In Q3 we have met several of the objectives for 2017 and I am in particular proud of the accomplishments that will strengthen the foundation for Orexo in 2018 and beyond.

From a financial perspective we continue our track record of positive cash flow from operations and have now surpassed two years of unbroken positive quarterly cash flow. I am also pleased to announce we have reached positive EBITDA (and EBIT) year-to-date, which is one of the targets in our guidance for the full-year. The positive result is driven primarily by the continued positive profit contribution from our US business, strong Abstral® performance in Europe and continued firm cost management.

Market access is the main driver of market share and growth in the US market for Zubsolv® and has gained significant focus and priority in 2017. Looking forward to 2018, we managed to secure the best improvements in market access for Zubsolv since 2014 and overall our market access in 2018 will be the best ever for Zubsolv. In the commercial segment Zubsolv’s formulary access beginning January 1 will be the best of any product in the buprenorphine/naloxone market, whether branded or generic. In the fast-growing public segment Zubsolv will have significant improvement in access, both in parity with competitors and some exclusive preferred positions within Medicare Part D. These improvements in market access are the result of our relentless efforts to make Zubsolv the most valuable choice from a medical and financial perspective for patients and payers in the US. These market access gains combined with our improvements in the supply chain will ensure affordable access to this life saving treatment for more patients, while Orexo maintains healthy gross margins.

While Zubsolv in the US remains our main focus, we are constantly working to strengthen and broaden our product offering and pipeline with new products and projects. The newest and most important near-term revenue generating project will be the launch of Zubsolv in Europe. With the positive opinion from the European committee, CHMP, in September, Zubsolv is well on track to receive approval later this year by the European Commission and for our partner Mundipharma to start launching Zubsolv during the first half of 2018. Upon launch, Zubsolv will be the first ever, fast-dissolving alternative to Suboxone® tablets in Europe.

Additionally, we have filed a patent application for our OX382 project in September and we are aiming to bring to market the first ever swallowable oral formulation of buprenorphine. A swallowable tablet is generally preferred by patients and physicians, due to the added convenience and in opioid dependence treatment it allows for improved efficiency in the multitude of clinics using supervised treatment settings. The next step will be a clinical phase I trial scheduled to start in Q1, 2018.

One of my overarching objectives has been to make Orexo profitable and with the current trajectory for 2017 we expect to present a positive net profit for the full year and we have reached a positive net cash position, thus eliminating any financing risk of the corporate bond issued in 2014. Both of these factors are testimony to our ability to drive effectiveness and apply strict cost controls while improving the foundations to grow our top line in the years to come. With the positive development in market access in the US, improved supply chain, approval of Zubsolv in Europe and updated pipeline I am confident we have paved the way for profitable growth in 2018 and beyond.

Uppsala, Sweden, October 19 2017

 

Nikolaj Sørensen
President and CEO