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Medivir — Interim / Quarterly Report 2008
Feb 19, 2009
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Interim / Quarterly Report
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Press Release, 19 February 2009
Medivir, Financial Statement, 1 January – 31 December 2008
- Net sales were SEK 97.2 (249.6) m. In May, Medivir signed another agreement with Tibotec Pharmaceuticals Ltd. regarding hepatitis C, triggering a EUR 5 m payment. A milestone payment of EUR 2.6 m was received in December when a CD (candidate drug) was designated.
- The loss after tax was SEK -99.2 (-29.3) m.
- Earnings per share were SEK -4.76 (-1.74).
- Cash flow from operating activities was SEK -34.8 (-70.5) m.
- Liquid assets as of 31 December were SEK 284.4 (329.3) m.
- Ron Long appointed as CEO.
Fourth quarter in brief
Several significant project events were reported in the quarter: Clinical data and milestone payments on our hepatitis C projects, in tandem with continued work on Lipsovir's® NDA. In December, Medivir reported that Lars Adlersson would be leaving the company after six years as CEO.
The highlights can be summarized as follows:
- Positive phase IIa data from the first two dose groups for TMC435 against hepatitis C was presented at the Annual Meeting of the AASLD (American Association for the Study of Liver Diseases) in early November.
- An NDA for Lipsovir® was filed with the US (FDA) and European regulatory authorities.
- Milestone payment of EUR 2.6 m on designation of a CD in the hepatitis C collaboration with Tibotec in the polymerase segment.
Ron Long CEO
Huddinge, Sweden, 19 February 2008
For more information, please contact:
Rein Piir, CFO and VP, Investor Relations: +46 (0)70 853 7292 or +46 (0)8 546 83123.
FORTHCOMING FINANCIAL INFORMATION
The Three-month Interim Report will be published on 23 April 2009. The AGM will be held at 3pm on 23 April 2009.
The Six-month Interim Report will be published on 9 July 2009.
The Nine-month Interim Report will be published on 21 October 2009.
The Report will be available at Medivir's Website, www.medivir.se from this date under the 'Investor/Media' heading.
Business highlights in the fourth quarter 2008
Medivir receives milestone payment from its HCV collaboration with Tibotec in the polymerase segment
In May 2008, Medivir entered into an R&D Licensing Agreement in the hepatitis C (HCV) polymerase segment with Ortho Biotech Products LP and Tibotec BVBA in Mechelen, Belgium. The aim of this collaboration is to identify and develop orally active inhibitors of the HCV polymerase NS5B.
A preclinical CD was designated in this collaboration project in December, which triggered a EUR 2.6 m milestone payment to Medivir. Tibotec is responsible for work on the preclinical regulatory phase of the project, which is now underway, and for clinical development and marketing of these compounds.
Tibotec has secured exclusive rights to markets in all countries apart from the Nordic region, which Medivir is retaining. Medivir may receive up to EUR 137 m in future milestone payments for the first compound that reaches market registration, and further milestone payments if more than one compound reaches the market, as well as royalties on global product sales. The agreement also includes research support for Medivir for one year.
Positive phase IIa data from hepatitis C patients treated with TMC435 presented at AASLD Annual Meeting
TMC435 is a protease inhibitor jointly developed by Medivir and Tibotec to treat hepatitis C virus (HCV) infections. Alongside its collaboration partner Tibotec, Medivir presented data from the first two dose groups from the phase IIa trial with TMC435 in November. Results from the other dose groups will be published in 2009. Planning of the forthcoming phase IIb studies have been initiated and the studies are expected to start in the spring.
Results from the first two dose groups show:
- Strong and dose-dependent antiviral activity at doses of 25 mg and 75 mg TMC435 once daily.
- In the group receiving four weeks' treatment with TMC435 at 75 mg/day + standard of care treatment (SoC), plasma viral load in all patients reduced sharply and was undetectable (<10 IU/ml) in 8 of 9 subjects, (89%). The viral loading in the ninth patient was below lower limit of quantification (<25 IU/ml).
- No serious adverse events related to TMC435 were observed.
- Steady-state plasma levels of TMC435 were achieved after three days' dosing. Plasma levels immediately before the next dose were 10-30 times higher than the expected effective dose level which confirms that TMC435 has a good clinical dose margin.
