Active Biotech — Interim / Quarterly Report 2013

Nov 7, 2013

Active Biotech AB Interim Report January – September 2013

Laquinimod

• Analysis of data from the Phase III ALLEGRO study shows that laquinimod provides a beneficial impact on brain tissue damage; Laquinimod-treated patients accumulated significantly less brain tissue damage caused by neurodegeneration
• New data presented at ECTRIMS shows that laquinimod has an effect on both inflammation and the underlying mechanisms associated with disease progression in multiple sclerosis
• Teva is planning to commence clinical trials in Huntington's disease and primary progressive multiple sclerosis (PPMS)
• Teva will initiate a further clinical trial in multiple sclerosis (LIBRETTO)

Tasquinimod

• Phase III 10TASQ10 study is proceeding as planned; the primary analysis of progression-free survival (PFS) and survival (OS) is expected in 2014
• Active Biotech received a milestone payment of EUR 12 M from Ipsen

ANYARA

Detailed analysis provides further support for ANYARA's efficacy in a biomarker-defined sub-group of renal cell cancer patients; the result from the Phase II/III study was presented at the 2013 European Cancer Congress

Paquinimod (57-57)

Evaluation under way of clinical trial in systemic sclerosis

ISI

Project proceeding according to plan

Financial summary

SEK M		Q3		Jan - Sept
	2013	2012	2013	2012	2012
Net sales	107.0	39.8	111.9	136.4	227.9
Operating loss	27.9	-48.2	-128.6	-168.7	-163.2
Profit/Loss after tax	29.2	-51.6	-130.0	-175.1	-175.0
Profit/loss per share	0.39	-0.75	-1.77	-2.54	-2.54

For further information, please contact: Tomas Leanderson, President and CEO Tel: +46 (0)46-19 20 95 Hans Kolam, CFO Active Biotech AB Tel: +46 (0)46-19 20 44 (Corp. Reg. No. 556223-9227)

Box 724, 220 07 Lund Tel: +46 (0)46-19 20 00

The report is also available at www.activebiotech.com Fax +46 (0)46-19 11 00

Laquinimod – a novel oral immunomodulatory compound for the treatment of autoimmune diseases

Laquinimod is a quinoline compound under development for the treatment of such diseases as multiple sclerosis (MS). Active Biotech has an agreement with the Israeli company Teva Pharmaceutical Industries Ltd (June 2004) covering the development and commercialization of laquinimod. Data was presented in September 2009 showing that laquinimod has both neuroprotective and anti-inflammatory properties. In December 2010, positive results from the Phase III ALLEGRO study were presented. Laquinimod met the primary endpoint of reducing the annualized relapse rate and significantly slowed progression of disability. On August 1, 2011, the initial results were announced from the second Phase III BRAVO study. The BRAVO findings supported the direct effect of laquinimod in the central nervous system (CNS) and were in line with the results of the first laquinimod Phase III trial, ALLEGRO. In July 2012, Teva submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA). ). CHMP's (Committee for Medicinal Products for Human Use) scientific opinion on whether the application may be authorized or not is expected before year-end 2013. If the application is successful, laquinimod could be approved in Europe during 2014. In addition to the ongoing MS clinical trials, laquinimod has undergone clinical Phase II trials for the treatment of Crohn's disease and Lupus. The Phase III study CONCERTO is under way with the primary endpoint of time to confirmed disability progression. This study will also examine the impact of laquinimod on endpoints such as percentage change in brain volume and other clinical and MRI markers of disease activity.

– On July 29, Active Biotech's partner Teva announced that it will commence an international scientific research collaboration relating to Huntington's disease. The collaboration will focus on the laquinimod candidate drug. Huntington's disease is a neurodegenerative disease, causing certain cells of the brain to gradually die. The effects of the disease include uncontrolled movements and personality and emotional disturbances.

