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CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC=
rjYrJUHPDVbu1NKaBE-3DLeYJ_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2=
FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN=
n-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSwCY5b3k3IPeAZ2Oyhp-2Fd2=
fpAp4vB4-2FEOjhliVYCBr41akPdEnsDj8TrtQRN5pwG0-2F4Nbs3nPhYgH-2FMvLx12KiCfYFP=
MLYBfQucDGm2JOzNiP2Wlt0c8U7Wo5HpdudW4-2BZ18TWbbWR2Nua1BOLtwgbz7MnQaSz5vnaLM=
2KaFcagzW1CYc35PpPjUxhv7VxbND0ed1bpWVo-3D
** UCB on Growth Path for a Decade Plus
------------------------------------------------------------
=C2=B7 Revenue in 2023 reached =E2=82=AC 5.25 billion (-5%; -6% CER^1), net=
sales were =E2=82=AC 4.87 billion (-5%; -6% CER^1) =E2=80=93 in-line with =
financial guidance
=C2=B7 Strong performance by newly launched growth drivers (net sales growt=
h at Act rates): EVENITY^=C2=AE +140%, FINTEPLA^=C2=AE +94%, BIMZELX^=C2=AE=
+323%. RYSTIGGO^=C2=AE with =E2=82=AC 19 million since July, ZILBRYSQ^=C2=
=AE launched globally since Q1 2024=C2=A0
=C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 1.35 billion =
(+7%; -1% CER^1),=C2=A0
=C2=B7 25.7% of revenue =E2=80=93 better than the guidance due to higher EV=
ENITY^=C2=AE contribution and good cost management
=C2=B7 U.S. FDA accepted the filings of BIMZELX^=C2=AE for psoriatic arthri=
tis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosi=
ng spondylitis (AS). The application for hidradenitis suppurativa (HS) has =
also been submitted to FDA. FDA action and potential approvals expected for=
all indications before the end of 2024
=C2=B7 Financial guidance for 2024: Revenue expected to grow to =E2=82=AC 5=
.5-5.7 billion, adjusted EBITDA^2 23.0-24.5% of revenue, Core EPS^3 of =E2=
=82=AC 3.70-4.40
=C2=A0
UCB Full-Year Report 2023, Brussels (Belgium), 28 February 2024 =E2=80=93 7=
:00 (CET) =E2=80=93 regulated information=C2=A0
"Our 2023 performance showcases our unwavering commitment to ensuring peopl=
e with severe diseases can live the life they like, as free as possible fro=
m challenges of disease, reaching more than 3.2 million patients globally w=
ith severe immunological and neurological conditions. In the last 14 months=
we obtained 14 approvals, across 6 patient populations and across 3 contin=
ents, fuelling our growth for a decade plus. As an example, superior patien=
t experience and UCB's dedication have allowed to double the number of pati=
ents using BIMZELX =C2=AE in Europe over six months," Jean-Christophe Telli=
er, CEO UCB commented. "For future growth, we are studying innovative, pote=
ntial medicines for 10 patient populations in 12 clinical development progr=
ams with expected news flow in 2024. What guides us is our belief that ever=
yone deserves to live the best life that they can. We are therefore pleased=
with the growing access to our medicines across geographies, and we contin=
ue to decrease our greenhouse gas emissions in line with our commitment to =
reach net zero emissions.=E2=80=9D
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhjKAJ3KOY17T5GTzv8YHlbUjtQf=
leldaz8xKqwH9eHrN40OImfdQsMT32lHYIfL0DB9XCY_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT=
FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx=
s8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSwCY5b=
3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDvlcAaEA5ZhciXsBAyoHP4sP8-=
2FNOeQQRmXOWatO758m4-2F4fOcdQ3ZDKs8Z1Mu5Mrbw-2F7qlHg02NJldU2djs6S3YHQfYM3eC=
rcB6LURWlId-2FmfKHOROQ4mRcZdWkoWbZM6wYnK1oIE7dqbyZRn06GagA-3D
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
FY 2023 revenue reached =E2=82=AC 5.25 billion (-5%; -6% CER^1). Net sales =
reached =E2=82=AC 4.87 billion (-5%; -6% CER1), based on the stable perform=
ance of CIMZIA^=C2=AE and the strong growth of BRIVIACT^=C2=AE, FINTEPLA^=
=C2=AE and BIMZELX^=C2=AE. As expected, this was more than offset by the co=
ntracting effects from the losses of exclusivity of two products.=C2=A0
Underlying profitability (adjusted EBITDA^2) reached =E2=82=AC 1.35 billion=
(7%; -1% CER^1), despite lower revenue due to the losses of exclusivity, h=
igher operating expenses =E2=80=93 reflecting the investments into the futu=
re growth of UCB, namely into product launches - and compensated by higher =
operating income.=C2=A0
Profit amounted to =E2=82=AC 343 million (-18%; -34% CER^1). Core EPS^3 wer=
e =E2=82=AC 4.20 after =E2=82=AC 4.37 in 2022. The Board of Directors of UC=
B proposes a dividend of =E2=82=AC 1.36 per share (gross), + 3 cents.
