Quarterly Report • Aug 14, 2008
Quarterly Report
Open in ViewerOpens in native device viewer
Orexo AB, P.O. Box 303, SE-751 05 Uppsala, Sweden Tel: +46 18-780 88 00, Fax: +46 18-780 88 88, E-mail: [email protected] Internet: www.orexo.com Corp. reg. no. 556500-0600
Uppsala, August 14, 2008
| MSEK | 3 months | 3 months | 6 months | 6 months | 12 months |
|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2007 | |
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
| Net revenues | 56.2 | 8.8 | 80.2 | 15.2 | 76.8 |
| Loss after tax | -28.3 | -56.6 | -90.5 | -94.5 | -172.6 |
| Loss per share, | -1.31 | -4.06 | -4.19 | -6.80 | -11.42 |
| before dilution (SEK) | |||||
| Loss per share, after | -1.31 | -4.06 | -4.19 | -6.80 | -11.42 |
| dilution (SEK)2 |
Torbjörn Bjerke, President and CEO, comments:
"Orexo continued its strong development and we took further steps during the past quarter towards our goal of developing Orexo into a profitable pharmaceutical company. The company is growing at all levels, with successes for several of our products and new recruitment of key personnel.
During the period, Orexo received a positive opinion recommending approval from EMEA for Abstral in Europe. This was an important building block in our goal of becoming a profitable pharmaceuticals company. Sales of the product will begin in Sweden during August this year. I am convinced that Abstral will be an important therapy in the treatment of cancer patients suffering from breakthrough pain and look forward to further development of the product together with our business partner, ProStrakan Group.
We announced an expansion of our licensing agreement with ProStrakan regarding sales and marketing of Abstral also to the North American market. The new agreement also entails an increase in royalty levels by slightly more than 40 percent in both Europe and the US.
In summary, it was an eventful quarter with two very important events are the Approval for Rapinyl™/Abstral and the Agreement with Meda".
1) Refers to the Group unless otherwise stated. Figures in parentheses refer to the corresponding period of the preceding year. 2) Since a loss being reported, the same earnings are reported both after and before dilution.
The Annual General Meeting resolved to re-elect Monica Caneman, Johan Christenson, Staffan Lindstrand and Kjell Strandberg, and to elect new members Ray Hill and Bengt Samuelsson, as members of the Board of Directors. Håkan Åström was re-elected as Chairman of the Board of Directors until the close of the next Annual General Meeting.
The Meeting resolved to adopt a new employee stock option plan including the issuance of warrants and approval of disposal of the warrants under the employee stock option plan. The employee stock option plan consists of 470,000 employee stock options. Each employee stock option can be exercised to acquire one share in Orexo against payment of an exercise price determined as 110 percent of the market value of the Orexo share at the date of allotment.
The Meeting resolved to adopt a Board Member Shareholder Plan, including the issuance of 27,500 warrants and approval of disposal of the warrants issued under the Board Member Shareholder Plan. Board members participating in Orexo's Board Member Shareholder Plan will receive 50% of their director fee and any fee for committee work in cash and will be allocated a number of Board Member shares, whose value at the time of allotment shall correspond to 50% of the director fee and any fee for committee work. The right to acquire new shares under the Shareholder Plan is subject to the Board member continuing to serve as a Board member throughout all or part of the period in office.
Sublinox™ (OX22) for temporary treatment of sleeping disorders contains the well-documented active substance zolpidem, one of the world's most-used drugs for treatment of sleeping disorders. Sublinox™ (OX22) uses a unique and patented sublingual tablet formulation that provides fast and reliable onset effect. A recently completed Phase III study confirmed that Sublinox™ (OX22) produces a more rapid effect than other zolpidem tablet formulations. The FDA application for Sublinox™ (OX22) was submitted during the second quarter of 2008.
OX-NLA is a nasal spray formulation containing the antihistamine substance cetirizine. The liposomes in OX-NLA give the product its unique characteristics. OX-NLA is documented for treatment of allergic and non-allergic rhinitis, one of Meda's principal treatment areas. The product is at the start of Phase III. Meda will take over and finance continued development. Meda has also acquired the exclusive rights for combination products based on OX-NLA.
As compensation for the exclusive global rights for Sublinox™ (OX22) and OX-NLA, Meda paid MUSD 20, of which the entire initial one-time payment was attributable to OX22. Meda will also make the following one-time compensation payments to Orexo in conjunction with the achievement of certain milestones in annual sales.
| Sublinox™ (OX22) | OX-NLA | |||
|---|---|---|---|---|
| Upon registration approval by the FDA |
MUSD 30 | MUSD 15 | ||
| Milestones for annual sales |
Sales > MUSD 150 > MUSD 200 > MUSD 400 |
One-time payment MUSD 20 MUSD 20 MUSD 20 |
Sales > MUSD 150 > MUSD 300 |
One-time payment MUSD 20 MUSD 20 |
Orexo will receive a double-digit royalty payment from Meda's sales.
Abstral/Rapinyl™, which is intended for treatment of breakthrough pain in cancer, has been approved for registration in Europe by the EMEA's Committee for Medical products for Human Use (CHMP). Approval means that the product will be launched in Sweden during the third quarter and plans are also under way for launch in other European countries under the brand name Abstral toward the end of the year.
In conjunction with the approval, ProStrakan reached an agreement with the EMEA to provide EMEA with additional safety data from the ongoing clinical studies.
After the initial evaluation, the registration application for SublinoxTM (OX22) was accepted as complete for final evaluation. SublinoxTM contains the well-known active substance zolpidem, is based on Orexo's sublingual tablet technology and is a tablet that quickly disintegrates under the tongue.
The data on which the application is based includes a clinical study of patients suffering from sleeping disorders completed in October 2007. The study showed that SublinoxTM induced sleep 30 percent faster, compared with Ambien/Stilnoct, and that patients slept the entire night. The safety profile for SublinoxTM was comparable to Ambien/Stilnoct.
In July, Endo Pharmaceuticals took a decision to return Rapinyl™ to Orexo as a result of a decision by the company's new management to change strategy. Up until the return, Orexo had received a total of MUSD 26.9 in license revenues from Endo Pharmaceuticals. In addition, Endo had invested about MUSD 40 in development of Rapinyl™.
Endo will complete and finance the Phase III studies now in progress. When the agreement with Endo is terminated a fee of USD 750,000 is to be paid to Orexo. This is estimated to take place no later than January 30, 2009.
Orexo has consequently expanded the licensing agreement with ProStrakan Group plc, the international specialty pharmaceuticals company, to include North America as a new territory. ProStrakan, which was previously Orexo's partner for sales and marketing of Rapinyl™/Abstral in Europe, will now also be responsible for sales and marketing of Rapinyl™/Abstral in North America. Abstral was approved for marketing in Europe in June this year.