Tasquinimod – an immunomodulatory, anti-metastatic substance for the treatment of prostate cancer The development of tasquinimod is principally focused on the treatment of prostate cancer. Tasquinimod is an immunomodulatory, anti-metastatic substance that indirectly affects the tumor's ability to grow and spread. It was announced in December 2009 that the primary endpoint of the Phase II study, to reduce the fraction of patients with disease progression during the six-month period of treatment using tasquinimod, had been attained. In April 2011, Active Biotech and Ipsen (Euronext: IPN; ADR: IPSEY) entered a broad partnership for the co-development and commercialization of Active Biotech's compound, tasquinimod. Under the terms of the agreement, Active Biotech granted Ipsen exclusive rights to commercialize tasquinimod worldwide, except for North and South America and Japan, where Active Biotech retains all commercial and marketing rights. Both companies will codevelop tasquinimod for the treatment of castrate-resistant prostate cancer (CRPC), with the possibility of developing tasquinimod in other cancer indications. In December 2012, patient enrollment was successfully completed to the ongoing clinical Phase III trial for tasquinimod, with 1,245 randomized patients as planned in the clinical protocol. The primary analysis of progression free survival (PFS) for the Phase III study will be carried out in 2014, at the same time as the first interim overall survival (OS) analysis. In October 2012, Ipsen initiated a proof-of-concept Phase II clinical trial to evaluate the clinical efficacy of tasquinimod used as maintenance therapy in patients with metastatic castrateresistant prostate cancer (mCRPC) who have not progressed after a first-line docetaxel-based chemotherapy. In addition, Ipsen has initiated a proof-of-concept Phase II clinical trial with tasquinimod to evaluate the safety and efficacy of tasquinimod in advanced or metastatic hepatocellular, ovarian, renal cell and gastric carcinomas in patients whose condition has nonetheless deteriorated after standard therapies. Furthermore, an investigator-sponsored clinical Phase I trial (CATCH) is under way to determine the recommended dose of tasquinimod in combination with cabazitaxel in patients with mCRPC.

– The ongoing clinical Phase III trial 10TASQ10 is a global, randomized, double-blind, placebocontrolled study of mCRPC patients. The aim of the study is to confirm tasquinimod's efficacy on the disease, with radiological progression-free survival (PFS) as the primary endpoint and overall survival (OS) as the secondary endpoint. The study is proceeding according to plan and the primary analysis of progression-free survival and survival is expected in 2014.

– The other clinical studies with tasquinimod are proceeding according to schedule.

ANYARA – fusion protein for immunological treatment of renal cell cancer

ANYARA is a TTS (Tumor Targeted Superantigen) compound that makes cancer treatment tumorspecific. The development of ANYARA is mainly focused on renal cell cancer. Positive data was reported in connection with the interim analysis in Phase II/III and from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. In July 2009, the results from two Phase I studies of ANYARA were published in the Journal of Clinical Oncology, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy – docetaxel (Taxotere®) – in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel. ANYARA has been granted orphan-drug status by the EMA for the indication renal cell cancer. Overall survival (OS) and progression-free survival (PFS) data from the ANYARA Phase II/III study in renal cell cancer was presented in June 2013. The study encompassed 513 patients and was designed to evaluate the efficacy of ANYARA (naptumomab estafenatox) in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary endpoint was improved overall survival, which was not achieved in the overall ITT population, but was attained in a biomarker-defined subgroup of 130 patients. In this subgroup, the median OS for the ANYARA vs. placebo treatment arm were 63.3 vs. 31.1 months (HR: 0.59; p=0.020), respectively. The median PFS were 13.7 (ANYARA) vs. 5.8 (placebo) months (HR: 0.62; p=0.016).

– At the 2013 European Cancer Congress on September 12, a new and more detailed analysis of a biomarker-defined subgroup was presented that provides further support to the previous findings (see above) that low baseline levels of pre-formed antibodies against ANYARA or low levels of the cytokine IL-6, independently predict anti-tumor efficacy after ANYARA+IFN-alpha treatment. A clinical development plan for this subgroup is currently being discussed with the regulatory authorities.

Paquinimod (57-57) – novel oral immunomodulatory compound for the treatment of systemic sclerosis Paquinimod is a quinoline compound primarily intended for the treatment of systemic sclerosis. This rare disease is classified as an orphan drug indication. In February 2011, paquinimod was granted orphan medicinal product status in Europe for the indication systemic sclerosis. The EMA's Orphan Medicinal Product Designation is implemented to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or chronically debilitating. Under EMA guidelines, Orphan Medicinal Product Designation provides ten years of potential market exclusivity if the product candidate is approved for marketing in the European Union.

