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UCB Earnings Release 2015

Feb 26, 2016

4017_er_2016-02-26_1798c233-3670-4892-af62-90994da76d98.pdf

Earnings Release

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Brussels (Belgium), 26 February 2016 – 7:00 (CET) – regulated information – UCB Full Year Report 2015:

UCB with progress on its growth path delivering value to patients and shareholders

  • Product growth drive top and bottom line growth supported by exchange rates
  • Kremers Urban divestiture increases financial and strategic flexibility
  • R&D update: Briviact® (brivaracetam) for epilepsy approved in EU and U.S.; first Phase 3 study FRAME with romosozumab reports positive topline results; early pipeline strengthened
  • Financial outlook 2016: Revenue expected at approximately € 4.0-4.1 billion, recurring EBITDA of € 970–1 010 million, Core EPS in the range of € 2.90-3.20.

"The continued growth of UCB's main products in 2015 delivered strong earnings. Our patient value strategy aims to deliver superior value to patients. This will enable us to deliver significant growth to our shareholders," said Jean-Christophe Tellier, CEO UCB. "Going forward we continue to grow our product portfolio, we launch Briviact® and prepare the launch of romosozumab. At the same time, we continue to invest into our promising pipeline to deliver future breakthrough solutions for patients."

Revenue and net sales increased driven by product growth: Cimzia®, Vimpat®, Neupro® and Keppra® combined reached net sales of € 2.76 billion (+29%) - representing now 77% of net sales.

35% higher underlying profitability (recurring EBITDA2 ) reflecting higher revenue and a lower operating expenses ratio.

Profit for the Group amounted to € 674 million, after € 199 million in 2014, of which € 623 million (after € 209 million) is attributable to UCB shareholders, and includes the gain on the divestiture of Kremers Urban.

UCB Financial Results 2015:

€ million 2015 2014 Actual CER1
Revenue 3.88bn 3.34bn 16% 9%
Net sales 3.51bn 2.94bn 20% 12%
rEBITDA2 821m 609m 35% 18%
Core EPS3 2.17 1.69 28% 9%
Dividend per share 1.10 1.06 4%

The UCB Board of Directors proposes a gross dividend of € 1.10 per share, +4%.

1 CER = constant exchange rates

2 rEBITDA = recurring Earnings Before Interest, Taxes, Depreciation and Amortization

3 Core EPS = Core Earnings Per Share

R&D update

Bone - in February 2016, UCB and Amgen announced positive top-line results from the Phase 3 placebo-controlled study in postmenopausal women with osteoporosis (FRAME). FRAME met all co-primary endpoints by reducing the incidence of new vertebral fractures through months 12 and 24 in postmenopausal women with osteoporosis treated with romosozumab.

The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months. The secondary endpoint of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met.

ARCH, a Phase 3 study which includes an active comparator is expected to report results in 2017. BRIDGE, a Phase 3 study evaluating romosozumab in male osteoporosis is expected to report headline results in H1 2016.

Immunology - in September, UCB initiated a Phase 3 study for the U.S. to assess the efficacy and safety of Cimzia® (certolizumab pegol) in the treatment of adults with active non-radiographic axial spondyloarthritis (nraxSpA). First headline results are expected in 2018.

In 2015, Cimzia® was approved for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate or other diseasemodifying anti-rheumatic drugs, both in Japan (May 2015) and in Europe (December 2015) based on the results of two Phase 3 clinical trials, C-OPERA™ and C-EARLY™ (52 weeks). By demonstrating that Cimzia® provides significant clinical benefit and inhibition of progression of radiographic damage, both studies support the concept of an early window of opportunity for treatment in these patients.

The C-EARLY™ trial continued from week 52 to 104 and evaluated treatment strategies to sustain a low disease activity state, without a flare, when Cimzia® dosing is maintained, reduced or stopped. A lower number of patients than expected qualified for entry to the second period resulting in outcomes that were clinically meaningful but did not reach statistical significance. Patients who stopped Cimzia® had a tendency to worsen over time. Results have been submitted for presentation at a scientific congress in 2016.

In October, the learn phase exploratory development study with bimekizumab (UCB4940) in patients with psoriatic arthritis yielded positive topline results, supporting UCB's hypothesis that targeting both ligands, IL-17A and IL-17F translates into potentially improved clinical patient benefit. UCB is now preparing the Phase 2b program in various indications, planned to start in H2 2016.

In October, UCB6673 for immunotherapy in collaboration with the King's College London entered into Phase 1.

Neurology - in October, the Phase 3 study to evaluate Vimpat® (lacosamide) as monotherapy in the treatment of adults with partial-onset seizures generated positive results. Filing with the European authorities took place in January 2016.

Briviact® (brivaracetam) as adjunctive therapy for partial-onset seizures in patients from 16 years of age was filed in January 2015 with the U.S. and EU regulatory authorities. Briviact® was approved in the EU in January 2016 and in the U.S. in February 2016.

All other clinical development programs are continuing as planned.

Cimzia® (certolizumab pegol) net sales of
nearly € 1.1 billion are driven by continuously
broadened access to patients living with
inflammatory TNF mediated diseases. Net sales
in Japan reflect the order pattern of UCB's
partner which is normalizing going forward; the
in-market performance shows continued growth
trend.
Vimpat® (lacosamide)
is reaching more and
more people living with epilepsy and achieved
net sales of € 679 million. Since late 2014
Vimpat® is available in the U.S. for
monotherapy treatment of partial onset
seizures.
Neupro® (rotigotine), the patch for Parkinson's
disease and restless legs syndrome, continued
its growth trend and reached net sales of
€ 258 million.
Keppra® (levetiracetam) for epilepsy net sales
were € 737 million, up by 11%. In the U.S.,
Keppra® net sales benefited from short supply
in the market and showed continued growth in
Japan and international markets.

