Orexo Ab · OMXSTO:ORX
Orexo Ab — Carnegie Nordic Healthcare Seminar 2025
21 slides from Orexo Ab's conference presentation, Mar 12, 2025
Slide 1: A commercial-stage pharma company developing drugs through drug delivery technologies
A commercial-stage pharma company, developing drugs through cutting-edge drug delivery technologies March 2025
Slide 2: Legal disclaimer
2 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 concerning Orexo. Unless otherwise stated, Or
Slide 3: Orexo in brief
3 Orexo in brief Comments Q2 Strong cash generation Net Revenue LTM 1 from lead product 30 years of experience Addresses unmet needs developing improved within opioid use disorder SEK m 5.600 pharmaceuticals based on (OUD) and other areas proprietary drug delivery where our technologies can technolo
Slide 4: Commercial products and development pipeline
4 Commercial products and development pipeline Approved and/or Launched Product or Project/Indication/Technology Partners Exploratory Preclinical Clinical development phases Registration US EU RoW Zubsolv® Opioid Use Disorder (OUD) / Sublingual platform Commercial Abstral® Breaktrough Cancer Pain /
Slide 5: The scalable AmorphOX platform takes Orexo beyond the OUD treatment area
5 The scalable AmorphOX® platform takes Orexo beyond the OUD treatment area Examples of both internal and partnered projects Small molecules Peptides Biologics Apomorphine Olanzapine Eletriptan Cetrorelix Enzyme Virus like Attenuated particle Virus Retained titer levels, Retained activity after Reta
Slide 6: Commercial
6 Commercial Robust commercial platform targeting OUD regions 6
Slide 7: Committed to improve the life of patients suffering from OUD
7 Committed to improve the life of patients suffering from OUD The unmet need in the US 5.9 m 64,000 the number of fatal overdoses are dependent on opioids1 caused by opioids annually2 2.3 m USD 1,500 bn are undergoing treatment1 The societal cost of the US opioid crisis3 Our approach Medication-Ass
Slide 8: Zubsolv with a robust commercial platform targeting OUD regions
8 Zubsolv® with a robust commercial platform targeting OUD regions Differentiated position Broad commercial infrastructure ✓ Broadest range of doses allowing ✓ Sales territories in nearly all large metropolitan areas 98 % precise titration & individualized Ratio of patients in the Commercial payer s
Slide 9: Slightly accelerating market growth & stabilized Zubsolv development
9 Slightly accelerating market growth & stabilized Zubsolv® development Market development (NTRx) Q4 2024: Market development by segment Q4 YoY +6% • Commercial growth YoY +19% and Medicare +9% 6 000 000 • Continued but slowing decline in Medicaid -2% YoY Q4 QoQ +2% • Medicaid remain the largest mar
Slide 10: US market drivers support continued growth for Zubsolv and upcoming OX124 launch
10 US market drivers support continued growth for Zubsolv® and upcoming OX124 launch ➢ New legislation (Mainstreaming Addiction Treatment Act, 2023) 2-5 % aimed to increase access to treatment long-term removing restrictions for prescription of MAT ➢ New funding from opioid litigation of an accumula
Slide 11: Settlement reached with Sun Pharmaceuticals after over 4 years of Zubsolv IP litigation
11 Settlement reached with Sun Pharmaceuticals after over 4 years of Zubsolv® IP litigation OX640 – an intranasal rescue medication for allergic reactions with powder-based epinephrine. Based on ▪ The agreement resolves the patent litigation initiated by Orexo in 2020 after Sun filed an ANDA to mark
Slide 12: AmorphOX
12 AmorphOX® The next-generation drug delivery technology unlocks a broad range of new opportunities in the development of innovative drugs
Slide 13: AmorphOX is a unique drug delivery technology
13 AmorphOX® is a unique drug delivery technology The challenge AmorphOX unique strengths Amorphous materials, commonly used in drug development, are rapidly absorbed but tend to be unstable limiting routes of administration, distribution and storage 1 AmorphOX unique properties ensure physical and
Slide 14: OX124 (registration phase) – high dose rescue medication for opioid overdose with naloxone
14 OX124 (registration phase) – high dose rescue medication for opioid overdose with naloxone • Large health issue in the US with >64.000 deaths from opioid Rescue drug market Global overdose rescue Projected global in the US (USD) market size 2022 (USD) 2 annual growth 3 overdoses annually1 • OX124
Slide 15: OX640 (clinical phase) – emergency treatment of allergic reactions, incl. anaphylaxis
15 OX640 (clinical phase) – emergency treatment of allergic reactions, incl. anaphylaxis Rescue drugglobal Epinephrine market Growth rate CAGR • First line treatment today: intramuscular auto-injectors. in the US (USD) market size 2023 (USD) 1 2024-2033 1 In 2024 the first nasal product was approved
Slide 16: Financial & legal
16 Financial & legal 16
Slide 17: Improving profitability and removing uncertainties
17 Improving profitability and removing uncertainties Income statement Oct-Dec Oct-Dec FY FY Comments Q2 SEK m 2024 2023 2024 2023 2024 – the best EBITDA result since 2019 ✓ Positive EBITDA both full year, SEK +48.9 m (-32,5) and in Net revenue (NR) 160.3 166.0 590.0 638.8 Q4, SEK +28.9 m (12.4) exp
Slide 18: Legal update
18 US government agency investigation related to ZUBSOLV® Legal Subpoena issued by the US authorities update ▪ 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
Slide 19: The value story
19 The value story
Slide 20: Several potential value triggers near term
20 Several potential value triggers near term Zubsolv® value potential after Partnering around AmorphOX® OX124 resubmitted to 1 removing IP litigation threat 2 drug delivery technology 3 FDA and launch in the US • Stabilizing sales and profit contributions from • OX640 for treatment of anaphylaxis i
Slide 21: Thanks
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