Crucell NV 6-K 2009
REPORT OF FOREIGN PRIVATE
November 11, 2008
P.O. Box 2048
2333 CN Leiden
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F [ x ] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [ x ]
Achieves Profitability in Q3 2008
Leiden, The Netherlands (November 11, 2008) Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the third quarter of 2008, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.
1 Constant currencies = Weighted average EUR/USD rate of 1.38 in 2007.
Key Figures Q3 2008:
Crucell's Chief Executive Officer Ronald Brus said:
These results showing profitability represent a great achievement in the history of Crucell.
Our financial strength as well as the sustainable business we operate in, enables us to pursue our ambition to increase the number of people we can protect from infectious diseases. I am very pleased to be able to raise our revenue forecast for 2008 on the back of these strong results.
Product and Business Update
Product sales for the third quarter of 2008 amounted to €65.6 million and represent sales of paediatric vaccines (44%), travel and endemic vaccines (16%), respiratory vaccines (30%) and other products (10%).
In the third quarter of 2008 we saw strong growth of our paediatric vaccines, mainly driven by Quinvaxem®.
Travel and Endemic
The third quarter of 2008 showed solid growth of our travel and endemic portfolio. We continue to see significant untapped demand and potential for geographical expansion of our travel portfolio.
The third quarter of 2008 showed solid growth, compared to the same quarter of 2007 of our flu vaccine Inflexal® V.
exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF, while sanofi pasteur will have exclusive distribution rights for all other territories and co-exclusive distribution rights in China.
Positive preliminary results of our Phase II U.S. study were presented at the 19th annual RITA meeting in Atlanta on October 1, 2008. There was no serious adverse event reported. These results triggered another milestone payment from sanofi pasteur, at the end of September, as part of the total eligible amount of €66.5 million. This antibody combination is to be used in combination with a rabies vaccine for post-exposure prophylaxis (PEP) against this fatal disease.
The Crucell Ambition:
In the last few months The Crucell Ambition program has been rolled out throughout the whole organization and the executive board has met with more than 50% of Crucells employees from different parts of the organization. The Crucell Ambition program encompasses coordinated efforts in four priority areas, which have been carefully defined after a thorough review of Crucells operations, objectives and potential. These are:
1. ORGANIZATION & PEOPLE. Development of our organization and our people is the foundation for achieving our ambition as a company. Multiple measures are being implemented to achieve this.
2. FOCUS. Crucell is clearly focused on its mission to protect lives from infectious diseases by bringing innovation to global health. We are building on our strengths by prioritizing those programs that are in line with this ambition and that contribute to our strategic and financial objectives.
3. OPERATIONAL EXCELLENCE. Crucell launched its Healthy Ambition operational excellence program at the start of 2008 and is now implementing the validated plans drawn up in the first half of the year. By streamlining and optimizing our business processes, the program is expected to generate cost reductions of €30 million by the end of 2009.
4. DELIVER ON PROMISES. Crucell has set its sights high and is firmly committed to delivering on its ambitious promises. Evidence-based target setting and a company-wide emphasis on organization and people, focus and operational excellence will enable us to do so.
PER.C6® technology platform:
Revenue and Other Operating Income
Increase of license revenues was driven by milestone payments triggered by the Phase II clinical study of our Rabies program, the progress on sanofi pasteurs FluCell program as well as license income from Talecris Biotherapeutics.
Product sales for the third quarter amounted to €65.6 million and represent sales of paediatric vaccines (44%), travel and endemic vaccines (16%), respiratory vaccines (30%) and other products (10%).
License revenues were €10.4 million in the third quarter, an increase of €8.6 million compared to the same quarter of 2007. License revenues consist of initial payments from new contracts as well as milestones and other payments on existing contracts.
Service fees for the quarter were €2.6 million, compared to €3.7 million last year. Service fees represent revenue for product development activities performed under contracts with partners and licensees.
Other operating income was €3.5 million for the quarter, compared to €1.9 million in the third quarter of 2007.
of Goods Sold
Gross margins of 50% compared to 36% in the third quarter of 2007. Gross margins in the third quarter of this year are positively influenced by a significant increase in license income, sales of our flu product (Inflexal® V) and better production yields, as well as improved plant utilization due to higher volumes. Positive currency effects also contributed approximately 2.5 percentage points to gross margins.
R&D expenses for the third quarter amounted to €17.7 million, which represents a €5.3 million increase versus the third quarter of 2007. The increase can be attributed to the timing of specific R&D expenses during the year. Overall R&D spending for the full year is expected to be around € 70 million.
SG&A expenses for the quarter were €15.9 million, which represents a €0.6 million increase versus the third quarter of 2007. This increase was due to higher one-off expenses in the same quarter last year and includes costs related to the Healthy Ambition operational excellence program.
Net financial income and divestments in the third quarter of €2.6 million was the result of foreign exchange gains mainly caused by the increase of the U.S. dollar against the Euro and the sale of Kenta for €1.6 million.
Investments in associates and joint ventures amounted to €8.5 million and mainly represent investments in AdImmune and PERCIVIA. Crucell's investment in Galapagos NV is classified under available-for-sale investments.
Total equity on September 30, 2008 amounted to €424.5 million. A total of 65.7 million ordinary shares were issued and outstanding on September 30, 2008.
Investment in working capital increased significantly, mainly due to build-up of paediatric vaccine inventory, in anticipation of strong 2009 sales.
Flow and Cash Position
Net cash used in operating activities in the third quarter of 2008 was €9.9 million, driven by a €26 million net increase in working capital. Overall investments in net working capital increased mainly due to inventory build-up of Quinvaxem®. In anticipation of the expected further growth of Quinvaxem® in 2009, we will continue to build stock of Quinvaxem® in the fourth quarter of 2008.
Net cash used in investing activities in the third quarter amounted to €4.4 million. Net cash from financing activities in the third quarter amounted to €11.3 million.
Call and Webcast
Following a presentation of the results, the lines will be opened for a question and answer session.
The live audio webcast can be accessed via the homepage of Crucell's website at www.crucell.com and will be archived and available for replay following the event.
For further information please contact:
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.