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UCB [BE0003739530 / UCB]

UCB Media Room: Half Year Report 2020

INFORMATION REGLEMENTEE


[27/07/2020 | 07:02]
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** UCB Half Year Report 2020: UCB=E2=80=99s resilient product portfolio dri=
ves continued company growth
------------------------------------------------------------

=C2=B7 Revenue increased to =E2=82=AC 2.6 billion and net sales to =E2=82=
=AC 2.5 billion, both +12%, +9% CER^1=C2=A0or +10% at CER and adjusted for =
divestitures respectively
=C2=B7 Underlying profitability (adj. EBITDA^2) was =E2=82=AC 783 million (=
+8%, 0% CER) or a ratio of 30%
=C2=B7 Ra Pharma acquisition closed early April, Engage Therapeutics acquir=
ed in June,=C2=A0co-promotion agreement for Cimzia^=C2=AE with Ferring in J=
uly
=C2=B7 R&D update: bimekizumab in psoriasis with positive Phase 3b results;=
padsevonil in drug-resistant focal epilepsy terminated; Phase 3 with dapir=
olizumab pegol in SLE to start
=C2=B7 Financial outlook for 2020 confirmed: Revenue expected to reach =E2=
=82=AC 5.05 =E2=80=93 5.15 billion, adjusted EBITDA^2 should reach 26 - 27%=
of revenue, Core EPS^3 of =E2=82=AC 4.40 - 4.80 expected

Brussels (Belgium), 27 July 2020 =E2=80=93 7:00 (CEST) =E2=80=93 regulated =
information =E2=80=93=C2=A0

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2-2FFv8VoUUx7n7ixQ4RzNPVM2vTOJ9qdOH2FH9wvyek4-3D

Acquisitions and Agreements

April 2020 =E2=80=93 Closing of Ra Pharma acquisition - the acquisition of =
Ra Pharmaceuticals, Inc. has been successfully completed and Ra Pharma is n=
ow a wholly-owned subsidiary of UCB. This acquisition should enhance UCB=E2=
=80=99s leadership potential in myasthenia gravis by adding zilucoplan, a p=
eptide inhibitor of complement component 5 (C5) currently in Phase 3, to th=
e UCB pipeline alongside to UCB=E2=80=99s rozanolixizumab, an FcRn targetin=
g antibody also in Phase 3. Zilucoplan is a novel investigational molecule =
also being evaluated in other complement-mediated diseases including amyotr=
ophic lateral sclerosis (ALS) and immune-mediated necrotizing myopathy (IMN=
M).

June 2020 - UCB acquires Engage Therapeutics, a clinical-stage pharmaceutic=
al company developing Staccato^=C2=AE Alprazolam for the rapid termination =
of an active epileptic seizure. Staccato^=C2=AE Alprazolam is an investigat=
ional drug (Phase 2b) designed to be used as a single-use epileptic seizure=
rescue therapy that combines the Staccato^=C2=AE delivery technology with =
alprazolam, a benzodiazepine.

July 2020 =E2=80=93 UCB and Ferring Pharmaceuticals Inc. have entered into =
a co-promotion agreement to commercialize the prefilled syringe formulation=
of Cimzia^=C2=AE (certolizumab pegol) in the United States for the treatme=
nt of Crohn=E2=80=99s disease (CD). UCB will continue to be responsible for=
all product-related activities, including revenue recognition. UCB will co=
ntinue to promote and to commercialize the lyophilized formulation of Cimzi=
a^=C2=AE for all indications as well as the prefilled syringe formulation f=
or the rheumatology and dermatology indications

R&D update=C2=A0
In March, the evolving COVID-19 pandemic led UCB to pause new patient recru=
itment into ongoing clinical studies and to postpone all new study starts. =
This has led to some delays of UCB=E2=80=99s clinical studies. As from end-=
May 2020, UCB began to restart clinical study recruitment, including new st=
udy starts, at clinical trials sites that meet the restart criteria. The la=
test timelines for UCB=E2=80=99s clinical development programs are shown be=
low. UCB will continue to monitor the impact of COVID-19 on all ongoing cli=
nical trials and will implement changes as necessary.=C2=A0

