GIVEN IMAGING LTD.
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Date: November 7, 2012
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By:
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/s/ Ido Warshavski | |
Name: Ido Warshavski | |||
Title: General Counsel & Corporate Secretary |
Exhibit
99.1
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Description
Press release dated November 6, 2012, announcing results of the third quarter ended September 30, 2012.
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·
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The Company recently had a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss the process for market clearance of the PillCam COLON 2 capsule for the visualization of the colon. Based on the meeting, the company plans to submit this product for FDA clearance in the next few weeks under the direct de novo route.
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·
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In September, the Company announced that it filed for PillCam® COLON 2 regulatory approval in Japan. The submission to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) includes the results of the PillCam COLON 2 pivotal clinical trial which was designed to evaluate the PillCam COLON 2 as a tool to visualize the mucosal layer of the colon for pathologies including colorectal cancer.
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·
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In October, Given Imaging announced the acquisition of the assets related to the SmartPill® GI Monitoring System from The SmartPill Corporation, a U.S.-based company, for $6 million and an earn-out component, based on sales of the SmartPill product between 2013 and 2016. The SmartPill System measures gastric emptying and total GI (stomach, small bowel and colon) transit times and is used to evaluate motility disorders like gastroparesis and constipation. A Category 1 CPT code with a value of $873.25 becomes effective on January 1, 2013 for the SmartPill Wireless Motility Capsule Procedure.
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·
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Given Imaging recently announced that it is evaluating a range of strategic options, including preliminary non-binding indications of interest received from a number of parties relating to a possible merger or sale of the Company. The Company intends to continue to actively explore these and other alternatives, including a strategic alliance or additional acquisitions. The Board of Directors has appointed an executive committee consisting of the Chairman and two independent directors to oversee the process. The investment banking firm Barclays is assisting the Company in this process.
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Given Imaging Ltd. and its Consolidated Subsidiaries
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||||||||||||
Excluded Items
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||||||||||||
For the Three Months Ended September 30, 2011 and 2012
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||||||||||||
(Unaudited, dollars in thousands)
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Research
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Selling
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General
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Tax
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|||||||||||||||||||||
Gross
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And
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And
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And
|
Expense
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||||||||||||||||||||
Profit
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Development
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Marketing
|
Admin
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(Benefit)
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Total
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|||||||||||||||||||
Three month period
|
||||||||||||||||||||||||
ended September 30, 2012
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||||||||||||||||||||||||
Compensation expenses
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$ | - | $ | 194 | $ | 696 | $ | 741 | $ | - | $ | 1,631 | ||||||||||||
Sierra PPA
|
348 | - | 81 | - | (170 | ) | 259 | |||||||||||||||||
Total
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$ | 348 | $ | 194 | $ | 777 | $ | 741 | $ | (170 | ) | $ | 1,890 | |||||||||||
Three month period
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||||||||||||||||||||||||
ended September 30, 2011
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||||||||||||||||||||||||
Compensation expenses
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$ | - | $ | 157 | $ | 475 | $ | 738 | $ | - | $ | 1,370 | ||||||||||||
