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UCB (EBR:UCB) UCB Media Room: 2020 Full Year Results

Transparency directive : regulatory news

25/02/2021 07:02
https://mb.cision.com/Public/18595/3295277/b42a6f1a02dbee45_800x800ar.jpg ** UCB - sustaining growth, now and into the future ------------------------------------------------------------ =C2=B7 Revenue increased to =E2=82=AC 5.3 billion (+9%, +8% CER ) net sales= to =E2=82=AC 5.1 billion (+8%, +7% CER) =C2=B7 Underlying profitability (adj. EBITDA ) was =E2=82=AC 1.4 billion (+= 1%, -4% CER) or 27% of revenue =C2=B7 R&D update: bimekizumab filed with FDA and EMA for psoriasis; timeli= nes for late stage pipeline confirmed =E2=80=93 despite pandemic =C2=B7 Financial outlook for 2021: Revenue expected to reach =E2=82=AC 5.45= =E2=80=93 5.65 billion,=C2=A0adjusted EBITDA2 27 - 28% of revenue, Core EP= S3 of =E2=82=AC 5.60 =E2=80=93 6.10 expected =C2=B7 Outlook 2025: revenue of at least =E2=82=AC 6 billion and adj. EBITD= A margin in the low to mid-thirties=C2=A0 UCB Full Year Report 2020:=C2=A0Brussels (Belgium), 25 February 2021 =E2=80= =93 7:00 (CET) =E2=80=93 regulated information =E2=80=93=C2=A0 Note: English, Dutch and French pdfs at the end of the release =E2=80=8B https://mb.cision.com/Public/18595/3295277/8701f07960e79a28_800x800ar.png= =E2=80=8B Acquisitions and agreements=C2=A0 In October 2020, UCB acquired a new campus located in Windlesham, Surrey fo= r its U.K. operations supporting cutting-edge research and development, ear= ly manufacturing and commercialization of medicines. The acquisition reflec= ts UCB=E2=80=99s commitment to retain the U.K. as one of its three global h= ubs for research and development, alongside Belgium and the U.S.=C2=A0 In November 2020, UCB acquired Handl Therapeutics, a rapidly growing and tr= ansformative gene therapy company based in Leuven, Belgium and entered into= a new collaboration with Lacerta Therapeutics, a Florida based clinical st= age gene therapy company. The new acquisition and collaboration will togeth= er serve to rapidly accelerate UCB=E2=80=99s ambition in gene therapy.=C2= =A0 Regulatory approvals=C2=A0 Vimpat^=C2=AE (lacosamide) - In October 2020, the Committee for Medicinal P= roducts for Human Use (CHMP) of the European Medicines Agency (EMA) has ado= pted a positive opinion on a license extension for the anti-epileptic drug = Vimpat^=C2=AE as adjunctive therapy in the treatment of primary generalized= tonic-clonic seizures (PGTCS) in adults, adolescents and children from 4 y= ears of age with idiopathic generalized epilepsy =E2=80=93 approved in the = European Union in December 2020.=C2=A0 In November 2020, the U.S. Food and Drug Administration (FDA) has approved = Vimpat^=C2=AE as adjunctive therapy in the treatment of primary generalized= tonic-clonic seizures in patients 4 years of age and older and Vimpat^=C2= =AE injection for intravenous use in children four years of age and older. R&D update=C2=A0 Bimekizumab - In September 2020, the U.S. Food and Drug Administration (FDA= ) and European Medicines Agency (EMA) accepted marketing application submis= sions for bimekizumab for the treatment of adults with moderate to severe p= laque psoriasis.=C2=A0 In July 2020, the Phase 3b study BE RADIANT, comparing bimekizumab to Cosen= tyx^=C2=AE (secukinumab) for the treatment of adults with moderate-to-sever= e plaque psoriasis, met all co- primary and ranked secondary endpoints, ach= ieving significantly greater efficacy than secukinumab.