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Active Biotech

Quarterly Report Aug 7, 2015

3133_ir_2015-08-07_3da6ad00-f683-473d-a7eb-930c33d13fb9.pdf

Quarterly Report

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Active Biotech AB Interim report January – June 2015

• Operations focused on the laquinimod projects and organization adjusted accordingly

Laquinimod

  • The pivotal CONCERTO clinical Phase III study in relapsing remitting MS (RRMS) is fully enrolled and results are expected in 2017
  • The first patient was enrolled for the ARPEGGIO Phase II study, which will evaluate laquinimod's potential for treatment of primary progressive multiple sclerosis (PPMS)
  • The Phase II study LEGATO-HD into Huntington's disease is proceeding according to plan
  • Laquinimod presented by Teva at the AAN Annual Meeting on April 18-25, 2015

Tasquinimod

  • Results from the Phase III study 10TASQ10 showed that treatment with tasquinimod significantly reduced the risk of radiographic cancer progression compared to placebo (rPFS, HR=0.69, CI 95%: 0.60 – 0.80) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy, but did not extend overall survival (OS, HR=1.09, CI 95%: 0.94 – 1.28).
  • Further development of tasquinimod discontinued and the collaboration agreement with Ipsen terminated

ISI

• Only commercial activities will be conducted from 2016

Financial summary

MSEK April - June Jan. - June Jan. - Dec.
2015 2014 2015 2014 2014
Net sales 3.2 2.7 6.1 4.9 10.4
Operating loss -70.1 -57.9 -127.5 -117.2 -228.5
Loss for the period -71.4 -57.7 -129.3 -117.9 -231.5
Loss per share (SEK) -0.79 -0.77 -1.44 -1.57 -3.02
Cash and cash equivalents 186.6 227.7 328.5

For further information, please contact:

Tomas Leanderson, President and CEO Active Biotech AB
Tel: +46 (0)46 19 20 95 Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Hans Kolam, CFO Tel: +46 (0)46 19 20 00
Tel: +46 (0)46 19 20 44 Fax: +46 (0)46 19 11 00

The report is also available at www.activebiotech.com

Laquinimod – a novel oral immunomodulatory compound for the treatment of neurodegenerative/inflammatory diseases

Laquinimod is a quinoline compound under development for the treatment of multiple sclerosis (MS) and Huntington's disease. Active Biotech has an agreement with the Israeli company Teva Pharmaceutical Industries Ltd (June 2004) covering the development and commercialization of laquinimod. 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 study BRAVO. 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, but did not achieve statistical significance regarding the primary clinical endpoint. The Phase III study CONCERTO is under way with the primary endpoint of time to confirmed disability progression. In November 2014, the first patient was screened for the LEGATO-HD clinical study, which will evaluate a daily dose (0.5, 1.0 or 1.5 mg) of laquinimod as a potential treatment for adult patients with Huntington's disease. It was announced in April 2015 that the first patient had been enrolled in the study "A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes" (ARPEGGIO) that will evaluate laquinimod's potential for treatment of primary progressive multiple sclerosis (PPMS).

– It was announced on June 25, 2015 that patient enrollment for the ongoing pivotal Phase III CONCERTO trial had been finalized, as well as a planned interim analysis of the study. The interim analysis was included as part of the protocol to confirm that the original assumptions are in line with the study and that the sample size is adequate. Based on an agreement with the FDA, under a Special Protocol Assessment (SPA) agreement, study completion will occur when either 260 events are reached or all patients complete 24 months of study treatment (whichever occurs first). CONCERTO study results are expected to be available toward mid-2017. Regulatory submission will follow study completion.

The CONCERTO trial is Teva's third Phase III study in relapsing remitting multiple sclerosis (RRMS) and explores daily doses of laquinimod of 0.6 mg and 1.2 mg. The study encompasses 2,199 and is intended to confirm the benefits of laquinimod as regards delays to additional disability progression, which is its primary endpoint. 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.