– An explorative clinical study in systemic sclerosis has been concluded. The study includes nine patients. The primary endpoint of the study is to document the safety profile of paquinimod therapy in this patient group and to study the effect on disease-related biomarkers. An analysis of data from the study is in progress.

ISI (Inhibition of S100 interactions) – preclinical project based on the mode of action of quinoline compounds

Active Biotech is conducting a research project aimed at utilizing the company's own preclinical results that were generated with respect to a target molecule for the quinoline (Q) compounds and their biological mode of action. The results of a target molecule for the Q compounds were published in PLoS Biology (Volume 7, Issue 4, pp. 800-812) in April 2009. The study showed that Q compounds bind to a molecule called S100A9, which is expressed in white blood cells involved in the regulation of immune responses. Furthermore, it is shown that S100A9 interacts with two known pro-inflammatory receptors (Toll-like receptor 4 (TLR4) and Receptor of Advanced Glycation End products (RAGE)) and that this interaction is inhibited by Q compounds. The project aims at producing new, patentable chemical substances that interact with the target molecule of the Q compounds.

– The project is proceeding according to plan. Efforts are centered on building up a patent portfolio around the compounds that interact with S100 proteins and the first patent applications have been filed. Selection of the first candidate drug is planned for 2014.

RhuDex® – a novel oral compound for the treatment of rheumatoid arthritis

In the project covering Active Biotech's patented CD80 antagonists, the RhuDex candidate drug is under development for the treatment of rheumatoid arthritis (RA). In April 2002, Active Biotech entered a licensing agreement with Avidex Ltd, now a wholly owned subsidiary of the German biotechnology company MediGene AG, according to which MediGene has the exclusive rights to develop CD80 antagonists and market products in which these compounds are included. Two Phase I trials have already been successfully concluded in which the RhuDex candidate drug was studied with respect to its safety, tolerability and pharmacokinetic properties in healthy volunteers.

– MediGene is planning a clinical Phase IIa study in primary biliary cirrhosis (PBC), a chronic liver disease. This is being carried out to confirm the mode of action of RhuDex in autoimmune diseases and facilitate the continued development of the drug. The study will be initiated in 2014 at the latest. For more information and the latest news about RhuDex, see www.medigene.com.

Events after the end of the period

Laquinimod

– On October 1, Active Biotech's partner Teva Pharmaceutical Industries published data from a new Phase III exploratory analysis that shows that laquinimod may reduce brain damage caused by neurodegeneration. Based on the study results, Teva plans to initiate a clinical trial in primary progressive multiple sclerosis (PPMS).

– On October 4, Teva presented a pooled data analysis of the Phase III ALLEGRO and BRAVO studies, which shows that laquinimod can have an effect on both inflammation and the broader underlying mechanisms associated with disease progression in relapsing-remitting multiple sclerosis.

– On November 4, it was announced that Active Biotech's partner Teva Pharmaceutical Industries Ltd. will initiate a further clinical trial, LIBRETTO, to evaluate the efficacy, safety and tolerability of two doses of oral laquinimod (0.6 and 1.2 mg/day), compared to interferon β-1a, in patients with relapsing remitting multiple sclerosis. Primary endpoint of the study will be brain atrophy.

Tasquinimod

– On October 9, Active Biotech announced that it had received EUR 12 M from its partner Ipsen relating to the Phase III 10TASQ10 study. The milestone payment was recorded as revenue in September 2013.

– In October 2013, the independent Data and Safety Monitoring Board (DSMB), which is monitoring the ongoing Phase III 10TASQ10 study, recommended that the trial continue in accordance with the protocol since no safety-related issues were noted.

Financial information

Comments on the Group's results for the period January – September 2013

Net sales amounted to SEK 111.9 M (136.4) and included a milestone payment from Ipsen amounting to SEK 104.1 M and SEK 7.8 M (9.8) in service and rental revenues. The corresponding period in 2012 included total milestone payments of SEK 126.7 M: SEK 91.6 M from Ipsen when half of the patients had been enrolled in the Phase III tasquinimod trial and SEK 35.1 M from Teva Pharmaceutical Industries on submission of a marketing authorization application for laquinimod to the European Medicines Agency (EMA).

