EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1 exhibit_99-1.htm


Exhibit 99.1
 
 
FOR IMMEDIATE RELEASE

For further information contact:

Fern Lazar/David Carey
Lazar Partners Ltd.
1-212-867-1768
flazar@lazarpartners.com/
dcarey@lazarpartners.com
 
GIVEN IMAGING REPORTS FIRST QUARTER 2011 RESULTS

First Quarter 2011 Revenues Increased 25% to a Record $40 Million  –

Non-GAAP Gross Margin Increased to 77.4% of Revenues –

Non-GAAP Operating Profit Increased 12% –

PillCam SB Sales in the EMEA Region Grew 18% –

Currency Fluctuations and Increased Taxes Reduced Net Income Compared to First Quarter 2010 –

YOQNEAM, Israel, May 4, 2011 - Given Imaging Ltd. (NASDAQ: GIVN) today announced financial results for the first quarter ended March 31, 2011.

Worldwide revenues were $40 million in the first quarter of 2011, a 25 percent increase from $32.1 million in the first quarter of 2010.  First quarter 2011 revenues include sales of $5.5 million from Sierra Scientific Instruments (Sierra), which the company acquired on April 1, 2010.  Gross margin on a non-GAAP basis in the first quarter of 2011 was 77.4 percent, compared to 77.1 percent in the first quarter of 2010.

Non-GAAP operating profit was $3.9 million, compared to $3.5 million in the first quarter of 2010.  On a non-GAAP basis, net income for the first quarter of 2011 was $3 million, or $0.10 per share on a fully diluted basis, compared to $4.4 million, or $0.14 per share on a fully diluted basis, in the first quarter of 2010.  On a GAAP basis, net income for the first quarter of 2011 was $0.7 million, or $0.02 per share, compared to $2.1 million, or $0.07 per share, in the same quarter of last year.  In the first quarter of 2011 finance expense, net, was $0.1 million, compared to finance income, net, of $0.98 million in the first quarter of 2010. Tax expense for the first quarter of 2011 was $0.7 million, compared to $0.1 million in the same quarter of last year.  A reconciliation of GAAP results to non-GAAP results is attached.
 
Cash and cash equivalents, short-term investments and marketable securities on March 31, 2011 totaled $83.9 million.

“We are pleased to report that we achieved a 25 percent increase in total revenues in the first quarter of 2011, fueled by sales of Sierra Scientific Instruments products, and by solid growth of our PillCam business in the EMEA and APAC regions," said Homi Shamir, president and CEO of Given Imaging.  “Looking ahead, we are encouraged by several positive developments, including recovery of our core PillCam SB business in the EMEA region, which looks to be back on track, and the recent FDA decision to clear the marketing of PillCam SB in the U.S for use in monitoring lesions that may indicate Crohn’s disease.  Finally, we are making progress towards starting the PillCam COLON pivotal trials in the U.S. and Japan.”
 
 
 

 
 
First Quarter 2011 Revenue Analysis

Revenues in the Americas region were $24.1 million, including revenues of $3.2 million from sales of Sierra products. In the same period in 2010 revenues in the Americas region were $20.5 million.  Revenues in the EMEA region were $11.2 million, including $1.5 million from sales of Sierra products, compared to $8.5 million in the same quarter last year.  APAC revenues were $4.7 million, including Sierra sales of $0.7 million, compared to $3.1 million in the same period in 2010.

Worldwide PillCam SB sales amounted to 54,200 capsules in the first quarter of 2011, compared to 50,900 capsules in the same period last year.  PillCam SB sales in the Americas region were 33,400 capsules, approximately the same as in the first quarter of last year.  PillCam SB sales in the EMEA region increased 18 percent to 15,000 capsules, compared to 12,700 capsules in the first quarter of 2010 and PillCam SB sales in the APAC region increased 26 percent to 5,800 capsules, compared to 4,700 capsules in the same period in 2010.

Supplemental first quarter data can be found at www.givenimaging.com in the Investor Relations section.

2011 Guidance

The company reaffirms its guidance for 2011 of revenues between $165 million and $173 million, GAAP EPS of $0.35 – $0.40, and non-GAAP EPS of $0.65 – $0.70.

Recent Developments

PillCam SB Expanded Indication
§
In March 2011, Given Imaging received clearance from the U.S. Food and Drug Administration (FDA) to promote the PillCam SB video capsule for use in monitoring lesions that may indicate Crohn's disease.

Sensor Belt Expanded Availability
§
In February 2011, the FDA cleared revised labeling regarding the use of the SensorBelt in patients with a higher than normal Body Mass Index (BMI) of up to 43.3 kg/m2.

