Brussels

TRL.1.2.0.0
View All Press Releases

Miko: Half-year results 2017

MIKO Euronext BE0003731453
MIKO
RELEASE 19 SEP 2017 20:03 CET
Source: Miko
Provider: Euronext
Attachment(s):
20170919-res-hy-2017-uk-def.pdf
View All Press Releases

Regulated information - Ageas and Norges Bank: Transparency notification

AGEAS Euronext BE0974264930
AGS
RELEASE 19 SEP 2017 17:40 CET
Regulated information - Ageas and Norges Bank: Transparency notification

In accordance with the rules on financial transparency*, Norges Bank has notified Ageas on 15 September 2017 that, on 14 September 2017, its shareholding stands at 2.99%.

* article 14, paragraph 1 of the law of 2 May 2007 on disclosure of major holdings us provisions

Ageas is a listed international insurance Group with a heritage spanning 190 years. It offers Retail and Business customers Life and Non-Life insurance products designed to suit their specific needs, today and tomorrow. As one of Europe`s larger insurance companies, Ageas concentrates its activities in Europe and Asia, which together make up the major part of the global insurance market. It operates successful insurance businesses in Belgium, the UK, Luxembourg, France, Italy, Portugal, Turkey, China, Malaysia, India, Thailand, Vietnam, Laos, Cambodia, Singapore, and the Philippines through a combination of wholly owned subsidiaries and long term partnerships with strong financial institutions and key distributors. Ageas ranks among the market leaders in the countries in which it operates. It represents a staff force of over 40,000 people and reported annual inflows close to EUR 32 billion in 2016 (all figures at 100%).


Source: Ageas
Provider: Thomson Reuters ONE
View All Press Releases

Role Evolutions at Moleskine

D''IETEREN Euronext BE0974259880
DIE
RELEASE 19 SEP 2017 15:00 CET
See attachment(s) / Voir document(s) joint(s) / Zie bijlage / Ver documento(s) em anexo
Source: D'IETEREN
Provider: Les Echos
Attachment(s):
Appendix
View All Press Releases

Befimmo SA - Befimmo and Silversquare join forces to rethink office property - Embargo 19.09.2017 2.00 PM

BEFIMMO Euronext BE0003678894
BEFB
RELEASE 19 SEP 2017 14:01 CET
Befimmo SA - Befimmo and Silversquare join forces to rethink office property - Embargo 19.09.2017 2.00 PM

Befimmo, owner-operator, developer and manager of quality office buildings, and Silversquare, coworking pioneer in Belgium, announce a new strategic partnership: Silversquare @Befimmo
 
Silversquare @Befimmo is aware of changing lifestyles and work patterns and wants to offer its members much more than just m² of office space. The new entity plans to expand its presence in the Befimmo buildings, to offer their users the strengths around which Silversquare has built its position as a market leader in coworking, namely facilitation, emulation, team spirit and flexible spaces, and set up a network that offers more access to a diversity of workplaces.
 
Please click on the following link to consult the full press release:
Source: Befimmo SA
Provider: Thomson Reuters ONE
View All Press Releases

Umicore - Acquisition of own shares

UMICORE Euronext BE0003884047
UMI
RELEASE 19 SEP 2017 08:30 CET
Umicore - Acquisition of own shares

On the basis of Article 207 of the Royal Decree of 30 January 2001, as amended on 26 April 2009, implementing the Belgian Companies Code, Umicore announces the following share buy-back transactions.

Date of acquisition Number of shares % of total shares Average price (EUR) Highest price (EUR) Lowest price (EUR)
14/09/2017 7,000 0.01% 67.25 67.55 66.85
15/09/2017 11 0.00% 66.90 66.90 66.90
Total for the week 7,011 0.01% 67.25 67.55 66.85
Total in 2017 356,011 0.32% 50.07 67.55 48.19

 All details related to the acquisition of own shares by Umicore can be found here.

