1
- commercial stage pharma company with an exciting pipeline
June 2024
Orexo supports
the UN's Agenda
2030 with a focus on:
2
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, Orexo is the source for all data contained in this presentation. Such data is provided as at the date of this presentation and is subject to change without notice.
- This presentation does not constitute or form part of, and should not be construed as, an offer or invitation for the sale of or the subscription of, or a solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any offer, contract, commitment or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of Orexo
- The shares of Orexo have not been registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States (as such term is defined in Regulation S under the Securities Act) except pursuant to an exemption from, or a transaction not subject to, the registration requirements of the Securities Act or unless registered under the Securities Act.
- The information in this presentation has not been independently verified. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained herein. None of Orexo, any of its shareholders, or any of their respective subsidiary undertakings or affiliates or any of such person's directors, officers or employees, advisers or other representatives, accepts any liability whatsoever (whether in negligence or otherwise) arising, directly or indirectly, from the use of this presentation or otherwise arising in connection therewith.
- This presentation includes forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance, achievements or industry results to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this presentation and Orexo expressly disclaim any obligation or undertaking to release any update of, or revisions to, any forward-looking statements in this presentation as a result of any change in our expectations or any change in events, conditions or circumstances on which these forward-looking statements are based.
- This presentation is not a prospectus in accordance with the Swedish Financial Instruments Trading Act (Sw. lagen (1991:981) om handel med finansiella instrument) or any other Swedish laws or regulations. Neither the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) nor any other Swedish regulatory body has examined, approved or registered this presentation.
3
Orexo in brief
Orexo is a Swedish pharmaceutical company with over 25 years of experience developing improved pharmaceuticals based on proprietary drug delivery technologies.
Addresses unmet needs
among patients and healthcare systems with a focus on opioid use disorder (OUD) and adjacent diseases
Own commercial platform
in the US, incl the lead pharma product Zubsolv® for OUD & complementary digital mental health programs.
R&D pipeline based on the
AmorphOX® - a drug
delivery platform tested on a broad range of small & large molecules showing:
- Improved stability
- Reduced sensitivity to temperature changes
- Superior bio-availability.
Net Revenues LTM1 USD 58.7m
EBITDA LTM USD 2.3m
Of which US Commercial USD 18.3 m
Liquid funds
USD 19.1 m
Note: OX124, high dose overdose rescue medication filed with the FDA in Q4 2023. prototype photo used. Conversion rate USD/SEK 10.39.
1. Last Twelve Months.
4
Commercial products and development pipeline
Commercial products
R&D
Product or Project/Indication/Technology | Exploratory | Preclinical | Clinical development phases | Registration | Approved and/or Launched | |||
Partners | ||||||||
US | EU | RoW | ||||||
Zubsolv® Opioid Use Disorder (OUD) / Sublingual platform | ||||||||
Abstral® Breaktrough Cancer Pain / Sublingual platform
Edluar® Insomnia / Sublingual platform
DMHP1 OUD, alcohol mgmt, depression / Broca technology platform
OX124 Naloxone, Opioid Overdose / AmorphOX®
OX125 Nalmefene, Opioid Overdose / AmorphOX
OX640 Adrenaline, allergic reactions / AmorphOX
Others (small and large molecules) AmorphOX
OX-MPI Vipoglanstat, Endometriosis
1. Digital Mental Health Programs, incl. MODIA®, Vorvida® and Deprexis®
5
US market: Commercial products targeting a large unmet need
Fatal overdoses have surged due to synthetic opioids1
deaths | 120000 |
80000 | |
100000 | |
of | 60000 |
Number | |
20000 | |
40000 | |
0 |
2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | |
Total overdose deaths | All opioid overdoses | ||||||
Synthetic opioids eg fentanyl | |||||||
Maintenance | Digital mental | Rescue | |||||
treatment | health program medication |
Launch expected
late 2024
8,900,000
are misusing opioids2
6,100,000
are dependent on opioids3
2,400,000
are undergoing treatment4
"Giana made the switch to heroin, and it was all downhill from there."
Elise discovered her daughter's opioid dependence months before she died from an overdose.
1 Center of Disease Control. 2,3,4 Substance Abuse and Mental Health Services Administration
Read more at the Orexo blog
6
Zubsolv® an important cash generator
Net revenues | Sales and market dynamic in Q1 | Long-term growth drivers |
since launch 2013 | ||
USD m | • 4% price increase from Jan. 1, stable Zubsolv |
sales to pharmacies, but the sector saw | |
510 | significant drop in wholesaler inventory in |
Feb./Mar. Expected to normalize in Q2. | |
• Low market growth in prescriptions of 3% vs | |
Q1 2023 and 1% vs Q4 2023. Significant decline |
in Medicaid with minus 9% YoY following Medicaid disenrollment. Commercial growth of 9% YoY.
• Zubsolv declined slightly with 4% versus Q1 2023 and 2% vs Q4, explained by United Health Group/Humana and Medicaid market decline.
• Zubsolv outperformed the Medicaid segment both YoY +0% and QoQ -2%. Continued double- digit growth in new Medicaid contracts YoY.
Note: Conversion rate USD/SEK 10.39.
