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Given Imaging Pays Outstanding Royalty Obligation to Israel's Office of the Chief Scientist
Company Also Revises Financial Effect of Termination of Ethicon Endo-Surgery Agreement
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - January 2, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ), the
global leader in capsule endoscopy, today announced that it has paid its
outstanding royalty obligation and accrued interest of approximately $5
million to Israel's Office of the Chief Scientist of the Ministry of
Industry, Trade and Labor ("OCS"). Given Imaging was committed to pay
royalties for several programs to the OCS on proceeds from sales of
products that the Israeli Government participated in by way of research and
development grants. This repayment will result in a one-time charge of
approximately $5.7 million to the Company's income statement in the fourth
quarter of 2007.
"Given Imaging has a solid cash balance of over $100 million, enabling us
to make an earlier repayment of this interest bearing obligation, and we
expect this will have a positive impact on future earnings," said Yuval
Yanai, Chief Financial Officer of Given Imaging.
The Company also announced that based on an acceleration of the termination
of the cooperation agreement with Ethicon Endo-Surgery, the Company has
revised its estimates of the financial effect of the termination of the
cooperation agreement with Ethicon Endo-Surgery. The Company now expects to
record a pre-tax gain of approximately $23 million in the fourth quarter of
2007, and an additional pre-tax gain of approximately $5.4 million in the
first quarter of 2008.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing,
producing and marketing innovative, patient-friendly products for detecting
gastrointestinal disorders. The company's technology platform is the
PillCam® Platform, featuring the PillCam video capsule, a disposable,
miniature video camera contained in a capsule, which is ingested by the
patient, a sensor array, data recorder and RAPID® software. Given Imaging
has a number of available capsules: the PillCam SB video capsule to
visualize the entire small intestine which is currently marketed in the
United States and in more than 60 other countries; the PillCam ESO video
capsule to visualize the esophagus; the Agile™ patency capsule to
determine the free passage of the PillCam capsule in the GI tract and the
PillCam COLON video capsule to visualize the colon that has been cleared
for marketing in the European Union, and is pending clearance with the
United States Food and Drug Administration. More than 600,000 patients
worldwide have benefited from the PillCam capsule endoscopy procedure.
Given Imaging's headquarters, manufacturing and R&D facilities are located
in Yoqneam, Israel. It has operating subsidiary companies in the United
States, Germany, France, Japan and Australia. For more information, visit
http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning
of the "safe harbor" provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These forward-looking statements include, but are not
limited to, projections about our business and our future revenues,
expenses and profitability. Forward-looking statements may be, but are not
necessarily, identified by the use of forward-looking terminology such as
"may," "anticipates," "estimates," "expects," "intends," "plans,"
"believes," and words and terms of similar substance. Forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause the actual events, results, performance, circumstances or
achievements of the Company to be materially different from any future
events, results, performance, circumstances or achievements expressed or
implied by such forward-looking statements. Factors that could cause actual
events, results, performance, circumstances or achievements to differ from
such forward-looking statements include, but are not limited to, the
following: (1) satisfactory results of clinical trials with PillCam Colon
(2) our ability to receive regulatory clearance or approval to market our
products or changes in regulatory environment, (3) our success in
implementing our sales, marketing and manufacturing plans, (4) protection
and validity of patents and other intellectual property rights, (5) the
impact of currency exchange rates, (6) the effect of competition by other
companies, (7) the outcome of future litigation, including patent
litigation with Olympus Corporation, (8) the reimbursement policies for our
product from healthcare payors, (9) quarterly variations in operating
results, (10) the possibility of armed conflict or civil or military unrest
in Israel, and (11) other risks and factors disclosed in our filings with
the U.S. Securities and Exchange Commission, including, but not limited to,
risks and factors identified under such headings as "Risk Factors,"
"Cautionary Language Regarding Forward-Looking Statements" and "Operating
Results and Financial Review and Prospects" in the Company's Annual Report
on Form 20-F for the year ended December 31, 2006. You are cautioned not to
place undue reliance on these forward-looking statements, which speak only
as of the date of this press release. Except for the Company's ongoing
obligations to disclose material information under the applicable
securities laws, it undertakes no obligation to release publicly any
revisions to any forward-looking statements, to report events or to report
the occurrence of unanticipated events.