 

For more information

Investor Relations

Evelien Goovaerts                                         +32 2 227 78 38                    evelien.goovaerts@umicore.com

Eva Behaeghe                                               +32 2 227 70 68                          eva.behaeghe@umicore.com

Source: Umicore
Provider: Thomson Reuters ONE
View All Press Releases

Solvay restates financial information following discontinuation of polyamide and updates 2017 guidance

SOLVAY Euronext BE0003470755
SOLB
RELEASE 19 SEP 2017 07:10 CET
Solvay restates financial information following discontinuation of polyamide and updates 2017 guidance

Brussels, September 19, 2017, 07:10 --- Solvay publishes today restated consolidated financial information for 2015, 2016 and the first half of 2017, reflecting the reclassification in discontinued operations of the polyamide activities to be sold to BASF. The planned divestment, with an enterprise value of EUR1.6 billion, is aimed to close in the third quarter of 2018, after completion of consultation with the relevant social bodies, and subject to certain conditions including customary regulatory approvals.  

Solvay`s full year guidance is updated to reflect the perimeter change and significant changes in exchange rates. The Polyamide business performed particularly strongly this year and its discontinuation reduces the Group`s 2017 EBITDA growth. The weakening of most foreign currencies versus the euro also reduces profit reported in euros.  Based on current exchange rates, Solvay estimates 6% to 8% underlying EBITDA growth for the full year 2017. 

Solvay remains on track to achieve the previous guidance of more than EUR800 million of free cash flow.

"This development is another significant milestone in the evolution of our portfolio.  Further, the continued focus on operational performance positions us well to continue to deliver on all our strategic commitments," said Karim Hajjar, CFO of Solvay.

The table below summarizes the changes to underlying [1] key figures.    

Underlying figures 2015 FY pro forma [2] 2016 FY  2017 H1 
(in EUR m) As published Restate-ment Restated As published Restate-ment Restated As published Restate-ment Restated
Net sales, of which 11,415 (1,341) 10,074 10,884 (1,315) 9,569 5,990 (809) 5,181
Performance Chemicals 2,526 149 2,675 2,460 121 2,581 1,333 69 1,403
Functional Polymers 1,490 (1,490) - 1,436 (1,436) - 879 (879) -
EBITDA, of which 2,125 (187) 1,938 2,284 (208) 2,075 1,321 (138) 1,183
Performance Chemicals 628 (15) 612 695 23 718 374 27 401
Functional Polymers 141 (141) - 222 (222) - 153 (153) -
Corporate & Business Services (245) (30) (275) (227) (10) (237) (111) (12) (123)
Yoy growth of EBITDA       +7.5%   +7.1% +15%   +13%
EBITDA margin 19%   19% 21%   22% 22%   23%
Basic earnings per share from cont. ops. 5.95 (0.88) 5.07 7.06 (1.04) 6.02 5.15 (0.87) 4.27
Yoy growth of basic EPS from cont. ops.       +19%   +19% +47%   +43%
Capex from cont. ops. (1,057) 61 (996) (929) 90 (839) (351) 30 (321)
Cash conversion 50%   49% 59%   60% 73%   73%
Free cash flow from cont. ops. 394 (85) 309 736 (78) 658 245 6 251
                   


The remaining business activities in the segment Functional Polymers will be reported under the segment Performance Chemicals. These activities consist of Solvay`s PA6.6 fiber business in Latin America and Solvay`s stake in the Russian PVC joint venture Rusvinyl, which is reported according to the equity method. The EBITDA restatements in the Corporate & Business Services segment result from residual costs that were previously allocated to the discontinued business activities. Cost reduction measures to absorb these residual costs will continue to feature prominently in Solvay`s operational excellence programs.

The financial reporting for the following reporting periods will be published on this restated basis. The balance sheet at September 30, will represent the discontinued polyamide activity into assets held for sale and associated liabilities.

More detailed figures are provided in the following pages of the enclosed document and comprise:

  • Group restated income statement on an IFRS basis per quarter for 2016 and 2017;
  • Group restated income statement on an underlying basis [1] for the full year 2015 pro forma [2] and per quarter in 2016 and 2017;
  • Group restated capex and free cash flow from continuing operations for the full year 2015 pro forma [2] and per quarter in 2016 and 2017;
  • Segment restated net sales, underlying EBITDA and underlying EBIT per quarter in 2016 and 2017, as well as for the full year 2015 pro forma, and capex for the full year 2015 pro forma and 2016;
  • Reconciliation per quarter and year of "as published" figures with restated figures on an IFRS basis and on an underlying basis for 2016 and 2017 per quarter and 2016 full year.

The 2016 full year figures on an IFRS basis have been audited. Other figures are provided on an unaudited basis, i.e. quarterly figures, underlying figures and pro forma 2015 figures.

An excel version of the tables is provided on Solvay`s website on: http://www.solvay.com/en/investors/news_and_results/results/2017/index.html.