Sandrine Dufour, CFO UCB says: =E2=80=9CA year with good product growth and=
strong launches - we are pleased to deliver again solid financial results.=
As expected, we=E2=80=99re seeing the impacts from the losses of exclusivi=
ty for two products diminishing in the second half and thanks to the strong=
revenue performance of our growth assets, we returned to growth in the sec=
ond half with almost +3%. Continued smart resource allocation and a strong =
contribution from EVENITY^=C2=AE enabled us to invest in the product launch=
es. In 2024, we will accelerate our investments launching three products ar=
ound the globe, including a direct to consumer (DTC) campaign in the U.S. f=
or BIMZELX^=C2=AE, previously slated for 2023. We are on our way to deliver=
growth for a decade plus. Our financial guidance for 2024 foresees a growi=
ng top line and an almost stable adjusted EBITDA margin. Our commitment for=
2025 for growing the top line to at least =E2=82=AC 6 billion and an impro=
ved margin stands.=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 2023 to a clinical development pipeline with 12 clinical programs o=
ngoing spanning 10 different medicines, set to help 10 different patient po=
pulations. Since January 2023 and in the key regions U.S., EU and Japan, UC=
B obtained 14 approvals across six patient populations. 8 regulatory review=
s are ongoing. Below the details since the Half-Year Report 2023:
Regulatory Update
In June 2023, E KEPPRA=C2=AE (levetiracetam) was approved in Japan for the =
treatment of partial-onset epileptic seizures in young patients (1m-<4years=
of age).
In July 2023, the European Medicines Agency (EMA) has accepted for review t=
he marketing authorization application of bimekizumab for the treatment of =
adults with moderate to severe hidradenitis suppurativa (HS), a chronic, re=
current, and debilitating skin condition with high unmet medical need.=C2=
=A0
In July 2023, UCB submitted the marketing authorization application for the=
epilepsy medicine BRIVIACT^=C2=AE (brivaracetam) to PMDA in Japan. This ap=
plication is for the treatment of partial onset seizures (POS) with or with=
out secondary generalization in adult patients (=E2=89=A516 years of age) w=
ith monotherapy and adjunctive therapy.
In September 2023, UCB announced the approval of RYSTIGGO^=C2=AE (rozanolix=
izumab) and ZILBRYSQ^=C2=AE (zilucoplan) for the treatment of adult patient=
s with generalized myasthenia gravis (gMG) in Japan, where RYSTIGGO^=C2=AE =
is indicated for patients inadequately responding to corticosteroids or non=
-corticosteroid immunosuppressants and ZILBRYSQ^=C2=AE is indicated for pat=
ients who inadequately respond to steroids or other immunosuppressants. In =
February 2023, PMDA in Japan accepted for review the filing of rozanolixizu=
mab in a priority review.
In October 2023, UCB announced U.S. FDA approval of ZILBRYSQ^=C2=AE (ziluco=
plan) for the treatment of adults with generalized myasthenia gravis (gMG) =
who are anti-acetylcholine receptor antibody-positive (anti-AChRAb+). ZILBR=
YSQ^=C2=AE is the first once-daily subcutaneous, targeted C5 complement inh=
ibitor for gMG. It is the only once-daily gMG-targeted therapy for self-adm=
inistration.
In October 2023, the U.S. FDA approved BIMZELX^=C2=AE (bimekizumab-bkzx), t=
he first and only IL-17A and IL-17F inhibitor, for the treatment of adults =
with moderate to severe plaque psoriasis who are candidates for systemic th=
erapy or phototherapy.
