OREXO CLOSER TO LAUNCHING ZUBSOLV™ (OX219) – NEW TREATMENT OF OPIOID DEPENDENCE
During the interim period
· Net revenues amounted to MSEK 242.7 (142.9).
· Revenues from launched products increased by 105 percent to MSEK 190.1
· EBITDA amounted to MSEK -52.5 (-76.9 ).
· Earnings after tax were MSEK -63.6 (-121.0).
· Earnings per share were SEK -2.14 (-4.61).
· Cash flow from operating activities amounted to MSEK 105.5 (-70.3).
· Cash and cash equivalents amounted to MSEK 306.2 (294.3).
· Fixed royalty related to Abstral® according to the new agreement amounted to
MSEK 59.4 (17.7) during third quarter.
· In September, an application for registration of Zubsolv (OX219) was
submitted to the FDA five months earlier than planned.
· During the third quarter Orexo performed a buyback of the company’s own
shares, in total amounting to MSEK 53.
After the interim period
· In October Guggenheim Securities LLC was retained to explore strategic
alternatives for commercialization in the US.
During the third quarter we reached an important milestone when we submitted an
application for the registration of Zubsolv™ (OX219) to the U.S. Food and Drug
Administration, FDA. Zubsolv is a product for the treatment of opioid
dependence. Thanks to a great effort by our co-workers, we managed to do this
five months earlier than originally planned, which I am very impressed by.
There is a considerable market potential for Zubsolv in the USA, in a fast
growing market. Zubsolv has several important patient friendly properties which
make the tablet easy to use (such as rapid dissolution and smaller tablet size).
We believe Zubsolv to be competitive product and anticipate that we can take
considerable market shares and achieve sales of up to 500 million dollars a
year. The launch of Zubsolv is planned for the third quarter of 2013. In order
to strengthen Zubsolv’s competitiveness, we have initiated a new development
program to further differentiate our product from those of our competitors.
However, besides the very interesting prospects with Zubsolv, as previously
announced we entered into a new agreement with ProStrakan regarding Abstral®
during the second quarter. The agreement has strengthened Orexo financially and
we will regain the Abstral product rights in the USA during the first quarter of
2013. Our future presence in the USA will thus be based on Orexo offering the
market two attractive products – Zubsolv and Abstral. We have engaged Guggenheim
Securities, LLC as a financial advisor to explore different strategic
alternatives for commercialization in the USA. Based on the analysis, we will
announce at the end of this year how our commercialization plan for the USA will
be designed. As a consequence of this ongoing strategic review, the buyback of
shares will not be restarted now.
President and CEO
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:
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
For further information, please contact:
Anders Lundström, CEO, tel: +46 (0)706 67 22 66, e-mail:
Carl-Johan Blomberg, CFO, tel: +46 (0)706 33 67 11, e-mail: carl
Orexo AB publ discloses the information provided herein pursuant to the
Securities Markets Act. The information was provided for public release on
October 25, 2012, 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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