https://mb.cision.com/Public/18595/3810107/b359c1f1fb339964_800x800ar.png
** UCB now at the inflection point =E2=80=93 ready to start a new phase of =
growth
------------------------------------------------------------
=C2=B7 Revenue reached =E2=82=AC 2.6 billion (-11%; -13% CER1), net sales w=
ere =E2=82=AC 2.4 billion (-12%; -14% CER^1)
=C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 801 million (=
-2%; -9% CER^1), 31% of revenue
=C2=B7 CIMZIA^=C2=AE continued growth, VIMPAT^=C2=AE generic erosion as ant=
icipated, FINTEPLA^=C2=AE, EVENITY^=C2=AE and BIMZELX^=C2=AE with strong la=
unches; Zogenix becoming earnings accretive=C2=A0
=C2=B7 4 approvals and launches: FINTEPLA^=C2=AE in Lennox-Gastaut syndrome=
(LGS) in the EU, BIMZELX^=C2=AE in psoriatic arthritis (PsA) and across th=
e full spectrum of axial spondyloarthritis (axSpA) in the EU, RYSTIGGO=C2=
=AE in generalized myasthenia gravis (gMG) in the U.S.; 10 regulatory filin=
gs under review in the U.S., the EU and Japan=C2=A0
=C2=B7 Financial guidance for 2023 confirmed: Revenue expected to reach =E2=
=82=AC 5.15 - 5.35 billion, adjusted EBITDA^2 22.5 - 23.5% of revenue, Core=
EPS3 of =E2=82=AC 3.40 - 3.80=C2=A0
=C2=A0
UCB Half-Year Report 2023, Brussels (Belgium), 27 July 2023 =E2=80=93 7:00 =
(CEST) =E2=80=93 regulated information =C2=A0
"We had a robust first half 2023, delivered good product growth and strong =
launches while absorbing the impacts from the anticipated loss of exclusivi=
ty for E KEPPRA^=C2=AE and VIMPAT^=C2=AE. These impacts are receding, and w=
e have now reached the inflection point with overall company growth going f=
orward," Jean-Christophe Tellier, CEO UCB commented. "We are pleased to ser=
ve more than 10 000 people living with psoriasis around the globe where BIM=
ZELX^=C2=AE is available for patients. BIMZELX^=C2=AE now captures greater =
than one third of new prescriptions of IL17 products for psoriasis. We are =
working with the U.S. agency FDA and are expecting action for bimekizumab i=
n Q3 2023. We are looking forward to bringing our newly U.S. approved RYSTI=
GGO^=C2=AE to people living with generalized myasthenia gravis. We like to =
thank our employees and partners for their great efforts and together, we a=
re working towards our strong long-term growth and our ambition to create v=
alue for all stakeholders, now and into the future.=E2=80=9D=C2=A0
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HY 2023 revenue reached =E2=82=AC 2.6 billion (-11%; -13% CER^1). Net sales=
reached =E2=82=AC 2.4 billion (-12%; -14% CER^1). This reflects the antici=
pated generic erosion of VIMPAT^=C2=AE in the U.S. and the EU and of E KEPP=
RA^=C2=AE in Japan. The growth of the UCB product portfolio was driven by C=
IMZIA^=C2=AE, BRIVIACT^=C2=AE, BIMZELX^=C2=AE, FINTEPLA^=C2=AE and EVENITY^=
=C2=AE.
Underlying profitability (adjusted EBITDA^2) reached =E2=82=AC 801 million =
(-2%; -9% CER^1), reflecting lower revenue and lower operating expenses. Th=
ese were driven by higher marketing and selling expenses, lower research an=
d development expenses, lower general and administrative expenses and signi=
ficantly higher other operating income =E2=80=93 also supported by a one-ti=
me income from a product sale. The adjusted EBITDA ratio for the first six =
months of 2023 (in % of revenue) reached 31%, compared to the first six mon=
ths 2022 with 28%.
