UCB (EBR:UCB) UCB Media Room: UCB Full Year Results 2022

Transparency directive : regulatory news

22/02/2023 07:04

https://mb.cision.com/Public/18595/3720385/8142c1296f8c047c_800x800ar.png ** UCB managed 2022 headwinds and is ready for 2023 launches ------------------------------------------------------------ =C2=B7 Revenue reached =E2=82=AC 5.52 billion (-4%; -7% CER^1), net sales w= ere =E2=82=AC 5.14 billion=C2=A0(-6%; -8% CER^1). CIMZIA has reached UCB=E2= =80=99s projected peak sales target of =E2=82=AC two billion ahead of 2024 =C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 1.26 billion = (-23%; -21% CER^1),=C2=A022.8% of revenue =C2=B7 Multiple launches in 2023 expected: in psoriasis in the U.S., in pso= riatic arthritis (PsA) and across the full spectrum of axial spondyloarthri= tis (axSpA) in the EU and Japan, in generalized myasthenia gravis (gMG) in = the U.S., EU and Japan and in Lennox Gastaut Syndrome (LGS) in the EU - alr= eady approved =C2=B7 Financial guidance for 2023: Revenue expected to reach =E2=82=AC 5.1= 5 - 5.35 billion, adjusted EBITDA^2 22.5 - 23.5% of revenue, Core EPS^3 of = =E2=82=AC 3.40 - 3.80 =C2=A0 UCB Full-Year Report 2022, Brussels (Belgium), 22 February 2023 =E2=80=93 7= :00 (CET) =E2=80=93 regulated information=C2=A0 "In 2022 we reached more than 3.4 million people living with severe immunol= ogical and neurological diseases and we are in full preparation to bring ne= w treatment options in the future, all of this while managing the headwinds= . In 2022, we were confronted with a delay launching bimekizumab in the U.S= . Today, UCB is very confident to bring bimekizumab to people living with p= soriasis in the U.S. =E2=80=93 with regulatory feedback expected in Q2 2023= . In 2023, we also aim to bring new treatment options to people living with= generalized myasthenia gravis. What guides us is our belief that everyone = deserves to live the best live that they can," Jean-Christophe Tellier, CEO= UCB commented. "Acting with focus and care, keeping our impact on society = and the planet in mind, we are pleased with the progress we made towards ou= r extra-financial targets, recognized by key ESG ratings. Together with our= employees and partners we are working towards our strong long-term growth = and our ambition to create value for all stakeholders, now and into the fut= ure.=E2=80=9D=C2=A0 https://mb.cision.com/Public/18595/3720385/9ac6ad735854bb10_800x800ar.png https://mb.cision.com/Public/18595/3720385/a850d0057578a7cb_800x800ar.png ^1 CER =3D constant exchange rates ^2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation a= nd Amortization charges ^3 Core EPS =3D core earnings per share FY 2022 revenue reached =E2=82=AC 5.52 billion (-4%; -7% CER1). Net sales r= eached =E2=82=AC 5.14 billion (-6%; -8% CER^1), based on the continued grow= th of UCB=E2=80=99s product portfolio and the newly acquired product FINTEP= LA^=C2=AE. This was more than offset by the contracting effects of the loss= of exclusivity of two products. Underlying profitability (adjusted EBITDA^2) reached =E2=82=AC 1.26 billion= (-23%; -21% CER^1), reflecting lower revenue due to the loss of exclusivit= y and the integration of Zogenix, which explains higher total operating exp= enses. Strong cost discipline allowed the absorption of inflation costs. Ma= rketing and selling expenses reflect investments behind ongoing and upcomin= g launches, research and development expenses reflect the pipeline progress= . Higher other operating income was driven by EVENITY^=C2=AE.=C2=A0 Profit decreased to =E2=82=AC 418 million (-61%; -55% CER^1). Core EPS^3 we= re =E2=82=AC 4.37 after =E2=82=AC 6.49 in 2021. The Board of Directors of U= CB proposes a dividend of =E2=82=AC 1.33 per share (gross), +2%. Sandrine Dufour, CFO UCB says: =E2=80=9CWe are pleased to deliver 2022 fina= ncial results at the upper end of our financial guidance shared in June 202= 2. We successfully integrated Zogenix - diluting our earnings significantly= but slightly less than anticipated. As expected, we=E2=80=99re seeing the = impacts from the loss of exclusivity for E KEPPRA^=C2=AE in Japan and VIMPA= T^=C2=AE in the U.S. and Europe reflected in our topline. Smart resource al= location enabled us to invest behind the planned product launches and stron= g cost discipline mitigated the impacts from inflation. In 2023, although w= e will see the full annualized effect of the loss of exclusivity to VIMPAT^= =C2=AE and the inflation costs, we will continue to invest behind multiple = launches also benefiting from the Zogenix acquisition becoming earnings acc= retive.