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Medivir Annual Report 2009

Feb 18, 2010

3177_10-k_2010-02-18_a08a5bc7-b403-4114-87d3-a7eb33f86f0d.pdf

Annual Report

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Press Release, 18 February 2010

Financial Statement, 1 January – 31 December 2009

  • Net sales were SEK 25.7 (97.2) m.
  • The loss after tax was SEK -135.4 (-99.2) m.
  • Earnings per share were SEK -6.49 (-4.76).
  • Cash flow from operating activities was SEK -135.1 (-34.8) m.
  • Cash and cash equivalents as of 31 December were SEK 143.6 (284.4) m.

Comments from the CEO

"Medivir had a very satisfactory 2009. Our cold sore product secured market approval in the US and Europe and is well positioned for launch. This will take place under the XerclearTM trademark in Europe, and under the XereseTM trademark in the US during 2010. We made major advances in our existing infectious diseases portfolio in partnership with Tibotec/Johnson & Johnson and are looking forward to the clinical results from phase IIb trials on TMC435 in 2010. Our ambition is for Medivir to evolve from a research and development enterprise into a profitable pharmaceutical company with its own products and its own marketing resources," commented Ron Long, Medivir's CEO

Fourth quarter in brief

Several significant project events were reported in the quarter.

The highlights can be summarized as follows:

  • Our cold sore pharmaceutical, branded Xerclear™ in Europe, secured market approval in 14 countries.
  • New clinical phase IIa data was reported on TMC435, against hepatitis C. This project is currently in a number of major phase IIb trials.
  • Epiphany Biosciences, Medivir's partner on valomaciclovir (MIV-606), presented positive results from its phase IIb trial on shingles patients.

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 29 April 2010. The Annual General Meeting (AGM) will be held on 29 April 2010. The Six-month Interim Report will be published on 8 July 2010. The Nine-month Interim Report will be published on 22 October 2010.

More information on Medivir's operations is available on the company's website, www.medivir.se. Financial Reports are available under the 'Investor/Media' heading.

Medivir AB Telephone Facsimile Contact
PO Box 1086 +46 8 5468 3100 +46 8 5468 3199 [email protected]
SE-14122 Huddinge www.medivir.se
SWEDEN

Highlights after the end of the reporting period

EUR 5 m milestone received

An advance milestone payment of 5 MEUR was received from Medivir's partner Tibotec at the end of January.

Medivir partnered with Meda for North American commercialisation of XereseTM (Lipsovir® )

In mid-February, Medivir entered an agreement for commercialisation of Medivir's cold sore product which will be marketed under the trade name XereseTM on North American markets.

Under the terms of the agreement Meda is granted the exclusive right to market sell and distribute XereseTM in the Unibted States, Canada and Mexico for the treatment of cold sores (herpes labialis) In addition to funding the commercial development of Xerese™, Meda will pay to Medivir up-front and pre-launch milestones totalling 5 MUSD and double-digit royalties on sales.

Highlights in the fourth quarter 2009

Xerclear™ approved in Europe with a competitive label

Medivir's cold sore pharmaceutical, previously called Lipsovir® , was approved by the European pharmaceutical regulatory authorities for marketing and sale in 14 countries in October. In Europe, this product will be branded Xerclear™.

The approved label for Xerclear™ in Europe is:

"Treatment of early signs and symptoms of recurrent herpes labialis (cold sores) to reduce the progression of cold sore episodes to ulcerative lesions in immunocompetent adults and adolescents (12 years of age and older)."

No other cold sore product has a similar label which we believe will give Xerclear™ a competitive advantage. The product was approved for the US market with a similarly strong label in August 2009 and will be sold on North American markets under the trade name XereseTM .

The remaining step in the process before product launch in the 14 European countries is a national phase determining product packaging and legal status (prescription or OTC). Five countries, including Sweden, Finland and Denmark, are complete, while the process is ongoing in other countries, and scheduled for completion during the first half of 2010.

Xerclear™ to be launched in Sweden during March 2010

In December, Sweden's Medical Products Agency published its definitive statement of opinion, with the effect that Xerclear™ can be sold in the 5 g package Rx and OTC in the 2 g package. Medivir will launch Xerclear™ starting with the 5g packs in March 2010.

The ambition is to enter a commercial partnership for summer 2010 for the launch of Xerclear™ in other European markets during the second half of 2010.

TMC435 in clinical development

TMC435 is a protease inhibitor developed by Tibotec/Johnson & Johnson in partnership with Medivir for treating hepatitis C virus infections (HCV). TMC435 is currently in three major clinical phase IIb trials involving nearly 1,000 patients.