Profit amounted to =E2=82=AC 311 million (-22%; -33% CER^1). Core EPS^3 wer=
e =E2=82=AC 2.63 after =E2=82=AC 3.15 in the first six months 2022.
Sandrine Dufour, CFO UCB says: =E2=80=9CWe are pleased to deliver healthy f=
inancial results for the first six months 2023 and to confirm our financial=
guidance for 2023. We see the inflection point in the net sales performanc=
e, leaving the loss of exclusivity impacts behind us and bringing company g=
rowth. We successfully integrated Zogenix which is becoming earnings accret=
ive as expected. The second half of the year is planned to be marked by sig=
nificant investments behind the ongoing and upcoming launches.=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, wit=
h an unprecedented regulatory and clinical pipeline, set to help people liv=
e their best possible lives.
UCB is expecting action from the U.S. agency for bimekizumab in Q3 2023.
In June, the European Commission granted marketing authorization for BIMZEL=
X=C2=AE (bimekizumab) for the treatment of adult patients with active psori=
atic arthritis (PsA) and adult patients with active axial spondyloarthritis=
(axSpA).
In July, the European Medicines Agency (EMA) has accepted for review the ma=
rketing authorization application of bimekizumab for the treatment of adult=
s with moderate to severe hidradenitis suppurativa (HS).
In June, fenfluramine was filed with the Japanese regulatory authority for =
the treatment of patients with Lennox-Gastaut syndrome (LGS) and orphan dru=
g designation was granted in May 2023.
In February, the regulatory agency in Japan accepted the filing for review =
of rozanolixizumab for the treatment of adults with generalized myasthenia =
gravis (gMG).
In June, FDA granted marketing authorization for RYSTIGGO=C2=AE (rozanolixi=
zumab-noli) for the treatment of gMG. Rozanolixizumab is a subcutaneous (SC=
) monoclonal antibody targeting the neonatal Fc receptor (FcRn) for the tre=
atment of adults with gMG who are anti-acetylcholine receptor (AChR) or ant=
i-muscle-specific tyrosine kinase (MuSK) antibody positive.
In June, E Keppra^=C2=AE (levetiracetam) was approved in Japan for the trea=
tment of partial-onset epileptic seizures in young patients (1m-4years of a=
ge)
All other clinical development programs are continuing as planned.
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) serving people living with inflammatory =
TNF-mediated diseases is showing a stronger volume growth than the anti-TNF=
market =E2=80=93 based on differentiation and driven by continued growth i=
n the U.S. and strong growth in international markets. In Japan, order patt=
ens by partner Astellas led to lower net sales in the first half of 2023. T=
he underlying prescription trend, however, is positive.
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KEPPRA^=C2=AE (levetiracetam) for people living with epilepsy reported lowe=
r net sales. The generic erosion in Japan started early January 2022 and wa=
s stronger than expected due to multiple generics and governmental support =
for generic levetiracetam. The erosion continued during the first six month=
s of 2023, however, at a slower pace than expected. The loss of exclusivity=
in the U.S. and Europe occurred more than 10 years ago.=C2=A0
https://mb.cision.com/Public/18595/3810107/a12be4b52a7fdf02_800x800ar.png
BRIVIACT^=C2=AE (brivaracetam) is available for people living with epilepsy=
and showed significant growth in all regions. Briviact^=C2=AE has a differ=
ent mode of action from Vimpat^=C2=AE and differentiates from Keppra^=C2=AE=
. UCB expects peak sales of =E2=82=AC600 million by 2026.
https://mb.cision.com/Public/18595/3810107/934e0d57839895ac_800x800ar.png
VIMPAT^=C2=AE (lacosamide) is available for people living with epilepsy. Th=
e expected generic erosion in the U.S. and the EU started in March and Sept=
ember 2022, respectively, negatively impacted the overall net sales. The ot=
her regions showed good, continued growth.
https://mb.cision.com/Public/18595/3810107/a6436d1c0ca141f7_800x800ar.png
FINTEPLA^=C2=AE (fenfluramine) was acquired via Zogenix in March 2022 and i=
s approved for seizures associated with rare epileptic syndromes, Dravet sy=
ndrome and Lennox Gastaut syndrome, providing new treatment options for pat=
ients and families living with these rare syndromes that are particularly c=
hallenging to treat.
