Orexo Ab · OMXSTO:ORX
Orexo Ab — Investor Day (March 2020)
92 slides from Orexo Ab's investor day presentation, Mar 17, 2020
Slide 1: Capital Market Day, March 17, 2020
Develops and commercializes improved pharmaceuticals and digital therapies – with the aim of becoming a leader within the treatment of addiction Capital Market Day, March 17, 2020 Nasdaq Stockholm: ORX US OTC Market: ORXOY (ADR)
Slide 2: Agenda
Agenda Time pm CET Topic Presenter Part 1 – Growth Strategy 1:30 – 1:45 Strategy for short- and long-term growth Nikolaj Sørensen, CEO and President 1:45 – 2:00 Growing the Zubsolv® franchise Robert DeLuca, President of Orexo US Inc. Part 2 – Pharma Pipeline 2:00 – 2:20 A pipeline with signi
Slide 3: Part 1 – Growth Strategy
Part 1 – Growth Strategy Growing the Zubsolv® franchise - Nikolaj Sørensen, CEO and President
Slide 4: 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 5: Limited impact from the COVID-19 virus currently
Limited impact from the COVID-19 virus currently1 Development Supply Sales Finance OX125 - Preparations for Zubsolv® - Manufacturing Zubsolv® and vorvida® - Orexo has SEK 817m in cash first clinical trial progress as of Zubsolv® is solely done in Sales calls have been and a profitable operations pla
Slide 6: 2012 – 2019 successful strategic focus on building a solid foundation
2012 – 2019 successful strategic focus on building a solid foundation EBITDA SEK m 2012-2019 300 SEK 817m Launch Zubsolv® in the US 250 Cash position 200 150 First actions taken to broaden the US commercial platform 100 50 2012 Secure profitability 0 2019 -50 Ensure a sustainable business -100
Slide 7: 2019 delivered the strongest financial results ever
2019 delivered the strongest financial results ever Group net revenues Growth SEK 845 m 8% 85% from Zubsolv® (Zubsolv® 16%) Group EBITDA Growth SEK 272 m 133% US EBIT Growth SEK 351 m 77% Cash position Positive net cash position SEK 817 m SEK 527 m 7
Slide 8: Profit contributions from Zubsolv enable building a broader Orexo
The profit contributions from Zubsolv® enables investments in building a broader and stronger Orexo Broaden… Establish ..the portfolio of commercial products to be ..a new revenue generating business area promoted by our existing US organization in within Digital Therapeutics (DTx) and launch 2020 f
Slide 9: Objectives for the Capital Markets Day
Objectives for the Capital Markets Day What we would like to achieve today: • Enable our shareholders and future investors to make a fair valuation of our pipeline • Present why Orexo find Digital Therapeutics is a significant opportunity for the company and how it improve treatment outcome • Create
Slide 10: Part 1 – Growth Strategy
Part 1 – Growth Strategy Growing the Zubsolv® franchise - Robert DeLuca, President Orexo US Inc.
