Slides
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A commercial-stage pharma company, developing drugs through cutting-edge drug delivery technologies June 10, 2025
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2 • 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 concerning Orexo. Unless otherwise stated, Orexo is the source for all data contained in this presentation. Such data is provided as at the date of this presentation and is subject to change without notice. • This presentation does not constitute or form part of, and should not be construed as, an offer or invitation for the sale ofor the subscription of, or a solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any offer, contract, commitment or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of Orexo • The shares of Orexo have not been registered under the U.S. Securities Act of 1933, as amended (the “Securities Act"), and may not be offered or sold in the United States (as such term is defined in Regulation S under the Securities Act) except pursuant to an exemption from, or a transaction not subject to, the registration requirements of the Securities Act or unless registered under the Securities Act. • The information in this presentation has not been independently verified. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained herein. None of Orexo, any of its shareholders, or any of their respective subsidiary undertakings or affiliates or any of such person’s directors, officers or employees, advisers or other representatives, accepts any liability whatsoever (whether in negligence or otherwise) arising, directly or indirectly, from the use of this presentation or otherwise arising in connection therewith. • This presentation includes forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance, achievements or industry results to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this presentation and Orexo expressly disclaim any obligation or undertaking to release any update of, or revisions to, any forward-looking statements in this presentation as a result of any change in our expectations or any change in events, conditions or circumstances on which these forward-looking statements are based. • This presentation is not a prospectus in accordance with the Swedish Financial Instruments Trading Act (Sw. lagen (1991:981) om handel med finansiella instrument) or any other Swedish laws or regulations. Neither the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) nor any other Swedish regulatory body has examined, approved or registered this presentation. Legal disclaimer
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3 Comments Q2 Orexo – rooted in science, proven in market Net Revenue LTM 1 Orexo develops and commercializes improved pharmaceuticals based on proprietary drug delivery technologies, with a strong US presence and global partnerships across multiple therapeutic areas. - largest shareholder at 28 % Committment TeamApproach o Tackling opioid misuse o Advancing drug delivery innovation o Expanding global therapeutic impact. o Home to highly skilled scientists & researchers o Energizing & collaborative workplace o Inclusive & respectful culture for growth. o Commercializing OUD1 treatments in the US o Enhancing known APIs with propritary drug delivery technologies o Partnering globally for development & commercialization in other areas. 30 yrs of experience developing improved pharmaceuticals based on proprietary drug delivery technologies. 1 Opioid use disorder
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4 Orexo facts & figures P&L SEK m Q125 Q124 FY24 FY23 Net revenues (NR) 146.2 139.3 590.0 638.8 of which US Comm. 133.0 129.3 560.3 Gross Profit 125.5 126.0 517.9 550.0 OPEX -130.7 -130.7 -658.2 -659.5 EBIT -5.2 -4.7 -140.3 -109.5 EBITDA 5.9 15.9 48.9 -32.5 SEK m 119 + SEK 30 m invested in own corporate social bond Strong cash generation from US Commercial Q1 2025: Stable Zubsolv sales & postive EBITDA SEK m 5.750 Accrued Net Sales since 2013 from lead product 677.7 Solid financial position 1 SAMHSA Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Useand Health.Center of Disease Control and Prevention. US Joint Economic Committee, data refers to 2020. Financial backboneInnovation by numbers 4 Innovated products of which 3 based on the sublingual platform 5 Clinical trials conducted with > 25 Approved markets 1995 Founded as a drug delivery Co. in Uppsala, Sweden 2000 (helicobacter pylori) reach 1st market approval (insomnia) 1st market approval 2008 2009 (breakthrough cancer) pain reach 1st market approval 2013 for OUD FDA approved and Orexo sets up a US subsidiary 2021 launch of next-generation technology 2025 1 reg. phase & 2 clinical phase rescue medications in pipeline Key milestones Long experience from partnering