– It was announced on April 23, 2015 that the first patient had been enrolled in the study "A Randomized Placebocontrolled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes" (ARPEGGIO), that will evaluate laquinimod's potential for treatment of primary progressive multiple sclerosis (PPMS). No treatment is currently available for PPMS, which means it is an indication with an extensive medical need. ARPEGGIO is a multinational, multicenter, randomized, double-blind, placebo-controlled clinical study with parallel groups that will evaluate two doses of laquinimod (0.6 and 1.5 mg per day) compared with placebo in PPMS patients. The primary endpoint of the study is brain atrophy, defined as the percentage brain volume change in (PBVC) as measured with MRI. The study will include about 375 patients in the US, Canada and Europe.

– The clinical study LEGATO-HD is progressing according to plan and will evaluate the efficacy, safety and tolerability of once-daily oral laquinimod (0.5, 1.0 or 1.5 mg) as a potential treatment for adult patients with Huntington's disease. The primary endpoint for LEGATO-HD is change from baseline in the Unified Huntington's Disease Rating Scale-Total Motor Scale (UHDRS-TMS) as defined by the sum of the scores of all UHDRS-TMS sub-items after 12 months of treatment.

– Teva held a number of presentations of laquinimod at the 67th American Academy of Neurology (AAN) Annual Meeting on April 18-25, 2015, addressing such aspects as the design of the clinical Phase II study ARPEGGIO.

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. 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.

– On April 16, 2015, the results of the Phase III trial 10TASQ10, a global, randomized, double-blind, placebocontrolled study of mCRPC patients, were presented. The aim of the study was to confirm tasquinimod's efficacy on the disease, with radiological progression-free survival (PFS) as the primary clinical endpoint and overall survival (OS) as the secondary clinical endpoint. Results from the Phase III study 10TASQ10 showed that treatment with tasquinimod significantly reduced the risk of radiographic cancer progression compared to placebo (rPFS, HR=0.69, CI 95%: 0.60 – 0.80) (primary endpoint) in patients with mCRPC who have not received chemotherapy. However, the treatment with tasquinimod did not extend overall survival (OS, HR=1.09, CI 95%: 0.94 – 1.28).

Despite the favorable safety profile, total efficacy results did not support positive benefit risk balance in this population. Therefore the companies have decided to discontinue all studies in and all further development of tasquinimod. Full results will be presented at an upcoming scientific conference. Another consequence of the study results was that the partnership agreement with Ipsen was ended. This also means that the further development of tasquinimod by Ipsen in other indications will be terminated.

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. This project is based on preclinical studies and has potential treatment applications in both degenerative diseases and cancer.

– Efforts have been focused on building a patent portfolio around the substances that interact with S100 proteins and impede their interaction with their receptors. The company has submitted three priority applications for the purpose of obtaining patent protection for three, chemically unrelated, substance groups. As a consequence of the events in the tasquinimod project, only commercial activities will be conducted for the ISI project from 2016.

Organizational changes

As announced in a press release published on June 1, 2015, the company has decided to focus the operations on the laquinimod projects and conduct only commercial activities for all other projects from January 1, 2016. Negotiations with trade unions have been completed and the company's new organization will comprise 19 employees. Employees who have been made redundant will end their employment successively in 2015 and 2016 in accordance with statutory periods of termination notice.

Financial information

Comments on the Group's results for the period January – June 2015

Net sales amounted to SEK 6.1 M (4.9) and included service and rental revenues.

The operation's research and administration expenses amounted to SEK 133.6 M (122.0), of which research expenses amounted to SEK 123.7 M (112.2). The increase in expenses during the period was due to the higher planned costs related to the read-out of the Phase III results for tasquinimod against prostate cancer. The other research projects – the ANYARA renal cell cancer project, 57-57 for the treatment of scleroderma and the preclinical research project ISI – only had a marginal impact on the cost development between the years. The out-licensed projects comprising laquinimod and RhuDex are financed by the relevant partners.

The operating loss for the period amounted to SEK 127.5 M (loss: 117.2). The change in earnings compared with the year-earlier period was attributable to higher research expenses for the Phase III tasquinimod trial. Administrative

expenses totaled SEK 10.0 M (9.8), the net financial expense for the period to SEK 2.9 M (expense: 1.8) and the loss after tax to SEK 129.3 M (loss: 117.9).

Comments on the Group's results for the period April – June 2015

Net sales amounted to SEK 3.2 M (2.7) and included service and rental revenues.

