Orexo Ab · OMXSTO:ORX
Orexo Ab — ABGSC Life Science Summit 2022
26 slides from Orexo Ab's conference presentation, May 18, 2022
Slide 1: A pharmaceutical & digital therapeutics company
ABGSC LIFE SCIENCE SUMMIT 1 A pharma- ceutical & digital therapeutics company MAY 18 2022 Orexo supports the UN’s Agenda 2030 with a focus on: 1
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 US Pharma brief Commercial US Pharma platform since 2013, incl. market access team and sales representatives who on a daily basis visit physicians, medical clinics and minor hospitals. HQ & Pipeline Development of improved drugs based on well-known substances combined with innovative prop
Slide 4: US Pharma
4 US Pharma 4
Slide 5: ZUBSOLV for the treatment of opioid use disorder
5 ZUBSOLV® for the treatment of opioid use disorder ZUBSOLV® short facts Technology Sublingual Product advantages include: Indication Opioid use disorder • Higher bioavailability Market approvals US, EU and Australia • Fast dissolve time • Preferred menthol flavor US launch 2013 • Broadest range of
Slide 6: The opioid crisis - one of the largest health crises ever in the US
6 The opioid crisis - one of the largest health crises ever in the US 10 million Americans misusing opioids 4 million In need of treatment 1.4 million Under treatment 120 000 100 000 “Giana made the switch Overdose deaths 80 000 to heroin, and it was all have surpassed 60 000 downhill from there.” 4
Slide 7: ZUBSOLV is an important cash generator
7 ZUBSOLV® is an Accumulated net revenues US Pharma net revenues 2 important cash 4.2 535 SEK M billion SEK generator Since US launch 2013 – Q1 2022 LTM Q1 2022 Key operational highlights in Q1 2022 ZUBSOLV® EBIT (SEK M) and EBIT margin, LTM Q1 2022 400 60,0% ZUBSOLV® added to preferred NY Medicai
Slide 8: Multiple drivers for long term growth
8 Multiple drivers 1 2 for long term growth Covid-19 effects likely to Multiple comprehensive diminish improving patient activities on-going on federal access to care and Q2-Q4 and state levels to enable historically with improving more patients access to growth rates treatment 3 4 Improved market a
Slide 9: HQ & Pipeline
. a Ha Pipeline 1. t A
Slide 10: Pharma products and development pipeline
10 Pharma products and development pipeline Pharmaceuticals Phase Approved and/or Launched Product/ Project Exploratory Preclinical Registration 1 2 3 US EU RoW ZUBSOLV® Opioid Use Disorder/ sublingual platform Abstral® Breaktrough Cancer Pain/ sublingual platform Edluar® Insomnia/ sublingual platfo
Slide 11: OX124 & OX125 – overdose rescue medications
11 OX124 & OX125 – overdose rescue medications Significant health issue in the US with >107.000 deaths from overdose last 12 months Current US market exceeding USD 400 million Based on amorphOX™ and designed to treat overdoses caused by synthetic opioids, such as fentanyl OX124 clinically di
Slide 12: OX640 – emergency treatment of allergic reactions
12 OX640 – emergency treatment of allergic reactions Needle free and based on amorphOX™ Improved handling and storage (doubling shelf life of existing products) No bisulfite antioxidant and preservative free Improved convenience and acceptability vs injection products increases likelihood of
Slide 13: Orexo internal platform building on the amorphOX technology
13 Orexo internal platform building on the amorphOX™ technology Superior pharmacokinetic Excellent stability even under Three granted US patents and several patent applications have properties with more rapid onset, accelerated conditions and proven been filed with potential higher peak and ov
Slide 14: amorphOX works for a broad scope of drugs
14 amorphOX™ Adrenaline Apomorphine Naloxone works for a broad scope of drugs 0.5% after 6 months 0.2% after 9 months ≤0.1% after 12 months Loxapine Ketorolac Nalmefene 0.2% after 12 months 0.8% after 6 months ≤0.1% after 15 months Chemical degradation after accelerated stability studies at 40oC/75%
Slide 15: amorphOX and macromolecules
15 amorphOX™ and macromolecules Recent protein example Enzyme of 464 kDa (~1000 amino acids) Successfully formulated in the amorphOXTM platform High yield Free-flowing powder Narrow particle size distribution Enzymatic activity fully retained after: manufacturing 1M storage @ 40oC/75
Slide 16: Digital Therapeutics (DTx)
16 DTx in brief Subsection of digital health Evidence-based therapeutic intervention Prevent, manage, or treat a medical disorder or disease Particularly applicable in the Digital mental illness & addiction space Standalone or along Therapeutics (DTx) with pharma treatment Available 24/7
Slide 17: Strong underlying trends will force the DTx market to gain traction
17 Strong underlying trends will force the DTx market to gain traction Healthcare systems challenged Widespread technology acceptance Aging population and sky-rocketing Covid-19 has further pushed forward the costs are forcing the healthcare ongoing tech revolution and the use of providers to rethin
Slide 18: Orexo is at the leading edge of digitalization in DTx
18 Orexo is at the leading edge of digitalization in Establishing Reimbursement the pursuit to take DTx Orexo working in tight collaboration with world leaders in digital health to from its infancy to make DTx accessible to all patients. become a natural part of However, universal reimbursement pr
Slide 19: Clinically proven DTx in collaboration with GAIA AG
19 Clinically proven DTx in Instructions for Opioid dependence Alcohol misuse Depression use collaboration Ongoing randomized Evaluated in 1 Evaluated in 13 with GAIA AG Clinical clinical trial, randomized clinical randomized clinical evidence1 trial, trials, 400 patients > 600 patients > 2.800 pati
Slide 20: Orexo has worked intensively to gain awareness and experience
20 Orexo has worked intensively to gain awareness and experience from physians, clinic staff and patients of our DTx >1800 users of one of the DTx in Orexo >500 users of modiaTM through sponsored early access programs modiaONE and clinical trial • Healthcare staff at large healthcare • >250 users of
Slide 21: Financial & legal
21 Financial & legal
Slide 22: Q1 2022 LTM – A transformative period building for future growth
22 Q1 2022 LTM – Group net revenues US Pharma net revenues A transformative 592 535 SEK M SEK M period building for future growth EBITDA US Pharma EBIT 134 296 SEK M SEK M Significant investments in – • establishing digital therapeutics business and development of OX124 Cash position US Pharma EBIT
Slide 23: Legal update – no changes in Q1 2022
23 Legal ZUBSOLV ® patent Subpoena update – dispute vs Sun Therapueutics with regards to ZUBSOLV ® no changes in Q1 2022 No changes in Q1 9 patents listed in No changes in Q1 Very limited activities in Q1 the Orange Book No additional information Expiring dates Dec 2027 received since issuan
Slide 24: Future value drivers
24 Future value drivers 24
Slide 25: Why Orexo?
25 Why Orexo? Profitable US Pharma Unique pharmaceutical Pioneer in digital therapies pipeline and technology SEK 84 m in EBIT Developed an entirely new Digital health market is in contribution Q1 and 42 and unique drug delivery it’s early stages, but quarters left to patent technology, amorph
Slide 26: Thanks
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: [email protected], Phone: +46 (0)18 780 88 00 Subsidiary US, Orexo US Inc. 150 Headquarters Plaza