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UCB [BE0003739530 / UCB]

UCB’s strong performance enables continued investment into future growth drivers

INFORMATION REGLEMENTEE


[25/07/2019 | 07:00]
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** UCB=E2=80=99s strong performance enables continued investment into futur=
e growth drivers
------------------------------------------------------------

=C2=B7 Revenue reached =E2=82=AC 2.3 billion (+2%, +4% CER)=C2=A0
=C2=B7 net sales increased to =E2=82=AC 2.2 billion (+3%, +5% CER =E2=80=93=
adjusted =C2=A0+11%, +7% CER)
=C2=B7 Underlying profitability (rEBITDA ) was =E2=82=AC 724 million (-9%, =
-1% CER) or a ratio of 31%
=C2=B7 R&D update: Vimpat=C2=AE with positive phase 3 results in PGTCS; fou=
r new phase 3 programs started: bimekizumab in psoriatic arthritis and axia=
l spondyloarthritis; padsevonil in in drug-resistant focal epilepsy; rozano=
lixizumab in myasthenia gravis
=C2=B7 Financial outlook for 2019 confirmed: Revenue expected to reach =E2=
=82=AC 4.6 - 4.7 billion, recurring EBITDA=C2=A0should reach 27 - 29% of re=
venue, Core EPS of =E2=82=AC 4.40 - 4.80 expected
=C2=B7 CFO transition in 2020

Brussels (Belgium), 25 July 2019 =E2=80=93 7:00 (CEST) =E2=80=93 regulated =
information =E2=80=93=C2=A0
UCB Half Year Report 2019:

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R&D update=C2=A0

Neurology
In January 2019, Vimpat^=C2=AE (lacosamide) was approved in Japan for the t=
reatment of partial onset seizures in children 4 years of age and older. In=
addition, two new formulations were approved: IV (intravenous) and dry syr=
up.

In June, the Vimpat^=C2=AE development program for the adjunctive treatment=
of primary generalized tonic-clonic seizures (PGTCS) in study participants=
4 years of age and older achieved statistically significant positive resul=
ts for both its primary (time to second seizure) and secondary efficacy (se=
izure freedom) endpoints. The novel primary endpoint =E2=80=9Ctime-to-secon=
d-seizure=E2=80=9D reduced placebo-exposure of patients substantially. Subm=
issions of this new indication are planned in the first half 2020 to multip=
le regulatory agencies.

In March, UCB started an international (U.S., EU, Japan and China) phase 3 =
study with padsevonil in drug-resistant focal epilepsy patients. First head=
line results are expected in H2 2021 and will complement those from the ong=
oing Phase 2b, expected in H1 2020. Padsevonil is an innovative drug purpos=
ely designed with a novel dual mechanism of action to address the needs of =
uncontrolled patients.=C2=A0

In May, Nayzilam^=C2=AE (midazolam) nasal spray was approved in the U.S. to=
treat intermittent, stereotypic episodes of frequent seizure activity in p=
eople living with epilepsy. UCB expects to make the treatment available to =
patients in the coming months.=C2=A0

In March, UCB started as planned a phase 2, proof-of concept, study with it=
s novel, subcutaneous FcRn (neonatal Fc receptor) monoclonal antibody, roza=
nolixizumab, in patients with chronic inflammatory demyelinating polyneurop=
athy (CIDP). First headline results are expected in H1 2021.

In June, UCB started as scheduled the confirmatory study (phase 3) with roz=
anolixizumab in patients with myasthenia gravis (MG). First headline result=
s are expected in H1 2021.

Immunology=C2=A0
In March, UCB announced the approval of Cimzia^=C2=AE (certolizumab pegol) =
in the U.S. to include a new indication for the treatment of adults with ac=
tive non-radiographic axial spondyloarthritis (nr-axSpA) with objective sig=
ns of inflammation.

In July and in China, Cimzia^=C2=AE was approved in combination with methot=
rexate for the treatment of moderate to severe, active rheumatoid arthritis=
in adult patients.

In March and April, the second and the third phase 3 program with bimekizum=
ab - in psoriatic arthritis and in axial Spondyloarthitis - were initiated,=
slightly earlier than planned. First topline results are expected at the e=
nd of 2021.

