Orexo AB · OMXSTO:ORX
Orexo AB — Handelsbanken Mid Small Cap Seminar (June 2021)
25 slides from Orexo AB's conference presentation, Jun 3, 2021
Slide 1: Handelsbanken Mid Small Cap Seminar
Improving the lives of people suffering from mental illness and substance use disorders Handelsbanken Mid Small Cap Seminar Nasdaq Stockholm: ORX June 3, 2021 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 – focusing on the large and growing space of mental illness and substance use disorders
Orexo – focusing on the large and growing space of treatment of mental illness and substance use disorders • Developed four commercial • Net revenues SEK 623 million Profitable US Pharma pharmaceutical products • EBITDA SEK 347 million operations with worldwide approval • EBIT Margin 53 percent • Co
Slide 4: OX124 - designed to reverse the effect of the most powerful synthetic opioids
OX124 - designed to reverse the effect of the most powerful synthetic opioids
Slide 5: OX124 – targeting a > USD 300 million market
OX124 – targeting a > USD 300 million market Expected launch in 2023 The unmet need Available rescue medications have been developed for heroin overdoses, but most patients are today dying from synthetic opioids like fentanyl. The use of Fentanyl and death from overdose has accelerated during Covid-
Slide 6: 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 Plasma OX124 • Rescue more patients with concentration Narcan® Nasal Spray the first dose (~34% of ove
Slide 7: Continued good progress with the aim to file with the FDA in mid-2022
Continued good progress with the aim to file with the FDA in the US mid-2022 Q1 progress 2021-2023 Continue testing commercial supply Commence the pivotal bridging study Q2-Q3 chain to meet FDA reliability demands Establish quality system and testing Mid- File the new drug application with FDA m
Slide 8: DTx – a high-potential market in its infancy
DTx – a high-potential market in its infancy TM
Slide 9: DTx - an attractive opportunity to diversify the company and drive future growth
DTx - an attractive opportunity to diversify the company and drive future growth • Continuous increase in scientific evidence of the value from digital health products • Covid-19 has significantly accelerated the utilization of non face to face interactions between healthcare providers and patients
Slide 10: 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 11: Orexo Digital Therapeutics (DTx)
Orexo Digital Therapeutics (DTx) Twelve weeks of digital cognitive behavioral therapy for mild 17 million patients in the US to moderate to severe depression suffered from depression pre- One of the most studied digital therapies in depression with Covid 11+ original trials in over 2,800 patients Tw
Slide 12: The Orexo portfolio has unparalleled clinical evidence and functionality in the DTx landscape
The Orexo portfolio has unparalleled clinical evidence and functionality in the DTx landscape DTx Landscape Only Orexo offers digital therapeutics with evidence from 11+ well-controlled clinical trials powered to evaluate efficacy. Our proprietary AI platform learns users’ preferences and is designe
Slide 13: Commercial activities remain focused on specific target groups in anticipation of reimbursement
Commercial activities remain focused on specific target groups in anticipation of reimbursement FDA Product Targeted Reimburse- Broad Pilot/trial approval/access available launch ment launch Pennsylvania EUA us.vorvida.com multiple From Q3, 2020 test expanded Test same route Subject to
Slide 14: Several important milestones reached recently
Several important milestones reached recently Payers & IDNs Agreement with Magellan Rx and two additional insurance companies to collect real world evidence (RWE) for modia™. Continued discussions with Trinity Health ND. Employers Large US Tech company is testing vorvida® and deprexis® with thei
Slide 15: Sales is improving, but remains limited in Q1
Sales is improving, but remains limited in Q1 • Covid-19 has made sales processes more complex and time consuming • Pilot test with direct to consumer promotion of vorvida® has been optimized with good results • Adjustment in price to get below 100$/month • To drive adoption Orexo introduced a “mone
Slide 16: ZUBSOLV® - contributing to a solid foundation for future growth
ZUBSOLV® - contributing to a solid foundation for future growth
Slide 17: Q121: The US opioid crisis fuels a market characterized by strong growth
Q121: The US opioid crisis fuels a market characterized by strong growth Market Q1: YoY growth impacted negatively by Covid-19 build-up in Q120 and QoQ by less selling days in Q121 Market Volume Sales, Quarterly NTRx Segment growth 2 500 000 Open +8% 2 000 000 Non-reimbursed +10% 1 500 000 Total mar
Slide 18: Q121: ZUBSOLV® stable in open segment QoQ, despite less selling days
Q121: ZUBSOLV® stable in open segment QoQ, despite less selling days The negative impact from formulary changes at UHC/Humana is decelerating Access segment NTRx development Growth QoQ 5,9 +0% Open 5,8 5,7 5,8 3,3 UHC/Humana 3,1 2,8 2,7 -8% 1,2 1,2 1,1 1,2 Non-Reimbursed -4% 1 R4W Average NTRx in Bo
Slide 19: Several possible triggers for ZUBSOLV® to return to growth in 2021
Several possible triggers for ZUBSOLV® to return to 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% …Legislative change in Kent
Slide 20: Financial, legal & near-term triggers
Financial, legal & near-term triggers
Slide 21: A transformative last 12 month period building for future growth
A transformative last 12 month period 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 LTM Q1´21even LTM1,2 US Pharma net revenues LTM Q1´21even et revenues SEK 621 m USD 66 m Group EBITDA
Slide 22: No changes in the two ongoing legal processes in Q1, except new patent issued for ZUBSOLV®
No changes in the two ongoing legal processes in Q1, except new patent issued for ZUBSOLV® Subpoena Patent infringement litigation against Sun Pharma • On July 14, 2020 Orexo US received subpoenas to • Orexo on September 13 filed a patent infringement provide US Authorities with certain information
Slide 23: Promising value triggers in 2021
Promising value triggers in 2021 H1 Agreements with payers for DTx products Orexo is in concrete discussions with insurance companies, both with regards to reimbursement and pilot projects to test one or more of the DTx in a real world setting. H1 Agreements with employers for DTx products The posit
Slide 24: Promising value triggers in 2021
Promising value triggers in 2021 H2 ZUBSOLV® stabilization and growth With the expectation of Covid-19 to have significantly reduced impact on our ability to meet customers and on the unemployment in the US, we expect to see ZUBSOLV® stabilize and grow Q3 Results from pivotal trial for OX124 Orexo e
Slide 25: Thank You
Thank You IR Contact: Lena Wange, IR & Communications Director, [email protected]. For more information please visit www.orexo.com. You can also follow Orexo at Twitter @orexoabpubl, LinkedIn and YouTube
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