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UCB Interim / Quarterly Report 2016

Oct 25, 2016

4017_iss_2016-10-25_ee38b492-11bf-4720-af8d-cb53f59ff14b.pdf

Interim / Quarterly Report

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Brussels (Belgium), 25 October 2016 – 7:00 (CEST) – regulated information – UCB First Nine Months Interim Report 2016:

UCB continues its growth path

  • Core product growth drives top line growth
  • R&D update: romosozumab filed with FDA, positive topline results in psoriasis with Cimzia® , Phase 2b study initiated for bimekizumab
  • Financial outlook 2016 confirmed

"Continuing our growth path in 2016 - driven by the ongoing growth of our main products - we are confirming our financial outlook for 2016 – trending towards the upper end of the range," said Jean-Christophe Tellier, CEO UCB. "We are further growing our product portfolio in epilepsy with launches of Briviact® in the EU and in North America as well as Vimpat® – together with our partner – in Japan. The offerings of Cimzia® for patients are being broadened by the AutoClicks® prefilled pen and by filing with the U.S. authorities to treat juvenile idiopathic arthritis. We have seen scientific presentations of the positive results from the Phase 3 program with romosozumab for the treatment of osteoporosis and filing with the U.S. authorities. At the same time, we continue the preparations with our partner to make romosozumab available to people living with osteoporosis"

Financial outlook 2016 confirmed - UCB expects continued growth, trending towards the upper end of the ranges: 2016 revenue should reach approximately € 4.0 - 4.1 billion; recurring EBITDA2 should increase to approximately € 970 - 1 010 million. Core earnings per share are expected in the range of € 2.90 - 3.20 based on an expected average of 188 million shares outstanding.

Revenue reported for the first nine months of 2016 are € 3.1 billion, a plus of 7% both at actual and constant exchange rates (CER) driven by the continued growth of UCB's main products, Cimzia® , Vimpat® , Neupro® and Keppra® combined reached net sales of € 2.3 billion (+12%):

1 CER = constant exchange rates

2 EBITDA = Earnings Before Interest, Taxes, Depreciation and Amortization charges

* Neurology also includes multiple sclerosis therapies in Asia (partner: Biogen) All figures are unaudited.

R&D update

Immunology

In August, the U.S. Food and Drug Administration (FDA) has accepted UCB's filing for a proposed new indication for Cimzia® (certolizumab pegol) to treat juvenile idiopathic arthritis (JIA). The filing acceptance is based on data from an open-label Phase 3 study to assess the pharmacokinetics, safety and efficacy of Cimzia® in children and adolescents (2 years to less than 18 years old).

Also in August, UCB reported positive topline results for RAPID-C, a Phase 3 study evaluating Cimzia® in rheumatoid arthritis in China.

In September, the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for AutoClicks® prefilled pen to provide different administration options for patients treated with Cimzia® .

In October, UCB and Dermira announced topline results from CIMPASI-2, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of Cimzia® in adult patients with moderate-to-severe chronic plaque psoriasis. In this trial, Cimzia® demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are from the first of three Phase 3 clinical trials to be reported evaluating Cimzia® in this patient population. Results are expected by the end of the first quarter of 2017.

In July 2016, UCB initiated a Phase 1 study with UCB7858, a fully humanized monoclonal antibody targeting a new mode of action with potential to disrupt disease progression in autoinflammatory diseases.

In September, a Phase 2b study was initiated for bimekizumab (IL-17A/F) for the treatment of psoriasis. This dose-ranging study aims to enroll around 240 patients with a primary outcome measure at 12 weeks. First results are expected in H2 2017.

For UCB4144/VR942, an immunomodulatory inhaled biologic for patients with uncontrolled asthma in development partnership with Vectura, Phase 2a shall start in 2017 - based on positive data from Phase 1.

Neurology

In July 2016, the Japanese regulatory authorities approved Vimpat® (lacosamide) as adjunctive therapy in the treatment of partialonset seizures in adult patients with epilepsy.

In August, Vimpat® was filed in Japan for the treatment of partial onset seizures as monotherapy.

Bone

In July, UCB and Amgen submitted the biologics license application (BLA) for romosozumab3 to the U.S. FDA - accepted for review in September - based on the FRAME study results for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

All other clinical development programs are continuing as planned.

$\epsilon$ million 9M 2016 9M 2015 Actual CFR 1
U.S. 588 512 15% 15%
Europe 258 212 22% 24%
Japan 25 5 $>100\%$ $>100\%$
International markets 62 46 35% 42%
Total Cimzia® 933 775 20% 21%

Immunology

Cimzia® (certolizumab pegol) for people living with inflammatory TNF mediated diseases reported net sales of € 933 million, driven by continued strong growth in all markets.

Net sales in neurology* with net sales of Vimpat ® , Keppra® and Briviact® as well as Neupro® and other are up 8% to € 1.36 billion. UCB's epilepsy franchise is strengthened by the launch of Briviact® (brivaracetam) in the EU (since January) and the U.S. (since June) with net sales of € 11 million for the first nine months of 2016.

$\epsilon$ million 9M 2016 9M 2015 Actual CER 1
U.S. 440 373 18% 18%
Europe 114 98 16% 16%
Japan $\mathbf{3}$
International markets 26 23 13% 19%
Total Vimpat® 583 495 18% 19%
$\epsilon$ million 9M 2016 9M 2015 Actual CER
U.S. 151 189 $-20%$ $-20%$
Europe 184 186 $-1\%$ $1\%$
Japan 77 68 13% 2%
International markets 129 122 6% 13%
Total Keppra ® 541 565 $-4%$ $-3%$
$\epsilon$ million 9M 2016 9M 2015 Actual CER
U.S. 57 56 3% 3%
Europe 122 110 11% 12%
Japan 30 26 17% 17%
International markets 10 8 27% 34%
Total Neupro® 219 199 10% 11%

Vimpat® (lacosamide) continues to reach more and more people living with epilepsy. Continuing its growth trend, Vimpat® achieved net sales of € 583 million. Since August, Vimpat® is also available for the treatment of partial onset seizures in Japan, in partnership with Daiichi Sankyo.

Keppra® (levetiracetam) for epilepsy reported net sales of € 541 million. In 2015 and in the U.S., net sales benefited from stocking effects, hence a decline in the U.S. while Japan and International markets report a positive net sales trend.

Neupro® (rotigotine), the patch for Parkinson's disease and restless legs syndrome, continuing its growth trend reached net sales of € 219 million.

For further information

Investor Relations

Antje Witte, Investor Relations, UCB T +32.2.559.94.14, [email protected]

Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588, [email protected]

Corporate Communications

France Nivelle, Global Communications, UCB T +32.2.559.9178, [email protected]

Laurent Schots, Media Relations, UCB T+32.2.559.92.64, [email protected]

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 500 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees.

Additionally, information contained in this document shall not constitute an 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.