Trial C205

Patient enrolment for the clinical phase IIb trial (C205) of treatment-naïve HCV G1 patients began in May 2009. C205 is a double-blind, placebo-controlled trial involving some 400 patients; patient enrolment was completed in the autumn.

In addition, all these some 400 patients will receive current SoC, which consists of interferon (PegIFNalpha-2a) and ribavirin.

C206

Patient enrolment started at the end of September 2009 for the clinical phase IIb trial (C206) on HCV G1 patients that have not previously responded to SoC, administered for 48 weeks. This trial is also a double-blind, placebo-controlled trial involving some 455 patients. Patient enrolment is in its final phase. All 455 patients will also receive current SoC.

C215, Japan

Patient enrolment for a clinical phase IIb trial involving some 93 treatment-naïve patients started in June. All patients will also receive current SoC. Patient enrolment is complete.

The design of these phase IIb trials has been based on factors including the positive part-results obtained on phase IIa trials, C201, reported at various medical conferences in 2009. These results showed that when administered in a single daily dose and over four weeks, TMC435 has very potent antiviral effect, is well tolerated and safe at the doses evaluated.

New phase IIa results on TMC435 on HCV patients that had not previously

responded to treatment presented at the Annual Meeting of the AASLD

These results, presented in poster format, are for interim analysis of four weeks' treatment of patients in Cohort 5 in Opera-1 (C201), a phase IIa clinical trial. This group of five patients had previously participated in a phase Ib monotherapy study for five days on TMC435 (C101).

Results

At Week 4, TMC435 given 200 mg once daily, QD, in combination with SoC (IFN + ribavirin) displayed potent antiviral activity in HCV genotype-1 patients who failed prior IFN-based therapy and had previously been exposed to TMC435.

Each of the four patients who completed treatment with TMC435 achieved HCV RNA levels below the lower limit of quantification (25 IU/mL) at Day 28 with three out of four patients having HCV RNA levels below the lower limit of detection (10 IU/mL). No viral breakthroughs were observed to Day 28.

Safety and tolerability

The safety profile of TMC435 was similar to that having been observed previously; TMC435 is well tolerated. There were no serious adverse events (AEs) and the AEs observed were mild to moderate in severity and not related to TMC435. The most common AE was influenza-like illness reported in four patients.

Four out of five patients completed triple therapy to Day 28. One patient discontinued treatment after 14 days due to an increase in serum bilirubin (grade 4). This patient already had elevated bilirubin (direct and indirect) levels at study entry. Bilirubin levels decreased after treatment discontinuation and no increases in alanine aminotransferase or aspartate aminotransferase were observed.

Epiphany Biosciences presented results from a phase IIb trial on MIV-606

Medivir's partner on (MIV-606 / EPB-348), Epiphany Biosciences, presented results from its phase to the trial where patients with shingles (herpes zoster) were treated with different doses of valomaciclovir.

Trial design

The study's primary endpoint was non-inferiority of once-daily valomaciclovir compared to thricedaily valaciclovir (Valtrex™) in terms of the time to healing of herpes rash to the formation of crusting.

This double-blinded study enrolled 373 patients, randomized into 3 arms in a double-blind design: 1g and 2g of once-daily valomaciclovir respectively and thrice-daily 1g valaciclovir (Valtrex™). There was also another group of 18 patients that received 3 grams of once-daily valomaciclovir.

Results

2g valomaciclovir administered once daily met the primary endpoint of at least equal healing as valaciclovir (Valtrex™) administered thrice-daily (current SoC). Valomaciclovir was also noninferior to valomaciclovir in terms of efficacy parameters such as "time to complete pain resolution", "time to rash resolution" and "time to cessation of new lesion formation." The highest dose of valomaciclovir (3g once daily) demonstrated superiority to valaciclovir with regards to healing time (p < 0.007).

Project portfolio

Two preclinical projects, HCV-POL and HIV-PI, are being conducted in partnership with Tibotec/J&J.

In the HCV-POL partnership, entered in May 2008, pharmaceuticals are being developed against hepatitis C with polymerase as their target enzyme. This project designated a CD in December 2008, which Tibotec is taking onwards towards clinical phase I trials. In 2009, the research partnership focused on identifying more drugable compounds, which was completed in May.

The HIV-PI project has been conducted, and fully funded, by Tibotec since year-end 2008. Its next goal is to designate CDs.