The operation's research and administration expenses amounted to SEK 73.3 M (60.7), of which research expenses amounted to SEK 68.7 M (55.3). The increase in expenses was due to the higher planned costs related to the readout of the Phase III results for tasquinimod against prostate cancer.

The operating loss for the period amounted to SEK 70.1 M (loss: 57.9). The change in earnings compared with the year-earlier period was attributable to higher research expenses for the Phase III tasquinimod trial. Administrative expenses amounted to SEK 4.7 M (5.3), the net financial expense for the period to SEK 1.8 M (expense: 0.3) and the loss after tax to SEK 71.4 M (loss: 57.7).

Cash flow, liquidity and financial position, Group for the period January – June 2015

Cash and cash equivalents at the end of the period amounted to SEK 186.6 M, compared with SEK 328.5 M at the end of 2014.

Cash flow for the period was a negative SEK 141.8 M (neg: 148.5), of which cash flow from operating activities accounted for a negative SEK 138.3 M (neg: 149.7) and cash flow from financing activities for a negative SEK 3.5 M (pos: 1.2).

Investments

Investments in tangible fixed assets amounted to 0.0 (neg: 0.1).

Comments on the Parent Company's results and financial position for the period January-June 2015

Net sales for the period amounted to SEK 11.1 M (9.6) and operating expenses to SEK 149.8 M (137.8). The Parent Company's operating loss for the period was SEK 138.7 M (loss: 128.3). Net financial income amounted to SEK 0.5 M (2.0) and the loss after financial items was SEK 138.2 M (loss: 126.3). Cash and cash equivalents including shortterm investments totaled SEK 173.9 M at the end of the period, compared with SEK 319.7 M on January 1, 2015.

Comments on the Parent Company's results and financial position for the period April-June 2015

Net sales for the period amounted to SEK 6.1 M (4.6) and operating expenses to SEK 81.9 M (68.3). The Parent Company's operating loss for the period was SEK 75.8 M (loss: 63.8). Net financial income amounted to SEK neg 0.1 M (1.3) and the loss after financial items was SEK 75.9 M (loss: 62.4).

Shareholders' equity

Consolidated shareholder's equity at the end of the period amounted to SEK 279.9 M, compared with SEK 405.3 M at year-end 2014. The number of shares outstanding at the end of the period totaled 89,908,298. At the end of the period, the equity/assets ratio for the Group was 48.7 percent, compared with 56.1 percent at year-end 2014. The corresponding figures for the Parent Company, Active Biotech AB, were 79.3 percent and 82.2 percent, respectively.

Organization

The average number of employees was 56 (59), of which the number of employees in the research and development organization accounted for 45 (46). At the end of the period, the Group had 56 employees.

