Annual Report • Feb 15, 2008
Annual Report
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Orexo AB, P.O. Box 303, SE-751 05 Uppsala, Sweden Tel: +46 (0) 18-780 88 00, Fax: +46 (0) 18-780 88 88, E-mail: [email protected] Internet: www.orexo.com Corp. reg. no 556500-0600
This text is an unofficial translation of the Year End Report prepared in Swedish. In the event of any discrepancy between the English translation and the official Swedish version, the Swedish version shall prevail.
Uppsala, February 15, 2008
| MSEK | 3 months | 3 months | 12 months | 12 months |
|---|---|---|---|---|
| 2007 | 2007 | 2007 | 2006 | |
| Oct–Dec | Oct–Dec | Jan–Dec | Jan–Dec | |
| Net revenues | 55.1 | 51.7 | 76.8 | 132.0 |
| Loss after tax | (44.0) | (12.4) | (172.6) | (33.0) |
| Earnings per share before dilution (SEK) |
(2.47) | (0.91) | (11.42) | (2.46) |
| Earnings per share after dilution (SEK)2 |
(2.47) | (0.91) | (11.42) | (2.46) |
1) Refers to the Group, unless stated otherwise in this report. Figures in parentheses are for the corresponding period of the preceding year. Biolipox is consolidated in the Group as of November 23, 2007.
2) Since earnings are negative, the same earnings per share are reported after dilution as before dilution.
Orexo is a specialty pharmaceutical company that focuses on developing patented new drugs by combining well-documented substances with innovative technologies, and developing new treatments for respiratory and inflammatory diseases.
To date, Orexo has outlicensed the distribution rights for Rapinyl™ for the US, the EU and Japan markets, and signed a research collaboration agreement with Boehringer Ingelheim to develop a new class of drugs to treat pain and inflammation. Orexo has also established a Nordic sales force, by entering into a joint venture with ProStrakan Ltd.
In 2007, Orexo took some important steps toward commercial success. Having completed clinical Phase III trials, Sublinox™ (OX22), Orexo's product for the treatment of sleep disturbances, is about to be submitted for registration in the US. During the year, Orexo's combinatory concept for the treatment of gastroesophageal reflux disease (GERD) received a European patent. In February 2008, a Phase II trial concerning pharmacodynamics in patients with reflux disease was completed. Data analysis is under way.
Rapinyl™, Orexo's product for the treatment of cancer breakthrough pain, was brought closer to the market, particularly through a new collaboration with ProStrakan on marketing of the products of both of the companies in the Nordic region, and through an agreement with Hospira on sales and marketing, particularly in Asia. Orexo's partner, Endo, was able to publish favorable results from the interim analysis of Phase II trial of Rapinyl™, supporting the contention that the product can be an effective treatment for breakthrough pain in cancer patients. Processing of the registration application for Rapinyl™ is currently under way for the European market.
However, the key step was Orexo's acquisition of Biolipox, which was completed on November 23, 2007. As a result of the acquisition, the combined companies form a larger and stronger entity. The strong product portfolio created by the merger has improved the outlook for the enterprise to enter into strategic partnerships with international pharmaceutical companies, and consequently the outlook for Orexo to achieve profitability.
In 2008, Orexo's primary objective will be to promote its existing collaborations and sign new license and development agreements. Accordingly, Orexo is optimizing its combined project portfolio and prioritizing projects deemed to have the best commercial potential.
In 2008, Orexo will focus on the following projects:
As a result of portfolio optimization, Orexo will sharply reduce operating expenses, and taking into account solely our agreed revenues from Endo Pharmaceuticals and Boehringer Ingelheim of about MSEK 57 and fully excluding milestone payments or new outlicensing revenues, operating results for the full fiscal year will be negative between MSEK 200 to 210. At December 31, 2007, the Group's cash and cash equivalents amount to MSEK 291.
The actions we are now taking strengthen the company's financial sustainability and conditions to achieve commercial successes through entering into license and development agreements.
The following pro forma statement of operations refers to Orexo AB including Biolipox AB, if the acquisitions had been carried out on January 1, 2007. The figures do not include the jointly owned ProStrakan AB, nor costs related to employee stock options.
| Pro forma 2007 Jan-Dec |
|
|---|---|
| Net revenues | 103.1 |
| Cost of goods sold | (13.7) |
| Gross profit | 89.4 |
| Selling costs | (7.7) |
| Administrative expenses | (100.2) |
| Research and development costs | (255.5) |
| Other operating income | 0.6 |
| Operating loss | (273.4) |
The European patent authority granted Orexo a patent for a combinatory concept for the treatment of GERD. The patent protects combinations of all H2 receptor blockers and protonpump inhibitors (PPI). The patent has already been granted in China, Australia and New Zealand. A patent application was filed for the North American market as well.
Orexo invested through a targeted new issue of MGBP 1.3 (MSEK 17.9) in ProStrakan plc's distribution company in the Nordic countries, forming a joint venture owned in equal parts by ProStrakan and Orexo. The new company holds the Nordic sales rights for both Orexo's and ProStrakan's products, including both future products and products already brought to market, namely Tostrex®, Rectogesic® and Droperidol®. Rapinyl™ and Sancuso®, both of which are proceeding through the European registration phase, will complement the product portfolio. ProStrakan holds distribution rights in Europe for Rapinyl™. Sancuso® is ProStrakan's product for the prevention of chemotherapy-induced nausea and vomiting.
ProStrakan Group plc, Orexo AB's European licensing partner for cancer breakthrough pain product Rapinyl™ on the European market, announced in September that Rapinyl™ will be reviewed by EMEA's Committee for Medicinal Products for Human Use (CHMP).
Due to a lack of consensus among the member countries during the EU regulatory approval process, the Decentralized Procedure (DCP), the product will now be transferred for review by the EMEA's Committee for Medicinal Products for Human Use (CHMP), where a majority decision is required to gain approval. A decision regarding the registration approval is expected to be made in the first half of 2008.
In October, Orexo completed the clinical Phase III program for Sublinox™ (OX22) by means of effect and local tolerance and safety trials conducted among patients with sleep disturbances, and obtained favorable results. The effect trials showed that Sublinox™ (OX22) acts as a 30 percent faster sleep aid than Ambien® for patients suffering from sleep disturbances. The study also showed that patients remain asleep throughout the night. The study strengthens existing documentation that Sublinox™ (OX22) is a safe and effective treatment for temporary insomnia.