In June, UCB and its partner Biogen initiated preparations for a phase 3 pr=
ogram with dapirolizumab pegol in patients with active systemic lupus eryth=
ematosus (SLE) despite standard-of-care treatment. The program is expected =
to start in H1 2020. This decision is based on the promising results of the=
phase 2b clinical trial, of which interim results were presented at EULAR =
in June 2019.

Bone=C2=A0

Early January 2019, UCB and Amgen announced the approval of Evenity^=C2=AE =
(romosozumab) in Japan. Evenity^=C2=AE is approved to reduce the risk of fr=
actures and increase bone mineral density in men and post-menopausal women =
with osteoporosis at high risk of fracture.=C2=A0

In April, Evenity^=C2=AE was approved in the U.S. for the treatment of oste=
oporosis in post-menopausal women at high risk for fracture.=C2=A0

In May, Evenity^=C2=AE was approved in South Korea and in June in Canada an=
d Australia.

In June, the Committee for Medicinal Products for Human Use (CHMP) of the E=
uropean Medicines Agency adopted a negative opinion for romosozumab. The co=
mpanies seek the re-examination of the CHMP opinion.

Net sales=C2=A0break-down by core product^5

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LEOzANLZyBpKjvq7ttKG-2FuKQwdcHYvGThklTQO87SRV-2B-2FTYTsC3mkMUCVezIYdqot0-2B=
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J-2FGdmFk2v5e5bq6d4LnNLgqkZniJ5sVlbB6VugkOY-3D

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HY 2019 financial highlights^6=C2=A0

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FnP9TJjsuMkXJ8qGjG4DUcKK5ju4s-2BQBuu8AU-3D

=E2=80=9CThe statutory auditor has issued an unqualified review report date=
d 24 July 2019 on the company=E2=80=99s condensed consolidated interim fina=
ncial statements as of and for the six month period ended 30 June 2019, and=
has confirmed that the accounting data reported in the press release is co=
nsistent, in all material respects, with the accounts from which it has bee=
n derived.=E2=80=9D

Revenue and net sales in the first six months of 2019 reached =E2=82=AC 2 3=
23 million (+2%; +4% at CER^8) and =E2=82=AC 2 219 million (+3%; +5% CER) r=
espectively. Net sales before =E2=80=9Cdesignated hedging reclassified to n=
et sales=E2=80=9D (+ =E2=82=AC 65 million in H1 2018 / - =E2=82=AC 51 milli=
on in H1 2019) were up by 9% (+5% CER). Adjusted for divestitures in 2018, =
mainly =E2=80=9CInnere Medizin=E2=80=9D (Germany), and Q1 2019, the iron su=
pplement Niferex^=C2=AE and before =E2=80=98designated hedges reclassified =
to net sales=E2=80=99 growth was +11%, underlying: +7% CER. This growth was=
driven by the continued positive performance of UCB=E2=80=99s core product=
s.=C2=A0

Royalty income and fees decreased to =E2=82=AC 33 million from =E2=82=AC 56=
million. Other revenue reached =E2=82=AC 71 million after =E2=82=AC 67 mil=
lion.=C2=A0

Gross profit reached =E2=82=AC 1 725 million reflecting a stable gross marg=
in.=C2=A0

Operating expenses reached =E2=82=AC 1 154 million (+11%; +8% CER) reflecti=
ng 14% higher marketing and selling expenses of =E2=82=AC 502 million - dri=
ven by the launch of Cimzia^=C2=AE in psoriasis and launch preparations for=
Cimzia^=C2=AE in active non-radiographic axial spondyloarthritis (nr-axSpA=
), 13% higher research and development expenses of =E2=82=AC 568 million =
=E2=80=93 driven by the pipeline progress and resulting in a R&D ratio of 2=
4% in the first six months of 2019 - and 8% higher general and administrati=
ve expenses of =E2=82=AC 96 million. This resulted in an operating expense =
ratio (in relation to revenue) of 50% after 46% in the first half 2018.

Underlying profitability =E2=80=93 rEBITDA^9 - reached =E2=82=AC 724 millio=
n after =E2=82=AC 794 million (-9%; -1% CER) driven by continued net sales =
growth compensated by higher operating expenses ratio and reflecting the in=
vestments into the future of UCB, namely into product launches and product =
development. The recurring EBITDA ratio for the first six months of 2019 (i=
n % of revenue) reached 31%, from 35% in 2018.