Outlook, including significant risks and uncertainties

The development of partnership agreements already signed are assumed to have a significant impact on future revenues and cash balances. Existing liquidity, financial and tangible assets and income from already signed agreements are 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 2014 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 April - June Jan. - June Jan. -Dec.
SEK M 2015 2014 2015 2014 2014
Net sales 3.2 2.7 6.1 4.9 10.4
Administrative expenses -4.7 -5.3 -10.0 -9.8 -17.0
Research and development costs -68.7 -55.3 -123.7 -112.2 -221.9
Operating profit/loss -70.1 -57.9 -127.5 -117.2 -228.5
Net financial items -1.8 -0.3 -2.9 -1.8 -5.3
Profit/loss before tax -71.9 -58.2 -130.4 -119.0 -233.7
Tax 0.6 0.6 1.1 1.1 2.2
Net profit/loss for the period -71.4 -57.7 -129.3 -117.9 -231.5
Comprehensive loss attributable to:
Parent Company shareholders -71.4 -57.7 -129.3 -117.9 -231.5
Non-controlling interests
Net profit/loss for the period -71.4 -57.7 -129.3 -117.9 -231.5
Comprehensive profit/loss per share before dilution (SEK) -0.79 -0.77 -1.44 -1.57 -3.02
Comprehensive profit/loss per share after dilution (SEK) -0.79 -0.77 -1.44 -1.57 -3.02
Statement of profit and loss and consolidated comprehensive income April - June Jan. - June Jan. -Dec.
SEK M 2015 2014 2015 2014 2014
Net profit/loss for the period -71.4 -57.7 -129.3 -117.9 -231.5
Other comprehensive income
Items that can not be reclassified into profit or loss
Change in revaluation reserve 1.8 1.8 3.6 3.6 7.2
Taxes attributable to other comprehensive income -0.4 -0.4 -0.8 -0.8 -1.6
Total comprehensive profit/loss for the period
Total other comprehensive profit/loss for the period attributable to:
-70.0 -56.3 -126.5 -115.1 -225.9
Parent Company shareholders -70.0 -56.3 -126.5 -115.1 -225.9
Non-controlling interests
Total comprehensive profit/loss for the period -70.0 -56.3 -126.5 -115.1 -225.9
Depreciation/amortization included in the amount of 3.0 3.0 6.1 6.1 12.3
Investments in tangible fixed assets 0.1 1.9
Weighted number of outstanding common shares before dilution (000s) 89908 74 924 89 908 74 924 76 755
Weighted number of outstanding common shares after dilution (000s) 89908 74 924 89 908 74 924 76 755
Number of shares at close of the period (000s) 89908 74 924 89 908 74 924 74 924
Consolidated statement of financial position June 30 Dec. 31
SEK M 2015 2014 2014
Tangible fixed assets 380.8 380.8 381.6
Long-term receivables 0.0 0.0 0.0
Total fixed assets 380.8 380.8 381.6
Current receivables 7.7 9.9 12.4
Cash and cash equivalents 186.6 227.7 328.5
Total current assets 194.4 237.5 340.9
Total assets 575.1 618.3 722.5
Shareholders equity 279.9 291.4 405.3
Long-term liabilities 219.5 225.9 222.6
Current liabilities 75.7 100.9 94.6
Total shareholders equity and liabilities 575.1 618.3 722.5
Consolidated statement of changes in shareholders equity June 30 Dec. 31
SEK M 2015 2014 2014
Opening balance 405.3 405.4 405.4
Transfer from revaluation reserve 1.1 1.1 2.2
New share issue 223.6
Net loss for the period -126.5 -115.1 -225.9
Balance at close of period 279.9 291.4 405.3
Condensed consolidated cash-flow statement Jan. - June Jan. - Dec.
SEK M 2015 2014 2014
Loss after financial items -130.4 -119.0 -233.7
Adjustment for non-cash items, etc. 6.1 6.1 12.3
Cash flow from operating activities
before changes in working capital -124.4 -112.8 -221.5
Changes in working capital -14.0 -36.8 -45.6
Cash flow from operating activities -138.3 -149.7 -267.1
Investments in tangible fixed assets - -0.1 -1.9
Cash flow from investing activities - -0.1 -1.9
New share issue - - 223.6
Loans raised/amortization of loan liabilities -3.5 1.2 -2.3
Cash flow from financing activities -3.5 1.2 221.3
Cash flow for the period -141.8 -148.5 -47.7
Opening cash and cash equivalents 328.5 376.2 376.2
Closing cash and cash equivalents 186.6 227.7 328.5
June 30 Dec. 31
Key figures 2015 2014 2014
Shareholders equity, SEK M 279.9 291.4 405.3
Equity per share, SEK 3.11 3.89 5.41
Equity/assets ratio in the Parent Company 79.3% 76.5% 82.2%
Equity/assets ratio in the Group 48.7% 47.1% 56.1%
Average number of annual employees 56 59 58

