Interim Report Q2 2018

Zubsolv® continues its strong performance

Q2 2018 highlights

  • Total net revenues of SEK 199.7 million (159.1), up 25.5 percent from Q2 previous year
  • Zubsolv US net revenue of SEK 158.4 million (124.1), up 27.6 percent in SEK and 29.8 percent in local currency compared to the same period last year
  • EBITDA of SEK 50.6 million (15.0)
  • Cash flow from operating activities of SEK 39.0 million (49.0), building a cash balance of SEK 494.8 million (294.3)
  • Launch of Zubsolv initiated in the EU, which triggered a milestone payment of EUR 3 million
  • Earnings per share, before dilution SEK 1.45 (0.09), earnings per share after dilution SEK 1.45 (0.09)
SEK million,
unless otherwise stated                
 
2018
Apr-Jun     
2017
Apr-Jun    
2018
Jan-Jun    
2017      
Jan-Jun   
 
12 mth    
Jul 2017 -      
Jun 2018
 
12 mth
Jul 2016 -      
Jun 2017
 
Net revenues  199.7  159.1  339.4  286.4  696.7  653.2 
whereof Zubsolv® US net revenue  158.4  124.1  289.5  238.2  537.1  508.8 
Cost of goods sold  -37.6  -35.8  -86.0  -82.0  -168.4  -165.2 
Operating expenses  -116.7  -113.5  -229.9  -218.0  -433.8  -435.8 
EBIT  45.4  9.8  23.5  -13.6  94.5  52.2 
EBIT margin, %  22.7  6.2  6.9  -4.7  13.6  8.0 
EBITDA  50.6  15.0  33.8  -3.2  115.2  72.2 
Earnings per share, before dilution, SEK          1.45  0.09  0.70  -0.91  2.29  0.78 
Earnings per share, after dilution, SEK      1.45  0.09  0.70  -0.91  2.28  0.78 
Cash flow from operating activities  39.0  49.0  144.9  76.9  214.6  190.6 
Cash and cash equivalents  494.8  294.3  494.8  294.3  494.8  294.3 

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 work on 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 leader 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.

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

Nikolaj Sørensen
President and CEO

For further information, please contact
Nikolaj Sørensen, CEO and President or Henrik Juuel, EVP and CFO
Tel: +46 18 780 88 00. Email: ir@orexo.com

Presentation
At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend an audiocast with a web presentation where Nikolaj Sørensen, CEO, and Henrik Juuel, CFO, will present the report. After the presentation a Q&A will be held. Questions can also be sent in advance to ir@orexo.com, no later than 11.00 am CET. Please view the instructions below on how to participate.
Internet: https://tv.streamfabriken.com/orexo-q2-2018
Telephone: SE: +46 856 642 664 UK: +44 203 0089 802 US: +1 855 7532 235
The presentation material will be available on Orexo´s website one hour prior to the audiocast.

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 8.00 am CET on July 11, 2018. 

Tags:

About Us

Orexo develops improved pharmaceuticals based on innovative drug delivery technologies.The focus is primarily on opioid dependence and pain but the aim is to address therapeutic areas where our competence and technologies can create value. The main market today is the US market for the treatment of opioid dependence where the product Zubsolv® is commercialized by Orexo. Other products are commercialized by license partners, including Zubsolv in markets outside of the US. Total net sales for 2016 amounted to SEK 705.9 million and the number of employees was 102. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) index and is available as ADRs on OTCQX (ORXOY) in the US. The head office, where also research and development is performed, is located in Uppsala, Sweden.