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:
September
30, 2008
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: 000-51030
OccuLogix,
Inc.
(Exact
name of registrant as
specified
in its charter)
Delaware
|
|
59
343 4771
|
|
|
|
(State
or other jurisdiction of incorporation or organization)
|
|
(I.R.S.
Employer Identification No.)
|
2600 Skymark Avenue, Unit 9,
Suite
103
, Mississauga, Ontario L4W
5B2
(Address
of principal executive offices)
(905)
602-0887
(Registrant’s
telephone number, including area code)
Indicate
by check mark
whether the
registrant (1) 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
x
No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, 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
|
Accelerated
filer
x
|
Non-accelerated filer
|
Smaller Reporting
Company
|
Indicate
by check mark whether the registrant is a shell company as defined in Rule 12b-2
of the Exchange Act. (Check one):Yes
o
No
x
Indicate the number of shares
outstanding of each of the issuer’s classes of common stock, as of the latest
practicable date.
9,828,409
as of
November 7,
2008
P
AR
T I.
|
FINANCIAL
INFORMATION
|
|
|
|
|
Item
1.
|
|
4
|
Item
2.
|
|
38
|
Item
3.
|
|
52
|
Item
4.
|
|
52
|
|
|
|
|
|
|
PART
II.
|
OTHER
INFORMATION
|
|
|
|
|
Item
1.
|
|
54
|
Item
2.
|
|
60
|
Item
3.
|
|
60
|
Item
4.
|
|
60
|
Item
5.
|
|
61
|
Item
6.
|
|
62
|
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements relating to
future events and our future performance within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, including, without limitation, statements
relating to our future business prospects and economic conditions in general;
statements regarding our cash needs to cover our operating activities and other
demands and burn rate; statements regarding our plans for development,
commercialization and seeking regulatory approval of our products; statements
regarding our strategy to minimize our market risk for our investments;
statements relating to our future business prospects and economic conditions in
general; statements relating to expansion of our distribution network;
statements regarding release of data; statements about our efforts to achieve an
orderly refocus on ongoing activities by reviewing and improving upon our
existing business processes and cost structure; statements regarding our ability
increase awareness of our products among eye care professionals and, in
particular, the key opinion leaders in the eye care professions; statements
regarding our geographic focus for commercialization; statements regarding our
conference and podium strategy and our efforts to ensure visibility and
evidence-based positioning of the TearLab™ test for DED among eye care
professionals; and statements regarding our product development activities and
our ability grow our business.
In some
cases, you can identify forward-looking statements by terms such as “may”,
“will”, “should”, “could”, “would”, “expects”, “plans”, “intends”,
“anticipates”, “believes”, “estimates”, “projects”, “predicts”, “potential” and
similar expressions intended to identify forward-looking statements.
Forward-looking statements are inherently subject to risks and uncertainties,
many of which are beyond our control. These statements involve known and unknown
risks, uncertainties and other factors that may cause our actual results,
performance or achievements to be materially different from any future results,
performance, time frames or achievements expressed or implied by the
forward-looking statements. As a result, our actual results could differ
materially from those anticipated in these forward-looking statements as a
result of various factors, including those set forth below under the caption
“Risk Factors.” For these statements, we claim the protection of the safe harbor
for forward-looking statements contained in the Private Securities Litigation
Reform Act of 1995.
Given
these risks, uncertainties and other factors, you should not place undue
reliance on these forward-looking statements. [Information regarding market and
industry statistics] contained in this Quarterly Report on Form 10-Q is included
based on information available to us that we believe is accurate. It is
generally based on academic and other publications that are not produced for
purposes of securities offerings or economic analysis. We have not reviewed or
included data from all sources and cannot assure you of the accuracy of the
market and industry data we have included.
Unless
the context indicates or requires otherwise, in this Quarterly Report on Form
10-Q, references to the “Company” shall mean OccuLogix, Inc. and its
subsidiaries. References to “$” or “dollars” shall mean U.S. dollars unless
otherwise indicated.
On
October 6, 2008, we effected a 1-for-25 reverse split of our common stock.
Historical share numbers and prices throughout this quarterly report on Form
10-Q are split-adjusted.
OccuLogix,
Inc.
PART
I.
|
FINANCIAL
INFORMATION
|
|
|
ITEM
1.
|
CO
NSOLIDA
TED FINANCIAL
STATEMENTS
|
OccuLogix,
Inc.
CONSOLIDATED
BALANCE SHEETS
(expressed
in U.S. dollars
)
(Unaudited)
(Going
Concern Uncertainty – See Note 1)
|
|
September
30,
2008
|
|
|
December
31,
2007
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
As
restated
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
|
2,107,933
|
|
|
|
2,235,832
|
|
Cash
restricted in use
|
|
|
200,000
|
|
|
|
―
|
|
Short-term
investments
|
|
|
413,678
|
|
|
|
―
|
|
Amounts
receivable, net
|
|
|
29,211
|
|
|
|
374,815
|
|
Prepaid
expenses
|
|
|
209,211
|
|
|
|
481,121
|
|
Deposits
|
|
|
21,680
|
|
|
|
10,442
|
|
Total
current assets
|
|
|
2,981,713
|
|
|
|
3,102,210
|
|
Fixed
assets, net
|
|
|
123,094
|
|
|
|
122,286
|
|
Patents
and trademarks, net
|
|
|
218,833
|
|
|
|
139,437
|
|
Investments
|
|
|
―
|
|
|
|
863,750
|
|
Other
non-current assets
|
|
|
249,504
|
|
|
|
―
|
|
Intangible
assets, net
|
|
|
9,871,654
|
|
|
|
11,085,054
|
|
Total
assets
|
|
|
13,444,798
|
|
|
|
15,312,737
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
434,652
|
|
|
|
1,192,807
|
|
Accrued
liabilities
|
|
|
3,462,124
|
|
|
|
2,873,451
|
|
Due
to stockholders
|
|
|
15,517
|
|
|
|
32,814
|
|
Deferred
revenue
|
|
|
97,444
|
|
|
|
―
|
|
Obligations
under warrants
|
|
|
68,281
|
|
|
|
―
|
|
Short-term
liabilities and accrued interest
|
|
|
7,008,755
|
|
|
|
―
|
|
Total
current liabilities
|
|
|
11,086,773
|
|
|
|
4,099,072
|
|
Deferred
income tax liability
|
|
|
2,379,814
|
|
|
|
2,259,348
|
|
Total
liabilities
|
|
|
13,466,587
|
|
|
|
6,358,420
|
|
Minority
interest
|
|
|
3,124,958
|
|
|
|
4,953,960
|
|
Stockholders’
equity (deficiency)
|
|
|
|
|
|
|
|
|
Capital
stock
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
57,306
|
|
|
|
57,306
|
|
Par
value of $0.025 per share
|
|
|
|
|
|
|
|
|
Authorized:
40,000,000; Issued and outstanding:
|
|
|
|
|
|
|
|
|
September
30, 2008 – 2,292,280; December 31, 2007 – 2,292,280
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
362,181,935
|
|
|
|
362,232,031
|
|
Accumulated
deficit
|
|
|
(365,385,988
|
|
|
|
(358,288,980
|
)
|
Total
stockholders’ equity (deficiency)
|
|
|
(3,146,747
|
|
|
|
4,000,357
|
|
Total
liabilities and stockholders’ equity (deficiency)
|
|
|
13,444,798
|
|
|
|
15,312,737
|
|
See
accompanying notes to interim consolidated financial statements
OccuLogix,
Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(expressed
in U.S. dollars except number of shares)
(Unaudited)
|
|
Three
months ended
|
|
|
|
September
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
As
restated
|
|
Revenue
|
|
|
|
|
|
|
|
Retina
|
|
|
23,900
|
|
|
|
—
|
|
Total
revenue
|
|
|
23,900
|
|
|
|
—
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
Retina
|
|
|
|
|
|
|
|
|
Cost
of goods sold, net of goods recovered
|
|
|
1,945
|
|
|
|
2,262,411
|
|
Royalty
costs
|
|
|
—
|
|
|
|
25,000
|
|
Total
cost of goods sold
|
|
|
1,945
|
|
|
|
2,287,411
|
|
|
|
|
21,955
|
|
|
|
(2,287,411
|
)
|
Operating
expenses
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
947,830
|
|
|
|
2,471,586
|
|
Clinical
and regulatory
|
|
|
671,612
|
|
|
|
3,076,010
|
|
Sales
and marketing
|
|
|
218,895
|
|
|
|
501,868
|
|
Restructuring
charges
|
|
|
74,128
|
|
|
|
—
|
|
Impairment
of intangible asset
|
|
|
—
|
|
|
|
20,923,028
|
|
|
|
|
1,912,465
|
|
|
|
26,972,492
|
|
Loss
from operations
|
|
|
(1,890,510
|
)
|
|
|
(29,259,903
|
)
|
Other
income (expense)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
17,946
|
|
|
|
137,137
|
|
Changes
in fair value of warrant obligation
|
|
|
(68,281
|
)
|
|
|
856,969
|
|
Interest
expense
|
|
|
(169,540
|
)
|
|
|
(588
|
)
|
Amortization
of deferred financing charges
|
|
|
(48,000
|
)
|
|
|
—
|
|
Other
|
|
|
131,655
|
|
|
|
(5,693
|
)
|
Minority
interest
|
|
|
1,393,410
|
|
|
|
217,436
|
|
|
|
|
1,257,190
|
|
|
|
1,205,261
|
|
Loss
from continuing operations before income taxes
|
|
|
(633,320
|
)
|
|
|
(28,054,642
|
)
|
Income
tax (expense) recovery
|
|
|
(1,649,632
|
)
|
|
|
8,449,188
|
|
Loss
from continuing operations
|
|
|
(2,282,952
|
)
|
|
|
(19,605,454
|
)
|
Loss
from discontinued operations
|
|
|
—
|
|
|
|
(1,082,842
|
)
|
Net
loss for the period
|
|
|
(2,282,952
|
)
|
|
|
(20,688,296
|
)
|
Weighted
average number of shares outstanding - basic and diluted
|
|
|
2,292,280
|
|
|
|
2,292,280
|
|
Net
Loss per share – basic and diluted
|
|
|
(1.00
|
)
|
|
|
(9.03
|
)
|
See
accompanying notes to interim consolidated financial statements
OccuLogix,
Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(expressed
in U.S. dollars except number of shares)
(Unaudited)
|
|
Nine
months ended
|
|
|
|
September
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
As
restated
|
|
Revenue
|
|
|
|
|
|
|
Retina
|
|
|
158,300
|
|
|
|
90,000
|
|
Total
revenue
|
|
|
158,300
|
|
|
|
90,000
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
Retina
|
|
|
|
|
|
|
|
|
Cost
of goods sold, net of goods recovered
|
|
|
1,501
|
|
|
|
2,277,807
|
|
Royalty
costs
|
|
|
25,000
|
|
|
|
75,000
|
|
Total
cost of goods sold
|
|
|
26,501
|
|
|
|
2,352,807
|
|
|
|
|
131,799
|
|
|
|
(2,262,807
|
)
|
Operating
expenses
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
3,817,886
|
|
|
|
7,686,264
|
|
Clinical
and regulatory
|
|
|
2,502,792
|
|
|
|
7,204,181
|
|
Sales
and marketing
|
|
|
629,337
|
|
|
|
1,499,843
|
|
Restructuring
charges
|
|
|
1,029,646
|
|
|
|
—
|
|
Impairment
of intangible asset
|
|
|
—
|
|
|
|
20,923,028
|
|
|
|
|
7,979,661
|
|
|
|
37,313,316
|
|
Loss
from operations
|
|
|
(7,847,862
|
)
|
|
|
(39,576,123
|
)
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
68,495
|
|
|
|
568,809
|
|
Changes
in fair value of warrant obligation
|
|
|
(68,281
|
)
|
|
|
1,633,700
|
|
Interest
expense
|
|
|
(305,256
|
)
|
|
|
(8,242
|
)
|
Amortization
of deferred financing charges
|
|
|
(180,000
|
)
|
|
|
—
|
|
Impairment
of investment charge
|
|
|
(450,072
|
)
|
|
|
—
|
|
Other
|
|
|
151,893
|
|
|
|
(13,633
|
)
|
Minority
interest
|
|
|
1,964,540
|
|
|
|
783,447
|
|
|
|
|
1,181,319
|
|
|
|
2,964,081
|
|
Loss
from continuing operations before income taxes
|
|
|
(6,666,543
|
)
|
|
|
(36,612,042
|
)
|
Income
tax (expense) recovery
|
|
|
(430,465
|
)
|
|
|
11,615,549
|
|
Loss
from continuing operations
|
|
|
(7,097,008
|
)
|
|
|
(24,996,493
|
)
|
Loss
from discontinued operations
|
|
|
—
|
|
|
|
(3,267,891
|
)
|
Net
loss for the period
|
|
|
(7,097,008
|
)
|
|
|
(28,264,384
|
)
|
Weighted
average number of shares outstanding - basic and diluted
|
|
|
2,292,280
|
|
|
|
2,256,871
|
|
Net
loss per share – basic and diluted
|
|
|
(3.10
|
)
|
|
|
(12.52
|
)
|
See
accompanying notes to interim consolidated financial statements
OccuLogix,
Inc.
