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Orexo

Quarterly Report Nov 10, 2008

3093_10-q_2008-11-10_89c4b250-66fa-43d7-85c6-539f343e7d0c.pdf

Quarterly Report

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Orexo AB (publ) – Interim report January-September 2008

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, November 10, 2008

Orexo AB (publ) – Interim report January-September 2008

Key events during the period

  • Net revenues amounted to MSEK 141.2 (21.7)
  • A loss of MSEK 88.6 (loss: 128.6) was reported after tax
  • Earnings per share amounted to a loss of SEK 4.10 (loss: 9.24)
  • Cash flow from operating activities was negative in an amount of MSEK 94.2 (neg. 131.8)
  • The exclusive world rights to two Orexo pharmaceuticals, Sublinox™ (OX22) and OX-NLA, were licensed to Meda AB.
  • Abstral®/Rapinyl was approved for registration in Europe by the EMEA's Committee for Medicinal Products for Human Use (CHMP).

Third quarter of 2008

  • Net revenue amounted to MSEK 61.0 (6.5). A profit of MSEK 1.9 (loss: 34.1) was reported for the third quarter, corresponding to earnings per share of SEK 0.09 (loss: 2.44)
  • Cash flow from operating activities was negative in an amount of MSEK 51.3 (neg. 34.3)
  • Abstral® was approved for marketing in the UK
  • Orexo announced licensing agreements for Abstral®/Rapinyl with ProStrakan and changed partners in the US
  • The registration application for SublinoxTM (OX22) was accepted after the first evaluation as complete for final evaluation by the Food and Drug Administration (FDA) in the US
  • Orexo initiated a clinical Phase II program for OX914 a new product candidate for treatment of inflammatory respiratory diseases
  • Orexo and Boehringer Ingelheim extended their research agreement regarding OX-MPI

Key events after the closing date

• On October 31, the rights for Rapinyl in North America were transferred from Orexo's previous partner Endo Pharmaceuticals to ProStrakan Ltd. In conjunction with the transfer, Orexo received MUSD 0.75 from Endo according to the previous agreement. Orexo also received MUSD 2.6 in compensation from Endo to finance the Phase III studies now in progress. In addition, ProStrakan will pay MUSD 2 to Orexo in conjunction with the takeover.

Condensed statement of operations 1

MSEK 3 months 3 months 9 months 9 months 12 months
2008 2007 2008 2007 2007
July-Sept. July-Sept. Jan.-Sept. Jan.-Sept. Jan.-Dec.
Net revenues 61.0 6.5 141.2 21.7 76.8
Profit/loss after tax 1.9 -34.1 -88.6 -128.6 -172.6
Loss per share, before 0.09 -2.44 -4.10 -9.24 -11.42
dilution (SEK)
Loss per share, after 0.09 -2.44 -4.10 -9.24 -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 most important events during the third quarter and until today were:

  • Launch of Abstral® in Sweden and the start of sales.
  • Approval of Abstral® for marketing in the UK. The decision was announced earlier than anticipated, and the launch of Abstral® in Europe's largest market can now take place toward the end of the year.
  • We are satisfied that the transfer of the rights to Rapinyl in North America took place earlier than planned. We and our partner ProStrakan will now conclude the Phase III studies, which are expected to be completed in December. At the same time, we are preparing the submission of the registration application and marketing of Rapinyl in North America.

Key events during the period

Abstral® approved for marketing in the UK

The British authority MHRA (Medicines and Healthcare products Regulatory Agency) approved Abstral® (intended for breakthrough pain in cancer patients) for marketing in the UK. As a consequence of this approval, Orexo received a partial payment of MUSD 1.

The approval was granted earlier than expected, meaning that ProStrakan can conclude pricing negotiations and move up the launch in the UK to the end of 2008 with the result that sales of Abstral® can take place in the UK during all of 2009.

Launch of Abstral® in Sweden

Abstral® was launched in Sweden during the third quarter 2008. The product is sold through Orexo's joint venture with ProStrakan.

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.

FDA began final evaluation of SublinoxTM

The registration application for SublinoxTM was accepted after the first evaluation as complete for a final evaluation by the Food and Drug Administration (FDA) in the US. SublinoxTM contains the well-known active substance zolpidem and is based on Orexo's proprietary technology to produce a tablet that quickly dissolves under the tongue.

Data on which the application was based includes a clinical study of patients with sleeping disorders that was completed in October 2007. The study showed that SublinoxTM induced sleep 30 percent faster after administration, compared with Ambien/Stilnoct. The study also showed that patients remain asleep throughout the night. The safety profile for Sublinox™ was comparable with Ambien/Stilnoct.

