-- Revenues Increased 15% Over Q3 2006
-- Q3 2007 GAAP Net Income Increased 123% to $1.7 million, or $0.05 per
share vs. Q3 2006 Net Income of $741,000 or $0.02 per share on a fully
diluted basis
-- Q3 2007 non-GAAP Net Income increased 153% to $4.7 million or, $0.15
per share vs. Q3 2006 Net Income of $1.9 million or $0.06 per share on a
fully diluted basis
-- Company lowering 2007 revenue guidance but reaffirming EPS guidance
Given Imaging Ltd. (
-- National Government Services (NGS), the Medicare Part B Carrier
serving more than 6 million individuals in New York, New Jersey, Kentucky
and Indiana, issued a new coverage policy for cirrhotic patients for the
evaluation of esophageal varices using capsule endoscopy of the esophagus.
The policy becomes effective December 1st.
PillCam SB Reimbursement
-- NGS also revised language pertaining to PillCam SB by expanding the
base of reimbursed indications to include the detection of small bowel
tumors, evaluation of malabsorption syndrome, and small bowel evaluation
prior to a small bowel surgical resection to control loss of blood or
protein.
Third Quarter Conference Call / Webcast Information
U.S. Call / Webcast
Given Imaging will host a conference call for English speakers at 9am ET on
Thursday, November 1. To participate in this teleconference, please dial
(866) 409-1560 fifteen minutes before the conference begins. Callers
outside of the U.S. should dial (913) 312-6690. The call will also be
webcast live at www.givenimaging.com. To access, click "About Given
Imaging." The webcast will be available in the Investor Relations section.
A replay of the call will be available for two weeks on the Company's
website, or until November 15, 2007 by dialing (888) 203-1112. Callers
outside of the U.S. should dial (719) 457-0820. The replay participant code
is 6368714.
Hebrew Call
The Company will host a separate conference call in Hebrew on November 1 at
9am Israel time. To access this call, please dial +972 3 9180609 fifteen
minutes before this conference begins. A replay of the call will be
available until November 6 by dialing +972 3 9255928.
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.
Use of Non-GAAP Measures
This press release provides financial measures for net income and basic and
diluted earnings per share that exclude stock-based compensation expense
and patent litigation expenses and are therefore not calculated in
accordance with generally accepted accounting principals (GAAP). Management
believes that these non-GAAP financial measures provide meaningful
supplemental information regarding our performance that enhances
management's and investors' ability to evaluate the Company's net income
and earnings per share and to compare it with historical net income and
earnings per share prior to the adoption of FAS 123R and the beginning of
our patent litigation in the U.S.
The presentation of this non-GAAP financial information is not intended to
be considered in isolation or as a substitute for the financial information
prepared and presented in accordance with GAAP. Management uses both GAAP
and non-GAAP measures when evaluating the business internally and therefore
felt it is important to make these non-GAAP adjustments available to
investors.
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.
Given Imaging Ltd. and its Subsidiaries
Consolidated Balance Sheets
In thousands except share data
September 30 December 31
------------ ------------
2007 2006
------------ ------------
(Unaudited) (Audited)
------------ ------------
Assets
Current assets
Cash and cash equivalents $ 42,094 $ 44,510
Short-term investments 27,842 17,245
Accounts receivable:
Trade (Net of provisions for doubtful debts of
$726 and of $787 as of September 30, 2007,
and December 31, 2006, respectively) 18,884 18,887
Other 3,761 1,463
Inventories 18,882 18,168
Prepaid expenses 2,262 1,340
Deferred taxes 1,683 1,374
Advances to suppliers 257 82
------------ ------------
Total current assets 115,665 103,069
------------ ------------
Deposits 918 469
Assets held for severance benefits 2,657 1,984
Marketable Securities 33,407 34,769
Fixed assets, at cost, less accumulated
depreciation 14,841 14,811
Other assets, at cost, less accumulated