The financial glossary may be consulted on:          
http://www.solvay.com/en/investors/shareholders-corner/solvay-in-action/sia-glossary.html.

[1]  Besides IFRS accounts, Solvay presents underlying income statement performance indicators to provide a more consistent and comparable indication of the Group`s financial performance. These adjust IFRS figures for the non-cash Purchase Price Allocation (PPA) accounting impacts related to acquisitions, for the coupons of perpetual hybrid bonds, which are classified as dividends under IFRS but treated as financial charges in the underlying statements, and for other elements to produce a measure that would otherwise distort the analysis of the Group`s underlying performance.

[2]  Solvay presents pro forma financial information on an unaudited basis for 2015, as if the acquisition of Cytec had taken place on January 1, 2015. It combines Solvay`s and Cytec`s income and cash flow statements on a stand-alone basis, after alignment of accounting policies and purchase price allocation impacts (i.e. amortization of intangible fair value step-ups and recognition in cost of goods sold of the inventory fair value step-up). The pro forma information also takes into account the estimated additional financing costs related to the acquisition as well as the acquisition related costs. However, expected synergies have not been reflected.

      Follow us on twitter @SolvayGroup

 Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were EUR 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world`s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Caroline Jacobs Kimberly Stewart Jodi Allen Geoffroy Raskin Bisser Alexandrov
Media Relations Investor Relations Investor Relations Investor Relations Investor Relations
+32 2 264 1530 +32 2 264 3694 +1 973 357 3283 +32 2 264 1540 +32 2 264 3687
Source: Solvay S.A.
Provider: Thomson Reuters ONE
View All Press Releases

TiGenix Business and Financial Update for the First Half 2017

TIGENIX Euronext BE0003864817
TIG
RELEASE 19 SEP 2017 07:00 CET
TiGenix Business and Financial Update for the First Half 2017

PRESS RELEASE
Regulated information

TiGenix Business and Financial Update for the First Half 2017
(Conference call and webcast today at 15:00 CET)

Leuven (BELGIUM) - September 19, 2017, 07:00h CET - TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, today reported its business and financial highlights for the six months` ended June 30, 2017.

Key business and financial highlights for the first half of 2017 and post period events: 

  • Cx601 continued to reach significant value inflection points in Europe and the U.S.
    • Responses to the Day 180 LoOI submitted in September 2017. The Day 181 file for Cx601 falls within the first week of October, which may lead to a CHMP opinion in 2017
    • European Commission decision will trigger a payment of EUR 15.0 million from Takeda Pharmaceuticals upon marketing authorization
    • The Swiss Agency for Therapeutic Products ("Swissmedic") accepted for review the file on Cx601 for the treatment of complex perianal fistulas in patients with Crohn`s disease
    • TiGenix obtained a commercial production license for its expanded manufacturing facility in Madrid to provide capacity for the potential initial European commercial roll out of Cx601. The expanded facility also secures manufacturing capacity for other pipeline products
    • The global pivotal Phase III trial to support a future U.S. registration for Cx601 formally launched in Europe and Israel in June 2017
    • TiGenix opened its U.S. headquarters at the epicenter of the Boston area biotech hub 
    • Strengthened U.S. operations with two senior appointments: Dr Gregory Gordon, Head of Medical Department (US) and Annette Valles-Sukkar, Associate Director, Clinical Project
    • Cx601 delivered positive follow-up results at 104 weeks, confirming the long-term safety and efficacy profile
  • Continued progress with pipeline
    • First patient enrolled in Phase I/II clinical trial of Cx611 for the treatment of severe sepsis
    • Phase I/II trial results of AlloCSC-01 in Acute Myocardial Infarction (AMI) announced
  • Strong cash position at June 30, 2017 of EUR 56.5 million

"In the recent period, we have continued to make good progress towards bringing to market our lead product, Cx601, as an important new treatment option for patients suffering from a severe and debilitating complication of Crohn`s disease," said Eduardo Bravo, CEO at TiGenix. "In Europe, we are now close to a CHMP opinion which may be received this year. Our partnership with Takeda and the preparations for European launch are progressing well. Looking beyond the European market, we successfully launched our global Phase III trial to support a future regulatory filing in the U.S. and continue to explore routes to accelerate access to the product for U.S. patients. With the progress for Cx601, its potential in new indications, and the continued advancement of our pipeline, we look forward to the coming months with great excitement."

