Skip to main content

Market Overview

UCB Half Year Report 2019: UCB's Strong Performance Enables Continued Investment Into Future Growth Drivers

Share:

BRUSSELS, July 25, 2019 /PRNewswire/ --

– Regulated information –

  • Revenue reached € 2.3 billion (+2%, +4% CER1)
    net sales increased to € 2.2 billion (+3%, +5% CER – adjusted2 +11%, +7% CER)
  • Underlying profitability (rEBITDA3) was € 724 million (-9%, -1% CER) or a ratio of 31%
  • R&D update: Vimpat® with positive phase 3 results in PGTCS; four new phase 3 programs started: bimekizumab in psoriatic arthritis and axial spondyloarthritis; padsevonil in in drug-resistant focal epilepsy; rozanolixizumab in myasthenia gravis
  • Financial outlook for 2019 confirmed: Revenue expected to reach € 4.6 - 4.7 billion, recurring EBITDA3 should reach 27 - 29% of revenue, Core EPS of € 4.40 - 4.80 expected
  • CFO transition in 2020

"The strong financial performance in the first six months 2019 enables us as planned to accelerate our investments into future growth drivers," said Jean-Christophe Tellier, CEO UCB. "Our ambition is to create patient value for specific populations. From our promising late-stage pipeline we had already two product approvals and started four new phase 3 programs. In this context, we are confirming our financial outlook for the full year 2019, while we also reconfirm our commitment to competitive profitability in the mid-term."

Core product net sales

 

« Core product net sales

 

Revenue for the first six months of 2019 reached € 2.3 billion (+2%; +4% at CER).
Net sales went up by 3% to € 2.2 billion (+5% CER), driven by the continued growth of UCB's core products.

Underlying profitability (rEBITDA3) reached € 724 million (-9%; -1% CER) due to higher operating expenses - reflecting the investments into the future of UCB, namely into product launches and product development.

Profit of the Group was to € 437 million of which € 411 million (-24%; -14% CER) is attributable to the UCB shareholders.

Core earnings per share4 were € 2.42 after € 3.09.

UCB's financial results HY 2019

 

€ million

2019 HY

2018 HY

Act

CER

Revenue

2 323

2 269

2%

4%

Net sales

2 219

2 146

3%

5%

rEBITDA3

724

794

-9%

-1%

Number of shares (m)

187

188

-1%


Core EPS4 (€)

2.42

3.09

-22%

-12%

 

R&D update

Neurology

In January 2019, Vimpat® (lacosamide) was approved in Japan for the treatment of partial onset seizures in children 4 years of age and older. In addition, two new formulations were approved: IV (intravenous) and dry syrup.

In June, the Vimpat® 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 results for both its primary (time to second seizure) and secondary efficacy (seizure freedom) endpoints. The novel primary endpoint "time-to-second-seizure" reduced placebo-exposure of patients substantially. Submissions of this new indication are planned in the first half 2020 to multiple 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 headline results are expected in H2 2021 and will complement those from the ongoing Phase 2b, expected in H1 2020. Padsevonil is an innovative drug purposely designed with a novel dual mechanism of action to address the needs of uncontrolled patients.

In May, Nayzilam® (midazolam) nasal spray was approved in the U.S. to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy. UCB expects to make the treatment available to patients in the coming months. In March, UCB started as planned a phase 2, proof-of concept, study with its novel, subcutaneous FcRn (neonatal Fc receptor) monoclonal antibody, rozanolixizumab, in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). First headline results are expected in H1 2021.

In June, UCB started as scheduled the confirmatory study (phase 3) with rozanolixizumab in patients with myasthenia gravis (MG). First headline results are expected in H1 2021.

Immunology 

In March, UCB announced the approval of Cimzia® (certolizumab pegol) in the U.S. to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

In July and in China, Cimzia® was approved in combination with methotrexate 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 bimekizumab - in psoriatic arthritis and in axial Spondyloarthitis - were initiated, slightly earlier than planned. First topline results are expected at the end of 2021.

In June, UCB and its partner Biogen initiated preparations for a phase 3 program with dapirolizumab pegol in patients with active systemic lupus erythematosus (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

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

In April, Evenity® was approved in the U.S. for the treatment of osteoporosis in post-menopausal women at high risk for fracture.

In May, Evenity® was approved in South Korea and in June in Canada and Australia.

In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a negative opinion for romosozumab. The companies seek the re-examination of the CHMP opinion.

Net sales break-down by core product5

Immunology

Cimzia® (certolizumab pegol) for patients living with autoimmune and inflammatory TNF mediated diseases, net sales went up to € 782 million, driven by continued, sustainable growth in all regions. Growth is also driven by new patient populations like women in child bearing age and people living with psoriasis.

 








€ million

2019 HY

2018 HY

Act

CER


U.S.

480

416

15%

8%


Europe

208

192

8%

8%


International markets

94

71

31%

32%


Total Cimzia®

782

679

15%

10%







 

Neurology: UCB's epilepsy franchise reached net sales of € 1.25 billion, a plus of 12%.

Vimpat® (lacosamide), with net sales of € 622 million, shows continued strong growth in all regions thanks to reaching more and more people living with epilepsy.

 








€ million

2019 HY

2018 HY

Act

CER


U.S.

472

387

22%

14%


Europe

111

100

11%

11%


View Comments and Join the Discussion!
 
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com