Orexo AB and specialty pharma company Hospira signed a distribution agreement giving Hospira exclusive rights to market and sell Rapinyl™, Orexo's patented product for the treatment of cancer breakthrough pain, in southeast Asia, including Australia and New Zealand. The market rights have already been outlicensed in the US, the EU and Japan, and a distribution agreement has been signed for the CIS (Russia and other countries of the former Soviet Union), Bulgaria and Romania.
In October, Orexo AB and the main shareholders in Biolipox AB reached an agreement whereby Orexo would acquire Biolipox, an innovative Swedish research-based pharmaceutical company that develops new treatments for inflammation diseases including pain and respiratory-tract diseases such as asthma and chronic obstructive pulmonary disease (COPD).
Through this acquisition, Orexo gained:
The transaction entailed Orexo's acquisition of the shares and warrants in Biolipox through a cash issue consisting of 7,630,895 shares in Orexo and 926,000 warrants to subscribe for the corresponding number of shares in Orexo. The warrants issued may only be exercised by prior Biolipox shareholders if outlicensing agreements have been signed for one or more of the projects OX-NLA, OX-CLI or OX2477, or partial compensation is received for the OX-MPI project. If none of these events occurs before December 31, 2009, the warrants will expire.
An Extraordinary General Meeting held on November 13, 2007 authorized the Board, in conjunction with the acquisition of Biolipox AB and without preferential rights to the shareholders, on one or more occasions, to decide on the issue of a maximum of 8,560,000 new shares and the issue of warrants. It was decided that payment for the newly issued shares would be capital issued in kind comprising shares and options in Biolipox AB. In addition, the General Meeting appointed Laurent Ganem and Antoine Papiernik as new members of the Board. Zsolt Lavotha resigned from the Board in conjunction with the Extraordinary General Meeting.
Prior to its acquisition by Orexo, Biolipox completed the previously announced acquisition of most of the research and development assets of the Canadian biopharma company, Inflazyme.
After completing its acquisition of Biolipox, Orexo decided to modify its Group management. The new Group management team consists of Torbjörn Bjerke (President and CEO), Claes Wenthzel (Vice President and CFO), Thomas Lundqvist (Vice President and Executive Advisor), Göran Smedgård (Senior Vice President – Business Development) and Göran Tornling (Senior Vice President – R&D).
Orexo's license partner, Endo Pharmaceuticals, published favorable results from a previously announced projected statistical interim analysis of an ongoing Phase II, placebo-controlled, double-blind trial for Rapinyl™. The results show that Rapinyl™ can provide an effective treatment of breakthrough pain in cancer patients. Data from the interim analysis involving 61 patients showed that Rapinyl® has achieved its primary endpoints – pain relief within 0–30 minutes of administration of the medicine (SPID 0–30) – and that the results were statistically significant (p=0.0004). All secondary endpoints were also achieved. A statistically significant effect, compared with placebo, was observed only 10 minutes after administration.
Orexo's primary objective for 2008 is to promote its existing collaborations and sign new license and development agreements. Accordingly, Orexo prioritizes the projects offering the best commercial possibilities.
Orexo is focusing on the following projects:
The portfolio optimization will allow Orexo to reduce its operating costs.
A pharmacokinetic study involving healthy trial subjects has been completed. Analysis of the data is under way. The results are to provide the basis for outlicensing.
A preparatory meeting was held of January 15 with the FDA regarding the registration application for SublinoxTM (OX22) in the US. The meeting confirmed Orexo's registration strategy and work with submission of the registration application in the first quarter of 2008 is progressing as planned.
For OX-NLA, a tolerability study of a final formulation in patients with rhinitis (hay fever) was completed. Analysis of the data is under way.
A Phase II study for OX17 regarding the pharmacological dynamic was concluded in patients with GERD. Data analysis is under way.
Diabact® UBT/Heliprobe™ System– Diabact® UBT s Orexo's first commercialized product. Like the Heliprobe™ System, Diabact® UBT is a breath test used to diagnose the presence of Helicobacter pylori, the bacteria that cause gastric ulcers. Breath tests are recommended by expert groups for Helicobacter pylori in Europe as the primary choice and the most reliable noninvasive test to diagnose active infection. Its advantages include the fact that it prevents the patient having to undergo a gastroscopy examination, which many consider unpleasant. The societal benefits are, for example, that the examination is fast, easy and less expensive than gastroscopy.
Distribution and marketing agreements for Diabact® UBT have been signed for Austria, Finland, Germany, Hong Kong, Ireland, Serbia, Sweden and the UK. In Japan, a licensing agreement was signed with Kyowa Hakko Kogyo Co. Ltd. The Heliprobe™ System has distribution and marketing agreements in approximately twenty countries in the Middle East, Asia and Eastern Europe.
Rapinyl® – for the treatment of acute pain is in Phase III in the US and in the registration phase in Europe. Rapinyl™ was developed for the treatment of cancer-related breakthrough pain as its primary indication. Orexo's principal technology, the sublingual dosage method, whereby a fastdissolving tablet is placed under the tongue, enables a quicker onset of action and more predictable effects – on-demand features. Licensing agreements for Rapinyl™ have been signed with Endo Pharmaceuticals for the North American market, ProStrakan Group plc for the European market and Kyowa Hakko Kogyo Ltd for the Japanese market. Distribution agreements for CIS (Russia and other former members of the Soviet Union), Bulgaria and Romania have been signed with Gedeon Richter Ltd and with Hospira in Asia Pacific markets including Australia and New Zealand.
In December 2005, Endo Pharmaceuticals launched Phase III studies on Rapinyl™. Endo Pharmaceuticals announced positive results from an interim analysis of the Phase III studies in December 2007. Endo previously has announced that it intends to submit a registration application for the North American market during the first half of 2008. Rapinyl™ is undergoing registration in the European market. The registration process was transferred to EMEA's Committee for Medicinal Products for Human Use (CHMP), a decision regarding the registration approval is expected to be made in the first half of 2008.