CONSOLIDATED
STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(expressed
in U.S. dollars)
(Unaudited)
|
|
Voting
common stock at par value
|
|
|
Additional
paid-in
|
|
|
Accumulated
|
|
|
Net
stockholders’ equity
|
|
|
|
shares
issued
|
|
|
capital
|
|
|
deficit
|
|
|
(deficiency)
|
|
|
|
#
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2007 - restated
|
|
|
2,292,280
|
|
|
|
57,306
|
|
|
|
362,232,031
|
|
|
|
(358,288,980
|
)
|
|
|
4,000,357
|
|
Stock-based
compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
(50,096
|
)
|
|
|
—
|
|
|
|
(50,096
|
)
|
Net
loss for the nine month period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(7,097,008
|
)
|
|
|
(7,097,008
|
)
|
Balance,
September 30, 2008
|
|
|
2,292,280
|
|
|
|
57,306
|
|
|
|
362,181,935
|
|
|
|
(365,385,988
|
)
|
|
|
(3,146,747
|
)
|
See
accompanying notes to interim consolidated financial statements
OccuLogix,
Inc.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(expressed
in U.S. dollars)
(Unaudited)
|
|
Nine
months ended
September
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
As
restated
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
Net
loss for the period
|
|
|
(7,097,008
|
)
|
|
|
(28,264,384
|
)
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Write-down
of inventory
|
|
|
—
|
|
|
|
2,782,494
|
|
Stock-based
compensation and stock-based restructuring charges
|
|
|
(50,096
|
)
|
|
|
1,362,813
|
|
Amortization
and write-down of fixed assets
|
|
|
42,296
|
|
|
|
730,201
|
|
Amortization
and write-down of patents and trademarks
|
|
|
16,174
|
|
|
|
195,495
|
|
Amortization
of intangible asset
|
|
|
903,400
|
|
|
|
4,489,655
|
|
Amortization
of deferred financing charges
|
|
|
180,000
|
|
|
|
—
|
|
Provision
for obligation under warrants
|
|
|
68,281
|
|
|
|
—
|
|
Impairment
of intangible asset
|
|
|
—
|
|
|
|
20,923,028
|
|
Accretion
expense
|
|
|
—
|
|
|
|
632,471
|
|
Changes
in fair value of warrant obligation
|
|
|
—
|
|
|
|
(1,633,700
|
)
|
Impairment
of investments
|
|
|
450,072
|
|
|
|
—
|
|
Deferred
tax liability, net
|
|
|
430,465
|
|
|
|
(14,786,470
|
)
|
Minority
interest
|
|
|
(1,964,540
|
)
|
|
|
(783,447
|
)
|
Options
of OcuSense Inc. vested for minority shareholders
|
|
|
135,538
|
|
|
|
84,838
|
|
Loss
on disposal of fixed assets
|
|
|
7,584
|
|
|
|
—
|
|
Net
change in non-cash working capital balances related to
operations
|
|
|
572,692
|
|
|
|
965,871
|
|
Cash
used in operating activities
|
|
|
(6,305,142
|
)
|
|
|
(13,301,135
|
)
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
Sale
of short-term investments
|
|
|
—
|
|
|
|
7,785,000
|
|
Additions
to fixed assets, net of proceeds
|
|
|
(50,686
|
)
|
|
|
(190,341
|
)
|
Additions
to patents and trademarks
|
|
|
(95,571
|
)
|
|
|
(91,010
|
)
|
Cash
restricted in use
|
|
|
(200,000
|
)
|
|
|
—
|
|
Payment
for acquisition of Solx, Inc., net of cash acquired
|
|
|
—
|
|
|
|
(3,000,000
|
)
|
Cash
provided by (used in) investing activities
|
|
|
(346,257
|
)
|
|
|
4,503,649
|
|
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
Proceeds
from the exercise of common stock options
|
|
|
—
|
|
|
|
2,228
|
|
Proceeds
from issuance of common stock
|
|
|
—
|
|
|
|
10,016,000
|
|
Proceeds
from issuance of the bridge financings
|
|
|
6,703,500
|
|
|
|
—
|
|
Issuance
costs
|
|
|
(180,000
|
)
|
|
|
(816,493
|
)
|
Cash
provided by financing activities
|
|
|
6,523,500
|
|
|
|
9,201,735
|
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents during the
period
|
|
|
(127,899
|
)
|
|
|
404,249
|
|
Cash
and cash equivalents, beginning of period
|
|
|
2,235,832
|
|
|
|
5,740,697
|
|
Cash
and cash equivalents, end of period
|
|
|
2,107,933
|
|
|
|
6,144,946
|
|
See
accompanying notes to interim consolidated financial statements
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(expressed
in U.S. dollars except as otherwise stated)
September
30, 2008
(Unaudited)
1.
|
BASIS
OF PRESENTATION, GOING CONCERN UNCERTAINTY AND SIGNIFICANT ACCOUNTING
POLICIES
|
Basis
of presentation
The
accompanying unaudited interim consolidated financial statements have been
prepared in accordance with United States generally accepted accounting
principles, referred to as U.S. GAAP. These unaudited interim consolidated
financial statements contain all normal recurring adjustments and estimates
necessary to present fairly the financial position of OccuLogix, Inc. , referred
to as OccuLogix or the Company, as at September 30, 2008 and the results of its
operations for the three and nine months then ended. These unaudited interim
consolidated financial statements should be read in conjunction with the
restated consolidated financial statements and notes included in the Company’s
latest Annual Report on Form 10K/A filed with the U.S. Securities and Exchange
Commission, or the SEC, on August 27, 2008. Interim results are not necessarily
indicative of results for a full year.
Reverse
Stock Split
On
September 30, 2008, the Company’s Board of Directors approved a reverse stock
split referred to as the Reverse Stock Split with an effective date of October
7, 2008 of the Company’s Common Stock utilizing a 1:25 consolidation ratio. As a
result of the Reverse Stock Split, every twenty-five shares of the Company’s
issued and outstanding Common Stock were consolidated into one share of the
Company’s Common Stock respectively. In addition, the exercise prices of the
Company’s stock options and the conversion prices of the Company’s outstanding
warrants have been adjusted, such that, the number of shares potentially
issuable on the exercise of stock options and/or the exercise of warrants will
reflect the 1:25 consolidation ratio. Accordingly, all of the
Company’s issued and outstanding Common Stock and all outstanding stock options
to purchase Common Stock and warrants to purchase Common Stock for all periods
presented have been restated to reflect the Reverse Stock Split.
Going
concern uncertainty
The
consolidated financial statements have been prepared on the basis that the
Company will continue as a going concern. However, the Company has sustained
substantial losses of $69,829,983 for the year ended December 31, 2007 and
$5,768,903 and $28,264,384 for the nine months ended September 30, 2008 and
2007, respectively. The Company’s working capital deficiency at September 30,
2008 is $8,105,060, which represents a $7,108,198 increase in its working
capital deficiency from $996,862 at December 31, 2007. As a result of
the Company’s history of losses and financial condition, there is substantial
doubt about the ability of the Company to continue as a going
concern.
On
February 19, 2008, the Company announced that it had secured a bridge loan in an
aggregate principal amount of $3,000,000 (less transaction costs
of $180,000) from a number of private parties. The loan bore interest at a
rate of 12% per annum and had a 180-day term, which was extended to 270 days.
The Company pledged its shares of the capital stock of OcuSense, Inc., or
OcuSense, as collateral for the loan.
On May 5,
2008, the Company announced that it had secured a bridge loan in an aggregate
principal amount of $300,000 from a number of private parties, referred to as
the Additional Bridge Loan I. The Additional Bridge Loan I constituted an
increase to the principal amount of the $3,000,000 principal amount bridge loan
that the Company announced on February 19, 2008, or the Original Bridge Loan,
and was advanced on substantially the same terms and conditions as the Original
Bridge Loan, pursuant to an amendment of the loan agreement for the Original
Bridge Loan. The Additional Bridge Loan I bore interest at a rate of 12% per
annum and had the same maturity date as the Original Bridge Loan. The Company
pledged its shares of the capital stock of OcuSense as collateral for the
loan.
On July
28, 2008, the Company announced that it had secured an additional bridge loan in
an aggregate principal amount of $3,403,500
from a number of private
parties, referred to as the Additional Bridge Loan II. $2,893,500 of the
principal amount of the Additional Bridge Loan II was advanced by certain of the
investors who had agreed to purchase shares of the Company’s common stock in the
proposed private placement of $5,066,500 of the Company’s common stock, first
announced on May 20, 2008. The Company agreed to reduce the dollar
amounts of these investors’ respective commitments in the private placement by
the principal amount of the Additional Bridge Loan II that each of them advanced
to the Company. The Company closed the private placement for gross aggregate
proceeds of $2,173,000. (See Note 22 A – Subsequent Events.)
