GlucoTrack, Inc. - Quarter Report: 2012 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
||
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the quarterly period ended June 30, 2012
|
||
or
|
||
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the transition period from ________________ to ________________
|
Commission File Number: 333-176415
INTEGRITY APPLICATIONS, INC.
(Exact name of registrant as specified in its charter)
Delaware
|
98-0668934
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
102 Ha’Avoda Street
P.O. Box 432
Ashkelon, Israel
|
L3 78100
|
|
(Address of principal executive offices)
|
(Zip Code)
|
972 (8) 675-7878
|
||
(Registrant’s telephone number, including area code)
|
N/A
|
||
(Former name, former address and former fiscal year, if changed since last report)
|
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes o No x
(Note: As a voluntary filer not subject to the filing requirements, the registrant filed all reports under Section 13 or 15(d) of the Exchange Act required for the periods since November 14, 2011, the date that its initial Registration Statement on Form S-1 was declared effective by the Securities and Exchange Commission).
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o
|
Accelerated filer o
|
|
Non-accelerated filer o (Do not check if a smaller reporting company)
|
Smaller reporting company x
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
As of August 3, 2012, 5,295,543 shares of the Company’s common stock, par value $0.001 per share, were outstanding.
INTEGRITY APPLICATIONS, INC.
TABLE OF CONTENTS
Page No.
|
||
PART I - FINANCIAL INFORMATION
|
||
3 | ||
3
|
||
4
|
||
5 | ||
11
|
||
12
|
||
16
|
||
21
|
||
21
|
||
PART II - OTHER INFORMATION
|
||
22
|
||
23
|
||
24
|
||
25
|
2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
US dollars (except share data)
|
||||||||
June 30,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
(unaudited)
|
||||||||
A S S E T S
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
758,367 | 1,896,504 | ||||||
Other current assets
|
100,577 | 92,817 | ||||||
Total current assets
|
858,944 | 1,989,321 | ||||||
Property and Equipment, Net
|
71,790 | 82,868 | ||||||
Funds in Respect of Employee Rights Upon Retirement
|
113,700 | 110,310 | ||||||
Total assets
|
1,044,434 | 2,182,499 | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current Liabilities
|
||||||||
Accounts payable
|
136,226 | 71,763 | ||||||
Other current liabilities
|
227,938 | 211,278 | ||||||
Total current liabilities
|
364,164 | 283,041 | ||||||
Long-Term Loans from Stockholders
|
596,061 | 606,144 | ||||||
Liability for Employee Rights Upon Retirement
|
229,153 | 241,176 | ||||||
Warrants with Down-Round Protection
|
40,848 | 83,899 | ||||||
Total liabilities
|
1,230,226 | 1,214,260 | ||||||
Stockholders’ Equity (Deficit)
|
||||||||
Common Stock of US$ 0.001 par value ("Common Stock"):
|
||||||||
40,000,000 shares authorized as of June 30, 2012 and December 31, 2011; 5,295,543 shares issued and outstanding as of June 30, 2012 and December 31, 2011
|
5,296 | 5,296 | ||||||
Additional paid in capital
|
13,655,065 | 13,457,828 | ||||||
Accumulated other comprehensive income
|
43,777 | 22,634 | ||||||
Deficit accumulated during the development stage
|
(13,889,930 | ) | (12,517,519 | ) | ||||
Total stockholders' equity (deficit)
|
(185,792 | ) | 968,239 | |||||
Total liabilities and stockholders’ equity (deficit)
|
1,044,434 | 2,182,499 |
The accompanying notes are an integral part of the consolidated financial statements.
|
3
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
US dollars (except share data)
|
||||||||||||||||||||
Six month period ended June 30,
|
Three month period ended June 30,
|
Cumulative period
from September 30, 2001 (date of inception) through June 30,
|
||||||||||||||||||
2012
|
2011
|
2012
|
2011
|
2012(*) | ||||||||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||||||||||
Research and development expenses, net
|
953,528 | 781,114 | 508,462 | 407,631 | 9,509,242 | |||||||||||||||
General and administrative expenses
|
448,548 | 254,736 | 245,613 | 89,098 | 2,610,282 | |||||||||||||||
Other income
|
- | - | - | - | (912 | ) | ||||||||||||||
Operating loss
|
1,402,076 | 1,035,850 | 754,075 | 496,729 | 12,118,612 | |||||||||||||||
Financing (income) expenses, net
|
(29,665 | ) | 21,071 | (16,617 | ) | 19,928 | 1,771,318 | |||||||||||||
Loss for the period
|
1,372,411 | 1,056,921 | 737,458 | 516,657 | 13,889,930 | |||||||||||||||
Other comprehensive (income) loss:
|
||||||||||||||||||||
Foreign currency translation adjustment
|
(21,143 | ) | (24 | ) | (32,704 | ) | (41,239 | ) | (43,777 | ) | ||||||||||
Comprehensive loss
|
1,351,268 | 1,056,897 | 704,754 | 475,418 | 13,846,153 | |||||||||||||||
Loss per share (Basic and Diluted) (Note 4)
|
0.26 | 0.22 | 0.14 | 0.10 | ||||||||||||||||
Weighted average number of shares outstanding (Basic and Diluted) (Note 4)
|
5,295,543 | 4,922,582 | 5,295,543 | 4,989,720 |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
4
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (*)
US Dollars (except share data)
|
||||||||||||||||||||||||
Accumulated
|
Deficit | |||||||||||||||||||||||
Common Stock
|
other
|
accumulated
|
Total | |||||||||||||||||||||
Number
of shares
|
Amount
|
Additional
paid in capital
|
comprehensive
loss
|
during
development stage
|
stockholders
equity (deficit)
|
|||||||||||||||||||
September 30, 2001 (date of inception)
|
||||||||||||||||||||||||
2,136,307 Common Stock of US$ 0.001 per share issued for cash
|
2,136,307 | 2,136 | 38,306 | - | - | 40,442 | ||||||||||||||||||
Loss for the period
|
- | - | - | - | (63,293 | ) | (63,293 | ) | ||||||||||||||||
Other comprehensive loss
|
- | - | - | (5 | ) | - | (5 | ) | ||||||||||||||||
Balance as of December 31, 2002
|
2,136,307 | 2,136 | 38,306 | (5 | ) | (63,293 | ) | (22,856 | ) | |||||||||||||||
Loss for the year
|
- | - | - | - | (350,290 | ) | (350,290 | ) | ||||||||||||||||
Other comprehensive loss
|
- | - | - | (15,035 | ) | - | (15,035 | ) | ||||||||||||||||
Balance as of December 31, 2003
|
2,136,307 | 2,136 | 38,306 | (15,040 | ) | (413,583 | ) | (388,181 | ) | |||||||||||||||
Loss for the year
|
- | - | - | - | (288,233 | ) | (288,233 | ) | ||||||||||||||||
Other comprehensive loss
|
- | - | - | (15,069 | ) | - | (15,069 | ) | ||||||||||||||||
Issuance of 42,727 Common Stock for cash at US$ 1.76 per share on March 16, 2004
|
42,727 | 43 | 74,957 | - | - | 75,000 | ||||||||||||||||||
Issuance of 72,773 Common Stock for cash of US$ 1.72 per share on November 25, 2004
|
72,773 | 73 | 128,783 | - | - | 128,856 | ||||||||||||||||||
Balance as of December 31, 2004
|
2,251,807 | 2,252 | 242,046 | (30,109 | ) | (701,816 | ) | (487,627 | ) |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
5
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (*) (cont.)