OX-MPI – Selective prostaglandin-inhibitor 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 Magnecyl) and the more recently developed COX-2 inhibitors (for example Vioxx and Celebrex). The mechanism is based on the discovery of a specific enzyme, prostagland (PG) E2 synthesis (mPGES), a bodily substance that plays a central role in many inflammatory processes. Many molecules develop in parallel to develop the best properties for a drug and a patent portfolio with potential pharmaceutical candidates has been prepared. The project has been under way since 2005 in cooperation with Boehringer Ingelheim GmbH, Germany, which has acquired the global sales rights.
Sublinox™ (OX22) – for the treatment of sleep disturbances, is in Phase III development. Sublinox™ (OX22) is based on Orexo's sublingual tablet technology. In 2006, the US insomnia market amounted to SEK 3.3 billion (according to IMS sales data).
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 pf temporary insomnia with positive results. The effect trials confirm that Sublinox™ (OX22) acts as a 30 percent faster sleep aid than what Ambien® does for patients suffering from sleep disturbances. The study also shows that patients remain asleep throughout the night. The study strengthens existing documentation that Sublinox™ (OX22) is a safe and effective treatment for temporary insomnia.
A preparatory meeting was held of January 15 with the FDA regarding the registration application for SublinoxTM (OX22) in the US. The meeting confirmed Orexo's registration strategy and work with submission of the registration application in the first quarter of 2008 is progressing as planned.
OX17 - for the treatment of GERD (gastro esophageal reflux disease), a disorder that gives the patient recurrent heartburn, involving acidic regurgitation linked to stomachache, discomfort and sharp pains in the esophagus. OX17 is a patent-pending fixed combination of two well-proven 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 was concluded in patients with GERD. Data analysis is under way.
OX914 – for the treatment of COPD and asthma. The aim of this project is to develop an orally active product that blocks the PDE4 enzyme that exists in many inflammatory cells. In clinical studies with various substances to 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 the placebo.
OX2477 – an entirely new class of pharmaceutical against asthma and COPD. Orexo has discovered a new group of mediators, eoxines, that are formed primarily in cells in respiratory passages and which have shown powerful anti-inflammatory effects. Release of the eoxines in the lungs can, therefore, provide an important contribution to the inflammation that is seen in, for example, COPD and asthma. The project aims to develop an entirely new class of pharmaceutical against asthma, COPD and other inflammatory diseases.
OX-CLI – a new generation of pharmaceuticals to treat asthma, COPD and rhinitis. Orexo is developing an orally administered, double-acting drug with both trachea widening and anti-
inflammation effects. Studies in animals that lack the actual target protein have shown significantly reduced inflammatorical responses in various asthma and COPD models. Orexo has identified own molecules that show favorable effects in different pharmacological models. A patent portfolio with potential pharmaceutical candidates has been prepared.
OX-NLA – quick-acting effect for treatment of allergic and non-allergic rhinitis. NLA nasal spray for treatment of allergic and non-allergic rhinitis contains an active component cetirizin. Orexo has developed a unique formulation that reduces cetirizin's local irritating properties. Clinical Phase II studies have shown both good and fast-acting effects, which makes NLA suitable for treatment "as needed." Local treatment in the nose also reduces the risk for systematic side-effects, such as drowsiness. A final formulation has been selected and is currently being tested in a clinical Phase II study that was concluded in December 2007. Analysis of the data is under way.
OX-LSAID – for the treatment of moderate to heavy asthma. The LSAID-program contains nonsteroid 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. Data analysis is under way. The results will be the basis of outlicensing.
OX40 – for the acute treatment of moderate and severe migraine. Orexo's ambition is to formulate OX40 to provide a fast and predictable onset of effect, which is an essential characteristic for effective on-demand medication.
OX30 – slow and controlled release of opioids for the treatment of chronic pain and has also potential to reduce the abuse risk.
OX23 – for the treatment of acute pain. Based on Orexo's sublingual technology – the sublingual dosage form, in which a promptly dissolved tablet is placed under the tongue – which combines rapid dissolving, prompt onset of effect and predictable effects – typical "on demand" properties.
| 3 months | 3 months 12 months 12 months | |||
|---|---|---|---|---|
| 2007 | 2006 | 2007 | 2006 | |
| MSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Net revenues | 55.1 | 51.7 | 76.8 | 132.0 |
| Cost of goods sold | (4.2) | (5.2) | (14.4) | (11.1) |
| Gross profit | 50.9 | 46.5 | 62.4 | 120.8 |
| Selling costs | (5.2) | (2.6) | (11.7) | (7.8) |
| General and administrative expenses | (25.4) | (19.8) | (74.2) | (57.5) |
| Research and development costs | (65.3) | (37.5) | (156.0) | (94.5) |
| Other operating income and expenses | (1.1) | (1.2) | (1.1) | (1.6) |
| Operating loss | (46.1) | (14.6) | (180.6) | (40.6) |
| Net financial items | 2.0 | 2.1 | 7.8 | 7.6 |
| Profit/loss after financial items | (44.1) | (12.5) | (172.8) | (33.0) |
| Tax | 0.1 | 0.0 | 0.2 | 0.0 |
| Net result of the period | (44.0) | (12.4) | (172.6) | (33.0) |
Net revenues for 2007 amounted to MSEK 76.8 (132.0). The decrease from the year-earlier period is attributable to licensing revenues received during 2006 from ProStrakan Group plc. The decline was partly offset by the sale of Kibions Heliprobe™ System, a product that the Group acquired in conjunction with the acquisition of Noster System AB in June 2006, and from August 1, 2007 by the sale of the company (Prostakan AB) jointly owned with ProStrakan Group plc.
Revenues were distributed as follows:
| MSEK | Oct-Dec 2007 | Oct-Dec 2006 | Jan-Dec 2007 | Jan-Dec 2006 |
|---|---|---|---|---|
| Diabact® UBT | 1.5 | 3.5 | 5.2 | 7.7 |
| Heliprobe™ System | 5.1 | 4.7 | 19.7 | 9.6 |
| ProStrakan AB J/V 50% | 2.0 | - | 2.7 | - |
| License revenue | 34.0 | 40.0 | 34.0 | 106.5 |
| Rapinyl® | ||||
| Other revenues | 12.5 | 3.5 | 15.2 | 8.2 |
| Total | 55.1 | 51.7 | 76.8 | 132.0 |
During the period October December 2007, net revenues were MSEK 55.1 (51.7). The fourth quarter of 2007 includes revenues from the acquisition of Biolipox AB and from Prostrakan AB, which was not the case in the year-earlier period. Revenues from Biolipox AB pertain to payments for research work from Boehringer Ingelheim and are reported under other revenues. Biolipox is consolidated in the Group as of November 23, 2007.