The phase IIa trial that started in the first quarter 2008 is a randomized, double-blind, placebocontrolled trial with TMC435 administered orally with increasing doses. This trial involves 96 previously untreated (naive) patients and 34 patients that had previously not responded to treatment with other pharmaceuticals, all with chronic hepatitis C genotype 1 infections.
Patients receive either TMC435 or placebo, one tablet daily for 28 days together with SoC, peginterferon alpha-2a (Pegasys® ) and ribavirin (Copegus® ). Thereafter the patients continue treatment for 24 or 48 weeks, depending on therapy response. Patients are then monitored for a further 24 weeks after SoC treatment to evaluate how many are cured, i.e. no longer have quantifiable levels of hepatitis C virus.
Eight out of nine (89%) of patients in the group treated for four weeks with 75 mg of TMC 435 plus SoC attained rapid viral response (RVR), against 33% in the SoC group. The first two dose groups (25 mg and 75 mg) involved 50 patients. Half of these patients were treated with TMC435 or placebo only for the first week, followed by TMC435 or placebo + SoC for three weeks. The other half was treated with TMC435 or placebo + SoC for four weeks. An important marker of pharmaceutical effect after these four weeks is how many patients are free of the virus (RVR), defined as viral load of less than 10 IU/ml.
NDA for Lipsovir® filed with the US (FDA) and European regulatory authorities
In October, Medivir filed a new drug application (NDA) with the US (FDA) and EU regulatory authorities for Lipsovir® , a topical product for preventing and treating cold sores. In December, these authorities announced that they had validated the NDA and that their review and evaluation process had begun. This means we expect to receive the outcome of this process in the later part of autumn 2009.
Lipsovir® is a patented combination of hydrocortisone (anti-inflammatory agent) and acyclovir (antiviral agent) in a proprietary cream base developed by Medivir.
Results from the phase III program demonstrate the possibility of preventing the incidence of cold sores through early treatment onset, which has not been demonstrated by available products. Thus Lipsovir® can offer patients with recurrent cold sores an improved treatment alternative compared to current therapy.
The objective is to enter partnerships to commercialize Lipsovir® globally.
Lars Adlersson leaves Medivir AB
On December 15, it was announced that Lars Adlersson would leave the position as CEO of Medivir AB, effective January 31, 2009. During his six years as CEO he has significantly contributed to the development of the company.
Business highlights after the end of the period
Medivir appoints a new CEO
In January, Medivir's Board of Directors appointed Ron Long as CEO of Medivir AB, effective 1 February 2009. Mr. Long was born in 1947 and was elected to Medivir's Board in 2007. He has extensive and long-term experience of the pharmaceuticals and life science industries.
Medivir designates MIV-710 a Candidate Drug (CD) for Osteoporosis and Osteoarthritis
In Medivir's pipeline there are selective inhibitors of cathepsin K for the treatment of osteoporosis and osteoarthritis. In February Medivir designated a highly active and selective small molecule inhibitor of cathepsin K, MIV-710, as Candidate Drug (CD).
MIV-710 shows very pronounced efficacy, based on biomarkers for osteoporosis in preclinical models, with a long duration of effect after once daily oral dosing. MIV-710 dose-dependently attenuates the breakdown of bone, the hallmark of osteoporosis, whilst maintaining the beneficial bone formation. MIV-710 is expected to be dosed conveniently only once daily as a tablet and at low doses, due to it's favorable potency and pharmacokinetic properties.
Medivir is now in a strong position to move into out licensing discussions for the cathepsin K program including MIV-710 and MIV-701 which both have the potential to become a first-in-class treatment option in this important disease area.
Medivir sharpens the strategic focus and strengthens its financial position
Medivir employees have today been informed that in 2009 Medivir will start implementing cost savings activities which may include staff reductions, and that Medivir will initiate consultations with the respective unions.
Project portfolio
At year-end 2008, Medivir had 103 employees, 74 of whom were active in its preclinical organization and 7 in pharmaceuticals development and sales. The remaining employees work in business development or various support functions.
Work in Medivir's Development function during the year focused on the phase III program and the NDA submission of the labial herpes project Lipsovir® and clinical trials on TMC435 in collaboration with Tibotec.
