LEIDEN, Netherlands, March 12 /PRNewswire/ -- Crucell N.V. (Nasdaq: CRXL; EAX Amsterdam: CRXL), a leading biotechnology company focused on the discovery of unique drug targets on disease associated cells and on the development of huMADE(TM) biopharmaceuticals, today announced its full year financial results for 2000.
* Highlights of 2000
* Total net revenues were up 116% to EUR 6.9 million (US$ 6.4 million)
* Cash balance of EUR 136 million (US$ 126.2 million) at year end
* Merger and integration of IntroGene B.V. and U-BiSys B.V.
* IPO on Nasdaq and Euronext (Amsterdam) raising gross proceeds of EUR
144 million (US$ 119 million)
* Four new non-exclusive PER.C6 license agreements signed
* One exclusive license agreement signed with Merck & Co, Inc., bringing the total number of license agreements to 14 by year end
* Development of in-house product pipeline of human antibodies for treatment of cancer and inflammatory diseases and vaccines (e.g. influenza vaccine)
* Strengthening of intellectual property position with 13 new patent applications, and 3 newly issued patents
* Government subsidy of EUR 1.3 million (US$ 1.2 million) for oncology co-operation with University Medical Center Utrecht was granted
* Opening of new headquarters in the Leiden BioScience Park
Full year results
Revenues for the full year increased 116% to EUR 6.9 million (US$ 6.4 million), mainly consisting of license fees, compared to EUR 3.2 million (US$ 2.9 million) for the corresponding year ended December 31, 1999. In line with expectations, the pro forma loss amounted to EUR 11.2 million (US$ 10.3 million), or EUR (0.46) per share (US$ 0.42), as compared to EUR 7.3 million (US$ 6.8 million) in 1999, or EUR (0.42) per share (US$ 0.39).
The pro forma results exclude a charge of EUR 5.1 million (US$ 4.7 million) for amortization of goodwill and other intangible assets related to the merger between IntroGene B.V. and U-BiSys B.V. to form Crucell, as well as a non-recurring non-cash write-off of in-process research and development of EUR 84.1 million (US$ 77.6 million) relating to the merger, and a non-cash charge relating to stock option plans, of EUR 31.2 million (US$ 28.8 million). Including non-cash charges, the total loss for the year was EUR 131.6 million (US$ 121.5 million), or EUR 5.38 net loss per share (US$ 4.97) compared with a net loss of EUR 7.4 million for 1999. (Please refer to the details section of the full year results for more information.)
Crucell ended the year with EUR 136.0 million (US$ 126.2 million) in cash.
Fourth quarter results
Revenues for the fourth quarter increased nine-fold to EUR 4.5 million (US$ 4.1 million) compared with EUR 0.5 million (US$ 0.5 million) for the corresponding quarter in 1999. Crucell's pro forma net loss in the fourth quarter amounted to EUR 3.8 million (US$ 3.5 million), compared to EUR 3.1 million (US$ 2.8 million) in the same quarter of 1999.
The pro forma net loss excludes amortization of goodwill and other intangible assets of EUR 2.5 million (US$ 2.3 million) related to the merger between U-BiSys B.V. and IntroGene B.V. to form Crucell and a non-cash charge of EUR 15.4 million (US$ 14.2 million) related to issuance of new stock options. The total loss for the fourth quarter amounted to EUR 21.7 million (US$ 20.0 million), compared to EUR 3.0 million (US$ 2.8 million) in the same quarter of the previous year.
``2000 has been a very rewarding and exciting year for us. We increased the number of PER.C6 licenses to 14, which provide revenues in the short, medium and long term. We were also able to conclude an exclusive agreement with Merck & Co., Inc., bringing further endorsement of our PER.C6 technology platform in the area of vaccines. Furthermore, we merged and integrated two companies, and listed the new entity, Crucell, on both Nasdaq and Euronext in October. In doing so, we managed to raise the amount of capital we aimed for to fund our research and development plans for the next three years,'' commented Dinko Valerio, President and CEO of Crucell. ``With these achievements we have laid the foundation to further grow our company, advance our in-house product pipeline, and to extend our list of partners.''