=E2=80=9D Regulatory and Clinical Pipeline Update UCB continuously innovates and strives to find new ways to deliver solution= s to people living with severe immunological and neurological diseases, lea= ding in 2022 to an unprecedented regulatory and clinical pipeline, set to h= elp people live their best possible lives. Bimekizumab=C2=A0 In September 2022, the European Medicines Agency (EMA) accepted for regulat= ory review the two marketing authorization applications (MAA) for bimekizum= ab for the treatment of adult patients with active psoriatic arthritis (PsA= ), and adult patients with active axial spondyloarthritis (axSpA).=C2=A0 In May 2022, UCB announced that the U.S. Food and Drug Administration (FDA)= issued a Complete Response Letter (CRL) regarding the Biologics License Ap= plication (BLA) for bimekizumab for the treatment of adults with moderate t= o severe plaque psoriasis. The letter indicated that the FDA could not appr= ove the application in its current form and that certain pre-approval inspe= ction observations of UCB's manufacturing site in Belgium must be resolved = before approval of the application. The CRL is not related to efficacy nor = to safety of bimekizumab. In November 2022, UCB announced that it had resub= mitted the BLA to the FDA for bimekizumab for the treatment of adults with = moderate to severe plaque psoriasis. In December 2022, the FDA accepted the= BLA resubmission for review. The FDA validated the resubmission as =E2=80= =98Class 2=E2=80=99 with a six-month review period. UCB expects the FDA act= ion in Q2 2023.=C2=A0 In December 2022, UCB announced positive top-line results from two Phase 3 = studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safety of = bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS)= . HS is a chronic, recurring, painful, and debilitating inflammatory skin d= isease. The two Phase 3 studies met their primary and key secondary endpoin= ts with statistical significance and consistent clinical relevance. The pos= itive results from these two studies will form the basis of global regulato= ry license application submissions for bimekizumab in hidradenitis suppurat= iva starting in Q3 2023. =C2=A0 Brivaracetam In October 2022, UCB announced positive top-line results from the latest Ph= ase 3 study of brivaracetam. The study was designed to evaluate the efficac= y and safety of adjunctive brivaracetam in participants from Asia (=E2=89= =A516 to 80 years of age) with partial epilepsy seizures with or without se= condary generalization. The study met the primary and all secondary endpoin= ts. UCB plans regulatory submissions in Japan in Q3 2023. FINTEPLA^=C2=AE (fenfluramine) In September 2022, FINTEPLA^=C2=AE (fenfluramine) oral solution was approve= d by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the tre= atment of seizures associated with Dravet syndrome as an add-on therapy to = other anti-epileptic medicines for patients 2 years of age and older. Fenfl= uramine will be marketed by Nippon Shinyaku Co., Ltd. based on the exclusiv= e sales agreement signed in 2019 between Zogenix Inc., (acquired by UCB in = 2022) and Nippon Shinyaku Co., Ltd. UCB is now the Marketing Authorization = holder. In December 2022, FINTEPLA^=C2=AE was recommended by the Committee for Medi= cinal Products for Human Use (CHMP) for marketing authorization in the Euro= pean Union (EU) for the adjunctive treatment of seizures associated with Le= nnox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic me= dicines for patients two years of age and older. In February 2023, UCB anno= unced the European marketing authorization for FINTEPLA^=C2=AE (fenfluramin= e) in LGS. Additionally, the European Commission has also adopted the EMA C= ommittee for Orphan Medicinal Products (COMP) recommendation that the orpha= n designation for fenfluramine be maintained.