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05kBNYlewis6mOOPoprkhzqkfJFWRhJJCpKRVg1XYDw6Yppyxvso56LHbEjcGEfwDSkt88bT2-2=
Bv0i34iVErG1YT6DrCyBSkq5PMV6ubLfK4ztmWpjGml1SLw-3D

In January 2020, Cimzia^=C2=AE (certolizumab pegol) was approved by the Jap=
anese health authorities for the treatment plaque psoriasis, psoriatic arth=
ritis, pustular psoriasis and psoriatic erythroderma for which existing tre=
atment methods are not sufficiently effective. The approval makes Cimzia^=
=C2=AE the first Fc-free, PEGylated anti-TNF treatment option now available=
for these patients in Japan.=C2=A0During the first quarter 2020, Vimpat^=
=C2=AE (lacosamide) for the adjunctive treatment of primary generalized ton=
ic-clonic seizures (PGTCS) in study participants 4 years of age and older w=
as filed with the U.S., EU and Japanese regulatory agencies.

In March, UCB reported that the Phase 2b study with padsevonil in drug-resi=
stant focal epilepsy patients did not reach statistical significance for ei=
ther of the primary endpoints. Padsevonil was generally well-tolerated and =
its safety profile was consistent with that seen in earlier studies. Furthe=
r analysis of the data led UCB to the decision to terminate the padsevonil =
program as it did not offer sufficient benefit for people living with epile=
psy over existing anti-epileptic treatment options.

In July, the Phase 3b study BE RADIANT, comparing bimekizumab to secukinuma=
b for the treatment of adults with moderate-to-severe plaque psoriasis, met=
all primary and ranked secondary endpoints, achieving significantly greate=
r efficacy than secukinumab.

In Q3, UCB and its partner Biogen will include the first patients into the =
Phase 3 program with dapirolizumab pegol in patients with active systemic l=
upus erythematosus (SLE) despite standard-of-care treatment. First headline=
results are expected in H1 2024.

Net sales break-down by core product^4

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EGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2=
F2X9c9g1wZGQAM-2FefxE8jF4LpUwfC2eUOYrmTSV-2F2qAyVIRjr2DlxqRDbeBpdqZKjBKG-2F=
C6ebb7Rdo99Ot6ygucqpHpEQpPhDVM0wwD4t-2Bvvd2-2BYlnWWZPe4IpXH-2FvRz8toZTKORrs=
0CgN8XsftYpobA2YAMeSzRNOpLnTPQZj-2B8sMgG-2BkBMUocmV0gFWbM8F0aPfd1-2FLlHnap0=
VxLM25Ffxu8FqIhW9u7sn-2BYsoiqcUVJdXv9B7-2FtK-2Fgnt4GMq2JbPFNBUEDU-3D

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ebb7Rdo99Ot6ygucqpHpEQpPhDVM0wwD4t-2Bvvd2-2BYlnWWQfDuNmQIUkhlCt-2BcVN-2FB-2=
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S8VwnVsHHXesOEi9Q3GH8LO9kmBqbC5qQ04Bd8NZCxf5AZC1JjJ5H5U0kS5a5Hr40-3D

In December 2019, UCB launched Nayzilam^=C2=AE (midazolam) Nasal Spray^CIV,=
the first and only nasal rescue treatment for epilepsy seizure clusters in=
the U.S. Net sales in the first six months 2020 were =E2=82=AC 11 million.