Non-recurring income was =E2=82=AC 27 million after =E2=82=AC 19 million in=
come in 2018.=C2=A0

Net financial expenses increased to =E2=82=AC 53 million from =E2=82=AC 46 =
million.=C2=A0

Income tax expenses were =E2=82=AC 108 million compared to =E2=82=AC 56 mil=
lion in June 2018. The average effective tax rate on recurring activities w=
as 20% compared to 9% in the same period of last year, but in line with the=
2018 full year effective tax rate. The low tax rate in the first six month=
s 2018 was driven by phasing of expenses and the U.S. tax reform.

Profit of the Group amounted to =E2=82=AC 437 million (after =E2=82=AC 574 =
million), of which =E2=82=AC 411 million is attributable to UCB shareholder=
s and =E2=82=AC 26 million (after =E2=82=AC 23 million) to non-controlling =
interests.

Core earnings per share, which reflect profit attributable to UCB sharehold=
ers, adjusted for the after-tax impact of non-recurring items, the financia=
l one-offs, the after-tax contribution from discontinued operations and the=
net amortization of intangibles linked to sales, reached =E2=82=AC 2.42 af=
ter =E2=82=AC 3.09 based on 187 million weighted average shares outstanding=
.=C2=A0

Outlook 2019 confirmed - UCB confirms its expectations for 2019 revenue to =
reach approximately =E2=82=AC 4.6 =E2=80=93 4.7 billion, recurring EBITDA i=
n the range of 27 - 29% of revenue and core earnings per share are therefor=
e expected in the range of =E2=82=AC 4.40 =E2=80=93 4.80 based on an averag=
e of 188 million shares outstanding.=C2=A0

CFO transition in 2020 - Five consecutive years of growth and strong half-y=
ear results in 2019 have underscored UCB=E2=80=99s robust performance over =
time. UCB is poised to further accelerate and expand to deliver on its Pati=
ent Value ambition, potentially launching 6 new products in the next 5 year=
s.

With this goal in mind, UCB continues to focus its energies on strengthenin=
g its operating model to ensure maximum agility to meet our growth expectat=
ions for the years ahead. As part of this evolution, UCB implements in the =
coming months changes to its Executive Committee=E2=80=99s structure. These=
changes will involve adjusting the size of the Committee; allowing it to e=
nhance the focus on the company=E2=80=99s core activity areas with increase=
d agility. This will enable UCB to further evolve its patient value strateg=
y.

In this context, UCB also announces that, after close to 13 years in the ro=
le, the company=E2=80=99s Chief Financial Officer, Detlef Thielgen, will be=
transitioning out within a year from now. A search for a successor has jus=
t begun.

CEO Jean-Christophe Tellier said: =E2=80=9CDuring his 13 years at UCB, Detl=
ef has played an instrumental part in UCB=E2=80=99s success and in bringing=
the company to the strong position it enjoys today. On behalf of the Board=
, of the Executive Committee and of all UCB teams, I would like to thank De=
tlef for his dedication to UCB over the years and for successfully helping =
to lead the company through its different transformation phases. Detlef and=
I will continue to work closely together to drive UCB forward, deliver on =
our objectives and ambition and ensure a smooth transfer of responsibilitie=
s and knowledge to his future successor.=E2=80=9D

Find the HY financial reports on UCB website: https://u7061146.ct.sendgrid.=
net/wf/click?upn=3D84Em28S1K9SvtzcUtu04ErpjuafE3tnUOcM54kcV9dw3rsQbN-2B-2BP=
2RCdX9RB-2Fatlw2yIKxWhhf4W2ZX11IzjVg-3D-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8Rp=
J4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1=
TsABXt0NQIRwod882ckG3uoKCZbOfjSFJNYfSriR-2BUNWxsgjIzdOTGRvBoj-2FB-2BJ8-2BvM=
OTgGPQK6LZY7OGLEOzANLZyBpKjvq7ttKG-2FuKQwdcHYtt-2BaMAjn9uaAem-2BwLPomRdP5oL=
p4LnIpZXYd9BgBg21N-2FGYY1CMU-2FVCH8nLLGXXtVr9DZvlHw9wZM1a-2BQmBtMx29AmLZdji=
OcH6isX-2BbeyL6IISDC1czsS1VxKGhikOTRHUkia7EOMgh0SN553ixbQ-3D