US Dollars (except share data)
|
||||||||||||||||||||||||
Accumulated
|
Deficit | |||||||||||||||||||||||
Common Stock
|
other |
accumulated
|
Total | |||||||||||||||||||||
Number
of shares
|
Amount
|
Additional
paid in capital
|
comprehensive
loss
|
during
development stage
|
stockholders
equity (deficit)
|
|||||||||||||||||||
Balance as of January 1, 2005
|
2,251,807 | 2,252 | 242,046 | (30,109 | ) | (701,816 | ) | (487,627 | ) | |||||||||||||||
Loss for the year
|
- | - | - | - | (1,055,594 | ) | (1,055,594 | ) | ||||||||||||||||
Other comprehensive income
|
- | - | - | 8,542 | - | 8,542 | ||||||||||||||||||
Issuance of 218,281 Common Stock for cash of US$ 1.72 per share on January 14, 2005
|
218,281 | 218 | 374,782 | - | - | 375,000 | ||||||||||||||||||
Issuance of 291,051 Common Stock for cash of US$ 1.72 per share on April 5, 2005
|
291,051 | 291 | 499,709 | - | - | 500,000 | ||||||||||||||||||
Issuance of 59,389 Common Stock for cash of US$ 3.37 per share on May 31, 2005
|
59,389 | 60 | 199,940 | - | - | 200,000 | ||||||||||||||||||
Stock-based compensation
|
52,147 | 52 | 189,564 | - | - | 189,616 | ||||||||||||||||||
Balance as of December 31, 2005
|
2,872,675 | 2,873 | 1,506,041 | (21,567 | ) | (1,757,410 | ) | (270,063 | ) | |||||||||||||||
Loss for the year
|
- | - | - | - | (1,282,842 | ) | (1,282,842 | ) | ||||||||||||||||
Other comprehensive loss
|
- | - | - | (57,127 | ) | - | (57,127 | ) | ||||||||||||||||
Issuance of 87,315 Common Stock for cash of US$ 1.47 per share on January 26, 2006
|
87,315 | 87 | 128,118 | - | - | 128,205 | ||||||||||||||||||
Issuance of 1,899 Common Stock for cash of US$ 3.63 per share on March 31, 2006
|
1,899 | 2 | 6,888 | - | - | 6,890 | ||||||||||||||||||
Issuance of 13,786 Common Stock for cash of US$ 3.63 per share on June 16, 2006
|
13,786 | 14 | 49,986 | - | - | 50,000 | ||||||||||||||||||
Issuance of 14,113 Common Stock for cash of US$ 3.63 per share on June 30, 2006
|
14,113 | 14 | 51,166 | - | - | 51,180 | ||||||||||||||||||
Issuance of 51,207 Common Stock for cash of US$ 3.91 per share on August 15, 2006
|
51,207 | 51 | 199,949 | - | - | 200,000 | ||||||||||||||||||
Issuance of 301,948 Common Stock for cash of US$ 4.31 per share on October 5, 2006
|
301,948 | 302 | 1,299,698 | - | - | 1,300,000 | ||||||||||||||||||
Issuance of 348,402 Common Stock for cash of US$ 4.31 per share on December 14, 2006
|
348,402 | 349 | 1,372,146 | - | - | 1,372,495 | ||||||||||||||||||
Stock-based compensation
|
63,395 | 63 | 277,434 | - | - | 277,497 | ||||||||||||||||||
Balance as of December 31, 2006
|
3,754,740 | 3,755 | 4,891,426 | (78,694 | ) | (3,040,252 | ) | 1,776,235 |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
6
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (*) (cont.)
US Dollars (except share data)
|
||||||||||||||||||||||||||||
Accumulated
|
Deficit | |||||||||||||||||||||||||||
Common Stock
|
other | Receivable in |
accumulated
|
Total | ||||||||||||||||||||||||
Number
of shares
|
Amount
|
Additional paid in capital
|
comprehensive
income (loss)
|
respect of
stock issuance
|
during
development stage
|
stockholders
equity (deficit)
|
||||||||||||||||||||||
Balance as of January 1, 2007
|
3,754,740 | 3,755 | 4,891,426 | (78,694 | ) | - | (3,040,252 | ) | 1,776,235 | |||||||||||||||||||
Loss for the year
|
- | - | - | - | - | (1,593,205 | ) | (1,593,205 | ) | |||||||||||||||||||
Other comprehensive income
|
- | - | - | 84,528 | - | - | 84,528 | |||||||||||||||||||||
Stock-based compensation
|
28,707 | 29 | 274,630 | - | - | - | 274,659 | |||||||||||||||||||||
Balance as of December 31, 2007
|
3,783,447 | 3,784 | 5,166,056 | 5,834 | - | (4,633,457 | ) | 542,217 | ||||||||||||||||||||
Loss for the year
|
- | - | - | - | - | (1,528,981 | ) | (1,528,981 | ) | |||||||||||||||||||
Other comprehensive income
|
- | - | - | 110,134 | - | - | 110,134 | |||||||||||||||||||||
Issuance of 61,989 Common Stock for cash of US$ 5.52 per share on September 27, 2008
|
61,989 | 62 | 341,938 | - | - | - | 342,000 | |||||||||||||||||||||
Issuance of 104,220 Common Stock for cash of US$ 5.52 per share on October 7, 2008
|
104,220 | 104 | 574,896 | - | (75,000 | ) | - | 500,000 | ||||||||||||||||||||
Stock-based compensation
|
- | - | 84,380 | - | - | - | 84,380 | |||||||||||||||||||||
Balance as of December 31, 2008
|
3,949,656 | 3,950 | 6,167,270 | 115,968 | (75,000 | ) | (6,162,438 | ) | 49,750 |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
7
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (*) (cont.)
US Dollars (except share data)
|
||||||||||||||||||||||||||||
Accumulated
|
Deficit | |||||||||||||||||||||||||||
Common Stock
|
other | Receivable in |
accumulated
|
Total | ||||||||||||||||||||||||
Number
of shares
|
Amount
|
Additional paid in capital
|
comprehensive
income (loss)
|
respect of
stock issuance
|
during
development stage
|
stockholders
equity (deficit)
|
||||||||||||||||||||||
Balance as of January 1, 2009
|
3,949,656 | 3,950 | 6,167,270 | 115,968 | (75,000 | ) | (6,162,438 | ) | 49,750 | |||||||||||||||||||
Loss for the year
|
- | - | - | - | - | (1,202,296 | ) | (1,202,296 | ) | |||||||||||||||||||
Other comprehensive loss
|
- | - | - | (13,367 | ) | - | - | (13,367 | ) | |||||||||||||||||||
Issuance of 50,342 Common Stock for cash of US$ 6.02 per share in January 2009
|
50,342 | 50 | 302,950 | - | - | - | 303,000 | |||||||||||||||||||||
Repayment of receivable in respect of stock issuance
|
- | - | - | - | 75,000 | - | 75,000 | |||||||||||||||||||||
Stock-based compensation
|
- | - | 12,171 | - | - | - | 12,171 | |||||||||||||||||||||
Balance as of December 31, 2009
|
3,999,998 | 4,000 | 6,482,391 | 102,601 | - | (7,364,734 | ) | (775,742 | ) | |||||||||||||||||||
Loss for the year
|
- | - | - | - | - | (2,788,446 | ) | (2,788,446 | ) | |||||||||||||||||||
Other comprehensive loss
|
- | - | - | (119,019 | ) | - | - | (119,019 | ) | |||||||||||||||||||
Issuance of 530,600 Common Stock for cash of US$ 6.25 per share in December 2010, net of related expenses
|
530,600 | 531 | 2,356,501 | - | - | - | 2,357,032 | |||||||||||||||||||||
Stock-based interest compensation to convertible notes holders
|
194,391 | 194 | 1,214,749 | - | - | - | 1,214,943 | |||||||||||||||||||||
Conversion of convertible notes
|
119,586 | 120 | 694,676 | - | - | - | 694,796 | |||||||||||||||||||||
Stock-based compensation
|
- | - | 14,575 | - | - | - | 14,575 | |||||||||||||||||||||
Balance as of December 31, 2010
|
4,844,575 | 4,845 | 10,762,892 | (16,418 | ) | - | (10,153,180 | ) | 598,139 |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
8
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (*) (cont.)
US Dollars (except share data)
|
||||||||||||||||||||||||||||
Accumulated
|
Deficit | |||||||||||||||||||||||||||
Common Stock
|
other | Receivable in |
accumulated
|
Total | ||||||||||||||||||||||||
Number
of shares
|
Amount
|
Additional paid
in capital
|
comprehensive
loss
|
respect of
stock issuance
|
during
development stage
|
stockholders
equity (deficit)
|
||||||||||||||||||||||
Balance as of January 1, 2011
|
4,844,575 | 4,845 | 10,762,892 | (16,418 | ) | - | (10,153,180 | ) | 598,139 | |||||||||||||||||||
Loss for the year
|
- | - | - | - | - | (2,364,339 | ) | (2,364,339 | ) | |||||||||||||||||||
Other comprehensive income
|
- | - | - | 39,052 | - | - | 39,052 | |||||||||||||||||||||
Issuance of 16,320 Common Stock for cash of US$ 6.25 per share in January 31, 2011, net of related expenses
|
16,320 | 16 | 83,164 | - | - | - | 83,180 | |||||||||||||||||||||
Issuance of 90,768 Common Stock for cash of US$ 6.25 per share in March 31, 2011, net of related expenses
|
90,768 | 91 | 479,810 | - | - | - | 479,901 | |||||||||||||||||||||
Issuance of 40,000 Common Stock for cash of US$ 6.25 per share in April 29, 2011, net of related expenses
|
40,000 | 40 | 191,682 | - | - | - | 191,722 | |||||||||||||||||||||
Issuance of 34,200 Common Stock for cash of US$ 6.25 per share in May 31, 2011, net of related expenses
|
34,200 | 34 | 179,992 | - | - | - | 180,026 | |||||||||||||||||||||
Issuance of 269,680 Common Stock for cash of US$ 6.25 per share on July 29, 2011, net of related expenses
|
269,680 | 270 | 1,466,115 | - | - | - | 1,466,385 | |||||||||||||||||||||
Fair value of warrants with down-round protection issued in connection with Common Stock issuances
|
- | - | (83,899 | ) | - | - | - | (83,899 | ) | |||||||||||||||||||
Stock-based compensation
|
- | - | 378,072 | - | - | 378,072 | ||||||||||||||||||||||
Balance as of December 31, 2011
|
5,295,543 | 5,296 | 13,457,828 | 22,634 | - | (12,517,519 | ) | 968,239 |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
9
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (*) (cont.)
US Dollars (except share data)
|
||||||||||||||||||||||||||||
Accumulated
|
Deficit | |||||||||||||||||||||||||||
Common Stock
|
other
|
Receivable in |
accumulated
|
Total | ||||||||||||||||||||||||
Number
of shares
|
Amount
|
Additional paid
in capital
|
comprehensive
loss
|
respect of
stock issuance
|
during
development stage
|
stockholders
equity (deficit)
|
||||||||||||||||||||||
Balance as of January 1, 2012
|
5,295,543 | 5,296 | 13,457,828 | 22,634 | - | (12,517,519 | ) | 968,239 | ||||||||||||||||||||
Loss for the period of six months
|
- | - | - | - | - | (1,372,411 | ) | (1,372,411 | ) | |||||||||||||||||||
Other comprehensive loss
|
- | - | - | 21,143 | - | - | 21,143 | |||||||||||||||||||||
Stock-based compensation
|
- | - | 197,237 | - | - | - | 197,237 | |||||||||||||||||||||
Balance as of June 30, 2012 (unaudited)
|
5,295,543 | 5,296 | 13,655,065 | 43,777 | - | (13,889,930 | ) | (185,792 | ) |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
10
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
US dollars
|
||||||||||||
Six month period ended June 30,
|
Cumulative period
from September 30, 2001 (date of inception) through June 30,
|
|||||||||||
2012
|
2011
|
2012(*) | ||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||
Cash flows from operating activities:
|
||||||||||||
Loss for the period
|
(1,372,411 | ) | (1,056,921 | ) | (13,889,930 | ) | ||||||
Adjustments to reconcile loss for the period to net cash used in operating activities:
|
||||||||||||
Depreciation
|
12,741 | 10,398 | 145,227 | |||||||||
Increase (decrease) in liability for employee rights upon retirement
|
(5,945 | ) | 9,553 | 217,757 | ||||||||
Stock-based compensation
|
197,237 | 189,355 | 1,428,140 | |||||||||
Stock-based interest compensation to convertible notes holders
|
- | - | 1,214,943 | |||||||||
Change in the fair value of warrants with round-down protection
|
(43,051 | ) | - | (43,051 | ) | |||||||
Linkage difference on principal of loans from stockholders (**)
|
5,869 | (8,733 | ) | 182,918 | ||||||||
Interest on convertible notes
|
- | - | 78,192 | |||||||||
Gain on sale of property and equipment
|
- | - | (912 | ) | ||||||||
Gain from trading marketable securities
|
- | - | (12,920 | ) | ||||||||
Changes in assets and liabilities:
|
||||||||||||
Decrease (increase) in other current assets
|
(8,121 | ) | 27,658 | (91,408 | ) | |||||||
Increase (decrease) in accounts payable
|
67,012 | 31,671 | 140,154 | |||||||||
Increase (decrease) in other current liabilities
|
22,694 | (80,814 | ) | 230,080 | ||||||||
Net cash used in operating activities
|
(1,123,975 | ) | (877,833 | ) | (10,400,810 | ) | ||||||
Cash flows from investment activities:
|
||||||||||||
Decrease (increase) in funds in respect of employee rights upon retirement
