Orexo Ab · OMXSTO:ORX
Orexo Ab — Corporate Update (October 2020)
45 slides from Orexo Ab's corporate update, Oct 1, 2020
Slide 1: Update on Orexo Digital Therapeutics
Develops and commercializes improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health Update on Orexo Digital Therapeutics Nasdaq Stockholm: ORX October 1st 2020 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: Objective of today's telco
Objective of today’s telco Objective of today’s telco Share the progress in developing our new digital therapy business Provide more insights into the scientific evidence supporting out digital therapies Provide context to the agreements with GoGoMeds and Trinity Health (ND) Launch the brand n
Slide 4: Speakers
Speakers Nikolaj Sørensen Michael Sumner Dennis Urbaniak President and CEO Chief Medical Officer EVP Digital Therapeuitics
Slide 5: Agenda
Agenda • Strong financials to drive future growth • DTx: a branch out strategy from OUD and pharma • deprexis®and vorvida®: clinical evidence • DTx: commercial progress • Orexo: a unique life science company in Sweden 5
Slide 6: Orexo in brief
Orexo in brief Corporate Headquarters • Developed four commercial products with worldwide (Uppsala, Sweden) approval Corporate functions and Development • Addresses unmet need within the growing space of substance use disorders (SUD) and mental health • Broad product portfolio and development pipeli
Slide 7: 2012-2019 successful strategic focus on building a solid foundation for investments in future growth drivers
2012 – 2019 successful strategic focus on building a solid foundation for investments in future growth drivers Strong cash position and cash flow from ZUBSOLV®.. ..enable investments in future growth EBITDA SEK m 2012-2019 Acquire US rights to vorvida® SEK 817 m 300 and deprexis® Cash 250 position
Slide 8: Product & pipeline portfolio addressing large markets with unmet patient needs
Product & pipeline portfolio addressing large markets with unmet patient needs Phase Approved/Launched Exploratory Preclinical Registration 1 2 3 US EU RoW Pharmaceuticals Opioid Use Disorder ZUBSOLV® Abstral® Breakthrough Cancer Pain, Kyowa Kirin Edluar® Insomnia Mylan Worldwide OX124 Naloxone - Op
Slide 9: Agenda
Agenda • Strong financials to drive future growth • DTx: a branch out strategy from OUD and pharma • deprexis®and vorvida®: clinical evidence • DTx: commercial progress • Orexo: a unique life science company in Sweden 9
Slide 10: Leveraging our existing commercial pharma platform makes DTx an attractive opportunity
Leveraging our existing commercial pharma platform makes DTx an attractive opportunity to diversify the company and drive future growth • Almost all industries have been transformed or are under transformation by digitalization; healthcare is not an exception • To meet increased demand from an aging
Slide 11: Mental health represents a natural branch-out opportunity for Orexo
Mental health represents a natural ”branch-out” opportunity for Orexo due to its significant co-occurence with drug addictions • Drug addiction, also called substance use disorder, is a disease that affects a person's brain and behavior and leads to an inability to control the use of a drugs Drug Co
Slide 12: Our ambition is to become a leader in digital therapeutics
Our ambition is become a leader in digital therapeutics, leveraging our existing commercial infrastructure and new technical platforms to scale up Enter DTx Establish the platform Expand presence and portfolio TM 12
Slide 13: With digital therapies, Orexo is well positioned to address unmet needs
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 14: Digital therapeutics is in early stages and several hurdles need to be addressed
Digital therapeutics is in early stages and 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 reimbu
Slide 15: Agenda
Agenda • Strong financials to drive future growth • DTx: a branch out strategy from OUD and pharma • deprexis®and vorvida®: clinical evidence • DTx: commercial progress • Orexo: a unique life science company in Sweden 15
Slide 16: At a Glance: Burden of depression in the US
At a Glance: Burden of depression in the US 7.1% of adults had ≥1 Major depression (MDE) in the past year1 3–4× increase in symptom prevalence during COVID-19 ~2 million YLDs4 4.5% had ≥1 MDE with severe pandemic2,3 impairment1 Associated with various health conditions including heart disease, A fac
Slide 17: Unmet treatment needs in depression
