Orexo Interim Report Q3 2024
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.
Orexo ha riportato i risultati finanziari del terzo trimestre 2024 con ricavi netti totali di SEK 136,5 milioni, in calo rispetto ai SEK 156,1 milioni del terzo trimestre 2023. L'azienda ha registrato un EBITDA negativo di SEK -0,7 milioni, migliorando rispetto ai SEK -9,5 milioni dell'anno scorso. I ricavi del segmento commerciale statunitense sono scesi a SEK 131,0 milioni da SEK 140,4 milioni. Gli utili netti sono peggiorati a SEK -41,9 milioni rispetto ai SEK -33,3 milioni. La FDA ha richiesto ulteriori dati tecnici per l'OX124, il loro farmaco di soccorso ad alta dose di naloxone. Nonostante le difficoltà, tra cui costi legali più elevati e vendite di Zubsolv in calo, l'azienda ha mantenuto le sue previsioni finanziarie per il 2024 e ha avviato uno studio di fase 1 per OX640 in pazienti con rinite allergica.
Orexo reportó los resultados financieros del tercer trimestre de 2024 con ingresos netos totales de SEK 136,5 millones, en comparación con SEK 156,1 millones en el tercer trimestre de 2023. La compañía presentó un EBITDA negativo de SEK -0,7 millones, mejorando desde SEK -9,5 millones del año pasado. Los ingresos del segmento comercial de EE. UU. cayeron a SEK 131,0 millones desde SEK 140,4 millones. Las ganancias netas se deterioraron a SEK -41,9 millones desde SEK -33,3 millones. La FDA solicitó datos técnicos adicionales para OX124, su medicamento de rescate de naloxona a alta dosis. A pesar de los desafíos, incluidos mayores costos legales y menores ventas de Zubsolv, la compañía mantuvo su guía financiera para 2024 e inició un estudio de fase 1 para OX640 en pacientes con rinitis alérgica.
Orexo는 2024년 3분기 재무 결과를 발표하며 전체 순수익이 1억 3,650만 SEK로 2023년 3분기의 1억 5,610만 SEK에서 감소했다고 밝혔습니다. 회사는 EBITDA가 -70만 SEK로 지난해 -950만 SEK에서 개선되었다고 보고했습니다. 미국 상업 부문의 수익은 1억 3,100만 SEK로 1억 4,040만 SEK에서 줄어들었습니다. 순이익은 -4,190만 SEK로 -3,330만 SEK에서 악화되었습니다. FDA는 고용량 날록손 구급 약인 OX124에 대한 추가 기술 데이터를 요청했습니다. 더불어 높은 법률 비용과 감소한 Zubsolv 판매 등 도전 과제가 있었지만, 회사는 2024년 재무 전망을 유지하고 OX640의 알레르기 비염 환자를 위한 1상 연구를 시작했습니다.
Orexo a annoncé les résultats financiers du troisième trimestre 2024 avec des revenus nets totaux de 136,5 millions SEK, en baisse par rapport à 156,1 millions SEK au troisième trimestre 2023. L'entreprise a enregistré un EBITDA négatif de -0,7 million SEK, en amélioration par rapport à -9,5 millions SEK l'année précédente. Les revenus du secteur commercial américain ont diminué à 131,0 millions SEK contre 140,4 millions SEK. Les bénéfices nets se sont détériorés à -41,9 millions SEK contre -33,3 millions SEK. La FDA a demandé des données techniques supplémentaires pour OX124, leur médicament de secours à dose élevée de naloxone. Malgré les défis, y compris des coûts juridiques plus élevés et des ventes de Zubsolv en baisse, l'entreprise a maintenu ses prévisions financières pour 2024 et a lancé une étude de phase 1 pour OX640 chez des patients atteints de rhinite allergique.
Orexo hat die finanziellen Ergebnisse für das 3. Quartal 2024 mit einem Gesamtumsatz von 136,5 Millionen SEK bekannt gegeben, was einem Rückgang von 156,1 Millionen SEK im 3. Quartal 2023 entspricht. Das Unternehmen verzeichnete ein negatives EBITDA von -0,7 Millionen SEK, eine Verbesserung gegenüber -9,5 Millionen SEK im Vorjahr. Die Umsätze im US Commercial Segment sanken auf 131,0 Millionen SEK von 140,4 Millionen SEK. Der Nettoertrag verschlechterte sich auf -41,9 Millionen SEK von -33,3 Millionen SEK. Die FDA forderte zusätzliche technische Daten für OX124, ihr hochdosiertes Naloxon-Notfallmedikament. Trotz Herausforderungen, einschließlich höherer Rechtskosten und sinkender Zubsolv-Verkäufe, hielt das Unternehmen an seiner Finanzprognose für 2024 fest und begann eine Phase-1-Studie für OX640 bei Patienten mit allergischer Rhinitis.
- 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
- 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,
Q3 2024 highlights
› Total net revenues of
› EBITDA of
› Net earnings of
› US Commercial segment net revenues of
› Cash flow from operating activities of
› Earnings per share before and after dilution amounted to
› 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
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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.
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Orexo Q3 2024 Interim Report |
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SOURCE Orexo
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