amortization 3,595 3,075
------------ ------------
Total Assets $ 171,083 $ 158,177
============ ============
Given Imaging Ltd. and its Subsidiaries
Consolidated Balance Sheets
In thousands except share data
September 30 December 31
------------ ------------
2007 2006
------------ ------------
(Unaudited) (Audited)
------------ ------------
Liabilities and shareholders' equity
Current liabilities
Current installments of obligation under capital
lease $ 25 $ 13
Accounts payable
Trade 7,346 5,550
Other 15,906 14,620
Deferred income 4,701 3,871
----------- -----------
Total current liabilities 27,978 24,054
----------- -----------
Long-term liabilities
Deferred income 19,136 20,411
Obligation under capital lease, net - 20
Liability for employee severance benefits 3,149 2,407
----------- -----------
Total long-term liabilities 22,285 22,838
----------- -----------
Total liabilities 50,263 46,892
----------- -----------
Minority interest 2,779 3,499
----------- -----------
Shareholders' equity
Share capital:
Ordinary Shares, NIS $0.05 par value each
(90,000,000 shares authorized; 29,182,574 and
28,641,291 shares issued and fully paid as of
September 30, 2007, and December 31, 2006,
respectively) 342 335
Additional paid-in capital 164,095 156,197
Capital reserve 2,166 2,166
Accumulated deficit (48,562) (50,912)
----------- -----------
Total shareholders' equity 118,041 107,786
----------- -----------
Total liabilities and shareholders' equity $ 171,083 $ 158,177
=========== ===========
Given Imaging Ltd. and its Subsidiaries
Consolidated Statements of Operations
In thousands except share and per share data
Nine month period Three month period Year ended
ended September 30 ended September 30 December 31
--------------------- --------------------- -----------
2007 2006 2007 2006 2006
---------- ---------- ---------- ---------- ----------
(Unaudited)(Unaudited)(Unaudited)(Unaudited) (Audited)
---------- ---------- ---------- ---------- ----------
Revenues $ 78,572 $ 67,557 $ 27,676 $ 24,050 $ 95,029
Cost of revenues (19,960) (16,969) (7,114) (6,058) (24,154)
---------- ---------- ---------- ---------- ----------
Gross profit 58,612 50,588 20,562 17,992 70,875
---------- ---------- ---------- ---------- ----------
Operating expenses
Research and
development, gross (9,093) (9,374) (3,105) (2,753) (12,678)
Royalty bearing
participation 1,673 1,287 980 447 1,867
---------- ---------- ---------- ---------- ----------
Research and
development, net (7,420) (8,087) (2,125) (2,306) (10,811)
Sales and marketing
expenses (38,581) (37,123) (13,169) (11,239) (50,732)
General and
administrative
expenses (14,507) (12,254) (5,486) (4,410) (16,027)
---------- ---------- ---------- ---------- ----------
Total operating
expenses (60,508) (57,464) (20,780) (17,955) (77,570)
---------- ---------- ---------- ---------- ----------
Operating loss (1,896) (6,876) (218) 37 (6,695)
Financing income,
net 4,015 2,958 2,086 581 3,980
---------- ---------- ---------- ---------- ----------
Profit (loss) before
taxes on income 2,119 (3,918) 1,868 618 (2,715)
Taxes on income (489) (28) (245) (254) (127)
---------- ---------- ---------- ---------- ----------
Profit (loss) before
minority share 1,630 (3,946) 1,623 364 (2,842)
Minority share in
losses of
subsidiary 720 977 33 377 1,334
---------- ---------- ---------- ---------- ----------
Net profit (loss) $ 2,350 $ (2,969)$ 1,656 $ 741 $ (1,508)
========== ========== ========== ========== ==========
Basic profit (loss)
per Ordinary Share $ 0.08 $ (0.10)$ 0.06 $ 0.02 $ (0.05)
========== ========== ========== ========== ==========
Diluted profit (loss)
per Ordinary Share $ 0.08 $ (0.10)$ 0.05 $ 0.02 $ (0.05)
========== ========== ========== ========== ==========
Weighted average
number of Ordinary
Shares used to
compute basic profit
(loss) per Ordinary
Share 28,880,299 28,017,914 29,119,996 28,061,356 28,053,849
========== ========== ========== ========== ==========
Weighted average
number of Ordinary
Shares used to
compute diluted profit
(loss) per Ordinary
Share 30,911,256 28,017,914 31,239,196 29,377,249 28,053,849
========== ========== ========== ========== ==========
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR