Orexo (ORX) Q2 2024 earnings summary

Executive summary

• Q2 2024 featured a rebound in Zubsolv sales, positive EBITDA of SEK 5.0m, and a delay in OX124 FDA approval due to a Complete Response Letter requiring additional technical data and a new human factor study, which was completed in July.

• Abstral royalties declined due to expiring contracts and negative adjustments, partially offset by increased Zubsolv revenues in Europe.

• Net earnings declined to SEK -35.9m from SEK -12.6m year-over-year, mainly due to higher bond loan costs and non-recurring refinancing expenses.

• Sustainability efforts were recognized with a Gold rating from EcoVadis, placing the company among the top 5% of 70,000 businesses reviewed globally.

Financial highlights

• Q2 2024 net revenues were SEK 154.0m, with US Commercial contributing SEK 147.9m (USD 13.9m), up 1.7% year-over-year.

• EBITDA was SEK 5.0m for the quarter; adjusted EBITDA excluding non-recurring costs was SEK 12.6m.

• Cash and cash equivalents at quarter-end were SEK 139.7m, down from SEK 198m in Q1, mainly due to bond refinancing.

• Net loss for Q2 2024 was SEK -35.9m, compared to SEK -12.6m in Q2 2023, due to higher financial costs.

• Completed SEK 500m senior secured callable floating rate social bond issuance.

Outlook and guidance

• 2024 guidance reaffirmed: buprenorphine/naloxone market expected to grow 2–5%, Zubsolv net sales in USD to be in line with 2023, OPEX (excluding D&A) to decline below SEK 520–530m, and positive full-year EBITDA expected.

• Risks to guidance include wholesaler inventory adjustments, potential DOJ settlement, and increased R&D for OX124 resubmission.

• OX124 approval and launch timelines extended; new guidance pending further FDA discussions.