Consolidated selling expenses for the full year amounted to MSEK 11.7 (7.8), and to MSEK 5.2 (2.6) for the period October-December 2007. The increase in expenses is attributable to Orexo's efforts in its operations for exhaling tests in Kibion AB, covering the products Diabact®UBT and Heliprobe™ System, and to ProStrakan AB.
Administrative expenses for 2007 amounted to MSEK 74.2 (57.4) and to MSEK 25.4 (19.8) for the period October-December 2007. Compared with 2006, MSEK 1.3 of the expenses increase is due to Biolipox AB and MSEK 7.0 to non-recurring restructuring costs.
The company's share price declined during the period October-December, which resulted in a decline in the allocation for estimated social fees. This resulted in a positive effect on earnings for the company's employee stock options program of MSEK 1.9 (loss 3.6).
For the full year, the earnings effect of the employee stock options program totaled to a loss of MSEK 1.4 (loss 7.4), of which MSEK 0.2 (loss 4.5) is attributable to administrative personnel and to a loss of MSEK 1.6 (loss 2.9) to R&D personnel.
Program expenses refer to both the estimated cost of the value of the employees' service during the period and the portion of the estimated social security fees during the period. The company will need to pay social security fees on the gain that may result from the exercise of the employee stock options, estimated as the difference between the strike price of the employee stock option and the market value of the shares.
The social security fees that may arise due to the employee stock option program have been largely hedged – financially and therefore in cash-flow terms – through the issue of warrants to one of Orexo's subsidiaries. This hedging does not qualify for hedge accounting according to IFRS.
Research and development expenses for full-year 2007 totaled MSEK 156.0 (94.5), with MSEK 65.3 (37.5) for the period October-December 2007.
The increase from the year-earlier period is attributable to a keener focus on the company's product development projects, partly in the from of a larger workforce but especially through increased resources for Phase III studies for Sublinox™ (OX22) and the Phase III program for OX17, as well as more employees and expenses in Biolipox AB after the acquisition.
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, and/or in which discussions have been initiated regarding outlicensing. These including Rapinyl™ for the treatment of acute pain, Sublinox™ (OX22) for the treatment of insomnia, OX17 for GERD, OX-NLA for treatment of allergic and non-allergic rhinitis, OX2477 that is an entirely new class of drugs to treat asthma and COPD and OX-CLI that is a new generation of pharmaceutical to treat asthma, COPD and rhinitis.
Research and development expenses for the full year included MSEK 3.3 in royalty costs. Orexo's total royalty costs attributable to Rapinyl™ can amount to a maximum of 10 percent of total license revenues for the product, or at most MSEK 30.0, of which MSEK 28.9 was paid as of December 31, 2007.
Depreciation for the period January-December 2007 totaled MSEK 5.9 (3.4).
Tax assets (deferred tax) for the period January-December 2007 amounted to MSEK 0.2 (0.0).
The operating loss for the year amounted to MSEK 180.6 (loss: 40.6). The loss after net financial items totaled MSEK 172.8 (loss: 33.0), with the after-tax loss totaling MSEK 172.6 (loss: 33.0).
The operating loss for the period October-December was MSEK 46.1 (loss: 14.6). The loss after net financial items was MSEK 44.0 (loss: 12.4).
Group cash and cash equivalents plus current investments amounted to MSEK 291.6 (332.5) at December 31, 2007.
Cash flow from operating activities for the full year was MSEK 165.4 (neg: 21.7). Cash flow after financing was positive at MSEK 15.2 (15.9). The acquisition of Biolipox AB generated cash and cash equivalents for the Group of MSEK 167.4.
During the period, short-term investments were made in accordance with the company's finance policy. According to the finance policy, liquidity is defined as the cash and cash equivalents required for the company's commercial obligations. All other liquidity is classed as surplus liquidity. At December 31, 2007, the Group's surplus liquidity was invested in banking and real estate (minimum rating A-), and corporate and institutional (minimum rating BBB), with maturities of up to February 2008.
Shareholders' equity at December 31, 2007 totaled MSEK 671.3 (324.3). The equity/assets ratio was 84 percent (85).
Gross investments in tangible fixed assets during the year totaled MSEK 49.3 (4.6). These investments primarily involve the remodeling of new premises and to some extent investments in production and research equipment.
The majority of the Group's business is carried out in the Parent Company, Orexo AB. Net revenues for 2007 amounted to MSEK 48.4 (118.2), with the loss after financial items totaling MSEK 159.9 (loss: 44.6). Investments totaled MSEK 49.3 (4.5). Cash and cash equivalents plus current investments in the Parent Company at December 31, 2007 amounted to SEK 109.5 (329.1).
In the acquisition of Inflazyme (see page 7), a supplemental payment was agreed contingent on certain goals being met. Part of the supplemental payment was reported as long-term liabilities and MSEK 36.3 was recognized as contingent liabilities since the later is not assessed as a probable payment based on pharmaceutical development statistics. As security for currency futures, MSEK 12 is blocked in a bank account and the amount is reported among pledged assets. At December 31, all currency futures had expired. As cash-flow hedging for social fees pertaining to the employee stock options issued by Biolipox, warrants were issued to Pyrinox AB. Orexo is committed to cover any deficit greater that the cover provided by the warrants. In addition, the acquisition of Noster System AB involved an agreement on a supplemental purchase price of not more than MSEK 7.2, which would become payable if the growth of Heliprobe™ System achieves pre-determined sales targets over the next few years. The amount was reported under contingent liabilities, since Orexo has not assessed it as probable. Otherwise, no significant changes in contingent liabilities or pledged assets occurred during the period.
The Board does not intend to propose a dividend for the 2007 fiscal year.
Orexo's share was traded at SEK 47 on December 28, 2007. The company's market capitalization, based on the number of shares outstanding on December 31, 2007, amounted to MSEK 1,016. At December 31, 2006, the company's market value amounted to MSEK 1,725.
| ABG Sundal Collier | Alexander Lindström |
|---|---|
| Carnegie AB | Kristofer Liljeberg-Svensson and Camilla Oxhamre |
| Handelsbanken Markets | Erik Hultgård |
| Kaupthing Bank | Benjamin Nordin |
| Redeye | Björn Andersson |
| Remium Securities | Johan Isaksson |
Orexo AB's Annual Report will be presented on the company's website not later than March 20, 2008 and will be sent to the shareholders who so requested.