The
Additional Bridge Loan II constituted an increase to the principal amount of the
$3,300,000 principal amount bridge loan of the Company that was outstanding, The
Original Bridge Loan of $3,000,000 was advanced on February 19, 2008, and the
Additional Bridge Loan I of $300,000 was advanced on May 5, 2008. The
Additional Bridge Loan II was advanced on substantially the same terms and
conditions as the Original Bridge Loan, pursuant to a further amendment to the
amended loan agreement governing the Original Bridge Loan.
The
Additional Bridge Loan II bore interest at a rate of 12% per annum and had the
same maturity date as the Original Bridge Loan. Like the repayment of
the Original Bridge Loan, the repayment of the Additional Bridge Loan II was
secured by a pledge by the Company of its majority ownership interest in
OcuSense.
Under the
terms of the loan agreement that governs the Original Bridge Loan, OccuLogix had
two prepayment options available to it, should it decide to not wait until the
maturity date to repay the loan. The Company has declared its
intention to exercise one of these prepayment options and proposes to repay the
Original Bridge Loan in full by issuing to the lenders shares of its common
stock, in an aggregate amount equal to the amount of outstanding principal and
accrued interest, at a 15% discount to the price paid by the private placement
investors. The Company prepaid the Additional Bridge Loans I and II
in the same manner. The prepayment of the Original Bridge Loan and
the Additional Bridge Loans I and II resulted in the issuance of a
3,304,511 shares of OccuLogix’s common stock, for which stockholder and
regulatory approval was obtained at the annual shareholders meeting on September
30, 2008. (See Note 22 A – Subsequent Events.)
The
proceeds of the Additional Bridge Loan II will be used for general corporate
purposes of the Company and OcuSense. Management believes that these proceeds,
together with the Company’s existing cash and the proceeds of the private
placement and full recovery of the outstanding auction rate securities, will be
sufficient to cover its operating activities and other demands only until
approximately June 2009. The Company currently is not generating cash
from operations, and most of its cash has been, and is being, utilized to fund
its operations and to fund deferred acquisition payments. The Company’s
operating expenses in the nine months ended September 30, 2008 have consisted
mostly of expenses relating to the completion of the product development of the
TearLab™ test for dry eye disease, or DED. Unless the Company raises
additional capital, it will not have sufficient cash to support its operations
beyond approximately June 2009.
On
October 9, 2007, the Company announced that its Board of Directors, or the
Board, had authorized management and the Company’s advisors to explore the full
range of strategic alternatives available to enhance shareholder value. These
alternatives may include, but are not limited to, the raising of capital through
the sale of securities, one or more strategic alliances and the combination,
sale or merger of all or part of OccuLogix. In making the announcement, the
Company stated that there can be no assurance that the exploration of strategic
alternatives will result in a transaction.
For some
time prior to the October 9, 2007 announcement, the Company had been seeking to
raise additional capital, with the objective of securing funding sufficient to
sustain its operations as it had been clear that, unless the Company was able to
raise additional capital, the Company would not have had sufficient cash to
support its operations beyond early 2008. The Board’s decisions to suspend the
Company’s RHEO™ System clinical development program and to dispose of SOLX Inc.,
or SOLX, were made and implemented in order to conserve as much cash as possible
while the Company continued its capital-raising efforts.
On
January 9, 2008, the Company announced the departure, or pending departure, of
seven members of its executive team and, commencing on February 1, 2008, a 50%
reduction in the salary of each of Elias Vamvakas, its Chairman and Chief
Executive Officer, and Tom Reeves, its former President and Chief Operating
Officer. By January 31, 2008, a total of 12 non-executive employees
of the Company left the Company’s employment. On June 30, 2008, Tom
Reeves also left the Company.
As at
September 30, 2008, the Company had investments in the aggregate principal
amount of $1,900,000 which consist of investments in four separate asset-backed
auction rate securities yielding an average return of 3.471% per
annum. However, as a result of market conditions, all of these
investments have recently failed to settle on their respective settlement dates
and have been reset to be settled at future dates with an average maturity of 43
days. Due to the current lack of liquidity for asset-backed
securities, or ARS, of this type, throughout 2008 the Company has concluded that
the carrying value of these investments was higher than their fair value.
Accordingly, these ARS were recorded at their estimated fair value which at
September 30, 2008 was $413,678, which represents a decline of $1,486,322 in the
carrying value of these investments. The Company considered this to be an
other-than-temporary reduction in the value. Accordingly, the loss
associated with these ARS of $450,072 in 2008 has been included as an impairment
of investments in the Company’s consolidated statement of operations for the
nine months ended September 30, 2008. As a result of a recent settlement
agreement among the New York Attorney General’s Office, the North American
Securities Administrators Association and Credit Suisse (USA) LLC, or Credit
Suisse, the financial institution through which the Company had purchased its
ARS, subsequent to September 30, 2008, the Company had the opportunity to have
Credit Suisse purchase from the Company, for full value plus accrued interest,
all of the Company’s outstanding ARS. Credit Suisse purchased all of these
ARS at the Company’s original cost of $1,900,000, plus accrued interest, when
each of these securities came up for auction. (See Note 22 C – Subsequent
Events.)
Previously
the Company did not know when it would be able to convert these investments into
cash and accordingly, management had classified these investments as a
non-current asset on its consolidated balance sheet in comparative periods. As a
result of the subsequent events discussed above, management has classified these
investments as current assets on its consolidated balance sheet as of September
30, 2008.
The ARS
investments are classified as available-for-sale under Statement of Financial
Accounting Standards (“SFAS”) No. 115- “Accounting for Certain Investments in
Debt and Equity” or SFAS No. 115, which states that where an impairment of an
available-for-sale investment has been reported, this impairment can only be
reversed when a recovery or gain of the amount reflected as an impairment charge
has been realized. At September 30, 2008, Credit Suisse had not yet purchased
any of the Company’s outstanding ARS and as such the Company has not reported
the recovery of the impairment charge and continues to reflect the ARS at
$413,678 consistent with the fair value reported by the Company in its prior
June 30, 2008 interim consolidated financial statements. No value has been
determined at September 30, 2008 regarding the existence of an obligation by
Credit Suisse to purchase the outstanding ARS from the Company subsequent to
September 30, 2008.
Prior to
September 30, 2008, the Company established a bank account in the Company’s name
and identified it as being in trust. The purpose of this trust
account was to accumulate the private placement funds subsequent to shareholder
approval at the September 30, 2008 shareholders’ meeting and prior to the
closing of the private placement transaction early in October 2008. While the
bank account was in the Company’s name, any funds in this trust account were not
available to the Company unless and until the private placement transaction
closed. Prior to September 30, 2008, $200,000 of funds from a member of the
private placement investors was deposited into the trust account. The Company
reported this amount as Cash restricted in use and set up a liability to the
investor in the same amount.
The
unaudited interim consolidated financial statements do not include any
adjustment relating to the recoverability and classification of recorded asset
amounts or the amounts and classification of liabilities that might be necessary
if the Company were not able to continue its existence as a going
concern.
Significant
accounting policies
These
unaudited interim consolidated financial statements have been prepared using
significant accounting policies that are consistent with the policies used in
preparing the Company’s audited consolidated financial statements for the year
ended December 31, 2007.
Management
believes that all adjustments necessary for the fair presentation of results,
consisting of normally recurring items, have been included in the unaudited
consolidated financial statements for the interim periods presented. The
preparation of financial statements in conformity with U.S. GAAP, requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those
estimates. The principal areas of judgment relate to the impairment of
long-lived and intangible assets, valuation of investments in marketable
securities and the value of stock option and warrant programs.
Recent
accounting pronouncements
In
September 2006, the Financial Accounting Standards Board, or FASB, issued
SFAS, No. 157, “Fair Value Measurements,” or SFAS No. 157. This standard
defines fair value, establishes a framework for measuring fair value in U.S.
GAAP and expands disclosure about fair value measurements. This pronouncement
applies to other accounting standards that require or permit fair value
measurements. Accordingly, this statement does not require any new fair value
measurement. This statement is effective for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. In
December 2007, FASB agreed to a one-year deferral of SFAS No. 157’s fair value
measurement requirements for non-financial assets and liabilities that are not
required or permitted to be measured at fair value on a recurring basis. The
Company adopted SFAS No. 157 on January 1, 2008, which had no effect
on the Company’s consolidated financial statements. Refer to Note 9, Fair Value
Measurements for additional information related to the adoption of SFAS
No. 157.
In
February 2007, FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities—Including an amendment of FASB
Statement No. 115,” or SFAS No. 159. SFAS No. 159 expands the use of fair
value accounting but does not affect existing standards which require assets or
liabilities to be carried at fair value. Under SFAS No. 159, a company may elect
to use fair value to measure accounts and loans receivable, available-for-sale
and held-to-maturity securities, equity method investments, accounts payable,
guarantees and issued debt. Other eligible items include firm commitments for
financial instruments that otherwise would not be recognized at inception and
non-cash warranty obligations where a warrantor is permitted to pay a third
party to provide the warranty goods or services. If the use of fair value is
elected, any up-front costs and fees related to the item must be recognized in
earnings and cannot be deferred (e.g., debt issue costs). The fair value
election is irrevocable and generally made on an instrument-by-instrument basis,
even if a company has similar instruments that it elects not to measure based on
fair value. At the adoption date, unrealized gains and losses on existing items
for which fair value has been elected are reported as a cumulative adjustment to
beginning retained earnings. Subsequent to the adoption of SFAS No. 159, changes
in fair value are recognized in earnings. SFAS No. 159 is effective for fiscal
years beginning on or after November 15, 2007 and is required to be adopted
by the Company in the first quarter of fiscal 2008. The adoption of SFAS No. 159
has not had a material impact on the Company’s results of operations and
financial position.
On June
14, 2007, FASB ratified Emerging Issues Task Force, or EITF, 07-3, “Accounting
for Non-Refundable Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities,” or EITF 07-3. EITF 07-3 requires that all
non-refundable advance payments for research and development activities that
will be used in future periods be capitalized until used. In addition, the
deferred research and development costs need to be assessed for recoverability.
EITF 07-3 is applicable for fiscal years beginning after December 15, 2007 and
is to be applied prospectively without the option of early application. The
adoption of EITF 07-3 has not had a material impact on the Company’s
results of operations and financial position.
On
December 4, 2007, FASB issued SFAS No. 141(R) (revised 2007), “Business
Combinations,” or SFAS No. 141(R), and SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements” “or SFAS No 160”. Effective for
fiscal years beginning after December 15, 2008, the standards will improve,
simplify and converge internationally the accounting for business combinations
and the reporting of non-controlling interests in consolidated financial
statements.
SFAS No.