Sierra PPA
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237 | - | 81 | - | (126 | ) | 192 | |||||||||||||||||
Total
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$ | 237 | $ | 157 | $ | 556 | $ | 738 | $ | (126 | ) | $ | 1,562 |
Excluded Items
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||||||||||||
For the Nine Months Ended September 30, 2011 and 2012
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||||||||||||
(Unaudited, dollars in thousands)
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Research
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Selling
|
General
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Tax
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|||||||||||||||||||||
Gross
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And
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And
|
And
|
Expense
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||||||||||||||||||||
Profit
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Development
|
Marketing
|
Admin
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(Benefit)
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Total
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|||||||||||||||||||
Nine month period
|
||||||||||||||||||||||||
ended September 30, 2012
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||||||||||||||||||||||||
Compensation expenses
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$ | - | $ | 544 | $ | 1,434 | $ | 2,639 | $ | - | $ | 4,617 | ||||||||||||
Sierra PPA
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1044 | - | 243 | - | (514 | ) | 773 | |||||||||||||||||
Total
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$ | 1,044 | $ | 544 | $ | 1,677 | $ | 2,639 | $ | (514 | ) | $ | 5,390 | |||||||||||
Nine month period
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||||||||||||||||||||||||
ended September 30, 2011
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||||||||||||||||||||||||
Compensation expenses
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$ | - | $ | 499 | $ | 1,535 | $ | 3,438 | $ | - | $ | 5,472 | ||||||||||||
Sierra PPA
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711 | - | 243 | - | (381 | ) | 573 | |||||||||||||||||
Total
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$ | 711 | $ | 499 | $ | 1,778 | $ | 3,438 | $ | (381 | ) | $ | 6,045 |
Given Imaging Ltd. and its Consolidated Subsidiaries
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|||||||||||||||||
Reconciliation of GAAP results to non-GAAP results
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|||||||||||||||||
For the three months ended September 30, 2011 and 2012
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Condensed, in thousands except share and per share data
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Q3/12 | Q3/11 | |||||||||||||||||||||||
Specified
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Non
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Specified
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Non
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|||||||||||||||||||||
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GAAP
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Items (*)
|
GAAP
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GAAP
|
Items (*)
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GAAP
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||||||||||||||||||
Gross profit
|
$ | 35,204 | $ | 348 | $ | 35,552 | $ | 34,466 | $ | 237 | $ | 34,703 | ||||||||||||
Research and development, net
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5,185 | (194 | ) | 4,991 | 6,847 | (157 | ) | 6,690 | ||||||||||||||||
Sales and marketing
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17,939 | (777 | ) | 17,162 | 18,006 | (556 | ) | 17,450 | ||||||||||||||||
General and administrative
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5,634 | (741 | ) | 4,893 | 5,267 | (738 | ) | 4,529 | ||||||||||||||||
Income tax expense
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662 | 170 | 832 | 780 | 126 | 906 | ||||||||||||||||||
Net income attributable to shareholders
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$ | 6,006 | $ | 1,890 | $ | 7,896 | $ | 3,762 | $ | 1,562 | $ | 5,324 | ||||||||||||
Diluted EPS attributable to shareholders
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$ | 0.19 | $ | 0.06 | $ | 0.25 | $ | 0.12 | $ | 0.05 | $ | 0.17 |
Given Imaging Ltd. and its Consolidated Subsidiaries
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|||||||||||||||||
Reconciliation of GAAP results to non-GAAP results
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|||||||||||||||||
For the nine months ended September 30, 2011 and 2012
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|||||||||||||||||
Condensed, in thousands except share and per share data
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YTD 12
