Orexo AB · OMXSTO:ORX
Orexo AB — Life Science Investor Forum 2023
24 slides from Orexo AB's conference presentation, Jun 22, 2023
Slide 1: A commercial stage pharma company
1 A commercial stage pharma company June 2023 Orexo supports the UN’s Agenda 2030 with a focus on:
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 a commercial stage pharmaceutical company with an exciting pipeline
3 Orexo a commercial stage pharmaceutical company with an exciting pipeline A commercial stage Profitable US commercial New world leading nasal pharmaceutical company operations with a strong delivery technology - with three revenue focus on one of the largest amorphOX® is leading to generating phar
Slide 4: Business model covering the full value chain
4 Business model covering the full value chain…. 1 2 Develops new world leading Commercial operations in the US since 2013 fighting the opioid use disorder (OUD) drug delivery technologies epidemic Significant value contribution from ZUBSOLV® Developed four commercial • >SEK 4.7 billion in sales sin
Slide 5: Grounded in sustainability
5 …. grounded in sustainability At the core of a sustainable society are health and well-being, areas where Orexo makes significant impact
Slide 6: Commercial products and development pipeline
6 Commercial products and development pipeline Phase Approved and/or Launched Product or project/Indication/Technology Exploratory Preclinical Clinical development phases Registration 1 2 3 US EU RoW ZUBSOLV® Opioid Use Disorder/ sublingual platform Commercial products Abstral® Breaktrough Cancer Pa
Slide 7: US Commercial
7 US Commercial 7
Slide 8: US market: Commercial products targeting a large unmet need
8 US market: Commercial products targeting a large unmet need Fatal overdoses have surged due to synthetic opioids 1 120000 100000 9,200,000 80000 are misusing opioids2 60000 40000 20000 0 5,600,000 2017 2018 2019 2020 2021 Total overdose deaths All opioid overdoses Synthetic opioids eg fentanyl are
Slide 9: ZUBSOLV an important foundation to Orexo's commercial operations
9 ZUBSOLV® an important foundation to Orexo´s commercial operations Net revenues US Pharma EBIT (SEK m) and EBIT margin (%) LTM 1 Market & Sales dynamic since launch 2013 (SEK m) 4,700 Market growth of 6% • Expected to increase with 400 60,0% improved access and financing 350 50,0% 300 40,0% 250 ZUB
Slide 10: Products under development
10 Products under development10
Slide 11: Orexo's development platform building on proprietary amorphOX technology
11 Orexo´s development platform building on the proprietary amorphOX® technology Validated in humans Excellent stability Wide applicability ✓ Superior pharmacokinetic ✓ Excellent stability even under ✓ Powder technology that works with a broad scope of small and properties with more rapid onset, acc
Slide 12: amorphOX – a versatile, world-class platform for intranasal drug delivery
12 amorphOX® – a versatile, world-class platform for intranasal drug delivery Chemical degradation after accelerated stability studies at 40oC/75% RH Apomorphine Cetrorelix Eletriptan Olanzapine Enzyme Loxapine 0.3% after 18 months 0.4% after 3 months 0.5% after 3 months 0.3% after 6 months Ketorola
Slide 13: OX124 & OX125 – overdose rescue medications
13 OX124 & OX125 – overdose rescue medications Rescue drug market Global overdose rescue Projected global • Significant health issue in the US with >107.000 deaths from in the US market (USD) size (USD) 1 annual growth 1 overdoses in 2021 • Based on amorphOX® and designed to treat overdoses 1,100 10
Slide 14: OX640 – emergency treatment of allergic reactions
14 OX640 – emergency treatment of allergic reactions Rescue drug market Auto-injector global Projected global • First line treatment today: intramuscular auto-injectors in the US (USD) market size (USD) annual growth • OX640 offers clear differentiation to current market 4,000 9 leader and products
Slide 15: OX640: The power to transform emergency treatment of allergic reactions
15 OX640: The power to transform emergency treatment of allergic reactions Going from this… … to this https://www.mcguffmedical.com/epipen-03mg-11000-single-use-auto-injector-2box https://www.emerade.com/se/v/artiklar/anvandarvanlighet ~ 15.3 cm ~ 14.3 cm ~ 8 cm ~ 7 cm ~ 5.5-6 cm ~ 2.5 cm ~ 3.5 cm ~
Slide 16: OX640: Nasal epinephrine enabled by amorphOX
16 OX640: Nasal epinephrine enabled by amorphOX® - remains stable in any life situation OX640 EpiPen® 30 Epinephrine degradation (%) 25,5 25 20 16,7 OX640 will work 15 independent on 10 8,4 temperature 7,0 5 0,7 1,4 1,8 0,1 0,1 0,4 0 0 1 3 6 12 18 Months
Slide 17: Sustainability at the core of establishing the supply chain for nasal delivery products
17 Sustainability at the core of establishing the supply chain for nasal delivery products In Q1 2023 an extended sustainability evaluation including all suppliers in the commercial supply chain for OX124 was initiated. The assessment includes: • Management Systems • Ethics & Labor • Health & Safety
Slide 18: Financial & legal overview
18 Financial & legal overview
Slide 19: A transformative period building for future growth
19 2022/2023 - Group net revenues LTM US Pharma net revenues LTM A transformative 624 572 SEK M SEK M period building for future growth EBITDA LTM US Pharma EBITDA LTM 159 299 SEK M SEK M Significant investments in – • developing the pipeline, establishing the DTx business, conducting clinical trial
Slide 20: Q1 2023 EBITDA positive excluding external non-repeating costs
20 Q1 2023 EBITDA positive excluding external non-repeating costs SEK M External non-repeating -30 costs EBITDA 83 -33 21 -20 -42 -41 US Pharma DTx HQ & EBITDA Clinical Legal Total EBITDA EBITDA EBITDA* Pipeline studies processes EBITDA • MODIA® study • OX640 project • OX124 project • Sun Litigation
Slide 21: Legal update
21 Legal ZUBSOLV ® patent US authorities' update dispute vs investigation Sun Pharmaceuticals with regards to ZUBSOLV ® promotion ✓ In Q1 2023 the trial was conducted in ✓ In Q1 2023 additional information the US District Court for the District of have been shared at the request New Jersey. of the a
Slide 22: Future value drivers
22 Future value drivers
Slide 23: Several significant milestones near term
23 Several significant milestones near term • Corporate profitability in sight1 • Increased income from partners • Main current external cost drivers will diminish during H2 2023 and significant reduction in direct expenses for DTx • No new activities driving external expenses to be initiated withou
Slide 24: Thanks
24 Thanks The opioid crisis is one of the largest health crises in the US in modern times. Our core commitment is to improve these people’s lives with pioneering and holistic treatment solutions. www.orexo.com