ProStrakan has established offices with management and sales personnel in the US and is currently recruiting 67 sales representatives in partnership with NovaQuest (part of the Quintiles Group).
In respect of the transfer from Endo and the new agreement for the North American market, Orexo will receive MUSD 2 from ProStrakan. This is estimated to take place no later than January 30, 2009. In addition, Orexo may receive a further MUSD 27 in application and sales-level compensation and milestones, excluding the MUSD 2 received at effective date of the agreement. In the earlier agreement with Endo could the total amount in sales milestones be up to MUSD 39.2.
In conjunction with signing of the contract, the existing contract pertaining to Europe was also amended. The milestone compensation linked to approval in the five largest markets was reduced from MEUR 5 to MUSD 5, and sales-level compensation in Europe was increased from MEUR 10 to MEUR 19.9. At the same time, royalty payments were raised by 7 to 9 percentage points, corresponding to an increase of slightly more than 40 percent. The royalty compensation in North America was increased by a corresponding amount, in relation to the previous agreement with Endo.
Orexo is a pharmaceutical company focusing on the development of new, patented drugs by combining well-documented substances with innovative technologies and of new treatment forms for respiratory and inflammatory diseases.
Orexo has a broad and competitive product portfolio in the late development phase, with two products on the market, five products in clinical phases and two in the registration phase.
Orexo has licensed out the marketing rights to Rapinyl™/Abstral for the North American, European, Asian and Japanese markets, world rights for Sublinox™ (OX22) and OX-NLA, and is cooperating with Boehringer Ingelheim in the development of a new pharmaceutical drug class for treatment of pain and inflammation. Orexo has also established a Nordic sales organization through a joint venture with ProStrakan.
Diabact® UBT/Heliprobe™ System – Diabact® UBT is Orexo's first commercialized product. It is based on Orexo's patent-protected fast-dissolving tablet. The tablet contains analysis substances and is swallowed with water, meaning that no solution mixture needs to be prepared. A breath test is performed as early after ten minutes. The result is more cost-effective medical care, since time-consuming preparatory measures are eliminated. The sample is analyzed in a laboratory, and the result is available within two to three days.
The Heliprobe™ System breath test is also very user-friendly for both patients and medical personnel. The test result is available just 10 to 15 minutes after the patient has swallowed a urea capsule containing a mild radioactive component, which makes immediate analysis possible.
Distribution and marketing agreements for Diabact® UBT have been signed for markets in the UK, Finland, Denmark, Hong Kong, Ireland, Germany, Austria, Serbia and Sweden. The technology is licensed in the Japanese market.
Since the Heliprobe™ System has been launched in more than 30 countries, including Eastern Europe, the Middle East and Asia, Kibion has access to well-established distribution and sales channels in a number of markets with substantial potential.
Rapinyl™/Abstral – for the treatment of acute pain is approved for sale in Europe and is in Phase III in the US. Rapinyl™/Abstral was developed for the treatment of cancer-related breakthrough pain as its primary indication. Orexo's principal technology, the sublingual dosage method, whereby a fast-dissolving tablet is placed under the tongue, enables rapid and predictable onset of drug effect with "on-demand" features. License agreements for Rapinyl™/Abstral have been signed with ProStrakan Group Ltd. for the European and North American markets and with Kyowa Hakko for the Japanese market. Distribution agreements for the CIS (Russia and other
countries in the former Soviet Union), Bulgaria and Rumania have been signed with Gedeon Richter and for Southeast Asia, including Australia and New Zealand with Hospira.
In December 2005, Phase III studies began in the USA on Rapinyl™/Abstral. Positive results from an interim analysis of the Phase III study were announced in December 2007. When all 100 patients Phase III studies have been completed, a registration application will be submitted to the FDA in the US. At present, it is expected that this will take place toward the end of this year.
Sublinox™ (OX22) – for the treatment of sleeping disorders. Sublinox™ (OX22) is based on Orexo's sublingual tablet technology. In 2006, the US insomnia market was worth MUSD 3.3 billion (according to IMS sales data).
After the close of the period, a license agreement regarding Sublinox™ (OX22) was signed with Meda covering exclusive world rights.
During October, Orexo completed the Phase III program by conducting the effect, local tolerance and safety study trials among patients using Sublinox™ (OX22) – for the treatment of temporary insomnia – with positive results. The efficacy trials confirmed that Sublinox™ (OX22) renders a 30 percent faster onset of sleep compared with Ambien™, in patients suffering from sleeping disorders. The study also showed that more patients remain asleep throughout the night. The study strengthens existing documentation that Sublinox™ (OX22) is a safe and effective treatment for temporary insomnia.
OX-MPI – Selective prostaglandin E2 synthesis inhibitors for pain, inflammation and rheumatism. The project is aimed at developing a new, effective pharmaceutical for pain, inflammation and fever with fewer side-effects than existing drugs such as the classic NSAID preparation (for example diclofenac) and the more recently developed COX-2 inhibitors (for example, Vioxx and Celebrex). The mechanism is based on the discovery of a specific enzyme, prostaglandin (PG) E2 synthase (mPGES), a bodily substance that plays a central role in many inflammatory processes. The project is partnered with Boehringer Ingelheim GmbH, Germany, which has acquired the global sales rights. Orexo retained co-promotion rights to markets in the Nordic countries and the Baltic States.
OX-NLA – fast-acting effect for treatment of allergic and nonallergic rhinitis.
A license agreement covering exclusive worldwide commercialization rights for OX-NLA was signed with Meda during the quarter. Under the agreement, Meda is responsible for the project's continued development, including all related costs.
OX-NLA nasal spray for treatment of allergic and non-allergic rhinitis contains the active component cetirizine. Orexo has developed a unique formulation that reduces cetirizine's local irritating properties. Clinical Phase II studies have shown both good and fast-acting effects, making NLA suitable for on-demand treatment. Local treatment in the nose reduces the risk for systematic side effects, such as drowsiness.
In a recently completed study of patients with rhinitis, OX-NLA nasal spray showed favorable tolerance without local side effects in the form of stinging and pain. The conclusion is that the liposomes in OX-NLA Nasal Spray appear to mask the irritating effects of cetirizine.
OX17 – for the treatment of GERD (gastro esophageal reflux disease), a disorder that gives the patient recurrent heartburn involving acidic regurgitation linked to stomach ache, discomfort and sharp pains in the esophagus. OX17 is a patent-pending fixed combination of two well-established active substances that each inhibits acid secretion in the stomach; an H2-receptor blocker and a proton pump inhibitor (PPI). To date, patents have been granted in Europe, China, Australia and New Zealand.
