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Orexo Interim Report Q3 2024

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Orexo reported Q3 2024 financial results with total net revenues of SEK 136.5m, down from SEK 156.1m in Q3 2023. The company posted a negative EBITDA of SEK -0.7m, improving from SEK -9.5m last year. US Commercial segment revenues declined to SEK 131.0m from SEK 140.4m. Net earnings deteriorated to SEK -41.9m from SEK -33.3m. The FDA requested additional technical data for OX124, their high-dose naloxone rescue medication. Despite challenges, including higher legal costs and lower Zubsolv sales, the company maintained its 2024 financial guidance and initiated a phase 1 study for OX640 in allergic rhinitis patients.

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Positive

  • EBITDA improved to SEK -0.7m from SEK -9.5m year-over-year
  • Operating expenses decreased by 15%
  • Operating cash flow improved to SEK -13.4m from SEK -21.9m

Negative

  • Total net revenues declined to SEK 136.5m from SEK 156.1m
  • Net earnings deteriorated to SEK -41.9m from SEK -33.3m
  • US Commercial segment revenues decreased to SEK 131.0m from SEK 140.4m
  • Cash position declined to SEK 114.9m from SEK 184.2m year-over-year
  • FDA delayed OX124 approval requesting additional data

UPPSALA, Sweden, Oct. 24, 2024 /PRNewswire/ --

Q3 2024 highlights

›  Total net revenues of SEK 136.5 m (156.1)

›  EBITDA of SEK -0.7 m (-9.5)

›  Net earnings of SEK -41.9 m (-33.3)

›  US Commercial segment net revenues of SEK 131.0 m (140.4), in local currency USD 12.6 m (13.0)

›  Cash flow from operating activities of SEK -13.4 m (-21.9), cash and cash equivalents of SEK 114.9 m (184.2)

›  Earnings per share before and after dilution amounted to SEK -1.21 (-0.97)

›  Orexo AB´s sustainability work ranked among the top five percent of all 70,000 businesses worldwide reviewed by EcoVadis

›   For OX124, our high dose naloxone rescue medication for opioid overdose, a complete response letter was received from the FDA requesting additional technical data on the final commercial product as well as further information from a new human factors study (HF study). A new HF study was successfully conducted in July.

›     The financial guidance for 2024 reiterated.

Important events after the end of the ­period

 ›     An exploratory phase 1 clinical study was initiated for OX640 in participants with allergic rhinitis.

SEK m unless otherwise stated            

2024

Jul-Sep          

2023

Jul-Sep          

2024

Jan-Sep          

2023

Jan-Sep                              

2023

Jan-Dec                                      

Net revenues                                   

136.5

156.1

429.7

472.8

638.8

Cost of goods sold                                   

-20.1

-22.8

-49.7

-68.8

-88.9

Operating expenses                                   

-138.1

-161.9

-422.3

-505.0

-659.5

EBIT                                

-21.7

-28.6

-42.2

-100.9

-109.5

EBIT margin                                  

-15.9 %

-18.4 %

-9.8 %

-21.3 %

-17.1 %

EBITDA                                   

-0.7

-9.5

20.2

-44.8

-32.5

Earnings per share, before dilution, SEK                 

-1.21

-0.97

-2.51

-3.19

-3.73

Earnings per share, after dilution, SEK                   

-1.21

-0.97

-2.51

-3.19

-3.73

Cash flow from operating activities                                   

-13.4

-21.9

-38.8

-92.4

-95.0

Cash and cash equivalents                                   

114.9

184.2

114.9

184.2

171.0

CEO Comments in brief

The third quarter has been challenging, starting with the delay of OX124's approval and, from a financial perspective, we had a marginally negative EBITDA. This negative EBITDA result was primarily due to higher legal costs, retrospective adjustments of the Abstral® royalties and lower Zubsolv® sales. The development was partly compensated by a 15 percent drop in expenses. Zubsolv prescription volumes in the US are stable, but sales were negatively impacted by a reduction in inventory levels at wholesalers and a weakening USD.

Looking beyond the third quarter, I am pleased to see Zubsolv sales continuing to show stable demand and growth in some segments. We remain optimistic that we can get OX124, our high dose rescue medication for opioid overdose, approved and expand treatment alternatives for patients suffering from opioid use disorder. In the quarter we made progress in our business development efforts, attracting new companies to leverage our AmorphOX® technology, and we continue to see interest in OX640. Also, there are signs that we are making some progress to resolve the legal disputes in the US.

Nikolaj Sørensen
President and CEO

Contact persons quarterly report
Nikolaj Sørensen, President and CEO,
Fredrik Järrsten, EVP and CFO
ena Wange, IR & Communications Director
Tel: +46 18 780 88 00, +1 855 982 7658,
E-mail: ir@orexo.com.

Presentation

On October 24, at 2 pm CET analysts, investors and ­media are invited to attend a presentation, incl. a Q&A.

To attend via teleconference where you can ask questions verbally:
https://conference.financialhearings.com/teleconference/?id=50048738

When registered you will be provided ­phone ­numbers and a conference ID to access the ­conference.

To attend via webcast:
https://ir.financialhearings.com/orexo-q3-report-2024

Prior to the call, presentation material will be ­available on the website under Investors/Reports/ Archive.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact persons set out above at 8 am CET on October 24, 2024.

This information was brought to you by Cision http://news.cision.com.

https://news.cision.com/orexo/r/orexo-interim-report-q3-2024,c4055702

The following files are available for download:

https://mb.cision.com/Main/694/4055702/3071614.pdf

Orexo Q3 2024 Interim Report

 

Cision View original content:https://www.prnewswire.com/news-releases/orexo-interim-report-q3-2024-302285670.html

SOURCE Orexo

FAQ

What were Orexo's (ORXOY) Q3 2024 revenue and earnings?

Orexo reported Q3 2024 total net revenues of SEK 136.5m and net earnings of SEK -41.9m.

What happened with Orexo's (ORXOY) OX124 drug approval in Q3 2024?

The FDA issued a complete response letter for OX124, requesting additional technical data on the final commercial product and further information from a new human factors study.

How much cash does Orexo (ORXOY) have as of Q3 2024?

Orexo reported cash and cash equivalents of SEK 114.9m as of Q3 2024.
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