The Annual General Meeting will be held in Stockholm, Thursday, April 3, 2008 at 5:00 p.m. The notice will be released not later than March 6, 2008.
| Interim report, January-March 2008 | May 7 |
|---|---|
| Interim report, April-June 2008 | August 14 |
| Interim report, July-September 2008 | November 10 |
| Year-end Report 2008 | at latest February 28, 2009 |
Uppsala, February 15, 2008
Orexo AB (publ)
Torbjörn Bjerke, 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 & CFO , tel +46 (0)18-780 88 44, e-mail: [email protected]
We have reviewed the appended report for the period January 1 to December 31, 2007. The Board of Directors is responsible for the preparation and fair presentation of this interim report in accordance with the Annual Accounts Act. 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 is substantially less 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 yearend report has not in all significant respects been compiled in accordance with the Annual Accounts Act and IAS 34 and for the Parent Company in accordance with the Annual Accounts Act.
Uppsala, February 15, 2008 Öhrlings PricewaterhouseCoopers
Leonard Daun Authorized Public Accountant
| SEK 000's | 2007 | 2006 | |
|---|---|---|---|
| Notes | Dec 31 | Dec 31 | |
| ASSETS | |||
| Fixed assets | |||
| Tangible fixed assets | 57,790 | 6,392 | |
| Goodwill | 16,030 | 8,988 | |
| Intangible fixed assets | 6 | 377,335 | 1,974 |
| Total fixed assets | 451,155 | 17,354 | |
| Current assets | |||
| Inventories | 13,294 | 9,234 | |
| Accounts receivable | 45,826 | 20,810 | |
| Current investments | 56,126 | ||
| Cash and bank balances | 291,598 | 276,408 | |
| Total current assets | 350,718 | 362,578 | |
| Total assets | 801,873 | 379,932 | |
| SHAREHOLDERS' EQUITY AND | 3 | ||
| LIABILITIES | |||
| Share capital | 8,647 | 5,554 | |
| Capital contributions | 872,646 | 351,633 | |
| Accumulated losses | (210,041) | (32,837) | |
| Total shareholders' equity | 671,252 | 324,350 | |
| Long-term liabilities | |||
| Provisions | 162 | 4,819 | |
| Long-term liabilities | 9,595 | ||
| Deferred tax liability | 877 | 356 | |
| Total long-term liabilities | 10,634 | 5,175 | |
| Current liabilities | |||
| Current liabilities, non-interest-bearing | 119,987 | 50,407 | |
| Total liabilities | 130,621 | 55,582 | |
| Total shareholders' equity and liabilities | 801,873 | 379,932 | |
| Pledged assets | 14,500 | 3,500 | |
| Contingent liabilities | 43,550 | 7,250 |
| SEK 000´s | 3 months | 3 months | 12 months | 12 months | ||
|---|---|---|---|---|---|---|
| Notes | 2007 | 2006 | 2007 | 2006 | ||
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |||
| Net revenues | 55,079 | 51,665 | 76,757 | 131,956 | ||
| Cost of goods sold | 2 | (4,195) | (5,201) | (14,384) | (11,151) | |
| Gross profit | 50,884 | 46,464 | 62,373 | 120,805 | ||
| Selling expenses | 2 | (5,220) | (2,622) | (11,690) | (7,849) | |
| General and administrative expenses | 2 | (25,397) | (19,780) | (74,224) | (57,437) | |
| Research and development costs | 2 | (65,320) | (37,527) | (155,972) | (94,512) | |
| Other operating income | 183 | 214 | 9,958 | 678 | ||
| Other operating expenses | 2 | (1,199) | (1,355) | (11,014) | (2,275) | |
| Operating profit/loss | (46,069) | (14,606) | (180,569) | (40,590) | ||
| Earnings from financial | ||||||
| investments | ||||||
| Interest income | 2,433 | 2,145 | 8,231 | 7,516 | ||
| Interest expenses | (1) | (1) | (23) | (24) | ||
| Other financial expenses | (473) | - | (473) | 115 | ||
| Total earnings after financial items | (44,110) | (12,462) | (172,834) | (32,983) | ||
| Tax on the year's income | 114 | 40 | 237 | 40 | ||
| Net loss for the period | (43,996) | (12,422) | (172,597) | (32,943) | ||
| Loss per share, before dilution, SEK | (2.47) | (0.91) | (11.42) | (2.46) | ||
| Earnings per share after dilution, SEK | (2.47) | (0.91) | (11.42) | (2.46) | ||
| Average number of shares, before dilution | 17,783,010 | 13,683,000 | 15,108,176 | 13,390,854 | ||
| Average number of shares, after dilution | 18,858,697 | 13,897,550 | 16,183,863 | 13,605,404 | ||
| Number of shares, before dilution | 21,617,395 | 13,884,750 | 21,617,395 | 13,884,750 | ||
| Number of shares, after dilution | 22,693,082 | 14,099,300 | 22,693,082 | 14,099,300 |
| Notes | 3 months 2007 |
3 months 2006 |
12 months 2007 |
12 months 2006 |
|
|---|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | ||
| Continuing operations Loss before interest expense and interest income |
(46,069) | (14,606) | (180,569) | (40,590) | |
| Interest income | (1) | (1) | (23) | (24) | |
| Interest expenses Other financial expenses |
2,433 (473) |
2,145 | 8,231 (473) |
7,516 | |
| Adjustment for items not included in cash flow | 4 | 694 | (2,559) | 7,461 | 11,335 |
| Cash flow from continuing operations before changes in working capital |
(43,416) | (15,021) | (165,373) | (21,763) | |
| Change in working capital | |||||
| Accounts receivable | (444) | 12,895 | 2,537 | (10,282) | |
| Other current receivables | (7,896) | (134) | (18,266) | (369) | |
| Inventories | (2,366) | (2,167) | (4,060) | (6,206) | |
| Current liabilities | 34,903 | 20,704 | 37,069 | 29,428 | |
| Provisions | (1,746) | (3,632) | (4,657) | (8,608) | |
| Cash flow from continuing operations | (20,965) | 12,645 | (152,750) | (17,800) | |
| Investing activities | |||||
| Acquisition of machinery and equipment | (7,569) | (778) | (49,318) | (4,562) | |
| Divestment of current investments | 9,951 | 18,456 | 56,126 | 33,505 | |
| Acquisition of subsidiaries/joint venture | 167,936 | - | 158,151 | (8,195) | |
| Cash flow after investments | 148,813 | 30,323 | 12,209 | 2,948 | |
| Change in financing | |||||
| Proceeds from new share issue | 255 | 12,609 | 2,981 | 12,971 | |
| Cash flow after financing activities | 149,068 | 42,932 | 15,190 | 15,919 | |
| Cash flow for the year Cash and cash equivalents, at the beginning of |
|||||
| period | 142,530 | 233,476 | 276,408 | 260,489 | |
| Changes in cash and cash equivalents | 149,068 | 42,932 | 15,190 | 15,919 | |