In November 2023, UCB filed bimekizumab for the treatment of hidradenitis s=
uppurativa (HS), a chronic, painful, and debilitating skin condition, with =
PMDA in Japan.
In December 2023, ZILBRYSQ^=C2=AE (zilucoplan) was approved in the European=
Union for the treatment of adults with gMG who are anti-AChRAb+. In Septem=
ber 2023, UCB received CHMP positive opinion for zilucoplan for the treatme=
nt of adults with gMG in Europe.
In December 2023, BIMZELX^=C2=AE was approved in Japan for the treatment of=
adult patients with active psoriatic arthritis (PsA), adult patients with =
active ankylosing spondylitis (AS) and adult patients with active non-radio=
graphic axial spondyloarthritis (nr-axSpA). In January 2023, PMDA in Japan =
had accepted for review the filing for BIMZELX^=C2=AE in these indications.
In early January 2024, RYSTIGGO^=C2=AE (rozanolixizumab) was approved in th=
e European Union for the treatment of adults with generalized myasthenia gr=
avis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specif=
ic tyrosine kinase (MuSK) antibody positive. In November 2023, UCB received=
the CHMP positive opinion for rozanolixizumab for treatment of adults with=
generalized myasthenia gravis in Europe.
In February 2024, UCB announced that the U.S. FDA accepted the supplemental=
biologics license applications (sBLA) seeking approval of BIMZELX^=C2=AE (=
bimekizumab-bkzx) for three new spondyloarthritides indications: psoriatic =
arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and an=
kylosing spondylitis (AS). The fourth sBLA for hidradenitis suppurativa (HS=
) has also been submitted to FDA. UCB expects FDA action and potential appr=
ovals for all indications before the end of 2024.=C2=A0
Pipeline Update
In November 2023, first patients were included in a phase 2a study with UCB=
0022. UCB0022 is designed to enhance the potency of endogenous dopamine =E2=
=80=98when and where needed=E2=80=99. UCB0022 is an orally available, brain=
-penetrant, small molecule acting as a Dopamine-1 receptor positive alloste=
ric modulator. UCB0022 could bring, as symptomatic treatment, significant p=
ositive impact on the quality of life of people who are suffering from Park=
inson=E2=80=99s symptoms despite an adequately dosed treatment without both=
ersome side effects that can result from Dopamine-receptor overstimulation.=
First results are expected in H1 in 2025.
During H2 2023, UCB9741 and UCB1381 progressed successfully and moved into =
Phase 2a status with first headline results expected in H2 2024. Atopic Der=
matitis (AtD) is a common inflammatory skin disorder with higher prevalence=
rates among children. Despite evolving standard of care, unmet needs for m=
oderate to severe AtD patients persist. Multiple pathways are believed to b=
e the driver of pathobiology in AtD, as such UCB is developing two anti-bod=
ies targeting distinct pathways.
All other clinical studies are continuing as planned, with headline results=
expected for 11 programs in 2024.
Net sales break-down by key products
Due to rounding, some financial data may not add up in the tables.=C2=A0
CIMZIA^=C2=AE (certolizumab pegol) reached more than 180 000 people living =
with inflammatory TNF-mediated diseases. CIMZIA^=C2=AE is showing a stronge=
r growth than the anti-TNF market =E2=80=93 based on differentiation. CIMZI=
A^=C2=AE is offering treatment for women of childbearing age across 6 indic=
ations and for rheumatoid arthritis patients with high rheum factor levels.=
In Europe as well as in international markets growth trend continues. Volu=
me growth in the U.S. remains robust with 5% plus. Also in Japan, volume gr=
owth was positive but over-compensated by the regular mandatory price cut.
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhj4aBe5pnwoX2fpJW3e3XKP37Mg=
zWY6j7whV5SIYPmKRkrCh4BB33vYHC-2Bv-2FIfa2lJQSj2_2dCLUNbuBjhX746-2FvM63L9Hyn=
3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93D=
wfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSw=
CY5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDqUqGjQEP4XwSPLJTwHTPi=
zINuOaK13YYE1fqXLvcpjWbaX5XEwxVzGxbw-2Ff1G56nkbcDt1871bq-2FGKBpm-2B1jVAZV80=
HE-2BmsqpxX8ajguVpOVENY9lzJS0ICGh-2FJg1FLfJQf9oG0rGU4YbxmybsUGWE-3D
VIMPAT^=C2=AE (lacosamide) was accessed by over 500 000 people living with =
epilepsy and is experiencing generic competition since March 2022 in the U.=
S. and since September 2022 in Europe due to loss of exclusivity. In Japan,=
the net sales show continued growth.