=C2=A0 Dapirolizumab pegol: in August 2020, UCB and its partner, Biogen, included = the first patients into the Phase 3 program with dapirolizumab pegol in pat= ients with active systemic lupus erythematosus (SLE) despite standard-of-ca= re treatment. First headline results are expected in H1 2024. Rozanolixizumab: UCB is focusing its resources to new patient populations w= ith autoantibody mediated neuro-inflammation and high unmet medical need. W= ith these patients potentially benefitting from rozanolixizumab, UCB is pre= paring the start of two clinical programs already during 2021 =E2=80=93 nex= t to the ongoing Phase 3 studies in generalized myasthenia gravis (gMG) and= immune thrombocytopenia (ITP). People living with chronic inflammatory dem= yelinating polyneuropathy (CIDP) are a heterogenous and complex patient pop= ulation, with approximately only 30% having detectable autoantibodies. Whil= e the Phase 2a study in CIDP patients supports the conduct of a confirmator= y clinical study, UCB decided to prioritize autoantibody mediated neuro-inf= lammation indications over CIDP. Bepranemab (UCB0107) Initiation of a Phase 2 study in Alzheimer=E2=80=99s d= isease (AD) is planned for mid-2021, following the partnership agreement wi= th Roche/Genentech. This will allow to evaluate the potential of bepranemab= in a tau-mediated disease and subsequently explore options in different ta= uopathy populations, including progressive supranuclear palsy (PSP). In context with the pandemic, there are no changes to the expected timeline= s for the late stage pipeline projects. Net sales break-down by core product https://mb.cision.com/Public/18595/3295277/ba592c913e843e56_800x800ar.png https://mb.cision.com/Public/18595/3295277/802fd098eb7ab2f1_800x800ar.png= =E2=80=8B=E2=80=8B Nayzilam^=C2=AE (midazolam) Nasal Spray^CIV, a nasal rescue treatment for e= pilepsy seizure clusters in the U.S. is successfully launched since Decembe= r 2019 and reached net sales of =E2=82=AC 26 million. Evenity^=C2=AE (romosozumab) had its first European launch in March 2020, f= or the treatment of severe osteoporosis in postmenopausal women at high ris= k of fracture, and reported net sales of =E2=82=AC 2 million, impacted by t= he pandemic which significantly impedes outreach to new patient populations= . Evenity^=C2=AE is being launched globally by Amgen, Astellas and UCB sinc= e 2019, with net sales outside Europe reported by Amgen and Astellas. 2020 FY financial highlights https://mb.cision.com/Public/18595/3295277/86ca0f614bac0608_800x800ar.png =E2=80=8BRevenue in 2020 increased by 9% (+8% CER) to =E2=82=AC 5 347 milli= on and net sales increased by 8% (+7% CER) to =E2=82=AC 5 052 million. Net = sales before =E2=80=9Cdesignated hedging reclassified to net sales=E2=80=9D= were =E2=82=AC5 022 million with a plus of 5% (+7% CER). This growth was d= riven by the resilient UCB product portfolio - despite the pandemic.=C2=A0 Royalty income and fees were =E2=82=AC 96 million, plus 22% and benefitting= from a one-time royalty recognized. Other revenue increased by 28% to =E2= =82=AC 199 million due to higher contract manufacturing, milestones and oth= er payments from R&D partners.=C2=A0 Gross profit reached =E2=82=AC 3 984 million, with a plus of 9% (+8% CER) a= nd reflecting a slightly improved gross margin compared to 2019.=C2=A0 Operating expenses went up to =E2=82=AC 2 891 million (+14%; +16% CER) refl= ecting=C2=A0 =C2=B7 10% higher marketing and selling expenses of =E2=82=AC 1 221 million - driv= en by the launch of Cimzia=C2=AE in active non-radiographic axial spondyloa= rthritis (nr-axSpA) in the U.S. and the launches in Japan and China, the la= unch of Nayzilam=C2=AE in the U.S. and Evenity=C2=AE in Europe as well as l= aunch preparations for bimekizumab for people living with psoriasis, ziluco= plan and rozanolixizumab in myasthenia gravis and include expenses in conne= ction with accelerated digital transformation in the pandemic context to be= tter interactions, targeting and marketing =C2=B7 23% higher research and development expenses of =E2=82=AC 1 569 mill= ion =E2=80=93 which include for the first time the R&D expenses for the acq= uired Ra Pharma, Engage Therapeutics and Handl Therapeutics R&D programs. O= ngoing high investments in UCB=E2=80=99s progressing pipeline encompass fiv= e late stage assets and include expenses in connection with digital transfo= rmation for better patient experience and faster development time. Slightly= lower R&D expenses due to the pandemic related to the recruitment pause in= the first half 2020 were compensated by higher pandemic related expenses f= or the safety of patients as well as ensuring patient recruitment in the se= cond half of the year. Hence, the R&D ratio reached 29% in 2020 after 26% i= n 2019.