141(R) improves reporting by creating greater consistency in the accounting and
financial reporting of business combinations, resulting in more complete,
comparable and relevant information for investors and other users of financial
statements. To achieve this goal, the new standard requires the acquiring entity
in a business combination to recognize all (and only) the assets acquired and
liabilities assumed in the transaction; establishes the acquisition-date fair
value as the measurement objective for all assets acquired and liabilities
assumed; and requires the acquirer to disclose to investors and other users all
of the information they need to evaluate and understand the nature and financial
effect of the business combination.
SFAS No.
160 improves the relevance, comparability and transparency of financial
information provided to investors by requiring all entities to report
non-controlling (minority) interests in subsidiaries in the same way - as equity
in the consolidated financial statements. Moreover, SFAS No. 160 eliminates the
diversity that currently exists in accounting for transactions between an entity
and non-controlling interests by requiring they be treated as equity
transactions.
Early
adoption of SFAS No. 141(R) and SFAS No. 160 is prohibited. Management is
currently evaluating the requirements of these standards and has not yet
determined the impact, if any, on the Company’s consolidated financial
statements.
In
March 2008, FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities - An Amendment of FASB Statement
No. 133,” or SFAS No. 161. SFAS No. 161 enhances the required
disclosures regarding derivatives and hedging activities, including disclosures
regarding how an entity uses derivative instruments, how derivative instruments
and related hedged items are accounted for under SFAS No. 133, “Accounting
for Derivative Instruments and Hedging Activities,” and how derivative
instruments and related hedged items affect an entity’s financial position,
financial performance and cash flows.
SFAS
No. 161 is effective for fiscal years beginning after November 15,
2008. Management is currently evaluating the requirements of SFAS No. 161
and has not yet determined the impact, if any, on the Company’s consolidated
financial statements.
In June
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles” or SFAS No. 162. SFAS No. 162 identifies the sources of
accounting principles and the framework for selecting the principle used in the
preparation of financial statements presented in conformity with U.S. GAAP. This
Statement is effective 60 days following the SEC’s approval of the Public
Company Accounting Oversight Board amendment to AU Section 411, “
The Meaning of
Present Fairly
in Conformity with Generally Accepted Accounting Principles”. The adoption of
SFAS No. 162 is not expected to have any impact on the Company’s consolidated
financial statements.
2.
|
RESTATEMENT
OF CONSOLIDATED FINANCIAL
STATEMENTS
|
Correction
of an error in comparative periods related to the method of consolidation of
OcuSense, Inc.
During
the second quarter of 2008, the Company restated its consolidated financial
statements.
Background
Information
On
November 30, 2006, OccuLogix acquired 1,754,589 Series A preferred shares of
OcuSense. The purchase price of these shares was made up of two fixed payments
of $2.0 million, one to be made on the November 30, 2006 date of the
closing of the transaction and the other on January 3, 2007. In
addition, subject to OcuSense achieving certain milestones, the Company was
required to pay two additional milestone payments of $2.0 million
each.
Upon
acquiring the Series A preferred shares, OccuLogix and the existing common
shareholders entered into a voting agreement. The voting agreement
provides the founding shareholders of OcuSense, as defined in the voting
agreement, with the right to appoint two directors and OccuLogix with the right
to also appoint two directors. A selection of a fifth director is
mutually agreed upon by both OccuLogix and the founding stockholders, each
voting as a separate class. The voting agreement is subject to
termination under the following scenarios: a) a change of control; b) majority
approval of each of OccuLogix and the founding stockholders; and c) conversion
of all outstanding shares of the Company’s preferred shares to common
shares. OccuLogix has the ability to force the conversion of all of
the preferred shares to common shares and thus has the ability to effect a
termination of the voting agreement, but this would require conversion of its
own preferred shares and the relinquishment of the rights and obligations
associated with the preferred shares.
The
rights and obligations of the Series A preferred shareholders are as
follows:
·
|
Voting
– Holders of the Series A preferred shares are entitled to vote on an
as-converted basis. Each Series A preferred share is entitled
to one vote per share.
|
·
|
Conversion
features – Series A preferred shares are convertible to common
shares on a one-for-one basis at the option of
OccuLogix.
|
·
|
Dividends
– The preferred shares are entitled to non-cumulative dividends at 8%, and
additional dividends would be shared between common and preferred shares
on a per-share basis.
|
·
|
Redemption
features – Subsequent to November 30, 2011, the preferred shares may be
redeemed, at the option of OccuLogix, at the higher of the original issue
price and the fair market value of the common shares into which the
preferred shares could be
converted.
|
·
|
Liquidation
preferences – Series A preferred shares have a liquidation preference over
common shares up to the original issue price of the preferred shares
(including the milestone payments).
|
Immediately
after the OccuLogix investment in OcuSense, OcuSense had the following capital
structure:
Description
|
|
Number
|
|
Common
shares
|
|
|
1,222,979
|
|
Series
A preferred shares – OccuLogix
|
|
|
1,754,589
|
|
Series
A preferred shares – Other unrelated parties
|
|
|
67,317
|
|
Total
|
|
|
3,044,885
|
|
|
|
|
|
|
Potentially
dilutive instruments
|
|
|
|
|
Warrants
|
|
|
89,965
|
|
Stock
options
|
|
|
367,311
|
|
Fully
diluted
|
|
|
3,502,161
|
|
Based on
the above capital structure, on a fully diluted basis, OccuLogix’s voting
percentage was determined to be 50.1%. On a current voting basis,
OccuLogix’s voting interest is 57.62%. The Company previously consolidated
OcuSense based on an ownership percentage of 50.1%
Interpretation and Related
Accounting Treatment
Since
November 30, 2006, the date of the acquisition, the Company has consolidated
OcuSense on the basis of a voting control model, as a result of the fact that it
owns more than 50% of the voting stock of OcuSense and the fact that the
Company has the ability to convert its Series A preferred shares into common
shares, which would result in termination of the voting agreement between the
founders and OccuLogix and which would result in OccuLogix gaining control of
the board of directors.
However,
after further consideration, the Company has now determined that, as a result of
the voting agreement between OccuLogix and certain founding stockholders of
OcuSense, OccuLogix is not able to exercise voting control as contemplated in
Accounting Research Bulletin, or ARB, 51, “Consolidated Financial Statements,”
or ARB 51, unless the Company converts its Series A preferred
shares. For the purpose of assessing voting control in accordance
with ARB 51, U.S. GAAP does not take into consideration such conversion rights.
Accordingly, OccuLogix does not have the ability to exercise control of
OcuSense, in light of the voting agreement that existed as of September 30, 2008
between the founding stockholders and OccuLogix.
In
addition to the above consideration, the Company determined that OcuSense is a
variable interest entity, or VIE, and that OccuLogix is the primary beneficiary
based on the following:
·
|
OcuSense
is a development stage enterprise (as defined under SFAS No. 7,
“Accounting and Reporting by Development Stage Enterprises”) and therefore
is not considered to be a business under U.S.
GAAP. Accordingly, OcuSense is not subject to the business
scope exception.
|
·
|
The
Company noted that the holders of the Series A preferred shares (including
OccuLogix) have the ability to redeem their shares at the greater of their
original subscription price and their fair value on an as-converted
basis. As such, their investment is not considered to be
at-risk equity.
|
·
|
Additionally,
as a result of the voting agreement between OccuLogix and the founding
stockholders of OcuSense, voting control of OcuSense is shared between
OccuLogix and OcuSense. Accordingly, the common stockholders,
who represent the sole class of at-risk equity, cannot make decisions
about an entity’s activities that have a significant effect on the success
of the entity without the concurrence of
OccuLogix.
|
FIN
46(R), “Consolidation of Variable Interest Entities,” or FIN 46(R), requires
that the enterprise which consolidates the VIE be the primary beneficiary of
that entity. The primary beneficiary is the entity that will absorb a majority
of the VIE’s expected losses, receive a majority of the entity’s expected
returns, or both. At the time of acquisition, it was expected that the Company
would contribute virtually all of the required funding until commercialization
through the acquisition of the Series A preferred shares and future milestone
payments as described above. The common stockholders were expected to
make nominal equity contributions during this period. Therefore,
based primarily on qualitative considerations, the Company believes that it is
the primary beneficiary of OcuSense and should consolidate OcuSense using the
variable interest model.
The
Company has noted that the initial measurement of assets, liabilities and
non-controlling interests under FIN 46(R) differs from that which is required
under SFAS No. 141, “Business Combinations”. In particular, under FIN
46(R), assets, liabilities and non-controlling interest shall be measured
initially at their fair value. The Company previously recorded non-controlling
interest based on the historical carrying values of OcuSense’s assets and
liabilities, and as a result consolidation under FIN 46(R) resulted in material
revisions to the amounts previously reported in the Company’s consolidated
financial statements.
Assets
acquired and liabilities assumed consisted solely of working capital and of a
technology intangible asset relating to patents owned by
OcuSense. Before consideration of deferred tax, the fair value of the
assets acquired was greater than the fair value of the liabilities assumed and
the non-controlling interest. Because OcuSense does not comprise a
business, as defined in EITF 98-3, “Determining Whether a Non-monetary
Transaction Involves Receipt of Productive Assets or of a Business”, the
Company applied the simultaneous equation method as per EITF 98-11,
“Accounting for Acquired Temporary Differences in Certain Purchase Transactions
That Are Not Accounted for as Business Combinations”, and adjusted the assigned
value of the non-monetary assets acquired (consisting solely of the technology
asset) to include the deferred tax liability.
The
Company also considered the appropriate accounting for the milestone payments,
as a result of the fact that it has determined that it should apply the initial
measurement guidance in FIN 46(R). The Company notes that subsequent
to initial consolidation, the milestone payment liability represents a
contingent liability to a controlled subsidiary, and as such, the liability will
eliminate on consolidation. Previously, the Company adjusted the
minority interest at the date of each milestone payment to reflect the
non-controlling interest’s share in the additional cash of the subsidiary, with
an offsetting increase to the non-monetary assets acquired (consisting solely of
the technology intangible asset) reflecting the increased actual cost of
obtaining those non-monetary assets.