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhjFtIlBFTLrPZTmfaHPJwgR-2Fv=
fAJ-2BWxZddmBJIYYML4iKYH43iNaLMqRDM89EngFL5yBU1_2dCLUNbuBjhX746-2FvM63L9Hyn=
3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93D=
wfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSw=
CY5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDgn-2Bl-2B-2BFhOj3d2x-=
2BM5h06qsyz3h9fAZYdcEijowFvnhNSVsZqBStKUoGmel1aEVLFGwCT5p3p4dqk9B-2B7xqgFBI=
XDfb0HgTvz-2BcOdTr98HSwy79Xslpemrgnvnx0nVbjHw5EwnRVzhVPxv5ZNobGsoU-3D
KEPPRA^=C2=AE (levetiracetam) reached over 1.7 million people living with e=
pilepsy. Net sales went down due to continued generic erosion in Japan sinc=
e 2022. In all other markets, KEPPRA^=C2=AE is off patent for more than a d=
ecade.
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhjeqX3czWaeTQuGuiTKDcou4MmU=
QPRgygQx-2BQVt8AhetBfR6X2BmZXLiJc-2BW6oZd4eaoym_2dCLUNbuBjhX746-2FvM63L9Hyn=
3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93D=
wfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSw=
CY5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDmkfvNGP4BXEWDAtHsl6qB=
VYoaP4rfVsyASm8sMgb-2FnnXtj9C93yCW401cGTjOtRu4FLUBAGjWJXczjl3kEovUIvSw58T4b=
7iCm5gAun6D4TtmFT83-2BqczjbKlKPLXizw5HL5w2fYg9W307K9t2MdGs-3D
BRIVIACT^=C2=AE (brivaracetam), was used by 190 000 people living with epil=
epsy and showed significant growth in all regions it is available to patien=
ts. BRIVIACT^=C2=AE is currently under regulatory review in Japan. BRIVIACT=
^=C2=AE has a different mode of action from Vimpat=C2=AE and differentiates=
from KEPPRA^=C2=AE.=C2=A0
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhjj04tybEfXNFPM30zKGhcKMAld=
GAEB7yT-2FFOigJrsaRemEJZ8qEUxXbHU4KuEprrkC1mI_2dCLUNbuBjhX746-2FvM63L9Hyn3K=
nTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93Dwf=
Ixs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSwCY=
5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDkAHuKzOGO7ePuLPcD-2FRd3=
QFkF2tYicPpQKfkSTsO2b3nbE-2BJMKM15LbhW8LKD8ve8zkmt9sk9UhaTGohukcCcotnxdoxEt=
ad8FEk4N-2BSa-2BeYUDiwXO9QZZH2GWj-2FX9xjYvHFslSVAgRmejIN8vSung-3D
FINTEPLA^=C2=AE (fenfluramine) reached more than 3 000 patients and their f=
amilies living with seizures associated with rare epileptic syndromes - Dra=
vet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). Partner Nippon Shinyak=
u in Japan books the in-market sales. FINTEPLA^=C2=AE was added to the UCB =
portfolio in March 2022. Following a settlement in a patent dispute in late=
2023, UCB is now considering Q4 2033 as a later loss of exclusivity in the=
U.S.
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhj234K6HV1Bi76GTtE-2BG4MA5i=
AMD7TaqqEL-2FbBDRK4w-2B4wCP6sOBxzxiNozyxwW-2FPnsjSS_2dCLUNbuBjhX746-2FvM63L=
9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeF=
O93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2y=
rJSwCY5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDhgX5XcENjrsbmckwc=
V-2BmcVnz6MB6G9tMoI8nMxZdQhfa-2BzPaIYsQnieWM3IOHoQlWlkj3fEP5zsy0nhhp20fnwnd=
wMKJXm9MN6sl3X6mEFM4EdRujyiKYdvpOO58prrrWxwpqGXyaPnhrCqizckh4E-3D
BIMZELX^=C2=AE (bimekizumab) is available to people living with psoriasis i=
n more than 40 countries, including the U.S. since mid-November 2023. Addit=
ionally, it is available to people living with active psoriatic arthritis (=
PsA), with active ankylosing spondylitis (AS) and active non-radiographic a=
xial spondyloarthritis (nr-axSpA) in Europe since May 2023 and in Japan sin=
ce December 2023. More than 18 000 patients had access to the product.