The cathepsin K project addresses a wide range of indications in bone disorders. This project has two clinical CDs, which have distinct profile differences and may address different therapy areas.

Medivir's protease-based project in Alzheimer's disease (BACE) is in preclinical optimization.

Primarily, the cathepsin S project addresses neuralgia, and is in preclinical optimization.

Project Indication(s) Partners/-
date of
agreement
Terms Medivir's
markets
Explorati
ve phase
Optimiz
ation
Preclini cal dev. Phase I Phase
II
Phase
III
US
NDA
EU
MAA
Xerclear™
(ME-609)
Labial herpes In-house
TMC435
(HCV PI)
Hepatitis C Tibotec / 2004 EUR 80.5 m + royalties
FTE funding
Nordic region
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
MIV-711
(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 Neuropathic pain,
rheumatoid arthritis,
multiple sclerosis
In-house
COPD PI COPD In-house World exc. China
Renin Hypertension In-house
Protease inhibitor Polymerase inhibitor Polymerase inhibitor/hydrocortisone

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
Explorati
ve phase
Optimiz
ation
Preclini cal dev. Phase I Phase
II
Phase
III
NDA
Valomaciclovir Shingles,
(MIV-606)
mononucleosis 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 & 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.

5

Consolidated earnings and financial position

Turnover and earnings, 1 January - 31 December 2009

Net sales were SEK 25.7 (97.2) m. Net sales in the period included remuneration for research collaboration on hepatitis C of SEK 8.9 m and an allocated one-off payment of SEK 15.4 m from Tibotec Pharmaceuticals Ltd. In the corresponding period of the previous year, net sales were mainly payments from Tibotec Pharmaceuticals Ltd. These consisted of an allocated one-off payment of SEK 30.8 m and a SEK 32.0 m milestone payment on hepatitis C, and SEK 29.3 m research partnership on hepatitis C and HIV protease inhibitors.

Operating costs were SEK -175.3 (-215.7) m, comprising external costs of SEK -72.3 (-101.6) m, personnel costs of SEK -92.7 (-103.8) m and depreciation and amortization of SEK -10.4 (-10.3) m. The reduced external costs are mainly due to lower research costs. The reduction of personnel costs is mainly due to staff reductions. Restructuring costs of SEK 8.3 m were charged to profit in the period. SEK 7.5 m of these costs relate to staff reductions.

The operating loss was SEK -139.8 (-113.7) m. The lower figure is mainly a consequence of lower operating income because net sales fell by SEK 71.5 m but was partially offset by reduced operating costs of SEK 40.4 m. Profit from financial investments was SEK 4.4 (13.7) m. The net loss for the period was SEK -135.4 (-99.2) m.

Turnover and earnings, 1 October-31 December 2009

Net sales in the period were SEK 1.2 (65.2) m. Net sales in the period primarily related to revenues for a co-promotion deal with GlaxoSmithKline of SEK 1.0 m. In the corresponding period of the previous year, net sales were mainly payments from Tibotec Pharmaceuticals Ltd., consisting of an allocated one-off payment of SEK 21.2 m and a milestone payment of SEK 32.0 m for hepatitis C and SEK 9.4 m on research partnerships on hepatitis C and HIV protease inhibitors.

Operating costs were SEK -46.9 (-67.8) m, comprising external costs of SEK -17.4 (-33.6) m, personnel costs of SEK -27.0 (-31.6) m and depreciation and amortization of SEK -2.5 (-2.6) m. the operating loss was SEK -42.5 (0.0) m. The reduced external costs were mainly due to lower research costs. The reduction of personnel costs is mainly due to staff reductions. The profit from financial investments was SEK 0.1 (3.2) m. The net loss for the period was SEK -42.4 (3.2) m. The lower profit is mainly a result of reduced operating income, but was partly offset by reduced costs.

Cash flow and financial position

Cash flow from operating activities was SEK -135.1 (-34.8) m. The SEK 100.3 m deterioration is mainly due to reduced operating profit of SEK 26.1 m, worse net interest income/expense including dividends of SEK 7.8 m and a SEK 63.0 m change in working capital. In 2008, working capital was positively affected mainly by lower current receivables.

As of 1 January, cash and cash equivalents including short-term investments with a maximum maturity of three months were SEK 284.4 (329.3) m and were SEK 143.6 (284.4) m at the end of the period, a change of SEK -140.8 (-44.9) m in the period.

The company's current financial assets are judged to assure funding of operations until the first quarter of 2011 inclusive. In accordance with its finance policy, Medivir invests its financial assets in fixed-income securities with low risk.

