LEIDEN, Netherlands, Oct. 14 /PRNewswire-FirstCall/ -- Dutch antibody and vaccine company Crucell N.V. (Nasdaq: CRXL; Euronext) today announced its financial results for the third quarter 2002. During the third quarter 2002, Crucell's revenues were EUR 2.0 million (US$ 2.0 million) compared to EUR 3.2 million (US$ 3.1 million) for the same quarter last year. Crucell's revenues for the first nine months of 2002 were EUR 7.0 million (US$ 6.9 million), a 32% increase over the same period last year. The net loss for the third quarter 2002 was EUR 6.5 million (US$ 6.4 million) compared to EUR 6.0 million (US$ 5.9 million) for the same quarter last year.
Highlights Third Quarter 2002
-- Crucell and Genexine announce PER.C6(TM) agreement for Hepatitis B
vaccine
-- Crucell and the US National Institutes of Health (NIH) extend Ebola
vaccine agreement to include Marburg and Lassa vaccines
-- Crucell signs PER.C6(TM) licensing agreement with GenVec for BioBypass
-- Crucell and Johns Hopkins University announce research agreement for
antibodies against Langerhans Cell Histiocytosis (LCH)
-- Crucell signs PER.C6(TM) agreement with NatImmune for production of
therapeutic proteins
-- Crucell appoints Dr. Jaap Goudsmit as Chief Scientific Officer
Key Figures per Quarter
(EUR 000s, except per share data)
Q3 2002 % change Q3 2001
Revenues 2.0 (36.6%) 3.2
Net loss (6.5) (9.5%) (6.0)
Net loss per share
(basic and diluted) (0.18) (5.9%) (0.17)
Cash and cash equivalents
on September 30, 2002
and December 31, 2001 110.3 120.2
Details of the Financial Results
Revenues
Crucell's revenues for the third quarter 2002 were EUR 2.0 million (US$ 2.0 million), a 37% decrease from EUR 3.2 million (US $ 3.1 million) in the same quarter last year. License revenues earned in the third quarter 2002 were EUR 1.5 million (US$ 1.4 million), compared to EUR 2.9 million (US$ 2.9 million) in the third quarter 2001 which included the initial payments from Johnson & Johnson / Centocor. New license agreements closed in the third quarter of 2002 include an agreement with Korean company Genexine, an agreement with US-based GenVec, and a research license agreement with Danish company NatImmune. Government subsidies and other revenues amounted to EUR 0.5 million (US$ 0.5 million) in the third quarter 2002, compared to EUR 0.2 million (US$ 0.2 million) in the same quarter in 2001.
Crucell's revenues are related to specific contractual agreements and can therefore vary significantly from quarter to quarter. Crucell seeks to increase revenues from year to year.
Results
The net loss for the third quarter 2002 was EUR 6.5 million (US$ 6.4 million), or EUR 0.18 net loss per share (US$ 0.18), compared to a net loss of EUR 6.0 million (US$ 5.9 million) for the third quarter 2001, or EUR 0.17 per share (US$ 0.17).
Total research and development expenses in the third quarter 2002 were EUR 6.2 million (US$ 6.0 million), compared to EUR 4.5 million (US$ 4.4 million) in the third quarter 2001. Selling, general and administrative expenses for the third quarter 2002 were EUR 2.6 million (US$ 2.5 million), compared to EUR 2.1 million (US$ 2.0 million) for the same quarter in 2001.
Cash Flow and Cash Position
Total cash used in operations was EUR 13.1 million (US$ 12.8 million) in the first nine months of 2002, compared to EUR 10.9 million (US$ 10.7 million) in the comparable period of 2001. The increase in cash used in operations was primarily attributable to increased investment in research and development. Cash invested in plant and equipment in the first nine months of 2002 was EUR 2.3 million (US$ 2.2 million), compared to EUR 2.6 million (US$ 2.5 million) for the first nine months in 2001. Financing activities for the nine months ended September 30, 2002 relate primarily to sale lease back transactions which generated proceeds of EUR 4.6 million (US$ 4.5 million).
The company's cash and cash equivalents amount to EUR 110.3 million (US$ 108.2 million) on September 30, 2002.