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhjxWVSUtS00QQL4qyV78pgSrdEw=
QEGdfdf858OMLvnnRxaTDoRpXEDNXZSAiyhPYMOiD00_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT=
FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx=
s8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSwCY5b=
3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDtbFyFNC5mDjFgEcgAkDoCFGmW=
SlOdi0CQEBuMCE1vZz3Ga5Xh45yyVVaFjUDI-2Bx2Bq6U-2BfFJ-2BCBq5YHfi2bSSC4WWp8aC-=
2BUAezPCbAs-2BuBv7FliksZHXzw3JRN1ynn8PHvuU0lxy2YT6L4PfBNDyyk-3D
NAYZILAM^=C2=AE (midazolam) Nasal SprayCIV, a nasal rescue treatment for ep=
ilepsy seizure clusters in the U.S. reached over 70 000 patients and net sa=
les of =E2=82=AC 94 million, a plus by 21% (24% CER)
EVENITY^=C2=AE (romosozumab) since launch globally reached more than 600 00=
0 women living with postmenopausal osteoporosis at high risk of fracture. N=
et sales in Europe increased to =E2=82=AC 60 million after =E2=82=AC 25 mil=
lion in 2022. EVENITY^=C2=AE is being launched successfully globally by Amg=
en, Astellas and UCB since 2019, with net sales outside Europe reported by =
the partners. EVENITY^=C2=AE showed strong growth annualizing worldwide sal=
es of more than US$ 1 billion. The worldwide profit contribution from EVENI=
TY^=C2=AE is recognized under 'Other operating income=E2=80=99.
RYSTIGGO^=C2=AE (rozanolixizumab-noli), a new treatment option for people l=
iving with generalized myasthenia gravis (gMG) was launched in the U.S. in =
July 2023. In 2023, net sales amounted to =E2=82=AC 19 million. At the end =
of 2023, RYSTIGGO^=C2=AE was launched in Japan and the launches throughout =
Europe are starting in Q1 2024.=C2=A0
2023 FY financial highlights
Due to rounding, some financial data may not add up in the tables.
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CyBv9bezcPT-2BuItTLKIHepbJqshy5KVF-2BTLfuY-2FzGXhjM8YNOhQWYQZEOFaFtE7uP-2Bw=
yJa0jhMK9y7ZA7u4xcfgJR1O77vZmszngil9039t3W_HZ_2dCLUNbuBjhX746-2FvM63L9Hyn3K=
nTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93Dwf=
Ixs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJSwCY=
5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDr3xpQgfDIHe0Gu62Ppd860o=
PIe-2FkbHVvz2tcR1LJ0ThARyWmCA1bl4XSWFJkt5ww-2Fq93as33WLqmstObobvRjkNRJO-2B8=
T9MaclZuh8EhrFZxSKWdew-2FvfE7CsY4KQhZzCvZ5deuJ03xwraX0bPt1x4-3D
=E2=80=9CThe statutory auditor has issued an unqualified report with no emp=
hasis of matter paragraph dated 27 February 2024 on the company=E2=80=99s c=
onsolidated accounts as of and for the year ended 31 December 2023, 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 2023 reached =E2=82=AC 5 252 million (-5%; -6% CER^1) and net sa=
les were =E2=82=AC 4 867 million (-5%; -6% CER^1). This was driven by the c=
ontinued growth of UCB=E2=80=99s product portfolio =E2=80=93 namely BRIVIAC=
T^=C2=AE, NAYZILAM^=C2=AE and FINTEPLA^=C2=AE showed double digit growth. C=
IMZIA^=C2=AE is the largest drug in the portfolio, showing stable performan=
ce and an increase at constant rates. EVENITY^=C2=AE as well as newly launc=
hed BIMZELX^=C2=AE more than doubled net sales. This performance was over-c=
ompensated by the known effects of the loss of exclusivity for VIMPAT^=C2=
=AE in the U.S. and Europe and E KEPPRA^=C2=AE in Japan.
