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Biotech / Medical : Swallow a pill, see your insides....GIVN corners market

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To: RSkarsten who started this subject4/30/2002 6:26:23 PM
From: RSkarsten   of 30
 
GIVEN IMAGING LTD - News Release - 2002-04-29 22:42

Given Imaging Announces First Quarter 2002 Results

Given Imaging Announces First Quarter 2002 Results

YOQNEAM, Israel, Apr 30, 2002 /PRNewswire-FirstCall via COMTEX/ -- Given Imaging
Ltd. (Nasdaq: GIVN), today announced first quarter results for the period ended
March 31, 2002.

The Company announced sales of $5.2 million for the first quarter of 2002, 50%
higher than the fourth quarter of 2001. The first quarter represents the second
full quarter of sales for the Company for both the U.S. and European markets
following FDA clearance of the Given(R) Diagnostic Imaging system in August
2001.

On a geographic basis, sales of the Given System in the United States accounted
for 53% of the quarterly revenues. A geographic breakdown of first quarter 2002
sales is as follows:

(millions of U.S. dollars)

United States $2.8
Europe $1.7
ROW $0.7

First Quarter 2002 Financials

Revenues totaled $5.2 million for the first quarter. Gross profit was 52% of
revenues, slightly higher than fourth quarter of 2001. Operating expenses were
$7.9 million, a decrease of 7% from the fourth quarter of 2001. The loss for the
first quarter excluding the costs related to the withdrawn follow-on financing
was $4.9 million compared to a loss of $6.5 million in the fourth quarter of
2001. Net loss for the first quarter of 2001, including the costs related to the
withdrawn follow-on financing was $5.7 million, or $0.23 per share.

First Quarter Highlights

"First quarter sales growth demonstrates our progress in gaining broad market
acceptance of the Given Imaging System," commented Dr. Gavriel Meron, President
and CEO of Given Imaging, Ltd. "Importantly, the growing base of clinical data
and discussion within the medical community about the role of capsule endoscopy
in the practice of gastroenterology provides physicians with the confidence that
they can use our system to diagnose conditions that were previously much more
difficult to detect. A number of these clinical studies will be presented at
Digestive Disease Week in May and we expect to further demonstrate our clinical
achievements there."

During the first quarter, Given Imaging accomplished the following milestones:

-- More than 4,700 M2A capsules were sold in the first quarter,
of which approximately 3,100 represent reorders.

-- The Given System installed base reached more than 380, with
172 systems installed in the United States.

-- Given Imaging hosted its first Conference on Capsule miniature video camera
contained in a capsule that is ingested by a patient and delivers high quality
color images in a painless and noninvasive manner. The test can be conducted
while a patient continues normal daily activities. The system received clearance
from the FDA in August 2001 and received permission to affix the CE mark in May
2001. It is currently available in the USA, Canada, Europe, Brazil, Puerto Rico,
Venezuela, Mexico, Australia, New Zealand, and Israel. Many thousands of
patients suffering from diseases in the small intestine such as Crohn's, celiac
disease, unexplained abdominal pain with diarrhea, polyposis, intestinal tumors,
iron deficiency anemia and obscure bleeding have already benefited from this
innovative technology. For more information, visit givenimaging.com.

This press release contains forward-looking statements, including projections
about our business, within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934. For example,
statements in the future tense, words such as "anticipates," "estimates,"
"expects," "intends," "plans," "believes," "intends" and words and terms of
similar substance used in connection with any discussion of future operating or
financial performance identify such forward-looking statements. Those
forward-looking statements are not guarantees of future performance and actual
results could differ materially from our current expectations as a result of
numerous factors, including but not limited to the following: changes in
regulatory environment, our success in implementing our sales, marketing and
manufacturing plan, protection and validity of patents and other intellectual
property rights, the impact of currency exchange rates, the effect of
competition by other companies, the outcome of future litigation, the
reimbursement policies for our product from healthcare payors, and other risks
disclosed in our filings with the U.S. Securities Exchange Commission.

Given Imaging Ltd. And Its Consolidated Subsidiaries
(A Development Stage Company)
Consolidated Balance Sheets
U.S. $ in thousands except per share data

December 31, March 31,
2001 2002
(Audited) (Unaudited)

Assets

Cash and cash equivalents $61,230 $53,698
Current assets 7,729 9,925

Total current assets 68,959 63,623

Fixed assets, net 5,104 6,221

Other assets, net 1,860 2,010

Total Assets $75,923 $71,854

Liabilities and shareholders' equity

Current liabilities 5,875 7,242
Deferred revenue 193 332

Total current liabilities 6,068 7,574

Long-term liabilities 522 617

Shareholders' equity 69,333 63,663

Total liabilities and shareholders' equity $75,923 $71,854

Given Imaging Ltd. And Its Consolidated Subsidiaries
(A Development Stage Company)
Consolidated Statements Of Operations
U.S. $ in thousands except per share data

Quarter ended March 31,
2001 2002
(Unaudited) (Unaudited)

Revenues $-- $5,216

Cost of revenues -- (2,503)

Gross profit -- 2,713

Research and development costs (1,084) (1,993)
Marketing expenses (1,476) (4,831)
General and administrative expenses (385) (1,084)

Operating loss (2,945) (5,195)

Financing income, net 272 281
Expenses of withdrawn public offering (836)

Net loss $ (2,673) $ (5,750)

Basic and diluted loss per Ordinary Share $(0.37) $(0.23)

Weighted average number of Ordinary
Shares outstanding used in basic and
diluted loss per Ordinary
Share calculation 8,804,188 25,104,913

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SOURCE Given Imaging Ltd.

CONTACT: Yoram Ashery of Given Imaging Ltd., or David Carey of Lazar
Partners Ltd., +1-866-GIVEN-IR, dcarey@lazarpartners.com

URL: givenimaging.com
prnewswire.com

Copyright (C) 2002 PR Newswire. All rights reserved.

-0-

KEYWORD: Israel
INDUSTRY KEYWORD: CPR
SUBJECT CODE: ERN

STOCK SYMBOLS: [(givn)]
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