|
(6,470 | ) | (11,699 | ) | (109,274 | ) | ||||||
Purchase of property and equipment
|
(3,516 | ) | (47,750 | ) | (212,289 | ) | ||||||
Proceeds from sale of property and equipment
|
- | - | 4,791 | |||||||||
Investment in marketable securities
|
- | - | (388,732 | ) | ||||||||
Proceeds from sale of marketable securities
|
- | - | 406,995 | |||||||||
Short-term loan granted to related party, net of repayments
|
- | - | (14,252 | ) | ||||||||
Net cash provided by (used in) investment activities
|
(9,986 | ) | (59,449 | ) | (312,761 | ) | ||||||
Cash flows from financing activities
|
||||||||||||
Credit from banking institutions (repayment)
|
- | (18,977 | ) | (6,218 | ) | |||||||
Proceeds from issuance of convertible notes
|
- | - | 1,144,000 | |||||||||
Repayment of convertible notes
|
- | - | (527,396 | ) | ||||||||
Proceeds from issuance of Common Stock, net of issuance expenses
|
- | 934,829 | 10,406,380 | |||||||||
Proceeds from stockholders loans
|
- | - | 347,742 | |||||||||
Net cash provided by financing activities
|
- | 915,852 | 11,364,508 | |||||||||
Effect of exchange rate changes on cash and cash equivalents
|
(4,176 | ) | 28,457 | 107,430 | ||||||||
Increase (decrease) in cash and cash equivalents
|
(1,138,137 | ) | 7,027 | 758,367 | ||||||||
Cash and cash equivalents at beginning of the period
|
1,896,504 | 1,494,248 | - | |||||||||
Cash and cash equivalents at end of the period
|
758,367 | 1,501,275 | 758,367 |
(*)
|
As described in Note 1A, the financial statements were retroactively restated to reflect the historical financial statements of the subsidiary A.D. Integrity Applications Ltd., which merged with a subsidiary of the Company on July 15, 2010, as part of a structural reorganization of the Group.
|
(**)
|
Represents charges taken to reflect changes in the Israeli Consumer Price index with respect to loans from stockholders that are denominated in New Israeli Shekels and linked to the Israeli Consumer Price Index.
|
The accompanying notes are an integral part of the consolidated financial statements.
|
11
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1
|
–
|
GENERAL
|
|
A.
|
Integrity Applications, Inc. (the "Company") was incorporated on May 18, 2010, under the laws of the State of Delaware. On July 15, 2010, Integrity Acquisition Corp. Ltd. (hereinafter: "Integrity Acquisition"), a wholly owned Israeli subsidiary of the Company which was established on May 23, 2010, completed a merger with A.D. Integrity Applications Ltd. (hereinafter: "Integrity Israel"), an Israeli corporation which was previously held by the stockholders of the Company. Pursuant to the merger, all stockholders, option holders and warrant holders of Integrity Israel received an equal number of shares, options and warrants of the Company, as applicable in exchange for their shares, options and/or warrants in Integrity Israel. Following the merger, Integrity Israel remained a wholly-owned subsidiary of the Company. As the merger transaction constitutes a structural reorganization, the merger has been accounted for at historical cost in a manner similar to a pooling of interests. On this basis, stockholders’ equity (deficit) has been retroactively restated such that each ordinary share of Integrity Israel is reflected in stockholders' equity as a share of Common Stock of the Company as of the date of the issuance thereof by Integrity Israel. In addition, the historical financial statements of the Company for all dates and periods prior to May 18, 2010 have been retroactively restated to reflect the activities of Integrity Israel.
|
In November 2011, the Company completed registration of part of its shares with the US Securities and Exchange Commission (SEC) on Form S-1 under the Securities Act of 1933.
Integrity Israel was incorporated in 2001 and commenced its operations in 2002. Integrity Israel, a medical device company, focuses on the design, development and commercialization of non-invasive glucose monitoring devices for home use by persons suffering with diabetes.
Since its inception, Integrity Israel has devoted substantially all of its efforts to business planning, research and development and raising capital, and has not yet generated any revenues. Accordingly, Integrity Israel (and therefore the Company) is considered to be in the development stage as defined in Financial Accounting Standards Board ("FASB") Accounting Standards Codification (ASC) Topic 915, "Development Stage Entities".
|
B.
|
Going concern uncertainty
|
Since its incorporation (May 18, 2010), the Company has not had any operations other than those carried out by Integrity Israel. The development and commercialization of Integrity Israel's product is expected to require additional substantial expenditures. Integrity Israel has not yet generated any revenues from its operations to fund its activities, and therefore is dependent upon external sources for financing its operations. There can be no assurance that Integrity Israel and, therefore, the Company will succeed in obtaining the necessary financing to continue their operations. Since inception, Integrity has incurred accumulated losses of US$ 13,889,930 and cumulative negative operating cash flow of US$ 10,400,810. These factors raise substantial doubt about Integrity Israel and the Company's ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. During 2010, the Company raised funds via the issuance of Common Stock (including via the conversion of convertible notes), in a total amount of approximately US$ 4 million (before related expense). During 2011, the Company raised funds via the issuance of Common Stock in a total amount of approximately US$ 2.4 million (net of related expenses). The Company will need to secure additional capital in the future in order to meet its anticipated liquidity needs. The Company would expect to secure additional capital primarily through the sale of additional Common Stock or other equity securities and/or debt financing. Funds from these sources may not be available to the Company on acceptable terms, if at all, and they cannot give assurance that they will be successful in securing such additional capital.
12
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE 1
|
–
|
GENERAL (cont.)
|
|
C.
|
Risk factors
|
The Company and Integrity Israel (collectively, the "Group") have a limited operating history and face a number of risks, including uncertainties regarding finalization of the development process, demand and market acceptance of the Group's products, the effects of technological changes, competition and the development of other new products by competitors. Additionally, other risk factors also exist, such as the ability to manage growth and the effect of planned expansion of operations on the Group's future results.
In addition, the Group expects to continue incurring significant operating costs and losses in connection with the development of its product and increased marketing efforts.