General Market Developments and Outlook
In the vaccine market, the threat of bioterrorism is a catalyst for vaccine development. Furthermore, emerging diseases in the US, such as West Nile virus, are also driving the demand for effective vaccines. Billions of dollars in funding from government and non-governmental organizations are currently available to support the development of vaccines in these areas. New FDA rules for vaccine approval could potentially reduce the time to market.
The market continues to be faced with a shortage in antibody production capacity, a field in which Crucell actively markets its PER.C6(TM) production platform. The company also continues to develop alliances with contract manufacturing organizations to increase capacity and to make PER.C6(TM) derived products widely available. Crucell actively promotes its PER.C6(TM) production cell line for the production of new viral vaccines.
Although sales of existing antibodies are accelerating, the market faced a number of setbacks in the development and approval of new products world-wide. Due to limited early licensing opportunities currently available, Crucell is focusing on further in-house development of its pre-clinical product leads.
The company is expected to reach profitability once products are brought to market by licensees using Crucell's technology.
Note: Euros are translated at the September 30th exchange rate of 0.981 to US Dollars.
About Crucell
Crucell N.V. discovers and develops biopharmaceuticals that use the human immune system to combat cancer, infectious diseases and other conditions. Crucell leverages its patented technologies, MAbstract(TM), AdVac(TM), and PER.C6(TM), for discovery, development and production of antibodies and vaccines. Crucell offers its technologies to the pharmaceutical and biotechnology industry and also uses them to create its own product pipeline. Partners include Merck & Co. for the HIV vaccine, the National Institutes of Health (NIH) for the Ebola vaccine and Centocor, a Johnson & Johnson company, for the CD46 antibody for treatment of various types of cancer. In addition, Crucell has over 20 licensees for its PER.C6TM technology. These include Novartis, GSK, Aventis and Schering AG. With headquarters in Leiden, The Netherlands, the company currently employs 200 people. Crucell is listed on Euronext and NASDAQ (ticker symbol CRXL). For more information visit 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 June 13, 2002, and the section entitled "Risk Factors". The company prepares its financial statements under generally accepted accounting principles in the United States.
CRUCELL N.V.
PRO FORMA CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands of Euros)
3 months ended 9 months ended
September 30, September 30,
2002 2001 2002 2001
(unaudited) (unaudited) (unaudited) (unaudited)
REVENUES:
License EUR 1,472 EUR 2,944 EUR 5,239 EUR 4,487
Government grants
and other revenues 531 217 1,778 827
Total Revenues 2,003 3,161 7,017 5,314
COSTS AND EXPENSES:
Research and
development 6,157 4,496 17,929 12,620
Selling, general
and administrative 2,572 2,077 7,327 6,710
Total costs and expenses 8,729 6,573 25,256 19,330
PRO FORMA LOSS FROM
OPERATIONS (6,726) (3,412) (18,239) (14,016)
Interest income 881 1,256 2,730 5,033
Foreign currency
income/(loss) (1) (27) 27 451
Equity in losses of
unconsolidated
investments -- (942) (507) (1,937)
NET LOSS BEFORE PROVISION
FOR INCOME TAXES (5,846) (3,125) (15,989) (10,469)
Provisions for income
taxes -- -- -- --
PRO FORMA NET LOSS EUR (5,846) EUR (3,125) EUR (15,989) EUR (10,469)
The above pro forma statement of operations for the 3 and 9 months ended
September 30, 2002 and 2001 respectively have been adjusted to present
Crucell's operating results excluding non-cash charges related to
developed technology amortization, goodwill amortization and stock
options.