Slide 11: Zubsolv is well positioned to remain a strong profit contributor
Zubsolv® is well positioned to remain a strong profit contributor >12 years of patent protection for Zubsolv® remains …Zubsolv patents extend to Q4 2032 and Zubsolv® cannot be substituted by pharmacies with generic versions of Suboxone Tablet or Film Zubsolv® continues to be a significant profit gen
Slide 12: Zubsolv has grown Year-over-Year despite increasing competition
Zubsolv® has grown Year-over-Year despite increasing competition US Net Revenues US Operating Profit USD million USD million 76 40 37 71 30 56 57 22 49 20 11 33 10 5 - (10) 1 (10) (14) (12) (20) 2013 2014 2015 2016 2017 2018 2019 2013 2014 2015 2016 2017 2018 2019 7 10 13 17 20 19 23 (14) (26) (36)
Slide 13: Full year market growth of 14% 2019 vs 2018 continues in Q1
Full year market growth of 14% 2019 vs 2018 continues in Q1 New market definitions to be applied by Orexo Market Volume Sales Q1 YTD Growth Quarterly NTRx Total Market: +14% 2 000 000 By Segment 1 800 000 Open +14% 1 600 000 Non-reimbursed +13% 1 400 000 1 200 000 Definitions Payers / Market Access
Slide 14: Zubsolv growing in the open business, overall volume declining
Zubsolv® growing in the open business, but overall volume declining from competition in former exclusive contracts Open Market Access UHC/Humana/Cash Non-Reimbursed Market Changes Zubsolv NTRx YoY Q1TD (thousands) Zubsolv NTRx YoY Q1 TD (thousands) Zubsolv NTRx YoY Q1TD (thousands) From year 2019 to
Slide 15: Zubsolv growth in open business explained by unrestricted PBM access
Zubsolv® growth in open business explained by unrestricted access to all large national commercial PBMs Prescription incremental growth to major national PBMs Zubsolv NTRx YoY Q1TD (thousands) Total increase of 2,759 NTRx 2 229 year-to-date Opportunity to continue to grow business and to translate s
Slide 16: Several possible triggers for Zubsolv growth in 2020 and beyond
Several possible triggers for Zubsolv® growth in 2020 and beyond Continued improved market access …Orexo continues to aggressively pursue expanding market access in Medicare and Medicaid …Largest branded competitor likely to lose reimbursement over time Competition from “the preferred” authorized ge
Slide 17: Part 2 – Pharma Pipeline
Part 2 – Pharma Pipeline A pipeline with significant future potential - Johannes Doll, EVP and Chief Commercial Officer
Slide 18: 3 convincing development assets addressing critical unmet needs
3 convincing development assets addressing critical unmet needs OX124 – opioid overdose OX125 – opioid overdose OX338 – non-opioid pain A powerful rescue A rescue medication to A non-opioid pain killer medication, designed to reverse opioid overdoses, with opioid-level efficacy reverse opioid overdo
Slide 19: Orexo R&D pipeline
Orexo R&D pipeline • OX124 – nasal naloxone rescue drug • OX125 – nasal nalmefene rescue drug • OX338 – oral ketorolac 19
Slide 20: OX124 at a glance
OX124 at a glance The unmet need Our aim The potential Available rescue medications A rescue medication that is have been developed for heroin overdoses, but most patients are stronger and longer-acting, and thus effective in reversing 70-110 dying from synthetic opioids like overdoses caused by syn
Slide 21: Deaths from synthetic opioids continue to rise
While overall deaths from opioid overdoses showed a slight decline in 2018, deaths from synthetic opioids continue to rise Deaths from opioid overdose By type of opioid, United States 50 000 Any opioid 45 000 40 000 35 000 30 000 Synthetic opioids 25 000 Deadly dose comparison 20 000 15 000 Heroin N
Slide 22: The market for rescue drugs – key figures
The market for rescue drugs – key figures 47 thousand 1-2 million ~10 million Deaths from opioid Doses of naloxone rescue Doses of naloxone rescue overdoses1 medications administered2 drugs distributed 1 Year 2018, NCHS, National Vital Statistics System, Mortality. Jan 2020 2 Clarion Healthcare anal
Slide 23: The market for rescue medications has seen a significant increase