The operation's research and administration expenses amounted to SEK 240.5 M (305.2), of which research expenses amounted to SEK 228.0 M (294.0). The decrease in expenses was attributable to planned lower costs for the ongoing clinical Phase III trial of tasquinimod for the treatment of prostate cancer. Under the partnership agreement with Ipsen, Active Biotech will receive clinical, regulatory and commercial milestone payments on fulfillment of defined goals. Provided that these milestones are met, the Phase III trial will be financed in full by Ipsen. The other research projects – the Phase III trial for the ANYARA renal cell cancer project, the explorative study for the 57-57 project and the preclinical research project ISI – only had a marginal impact on the cost development between the years. The outlicensed projects comprising laquinimod and RhuDex are financed by the relevant partners.

The operating loss for the period amounted to SEK 128.6 M (loss: 168.7). The earnings improvement of SEK 40.1 M compared with the year-earlier period was attributable to lower research costs due to the ongoing Phase III tasquinimod trial being fully enrolled since December 2012 and the fact that the patients are in the treatment phase. Administration expenses totaled SEK 12.5 M (11.2). The net financial expense for the period amounted to SEK 3.0 M (expense: 8.3) and the loss after tax was SEK 130.0 M (loss: 175.1).

Comments on the Group's results for the period July – September 2013

The operation reported positive earnings for the period, with operating profit amounting to SEK 27.9 M (loss: 48.2).

During the period, a milestone payment totaling SEK 104.1 M from Ipsen related to the collaboration agreement for tasquinimod was recognized as revenue. The corresponding period in 2012 included a milestone payment of SEK 35.1 M from Teva Pharmaceutical Industries. In addition, service and rental revenues totaling SEK 2.9 M (4.7) were reported.

The operation's research and administration expenses amounted to SEK 79.1 M (88.0), of which research expenses amounted to SEK 75.3 M (84.8). The decrease in expenses was attributable to planned lower costs for the ongoing clinical Phase III trial of tasquinimod for the treatment of patients with prostate cancer. Administration expenses totaled SEK 3.8 M (3.2). The net financial income for the period amounted to SEK 0.8 M (expense: 4.1) and the profit after tax was SEK 29.2 M (loss: 51.6).

Cash flow, liquidity and financial position, Group

Cash and cash equivalents at the end of the period amounted to SEK 322.2 M, compared with SEK 216.7 M at the end of 2012. Cash and cash equivalents do not include SEK 104.1 M recognized as revenue during the reporting period but where payment was made according to contractual conditions on October 9, 2013.

Cash flow for the period was SEK 105.6 M (neg: 156.4), of which cash flow from operating activities accounted for a negative SEK 158.1 (neg: 150.3). Cash flow from financing activities totaled SEK 263.8 M (neg: 6.1), of which the directed share issue of 6 000 000 shares to Investor raised approximately SEK 270 M.

Investments

Investments in tangible fixed assets amounted to SEK 0.1 M (0.0).

Comments on the Parent Company's results and financial position for the period January-September 2013

Net sales for the period amounted to SEK 119.0 M (142.8) and operating expenses to SEK 264.1 M (328.8). The Parent Company's operating loss for the period was SEK 145.1 M (loss: 186.1).

Net financial income amounted to SEK 3.2 M (expense: 0.1) and the expense after financial items was SEK 141.8 M (loss: 186.2). Cash and cash equivalents including short-term investments totaled SEK 315.7 M at the end of the period, compared with SEK 208.9 M on January 1, 2013.

Comments on the Parent Company's results and financial position for the period July-September 2013

Net sales for the period amounted to SEK 109.1 M (41.5) and operating expenses to SEK 86.7 M (96.0). The Parent Company's operating profit for the period was SEK 22.4 M (loss: 54.5).

Net financial income amounted to SEK 1.6 M (expense: 0.2) and the income after financial items was SEK 24.1 M (loss: 54.3).