The clinical trial program confirms that effective inhibition of acid secretion is rapidly achieved after taking the first dose. Effective acid inhibition can be maintained as long as the symptoms persist. This is a favorable and unique clinical profile for a drug intended for the treatment of GERD. The clinical results were presented at the "Digestive Disease Week" conference in Los Angeles, California, in the US on May 21, 2006. A pharmacological dynamic study has been concluded on patients suffering from GERD and the clinical data confirms that OX17 has a competitive profile for treatment of GERD.
OX914 – for the treatment of COPD and asthma. The aim of this project is to develop an orallyactive product that blocks the PDE4 enzyme existing in many pro-inflammatory cells. In clinical studies of various substances that inhibit PDE4, several companies have demonstrated positive treatment effect in COPD and asthma. However, no substance has reached the market, mainly due to side effects, primarily nausea. OX914 has shown favorable effects in preclinical models of COPD and asthma and clinical studies have not shown increased frequency of nausea compared with placebo.
OX2477 – Is a part of an entirely new class of agents with treatment potential for asthma and COPD. Orexo has discovered a new group of mediators, eoxins, that are formed primarily in cells in respiratory passages and have shown powerful pro-inflammatory effects. Accordingly, release of eoxins in the lungs could make an important contribution to the inflammatory process in COPD and asthma. The project aims to develop an entirely new class of pharmaceuticals against asthma, COPD and other inflammatory diseases.
OX-CLI – a new generation of agents with treatment potential in asthma, COPD and rhinitis. Orexo is developing an orally administered, dual-acting drug with bronchodilating and antiinflammatory effects. Studies in animals that lack the target protein have shown significantly reduced inflammatory responses in various asthma and COPD models. Orexo has identified molecules that show favorable effects in different pharmacological models. A patent portfolio with potential candidate drugs has been prepared.
OX-LSAID – for the treatment of moderate to severe asthma. The LSAID-program contains nonsteroidal anti-inflammatory substances that have shown favorable effects in preclinical asthma models. Clinical studies have shown effects on certain parameters in patients with asthma.
OX19 – for the treatment of daytime and nocturnal urinary incontinence (nocturia). In addition to the treatment of nocturia, OX19 also focuses on the short-term, on-demand treatment of urinary incontinence in women suffering from an overactive bladder. A pharmacological study in healthy persons has been concluded. Orexo will seek partners for continued development of the nasal powder preparation of desmopressin.
OX40 – for the acute treatment of moderate and severe migraine. The plan for the project is to develop a candidate drug with a fast and predictable onset of effect, an essential characteristic for effective on-demand medication.
OX23 – for the treatment of acute pain. Based on Orexo's sublingual technology – the sublingual dosage form allowing a rapid dissolution of a tablet placed under the tongue resulting in a prompt onset of effect and predictable effects – typical "on-demand" properties.
| MSEK | 3 months 2008 |
3 months 2007 April-June April- June |
6 months 2008 Jan.- June |
6 months 2007 Jan.- June |
12 months 2007 Jan.-Dec. |
|---|---|---|---|---|---|
| Net revenue | 56.2 | 8.8 | 80.2 | 15.2 | 76.8 |
| Cost of goods sold | -5.0 | -4.1 | -8.9 | -6.8 | -14.4 |
| Gross profit | 51.2 | 4.7 | 71.3 | 8.4 | 62.4 |
| Sales costs | -10.6 | -9.3 | -18.6 | -13.5 | -27.0 |
| Administrative expenses | -12.4 | -12.1 | -27.7 | -22.9 | -58.9 |
| Research and development costs | -59.1 | -41.6 | -121.2 | -70.4 | -156.0 |
| Other operating income and expenses | -0.2 | -0.2 | 0.6 | -0.2 | -1.1 |
| Operating loss | -31.0 | -58.5 | -95.5 | -98.6 | -180.6 |
| Net financial items | 2.6 | 1.9 | 4.8 | 4.1 | 7.7 |
| Loss after financial items | -28.4 | -56.6 | -90.7 | -94.5 | -172.8 |
| Tax | 0.1 | 0.0 | 0.2 | 0.0 | 0.2 |
| Net loss for the period | -28.3 | -56.6 | -90.5 | -94.5 | -172.6 |
Consolidated net revenue for the period January – June 2008 amounted to MSEK 80.2 (15.2). The sharp increase compared with the preceding year was primarily due to licensing revenues from Meda, from which Orexo received MSEK 118 (MUSD 20) in one-time compensation. These revenues will be booked linearly up until FDA approval has been gained (12 months). MSEK 29.5 was recognized up until June 30, 2008. However, revenues from the partnership with Boehringer Ingelheim GmbH relating to OX-MPI and from the joint venture company ProStrakan also contributed to net revenue.
| MSEK | Jan.-June 2008 | Jan.-June 2007 | Jan.-Dec. 2007 |
|---|---|---|---|
| Diabact® UBT | 2.6 | 3.0 | 5.2 |
| Heliprobe™ System | 11.7 | 9.7 | 19.7 |
| ProStrakan AB J/V 50% | 4.4 | - | 2.7 |
| License revenue | 29.5 | - | 34.0 |
| Other | 32.0 | 2.5 | 15.2 |
| Total | 80.2 | 15.2 | 76.8 |
Net revenue was distributed as follows:
During the period April – June 2008, net revenue amounted to MSEK 56.2 (8.8).
Consolidated selling expenses amounted to MSEK 18.6 (13.5) for the period January – June 2008 and to MSEK 10.6 (9.3) for the period April - June 2008.
Selling expenses primarily include costs for business development linked to the licensing-out of Orexo's projects and costs in Kibion AB and the joint venture company ProStrakan AB. The increase in selling expenses between the corresponding periods of 2007 and 2008 was increased cost for business development mainly outlicensing and costs in the joint venture (ProStrakan AB).
Administrative expenses amounted to MSEK 27.7 (22.9) for the period January – June 2008 and to MSEK 12.4 (12.1) for the period April-June 2008.
The increase with respect to the corresponding period for 2007 was primarily due to the acquisition of Biolipox, but also due to the new premises in Uppsala following the move in summer 2007.
Research and development expenses amounted to MSEK 121.2 (70.4) for the period January–June 2008 and to MSEK 59.1 (41.6) for April–June 2008.
The increase in research and development expenses compared with the corresponding period for 2007 was attributable to the acquisition of Biolipox AB in November 2007.