| Cash and cash equivalents, at the close of | |||||
| period | 291,598 | 276,408 | 291,598 | 276,408 |
| 3 months | 3 months | 12 months | 12 months | ||
|---|---|---|---|---|---|
| 2007 | 2006 | 2007 | 2006 | ||
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | ||
| Operating margin, % | (84) | (28) | (235) | (31) | |
| Profit margin, % | (80) | (24) | (225) | (25) | |
| Return on total capital, % | (8) | (3) | (45) | (9) | |
| Return on equity, % | (10) | (4) | (53) | (10) | |
| Return on capital employed, % | (10) | (4) | (53) | (10) | |
| Debt/equity ratio, multiple | 0 | 0 | 0 | 0 | |
| Equity/assets ratio, % | 84 | 85 | 84 | 85 | |
| Current ratio, % | 292 | 719 | 292 | 719 | |
| Acid ratio, % | 281 | 701 | 281 | 701 | |
| Average number of shares, before dilution | 17,783,010 | 13,683,000 | 15,108,176 | 13,390,854 | |
| Average number of shares, after dilution | 18,858,697 | 13,897,550 | 16,183,863 | 13,605,404 | |
| Number of shares, after full dilution | 23,010,220 | 14,319,750 | 23,010,220 | 14,319,750 | |
| Number of shares, before dilution | 21,617,395 | 13,884,750 | 21,617,395 | 13,884,750 | |
| Number of shares, after dilution | 22,693,082 | 14,099,300 | 22,693,082 | 14,099,300 | |
| Loss per share before dilution, SEK | (2.47) | (0.91) | (11.42) | (2.46) | |
| Earnings per share after dilution, SEK | (2.47) | (0.91) | (11.42) | (2.46) | |
| Shareholders' equity, before dilution, SEK | 31.05 | 23.36 | 31.05 | 23.36 | |
| Shareholders' equity per share, after dilution, | |||||
| SEK | 29.58 | 23.00 | 29.58 | 23.00 | |
| Number of employees at close of period | 129 | 61 | 129 | 61 | |
| Average number of employees | 102 | 58 | 80 | 50 | |
| Shareholders' equity | 671,252 | 324,350 | 671,252 | 324,350 | |
| Capital employed | 671,252 | 324,350 | 671,252 | 324,350 |
Operating margin: Operating profit/loss as a percentage of net revenues.
Profit margin: Profit/loss after financial items as a percentage of net revenues.
Return on total capital: Operating profit/loss plus financial income as a percentage of average balance sheet total.
Return on shareholders' equity: Profit/loss of the period as a percentage of average shareholders' equity.
Return on capital employed: Operating profit/loss plus financial income as a percentage of average capital employed.
Capital employed: 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 e 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 for through options outstanding.
Number of shares after dilution: Calculation of the dilution from options issued by the company up to 2005 has been carried out in accordance with IAS 33.
Earnings per share before dilution: Profit/loss divided by average number of shares outstanding before dilution.
Earnings per share after dilution: Profit/loss divided by average number of shares outstanding after dilution.
Shareholders' equity per shares before dilution: Shareholders' equity divided by the number of shares before dilution at the close of the period.
Shareholders' equity per share after dilution: Shareholders' equity divided by the number of shares after dilution at the close of the period.
| SEK 000's | 2007 | 2006 | ||
|---|---|---|---|---|
| Notes | Dec 31 | Dec 31 | ||
| ASSETS | ||||
| Fixed assets | ||||
| Tangible fixed assets | 50,903 | 6,316 | ||
| Intangible fixed assets | 566 | 633 | ||
| Shares in subsidiaries/Joint | ||||
| Ventures | 523,842 | 100 | ||
| Total fixed assets | 575,311 | 7,049 | ||
| Current assets | ||||
| Inventories | 4,362 | 4,982 | ||
| Accounts receivable | 40 | 4,263 | ||
| Current receivables | 53,030 | 32,141 | ||
| Current investments | - | 56,126 | ||
| Cash and bank balances | 109,511 | 273,021 | ||
| Total current assets | 166,943 | 370,533 | ||
| Total assets | 742,254 | 377,582 | ||
| SHAREHOLDERS' EQUITY, PROVISIONS AND LIABILITIES |
8 | |||
| Restricted equity | 858,995 | 340,870 | ||
| Accumulated losses | (193,062) | (12,464) | ||
| Total shareholders' equity | 665,932 | 328,406 | ||
| Long-term liabilities | ||||
| Provisions | 162 | 4,820 | ||
| Total long-term liabilities | 162 | 4,820 | ||
| Current liabilities, non-interest bearing, |
76,160 | 44,356 | ||
| Total liabilities | 76,322 | 49,176 | ||
| Total shareholders' equity and liabilities |
742,254 | 377,582 | ||
| Pledged assets | 2,500 | 2,500 | ||
| Contingent liabilities | 11,050 | 11,050 |
| SEK 000´s | 3 months 2007 |
3 months 2006 |
12 months 2007 |
12 months 2006 |
|
|---|---|---|---|---|---|
| Notes | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Net revenues | 42,506 | 44,309 | 48,389 | 118,217 | |
| Cost of goods sold | 7 | - | (393) | (2,409) | (1,660) |
| Gross profit | 42,506 | 43,916 | 45,980 | 116,557 | |
| Selling expenses | 7 | (641) | (1,149) | (641) | (1,149) |
| General and administrative | |||||
| expenses | 7 | (20,911) | (19,785) | (69,094) | (57,442) |
| Research and development costs | 7 | (52,114) | (36,842) | (143,225) | (95,300) |
| Other operating income | 71 | 199 | 9,674 | 298 | |
| Other operating expenses | 7 | (777) | (1,064) | (10,413) | (1,636) |
| Operating profit/loss | (31,866) | (14,725) | (167,719) | (38,672) | |
| Earnings from financial | |||||
| investments | |||||
| Impairment of shares in | |||||
| subsidiaries | - | (14,000) | - | (14,000) | |
| Interest income | 1,228 | 2,386 | 7,832 | 8,000 | |
| Interest expenses | (1) | (1) | (11) | (9) | |
| Other financial expenses Total earnings after financial |
- | - | - | 115 | |
| items | (30,639) | (26,340) | (159,898) | (44,566) | |
| Net profit/loss for the period | (30,639) | (26,340) | (159,898) | (44,566) |
This Year-End Report was prepared pursuant to IAS 34, Interim Financial Reporting, which complies with the requirements of the Swedish Financial Accounting Standards Council's recommendation RR 31, Interim Financial Reporting for Groups. As of 2005, Orexo applies IFRS as approved by the EU. The accounting principles and calculation methods comply with those applied in preparing the 2006 Annual Report.
