1

  1. commercial stage pharma company with an exciting pipeline

June 2024

Orexo supports

the UN's Agenda

2030 with a focus on:

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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.

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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:

  1. Improved stability
  2. Reduced sensitivity to temperature changes
  3. 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

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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.

  1. 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
  2. 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.

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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

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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

  1. 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

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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.

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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.

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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.