Research and development expenses include expenses for employees, employee stock options, premises, external costs for clinical trials, drug registration and laboratory services, as well as depreciation of equipment and amortization of acquired patents and other intangible assets. Orexo has no capitalized research and development costs. The company has several development projects in advanced phases, including Rapinyl™/Abstral for the treatment of acute pain, OX-MPI for treatment of pain, inflammation and rheumatism, Sublinox™ (OX22) for the treatment of sleeping disorders, OX17 for GERD, OX-NLA for treatment of allergic and non-allergic rhinitis (hay fever), OX2477, a completely new class of pharmaceuticals for asthma and COPD, and OX-CLI, a new generation of pharmaceuticals for the treatment of asthma, COPD and rhinitis.
For the period April-June 2008, the company's costs for the employee stock option plan totaled MSEK 3.4 (2.0). The higher costs during the quarter were due to an increase in the number of outstanding options resulting from the acquisition of Biolipox in November 2007, allotments in February 2008 according to the stock option plan resolved by the 2007 Annual General Meeting, the Board Member share ownership plan approved by the 2008 Annual General Meeting and amounts vested by employees during this and previous stock option plans during the period. The increase in share price during the period also resulted in increased costs being recognized as a provision for calculated social security fees.
For the period January-June 2008, costs for the employee stock option plan amounted to MSEK 5.8 (3.5), of which MSEK 2.8 (1.3) was attributable to administrative employees, MSEK 2.7 (1.9) to research and development-related personnel and MSEK 0.3 (0.3) to sales-related personnel.
Other income and expenses, consisting primarily of exchange-rate gains and losses, amounted to income of MSEK 0.6 (expense: 0.2) for the period January – June 2008 and to an expense of MSEK 0.2 (expense: 0.2) for the period April-June 2008.
Depreciation/amortization amounted to MSEK 5.5 (2.1) for the period January–June 2008 and to MSEK 2.6 (1.0) for the period April–June 2008. The increase was primarily due to investments during 2007 in new office premises and the acquisition of Biolipox AB.
Tax expenses during January–June 2008 amounted to MSEK 0.2 (0.0).
The operating loss for the period January – June 2008 amounted to MSEK 95.5 (loss: 98.6). The loss after net financial items was MSEK 90.7 (94.5), and the loss after tax was MSEK 90.5 (94.5). Between comparable periods, revenue increased strongly, mainly due to the license revenue from Meda that was received during
The operating loss for the period April – June was MSEK 31.0 (loss: 58.5). The loss after financial items was MSEK 28.4 (loss: 56.6), and the loss after tax was MSEK 28.3 (loss: 56.6).
The Group's cash and cash equivalents amounted to MSEK 247.1 (187.8) at June 30, 2007 and short-term investments amounted to MSEK 0 (30.9).
Cash flow from operating activities for the period January–June 2008 was a negative MSEK 42.8 (neg: 97.5). Cash flow after financing was a negative amount of MSEK 44.5 (neg. 88.6).
Cash flow from operating activities for the period April–June 2008 was a negative MSEK 45.7 (neg. 48.6). Cash flow after financing was a negative amount of MSEK 45.5 (neg. 13.1).
Shareholders' equity on June 30, 2008 amounted to MSEK 585.1 (235.3). The equity/assets ratio was 77 percent (80 percent).
Gross investments in tangible fixed assets amounted to MSEK 1.3 (19.1) for the period January–June 2008 and to MSEK 0.1 (12.7) for the period April–June 2007. The decline from the corresponding period was primarily attributable to remodeling of new premises and investments in production and research equipment during 2007.
The majority of the Group's business is carried out in the parent company, Orexo AB. Net revenues for the period January–June 2008 amounted to MSEK 46.2 (5.5) and the loss after net financial items was MSEK 76.1 (loss: 95.8). Investments amounted to MSEK 5.9 (19.1). The Parent Company's cash and cash equivalents and current investments totaled MSEK 83.1 (217.2).
The agreement reached in conjunction with the acquisition of Inflazyme included a supplementary purchase consideration conditional upon achievement of certain targets. Portions of this supplementary purchase price are recognized as long-term liabilities, and MSEK 36.3 is carried as a contingent liability, since it is not considered probable that payment will be required based on pharmaceutical trend statistics. As a cash-flow hedge for social security fees relating to employee stock options issued by Biolipox, stock options were issued to Pyrinox AB. Orexo has undertaken to cover any deficit in addition to the amount covered by the employee stock options. Furthermore, in conjunction with the acquisition of Noster System AB, Orexo agreed to pay a supplementary purchase consideration of not more than MSEK 7.2, which would become payable if the growth of Heliprobe™ System achieves pre-determined sales targets up to December 31, 2009. The amount is reported under contingent liabilities. Otherwise, no significant changes in contingent liabilities or pledged assets occurred during the period.
Orexo is a group in the development stage with only two products on the market and a number of other product candidates in various development stages, of which some are in late-stage clinical development. Research and development of pharmaceuticals are characterized by significant operating risks. Many factors affect the probability that a drug project will result in an approved pharmaceutical. For example, a potential drug candidate that demonstrated favorable effects in animal models may lack any significant effect on humans. Risks for side-effects can also complicate the drug project. However, the risk of not reaching the market diminishes as the project passes through the various phases in the development process. If the Group's clinical trials are not successful, Orexo would lose the possibility to license out or commercialize those programs as products.
Orexo's competitors are large pharmaceutical and biotech companies with substantial financial resources and which conduct research in the same areas as Orexo. There is a risk that these competitors develop a pharmaceutical that is better than those developed by Orexo, or that they reach the market faster, whereby the future value of the Group's products will be lower than originally expected.
Orexo is dependent on partners, and is expected to remain so in the future, for development, implementation of clinical trials, approval from regulatory authorities regarding manufacturing, marketing and sales of the Group's product candidates. Orexo's and its partners' facilities and processes require the approval of the regulatory authorities and the manufacture and storage of pharmaceuticals and biological products involve environmental risks and are subject to environmental legislation, which can delay or disrupt operations. Changes to the healthcare system can also impact Orexo's operations and profitability.
Orexo is dependent on its personnel and certain key individuals. In the event they should terminate their employment this could disrupt and delay development processes. To motivate and retain personnel and key individuals, the company offers such incentives as an options program aimed at all employees.
Orexo's operations entail exposure to risks due to changes in interest rates, exchange rates, credit and counterparty risks as well as liquidity and financing risks. Orexo has developed guidelines and policies to manage and limit these risks effectively.
Orexo's share was introduced on November 9, 2005 at a price of SEK 90 and was traded at SEK 59 on June 30, 2008. The company's market capitalization, based on the number of shares outstanding on June 30, 2008, was SEK 1.3 billion.