Evenity^=C2=AE (romosozumab) for the treatment of severe osteoporosis in po=
stmenopausal women at high risk of fracture had its first European launch i=
n March 2020 and reported net sales of =E2=82=AC 1 million.=C2=A0

^4Due to rounding, some financial data may not add up in the tables.
=C2=A0
HY 2020 financial highlights=C2=A0
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c9g1wZGQAM-2FefxE8jF4LpUwfC2eUOYrmTSV-2F2qAyVIRjr2DlxqRDbeBpdqZKjBKG-2FC6eb=
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tvLHE68NTP635Coowkt3tUVzhyuku0OHOI7LGGByx3-2FBrU6Sb8wWw-3D
Find the HY financial report on UCB website: https://u7061146.ct.sendgrid.n=
et/ls/click?upn=3DTeZUXWpUv-2B6TCY38pVLo9kHtGd-2Bufj1oY9cyqgIeB4OK-2Fuq2x8r=
cpdQXlMvVCA5oT3o-2BOG08p1fCoPNfW28LDg-3D-3D_mGu_xDPID0vOuylFAU8fv4e60wei4Jx=
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2F2X9c9g1wZGQAM-2FefxE8jF4LpUwfC2eUOYrmTSV-2F2qAyVIRjr2DlxqRDbeBpdqZKjBKG-2=
FC6ebb7Rdo99Ot6ygucqpHpEQpPhDVM0wwD4t-2Bvvd2-2BYlnWWZy4l6QYHE25L1Ei-2FbBsMj=
xcUGIIiMMcqr9UAFBo1LBleL-2FD9mrZZ9wh7aJC8kcScY4PfGjY2LbWI9aDGuiSswVGKL20STI=
NS64ENKVl2I0BgcLSMheKd6L3NdXFb1hUsDn5ghZiHHoh1-2FLrW63MtYw-3D

^5Due to rounding, some financial data may not add up in the tables.=C2=A0
^6For the net financial cash / debt, the reporting date for comparative per=
iod is 31 December 2019.

Revenue and net sales in the first six months of 2020 reached =E2=82=AC 2 6=
08 million and =E2=82=AC 2 491 million, both +12%, +9% CER or +10% at CER a=
nd adjusted for divestitures respectively. Net sales before =E2=80=9Cdesign=
ated hedging reclassified to net sales=E2=80=9D (- =E2=82=AC 51 million in =
H1 2019 / - =E2=82=AC 9 million in HY 2020) were up by 10% (+9% CER). This =
growth was driven by the continued positive and resilient=C2=A0performance =
of UCB=E2=80=99s product portfolio. Royalty income and fees increased to =
=E2=82=AC 38 million from =E2=82=AC 33 million. Other revenue increased to =
=E2=82=AC 79 million from =E2=82=AC 71 million.=C2=A0

Gross profit increased to =E2=82=AC 1 925 million in-line with topline grow=
th and reflecting a stable gross margin of 74%.=C2=A0

Operating expenses reached =E2=82=AC 1 311 million (+14%; +13% CER) driven =
by=C2=A0

=C2=B7
13% higher marketing and selling expenses of =E2=82=AC 569 million =E2=80=
=93 due to launches and prelaunch activities: Cimzia^=C2=AE in non-radiogra=
phic axial spondyloarthritis in the U.S. and the launches in China and Japa=
n, Nayzilam^=C2=AE in the U.S., Evenity^=C2=AE in Europe as well as launch =
preparations for bimekizumab for the treatment of psoriasis;=C2=A0

=C2=B7 21% higher research and development expenses of =E2=82=AC 689 millio=
n which include the first time R&D expenses for the Ra Pharma development p=
rogram, the termination costs (=E2=82=AC 38 million) in connection with the=
termination of the project padsevonil in focal onset seizures as well as h=
igh investments in UCB=E2=80=99s progressing clinical pipeline encompassing=
five late stage assets. The R&D ratio reached 26% in the first six months =
of 2020 after 24% in HY 2020.
=C2=B7 2% lower general and administrative expenses of =E2=82=AC 94 million=
, also reflecting lower costs due to Covid-19 pandemic and including a dona=
tion of =E2=82=AC 3 million in connection with COVID-19 pandemic.=C2=A0
=C2=B7 other operating income of =E2=82=AC 41 million driven by the collabo=
ration with Amgen for the commercialization of Evenity^=C2=AE.=C2=A0

This resulted in a stable operating expense ratio (in relation to revenue) =
of 50%.

