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Orexo Interim Report Q4 2023, incl. Full Year Report

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In the press release from February 8, 2024, Orexo AB reported a positive EBITDA in H2, setting the target for FY 2024. The total net revenues were SEK 166.0 m, with the US Pharma segment (Zubsolv® US) net revenues of SEK 151.3 m. The MODIA® study didn't meet the primary end-points, but showed high rates of treatment response. Robin Evers was elected as a board member, and the FDA accepted the New Drug Application filing for review of OX124, a high-dose rescue medication for opioid overdose with naloxone. The financial outlook for 2024 includes a 2-5% growth in the buprenorphine/naloxone market and positive EBITDA for the FY 2024.
Positive
  • Positive EBITDA in H2
  • Total net revenues of SEK 166.0 m
  • US Pharma segment net revenues of SEK 151.3 m
  • High rates of treatment response in the MODIA® study
  • FDA acceptance of New Drug Application filing for OX124
  • Financial outlook for 2024 includes growth in the buprenorphine/naloxone market and positive EBITDA
Negative
  • Net earnings of SEK -18.6 m
  • Cash flow from operating activities of SEK -2.6 m
  • Earnings per share before and after dilution amounted to SEK -0.54
  • The MODIA® study didn't meet the primary end-points

UPPSALA, Sweden, Feb. 8, 2024 /PRNewswire/ -- Positive EBITDA in H2 setting the target for FY 2024

Q4 2023 highlights

  • Total net revenues of SEK 166.0 m (156.1)
  • EBITDA of SEK 12.4 m (-53.1), EBITDA excluding costs for legal processes and external non-­repeating ­­clinical trials, SEK 23.4 m (-0.1)
  • Net earnings of SEK -18.6 m (-91.8)
  • US Pharma segment (Zubsolv® US) net revenues of SEK 151.3 m (142.6), in local currency USD 14.2 m (13.3), US Pharma EBIT of SEK 75.4 m (77.0)
  • Cash flow from operating activities of SEK -2.6 m (-48.9), cash and invested funds of SEK 171.0 m (351.9)
  • Earnings per share before and after dilution amounted to SEK -0.54 (-2.67)
  • The MODIA® study didn't meet the ­primary end-points, but showed high rates of treatment ­response in both study arms, with no adverse events associated with the use of MODIA
  • Robin Evers elected as board member at the Extraordinary General Meeting. He replaces ­Henrik ­Kjaer ­Hansen who has resigned. Kjaer Hansen has instead been appointed ­c­­hairman of the Nomination Committee, representing Novo Holdings A/S.
  • FDA accepted the New Drug Application filing for review of OX124, a high-dose rescue medication for opioid overdose with naloxone
  • Financial outlook provided for 2024 on page 15.

Important events after the end of the ­period

  • MODIA and Vorvida® will be reimbursed within the US Veterans Affairs Federal Supply Schedule as of January 1, 2024.

SEK m  unless otherwise stated

2023
                                    Oct-Dec

2022
                                    Oct-Dec

2023
                                    Jan-Dec

2022
                                    Jan-Dec

Net revenues

166.0

156.1

638.8

624.3

Cost of goods sold

-20.1

-25.9

-88.9

-102.6

Operating expenses

-154.5

-201.3

-659.5

-705.6

EBIT

-8.6

-71.1

-109.5

-183.9

EBIT margin

-5.2 %

-45.6 %

-17.1 %

-29.5 %

EBITDA

12.4

-53.1

-32.5

-115.2

Earnings per share. before dilution. SEK

-0.54

-2.67

-3.73

-5.17

Earnings per share. after dilution. SEK

-0.54

-2.67

-3.73

-5.17

Cash flow from operating activities

-2.6

-48.9

-95.0

-156.6

Cash and invested funds

171.0

351.9

171.0

351.9

 

Financial outlook 2024

  • The buprenorphine/naloxone market will grow 2-5 percent, based on current growth trajectory
  • Zubsolv net sales in USD will be in line with 2023
  • Cost control is a priority and OPEX excluding depreciation and amortization will decline from SEK 582 m in 2023 to
    below SEK 530 m in 2024
  • Positive EBITDA for the FY 2024.

The financial outlook 2024 is based on a forward looking assumption of a USD/SEK exchange rate of 10.28 calculated
as an average of December 2023 by the Riksbanken.

Strong recovery in financial results and FDA initiated the review of OX124 

CEO Comments in brief

"I am pleased to report a Q4 result delivering a positive EBITDA and strong Zubsolv® net sales both compared to Q4 2022 and Q3 2023. Zubsolv net sales year over year grew more than 6 percent in both SEK and USD, and nearly 8 percent quarter over quarter. I am also delighted to share that we are continuing to drive efficiencies across the business and have reduced operating expenses by 23 percent from last year. This recovery in financial performance is not driven by exchange rates, on the contrary, our EBITDA in H2 would have been nearly SEK 8 million higher if we had applied the exchange rates from end of 2022. 

I am also pleased to announce that we, despite currency headwinds, reached our financial guidance for 2023, and in particular the positive EBITDA for H2. With relatively stable exchange rates and no other extraordinary events in 2024, we are confident we can reach a positive EBITDA for the FY 2024."

To read the full CEO Comments view attached PDF.

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

Presentation
On Feb. 8, 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=2001504

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-q4-2023

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

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 February 8, 2024.

The following files are available for download:

https://mb.cision.com/Main/694/3924484/2589855.pdf

Orexo Interim Report Q4 2023, incl Full Year published February 8, 2024

 

Cision View original content:https://www.prnewswire.com/news-releases/orexo-interim-report-q4-2023-incl-full-year-report-302057213.html

SOURCE Orexo

FAQ

What were the total net revenues reported in the press release?

The total net revenues reported were SEK 166.0 m.

What is the ticker symbol for Orexo AB?

The ticker symbol is ORXOY.

What is the financial outlook for 2024?

The financial outlook includes a 2-5% growth in the buprenorphine/naloxone market and positive EBITDA for the FY 2024.

What study did not meet the primary end-points?

The MODIA® study did not meet the primary end-points.

What medication was the FDA reviewing in the press release?

The FDA was reviewing OX124, a high-dose rescue medication for opioid overdose with naloxone.

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