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BIMZELX^=C2=AE (bimekizumab) for people living with psoriasis is being laun=
ched throughout Europe, the UK, Japan, Canada and further countries. Total =
net sales were =E2=82=AC 52 million (after =E2=82=AC 10 million), thereof =
=E2=82=AC 43 million in Europe (after =E2=82=AC 9 million). UCB is serving =
more than 10 000 people living with psoriasis around the globe, where BIMZE=
LX^=C2=AE is available for patients and it now captures more than one third=
of new prescriptions of IL17 products for psoriasis. For the U.S., the reg=
ulatory review is ongoing with an expected action by the U.S. authority in =
Q3 2023.
EVENITY^=C2=AE (romosozumab) for women living with severe postmenopausal os=
teoporosis at high risk of fracture saw its net sales in Europe increased t=
o =E2=82=AC 24 million after =E2=82=AC 9 million. EVENITY^=C2=AE is being l=
aunched successfully globally by Amgen, Astellas and UCB since 2019, with n=
et sales outside Europe reported by the partners.
NAYZILAM^=C2=AE (midazolam) Nasal Spray^CIV, a nasal rescue treatment for e=
pilepsy seizure clusters reached net sales of =E2=82=AC 42 million in the U=
.S., an increase of 17% (+16% CER).
2023 HY financial highlights
Due to rounding, some financial data may not add up in the tables.
https://mb.cision.com/Public/18595/3810107/b763f87cfd63f245_800x800ar.png
=C2=A0
=E2=80=9CThe statutory auditor has issued an unqualified report with no emp=
hasis of matter paragraph dated 26 July 2023 on the company=E2=80=99s conso=
lidated accounts as of and for the year ended 30 June 2023 and has confirme=
d that the accounting data reported in the accompanying press release is co=
nsistent, in all material respects, with the accounts from which it has bee=
n derived.=E2=80=9D
Revenue in the first six months of 2023 reached =E2=82=AC 2 589 million (-1=
1%; -13% CER1) and net sales were =E2=82=AC 2 378 million (-12%; -14% CER^1=
). Net sales reflect the generic erosion of VIMPAT^=C2=AE in the U.S. and E=
urope and of E KEPPRA^=C2=AE in Japan =E2=80=93 compensated by positive CIM=
ZIA^=C2=AE growth and strong launches of FINTEPLA^=C2=AE, EVENITY^=C2=AE an=
d BIMZELX^=C2=AE.
Royalty income and fees were =E2=82=AC 42 million (-7%; -8% CER^1) and othe=
r revenue was =E2=82=AC 169 million (-3%; -3% CER^1) due to milestones =E2=
=80=93 including a one-time amount of =E2=82=AC 70 million for VIMPAT^=C2=
=AE partnership activities in Japan =E2=80=93 and other payments from R&D p=
artners.
Adjusted gross profit before =E2=80=9Camortization of intangible assets lin=
ked to sales=E2=80=9D was =E2=82=AC 2 004 million (-11%; =E2=80=9113% CER^1=
) and in-line with the net sales performance. The adjusted gross margin is =
stable at 77%.=C2=A0
Gross profit after =E2=80=9Camortization of intangible assets linked to sal=
es=E2=80=9D reached =E2=82=AC 1 787 million =E2=80=93 a gross margin of 69%=
after 71% in June 2022 and reflecting the addition of FINTEPLA^=C2=AE amor=
tization.