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/wf/click?upn=3DG6=
2jSYfZdO-2F12d8lSllQB7X3kY45D7w88RKNKEbAnX0-2F1zQ88a9vCM-2BgubLI-2B7DyADnXE=
LuhvARZBxdC6YUB5rpLWDuls6965CuB1LgCuKkY4mX2f3CX628w-2BcOu0J9q_-2B-2Ft0TnE1o=
EbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeT=
efElHQ9EZfLoWbvi8z1TsABXt0NQIRwod882ckG3uoKCZbOfjSFJNYfSriR-2BUNWxsgjIzdOTG=
RvBoj-2FB-2BJ8-2BvMOTgGPQK6LZY7OGLEOzANLZyBpKjvq7ttKG-2FuKQwdcHYkjd0P-2BFzq=
NzPbmk-2Blz4cWkdS5mTDxpQ-2BYm68bExbuzdHPuzZag9M-2FzwEBNeoPaCeKEuPpyY1E1Gmjj=
P47IwLbh8pxNoNXtC-2FtGWG4Iu4P-2BrsMAiUbdNzdo-2FEJnFuz11zKR5M5e-2FFCLbYtgbfg=
yKkcw-3D

For further information, UCB:

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

Florence Robert,
Investor Relations, UCB
T +32.2.559.7476
florence.robert@ucb.com

Corporate Communications
France Nivelle =C2=A0
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

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 4.6=
billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news

Forward looking statements=C2=A0
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=
cause actual results to differ materially from those that may be implied b=
y such forward-looking statements contained in this press release. Importan=
t factors that could result in such differences include: changes in general=
economic, business and competitive conditions, the inability to obtain nec=
essary regulatory approvals or to obtain them on acceptable terms, costs as=
sociated with research and development, changes in the prospects for produc=
ts in the pipeline or under development by UCB, effects of future judicial =
decisions or governmental investigations, product liability claims, challen=
ges to patent protection for products or product candidates, changes in law=
s or regulations, exchange rate fluctuations, changes or uncertainties in t=
ax 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.

1. CER =3D constant exchange rates
2. Adjusted for divestitures and designated hedges reclassified to net sale=
s=C2=A0
3. rEBITDA =3D recurring Earnings Before Interest, Taxes, Depreciation and =
Amortization charges
4. Core EPS =3D core earnings per share
5. Due to rounding, some financial data may not add up in the tables.
6. Due to rounding, some financial data may not add up in the tables.
7. Due to rounding, some financial data may not add up in the tables.=C2=A0
8. CER =3D constant exchange rates
9. rEBITDA =3D recurring Earnings Before Interest, Taxes, Depreciation and =
Amortization charges
=C2=A0
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Press Release HY 2019 final FR (https://u7061146.ct.sendgrid.net/wf/click?u=
pn=3DG62jSYfZdO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxefo1K5IYIFz1aHofv7PgimwPxC0=
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Press Release HY 2019 final NL (https://u7061146.ct.sendgrid.net/wf/click?u=
pn=3DG62jSYfZdO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxefo1K5IYIFz1aHofv7PgimwPHwV=
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Capture 1 HY 2019 (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZ=
dO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxefo1K5IYIFz1aHofv7PgimwQOAORXvVPVw99fYlp=
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Capture 2 HY 2019 (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZ=
dO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxefo1K5IYIFz1aHofv7PgimwumXZGLXbH9n2mBj1c=
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Capture 3 HY 2019 (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZ=
dO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxefo1K5IYIFz1aHofv7Pgimwomxvd8xVEUpe3C9G0=
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Image
Capture 4 HY 2019 bis (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62j=
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=0D
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Bz2p53T0v-2BoEIvbo6vDi8C-2BOyFzyb6obo-2BzKSgNKq4mrvuMMTpINSS2ZhKfeSCaVes3cb=
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EYCTGGs2URdOTQDcNT4Xt8b4gM3BY-3D=0D
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