Analysts who monitor Orexo
Carnegie AB Camilla Oxhamre Handelsbanken Markets Erik Hultgård Redeye Björn Andersson
ABG Sundal Collier Alexander Lindström and Jenni Ruottinen SEB Gustaf Vahlne and Lars Hevreng
| Interim Report, January-September 2008 | November 10 |
|---|---|
| Year-end Report 2008 | not later than February 28, 2009 |
The Board of Directors and the President certify that this interim report presents a fair overview of the operations, financial position and earnings of the company and the Group and that it describes any significant risks and uncertainties facing the company and the companies included in the Group.
Uppsala, August 14, 2008
Orexo AB (publ)
Håkan Åström Monica Caneman Johan Christenson Chairman of the Board Board member Board member
Raymond Hill Staffan Lindstrand Bengt Samuelsson Board member Board member Board member
Kjell Strandberg Torbjörn Bjerke Board member President and CEO
For further information, please contact:
Torbjörn Bjerke, President and CEO, tel +46 (0) 18-780 88 12, e-mail: [email protected] Claes Wenthzel, Executive Vice President and CFO, tel 018-780 88 44, e-mail: [email protected]
We have reviewed the appended report for the period January 1 to June 30, 2008 for Orexo AB (publ). The company's management is responsible for the preparation and fair presentation of this interim report in accordance with the Annual Accounts Act and IAS 34. Our responsibility is to express an opinion on this interim report based on our review.
We conducted our review in accordance with the Standard on Review Engagements SÖG 2410, Review of Interim Financial Information Performed by the Independent Auditor of the Entity, issued by FAR. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review has a different purpose and is substantially more limited in scope than an audit conducted in accordance with Standards on Auditing in Sweden RS and other generally accepted auditing practices. The procedures performed in a review do not enable us to obtain a level of assurance that would make us aware of all significant matters that might be identified in an audit.
Therefore, the conclusion expressed based on a review does not give the same level of assurance as a conclusion expressed based on an audit. Based on our review, nothing has come to our attention that causes us to believe that the appended interim report has not in all significant respects been compiled in accordance with IAS 34 and the Annual Accounts Act for the Group and in accordance with the Annual Accounts Act for the Parent Company.
Uppsala, August 14, 2008 PricewaterhouseCoopers
Leonard Daun Authorized Public Accountant
(SEK 000s)
| Notes | June 30, 2008 |
June 30, 2007 |
Dec. 31, 2007 |
|
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible fixed assets | 54,466 | 23,696 | 57,790 | |
| Goodwill | 16,030 | 8,988 | 16,030 | |
| Intangible fixed assets | 376,764 | 1,629 | 377,335 | |
| Total fixed assets | 447,260 | 34,313 | 451,155 | |
| Current assets | ||||
| Inventories | 14,452 | 10,437 | 13,294 | |
| Accounts receivable and other receivables | 47,407 | 29,706 | 42,261 | |
| Tax receivables | 3,773 | 1,853 | 3,565 | |
| Short-term investments | 0 | 30,929 | - | |
| Cash and bank balances | 247,134 | 187,778 | 291,598 | |
| Total current assets | 312,766 | 260,703 | 350,718 | |
| Total assets | 760,026 | 295,016 | 801,873 | |
| SHAREHOLDERS' EQUITY AND | ||||
| LIABILITIES | 3 | |||
| Share capital | 8,647 | 5,584 | 8,647 | |
| Capital contributions | 839,579 | 361,640 | 835,202 | |
| Accumulated losses | -263,102 | -131,967 | -172,597 | |
| Total shareholders' equity | 585,124 | 235,257 | 671,252 | |
| Long-term liabilities | ||||
| Provisions | 1,074 | 5,226 | 162 | |
| Long-term liabilities | 9,100 | - | 9,595 | |
| Deferred tax liability | 647 | 317 | 877 | |
| Total long-term liabilities | 10,821 | 5,543 | 10,634 | |
| Current liabilities, non-interest-bearing | 164,081 | 54,216 | 119,987 | |
| Total liabilities | 174,902 | 59,759 | 130,621 | |
| Total shareholders' equity and liabilities |
760,026 | 295,016 | 801,873 | |
| Pledged assets | 2,500 | 2,500 | 14,500 | |
| Contingent liabilities | 43,550 | 7,250 | 43,550 |
(SEK 000s)
| Notes | 3 months 2008 |
3 months 2007 |
6 months 2008 |
6 months 2007 |
12 months 2007 |
|
|---|---|---|---|---|---|---|
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | ||
| Net revenue | 56,246 | 8,806 | 80,241 | 15,208 | 76,757 | |
| Cost of goods sold | 2 | -5,007 | -4,130 | -8,903 | -6,811 | -14,384 |
| Gross profit | 51,239 | 4,676 | 71,338 | 8,397 | 62,373 | |
| Selling expenses | 2 | -10,582 | -9,257 | -18,584 | -13,494 | -26,982 |
| Administrative expenses | 2 | -12,377 | -12,170 | -27,678 | -22,983 | -58,932 |
| Research and development costs | 2 | -59,064 | -41,584 | -121,248 | -70,441 | -155,972 |
| Other operating income | 1,746 | 6,757 | 2,619 | 9,596 | 9,958 | |
| Other operating expenses | 2 | -1,988 | -6,887 | -1,988 | -9,757 | -11,014 |
| Operating loss | -31,026 | -58,465 | -95,541 | -98,682 | -180,569 | |
| Earnings from financial | ||||||
| investments | ||||||
| Interest income | 2,708 | 1,846 | 4,981 | 4,135 | 8,231 | |
| Interest expenses | -140 | -1 | -175 | -18 | -23 | |
| Other financial expenses | 0 | 0 | 0 | 0 | -473 | |
| Total loss from financial | ||||||
| investments | -28,458 | -56,620 | -90,735 | -94,565 | -172,834 | |
| Tax | 115 | 20 | 230 | 40 | 237 | |
| Net loss for the period | -28,343 | -56,600 | -90,505 | -94,525 | -172,597 | |
| Loss per share, before dilution, SEK | -1.31 | -4.06 | -4.19 | -6.80 | -11.42 | |
| Earnings per share, after dilution, SEK | -1.31 | -4.06 | -4.19 | -6.80 | -11.42 | |
| Average number of shares, before | ||||||
| dilution | 21,617,395 | 13,928,161 | 21,617,395 | 13,907,393 | 15,108,176 | |
| Average number of shares, after | ||||||
