Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2013. Zubsolv®, now with broader market access First quarter 2014 · Total net revenues amounted to MSEK 101.9 (139.8). Revenues from launched products, excluding one-off milestone, amounted to MSEK 101.9 (72.1). · Earnings after tax were MSEK -21.1 (27.5). · Earnings per share were SEK -0.66 (0.95). · Cash flow from operating activities amounted to MSEK -99.7 (-5.0). · Cash and cash equivalents amounted to MSEK30.7 (218.9) before non-utilized credit facilities of MSEK 105. · Reimbursement agreement for Zubsolv signed with UnitedHealth Group and OptumRx. After the period · Orexo has engaged Pareto Securities to investigate the market regarding issuance of a corporate bond. Proceeds would be used to finance the continued development and commercialization of Zubsolv and to reduce the existing bank debt. +-----------------------------------+-------+-------+-------+ |MSEK | 2014| 2013| 2013| +-----------------------------------+-------+-------+-------+ | |Jan-Mar|Jan-Mar|Jan-Dec| +-----------------------------------+-------+-------+-------+ |Net revenues | 101.9| 139.8| 429.4| +-----------------------------------+-------+-------+-------+ |Revenues from launched products | 101.9| 136.4| 421.6| +-----------------------------------+-------+-------+-------+ |EBIT | -16.2| 30.2| -139.7| +-----------------------------------+-------+-------+-------+ |EBITDA | -13.7| 31.5| -89.1| +-----------------------------------+-------+-------+-------+ |Earnings after tax | -21.1| 27.5| -154.9| +-----------------------------------+-------+-------+-------+ |Earnings per share, SEK | -0.66| 0.95| -5.16| +-----------------------------------+-------+-------+-------+ |Cash flow from operating activities| -99.7| -5.0| -265.8| +-----------------------------------+-------+-------+-------+ |Cash and cash equivalents | 30.7| 218.9| 105.6| +-----------------------------------+-------+-------+-------+ Teleconference CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference today on two occasions: 9:00am CET Telephone: SE: +46 8 519 993 61, UK: +44 20 319 405 54 or US: +1 855 269 26 07 http://financialhearings.nu/140425/orexo-eu/ 2:00pm CET Telephone: SE: +46 8 519 993 55, UK: +44 20 319 405 50 or US: +1 855 269 26 07 http://financialhearings.nu/140425/orexo-us/ For further information, please contact: Nikolaj Sørensen, CEO or Henrik Juuel, EVP and CFO Tel: +46 (0)18 780 88 00, E-mail: ir@orexo.com CEO’s comments During the quarter, Orexo’s focus has been to continue to improve the reimbursement status of Zubsolv. I am pleased to see that our dedication and efforts continue to pay off, with the announcement of an exclusive agreement with the largest insurance company in the USA, UnitedHealth Group. This agreement makes Zubsolv the only buprenorphine/naloxone product available to patients within UnitedHealth Group’s highly controlled plans. During the quarter, sales of Zubsolv doubled compared to the end of 2013, as a result of the brand exclusivity agreement with CVS Caremark and Medimpact. With this improved reimbursement, level we restricted the terms of the patient support program in order to increase the profitability of each prescription. As a result, the number of tablets per script nearly doubled within a few weeks, which temporarily slowed the growth of prescriptions week on week, but had a very positive impact on sales. Improving reimbursement is currently the single most important commercial initiative to reach more patients. Zubsolv is clearly benefiting from being reimbursed in parity with or better than our competitors and we continue to work intensively to improve this position further. In addition to UnitedHealth Group, we have during the period either signed agreements or secured reimbursement improvements with several regional plans where Zubsolv has not previously been reimbursed. For example these plans cover patients located in the metro -Philadelphia area, Pittsburgh vicinity and across Ohio. The regional plans are, on a nationwide scale, smaller but they are critical to gain market leadership in high value concentrated U.S. geographies. The improvement of regional coverage will continue during the second quarter and I expect that this will start to have an effect on sales from late in the second quarter, in parallel with the agreement with UnitedHealth Group. As a result of what we have learned during the initial launch period, the sales force has been restructured during the first quarter. We have increased the number of representatives in some areas with good market access, and replaced a part of the sales force with representatives having a higher competency and experience profile relative to the addiction specialty field. This restructuring has led to a typical disruption in sales force performance, but we have also experienced territories where sales representatives with a consistent visit frequency and selling approach in their calls clearly are achieving better results. Therefore, we are monitoring and working closely with our partner Publicis Touchpoint Solutions to improve the sales force performance and ability to impact prescriptions. We continue to work hard to strengthen the differentiation of Zubsolv, and the three new clinical studies ongoing are expected to improve our dialogue with prescribers and increase confidence in Zubsolv and Orexo as the first results become available this summer. We are also working intensively to broaden our dosage range offerings. Zubsolv is still in a launch mode and I expect the sales development to improve in a stepwise fashion as reimbursement improves and as the results of our clinical trials become available. We are well on track to reach our competitive reimbursement target level for Zubsolv. I am optimistic that this together with our highly dedicated US and SE organization, will enhance the conditions for strong sales growth in 2014. Nikolaj Sørensen President and CEO Please note Orexo AB publ discloses the information provided herein pursuant to the Financial Instruments Trading Act and/or the Securities Market Act. The information was provided for public release on April 25, 2014, 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.
Interim report January-March 2014
| Source: Orexo AB
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