Orexo Ab · OMXSTO:ORX
Orexo Ab — ABGSC Life Science Summit (May 2021)
23 slides from Orexo Ab's conference presentation, May 25, 2021
Slide 1: ABGSC Life Science Summit
Improving the lives of people suffering from mental illness and substance use disorders ABGSC Life Science Summit Nasdaq Stockholm: ORX May 25, 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 treatment of mental illness
Orexo – focusing on the large and growing space of treatment of mental illness • 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 • Commercial presence in the US
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 business promoted by our US Pharma and area within DTx with three revenue Digital Therapeutics businesses generating products in the US market in 2021 Orexo ob
Slide 5: 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 6: 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 7: Continued good progress with the aim to file with the FDA in the US 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: Orexo Digital Therapeutics (DTx)
Orexo Digital Therapeutics (DTx) Twelve weeks of digital cognitive behavioral therapy for mild 17 million patients in the US suffered to moderate to severe depression from depression pre-Covid One of the most studied digital therapies in depression with 11+ original trials in over 2,800 patients Twe
Slide 10: 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 11: 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 12: 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 13: DTx sales still to accelerate, some preliminary drivers developing
DTx sales still to accelerate, some preliminary drivers developing Several important milestones reached during the quarter • Agreement with Magellan Rx and two additional insurance companies to collect real world evidence (RWE) for modia™ • Large US Tech company is testing the vorvida® and deprexis®
Slide 14: ZUBSOLV® - contributing to a solid foundation for future growth
ZUBSOLV® - contributing to a solid foundation for future growth
Slide 15: Q1´21: The US opioid crisis fuels a market characterized by strong growth
Q1´21: The US opioid crisis fuels a market characterized by strong growth Market Q1: YoY growth impacted negatively by Covid-19 build-up in Q1´20 and QoQ by less selling days in Q1´21 Q1’21 vs Q1’20 Growth Market Volume Sales, Quarterly NTRx Total Market: +9% 2 500 000 By Segment Open +8% 2 000 000
Slide 16: Q1´21: ZUBSOLV® stable in open segment QoQ, despite less selling days
Q1´21: ZUBSOLV® stable in open segment QoQ, despite less selling days The negative impact from formulary changes at UHC/Humana is decelerating ZUBSOLV® growth ZUBSOLV® by Access Segments, R4W Average NTRx in Bold Color; Single Week NTRx in Lighter Shade (Q1 2021 vs Q4 2020) Open (excl non-retail) UH
Slide 17: 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 18: Financial & legal information
Financial & legal information
Slide 19: 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 20: 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 21: Promising value triggers in 2021
Promising value triggers in 2021 Q1 Agreements with insurance companies for DTx products Magellan Rx and two BCBS insurance Orexo is in concrete discussions with insurance companies, both with regards to reimbursement and companies to pilot projects to test one or more of the DTx in a real world s
Slide 22: 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 23: 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