The
Company notes that because the non-controlling interest is required to be
measured at fair value on acquisition of OcuSense, the fair value of the
milestone payments as of the date of acquisition will be embedded in the initial
measurement of non-controlling interest. As such, it would be
inappropriate to record additional minority interest based on the full amount of
the milestone payment applicable to the minority
interest. Accordingly, the Company has accounted for the milestone
payments as follows:
-
|
The
Company determined the fair value of the milestone payments on the date of
acquisition by incorporating the probability that the milestone payments
will be made, as well as the time value associated with the planned
settlement date of the payments.
|
-
|
Upon
payment of the milestone payments, the Company recorded the minority
interest portion of the change in fair value of the milestone payment
(i.e., the minority interest portion of the ultimate value of the
milestone payment less the initial fair value determination) as an
expense, with a corresponding increase to minority interest, to reflect
the additional value provided to the minority interest in excess of that
contemplated on the acquisition
date.
|
The
following is a summary of the significant effects of the restatements on the
Company’s consolidated balance sheet as of December 31, 2007 and its
consolidated statements of operations for the three months ended September 30,
2007 and its consolidated statements of operations and consolidated statements
of cash flows for the nine months ended September 30, 2007.
|
|
As
at December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
previously reported
|
|
|
Adjustment
|
|
|
As
restated
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
|
Intangible
assets
|
|
|
5,770,677
|
|
|
|
5,314,377
|
|
|
|
11,085,054
|
|
Deferred
income tax liability
|
|
|
—
|
|
|
|
2,259,348
|
|
|
|
2,259,348
|
|
Minority
interest
|
|
|
—
|
|
|
|
4,953,960
|
|
|
|
4,953,960
|
|
Additional
paid-in capital
|
|
|
362,402,899
|
|
|
|
(170,868
|
)
|
|
|
362,232,031
|
|
Accumulated
deficit
|
|
|
(356,560,917
|
)
|
|
|
(1,728,063
|
)
|
|
|
(358,288,980
|
)
|
|
Three
months ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
previously reported
|
|
|
Adjustment
|
|
|
As
restated
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
(2,310,996
|
)
|
|
|
(160,590
|
)
|
|
|
(2,471,586
|
)
|
Minority
interest
|
|
|
703,039
|
|
|
|
(485,603
|
)
|
|
|
217,436
|
|
Recovery
of income taxes
|
|
|
8,831,267
|
|
|
|
(382,079
|
)
|
|
|
8,449,188
|
|
Loss
from continuing operations
|
|
|
(18,577,182
|
)
|
|
|
(1,028,272
|
)
|
|
|
(19,605,454
|
)
|
Loss
from discontinued operations
|
|
|
(1,082,842
|
)
|
|
|
—
|
|
|
|
(1,082,842
|
)
|
Net
loss for the period
|
|
|
(19,660,024
|
)
|
|
|
(1,028,272
|
)
|
|
|
(20,688,296
|
)
|
Loss
per share
|
|
|
(8.58
|
)
|
|
|
|
|
|
|
(9.03
|
)
|
|
Nine
months ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
previously reported
|
|
|
Adjustment
|
|
|
As
restated
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
(7,116,175
|
)
|
|
|
(570,089
|
)
|
|
|
(7,686,264
|
)
|
Minority
interest
|
|
|
1,747,823
|
|
|
|
(964,376
|
)
|
|
|
783,447
|
|
Recovery
of income taxes
|
|
|
11,833,829
|
|
|
|
(218,280
|
)
|
|
|
11,615,549
|
|
Loss
from continuing operations
|
|
|
(23,243,750
|
)
|
|
|
(1,752,744
|
)
|
|
|
(24,996,493
|
)
|
Loss
from discontinued operations
|
|
|
(3,267,891
|
)
|
|
|
—
|
|
|
|
(3,267,891
|
)
|
Net
loss for the period
|
|
|
(26,511,640
|
)
|
|
|
(1,752,744
|
)
|
|
|
(28,264,384
|
)
|
Loss
per share
|
|
|
(11.75
|
)
|
|
|
|
|
|
|
(12.52
|
)
|
|
Nine
months ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
previously reported
|
|
|
Adjustment
|
|
|
As
restated
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Consolidated
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
|
|
|
(13,301,135
|
)
|
|
|
—
|
|
|
|
(13,301,135
|
)
|
Net
loss for the period
|
|
|
(26,511,640
|
)
|
|
|
(1,752,744
|
)
|
|
|
(28,264,384
|
)
|
Amortization
of intangible assets
|
|
|
3,919,566
|
|
|
|
570,089
|
|
|
|
4,489,655
|
|
Deferred
tax liability, net
|
|
|
(15,004,750
|
)
|
|
|
218,280
|
|
|
|
(14,786,470
|
)
|
Minority
interest
|
|
|
(1,747,823
|
)
|
|
|
964,376
|
|
|
|
(783,447
|
)
|
The
Company’s intangible assets consist of the value of the exclusive distribution
agreements that the Company has with its major suppliers and other
acquisition-related intangible assets. The Company has no indefinite-lived
intangible assets. The distribution agreements and other acquisition-related
intangible assets are amortized using the straight-line method over an estimated
useful life of 15 and 10 years, respectively.
The
Company’s other intangible assets consisted of the value of the exclusive
distribution agreements the Company had with Asahi Medical, the manufacturer of
the Rheofilter filters and the Plasmaflo filters, and Diamed Medizintechnik
GmbH, or Diamed, and MeSys GmbH, or MeSys, the designer and the manufacturer,
respectively, of the OctoNova pumps. The Rheofilter filter, the Plasmaflo filter
and the OctoNova pump are components of the RHEO™ System, the Company’s product
for the treatment of Dry AMD. On November 1, 2007, the Company announced an
indefinite suspension of the RHEO™ System clinical development program for Dry
AMD and is in the process of winding down the RHEO-AMD study as there is no
reasonable prospect that the RHEO™ System clinical development program will be
relaunched in the foreseeable future. In accordance with SFAS
No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” or
SFAS No. 144”, the Company concluded that its indefinite suspension of the RHEO™
System clinical development program for Dry AMD was a significant event which
may affect the carrying value of its distribution agreements. Accordingly,
management was required to re-assess whether the carrying value of the Company’s
distribution agreements was recoverable as at December 31, 2007. Based on
management’s estimates of undiscounted cash flows associated with the
distribution agreements, the Company concluded that the carrying value of the
distribution agreements was not recoverable as at December 31, 2007.
Accordingly, the Company recorded an impairment charge of $20,923,028 during the
year ended December 31, 2007 to record the distribution agreements at their fair
value as at December 31, 2007, bringing the net balance to nil.
As a
result, amortization expense from continuing operations for the nine months
ended September 30, 2008 in connection with the RHEO™ System distribution
agreements is nil.
On
December 19, 2007, the Company sold to SOLX Acquisition, Inc., or SOLX
Acquisition, all of the issued and outstanding shares of the capital stock of
SOLX, which had been the Glaucoma division of the Company prior to the
completion of the transactions provided for in the stock purchase agreement. The
sale transaction established fair values for the Company’s recorded goodwill and
the Company’s shunt and laser technology and regulatory and other intangible
assets acquired upon the acquisition of SOLX on September 1, 2006. Accordingly,
management was required to re-assess whether the carrying value of the Company’s
shunt and laser technology and regulatory and other intangible assets was
recoverable as at December 1, 2007. Based on management’s estimates of
undiscounted cash flows associated with these intangible assets, the Company
concluded that the carrying value of these intangible assets was not recoverable
as at December 1, 2007. Accordingly, the Company recorded an impairment charge
of $22,286,383 during the year ended December 31, 2007 to record the shunt and
laser technology and regulatory and other intangible assets at their fair value
as at December 31, 2007, bringing the net balance to nil. The results of
operations of SOLX for the three months and nine months ended September 30, 2007
are classified as results of discontinued operations in these consolidated
financial statements.
As at
September 30, 2008 and 2007, the remaining weighted average amortization period
for the distribution agreement intangible assets is nil and nil years,
respectively.
On
November 30, 2006, the Company acquired 50.1% of the capital stock of OcuSense,
measured on a fully diluted basis, or 57.62% of the capital stock of OcuSense,
measured on an issued and outstanding basis. OcuSense’s first product, which is
currently under development, is a hand-held tear film test for the measurement
of osmolarity, a quantitative and highly specific biomarker that has shown to
correlate with dry eye disease, or DED. The test is known as the TearLab™ test
for DED. The results of OcuSense’s operations have been included in the
Company’s consolidated financial statements since November 30,
2006.
Under FIN
46(R), assets, liabilities and non-controlling interest shall be measured at
their fair value. The Company previously recorded non-controlling interest at
historical carrying values. As a result, consolidation under FIN 46(R) results
in material revisions to the amounts previously reported in the Company’s
consolidated financial statements.
Assets
acquired and liabilities assumed consisted solely of working capital and of a
technology intangible asset relating to patents owned by
OcuSense. The Company anticipates that before consideration of
deferred tax, the fair value of the assets acquired will be greater than the
fair value of the liabilities assumed and the non-controlling interest. Because
OcuSense does not comprise a business, as defined in EITF 98-3, “Determining
Whether a Non-monetary Transaction Involves Receipt of Productive Assets or of a
Business”, the Company applied the simultaneous equation method as per EITF
98-11, and adjusted the assigned value of the non-monetary assets
acquired (consisting solely of the technology asset) to include the deferred tax
liability.
In
estimating the fair value of the intangible assets acquired, the Company
considered a number of factors, including discussions with OcuSense management,
review of historical financial information, future revenue and expense estimates
and a review of the economic and competitive environment. As a result, the
Company used the income approach to value OcuSense’s TearLab™ technology and the
cost approach to value the intangible assets acquired.
Intangible
assets subject to amortization consist of the following:
|
|
As
at September 30, 2008
|
|
|
|
Cost
less tax loss benefited
|
|
|
Accumulated
amortization
|
|
|
|
$
|
|
|
$
|
|
TearLab™
technology
|
|
|
12,172,054
|
|
|
|
2,300,400
|
|
Less
accumulated amortization
|
|
|
2,300,400
|
|
|
|
|
|
|
|
|
9,871,654
|
|
|
|
|
|
Intangible
assets were reduced by $310,000 in the nine months ended September 30,
2008 to reflect the effect of acquired tax losses benefited which became
unrestricted in the period.
|
|
|
|
As
at December 31, 2007
|
|
|
|
Cost
less tax loss benefited
|
|
|
Accumulated
amortization
|
|
|
|
$
|
|
|
$
|
|
TearLab™
technology
|
|
|
12,482,054
|
|
|
|
1,397,000
|
|
Less
accumulated amortization
|
|
|
1,397,000
|
|
|
|
|
|
|
|
|
11,085,054
|
|
|
|
|
|
Intangible
assets were reduced by $413,333 in the year ended December 31, 2007 to
reflect the effect of acquired tax losses benefited which became
unrestricted in the year.
|
|
Estimated
amortization expense for the intangible assets for each of the next four years
and thereafter is as follows:
|
|
Amortization
of intangible assets
|
|
|
|
$
|
|
Remainder
of 2008
|
|
|
322,385
|
|
2009
|
|
|
1,289,539
|
|
2010
|
|
|
1,289,539
|
|
2011
|
|
|
1,289,539
|
|
2012
and thereafter
|
|
|
5,680,652
|
|
|
|
|
9,871,654
|
|
Amortization
expense of $903,400 from continuing operations for the nine months ended
September 30, 2008 is attributable to OcuSense. Amortization expense from
continuing operations for the nine months ended September 30, 2007 of $2,664,153
was derived from OcuSense and the RHEO
TM
System distribution
agreements. Amortization expense from discontinued operations for the
nine months ended September 30, 2008 and 2007 was nil and $2,235,000,
respectively.
