Orexo AbOMXSTO: ORX

Q1 2026 Interim Report MASTER

· MarketScreener

Q1 2026

Interim report April 28, 2026

Well positioned to advance pipeline to value inflection points



Well positioned to advance pipeline to value inflection points

The sale of Zubsolv® US continues to impact the balance sheet and P&L

  • Redemption of the corporate bond

  • Payment of rebates and returns related to 2025 and earlier sale of Zubsolv

  • Restructuring of the organization

  • Transaction related fees and costs

Cash: SEK 334 m excl. SEK 52 m attributable to Dexcel



Successful transition after Zubsolv US divestment

Development programs making

steady progress

Exploring new applications of AmorphOX®

3



>30 yrs

of experience developing improved

pharmaceuticals based on proprietary drug delivery technologies.

- largest shareholder at 26 %

SEK 334 m

Cash position March. 31 2026





3 strategic focus areas to maximize value of the AmorphOX technology

EXPLORE

New applications of the AmorphOX® technology are key to unlocking substantial future value creation and partnership generation

DEVELOP

Proprietary projects drive greater value capture and renewed commercialization opportunities for Orexo, either standalone or together with a partner

PARTNER

Power partners' proprietary projects with the

AmorphOX technology

4



Preclinical PK study: Intranasal semaglutide formulated by AmorphOX vs oral formulation

Expanding the nasal semaglutide program to incl. oral delivery
  • GLP-1 semaglutide (nasal delivery): Exploratory formulation work progressed to improve bioavailablilty, supporting continued in-vivo evaluation

  • AmorphOX® - oral semaglutide delivery: Initiated formulation development of an oral semaglutide tablet ahead of a planned preclinical in-vivo proof-of-concept study in H2 2026.

    In addition, multiple patent applications filed.

  • Vaccine project (nasal delivery): Focused on expanding the evidence base through potential collaboration with Abera Bioscience and additional industry and academic partners.

AmorphOX formulations

Oral tablet1





Semaglutide stability at 40°C/75% RH

Semaglutide content (%)

100

80

60

40



20

Note: Rybelsus® is a registered trademark of Novo Nordisk A/S

1. Exposure of AmorphOX formulations were lower than injectable reference.

0

0 1 3 6

Months

EXPLORE

5



DEVELOP

Proprietary programs advanced to potential inflection points
  • Izipry continued to progress stability and reliability studies. NDA resubmission to the FDA is planned for Q3 2026.

  • OX640 accelerated its commercial-scale manufacturing readiness ahead of entering pivotal clinical studies. Also Human Factors studies were initiated.

  • First in-vivo study conducted for OX390, with data read-out in Q2 2026. Type C meeting planned with BARDA1 for in 2026 with focus on non-clinical plan.

1 BARDA contributes with the majority of the financing of the project and is valued up to USD 51 m. Upon a potential approval Orexo owns all rights to the product.

6

IZIPRY approaching FDA resubmission in Q3 2026

IZIPRY is based on AmorphOX® and designed to treat overdoses caused by synthetic opioids, such as fentanyl and fentanyl analogues

Orexo will seek partnership for US

commercialization



PARTNER 7

Scale and commercialize through strategic collaborations
  • The AmorphOX technology has applications beyond what Orexo can pursue independently.

  • Significant opportunities exist in development-stage products facing challenges with stability and/or bioavailability.

  • Orexo collaborates with both smaller and larger companies to assess the feasibility of applying AmorphOX® to their products or APIs.

  • The ambition is to expand this project portfolio beyond early-stage feasibility studies.



    Income statement

    Income statement SEK m

    Q1 2026

    Q1 2025

    Jan - Dec

    2025



    Comments Q1

    Net revenues

    5.0

    13.2

    26.0

    Cost of goods sold (COGS)

    -0.5

    -4.7

    -14.5

    Gross Profit

    4.6

    8.5

    11.5

    Operating Costs

    -79.5

    -84.7

    -364.3

    EBIT

    -75.0

    -76.3

    -352.7

    Net financial items

    -29.2

    -14.1

    -50.3

    EBT

    -104.2

    -90.3

    -403.0

    Net revenues SEK 5 m (13.2)

    • Lower Abstral ROW royalties due to expiring markets in line with the license agreement

    • Higher Edluar royalties mainly due to higher partner sales in Canada.

    • Lower Zubsolv ex-US revenues reflecting the absence of tablet sales to Orexo's partner Accord Healthcare while finalizing their Zubsolv manufacturing setup

      OPEX SEK -79.5 m (-84.7):

    • Lower Selling expenses due to lower marketing related costs for Izipry , DMHP activities and for positive adjustment for long-term incentive programs

    • Higher Admin expenses explained by higher expenses for DOJ investigation

    • Higher R&D costs due to higher costs for OX640 and OX390 partly offset by lower internal costs

      Tax

      -1.0

      -0.3

      -0.3

      Net profit/loss for continued

      operations

      -105.2

      -90.6

      -403.3

    • Higher Other operating income and expenses explained by higher BARDA reimbursement of OX390 related costs of SEK 7.1 m (0.0), higher fx gains partly offset by lower insurance reimbursement of DOJ investigation related legal expenses.