As mentioned above, the Group has not yet generated any revenues from its operations to fund its activities and therefore the Group is dependent on the receipt of additional funding from its stockholders and investors in order to continue as a going concern.
|
D.
|
Use of estimates in the preparation of financial statements
|
The preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to stock based compensation and to the going concern assumption.
NOTE 2
|
–
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
A.
|
Basis of presentation
|
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements.
In the opinion of management, the unaudited interim financial statements furnished herein include all adjustments necessary (consisting of normal recurring adjustments) for a fair presentation of the Company’s financial position at June 30, 2012 and the results of its operations and cash flow for each of the six and three month periods then ended.
Interim financial statements are prepared on a basis consistent with the Company’s annual financial statements. Results of operations for the six and three month periods ended June 30, 2012 are not necessarily indicative of the operating results that may be expected for the year ending December 31, 2012.
The consolidated balance sheet as of December 31, 2011 was derived from the audited financial statements at that date but does not include all of the information and notes required by accounting principles generally accepted in the United States of America for complete financial statements. For further information, refer to the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2011.
13
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE 2
|
–
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)
|
|
B.
|
Recently issued accounting pronouncements
|
|
1.
|
ASC Topic 220, "Comprehensive Income"
|
Effective January 1, 2012, the Company adopted retrospectively the provisions of Accounting Standard Update No. 2011-05, “Comprehensive Income (Topic 220) - Presentation of Comprehensive Income” (“ASU 2011-05”). ASU 2011-05 eliminated the option to present the components of other comprehensive income as part of the statement of equity and requires an entity to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income (as applied by the Company) or in two separate but consecutive statements.
The adoption of ASU 2011-05 did not have a material impact on the unaudited consolidated financial statements.
|
2.
|
ASC Topic 210, “Balance Sheet”
|
In December 2011, the FASB issued Accounting Standard Update (ASU) 2011-11, “Balance Sheet (Topic 210) - Disclosures about Offsetting Assets and Liabilities” (ASU 2011-11). ASU 2011-11 enhances disclosures about financial instruments and derivative instruments that are either offset in accordance with the Accounting Standards Codification or are subject to an enforceable master netting arrangement or similar agreement.
The amended guidance will be effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods (fiscal year 2013 for the Company) and should be applied retrospectively to all comparative periods presented.
The Company is currently evaluating the impact that the adoption of ASU 2011-11 would have on its consolidated financial statements, if any.
NOTE 3
|
–
|
EVENTS DURING THE REPORTED PERIOD
|
On March 12, 2012, the Company granted to Company's employees options to purchase 17,500 shares of the company's Common Stock at an exercise price of US$6.25 per share. All options were granted in accordance with and subject to the terms of the Company's 2010 incentive Compensation Plan.
The fair value of options granted was estimated at the dates of grant using the Black-Scholes option pricing model. The following are the data and assumptions used:
Dividend yield (%)
|
0 | |||
Expected volatility (%) (*)
|
50 | |||
Risk free interest rate (%)
|
2 | |||
Expected term of options (years) (**)
|
6 | |||
Exercise price (US dollars)
|
6.25 | |||
Share price (US dollars) (***)
|
6.25 | |||
Fair value (US dollars)
|
3.08 |
|
(*)
|
Due to the fact that there is no public market for the Company's common stock, the expected volatility is based on the historic volatility of public companies which operate in the same industry sector.
|
|
(**)
|
Due to the fact that the Company does not have historical exercise data, the expected term was determined based on the "simplified method" in accordance with Staff Accounting Bulletin No. 110.
|
|
(***)
|
The fair value of the share was based on the most recent share prices, as applicable to each grant.
|
The total non-cash compensation is approximately US$ 50,000.
14
INTEGRITY APPLICATIONS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE 4
|
–
|
LOSS PER SHARE
|
Basic loss per share is computed by dividing net loss for the period by the weighted average number of shares outstanding during the period.
The loss and the weighted average number of shares used in computing basic and diluted loss per share for the six and three month periods ended June 30, 2012 and 2011 are as follows:
US dollars
|
||||||||||||||||
Six month period
ended June 30,
|
Three month period
ended June 30,
|
|||||||||||||||
2012
|
2011
|
2012
|
2011
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Loss used for the period
|
1,372,411 | 1,056,921 | 737,458 | 516,657 |
Number of shares
|
||||||||||||||||
Six month period
ended June 30,
|
Three month period
ended June 30,
|
|||||||||||||||
2012
|
2011
|
2012
|
2011
|
|||||||||||||
Number of shares:
|
||||||||||||||||
Weighted average number of shares used in the computation of basic and diluted earnings per share
|
5,295,543 | 4,922,582 | 5,295,543 | 4,989,720 | ||||||||||||
Total weighted average number of ordinary shares related to outstanding options and warrants excluded from the calculations of diluted loss per share (*)
|
600,232 | 555,764 | 600,232 | 555,764 |
|
(*)
|
All outstanding stock options and warrants have been excluded from the calculation of the diluted net loss per share for all the reported periods, since the effect of the shares issuable with respect of these instruments was anti-dilutive.
|
15
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements. These forward looking statements include statements about our expectations, beliefs or intentions regarding our product development efforts, business, financial condition, results of operations, strategies or prospects. All statements other than statements of historical fact included in this Quarterly Report on Form 10-Q, including statements regarding our future activities, events or developments, including such things as future revenues, product development, market acceptance, responses from competitors, capital expenditures (including the amount and nature thereof), business strategy and measures to implement strategy, competitive strengths, goals, expansion and growth of our business and operations, plans, references to future success, projected performance and trends, and other such matters, are forward-looking statements. The words “believe,” “expect,” “intend,” “anticipates,” or “propose,” and other similar words and phrases, are intended to identify forward-looking statements. The forward-looking statements made in this Quarterly Report on Form 10-Q are based on certain historical trends, current conditions and expected future developments as well as other factors we believe are appropriate in the circumstances. These statements relate only to events as of the date on which the statements are made and we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this prospectus are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Whether actual results will conform to our expectations and predictions is subject to a number of risks and uncertainties that may cause actual results to differ materially. Risks and uncertainties, the occurrence of which could adversely affect our business, include the risks identified under the caption “Risk Factors” included in our annual report on Form 10-K for the year ended December 31, 2011, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and in Part II, Item 1A of this Quarterly Report on Form 10-Q.
The following discussion should be read in conjunction with the condensed consolidated financial statements and the notes thereto included in Item 1 of this Quarterly Report on Form 10-Q.
