Orexo Interim Report Q1 2023

Rhea-AI Summary

Orexo reported its Q1 2023 financial results, with net revenues of SEK 158.8 million, slightly down from SEK 159.4 million in Q1 2022. The company experienced a significant EBITDA decline, reporting SEK -41.1 million compared to SEK 2.8 million last year. Net earnings also saw a loss of SEK -63.9 million, worse than the previous SEK -23.6 million. Despite stable ZUBSOLV® sales in both SEK and USD, operating expenses surged by 30.6%, totaling SEK 189.4 million. A New Drug Application for OX124 has been submitted to the FDA, but challenges in the packaging line require a resubmission planned for Q3 2023. Cash flow from operations stood at SEK -61.6 million, with cash reserves down to SEK 278.9 million.

Positive

• Stable ZUBSOLV® US sales in USD compared to Q4.
• Exploratory feasibility studies of amorphOX® initiated with international partners.
• NDA submitted for OX124, high-dose rescue medication for opioid overdose.

Negative

• EBITDA decreased to SEK -41.1 million, a decline of 1,567.9%.
• Net earnings reported a loss of SEK -63.9 million, worsening from previous losses.
• Operating expenses rose significantly by 30.6%, totaling SEK 189.4 million.
• Cash and invested funds decreased to SEK 278.9 million, down 36.3% from the previous year.
• FDA requested resubmission of NDA for OX124 due to packaging line issues.

UPPSALA, Sweden, April 27, 2023 /PRNewswire/ -- Focusing operations on Orexo´s strengths

Q1 2023 highlights           

• Total net revenues of SEK 158.8 m (159.4)           
• EBITDA of SEK -41.1 m (2.8), EBITDA excluding legal costs and costs for non-repeating clinical trials, SEK 20.9 m (32.2) 
• Net earnings of SEK -63.9 m (-23.6)           
• US Pharma segment (ZUBSOLV® US) net revenues of SEK 140.3 m (139.1), in local currency USD 13.5 m (14.8), US Pharma EBIT of SEK 74.3 m (84.0)           
• Cash flow from operating activities of SEK -61.6 m (-61.6), cash and invested funds of SEK 278.9 m (437.8)           
• Earnings per share before and after dilution amounted to -1.86 (-0.69)          
• Exploratory feasibility studies of amorphOX® initiated in collaboration with two international biopharmaceutical and vaccine companies           
• New Drug Application (NDA) submitted with the FDA for OX124, high-dose rescue medication for opioid overdose

Important events after the end of the period           

• Due to issues in the outsourced packaging line FDA has requested Orexo to resubmit the NDA, which is planned to take place in Q3, 2023

SEK m, unless otherwise stated	2023 Jan-Mar	2022 Jan-Mar	% change quarter	2022 Jan-Dec
Net revenues	158.8	159.4	-0.4 %	624.3
Cost of goods sold	-28.7	-27.5	4.2 %	-102.6
Operating expenses	-189.4	-145.1	30.6 %	-705.6
EBIT	-59.3	-13.2	350.0 %	-183.9
EBIT margin	-37.4 %	-8.3 %	29.1 %	-29.5 %
EBITDA	-41.1	2.8	-1,567.9 %	-115.2
Earnings per share, before dilution, SEK	-1.86	-0.69	169.6 %	-5.17
Earnings per share, after dilution, SEK	-1.86	-0.69	169.6 %	-5.17
Cash flow from operating activities	-61.6	-61.6	0.0 %	-156.6
Cash and invested funds	278.9	437.8	-36.3 %	351.9

 

Comments by the CEO, Nikolaj Sørensen

Navigating troubled waters 

"As expected, the first quarter has been intensive for Orexo with submission of the of OX124 file to the FDA, completion of the District Court Hearing in the patent litigation and integration of the DTx team into the US Pharma organization. ZUBSOLV® sales in SEK was in line with last year, supported by currency tailwinds, and ZUBSOLV® US sales have stabilized comparing to Q4 in USD. As expected, EBITDA compared to last year is lower explained by the increase in non-repeating expenses. These expenses will decline in the next quarters as we approach the critical milestones for the company with the decision in the District Court and the completion of the MODIA® clinical trial. Removing these non-repeating expenses from the P&L, EBITDA would have been positive in the quarter. I am disappointed with the news right after the quarter ended, that we had issues with the packaging line for OX124 and need to make a new submission to FDA later this year. If the final tests at our contract manufacturing partner are successful, we are expecting to resubmit the OX124 file with the FDA in Q3." 

For full CEO comments view the attached PDF

For further information, please contact
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
At 2 pm CET the same day as the announcement of the report Orexo invites analysts, investors and media to attend a presentation where Nikolaj Sørensen, CEO and Fredrik Järrsten, CFO, will present the report and host a Q&A.
 
To attend via teleconference where you can ask questions verbally use this link: 
https://conference.financialhearings.com/teleconference/?id=200679
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-q1-2023

Prior to the call presentation material will be available on Orexo´s website 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 April 27, 2023. 

The following files are available for download:

https://mb.cision.com/Main/694/3759169/2015397.pdf

Orexo Interim Report Q1 2023

View original content:https://www.prnewswire.com/news-releases/orexo-interim-report-q1-2023-301809298.html

SOURCE Orexo

FAQ

What were Orexo's Q1 2023 net revenues?

Orexo's Q1 2023 net revenues were SEK 158.8 million.

What is the EBITDA reported by Orexo for Q1 2023?

Orexo reported an EBITDA of SEK -41.1 million for Q1 2023.

What challenges did Orexo face regarding the FDA submission for OX124?

Orexo faced issues with the outsourced packaging line, requiring a resubmission of the NDA for OX124, planned for Q3 2023.

How much did Orexo's cash reserves decrease by in Q1 2023?

Orexo's cash and invested funds decreased to SEK 278.9 million, a reduction of 36.3%.

What were the earnings per share for Orexo in Q1 2023?

Orexo's earnings per share before and after dilution amounted to SEK -1.86.