Shareholders' equity

Consolidated shareholder's equity at the end of the period amounted to SEK 485.5 M, compared with SEK 339.9 M at year-end 2012. The number of shares outstanding at the end of the period totaled 74,923,582. At the end of the period, the equity/assets ratio for the Group was 59.4 percent, compared with 48.8 percent at year-end 2012. The corresponding figures for the Parent Company, Active Biotech AB, were 84.6 percent and 77.6 percent, respectively.

Organization

The average number of employees was 62 (77), of which the number of employees in the research and development organization accounted for 50 (63). At the end of the period, the Group had 59 employees.

Outlook, including significant risks and uncertainties

A vital factor for Active Biotech's long-term financial strength and stability is the company's ability to develop pharmaceutical projects to the point at which partnership agreements can be entered into and the partner can assume responsibility for future development and commercialization of the project. During this development phase, the value of projects is expected to increase. The development of partnership agreements already signed and the addition of new agreements are assumed to have a significant impact on future revenues and cash balances. Income from already signed agreements and existing cash and cash equivalents is expected to finance operations.

A research company such as Active Biotech is characterized by a high operational and financial risk, since the projects in which the company is involved are at the clinical phase, where a number of factors have an impact on the likelihood of commercial success. In brief, the operation is associated with risks related to such factors as pharmaceutical development, competition, advances in technology, patents, regulatory requirements, capital requirements, currencies and interest rates. Since no significant changes took place with regard to risks and uncertainties during the period, refer to the detailed account of these factors presented in the Directors' Report in the 2012 Annual Report. Since the Group's operations are primarily conducted in the Parent Company, risks and uncertainties refer to both the Group and the Parent Company.

Consolidated profit and loss		Q3		Jan - Sept
SEK M	2013	2012	2013	2012	Full Year 2012
Net sales	107.0	39.8	111.9	136.4	227.9
Administrative expenses	-3.8	-3.2	-12.5	-11.2	-15.8
Research and development costs	-75.3	-84.8	-228.0	-294.0	-375.3
Operating profit/loss	27.9	-48.2	-128.6	-168.7	-163.2
Net financial items	0.8	-4.1	-3.0	-8.3	-8.7
Profit/loss before tax	28.7	-52.3	-131.7	-177.0	-172.0
Tax	0.6	0.6	1.7	1.9	-3.1
Net profit/loss for the period	29.2	-51.6	-130.0	-175.1	-175.0
Comprehensive loss attributable to:
Parent Company shareholders	29.2	-51.6	-130.0	-175.1	-175.0
Non-controlling interests	–	–	–	–	–
Net profit/loss for the period	29.2	-51.6	-130.0	-175.1	-175.0
Comprehensive profit/loss per share before dilution (SEK)	0.39	-0.75	-1.77	-2.54	-2.54
Comprehensive profit/loss per share after dilution (SEK)	0.39	-0.75	-1.77	-2.54	-2.54

Statement of consolidated comprehensive income	Q3		Jan - Sept	Full Year
SEK M	2013	2012	2013	2012	2012
Net profit/loss for the period	29.2	-51.6	-130.0	-175.1	-175.0
Other comprehensive income
Items that can not be reclassified into profit or loss
Change in revaluation reserve	1.8	1.8	5.4	5.4	7.2
Taxes attributable to other comprehensive income	-0.4	-0.5	-1.2	-1.4	3.8
Total comprehensive profit/loss for the period	30.6	-50.3	-125.8	-171.1	-164.1
Total other comprehensive profit/loss for the period attributable to:
Parent Company shareholders	30.6	-50.3	-125.8	-171.1	-164.1
Non-controlling interests	–	–	–	–	–
Total comprehensive profit/loss for the period	30.6	-50.3	-125.8	-171.1	-164.1
Depreciation/amortization included in the amount of	3.2	3.2	9.7	9.6	12.9
Investments in tangible fixed assets	0.0	0.0	0.1	0.0	0.0
Weighted number of outstanding common shares before dilution (000s)	74924	68924	73 627	68 924	68 924
Weighted number of outstanding common shares after dilution (000s)	74924	68924	73 627	68 924	68 924
Number of shares at close of the period (000s)	74924	68924	74 924	68 924	68 924