| dilution | 22,797,594 | 14,187,810 | 22,823,435 | 14,167,042 | 16,183,863 | |
| Number of shares, before dilution | 21,617,395 | 13,961,250 | 21,617,395 | 13,961,250 | 21,617,395 | |
| Number of shares, after dilution | 22,823,435 | 14,220,899 | 22,823,435 | 14,220,899 | 22,693,082 |
| (SEK 000s) | 3 months | 3 months | 6 months | 6 months | 12 months | |
|---|---|---|---|---|---|---|
| Notes | 2008 | 2007 | 2008 | 2007 | 2007 | |
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | ||
| Continuing operations | ||||||
| Loss before interest income and interest expense |
-31,026 | -58,465 | -95,541 | -98,682 | -180,569 | |
| Interest income | 2,708 | 1,846 | 4,981 | 4,135 | 8,231 | |
| Interest expenses | -140 | -1 | -175 | -18 | -23 | |
| Other financial expenses | -473 | |||||
| Adjustment for items not included in | ||||||
| cash flow | 4 | 6,103 | 2,993 | 11,355 | 5,589 | 7,461 |
| Cash flow from operations before | ||||||
| changes in working capital | -22,355 | -53,627 | -79,380 | -88,976 | -165,373 | |
| Change in working capital | ||||||
| Accounts receivable | -6,482 | -5,640 | -9,953 | -935 | 2,537 | |
| Other current receivables | -6,796 | -1,119 | 4,599 | -9,814 | -18,266 | |
| Inventories | -222 | -2,641 | -1,158 | -1,203 | -4,060 | |
| Current liabilities | 80,910 | 13,972 | 42,626 | 3,019 | 37,069 | |
| Provisions | 745 | 495 | 912 | 407 | -4,657 | |
| Long-term liabilities | -124 | - | -495 | - | - | |
| Cash flow from continuing | ||||||
| operations | 45,676 | -48,560 | -42,849 | -97,502 | -152,750 | |
| Investing activities | ||||||
| Acquisition of machinery & equipment | -139 | -12,671 | -1,299 | -19,051 | -49,318 | |
| Divestment of machinery & equipment | - | - | 11 | - | - | |
| Acquisition of current investments | - | - | - | -19,762 | -19,762 | |
| Divestment of current investments | - | 45,473 | - | 44,959 | 75,888 | |
| Acquisition of shares in subsidiaries | - | - | -327 | - | 158,151 | |
| Cash flow after investments | 45,537 | -15,758 | -44,464 | -91,356 | 12,209 | |
| Change in financing | ||||||
| Proceeds from new share issue | 0 | 2,706 | 0 | 2,726 | 2,981 | |
| Cash flow after financing | ||||||
| activities | 45,537 | -13,052 | -44,464 | -88,630 | 15,190 | |
| Cash flow for the period | ||||||
| Cash and cash equivalents at the | ||||||
| beginning of period | 201,597 | 200,830 | 291,598 | 276,408 | 276,408 | |
| Change in cash and cash equivalents | 45,537 | -13,052 | -44,464 | -88,630 | 15,190 | |
| Cash & cash equivalents at end of | ||||||
| period | 247,134 | 187,778 | 247,134 | 187,778 | 291,598 |
| KEY FIGURES (SEK 000s) |
3 months April-June |
3 months April-June |
6 months Jan.-June |
6 months Jan.-June |
12 months Jan.-Dec. |
|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2007 | |
| Operating margin, % | -55 | -664 | -119 | -649 | -235 |
| Profit margin, % | -51 | -643 | -113 | -622 | -225 |
| Return on total capital, % | -4 | -18 | -12 | -28 | -45 |
| Return on shareholders' equity, % | -5 | -21 | -14 | -33 | -53 |
| Return on capital employed, % | -5 | -21 | -14 | -33 | -53 |
| Debt/equity ratio, multiple | 0 | 0 | 0 | 0 | 0 |
| Equity/assets ratio, % | 77 | 80 | 77 | 80 | 84 |
| Current ratio, % | 191 | 481 | 191 | 481 | 292 |
| Acid ratio, % | 182 | 462 | 182 | 462 | 281 |
| Average number of shares, before dilution | 21,617,395 | 13,928,161 | 21,617,395 | 13,907,393 | 15,108,176 |
| Average number of shares, after dilution | 22,797,594 | 14,132,683 | 22,823,435 | 14,167,042 | 16,183,863 |
| Number of shares after full dilution | 23,398,558 | 14,896,025 | 23,398,558 | 14,896,025 | 23,010,220 |
| Number of shares, before dilution | 21,617,395 | 13,961,250 | 21,617,395 | 13,961,250 | 21,617,395 |
| Number of shares, after dilution | 22,823,435 | 14,220,899 | 22,823,435 | 14,220,899 | 22,693,082 |
| Loss per share, before dilution, SEK | -1.31 | -4.06 | -4.19 | -6.80 | -11.42 |
| Loss per share, after dilution, SEK | -1.31 | -4.06 | -4.19 | -6.80 | -11.42 |
| Shareholders' equity per share, before | |||||
| dilution, SEK | 27.07 | 16.85 | 27.07 | 16.85 | 31.05 |
| Shareholders' equity per share, after dilution, | |||||
| SEK | 25.64 | 16.54 | 25.64 | 16.54 | 29.58 |
| Number of employees at the end of the period | 120 | 71 | 120 | 71 | 129 |
| Average number of employees | 125 | 69 | 125 | 68 | 80 |
| Shareholders' equity | 585,124 | 235,257 | 585,124 | 235,257 | 671,252 |
| Capital employed | 585,124 | 235,257 | 585,124 | 235,257 | 671,252 |
Operating margin: Operating profit/loss as a percentage of net sales.
Profit margin: Profit/loss after financial items as a percentage of net sales.
Return on total capital: Operating profit/loss plus financial revenues as a percentage of average balance-sheet total.
Return on shareholders' equity: Profit/loss for the period as a percentage of average adjusted shareholders' equity.
Return on capital employed: Operating profit/loss plus financial revenues as a percentage of average capital employed.
Capital employed: Average of interest-bearing liabilities and shareholders' equity.
Debt/equity ratio: Interest-bearing liabilities divided by shareholders' equity.
Equity/assets ratio: Shareholders' equity in relation to total assets.
Current ratio: Current assets as a percentage of current liabilities.
Acid ratio: Current assets, excluding inventories, as a percentage of current liabilities.
Number of shares after full dilution: Total number of shares plus the maximum number of shares that can be subscribed through options outstanding.
Number of shares, after dilution: Calculation of the dilution from options issued by the company through 2005 was carried out in accordance with IAS 33.
Earnings per share before dilution: Profit/loss divided by the average number of shares outstanding before dilution.
