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
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