-- Regulatory
In late October, the company received the CE Mark to market
PillCam™ COLON throughout the European Union.
-- PillCam SB Reimbursement
-- France: In late July, the French National Authority for Health
completed the first step in advancing universal reimbursement for
PillCam SB capsule. The codification process is expected to be
completed during 2007.
-- Israel: Israel's Ministry of Health approved reimbursement for
PillCam SB for patients with iron deficiency anemia as a result of
obscure gastrointestinal bleeding as well as for suspected Crohn's
disease.
-- Spain: Spain's National Health Service now includes PillCam™
Capsule Endoscopy for the small bowel in its portfolio of health
services. Individuals with symptoms of persistent obscure
gastrointestinal bleeding of presumed small bowel origin following
negative upper and lower endoscopies may undergo the PillCam SB
procedure at hospitals and clinics that offer it.
-- PillCam ESO Reimbursement
First Coast Service Options, Inc., which administers Florida and
Connecticut Medicare, designated PillCam ESO as a diagnostic tool for
patients who are unable to undergo conventional endoscopy or are
diagnosed with portal hypertension and require immediate evaluation of
esophageal varices. Over 3 million individuals will now have access to
PillCam ESO under this designation.
Nine Month Financial Results
For the nine month period ended September 30, 2006, sales were $67.6
million compared to $62.4 million in the same period in 2005. Gross profit
for the nine month period was 74.9% compared to 74.2% in 2005. On a GAAP
basis, net loss for the first nine months of 2006 was $3.0 million or $0.10
per share, compared to net income of $2.8 million, or $0.095 per share, on
a fully diluted basis for the same period in 2005. The nine month period
ended September 30, 2006 includes the impact of $4.1 million in expenses
due to the adoption of FAS 123R. The Company reported non-GAAP net income
of $1.2 million, or $0.04 per share, on a diluted basis in the nine months
of 2006.
2006 Guidance
The company reiterates its full year 2006 guidance of revenues of between
$92 million to $97 million. The Company also announced that it increased
its prior guidance for non-GAAP, fully diluted earnings per share from a
range of $0.04 to $0.14 to $0.07 to $0.14 for the full year 2006.
Third Quarter Webcast Information
Given Imaging will host a conference call tomorrow, Thursday, November 2,
2006, at 9:00 am Eastern time to discuss third quarter results. To
participate in the teleconference, please dial 800-753-9048 fifteen minutes
before the conference begins. International callers should dial
913-312-1278. The call will also be webcast live at www.givenimaging.com. A
replay of the call will be available for thirty days on the company's
website, or until November 10, 2006 by dialing 888-203-1112. International
callers should dial 719-457-0820. The replay participant code is 4578816.
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 three commercially 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 50 other countries; the PillCam ESO
video capsule to visualize the esophagus; and the Agile™ patency capsule
to determine the free passage of the PillCam capsule in the GI tract. The
PillCam COLON video capsule to visualize the colon has been cleared for
marketing in the European Union and multi-center clinical trials are
underway in Europe and the U.S. A capsule to visualize the stomach is under
development. More than 400,000 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
direct sales and marketing operations in the United States, Germany and
France, and local offices in Japan, Spain 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) 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 impact of the newly adopted SFAS 123R for expensing
option-based payments, (11) the possibility of armed conflict or civil or
military unrest in Israel, and (12) 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, 2005. 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 Consolidated Subsidiaries
Consolidated Balance Sheets
In thousands except share data
September 30, December 31,
------------ -----------
2006 2005
------------ -----------
(Unaudited) (Audited)
------------ -----------
Assets
Current assets
Cash and cash equivalents $ 35,206 $ 65,356
Short-term investments 12,966 288
Accounts receivable:
Trade (Net of provisions for doubtful debts of
$700 and $431 as of September 30, 2006 and
December 31, 2005, respectively) 16,543 18,325
Other 1,634 6,264
Inventories 18,445 16,172
Prepaid expenses 2,081 1,020
Deferred taxes 1,448 1,219
