-- In November, the Company introduced its second-generation PillCam®
COLON capsule at the Gastro 2009 Conference in London. This advanced
PillCam system contains proprietary, innovative technologies, including
intelligent functionality and superior imaging, designed to provide
physicians with clear and precise views of the colon and polyps of
interest. Following receipt of the CE mark in September 2009, The
Company plans to gradually make PillCam COLON 2 available in Europe
during 2010.
-- At the UEGW meeting, independent investigators presented results of an
initial 98-patient feasibility PillCam COLON 2 study. The study was
published in the December 2009 edition of the journal Endoscopy. To
access the study visit:
http://delivery.sheridan.com/downloads/mobile/THIEME_161122_CP.exe
Conference Call / Webcast Information
U.S. Call / Webcast
The company will host a conference call in English at 9:00am ET on
Wednesday, February 17, 2010. To participate in this teleconference, please
dial 888-684-1277 fifteen minutes before the conference is scheduled to
begin. Callers outside of the U.S. should dial 913-312-1483. The call will
also be webcast live at www.givenimaging.com. A replay of the call will be
available for two weeks on the company's website, or until March 3, 2010,
by dialing 888-203-1112. Callers outside of the U.S. should dial
719-457-0820. The replay participant code is 6876444.
A separate conference call in Hebrew will take place on February 17, at
2:00pm Israel time, 7am ET. To access this call, please dial +972 3 9180609
ten minutes before the call is scheduled to begin. A replay of the call
will be available from February 17th until February 19th by dialing +972 3
9255900.
Upcoming Events
Given Imaging management will be presenting at the following investor
conferences:
-- February 23 -- Yuval Yanai, Chief Financial Officer, will present at
the NASDAQ OMX/Oppenheimer 14th Israeli Equities Conferences in New
York City. Mr. Yanai's presentation is scheduled for 1:55pm ET. This
presentation will be webcast live at www.givenimaging.com.
-- February 25 -- Homi Shamir, President and CEO, will present at the
Lazard Capital Markets Medical Device Conference in Salt Lake City.
-- March 3 -- Yuval Yanai will present to a group of institutional
investors at an event sponsored by Morgan Stanley in Brussels, Belgium.
-- March 4 -- Homi Shamir will present at the Morningstar/NYSSA Healthcare
Conference in New York City. Mr. Shamir's presentation is scheduled
for 11am ET.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis by
developing innovative, patient-friendly tools based on its PillCam®
Platform. PillCam capsule endoscopy provides physicians with natural images
of the small intestine via PillCam SB, the esophagus through PillCam ESO
and the colon with PillCam COLON [PillCam COLON is not cleared for use in
the USA]. The PillCam capsules are miniature video cameras that patients
ingest. Given Imaging's other capsule products include Agile™ patency
capsule, to verify intestinal patency, and Bravo®, the only wireless,
catheter-free, 48-hour pH test commercially available for pH testing to
assess gastroesophageal reflux disease (GERD). Given Imaging's products use
cutting-edge, wireless technology and advanced software to enable
gastroenterologists to better diagnose diseases of the esophagus, small
bowel and colon and more accurately treat patients. All Given Imaging
products allow patients to maintain normal activities. Given Imaging's
headquarters, manufacturing and R&D facilities are located in Yoqneam,
Israel, with operating subsidiaries in the United States, Germany, France,
Japan, Australia and Singapore. For more information, please visit
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 certain items and are therefore not
calculated in accordance with generally accepted accounting principles
(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.
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.
Forward-Looking Statements
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) our ability to develop and bring to market new products, (2)
our ability to successfully complete any necessary or required clinical
studies with our products, (3) our ability to receive regulatory clearance
or approval to market our products or changes in regulatory environment,
(4) our success in implementing our sales, marketing and manufacturing
plans, (5) the level of adoption of our products by medical practitioners,
(6) the emergence of other products that may make our products obsolete,
(7) lack of an appropriate bowel preparation materials to be used with our
PillCam COLON capsule, (8) protection and validity of patents and other
intellectual property rights, (9) the impact of currency exchange rates,
(10) the effect of competition by other companies, (11) the outcome of
significant litigation, (12) our ability to obtain reimbursement for our
product from government and commercial payors, (13) quarterly variations in
operating results, (14) the possibility of armed conflict or civil or
military unrest in Israel, (15) the impact of global economic conditions,
(16) our ability to successfully integrate acquired businesses, (17)
changes and reforms in applicable healthcare laws and regulations and (18)
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, 2008. 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.