=C2=A0 =C2=B7 with +1% almost stable general and administrative expenses of =E2=82= =AC 196 million, reflecting lower costs due to COVID-19 pandemic compensate= d by digital business transformation activities and the contribution to the= UCB fund (=E2=82=AC 5 million) in connection with COVID-19 pandemic. Other operating income doubled to =E2=82=AC 95 million after =E2=82=AC 48 m= illion in 2019 - driven by an income of =E2=82=AC 96 million in connection = with the commercialization of Evenity^=C2=AE in collaboration with Amgen, a= fter an income of =E2=82=AC 8 million in 2019, compensating mainly UCB=E2= =80=99s marketing & selling as well as R&D expenses. UCB=E2=80=99s share to= the total Evenity=C2=AE contribution has turned to positive earnings for t= he first time. In 2019, =E2=80=9Cother=E2=80=9D operating items were impact= ed by one-time positive contributions from investment grants, gain on dives= titure and release of provisions.=C2=A0 Underlying operational profitability =E2=80=93 adjusted (recurring) EBITDA = - reached =E2=82=AC 1 441 million (+1%, -4% CER) driven by continued revenu= e growth and higher operating expenses, reflecting the investments into the= future of UCB, namely into product launches and clinical development. The = adjusted EBITDA ratio for 2020 (in % of revenue) reached 27%, from 29% in 2= 019. Total impairment, restructuring and other income/expenses (formerly called = =E2=80=9Cnon-recurring=E2=80=9D) were expenses of =E2=82=AC 122 million aft= er =E2=82=AC 50 million in 2019. In 2020, this includes fees related to the= acquisitions, restructuring expenses and an increase of provisions. In 201= 9, UCB strengthened its operating model to ensure maximum agility to meet t= he growth expectations for the years ahead, leading to higher restructuring= expenses. Net financial expenses went down to =E2=82=AC 93 million from =E2=82=AC 107= million in 2019, thanks to lower hedging costs, reduction of interest paya= ble due to the repaid bond in March 2020, compensated by higher interest ex= penses due to the debt financing of the Ra Pharma acquisition. Income tax expenses were =E2=82=AC 119 million compared to =E2=82=AC 146 mi= llion in 2019. The effective tax rate is 13% after 15% in 2019. Profit amounted to =E2=82=AC 761 million (after =E2=82=AC 817 million), of = which =E2=82=AC 732 million (after =E2=82=AC 792 million) is attributable t= o UCB shareholders and =E2=82=AC 29 million (after =E2=82=AC 25 million) to= non-controlling interests. Core earnings per share, which reflect profit attributable to UCB sharehold= ers, adjusted for the after-tax impact of to be adjusted items, the financi= al one-offs, the after-tax contribution from discontinued operations and th= e net amortization of intangibles linked to sales, reached =E2=82=AC 5.36 a= fter =E2=82=AC 5.20 based on 189 million weighted average shares outstandin= g (+1%)=C2=A0 Dividend - The Board of Directors of UCB proposes a dividend of =E2=82=AC1.= 27 per share (gross), +2%. Outlook 2021: For 2021, UCB is aiming for revenues in the range of =E2=82= =AC 5.45 =E2=80=93 5.65 billion thanks to the current core product growth a= nd new patient populations being served, based on current assessment of the= ongoing pandemic. UCB will continue to advance its late stage development = pipeline and prepare upcoming launches to offer potential new solutions for= patients.=C2=A0 Underlying profitability, adjusted EBITDA, is expected in the range of 27 -= 28% of revenue, reflecting the high R&D and marketing & sales investment l= evels. Core earnings per share are therefore expected in the range of =E2= =82=AC 5.60 =E2=80=93 6.10 based on an average of 189 million shares outsta= nding. The figures for the outlook 2021 as mentioned are calculated on the = same basis as the actual figures for 2020.