Orexo signed license agreement with ProStrakan in North America

In July, Endo Pharmaceuticals decided to return Rapinyl to Orexo as a result of a change in strategy by the company's new management. Prior to the return, Orexo had received a total of MUSD 26.9 in license revenues from Endo Pharmaceuticals. In addition, Endo had invested approximately MUSD 40 in development of Rapinyl.

Orexo expanded its licensing agreement with the international specialty pharmaceuticals company ProStrakan Group plc to also include North America. ProStrakan, which was already Orexo's partner for sales and marketing of Abstral®/Rapinyl in Europe, will now also be responsible for sales and marketing of the product in the US. In Europe, the EMEA decided to recommend approval of Abstral® in June of this year.

ProStrakan has established offices with management and marketing in the US and is currently recruiting 67 sales representatives in partnership with NovaQuest (part of the Quintiles Group).

In conjunction with the transfer from Endo and in accordance with the new agreement for the North American market, Orexo received MUSD 2 from ProStrakan. Orexo may receive up to an additional MUSD 27 in application and sales-level compensation, excluding the MUSD 2 received on the effective date of the agreement. In the earlier agreement with Endo, sales-level compensation could have reached a total of MUSD 39.2.

In conjunction with the signing of the agreement, the existing agreement pertaining to Europe was also amended. Milestone payments linked to approval in the five largest markets were reduced from MEUR 5 to MUSD 5, while sales-level compensation was increased from MEUR 10 to MEUR 19.9. At the same time royalty compensation was increased by 7-9 percentage units. Royalty compensation in North America was increased with a corresponding amount in relation to the previous agreement with Endo.

Orexo initiated a clinical Phase II program for OX914 – a new product candidate for treatment of inflammatory respiratory diseases

OX914 is a new product candidate for treatment of inflammatory respiratory diseases.

OX914 acts by a mechanism called a PDE4 inhibition with an enhanced safety profile over other agents in this class. Orexo is developing OX914 for treatment of asthma, chronic obstructive pulmonary disease (COPD or smoker's disease) and rhinitis (hay fever).

A study has been initiated in which patients will be treated with OX914 using a pathology model for inflammatory respiratory diseases. Some 36 patients with seasonal allergic rhinitis will be treated with a placebo or OX914 in dosages of 15 or 50 mg for two weeks in a double-blind, threeway cross-over study. The effects on nasal symptoms and anti-inflammatory responses, as well as safety and tolerance will be documented.

The global market for respiratory products is about USD 17 billion.

Orexo and Boehringer Ingelheim extended research agreement

The existing three-year research partnership was extended by an additional 12 months as of November of this year. This research is being conducted within the framework of the global rights to develop and market a new and effective pharmaceutical for treatment of pain and inflammation.

The agreement comprises an extension of the original partnership that started in 2005 and valued at MEUR 250, excluding royalties. With respect to the next milestone payment from the partnership with Boehringer Ingelheim, Orexo expects this to take place during the first half of 2009.

The objective of the partnership is to develop a pharmaceutical that selectively inhibits the prostaglandin enzyme (PG) E synthase (mPGES) to reduce the formation of PGE2, a bodily substance that plays a central role in many inflammatory processes. Such a more selectively targeted active mechanism may result in drugs with fewer side effects than existing pain medications, such as the classic NSAID preparations.

Key events after the closing date

On October 31, the North American rights for Rapinyl were transferred from Orexo's former partner Endo Pharmaceuticals to ProStrakan Ltd. In conjunction with the transfer, Orexo received MUSD 0.75 from Endo in accordance with the previous agreement. Orexo also received MUSD 2.6 in compensation from Endo to finance the Phase III studies now in progress. In addition, ProStrakan will pay Orexo MUSD 2 in conjunction with the transfer.

Operations

Orexo in brief

Orexo is a pharmaceutical company focusing on the development of new, patented drugs by combining well-documented substances with innovative technologies and developing new treatment forms for respiratory and inflammatory diseases.

Orexo has a broad and competitive product portfolio in the late development phase, with three products on the market, three products in clinical phases and one in the registration phase.

Orexo has licensed out the marketing rights for Abstral®/Rapinyl for the North American, European and Japanese markets, world rights for Sublinox™ (OX22) and OX-NLA, and is cooperating with Boehringer Ingelheim in the development of a new pharmaceuticals class for treatment of pain and inflammation. Orexo has also established a Nordic sales organization through a joint venture with ProStrakan.

