Orexo AB · OMXSTO:ORX
Orexo AB — Life Science Investor Forum 2021
27 slides from Orexo AB's conference presentation, Mar 25, 2021
Slide 1: Life Science Investor Forum, March 25th 2021
Develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health Life Science Investor Forum, March 25th 2021 Nasdaq Stockholm: ORX US OTC Market: ORXOY (ADR)
Slide 2: Legal Disclaimer
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, Orex
Slide 3: Orexo in brief
Orexo in brief Corporate Headquarters • Developed four commercial pharmaceutical products with worldwide approval (Uppsala, Sweden) Corporate functions and • Addresses unmet needs within the growing space of Development mental illness and addiction disorders • Broad product portfolio and development
Slide 4: Strategic agenda to drive long-term growth
Strategic agenda to drive long-term growth Broadening… Establishing… …the portfolio of commercial products to be …. a new revenue generating promoted by our US Pharma and business area within DTx with three Digital Therapeutics businesses revenue generating products in the US market in 2021 Orexo ob
Slide 5: Products approved worldwide & pipeline of potential future assets
Products approved worldwide & pipeline of potential future assets Pharmaceuticals Phase Approved and/or Launched Product/ Project Exploratory Preclinical Registration 1 2 3 US EU RoW ZUBSOLV® Opioid Use Disorder Partner: Accord Healthcare (EU market) Abstral® Breaktrough Cancer Pain Partner: Kyowa K
Slide 6: Digital therapeutics to become an integral part of the healthcare landscape
Digital therapeutics to become an integral part of the healthcare landscape SUD and mental health issues are one of the main areas most in need of innovative ways to deliver treatment Digital therapies Approved and/or Launched Technical Development Registration US EU RoW deprexis® Depression Partner
Slide 7: ZUBSOLV - stable and strong EBIT, despite challenging market due to Covid-19
ZUBSOLV® - stable and strong EBIT, despite challenging market due to Covid-19
Slide 8: 2020 market volume showed strongest growth rate since ZUBSOLV launch
2020 market volume showed strongest growth rate since ZUBSOLV® launch New market definitions applied by Orexo Q4 2020 vs Q4 2019 Growth Market Volume Sales, Quarterly NTRx 2 500 000 Total Market: +13% Open By Segment 2 000 000 Non-reimbursed +10% +18% 1 500 000 Definitions Payers / Market Access • “
Slide 9: Open segment resilient throughout 2020 despite market challenges
Open segment resilient throughout 2020 despite market challenges UHC/Humana continue to decline, but the decline is fading during Q4 ZUBSOLV® by Access Segments R4W Average NTRx in Bold Color; Single Week NTRx in Lighter Shade Open (excl non-retail) UHC/Humana Non-Reimbursed 5994 5787 5811 5672 5712
Slide 10: Several possible triggers for ZUBSOLV growth in 2021
Several possible triggers for ZUBSOLV® growth in 2021 Continued improvement in ZUBSOLV® market access …ESI & Cigna have now listed ZUBSOLV® as the only preferred branded product on their Commercial and Medicare formularies. …Commercial access increased to 99% Strong bi-partisan support to increase a
Slide 11: OX124 - overdose rescue medication, on track to file mid-2022
OX124 - overdose rescue medication, on track to file mid-2022
Slide 12: OX124 - a new stronger rescue medication with naloxone
OX124 - a new stronger rescue medication with naloxone Expected launch in the US in 2023 The unmet need Available rescue medications have been developed for heroin overdoses, but most patients are dying from synthetic opioids like fentanyl today Our aim A rescue medication that is stronger and longe
Slide 13: OX124 will enter a >USD 300 million market
OX124 will enter a >USD 300 million market Recent market development • Covid-19 making the unmet need even more severe: ‐ According to estimated numbers 83,000 Americans died of an overdose in 2020, an increase of 21 percent1 ‐ Synthetic opioids are now representing 76 percent of opioid related deat
Slide 14: OX124 has shown better PK profile than Narcan Nasal Spray
OX124 has shown better PK profile than Narcan® Nasal Spray Faster, stronger and longer-acting vs Narcan® Nasal Spray Expected patient benefit Results from exploratory PK study in healthy volunteers, 2019 Plasma OX124 • Rescue more patients with concentration Narcan® Nasal Spray the first dose (~34%