Research on two preclinical projects, HCV-Pol and HIV-PI, is conducted in partnership and was financed by Tibotec in the year. The cathepsin K project advanced towards designation of one further CD in February 2009.
The most resourced preclinical project at year-end 2008 was a project against Alzheimer's (BACE). This project has made rapid progress and BACE inhibitors shows effect in preclinical model.
| Partners/- date of |
Explorative | Optimiz | Preclinic | Phase | Phase | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Project | Indication(s) | agreement | Terms | Medivir's markets | phase | ation | al dev.* Phase I | II | III | |
| Lipsovir® (ME-609) |
Labial herpes | In-house | ||||||||
| TMC435 (HCV PI) |
Hepatitis C | Tibotec / 2004 | EUR 80.5 m + royalties FTE funding |
Nordic region | ||||||
| MIV-701 (Cath K) |
Osteoporosis, osteoarthritis, bone metastases |
In-house | ||||||||
| HCV POL | Hepatitis C | Tibotec / 2008 | EUR 142-272 m + royalties, FTE funding |
Nordic region | ||||||
| MIV-710 (Cath K) |
Osteoporosis, osteoarthritis, bone metastases |
In-house | ||||||||
| HIV PI | HIV | Tibotec / 2006 | EUR 64 m + royalties, FTE funding |
Nordic region | ||||||
| BACE | Alzheimer's | In-house | ||||||||
| Cathepsin S Rheumatoid artritis, In-house multiple sclerosis |
||||||||||
| COPD PI | COPD | In-house | World exc. China | |||||||
| Renin | Hypertension | In-house | ||||||||
| Protease inhibitor | Polymerase inhibitor | Polymerase inhibitor/hydrocortisone | ||||||||
| 4 |
Medivir AB Telephone Fax Contact PO Box 1086 +46 (0)8 546 83100 +46 (0)8 546 83199 [email protected] SE-14122 Huddinge www.medivir.se SWEDEN
Medivir HIV Franchise AB administers the polymerase-based projects against HIV, HBV, shingles and glandular fever.
| Project | Indication(s) | Partners/- date of agreement |
Terms | Medivir's markets | Explorative phase |
Optimiz ation |
Preclinic | al dev.* Phase I | Phase II |
Phase III |
|---|---|---|---|---|---|---|---|---|---|---|
| (ME-606) | Valomaciclovir Shingles, mono- nucleosis |
Epiphany Bio- | USD 24.5m + royalties sciences /2006 Epiphany shares |
Nordic region | ||||||
| Alovudine (MIV-310) |
HIV | Mefuvir/2007 | Royalties | World exc. Asia | ||||||
| Lagociclovir (MIV-210) |
Hepatitis B, HIV | Hainan Noken | USD 7 m + royalties | World exc. Asia | ||||||
| MIV-150 | HIV | Population Council / 2003 |
Option of 50% of Western world |
|||||||
| MIV-160 | HIV | Mefuvir | Mefuvir shares and royalties |
World exc. China, Taiwan and Macao |
||||||
| MIV-410 | HIV, CMV | Presidio/2006 | USD 52.25m + royalties Nordic region and UK Presidio shares |
Option on Europe | ||||||
| Polymerase inhibitor |
For a detailed description of all projects, please see Medivir's website www.medivir.se under Research & Development.
Consolidated earnings and financial position
Turnover and earnings, 1 January - 31 December 2008
Net sales were SEK 97.2 (249.6) m for the year. In May, Medivir signed an agreement with Tibotec Pharmaceuticals Ltd. regarding hepatitis C in the polymerase segment, triggering a oneoff payment of SEK 46.2 m (EUR 5 m). This payment has been allocated over the assessed agreement term, and SEK 30.8 m of revenue has been recognized. In December, the research collaboration on hepatitis C triggered a milestone payment of SEK 32.0 m (EU 2.6 m). Turnover in the year also included remuneration of SEK 29.3 m for research collaboration on HIV protease inhibitors and hepatitis C from Tibotec Pharmaceuticals Ltd.
