YOQNEAM, ISRAEL, Oct 31, 2007 (MARKET WIRE via COMTEX News Network) -- Given Imaging Ltd. (NASDAQ: GIVN)
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. (NASDAQ: GIVN) today announced unaudited
financial results for the third quarter ended September 30, 2007.
Worldwide revenues increased by 15% to $27.7 million compared to
$24.0 million in the third quarter of 2006. Gross margin in the third
quarter of 2007 was 74.3%, compared to 74.8%, in the third quarter of
2006.
"Worldwide revenues in the third quarter increased by 15%, and we are
confident that our strategy will deliver strong revenue growth going
forward," said Homi Shamir, president and CEO of Given Imaging.
"Revenue in the third quarter and our expected revenue for fiscal year
2007 have been impacted by several factors -- first, a delay in our
plan to bring PillCam COLON to the U.S. market this year as a result
of our ongoing discussions with the U.S. Food and Drug Administration
regarding clearance of PillCam COLON; second, the delay associated
with receiving a monetary code for PillCam SB in France which we now
expect to occur in the first half of 2008; and third, a shortfall in
sales in one of our U.S. regions where actions have been taken to
address operational issues. As a result, we now expect revenues in
2007 to be in the $109 - $112 million range, which represents growth
of 15% - 18% compared to 2006. We reaffirm our Net Income and EPS
guidance for 2007 of full year 2007 GAAP, fully-diluted earnings per
share in the range of $0.21 and $0.31, and non-GAAP, fully-diluted
earnings per share in the range of $0.34 to $0.44." GAAP net income
and EPS guidance excludes the effect of patent litigation expenses.
On a GAAP basis, the Company reported net income of $1.7 million, or
$0.05 per share on a fully diluted basis in the third quarter of 2007,
compared to net income of $741,000, or $0.02 per share in the third
quarter of 2006.
On a non-GAAP basis, the Company reported net income of $4.7 million,
or $0.15 per share on a fully diluted basis in the third quarter of
2007 compared to net income of $1.9 million, or $0.06 per share, in
the third quarter of 2006. Non-GAAP amounts exclude the effect of
FAS123R ($1.6 million) and patent litigation expenses ($1.4 million).
For the third quarter of 2007, net cash provided by operating
activities totaled $2.0 million. Cash, cash equivalents and
marketable securities at September 30, 2007 totaled $103.3 million.
Third Quarter 2007 Revenue Analysis
Sales in the Americas region increased by 5.8% to $18.1 million
compared to $17.1 million in the same period in 2006. EMEA sales
increased 19.6% to $6.1 million compared to $5.1 million in the same
period in 2006, while Asia/Pacific sales increased 89% to $3.4
million compared to $1.8 million in the same period in 2006. The
increase in Asia/Pacific revenues mainly reflects initial sales of
workstations and PillCam SB in Japan.
Worldwide PillCam SB sales were approximately 46,300, an increase of
11.6% compared to the same period last year. PillCam SB sales in the
Americas increased 11.3%, while PillCam SB sales in the EMEA region
and Asia/Pacific increased 11.5% and 11.1% respectively.
PillCam sales accounted for 87% of total revenues compared to 80% of
total sales in the same period of last year. Reorders of PillCam SB
increased 3.9% to approximately 42,300 compared to the third quarter
of 2006.
Supplemental third quarter data can be found at www.givenimaging.com
in the Investor Relations section.
Nine Month Financial Results
For the nine month period ended September 30, 2007, sales were $78.6
million compared to $67.6 million in the same period in 2006. Gross
profit for the nine month period was 74.6% compared to 74.9% in 2006.
On a GAAP basis, net income for the first nine months of 2007 was
$2.35 million, or $0.08 per share on a fully diluted basis, compared
to a net loss of $3.0 million, or ($0.10) per share, for the same
period in 2006. The Company reported non-GAAP net income of $9.1
million, or $0.29 per share, on a fully diluted basis in the nine
months of 2007 compared to a net income of $1.2 million, or $0.04 per
share in the same period in 2006. Non-GAAP amounts exclude the effect
of the adoption of FAS123R ($4.0 million) and patent litigation
expenses ($2.8 million).
Recent Highlights
PillCam ESO Reimbursement
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(R) 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(R) 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(TM) 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
========== ========== ========== ========== ==========
For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-(866) GIVEN-IR
Email Contact
Email Contact
SOURCE: Given Imaging
http://www2.marketwire.com/mw/emailprcntct?id=C788000CE3F06156
http://www2.marketwire.com/mw/emailprcntct?id=691154835DF3A220
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