Earnings per share after dilution: Profit/loss divided by the average number of shares outstanding after dilution.
Shareholders' equity per share, before dilution: Shareholders' equity divided by the number of shares before dilution at the close of the period.
(SEK 000s)
| Notes | June 30 2008 |
June 30 2007 |
Dec. 31 2007 |
|
|---|---|---|---|---|
| ASSETS | ||||
| Fixed assets | ||||
| Tangible fixed assets | 53,358 | 23,629 | 50,903 | |
| Financial fixed assets | 501 | 436 | 566 | |
| Shares in subsidiaries/Joint ventures | 524,169 | 100 | 523,842 | |
| Total fixed assets | 578,028 | 24,165 | 575,311 | |
| Current assets | ||||
| Inventories | 6,079 | 2,575 | 4,362 | |
| Accounts receivable and other receivables | 61,423 | 48,010 | 51,987 | |
| Tax receivables | 1,828 | 1,753 | 1,083 | |
| Current investments | 0 | 211,085 | - | |
| Cash and bank balances | 83,067 | 6,105 | 109,511 | |
| Total current assets | 152,397 | 269,528 | 166,943 | |
| Total assets | 730,425 | 293,693 | 742,254 | |
| SHAREHOLDERS' EQUITY, PROVISIONS AND LIABILITIES |
6 | |||
| Restricted equity Non-restricted equity |
299,398 292,968 |
364,402 -126,346 |
299,398 366,534 |
|
| Total shareholders' equity | 592,366 | 238,056 | 665,932 | |
| Long-term liabilities Provisions |
1,074 | 5,226 | 163 | |
| Total long-term liabilities | 1,074 | 5,226 | 163 | |
| Current liabilities, non-interest-bearing | 136,985 | 50,411 | 76,159 | |
| Total liabilities | 138,059 | 55,637 | 76,322 | |
| Total shareholders' equity, provisions and liabilities |
730,425 | 293,693 | 742,254 | |
| Pledged assets | 2,500 | 2,500 | 2,500 | |
| Contingent liabilities | 11,050 | 11,050 | 11,050 |
(SEK 000s)
| Notes | 3 months April-June |
3 months April-June |
6 months Jan.-June |
6 months Jan.-June |
12 months Jan.-Dec. |
|
|---|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2007 | ||
| Net Revenue | 38,164 | 2,447 | 46,216 | 5,509 | 48,389 | |
| Cost of goods sold | 5 | 0 | -1,281 | 0 | -2,346 | -2,409 |
| Gross profit | 38,164 | 1,166 | 46,216 | 3,163 | 45,980 | |
| Selling expenses | 5 | -5,510 | -7,633 | -8,189 | -10,378 | -15,408 |
| Administrative expenses | -12,673 | -12,195 | -25,114 | -22,688 | -54,327 | |
| Research and development costs | -52,154 | -41,370 | -91,548 | -70,440 | -143,225 | |
| Other operating income | 1,188 | 6,766 | 1,474 | 9,495 | 9,674 | |
| Other operating expenses | 5 | -1,138 | -6,804 | -1,138 | -9,578 | -10,413 |
| Operating loss | -32,123 | -60,070 | -78,299 | -100,426 | -167,719 | |
| Earnings from financial | ||||||
| investments | ||||||
| Interest income | 1,375 | 2,122 | 2,303 | 4,652 | 7,832 | |
| Interest expense | -121 | - | -138 | -6 | -11 | |
| Total loss from financial | ||||||
| investments | -30,869 | -57,948 | -76,134 | -95,780 | -159,898 | |
| Net loss for the period | -30,869 | -57,948 | -76,134 | -95,780 | -159,898 |
This interim report was prepared in accordance with IAS 34, Interim Financial Reporting, which complies with the requirements stipulated in the Swedish Financial Accounting Standards Council's recommendation RFR 1.1, Interim Financial Reporting for Groups. As of 2005, Orexo has applied IFRS as approved by the EU. The accounting principles and calculation methods comply with those applied in preparing the 2007 Annual Report.
In this interim report, the classification between selling costs and administrative expenses was changed. Business development is now classified as a selling expense and not as an administrative expense. Historical figures were recalculated according to the new classification.
The Parent Company's accounting was prepared in accordance with RFR 2.1.
In other respects, the accounting principles applied in this interim report are described in greater detail in the notes to the 2007 Annual Report.
The amounts below are in SEK thousands, unless otherwise indicated.
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2007 | |
| Raw materials and supplies | 8,001 | 3,502 | 15,720 | 9,698 | 26,835 |
| Other external costs | 40,990 | 41,342 | 88,073 | 62,421 | 132,307 |
| Personnel costs | 37,388 | 21,526 | 69,110 | 39,974 | 92,967 |
| Depreciation and impairment | 2,638 | 1,030 | 5,497 | 2,093 | 5,875 |
| Re-invoicing of rebuilding costs | 6,628 | 9,300 | 9,300 | ||
| TOTAL | 89,017 | 74,028 | 178,400 | 123,486 | 267,284 |
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2007 | |
| Shareholders' equity brought forward | |||||
| according to balance sheet | 611,085 | 287,655 | 671,252 | 324,350 | 324,350 |
| Loss for the period | -28,343 | -56,600 | -90,505 | -94,525 | -172,597 |
| Subscription of shares through the | |||||
| exercise of warrants | 2,706 | 2,726 | 2,981 | ||
| New share issues | - | - | 438,775 | ||
| New share of employee stock options | - | - | 52,875 | ||
| Employee stock options, value of | |||||
| employees' service | 2,382 | 1,494 | 4,377 | 2,704 | 5,989 |
| Acquired value of employee stock options |
- | - | 18,879 | ||
| Amount at close of period | 585,124 | 235,255 | 585,124 | 235,255 | 671,252 |
The number of shares outstanding at June 30, 2008, was 21,617,395, all of which were common shares. All shares carry entitlement to one vote each. No increase in the number of shares outstanding occurred during the period.
At June 30, there were 2,750,625 options outstanding carrying subscription rights corresponding to 2,251,163 shares in Orexo and exchange of 499,462 options to shares in Orexo3. Each option issued by Biolipox AB carries the right of exchange for one share in Orexo AB, and the corresponding number of shares is held by the independent company Pyrinox AB.
