During Q2 Zubsolv continued its strong performance, building on the improved market access for 2018. The strong Zubsolv growth is the main driver behind the total revenue growth in SEK of 25 percent and an EBITDA of SEK 51 million. Q2, 2018 was one of the best quarters ever in Orexo’s history in terms of these measures.
Zubsolv® grew more than 20 percent in prescribed tablets compared to Q2 2017 and Zubsolv sales are the most important driver of Orexo’s profitability and growth. Profitability has also improved due to our workon reducing the cost of goods, which is starting to show some effects. Furthermore, the milestone payment of EUR 3 million following the launch of Zubsolv in Europe also contributed to a positive result. From a company perspective, I find it promising that we are able to be profitable even when excluding the milestone payment for Zubsolv Europe and any significant royalties from Abstral and Edluar. With continued improvements in the cost of goods expected in the second half of this year and royalties from Abstral in Europe, 2018 is on track to becoming a record year for Orexo in terms of profitability and sales.
We are intensifying our efforts to develop new products and during Q4 we will start a phase I trial for our OX124 naloxone rescue medication. Our aim is to develop a product with a unique product profile addressing some of the shortcomings of the market eader in the US today. The final timeline of development is dependent on the result of the phase I trial. From a corporate perspective, I am very proud that we are ready to test OX124 in humans about a year after the project was started in our development department. The company is leaving no stone unturned in its efforts to continue to streamline the process from idea to phase I trial and OX124 is a testimony to the capabilities of the organization."The company is leaving no stone
"The company is leaving no stone unturned in its efforts to continue to streamline the process from idea to phase I trial and OX124 is a testimony to the capabilities of the organization"
During the quarter the market has been very dynamic with the launch of a new depot formulation of buprenorphine in the US and the approval of two generic versions of the market leader Suboxone Film. The uptake of the depot formulation has been slow, which is in line with our expectations. With the current regulatory landscape and the complexity associated with prescribing a depot formulation, the impact on Zubsolv is most likely limited. With potential near-term generic competition for Suboxone Film, the market leader, the market landscape will change. However, we are already competing with several generics and while there eventually could be some additional price pressure from Suboxone Film, the market dynamic among actively promoted brands will change which can lead to opportunities, for Orexo and Zubsolv in the US.
While I am pleased with business performance in the quarter, I am disappointed that we have not yet received a decision in the litigation process against Actavis on one of the three Zubsolv US patents expiring in 2032. It is now more than nine months since the final hearing in the Court of Appeals and we had expected a decision by now. However we remain optimistic about a positive outcome and a resolution shortly, but are not able to provide more specific guidance.
Financial performance in Q2 has been strong and looking ahead to the second half I feel confident we will continue with strong performance for the rest of the year. This will further improve the foundation for future growth and enable us to continue the exciting journey towards becoming a leading addiction company.
Uppsala, Sweden, July 11, 2018
President and CEO