Orexo Q1 2025 slides: stable revenue growth amid pipeline advancements

Introduction & Market Context

Orexo AB (STO:ORX) presented its first quarter 2025 financial results on May 6, showcasing stable performance despite market volatility. The Swedish pharmaceutical company, which focuses on opioid addiction and dependency treatments, reported modest revenue growth while maintaining positive EBITDA in a challenging environment. Orexo’s stock rose 1.38% following the presentation, closing at 14.70 SEK.

The company emphasized its limited exposure to current external uncertainties, including potential tariffs and exchange rate fluctuations. Orexo highlighted that its lead product Zubsolv is manufactured locally in the U.S. and Europe, mitigating supply chain risks, while approximately 80% of exchange rate impact on revenue is naturally hedged at the EBIT level due to its expense structure.

Quarterly Performance Highlights

Orexo reported net revenues of 146.2 SEK million in Q1 2025, representing a 5% increase from 139.3 SEK million in the same period last year. The company maintained positive EBITDA of 5.9 SEK million, though this marked a decline from 15.9 SEK million in Q1 2024, primarily due to currency headwinds and reduced royalties from Abstral.

As shown in the following quarterly highlights:

Zubsolv, Orexo’s lead product for opioid use disorder, delivered stable revenue in both SEK and USD terms. The company noted that Q1 is traditionally volatile due to the reset of high deductibles and formulary changes, which particularly affect the commercial segment where Zubsolv has strong positioning.

The detailed breakdown of Zubsolv’s performance reveals market dynamics affecting the product:

Detailed Financial Analysis

Orexo’s net revenue growth of 2.9% was primarily driven by Zubsolv’s performance in the U.S. commercial segment, which contributed 133.0 SEK million in Q1 2025 compared to 129.3 SEK million in Q1 2024. The company also saw growth in Zubsolv sales outside the U.S., which increased to 8.1 SEK million from just 0.2 SEK million a year earlier.

The following chart illustrates the revenue breakdown by segment:

Despite the revenue growth, Orexo’s operating expenses remained stable at 130.7 SEK million, unchanged from Q1 2024. However, increased cost of goods sold and negative financial items impacted the bottom line, resulting in a net loss of 15.9 SEK million compared to 8.9 SEK million in the prior-year period.

The income statement details show the key financial metrics:

A significant positive development was the improvement in cash flow from operating activities, which reached 32.9 SEK million in Q1 2025, a substantial improvement from -18.9 SEK million in Q1 2024. However, the company’s cash position decreased to 119.1 SEK million from 198.0 SEK million a year earlier.

The cash flow statement provides further details:

Pipeline & Development Updates

Orexo reported progress with its development pipeline, particularly with OX640, an intranasal rescue medication for allergic reactions. Following successful clinical studies demonstrating faster absorption compared to intramuscular injections, partnering discussions have intensified with potential regional and global partners.

The following slide details the OX640 development status:

For OX124, an opioid overdose treatment based on the company’s AmorphOX technology, Orexo provided an updated timeline for resubmission to the FDA. The company expects delivery of critical components for the nasal device in July 2025, enabling testing in preparation for a mid-2026 filing.

Additionally, Orexo highlighted its collaboration with Abera Bioscience to develop nasal powder vaccines using the AmorphOX technology, with promising in vivo study results for an influenza vaccine candidate.

Strategic Initiatives & Outlook

Looking ahead, Orexo reaffirmed its financial outlook for 2025, projecting Zubsolv net sales in the range of USD 50-55 million and positive EBITDA for the full year. The company expects the buprenorphine/naloxone market to grow by 2-5% based on current trends.

The financial outlook details are presented here:

Orexo’s strategic initiatives focus on three key areas: growing revenues and profit contributions, improving access to treatment, and capitalizing on the AmorphOX drug delivery technology through partnerships and new product development.

As illustrated in the company’s strategic framework:

The company continues to face an ongoing investigation by U.S. authorities related to certain historic marketing messaging campaigns, though Orexo maintains that the investigation concerns have no merit and is seeking to negotiate a resolution.

With its stable commercial business providing a foundation, Orexo appears positioned to advance its pipeline while navigating market challenges in 2025.

Full presentation:

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.