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YTD 11
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|||||||||||||||||||||||
Specified
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Non
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Specified
|
Non
|
|||||||||||||||||||||
|
GAAP
|
Items (*)
|
GAAP
|
GAAP
|
Items (*)
|
GAAP
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||||||||||||||||||
Gross profit
|
$ | 101,183 | $ | 1,044 | $ | 102,227 | $ | 98,956 | $ | 711 | $ | 99,667 | ||||||||||||
Research and development, net
|
18,530 | (544 | ) | 17,986 | 17,927 | (499 | ) | 17,428 | ||||||||||||||||
Sales and marketing
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55,431 | (1,677 | ) | 53,754 | 55,124 | (1,778 | ) | 53,346 | ||||||||||||||||
General and administrative
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16,839 | (2,639 | ) | 14,200 | 17,518 | (3,438 | ) | 14,080 | ||||||||||||||||
Income tax expense
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1,646 | 514 | 2160 | 2,088 | 381 | 2,469 | ||||||||||||||||||
Net income attributable to shareholders
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$ | 9,250 | $ | 5,390 | $ | 14,640 | $ | 6,356 | $ | 6,045 | $ | 12,401 | ||||||||||||
Diluted EPS attributable to shareholders
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$ | 0.29 | $ | 0.17 | $ | 0.46 | $ | 0.20 | $ | 0.20 | $ | 0.40 |
September 30
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December 31
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2012
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2011
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Assets
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Current assets
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Cash and cash equivalents
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$ | 42,350 | $ | 24,285 | ||||
Short-term investments
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37,162 | 64,762 | ||||||
Accounts receivable:
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Trade
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30,229 | 32,406 | ||||||
Other
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4,596 | 5,259 | ||||||
Inventories
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24,988 | 22,921 | ||||||
Prepaid expenses
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2,630 | 1,373 | ||||||
Deferred tax assets
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3,613 | 1,538 | ||||||
Advances to suppliers
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1,416 | 1,207 | ||||||
Total current assets
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146,984 | 153,751 | ||||||
Assets held for employee severance payments
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7,264 | 6,854 | ||||||
Long-term investments
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39,627 | 16,003 | ||||||
Non-current Inventory
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4,654 | 4,926 | ||||||
Other long term assets
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1,046 | 1,266 | ||||||
Fixed assets, at cost, less accumulated depreciation
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12,516 | 12,301 | ||||||
Intangible assets, less accumulated amortization
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28,308 | 29,075 | ||||||
Goodwill
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24,089 | 24,089 | ||||||
Total Assets
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$ | 264,488 | $ | 248,265 |
September 30
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December 31
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|||||||
2012
|
2011
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|||||||
Liabilities and equity
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||||||||
Current liabilities
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||||||||
Current installments of obligation under capital lease
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$ | 44 | $ | 139 | ||||
Accounts payable:
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||||||||
Trade
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8,151 | 8,081 | ||||||
Other
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27,295 | 28,397 | ||||||
Deferred income
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559 | 521 | ||||||
Total current liabilities
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36,049 | 37,138 | ||||||
Long-term liabilities
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Obligation under capital lease, net
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86 | 120 | ||||||
Liability in respect of employees’ severance payments
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8,024 | 7,720 | ||||||
Deferred tax liabilities
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4,848 | 5,362 | ||||||
Total long-term liabilities
