EX-99 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

Israel Investor Contact:
Nava Ladin
Gelbart Kahana Investor Relations
+972-3-6074717
nava@gk-biz.com
 
GIVEN IMAGING REPORTS FIRST QUARTER 2013 FINANCIAL RESULTS
 
- First Quarter 2013 Revenues of $40.6 million –

-  First Quarter 2013 GAAP and Non-GAAP EPS ($0.01) and $0.06, Respectively -

- First Quarter 2013 GAAP and Non-GAAP Gross Margin 77% and 78%, Respectively –

YOQNEAM, Israel, May 8, 2013 - Given Imaging Ltd. (NASDAQ: GIVN) today announced financial results for the first quarter ended March 31, 2013.
 
Revenues were $40.6 million in the first quarter of 2013, a decrease of 2.9 percent compared to $41.8 million in the first quarter of 2012.  Gross margin on a GAAP-basis in the first quarter of 2013 was 77.1 percent, compared to 75.6 percent in the first quarter of 2012.  Gross margin on a non-GAAP-basis in the first quarter of 2013 was 78.1 percent, compared to 76.2 percent in the first quarter of 2012.
 
On a GAAP-basis, operating profit was $0.1 million in the first quarter of 2013, compared to $0.4 million in the first quarter of 2012. Non-GAAP operating profit was $2.0 million in the first quarter of 2013, compared to $2.1 million in the same period in 2012.
 
On a GAAP-basis, net loss for the first quarter of 2013 was $0.2 million, or ($0.01) per share, compared to net income of $0.2 million, or $0.01 per share, in the same period in 2012.  On a non-GAAP-basis, net income for the first quarter of 2013 was $1.5 million, or $0.05 per share on a fully diluted basis, compared to a net income of $1.8 million, or $0.06 per share on a fully diluted basis in the first quarter of 2012.
 
A reconciliation of GAAP results to non-GAAP results is attached.
 
 
 

 
 
Cash used in operating activities in the first quarter was 2013 was $2.2 million. Cash and cash equivalents, short-term investments and marketable securities on March 31, 2013 totaled $121.8 million.
 
“While we achieved record first quarter revenues in both the EMEA and APAC regions, total revenues were below our expectations due to a shortfall in sales execution in the Americas region. We are encouraged by our second quarter strong revenues to date and we remain on track to meet the full-year 2013 financial guidance that we provided earlier this year. We are also encouraged by our advanced discussions with both U.S. and Japanese regulatory authorities regarding approvals for PillCam COLON 2” said Homi Shamir, President and CEO, Given Imaging.
 
First Quarter 2013 Revenue Analysis
 
Revenues in the Americas region in the first quarter of 2013 decreased 11 percent to $23.9 million from $26.7 million in the same period in 2012.  The decrease is attributable to lower sales of PillCam and functional GI diagnostics products. Revenues in the EMEA region increased 8 percent to $11.6 million compared to $10.8 million in the same period in 2012.  APAC revenues increased by 20 percent to $5.1 million, compared to $4.2 million in the same period in 2012.
 
Worldwide PillCam SB sales decreased three percent to 54,600 capsules in the first quarter of 2013, compared to 56,500 capsules in the same period in 2012. PillCam SB sales in the Americas region decreased by eight percent to 30,800 capsules in the first quarter of 2013, compared to 33,700 capsules in the first quarter of 2012.  PillCam SB sales in the EMEA region increased by three percent to 15,500 capsules, compared to 15,100 capsules in the first quarter of 2012, while PillCam SB sales in the APAC region increased by seven percent to 8,300 capsules, compared to 7,700 capsules in the same period in 2012.
 
Worldwide sales of functional GI diagnostics products including the Bravo pH Monitoring System, Digitrapper pH-Z, ManoScan and SmartPill products decreased by 12 percent to $11.0 million in the first quarter of 2013 compared to $12.6 million in the same period in 2012.  In the Americas region, functional GI diagnostics product revenue decreased by 17 percent in the first quarter of 2013 to $8.3 million compared to $10.0 million in the same period in 2012. Functional GI diagnostics revenue in the EMEA region increased by 23 percent to $2.3 million, while revenue in the APAC region was $0.4 million, a decrease of 38 percent compared to the same quarter last year.
 