Unmet treatment needs in depression 2017 Past Year Treatment Received Among Adults with MDE2 Medication Only, • Despite the availability of effective 6% interventions for depression, delays in initial No Treatment, treatment contact remain problematic1 35% • A longer duration (i.e., >6 months) of un
Slide 18: Overview of deprexis
Overview of deprexis® • deprexis® is a clinically-proven digital therapeutic for adjunctive treatment of symptoms of depression, rooted in evidence-based, Cognitive Behavioral Therapy (CBT) and other psychological approaches. • Designed to offer tailored, interactive psychotherapy interventions via
Slide 19: deprexis has been studied in RCTs including >2800 patients
deprexis® has been studied in 11 RCTs including >2800 patients Study N Evidence Meyer (2009) 396 First RCT to demonstrate the effectiveness of deprexis vs care as usual (CAU) Berger (2011) 76 Both guided and unguided use of deprexis were shown to be effective vs CAU Moritz (2012) 210 Replicated resu
Slide 20: deprexis demonstrates consistent clinical effect across multiple settings
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: 0.40–0.62) and low heterogeneity (I2= 26 %) Study Statistics Sample Size St
Slide 21: Beevers (2017): Effectiveness of an internet intervention for depression
Beevers (2017): Effectiveness of an internet intervention (deprexis®) for depression in a US adultsample • A parallel-group, pragmatic randomized controlled trial in treatment-seeking adults with elevated depression • Randomized to receive an 8-week course of treatment immediately or after an 8-week
Slide 22: deprexis demonstrated significantly lower self-reported depression symptoms
deprexis® demonstrated significantly lower self-reported depression symptoms post-treatment Intent-To-Treat Sample QIDS-SR Scores From Baseline in 8 Weeks deprexis® was also associated with improvements 18 in other facets of depression and anxiety: 16 • 5.8-point improvement on the HRSD (d = 0.68; 1
Slide 23: deprexis was associated with a ~6-point reduction in BDI score
deprexis® was associated with a ~6-Point reduction in BDI score Change in Depression (Completers) • deprexis® was associated with a moderate deprexis (n = 320) TAU/WL (n = 76) effect size vs TAU after 9 weeks of 30,00 27,11 27,15 treatment (d = 0.64) n = 76 n = 57 26,72 • 9-week pre-post effect size
Slide 24: At a Glance: Burden of unhealthy alcohol consumption in the US
At a Glance: Burden of unhealthy alcohol consumption in the US 16.6 million binge drinka ≥5 5.1% of adults engaged in Causal factor in >200 short- or times in the past month1 heavy drinkingb on average long-term disease and injury over the past year2 conditions3 1 million (female) and 3.2 93,296 dea
Slide 25: Overview of vorvida
Overview of vorvida® • vorvida® delivers evidence-based Cognitive-Behavioral Therapy techniques via an internet-based intervention in order to reduce alcohol consumption among adults with problematic drinking behaviors • vorvida® does not require human guidance or support; the program uses artificia
Slide 26: Zill study design
Zill study design1,2 • Parallel-group pragmatic randomized controlled trial conducted in Germany to test the effectiveness of vorvida® in reducing alcohol consumption versus Care As Usual (CAU) • 608 patients completed the baseline questionnaire and were randomized 1:1 to receive vorvida® or CAU • I
Slide 27: Zill outcome measures
Zill outcome measures1,2 • Primary outcome measure: • Average daily consumption of grams of pure alcohol determined by: • Quantity-Frequency-Index (QFI): Measures self-reported alcohol consumption during past 30 days • Timeline-Follow-Back (TFB): Measures self-reported beverage consumption during th
Slide 28: vorvida was associated with a reduction in average daily alcohol consumption
vorvida® was associated with a reduction in average daily alcohol consumption Quantity-Frequency-Index (QFI) Timeline-Follow-Back (TFB) Vorvida (n = 306) CAU (n= 302) Vorvida (n = 306) CAU (n = 302) 70 60 Pure Alcohol per Day in Grams Over Past 7 Pure Alcohol per Day in Grams Over Past 30 60 50 50 4
Slide 29: Secondary Outcome: Change in drinking behaviors
Secondary Outcome: Change in drinking behaviors Binge Drinking Drunkenness Vorvida (n = 306) CAU (n= 302) Vorvida (n = 306) CAU (n = 302) 18.0 5.0 16.8 4.6 Number of Days of Drunkenness Within Number of Days of Binge Drinking Within 16.0 4.4 4.4 15.3 14.6 4.1 Past 30 Days (marginal mean) 14.0 14.5 4