=C2=A0 Outlook for 2025: For the first time UCB shares its growth ambition for 202= 5, despite upcoming patent expirations. Based on the strong product portfol= io and the promising late-stage pipeline assets, UCB aims to lead in specif= ic populations by 2025, creating value for patients now and into the future= . Revenue in 2025 are expected to reach at least =E2=82=AC six billion and = the underlying profitability (adj. EBITDA) should reach the low to mid-thir= ties in percent of revenue. Outlook 2021 & 2025: Based on UCB=E2=80=99s current assessment of the Covid= -19 pandemic, UCB remains confident in the fundamental underlying demand fo= r its products in the short-term and its prospects for long-term growth. UC= B will continue to closely follow evolving COVID-19 pandemic and its conseq= uences to the business environment diligently to assess potential near- and= mid-term challenges. =C2=A0 Changes to the Board of Directors: In October 2020, UCB announced that at t= he UCB Annual General Meeting on April 29, 2021, Evelyn du Monceau will hav= e reached the statutory age limit and will step down as Chair and Director = of the Board of UCB SA/NV. She will retire from the Board after 4 years as = UCB=E2=80=99s Chair and over 35 years as UCB Board member.=C2=A0 The mandates of Albrecht De Graeve, Viviane Monges and Roch Doliveux will e= xpire at the Annual General Meeting of April 29, 2021 (AGM 2021). Roch Doli= veux informed the Board that, for personal reasons, he will not be candidat= e for a further renewal of his mandate and will therefore leave the Board a= nd UCB at the end of the term of his current mandate (i.e. the AGM 2021). The Board will propose the following appointments to the AGM of April 29, 2= 021: =C2=B7 The appointment of Mr. Stefan Oschmann as independent Director. If elected = by the AGM 2021, Stefan Oschmann will become the Chair of the Board in repl= acement of Mrs. Evelyn du Monceau.=C2=A0 =C2=B7 The appointment of Mrs. Fiona du Monceau as Director. If elected by = the AGM 2021, she will become Vice Chair of the Board in replacement of Pie= rre Gurdjian, who will stay in the Board as independent Director for the re= mainder of his mandate. Fiona du Monceau is a representative of the Referen= ce Shareholder and does not qualify as independent Director in accordance w= ith the criteria of the 2020 Code. =C2=B7 The appointment of Mr. Jonathan Peacock as independent Director. Jon= athan Peacock meets all criteria of the 2020 Code and the Board to qualify = as independent Director. If he is elected by the AGM 2021, Jonathan Peacock= will become the Chair of the Audit Committee in replacement of Albrecht De= Graeve. =C2=B7 The renewal of the mandate of Albrecht De Graeve as Director. Albrec= ht De Graeve will qualify as independent Director only for the first year o= f his renewed mandate of 4 years (until the General Meeting of 2022). If re= -elected, Albrecht De Graeve will stay as independent member of the Audit C= ommittee for one additional year (until the General Meeting of April 2022).= From the General Meeting of 2022 until the end of his mandate (2025) Albre= cht De Graeve will remain non-independent member of the Board and will no l= onger be member of the Audit Committee.=C2=A0 =C2=B7 The renewal of the mandate of Mrs. Viviane Monges as independent mem= ber of the Board. If her mandate is renewed by the AGM 2021, Viviane Monges= will remain independent member of the Audit Committee.=C2=A0 =C2=B7 In January 2021, UCB announced the cooptation of Professor Susan Gas= ser as new member of UCB's Board of Directors, to be ratified at UCB=E2=80= =99s next General Assembly on April 29, 2021. Prof Gasser replaces Professo= r Alice Dautry who has reached the statutory age limit. The cooptation of P= rof Susan Gasser was conducted in accordance with both the statutory rules = of UCB and the BCCA. If approved at the next general assembly, Prof Gasser = will qualify as an independent Board member and serve a 4-year mandate. She= would also be appointed as a member of the Scientific Committee of the Boa= rd. The mandate of Price Waterhouse Cooper (PwC) will end at the AGM 2021. By a= pplication of the European and Belgian mandatory rotation rules applicable = to external auditors, PwC is no longer eligible for re-election as an