Business highlights for the first half 2017 and post-period events

Cx601 continued to reach major value inflection points

TiGenix submitted responses to the Cx601 Marketing Authorization (MA) Application Day 180 List of Outstanding Issues from the Committee for Medicinal Products for Human Use (CHMP) in September 2017.

The submission of the responses to the CHMP Day 180 LoOI is part of the standard regulatory procedure, following which - on the so-called Day 181 - the European Medicines Agency (EMA) continues the review of a file after a clock stop.

The Day 181 for the Cx601 file falls within the first week of October, an approximate one month adjustment to the previously anticipated review calendar agreed with the EMA. TiGenix is confident it has provided detailed and clarifying responses to the CHMP, which may lead to a CHMP opinion in 2017.

The Company`s centralized European MA Application to the EMA was supported by the positive 24 and 52-week Phase III data from the ADMIRE-CD Phase III clinical trial. TiGenix is eligible to receive from Takeda a EUR 15.0 million milestone payment upon receipt of the MA.

In June, TiGenix, together with its partner Takeda, announced that the Swiss Agency for Therapeutic Products ("Swissmedic") accepted for review the file on Cx601 to treat complex perianal fistulas in patients with Crohn`s disease. Cx601 was previously granted orphan drug status by Swissmedic in September 2016, recognizing the severe and debilitating nature of the disease. The Swissmedic filing submission included the Phase III ADMIRE-CD trial data for Cx601.  The submission to Swissmedic represented a key milestone in the commercialization of Cx601 in Switzerland.

Also in June, TiGenix formally launched the global pivotal phase III clinical trial for Cx601 for the treatment of complex perianal fistulas in patients with Crohn`s disease, which is designed to support a future regulatory filing for Cx601 in the U.S. The first investigator meeting was held on June 8 and June 9 in Rome, Italy, and brought together more than 60 leading gastroenterologists, colorectal surgeons and study co-ordinators from 30 confirmed clinical trial sites across Belgium, Czech Republic, Italy, Poland and Spain. Similar investigator meetings are planned to take place in Europe (EU), Israel, the United States and Canada from the fourth quarter of 2017.

The global pivotal Phase III trial is a randomized, double-blind, placebo-controlled study designed to confirm the efficacy and safety of a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn`s disease patients. The trial design is similar to the European Phase III ADMIRE-CD trial for Cx601, with an identical primary endpoint. In January 2017, the U.S. Food and Drug Administration (FDA) agreed to the design of the protocol for the global Phase III trial, and confirmed that a future U.S. Biologics License Application (BLA) could be filed based on the study results at week 24, instead of week 52, from a broader patient population than the initial Special Protocol Assessment (SPA) formally endorsed in August 2015. With these adjustments, the trial should benefit from an expedited recruitment process, leading to shorter timelines, an earlier filing, and the possibility of an earlier approval in the U.S.

In parallel, TiGenix continues to explore further expedited pathways to accelerate the submission and review process for its future BLA in the United States.

In June, TiGenix opened its U.S. headquarters in Cambridge, Massachusetts. Establishing U.S. operations is a significant step for TiGenix and will support its strategic goal of developing and commercializing Cx601 in the U.S. TiGenix` U.S. operations are based at the Cambridge Innovation Center in Kendall Square, at the epicenter of the Boston-area biotech hub. TiGenix has since strengthened its U.S. operations with two senior appointments: Dr Gregory Gordon, Head of Medical Department (U.S.) and Annette Valles-Sukkar, Associate Director, Clinical Project.

In September, TiGenix obtained a license for the commercial production of expanded adipose-derived stem cells (eASCs) at its expanded manufacturing facility in Madrid. The manufacturing license follows an inspection by the Spanish Medicines Agency (AEMPS), and provides production capacity for the potential initial European commercial roll out of Cx601. The expanded facility will also provide sufficient capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611.

Throughout the period, TiGenix has continued to communicate the positive results from the ADMIRE-CD Phase III clinical trial. In March, TiGenix announced positive follow-up results at 104 weeks, confirming the long-term safety and efficacy profile of Cx601 for the treatment of complex perianal fistulas for Crohn`s disease patients.

The 52-week results have also been presented at a number of important international conferences including the12th Congress of the European Crohn`s and Colitis Organisation (ECCO) in February and at the 2017 Digestive Disease Week (DDW) annual meeting, one of the most prestigious congresses in gastroenterology (GI), in May 2017.