Slide 30: modia will offer easily accessible behavioral health treatment for OUD
modia™ will offer easily accessible behavioral health treatment for OUD • Medication-Assisted Treatment (MAT) is to be used as part of a complete treatment plan which includes counseling and psychosocial support1 • However, many patients with OUD do not have access to counseling and psychosocial sup
Slide 31: Our name: modia
OUR NAME Our na me TM O u r n a m e , M O D I A ™ , c o m e s f rom the roots of several other words: ‘Mod’ deri ved f rom m o d e r n a n d m o d e a n d ‘dia’ f rom day, s p e a k i n g to a n e w cha pter in opioid a ddi cti on treatment. It ca ptures the feeling of b e i n g forward- l ooki ng a
Slide 32: Agenda
Agenda • Strong financials to drive future growth • DTx: branch out strategy from OUD and pharma • deprexis®and vorvida®: clinical evidence • DTx: Goodcommercial commercialprogress progress • Orexo: a unique life science company in Sweden 32
Slide 33: vorvida video
vorvida® video View audio presentation 33
Slide 34: Orexo aims at digital therapeutics with evidence-based therapeutic interventions
Orexo aims at digital therapeutics (DTx) with evidence-based therapeutic interventions while improving efficiency in the delivery of health care Orexo current DTx Common Features • Digitized counseling designed on best practice standards of delivering Cognitive Behavioral Therapy (CBT) • Products su
Slide 35: Several important milestones have been reached and broader commercialization is about to start
Several important milestones have been reached and a broader commercialization is about to start Good progress in the launch of the first two DTx.. ..but we are still in early stages Medical need and treatment value of No established reimbursement and our DTxs is established and well distribution
Slide 36: Launch in July had a focus on payors to start discussions on reimbursement
Launch in July had a focus on payors to start discussions on the optimal reimbursement model and to start a process to win contracts Alternative Payor Models Pharmaceutical Model • Reimbursement similar to pharmaceuticals or other medical benefits by insurance companies and employers Focus Framework
Slide 37: Examples of agreements are GoGoMeds and Trinity Health (ND)
Examples of agreements are GoGoMeds and Trinity Health (ND) Both agreement are good stepping stones to larger opportunities within their networks • Partnership to make deprexis® and vorvida® • Trinity Health is a large network of non-profit available for adjunctive treatment of depression healthcare
Slide 38: Our investment and go to market strategy is highly targeted
Our investment and go to market strategy is highly targeted and will scale as access is created in high need markets 1 2 3 4 5 Insight-Driven Precision Access Customer Scaling and Strategy Targeting Creation Engagement Resource and Value Optimization Creation Current launch focus 38
Slide 39: Developing user experience driven program content
To complement the significant evidence supporting our products, we are developing user experience driven program content vorvida® website and online purchasing and reimbursement platform is now LIVE! deprexis® “Day 1” site meetdeprexis.com vorvida® marketing materials vorvida® website us.vorvida.com
Slide 40: Patient engagement a key to understand the disease and gain credibility
Patient engagement a key to understand the disease and gain credibility for our products 40
Slide 41: Orexo offers a range of services to ensure patient engagement and support
Patients suffering from depression or alcohol misuse are vulnerable and Orexo offers a range of services to ensure patient engagement and support vorvida® patient services, available from September include specialty hub services for insurance reimbursement, customer service, e-commerce storefronts,
Slide 42: Agenda
Agenda • Strong financials to drive future growth • DTx: a branch out strategy from OUD and pharma • deprexis®and vorvida®: clinical evidence • DTx: Goodcommercial commercialprogress progress • Orexo: a unique life science company in Sweden 42
Slide 43: Value drivers for long-term growth 1-2
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 44: Value drivers for long-term growth 3-5
Value drivers for long-term growth 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 commercial exc
Slide 45: Q&A
Q&A 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