The Parent Company's accounting was prepared in accordance with RR32.
In other respects, the accounting principles applied in this interim report are described in greater detail in the notes to the 2006 Annual Report.
The amounts below are in SEK thousands, unless otherwise indicated.
| 2007 | 2006 | 2007 | 2006 | |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Raw materials and supplies | 13,326 | 5,737 | 26,835 | 13,982 |
| Other external costs | 51,181 | 39,626 | 132,307 | 86,110 |
| Personnel costs | 34,456 | 20,109 | 92,967 | 69,687 |
| Depreciation and impairment | 2,368 | 1,013 | 5,875 | 3,445 |
| Re-invoicing, rebuilding materials | - | - | 9,300 | - |
| TOTAL | 101,331 | 66,485 | 267,284 | 173,224 |
| 2007 | 2006 | 2007 | 2006 |
|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| 202,553 | 323,200 | 324,350 | 338,909 |
| (43,996) | (12,422) | (172,597) | (32,943) |
| - | 4,607 | - | 4,607 |
| 255 | 8,002 | 2,981 | 8,364 |
| 438,775 | - | 438,775 | - |
| 52,875 | 52,875 | ||
| 1,911 | 963 | 5,989 | 5,052 |
| 18,879 | 18,879 | ||
| - | - | - | 361 |
| 671,252 | 324,350 | 671,252 | 324,350 |
The number of shares outstanding at December 31, 2007 amounted to 21,617,395, of which all were common shares. All shares carry entitlement to one vote each. The number of shares outstanding increased as a result of the exercise of stock employee options and warrants in the amount of 101,750 since December 31, 2006 and 7,630,895 through new issue.
| Outstanding shares at January 1, 2007 | 13,884,750 |
|---|---|
| Share subscription through exercise of employee stock options | +42,500 |
| Share subscription through exercise of warrants | +59,250 |
| New issue of shares at acquisition of Biolipox AB | +7,630,895 |
| Number of share outstanding at December 31, 2007 | 21,617,395 |
At December 31 there were a total of 2,299,316 options outstanding carry rights corresponding to 1,764,775 shares in Orexo and exercise of 534,541 options for shares in Orexo2. The acquisition of Biolipox increased the number of options by 534,541 after adjustment of which 408,436 are employee stock options and 126,105 warrants intended for cash flow hedging of social fees. Each option issued by Biolipox AB carries the right to exchange for one share in Orexo AB and the corresponding number of shares is received by the independent company Pyrinox AB.
The list below shows the change in the number of options during the period January 1, 2007 to December 31, 2007 distributed in each category.
| Opening 1/1 2007 |
- | + | Closing 31/12 2007 |
|
|---|---|---|---|---|
| Personnel-related options | ||||
| Of which: Decided and allotted employee stock options |
329,800 | (113,250) | 156,975 | 373,525 |
| Decided and allotted warrants | 74,500 | (59,250) | - | 15,250 |
| Decided but not allotted employee stock options 2005, 2006 and 2007 |
195,000 | (156,975) | 333,975 | 372,000 |
| Warrants held by subsidiary for cash-flow hedging of social security fees |
78,000 | - | - | 78,000 |
| Total decided options Employee stock options taken over from Biolipox AB (no dilution effect, included |
677,300 | (329,475) | 490,950 | 838,775 |
| in newly issued shares in conjunction with acquisition of Biolipox) |
- | - | 408,436 | 408,436 |
| Warrants taken over from Biolipox AB subsidiary for cash-flow hedging of social security fees (no dilution effect) |
- | - | 126,105 | 126,105 |
| Total options from Biolipox | - | - | 534,541 | 534,541 |
| Total options to employees | 677,300 | (329,475) | 1,025,491 | 1,373,316 |
| Other options | ||||
| Warrants related to supplemental payment in acquisition of Biolipox AB |
- | - | 926,000 | 926,000 |
| Total options outstanding | 677,300 | (329,475) | 1,951,491 | 2,299,316 |
2 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 the period October-December, 25,250 new shares were subscribed through exercise of options, of which 4,000 related to Orexo's employee stock options and 21,250 to warrants.
In February 2007, options were allotted that in total carry subscription rights to 156,975 shares, distributed among 76,000 shares for company officers and 80,975 shares to other employees. The President was not allotted any options under this program. The subscription price was SEK 119 per share and the term of options extends through December 31, 2016. One third of the total employee options are earned on each of the three annual dates immediately following February 2, 2007. The market value, as calculated using the Black & Scholes method, amounted to SEK 35.53 per option.
At Orexo's Annual General Meeting on April 23, 2007, 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 372,000 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 the market value of the Orexo share on the date of allocation. A total of 333,975 subscription warrants were issued to the wholly owned subsidiary Pharmacall AB as a hedge for the program. Full exercise of the warrants will result in a dilution of about 1.5%.
