EXHIBIT A
GIVEN IMAGING ANNOUNCES FIRST QUARTER 2002 RESULTS
Yoqneam, Israel, April 30, 2002 -- 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first quarter excluding the costs related to the withdrawn follow-on financing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withdrawn follow-on financing was $5.7 million, or $0.23 per share.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 Endoscopy in
Rome. More than 90 leading gastroenterologists from 12 countries
attended to share science and exchange clinical experience for
physicians using the M2A capsule.
- Clinical data presented at German and French medical conferences
further validated the diagnostic yields of the M2A capsule endoscope.
The data presented showed that the capsule endoscope detected up to
80% of small bowel abnormalities and showed that physicians are using
the capsule to diagnose an expanded list of indications.
- Completion of the Company's 18,000 square foot manufacturing facility
in Israel. The facility houses the semi-automated production line
including medical grade clean rooms. The new line increases production
capacity to 10,000 capsules per month.
- Twelve new distribution agreements were signed bringing the total
number of countries where the Given Diagnostic Imaging System is
available to 33. Coverage in Western Europe is complete with the
addition of Denmark, Switzerland, Norway, Ireland and Greece. The
Company also signed agreements in Russia and the countries that made
up the former Yugoslavia. Coverage in Asia expanded with agreements in
Korea and India, and in Latin America, with Chile, Peru and Ecuador.
First Quarter Webcast Information
Given Imaging will host a live webcast tomorrow, Wednesday, May 1, 2002, at
10:00 am Eastern Time (5:00 pm Israel time) to discuss first quarter 2002
results. The presentation will be webcast through the Company's website
www.givenimaging.com.
About Given Imaging
Given Imaging produces and markets the Given Diagnostic System, which features
the M2A(R) Capsule Endoscope, a fundamentally new approach to examining the
gastrointestinal tract. The system uses a disposable 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 www.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.
# # #
(Financial tables follow)
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
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Total current assets 68,959 63,623
Fixed assets, net 5,104 6,221
Other assets, net 1,860 2,010
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Total Assets $75,923 $71,854
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Liabilities and shareholders' equity
Current liabilities 5,875 7,242
Deferred revenue 193 332
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Total current liabilities 6,068 7,574
Long-term liabilities 522 617
Shareholders' equity 69,333 63,663
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Total liabilities and shareholders' equity $75,923 $71,854
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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)
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Basic and diluted loss per Ordinary Share $ (0.37) $ (0.23)
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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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