In the previous year, turnover was SEK 249.6 m, largely comprising three milestone payments of SEK 182.3 m (EUR 19.5 m) for the protease inhibitor TMC435 against hepatitis C from Tibotec Pharmaceuticals Ltd. Turnover also included SEK 34.1 m of remuneration for research collaboration on hepatitis C and HIV protease inhibitors from Tibotec Pharmaceuticals Ltd. and an allocated one-off payment of SEK 9.2 m on HIV protease inhibitors. Turnover also included remuneration of SEK 17.7 m on the MIV-606 shingles project from Epiphany Biosciences.
Operating costs were SEK -215.7 (-290.8) m, comprising external costs of SEK -101.6 (-168.1) m, personnel costs of SEK -103.8 (-99.0) m, depreciation and amortization of SEK -10.3 (-10.8) m and impairment losses of SEK -0.0 (-12.9) m. The reduced operating costs mainly related to lower costs for the Lipsovir® and MIV-701 projects, because of the clinical trials that were conducted in the previous year. Impairment losses in the previous year were on the balance sheet item 'non-current assets held for sale' of Medivir UK.
The operating loss was SEK -113.7 (-37.3) m. The profit reduction is mainly a consequence of lower operating income. Profit from financial investments was SEK 13.7 (8.5) m. The increase in profits from financial investments is due mainly to rising interest rates. The net loss for the year was SEK -99.2 (-29.3) m.
SE-14122 Huddinge www.medivir.se SWEDEN
Turnover and earnings, 1 October - 31 December 2008
Net sales were SEK 65.2 (168.8) m in the period. Turnover consisted of an allocated up-front payment of SEK 21.2 m at signing and a milestone payment of SEK 32.0 m (EUR 2.6 m) relating to hepatitis C from Tibotec Pharmaceuticals Ltd. Turnover also included remuneration of SEK 9.4m from research collaboration on HIV protease inhibitors and hepatitis C from Tibotec Pharmaceuticals Ltd. Turnover in the corresponding period of the previous year was SEK 168.8m, mainly relating to the two milestone payments totaling SEK 159.7 m (EUR 17.0 m) on the HCV protease inhibitors from Tibotec Pharmaceuticals Ltd. and SEK 8.5 m of remuneration for research collaboration on HIV protease inhibitors from Tibotec Pharmaceuticals Ltd.
Operating costs were SEK -67.8 (-65.5) m, comprising external costs of SEK -33.6 (-35.1) m, personnel costs of SEK -31.6 (-27.6) m and depreciation and amortization of SEK -2.6 (-2.8) m. The operating loss was SEK 0.0 (106.1) m, the net financial position was SEK 3.2 (2.4) m and the loss after financial items was SEK 3.2 (108.5) m. The net loss for the period was SEK 3.2 (108.5)m. The reduced profit is mainly a result of lower operating income.
Cash flow and financial position
Cash flow from operating activities was SEK -34.8 (-70.5) m, a change of SEK 35.7 m. In yearon-year terms, cash flow from operating activities was positively affected by changes in working capital, mainly from reduced current receivables.
Cash flow from financing activity was SEK 0.0 (217.3) m. In the first quarter of 2007, a new share issue raised SEK 215.0 m net of issue costs. The consolidated equity ratio at year-end was 77.4 (83.7) %.
Liquid assets including short-term investments with a maximum maturity of three months were SEK 284.4 (329.3) m at year-end.
Investments, depreciation, amortization and impairment losses
Gross investments in tangible and intangible fixed assets were SEK 9.9 (12.9) m in the year, in research equipment and existing research premises. Sales of fixed assets were SEK 0.4 (0.1) m. Depreciation and amortization in the year reduced profit by SEK -10.3 (-10.8) m and impairment losses reduced it by SEK 0.0 (-12.9) m. In the previous year, impairment losses related to the 'non-current assets held for sale' balance sheet item of Medivir UK.
Shareholders' equity, share data and stock options
The share capital at year-end was SEK 104.2 (104.2) m and shareholders' equity was SEK 287.6 (384.0) m. The number of shares was 20,843,547 (20,843,547), of which 660,000 (660,000) were class A and 20,183,547 (20,183,547) class B shares with a nominal value of SEK 5. There were 970,000 outstanding options at the end of the year, corresponding to 1,102,300 class B shares. No options were converted or expired in the year. The number of outstanding options could increase shareholders' equity by SEK 82.9 m and upon full conversion; the total number of shares could amount to 21,945,847.