* Based on fully diluted shares of 30,423,162 at Dec 31, 2009, and
30,798,360 at Dec 31, 2008
Given Imaging Ltd. and its Consolidated Subsidiaries
Specified Items
For the Three Months Ended December 31, 2008 and 2009
(Unaudited, dollars in thousands)
Termination
Research Selling General Of
And And And Marketing Other Tax
Development Marketing Admin Agreement Expenses Benefit Total
Three month
period
ended
December
31, 2009
Compensation
expenses $ (29) $ 110 $ 1,309 $ - $ - $ - $ 1,390
Impairment
of Goodwill - - - - 483 - 483
Tax benefit - - - - - (857) (857)
------- -------- -------- -------- -------- ------- -------
Total $ (29) $ 110 $ 1,309 $ - $ 483 $ (857) $ 1,016
======= ======== ======== ======== ======== ======= =======
Three month
period
ended
December
31, 2008
Compensation
expenses $ 37 $ 453 $ 1,302 $ - $ - $ - $ 1,792
Write-off of
Bravo IPR&D 4,700 - - - - - 4,700
Impairment
of goodwill - - - - 406 - 406
Total $ 4,737 $ 453 $ 1,302 $ - $ 406 $ - $ 6,898
======= ======== ======== ======== ======== ======= =======
Given Imaging Ltd. and its Consolidated Subsidiaries
Specified Items
For the Twelve Months Ended December 31, 2008 and 2009
(Unaudited, dollars in thousands)
Termination
Research Selling General Of
And And And Marketing Other Tax
Development Marketing Admin Agreement Expenses Benefit Total
Twelve month
period
ended
December
31, 2009
Compensation
expenses $ 257 $ 1,619 $ 5,392 $ - $ - $ - $ 7,268
Impairment
of goodwill - - - - 483 - 483
Tax
(benefit) - - - - - (2,608) (2,608)
-------- -------- ------- ------- -------- ------- -------
Total $ 257 $ 1,619 $ 5,392 $ - $ 483 $(2,608) $ 5,143
======== ======== ======= ======= ======== ======= =======
Twelve month
period
ended
December
31, 2008
Compensation
expenses $ 307 $ 1,756 $ 4,855 $ - $ - $ - $ 6,918
IP
Litigation
expenses - - 3,375 - - - 3,375
Patent
litigation
settlement - - (2,333) - - - (2,333)
Termination
of
marketing
agreement - - - (5,443) - - (5,443)
Impairment
of goodwill - - - - 406 - 406
Write-off of
Bravo IPR&D 4,700 - - - - - 4,700
-------- -------- ------- ------- -------- ------- -------
Total $ 5,007 $ 1,756 $ 5,897 $(5,443) $ 406 $ - $ 7,623
======== ======== ======= ======= ======== ======= =======
Given Imaging Ltd. and its Consolidated Subsidiaries
Reconciliation of GAAP results to non-GAAP results
For the three and nine months ended December 31, 2009 and 2008
Condensed, in thousands except share and per share data
Q4 2009 Q4 2008
Specified Non Specified Non
GAAP Items (*) GAAP GAAP Items (*) GAAP
------- ------- ------- ------- -------- -------
Revenues $40,040 - $40,040 $33,776 - $33,776
Cost of revenues (9,379) - (9,379) (9,265) - (9,265)
------- ------- ------- ------- -------- -------
Gross profit 30,661 - 30,661 24,511 - 24,511
------- ------- ------- ------- -------- -------
Gross profit as a %
of revenues 76.6% - 76.6% 72.6 % - 72.6%
Operating expenses
Research and
development, net (4,211) (29) (4,240) (7,857) 4,737 (3,120)
Sales and marketing (16,171) 110 (16,061) (14,333) 453 (13,880)
General and
administrative (4,898) 1,309 (3,589) (4,871) 1,302 (3,569)
Termination of
marketing agreement - - - - - -
Other, net (889) 483 (406) (867) 406 (461)
------- ------- ------- ------- -------- -------
Total operating
expenses (26,169) 1,873 (24,296) (27,928) 6,898 (21,030)
------- ------- ------- ------- -------- -------
Operating profit
(loss) 4,492 1,873 6,365 (3,417) 6,898 3,481
Operating profit as
a % of revenues 11.2% 15.9% (10.1%) 10.3%
------- ------- ------- ------- -------- -------
Financing income,
net 308 - 308 809 - 809