The
Company determined that, as of September 30, 2008, there have been no
significant events which may affect the carrying value of OcuSense's
TearLab™ technology. However, the Company’s prior history of losses and losses
incurred during the current fiscal year reflect a potential indication of
impairment, thus requiring management to assess whether the TearLab™
technology was impaired as at September 30, 2008. Based on management’s
estimates of forecasted undiscounted cash flows as at September 30, 2008, the
Company concluded that there is no indication of an impairment
of OcuSense's TearLab™ technology. Therefore, no impairment charge was
recorded during the nine months ended September 30, 2008.
4.
|
DISCONTINUED
OPERATIONS
|
On
December 19, 2007, SOLX Acquisition purchased from the Company all of the issued
and outstanding shares of the capital stock of SOLX, which had been the Glaucoma
division of the Company prior to the completion of this transaction. The
consideration for the purchase and sale of all of the issued and outstanding
shares of the capital stock of SOLX consisted of: (i) on the closing
date of the sale, the assumption by SOLX Acquisition of all of the liabilities
of the Company related to SOLX’s business, incurred on or after December 1,
2007, and the Company’s obligation to make a $5,000,000 payment to the former
stockholders of SOLX due on September 1, 2008 in satisfaction of the outstanding
balance of the purchase price of SOLX; (ii) on or prior to February 15, 2008,
the payment by SOLX Acquisition of all of the expenses that the Company had paid
to the closing date, as they related to SOLX’s business during the period
commencing on December 1, 2007; (iii) during the period commencing on the
closing date and ending on the date on which SOLX achieves a positive cash flow,
the payment by SOLX Acquisition of a royalty equal to 3% of the worldwide net
sales of the SOLX 790 Laser and the SOLX Gold Shunt, including next-generation
or future models or versions of these products; and (iv) following the date on
which SOLX achieves a positive cash flow, the payment by SOLX Acquisition of a
royalty equal to 5% of the worldwide net sales of these products. In order to
secure the obligation of SOLX Acquisition to make these royalty payments, SOLX
granted to the Company a subordinated security interest in certain of its
intellectual property. No value was assigned to the royalty payments as the
determination of worldwide net sales of SOLX’s products is subject to
significant uncertainty.
The sale
transaction described above established fair values for certain of the Company’s
acquisition-related intangible assets and goodwill. Accordingly, the Company
performed an impairment test of these assets at December 1, 2007. Based on this
analysis, during the year ended December 31, 2007, the Company recognized a
non-cash goodwill impairment charge of $14,446,977 and an impairment charge of
$22,286,383 to record its acquisition-related intangible assets at their fair
value as of December 31, 2007.
The
Company’s results of operations related to discontinued operations for the three
months and the nine months ended September 30, 2008 and 2007 are as
follows:
|
|
Three
months ended September 30,
|
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
―
|
|
|
|
15,225
|
|
|
|
―
|
|
|
|
176,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
―
|
|
|
|
13,423
|
|
|
|
―
|
|
|
|
111,397
|
|
Royalty
costs
|
|
|
―
|
|
|
|
6,250
|
|
|
|
―
|
|
|
|
21,233
|
|
Total
cost of goods sold
|
|
|
―
|
|
|
|
19,673
|
|
|
|
―
|
|
|
|
132,630
|
|
|
|
|
―
|
|
|
|
(4,448)
|
|
|
|
―
|
|
|
|
43,495
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
―
|
|
|
|
965,986
|
|
|
|
―
|
|
|
|
3,003,944
|
|
Clinical
and regulatory
|
|
|
―
|
|
|
|
776,105
|
|
|
|
―
|
|
|
|
2,141,355
|
|
Sales
and marketing
|
|
|
―
|
|
|
|
185,561
|
|
|
|
―
|
|
|
|
695,549
|
|
|
|
|
―
|
|
|
|
1,927,652
|
|
|
|
―
|
|
|
|
5,840,848
|
|
|
|
|
―
|
|
|
|
(1,932,100
|
)
|
|
|
―
|
|
|
|
(5,797,353
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
net expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and accretion expense
|
|
|
―
|
|
|
|
(222,374
|
)
|
|
|
―
|
|
|
|
(632,158
|
)
|
Other
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
(9,301
|
)
|
|
|
|
―
|
|
|
|
(222,374
|
)
|
|
|
―
|
|
|
|
(641,459
|
)
|
Loss
from discontinued operations before income taxes
|
|
|
―
|
|
|
|
(2,154,474
|
)
|
|
|
―
|
|
|
|
(6,438,812
|
)
|
Recovery
of income taxes
|
|
|
―
|
|
|
|
1,071,632
|
|
|
|
―
|
|
|
|
3,170,921
|
|
Loss
from discontinued operations
|
|
|
―
|
|
|
|
(1,082,842
|
)
|
|
|
―
|
|
|
|
(3,267,891
|
)
|
|
|
September
30, 2008
|
|
December
31, 2007
|
|
|
|
Cost
|
|
|
Accumulated
amortization
|
|
|
Cost
|
|
|
Accumulated
amortization
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Furniture
and office equipment
|
|
|
22,794
|
|
|
|
14,099
|
|
|
|
101,903
|
|
|
|
50,854
|
|
Computer
equipment and software
|
|
|
188,558
|
|
|
|
147,724
|
|
|
|
197,317
|
|
|
|
155,928
|
|
Leasehold
improvements
|
|
|
―
|
|
|
|
―
|
|
|
|
6,335
|
|
|
|
704
|
|
Medical
equipment
|
|
|
966,580
|
|
|
|
934,181
|
|
|
|
1,163,135
|
|
|
|
1,138,918
|
|
Plates,
tools and dies
|
|
|
42,846
|
|
|
|
1,680
|
|
|
|
―
|
|
|
|
―
|
|
|
|
|
1,220,778
|
|
|
|
1,097,684
|
|
|
|
1,468,690
|
|
|
|
1,346,404
|
|
Less
accumulated amortization
|
|
|
1,097,684
|
|
|
|
|
|
|
|
1,346,404
|
|
|
|
|
|
|
|
|
123,094
|
|
|
|
|
|
|
|
122,286
|
|
|
|
|
|
Amortization
expense was $42,296 and $730,201 during the nine months ended September 30, 2008
and 2007, respectively, of which nil and $180,691 is included as amortization
expense of discontinued operations for the nine months ended September 30, 2008
and 2007, respectively.
On
November 1, 2007, the Company announced an indefinite suspension of the RHEO™
System clinical development program for Dry AMD and is in the process of winding
down the RHEO-AMD study as there is no reasonable prospect that the RHEO™ System
clinical development program will be relaunched in the foreseeable future. In
accordance with SFAS No. 144, the Company determined that the carrying value of
certain of the Company’s medical equipment was not recoverable at December 31,
2007.
Accordingly,
during the year ended December 31, 2007, the Company recorded a reduction to the
carrying value of certain of its medical equipment of $431,683 which reflects a
write-down of the value of this medical equipment to nil at December 31, 2007
and September 30, 2008. The assets written down had been used in the clinical
trials of the RHEO™ System.
6.
|
PATENTS
AND TRADEMARKS
|
|
|
September
30, 2008
|
|
|
December
31, 2007
|
|
|
|
Cost
|
|
|
Accumulated
amortization
|
|
|
Cost
|
|
|
Accumulated
amortization
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents
|
|
|
319,020
|
|
|
|
127,427
|
|
|
|
236,854
|
|
|
|
113,013
|
|
Trademarks
|
|
|
133,615
|
|
|
|
106,375
|
|
|
|
120,211
|
|
|
|
104,615
|
|
|
|
|
452,635
|
|
|
|
233,802
|
|
|
|
357,065
|
|
|
|
217,628
|
|
Less
accumulated amortization
|
|
|
233,802
|
|
|
|
|
|
|
|
217,628
|
|
|
|
|
|
|
|
|
218,833
|
|
|
|
|
|
|
|
139,437
|
|
|
|
|
|
Amortization
expense was $16,174 and $195,495 during the nine months ended September 30, 2008
and 2007, respectively.
Patents
and trademarks are recorded at historical cost and amortized over a period not
exceeding 10 years.
Based on
the November 1, 2007 announcement and in accordance with SFAS No. 144, the
Company determined that the carrying value of certain of the Company’s patents
and trademarks was not recoverable as at December 31, 2007. Accordingly, during
the year ended December 31, 2007, the Company recorded a $190,873 reduction to
the carrying value of its patents and trademarks related to the RHEO™ System
which reflects a write-down of these patents and trademarks to a value of nil at
September 30, 2008 and December 31, 2007.
The
Company evaluates inventory for estimated excess quantities and obsolescence,
based on expected future sales levels and projections of future demand, with the
excess inventory provided for. In addition, the Company assesses the impact of
changing technology and market conditions.
In light
of the Company’s financial position as at September 30, 2007 and November 1,
2007, the Company announced an indefinite suspension of the RHEO™ System
clinical development program for Dry AMD. That decision was made
following a comprehensive review of the respective costs and development
timelines associated with the products in the Company’s portfolio and, in
particular, the fact that, if the Company was unable to raise additional
capital, it would not have had sufficient cash to support its
operations beyond early 2008. Accordingly, the Company wrote down the value of
its treatment sets and OctoNova pumps, the components of the RHEO™ System, to
nil as at December 31, 2007 since the Company is not expected to be able to sell
or utilize these treatment sets and OctoNova pumps prior to their expiration
dates, in the case of the treatment sets, or before the technologies become
outdated.
As at
September 30, 2008 and December 31, 2007, the Company had inventories
related to RHEO
TM
System activities of
$133,761 and $7,295,545, respectively, reduced by inventory reserves of $133,761
and $7,295,545, respectively. During the nine months ended September 30, 2008
and 2007, the Company recognized a provision related to inventory of nil and
nil, respectively, based on the above analysis.
As at
September 30, 2008 and December 31, 2007, the Company had investments in the
aggregate principal amount of $1,900,000 which consist of investments in four
separate asset-backed ARS currently yielding an average return of 3.471% per
annum. Contractual maturities for these ARS are greater than eight years with an
interest rate reset date for these investments averaging approximately every
43 days. Historically, the carrying value of ARS approximated fair value
due to the frequent resetting of the interest rates. With the liquidity issues
experienced in the global credit and capital markets, the Company’s ARS have
experienced multiple failed auctions. During late 2007 and 2008, while the
Company continued to earn and receive interest on these investments at the
maximum contractual rate, the estimated fair value of these ARS was no longer
believed to approximate par value. Refer to Note 9 for discussion on how the
Company determines the fair value of its investment in ARS.
Although
the Company continues to receive payment of interest earned on these securities,
the Company did not previously know when it would be able to convert these
investments into cash. Accordingly, management had classified these
investments as a non-current asset on its consolidated balance sheets as at
December 31, 2007, March 30, 2008 and June 30, 2008. As a result of a recent
settlement agreement among the New York Attorney General’s Office, the North
American Securities Administrators Association and Credit Suisse, the financial
institution through which the Company had purchased its ARS, subsequent to
September 30, 2008, the Company had the opportunity to have Credit Suisse
purchase from the Company, for full value plus accrued interest, all of the
Company’s outstanding ARS.