Supplemental first quarter data can be found at www.givenimaging.com in the Investor Relations section.
 
Digestive Disease Week 2013
 
Over 120 studies will be presented at Digestive Disease Week 2013 featuring Given Imaging's complete product portfolio including PillCam® SB, PillCam® COLON 2(*), PillCam® ESO, Bravo® pH monitoring, Digitrapper® pH-z monitoring, ManoScan™ high resolution manometry and the SmartPill® motility monitoring system.  Digestive Disease Week takes place in Orlando May 18-21, 2013.
 
The Company will host a meeting with members of the financial community with several key GI opinion leaders to review  highlights of the conference.  The meeting will take place on Tuesday, May 21st, 2013 at 10:00am ET/5:00pm Israel time.  A live audio webcast will be available in the investor relations section of the company’s website, www.givenimaging.com.
 
 
2

 
 
Conference Call / Webcast Information
 
Given Imaging will host a conference call on Thursday, May 9, 2013 at 9:00am ET, 4:00pm Israel time to discuss first quarter 2013 financial results. To participate in the teleconference, please dial the following numbers fifteen minutes before the call is scheduled to begin:  U.S. and Canada, 888-438-5491; Israel, 1-80-924-5906.  Callers in other countries should dial 719-785-1753. 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 23, 2013, by dialing 888-203-1112. Callers in Israel should dial 1-80-924-6038. Callers outside of the U.S. and Israel should dial 719-457-0820. The replay participant code is 3944471.
 
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.
 
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® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan™ high-resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z impedance, and the SmartPill® GI monitoring systems. 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, Hong Kong and Brazil. For more information, please visit www.givenimaging.com.
 
 
3

 
 
(*) Pending 510(k), not available for sale within the United States
 
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. Such forward-looking statements include statements relating to the Company exploring strategic alternatives and considering possible strategic transactions involving the Company. 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 ability of the Company to reach agreement on any strategic alternative and/or to complete any such alternative, as well as 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) quality issues and adverse events related to our products, such as capsule retention, aspiration and failure to attach or detach, bleeding or perforation that could require us to recall products and impact our sales and net income, 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, 2012. 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 to the extent expressly required under applicable law, the Company 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
Specified Items
For the Three Months Ended March 31, 2013 and 2012
(Unaudited, dollars in thousands)
 
         
Research
   
Selling
   
General
   
Tax
       
   
Gross
   
And
   
And
   
And
   
Expense
       
   
Profit
   
Development
   
Marketing
   
Admin
   
(Benefit)
   
Total
 
                                     
Three month period
                                   
ended March 31, 2013
                                   
                                     
Compensation expenses
  $ -     $ 196     $ 418     $ 782     $ -     $ 1,396  
Sierra  and SmartPill PPA
    399       -       93       -     $ (171 )     321  
Total
  $ 399     $ 196     $ 511     $ 782     $ (171 )   $ 1,717  
                                                 
Three month period
                                               
ended March 31, 2012
                                         
                                                 
Compensation expenses
  $ -     $ 158     $ 229     $ 1,042     $ -     $ 1,429  
Sierra  PPA
    237       -       81       -     $ (171 )     147  
Total
  $ 237     $ 158     $ 310     $ 1,042     $ (171 )   $ 1,576  
 
 
5

 

 
Given Imaging Ltd. And its Consolidated Subsidiaries
Reconciliation of GAAP results to non-GAAP results
For the three months ended March 31, 2013 and 2012
Condensed, in thousands except share and per share data
 
         
Specified
   
Non
 
Three months ended March 31, 2013
 
GAAP
   
Items (*)
   
GAAP
 
                   
Gross profit
  $ 31,310     $ 399     $ 31,709  
Research and Development, net
    5,971       (196 )     5,775  
Sales and Marketing
    19,631       (511 )     19,120  
General and administrative
    5,561       (782 )     4,779  
Income tax expense
    312       171       483  
Net income (loss) attributable to shareholders
  $ (221 )   $ 1,717     $ 1,496  
                         