------- ------- ------- ------- -------- -------
Profit (loss) before
taxes on income 4,800 1,873 6,673 (2,608) 6,898 4,290
Income tax benefit
(expense) 382 (857) (475) (17) - (17)
------- ------- ------- ------- -------- -------
Net Profit (loss) 5,182 1,016 6,198 (2,625) 6,898 4,273
Net loss
attributable to
non-controlling
interest 187 - 187 562 - 562
------- ------- ------- ------- -------- -------
Net profit (loss)
attributable to
shareholders $ 5,369 $ 1,016 $ 6,385 $(2,063) $ 6,898 $ 4,835
======= ======= ======= ======= ======== =======
Net profit (loss)
attributable to
shareholders
as a
% of revenues 13.4% 15.9% (6.1)% 14.3%
Earnings per share
Basic Earnings
(losses)
attributable to
shareholders per
Ordinary Share $ 0.18 $ 0.04 $ 0.22 $ (0.07) 0.24 $ 0.17
======= ======= ======= ======= ======== =======
Diluted Earnings
(losses)
attributable to
shareholders per
Ordinary Share $ 0.17 $ 0.03 $ 0.20 $ (0.07) 0.23 $ 0.16
======= ======= ======= ======= ======== =======
(*) See specified items
Given Imaging Ltd. and its Consolidated Subsidiaries
Reconciliation of GAAP results to non-GAAP results
For the three and nine months ended December 31, 2009 and 2008
Condensed, in thousands except share and per share data
YTD 2009 YTD 2008
Specified Non Specified Non
GAAP Items (*) GAAP GAAP Items (*) GAAP
-------- -------- -------- -------- -------- --------
Revenues $141,763 - $141,763 $125,108 - $125,108
Cost of
revenues (33,145) - (33,145) (33,001) - (33,001)
-------- -------- -------- -------- -------- --------
Gross profit 108,618 - 108,618 92,107 - 92,107
-------- -------- -------- -------- -------- --------
Gross profit
as a % of
revenues 76.6% - 76.6% 73.6% - 73.6%
Operating
expenses
Research and
development,
net (16,733) 257 (16,476) (18,296) 5,007 (13,289)
Sales and
marketing (61,428) 1,619 (59,809) (60,902) 1,756 (59,146)
General and
administrative (18,919) 5,392 (13,527) (19,320) 5,897 (13,423)
Termination of
marketing
agreement - - - 5,443 (5,443) -
Other, net (1,220) 483 (737) (867) 406 (461)
-------- -------- -------- -------- -------- --------
Total operating
expenses (98,300) 7,751 (90,549) (93,942) 7,623 (86,319)
-------- -------- -------- -------- -------- --------
Operating
profit (loss) 10,318 7,751 18,069 (1,835) 7,623 5,788
Operating
profit as a %
of revenues 7.3% 12.7% (1.5%) 4.6%
-------- -------- -------- -------- -------- --------
Financing
income, net 1,584 - 1,584 4,004 - 4,004
-------- -------- -------- -------- -------- --------
Profit before
taxes on
income 11,902 7,751 19,653 2,169 7,623 9,792
Income tax
benefit
(expense) 1,542 (2,608) (1,066) (250) - (250)
-------- -------- -------- -------- -------- --------
Net Profit 13,444 5,143 18,587 1,919 7,623 9,542
Net loss
attributable
to
non-controlling
interest 891 - 891 2,087 - 2,087
-------- -------- -------- -------- -------- --------
Net profit
attributable
to
shareholders $ 14,335 $ 5,143 $ 19,478 $ 4,006 $ 7,623 $ 11,629
======== ======== ======== ======== ======== ========
Net profit
attributable
to
shareholders
as a % of
revenues 10.1% 13.7% 3.2% 9.3%
Earnings per
share
Basic Earnings
attributable
to
shareholders
per Ordinary
Share $ 0.49 $ 0.18 $ 0.67 $ 0.14 $ 0.26 $ 0.40
======== ======== ======== ======== ======== ========
Diluted
Earnings
attributable
to
shareholders
per Ordinary
Share $ 0.47 $ 0.17 $ 0.64 $ 0.13 $ 0.25 $ 0.38
======== ======== ======== ======== ======== ========
(*) See specified items
Given Imaging Ltd. and its Subsidiaries
Consolidated Balance Sheets
(In thousands except per share data)
December 31,
-----------------
2009 2008
Assets
Current assets
