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Exhibit 99.1(A)
[LOGO] GIVEN(R) IMAGING
FINAL - TO BE RELEASED JAN 28, 4:30 PM EST
FOR IMMEDIATE RELEASE
FOR FURTHER INFORMATION CONTACT:
Yoram Ashery or Fern Lazar
Given Imaging Ltd. Lazar Partners Ltd.
1-(866) GIVEN-IR
flazar@lazarpartners.com
GIVEN IMAGING ANNOUNCES FOURTH QUARTER AND YEAR END RESULTS
YOQNEAM, ISRAEL, JANUARY 28, 2002 -- Given Imaging Ltd. (NASDAQ:GIVN), today
announced fourth quarter and year end results for the period ended December 31,
2001.
The Company announced sales of $3.5 million for the fourth quarter of 2001 and
$4.7 million for the full year. The fourth quarter was the first full quarter of
sales for the Company for both the U.S. and European market following FDA
clearance of the Given(R) Diagnostic Imaging system in August 2001. Sales
reflect strong fourth quarter demand for the Given System from physicians, as
well as an increase in capsule sales.
On a geographic basis, sales of the Given System in the United States accounted
for just under half of total annual revenues. A geographic breakdown of annual
sales is as follows:
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(MILLIONS OF US DOLLARS)
United States $2.2
Europe $2.0
ROW $0.5
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FOURTH QUARTER AND FULL YEAR 2001 FINANCIALS
Revenues totaled $3.5 million during the fourth quarter. Gross profit was 51% of
revenues. Net loss for the fourth quarter was $6.5 million, or $0.26 per share,
on an adjusted, post-initial public offering basis of 25,104, 913 shares.
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For the year ended December 31, 2001, revenues were $4.7 million and gross
profit was 48% of revenues. Net loss for the full year 2001 was $18.7 million.
Net loss for the year was $0.74 per share, on an adjusted, post-initial public
offering basis of 25,104,913 shares.
FOURTH QUARTER HIGHLIGHTS
During the Fourth quarter, Given Imaging accomplished the following milestones:
- More than 3,600 M2A capsules were sold in 2001, of which
approximately 2,000 represent reorders.
- The Given System installed base reached 225, with 95 systems
installed in the United States. Of this number, 166 systems were
sold commercially and 59 were provided to physicians to support our
sponsored clinical trials.
- The Company entered into a group purchasing agreement with Premier,
one of the largest purchasing organizations in the United States,
for marketing the Given System to Premier's network of more than
1,600 members and affiliated hospitals.
- Over 580 patients have ingested the M2A capsule as part of our
ongoing sponsored clinical trials. Preliminary unpublished results
from ongoing clinical trials support previous findings of the
diagnostic yield of the M2A capsule, and consistently show the M2A
capsule to produce a higher diagnostic yield than any other modality
to which the capsule was compared.
- Ten new distribution agreements, in Canada, Austria, Belgium, United
Kingdom, Sweden, The Netherlands, Brazil, Puerto Rico, China and
Taiwan, bringing the Company's global distribution coverage to 22
countries by the end of 2001. Our distributors in China and Taiwan
are required to receive government clearance before marketing and
selling the Given System.
FOURTH QUARTER WEBCAST INFORMATION
Given Imaging will host a live webcast tomorrow, Tuesday, January 29, 2002, at
10:00 am Eastern Standard Time (5:00 pm Israel time) to discuss its 2001
results. The presentation will be webcast through the Company's website
www.givenimaging.com.
ABOUT GIVEN IMAGING
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Given Imaging produces and markets the Given Diagnostic Imaging System featuring
its M2A 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, the European Union and in
other countries around the world.
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GIVEN IMAGING LTD. AND ITS CONSOLIDATED SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS
U.S. $ IN THOUSANDS EXCEPT PER SHARE DATA
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DECEMBER 31, DECEMBER 31,
2000 2001
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(AUDITED) (AUDITED)
ASSETS
Cash and cash equivalents $ 21,360 $ 61,230
Current assets 1,362 7,729
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Total current assets 22,722 68,959
Fixed assets, net 2,248 5,104
Other assets, net 560 1,860
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TOTAL ASSETS $ 25,530 $ 75,923
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities 2,138 5,875
Deferred revenue 193
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Total current liabilities 2,138 6,068
Long-term liabilities 317 522
Shareholders' equity 23,075 69,333
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 25,530 $ 75,923
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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
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YEAR ENDED DECEMBER 31,
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2000 2001
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(AUDITED) (AUDITED)
Revenues $ -- $ 4,733
Cost of revenues -- (2,476)
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Gross profit -- 2,257
Research and development costs (3,825) (6,112)
Marketing expenses (2,923) (12,902)
General and administrative expenses (1,224) (2,664)
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Operating income (loss) (7,972) (19,421)
Net income (loss) $ (7,539) $ (18,657)
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Basic and diluted income (loss) per
Ordinary Share $ (1.14) $ (1.60)
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Ordinary Shares outstanding used in basic and
diluted income (loss) per Ordinary Share calculation (1) 8,804,188 12,879,369
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ADDITIONAL PER SHARE INFORMATION:
Diluted income (loss) per ordinary share on an as adjusted basis
bsis post pubic offering $ (0.74)
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Ordinary shares outstanding post public offering 25,104,913
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(1) Excluding stock based compensation
- more -
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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.
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