Revenue and net sales increased to €3.88 billion (+16%; +9% CER) and €3.51 billion (+20%; +12% CER) respectively driven by product growth and supported by tailwind from foreign exchange rates.

Royalty income increased to € 176 million (+9%; 0% CER). Other revenue decreased to € 188 million (-23%; -27% CER), mainly due to received milestone payments in 2014.

Gross profit went up to € 2.7 billion (+19%, +9% CER), due to the net sales growth and improved product mix. Operating expenses increased under-proportionally to revenue and net sales and were higher by 12% reaching € 2.1 billion (+5% CER). This is reflecting marketing and selling expenses of € 904 million, research and development expenses of € 1 037 million and general and administrative expenses of € 192 million.

  • 2 rEBITDA = recurring Earnings Before Interest, Taxes, Depreciation and Amortization
  • 3 Core EPS = Core Earnings Per Share

Underlying profitability –recurring EBITDA2 - reached € 821 million (+35%; +18% CER), driven by strong net sales growth, higher gross margin and an under-proportional growth of operating expenses supported by tailwind from foreign exchange rates in 2015.

Non-recurring expenses were € 55 million after € 107 million, due to a gain from the divestiture of UCB's established brands in India. Net financial expenses went down to € 96 million from € 162 million, driven by lower interest expenses due to the pay-down of the outstanding retail bond which matured November 2014. Income tax expenses were € 111 million reflecting an average tax rate on recurring activities of 24%.

Profit from discontinued operations, reflecting the divestiture and activities respectively of Kremers Urban, reached € 359 million after € 94 million respectively. In September 2015, UCB entered a definitive agreement with Lannett to sell its U.S. specialty generics business, Kremers Urban. Upon closing of the deal in November 2015, UCB received approximately US\$ 1.23 billion consisting of cash consideration of US\$ 1.03 billion (subject to certain adjustments) and US\$ 200 million senior unsecured notes issued to UCB by Lannett.

Profit of the Group was € 674 million and of which € 623 million is attributable to UCB shareholders and a profit of € 51 million to non-controlling interests. In 2014, € 199 million were attributable to UCB shareholders and a loss of € 10 million to non-controlling interests.

Core earnings per share, which reflect profit attributable to UCB shareholders after tax effects of non-recurring items, financial one-offs and amortization of intangibles, reached € 2.17 per share based on 192 million weighted average shares outstanding from € 1.69 per share based on 191 million shares in 2014 (+28%; +9% CER).

The Board of Directors of UCB proposes a dividend of € 1.10 per share (gross), an increase by four €-Cents or 4%.

Outlook 2016 - UCB expects continued growth. 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.

FY 2015 – Financial highlights

A full financial report on the consolidated results is available on the UCB website: http://www.ucb.com/investors/Financials/

ACTUAL 1 VARIANCE
$\epsilon$ million 2015 2014 ACTUAL
RATES
CER 2
Revenue 3876 3 3 4 4 16% 9%
Net sales 3 5 1 2 2938 20% 12%
Royalty income and fees 176 163 9% 0%
Other revenue 188 243 $-23%$ $-27%$
Gross profit 2 7 19 2 2 9 1 19% 9%
Marketing and selling expenses $-904$ $-779$ 16% 9%
Research and Development expenses $-1037$ $-928$ 12% 6%
General and administrative expenses $-192$ $-201$ $-4%$ $-8%$
Other operating income/expenses (-) $-9$ $-4$ >100% 29%
Recurring EBIT (REBIT) 577 379 52% 28%
Non recurring income/expenses (-) $-55$ $-107$ $-49%$ $-40%$
EBIT (operating profit) 522 273 92% 55%
Net financial expenses $-96$ $-162$ $-41%$ $-43%$
Profit before income taxes 426 111 >100% >100%
Income tax expenses (-)/credit $-111$ $-6$ >100% >100%
Profit from continuing operations 315 105 >100% >100%
Profit/loss (-) from discontinued operations 359 94 >100% >100%
Profit 674 199 >100% >100%
Attributable to UCB shareholders 623 209 >100% >100%
Attributable to non-controlling interests 51 $-10$ n.s. n.S.
Recurring EBITDA 821 609 35% 18%
Capital expenditure (including intangible assets) 146 161 $-9%$ n.S.
Net financial debt 921 1611 $-43%$ n.s.
Operating cash flow from continuing operations 204 537 $> -100%$ n.S.
Weighted average number of shares - non diluted 192 191 1% n.s.
EPS ( $\epsilon$ per weighted average number of shares - non diluted) 3.25 1.10 >100% >100%
Core EPS (€ per weighted average number of shares - non diluted) 2.17 1.69 28% 9%
  1. Due to rounding, some financial data may not add up in the tables included in this management report. 2 CER : constant exchange rates

"The statutory auditor has issued an unqualified report with no emphasis of matter paragraph dated 25 February 2016 on the company's consolidated accounts as of and for the year ended 31 December 2015, and has confirmed that the accounting data reported in the accompanying press release is consistent, in all material respects, with the accounts from which it has been derived."

For further information

Investor Relations

Antje Witte, Investor Relations, UCB

T +32.2.559.94.14, [email protected] T +32.2.559.9178, [email protected]

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

Corporate Communications

France Nivelle, Global Communications, UCB

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 7 700 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.