Alongside the DDW presentation, TiGenix hosted a key opinion leader (KOL) event, where leading experts in the GI field met to discuss the unmet medical need in treating complex perianal fistulas. The clinical data of Cx601 was reviewed at the meeting and further insight was provided into why Cx601 has the potential to become a breakthrough therapy in the management of complex perianal fistulas in patients with Crohn`s disease.

Underlining TiGenix` commitment to the treatment of this debilitating condition, the Company has entered into partnerships with the largest patient advocacy groups focused on Crohn`s disease and ulcerative colitis. In the United States, TiGenix has joined the Crohn`s and Colitis Foundation`s President`s Corporate Circle, and in Europe, TiGenix has signed a sponsorship agreement with the European Federation of Crohn`s and Ulcerative Colitis Associations (EFCCA). The Company will work with both organizations to broaden the understanding and awareness of complex perianal fistulas in Crohn`s disease.  

Progress with pipeline

Beyond Cx601, TiGenix continues to advance its pipeline of allogeneic products.

Cx611 is TiGenix` potential first-in-class, intravenous, allogeneic (or donor derived) stem cell therapy intended for the treatment of severe sepsis, a major cause of mortality in the developed world. A Phase Ib/IIa (SEPCELL) clinical trial for Cx611 for the treatment of severe sepsis in community-acquired pneumonia (CAP) was launched in the second half of 2016 and the first patient was dosed in January 2017. Data is expected to be available in 2019 and we believe that Cx611 represents a highly innovative potential treatment for this indication.

In March 2017, TiGenix announced the top-line results for the Phase I/II (CAREMI) study of AlloCSC-01 in Acute Myocardial Infarction (AMI). CAREMI was the first-in-human clinical trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of AlloCSCs in patients with AMI and left ventricular dysfunction treated within the first week post-AMI. CAREMI was not powered to establish efficacy, therefore no conclusion was drawn on the secondary efficacy endpoints.

All safety objectives of the study were met. No mortality or major cardiac adverse events (MACE) were found at 30 days meeting the primary endpoint of the study. In addition, neither mortality nor MACE were found at 6 months or 12 months follow-up. Of particular relevance to this allogeneic approach, no immune-related adverse events were recorded at one-year follow-up. A larger reduction in infarct size was found in one pre-specified subgroup associated with poor long-term prognosis which represents more than half of the patient population of the randomization phase of the study. This findings revealed valuable insight, and provided a specific direction for potential studies in a targeted subset of high-risk patients.

Financial highlights for the first half 2017

Key figures for the first half 2017 (consolidated)

During the first half of 2017, total revenues amounted to EUR 0.6 million compared to EUR 0.9 million to the same period in 2016. This slight decrease is related to the reduction in royalties and other operating income following the Company`s decision to withdraw the market authorization for ChondroCelect in July 2016 and terminate the agreements with Sobi.

In the first half of 2017 we have continued to progress significantly in our pipeline. In line with our expectations as we advance our clinical programs, research and development expenses for the first half of 2017 amounted to EUR 16.6 million, compared to EUR 9.7 million for the same period in 2016, mainly attributable to clinical activities in connection with the launch of our global pivotal Phase III trial to support a future filing for Cx601 in the US, and launch of the Phase Ib/IIa clinical trial for Cx611 in severe sepsis.

General and Administrative expenses in the first half of 2017 slightly increased and amounted to EUR 4.4 million, compared to EUR 4.3 million for the same period in 2016.

As a result of the above, the operating loss for the first half of 2017 amounted to EUR 20.5 million compared to EUR 13.1 million during the same period in 2016.

The net financial expense of the first six months of 2017 amounted to EUR 5.7 million, compared to a net financial income of EUR 3.7 million during the same period in 2016. This primarily relates to a non-cash item; the change in the fair value (non-cash) of the embedded derivative on the convertible bonds issued in March 2015 (in line with the increase in share price during the period).

Primarily as a result of the planned increase in the research and development expenses associated with the progress in our clinical development activities and the non-cash change in net financial expense described above, the loss for the first half 2017 amounted to EUR 26.2 million, compared to EUR 9.4 million for the same period in 2016 (which was positively affected by a non-cash fair value gain).

At the end of June 2017, the Company had cash and cash equivalents of EUR 56.5 million, compared to EUR 78.0 million at the beginning of the year. This is in line with our expectations and is mainly due to the net cash used in operating activities during the first half 2017.

