LEIDEN, Netherlands, Jan. 24, 2005 (PRIMEZONE) -- Dutch biotechnology company Crucell N.V. (Nasdaq:CRXL) (Euronext:CRXL) today announced its 2004 financial results. Revenue for the year ended December 31, 2004 was Euro 22.6 million (US$ 30.9 million), representing a three-fold increase over the Euro 7.4 million (US$ 10.1 million) reported in 2003. Cash burn was Euro 10.5 million (US$ 14.3 million), less than half the cash burn of Euro 23.4 million (US$ 32.0 million) recorded in 2003.
"The past year was our strongest in four years as a public company," noted Ronald H.P. Brus, MD, Crucell's President and Chief Executive Officer. "We achieved all key product development milestones, added several new partners, including sanofi aventis for the next-generation flu vaccine, broadened the licensing base for our cell-based manufacturing technology, and secured the involvement of Genentech in evaluating the STAR(tm) technology we acquired last year. All of this adds to our confidence that 2005 will provide significant opportunities for continued growth," he continued. "While maintaining our focus on our vaccine development, we plan to enter into further development initiatives as strategic opportunities arise. We will continue to seek potential strategic partners. In addition, we may seek other sources of external funding to finance these initiatives, which may include a modest capital raising."
Net loss in 2004 dropped to Euro 21.3 million (US$ 29.1 million), compared to Euro 23.4 million (US$ 31.9 million) in 2003, even allowing for a Euro 3.9 million (US$ 5.3 million) increase in research and development expenses in line with the stepping up of core programs. At December 31, 2004 cash and cash equivalents stood at Euro 76.7 million (US$ 104.7 million). These cash reserves, combined with ongoing revenues received from technology licensing contracts, selective external funding of programs and government grants, are considered adequate to fund the Company's existing vaccine development programs until break-even.
Crucell's Chief Financial Officer Leonard Kruimer commented: "Our financial results reflect the strength of the Company's business model. The key priority for 2005 is to bring our vaccine programs into clinical trials. Our financial management strategy, proven ability to attract the best partners, and our careful control over cash burn make it clear we are ideally placed to bring our plans to fruition."
Full Year 2004 Highlights
-- Influenza: sanofi aventis (formerly Aventis Pasteur)
and Crucell announced a strategic agreement to develop
and commercialize novel PER.C6(R)-based influenza vaccines.
Clinical trials are set to begin in the third quarter
of 2005.
-- West Nile: The State of Israel granted market authorization
for a West Nile virus veterinary vaccine for geese
developed by Crucell together with the Israeli Kimron
Veterinary Institute; clinical trials of Crucell's
human West Nile virus vaccine are set to begin during
the fourth quarter of 2005, with agreement reached with
the Netherlands Vaccine Institute (NVI) for the manufacture
of the clinical trial vaccine lots at the NVI's new
BSL-3 plant.
-- Malaria: The National Institute of Allergy and
Infectious Diseases (NIAID) at the US National Institutes
of Health (NIH) agreed to support the development of
Crucell's candidate Malaria vaccine. Monkey trial
data announced in November 2004 showed excellent
immune responses for Crucell's AdVac(R)-based vaccine.
Clinical trials are set to begin in 2006.
-- Ebola: Experiments performed by the Vaccine Research
Center (VRC) of the US National Institutes of Health
(NIH) and the US Army Medical Research Institute
of Infectious Diseases (USAMRIID) demonstrated that
a single dose of Crucell's PER.C6(R)-based vaccine
protects macaque monkeys from Ebola infection.
Clinical trials are set to begin during the fourth
quarter of 2005.
-- AIDS: Crucell and the International AIDS Vaccine
Initiative (IAVI) signed an exclusive license agreement
to develop an AIDS vaccine based on Crucell's AdVac(R)
technology. Meanwhile, Merck's PER.C6(R)-based
HIV vaccine progressed to the next phase of clinical
trials, thereby delivering a milestone payment
to Crucell.
-- Rabies: Crucell discovered an anti-rabies antibody
product using its MAbstract(R) technology. The antibody
product has proven effective in protecting hamsters
against a lethal rabies challenge. Results of an
evaluation of how to proceed with development will be
announced in the second quarter of 2005.
-- SARS: The Lancet medical journal published the results
of a study demonstrating that a human monoclonal
antibody, discovered with the use of Crucell's
MAbstract(R) technology and produced on the
PER.C6(R) cell line, was able to effectively protect
ferrets from SARS.
-- Tuberculosis: Crucell and the Aeras Global TB Vaccine
Foundation announced a new collaboration on the
preclinical and clinical development of candidate
tuberculosis (TB) vaccines. Proof-of-concept trial
results will be announced in the second quarter of 2005.
-- ChromaGenics STAR(TM): Crucell completed the acquisition
of ChromaGenics B.V., adding its STAR(TM) technology
to Crucells' protein production business. In a
Genentech-funded joint evaluation program, Genentech
and Crucell are currently investigating whether
STAR(TM) technology can increase the production
yields of Genentech's proprietary systems.