Three months ended March 31, 2012
         
Specified
   
Non
 
   
GAAP
   
Items (*)
   
GAAP
 
Gross profit
  $ 31,646     $ 237     $ 31,883  
Research and Development, net
    6,744       (158 )     6,586  
Sales and Marketing
    18,763       (310 )     18,453  
General and administrative
    5,637       (1,042 )     4,595  
Income tax expense
    624       127       751  
Net income attributable to shareholders
  $ 201     $ 1,620     $ 1,821  
 
 
6

 
 
Given Imaging Ltd. and its Consolidated Subsidiaries
Interim Consolidated Balance Sheets
In thousands except share data
 (Unaudited)
 
   
March 31,
   
December 31,
 
   
2013
   
2012
 
Assets
           
             
Current assets
           
Cash and cash equivalents
  $ 31,711     $ 35,442  
Short-term investments
    59,836       58,446  
Accounts receivable:
               
  Trade
    27,245       31,279  
  Other
    4,852       4,654  
Inventories
    23,585       22,591  
Advances to suppliers
    1,140       1,349  
Deferred tax assets
    2,791       2,646  
Other current assets
    2,769       2,689  
                 
Total current assets
    153,929       159,096  
                 
Deposits
    881       924  
                 
Assets held for employees’ severance payments
    8,386       7,974  
                 
Long-term investments
    30,262       30,188  
                 
Non-current Inventory
    5,773       6,150  
                 
Fixed assets, less accumulated depreciation
    11,982       12,335  
                 
Intangible assets, less accumulated amortization
    29,747       30,705  
                 
Goodwill
    26,942       26,942  
                 
Total Assets
  $ 267,902     $ 274,314  

 
 
7

 
 
Given Imaging Ltd. and its Consolidated Subsidiaries
Interim Consolidated Balance Sheets
In thousands except share data
 (Unaudited)
 
   
March 31,
   
December 31,
 
   
2013
   
2012
 
Liabilities and equity
           
             
Current liabilities
           
             
Current installments of obligation under capital lease
  $ -     $ 38  
Accounts payable:
               
  Trade
    6,956       8,756  
  Other
    19,997       27,091  
Deferred income
    979       929  
Total current liabilities
    27,932       36,814  
                 
Long-term liabilities
               
Obligation under capital lease, net
    71       78  
Liability in respect of employees’ severance payments
    9,171       8,761  
Contingent consideration in respect of business combination
    1,113       1,038  
Deferred tax liabilities
    4,504       4,675  
Total long-term liabilities
    14,859       14,552  
Total liabilities
    42,791       51,366  
                 
Equity
               
                 
Ordinary Shares, NIS 0.05 par value each (90,000,000
               
 shares authorized;   31,371,861 and 31,080,876 shares
               
 issued and fully paid as of March 31, 2013 and
               
 December 31, 2012, respectively)
    369       367  
Additional paid-in capital
    221,480       219,103  
Capital reserve
    1,591       1,591  
Accumulated other comprehensive income
    271       266  
Retained earnings
    1,400       1,621  
Total Equity
    225,111       222,948  
                 
Total liabilities and equity 
  $ 267,902     $ 274,314  

 
8

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

    Three month period ended    
Year ended
 
    March 31,    
December 31,
 
   
2013
   
2012
   
2012
 
Revenues
  $ 40,620     $ 41,839     $ 180,501  
Cost of revenues
    (9,310 )     (10,193 )     (42,971 )
                         
Gross profit
    31,310       31,646       137,530  
                         
Operating expenses
                       
Research and development, gross
    (6,101 )     (7,156 )     (25,627 )
Government grants
    130       412       1,439  
Research and development, net
    (5,971 )     (6,744 )     (24,188 )
                         
Sales and marketing
    (19,631 )     (18,763 )     (76,272 )
General and administrative
    (5,561 )     (5,637 )     (22,746 )
Other, net
    (48 )     (101 )     (455 )
                         
Total operating expenses
    (31,211 )     (31,245 )     (123,661 )
                         
Operating profit
    99       401       13,869  
Financing income (expenses), net
    (8 )     331       847  
                         