Slide 15: Strong progress with the aim to launch in the US in 2023
Strong progress with the aim to launch in the US in 2023 Q4 progress 2021-2022 Established the full commercial supply chain of both devices and the API Q2-Q3 Perform the pivotal bridging study (Naloxone) Received positive feedback from FDA on Mid- the investigational new drug (IND) 22 File the N
Slide 16: Digital Therapeutics - expanding the commercialization model
Digital Therapeutics - expanding the commercialization model
Slide 17: With digital therapies, Orexo is well positioned to take a leading role
With 3 digital therapies, Orexo is well positioned to take a leading role addressing unmet needs within SUD and mental health issues deprexis® vorvida® OXD01/modia™ deprexis® is a fully automated A fully automated digital therapy “Digitizing” counselling at scale to digital therapy to help patients
Slide 18: Digital therapeutics is in its infancy - several hurdles need to be addressed
Digital therapeutics is in its infancy - while the potential is significant, several hurdles need to be addressed before the market takes off Commercialization Reimbursement • Optimal pathways to commercialize and scale DTx are • Many payors still to establish payment and still unchartered reimburse
Slide 19: Clinical evidence is critical for DTx to gain traction in health care
Clinical evidence is critical for DTx to gain traction in health care deprexis® demonstrates consistent clinical effect across multiple settings Meta-analysis of 12 RCTs demonstrated the effectiveness of deprexis for reducing depressive symptoms with a moderate effect size (g = 0.51, 95% CI: 0.40–0.
Slide 20: Agreement with Magellan Rx Management to complete a Real World Evidence study of modia
Agreement with Magellan Rx Management to complete a Real World Evidence study of modia™ is a major step forward for Orexo Magellan is a leading US payer Magellan and ApexB.io will work with Orexo to define a study meeting the requirements of payers in the US • Behavioral Health Management & Specialt
Slide 21: High expectations to 2021 for the Digital Therapeutics business
High expectations to 2021 for the Digital Therapeutics business • Piloting of reimbursement pathways and commercialization concepts continues during Q1 • With positive outcome, Orexo’s financial strength enables rapid acceleration of commercial efforts • Partnership with larger health care providers
Slide 22: Financial information
Financial information
Slide 23: 2020 – A transformative year building for future growth
2020 – A transformative year building for future growth Numbers reflects loss in Abstral® royalty due to patent expiration and investments in the build-up of DTx venture Group net revenues 2020 1,2et revenues LTM1,2 US Pharma net revenues 2020 1et revenues SEK 664 m (USD 77 m) USD 68 m Group EBITDA
Slide 24: No changes in the two ongoing legal processes in Q4
No changes in the two ongoing legal processes in Q4, except new patent issued for ZUBSOLV® in Dec. and listed in Orange book in January Subpoena Patent infringement litigation against Sun Pharma • On July 14, 2020 Orexo US received subpoenas to • Orexo on September 13 filed a patent infringement pro
Slide 25: Value drivers for long-term growth
Value drivers for long-term growth 1 - 5 1 Product portfolio addressing large and growing markets Focusing on becoming a leader in the large and growing space of substance use disorders and mental health. In parallel, Orexo is also addressing the ongoing opioid epidemic, one of the largest health cr
Slide 26: Value drivers for long-term growth - Future value drivers
Value drivers for long-term growth 1 - 5 Future value drivers 3 Strong cash conversion to support growth Lead product ZUBSOLV®, for the treatment of opioid use disorder, is a strong cash and profit contributor, enabling continued investment in on-market products and R&D. 4 Leveraging our US commerci
Slide 27: Thank You
Thank You IR Contact: Lena Wange, IR & Communications Director, ir@orexo.com. For more information please visit www.orexo.com. You can also follow Orexo at Twitter @orexoabpubl, LinkedIn and YouTube