PillCam Patent Infringement Lawsuit
§
The Regional Court (Patent Chamber) in Dusseldorf, Germany ruled that the MiroCam capsule endoscopy system manufactured by IntroMedic of South Korea infringed two patents asserted by Given Imaging. The court's rulings allow Given Imaging to prevent IntroMedic's German distributor, Medwork Medicinal Products and Services GmbH, from selling the current model of the MiroCam capsule and MiroView software in Germany. The defendant appealed this decision and commenced separate proceedings to invalidate the patents.
 
 
2

 
 
International Colon Capsule Expert Meeting
§
In February, the inaugural International Colon Capsule Expert Meeting took place in Italy, assembling a panel of gastrointestinal experts from around the world.  The purpose of the meeting was to discuss and develop guidelines for colon capsule endoscopy in accordance with the methodology established by the European Society of Gastrointestinal Endoscopy.  Guidelines are expected to be published in the fourth quarter of 2011.
 
Conference Call / Webcast Information

U.S. Call / Webcast
The company will host a conference call in English at 9:00 am ET on Thursday, May 5, 2011. To participate in this teleconference, please dial 888-715-1394 fifteen minutes before the conference is scheduled to begin. Callers outside of the U.S. should dial 913-312-1513. 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 May 19, 2011, by dialing 888-203-1112. Callers outside of the U.S. should dial 719-457-0820. The replay participant code is 3018955.

Hebrew Call
A separate conference call in Hebrew will take place on May 5, 2011 at 2:00 pm Israel time, 7:00 am ET. To access this call, please dial + 972-3-918-0609ten minutes before the conference is scheduled to begin. A replay of the call will be available from May 8 until May 10, 2011 by dialing +972-3-925-5900.

About Given Imaging Ltd.
Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States.], industry-leading ManoScan high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam and Hong Kong. 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.
 
 
3

 
 
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, (18) adverse events related to our products or product quality issues that could require us to recall products and impact our sales, and (19) 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, 2010. 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.

# # #

Financial Tables Follow
 
 
4

 
 
Given Imaging Ltd. and its Consolidated Subsidiaries
Excluded Items
For the Three Months Ended March 31, 2011 and 2010
(Unaudited, dollars in thousands)

         
Research
   
Selling
   
General
   
 
   
Tax
       
   
Gross
   
And
   
And
   
And
   
Other
   
Expense
       
   
Profit
   
Development
   
Marketing
   
Admin
   
Expenses
   
(Benefit)
   
Total
 
                                           
Three month period
                                         
ended March 31, 2011
                                     
                                           
Compensation expenses
  $ -     $ 182     $ 561     $ 1,394     $ -     $ -     $ 2,137  
Sierra PPA
    237       -       81       -       -       (127 )     191  
Total
  $ 237     $ 182     $ 642     $ 1,394     $ 0     $ (127 )   $ 2,328  
                                                         
Three month period
                                                       
ended March 31, 2010
                                                 
                                                         
Compensation expenses
  $ -     $ 83     $ 327     $ 1,203     $ -     $ -     $ 1,613  
Sierra acquisition expenses
    -       -       -       686       -       -       686  
Total
  $ 0     $ 83     $ 327     $ 1,889     $ 0     $ 0     $ 2,299  

 
5

 
 
Given Imaging Ltd. and its Consolidated Subsidiaries
Reconciliation of GAAP results to non-GAAP results
For the Three months ended March 31, 2011 and 2010
Condensed, in thousands except share and per share data

          Q1 2011                 Q1 2010        
         
Specified
   
Non
         
Specified
   
Non
 
   
GAAP
   
Items (*)
   
GAAP
   
GAAP
   
Items (*)
   
GAAP
 
Revenues
  $ 39,969       -     $ 39,969     $ 32,097       -     $ 32,097  
Cost of revenues
    (9,267 )     237       (9,030 )     (7,336 )     -       (7,336 )
                                                 
Gross profit
    30,702       237       30,939       24,761       -       24,761  
Gross profit as a % of revenues
    76.8 %     -       77.4 %     77.1 %     -       77.1 %
                                                 
Operating expenses
                                               
Research and development, net
    (5,461 )     182       (5,279 )     (3,777 )     83       (3,694 )
Sales and marketing
    (17,249 )     642       (16,607 )     (14,749 )     327       (14,422 )
General and administrative
    (6,522 )     1,394       (5,128 )     (5,134 )     1,889       (3,245 )
Other, net
    (17 )     -       (17 )     (63 )     -       (63 )
                                                 
Total operating expenses
    (29,249 )     2,218       (27,031 )     (23,723 )     2,299       (21,424 )
                                                 
