Revenues for the first quarter amounted to EUR 0.9 million (US$ 0.8 million), which is equal to EUR 0.9 million (US$ 0.8 million) for the corresponding 3 months ended March 31, 2000. In line with management's expectations, the pro forma loss amounted to EUR 2.9 million (US$ 2.5 million), or EUR 0.08 per share (US$ 0.07), as compared to EUR 2.5 million (US$ 2.3 million) for the same period in 2000, or EUR 0.14 per share (US$ 0.13).

The pro forma results exclude a non-cash charge of EUR 2.5 million (US$ 2.3 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 in June 2000, as well as a non-cash charge relating to stock option plans, of EUR 0.2 million (US$ 0.15 million). Including non-cash charges, the total loss for the first quarter was EUR 5.6 million (US$ 5.0 million), or EUR 0.16 net loss per share (US$ 0.14) compared with a net loss of EUR 2.5 million for the first quarter of 2000, or EUR 0.14 per share (US$ 0.13).

Crucell ended the first quarter with Euro 132 million in cash ($ 119 million).

"During the first quarter we set in place the necessary steps to grow our organization and to ensure we can reach our targets for 2001', commented Dinko Valerio, President and Chief Executive Officer of Crucell. "We signed up a new PER.C6 licensee, and also started our program to assist our partners with the development of PER.C6-derived products, by producing clinical grade material for them. Furthermore, we were happy to see that Merck & Co., Inc. started early clinical trials with their HIV vaccine in February that was produced using our cell line production technology PER.C6 under exclusive license agreement. This we see of course as a strong validation of our technology. On the intellectual property front, we were happy to welcome our new Executive Director of Intellectual Property, Bart Klein. All in all, we have made the expected progress on all fronts.'


Highlights of the first quarter 2001
- Merck & Co., Inc. initiated clinical trials for testing an HIV vaccine program, produced on PER.C6, under an exclusive license agreement with Crucell.
- Executed a licensing agreement with US based Cell Genesys Inc. (Nasdaq: CEGE), a leading gene therapy company focused on the development and commercialization of cancer vaccines and gene therapies, for access to Crucell's PER.C6 technology
- One new US patent was issued, strengthening our position in the vector technology field.
- Appointed Bart Klein as Executive Director of Intellectual Property
- Executed a production agreement with US based DirectGene Inc. to manufacture their therapeutic product for clinical studies in the USA. DirectGene has clinical gene therapy development programs in prostate cancer, osteosarcoma, breast cancer, brain tumors and osteoporosis
- Started production of recombinant adenoviral clinical batches at Crucell's Good Manufacturing Practice (GMP) facilities based in Leiden. Crucell is offering vector generation and GMP services to PER.C6TM licensees

Outlook
In the remainder of the year Crucell expects to be implementing its strategy to move 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 proprietary MAbstract-derived products. Crucell plans to expand its team with additions in the research and development groups and business development. We expect to enter into agreements related to our human antibody technology MAbstract, and to our PER.C6 technology.
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.

 

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