Cash and cash equivalents $ 46,458 $ 31,697
Short-term investments 31,736 28,509
Accounts receivable:
Trade, net 24,742 21,673
Other 3,799 4,662
Inventories 17,302 18,931
Advances to suppliers 534 3,540
Deferred tax assets 2,207 1,178
Prepaid expenses 1,036 1,631
-------- --------
Total current assets 127,814 111,821
Deposits 1,062 1,094
Assets held for employees' severance payments 4,968 3,686
Marketable securities 16,956 30,063
Long-term inventory 6,015 -
Fixed assets, less accumulated depreciation 13,843 15,115
Deferred tax assets 192 -
Intangible assets less accumulated amortization 11,284 12,067
Goodwill 3,586 4,069
-------- --------
Total Assets $185,720 $177,915
======== ========
Given Imaging Ltd. and its Subsidiaries
Consolidated Balance Sheets
(In thousands except share data)
December 31,
------------------
2009 2008
Liabilities and shareholders' equity
Current liabilities
Current installments of obligation under capital lease $ 145 $ 114
Accounts payable:
Trade 6,789 7,418
Other 20,060 17,612
Deferred income 234 1,523
-------- --------
Total current liabilities 27,228 26,667
-------- --------
Long-term liabilities
Obligation under capital lease 356 485
Liability in respect of employees' severance payments 5,530 4,599
-------- --------
Total long-term liabilities 5,886 5,084
-------- --------
Total liabilities 33,114 31,751
-------- --------
Commitments and contingencies
Equity
Shareholders' equity:
Ordinary Shares, NIS 0.05 par value each
(90,000,000 shares authorized as of December 31, 2008
and 2009, 29,257,785 and 29,370,972 shares issued and
fully paid as of December 31, 2008 and 2009,
respectively) 345 343
Additional paid-in capital 182,203 173,983
Capital reserve 2,166 2,166
Accumulated other comprehensive income (loss) 399 (600)
Accumulated deficit (33,185) (31,721)
-------- --------
Shareholders' equity 151,928 144,171
-------- --------
Non-controlling interests 678 1,993
-------- --------
Total equity 152,606 146,164
-------- --------
Total liabilities, shareholders' equity and
non-controlling interests $185,720 $177,915
======== ========
Given Imaging Ltd. and its Subsidiaries
Consolidated Statements of Operations
(In thousands except share and per share data)
Year ended December 31,
----------------------------------
2009 2008 2007
---------- ---------- ----------
Revenues $ 141,763 $ 125,108 $ 112,868
Cost of revenues (33,145) (33,001) (29,721)
Early repayment of royalty bearing
government Grants - - (4,843)
---------- ---------- ----------
Gross profit 108,618 92,107 78,304
---------- ---------- ----------
Operating expenses
Research and development, gross (17,842) (15,126) (12,847)
In-process research and development
acquired in a business combination - (4,700) -
---------- ---------- ----------
(17,842) (19,826) (12,847)
Government grants 1,109 1,530 1,242
---------- ---------- ----------
Research and development, net (16,733) (18,296) (11,605)
Sales and marketing (61,428) (60,902) (55,446)
General and administrative (18,919) (19,320) (20,981)
Termination of marketing agreement - 5,443 22,860
Other, net (1,220) (867) (422)
---------- ---------- ----------
Total operating expenses (98,300) (93,942) (65,594)
---------- ---------- ----------
Operating profit (loss) 10,318 (1,835) 12,710
Financial income, net 1,584 4,004 5,520
---------- ---------- ----------
Profit before taxes on income 11,902 2,169 18,230
Income tax benefit (expense) 1,542 (250) (4,548)
---------- ---------- ----------
Net Profit 13,444 1,919 13,682
Net loss attributable to
non-controlling interest 891 2,087 1,503
---------- ---------- ----------