In conjunction with the acquisition of Biolipox AB four employee stock option program outstanding were taken over (programs 2003/2010, 2005/2014, 2005/2015 and 2006/2016) with unchanged terms except that the employee stock options carry rights to shares in Orexo instead of Biolipox. Each original employee stock option after the acquisition carries rights to 0.45854 shares in Orexo. The employee stock option comprises options carrying rights to a total of 408,436 shares in Orexo. Orexo has issued the corresponding number of shares to Pyrinox AB, owned by the former majority owners in Biolipox, to secure the delivery of the shares in the employee stock option programs. The employee stock options have been allotted at no cost to Biolipox employees and vesting occurs annually after allotment by one fourth of the total number of allotted options per program. The employee stock options may be exercised at the earliest on November 23, 2008, with the limitation as stated above, and the subscription price is SEK 0.25 per share. The final date for exercising the employee stock options is December 31 of the various programs' expiration year.
In conjunction with the acquisition of Biolipox AB the terms for the Biolipox warrants intended to hedge social fees. Each warrant carries rights to acquire 0.45854 shares in Orexo instead of one share in Biolipox. The warrants carry rights to a total of 126,105 shares in Orexo. Orexo has issued the corresponding number of shares to Pyrinox AB to secure the delivery of the shares to the warrants and the subscription price is SEK 0.25.
It was decided at Orexo's Extraordinary General Meeting on November 13, 2007 to issue 926,000 warrants as supplemental payment for the acquisition of Biolipox AB. Each warrant can be used to acquire one share in Orexo, on the condition that one of the value-creating events (see page 7) that call for payment of the supplemental consideration occurs not later than December 31, 2009. The subscription price is SEK 500 per share until that time that one of the value-creating events that call for payment of the supplemental consideration occurs and thereafter SEK 0.40 per share. Last exercise date for the warrants is December 31, 2009.
| 2007 | 2006 | 2007 | 2006 | |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Depreciation/amortization and | ||||
| impairment | 2,368 | 1,012 | 5,875 | 3,444 |
| Calculated costs for employee | ||||
| stock option program | (1,885) | (3,611) | 1,381 | 7,413 |
| Bad debt | - | - | - | 193 |
| Recovered VAT on issuance | ||||
| expenses | - | - | - | 361 |
| Miscellaneous | 211 | 40 | 205 | (76) |
| Total | 694 | (2,559) | 7,461 | 11,335 |
On August 1 Orexo AB and ProStrakan Group plc entered an agreement to acquire 50 percent of its sales company for the Nordic market, ProStrakan AB, for a private placement for cash. If the acquisition had occurred on January 1, 2007, consolidated net revenues would have been MSEK 2.9 higher at net loss MSEK 0.4 higher.
On November 23, Orexo AB gained controlling influence and thereby control of the acquired company Biolipox AB. The company is consolidated in Orexo from the same date.
The acquired company contributed MSEK 4.0 in net revenues and a net loss of MSEK 11.8 for the period November 23 to December 31, 2007. If the acquisition had occurred on January 1, 2007 the Group's net revenues would have been MSEK 29.1 higher and the periods' net loss MSEK 96.8 higher.
The acquisition was financed through the new issue of 7,630,895 shares in Orexo AB valued at SEK 57.5 per share and the issue of 926,000 warrants valued at SEK 57.1 each and a conditional supplemental payment. For the supplemental payment to be paid, four value-creating events must occur before the close of 2009, which the company views as probable.
The acquisition value amounts to MSEK 524.3. The calculation of the acquisition value is based on the estimated value of the newly issued shares and the warrants, acquired employee stock options and the expenses involved in the acquisition.
Acquired net assets and goodwill (MSEK):
| Newly issued shares Issued warrants Direct expenses in conjunction with the acquisition |
438.7 52.9 13.8 |
|---|---|
| Acquisition value of employee stock options | 18.9 |
| Total purchase price | 524.3 |
| Fair value of acquired net assets | (524.3) |
| Goodwill | 0.0 |
The assets and liabilities included were (MSEK):
| Fair value | Acquired | |
|---|---|---|
| carrying value | ||
| Intangible assets | ||
| - Patented technology | 338.4 | - |
| - Product rights | 35.2 | 35.2 |
| Tangible fixed assets | 7.1 | 7.1 |
| Current receivables | 9.1 | 9.1 |
|---|---|---|
| Cash and cash equivalents | 181.2 | 181.2 |
| Current liabilities | (37.1) | (37.1) |
| Long-term liabilities | (9.6) | (9.6) |
| Acquired net assets | 524.3 | 185.9 |
| Expenses in conjunction with the acquisition (MSEK): | ||
| Expenses for the acquisition | (13.8) | |
| Cash and cash equivalents in the acquired company | 181.2 | |
| Change in Group cash and cash equivalents | 167.4 |
| 2007 | 2006 | 2007 | 2006 | |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Raw materials and consumables | 3,435 | 1,067 | 9,162 | 4,909 |
| Other external expenses | 45,546 | 38,341 | 125,146 | 82,919 |
| Personnel costs | 23,932 | 18,896 | 77,603 | 66,081 |
| Depreciation/amortization and | ||||
| impairment | 1,530 | 929 | 4,571 | 3,278 |
| Re-invoicing, rebuilding materials. | - | - | 9,300 | - |
| TOTAL | 74,443 | 59,233 | 225,782 | 157,187 |
| 2007 Oct-Dec |
2006 Oct-Dec |
2007 Jan-Dec |
2006 Jan-Dec |
|
|---|---|---|---|---|
| Shareholders' equity brought forward, according to the balance sheet |
205,951 | 327,174 | 328,406 | 340,633 |
| Profit/loss for the period | (30,639) | (26,340) | (159,898) | (44,566) |
| Exercised hedge options Share subscription through exercise of |
- | 4,607 | - | 4,607 |
| warrants | 255 | 8,002 | 2,981 | 8,319 |
| New issue of shares | 438,776 | - | 438,776 | - |
| New issue of warrants Employee stock options, value of |
52,875 | - | 52,875 | - |
| employees' services | 1,314 | 963 | 5,392 | 5,052 |
| Recovered VAT on issuance expenses | - | - | - | 361 |
| Group contribution received | (2,600) | 14,000 | (2,600) | 14,000 |
| Amount at close of period | 665,932 | 328,406 | 665,932 | 32,406 |
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