Orexo's product portfolio

Commercialized products

Abstral®/Rapinyl – for the treatment of acute pain is approved for sale in Europe and is in Clinical Phase III in the US. Abstral®/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 fast-dissolving tablet is placed under the tongue, enables rapid onset of effect and a predictable effect with "on-demand" features. License agreements for Abstral®/Rapinyl have been signed with ProStrakan Group Ltd. for the European and North American markets and with Kyowa Hakko Kirin for the Japanese market. Distribution agreements for the CIS (Russia and other countries in the former Soviet Union), Bulgaria and Romania have been signed with Gedeon Richter and with Hospira for Southeast Asia, including Australia and New Zealand.

In December 2005, Phase III studies began on Abstral®/Rapinyl in the US. Positive results from an interim analysis of the Phase III study were announced in December 2007. When the Phase III study comprising all 100 patients has been completed, a registration application will be submitted to the FDA in the US.

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 bodily substances and is swallowed with water, meaning that no solution mixture needs to be prepared. A breath test is performed as early as ten minutes after administration. The result is more costeffective 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 dose, 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 to the Japanese market.

The Heliprobe™ System has been launched in more than 30 countries, including Eastern Europe, the Middle East and Asia, Orexo has access to well-established distribution and sales channels in a number of markets with substantial potential.

Prioritized projects in which licensing agreements have been signed

Sublinox™ – for the treatment of sleeping disorders. Sublinox™ is based on Orexo's sublingual tablet technology. In 2006, the US insomnia market was worth USD 3.3 billion (according to IMS sales data).

A licensing agreement with exclusive world rights has been signed with Meda.

During October 2007, Orexo completed the Phase III program by conducting the effect, local tolerance and safety study trials among patients using Sublinox™ – for the treatment of temporary insomnia – with positive results. The efficacy trials confirmed that Sublinox™ renders a 30 percent faster onset of sleep, compared with Ambien™, in patients suffering from sleeping disorders. The study also showed that patients remain asleep throughout the night. The study strengthens existing documentation that Sublinox™ is a safe and effective treatment for temporary insomnia.

OX-MPI – Selective prostaglandin E2 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 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 has been conducted since 2005 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 has been signed with Meda. 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 nonallergic 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.

Other prioritized projects

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 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. Orexo is initiating a clinical Phase II program for OX914 that is expected to be completed during the first half of 2009, after which discussions of licensing agreements will begin.

Prioritized projects for which licensing discussions have begun

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. With regard to licensing discussions under way for OX17, these are ongoing with a number of companies, but to ensure the best agreement possible, it will not be possible to conclude an agreement before year-end.

OX2477 – an entirely new class of agents with treatment potential for asthma and COPD. Orexo has discovered a new group of mediators, eoxines, that are formed primarily in cells in respiratory passages and have shown powerful pro-inflammatory effects. Accordingly, release of eoxines 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.

The period in figures, January 1 – September 30, 2008

3 months 3 months 9 months 9 months 12 months
2008 2007 2008 2007 2007
MSEK July-Sept. July- Sept.Jan.- Sept.Jan.- Sept. Jan.-Dec.
Net revenues 61.0 6.5 141.2 21.7 76.8
Cost of goods sold -4.3 -3.4 -13.2 -10.2 -14.4
Gross profit 56.7 3.1 128.0 11.5 62.4
Selling expenses -6.7 -5.0 -25.3 -18.5 -27.0
Administrative expenses -10.8 -13.8 -38.4 -36.8 -58.9
Research and development costs -41.4 -20.2 -162.6 -90.7 -156.0
Other operating income and costs 1.5 0.1 2.1 0.0 -1.1
Operating loss -0.7 -35.8 -96.2 -134.5 -180.6
Net financial items 2.5 1.6 7.3 5.8 7.7
Profit/loss after financial items 1.8 -34.2 -88.9 -128.7 -172.8
Tax 0.1 0.1 0.3 0.1 0.2
Net profit/loss for the period 1.9 -34.1 -88.6 -128.6 -172.6

Condensed consolidated statement of operations

Revenue

Net revenue

Consolidated net revenue for the period January – September 2008 amounted to MSEK 141.2 (21.7). The sharp increase in the third quarter, compared with the preceding year, was primarily due to licensing revenues of MSEK 30 from Meda for licensing of Sublinox and MSEK 6 from ProStrakan Group Plc in conjunction with the approval of Abstral® in the UK but also revenues from the partnership with Boehringer Ingelheim GmbH relating to OX-MPI and compensation from Endo and from the joint-venture company ProStrakan AB.

Sales of Abstral® amounted to MSEK 1,1 during the period (whereof 50% is Orexo's share). The sales are related to inventory build-up at Apoteket, this inventory is estimated to cover 2008.