Net profit attributable to shareholders $ 14,335 $ 4,006 $ 15,185
========== ========== ==========
Earnings per share:
Basic Earnings per Ordinary Share $ 0.49 $ 0.14 $ 0.52
========== ========== ==========
Diluted Earnings per Ordinary Share $ 0.47 $ 0.13 $ 0.49
========== ========== ==========
Weighted average number of Ordinary
Shares used to compute basic Earnings
per Ordinary Share 29,281,897 29,254,035 28,961,968
========== ========== ==========
Weighted average number of Ordinary
Shares used to compute diluted
Earnings per Ordinary Share 30,423,162 30,798,360 31,030,459
========== ========== ==========
Given Imaging Ltd. and its Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
Year ended December 31,
----------------------------
2009 2008 2007
-------- -------- --------
Cash flows from operating activities:
Net profit $ 13,444 $ 1,919 $ 13,682
Adjustments required to reconcile net profit
to net cash provided by operating activities:
Depreciation and amortization 6,096 5,183 4,771
In-process research and development - 4,700 -
Goodwill impairment 483 406 -
Deferred tax assets (1,221) 172 24
Stock based compensation 7,268 6,918 5,651
Excess tax benefits related to stock based
compensation - - (693)
Other 570 621 380
Decrease (increase) in accounts receivable -
trade (3,069) 1,642 (4,428)
Decrease (increase) in other accounts
receivable 863 5,723 (8,922)
Decrease (increase) in prepaid expenses 595 (342) 51
Decrease (increase) in advances to suppliers 3,006 (3,350) (108)
Decrease (increase) in inventories (4,386) (2,971) 2,208
Increase (decrease) in accounts payable 1,819 (3,287) 8,570
Decrease in deferred income (1,289) (7,856) (14,903)
-------- -------- --------
Net cash provided by operating activities 24,179 9,478 6,283
-------- -------- --------
Cash flows from investing activities:
Purchase of fixed assets and intangible
assets (4,794) (6,300) (5,772)
Purchase of fixed assets, intangible assets,
and goodwill in a business combination - (16,660) -
Deposits 34 (192) (355)
Proceeds from sale of trading and marketable
securities and short term investments 38,085 67,743 23,845
Proceeds from sales of fixed assets - 61 -
Investments in trading and marketable
securities (27,410) (61,986) (36,584)
-------- -------- --------
Net cash provided by (used in) investing
activities 5,915 (17,334) (18,866)
-------- -------- --------
Cash flows from financing activities:
Principal payments on capital lease
obligation (131) (120) (37)
Proceeds from the issuance of Ordinary Shares 954 252 4,280
Dividend distribution (15,799) - -
Excess tax benefits related to stock based
compensation - - 693
Purchase of shares from a noncontrolling
shareholder in a subsidiary (382) - -
Issuance of shares by a consolidated company - 2,288 -
-------- -------- --------
Net cash provided by (used in) financing
activities (15,358) 2,420 4,936
-------- -------- --------
Effect of exchange rate changes on cash 25 30 240
-------- -------- --------
Increase (decrease) in cash and cash
equivalents 14,761 (5,406) (7,407)
Cash and cash equivalents at beginning of
year 31,697 37,103 44,510
-------- -------- --------
Cash and cash equivalents at end of year $ 46,458 $ 31,697 $ 37,103
======== ======== ========
Supplementary cash flow information
Year ended December 31,
----------------------------
2009 2008 2007
-------- -------- --------
Income taxes paid $ 877 $ 259 $ 1,098
======== ======== ========
Assets acquired under capital lease - $ 109 $ 569
======== ======== ========
Contact Information: For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 212-867-1768