Royalty income and fees were =E2=82=AC 77 million (-9%; -7% CER^1) and othe=
r revenue went up by 5% (6% CER^1) to =E2=82=AC 308 million due to continue=
d partnership activities, milestones and other payments from R&D partners a=
nd include a one-time amount of =E2=82=AC 70 million from a milestone.=C2=
=A0
Adjusted Gross profit (Gross Profit before =E2=80=9Camortization of intangi=
ble assets linked to sales=E2=80=9D) was =E2=82=AC 4 033 million (-5%; -6% =
CER^1) and well in-line with the net sales performance. The adjusted gross =
margin remained stable at 76.8% as in 2022.=C2=A0
Gross profit after =E2=80=9Camortization of intangible assets linked to sal=
es=E2=80=9D reached =E2=82=AC 3 545 million =E2=80=93 a gross margin of 67.=
5% after 69.7% in 2022 and reflecting the addition of FINTEPLA^=C2=AE amort=
ization. This amortization has been revised in late 2023 following a settle=
ment in a patent dispute in the U.S. UCB is now considering Q4 2033 as the =
loss of exclusivity in the U.S.
Operating expenses declined to =E2=82=AC 2 888 million (-9%; -7% CER1) refl=
ecting higher marketing and selling expenses, lower research and developmen=
t expenses, slightly higher general and administration expenses and an =E2=
=80=9Cother operating income=E2=80=9D which more than doubled. Total operat=
ing expenses are consisting of:
=C2=B7 7% higher marketing and selling expenses of =E2=82=AC 1 594 million =
(+10% CER^1) =E2=80=93 focused reallocation and cost discipline allowed to =
invest behind the launches and pre-launch activities for UCB=E2=80=99s grow=
th drivers: Global FINTEPLA^=C2=AE launch activities in two indications, gl=
obal BIMZELX^=C2=AE launch activities in up to four indications, global lau=
nch activities for RYSTIGGO^=C2=AE and ZILBRYSQ^=C2=AE. =C2=A0
=C2=A0
=C2=B7 2% lower research and development expenses of =E2=82=AC 1 630 millio=
n (-1% CER^1) reflect the continued investments in UCB=E2=80=99s progressin=
g R&D pipeline today encompassing 10 potential new treatment options in cli=
nical studies for patients living with severe diseases in 5 phase 3 trials =
and 7 proof-of-concept (phase 2a) trials as well as ongoing earlier researc=
h activities. The R&D ratio reached 31% in 2023 after 30% in 2022 due to lo=
wer revenue.
=C2=B7 2% higher general and administrative expenses of =E2=82=AC 230 milli=
on (+3% CER)=C2=A0
=C2=B7 other operating income went up to =E2=82=AC 566 million following =
=E2=82=AC 216 million in 2022 =E2=80=93 driven by the net contribution of =
=E2=82=AC 368 million (+53%) from EVENITY^=C2=AE. Other =E2=80=98other oper=
ating income=E2=80=99 was from the sale of a portfolio of established brand=
s in Europe (=E2=82=AC 145 million), in early 2023. =C2=A0
Underlying operational profitability =E2=80=93 adjusted EBITDA^2 =E2=80=93 =
increased by 7% to =E2=82=AC 1 349 million (-1% CER^1) due to efficient per=
formance and cost management: lower revenue due to generic erosion, high op=
erating expenses - reflecting the investments into the future growth of UCB=
, namely into product launches - and compensated by high operating income. =
The adjusted EBITDA ratio for 2023 (in % of revenue) reached 25.7%, after 2=
2.8% in 2022.
Total impairment, restructuring and other expenses decreased to =E2=82=AC 5=
3 million, after =E2=82=AC 90 million in 2022. In 2022, this was mainly dri=
ven by fees and restructuring expenses related to the acquisition of Zogeni=
x in March 2022.
Net financial expenses went up to =E2=82=AC 163 million from =E2=82=AC 74 m=
illion, based on higher interest rates as well as higher interest cost due =
to higher net debt in connection with the acquisition of Zogenix in March 2=
022. Also, positive currency income in 2022 did not reoccur in 2023.
Income tax expenses were =E2=82=AC 98 million compared to =E2=82=AC 91 mill=
ion in 2022. The average effective tax rate was 22% compared to 18% in 2022=
, reflecting the lower earnings and the earnings mix.
Profit amounted to =E2=82=AC 343 million (-18%; -34% CER^1).