=C2=A0 Zilucoplan In November 2022, the NDA and the MAA for zilucoplan, a self-administered (= via subcutaneous injection) peptide inhibitor of complement component 5 (C5= inhibitor), were accepted by FDA and EMA, respectively, for review seeking= approval for the treatment of generalized myasthenia gravis (gMG) in adult= patients who are acetylcholine receptor antibody positive (AChR-Ab+). UCB = expects to receive feedback from the agencies in Q4 2023.=C2=A0 Doxecitine and doxribtimine (doxTM, MT1621) Doxecitine and doxribtimine (doxTM), a dual substrate pyrimidine nucleoside= enhancement therapy being developed for the treatment of patients with thy= midine kinease 2 deficiency (TK2d), an ultra-rare debilitating and life-thr= eatening genetic mitochondrial disorder, causing progressive and severe mus= cle weakness. Following in-depth evaluation and alignment meetings with key= regulatory agencies on the filing strategy for doxTM, regulatory submissio= ns are now planned for H1 2024. Rozanolixizumab In January 2023, FDA accepted the filing and granted priority review for th= e BLA for rozanolixizumab - a subcutaneously infused monoclonal antibody ta= rgeting the neonatal Fc receptor (FcRn), for the treatment of adults with g= eneralized myasthenia gravis (gMG) who are anti-acetylcholine receptor (ACh= R) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. UCB ex= pects to receive feedback from the FDA in Q2 2023. The FDA Priority Review designation follows the December 2022 EMA validatio= n of the MAA for rozanolixizumab for the treatment of adults with AChR or M= uSK antibody positive gMG. UCB expects to receive initial feedback for Euro= pe in Q1/Q2 2024.=C2=A0 In Q4 2022, UCB initiated a Phase 2a (proof-of-concept) study to evaluate t= he efficacy and safety of rozanolixizumab to treat adult study participants= with severe fibromyalgia syndrome. First topline results are expected in H= 2 2024. Fibromyalgia is a common, severe and debilitating disorder of unkno= wn etiology characterized by widespread musculoskeletal pain, fatigue, slee= p disturbances, and mood disorders.=C2=A0 Bepranemab is a recombinant, humanized, full-length immunoglobulin G4 monoc= lonal anti-tau antibody currently under clinical investigation for the trea= tment of patients with Alzheimer=E2=80=99s disease (AD) in partnership with= Roche/Genentech. The efficacy, safety and tolerability of bepranemab in pa= tients with early AD are investigated in a Phase 2 study, which started in = Q2 2021. Recruitment for this study was completed ahead of time and topline= results are now expected earlier, in Q4 2024. UCB0599 is an orally bioavailable and brain-barrier-penetrant small molecul= e that prevents the pathological misfolding and accumulation of alpha-synuc= lein, a protein which plays a key role in Parkinson=E2=80=99s disease (PD) = pathology. By inhibiting the disease-causing biology of alpha-synuclein mis= folding, it is believed that the progression of PD can be slowed or halted.= Under a global co-development and co-commercialization agreement with Nova= rtis, UCB is conducting a phase 2a study with UCB0599 for study participant= s with early-stage PD. In 2022, an additional dosing arm was introduced int= o the study. Recruitment is complete and topline results are now expected i= n Q4 2024. UCB initiated Phase 1b studies in atopic dermatitis addressing two differen= t targeted immune pathways with UCB9741 and UCB1381. These early studies ev= aluate the safety, pharmacokinetics and efficacy in people with moderate-to= -severe atopic dermatitis. Atopic dermatitis is a chronic condition that ca= uses dry, itchy and inflamed skin and can affect people at all ages. All other clinical development programs are continuing as planned.=C2=A0 =C2=A0 Net sales break-down by product Due to rounding, some financial data may not add up in the tables.