Outlook for the coming periods:

  • 2H 2017 - Cx601 CHMP opinion
  • 2H 2017 - Plan on new indications for Cx601
  • 1H 2018 - EUR 15.0 million milestone potential payment by Takeda on EU approval decision
  • 1H 2018 - Takeda to launch Cx601 in EU markets
  • 1H 2018 - Cx601 IND and start of recruitment in U.S. centers

Interim financial statements

The interim financial statements for the first half of 2017 will be available as of Wednesday 20 September 2017 in the investor section of the TiGenix website, http://www.tigenix.com

Conference call and webcast presentation

TiGenix will conduct a conference call on 19 September 2017, at 15:00 CET / 09:00am ET, which will also be webcast. To participate in the conference call, please call on the following numbers to participate:

Confirmation Code: 1049542

London, United Kingdom:  +44(0)20 3427 1917
New York, United States of America:  +1 212 444 0896
Paris, France:  +33(0)1 70 48 01 66
Brussels, Belgium:  +32(0)2 404 0662
Madrid, Spain:  +34 91 114 6581
Amsterdam, Netherlands:  +31(0)20 721 9158

The webcast can be followed live online via the link: http://edge.media-server.com/m/p/naozpxws

The press release and the webcast slide presentation will be made available on the TiGenix website. A replay of the webcast will be available on the website shortly after the live webcast has finished.

For more information

Claudia D`Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta@tigenix.com

About TiGenix
TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, expanded stem cells.

TiGenix` lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn`s disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix` second adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe sepsis - a major cause of mortality in the developed world. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com.

About Cx601
Cx601 is a local administration of allogeneic (or donor derived) expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn`s disease patients that have previously failed conventional therapy. Crohn`s disease is a chronic inflammatory disease of the intestine and complex perianal fistulas are a severe and debilitating complication for which there is currently no effective treatment. Cx601 was granted orphan drug designation by the European Commission in 2009. TiGenix completed a European Phase III clinical trial (ADMIRE-CD) in August 2015. The 24-week data were published in the Lancet and showed both the primary endpoint and the safety and efficacy profile were met.[i]  A follow-up analysis was completed at 52 weeks and 104 weeks post-treatment, confirming the sustained efficacy and safety profile of the product.[ii] The 24-week results of the Phase III ADMIRE-CD trial were published in The Lancet in July 2016.i Based on the positive 24 weeks Phase III study results, TiGenix submitted a Marketing Authorization Application to the European Medicines Agency (EMA) and a CHMP opinion is expected in 2017. A global Phase III clinical trial intended to support a future U.S. Biologic License Application (BLA) started in 2017, based on a trial protocol that has been agreed with the Food and Drug Administration (FDA) through a special protocol assessment procedure (SPA). In July 2016, TiGenix entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired exclusive rights to develop and commercialize Cx601 for complex perianal fistulas in Crohn`s patients outside of the U.S.

About Cx611
Cx611 is an intravenous administration of allogeneic expanded adipose-derived stem cells (eASCs) for the treatment of severe sepsis. Sepsis is a life-threatening complication of infection leading to systemic inflammation and organ failure and is the leading cause of death in the developed world. In May 2015, TiGenix completed a Phase I sepsis challenge trial (CELLULA) that demonstrated a favorable safety and tolerability profile for Cx611. Based on the results of this study, TiGenix launched a Phase I/II clinical trial (SEPCELL) in 2016 evaluating Cx611 for the treatment of severe sepsis secondary to community-acquired pneumonia (sCAP) in patients who require mechanical ventilation and/or vasopressors. The first patient was dosed in January 2017 and data is expected in 2019. The trial has received funding from the European Union`s Horizon 2020 research and innovation programme under grant agreement No 681031 and is being carried out through the SEPCELL consortium, which gathers six partners from four European countries. See www.sepcell.eu for more information.

About AlloCSC-01
AlloCSC-01 is an intracoronary administration of allogeneic cardiac stem cells for the treatment of ischemic heart disease. A phase I/II clinical trial (CAREMI) evaluating AlloCSC-01 in Acute Myocardial Infarction (AMI) met its primary endpoint with no mortality or major cardiac adverse events (MACE) found after 30 days of treatment. No mortality or MACE were found at 6 or 12 months follow-up and there were no immune-related adverse events at 12 months follow-up. The CAREMI trial has benefitted from the support of the CAREMI consortium (Grant Number 242038, http://www.caremiproject.eu/) funded by the Seventh Framework Programme of the European Commission under the coordination of the Centro Nacional the Investigaciones Cardiovasculares (CNIC) and the Centro Nacional de Biotecnología and the participation of research institutions and companies from nine EU countries.