The market for rescue medications has seen a significant increase Naloxone Sales Volume Million Units 10,4 34% 8,2 CAGR 5,8 2017 2018 2019 Source: IQVIA National Sales Perspective, adjusted for est. NarcanDirect sales (not captured by IQVIA) 23
Slide 24: Narcan Nasal Spray is currently dominating the branded market
Narcan Nasal Spray is currently dominating the branded market Narcan Nasal Spray Net Sales USD Million 285-315 280 178 75 2017E1 2018E2 2019A3 2020 guidance3 1 Year 2017 estimated based on royalty payments to Opiant 2 Year 2018 Zacks Small Cap Research 3 Emergent Biosolutions Reports 24
Slide 25: Mandatory coRx in more states could further accelerate market growth
Mandatory coRx in more states could further accelerate market growth Mandatory coRx… … leading to further upside • 15-20 million patients at risk of From Emergent Biosolutions’ investor presentation: accidental overdose due to high- dose opioids for pain • 9 states have implemented legislation to ma
Slide 26: Pipeline overview – several development projects are underway
Pipeline overview – several development projects are underway Pre-clinical Clinical NDA filed Approved Narcan, launched OX124, Planned NDA ’21 NDA filed Q3 ’19 (8mg) ’16 Nasal Narcan generic, Multi-dose, Approved Apr ’19, Possible NDA ’20 Ongoing litigation Long-Acting Zimhi, Evzio, injectable Pre-f
Slide 27: We have shown better PK profile than Narcan Nasal Spray
We have 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% of
Slide 28: Only player with a presence in the retail segment
We are currently the only player with a presence in the retail segment (doctors’ offices) Orexo field force – US sales territories • Retail is the fastest growing segment • Orexo’s field force already covers most relevant geographies in the US • Currently 51 sales territories organized in 6 regions
Slide 29: Anticipating OX124 net sales of USD 70-110 million
We are anticipating OX124 net sales of USD 70-110 million Rescue drugs market development OX124 Net Sales 5 years post launch Forecast, units Million 20,3 Forecast, USD Million 18,4 16,7 110 15,2 13,8 90 12,6 11,4 70 10,4 Assuming conservative 10% volume growth p.a. 2019 2020 2021 2022 2023 2024 202
Slide 30: Preparing for the pivotal trial in Q4 of this year
We are currently preparing for the pivotal trial in Q4 of this year 2020 2021 2022 Pivotal trial Filing1 Launch1 1 Assumes FDA fast track designation 30
Slide 31: Orexo R&D pipeline
Orexo R&D pipeline • OX124 – nasal naloxone rescue drug • OX125 – nasal nalmefene rescue drug • OX338 – oral ketorolac 31
Slide 32: OX125 at a glance
OX125 at a glance The unmet need Our aim The potential Available rescue medications A powerful rescue medication for have been developed for heroin overdoses, but most patients are situations where very long-lasting effect is required, e.g., in remote 40-60 dying from synthetic opioids like areas, a
Slide 33: Areas where nalmefene may be better suited than naloxone
While we expect naloxone to remain the dominant rescue drug, there are distinct areas where nalmefene may be better suited Nalmefene Where it may be better suited than naloxone • Opioid antagonist (like Rural areas naloxone) • Long acting rescue drug optimal for areas • More potent than with long tr
Slide 34: Competition for nalmefene products is more limited
Competition for nalmefene products is more limited Pre-clinical Clinical NDA filed Approved Estimated filing ‘20 Nasal OX125, Planned NDA ’22 Injection, FDA fast track designation1 Injectable Note: Pipeline does not include 6 month nalmefene implant (Titan / Opiant, Proneura technology) intended for
Slide 35: Anticipating OX125 net sales of USD 40-60 million
We are anticipating OX125 net sales of USD 40-60 million Rescue drugs market development OX125 Net Sales 5 years post launch Forecast, units Million 20,3 Forecast, USD Million 18,4 16,7 60 15,2 50 13,8 12,6 11,4 40 10,4 Assuming conservative 10% volume growth p.a. 2019 2020 2021 2022 2023 2024 2025
Slide 36: First clinical trial in humans for OX125 is about to start
The first clinical trial in humans for OX125 is about to start 2020 2021 2022 2023 First human Pivotal trial Filing Launch trial 36
Slide 37: Orexo R&D pipeline