exter= nal Statutory Auditor. Based on a selection process overseen by the UCB Aud= it Committee, the resultant recommendation and approval by the company=E2= =80=99s works council, the Board will therefore propose the appointment of = the audit firm Mazars Bedrijfsrevisoren - R=C3=A9viseurs d=E2=80=99Entrepri= ses CVBA/SCRL as its statutory auditor for a mandate of 3 years (legal term= ) at the AGM of April 29, 2021. Sustainability is UCB=E2=80=99s business approach and critical to long-term= success and UCB=E2=80=99s contribution to society. =C2=B7 In this context, the company made progress to enable access to its solution= s for all patients who need them and started to report on the access perfor= mance.=C2=A0 =C2=B7 As part of the broader aim to foster a positive working environment = for all employees, UCB launched of a new health safety and well-being index= .=C2=A0 =C2=B7 UCB continued to work to minimize its impact on the environment and = to protect our planet=E2=80=99s health, working towards ambitious environme= ntal targets.=C2=A0 2020 also saw a sustainability governance framework established comprised o= f the new internal Sustainability Governance Committee and an External Sust= ainability Advisory Board that gathers external experts to provide an outsi= de perspective on UCB=E2=80=99s approach. As of 2020, UCB is a participant = in the United Nations (UN) Global Compact and UCB committed to make the UN = Global Compact and its principles an integral part of its business strategy= , day-to-day operations and organizational culture. Find the FY financial reports on UCB website: http://www.ucb.com/investors/= Download-center=C2=A0 Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00= (GMT) / 14.00 (CET). Details are available on=C2=A0https://www.ucb.com/investors/UCB-financials/= Full-year-financial-results For further information Investor Relations Antje Witte, Investor Relations, UCB T +32.2.559.9414 antje.witte@ucb.com=C2=A0 Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588 isabelle.ghellynck@ucb.com=C2=A0 Global Communications Laurent Schots,=C2=A0 Media Relations, UCB T+32.2.559.9264 laurent.schots@ucb.com=C2=A0 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With more than 7 600 people in= approximately 40 countries, the company generated revenue of =E2=82=AC 5.3= billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow = us on Twitter: @UCB_news Forward looking statements=C2=A0 This press release contains forward-looking statements including, without l= imitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =E2= =80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=E2= =80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestimate= s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu= e=E2=80=9D and similar expressions. These forward-looking statements are ba= sed on current plans, estimates and beliefs of management. All statements, = other than statements of historical facts, are statements that could be dee= med forward-looking statements, including estimates of revenues, operating = margins, capital expenditures, cash, other financial information, expected = legal, arbitration, political, regulatory or clinical results or practices = and other such estimates and results. By their nature, such forward-looking= statements are not guarantees of future performance and are subject to kno= wn and unknown risks, uncertainties and assumptions which might cause the a= ctual results, financial condition, performance or achievements of UCB, or = industry results, to differ materially from those that may be expressed or = implied by such forward-looking statements contained in this press release.