Underlying profitability =E2=80=93 adjusted (recurring) EBITDA^7- reached =
=E2=82=AC 783 million after =E2=82=AC 724 million (+8%; +0% CER) driven by =
continued revenue growth and increased operating expenses, reflecting the i=
nvestments into the future of UCB, namely into product launches and clinica=
l development. The adjusted (recurring) EBITDA ratio for the first six mont=
hs of 2020 (in % of revenue) reached 30%, after 31% in 2019. In compliance =
with the ESMA Alternative Performance Measures guidelines, =E2=80=9Crecurri=
ng EBITDA=E2=80=9D is renamed into =E2=80=9Cadjusted EBITDA=E2=80=9D. The c=
alculation methodology remains unchanged.

Other expenses were =E2=82=AC 95 million =E2=80=93 due to restructuring exp=
enses and fees related to the acquisition of Ra Pharma and Engage Therapeut=
ics - after an income of =E2=82=AC 27 million in 2019.=C2=A0

Net financial expenses increased to =E2=82=AC 61 million from =E2=82=AC 53 =
million, due to the debt financing of the Ra Pharma acquisition.=C2=A0

Income tax expenses were =E2=82=AC 70 million compared to =E2=82=AC 108 mil=
lion in June 2019. The average effective tax rate was 15% compared to 20% i=
n the same period of last year, but in line with the 2019 full year effecti=
ve tax rate.=C2=A0

Driven by =E2=80=9Cother expenses=E2=80=9D Profit of the Group amounted to =
=E2=82=AC 388 million (after =E2=82=AC 437 million), of which =E2=82=AC 363=
million is attributable to UCB shareholders and =E2=82=AC 25 million (afte=
r =E2=82=AC 26 million) to non-controlling interests.

Core earnings per share, which reflect profit attributable to UCB sharehold=
ers, adjusted for the after-tax impact of one-time expenses, the financial =
one-offs, the after-tax contribution from discontinued operations and the n=
et amortization of intangibles linked to sales, reached =E2=82=AC 2.77 base=
d on 189 million weighted average shares outstanding after =E2=82=AC 2.42 b=
ased on 187 million weighted average shares outstanding.=C2=A0

Outlook 2020 confirmed - UCB confirms its expectations for 2020 revenue to =
reach approximately =E2=82=AC 5.05 =E2=80=93 5.15 billion, adjusted (recurr=
ing) EBITDA in the range of 26 - 27% of revenue and core earnings per share=
are therefore expected in the range of =E2=82=AC 4.40 =E2=80=93 4.80 based=
on an average of 188 million shares outstanding. Based on UCB=E2=80=99s cu=
rrent assessment of the Covid-19 pandemic, UCB remains confident in the fun=
damental underlying demand for its products and its prospects for long-term=
growth. UCB will continue to closely follow evolving COVID-19 pandemic dil=
igently to assess potential near- and mid-term challenges.=C2=A0

CFO transition in 2020 =E2=80=93 on July 1st, UCB welcomed Sandrine Dufour =
as Executive Vice President and Chief Financial Officer. Sandrine is now a =
member of UCB=E2=80=99s Executive Committee reporting to Jean-Christophe Te=
llier, UCB=E2=80=99s CEO and Chairman of the Executive Committee. Sandrine =
Dufour is a senior executive with a proven track record and deep financial =
expertise that stems from more than 25 years leading with successful nation=
al and global organizations. From 2015 to recently she held the role of CFO=
at Proximus, Belgium=E2=80=99s largest telecommunication company.

^7adj. EBITDA =3D adjusted (recurring) Earnings Before Interest, Taxes, Dep=
reciation and Amortization charges. In compliance with the ESMA Alternative=
Performance Measures guidelines, recurring EBITDA, is renamed into =E2=80=
=9Cadjusted EBITDA=E2=80=9D. The calculation methodology remains unchanged.

Today, UCB will host a conference call/video webcast at 08.00 (EDT) / 13.00=
(BST) 14.00 (CEST).