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Product or Project/Indication/Technology Exploratory Preclinical Clinical development phases Registration Approved and/or Launched US EU RoW Zubsolv® Opioid Use Disorder (OUD) / Sublingual platform1 Abstral® Breaktrough Cancer Pain / Sublingual platform Edluar® Insomnia / Sublingual platform OX124 Naloxone, Opioid Overdose / OX125 Nalmefene, Opioid Overdose / OX390 NCE, Overdose / OX640 Adrenaline, Anaphylaxis / Others (Small and large molecules) / 5 Commercial products and development pipeline CommercialR&D Partners 5
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6 Commercial Robust US commercial platform fighting the opioid crisis 6
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7 Committed to improve the life of patients suffering from OUD Elise discovered her daughter’s opioid dependence months before she died from an overdose. Read more at the Orexo blog “Giana made the switch to heroin, and it was all downhill from there.” 1 SAMHSA Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Useand Health. 2 Center of Disease Control and Prevention. 3 US Joint Economic Committee, data refers to 2020. 5.9 m are dependent on opioids1 USD 1,500 bn The societal cost of the US opioid crisis3 58,000 the number of fatal overdoses caused by opioids annually2 OX124 in registration phase (FDA) Medication-Assisted treatment (MAT) Digital support program Rescue medication The unmet need in the US Our approach 2.3 m are undergoing treatment1
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Q1 2025: Slightly lower bup/nal market growth Market development by segment (across retail) • YoY: Commercial +9%, Medicare +4%; Medicaid -3% • QoQ: Commercial -3%, Medicare -4%, Medicaid -2% • Market Share: Commercial 34%, Medicaid 37%, Medicare 14% Zubsolv® development • Overall: Weak quarter due to deductible resets and new Medicare rebate rules • QoQ / YoY: -8% / -6% • Across retail: Commercial -8% (mainly UHG), Medicaid - 2%, with growth in NY and Wisconsin offsetting decline, Medicare -14% (Humana D and rebate policy impact) 8 1 Based on IQVIA prescription data and include both retail and non-retail volumes. Note weekly prescription data is volatile and is influenced by public holidays, weather and changes to reimbursement. NOTE: An ACTIVE SUBPOENA regarding Zubsolv US sales was issued by US authorities in July 2020. For further details, refer to note 4 in the quarterly reports. Market development1 0 1 000 000 2 000 000 3 000 000 4 000 000 5 000 000 6 000 000 2020 Q3 2020 Q4 2020 Q1 2020 Q2 2020 Q3 2020 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2023 Q1 2023 Q2 2023 Q3 2023 Q4 2024 Q1 2024 Q2 2024 Q3 2024 Q4 2025 Q1 Q1 YoY +2% Q1 QoQ -2% NTRx SEK 133m Q1 2025: Zubsolv Net Revenues SEK 44m Q1 2025: US Commercial EBIT. EBIT margin 33%
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10 0 30 60 90 120 150 180 Time (min) Plasma concentration from clinical trial Faster onset Higher bioavialability The challenge The solution – AmorphOX, a powder-based technology Drug Carrier materials Amorphous materials, commonly used in drug development, are rapidly absorbed but tend to be unstable limiting routes of administration, distribution and storage AmorphOX unique properties ensure physical and chemical stability 2 AmorphOX is validated in multiple clinical trials 1 Traditional liquid AmorphOX is a versatile platform AmorphOX AmorphOX unique strengths 3 Improves: ✓ Small molecules ✓ Peptides ✓ Biologics ✓ OX124 – high-dose rescue medication (naloxone) ✓ OX125 – overdose rescue medication (nalmefen) ✓ OX640 – adrenalinproduct for anaphylaxis ✓ Withstands high and low temperatures ✓ Stability maintained over time AmorphOX® is a unique drug delivery technology 10
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Naloxone Enzyme Chemical degradation after accelerated stability studies in 40°C/75% RH Epinephrine 0.1% after 24 months Apomorphine 0.2% after 24 months Ketorolac Loxapine 0.3% after 24 months Eletriptan 0.5% after 12 months Cetrorelix 0.6% after 12 months ≤0.1% after 24 months Nalmefene ≤0.1% after 15 months0.8% after 6 months Covid Spike protein Olanzapine 0.2% after 6 months Retained activity after 1 month (40°C) Retained activity after 3 months (40°C) Attenuated Virus Retained titer levels, resilient to freeze thaw cycles Ganirelix 0.74% after 12 months Virus like particle Retained activity after processing Immuno- modulator 99% purity after 1 month (50°C) Examples of both internal and partnered projects Zavegepant ≤0.1% after 9 months The scalable AmorphOX® platform takes Orexo beyond the OUD treatment area Small molecules Peptides Biologics 11
