-- The American Medical Association (AMA) and the Center for Medicare and
Medicaid Services (CMS) assigned a Permanent Level 1 CPT Code for PillCam
ESO which became effective on January 1, 2007.
-- United Healthcare revised its small bowel capsule endoscopy coverage
to include suspected and known celiac disease. United Healthcare serves
more than 18 million customers.
-- Trailblazer Health Enterprises, a Part B Medicare carrier serving more
than 3.6 million individuals in Delaware, the District of Columbia,
Maryland, Texas and Virginia issued a new policy covering capsule endoscopy
of the small bowel for a variety of indications including celiac and
Crohn's disease. The policy also states that esophageal capsule endoscopy
may be used to evaluate esophageal varices in patients with portal
hypertension as an alternative to upper GI endoscopy.
Corporate Development
In January 2007, Given Imaging announced that it will lead a European
consortium for developing an integrated imaging-biosensing screening system
for cancer of the gastrointestinal tract.
2007 World Economic Forum
Given Imaging was honored at the 2007 World Economic Forum in Davos,
Switzerland as a Technology Pioneer.
Twelve Month Financial Results
For the year ended December 31, 2006, sales were $95 million compared to
$86.8 million in 2005. Gross profit for 2006 was 74.6% which was the same
as gross profit for 2005. On a GAAP basis, net loss for 2006 was $1.5
million or $0.05 per share, compared to net income of $6.3 million, or
$0.21 per share, on a fully diluted basis in 2005. The 2006 Statements of
Operations include the impact of $5.2 million in expenses due to the
adoption of FAS 123R. The Company reported non-GAAP net income of $3.7
million, or $0.13 per share, on a diluted basis in 2006.
2007 Guidance
The company expects full year 2007 revenues of between $114 million to $119
million. The company expects full year 2007 GAAP, fully diluted earnings
per share of between $0.21 - $0.31 per share. Non-GAAP, fully diluted
earnings per share in 2007 is expected to be in a range of $0.34 to $0.44.
Both GAAP and non-GAAP expected net income do not include expenses related
to the Company's patent litigation with Olympus.
Fourth Quarter Webcast Information
Given Imaging will host a conference call tomorrow, February 28, 2007, at
9:00 a.m. Eastern time to discuss fourth quarter and full year 2006
results. To participate in the teleconference, please dial (866) 293-8970
fifteen minutes before the conference begins. International callers should
dial (913) 312-1230. 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 March 7, 2007 by dialing
888-203-1112. International callers should dial 719-457-0820. The replay
participant code is 8791440.
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. Nearly 500,000 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 subsidiaries
Consolidated Balance Sheets
(In thousands except per share data)
December 31
------------------------------
2005 2006
Audited Unaudited
Assets
Current assets
Cash and cash equivalents $ 65,356 $ 44,510
Short-term investments 288 17,245
Accounts receivable:
Trade, net 18,325 18,887
Other 6,264 1,463
Inventories 16,172 18,168
Advances to suppliers 332 82
Deferred taxes 1,219 1,374
Prepaid expenses 1,020 1,340
-------------- --------------
Total current assets 108,976 103,069
Assets held for employees’ severance
payments 1,690 1,984
Marketable securities 21,664 34,769
Fixed assets, at cost, less accumulated
depreciation 13,862 14,811
Other assets, net 2,918 3,544
-------------- --------------
Total Assets $ 149,110 $ 158,177
============== ==============
Given Imaging Ltd. and its subsidiaries
Consolidated Balance Sheets
(In thousands except share data)
December 31
------------------------------
2005 2006
Audited Unaudited
Liabilities and shareholders' equity
Current liabilities
Current installments of obligation under
capital lease $ 11 $ 13
Accounts payable:
Trade 5,529 5,550
Other 13,886 14,620
Deferred income 3,333 3,871
------------- -------------
Total current liabilities 22,759 24,054
------------- -------------
Long-term liabilities
Deferred income 22,172 20,411
Obligation under capital lease 34 20
Liability in respect of employees’
severance payments 2,040 2,407
------------- -------------
Total long-term liabilities 24,246 22,838
------------- -------------
Total liabilities 47,005 46,892
------------- -------------
Commitments and contingencies
Minority interest 61 3,499
Shareholders’ equity
Share capital:
Ordinary Shares, NIS 0.05 par value each
(90,000,000 shares authorized as of
December 31, 2005 and 2006, 27,950,281
and 28,641,291 shares issued and fully
paid as of December 31, 2005 and 2006,
respectively) 327 335
Additional paid-in capital 148,955 156,197
Capital reserve 2,166 2,166
Accumulated deficit (49,404) (50,912)
------------- -------------
Total shareholders' equity 102,044 107,786
------------- -------------
Total liabilities and shareholders' equity $ 149,110 $ 158,177
============= =============
Consolidated Statements of Operations
(In thousands except share and per share data)
Year ended Three month period
December 31, Ended December 31,
------------------------ ------------------------
2005 2006 2005 2006
Audited Unaudited Unaudited Unaudited
----------- ----------- ----------- -----------
Revenues $ 86,776 $ 95,029 $ 24,400 $ 27,472
Cost of revenues 22,070 24,154 6,000 7,185
----------- ----------- ----------- -----------
Gross profit 64,706 70,875 18,400 20,287
----------- ----------- ----------- -----------
Operating expenses
Research and
development, gross (8,833) (12,678) (2,754) (3,304)
Royalty bearing
government grants 1,244 1,867 372 580
----------- ----------- ----------- -----------
Research and
development, net (7,589) (10,811) (2,382) (2,724)
Sales and marketing (43,281) (50,732) (11,054) (13,609)
General and
administrative (9,657) (16,027) (2,644) (3,773)
----------- ----------- ----------- -----------
Total operating
expenses (60,527) (77,570) (16,080) (20,106)
----------- ----------- ----------- -----------
Operating profit (loss) 4,179 (6,695) 2,320 181
Financial income, net 762 3,980 607 1,022
----------- ----------- ----------- -----------
Profit (loss) before
taxes on income and
minority share 4,941 (2,715) 2,927 1,203
Taxes on income 286 (127) 281 (99)
----------- ----------- ----------- -----------
Profit (loss) before
minority share 5,227 (2,842) 3,208 1,104
Minority share in
losses of subsidiary 1,116 1,334 313 357
----------- ----------- ----------- -----------
Net profit (loss) $ 6,343 $ (1,508) $ 3,521 $ 1,461
=========== =========== =========== ===========
Profit (loss) per share
Basic profit (loss) per
Ordinary Share $ 0.23 $ (0.05) $ 0.13 $ 0.05
=========== =========== =========== ===========
Diluted profit (loss)
per Ordinary Share $ 0.21 $ (0.05) $ 0.12 $ 0.05
=========== =========== =========== ===========
Weighted average number
of Ordinary Shares used
to compute basic profit
(loss) per Ordinary
Share 27,781,223 28,053,849 27,920,441 28,073,231
=========== =========== =========== ===========
Weighted average number
of Ordinary Shares used
to compute diluted profit
(loss) per Ordinary
Share 29,695,164 28,053,849 29,950,208 29,833,686
=========== =========== =========== ===========
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-(866) GIVEN-IR Email Contact Email Contact