Consolidated statement of financial position	Sept 30		Dec 31
SEK M	2013	2012	2012
Tangible fixed assets	380.9	382.0	381.5
Long-term receivables	0.0	0.0	0.0
Total fixed assets	380.9	382.0	381.5
Current receivables	113.8	10.5	98.6
Cash and cash equivalents	322.2	308.8	216.7
Total current assets	436.0	319.3	315.2
Total assets	816.9	701.3	696.7
Shareholders equity	485.5	332.4	339.9
Long-term liabilities	224.9	230.1	228.5
Current liabilities	106.5	138.9	128.3
Total shareholders equity and liabilities	816.9	701.3	696.7

Consolidated statement of changes in shareholders equity	Sept 30
SEK M	2013	2012	2012
Opening balance	339.9	502.0	502.0
Transfer from revaluation reserve	1.7	1.5	2.0
New share issue	269.8	–	–
Net loss for the period	-125.8	-171.1	-164.1
Balance at close of period	485.5	332.4	339.9

Condensed consolidated cash-flow statement		Jan - Sept
SEK M	2013	2012	Full Year 2012
Loss after financial items	-131.7	-177.0	-172.0
Adjustment for non-cash items, etc.	9.7	9.6	12.9
Cash flow from operating activities
before changes in working capital	-122.0	-167.4	-159.1
Changes in working capital	-36.2	17.1	-81.3
Cash flow from operating activities	-158.1	-150.3	-240.4
Investments in tangible fixed assets	-0.1	0.0	0.0
Cash flow from investing activities	-0.1	0.0	0.0
New share issue	269.8	–	–
Loans raised/amortization of loan liabilities	-6.0	-6.1	-8.1
Cash flow from financing activities	263.8	-6.1	-8.1
Cash flow for the period	105.6	-156.4	-248.5
Opening cash and cash equivalents	216.7	465.2	465.2
Closing cash and cash equivalents	322.2	308.8	216.7

	Sept 30
Key figures	2013	2012	2012
Shareholders equity, SEK M	485.5	332.4	339.9
Equity per share, SEK	6.48	4.82	4.93
Equity/assets ratio in the Parent Company	84.6%	76.0%	77.6%
Equity/assets ratio in the Group	59.4%	47.4%	48.8%
Average number of annual employees	62	77	76

Consolidated profit and loss by quarter

		2010				2011				2012				2013
SEK M	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4	Q1	Q2	Q3
Net sales	2.8	3.4	2.3	2.9	2.7	226.1	2.6	3.3	2.6	94.0	39.8	91.5	2.4	2.5	107.0
Administrative expenses	-4.6	-7.1	-4.0	-7.3	-5.3	-4.4	-3.2	-4.0	-3.8	-4.2	-3.2	-4.7	-4.2	-4.6	-3.8
Research and development costs	-49.1	-47.6	-45.6	-74.9	-68.3	-80.1	-76.2	-93.9	-99.4	-109.7	-84.8	-81.3	-75.2	-77.5	-75.3
Operating profit/loss	-51.0	-51.4	-47.3	-79.3	-70.9	141.5	-76.8	-94.7	-100.7	-19.9	-48.2	5.5	-77.0	-79.5	27.9
Net financial items	-2.5	-3.3	-1.2	2.4	1.6	4.3	-2.8	-5.7	1.0	-5.3	-4.1	-0.4	-1.6	-2.2	0.8
Profit/loss before tax	-53.5	-54.8	-48.5	-76.8	-69.3	145.8	-79.6	-100.4	-99.6	-25.1	-52.3	5.1	-78.6	-81.7	28.7
Tax	-	-	-	12.6	-	1.2	0.6	7.2	0.6	0.6	0.6	-5.0	0.6	0.6	0.6
Net profit/loss for the period	-53.5	-54.8	-48.5	-64.3	-69.3	147.0	-79.0	-93.2	-99.0	-24.5	-51.6	0.1	-78.0	-81.2	29.2