Profit  before taxes on income
    91       732       14,716  
Income tax expense
    (312 )     (624 )     (459 )
                         
Net profit  (loss)
    (221 )     108       14,257  
                         
Net  loss attributable to non-controlling interest
    -       93       93  
Net profit (loss) attributable to shareholders
  $ (221 )   $ 201     $ 14,350  
                         
Net change in respect of available for sale securities
    5       430       1,151  
Total comprehensive profit (loss) attributable to shareholders
  $ (216 )   $ 631     $ 15,501  
                         
Total comprehensive loss attributable to
                       
 non-controlling interest
    -       (93 )     (93 )
Total comprehensive profit (loss)
  $ (216 )   $ 538     $ 15,408  
                         
Earnings  per share
                       
                         
Basic Earnings (loss) attributable to shareholders per Ordinary Share
  $ (0.01 )   $ 0.01     $ 0.47  
                         
Diluted Earnings (loss) attributable to shareholders per Ordinary Share
  $ (0.01 )   $ 0.01     $ 0.45  
                         
Weighted average number of Ordinary Shares used
                       
 to compute basic Earnings  (loss) per Ordinary share
    31,227,150       30,579,090       30,853,581  
 
                       
Weighted average number of Ordinary Shares used
                       
 to compute diluted Earnings (loss) per Ordinary share
    31,227,150       31,477,929       31,563,208  
 
 
9

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

   
Three month period ended
   
Year ended
 
   
March 31,
   
December 31,
 
   
2013
   
2012
   
2012
 
Cash flows from operating activities:
                 
Net profit (loss)
  $ (221 )   $ 108     $ 14,257  
                         
Adjustments required to reconcile net profit
                       
 to net cash provided by (used in) operating activities:
                       
                         
Depreciation and amortization
    2,198       1,996       8,597  
Change in deferred taxes
    (316 )     (1,007 )     (1,795 )
Stock based compensation
    1,396       1,429       6,158  
Loss from disposal of fixed assets and intangible assets
    87       102       484  
Unrealized interest on contingent consideration
    75       -       -  
Decrease  in accounts receivable – trade
    4,034       2,820       977  
Decrease (increase) in accounts receivable – other
    (186 )     1,355       1,252  
Increase in other current assets
    (80 )     (852 )     (1,316 )
Decrease (increase) in advances to suppliers
    209       (172 )     (142 )
Increase in inventories
    (617 )     (472 )     (299 )
Decrease in accounts payable
    (8,960 )     (4,595 )     (691 )
Increase   in deferred income
    50       12       408  
Other
    109       (50 )     (62 )
Net cash  provided by (used in) operating activities
    (2,222 )     674       27,828  
                         
Cash flows from investing activities:
                       
Purchase of fixed assets and intangible assets
    (1,012 )     (1,480 )     (7,005 )
Other long term assets
    1       (599 )     (538 )
Acquisition of business, net of cash acquired (1)
    -       -       (6,000 )
Change in short-term deposit, net
    7,500       20,617       4,968  
Proceeds from sales and maturity of marketable securities
    246       2,000       13,343  
Investments in marketable securities
    (9,293 )     (12,322 )     (24,827 )
Net cash provided by (used in) investing activities
    (2,558 )     8,216       (20,059 )
                         
Cash flows from financing activities:
                       
Principal payments on capital lease obligation
    -       (41 )     (129 )
Proceeds from the issuance of Ordinary Shares
    983       1,337       4,115  
Purchase of shares from a non-controlling shareholder
                       
  in a subsidiary
    -       (658 )     (658 )
Net cash  provided by financing activities
    983       638       3,328  
                         
Effect of exchange rate changes on cash and cash equivalents
    66       46       60  
                         
Increase (decrease) in cash and cash equivalents
    (3,731 )     9,574       11,157  
Cash and cash equivalents at beginning of period
    35,442       24,285       24,285  
                         
Cash and cash equivalents at end of period
  $ 31,711     $ 33,859     $ 35,442  
                         
Supplementary cash flow information
                       
Income taxes paid
  $ 1,240     $ 122     $ 2,883  
 
10