Operating profit
    1,453       2,455       3,908       1,038       2,299       3,337  
Operating profit as a % of revenues
    3.6 %     -       9.8 %     3.2 %     -       10.4 %
 
                                               
Financing income (expense) ,net
    (96 )     -       (96 )     978       -       978  
                                                 
Profit before taxes on income
    1,357       2,455       3,812       2,016       2,299       4,315  
Income tax expense
    (592 )     (127 )     (719 )     (129 )     -       (129 )
                                                 
Net Profit
    765       2,328       3,093       1,887       2,299       4,186  
                                                 
Net (income) loss attributable to non-controlling interest
    (88 )     -       (88 )     166       -       166  
                                                 
Net profit attributable to shareholders
  $ 677     $ 2,328     $ 3,005     $ 2,053     $ 2,299     $ 4,352  
Net profit  attributable to shareholders  as  a % of revenues
    1.7 %     -       7.5 %     6.4 %     -       13.6 %
                                                 
Earnings  per share
                                               
Basic Earnings attributable to shareholders per Ordinary Share
  $ 0.02     $ 0.08     $ 0.10     $ 0.07     $ 0.08     $ 0.15  
Diluted Earnings attributable to shareholders per Ordinary Share
  $ 0.02     $ 0.08     $ 0.10     $ 0.07     $ 0.07     $ 0.14  
 
(*) See specified items on Excluded Items table
 
 
6

 
 
Given Imaging Ltd. and its Consolidated Subsidiaries
Interim Consolidated Balance Sheets
In thousands except share data
(Unaudited)

   
March 31
   
December 31
 
   
2011
   
2010
 
             
Assets
           
             
Current assets
           
Cash and cash equivalents
  $ 28,922     $ 34,619  
Short-term investments
    39,947       51,973  
Accounts receivable:
               
  Trade (Net of provisions for doubtful debts of $267
               
   and of $295 as of March 31, 2011 and December 31,
               
   2010, respectively)
    26,616       27,862  
  Other
    3,640       4,291  
Inventories
    21,509       19,076  
Prepaid expenses
    2,306       1,585  
Deferred tax assets
    1,664       1,638  
Advances to suppliers
    373       441  
                 
Total current assets
    124,977       141,485  
                 
Deposits
    1,244       1,212  
                 
Assets held for employee severance payments
    6,897       6,393  
                 
Marketable Securities
    14,999       3,873  
                 
Non-current Inventory
    5,077       5,626  
                 
Fixed assets, at cost, less accumulated depreciation
    13,498       13,709  
                 
Intangible assets, less accumulated amortization
    31,298       25,813  
                 
Goodwill
    24,089       24,089  
                 
Total Assets
  $ 222,079     $ 222,200  

 
7

 

Given Imaging Ltd. and its Consolidated Subsidiaries
Interim Consolidated Balance Sheets
In thousands except share data
(Unaudited)

   
March 31
   
December 31
 
   
2011
   
2010
 
             
Liabilities and equity
           
             
Current liabilities
           
             
Current installments of obligation under capital lease
  $ 166     $ 168  
Accounts payable
               
  Trade
    7,899       9,125  
  Other
    22,029       26,065  
Deferred income
    852       788  
Total current liabilities
    30,946       36,146  
                 
Long-term liabilities
               
Obligation under capital lease, net
    201       244  
Liability in respect of employees’ severance payments
    7,650       7,151  
Deferred tax liabilities
    5,744       5,871  
Total long-term liabilities
    13,595       13,266  
Total liabilities
    44,541       49,412  
                 
Equity
               
Shareholders’ equity
               
Ordinary Shares, NIS 0.05 par value each (90,000,000
               
 shares authorized; 30,027,447 and 29,829,277 shares
               
 issued and fully paid as of March 31, 2011 and
               
 December 31, 2010, respectively)
    353       350  
Additional paid-in capital
    198,882       194,899  
Capital reserve
    2,051       2,051  
Accumulated other comprehensive income
    94       95  
Accumulated deficit
    (24,030 )     (24,707 )
Shareholders' equity
    177,350       172,688  
Non-controlling interest
    188       100  
Total Equity
    177,538       172,788  
                 
Total liabilities and equity 
  $ 222,079     $ 222,200  

 
8

 
 
Given Imaging Ltd. and its Consolidated Subsidiaries
Interim Consolidated Statements of Operations
In thousands except share and per share data
(Unaudited)

   
Three month period ended
   
Year ended
 
   
March 31
   
December 31
 
   
2011
   
2010
   
2010
 
                         
Revenues
  $  39,969     $   32,097     $  157,809  
Cost of revenues
    (9,267 )     (7,336 )     (37,629 )
                         