- Based on last 4w and 6w average NTRx volume. Note weekly prescription data is volatile and is influenced by public holidays, weather and changes to reimbursement
- Last Twelve Months
- The Mainstreaming Addiction Treatment Act' effective Jan. 1, 2023, removes the cap on the numbers of patients HCP´s can treat and reduce the requirements for prescribing medication assisted treatments (MAT)
- Significant inflow of new funds to finance treatment initiatives from USD 54 billion abatement funds
- IMPROVED POSITION - Orexo is about to become the player in the US market with the most comprehensive treatment solutions for people suffering with OUD.
7
AmorphOX® - a versatile, world-class platform for intranasal drug delivery
Chemical degradation after accelerated stability studies at 40oC/75% RH | |||||
Apomorphine | Cetrorelix | Eletriptan | Olanzapine | Enzyme | Loxapine |
Retained activity after | |||||
0.4% after 24 months | 0.5% after 6 months | 0.5% after 12 months | 0.2% after 6 months | 1 month | 0.3% after 24 months |
Ketorolac | Nalmefene | Naloxone | Spike protein | ||
Epinephrine | |||||
Retained activity after | ||||
0.8% after 6 months | ≤0.1% after 15 months | ≤0.1% after 24 months | 1.8% after 18 months | 3 months |
7
8
OX124 has unique properties and is progressing towards launch late 2024/early 2025
Intranasal powder delivery of naloxone & nalmefene
High-dose rescue medication
containing naloxone, | Filed with | |
the FDA in | ||
OX124 | designed to reverse the | Q3 2023 |
amorphOX® | effect of the most |
powerful synthetic | |
opioids, such as fentanyl |
OX124 diiferentiation & competitive advantages
Rapid absorption and substantially higher plasma concentrations of naloxone compared to the current market leader - critical in avoiding brain damages, saving lives and preventing re-intoxificationduring the revival process
Unique properties compared with existing products i.e., being
Small in | Built-in desiccant to |
size, | protect the powder |
easy to | from any moist |
carry | exposure |
The usage and
application is simple, fast and most of all: high-dose
- powder-basedproduct while other products are liquid- based
The amorphOX powder-based technology provides for
longer shelf-life and makes it less vulnerable to temperature changes
If approved, OX124 will be the only product on the market that does not freeze at temperatures below zero degrees
1 Estimated market size based on historical data and company financial reports 2, 3 Center of Disease Control and Prevention
Easy to carry as OX124 comes in a unique device that is less bulky
OX124 has patents protecting the product until 2039
9
OX640 a new treatment of allergic reactions
Improved stability as a more sustainable solutions | ||||||||
Comparative stability study | Comparative light stability study | |||||||
at 40 Celsius/75% RH1 | at 1.2 M lux for 18h | |||||||
epinephrine | epinephrine | |||||||
Preservative-free | No antioxidants, no | content (%) | degradation (%) | |||||
26,8 | ||||||||
(which may cause | chelating agent, no | 110 | ||||||
allergic reactions) | pH adjustment | 105 | ||||||
100 | ||||||||
95 | ||||||||
Manufacturing | More convenient | 90 | ||||||
without precaution | storage and longer | |||||||
for light or need | shelf life | 85 | ||||||
for protective gas | ||||||||
OX640: Nasal | 80 | |||||||
3,2 | ||||||||
epinephrine enabled | 75 | |||||||
Highly improved | ||||||||
by amorphOX remains | months | 0,1 | 0,1 | |||||
stability versus any | 70 | |||||||
stable in | ||||||||
available liquid | ||||||||
any life situation | 0 | 1 | 3 | 6 | 9 | Initial | Light exposed solution | |
formulation | ||||||||
OX640 | EpiPen® | OX640 | EpiPen® | |||||
First clinical trial indicates a superior bio-availability of OX640 compared to other liquid based nasal epinephrine products1
Source: Company information. Notes: 1) Relative humidity.
1 First OX640 ´clinical study compared to Epipen and comparison with other liquid based nasal products in purely cross-over comparison and nothead to head studies.
10
Q1 2024 - starting 2024 with a positive EBITDA
Income statement | Q1 | Q1 | FY | |
USD m | 2024 | 2023 | 2023 | |
Net revenues (NR) | 13.4 | 15.3 | 61.5 | |
of which US Pharma | 12.4 | 13.5 | 55.6 | |
Gross Profit | 12.1 | 12.5 | 52.9 | |
OPEX | -12.6 | -18.2 | -63.4 | |
EBIT | -0.5 | -5.7 | -10.5 | |
EBITDA | 1.5 | -3.9 | -3.1 | |
Liquid funds | 19.1 | 26.9 | 16.5 | |
Comments Q2
Q1 2024 comments
- NR decline primarily due to higher wholesaler destocking, slightly lower demand and FX headwind. Also, Zubsolv EU impacted negatively.
- Significantly reduced OPEX due to lower costs for IP, US Commercialization org., and R&D
- Positive EBITDA
Other financial highlights:
-
Refinancing of the old bond by the issue of a
4 Y secured bond of SEK 500 m (USD 48.1) under a social financing framework.
Note: Conversion rate USD/SEK 10.39.
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Orexo AB published this content on 14 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 June 2024 11:09:05 UTC.