=C2=A0 CIMZIA^=C2=AE (certolizumab pegol) reached 180 000 people living with infla= mmatory TNF-mediated diseases. CIMZIA is showing a stronger growth than the= anti-TNF market =E2=80=93 based on differentiation and driven by double-di= git growth in the U.S. and Japan. CIMZIA has reached UCB=E2=80=99s projecte= d peak sales target of =E2=82=AC two billion - ahead of time. https://mb.cision.com/Public/18595/3720385/be5657c3b9d53c91_800x800ar.png VIMPAT^=C2=AE (lacosamide) was accessed by over 600 000 people living with = epilepsy and is experiencing generic competition since end of March 2022 in= the U.S. and since September 2022 in Europe due to loss of exclusivity in = these two regions. In Japan and international markets, the net sales show c= ontinued solid growth. https://mb.cision.com/Public/18595/3720385/8d9862bad355adc5_800x800ar.png KEPPRA^=C2=AE (levetiracetam) reached over 1.8 million people living with e= pilepsy. The generic erosion due to loss of exclusivity in Japan started ea= rly January 2022 and was stronger than expected due to multiple generics an= d governmental support for generic levetiracetam. Also, in the U.S. and Eur= ope the performance is reflecting generic competition. https://mb.cision.com/Public/18595/3720385/b06ccbe2d3c0e750_800x800ar.png BRIVIACT^=C2=AE (brivaracetam), was used by 190 000 people living with epil= epsy and showed significant growth in all regions. Briviact^=C2=AE has a di= fferent mode of action from Vimpat=C2=AE and differentiates from Keppra^=C2= =AE. https://mb.cision.com/Public/18595/3720385/ac8a9106aad5f2b6_800x800ar.png NEUPRO^=C2=AE (rotigotine), the patch for Parkinson=E2=80=99s disease and r= estless legs syndrome, used by over 340000 patients, recorded stable net sa= les in a competitive market environment. https://mb.cision.com/Public/18595/3720385/b1233e7b6caaf4dd_800x800ar.png FINTEPLA^=C2=AE (fenfluramine) is now part of the UCB epilepsy portfolio th= anks to the completed acquisition of Zogenix, Inc. in early March and reach= ed more than 1 000 patients and their families. FINTEPLA^=C2=AE is approved= for seizures associated with rare epileptic syndromes, Dravet (since mid-2= 020) in U.S. Europe and Lennox Gastaut syndrome (since late March 2022) in = the U.S., providing new treatment options for patients and families living = with these rare syndromes that are particularly challenging to treat. Net s= ales (March - December) were =E2=82=AC 116 million. The integration of Zoge= nix was successfully completed as planned by the end of 2022. NAYZILAM^=C2=AE (midazolam) Nasal SprayCIV, a nasal rescue treatment for ep= ilepsy seizure clusters in the U.S. reached over 90 000 patients and net sa= les of =E2=82=AC 78 million, a plus by 36% (+21% CER). BIMZELX^=C2=AE (bimekizumab) reached over 4 000 people living with psoriasi= s and is being launched throughout Europe, the UK, Japan, Canada and furthe= r countries. Net sales were =E2=82=AC 35 million (after =E2=82=AC 4 million= in 2021). For the U.S., the regulatory review is ongoing with an expected = decision by the U.S. authority in Q2 2023. EVENITY^=C2=AE (romosozumab) since launch globally reached more than 400 00= 0 women living with severe postmenopausal osteoporosis at high risk of frac= ture. Net sales increased to =E2=82=AC 25 million after =E2=82=AC 10 millio= n in 2021. It had its first European launch in March 2020 and was impacted = by the pandemic since then. EVENITY^=C2=AE is being launched successfully g= lobally by Amgen, Astellas and UCB since 2019, with net sales outside Europ= e reported by the partners. 2022 FY financial highlights Due to rounding, some financial data may not add up in the tables. https://mb.cision.com/Public/18595/3720385/843c14425d15808f_800x800ar.png =E2=80=9CThe statutory auditor has issued an unqualified report with no emp= hasis of matter paragraph dated 21 February 2023 on the company=E2=80=99s c= onsolidated accounts as of and for the year ended 31 December 2022, and has= confirmed that the accounting data reported in the accompanying press rele= ase is consistent, in all material respects, with the accounts from which i= t has been derived.