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12,958 | 13,202 | ||||||
Total liabilities
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49,007 | 50,340 | ||||||
Equity
|
||||||||
Shareholders’ equity
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||||||||
Ordinary Shares, NIS 0.05 par value each (90,000,000
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shares authorized; 31,007,088 and 30,448,838 shares
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||||||||
issued and fully paid as of September 30, 2012 and
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December 31, 2011, respectively)
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367 | 359 | ||||||
Additional paid-in capital
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216,814 | 208,838 | ||||||
Capital reserve
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1,591 | 2,051 | ||||||
Accumulated other comprehensive income (loss)
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188 | (885 | ) | |||||
Accumulated deficit
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(3,479 | ) | (12,729 | ) | ||||
Total shareholders' equity
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215,481 | 197,634 | ||||||
Non-controlling interest
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- | 291 | ||||||
Total Equity
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215,481 | 197,925 | ||||||
Total liabilities and equity
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$ | 264,488 | $ | 248,265 |
Nine-month period ended
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Three-month period ended
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Year ended
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September 30
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September 30
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December 31
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||||||||||||||||||
2012
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2011
|
2012
|
2011
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2011
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||||||||||||||||
Revenues
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$ | 131,754 | $ | 129,471 | $ | 45,403 | $ | 44,729 | $ | 177,955 | ||||||||||
Cost of revenues
|
(30,571 | ) | (30,515 | ) | (10,199 | ) | (10,263 | ) | (41,466 | ) | ||||||||||
Gross profit
|
101,183 | 98,956 | 35,204 | 34,466 | 136,489 | |||||||||||||||
Operating expenses
|
||||||||||||||||||||
Research and development, gross
|
(19,536 | ) | (18,743 | ) | (5,406 | ) | (7,128 | ) | (26,129 | ) | ||||||||||
Government grants
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1,006 | 816 | 221 | 281 | 1,113 | |||||||||||||||
Research and development, net
|
(18,530 | ) | (17,927 | ) | (5,185 | ) | (6,847 | ) | (25,016 | ) | ||||||||||
Sales and marketing
|
(55,431 | ) | (55,124 | ) | (17,939 | ) | (18,006 | ) | (75,014 | ) | ||||||||||
General and administrative
|
(16,839 | ) | (17,518 | ) | (5,634 | ) | (5,267 | ) | (23,078 | ) | ||||||||||
Other, net
|
(163 | ) | (324 | ) | 7 | (248 | ) | (397 | ) | |||||||||||
Total operating expenses
|
(90,963 | ) | (90,893 | ) | (28,751 | ) | (30,368 | ) | (123,505 | ) | ||||||||||
Operating income
|
10,220 | 8,063 | 6,453 | 4,098 | 12,984 | |||||||||||||||
Financing income , net
|
583 | 460 | 215 | 438 | 1,343 | |||||||||||||||
Income before taxes
|
||||||||||||||||||||
on income
|
10,803 | 8,523 | 6,668 | 4,536 | 14,327 | |||||||||||||||
Income tax expense
|
(1,646 | ) | (2,088 | ) | (662 | ) | (780 | ) | (2,158 | ) | ||||||||||
Net income
|
9,157 | 6,435 | 6,006 | 3,756 | 12,169 | |||||||||||||||
Net loss (income) attributable to
|
||||||||||||||||||||
non-controlling interest
|
93 | (79 | ) | - | 6 | (191 | ) | |||||||||||||
Net income attributable to
|
||||||||||||||||||||
shareholders
|
$ | 9,250 | $ | 6,356 | $ | 6,006 | $ | 3,762 | $ | 11,978 | ||||||||||
Net change in respect of
|
||||||||||||||||||||
available for sale securities
|
1,073 | (860 | ) | 783 | (752 | ) | (980 | ) | ||||||||||||
Total comprehensive income
|
||||||||||||||||||||
attributable to shareholders
|
$ | 10,323 | $ | 5,496 | $ | 6,789 | $ | 3,010 | $ | 10,998 | ||||||||||
Total comprehensive income
|
||||||||||||||||||||
(loss) attributable to
|
||||||||||||||||||||
non-controlling interest
|
(93 | ) | 79 | - | (6 | ) | 191 | |||||||||||||
Total comprehensive income
|
$ | 10,230 | $ | 5,575 | $ | 6,789 | $ | 3,004 | $ | 11,189 | ||||||||||
Earnings per share
|
||||||||||||||||||||
Basic Earnings attributable to
|
||||||||||||||||||||
shareholders per Ordinary Share
|
$ | 0.30 | $ | 0.21 | $ | 0.19 | $ | 0.12 | $ | 0.40 | ||||||||||
Diluted Earnings attributable to
|
||||||||||||||||||||
shareholders per Ordinary Share
|
$ | 0.29 | $ | 0.20 | $ | 0.19 | $ | 0.12 | $ | 0.39 | ||||||||||
Weighted average number
|
||||||||||||||||||||
of Ordinary Shares used to
|