Details of the financial results 2000
Revenues
Total revenues increased to EUR 6.9 million (US$ 6.4 million), compared to EUR 3.2 million in 1999. This increase is primarily due to a higher level of license fees (EUR 6.0 million in 2000 and EUR 2.2 million in 1999), as 4 new non-exclusive PER.C6 license agreements were signed. In particular, the higher level reflects the signing of one exclusive license agreement with Merck & Co, Inc. in the fourth quarter, granting them a license for the PER.C6 platform technology to develop vaccines for the prevention and treatment of one disease. Merck has the option to extend this exclusivity to cover three additional diseases in the future.
Government grants were EUR 0.87 million in 2000 (EUR 0.97 million in 1999).
Costs
On a pro forma basis, excluding non-cash charges for the amortization of goodwill and other intangible assets, charges related to stock option plans, and acquired in-process research and development, operational costs amounted to EUR 15.4 million (US$ 14.2 million), up 49% from 1999. R&D expenses increased by 35% to EUR 7.2 million (US$ 7.1 million), mostly as a result of increased staff numbers and the move into new facilities in October. Selling, General & Administrative expenses increased 64% to EUR 8.2 million (US$ 7.6 million) in 2000, compared to EUR 5.0 million (US$ 4.6 million) in 1999. The increase in SG&A expenses was mainly due to increased spending on protection of intellectual property and in-licensing of other technologies.
In 2000 the company adopted US accounting principles (US GAAP) to report its financial results. In accordance with these accounting principles significant non-cash charges were incurred for the merger between IntroGene B.V. and U-BiSys B.V. to form Crucell in June 2000, and also to the necessary changes in the company's option plans as a result of the merger, and to the issuance of new options.
These non-cash expenses are:
* The in-process research and development related to the merger with
U-BiSys which was valued at EUR 84.1 million (US$ 77.6 million).
* In connection with the merger with U-BiSys, the company recognized EUR
50.8 million (US$ 47.8 million) of goodwill and other intangible
assets, which will be amortized over 5 years. Amortization of goodwill
and other intangible assets for 2000 amounts to EUR 5.1 million.
* Pre-merger option plans were converted into Crucell option plans, which
resulted in a non-cash charge of EUR 15.7 million (US$ 14.5 million).
* Issuance of new options in the fourth quarter at an exercise price of
Euro 21.00 resulted in an additional non-cash charge of EUR
15.4 million (US$ 14.2 million).
IPO on October 27, 2000
Crucell issued 8 million primary shares on October 27 at a price of EUR 18 (US$ 14.89), and the company's stock is now traded on Euronext Amsterdam and Nasdaq National Market under ticker symbol CRXL. The company raised gross proceeds of EUR 144 million (US$ 119 million). Currently, the total number of shares outstanding is 35 million.
Outlook
In the year 2001 Crucell expects to be implementing its strategy to move its own products further into development. This will be done by out-licensing, co-development and further in-house development, while continuing to fill the pipeline with MAbstract-derived products. Crucell plans to expand their team with additions in the research and development groups, business development and intellectual property. We expect to sign agreements related to our human antibody technology MAbstract, as well as additional PER.C6 licenses. Furthermore, Crucell expects to sign a number of agreements with its partners for the production of clinical grade materials, thereby assisting them with their development process.
Due to the execution of Crucell's strategy, development costs are expected to increase, as some in-house products will be getting nearer to clinical development. Crucell also expects to begin collaboration for the development of its influenza vaccine, which is expected to be ready to enter into clinical trials in 2002.
Crucell plans to establish a second pilot plant facility for the pharmaceutical production of monoclonal antibodies using its PER.C6 cell line, both for its own in-house product development, as well as for its partners to help accelerate their development process.
About Crucell
Crucell is a leading biotechnology company focused on the discovery of unique drug targets on diseased cells and on the development of ``huMADE'' biopharmaceuticals. Crucell's two broadly applicable human technology platforms form the basis for this. The first is a human cell line expression platform, PER.C6, on which a wide range of biopharmaceuticals can be developed and manufactured, such as vaccines, antibodies, therapeutic proteins and gene therapy products. The second technology is called MAbstract, a set of tools based on phage antibody-display libraries and proprietary subtraction and selection technology, to discover novel drug targets and develop human monoclonal antibodies as therapeutics for a variety of diseases.
Crucell makes its technologies available under exclusive or non-exclusive license agreements, and has currently signed 15 agreements with major pharmaceutical and biotechnology companies for its PER.C6 technology. Crucell focuses on the development of therapeutics for treatment of cancer, inflammatory diseases and for the prevention and treatment of influenza and other infectious diseases... |