The
Company did not receive the settlement agreement until subsequent to September
30, 2008. The fair value of the Company’s investment in ARS as at
September 30, 2008 does not recognize any additional value arising from the
settlement agreement.
Credit Suisse purchased all of these ARS
at the Company’s original cost of $1,900,000, plus accrued interest, when each
of these securities came up for auction. (See Note 22 C – Subsequent
Events.)
The ARS
investments are classified as available-for-sale under SFAS No. 115 which states
that where an impairment of an available-for-sale investment has been reported,
this impairment can only be reversed when a recovery or gain of the amount
reflected as an impairment charge has been realized. At September 30, 2008,
Credit Suisse had not yet purchased any of the Company’s outstanding ARS and as
such the Company has not reported the recovery of the impairment charge and
continues to reflect the ARS at $413,678 consistent with the fair value reported
by the Company in its June 30, 2008 interim consolidated financial statements.
Since the ARS were purchased by Credit Suisse in the fourth quarter, the ARS
have been reported as current assets.
9.
|
FAIR
VALUE MEASUREMENTS
|
As
described in Note 1, the Company adopted SFAS No. 157 on January 1,
2008. SFAS No. 157, among other things, defines fair value, establishes a
consistent framework for measuring fair value and expands disclosure for each
major asset and liability category measured at fair value on either a recurring
or non-recurring basis. SFAS No. 157 clarifies that fair value is an exit
price, representing the amount that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants.
As such, fair value is a market-based measurement that should be determined
based on assumptions that market participants would use in pricing an asset or
liability. As a basis for considering such assumptions, SFAS No. 157
establishes a three-tier fair value hierarchy, which prioritizes the inputs used
in measuring fair value as follows:
Level
1.
|
Observable
inputs such as quoted prices in active
markets;
|
Level
2.
|
Inputs,
other than the quoted prices in active markets, that are observable either
directly or indirectly; and
|
Level
3.
|
Unobservable
inputs in which there is little or no market data, which require the
reporting entity to develop its own
assumptions.
|
Assets
measured at fair value on a recurring basis are as follows:
|
|
Fair
value September 30,
|
|
|
Quoted
prices in active markets for identical assets
|
|
Significant other
observable inputs
|
|
Significant
unobservable
inputs
|
|
Valuation
|
|
|
2008
|
|
|
(Level
1)
|
|
(Level
2)
|
|
(Level
3)
|
|
technique
|
Investments
in marketable securities (non-current)
|
|
$
|
413,678
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
413,678
|
|
|
|
(1
|
)
|
(1)
|
The
Company estimated the fair value of these ARS based on the following:
(i) the underlying structure of each security; (ii) the present
value of future principal and interest payments discounted at rates
considered to reflect current market conditions; (iii) consideration
of the probabilities of default, auction failure or repurchase at par for
each period; and (iv) estimates of the recovery rates in the event of
default for each security. These estimated fair values could change
significantly based on future market conditions. Refer to Note 8 for
further discussion of the Company’s investments in
ARS.
|
Assets
measured at fair value on a recurring basis using significant unobservable
inputs (Level 3):
|
|
Investments
in marketable securities
|
|
|
|
|
|
Balance
as at December 31, 2007
|
|
$
|
863,750
|
|
|
|
|
|
|
Losses
deemed to be other than temporary charged to other non-operating
expense
|
|
|
450,072
|
|
|
|
|
|
Balance
as at September 30, 2008
|
|
$
|
413,678
|
|
As a
result of a recent settlement agreement among the New York Attorney General’s
Office, the North American Securities Administrators Association and Credit
Suisse, the financial institution through which the Company had purchased its
ARS, subsequent to September 30, 2008, the Company had the opportunity to have
Credit Suisse purchase from the Company, for full value plus accrued interest,
all of the Company’s outstanding ARS. Credit Suisse purchased all of these
ARS at the Company’s original cost of $1,900,000, plus accrued interest, when
each of these securities came up for auction.
The
Company’s fair value measurement of the investment in ARS does not recognize any
additional value arising from the settlement agreement received subsequent
to September 30, 2008.
(See Note 22 C – Subsequent
Events.).
10.
|
SHORT-TERM LIABILITIES
AND ACCRUED INTEREST
|
On
February 19, 2008, the Company announced that it had secured a bridge loan in an
aggregate principal amount of $3,000,000 from a number of private
parties. Transaction costs, funded separately, were
$180,000 paid to Marchant Securities Inc., or Marchant, a related party for
introducing the Company to the bridge loan lenders. (See Note 14 – Related Party
Transactions.) The loan bore interest at a rate of 12% per annum and had a
180-day term, which had been extended to 270 days.
On May 5,
2008, the Company announced that it had secured a bridge loan in an aggregate
principal amount of $300,000 from a number of private parties. The Additional
Bridge Loan I constituted an increase to the principal amount of the $3,000,000
principal amount bridge loan that the Company announced on February 19, 2008,
the Original Bridge Loan, and was advanced on substantially the same terms and
conditions as the Original Bridge Loan, pursuant to an amendment of the loan
agreement for the Original Bridge Loan. The Additional Bridge Loan I bore
interest at a rate of 12% per annum and had the same maturity date as the
Original Bridge Loan.
On July
28, 2008, the Company announced that it had secured an additional bridge loan in
an aggregate principal amount of $3,403,500
from a number of private
parties. The Additional Bridge Loan II was advanced on substantially
the same terms and conditions as the Original Bridge Loan, pursuant to an
amendment of the loan agreement for the Original Bridge Loan. The Additional
Bridge Loan II bore interest at a rate of 12% per annum and had the same
maturity date as the Original Bridge Loan.
The
repayment of the loans was secured by a pledge by the Company of its shares of
the capital stock of OcuSense. Under the terms of the loan agreement, the
Company had two prepayment options available to it. Under the first prepayment
option, the Company may repay the loan in full by paying the lenders, in cash,
the amount of outstanding principal and accrued interest and issuing to the
lenders five-year warrants in an aggregate amount equal to approximately 19.9%
of the issued and outstanding shares of the Company’s common stock (but not to
exceed 20% of the issued and outstanding shares of the Company’s common stock).
The warrants would be exercisable into shares of the Company’s common stock at
an exercise price of $2.50 per share and would not become exercisable until the
180
th
day
following their issuance. Under the second prepayment option, provided that the
Company has closed a private placement of shares of its common stock for
aggregate gross proceeds of at least $1,000,000, the Company may repay the loan
in full by issuing to the lenders shares of its common stock, in an aggregate
amount equal to the amount of outstanding principal and accrued interest, at a
15% discount to the price paid by the private placement investors. Any exercise
by the Company of the second prepayment option would be subject to stockholder
and regulatory approval. (See Note 22 A) – Subsequent Events.)
Of the
$7,008,755 outstanding as at September 30, 2008, the principal portion of the
loans was $6,703,500 and the accrued interest was $305,255.
As
discussed in Note 2, OcuSense was determined to be a VIE and OccuLogix was the
primary beneficiary.
On
acquisition of OcuSense, FIN 46(R) requires that the non-controlling interest be
measured initially at fair value. Minority interest reflects the initial fair
value of the minority’s 42.38% interest in OcuSense’s net assets which are
comprised of working capital and intangible assets as at the November 30, 2006
acquisition date, less the minority’s proportionate interest in losses incurred
to date, plus the fair value of all vested options and warrants issued to
parties other than OccuLogix as of the date of acquisition, as well as the value
of options and warrants vested and issued after the acquisition
date.
In
addition, the Company has accounted for the milestone payments, made subsequent
to the acquisition date, as follows:
|
·
|
The
Company determined the fair value of the milestone payments on the date of
acquisition by incorporating the probability that the milestone payments
will be made, as well as the time value associated with the planned
settlement date of the payments.
|
|
·
|
Upon
payment of the milestone payments, the Company recorded the minority
interest portion of the change in fair value of the milestone payment
(i.e., the minority interest portion of the ultimate value of the
milestone payment less the initial fair value determination) as an
expense, with a corresponding increase to minority interest, to reflect
the additional value provided to the minority interest in excess of that
contemplated on the acquisition
date.
|
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
Minority
interest – beginning of period
|
|
|
4,953,960
|
|
|
|
6,110,834
|
|
Minority
share of net loss from operations
|
|
|
(1,964,540
|
)
|
|
|
(783,447
|
)
|
Fair
value of OcuSense stock-based compensation
|
|
|
135,538
|
|
|
|
84,838
|
|
Minority
interest – end of period
|
|
|
3,124,958
|
|
|
|
5,412,225
|
|
Minority
stockholders’ share of net losses from operations for the nine months ended
September 30, 2008 of $2,168,359 was offset by $203,819 to reflect a minority
increment for the beta milestone payment. Minority share of net loss
from operations for the nine months ended September 30, 2007 of $913,738 was
offset by $130,291 to reflect a minority increment for the alpha milestone
payment. These transactions are specific to the acquisition of
OcuSense. The increment represents the minority stockholders’ ownership
percentage of the variance between the actual milestone payments made and the
original fair value of the milestone payments reported when the Company acquired
its ownership interest in OcuSense. No future milestone payments remain to be
paid.
On
February 1, 2007, the Company entered into a securities purchase agreement, or
the Securities Purchase Agreement, with certain institutional investors,
pursuant to which the Company agreed to issue to those investors an aggregate of
267,094 shares of the Company’s common stock, referred to as the Shares, and
five-year warrants exercisable into an aggregate of 106,838 shares of the
Company’s common stock, referred to as the Warrants. The per share
purchase price of the units was $37.50, and the per share exercise price of the
Warrants is $55.00, and subsequently adjusted to $46.25. The Warrants
became exercisable on August 6, 2007. Pursuant to the Securities Purchase
Agreement, on February 6, 2007, the Company issued the Shares and the Warrants.
The gross proceeds of the sale of the Shares and Warrants totaled $10,016,000
(less transaction costs of $871,215). On February 6, 2007, the Company also
issued to Cowen and Company, LLC a warrant exercisable into an aggregate of
3,740 shares of the Company’s common stock, referred to as the Cowen Warrant, in
part payment of the placement fee payable to Cowen and Company, LLC for the
services it had rendered as the placement agent in connection with the sale of
the Shares and the Warrants. All of the terms and conditions of the Cowen
Warrant (other than the number of shares of the Company's common stock into
which the Cowen Warrant is exercisable) are identical to those of the Warrants.
The estimated grant-date fair value of the Cowen Warrant of $97,222 is included
in the transaction cost of $871,215.