MSEK Jan.-Sept. 2008 Jan.-Sept. 2007 Jan.-Dec. 2007
Diabact® UBT 4.1 3.7 5.2
Heliprobe™ System 17.2 14.6 19.7
ProStrakan AB J/V 50% 7.0 0.7 2.7
(of which Abstral® 50%) (0.6)
License revenue 65.3 0.0 34.0
Other 47.7 2.7 15.2
Total 141.2 21.7 76.8

Net revenue was distributed as follows:

During the period July – September 2008, net revenue amounted to MSEK 61.0 (6.5).

Expenses and earnings

Selling expenses

Consolidated selling expenses amounted to MSEK 25.3 (18.5) for the period January – September 2008 and to MSEK 6.7 (5.0) for the period July – September 2008.

Selling expenses primarily include costs for business development linked to the licensing 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 primarily an effect of increased investment in business development mainly for licensing and higher costs in the joint venture ProStrakan AB.

Administrative expenses

Administrative expenses amounted to MSEK 38.4 (36.8) for the period January – September 2008 and to MSEK 10.8 (13.8) for the period July – September 2008.

The increase with respect to the year-earlier period 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 costs

Research and development costs amounted to MSEK 162.6 (90.7) for the period January–September 2008 and to MSEK 41.4 (20.2) for July – September 2008. Of the period's expenses, MSEK 15.7 was re-invoiced to partners and is included in net revenues, meaning that the period's net costs for research and development amounted to MSEK 25.7.

Research and development costs include costs 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 for which discussions on licensing have been initiated or concluded. These include Abstral®/Rapinyl for the treatment of acute pain, OX-MPI for treatment of pain, inflammation and rheumatism, Sublinox™ for the treatment of sleeping disorders, OX 17 for GERD, OX-NLA for treatment of allergic and nonallergic 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.

Expenses for the company's employee stock option plan

For the period July – September 2008, the company's costs for the employee stock option plan totaled MSEK -2.6 (0.2). The reduction in costs during the quarter was due to the decline in the share price during the period, which resulted in reduced expenses, which are reported as a reduction in provisions for estimated social costs, and a change in the assessment of how great a proportion of the options that are expected to be earned, which resulted in a one-time effect during the quarter.

For the period January-September 2008, costs for the employee stock option plan amounted to MSEK 3.2 (3.3), of which MSEK 2.3 (1.2) was attributable to administrative employees, MSEK 1.1 (2.1) to research and development-related personnel and MSEK -0.2 (0.0) to sales-related personnel.

Other income and costs

Other income and costs, consisting primarily of exchange-rate gains and losses, amounted to income of MSEK 2.1 (0.0) for the period January – September 2008 and to income of MSEK 1.5 (0.1) for the period July – September 2008.

Depreciation/amortization

Depreciation/amortization amounted to MSEK 8.1 (3.5) for the period January–September 2008 and to MSEK 2.6 (1.4) for the period July – September 2008. The increase was primarily due to investments during 2007 in new office premises and the acquisition of Biolipox AB.

Tax

Tax expenses during January–September 2008 amounted to MSEK 0.3 (0.1).

Net loss

The operating loss for the period January – September 2008 amounted to MSEK 96.2 (loss: 134.5). The loss after net financial items was MSEK 89.0 (loss: 128.7), and the loss after tax was MSEK 88.6 (128.6). Between comparable periods, revenue increased strongly, mainly due to the license revenue from Meda that was received during 2008. At the same time, Orexo continued expanding its business, including the acquisition of Biolipox, which resulted in increased operating expenses.

The operating loss for the period July - September was MSEK 0.7 (loss: 35.8). Profit after financial items amounted to MSEK 1.8 (loss: 34.2), and profit after tax was MSEK 1.9 (loss: 34.1).

Financial position

The Group's cash and cash equivalents amounted to MSEK 195.7 (142.5) at September 30, 2008 and shortterm investments amounted to MSEK 0 (10.0).

Cash flow from operating activities for the period January–September 2008 was a negative MSEK 94.2 (neg: 131.8). Cash flow after financing was a negative MSEK 95.9 (neg: 133.9). Cash flow from operating activities for the period July–September 2008 was a negative MSEK 51.3 (neg. 34.3). Cash flow after financing was a negative MSEK 51.5 (neg: 45.2).

Shareholders' equity on September 30, 2008 amounted to MSEK 585.6 (202.6). The equity/assets ratio was 83 percent (79).

Investments

Gross investments in tangible fixed assets amounted to MSEK 1.5 (41.7) for the period January–September 2008 and to MSEK 0.2 (22.7) for the period July - September 2008. The decline from the year-earlier period was primarily attributable to remodeling of new premises during 2007.

Parent Company

The majority of the Group's business is carried out in the parent company, Orexo AB. Net revenues for the period January–September 2008 amounted to MSEK 90.4 (5.9) and the loss after net financial items was MSEK 77.7 (loss: 129.3). Investments amounted to MSEK 1.5 (41.7). The Parent Company's cash and cash equivalents and current investments totaled MSEK 36.7 (140.3).