Consolidated profit and loss by quarter

2011 2012 2013 2014 2015
SEK M Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
Net sales 2.7 226.1 2.6 3.3 2.6 94.0 39.8 91.5 2.4 2.5 107.0 4.0 2.1 2.7 2.6 2.9 2.9 3.2
Administrative expenses -5.3 -4.4 -3.2 -4.0 -3.8 -4.2 -3.2 -4.7 -4.2 -4.6 -3.8 -4.4 -4.5 -5.3 -3.7 -3.5 -5.3 -4.7
Research and dev. costs -68.3 -80.1 -76.2 -93.9 -99.4 -109.7 -84.8 -81.3 -75.2 -77.5 -75.3 -80.0 -56.9 -55.3 -54.6 -55.1 -55.0 -68.7
Operating profit/loss -70.9 141.5 -76.8 -94.7 -100.7 -19.9 -48.2 5.5 -77.0 -79.5 27.9 -80.4 -59.2 -57.9 -55.7 -55.6 -57.4 -70.1
Net financial items 1.6 4.3 -2.8 -5.7 1.0 -5.3 -4.1 -0.4 -1.6 -2.2 0.8 -2.2 -1.5 -0.3 -1.5 -1.9 -1.1 -1.8
Profit/loss before tax -69.3 145.8 -79.6 -100.4 -99.6 -25.1 -52.3 5.1 -78.6 -81.7 28.7 -82.6 -60.8 -58.2 -57.2 -57.6 -58.5 -71.9
Tax - 1.2 0.6 7.2 0.6 0.6 0.6 -5.0 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6
Net profit/loss for the period -69.3 147.0 -79.0 -93.2 -99.0 -24.5 -51.6 0.1 -78.0 -81.2 29.2 -82.1 -60.2 -57.7 -56.6 -57.0 -58.0 -71.4
Active Biotech Parent Company - Income Statement, condensed April - June Jan - Dec.
SEK M 2015 2014 2015 2014 2014
Net sales 6.1 4.6 11.1 9.6 18.0
Administration expenses -9.1 -9.7 -18.8 -18.6 -34.6
Research and development costs -72.8 -58.6 -131.0 -119.2 -235.5
Operating profit/loss -75.8 -63.8 -138.7 -128.3 -252.1
Profit/loss from financial items:
Interest income and similar income-statement items -0.1 0.7 0.1 1.6 2.4
Interest expense and similar income-statement items 0.0 0.6 0.4 0.4 -0.4
Profit/loss after financial items -75.9 -62.4 -138.2 -126.3 -250.0
Tax
Net profit/loss for the period -75.9 -62.4 -138.2 -126.3 -250.0
Statement of comprehensive income parent company
Net profit/loss for the period -75.9 -62.4 -138.2 -126.3 -250.0
Other comprehensive income
Total comprehensive profit/loss for the period -75.9 -62.4 -138.2 -126.3 -250.0
Active Biotech Parent Company - Balance sheet, condensed June. 30
SEK M 2015 2014 2014
Goodwill 88.8 105.0 96.9
Tangible fixed assets 0.5 0.6 0.6
Financial fixed assets 40.6 40.6 40.6
Total fixed assets 129.9 146.1 138.0
Current receivables 20.3 21.1 23.3
Short-term investments 146.8 185.8 76.7
Cash and bank balances 27.1 32.9 243.0
Total current assets 194.2 239.8 343.0
Total assets 324.1 386.0 481.0
Shareholders equity 257.0 295.2 395.2
Current liabilities 67.1 90.7 85.8
Total equity and liabilities 324.1 386.0 481.0

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: Fair value of financial instruments

June 30, 2015 Dec. 31, 2014
SEK M Level 2 Level 2
Short-term investments 146.8 76.7

The fair value of financial assets and liabilities essentially corresponds to the carrying amount in the balance sheet. The fair-value measurement of financial assets and liabilities has been conducted according to level 2 as defined in IFRS 7.27 A, with the exception of cash and cash equivalents, which is measured according to level 1. For more information, refer to Note 17 in the 2014 Annual Report. No significant changes have occurred in relation to the measurement made at December 31.

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

Interim reports 2015: November 6 Year-end report 2015: February 18, 2016 The reports will be available from these dates at www.activebiotech.com.

Lund, August 7, 2015

Active Biotech AB (publ)

Mats Arnhög
Chairman
Magnhild Sandberg-Wollheim
Board member
Peter Sjöstrand
Board member
Peter Thelin
Board member
Ingela Fritzson
Employee rep/
Board member
Anette Sundstedt
Employee rep/
Board member

Tomas Leanderson President and CEO

This interim report is unaudited.

Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal Phase III development for the treatment of relapsing remitting multiple sclerosis. Also, laquinimod is in Phase II development for the treatment of primary progressive multiple sclerosis and Huntington's disease. Furthermore, commercial activities are conducted for the ISI, ANYARA and paquinimod projects. 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 August 7, 2015 at 8:30 a.m.

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