UCB (EBR:UCB) UCB Media Room: update to 2022 financial guidance while maintaining 2025 financial guidance

Transparency directive : regulatory news

24/06/2022 07:00
https://mb.cision.com/Public/18595/3591103/aef626e665864e18_800x800ar.png ** UCB updates financial guidance for 2022 while maintaining 2025 financial= guidance ------------------------------------------------------------ =C2=B7 UCB aims to submit the response to the bimekizumab complete response= letter (CRL) by the end of 2022, triggering a later potential launch date = in the U.S. =C2=B7 Zogenix integration: earnings dilution in 2022, earnings accretive e= xpected from 2023 onwards =C2=B7 Combination of unprecedented, multiple external headwinds and diffic= ult macro situation lead to upward pressure on costs=C2=A0 =C2=B7 Updated financial guidance for 2022: Revenue expected in the range o= f =E2=82=AC 5.3 - 5.4 billion, adjusted EBITDA^2 in the range 21 - 22 % of = revenue, Core EPS^3 in the range of =E2=82=AC 3.70 - 4.00 =C2=A0 =C2=B7 Financial guidance for 2025 unchanged Brussels (Belgium), 24 June 2022 =E2=80=93 7:00 (CEST) =E2=80=93 regulated = information =E2=80=93 inside information=C2=A0 UCB is updating its 2022 financial guidance factoring in the impact of the = Zogenix acquisition, the complete response letter for bimekizumab in the U.= S. and macro-economic conditions. UCB=E2=80=99s foundation for growth is st= rong as demonstrated by recent positive clinical phase 3 study results whic= h will lead to regulatory submissions starting next quarter. The company is= confident in its ability to deliver value and growth for patients and all = other stakeholders through its strong fundamental underlying performance. U= CB reiterates its 2025 financial guidance. Jean-Christophe Tellier, CEO UCB says: =E2=80=9CWe aim to submit our respon= se to the complete response letter by the end of the year =E2=80=93 and are= fully committed to bring bimekizumab as treatment option to people living = with psoriasis in the U.S. We are updating our financial guidance, reflecti= ng the most recent events and the current macro situation. UCB=E2=80=99s un= derlying performance is solid, despite the impacts from the loss of exclusi= vity for E KEPPRA^=C2=AE in Japan since January and for VIMPAT^=C2=AE in th= e U.S. since March. We are very confident in our future launches and our st= rategic growth path ahead, supported by dynamic management and efficiency i= nitiatives in all areas of UCB. Our drive to create value for patients, now= and into the future, remains stronger than ever.=E2=80=9D=C2=A0 Bimekizumab complete response letter response timing UCB aims to submit the response to the bimekizumab complete response letter= (CRL) to the U.S. Food and Drug Administration (FDA) by the end of 2022. U= CB will address all observations and questions noted in the CRL and is full= y confident in the quality of its manufacturing process. Upon receiving the= response, the FDA will classify the response following the re-submission. = A Class 1 re-submission would imply a 2-month review cycle by the FDA post = the re-submission date, and a Class 2 re-submission would imply a 6-month r= eview cycle post the re-submission date.=C2=A0 Updated financial guidance 2022 -=C2=A0 Zogenix acquisition Following the close of the Zogenix, Inc. acquisition in early March 2022, t= he full integration process is nearly complete. This acquisition is now for= the first time reflected in UCB=E2=80=99s financial guidance. Together wit= h the team from Zogenix, UCB is bringing FINTEPLA^=C2=AE (fenfluramine) ora= l solution to patients and their families around the world living with Drav= et Syndrome and Lennox-Gastaut Syndrome (LGS). FINTEPLA^=C2=AE is available= in the U.S and Europe to treat seizures associated with Dravet Syndrome. I= n June, UK=E2=80=99s National Institute for Healthcare Excellence (NICE) is= sued a positive Final Appraisal Determination (FAD) recommending FINTEPLA^= =C2=AE (fenfluramine) oral solution for the treatment of seizures associate= d with Dravet Syndrome as an add-on therapy to other anti-epileptic medicin= es for patients two years of age and older. Since late March 2022, FINTEPLA= ^=C2=AE is approved in the U.S. for the treatment of Lennox-Gastaut Syndrom= e (LGS), in patients two years of age and older. The application review for= LGS in the EU and other regions is ongoing. The new financial guidance for 2022 takes into account the expected net sal= es contribution from FINTEPLA^=C2=AE as well as the additional research and= development, marketing and selling and other expenses, leading to a diluti= on of the UCB earnings, consistent with UCB=E2=80=99s assessment at the tim= e of the acquisition. The dilution to UCB=E2=80=99s adjusted EBITDA guidanc= e is expected around 2.5%-points in 2022. The acquisition is expected to be= earnings accretive from 2023 onwards. -=C2=A0 Bimekizumab complete response letter impact=C2=A0 UCB aims to submit the response to the bimekizumab complete response letter= (CRL) to the U.S. Food and Drug Administration (FDA) by the end of 2022. A= djustments to the 2022 financial guidance removed the 2022 net sales contri= bution in the U.S., adjusted the expenses while ensuring that the expected = launch is secured and reflect the gross profit and tax implications.=C2=A0 Since the second half of 2021, BIMZELX^=C2=AE (bimekizumab) is available to= people living with psoriasis in the European Union /European Economic Area= , Great Britain, Japan, Canada and approved in Australia.=C2=A0 -=C2=A0 Macro environment adding up Multiple external headwinds combined with a difficult macro-economic situat= ion are leading to upward pressure on costs - like significantly higher tha= n anticipated inflation including energy costs, the war in Ukraine includin= g drug supply and donations to Ukraine. These were reflected in the new upd= ated financial guidance for 2022. -=C2=A0 Adjusted financial guidance for 2022=C2=A0 For 2022, UCB is now aiming for revenues in the range of =E2=82=AC5.3 =E2= =80=93 5.4 billion based on continued core product growth and taking into a= ccount impacts from the loss of exclusivity for VIMPAT^=C2=AE in the U.S. (= March) and Europe (September) and the strong generic competition to E KEPPR= A^=C2=AE in Japan since January.