The equity ratio was 77.4 (83.7)%. Earnings per share, based on a weighted average number of outstanding shares, was SEK -4.76 (-1.74) and shareholders' equity per share was SEK 13.80 (18.42).
Employees
Medivir had 103 (97) employees at year-end, 49 (43) % of which were women.
Parent company
Medivir AB (publ), corporate identity no. 556238-4361, is the parent company of the group. The group's operations are mainly conducted in the parent company, and consist of research operations and administrative functions. Parent company net sales for the year were SEK 104.0 (254.3) m. Operating costs were SEK -214.5 (-273.8) m, divided between external costs of SEK -100.4 (-168.4) m, personnel costs of SEK -103.8 (-94.7) m and depreciation and amortization of SEK -10.3 (-10.8) m. The operating loss was SEK -107.7 (-17.1) m and the loss after financial items was SEK -98.8 (-27.2) m. The loss after financial items included a cost for covering the deficits of Medivir UK Ltd. of SEK -4.8 (-18.9) m. The net loss for the year was SEK -98.8 (-27.2) m. Purchases from Medivir UK Ltd. were SEK 0.0 (9.1) m. Sales to Medivir (UK) Ltd. amounted to SEK 4.7 (2.4) m. Purchases from Medivir HIV Franchise AB were SEK 2.1 (2.6)m. Sales to Medivir HIV Franchise AB amounted to SEK 2.1 (2.6) m.
Gross investments in tangible fixed assets were SEK 9.9 (16.9) m. Liquid assets including shortterm investments with a maximum maturity of three months amounted to SEK 283.2 (326.0) m. For comments on operations, please refer to the section "consolidated earnings and financial position".
Medivir's Nomination Committee
The Nomination Committee, consisting of Frank Larsson (representing Handelsbanken Fonder and Chairman of the Nomination Committee), Eva Gottfridsdotter-Nilsson (Länsförsäkringar Fonder), Bo Öberg (class A shareholders) and Anders Vedin (Chairman of the Board), is proposing at the Annual General Meeting 2009 that a new Board of Directors is appointed through the re-election of five members, namely Göran Pettersson (new Chairman of the Board), Björn C. Andersson, Anna Malm Bernsten, Ingemar Kihlström and Ron Long (CEO). Former members Lars-Göran Andrén, Magnus Falk, Donna Janson, Anders Vedin and Bo Öberg are not standing for re-election.
Outlook including significant risks and uncertainty factors
Developing new pharmaceuticals until approved registration and launch is a highly risky and capital-intensive process. Demand for Medivir's project portfolio is affected by external competitive conditions. Medivir is also subject to financial risks such as currency risk, interest risk, credit risk and liquidity risk.
Medivir's ability to produce new CDs, to enter partnerships on its projects and to bring its development projects to market launch and sale, is decisive to its future. The progress of existing partnerships and securing new partnerships will exert a major influence on Medivir's revenues and cash position.
Recent events in the global economy have given rise to increased general uncertainty, which in the long term, may affect Medivir's access to funding. For a more detailed statement of Medivir's outlook including significant risks and uncertainty factors, the reader is referred to the Report of the Directors in the Annual Report 2007.