Orexo R&D pipeline • OX124 – nasal naloxone rescue drug • OX125 – nasal nalmefene rescue drug • OX338 – oral ketorolac 37
Slide 38: OX338 at a glance
OX338 at a glance The unmet need Our aim The potential Opioids are still used Opioid-level pain relief for short- unnecessarily in many situations, further fuelling the opioid crisis term pain (up to 5 days) without the risk of addiction >100 million USD net sales (US market) 38
Slide 39: The opioid market is still massive and opioids are used unnecessarily
Despite some decline, the opioid market is still massive – and opioids continue to be used unnecessarily in many situations Opioid market United States1 Evidence for opioid over-prescribing USD billion United States Share of patients 75 6,2 -12% 5,6 with an opioid 4,8 prescription upon 11 discharge
Slide 40: Ketorolac is proven to be as effective as opioids
Ketorolac is proven to be as effective as opioids Examples for ketorolac’s proven efficacy Third Molar surgery Painful injuries “…this study suggests that 10 mg of “Ketorolac proved to be as effective as morphine oral ketorolac had superior in relieving pain and did so just as quickly. It analgesic
Slide 41: Differentiating OX338 vs. SPRIX and Generics
We are aiming at clearly differentiating OX338 vs. SPRIX and Generics SPRIX Nasal Spray Ketorolac Generics • Only branded product on the • First dose must be given as an IM market OX338 is expected to… or IV injection • Complicated storage and dosing • Oral Gx are only indicated for • … be much easi
Slide 42: Limited activity in the ketorolac pipeline, especially oral products
There is limited activity in the ketorolac pipeline, especially for oral products Pre-clinical Clinical NDA filed Approved/launched Oral Gx Toradol Oral OX338, Planned NDA ’22 Tablets Intrathecal Patient- Pre-mixed Toradol IV/IM injection Controlled Analgesia bag Gx injection Other PatchPump, unclea
Slide 43: We have shown better PK profile than SPRIX Nasal Spray
We have shown better PK profile than SPRIX® Nasal Spray Faster uptake and higher peak vs. SPRIX® Nasal Spray Results from exploratory PK study in healthy volunteers, 2019 (n=19) Plasma OX338 concentration SPRIX Nasal Spray Time 43
Slide 44: Potential from converting unnecessary opioid prescriptions to OX338
We see significant potential from converting unnecessary opioid prescriptions to OX338 Dental procedures Ambulatory surgeries ~11 million patients p.a. receive ~15 million patients p.a. receive opioids after a dental procedure opioids after an ambulatory surgery US net sales 5 years post launch US n
Slide 45: Key take-aways
Key take-aways • 3 late-stage development assets aiming at building the leading addiction company • All in areas with high unmet need and with clearly differentiated product characteristics • Highly complementary with Zubsolv® and our existing commercial infrastructure in the US • All successfully t
Slide 46: Part 3 – Digital Therapeutics
Part 3 – Digital Therapeutics DTx – new frontiers in patient care - Dennis Urbaniak, EVP Digital Therapeutics
Slide 47: COVID-19 demonstrates the benefits of digitization of healthcare
The COVID-19 global situation demonstrates the benefits of digitization of healthcare Hospitals stress at unprecedented levels Patients are flooding to virtual clinics and online medical councils Companies are boosting their digital strategy on the back of the coronavirus Digital and delivery servic
Slide 48: In a few months….
In a few months…. Patients …suffering from alcohol misuse will have access to a new digital therapy, vorvida®, which replaces the need for frequent visits to a counsellor during treatment ….will get their digital therapy reimbursed by their insurance company, just like any other medical intervention
Slide 49: Digital Therapeutics is a sub-category of Digital Health
Digital Therapeutics (DTx) is a sub-category of Digital Health Devices, sensors and wearables Examples include: Wearable and wireless devices Biometric sensors Telehealth Personalized Diagnostic products Examples include: Healthcare Telemedicine virtual visits Examples include: Remote patient monito