Assets pledged and contingent liabilities

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 was reported under contingent liabilities. Otherwise, no significant changes in contingent liabilities or pledged assets occurred during the period.

Significant risks and uncertainties

Uncertainty regarding success of development efforts

Orexo is a Group in the development stage with only three products on the market and a number of other product candidates in various development stages, of which some in the late clinical development phase. 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 lack the possibility to license out or commercialize new products.

Competing operations

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.

Partners and the authorities

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.

Key personnel

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.

Financial risk

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 effectively manage and limit these risks.

Share

Orexo's share was introduced on November 9, 2005 at a price of SEK 90 and was traded at SEK 42 on September 30, 2008. The company's market capitalization, based on the number of shares outstanding on September 30, 2008, was SEK 0.9 billion.

Analysts who monitor Orexo

ABG Sundal Collier Alexander Lindström
Carnegie Camilla Oxhamre
Handelsbanken Markets Erik Hultgård
Nordea Patrik Ling
Remium Johan Isaksson
Redeye Björn Andersson
SEB Gustaf Vahlne

Future reporting dates

Year-end Report 2008 February 17, 2009 Annual General Meeting 2009 April 23, 2009 Interim report, January – March 2009 May 6, 2009 Interim report, January – June 2009 August 21, 2009 Interim report, January – September 2009 November 10, 2009

Annual General Meeting 2009

Orexo's Annual General Meeting will be held on April 23, 2009 in Stockholm.

Uppsala, November 10, 2008

Orexo AB (publ)

Torbjörn Bjerke President and CEO

For further information, please contact Torbjörn Bjerke, President and CEO, tel: +46 18 780 88 12, e-mail: [email protected]

Claes Wenthzel, Vice President and CFO, tel: +46 18 780 88 44, e-mail: [email protected].

Review report

We have reviewed the appended interim report for the period January 1 to September 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, November 10, 2008 PricewaterhouseCoopers AB

Leonard Daun Authorized Public Accountant

CONSOLIDATED BALANCE SHEET

(SEK 000s)

Notes Sept. 30,
2008
Sept. 30,
2007
Dec. 31,
2007
ASSETS
Fixed assets
Tangible fixed assets 52,435 45,386 57,790
Goodwill 16,032 16,013 16,030
Other intangible assets 376,317 4,012 377,335
Total fixed assets 444,784 65,411 451,155
Current assets
Inventories 12,772 10,928 13,294
Accounts receivable and other receivables 50,519 26,190 42,261
Tax receivables 3,944 2,204 3,565
Short-term investments - 9,951 -
Cash and bank balances 195,662 142,530 291,598
Total current assets 262,897 191,803 350,718
Total assets 707,681 257,214 801,873
SHAREHOLDERS' EQUITY AND
LIABILITIES 3
Share capital 8,647 5,584 8,647
Capital contributions 838,216 363,014 835,202
Accumulated losses -261,218 -166,045 -172,597
Total shareholders' equity 585,645 202,553 671,252
Long-term liabilities
Provisions 526 1,908 162
Long-term liabilities 9,100 - 9,595
Deferred tax liability
Total long-term liabilities
531
10,157
992
2,900
877
10,634
Current liabilities, non-interest-bearing 111,879 51,761 119,987
Total liabilities 122,036 54,661 130,621
Total shareholders' equity 707,681 257,214 801,873
and liabilities
Pledged assets 2,500 2,500 14,500
Contingent liabilities 43,550 7,250 43,550

CONSOLIDATED STATEMENT OF OPERATIONS

(SEK 000s)

Notes 3 months
2008
July-Sept.
3 months
2007
July
Sept.
9
months
2008
Jan.-
Sept.
9
months
2007
Jan.-
Sept.
12
months
2007
Jan.-
Dec.
Net sales 60,970 6,470 141,211 21,678 76,757
Cost of goods sold 2 -4,339 -3,378 -13,242 -10,189 -14,384
Gross profit 56,631 3,092 127,969 11,489 62,373
Selling expenses 2 -6,685 -5,019 -25,269 -18,513 -26,982
Administrative expenses 2 -10,751 -13,801 -38,429 -36,784 -58,932
Research and development costs 2 -41,325 -20,211 -162,573 -90,652 -155,972
Other operating income 1,627 179 4,246 9,775 9,958
Other operating costs 2 -181 -58 -2,169 -9,815 -11,014
Operating loss -684 -35,818 -96,225 -134,500 -180,569
Earnings from financial
Investments
Interest income 2,468 1,663 7,449 5,798 8,231
Interest expenses -15 -4 -190 -22 -23
Other financial items 0 0 0 0 -473
Result after financial items 1,769 -34,159 -88,966 -128,724 -172,834
Tax 115 83 345 123 237
Net profit/loss for the period 1,884 -34,076 -88,621 -128,601 -172,597
Profit/loss per share, before dilution,
SEK 0.09 -2.44 -4.10 -9.24 -11.42
Earnings per share, after dilution, SEK
Average number of shares, before
0.09 -2.44 -4.10 -9.24 -11.42
dilution
Average number of shares, after
21,617,395 13,955,864 21,617,395 13,923,550 15,108,176
dilution 22,700,914 14,146,271 22,700,914 14,113,957 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 22,700,914 14,151,657 22,700,914 14,151,657 22,693,082