=C2=A0 UCB continues to invest in research and development to advance its late-sta= ge development pipeline and prepare for upcoming launches to offer potentia= l new solutions for patients. Underlying profitability, adjusted EBITDA, is= now expected in the range of 21 - 22% of revenue, also reflecting the cont= inued research and development and marketing & selling investment levels. C= ore earnings per share are therefore expected in the range of =E2=82=AC3.70= - 4.00 per share =E2=80=93 based on an average of 189 million shares outst= anding. The figures for the new financial guidance 2022 as mentioned above are calc= ulated on the same basis as the actual figures for 2021; they have been ext= ended by the consolidation of the acquisition of Zogenix, Inc.=C2=A0 UCB will publish its Half-Year Report 2022 on July 28, 2022. 2025 financial guidance =E2=80=93confirmed Supported by solid multiple scenario planning and sustainable efficiency ge= nerating initiatives in all areas of UCB - being introduced since Q4 2021 -= UCB maintains its financial guidance for 2025. Revenue in 2025 is expected= to reach at least =E2=82=AC 6 billion and the underlying profitability (ad= justed EBITDA) should reach the low to mid-thirties in percent of revenue. Based on UCB=E2=80=99s current assessment of the Covid-19 pandemic, UCB rem= ains confident in the fundamental underlying demand for its products in the= short-term and its prospects for long-term growth. UCB will continue to cl= osely follow the evolving COVID-19 pandemic and its consequences to the bus= iness environment diligently to assess potential near- and mid-term challen= ges. ----------------- 2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation an= d Amortization charges 3 Core EPS =3D core earnings per share For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T +32.2.559.9414 antje.witte@ucb.com Julien Bayet T: +32 2 559 9580 julien.bayet@ucb.com Global Communications 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 8 600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.8 billion in 2021. 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 guaranteeing of future performance and are subject to k= nown and unknown risks, uncertainties and assumptions which might cause the= actual results, financial condition, performance or achievements of UCB, o= r industry results, to differ materially from those that may be expressed o= r implied by such forward-looking statements contained in this press releas= e.=C2=A0 Important factors that could result in such differences include but are not= limited to: global spread and impacts of wars and pandemics. Including COV= ID-19, changes in general economic, business and competitive conditions, th= e inability to obtain necessary regulatory approvals or to obtain them on a= cceptable terms or within expected timing, costs associated with research a= nd development, changes in the prospects for products in the pipeline or un= der development by UCB, effects of future judicial decisions or governmenta= l investigations, safety, quality, data integrity or manufacturing issues; = potential or actual data security and data privacy breaches, or disruptions= of our information technology systems, product liability claims, challenge= s to patent protection for products or product candidates, competition from= other products including biosimilars, changes in laws or regulations, exch= ange rate fluctuations, changes or uncertainties in tax laws or the adminis= tration of such laws, and hiring and retention of its employees. There is n= o guarantee that new product candidates will be discovered or identified in= the pipeline, or that new indications for existing products will be develo= ped and approved. Movement from concept to commercial product is uncertain;= preclinical results do not guarantee safety and efficacy of product candid= ates in humans. So far, the complexity of the human body cannot be reproduc= ed in computer models, cell culture systems or animal models. The length of= the timing to complete clinical trials and to get regulatory approval for = product marketing has varied in the past and UCB expects similar unpredicta= bility going forward. Products or potential products which are the subject = of partnerships, joint ventures or licensing collaborations 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 pa= rtnership. UCB=E2=80=99 efforts to acquire other products or companies and = to integrate the operations of such acquired companies may not be as succes= sful as UCB may have believed at the moment of acquisition. Also, UCB or ot= hers could discover safety, side effects or manufacturing problems with its= products and/or devices after they are marketed. The discovery of signific= ant problems with a product similar to one of UCB=E2=80=99s products that i= mplicate an entire class of products may have a material adverse effect on = sales of the entire class of affected products. Moreover, sales may be impa= cted by international and domestic trends toward managed care and health ca= re cost containment, including pricing pressure, political and public scrut= iny, customer and prescriber patterns or practices, and the reimbursement p= olicies imposed by third-party payers as well as legislation affecting biop= harmaceutical pricing and reimbursement activities and outcomes. Finally, a= breakdown, cyberattack or information security breach could compromise the= confidentiality, integrity and availability of UCB=E2=80=99s data and syst= ems.=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. These forward-looking statements are made only as of the date of th= is press release, and do not reflect any potential impacts from the evolvin= g war in Ukraine and COVID-19 pandemic, unless indicated otherwise. The com= pany continues to follow the development diligently to assess the financial= significance of this to UCB. 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 2022 PR UCB Updated Guidance ENG (https://mb.cision.com/Public/18595/359110= 3/93c187013fac175c.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x109216x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium

UCB's latest news

24/06/2022 20:05
24/06/2022 20:00
24/06/2022 07:00
17/06/2022 20:00
10/06/2022 20:00
02/06/2022 20:00
25/05/2022 20:05
25/05/2022 20:00
24/05/2022 20:00
23/05/2022 08:31

Other stories

04/07/2022 00:11
03/07/2022 23:38
03/07/2022 23:30
03/07/2022 19:55
03/07/2022 17:13
03/07/2022 23:58
03/07/2022 13:30
03/07/2022 14:12
03/07/2022 19:57
02/07/2022 11:45
03/07/2022 19:50
03/07/2022 15:30
03/07/2022 20:22
03/07/2022 18:33
03/07/2022 20:12
03/07/2022 21:15
02/07/2022 22:08
03/07/2022 09:11
03/07/2022 13:05
03/07/2022 17:00
03/07/2022 16:31
02/07/2022 11:55
03/07/2022 23:34
03/07/2022 22:38
03/07/2022 09:14
03/07/2022 19:00
03/07/2022 22:38
03/07/2022 18:43
04/07/2022 00:34
03/07/2022 23:29
02/07/2022 08:27
03/07/2022 12:00
02/07/2022 19:56
02/07/2022 07:19
02/07/2022 03:14
03/07/2022 19:15
03/07/2022 10:11
03/07/2022 08:05