=E2=80=9D Revenue in 2022 reached =E2=82=AC 5 517 million (-4%; -7% CER^1) and net sa= les were =E2=82=AC 5 140 million (-6%; -8% CER^1). This was driven by the c= ontinued growth of UCB=E2=80=99s product portfolio =E2=80=93 namely CIMZIA= =C2=AE, BRIVIACT^=C2=AE, NAYZILAM^=C2=AE; EVENITY^=C2=AE as well as newly l= aunched BIMZELX^=C2=AE =E2=80=93 and the addition of FINTEPLA^=C2=AE. This = performance was slightly over-compensated by the effects of the loss of exc= lusivity for VIMPAT=C2=AE in the U.S. and Europe and E KEPPRA^=C2=AE in Jap= an. Royalty income and fees were =E2=82=AC 85 million (+8%; -3% CER^1) and othe= r revenue went up by 28% (+24% CER^1) to =E2=82=AC 292 million due to miles= tones and other payments from R&D partners and include a one-time amount of= =E2=82=AC 70 million from sale of intellectual property rights (olokizumab= ).=C2=A0 Gross profit before =E2=80=9Camortization of intangible assets linked to sa= les=E2=80=9D was =E2=82=AC 4 239 million (-6%; -7% CER^1) and in-line with = the net sales performance. The adjusted gross margin is 76.8% after 77.7% i= n 2021.=C2=A0 Gross profit after =E2=80=9Camortization of intangible assets linked to sal= es=E2=80=9D reached =E2=82=AC 3 843 million =E2=80=93 a gross margin of 69.= 7% after 75.1% in 2021 and reflecting the addition of FINTEPLA^=C2=AE amort= ization. Operating expenses increased to =E2=82=AC 3 168 million (+5%; +1 CER1) refl= ecting higher expenses due to the addition and integration of Zogenix. Stro= ng cost discipline allowed the absorption of inflation costs. Operating exp= enses are consisting of: =C2=B7 marketing and selling expenses of =E2=82=AC 1 489 million (+11%; +3%= CER^1) =E2=80=93 focused reallocation and cost discipline allowed to inves= t behind the launches and pre-launch activities for 2023: global FINTEPLA^= =C2=AE launch activities, global BIMZELX^=C2=AE launch activities as well a= s ongoing preparations for a launch in the U.S., global pre-launch activiti= es for rozanolixizumab and zilucoplan for people living with generalized my= asthenia gravis (gMG) and EVENITY^=C2=AE ongoing launches throughout Europe= . =C2=A0 =C2=A0 =C2=B7 research and development expenses of =E2=82=AC 1 670 million (+3%; 0= % CER^1) reflecting the continued investments in UCB=E2=80=99s progressing = pipeline which resulted in several ongoing regulatory reviews: bimekizumab = (several indications), rozanolixizumab, zilucoplan and FINTEPLA^=C2=AE. Dur= ing 2022, 6 phase 3 programs and 3 phase 2 programs were ongoing as well as= earlier clinical development, 3 new programs were added to the clinical pi= peline. The decision to terminate the clinical development in ITP led to te= rmination costs of =E2=82=AC 46 million in 2022. The R&D ratio reached 30% = in 2022 after 28% in 2021. =C2=B7 general and administrative expenses of =E2=82=AC 225 million (+9%; += 6%), due to the integration of Zogenix=C2=A0 =C2=B7 other operating income of =E2=82=AC 216 million following =E2=82=AC = 162 million in 2021 =E2=80=93 driven by an income of =E2=82=AC 240 million = (+59%) reflecting the net contribution from Amgen in connection with the co= mmercialization of EVENITY^=C2=AE. This was partly compensated by write-off= s on receivables. Underlying operational profitability =E2=80=93 adjusted EBITDA^2 =E2=80=93 = reached =E2=82=AC 1 260 million (-23%; +21% CER^1) driven by decreased reve= nue and increased operating expenses, reflecting the investments into the f= uture growth of UCB, namely into product launches and ongoing clinical deve= lopment. The adjusted EBITDA ratio for 2022 (in % of revenue) reached 22.8%= , after 28.4% in 2021. Total impairment, restructuring and other expenses increased to =E2=82=AC 9= 0 million, after =E2=82=AC 34 million in 2021. This was mainly driven by fe= es and restructuring expenses related to the acquisition of Zogenix in Marc= h 2022. Net financial expenses went up to =E2=82=AC 74 million from =E2=82=AC 58 mi= llion, based on higher interest rates as well as higher interest cost due t= o higher net debt in connection with the acquisition of Zogenix. Income tax expenses were =E2=82=AC 91 million compared to =E2=82=AC 170 mil= lion in 2021. The average effective tax rate was 17.8% compared to 13.9% in= 2021, reflecting the lower earnings and earnings mix. Profit amounted to =E2=82=AC 418 million (-61%; -55% CER^1). Reflecting low= er revenue due to the loss of exclusivity and higher operating expenses dri= ven by launch activities and launch preparations for the 2023 potential lau= nches. 