Investments, depreciation, amortization and impairment losses

Gross investments in tangible fixed assets in the period were SEK 1.4 (9.9) m; gross investments in intangible fixed assets were SEK 4.7 (0.0) m. Primarily, investments in tangible fixed assets are for research equipment. Investments in intangible fixed assets are mainly capitalized external costs and personnel costs for the completion of Xerclear™ after FDA approval of the product for marketing and sale in the US. Capitalized costs for this product will be amortized over the assessed useful life. No amortization for the product was charged to profit in the period, and amortization is scheduled to begin coincident with sales start in 2010. Sales of fixed assets were SEK 0.3 (0.4) m. Depreciation and amortization in the year of SEK -10.4 (-10.3) m was charged to profit.

Equity, share data and stock options

Share capital at the end of the period was SEK 104.2 (104.2) m and equity was SEK 153.9 (287.6) 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 beginning of the year. 210,000 options were forfeited in the 2004/2009 option plan in the period, due to their subscription period expiring. No options were converted in the period. The number of outstanding options was 760,000 at the end of the period, corresponding to 835,600 class B shares. Upon full conversion, the number of outstanding options could increase equity by SEK 56.4 m, and the total number of shares could thus amount to 21,679,147.

The equity ratio was 75.0 (77.4)%. Earnings per share, based on a weighted average number of outstanding shares, was SEK -6.49 (-4.76) and equity per share was SEK 7.38 (13.80).

Financial assets held for sale

Holdings of shares in Medivir's license partners Presidio Pharmaceuticals Inc. and Epiphany Biosciences Inc. have been classified as financial assets held for sale. Because these shares are not quoted, and accordingly, not registered on an active marketplace, no ongoing value changes have been recognized.

Employees

Medivir had 79 (103) employees at the end of the period, 48 (49)% of which were women. Thus the number of employees reduced by 24 in the period, mainly as a result of restructuring operations.

Transactions with related parties

No transactions occurred between Medivir and related parties that significantly affected the company's financial position and results of operations.

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 period were SEK 38.4 (104.0) m. Operating costs were SEK -174.5 (-214.5) m, divided between external costs of SEK - 71.4 (-100.4) m, personnel costs of SEK -92.7 (-103.8) m and depreciation and amortization of SEK -10.4 (-10.3) m. The operating loss was SEK -128.3 (-107.7) m. The loss from financial investments was SEK -6.7 (8.9) m. Profit from financial investments included a cost relating to covering the losses of Medivir (UK) Ltd. of SEK -11.0 (-4.8) m. The net loss for the period was SEK -135.0 (-98.8) m.

Sales to Medivir UK Ltd. were SEK 11.5 (4.7) m. Sales to Medivir HIV Franchise AB were SEK 1.3 (2.1) m. Purchasing from Medivir HIV Franchise AB was SEK 1.3 (2.1) m.

Gross investments in tangible fixed assets were SEK 1.4 (9.9) m and gross investments in intangible fixed assets were SEK 4.7 (0.0) m. Cash and cash equivalents including short-term investments with a maximum maturity of three months amounted to SEK 140.5 (283.2) m. For comments on operations, please refer to the section on consolidated earnings and financial position.

Medivir's Nomination Committee

For the AGM 2010, 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 Göran Pettersson (Chairman of the Board) is proposing the election of a new Board of Directors through the re-election of five members, namely Göran Pettersson (Chairman of the Board), Björn C. Andersson, Anna Malm Bernsten, Ingemar Kihlström and Ron Long (CEO).

Dividend

The Board of Directors is proposing no dividend for the financial year 2009.

AGM

The AGM will be held at 3 p.m. on Thursday, 29 April 2010 at the Polstjärnan Conference Facility, Sveavägen 77, Stockholm, Sweden.

Annual Report

Medivir's Annual Report is scheduled to be available from the company's website, www.medivir.se, from 23 March 2010. Printed copies of the Annual Report will be distributed to shareholders.

Outlook including significant risks and uncertainty factors

Developing new pharmaceuticals to approved registration and launch is a highly risky and capitalintensive process. Medivir's business model is characterized by high risk and the majority of projects never reach market registration. There are different types of risk to manage in operations, operational, i.e. project specific, financial as well as commercial risks as products reach the market. In recent years, Medivir has taken a goal-oriented and strategic approach to create the best possible prospects of running projects quickly and with balanced risks, but despite continued work on this, there are still factors the company cannot influence.