CONSOLIDATED CASH-FLOW STATEMENTS

(SEK 000s) Notes 3 months
2008
July-Sept.
3 months
2007
July-Sept.
9 months
2008
Jan.-Sept.
9 months
2007
Jan.-Sept.
12 months
2007
Jan.-Dec.
Continuing operations
Loss before interest income and
interest expense -684 -35,818 -96,225 -134,500 -180,569
Interest income 2,468 1,663 7,449 5,798 8,231
Interest expenses
Other financial expenses
-15 -4 -190 -22 -23
-473
Adjustment for items not included in
cash flow 4 31 1,178 11,386 6,767 7,461
Cash flow from operations
before changes in working
capital 1,800 -32,981 -77,580 -121,957 -165,373
Change in working capital
Accounts receivable -5,841 3,916 -15,794 2,981 2,537
Other current receivables 2,558 -556 7,157 -10,370 -18,266
Inventories 1,680 -491 522 -1,694 -4,060
Current liabilities -50,969 -853 -8,343 2,166 37,069
Provisions -548 -3,318 364 -2,911 -4,657
Long-term liabilities - - -495 - -
Cash flow from continuing
operations
-51,320 -34,283 -94,169 -131,785 -152,750
Investing activities
Acquisition of machinery and
equipment -152 -22,698 -1,451 -41,749 -49,318
Divestment of machinery and
equipment - - 11 - -
Acquisition of current investments - 20,978 - 46,175 -19,762
Divestment of current investments - - - - 75,888
Acquisition of shares in subsidiaries - -9,245 -327 -9,245 158,151
Cash flow after investments -51,472 -45,248 -95,936 -136,604 12,209
Change in financing
Proceeds from new share issue - - - 2,726 2,981
Cash flow after financing
activities -51,472 -45,248 -95,936 -133,878 15,190
Cash flow for the period
Cash and cash equivalents at the
beginning of period 247,134 187,778 291,598 276,408 276,408
Change in cash and cash equivalents -51,472 -45,248 -95,936 -133,878 15,190
Cash and cash equivalents at end
of period 195,662 142,530 195,662 142,530 291,598
KEY FIGURES 3 months 3 months 9 months 9 months 12 months
(SEK 000s) July-Sept. July-Sept. Jan.-Sept. Jan.-Sept. Jan.-Dec.
2008 2007 2008 2007 2007
Operating margin, % -1 -554 -68 -620 -235
Profit margin, % 3 -528 -63 -594 -225
Return on total capital, % 0 -12 -12 -41 -45
Return on shareholders' equity, % 0 -16 -14 -49 -53
Return on capital employed, % 0 -16 -14 -49 -53
Debt/equity ratio, multiple 0 0 0 0 0
Equity/assets ratio, % 83 79 83 79 84
Current ratio, % 235 371 235 371 292
Acid ratio, % 224 349 224 349 281
Average number of shares, before dilution 21,617,395 13,955,864 21,617,395 13,923,550 15,108,176
Average number of shares, after dilution 22,700,914 14,146,271 22,700,914 14,113,957 16,183,863
Number of shares after full dilution 23,349,608 14,896,025 23,349,608 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 22,700,914 14,151,657 22,700,914 14,151,657 22,693,082
Profit/loss per share, before dilution, SEK 0.09 -2.44 -4.10 -9.24 -11.42
Profit/loss per share, after dilution, SEK 0.09 -2.44 -4.10 -9.24 -11.42
Shareholders' equity per share, before
dilution, SEK 27.09 14.51 27.09 14.51 31.05
Shareholders' equity per share, after dilution,
SEK 25.80 14.31 25.80 14.31 29.58
Number of employees at the end of the period 124 74 124 74 129
Average number of employees 121 72 121 68 80
Shareholders' equity 585,645 202,553 585,645 202,553 671,252
Capital employed 585,634 202,553 585,645 202,553 671,252

Definitions

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.

Shareholders' equity per share, after dilution: Shareholders' equity divided by the number of shares after dilution at the close of the period.