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 4.37 a= fter =E2=82=AC 6.49 in 2021, based on stable 190 million weighted average s= hares outstanding. Dividend - The Board of Directors of UCB proposes a dividend of =E2=82=AC1.= 33 per share (gross), +2%. Guidance 2023: The year 2023 will be marked by ongoing launches and several= upcoming launches in the U.S. and Europe =E2=80=93 subject to regulatory a= pprovals. At the same time UCB is impacted by the full annualized and ongoi= ng generic erosion to VIMPAT^=C2=AE. For 2023, UCB expects revenues in the range of =E2=82=AC 5.15 - 5.35 billio= n based on expected launch contributions like the expected mid-year U.S. la= unch of bimekizumab for people living with psoriasis and taking into accoun= t the full annualized negative impacts from the loss of exclusivity for VIM= PAT^=C2=AE in the U.S. and Europe as well as based on continued solid contr= ibution from the existing product portfolio. UCB will continue to invest in upcoming launches to offer potential new sol= utions for people living with severe diseases and remains committed to inve= st into research and development advancing its late-stage development pipel= ine. UCB will also continue to execute strong cost discipline, sell non-cor= e assets and manage the significant impact of inflation in 2023. At the sam= e time, the integration of the Zogenix acquisition will become earnings acc= retive during 2023. Underlying profitability, adjusted EBITDA, is expected = in the range of 22.5 - 23.5% of revenue. Core earnings per share are theref= ore expected in the range of =E2=82=AC 3.40 - 3.80 per share-based on an av= erage of 190 million shares outstanding. =C2=A0 The figures for the financial guidance 2023 as mentioned above are calculat= ed on the same basis as the actual figures for 2022. Guidance for 2025 confirmed: UCB confirms its growth ambition for 2025. Bas= ed on the strong product portfolio and the promising assets currently under= regulatory review =E2=80=93 leading to multiple expected launches in all g= eographies. UCB aims to lead in five specific populations by 2025, creating= value for patients now and into the future. Revenue in 2025 is expected to= reach at least =E2=82=AC 6 billion and the underlying profitability (adjus= ted EBITDA) should reach the low to mid-thirties in percent of revenue. Guidance 2023 & 2025: Based on UCB=E2=80=99s current assessment of the Covi= d-19 pandemic, UCB remains confident in the fundamental underlying demand f= or its products in the short-term and its prospects for long-term growth. U= CB will continue to closely follow evolving COVID-19 pandemic and its conse= quences to the business environment diligently to assess potential near- an= d mid-term challenges. ---------------------------------- Find the financial reports on UCB website: http://www.ucb.com/investors/Dow= nload-center=C2=A0 Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00= (GMT) / 14.00 (CET) Register here: https://www.ucb.com/investors=C2=A0 For more information UCB: Investor Relations=C2=A0 Antje Witte T +32.2.559.9414 Antje.witte@ucb.com Julien Bayet T: +32 2 559 9580 Julien.bayet@ucb.com Global Communications=C2=A0 Laurent Schots T+32.2.559.9264 Laurent.schots@ucb.com 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 approximately 8 700 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Fol= low 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 pandemics (such as COVID-19), wars on territories wh= ere UCB has businesses, changes in general economic, business and competiti= ve conditions, the inability to obtain necessary regulatory approvals