Medivir's ability to produce new CDs, to enter partnerships on its projects, to develop its projects successfully to market launch and sale, and to secure funding of its operations, is decisive to its future. The progress of previously entered partnerships and future new partnerships will exert a major influence on Medivir's revenues and cash position. However, it is not possible to specify the exact timing of expected revenue flows. We will continue to take great care in prioritizing new business opportunities for our projects and managing our existing partnerships. The company's current financial assets are judged to assure funding of operations until the first quarter of 2011 inclusive. For a more detailed review of the future outlook, including significant risks and uncertainty factors, the reader is referred to the Report of the Directors in the Annual Report 2008.

Accounting policies

Medivir applies International Financial Reporting Standards (IFRS) as endorsed by the European Union. The significant accounting and valuation principles are stated on pages 48-51 of the Annual Report 2008. The group's Interim Reports are prepared according to IAS 34. The parent company uses the policies recommended in RFR 2.2 issued by RFR, the Swedish Financial Reporting Board.

The amendment of IAS 1, Presentation of Financial Statements, is applied from 1 January 2009. This amendment has affected Medivir's reporting retroactively from 31 December 2007. The amendment has implications including revenue and costs previously reported directly in equity now being reported in a separate statement directly after the Income Statement "Statement of Comprehensive Income". Another change is that new terminology in financial statements can be used, although this is not mandatory. Medivir has chosen to retain its previous terminology.

Other new or revised IFRS and interpretation statements from IFRIC that came into effect after 31 December 2008 did not have any material effect on the group's or parent company's financial position or results of operations.

CONSOLIDATED INCOME STATEMENT 2009 2008 2009 2008
SUMMARY (SEK m) Jan-Dec Jan-Dec Oct-Dec Oct-Dec
Turnover, etc.
Net sales
Work performed by the company for its own use and
25.7 97.2 1.2 65.2
capitalized 4.1 0 1.9 0
Other revenue 5.7 4.8 1.3 2.6
Total 35.5 102.0 4.4 67.8
Operating costs
Other external costs -72.3 -101.6 -17.4 -33.6
Personnel costs -92.7 -103.8 -27.0 -31.6
Depreciation and amortization -10.4 -10.3 -2.5 -2.6
Total -175.3 -215.7 -46.9 -67.8
Operating profit/loss -139.8 -113.7 -42.5 0.0
Profit/loss from financial investments 4.4 13.7 0.1 3.2
Profit/loss after financial items -135.4 -100.0 -42.4 3.2
Tax 0.0 0.8 0.0 0.0
Net profit/loss -135.4 -99.2 -42.4 3.2
Net profit/loss attributable to:
Equity holders of the parent -135.4 -99.2 -42.4 3.2
Earnings per share, calculated on profit/loss
attributable to equity holders of the parent in the
period
Basic and diluted earnings per share, (SEK per share) -6.49 -4.76 -2.03 0.15
Average number of shares, 000 20,844 20,844 20,844 20,844
Number of shares at end of period, 000 20,844 20,844 20,844 20,844
CONSOLIDATED STATEMENT OF
COMPREHENSIVE INCOME (SEK m)
2009
Jan-Dec
2008
Jan-Dec
2009
Oct-Dec
2008
Oct-Dec
Net profit/loss -135.4 -99.2 -42.4 3.2
Other comprehensive income
Exchange rate differences
Other comprehensive income for the period, net
0.4 0.6 0.5 0.5
after tax 0.4 0.6 0.5 0.5
Comprehensive income for the period -135.0 -98.6 -41.9 3.7
Comprehensive income attributable to:
Equity holders of the parent -135.0 -98.6 -41.9 3.7
CONSOLIDATED BALANCE SHEET SUMMARY 2009 2008
(SEK m) 31 Dec 31 Dec
Assets
Intangible fixed assets 4.6 0.5
Tangible fixed assets 26.9 35.8
Financial fixed assets 18.8 18.8
Inventories 0.6 0.0
Current receivables 10.6 32.0
Short-term investments 130.4 227.8
Cash and bank balances 13.2 56.6
Total assets 205.2 371.5
Liabilities and equity
Equity 153.9 287.6
Long-term liabilities 0.2 0.0
Current liabilities 51.1 83.9
Total liabilities and equity 205.2 371.5
STATEMENT OF CHANGES TO EQUITY
(SEK m)
Share
capital
Other
paid-up
capital
Exchange
rate
difference
Deficit
brought
forward
Total
equity
Opening balance, 1 January 2008 104.2 844.8 3.7 -568.8 384.0
Comprehensive income for the period 0.6 -99.2 -98.6
Staff stock option plans: value of employee
service 2.2 2.2
Closing balance, 31 December 2008 104.2 847.0 4.3 -668.0 287.6
Opening balance, 1 January 2009 104.2 847.0 4.3 -668.0 287.6
Comprehensive income for the period 0.4 -135.4 -135.0
Staff stock option plans: value of employee
service 1.2 1.2
Closing balance, 31 December 2009 104.2 848.2 4.8 -803.4 153.9