[i] Panés J, García-Olmo D, Van Assche G et al., Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn`s disease: a phase 3 randomized, double-blind controlled trial. The Lancet. 2016; 388(10051):1281-90.

[ii] Panes, J. et al., OP009 Long-term efficacy and safety of Cx601, allogeneic expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohn`s disease: 52-week results of a phase III randomised controlled trial. J Crohn`s Colitis. 2017; 11: S5-S5.

Source: TiGenix
Provider: Thomson Reuters ONE
View All Press Releases

Solvay enters into a binding agreement to sell its Polyamides business to BASF, a landmark in Solvay's transformation

SOLVAY Euronext BE0003470755
SOLB
RELEASE 19 SEP 2017 07:00 CET
Solvay enters into a binding agreement to sell its Polyamides business to BASF, a landmark in Solvay`s transformation

BASF agrees to acquire Polyamides for EUR 1.6 billion

Brussels, Sept. 19, 2017 --- Solvay has entered into a binding agreement with German chemical company BASF for the sale of its Polyamides business, a crucial step in Solvay`s transformation towards a multi-specialty chemicals company.

"Solvay`s planned divestment of Polyamides marks a tipping point in the profound transformation journey we began four years ago. Successful completion of this transaction will further reinforce Solvay as a multi-specialty chemical group, delivering superior growth and sustainable value," said Jean-Pierre Clamadieu, CEO of Solvay.

BASF is a strategic investor for Polyamides which complements both its business as well as its global presence. Solvay and BASF share the same commitment to best-in- class health, safety and environment standards on their sites.

Polyamides has grown profitability over the past years. As an integrated player, its activities range from upstream intermediates and polymers, to downstream with the development of high value-added engineering plastics. The transaction covers Solvay`s upstream and downstream polyamides business in Europe, North America and Asia, as well as the downstream engineering plastics business in Latin America and involves around 2,400 Solvay employees. Solvay will retain its upstream intermediates and downstream textile polyamide business in Latin America.

Under the proposed terms of the agreement, the transaction is based on an enterprise value of EUR1.6 billion, which represents ~8 EBITDA of 2016 and ~7 EBITDA in the last twelve months. The expected net cash proceeds are estimated to be around EUR1.1 billion. Taking into account the financial liabilities of about EUR0.2bn to be transferred to the acquirer, the net financial position of the Group will improve by about EUR1.3bn.

The polyamide business planned to be divested will be reclassified to assets and liabilities held for sale and discontinued operations at the end of September. As a result of the discontinuation, the retained Latin American polyamide business will incur an impairment of close to EUR(100) million to be booked at the end of September.  This impairment is expected to be more than compensated by the capital gain on the transaction at the closing.

The execution of definitive agreements is expected in the coming months following consultation with the relevant social bodies. Solvay and BASF aim to close the transaction in the third quarter of 2018, after customary regulatory approvals have been obtained and the formal consent of a Joint Venture partner has been received. The partner has already committed to grant its consent subject to the delivery of definitive documents with BASF.

      Follow us on twitter @SolvayGroup

Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were EUR 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world`s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Media Relations
  Caroline Jacobs Amandine Grison  
  Media Relations Media Relations  
  +32 2 264 1530 +33 1 40 75 81 49

 
 
Investor Relations
Kimberly Stewart Jodi Allen Geoffroy Raskin Bisser Alexandrov
+32 2 264 3694 +1 9733573283 +32 2 264 1540 +32 2 264 3687
       
Source: Solvay S.A.
Provider: Thomson Reuters ONE
View All Press Releases

Report on the progress of the share buy-back programme

KEYWARE TECH. Euronext BE0003880979
KEYW
RELEASE 18 SEP 2017 21:36 CET

REGULATED INFORMATION

 

Report on the progress of the share buy-back programme

Source: Keyware Technologies
Provider: Euronext
Attachment(s):
Report on the progress of the share buy-back programme
View All Press Releases

KBC Group: Publication of a transparency notification received by KBC Group NV

KBC Euronext BE0003565737
KBC
RELEASE 18 SEP 2017 18:00 CET
KBC Group: Publication of a transparency notification received by KBC Group NV

Press release
Outside trading hours - Regulated information*

Brussels, 18 September 2017, 18 h

Publication of a transparency notification received by KBC Group NV

(art. 14, 1st section of the Act of 2 May 2007 concerning the disclosure of significant participations)   

Summary of the notification

KBC Group NV has received a transparency notification dated 13 September 2017, which states that FMR LLC (Fidelity), as a result of a net sale of shares, now has crossed the reporting threshold of 3% downward. 