Slide 50: Regulatory and payer landscape is starting to adopt digital therapy
The regulatory and payer landscape is starting to adopt digital therapy … Significant movement in both US and Europe The two largest PBMs are reducing barriers for DTx The Digital Health Software Pre-certification Express Scripts is placing companies, offering (Pre-Cert) Program is part of an effort
Slide 51: Digital therapy is in its infancy
… but digital therapy is in its infancy Commercialization Reimbursement • Optimal pathways to commercialize and scale DTx are • Many payers still to establish payment and still unchartered reimbursement processes Pricing Disruptive technology • Entry barriers are low for offerings without clinical e
Slide 52: Establishing a pricing and payer model is critical for digital therapy
Establishing a pricing and payer model is critical for future success in digital therapy Alternative Payer Models Pharmaceutical Model • Reimbursement similar to pharmaceuticals or other medical benefits by insurance companies and employers Orexo sees several alternatives for Framework agreement mod
Slide 53: Pricing of digital therapy is scattered
The pricing of digital therapy is scattered, with significant differences driven by sophistication and clinical evidence High Counselling reSET = ca $1000 reSET-O = ca $1600 Price Level TBD Low None CLINICAL EVIDENCE Robust Pricing of Orexo DTx expected in the range of USD 600-1,000 per treatment 53
Slide 54: Digital therapy has potential to become a very important tool in addiction
Digital therapy has the potential to become a very important tool in the treatment of addiction The unmet need The value to patients Addiction is a highly stigmatized behavioural Patients can access a gold standard behavi- disease requiring a multi-faceted approach oral therapy with consistent and q
Slide 55: How we define our playing field
How we define our playing field Description Orexo position • Digital therapy products cover the full patient journey, • Our focus in on products that treat Aspect of ranging from Wellness and Prevention, symptom onset and a disease with measurable patient journey seeking care, diagnosis, condition m
Slide 56: Two digital therapies with potential to disrupt substance use disorder treatment
Two digital therapies with the potential to disrupt the current treatment of substance use disorder in the US vorvida® OXD01 A fully automated digital therapy scientifically “Digitizing” counselling at scale to offer with proven to reduce trouble-some drinking patterns in Zubsolv®, a full medication
Slide 57: A cohesive philosophy underpins the DTx commercial approach
A cohesive philosophy underpins the DTx commercial approach 1 2 3 4 5 Insight-Driven Precision Value Customer Resource Strategy Targeting Creation Engagement Optimization 57
Slide 58: Limited investments required to establish Digital business unit
Limited investments required to establish Digital business unit Establishing the Preparing vorvida® launch Launch ”digital therapy engine” • E-commerce infrastructure • Customer insight generation • Existing Orexo commercial • Payer and reimbursement hub • Marketing material and infrastructure to dr
Slide 59: The Orexo/GAIA partnered digital therapies – vorvida
The Orexo/GAIA partnered digital therapies – vorvida • vorvida® – digital therapy of alcohol misuse • OXD01 – digital therapy of opioid use disorder 59
Slide 60: vorvida at a glance
vorvida® at a glance The unmet need Our aim The US potential Alcohol misuse is a highly stigmatized, Establish vorvida® as the leading digital only few people seek professional help, and those who seek help will have issues finding quality support therapeutic for people suffering from alcohol misuse
Slide 61: 16.6 million Americans suffer some problematic drinking
16.6 million Americans suffer some problematic drinking and less than 10% are in treatment • Roughly 95 percent of Americans struggling with alcoholism 67.1 M Binge Alcohol Users do not feel they need treatment for their condition • In 2014, 431,000 women and 1.1 million men received treatment for a
Slide 62: So what is vorvida?