-- In the clinic: AME/Eli Lilly took the first antibody
produced on PER.C6(R) technology to clinical trials
in the U.S.
-- DSM Milestone: Crucell and DSM Biologics achieved
the first development milestone pertaining to their
protein production collaboration, with the joint
development program demonstrating industry-high yields;
-- Licensing: New PER.C6(R) licensing deals were secured
by the Crucell-DSM alliance with Biogen Idec,
PanGenetics, Merus, Chiron, GSK, Synergenics
LLC/Synco BioPartners Investments, MorphoSys and
Micromet; Crucell signed further PER.C6(R) deals
with NeoTropiX Inc, ML Laboratories, Wyeth, Vaxin,
Merial, Edwards Life Sciences and Chiron.
-- Midkap: Based on full-year 2004 turnover of shares,
Crucell was selected by Euronext Indices B.V. as a
candidate for inclusion in the Amsterdam Midkap
(AMX) index.
-- Intellectual property: Crucell brought its European
patent position in line with its position in the
U.S., securing European patents for PER.C6(R)
and AdVac(R) technology. The first legal proceedings
regarding infringement of the PER.C6(R) patent were
subsequently launched against CEVEC. A further
European Patent was added in January 2005
specifically relating to the application of
PER.C6(R) for vaccines.
-- Supervisory Board: Mr. Jan Pieter Oosterveld was
appointed to Crucell's Supervisory Board by
shareholders. Mr. Domenico Valerio, the Company's
founder and former President & Chief Executive Officer,
will continue to serve the Company in an advisory role
with an emphasis on investor- and public -relations,
and not as a member of the Supervisory Board. The
Priority Share Foundation Crucell N.V. is pleased
to nominate Mr. Arnold Hoevenaars RA as independent
Supervisory Board member. The Company shall seek
shareholders' approval for his appointment at the
Company's next Annual General Meeting on
June 2, 2005. Mr. Hoevenaars brings strong financial
and accounting experience to the board. He is a
chartered accountant and his previous positions
include, among others, Chairman of the Management
Board of the Achmea Group, Chairman of the Board
of Directors and Chairman/CEO of the Executive Board
of Eureko B.V. and member of the Management Board
and Chief Financial Officer of Royal Boskalis
Westminster N.V.
-- Management: Mr. Ronald H.P. Brus MD was appointed
as the new President, CEO and Chairman of the
Management Board of Crucell at the Annual General
Meeting of Shareholders on June 3, 2004. In addition,
CSO Mr. Jaap Goudsmit MD PhD, and CFO
Mr. Leonard Kruimer CPA, were appointed as members
of the Company's Management Board.
Key Figures 2004
(Euro million, except net loss per share)
2004 % change 2003
Revenue 22.6 + 205% 7.4
Net loss (21.3) (9.0%) (23.4)
Net loss per share
(basic and diluted) (0.59) (9.2%) (0.65)
Cash and cash equivalents
on December 31 76.7 (12%) 87.2
Details of the Financial Results Full Year 2004
Revenue
Crucell's revenue for the year 2004 was Euro 22.6 million (US$ 30.9 million), compared to Euro 7.4 million (US$ 10.1 million) in 2003. Licensing revenue in 2004 amounted to Euro 12.4 million (US$ 17.0 million), representing a significant increase on the figure of Euro 4.8 million (US$ 6.5 million) recorded in 2003.
Service fees increased to Euro 5.7 million (US$ 7.8 million) in 2004 compared to Euro 0.4 million (US$ 0.6 million) in 2003. This is a new line item added to the external reporting of Crucell's financial results and relates to work performed together with or on behalf of licensees or partners and funded by those licensees or partners.
Government grants and other revenues increased to Euro 4.5 million (US$ 6.1 million) from Euro 2.2 million (US$ 3.0 million). This growth largely reflects success in obtaining government grants to fund development programs.
Expenses and Results
Total research and development expenses in 2004 were Euro 26.1 million (US$ 35.7 million), compared to Euro 22.3 million (US$ 30.4 million) in 2003, the increase mainly relating to increased R&D staffing levels and laboratory expenses. This reflects the scaling up of the Company's core activity.
Selling, general and administrative (SG&A) expenses in 2004 were Euro 14.7 million (US$ 20.1 million), compared to Euro 7.6 million (US$ 10.4 million) in 2003. This increase was primarily driven by increases in non-cash expenses of Euro 4.8 million (US$ 6.5 million). Non-cash expenses consisted of a Euro 3.1 million (US$ 4.2 million) increase in warrant expenses as a result of share price increases, and a Euro 1.7 million (US$ 2.3 million) non-cash increase in compensation expense. This is related to a one-time, non-cash reduction of compensation expenses in 2003. The remaining Euro 2.3 million (US$ 3.1 million) increase in SG&A costs was due to increases in insurance premiums, advisory costs and compensation expenses over the year.
The net loss for the year 2004 amounted to Euro 21.3 million (US$ 29.1 million), compared to a net loss of Euro 23.4 million (US$ 31.9 million) in 2003. Net loss per share in 2004 was Euro 0.59 (US$ 0.80), compared to Euro 0.65 (US$ 0.89) in 2003.