Overview
Integrity Applications, Inc. is a development stage medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for use by persons suffering from diabetes. Our wholly-owned Israeli subsidiary, A.D. Integrity Applications Ltd., was founded in 2001 with a mission to develop, produce and market non-invasive glucose monitors for home use by diabetics. We have developed a non-invasive blood glucose monitor, the GlucoTrack® glucose monitoring device (the “GlucoTrack DF-F” or “GlucoTrack”), which is designed to help people with diabetes obtain blood glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot finger stick devices. The GlucoTrack DF-F utilizes a patented combination of ultrasound, electromagnetic and thermal technologies to obtain blood glucose measurements in less than one minute via a small sensor that is clipped onto one’s earlobe and connected to a small, handheld control and display unit, all without drawing blood. Integrity Israel conducted early clinical trials involving over 5,000 readings from approximately 350 patients over the last six years. Clinical data collected since 2009 at the Soroka University Medical Center in Be’er Sheva, Israel indicate a positive correlation between GlucoTrack DF-F readings and those obtained from conventional invasive devices. More specifically, a set of early clinical studies conducted on 116 subjects of various weights, ages, diabetes types and genders involved 2,364 measurements, of which 96% were within the clinically acceptable zones of the CEG (zones A and B). Similarly, approximately 97% of the 1,306 measurements in an at home study of 24 subjects were within clinically acceptable zones A and B of the CEG. Measurements are clinically acceptable, compared to a referenced invasive device, when the variance, if any, between the devices would have no worse than a benign effect on the patients. The initial studies involved small patient populations. Because of the small sample size, the results of these studies may not be indicative of future results. We began the performance and safety stage of formal clinical trials in Israel in connection with our CE Mark application in March 2012. We expect to begin clinical trials in the United States by late 2012 or early 2013, if our clinical trial protocol is approved by the United States Food and Drug Administration (the “FDA”).
The GlucoTrack DF-F has not yet been approved for commercial sale in the United States, the European Union or any other jurisdiction. There can be no assurance that approval for commercial sale in any jurisdiction will be obtained.
We have not yet generated any revenues from our operations and have incurred losses of US$ 13,889,930 from inception through June 30, 2012 and cumulative negative operating cash flow of US$ 10,400,810. We are dependent upon external sources for financing our operations and there can be no assurance that we will succeed in obtaining the necessary financing to continue our operations. As a result, our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
16
Unless the context otherwise requires, the terms “we”, “our”, “ours” and “us”, refer to A.D. Integrity Applications, Ltd., an Israeli corporation, which we refer to as Integrity Israel, for all periods prior to July 15, 2010 and to Integrity Israel and Integrity Applications, Inc., a Delaware corporation, which we refer to as Integrity U.S., on a combined basis, for all periods from and including July 15, 2010.
Recent Corporate Developments
Reorganization
On July 15, 2010, we completed a reverse triangular merger with Integrity Israel and Integrity Acquisition Corp. Ltd., an Israeli corporation and a wholly owned subsidiary of ours, pursuant to which Integrity Acquisition Corp. Ltd. merged with and into Integrity Israel and all of the stockholders and option holders of Integrity Israel became entitled to receive shares and options in us in exchange for their shares and options in Integrity Israel (the “Reorganization”). Following the Reorganization, the former equity holders of Integrity Israel received the same proportional ownership in us as they had in Integrity Israel prior to the Reorganization. As a result of the Reorganization, Integrity Israel became a wholly owned subsidiary of ours. Pursuant to a tax ruling from the Israeli tax authorities, the former stockholders and options holders of Integrity Israel will be exempt from tax liability with respect to the Reorganization until they sell their holdings in us, so long as they deposit all their shares and options with a trustee for a period of two years from the issuance of such shares or options, as applicable, in connection with the Reorganization, give their written consent to the tax ruling and satisfy certain additional conditions detailed in the ruling. As a result, any of our stockholders that complied with this tax ruling was unable to sell any of its shares of common stock in us prior to July 16, 2012. Approximately 82% of our stockholders at the time of the reorganization (holding 3,280,000 of 3,999,998 shares then outstanding) complied with the ruling.
Private Placement
On July 26, 2010, we commenced an offering of up to 2,000,000 shares of our common stock to accredited investors at a price of $6.25 per share in a private placement transaction (the “Private Placement”). The Private Placement resulted in the sale by us of an aggregate of 1,295,545 shares of common stock in seven closings held on December 16, 2010, December 30, 2010, January 31, 2011, March 31, 2011, April 29, 2011, May 31, 2011 and July 29, 2011, respectively. Purchasers of common stock in the Private Placement are entitled to anti-dilution protection until September 1, 2012 for certain issuances of common stock by us for less than $6.25 per share.
In connection with the Private Placement, we agreed to issue to Andrew Garrett, Inc., the placement agent for the Private Placement (the “Placement Agent”), in partial consideration for its services as such, warrants to purchase a number of shares of common stock equal to 10% of the number of shares sold at such closing. In total, we issued to the Placement Agent warrants to purchase up to an aggregate of 129,556 shares of common stock at an exercise price of $6.25 per share in connection with each closing of the Private Placement. The warrants have a five year term expiring on the fifth anniversary of the date on which the shares of common stock underlying such warrants are fully registered with the SEC.
Public Registration
In connection with the Private Placement, we agreed to file a registration statement covering the resale of the shares of common stock sold by us in the Private Placement. On August 22, 2011, we filed a registration statement (Registration No. 333-176415) relating to the resale by the selling stockholders named in the registration statement (as amended from time to time) of the 1,295,545 shares of our common stock issued in the Private Placement. The registration statement was declared effective by the SEC on November 14, 2011. All of the shares of common stock covered by the registration statement have been registered for resale by the selling stockholders named therein and we will not receive any of the proceeds from the sale of any shares of common stock sold by the selling stockholders thereunder.
There is no public market for our common stock. We are seeking a qualification for our common stock to be quoted on the Over-the-Counter Bulletin Board (the “OTCBB”); however, no assurance can be given as to our success in qualifying for quotation on the OTCBB.
17
Significant Accounting Policies
Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). In connection with the preparation of our financial statements, we are required to make assumptions and estimates about future events, and apply judgments that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures. We base our assumptions, estimates and judgments on historical experience, current trends and other factors that management believes to be relevant at the time our consolidated financial statements are prepared. On a regular basis, management reviews the accounting policies, assumptions, estimates and judgments to ensure that our financial statements are presented fairly and in accordance with U.S. GAAP. However, because future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates, and such differences could be material.
Our significant accounting policies are described in Note 2, Summary of Significant Accounting Policies, of the Notes to Condensed Consolidated Financial Statements appearing in our Annual Report on Form 10-K for the year ended December 31, 2011. Our management believes that, as for the financial statements for the periods included in this report, the stock based compensation and the going concern assessment are the critical accounting policy. However, due to the early stage of operations of the Company, there are no other accounting policies that are considered to be critical accounting policies by management.