Gross profit
    30,702       24,761       120,180  
                         
Operating expenses
                       
Research and development, gross
    (5,773 )     (4,024 )     (21,695 )
Government grants
    312       247       1,477  
Research and development, net
    (5,461 )     (3,777 )     (20,218 )
                         
Sales and marketing
    (17,249 )     (14,749 )     (67,114 )
General and administrative
    (6,522 )     (5,134 )     (25,138 )
Other, net
    (17 )     (63 )     (759 )
                         
Total operating expenses
    (29,249 )     (23,723 )     (113,229 )
                         
Operating income
    1,453       1,038       6,951  
Financing income (expense), net
    (96 )     978       2,599  
                         
Income  before taxes on income
    1,357       2,016       9,550  
Income tax expense
    (592 )     (129 )     (1,362 )
                         
Net income
    765       1,887       8,188  
                         
Net loss (income) attributable to non-controlling interest
    (88 )     166       290  
                         
Net income attributable to shareholders of the company
  $ 677     $  2,053     $  8,478  
                         
Earnings  per share
                       
                         
Basic Earnings attributable to shareholders per Ordinary Share
  $   0.02     $   0.07     $   0.29  
                         
Diluted Earnings attributable to shareholders per Ordinary Share
  $   0.02     $   0.07     $   0.28  
                         
Weighted average number of Ordinary Shares used
                       
 to compute basic Earnings  per Ordinary share
    29,434,741       29,427,767       29,670,842  
 
                       
Weighted average number of Ordinary Shares used
                       
 to compute diluted Earnings per Ordinary share
    30,356,969       30,646,418       30,525,654  

 
9

 

Given Imaging Ltd. and its Consolidated Subsidiaries
Consolidated Statements of Cash Flows
In thousands
(Unaudited)

   
Three month period ended
   
Year ended
 
   
March 31,
   
December 31,
 
   
2011
   
2010
   
2010
 
                   
Cash flows from operating activities:
                 
Net income
  $ 765     $ 1,887     $ 8,188  
                         
Adjustments required to reconcile net income
                       
 to net cash provided by (used in) operating activities:
                       
                         
Depreciation and amortization
    1,998       1,498       7,662  
Goodwill impairment
    -       -       20  
Deferred tax assets
    (26 )     206       761  
Deferred tax liabilities
    (127 )     -       (888 )
Stock option compensation
    2,137       1,613       8,482  
Loss from disposal of long-term assets
    27       -       739  
Other
    (10 )     87       304  
Decrease  in accounts receivable – trade
    1,246       3,028       560  
Decrease (increase) in accounts receivable – other
    651       (320 )     (488 )
Decrease (increase) in prepaid expenses
    (721 )     (559 )     (23 )
Decrease (increase) in advances to suppliers
    68       157       93  
Decrease (increase) in inventories
    (1,884 )     1,425       2,331  
Increase (decrease) in accounts payable
    (5,312 )     (5,210 )     3,389  
Increase  in deferred income
    64       252       554  
Net cash  provided by (used in) operating activities
    (1,124 )     4,064       31,684  
                         
Cash flows from investing activities:
                       
Purchase of fixed assets and intangible assets
    (7,299 )     (1,222 )     (5,056 )
Acquisition of Sierra, net of cash acquired 
    -       -       (34,709 )
Payment on account of business combination
    -       (35,000 )     -  
Deposits, net
    (28 )     (24 )     (6 )
Proceeds from sales of marketable securities and short term investments
    14,044       18,208       29,352  
Investments in trading and marketable securities
    (13,148 )     (7,546 )     (36,968 )
Net cash used in investing activities
    (6,431 )     (25,584     (47,387 )
                         
Cash flows from financing activities:
                       
Principal payments on capital lease obligation
    (41 )     (34 )     (143 )
Proceeds from the issuance of Ordinary Shares
    1,849       1,991       4,219  
Purchase of shares from a non-controlling shareholder in a  Subsidiary
    -       -       (403 )
Net cash  provided by financing activities
    1,808       1,957       3,673  
                         
Effect of exchange rate changes on cash
    50       80       191  
                         
Decrease in cash and cash equivalents
    (5,697 )     (19,483 )     (11,839 )
Cash and cash equivalents at beginning of period
    34,619       46,458       46,458  
                         
Cash and cash equivalents at end of period
  $ 28,922     $ 26,975     $ 34,619  
                         
Supplementary cash flow information
                       
Income taxes paid
  $ 50     $ 48     $ 234  

10