      EBIT SEK -75.0 m (-76.3)

      Net financial items operations SEK -29.2 m (-14.1):

      Net profit/loss for discontinued

      operations

      -28.7

      74.7

      1,042.6

      Net profit/loss

      -133.9

      -15.9

      639.3

      EBITDA continued operations

      -66.1

      -65.2

      -285.7

    • Higher bond loan costs of SEK -32.9 m (-11.5) following the early redemption of the outstanding senior secured social bond and by lower negative unrealized fx impact partly offset by higher interest income from bank accounts

      Net profit/loss SEK -105.2 m (-90.6)

      Net profit/loss discontinued operations SEK -28.7 m (74.7):

    • Mainly explained by post transaction related restructuring costs

8



Cash position

Cash flow SEK m

Q1 2026

Q1 2025

Jan - Dec

2025

Cash flow from operating activities

-33.3

-41.6

-195.4

Comments Q1

Investment activities

-0.2

-19.2

-19.2

Financing activities

-494.3

-5.9

-2.3

Cash flow (excl. exchange rate differences) continued operations

-527.9

-66.7

-216.9

Cash flow (excl. exchange rate differences) discontinued operations

-7.5

73.4

1,023.5

Exchange-rate differences in cash and cash equivalents

9.2

-10.8

-17.5

Cash and cash equivalents at the beginning of the period

912.4

123.3

123.3

Cash and cash equivalents at the end of period

386.2

119.1

912.4

Cash and cash equivalents Orexo

333.8

119.1

912.4

Cash and cash equivalents payable to Dexcel

52.3

-

-

Net cash position

386.2

-341.7

429.7

Cash and cash equivalents decreased with SEK 526 m from Q4 2025 (SEK 912 m) to SEK 386 m

SEK 490 m negative impact on financing activities from amortization of

the outstanding bond

SEK 33.3 m negative contribution from operating activities primarily impacted by:

  • Operating earnings of SEK -75.0 m

  • Interest and other financial expenses paid of SEK -26.9 m mainly due to early redemption of the bond loan

  • Adjustments for non-cash items of SEK -96.0 m mainly due to change in provisions -109.1 m from paid Zubsolv payer rebates

  • Positive changes in working capital of SEK 161.5 m

positively impacted by receivables SEK +164.9 m from collected Zubsolv sales related 2025 receivables partly offset by current liabilities SEK -3.4 m

Cash flow SEK from continued operations SEK -527.9 m

Cash flow from discontinued operations SEK -7.5 m (73.4) for the period mainly including post transaction related restructuring costs

9



Legal update

Subpoena issued by the US authorities in 2020

  • On July 14, 2020, Orexo became aware of an investigation by the US authorities which is ongoing

  • Based on communications from the US authorities, the company believes it refers to certain historic marketing messaging campaigns

  • Orexo, as of this date, is not aware of any filed civil or criminal case related to the

    investigation

  • Orexo´s position is that Zubsolv® has been promoted in a compliant and responsible manner, but Orexo is also seeking to negotiate a resolutions to this matter

  • Change in administration may slow down process due to US process of politically

appointed US prosecutors.

10



Value opportunities short, medium and long term

2026 2027 2028 2029 and beyond

Launched

products

IzipryTM OX640

  • Zubsolv® EU • Zubsolv US earn-out

  • Q3 FDA refiling • Q1 FDA approval

    • Partnering

  • Q4 pivotal trial start • H1 trial results

    • Start final pivotal trials

    • Zubsolv US earn-out

    • Outcome final pivotal trials

    • FDA / EMA submission

      • 2029 FDA / EMA approval

        OX390

      • Q2 in-vivo study results

        • BARDA financing stage 2

  • Conclusion of non-clinical program

    • Continued clinical studies, FDA review process, submission and approval

      Explore

      GLP-1

      Partnering is a continuous process for all projects without specific target dates

      agonist / vaccines

      • Additional in-vivo

        studies

        • First human studies

      (if in-vivo are successful)

  • Development plan • Continued clinical studies, FDA review process, submission and approval

11



12

Q&A

Financial Calendar

  • May 7, 2026, 4 pm

  • July 16, 2026, 7 am

  • Oct. 22, 2026, 7 am

  • Feb. 4, 2027, 7 am

Annual General Meeting

Interim Report Q2 2026

Interim Report Q3 2026

Interim Report Q4 2026, incl. Full Year Report

BD & Scientific Conferences

  • May 10, 2026

  • June 22-25, 2026

  • Sep. 16 -17, 2026

D. RDD 2026, Phoenix, AZ

BIO International San Diego, CA

IPAC-RS 2026 Nasal Innovation Forum



Orexo is headquartered in Uppsala, Sweden, with a US subsidiary in New Jersey. The company has been listed on Nasdaq Stockholm's main market since 2005 (STO: ORX) and trades as ADRs on the OTCQX market in the US (OTCQX: ORXOY).

Thanks

https://www.orexo.com

IR@orexo.com



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