The following table shows changes in the number of options in each category during the January–June 2008 period.
| Opening Jan. 1, 2008 |
- | + | Closing June 30, 2008 |
|
|---|---|---|---|---|
| Stock options targeted to employees | ||||
| Of which: | ||||
| Decided and allotted employee stock options Decided and allotted Board member stock |
373,525 | - | 372,000 | 745,525 |
| options | - | - | 16,388 | 16,388 |
| Decided and allotted subscription warrants Decided but not yet allotted employee stock |
15,250 | - | - | 15,250 |
| options 2008 | 372,000 | -372,000 | 470,000 | 470,000 |
| Subscription warrants held by subsidiaries for | ||||
| cash-flow hedging of social security fees | 78,000 | - | - | 78,000 |
| Total decided stock options | 838,775 | -372,000 | 858,388 | 1,325,163 |
| Employee stock options taken over from Biolipox AB (not resulting in dilution and included in newly issued shares in conjunction with the acquisition of Biolipox) |
399,167 | -35,079 | - | 364,088 |
| Subscription warrants taken over from Biolipox AB for cash-flow hedging of social |
||||
| security fees (not resulting in dilution) | 135,374 | - | - | 135,374 |
| Total stock options from Biolipox | 534,541 | -35,079 | - | 499,462 |
| Total stock options targeted to employees |
1,373,316 | -407,079 | 858,388 | 1,824,625 |
| Other options Subscription warrants constituting |
||||
| supplementary purchase consideration for the acquisition of Biolipox AB |
926,000 | - | - | 926,000 |
| Total outstanding stock options | 2,299,316 | -372,000 | 858,388 | 2,750,625 |
During the period April – June 2008, 35,079 Biolipox employee stock options were exercised, resulting in the holders exchanging their options for 35,079 shares, which were held by the independent company Pyrinox AB. The exercise of options thus did not result in Orexo issuing additional shares.
3 ) All data is adjusted for the 1:250 share split carried out in November 2005. As shown in the 2005 Annual Report, each old option carries rights to subscribe for 250 shares after the split. The above information pertains in all respects to the number of shares for which each option provides subscription entitlement. All of the details pertaining to options issued by Biolipox AB are recalculated by a factor of 0.45854, corresponding to the estimated value of the options related to the price of the Orexo share on date of acquisition. The figures reported for the options issued by Biolipox AB pertain to the number of shares to which each option can be exchanged following recalculation.
During February 2008, new employee stock options were allotted entitling the holders to subscribe for 372,000 new shares. The distribution among employees is as follows:
The exercise price was SEK 44 per share and the term of the options extends through December 31, 2017. One third of the total employee options are vested on each of the three annual dates immediately following February 21, 2008. The market value, as calculated using the Black & Scholes method, amounted to SEK 11.50 per option at the date of allotment.
At Orexo's Annual General Meeting on April 3, 2008, it was resolved to adopt a new employee stock option plan including the issuance of subscription warrants and approval of disposition of subscription warrants within the framework of the employee stock option plan. The employee stock option plan consists of 470,000 employee stock options. Each employee stock option may be exercised to acquire one share in Orexo in exchange for payment of an exercise price established as 110 percent of the market value of the Orexo share on the date of allotment. A total of 470,000 subscription warrants were issued to the wholly owned subsidiary Pharmacall AB as a hedge for the plan. Full exercise of the warrants will result in a dilution of about 2.0% of the share capital and votes in Orexo. None of these options have yet been allocated.
The Meeting resolved to adopt a Board Member Shareholder Plan including the issuance of 27,500 warrants and approval of disposal of the warrants issued under the Board Member Shareholder Plan. Board members participating in Orexo's Board Member Shareholder Plan will receive 50% of their Board fee and any fee for committee work in cash and will be allotted a number of Board Member shares, whose value at the time of allotment shall correspond to 50% of the Board fee and any fee for committee work. The right to acquire new shares by using the Board shares is contingent on whether the Board member remains a Board member during the whole or only part of his/her period of office. Each Board Member share can be exercised to acquire one share in Orexo against payment of an exercise price determined as the par value of the Orexo share. During May 2008, 16,388 options under the board member share plan were allocated to the board members and the options can be exercised up until and including 31 December 2015. One fourth of the options are vested following the publication of Orexo's interim report for the first quarter and one fourth following the publications of the interim reports for the second until the fourth quarter, respectively, during the mandate period for the financial year when the option holder is elected or re-elected. The market value, calculated in accordance with Black & Scholes valuation method, was SEK 55.15 per option at the time of allocation.
| April-June 2008 |
April-June 2007 |
Jan.-June 2008 |
Jan.-June 2007 |
Jan.-Dec. 2007 |
|
|---|---|---|---|---|---|
| Depreciation/amortization and | |||||
| impairments | 2,638 | 1,030 | 5,497 | 2,093 | 5,875 |
| Calculated costs for employee stock | |||||
| option program | 3,454 | 1,987 | 5,845 | 3,494 | 1,381 |
| Other | 11 | -24 | 13 | 2 | 205 |
| Total | 6,103 | 2,993 | 11,355 | 5,589 | 7,461 |
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2007 | |
| Raw materials and supplies | 2,565 | 505 | 3,693 | 5,233 | 9,162 |
| Other external costs | 31,609 | 41,515 | 62,459 | 62,006 | 125,146 |
| Personnel costs | 35,458 | 19,933 | 56,317 | 36,957 | 77,603 |
| Depreciation and impairment | 1,843 | 948 | 3,520 | 1,934 | 4,571 |
| Reinvoicing of rebuilding costs | 6,628 | 9,300 | 9,300 | ||
| TOTAL | 71,475 | 69,529 | 125,989 | 115,430 | 225,782 |
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
|---|---|---|---|---|---|
| Shareholders' equity brought forward | 2008 | 2007 | 2008 | 2007 | 2007 |
| according to balance sheet | 621,743 | 291,804 | 665,932 | 328,406 | 328,406 |
| Loss for the period | -30,869 | -57,948 | -76,134 | -95,780 | -159,898 |
| Subscription of shares through the | |||||
| exercise of warrants | 2,706 | 2,726 | 2,981 | ||
| New share issues | - | 2,704 | 438,776 | ||
| New issue of subscription warrants | - | - | 52,875 | ||
| Employee stock options, value of | |||||
| employees' service | 1,492 | 1,494 | 2,568 | - | 5,392 |
| Group contributions | - | - | - | - | -2,600 |
| Amount at the close of the period | 592,366 | 238,056 | 592,366 | 238,056 | 665,932 |
In July, Endo Pharmaceuticals decided to return Rapinyl™/Abstral to Orexo as a consequence of an extensive change in the company's strategy implemented by its new management. This created an opportunity for Orexo to extend the licensing agreement with the international specialty pharmaceuticals company ProStrakan Group plc to include the North America in addition to the EU. At the same time, Orexo's royalty fees in Europe and the North America were increased. For more detailed information, see page 6.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.