Going concern uncertainty
The development and commercialization of our product will require substantial expenditures. We have not yet generated any revenues and have incurred substantial accumulated losses and cumulative negative operating cash flows since inception. We currently have no sources of recurring revenue and are therefore dependent upon external sources for financing our operations. There can be no assurance that we will succeed in obtaining the necessary financing to continue our operations. As a result, our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. Management’s plans concerning these matters are described in Note 1B of the Notes to Condensed Consolidated Financial Statements appearing elsewhere in this report; however, management cannot assure you that its plans will be successful in addressing these issues. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Recently issued accounting pronouncements
1.
|
ASC Topic 220, "Comprehensive Income"
|
Effective January 1, 2012, the Company adopted retrospectively the provisions of Accounting Standard Update No. 2011-05, “Comprehensive Income (Topic 220) - Presentation of Comprehensive Income” (“ASU 2011-05”). ASU 2011-05 eliminated the option to present the components of other comprehensive income as part of the statement of equity and requires an entity to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income (as applied by the Company) or in two separate but consecutive statements.
The adoption of ASU 2011-05 did not have a material impact on the unaudited consolidated financial statements.
2.
|
ASC Topic 210, “Balance Sheet”
|
In December 2011, the FASB issued Accounting Standard Update (ASU) 2011-11, “Balance Sheet (Topic 210) - Disclosures about Offsetting Assets and Liabilities” (ASU 2011-11). ASU 2011-11 enhances disclosures about financial instruments and derivative instruments that are either offset in accordance with the Accounting Standards Codification or are subject to an enforceable master netting arrangement or similar agreement.
The amended guidance will be effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods (fiscal year 2013 for the Company) and should be applied retrospectively to all comparative periods presented.
The Company is currently evaluating the impact that the adoption of ASU 2011-11 would have on its consolidated financial statements, if any.
18
Results of Operations
Three Months Ended June 30, 2012 Compared to Three Months Ended June 30, 2011
Revenues
We did not have any revenues during the three months ended June 30, 2012 and 2011, as we have not yet commercialized our GlucoTrack product candidate.
Research and Development Expenses
Research and development expenses were $508,462 for the three months ended June 30, 2012, as compared to $407,631 for the prior-year period. The increase is primarily attributable to expenses incurred in connection with our formal clinical trials commenced in March 2012, including recruitment expenses, material expenses and other costs and expenses of administrating the clinical trials, increased compensation expenses resulting from an increase in the number of employees, development of a new model of the main unit for GlucoTrack DF-F and costs involved in expediting product readiness for clinical trials. Research and development expenses consist primarily of salaries and other personnel-related expenses, including stock-based compensation expenses, materials, sub-contractors, clinical trial expenses, travel expenses and other expenses related to the development of our product candidates. We expect research and development expenses to continue to increase in 2012 and beyond as we enter into more advanced stages of development of our GlucoTrack DF-F product candidate, including the continuation of formal clinical trials in Israel relating to our CE Mark application, and continue our efforts to develop additional product candidates.
General and Administrative Expenses
General and administrative expenses were $245,613 for the three months ended June 30, 2012, as compared to $89,098 for the prior-year period. The increase is primarily attributable to increased compensation expenses resulting from an increase in the number of employees, expenses related to stock-based compensation and increases in professional services expenses as a result of additional services incurred in connection with our compliance obligations as a public reporting company. General and administrative expenses consist primarily of salaries and other related expenses for executive, finance and administrative personnel, including stock-based compensation expense. Other general and administrative costs and expenses include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal and accounting services. We expect that our general and administrative costs and expenses will continue to increase in 2012 as we continue to incur increased costs to comply with the reporting and other obligations applicable to public reporting companies.
Financing (Income) Expense, net
Financing (income) expense, net was $(16,617) for the three months ended June 30, 2012, as compared to $19,928 for the prior-year period. The change is primarily attributable to a decrease in the fair value of warrants with down-round protection, offset by an increase in foreign exchange loss for balances denominated in New Israeli Shekels and an increase in linkage difference on principal of loans from shareholders.
Net Loss
Net loss was $737,458 for the three months ended June 30, 2012, as compared to $516,657 for the prior-year period.
Six Months Ended June 30, 2012 Compared to Six Months Ended June 30, 2011
Revenues
We did not have any revenues during the three months ended June 30, 2012 and 2011, as we have not yet commercialized our GlucoTrack product candidate.
Research and Development Expenses
Research and development expenses were $953,528 for the six months ended June 30, 2012, as compared to $781,114 for the prior-year period. The increase is primarily attributable to expenses incurred in connection with our formal clinical trials commenced in March 2012, including recruitment expenses, material expenses and other costs and expenses of administrating the clinical trials, increased compensation expenses resulting from an increase in the number of employees development of a new model of the main unit for GlucoTrack DF-F and costs involved in expediting product readiness for clinical trials. Research and development expenses consist primarily of salaries and other personnel-related expenses, including stock-based compensation expenses, materials, sub-contractors, clinical trial expenses, travel expenses and other expenses related to the development of our product candidates. We expect research and development expenses to continue to increase in 2012 and beyond as we enter into more advanced stages of development of our GlucoTrack DF-F product candidate, including the continuation of formal clinical trials in Israel relating to our CE Mark application and continue our efforts to develop additional product candidates.
19
General and Administrative Expenses
General and administrative expenses were $448,548 for the six months ended June 30, 2012, as compared to $254,736 for the prior-year period. The increase is primarily attributable to increased compensation expenses resulting from an increase in the number of employees expenses related to stock-based compensation and increases in professional services expenses as a result of additional services incurred in connection with our compliance obligations as a public reporting company. General and administrative expenses consist primarily of salaries and other related expenses for executive, finance and administrative personnel, including stock-based compensation expense. Other general and administrative costs and expenses include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal and accounting services. We expect that our general and administrative costs and expenses will continue to increase in 2012 as we incur increased costs to comply with the reporting and other obligations applicable to public reporting companies.
Financing (Income) Expense, net
Financing (income) expense, net was $(29,665) for the six months ended June 30, 2012, as compared to $21,071 for the prior-year period. The change is primarily attributable to a decrease in the fair value of warrants with down-round protection, offset by an increase in foreign exchange loss for balances denominated in New Israeli Shekels and an increase in linkage difference on principal of loans from shareholders.
Net Loss
Net loss was $1,372,411 for the six months ended June 30, 2012, as compared to $1,056,921 for the prior-year period.
Liquidity and Capital Resources
We currently have extremely limited liquidity. As of June 30, 2012, cash on hand was approximately $0.8 million. Based on our current strategy and operating plan, we believe that our cash and cash equivalents, will enable us to operate for a period of about 4 months from June 30, 2012. In order to fund our anticipated liquidity needs beyond such four month period (or possibly earlier if we change our current strategy or operating plan in a way that accelerates or increases our liquidity needs), we will need to raise additional capital.
Net Cash Used in Operating Activities for the Six Month Periods Ended June 30, 2012 and June 30, 2011
Net cash used in operating activities was $1,123,975 and $877,833 for the six month periods ended June 30, 2012 and 2011, respectively. Net cash used in operating activities primarily reflects the net loss for those periods of $1,372,411 and $1,056,921 respectively, which was reduced in part by stock-based compensation of $197,237 and $189,355, respectively ,the (increase) decrease of the liability for employee rights upon retirement of ($5,945) and $9,553 respectively and by cash provided due to the adjustment to the net loss and changes in operating assets and liabilities in the amounts of $81,585 and ($21,485) respectively.