So what is vorvida®? vorvida® is a digital therapeutic targeted to people with excessive alcohol use who wish to reduce their alcohol consumption • A 6-month treatment platform anchored in Cognitive Behavioral Therapy (CBT) • Web-based, self-directed, individualized treatment that can be used with o
Slide 63: The evidence for vorvida
The evidence for vorvida® • Randomized controlled trial: 608 adults with problematic alcohol consumption randomized to vorvida® or care as usual/waitlist. ‐ Mean reduction in alcohol consumption of 104g per week compared to control condition (169g vs 65g after 6 months) ‐ >10 fewer binge drinking da
Slide 64: Early qualitative market research feedback
Early qualitative market research feedback PCP Therapist Psychiatrist “[The product] looks great – “I think it looks great. Cognitive “As long as they are willing to it’s something somebody can Behavior Therapy is an use a smartphone and they are do online on a regular basis, in established theory t
Slide 65: vorvida net sales potential of USD 120-200 million
vorvida® net sales potential of USD 120-200 million vorvida® US Net Sales 5 years post launch Forecast, USD Million given price of USD 600 per treatment1 200 67.1 M Binge Alcohol Users 160 120 16.6 M Heavy Alcohol Users 0.50% 0.75% 1.00% 1.5 M in + + + 8% 10% 12% Treatment vorvida® Market Share • La
Slide 66: Expecting FDA clearance in Q2 and launch in Q3 2020
We are expecting clearance from FDA in Q2 and launch in Q3 2020 Q2 2020 Q3 2020 Q4 2020 - -> FDA clearance Focused Expanded launch with launch improved market access 66
Slide 67: The Orexo/GAIA partnered therapies – OXD01
The Orexo/GAIA partnered therapies – OXD01 • vorvida® – digital therapy of alcohol misuse • OXD01 – digital therapy of opioid use disorder 67
Slide 68: OXD01 at a glance
OXD01 at a glance The unmet need Our aim The US potential Access to consistent high-quality counselling is a Develop the first digital therapy showing growing bottleneck in treatment of OUD. Medical assisted treatment should be complemented with psychosocial support significant sustainable positive
Slide 69: Strong logic for Orexo to invest in OXD01
Strong logic for Orexo to invest in OXD01 Compulsory Part of Pharmacological Therapy • All Buprenorphin/Naloxone (Bup/Nal) come with label instructing it ”should be used as part of a complete treatment plan that includes counseling and psychosocial support” • Limited access to psychosocial support i
Slide 70: OXD01 has a US sales potential of USD 150-225 million
OXD01 has a US sales potential of USD 150-225 million and in addition Orexo has global rights to the product Buprenorphine MAT Market Development OXD01 US Net Sales 5 years post launch Forecast, Buprenorphine Treated Population Million Forecast, USD given price of USD 600 per treatment 2,5 225 2,3 1
Slide 71: Estimated timeline to market for OXD01
The current estimated timeline to market for OXD01 2020 2021 2022 Finalize Clinical trial Regulatory development filing 71
Slide 72: Key take-aways
Key take-aways Strong macro tailwinds for digital therapeutics with increasing demand and beneficial legislative initiatives Orexo has an early mover advantage to help shape the direction of digital therapeutics Non-traditional payer model approach vorvida ® strong US sales potential and estimated t
Slide 73: Part 3 – Digital Therapeutics
Part 3 – Digital Therapeutics GAIA – a global leader in DTx - Dr. Mario Weiss, CEO and founder of GAIA AG
Slide 74: GAIA: Inventing Digital Therapy (DTx)
GAIA: Inventing Digital Therapy (DTx) Dr. Mario Weiss, MBA CEO Orexo Capital Market Day Stockholm 17/03/2020 GAIA AG Science I Technology I Therapy www.gaia-group.com © 2020 GAIA AG
Slide 75: GAIA is leading the next disruption in healthcare: Digital therapy
GAIA is leading the next disruption in healthcare: Digital therapy ► GAIA’s digital therapeutics (DTx) are as effective as drugs and medical devices, demonstrated in both numerous RCT’s with over 9,000 patients in various healthcare settings and real- world experiences in the US, Latin America, Euro
Slide 76: Digital therapy is automating consultation
Digital therapy is automating consultation – Is this creating the next disruptive industry segment in healthcare? Global Rx market size: $780 billion¹ Global diagnostics market size: $214 billion² Digital therapy software Expenditures doctors & psychotherapists: US: $186 billion, D: $38 billion³ ¹Eu
Slide 77: Physician consultation time is high in demand but limited in supply
Physician consultation time is high in demand but limited in supply: Digital therapy is disrupting the service paradigm by providing 24/7 unlimited access to consultation. Pharmaceutical industry Past: Physicians prescribed a “recipe” (Rx) that instructed pharmacists to mix certain ingredients Outpu
Slide 78: Can consultation with software be as satisfying for patients?
But: Can consultation with software be as satisfying for the patients as a personal consultation? Feedback examples of GAIA products: Psychotherapeutic consultation Orthopaedic consultation ► “How would you assess the quality of GAIA’s ► “How would you rate GAIA’s software software elevida® compared
Slide 79: Is software consultation as effective as personal consultation?