Content of the notification

The notification contains following information:

  • Reason for the notification: acquisition or disposal of voting securities or voting rights
  • Notification by: FMR LLC (Fidelity)
  • Persons subject to the notification requirement: see annex 1
  • Date on which the threshold is crossed: 11 September 2017
  • Threshold that is crossed downward : 3%

(KBC Group`s Articles of Association set a notification threshold of 3% of the total number of voting rights. In addition, the legal thresholds of 5% or any multiple thereof also apply)

  • Denominator (number of shares KBC Group NV): 418 372 082
  • Notified details: see annex 1
  • Chain of controlled undertakings through which the holding is effectively held:
    "The holdings attributed to FMR LLC arise from holdings of various undertakings for collective investment that are managed by FMR Co, Inc,  Fidelity Institutional Asset Management Trust Company, FMR INVESTMENT MANAGEMENT (UK) LIMITED, STRATEGIC ADVISORS  INC, Fidelity Selectco, Inc.,  and FIAM LLC, each of which are entities that are subsidiaries of and controlled by FMR LLC. These undertakings for collective investment have granted FMR LLC discretionary power to vote the securities in accordance with the FMR LLC board proxy voting policy. FMR LLC is not a controlled undertaking."
  • The relevant notification is available at www.kbc.com > Investor relations > Shareholder information > Shareholder structure.

For more information, please contact:

Wim Allegaert, General Manager, Investor Relations, KBC Group
Tel + 32 2 429 50 51 - E-mail: wim.allegaert@kbc.be

Viviane Huybrecht, General Manager, Corporate Communication/Spokesperson, KBC Group
Tel + 32 2 429 85 45 - E-mail: pressofficekbc@kbc.be

* This press release contains information provided in compliance with European transparency legislation for listed companies. KBC Group NV is listed at NYSE Brussels.
 

KBC Group NV
Havenlaan 2 - 1080 Brussels
Viviane Huybrecht
General Manager, Corporate
Communication/
Spokesperson
Tel. + 32 2 429 85 45
 

 

Press Office
Tel. + 32 2 429 65 01
Tel. + 32 2 429 29 15
Fax + 32 2 429 81 60
E-mail:pressofficekbc@kbc.be
 

KBC press releases are available at www.kbc.com or can be obtained by sending an e-mail to pressofficekbc@kbc.be

 

Follow us on www.twitter.com/kbc_group

Check this document`s authenticity at www.kbc.com/en/authenticity .

Annex 1:

  1. Stemrechten
Voting rights
Vorige notificatie (aantal stemrechten)
Previous notification
(number of voting rights)
Na de transactie
After the transaction
    Aantal stemrechten
Number of voting rights
% van stemrechten
% of voting rights
    Gelinked aan effecten
Linked to securities
Niet gelinked aan effecten
Not linked to securities
Gelinked aan effecten
Linked to securities
Niet gelinked aan effecten
Not linked to securities
FMR LLC

 

 
0 * - * -
FMR Co., Inc. 9 249 311 * - * -
Fidelity Institutional Asset Management Trust Company 874 866 * - * -
FIAM LLC 732 885 * - * -
FMR INVESTMENT MANAGEMENT (UK) LIMITED 1 744 390 * - * -
STRATEGIC ADVISORS, INC 59 * * * *
FIDELITY Selectco, LLC 135 * - * -
Totaal
Total
12 601 646 * - * -

B) Equivalente financiële instru-menten (equivalent financial instruments) *

 

 

* Indien het aandeelhouderschap beneden de laagste drempel is gevallen, kan de kennisgever ervoor opteren geen cijfers in te vullen.
If the holding has fallen below the lowest threshold, the company has the option of not entering any numbers in this scheme.

Source: KBC Groep
Provider: Thomson Reuters ONE