||||||||||||||||||||
compute basic Earnings
|
||||||||||||||||||||
per Ordinary share
|
30,791,872 | 30,136,123 | 30,982,259 | 30,389,184 | 30,212,787 | |||||||||||||||
Weighted average number
|
||||||||||||||||||||
of Ordinary Shares used to
|
||||||||||||||||||||
compute dilute Earnings
|
||||||||||||||||||||
per Ordinary share
|
31,475,497 | 31,088,653 | 31,403,833 | 31,141,006 | 31,089,499 |
Nine-month period ended
|
Three-month period ended
|
Year ended
|
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September 30
|
September 30
|
December 31
|
||||||||||||||||||
2012
|
2011
|
2012
|
2011
|
2011
|
||||||||||||||||
Cash flows from operating
|
||||||||||||||||||||
activities:
|
||||||||||||||||||||
Net income
|
$ | 9,157 | $ | 6,435 | $ | 6,006 | $ | 3,756 | $ | 12,169 | ||||||||||
Adjustments required to
|
||||||||||||||||||||
reconcile net income
|
||||||||||||||||||||
to net cash provided by
|
||||||||||||||||||||
operating activities:
|
||||||||||||||||||||
Depreciation and amortization
|
6,320 | 6,193 | 2,109 | 2,123 | 8,296 | |||||||||||||||
Deferred tax assets
|
(2,075 | ) | (29 | ) | (224 | ) | 233 | 100 | ||||||||||||
Deferred tax liabilities
|
(514 | ) | (381 | ) | (170 | ) | (126 | ) | (509 | ) | ||||||||||
Stock based compensation
|
4,617 | 5,472 | 1,631 | 1,370 | 7,363 | |||||||||||||||
Loss (income) from disposal
|
||||||||||||||||||||
of long term assets
|
173 | 349 | (3 | ) | 249 | 397 | ||||||||||||||
Other
|
(44 | ) | 123 | 2 | 92 | 158 | ||||||||||||||
Decrease (increase) in
|
||||||||||||||||||||
accounts receivable – trade
|
2,027 | (1,943 | ) | (1,165 | ) | (1,773 | ) | (4,544 | ) | |||||||||||
Decrease(increase) in
|
||||||||||||||||||||
accounts receivable – other
|
1,298 | 1,465 | 829 | 129 | (968 | ) | ||||||||||||||
Decrease (increase) in prepaid
|
||||||||||||||||||||
expenses
|
(1,257 | ) | (474 | ) | (377 | ) | (235 | ) | 212 | |||||||||||
Increase in
|
||||||||||||||||||||
advances to suppliers
|
(209 | ) | (743 | ) | 383 | 13 | (766 | ) | ||||||||||||
Increase in
|
||||||||||||||||||||
inventories
|
(1,795 | ) | (3,113 | ) | (1,111 | ) | (1,011 | ) | (3,145 | ) | ||||||||||
Increase (decrease) in
|
||||||||||||||||||||
accounts payable
|
(978 | ) | (3,329 | ) | 1,203 | 1,071 | 1,433 | |||||||||||||
Increase (decrease) in
|
||||||||||||||||||||
deferred income
|
38 | (204 | ) | 62 | (52 | ) | (267 | ) | ||||||||||||
Net cash provided by
|
||||||||||||||||||||
operating activities
|
16,758 | 9,821 | 9,175 | 5,839 | 19,929 | |||||||||||||||
Cash flows from investing
|
||||||||||||||||||||
activities:
|
||||||||||||||||||||
Purchase of fixed assets and
|
||||||||||||||||||||
intangible assets
|
(5,791 | ) | (9,254 | ) | (2,474 | ) | (1,196 | ) | (10,551 | ) | ||||||||||
Other long term assets, net
|
(608 | ) | (33 | ) | 2 | 5 | (39 | ) | ||||||||||||
Changes in short term
|
||||||||||||||||||||
deposits, net
|
24,906 | (5,617 | ) | 8,487 | (10,409 | ) | (20,176 | ) | ||||||||||||
Proceeds from sales and
|
||||||||||||||||||||
maturity of marketable
|
||||||||||||||||||||
securities
|
4,050 | 10,140 | - | 1,000 | 11,141 | |||||||||||||||
Investments in marketable
|
||||||||||||||||||||
securities
|
(23,781 | ) | (16,910 | ) | (321 | ) | (2,000 | ) | (16,910 | ) | ||||||||||
Net cash provided by (used
|
||||||||||||||||||||
in) investing activities
|
(1,224 | ) | (21,674 | ) | 5,694 | (12,600 | ) | (36,535 | ) |
Nine-month period ended
|
Three-month period ended
|
Year ended
|
||||||||||||||||||
September 30
|
September 30
|
December 31
|
||||||||||||||||||
2012
|
2011
|
2012
|
2011
|
2011
|
||||||||||||||||
Cash flows from financing
|
||||||||||||||||||||
activities:
|
||||||||||||||||||||
Principal payments on capital
|
||||||||||||||||||||
lease obligation
|
(124 | ) | (125 | ) | (41 | ) | (43 | ) | (168 | ) | ||||||||||
Proceeds from the issuance
|
||||||||||||||||||||
of Ordinary Shares
|
3,367 | 6,304 | 442 | 1,023 | 6,585 | |||||||||||||||
Purchase of shares from a
|
||||||||||||||||||||
non-controlling shareholder
|
||||||||||||||||||||
in a subsidiary
|
(658 | ) | - | - | - | - | ||||||||||||||
Net cash provided
|
||||||||||||||||||||
by financing activities
|
2,585 | 6,179 | 401 | 980 | 6,417 | |||||||||||||||
Effect of exchange rate
|
||||||||||||||||||||
changes on cash and cash
|
||||||||||||||||||||
equivalents
|
(54 | ) | (88 | ) | (11 | ) | (178 | ) | (145 | ) | ||||||||||
Increase (decrease) in cash
|
||||||||||||||||||||
and cash equivalents
|
18,065 | (5,762 | ) | 15,259 | (5,959 | ) | (10,334 | ) | ||||||||||||
Cash and cash equivalents
|
||||||||||||||||||||
at beginning of period
|
24,285 | 34,619 | 27,091 | 34,816 | 34,619 | |||||||||||||||
Cash and cash equivalents
|
||||||||||||||||||||
at end of period
|
$ | 42,350 | $ | 28,857 | $ | 42,350 | $ | 28,857 | $ | 24,285 | ||||||||||
Supplementary cash flow
|
||||||||||||||||||||
information
|
||||||||||||||||||||
Income taxes paid
|
$ | 2,054 | $ | 1,689 | $ | 897 | $ | 594 | $ | 2,179 |