyl is spreading across the US
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 46 Xylazine adulteration of fentanyl is spreading across the US The percentage of fake powder fentanyl and fake fentanyl Xylazine has been identified in seized drug samples in every U.S. pills containing xylazi
Slide 47: Fentanyl-involved deaths with xylazine detected are increasing yearly
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 47 The number of fentanyl-involved deaths with xylazine detected is increasing yearly Male Overall 1.80 per 100K Female 0.03 per 100K Mortality rate per 100K for IMF-xylazine increased 60x between 2018-2023 Zhu
Slide 48: Medetomidine is increasingly being found mixed with fentanyl and xylazine
R&D DAY 2026 – OX390: MEDICAL COUNTERMEASURE PROGRAM 48 Medetomidine (i.e., “rhino tranq”) is increasingly being found mixed with fentanyl and xylazine • Medetomidine’s potency is 200-300 times greater than that of xylazine • According to DEA Office of Forensic Sciences, xylazine remains the numbe
Slide 49: Potential Reason for Increased Lethality
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 49 Potential Reason for Increased Lethality Xylazine may increase Opioid- Induced Respiratory Depression (OIRD) up to 100 times mu-opioid alpha-2 receptors receptors Fentanyl Fentanyl LD50 LD50 131mg/kg 1.3mg/k
Slide 50: The lack of targeted antidotes for alpha-2 agonist exposure is an unmet need
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 50 The lack of targeted antidotes for alpha-2 agonist exposure is an unmet need “Further work toward developing xylazine overdose and blocking treatments is warranted.” Future research should focus on developin
Slide 51: The solution – OX390 (atipamezole) intranasal powder
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 51 The solution – OX390 (atipamezole) intranasal powder Sealed storage Single use tube device
Slide 52: OX390 (atipamezole) – a de-risked human NCE
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 52 OX390 (atipamezole) – a de-risked human NCE α2 antagonist approved as Antisedan® for veterinary use in the US since 1996 • Reverses sedation due to xylazine, medetomidine in animals • Human development Cli
Slide 53: BARDA contract summary – a public-private collaboration
R&D DAY 2026 – OX390: MEDICAL COUNTERMEASURE PROGRAM 53 BARDA contract summary – a public-private collaboration to address a public health threat Contract awarded for base period of September 2025 - March 2027 • Cost-sharing contract valued at USD 8.5 m to cover pre-IND requirements • Four additio
Slide 54: Where we are today
R & D D AY 2 0 2 6 – OX 3 9 0 : M E D I C A L C O U N T E R M E A S U R E P R O G R A M 54 • In-vitro studies completed to optimize formulation • Four formulations selected for preclinical in-vivo PK study (Q2 2026) • Planning the nonclinical program needed for first in human PK study • Storage tu
Slide 55: Expert perspectives: Why countermeasures are needed
55 Expert perspectives: Why countermeasures are needed for the emerging threats from xylazine, medetomidine, and fentanyl combinations. Mark A. Smith PhD Davidson College, NC, US1 Rooted in science, proven in market 1. Recorded interview
Slide 56: Building a viable business model through business development
56 Building a viable business model through business development. Fredrik Järrsten, EVP and CFO, Head of Business Development Rooted in science, proven in market
Slide 57: Business Development is a fundamental element of a viable business model
R&D DAY 2026 – BUSINESS DEVELOPMENT & VALUE MODEL Business Development is a fundamental element of a viable business model Strategic Transformation • Sale of Zubsolv® strengthens financial flexibility and allows Orexo to transition into a Explore AmorphOX® platform- and development driven company
Slide 58: Building on a long track record of partnering experience
R&D DAY 2026 – BUSINESS DEVELOPMENT & VALUE MODEL Building on a long track record of partnering experience, providing additional funding A long history of partnerships... ...incl. transactions with significant financial impact Examples: 2012 Abstral® EU royalties sold for SEK 610 m 2013 Abstral US
Slide 59: Three strategic focus areas diversify Orexo's risk-reward profile
R & D D AY 2 0 2 6 – B U S I N E S S D E V E LO P M E N T & VA LU E M O D E L Three strategic focus areas diversify Orexo’s risk-reward profile Develop Orexo owns projects to be partnered at proprietary value inflection and Orexo can take an projects active role in commercialization Orexo Explore
Slide 60: Partnering at value inflection is a critical source of financing and de-risking
R & D D AY 2 0 2 6 – B U S I N E S S D E V E LO P M E N T & VA LU E M O D E L 60 Partnering at value inflection is a critical source of financing and de-risking • Access to API, know-how, Proof-of-concept based on strong scientific methods EXPLORE in-vivo and first human data • Cost share • Royalt
Slide 61: Short term business development and investment focus on OX640 and Izipry
R & D D AY 2 0 2 6 – B U S I N E S S D E V E LO P M E N T & VA LU E M O D E L 61 Short term business development and investment focus on OX640 and Izipry OX640 and Izipry are in pivotal development stage… … leading to significant investments in 2026-2028 R&D cost level Allocation of R&D investment
Slide 62: Business development is the main source of financing
R&D DAY 2026 – BUSINESS DEVELOPMENT & VALUE MODEL 62 Business development is the main source of financing 1 Zubsolv® divestment of USD 91 m plus earn-out 2 Research contribution from BARDA of up to USD 51 m Financing 3 Royalties from commercial products Zubsolv, Abstral® and Edluar® 4 Future miles
Slide 63: Q&A
63 Q&A ..including closing remarks by Rooted CEO Nikolaj Sørensen in science, proven in market
Slide 64: Building global leadership in amorphous drug delivery
R & D D AY 2 0 2 6 – C LO S I N G R E M A R K S 64 Ideasleadership Global For Vision And Mission Ppt Presentations and growth Company key Building global leadership in amorphous drug delivery objectives Strategic pillars to reach key objectives Drive global leadership in amorphous Advance projects
Slide 65: Thanks
R&D DAY 2026 – THANKS 65 Thanks lunch Rooted in science, proven in market