Cash Flow and Cash Position
Total cash used in 2004 amounted to Euro 10.5 million (US$ 14.3 million), compared to Euro 23.4 million (US$ 32.0 million) in 2003.
Cash used in operating activities in 2004 amounted to Euro 5.4 million (US$ 7.4 million), compared to Euro 22.1 million (US$ 30.1 million) in 2003. This reduction was primarily a result of cash receipts on our increased revenues and receipt of trade accounts receivable, partly offset by a Euro 3.2 million (US$ 4.4 million) reduction in deferred revenue on December 31, 2004 versus the previous year.
Cash used in investing activities in 2004 amounted to Euro 6.1 million (US$ 8.3 million) compared to Euro 2.0 million ($US 2.9 million) in 2003. Investments in plant and equipment amounted to Euro 2.1 million (US$ 2.9 million); the remaining Euro 4.0 million (US$ 5.5 million) represents the acquisition cost of ChromaGenics B.V.
Crucell generated Euro 1.0 million (US$ 1.4 million) in 2004 from financing activities, compared to Euro 0.7 million (US$ 0.9 million) in 2003.
Crucell's cash and cash equivalents amount to Euro 76.7 million (US$ 104.7 million) as of December 31, 2004.
Revenue and Results Fourth Quarter 2004
Crucell's revenue in the fourth quarter 2004 was Euro 6.5 million (US$ 8.9 million), compared to revenue of Euro 3.0 million (US$ 4.0 million) in the same quarter in 2003. Licensing revenues in the fourth quarter 2004 amounted to Euro 2.6 million (US$ 3.6 million), compared to Euro 1.6 million (US$ 2.1 million) in the fourth quarter 2003. Revenues in the fourth quarter consisted of upfront payments from new contracts as well as annual and other payments on existing contracts. Existing licenses with Cell Genesys and NatImmune were not renewed.
Government grants and other revenues amounted to Euro 1.9 million (US$ 2.6 million) in the fourth quarter 2004, compared to Euro 1.3 million (US$ 1.8 million) in the same period in 2003.
Crucell has in the past experienced significant fluctuations in quarterly revenues and expects to continue to experience such fluctuations in the future.
Research and development expenses increased in the fourth quarter 2004 to Euro 7.7 million (US$ 10.5 million), compared to Euro 5.5 million (US$ 7.5 million) in the fourth quarter of 2003. Selling, general and administrative expenses increased to Euro 4.4 million (US$ 5.9 million) versus Euro 2.7 million (US$ 3.7 million) in the same period 2003.
The net loss for the fourth quarter 2004 was Euro 6.8 million (US$ 9.3 million), compared to Euro 6.4 million (US$ 8.7 million) for the fourth quarter 2003.
NB: Euros converted to US Dollars at December 31, 2004 exchange rate of 1.36440.
Conference Call and Webcast
Crucell will conduct a conference call today, January 24, 2005, starting at 14:45 pm Central European Time (8:45 am US Eastern time). A presentation will be followed by a question and answer session. To participate in the conference call, please call one of the following toll-free numbers within 10 minutes prior to commencement:
866-328-4274 for the US; 0800-358-5261 for the UK; 0800-265-8531 for the Netherlands.
The event will be relayed by live audio webcast which can be accessed via the home page of Crucell's corporate website, www.crucell.com. The webcast will be available for replay from 18:00 pm CET and will be archived for four weeks thereafter.
About Crucell
Crucell N.V. is a biotechnology company focused on developing vaccines and antibodies that prevent and treat infectious diseases, including Ebola, influenza, malaria, West Nile virus and rabies. The company's development programs include collaborations with Aventis Pasteur for influenza vaccines, the U.S. National Institutes of Health for Ebola and malaria vaccines, and GlaxoSmithKline (GSK), Walter Reed Army Institute of Research and New York University for a malaria vaccine. Crucell's products are based on its innovative PER.C6(R) technology, which offers a safer, more efficient way to produce biopharmaceuticals. The company licenses its PER.C6(R) technology to the biopharmaceutical industry on a mostly non-exclusive basis. Licensees and partners include DSM Biologics, GSK, Centocor/J&J and Merck & Co., Inc. Crucell is headquartered in Leiden, The Netherlands, and is listed on the Euronext and NASDAQ stock exchanges (ticker symbol CRXL). For more information, please visit www.crucell.com.
This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on February 27, 2004, and the section entitled "Risk Factors". The company prepares its financial statements under generally accepted accounting principles in the United States (US GAAP).
Click here for a PDF version of this press release, including full external reporting financial figures:
http://hugin.info/132631/R/977103/144008.pdf
-0- -0- For further information please contact: Crucell N.V. Leonard Kruimer Chief Financial Officer Tel. +31-(0)71-524 8722 l.kruimer@crucell.com Elizabeth Goodwin Director IR & Corp. Communications Tel. +31-(0)71-524 8718 e.goodwin@crucell.com For Crucell N.V. in the USA: Thomas Redington Tel. +1 212-926-1733 tredington@redingtoninc.com