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UCB — Interim / Quarterly Report 2018
Apr 25, 2018
4017_iss_2018-04-25_f7eecf9a-0cfe-4b90-91d4-dfce72f26e63.pdf
Interim / Quarterly Report
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Brussels (Belgium), 25 April 2018 – 18:00 (CEST) – regulated information – UCB First Three Months Interim Report 2018:
UCB tracking well towards full year financial outlook
- Revenue reached € 1.07 billion: -5%, -1% CER; adjusted for allergy drug divestiture in 2017: +0%; +4% CER
- UCB's main five products reached € 839 million (-2%, +8% CER)
- R&D update: Cimzia® available for women with chronic inflammatory disease throughout the pregnancy journey; UCB0107 enters clinical phase 1; Element Genomics strengthens research platform; agreement to acquire midazolam nasal spray in epilepsy
- Financial outlook 2018 confirmed: Revenue expected to reach € 4.5 4.6 billion, recurring EBITDA2 should reach € 1.3 - 1.4 billion, Core EPS of € 4.30 - 4.70
"As expected and reflected in our financial outlook for 2018, we see headwind from foreign exchange rates. At constant exchange rates, UCB's growth drivers, our main products, are showing good continued growth. The label extension for Cimzia® enable us to create further value for our patients," said Jean-Christophe Tellier, CEO UCB. "Our promising pipeline, now encompassing 13 new molecular entities, is making good progress. Also, our research platform is strengthened by Element Genomics in the U.S. Our epilepsy portfolio will be strengthened with the addition of midazolam nasal spray."
Revenue for the first three months of 2018 reached € 1.07 billion, -5% at actual and -1% at constant exchange rates (CER). Adjusted by the one-time other revenue in Q1 2017 of € 56 million for out-licensing the OTC-allergy drug Xyzal® (levoceterizine), revenue was flat and grew by 4% CER.
Core driver of the continued growth are UCB's main products, Cimzia®, Vimpat®, Keppra®, Briviact® and Neupro® with combined net sales of € 839 million, -2% actual; +8% CER.
Financial outlook 2018 confirmed
2018 revenue is expected to reach approximately € 4.5 – 4.6 billion. Recurring EBITDA in the range of € 1.3 – 1.4 billion. Core earnings per share are therefore expected in the range of € 4.30 – 4.70 based on an average of 188 million shares outstanding.
R&D update
In March, UCB acquired Element Genomics in the U.S. to strengthen UCB's genomics and epigenomics research platform to identify novel drug targets.
Neurology
In January 2018, UCB filed Vimpat® (lacosamide) for pediatric patients living with partial-onset epilepsy at four years and older in Japan.
In February 2018, the phase 2b study with padsevonil started for drug resistant epilepsy patients. First results are expected in H1 2020.
In March 2018, UCB0107, a humanized, immunoglobulin monoclonal antibody with a specificity for human tau, entered the clinical phase 1 program. It is currently under investigation within UCB for the potential treatment of tauopathies, a group of incurable neurodegenerative diseases that include progressive supranuclear palsy (PSP) and Alzheimer's disease (AD). Pre-clinical data show that UCB0107 has greater efficacy in a seeding model using human AD and PSP seeds when compared with other antibodies.
In April, UCB took a step toward expanding its epilepsy portfolio with the signing of an agreement for the strategic acquisition (subject to the required antitrust filing and waiting period and customary closing conditions) of midazolam nasal spray (USL261) from Proximagen. USL261 is a nasally administered investigational midazolam formulation intended
as a rescue treatment of acute repetitive seizures in patients with epilepsy, which has completed Phase 3 clinical development and is expected to be filed as a New Drug Application in the U.S. in the course of 2018.
Immunology
A label update for Cimzia® (certolizumab pegol) in pregnancy and breastfeeding was approved in Europe (January 2018) and in the U.S. (March 2018), making it the first anti-TNF treatment option that could be considered for women with chronic inflammatory disease throughout the pregnancy journey.
In March, the Cimzia® pre-filed syringe received approval in the U.S. for the option to store it at room temperature for a single period of up to 7 days, within the approved shelf-life, thus helping better address patient needs.
Also in March 2018, UCB announced the filing of Cimzia® with the China Food and Drug Administration for the treatment of moderate-tosevere rheumatoid arthritis.
All other clinical development programs are continuing as planned.
| $\epsilon$ million | 3M 2018 | 3M 2017 | Act | CER |
|---|---|---|---|---|
| U.S. | 180 | 200 | $-10%$ | 4% |
| Europe | 92 | 84 | 10% | 11% |
| International markets | 38 | 34 | 12% | 24% |
| Total Cimzia® | 310 | 317 | $-2%$ | 8% |
Immunology
Cimzia® (certolizumab pegol) for people living with inflammatory TNF mediated diseases contributed net sales of € 310 million. In the U.S., increased competitive intensity in the Crohn's Disease market impacted the net sales growth.
| $\epsilon$ million | 3M 2018 | 3M 2017 | Act | CER. |
|---|---|---|---|---|
| U.S. | 177 | 186 | $-5%$ | 10% |
| Europe | 48 | 40 | 22% | 22% |
| International markets | 16 | 13 | 22% | 35% |
| Total Vimpat® | 242 | 239 | 1% | 13% |
Neurology
Vimpat® (lacosamide) continues to reach more and more people living with partial onset seizure epilepsy, shows continuous strong growth and achieved net sales of € 242 million.
| $\epsilon$ million | 3M 2018 | 3M 2017 | Act | CER |
|---|---|---|---|---|
| U.S. | 36 | 52 | $-31%$ | $-20%$ |
| Europe | 56 | 61 | $-8%$ | $-7%$ |
| International markets | 96 | 96 | 0% | 9% |
| Total Keppra ® | 189 | 210 | $-10%$ | $-3%$ |
Keppra® (levetiracetam) for epilepsy reached net sales of € 189 million, due to a normalized situation in the U.S. and good growth in international markets.
| $\epsilon$ million | 3M 2018 | 3M 2017 | Act | CFR. |
|---|---|---|---|---|
| U.S. | 21 | 11 | $93\% > 100\%$ | |
| Europe | 6 | $3 \rightarrow 100\% \rightarrow 100\%$ | ||
| International markets | 0 | $> 100\% > 100\%$ | ||
| Total Briviact® | 27 | 14 | $98\% > 100\%$ |
Briviact® (brivaracetam), available for people living with epilepsy continues to show very strong growth and achieved net sales of € 27 million.
| $\epsilon$ million | 3M 2018 | 3M 2017 | Act | CER |
|---|---|---|---|---|
| U.S. | 21 | 24 | $-10%$ | 4% |
| Europe | 43 | 39 | 10% | 10% |
| International markets | 7 | 11 | $-40%$ | $-34%$ |
| Total Neupro® | 71 | 74 | $-4\%$ | $1\%$ |
Neupro® (rotigotine), the patch for Parkinson's disease reached net sales of € 71 million. While showing continuous growth in U.S. and Europe, international markets show a decrease due to different shipment patterns compared to last year for Japan. In-market growth in Japan is unchanged strong with a plus of 9% in the first quarter.
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 € 4.5 billion in 2017. 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.