Active Biotech Parent Company - Income Statement, condensed		Q3	Jan - Sept	Full Year
SEK M	2013	2012	2013	2012	2012
Net sales	109.1	41.5	119.0	142.8	234.9
Administration expenses	-8.1	-7.5	-25.5	-24.1	-33.1
Research and development costs	-78.6	-88.5	-238.6	-304.7	-389.6
Operating profit/loss	22.4	-54.5	-145.1	-186.1	-187.8
Profit/loss from financial items:
Interest income and similar income-statement items	1.5	1.7	3.9	5.6	6.7
Interest expense and similar income-statement items	0.1	-1.5	-0.7	-5.7	-4.2
Profit/loss after financial items	24.1	-54.3	-141.8	-186.2	-185.3
Tax	–	–	–	–	–
Net profit/loss for the period	24.1	-54.3	-141.8	-186.2	-185.3
Statement of comprehensive income parent company
Net profit/loss for the period	24.1	-54.3	-141.8	-186.2	-185.3
Other comprehensive income	–	–	–	–	–
Total comprehensive profit/loss for the period	24.1	-54.3	-141.8	-186.2	-185.3

Active Biotech Parent Company - Balance sheet, condensed	Sept 30		Dec 31
SEK M	2013	2012	2012
Goodwill	117.1	133.2	129.2
Tangible fixed assets	0.7	0.9	0.8
Financial fixed assets	40.6	40.6	40.6
Total fixed assets	158.3	174.6	170.5
Current receivables	125.1	22.0	108.9
Short-term investments	303.0	198.5	189.5
Cash and bank balances	12.7	102.4	19.4
Total current assets	440.9	322.9	317.8
Total assets	599.2	497.6	488.3
Shareholders equity	507.0	378.1	379.1
Current liabilities	92.2	119.4	109.2
Total equity and liabilities	599.2	497.6	488.3

Any errors in additions are attributable to rounding of figures.

Note 1: Accounting policies

The interim report of the Group has been prepared in accordance with IAS 34, Interim Financial Reporting and applicable parts of the Annual Accounts Act. The interim report of the Parent Company has been prepared in accordance with Chapter 9 of the Annual Accounts Act. For the Group and the Parent Company, the same accounting policies and accounting estimates and assumptions were applied to this interim report as were used in the preparation of the most recent annual report.

Note 2: Actual value of financial instruments

	Sept 30, 2013	Dec 31, 2012
SEK M	Level 2	Level 2
Short-term investments	303.0	169.5
Current liabilities, derivatives	5.1	8.9

Fair value regarding financial assets and liabilities corresponds to the carrying amount in the balance sheet. The valuation of financial assets and the liabilities' fair value has been conducted according to level 2 as defined in IFRS 7.27 A, except cash and bank balance which is valued according to level 1. For more information see the Annual report 2012, Note 16. Compared with the valuation at December 31, there have been no significant changes.

Legal disclaimer

This financial report includes statements that are forward-looking and actual results may differ materially from those anticipated. In addition to the factors discussed, other factors that can affect results are developments in research programs, including clinical trials, the impact of competing research programs, the effect of economic conditions, the effectiveness of the company's intellectual patent protection, obstacles due to technological development, exchange-rate and interest-rate fluctuations, and political risks.

Financial calendar

Year-end report 2013: February 13, 2014 Interim reports 2014: April 24, August 7 and November 5 Year-end report 2014: February 11, 2015 The reports will be available from these dates at www.activebiotech.com.

Lund, November 7, 2013 Active Biotech AB (publ)

Tomas Leanderson President and CEO

Review report

Introduction

We have reviewed the summary interim financial information (interim report) of Active Biotech AB (publ) as of 30 September 2013 and the nine-month period then ended. The Board of Directors and the President are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.

Scope of 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. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing practices and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, for the Group in accordance with IAS 34 and the Annual Accounts Act, and for the Parent Company in accordance with the Annual Accounts Act.

Malmö, November 7, 2013 KPMG AB David Olow Authorized Public Accountant

Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, tasquinimod for prostate cancer and ANYARA primarily for the treatment of renal cell cancer. In addition, laquinimod has concluded Phase II development for Crohn's and Lupus. The company also has one additional project in clinical development, the orally administered compound paquinimod (57-57) for systemic sclerosis. Please visit www.activebiotech.com for more information.

Active Biotech is obligated to publish the information contained in this interim report in accordance with the Swedish Securities Market Act. This information was provided to the media for publication on November 7, 2013 at 8:30 a.m.