Details are available on https://u7061146.ct.sendgrid.net/ls/click?upn=3D4t=
NED-2FM8iDZJQyQ53jATUYVwmal3Wcv3TGQjjXjIx5Pjp07kbQIZcOPqgj29PaFw6cbyQn-2FX-=
2Fjndd3L-2FfyUI7h-2BcS5xt49HExEOhVBSfOU25BjAReR3w-2FWV4ZrsJjtxwZtOa_xDPID0v=
OuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52=
Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZGQAM-2FefxE8jF4LpUwfC2eUOYrmTSV-2F2qAyVIRjr2=
DlxqRDbeBpdqZKjBKG-2FC6ebb7Rdo99Ot6ygucqpHpEQpPhDVM0wwD4t-2Bvvd2-2BYlnWWZOf=
pe3pU-2FbJGjHNhhLlFGdLOF-2FM8W3xXaD4J4TT4s7kNOXS1D6ocMaCB47WBW-2BNmiy2yBX2G=
n-2FnF1fkbFfQX9Nk8nTuf4-2FEatqxCQAmkbZPl6L1336Ny28rAhtZT53E1pSBd93pKev-2FQ2=
mXR7TQgLk-3D

For further information:

Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

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 more than 7 500 people in=
approximately 40 countries, the company generated revenue of =E2=82=AC 4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news

Forward looking statements UCB
This press release contains forward-looking statements based on current pla=
ns, estimates and beliefs of management. All statements, other than stateme=
nts of historical fact, are statements that could be deemed forward-looking=
statements, including estimates of revenues, operating margins, capital ex=
penditures, cash, other financial information, expected legal, political, r=
egulatory or clinical results and other such estimates and results. By thei=
r nature, such forward-looking statements are not guarantees of future perf=
ormance and are subject to risks, uncertainties and assumptions which could=
delay, divert or change any of them this year and the next several years, =
that are difficult to predict, may be beyond UCB=E2=80=99s control and coul=
d cause UCB=E2=80=99s actual future financial results, goals, plans and obj=
ectives to differ materially from those that may be expressed in, or implie=
d by, such forward-looking statements contained in this press release. Impo=
rtant factors that could result in such differences include: the global spr=
ead and impact of COVID-19, changes in general economic, business and compe=
titive conditions, the inability to obtain necessary regulatory approvals o=
r to obtain them on acceptable terms, costs associated with research and de=
velopment, changes in the prospects for products in the pipeline or under d=
evelopment by UCB, effects of future judicial decisions or governmental inv=
estigations, product liability claims, challenges to patent protection for =
products or product candidates, changes in laws or regulations, exchange ra=
te fluctuations, changes or uncertainties in tax laws or the administration=
of such laws and hiring and retention of its employees. =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. UCB is providing this information as of the date of this document an=
d expressly disclaims any duty to update any information contained in this =
press release, either to confirm the actual results or to report a change i=
n its expectations.
There is no guarantee that new product candidates in the pipeline will prog=
ress to product approval or that new indications for existing products will=
be developed and approved. Products or potential products which are the su=
bject of partnerships, joint ventures or licensing collaborations may be su=
bject to differences between the partners. Also, UCB or others could discov=
er safety, side effects or manufacturing problems with its products after t=
hey are marketed.
Moreover, sales may be impacted by international and domestic trends toward=
managed care and health care cost containment and the reimbursement polici=
es imposed by third-party payers as well as legislation affecting biopharma=
ceutical pricing and reimbursement.
The updated financial guidance above does not reflect any potential impacts=
from the evolving COVID-19 pandemic. The company is following the developm=
ent diligently to assess the financial significance of this pandemic to UCB=
.=C2=A0
=C2=A0
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Chart 5 HY results July 27 2020 (https://u7061146.ct.sendgrid.net/ls/click?=
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Image
Chart 2 HY results July 27 2020 (https://u7061146.ct.sendgrid.net/ls/click?=
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3D=0D
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UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=