Core earnings per share, adjusted for the after-tax impact of to be adjuste=
d items, the financial one-offs, the after-tax contribution from discontinu=
ed operations and the net amortization of intangibles linked to sales, reac=
hed =E2=82=AC 4.20 after =E2=82=AC 4.37 in 2022, based on stable 190 millio=
n weighted average shares outstanding.
Dividend - The Board of Directors of UCB proposes a dividend of =E2=82=AC1.=
36 per share (gross), +2%.
Financial Guidance 2024 - The year 2024 will be marked by intense ongoing g=
lobal launches of the UCB growth drivers, BIMZELX^=C2=AE, RYSTIGGO^=C2=AE, =
ZILBRYSQ^=C2=AE and FINTEPLA^=C2=AE as well as EVENITY^=C2=AE.=C2=A0
For 2024, UCB is aiming for an increase of revenues to the range of =E2=82=
=AC 5.5 - =E2=82=AC 5.7 billion taking into account the launches and the co=
ntinued solid contributions from the existing product portfolio.
UCB will accelerate investments in launches around the globe to offer poten=
tial new solutions for people living with severe diseases and remains commi=
tted to invest into research and development advancing its late-stage and e=
arly development pipeline. At the same time, UCB will continue to be cost d=
isciplined and, as in 2023, to actively manage the tail of its portfolio. U=
nderlying profitability, adjusted EBITDA, is expected in the range of 23.0%=
- 24.5% of revenue. Core earnings per share are therefore expected in the =
range of =E2=82=AC 3.70 - 4.40 per share =E2=80=93 based on an average of 1=
90 million shares outstanding.=C2=A0
The figures for the financial guidance 2024 as mentioned above are calculat=
ed on the same basis as the actual figures for 2023.
Guidance for 2025: UCB confirms its growth ambition for 2025 based on the s=
trong product portfolio and the strong growth drivers. Revenue in 2025 is e=
xpected to reach at least =E2=82=AC 6 billion and the underlying profitabil=
ity (adjusted EBITDA) at the low end of the range of low to mid-thirties in=
percent of revenue.
1 Due to rounding, some financial data may not add up in the tables include=
d in this management report
2 CER =3D constant exchange rates
---------------------------------------------------------------------
Find the financial reports on UCB website: https://u7061146.ct.sendgrid.net=
/ls/click?upn=3Du001.b00YhNV2Nr0-2BaZn7eVNAdRuqs9DPo5j8zUQIRAJaO4yuVuthhHDj=
Eo1006G9NYf-2Bb1qrLT-2BZIzSD6ncswk4Fag-3D-3Dz7IH_2dCLUNbuBjhX746-2FvM63L9Hy=
n3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93=
DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x1UN8K-2FDrPv2yrJS=
wCY5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDh0fknBYfZQWla60dBJG-=
2BRmkZ39fR-2BCnplXr2Mgu-2Bmnr28wvaf-2F1BvCd4Ns7otl4tR8Cr0EghSm5EWo1V8UWf6jA=
c45K5JAjb0-2FCRAZdxaIYNDGMw1zvvRPvgdVNIf0Nxc5mpU-2FKEXfmWpOmJSU2Ap0-3D
Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00=
(GMT) / 14.00 (CET)
Register here: https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2Ba=
xUzlo7XKIuSly0rC2gh0pAj0jRFBrcUOJMNg4HBLipYiGLcQ3CKG3v-2FQZQG-8gS_2dCLUNbuB=
jhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ=
4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33KZ2-2BhPiDQWlaGPzVH0x=
1UN8K-2FDrPv2yrJSwCY5b3k3IPeAZ2Oyhp-2Fd2fpAp4vB4-2FEOjhliVYCBr41akPdEnsDtV7=
L-2FfCnv0x02zeNwUKODwPRKzYqps1-2BD3efl-2FjnNtW1pp356ZQYQCHJOhsgfDqVK-2BCkW8=
n-2Bth2qGf5Plvl6oO81oPNpTGp-2Fg5jAubQKthxcfJNxYWT6ThnmwZtEyXXccpjoKQEbubcOl=
n-2Fh19RFiE-3D
For further information, contact UCB:=C2=A0
Investor Relations=C2=A0=C2=A0 =C2=A0=C2=A0=C2=A0 =C2=A0
Antje Witte
T +32.2.559.9414
Antje.witte@ucb.com=C2=A0=C2=A0 =C2=A0
Julien Bayet
T: +32 2 559 9580
Julien.bayet@ucb.com=C2=A0=C2=A0 =C2=A0
Global Communications
Laurent Schots, Media Relations
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 9 000 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.3 billion in 2023. 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 =
limitation, statements containing the words =E2=80=9Cpotential=E2=80=9D, =
=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=9Csee=
ks=E2=80=9D, =E2=80=9Cestimates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cw=
ill=E2=80=9D, =E2=80=9Ccontinue=E2=80=9D and similar expressions. These for=
ward-looking statements are based on current plans, estimates and beliefs o=
f management. All statements, other than statements of historical facts, ar=
e statements that could be deemed forward-looking statements, including est=
imates of revenues, operating margins, capital expenditures, cash, other fi=
nancial information, expected legal, arbitration, political, regulatory or =
clinical results or practices and other such estimates and results. By thei=