Anders Vedin Björn C Andersson Lars-Göran Andrén Chairman Board member Board member
Anna Malm Bernsten Magnus Falk Donna Janson Board member Board member Board member
Ingemar Kihlström Göran Pettersson Bo Öberg Board member Board member Board member
Ron Long Board member/CEO
Huddinge, Sweden, 19 February 2009
| CONSOLIDATED INCOME STATEMENT | 2008 | 2007 | 2008 | 2007 |
|---|---|---|---|---|
| (SEK m) | Jan-Dec | Jan-Dec | Oct-Dec | Oct-Dec |
| Turnover, etc. | ||||
| Net sales | 97.2 | 249.6 | 65.2 | 168.8 |
| Other revenue | 4.8 | 3.8 | 2.6 | 2.8 |
| Total | 102.0 | 253.5 | 67.8 | 171.6 |
| Operating costs | ||||
| Other external costs | -101.6 | -168.1 | -33.6 | -35.1 |
| Personnel costs | -103.8 | -99.0 | -31.6 | -27.6 |
| Depreciation and amortization | -10.3 | -10.8 | -2.6 | -2.8 |
| Impairment loss | 0.0 | -12.9 | 0.0 | 0.0 |
| Total | -215.7 | -290.8 | -67.8 | -65.5 |
| Operating loss | -113.7 | -37.3 | 0.0 | 106.1 |
| Profit from financial investments | 13.7 | 8.5 | 3.2 | 2.4 |
| Loss after financial items | -100.0 | -28.8 | 3.2 | 108.5 |
| Tax | 0.8 | -0.5 | 0.0 | 0.0 |
| Net loss | -99.2 | -29.3 | 3.2 | 108.5 |
| Basic and diluted earnings per share, SEK | -4.76 | -1.74 | -0.15 | 5.24 |
| Average number of shares, 000 | 20,844 | 16,873 | 20,844 | 20,751 |
| Number of shares at end of year, 000 | 20,844 | 20,844 | 20,844 | 20,844 |
Medivir AB Telephone Fax Contact PO Box 1086 +46 (0)8 546 83100 +46 (0)8 546 83199 [email protected] SE-14122 Huddinge www.medivir.se SWEDEN
8
| CONSOLIDATED BALANCE SHEET SUMMARY |
2008 | 2007 |
|---|---|---|
| Assets | ||
| Intangible fixed assets | 0.5 | 0.9 |
| Tangible fixed assets | 35.8 | 35.9 |
| Financial fixed assets | 18.8 | 18.8 |
| Current receivables | 32.0 | 73.9 |
| Short-term investments | 227.8 | 311.5 |
| Cash and bank balances | 56.6 | 17.8 |
| Total assets | 371.5 | 458.9 |
| Liabilities and shareholders' equity | ||
| Shareholders' equity | 287.6 | 384.0 |
| Current liabilities, non interest-bearing | 83.9 | 74.9 |
| Total liabilities and shareholders' equity | 371.5 | 458.9 |
| STATEMENT OF CHANGES TO SHAREHOLDERS' EQUITY | 2008 | 2007 |
| (SEK m) | 31 Dec | 31 Dec |
| Opening balance | 384.0 | 186.3 |
| Exchange rate difference | 0.6 | 0.7 |
| Net loss | -99.2 | -29.3 |
| New share issue | 0.0 | 224.2 |
| Staff stock option plans: value of employee service | 2.2 | 2.1 |
| Closing balance | 287.6 | 384.0 |
| CONSOLIDATED CASH FLOW STATEMENT | 2008 | 2007 |
|---|---|---|
| SUMMARY (SEK m) | Jan-Dec | Jan-Dec |
| Cash flow from operating activities before changes in working | ||
| capital | -85.8 | -16.4 |
| Changes in working capital | 51.0 | -54.1 |
| Cash flow from operating activities | -34.8 | -70.5 |
| Investment activity | ||
| Acquisition/divestment of fixed assets | -9.7 | -12.4 |
| Cash flow from investment activity | -9.7 | -12.4 |
| Financing activity | ||
| New share issue | 0.0 | 224.2 |
| Amortization/change in loans | 0.0 | -6.9 |
| Cash flow from financing activity | 0.0 | 217.3 |
| Cash flow for the year | ||
| Liquid assets, opening balance | 329.3 | 195.1 |
| Change in liquid assets | -44.7 | 134.4 |
| Exchange rate difference in liquid assets | -0.3 | -0.2 |
| Liquid assets, closing balance | 284.4 | 329.3 |
| KEY FIGURES, SHARE DATA, OPTIONS | 2008 | 2007 |
|---|---|---|
| Jan-Dec | Jan-Dec | |
| Return on: | ||
| - equity, % | -29.5 | -10.3 |
| - capital employed, % | -29.6 | -9.9 |
| - total capital, % | -23.9 | -7.6 |
| Number of shares at beginning of year, 000 | 20,844 | 12,903 |
| Issues | 0 | 7,941 |
| Number of shares at end of year, 000 | 20,844 | 20,844 |
| - of which class A shares | 660 | 660 |
| - of which class B shares | 20,184 | 20,184 |
| Average number of shares, 000 | 20,844 | 16,873 |
| Outstanding warrants, 000 | 970 | 970 |
| - entitlement to class B shares at conversion, 000 | 1,102 | 1,102 |
| Share capital at end of year, SEK m | 104.2 | 104.2 |
| Shareholders' equity at end of year, SEK m | 287.6 | 384.0 |