= Important factors that could result in such differences include: the globa= l spread and impact of COVID-19, changes in general economic, business and = competitive conditions, the inability to obtain necessary regulatory approv= als or to obtain them on acceptable terms or within expected timing, costs = associated with research and development, changes in the prospects for prod= ucts in the pipeline or under development by UCB, effects of future judicia= l decisions or governmental investigations, safety, quality, data integrity= or manufacturing issues; potential or actual data security and data privac= y breaches, or disruptions of our information technology systems, product l= iability claims, challenges to patent protection for products or product ca= ndidates, competition from other products including biosimilars, changes in= laws or regulations, exchange rate fluctuations, changes or uncertainties = in tax laws or the administration of such laws, and hiring and retention of= its employees. There is no guarantee that new product candidates will be d= iscovered or identified in the pipeline, or that new indications for existi= ng products will be developed and approved. Movement from concept to commer= cial product is uncertain; preclinical results do not guarantee safety and = efficacy of product candidates in humans. So far, the complexity of the hum= an body cannot be reproduced in computer models, cell culture systems or an= imal models. The length of the timing to complete clinical trials and to ge= t regulatory approval for product marketing has varied in the past and UCB = expects similar unpredictability going forward. Products or potential produ= cts which are the subject of partnerships, joint ventures or licensing coll= aborations may be subject to disputes between the partners or may prove to = be not as safe, effective or commercially successful as UCB may have believ= ed at the start of such partnership. UCB=E2=80=99 efforts to acquire other = products or companies and to integrate the operations of such acquired comp= anies may not be as successful as UCB may have believed at the moment of ac= quisition. Also, UCB or others could discover safety, side effects or manuf= acturing problems with its products and/or devices after they are marketed.= The discovery of significant problems with a product similar to one of UCB= =E2=80=99s products that implicate an entire class of products may have a m= aterial adverse effect on sales of the entire class of affected products. M= oreover, sales may be impacted by international and domestic trends toward = managed care and health care cost containment, including pricing pressure, = political and public scrutiny, customer and prescriber patterns or practice= s, and the reimbursement policies imposed by third-party payers as well as = legislation affecting biopharmaceutical pricing and reimbursement activitie= s and outcomes. Finally, a breakdown, cyberattack or information security b= reach could compromise the confidentiality, integrity and availability of U= CB=E2=80=99s data and systems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and expressly disclaims any duty to= update any information contained in this press release, either to confirm = the actual results or to report or reflect any change in its forward-lookin= g statements with regard thereto or any change in events, conditions or cir= cumstances on which any such statement is based, unless such statement is r= equired pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. GenericFile UCB Press Release FY 2020 NL (https://mb.cision.com/Public/18595/3295277/b7= 9fa470e2eeb2da.pdf) GenericFile UCB Press Release FY 2020 FR (https://mb.cision.com/Public/18595/3295277/8a= a5c01a31338861.pdf) GenericFile UCB Press Release FY 2020 ENG (https://mb.cision.com/Public/18595/3295277/8= 527e42ee74d3e2b.pdf) Image FY 2020 Chart 1 Feb 25 2021 (https://mb.cision.com/Public/18595/3295277/b5e= 75596fe40c9fc_org.png) Image FY 2020 Chart 2 Feb 25 2021 (https://mb.cision.com/Public/18595/3295277/ba5= 92c913e843e56_org.png) Image FY 2020 Chart 2 bis Feb 25 2021 (https://mb.cision.com/Public/18595/3295277= /802fd098eb7ab2f1_org.png) Image FY 2020 Chart 3 Feb 25 2021 (https://mb.cision.com/Public/18595/3295277/86c= a0f614bac0608_org.png)=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x62301x1x6868579x24000= x6&Email=3Dregnews%40symexglobal.com.=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=


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