r nature, such forward-looking statements are not guaranteeing future perfo=
rmance and are subject to known and unknown risks, uncertainties, and assum=
ptions which might cause the actual results, financial condition, performan=
ce or achievements of UCB, or industry results, to be materially different =
from any future results, performance, or achievements expressed or implied =
by such forward-looking statements contained in this press release.=C2=A0
Important factors that could result in such differences include but are not=
limited to: global spread and impacts of wars and pandemics, changes in ge=
neral economic, business and competitive conditions, the inability to obtai=
n necessary regulatory approvals or to obtain them on acceptable terms or w=
ithin expected timing, costs associated with research and development, chan=
ges in the prospects for products in the pipeline or under development by U=
CB, effects of future judicial decisions or governmental investigations, sa=
fety, 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, challenges to patent protecti=
on for products or product candidates, competition from other products incl=
uding biosimilars, changes in laws or regulations, exchange rate fluctuatio=
ns, 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 discovered or identified in the pipeline, or th=
at new indications for existing products will be developed and approved. Mo=
vement from concept to commercial product is uncertain; preclinical results=
do not guarantee safety and efficacy of product candidates in humans. So f=
ar, the complexity of the human body cannot be reproduced in computer model=
s, cell culture systems or animal models. The length of the timing to compl=
ete clinical trials and to get regulatory approval for product marketing ha=
s varied in the past and UCB expects similar unpredictability going forward=
. Products or potential products which are the subject of partnerships, joi=
nt ventures or licensing collaborations may be subject to disputes between =
the partners or may prove to be not as safe, effective or commercially succ=
essful as UCB may have believed at the start of such partnership. UCB=E2=80=
=99s efforts to acquire other products or companies and to integrate the op=
erations of such acquired companies may not be as successful as UCB may hav=
e believed at the moment of acquisition. Also, UCB or others could discover=
safety, side effects or manufacturing problems with its products and/or de=
vices 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 material adverse effect on sales of the entire=
class of affected products. Moreover, sales may be impacted by internation=
al and domestic trends toward managed care and health care cost containment=
, including pricing pressure, political and public scrutiny, customer and p=
rescriber patterns or practices, and the reimbursement policies imposed by =
third-party payers as well as legislation affecting biopharmaceutical prici=
ng and reimbursement activities and outcomes. Finally, a breakdown, cyberat=
tack or information security breach could compromise the confidentiality, i=
ntegrity and availability of UCB=E2=80=99s data and systems.
Given these uncertainties, you are cautioned not to place any undue relianc=
e on such forward-looking statements. These forward-looking statements are =
made only as of the date of this press release, and do not reflect any pote=
ntial impacts from the evolving conflicts, wars, pandemics, as well as any =
other adversity, unless indicated otherwise. The company continues to follo=
w the development diligently to assess the financial significance of these =
events, as the case may be, to UCB.
UCB expressly disclaims any obligation or duty to update any forward-lookin=
g statements in this press release, either to confirm the actual results or=
to report or reflect any change in its forward-looking statements with reg=
ard thereto or any change in events, conditions or circumstances on which a=
ny such statement is based, unless such statement is required pursuant to a=
pplicable laws and regulations.
=C2=A0
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FY 2023 Chart Bimzelx (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001=
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FY 2023 Chart Financial Highlights (https://u7061146.ct.sendgrid.net/ls/cli=
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UCB PR FY2023 FR (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-=
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UCB PR FY2023 NL (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-=
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