PARENT COMPANY'S BALANCE SHEET

(SEK 000s)

Notes Sept. 30
2008
Sept. 30
2007
Dec. 31
2007
ASSETS
Fixed assets
Tangible fixed assets 51,712 45,250 50,903
Intangible fixed assets 468 413 566
Shares in subsidiaries/Joint ventures 524,169 18,379 523,842
Total fixed assets 576,349 64,042 575,311
Current assets
Inventories 4,253 2,145 4,362
Accounts receivable and other receivables 62,207 45,656 51,987
Tax receivables 2,182 2,062 1,083
Current investments - 9,951 -
Cash and bank balances 36,701 130,322 109,511
Total current assets 105,343 190,136 166,943
Total assets 681,692 254,178 742,254
SHAREHOLDERS' EQUITY,
PROVISIONS AND LIABILITIES
6
Restricted equity 299,398 365,775 299,398
Non-restricted equity 289,222 -159,824 366,534
Total shareholders' equity 588,620 205,951 665,932
Long-term liabilities
Provisions 526 1,908 163
Total long-term liabilities 526 1,908 163
Current liabilities, non-interest-bearing 92,546 46,319 76,159
Total liabilities 93,072 48,227 76,322
Total shareholders' equity, provisions
and liabilities
681,692 254,178 742,254
Pledged assets 2,500 2,500 2,500
Contingent liabilities 11,050 11,050 11,050

PARENT COMPANY'S STATEMENT OF OPERATIONS

(SEK 000s)

Notes 3 months 3 months
July
9
months
Jan.-
9
months
Jan.-
12
months
Jan.-
July-Sept.
2008
Sept.
2007
Sept.
2008
Sept.
2007
Dec.
2007
Net sales 44,192 374 90,408 5,883 48,389
Cost of goods sold 5 - -63 - -2,409 -2,409
Gross profit 44,192 311 90,408 3,474 45,980
Selling expenses 5 -2,808 -1,665 -10,997 -12,043 -15,408
Administrative expenses -10,172 -13,452 -35,286 -36,140 -54,327
Research and development costs -34,795 -20,671 -126,343 -91,111 -143,225
Other operating income 1,139 108 2,613 9,603 9,674
Other operating costs 5 -37 -58 -1,175 -9,636 -10,413
Operating loss -2,481 -35,427 -80,780 -135,853 -167,719
Earnings from financial
Investments
Interest income 898 1,952 3,201 6,604 7,832
Interest expenses -5 -4 -143 -10 -11
Total loss after financial
investments -1,588 -33,479 -77,722 -129,259 -159,898
Net loss for the period -1,588 -33,479 -77,722 -129,259 -159,898

Notes

1. Accounting principles

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.

Since the interim report 31 March 2008, 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.

The amounts below are in SEK thousands, unless otherwise indicated.

2. Costs distributed by type of cost

July-Sept. July-Sept. Jan.-Sept. Jan.-Sept. Jan.-Dec.
2008 2007 2008 2007 2007
Raw materials and supplies 8,496 3,811 24,216 13,509 26,835
Other external costs 30,312 18,705 118,385 81,126 132,307
Personnel costs 21,837 18,537 90,947 58,511 92,967
Depreciation and impairment 2,637 1,414 8,134 3,507 5,875
Reinvoicing of rebuilding costs - - - 9,300 9,300
TOTAL 63,282 42,467 241,682 165,953 267,284

3. Shareholders' equity

Changes in Group equity

July-Sept.
2008
July-Sept.
2007
Jan.-Sept.
2008
Jan.-Sept.
2007
Jan.-Dec.
2007
Shareholders' equity brought forward
according to balance sheet 585,124 235,255 671,252 324,350 324,350
Profit/loss for the period 1,884 -34,076 -88,621 -128,601 -172,597
Subscription of shares through the
exercise of warrants - - - 2,726 2,981
New share issues - - - - 438,775
New share of employee stock options
Employee stock options, value of
- - - - 52,875
employees' service
Acquired value of employee stock
-1,363 1,374 3,014 4,078 5,989
options - - - - 18,879
Amount at close of period 585,645 202,553 585,645 202,553 671,252

Shares outstanding

The number of shares outstanding at September 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.

Options

At September 30, there were 2,614,816 options outstanding carrying subscription rights corresponding to 2,121,213 shares in Orexo and the exchange of 493,603 options for 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– September 2008 period.