The following table reflects the differences between pro forma and as
reported net loss:
3 months ended 9 months ended
September 30, September 30,
2002 2001 2002 2001
(unaudited) (unaudited) (unaudited) (unaudited)
AS REPORTED PRO FORMA
NET LOSS (5,846) (3,125) (15,989) (10,469)
Developed technology
amortization (332) (332) (998) (998)
Goodwill amortization -- (2,207) -- (6,619)
Stock based compensation (368) (315) (995) (635)
NET LOSS (6,546) (5,979) (17,982) (18,721)
CRUCELL N.V.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands of Euros)
3 months ended 9 months ended
September 30, September 30,
2002 2001 2002 2001
(unaudited) (unaudited) (unaudited) (unaudited)
REVENUES:
License EUR 1,472 EUR 2,944 EUR 5,239 EUR 4,487
Government
grants and
other revenues 531 217 1,778 827
Total revenues 2,003 3,161 7,017 5,314
COSTS AND EXPENSES:
Research and
development 6,157 4,496 17,929 12,620
Selling, general
and administrative 2,572 2,077 7,327 6,710
Developed technology
amortization 332 332 998 998
Goodwill amortization -- 2,207 -- 6,619
Stock based
compensation 368 315 995 635
Total costs and expenses 9,429 9,427 27,249 27,582
LOSS FROM OPERATIONS (7,426) (6,266) (20,232) (22,268)
Interest income 881 1,256 2,730 5,033
Foreign currency
gain/(loss) (1) (27) 27 451
Equity in losses of
unconsolidated
partnership -- (942) (507) (1,937)
NET LOSS BEFORE PROVISION
FOR INCOME TAXES (6,546) (5,979) (17,982) (18,721)
Provision for
income taxes -- -- -- --
NET LOSS EUR (6,546) EUR (5,979) EUR (17,982) EUR (18,721)
BASIC AND DILUTED
NET LOSS PER SHARE:
Net loss per share
- basic and
diluted EUR (0.18) EUR (0.17) EUR (0.51) EUR (0.53)
Weighted average shares
outstanding
- basic and diluted 35,651 35,305 35,531 35,251
(Shares *1.000)
CRUCELL N.V.
CONSOLIDATED STATEMENTS OF CASH FLOW
(amounts in thousands of Euros)
9 months ended
September 30,
2002 2001
(unaudited) (unaudited)
Operating activities
Net Loss EUR (17,982) EUR (18,721)
Adjustments to reconcile operating
loss to net cash used in operating
activities:
Depreciation 1,911 878
Loss on disposal of plant and equipment 72 --
Amortization of deferred compensation 995 635
Intangible amortization 998 7,617
Equity in losses of unconsolidated investments 507 1,938
Change in operating assets and liabilities,
net of the effects of acquisitions:
Trade accounts receivable 2,452 (219)
Receivable from related parties and employees (12) (319)
Prepaid expenses and other current assets (1,063) (278)
Accounts payable (297) (4,297)
Accrued compensation and related benefits 1,014 490
Deferred revenue (1,171) 695
Accrued liabilities (502) 634
Net cash used in operating activities (13,078) (10,947)
Cash flow from investing activities
Investment in joint venture -- (145)
Investment in partnership -- (235)
Purchase of plant and equipment (2,277) (2,605)
Net cash used in investing activities (2,277) (2,985)
Cash flow from financing activities
Proceeds from the issuance of ordinary shares 810 221
Proceeds from sale and lease-back of property,
plant and equipment 4,585 961
Net cash provided by financing activities 5,395 1,182
Net decrease in cash and
cash equivalents EUR (9,960) EUR (12,750)
Cash and cash equivalents at beginning
of period 120,243 136,056
Cash and cash equivalents at end of period 110,283 123,306
CRUCELL N.V.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands)
September 30, December 31,
2002 2001
(unaudited)
Assets
Current assets:
Cash and cash equivalents EUR 110,283 EUR 120,243
Trade accounts receivable 659 3,111
Receivable from related parties and employees 397 239
Prepaid expenses and other current assets 2,331 1,268
Total current assets 113,670 124,861
Notes receivable from related
parties and employees 1,093 1,239
Investment in joint venture -- 507
Plant and equipment, net 11,129 13,104
Developed technology, net 3,659 4,657
Goodwill 30,891 30,891
Total assets EUR 160,442 EUR 175,259
Liabilities and shareholders' equity
Current liabilities:
Accounts payable EUR 2,044 EUR 2,341
Accrued compensation and related benefits 2,758 1,744
Deferred revenue 837 2,008
Accrued liabilities 4,723 4,453
Total current liabilities 10,362 10,546
Long term obligation under capital lease 1,543 --
Ordinary shares, Euro 0.24 par value;
89,199,990 shares authorized;
35,567,938 and 35,318,188 shares
issued and outstanding at September 30,2002
and December 31, 2001 respectively 8,536 8,477
Additional paid in capital 336,521 334,708
Deferred Compensation (4,401) (4,334)
Accumulated Deficit (192,119) (174,138)
Total shareholders' equity 148,537 164,713
Total liabilities and
shareholders' equity EUR 160,442 EUR 175,259
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