OREXO IS PREPARING ZUBSOLV™ FOR LAUNCH IN THE USA - DRUG APPLICATION ACCEPTED BY FDA WITH A JULY 6, 2013 TARGET APPROVAL DATE
Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2011.
During the year
- Net revenues amounted to MSEK 326.3 (199.6).
- Net revenues from launched products increased by 102 percent to MSEK 267.1 (132.4).
- Earnings after tax were MSEK -85.9 (-392.0).
- Earnings per share were SEK -2.92 (-14.43).
- Cash flow from operating activities amounted to MSEK 28.7 (-117.2).
- Cash and cash equivalents amounted to MSEK 228.1 (246.9).
- The licensing agreement with ProStrakan was renegotiated. ProStrakan/Kyowa Hakko Kirin retain the rights outside the USA and Orexo obtains the rights to Abstral in the USA and receives MSEK 610 in fixed royalties.
- In June Edluar®, for treatment of short-term insomnia, was approved in Europe.
- During the third quarter Orexo bought back company’s own shares, in total amounting to MSEK 53.
- In October, Orexo engaged Guggenheim Securities as financial advisor to explore different commercial partnership solutions for Zubsolv and Abstral in USA.
- A dose-finding phase II study was initiated in October for OX51, for the prevention of procedure-induced pain.
- In November, Kyowa Hakko Kirin submitted a New Drug Application for KW-2246 (Abstral) in Japan.
- In September, a New Drug Application for Zubsolv was submitted to the FDA. The application was accepted for review by the FDA in November and the planned date for notification of approval is July 6, 2013.
After the end of the year
- Orexo entered into a research agreement with AstraZeneca for respiratory disease OX-CLI program.
CEO Anders Lundström and CFO Carl-Johan Blomberg will present the report at a teleconference today at 10:00 a.m. CET. Presentation slides are available via the link and on the website. Internet: http://livecast.wehay.com/playontv/130131/orexo/
Telephone: +44 (0) 20 3003 2666 - Standard International Access; 020 089 6377 - Stockholm Toll Free; 0808 109 0700 - UK Toll Free; 1 866 966 5335 - USA Toll Free)
2012 was a successful year for Orexo. The most important event was the submission of the New Drug Application for Zubsolv™ (buprenorphine/naloxone) in the USA.
Zubsolv is a product for treatment of opioid dependence, a huge medical and societal problem in the USA. The current buprenorphine/naloxone market value is $1.5 billion and growing steadily. Zubsolv can be the first new improved product in this market.
In November FDA accepted the application for further review and we anticipate notification of approval in July 2013. Based on this anticipation, we focus more or less the entire company resources towards a launch of Zubsolv in the US market in September 2013. This comprises scaling up the manufacturing capacity in Sweden and the USA, the completion of a Zubsolv preference study with convincing results compared to the market leader Suboxone® Film and the preparation of three new clinical studies, all of which will start in the first half of 2013, with the aim to differentiate Zubsolv from competitors and to expand the label.
We are also working on creating a stronger product line for Zubsolv by developing a new taste and an expanded dose range of the current Zubsolv formulation. Furthermore, we are evaluating different strategic and commercial options for a successful commercialization in the US and we expect to have this in place well ahead of the launch.
I am very pleased that we successfully renegotiated the Abstral® agreement with ProStrakan. The new agreement gives us fixed royalty revenues from Abstral sales outside the US of SEK 610 million plus the right to earn additional royalties when certain sales levels are reached. At the same time Orexo obtains the rights to Abstral in the USA as from July 2013. In parallel to the preparation of the Zubsolv launch we are also actively evaluating the best commercial solution for Abstral in the US, and we will have this in place before July 2013.
During 2012 we have strengthened Orexo’s financial position and reduced cost levels. The success in these efforts has given us a good basis for generation of considerable revenues in the future. I look forward to developments during 2013 with confidence. With the current assumption of a regulatory approval of Zubsolv in July and subsequent launch in September 2013, we project that Orexo will turn profitable in late 2013 and cash flow positive in 2014.
President and CEO
For further information, please contact:
Anders Lundström, CEO, tel: +46 (0)706 67 22 66, e-mail: email@example.com
Carl-Johan Blomberg, CFO, tel: +46 (0)706 33 67 11, e-mail: firstname.lastname@example.org
Orexo AB publ discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on January 31, 2013, at 8:00 a.m. This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall prevail.
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