11

CONSOLIDATED CASH FLOW STATEMENT SUMMARY 2009 2008
(SEK m) Jan-Dec Jan-Dec
Cash flow from operating activities before changes in working capital -123.1 -85.8
Changes in working capital -12.0 51.0
Cash flow from operating activities -135.1 -34.8
Investment activity
Acquisition/divestment of fixed assets -5.8 -9.7
Cash flow from investment activity -5.8 -9.7
Cash flow for the period
Cash and cash equivalents, at beginning of period 284.4 329.3
Change in cash and cash equivalents -140.8 -44.7
Exchange rate difference in cash and cash equivalents 0.0 -0.3
Cash and cash equivalents, at end of period 143.6 284.4
KEY FIGURES, SHARE DATA, OPTIONS 2009 2008
Jan-Dec Jan-Dec
Return on:
- equity, % -61.3 -29.5
- capital employed, % -61.2 -29.6
- total assets, % -46.8 -23.9
Number of shares at beginning of period, 000 20,844 20,844
Number of shares at end of period, 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 20,844
Outstanding warrants, 000 760 970
- entitlement to class B shares at conversion, 000 836 1,102
Share capital at end of period, SEK m 104.2 104.2
Equity at end of period, SEK m 153.9 287.6
Basic and diluted earnings per share, SEK -6.49 -4.76
Equity per share, SEK 7.38 13.80
Net worth per share, SEK 7.38 13.80
Cash flow per share after investments, SEK -6.76 -2.14
Equity ratio, % 75.0 77.4

Definitions of key figures

Return on equity. Profit/loss after financial items less full tax as a percentage of average equity.

Return on capital employed. Profit/loss after financial items plus financial costs as a percentage of average capital employed.

Return on total assets. Profit/loss after financial items plus financial costs as a percentage of average total assets.

Equity per share. Equity divided by the number of shares at the end of the period.

Average number of shares. The unweighted average number of shares in the year.

Cash flow per share after investments. Cash flow after investments divided by the average number of shares.

Basic and diluted earnings per share. Profit/loss after financial items less full tax divided by the average number of shares.

Equity ratio. Equity in relation to total assets.

Net worth per share. Equity plus hidden assets in listed equities after deducting for deferred tax divided by number of shares at the end of the period.

Capital employed. Total assets less non interest-bearing liabilities including deferred tax liabilities.

PARENT COMPANY INCOME STATEMENT 2009 2008
(SEK m) Jan-Dec Jan-Dec
Turnover, etc.
Net sales 38.4 104.0
Work performed by the company for its own use and capitalized 4.1
Other revenue 3.7 2.8
Total 46.2 106.8
Operating costs
Other external costs -71.4 -100.4
Personnel costs -92.7 -103.8
Depreciation and amortization -10.4 -10.3
Total -174.5 -214.5
Operating profit/loss -128.3 -107.7
Profit/loss from financial investments -6.7 8.9
Profit/loss after financial items -135.0 -98.8
Net profit/loss -135.0 -98.8
PARENT COMPANY BALANCE SHEET SUMMARY 2009 2008
(SEK m) 31 Dec 31 Dec
Assets
Intangible fixed assets 4,6 0,5
Tangible fixed assets 26,9 35,8
Financial fixed assets 19,0 19,0
Inventories 0,6 0,0
Current receivables 9,2 28,7
Short-term investments 130,4 227,8
Cash and bank balances 10,1 55,4
Total assets 201,0 367,2
Liabilities and equity
Equity 153,8 287,6
Long-term liabilities 1,8 1,7
Current liabilities to 45,4 77,9
Total liabilities and equity 201,0 367,2
Björn C Andersson
Board member

Björn C Andersson Anna Malm Bernsten Ingemar Kihlström Board member Board member Board member

Ron Long Göran Pettersson CEO/Board member Chairman

Huddinge, Sweden, 17 February 2010

Review report

We have conducted a limited review of the financial statement for Medivir AB (publ) for the period 1 January – 31 December 2009. 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, 17 February 2010