or to= obtain them on acceptable terms or within expected timing, costs associate= d with research and development, changes in the prospects for products in t= he pipeline or under development by UCB, effects of future judicial decisio= ns or governmental investigations, safety, quality, data integrity or manuf= acturing issues; potential or actual data security and data privacy breache= s, or disruptions of our information technology systems, product liability = claims, challenges to patent protection for products or product candidates,= competition from other products including biosimilars, changes in laws or = regulations, exchange rate fluctuations, changes or uncertainties in tax la= ws or the administration of such laws, and hiring and retention of its empl= oyees. There is no guarantee that new product candidates will be discovered= or identified in the pipeline, or that new indications for existing produc= ts will be developed and approved. Movement from concept to commercial prod= uct is uncertain; preclinical results do not guarantee safety and efficacy = of product candidates in humans. So far, the complexity of the human body c= annot be reproduced in computer models, cell culture systems or animal mode= ls. The length of the timing to complete clinical trials and to get regulat= ory approval for product marketing has varied in the past and UCB expects s= imilar unpredictability going forward. Products or potential products which= are the subject of partnerships, joint ventures or licensing collaboration= s may be subject to disputes between the partners or may prove to be not as= safe, effective or commercially successful as UCB may have believed 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 companies may= not be as successful as UCB may have believed at the moment of acquisition= . Also, UCB or others could discover safety, side effects or manufacturing = problems with its products and/or devices after they are marketed. The disc= overy of significant problems with a product similar to one of UCB=E2=80=99= s products that implicate an entire class of products may have a material a= dverse effect on sales of the entire class of affected products. Moreover, = sales may be impacted by international and domestic trends toward managed c= are and health care cost containment, including pricing pressure, political= and public scrutiny, customer and prescriber patterns or practices, and th= e reimbursement policies imposed by third-party payers as well as legislati= on affecting biopharmaceutical pricing and reimbursement activities and out= comes. Finally, a breakdown, cyberattack or information security breach cou= ld compromise the confidentiality, integrity and availability of UCB=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. =C2=A0 GenericFile UCB Press Release FY 2022 final ENG (https://mb.cision.com/Public/18595/372= 0385/bee839f4593c88f2.pdf) Image Chart UCB FY 2022 financial results (https://mb.cision.com/Public/18595/372= 0385/9ac6ad735854bb10_org.png) Image Chart UCB Top Product Net Sales (https://mb.cision.com/Public/18595/3720385= /a850d0057578a7cb_org.png) Image Cimzia Net Sales (https://mb.cision.com/Public/18595/3720385/be5657c3b9d53c= 91_org.png) Image Vimpat Net Sales (https://mb.cision.com/Public/18595/3720385/8d9862bad355ad= c5_org.png) Image Keppra Net Sales (https://mb.cision.com/Public/18595/3720385/b06ccbe2d3c0e7= 50_org.png) Image Briviact Net Sales (https://mb.cision.com/Public/18595/3720385/ac8a9106aad5= f2b6_org.png) Image Neupro Net Sales (https://mb.cision.com/Public/18595/3720385/b1233e7b6caaf4= dd_org.png) Image 2022 FY Financial Highlights (https://mb.cision.com/Public/18595/3720385/84= 3c14425d15808f_org.png) GenericFile UCB Press Release FY 2022 final NL (https://mb.cision.com/Public/18595/3720= 385/bf365a003f62c94d.pdf) GenericFile UCB Press Release FY 2022 final FR (https://mb.cision.com/Public/18595/3720= 385/9c3884f82d8273dd.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x129507x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium

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