But: Is software consultation as effective as personal consultation with a physician or psychotherapist? Example: Effectiveness of GAIA’s therapy software deprexis® (depression treatment) RCT # of Patients Effectiveness (Cohen’s d) Meyer (2009) 396 Medium 0.639 Berger (2011) 76 Large (0.853) Moritz
Slide 80: The tech backbone: GAIA's AI software broca
The tech backbone: GAIA’s Artificial Intelligence (AI) software broca® simulates interaction between the patient and an empathetic physician/ therapist – highly individualized, fully automated and scalable. ► 100% mobile and cloud-based: for 24/7 usage on any mobile device (PC, tablet, smartphone) ►
Slide 81: Development pipeline focuses on large dynamic markets
Our development pipeline focuses on large dynamic markets: Neurology/Psychiatry (incl. SUD), Immunology, Oncology and Pain Examples: Headache/Migraine Fatigue in MS Depression/depressive symptoms Immuno-Oncology [Breast Cancer] Alcohol/Harmful drinking Digital psych-diagnostic Patient SDM Prostate C
Slide 82: Our development projects are in different stages
Our development projects are in different stages Oncology Immunology RA-I14B PS-I6b Neurology/ OXD-01 Psychiatry (incl. SUD) Miscellaneous DRB20b BPD-130 d-FAB Development Validation of Effects in RCTs Marketing and Sales Operations Licensing and Partnering Negotiations 82 © 2020 GAIA AG
Slide 83: GAIA cooperating with leading scientific institutions
GAIA is cooperating with leading scientific institutions in the development and evaluation of our DTx. Selection of R&D cooperation projects: ► HORIZON 2020: EU grant that is evaluating the possibilities to combine GAIA software with “wearable sensors” ► IDEMS (US patient MS society co-financed): Ev
Slide 84: Case study: fully automated psychotherapy (I)
Case study: - fully automated psychotherapy (I) ► Deprexis is a software that successfully simulates top of class psychotherapy against depression Overview ► Tailors interaction according to individual patients and therapy needs ► "Deep data" of every patient globally are anonymously captured and an
Slide 85: Case study: fully automated psychotherapy (II)
Case study: - fully automated psychotherapy (II) Current development status ► Deprexis proved its effectiveness and safety in 14 trials with over 7,000 patients ► 9 validated languages, ready to market globally with current focus on the US and Japan* The EVIDENT trial (sample 1013 patients) Psychoth
Slide 86: Hello, I am deprexis.
Hello, I am deprexis. www.deprexis.com 86 © 2020 GAIA AG
Slide 87: Thank you very much for your attention!
Thank you very much for your attention! Dr. Mario Weiss, MBA mario.weiss@gaia-group.com www.gaia-group.com 87 © 2020 GAIA AG
Slide 88: Part 4 – Outlook
Part 4 – Outlook Nikolaj Sørensen, CEO and President
Slide 89: Financial outlook 2020
Financial outlook 2020 › The buprenorphine/naloxone market will continue to show a double-digit growth › Net sales of Zubsolv® in the US are expected to be in line with 2019. The open formulary businesses will grow, while the previously highly rebated exclusive segments and cash will decrease › EBIT
Slide 90: 2020 a year with a steady news flow expected
2020 a year with a steady news flow expected Q2 Q3 Q4 › FDA clearance of vorvida® › Launch of vorvida® › Initiation of OX124 pivotal › Patent for nasal spray › FDA decision on fast track trial technology designation of OX124 › OX125 exploratory study › OXD01 development finished 90
Slide 91: Investment thesis
Strong value drivers for long-term growth 1. Addressing large markets 2. Strong financial position and with significant patient needs profitability Investment Focusing on becoming a leader within the large and growing space of addiction, Fueled by the sales of the lead product Zubsolv® which will co
Slide 92: Thank You!
Thank You! IR Contact: Lena Wange, IR & Communications Manager, ir@orexo.com. For more information please visit www.orexo.com. You can also follow Orexo at Twitter @orexoabpubl, LinkedIn and YouTube