Operating expenses decreased to =E2=82=AC 1 302 million (-15%; -14 CER^1) r=
eflecting lower expenses and higher other operating income. Operating expen=
ses are consisting of:
=C2=B7 higher marketing and selling expenses of =E2=82=AC 753 million (+3%;=
+4% CER^1) =E2=80=93 reflecting investments behind the launches and pre-la=
unch activities: Global FINTEPLA^=C2=AE launch activities, global BIMZELX^=
=C2=AE launch activities as well as preparation for the U.S., and global la=
unch preparations for RYSTIGGO^=C2=AE (rozanolixizumab) and zilucoplan in g=
eneralized myasthenia gravis.
=C2=B7 lower research and development expenses of =E2=82=AC 759 million (-5=
%; -4% CER^1) reflecting the continued investments in UCB=E2=80=99s progres=
sing late-stage pipeline encompassing five phase 3 projects and four phase =
2 projects as well as two projects in phase 1b as well as ongoing earlier s=
tage research activities. The R&D ratio reached 29% after 27% due to the lo=
wer topline.
=C2=B7 lower general and administrative expenses of =E2=82=AC 104 million (=
-9%; -9% CER^1), thanks to improved value-focused allocation of resources a=
nd ceasing integration costs for Zogenix as planned.
=C2=B7 higher other operating income of =E2=82=AC 315 million following =E2=
=82=AC 114 million in the first six months of 2022 =E2=80=93 driven by the =
net contribution from Amgen in connection with the commercialization of EVE=
NITY^=C2=AE of =E2=82=AC156 million after =E2=82=AC 108 million and by othe=
r operating income from the sale of a portfolio of established brands in Eu=
rope (=E2=82=AC 145 million).
Underlying operational profitability =E2=80=93 adjusted EBITDA^2 =E2=80=93 =
reached =E2=82=AC 801 million (-2%; -9% CER^1) driven by lower revenue and =
lower operating expenses. The adjusted EBITDA ratio (in % of revenue) reach=
ed 31%, after 28% in June 2022.
Total impairment, restructuring and other expenses decreased to =E2=82=AC 6=
million, after =E2=82=AC 61 million. Last year this was mainly driven by f=
ees and restructuring expenses related to the acquisition of Zogenix.
Net financial expenses went up to =E2=82=AC 79 million from =E2=82=AC 9 mil=
lion, stemming from higher net debt after the acquisition of Zogenix in Mar=
ch 2022, higher interest rates and a positive currency impact in 2022, not =
reoccurring in 2023.
Income tax expenses were =E2=82=AC 90 million (+10%; +8% CER^1). The averag=
e effective tax rate was 22% compared to 17% in June 2022. The increase in =
tax rate is explained by two items: an expected drop in profit before tax c=
ompared to 2022 where the tax charge remains stable and a one-off reversal =
of a deferred tax liability in 2022 which does not occur in 2023.
Profit decreased to =E2=82=AC 311 million (-22%; -33% CER^1) driven by lowe=
r revenue, lower operating expenses and lower other expenses, higher financ=
ial expenses, and higher taxes. The full amount is attributable to UCB shar=
eholders.
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 2.63 a=
fter =E2=82=AC 3.15 in June 2022, based on 189 million weighted average sha=
res outstanding.
Financial guidance for 2023 confirmed: Revenue is expected to reach =E2=82=
=AC 5.15 - 5.35 billion, adjusted EBITDA^2 22.5 - 23.5% of revenue and core=
EPS^3 of =E2=82=AC 3.40 - 3.80. The financial guidance for 2025 is unchang=
ed. =C2=A0
1 CER =3D constant exchange rates
2 adj. EBITDA =3D adjusted Earnings Before Interest, Taxes, Depreciation an=
d Amortization charges
3 Core EPS =3D core earnings per share
-----------------------
Find the financial reports on UCB website: http://www.ucb.com/investors/Dow=
nload-center=C2=A0
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Julien Bayet
T: +32 2 559 9580
Julien.bayet@ucb.com
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email 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
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UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium
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