Advances to suppliers 77 332
----------- -----------
Total current assets 88,400 108,976
----------- -----------
Deposits 457 401
Marketable securities 42,137 21,664
Assets held for severance benefits 1,821 1,690
Fixed assets, at cost, less accumulated
depreciation 15,327 13,862
Other assets, at cost, less accumulated
amortization 2,833 2,517
----------- -----------
Total assets $ 150,975 $ 149,110
=========== ===========
Given Imaging Ltd. and its Consolidated Subsidiaries
Consolidated Balance Sheets
In thousands except share data
September 30, December 31,
------------ -----------
2006 2005
------------ -----------
(Unaudited) (Audited)
------------ -----------
Liabilities and shareholders' equity
Current liabilities
Current installments of obligation under capital
lease $ 12 $ 11
Accounts payable:
Trade 3,894 5,529
Other 12,892 13,886
Deferred revenue 3,383 3,333
----------- -----------
Total current liabilities 20,181 22,759
----------- -----------
Long-term liabilities
Deferred income 20,824 22,172
Obligation under capital lease, net 21 34
Liability for employee severance benefits 2,217 2,040
----------- -----------
Total long-term liabilities 23,062 24,246
----------- -----------
Total liabilities 43,243 47,005
----------- -----------
Minority interest 3,856 61
Shareholders’ equity
Share capital:
Ordinary Shares, NIS 0.05 par value each
(90,000,000 shares authorized as of
September 30, 2006 and December 31, 2005,
28,073,231 and 27,950,281 shares issued
and fully paid as of September 30, 2006
and December 31, 2005, respectively) 329 327
Additional paid-in capital 153,754 148,955
Capital reserve 2,166 2,166
Accumulated deficit (52,373) (49,404)
----------- -----------
Total shareholders' equity 103,876 102,044
----------- -----------
Total liabilities and shareholders' equity $ 150,975 $ 149,110
=========== ===========
Given Imaging Ltd. and its Consolidated Subsidiaries
Consolidated Statements of Operations
In thousands except share and per share data
Nine-month period Three-month period Year
ended ended ended
September 30, September 30, December 31,
--------------------- --------------------- -----------
2006 2005 2006 2005 2005
--------- --------- --------- --------- ---------
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Audited)
--------- --------- --------- --------- ---------
Revenues $ 67,557 $ 62,376 $ 24,050 $ 19,841 $ 86,776
Cost of
revenues 16,969 16,070 6,058 4,618 22,070
---------- ---------- ---------- ---------- ----------
Gross profit 50,588 46,306 17,992 15,223 64,706
---------- ---------- ---------- ---------- ----------
Operating
expenses
Research and
development,
gross (9,374) (6,079) (2,753) (2,061) (8,833)
Royalty bearing
participation 1,287 872 447 374 1,244
---------- ---------- ---------- ---------- ----------
Research and
development,
net (8,087) (5,207) (2,306) (1,687) (7,589)
Sales and
marketing
expenses (37,123) (32,227) (11,239) (9,778) (43,281)
General and
administrative
expenses (12,254) (7,013) (4,410) (2,539) (9,657)
---------- ---------- ---------- ---------- ----------
Total operating
expenses (57,464) (44,447) (17,955) (14,004) (60,527)
---------- ---------- ---------- ---------- ----------
Operating
profit (loss) (6,876) 1,859 37 1,219 4,179
Financing
income, net 2,958 155 581 519 762
---------- ---------- ---------- ---------- ----------
Profit (loss)
before taxes
on income (3,918) 2,014 618 1,738 4,941
Taxes on income (28) 5 (254) (53) 286
---------- ---------- ---------- ---------- ----------
Profit (loss)
before
minority share (3,946) 2,019 364 1,685 5,227
Minority share
in losses of
subsidiary 977 803 377 253 1,116
---------- ---------- ---------- ---------- ----------
Net (loss)
profit $ (2,969) $ 2,822 $ 741 $ 1,938 $ 6,343
========== ========== ========== ========== ==========
Basic (loss)
profit per
Ordinary Share $ (0.10) $ 0.10 $ 0.02 $ 0.07 $ 0.23
========== ========== ========== ========== ==========
Diluted (loss)
profit per
Ordinary Share $ (0.10) $ 0.09 $ 0.02 $ 0.07 $ 0.21
========== ========== ========== ========== ==========
Weighted
average number
of Ordinary
Shares
outstanding
used in basic
profit per
Ordinary
Share
calculation 28,017,914 27,736,989 28,061,356 27,829,442 27,781,223
========== ========== ========== ========== ==========
Weighted
average number
of Ordinary
Shares
outstanding
used in
diluted profit
per Ordinary
Share
calculation 28,017,914 29,731,618 29,377,249 29,568,874 29,695,164
========== ========== ========== ========== ==========
Contact Information: For further information contact: Yuval Yanai Given Imaging Ltd. Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR Email Contact/ Email Contact