Opening
Jan. 1,
2008
- + Closing
Sept. 30, 2008
Stock options targeted to employees
Of which:
Decided and allotted employee stock options
Decided and allotted Board member stock
373,525 -89,450 412,500 696,575
options - - 16,388 16,388
Decided and allotted subscription warrants 15,250 - - 15,250
Decided but not yet allotted employee stock
options 2008
cash-flow hedging of social security fees
372,000 -372,000 389,000 389,000
Subscription warrants held by subsidiaries for
78,000 - - 78,000
Total decided stock options 838,775 -461,450 817,888 1,195,213
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)
Subscription warrants taken over from
399,167 -35,938 - 363,229
Biolipox AB for cash-flow hedging of social
security fees (not resulting in dilution)
135,374 -5,000 - 130,374
Total stock options from Biolipox 534,541 -40,938 - 493,603
Total stock options targeted to
employees
1,373,316 -502,388 817,888 1,688,816
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 -502,388 817,888 2,614,816
During the period July-September 2008, 859 Biolipox employee stock options were exercised in which the

holders exchanged their options for 859 Orexo shares held by the independent company Pyrinox AB. Consequently, exercise did not result in Orexo issuing additional shares. During the period January-September, Pyrinox sold 5,000 warrants for cash flow hedging of social security costs.

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. Reported figures regarding options issued by Orexo AB pertain to the number of shares for which each option entitles the holder to subscribe after the split. All figures relating to options issued by Biolipox AB were translated using a factor of 0.45854, which corresponded to the estimated value of the options in relation to the Orexo share price on the acquisition date. Reported figures regarding options issued by Biolipox relate to the number of shares for which each option may be exchanged after translation.

Allotment in February

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:

  • President: 50,000 shares
  • Other senior executives: 85,000 shares
  • Other employees: 237,000 shares

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.

New plan decided at the Annual General Meeting

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. Of these employee stock options, 40,500 were allotted without charge to employees during the July – September 2008 period. The distribution among employees was as follows:

Other senior executives: 30,000 options Other employees: 10,500 options

The subscription price for the options in SEK 56 per share, and the maturity period extends up until December 31, 2018. The market value as calculated by the Black & Scholes method amounted to SEK 15.38 per option on the allotment date.

The Meeting also 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 were allotted from the Board Member Shareholder Plan to Board members, and the options may be exercised up until December 31, 2015. Entitlement is earned with one fourth after the publication of Orexo's first quarter report and with one fourth following the publication of the interim reports for each of the quarters two to four during the term of office for the fiscal year in which the option holder was elected or re-elected. The market value as calculated by the Black & Scholes method, amounted to SEK 55.15 per option on the allotment date.

During the July – September period, the Board of Directors resolved to cancel option certificates with entitlement to subscription for 89,450 shares. The cancelled options relate to earned options for employees who have terminated their employment and therefore will not be able to exercise them.

4. Consolidated cash flow

Adjustment for items not included in cash flow

July-Sept.
2008
July-Sept.
2007
Jan.-Sept.
2008
Jan.-Sept.
2007
Jan.-Dec.
2007
Depreciation/amortization and
impairments 2,637 1,414 8,134 3,507 5,875
Calculated costs for employee stock
option program -2,596 -228 3,249 3,266 1,381
Other -10 -8 3 -6 205
Total 31 1,178 11,386 6,767 7,461

5. The Parent Company's costs distributed by type of cost

July-Sept.
2008
July-Sept.
2007
Jan.-Sept.
2008
Jan.- Sept.
2007
Jan.-Dec.
2007
Raw materials and supplies 4,420 494 8,113 5,727 9,162
Other external costs 22,450 17,594 84,909 79,600 125,146
Personnel costs 19,112 16,714 75,429 53,671 77,603
Depreciation and impairment 1,830 1,107 5,350 3,041 4,571
Reinvoicing of rebuilding costs - - - 9,300 9,300
TOTAL 47,812 35,909 173,801 151,339 225,782

6. Shareholders' equity

Changes in the Parent Company's shareholders' equity

July-Sept.
2008
July-Sept.
2007
Jan.-Sept.
2008
Jan.-Sept.
2007
Jan.-Dec.
2007
Shareholders' equity brought forward
according to balance sheet 592,366 238,056 665,932 328,406 328,406
Loss for the period -1,588 -33,479 -77,722 -129,259 -159,898
Subscription of shares through the
exercise of warrants - - - 2,726 2,981
New share issues - - - 4,078 438,776
New issue of subscription warrants - - - - 52,875
Employee stock options, value of
employees' service -2,158 1,374 410 - 5,392
Group contributions - - - - -2,600
Amount at the close of the period 588,620 205,951 588,620 205,951 665,932

7. Events after the close of the period

See page 2.

Note

Orexo AB Publ. discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on November 10, 2008 at 08:00 a.m. CET. This report has been prepared in both Swedish and English. In case of variation in the content of the two versions, the Swedish version shall take precedence.

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