Net Cash (Used) in Investing Activities for the Six Month Periods Ended June 30, 2012 and June 30, 2011
Net cash (used) in investing activities was $(9,986) and $(59,449) for the six month periods ended June 30, 2012 and 2011, respectively, and was used primarily to purchase equipment (such as computers, R&D and office equipment), and fund deposits in respect of employees rights upon retirement.
Net Cash Provided by Financing Activities for the Six Month Periods Ended June 30, 2012 and June 30, 2011
Net cash provided by financing activities was $0 and $915,852 for the six month periods ended June 30, 2012 and 2011, respectively. Cash provided by financing activities primarily reflects the capital raised in the amounts of $0 and $934,829 offset by credit line expenses in the amount of $0 and $18,977 respectively.
20
Off-Balance Sheet Arrangements
As of June 30, 2012, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not required for smaller reporting companies.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2012. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2012, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
The SEC, as required by Section 404 of the Sarbanes-Oxley Act, adopted rules requiring every company that files reports with the SEC to include a management report on such company’s internal control over financial reporting in its annual report. In addition, our independent registered public accounting firm must attest to our internal control over financial reporting. Our Annual Report on Form 10-K for the year ended December 31, 2011 did not include a report of management’s assessment regarding internal control over financial reporting due to a transition period established by SEC rules applicable to newly public companies. Management will be required to provide an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2012. We believe we will have adequate resources and expertise, both internal and external, in place to meet this requirement. However, there is no guarantee that our efforts will result in management’s ability to conclude that our internal control over financial reporting is effective as of December 31, 2012.
There were no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
21
PART II - OTHER INFORMATION
Item 1A. Risk Factors.
Except as set forth below and in Part II, Item 1A of our Quarterly Report on Form 10-Q for the quarter ended March 30, 2012, there have been no material changes to the factors disclosed in Part I, Item 1-A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2011.
We will require substantial additional funding, which may not be available to us on acceptable terms, or at all.
As of June 30, 2012, cash on hand was approximately $0.8 million. Based on our current strategy and operating plan, we believe that our cash and cash equivalents, will enable us to operate for a period of about four months from June 30, 2012.
In order to fund our anticipated liquidity needs beyond such four month period (or possibly earlier if we change our current strategy or operating plan in a way that accelerates or increases our liquidity needs), we will need to raise additional capital. Our future funding requirements will depend on many factors, including but not limited to:
·
|
our need to expand research and development activities;
|
·
|
the need and ability to hire additional management and scientific and medical personnel;
|
·
|
the effect of competing technological and market developments;
|
·
|
the need to implement additional internal systems and infrastructure, including financial and reporting systems;
|
·
|
the rate of progress and cost of our clinical trials;
|
·
|
the costs associated with establishing commercialization capabilities, including a sales force if we distribute our product other than through distributors;
|
·
|
the costs and timing of seeking and obtaining FDA and other non-U.S. regulatory clearances and approvals; and
|
·
|
the ability to maintain, expand and defend the scope of our intellectual property portfolio.
|
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, or at all, we may have to delay, reduce the scope of or eliminate clinical trials or research and development programs. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution, and debt financing, if available, may involve restrictive covenants. In addition to the dilution normally attendant to an equity offering, holders of our shares of common stock may experience additional dilution, in the event that we complete an equity offering prior to September 1, 2012, as a result of the anti-dilution protections afforded to the investors in the Private Placement.
22
Item 6. Exhibits.
Exhibit No.
|
Description
|
|
3.1
|
Certificate of Incorporation of Integrity Applications, Inc. (1)
|
|
3.2
|
Certificate of Amendment to Certificate of Incorporation of Integrity Applications, Inc. (1)
|
|
3.3
|
Bylaws of Integrity Applications, Inc. (1)
|
|
31.1
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2
|
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
32.2
|
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
101.INS
|
XBRL Instance Document (2)
|
|
101.SCH
|
XBRL Schema Document (2)
|
|
101.CAL
|
XBRL Calculation Linkbase Document (2)
|
|
101.LAB
|
XBRL Label Linkbase Document (2)
|
|
101.PRE
|
XBRL Presentation Linkbase Document (2)
|
|
101.DEF
|
XBRL Definition Linkbase Document (2)
|
(1)
|
Previously filed as an exhibit to the Company’s Registration Statement on Form S-1, as filed with the SEC on August 22, 2011.
|
(2)
|
To be filed within 30 days of the filing of this Quarterly Report on Form 10-Q pursuant to Rule 405(a)(2)(ii) of Regulation S-T.
|
23
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: August 14, 2012
INTEGRITY APPLICATIONS, INC.
|
|||
By:
|
/s/ Avner Gal
|
||
Name:
|
Avner Gal
|
||
Title
|
Chairman of the Board and Chief Executive Officer
|
By:
|
/s/ Jacob Bar-Shalom
|
||
Name:
|
Jacob Bar-Shalom
|
||
Title
|
Chief Financial Officer
(Principal Accounting Officer)
|
24
EXHIBIT INDEX
Exhibit No.
|
Description
|
|
3.1
|
Certificate of Incorporation of Integrity Applications, Inc. (1)
|
|
3.2
|
Certificate of Amendment to Certificate of Incorporation of Integrity Applications, Inc. (1)
|
|
3.3
|
Bylaws of Integrity Applications, Inc. (1)
|
|
31.1
|
Certification of Chief Executive Officer Pursuant to Exchange Act Rule 13a-14(a) or 15(d)-14(a), as Adopted Pursuant to Section 302 of the Sarbanes Oxley Act of 2002
|
|
31.2
|
Certification of Chief Financial Officer Pursuant to Exchange Act Rule 13a-14(a) or 15(d)-14(a), as Adopted Pursuant to Section 302 of the Sarbanes Oxley Act of 2002
|
|
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes Oxley Act of 2002
|
|
32.2
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes Oxley Act of 2002
|
|
101.INS
|
XBRL Instance Document (2)
|
|
101.SCH
|
XBRL Schema Document (2)
|
|
101.CAL
|
XBRL Calculation Linkbase Document (2)
|
|
101.LAB
|
XBRL Label Linkbase Document (2)
|
|
101.PRE
|
XBRL Presentation Linkbase Document (2)
|
|
101.DEF
|
XBRL Definition Linkbase Document (2)
|
(1)
|
Previously filed as an exhibit to the Company’s Registration Statement on Form S-1, as filed with the SEC on August 22, 2011.
|
(2)
|
To be filed within 30 days of the filing of this Quarterly Report on Form 10-Q pursuant to Rule 405(a)(2)(ii) of Regulation S-T.
|
25