| Basic and diluted earnings per share, SEK | -4.76 | -1.74 |
| Shareholders' equity per share, SEK | 13.80 | 18.42 |
| Net worth per share, SEK | 13.80 | 18.42 |
| Cash flow per share after investments, SEK | -2.14 | -4.91 |
| Equity ratio, % | 77.4 | 83.7 |
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| PARENT COMPANY INCOME STATEMENT (SEK m) |
2008 Jan-Dec |
2007 Jan-Dec |
|---|---|---|
| Turnover, etc. | ||
| Net sales | 104.0 | 254.3 |
| Other revenue | 2.8 | 2.4 |
| Total | 106.8 | 256.7 |
| Operating costs | ||
| Other external costs | -100.4 | -168.4 |
| Personnel costs | -103.8 | -94.7 |
| Depreciation and amortization | -10.3 | -10.8 |
| Total | -214.5 | -273.8 |
| Operating loss | -107.7 | -17.1 |
| Profit from financial investments | 8.9 | -10.1 |
| Loss after financial items | -98.8 | -27.2 |
| Net loss | -98.8 | -27.2 |
| PARENT COMPANY BALANCE SHEET | 2008 | 2007 |
|---|---|---|
| SUMMARY (SEK m) | 31 Dec | 31 Dec |
| Assets | ||
| Intangible fixed assets | 0.5 | 0.9 |
| Tangible fixed assets | 35.8 | 35.9 |
| Financial fixed assets | 19.0 | 19.0 |
| Current receivables | 28.7 | 69.5 |
| Short-term investments | 227.8 | 311.5 |
| Cash and bank balances | 55.4 | 14.5 |
| Total assets | 367.2 | 451.3 |
| Liabilities and shareholders' equity | ||
| Shareholders' equity | 287.6 | 384.2 |
| Long-term liabilities, non interest-bearing | 1.7 | 0.6 |
| Current liabilities, non interest-bearing | 77.9 | 66.5 |
| Total liabilities and shareholders' equity | 367.2 | 451.3 |
Accounting policies
Medivir observes IFRS (International Financial Reporting Standards) as endorsed by the EU. Significant accounting policies and valuation principles are stated on pages 36-40 of the Annual Report for 2007. New or revised IFRS that came into effect after 31 December 2007 have not had any material effect on the Consolidated Income Statement or Consolidated Balance Sheet. The Interim Report for the group has been prepared pursuant to IAS 34. The parent company observes terminology pursuant to RFR 2.1 issued by the Swedish Financial Reporting Board.
Review report
We have conducted a limited review of the Financial Statement for Medivir AB (publ) for the year 1 January – 31 December 2008. The preparation and presentation of these interim financial statements pursuant to IAS 34 and the Swedish Annual Accounts Act are the responsibility of the Board of Directors and Chief Executive Officer. Our responsibility is to report our conclusions concerning these interim financial statements on the basis of our limited review.
We have conducted our limited review pursuant to the Standard for Limited Review (SÖG) 2410 "Limited review of interim financial information conducted by the company's appointed auditor". A limited review consists of making inquiries, primarily to individuals responsible for financial and accounting matters, as well as performing analytical procedures and taking other limited review measures. A limited review has a different focus and significantly less scope than an audit according to RS Auditing Standards in Sweden and generally accepted auditing practice. The review procedures undertaken in a limited review do not enable us to obtain a level of assurance where we would be aware of all important circumstances that would have been identified had an audit been conducted. Therefore, a conclusion reported on the basis of a limited review does not have the level of certainty of a conclusion reported on the basis of an audit.
Based on our limited review, no circumstances have come to our attention that would give us reason to believe that the interim financial statements have not been prepared pursuant to IAS 34 and the Swedish Annual Accounts Act for the group, and pursuant to the Swedish Annual Accounts Act for the parent company, in all material respects.
PricewaterhouseCoopers AB
Claes Dahlén Authorized Public Accountant
Stockholm, Sweden, 19 February 2009