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12 OX124 (registration phase) – high dose rescue medication for opioid overdose with naloxone • Large health issue in the US with >58.000 deaths from opioid overdoses annually1 • OX124 is based on AmorphOX® and designed to treat overdoses caused by synthetic opioids representing >90% of the opioid overdoses • Formulations of OX124 clinically differentiated to market leader and generic versions of market leader Reduced uncertainty in FDA resubmission timeline CRL received in mid-2024. Delivery of components to nasal device expected early Q3 2025 enabling initiation of commercial testing. Resubmission expected mid-2026. Rescue drug market in the US (USD) Projected global annual growth 2 1,483 m 11 % Global overdose rescue market size 2022 (USD) 2 1 Center of Disease Control and prevention. 2 Naloxone Market Size, Share and Opportunities, 2025-2032. Note: images are prototypes and not final packages
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13 • First line treatment today: intramuscular auto-injectors. In 2024 the first nasal product was approved in the US and EU which can pave the way for transformative shift • If approved OX640 can have the following differentiating properties • Superior absorption and exposure • Fast acting • Longer shelf life • Less restrictive storage requirements • Improved dose conformity. • Partnering process ongoing for global commercialization. Positive data from two clinical studies OX640 (clinical phase) – emergency treatment of allergic reactions, incl. anaphylaxis Rescue drug market in the US (USD) Growth rate CAGR 2024-2033 1 3,200 m 12 % Epinephrine global market size 2023 (USD) 1 1 Epinephrine Market Trends, Share and Forecast, 2025-2032 Note: images are prototypes and not final packages
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14 Collaboration between Abera and Orexo to develop nasal powder vaccines using AmorphOX® Candidate(s): Influenza Funding: BERA vaccine platform This slide uses publicly available information. For more information on Abera, we refer to their website: https://aberabio.com/. For more information on CEPI, please visit: https://cepi.net/. For more information on Orexo, please visit: https://orexo.com/rd/the-amorphox-technology/ Abera at a glance: ▪ Swedish vaccine and biotechnology company founded in 2012 ▪ Development of innovative nasal vaccines based on proprietary and patented platform technologies AmorphOX® technology Drug Carrier materials Optionally, other excipients such as permeability enhancer • Abera's influenza vaccine candidate was successfully formulated using AmorphOX. • The AmorphOX® nasal powder vaccine elicited both systemic and local immune responses, potentially limiting infection spread. • This vaccine may eliminate cold chain needs due to enhanced stability. OMVs are formed when a bacterium’s outer membrane expands and separates. The BERA platform displays a green stem protein on its surface. . Disease-specific antigens bind to the Abera protein via a biological process. OMVs display multiple antigens, have immunostimulatory properties, and resemble viruses to enhance immunogenicity. In vivo study results: 14
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15 Future value drivers
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Maintain Zubsolv® revenue streams Obtain FDA approval and initiate US launch of OX124 Achieve milestones and receive royalties from existing and upcoming partnered products. Collaborating with other pharmaceutical companies to jointly create new products utilizing AmorphOX. Out-licensing products that leverage the AmorphOX technology, including OX640 Develop new products for Orexo to commercialize primarily within OUD. Approach for expansion 16 Responsible business Access to healthcare Environment & climate change Sustainable employees Growing revenues & profit contributions Capitalising the AmorphOX® technology Improving access to treatment Expand reimbursement of Zubsolv in the public payer segment and maintain access in the commercial payer segment Secure reimbursement for OX124 US launch. ESG
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Thanks For more information, please visit www.orexo.com. You can also follow Orexo at Twitter @orexoabpubl, LinkedIn and YouTube. Headquarter Sweden, Orexo AB, P.O. Box 303, 751 05 Uppsala, Sweden, E-mail: info@orexo.com, Phone: +46 (0)18 780 88 00 Subsidiary US, Orexo US Inc. 150 Headquarters Plaza East Tower Morristown, New Jersey 07960 United States E-mail: info-us@orexo.com, Phone: +1 (0)855 982 7658 Orexo is committed to the UN Global Compact corporate responsibility initiative and its principles in the areas of human rights, labor, environment and anti-corruption. Please read more on unglobalcompact.org