(b)
Stock-based compensation
The
Company has a stock option plan, the 2002 Stock Option Plan, or the Stock Option
Plan, which was most recently amended in June 2007 in order to, among other
things, increase the share reserve under the Stock Option Plan by 80,000. Under
the Stock Option Plan, up to 258,240 options are available for grant to
employees, directors and consultants. Options granted under the Stock Option
Plan may be either incentive stock options or non-statutory stock options. Under
the terms of the Stock Option Plan, the exercise price per share for an
incentive stock option shall not be less than the fair market value of a share
of stock on the effective date of grant and the exercise price per share for
non-statutory stock options shall not be less than 85% of the fair market value
of a share of stock on the date of grant. No option granted to a holder of more
than 10% of the Company’s common stock shall have an exercise price per share
less than 110% of the fair market value of a share of stock on the effective
date of grant.
Options
granted may be time-based or performance-based options. The vesting
of performance-based options is contingent upon meeting company-wide goals,
including obtaining the U.S. Food and Drug Administration, or FDA, approval of
the RHEO™ System and the achievement of a minimum amount of sales over a
specified period. Generally, options expire 10 years after the date of grant. No
incentive stock options granted to a 10% owner optionee shall be exercisable
after the expiration of five years after the effective date of grant of such
option; no option granted to a prospective employee, prospective consultant or
prospective director may become exercisable prior to the date on which such
person commences service; and, with the exception of an option granted to an
officer, director or consultant, no option shall become exercisable at a rate
less than 20% per annum over a period of five years from the effective date of
grant of such option unless otherwise approved by the Board.
The
Company has also issued options outside of the Stock Option Plan. These options
were issued before the establishment of the Stock Option Plan, when the
authorized limit of the Stock Option Plan was exceeded or as permitted under
stock exchange rules when the Company was recruiting executives. In addition,
options issued to companies for the purpose of settling amounts owing were
issued outside of the Stock Option Plan, as the Stock Option Plan prohibited the
granting of options to companies. The issuance of such options was approved by
the Board and granted on terms and conditions similar to those options issued
under the Stock Option Plan.
On
January 1, 2006, the Company adopted the provisions of SFAS No. 123(R),
“Share-Based Payments,” or SFAS No. 123(R), requiring the recognition of expense
related to the fair value of its stock-based compensation awards. The Company
elected to use the modified prospective transition method as permitted by SFAS
No. 123(R) and therefore has not restated its financial results for prior
periods. Under this transition method, stock-based compensation expense for each
of the years ended December 31, 2007 and 2006 includes compensation expense for
all stock-based compensation awards granted prior to, but not yet vested, as of
January 1, 2006 based on the grant-date fair value estimated in accordance with
the original provisions of SFAS No. 123. Stock-based compensation expense for
all stock-based compensation awards granted subsequent to January 1, 2006 was
based on the grant-date fair value estimated in accordance with the provisions
of SFAS No. 123(R). The Company recognizes compensation expense for stock option
awards on a straight-line basis over the requisite service period of the
award.
The
following table sets forth the total stock-based compensation expense resulting
from stock options included in the Company’s consolidated statements of
operations and changes in stockholders’ equity:
|
|
Three
months ended
September
30,
|
|
|
Nine
months ended
September
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
(54,999
|
)
|
|
|
205,558
|
|
|
|
32,223
|
|
|
|
733,667
|
|
Clinical
and regulatory
|
|
|
(50,462
|
)
|
|
|
42,634
|
|
|
|
3,292
|
|
|
|
233,852
|
|
Sales
and marketing
|
|
|
(52,123
|
)
|
|
|
139,848
|
|
|
|
(24,201
|
)
|
|
|
390,351
|
|
Restructuring
charges
|
|
|
74,128
|
|
|
|
—
|
|
|
|
74,128
|
|
|
|
—
|
|
Total
expense from continuing operations
|
|
|
(83,456
|
)
|
|
|
388,040
|
|
|
|
85,442
|
|
|
|
1,357,870
|
|
Expense
from discontinued operations
|
|
|
—
|
|
|
|
35,182
|
|
|
|
—
|
|
|
|
89,781
|
|
Stock-based
compensation expense before income taxes (i)
|
|
|
(83,456
|
)
|
|
|
423,222
|
|
|
|
85,442
|
|
|
|
1,447,651
|
|
(i) The
tax benefit associated with the Company’s stock-based compensation expense for
the nine months ended September 30, 2008 and 2007 is $36,100 and $579,000,
respectively. Neither amount has been recognized in the Company’s consolidated
financial statements for the nine months ended September 30, 2008 and 2007 as
there is a low probability that the Company will realize this
benefit.
Net cash
proceeds from the exercise of common stock options were nil and $2,228 for the
nine months ended September 30, 2008 and 2007, respectively. No income tax
benefit was realized from stock option exercises during the nine months ended
September 30, 2008 and 2007. In accordance with SFAS No. 123(R), the Company
presents excess tax benefits from the exercise of stock options, if any, as
financing cash flows rather than operating cash flows.
The
weighted-average fair value of stock options granted during the three months and
nine months ended September 30, 2008 and 2007 was $2.63, $19.50, $2.63 and
$39.25, respectively. Under the terms of SFAS123(R), options to former Company
executives which were modified with regard to normal revocation after
termination, were deemed to have been reissued, following the approval by the
shareholders at the Annual General Meeting held on September 30, 2008 of the
proposal to modify the options in question. The estimated fair value was
determined using the Black-Scholes option-pricing model with the following
weighted-average assumptions:
|
|
Three
months ended
September
30,
|
|
|
Nine
months ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility
|
|
|
107.4
|
%
|
|
|
76.3
|
%
|
|
|
107.4
|
%
|
|
|
76.5
|
%
|
Expected
life of options
|
|
6.89
years
|
|
|
6
years
|
|
|
6.89
years
|
|
|
5.85
years
|
|
Risk-free
interest rate
|
|
|
3.26
|
%
|
|
|
4.99
|
%
|
|
|
3.26
|
%
|
|
|
4.87
|
%
|
Dividend
yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
The
Company’s computation of expected volatility for the nine months ended September
30, 2007 was based on the Company’s historical stock prices to its initial
public offering in December 2004 and for prior periods a comparable company’s
historical stock prices were used as the Company did not have sufficient
historical data. A time-based average of the volatilities from each company was
then calculated and used. The Company’s computation of expected life was
estimated using the remaining useful life of the options. The risk-free interest
rate for an award is based on the U.S. Treasury yield curve with a term equal to
the expected life of the award on the date of grant. If options are granted in
the future, the Company’s computation of expected life will be based on either
one of the following: a modeling or simulating exercise behavior based on a
variety of stock price paths, estimating the expected term based on the period
that previous options were outstanding, or an estimated term based on the
expected terms of options granted by other similar companies and other similarly
structured awards.
A summary
of the option transactions during the nine months ended September 30, 2008 is
set forth below:
|
|
Number
of options outstanding
|
|
|
Weighted
average exercise price
$
|
|
|
Weighted
average remaining contractual life (years)
|
|
|
Aggregate
intrinsic value
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding,
December 31, 2007
|
|
|
191,499
|
|
|
|
41.04
|
|
|
|
7.41
|
|
|
|
—
|
|
Granted
|
|
|
59,069
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
85,781
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Outstanding, September
30, 2008
|
|
|
164,787
|
|
|
|
39.66
|
|
|
|
6.63
|
|
|
|
—
|
|
Vested
or expected to vest September 30, 2008
|
|
|
131,452
|
|
|
|
39.33
|
|
|
|
5.85
|
|
|
|
—
|
|
Exercisable,
September 30, 2008
|
|
|
127,445
|
|
|
|
39.37
|
|
|
|
5.77
|
|
|
|
—
|
|
The
aggregate intrinsic value in the table above represents the total pre-tax
intrinsic value (i.e., the difference between the Company’s closing stock price
on the last trading day of September 30, 2008 of $2.325 and the exercise price,
multiplied by the number of shares that would have been received by the option
holders if the options had been exercised on September 30, 2008. This amount is
nil for all the periods presented as the exercise price of all options
outstanding as at September 30, 2008 and December 31, 2007 is higher than $2.63,
the Company’s closing stock price on the last trading day prior to September 30,
2008.
As at
September 30, 2008, $171,271 of total unrecognized compensation cost related to
stock options is expected to be recognized over a weighted average period of
2.14 years.
(c)
Warrants
On
February 6, 2007, pursuant to the Securities Purchase Agreement between the
Company and certain institutional investors, the Company issued the Warrants to
these investors. The Warrants are five-year warrants exercisable into an
aggregate of 106,838 shares of the Company’s common stock. On February 6, 2007,
the Company also issued the Cowen Warrant to Cowen and Company, LLC in part
payment of the placement fee payable to Cowen and Company, LLC for the services
it had rendered as the placement agent in connection with the private placement
of the Shares and the Warrants pursuant to the Securities Purchase Agreement.
The Cowen Warrant is a five-year warrant exercisable into an aggregate of 3,740
shares of the Company’s common stock. The per share exercise price of the
Warrants is $46.25, subject to adjustment, and the Warrants became exercisable
on August 6, 2007. All of the terms and conditions of the Cowen Warrant (other
than the number of shares of the Company's common stock into which it is
exercisable) are identical to those of the Warrants.
The
Company accounts for the Warrants and the Cowen Warrant in accordance
with the provisions of SFAS No. 133, “Accounting for Derivative Instruments and
Hedging Activities,” or SFAS No. 133, along with related interpretation EITF No.
00-19, “Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company’s Own Stock,” or EITF No. 00-19. SFAS No. 133
requires every derivative instrument within its scope (including certain
derivative instruments embedded in other contracts) to be recorded on the
balance sheet as either an asset or liability measured at its fair value, with
changes in the derivative’s fair value recognized currently in earnings unless
specific hedge accounting criteria are met. Based on the provisions of EITF No.
00-19, the Company determined that the Warrants and the Cowen Warrant do not
meet the criteria for classification as equity. Accordingly, the Company has
classified the Warrants and the Cowen Warrant as a current liability at December
31, 2007 and September 30, 2008.
As at
September 30, 2008 the estimated fair value of the Warrants and the Cowen
Warrant was determined using the Black-Scholes option-pricing model with the
following weighted average assumptions:
Volatility
|
|
123%
|
Expected
life of Warrants
|
|
3.33
years
|
Risk-free
interest rate
|
|
2.71%
|
Dividend
yield
|
|
0%
|
The
Company initially allocated the total proceeds received, pursuant to the
Securities Purchase Agreement, to the Shares and the Warrants based on their
relative fair values. This resulted in an allocation of $2,052,578 to
obligations under warrants, which includes the fair value of the Cowen Warrant
of $97,222.
In
addition, SFAS No. 133 requires the Company to record the outstanding warrants
at fair value at the end of each reporting period, resulting in an adjustment to
the recorded liability of the derivative, with any gain or loss recorded in
earnings of the applicable reporting period. The Company, therefore, estimated
the fair value of the Warrants and the Cowen Warrant as at September 30, 2008
and determined the aggregate fair value to be $68,281, an increase of
approximately $68,281 over the measurement of the aggregate fair value of the
Warrants and the Cowen Warrant on December 31, 2007. The aggregate
fair value of the warrants have been $2,626,195, NIL, NIL, NIL, and $68,281 at
March 31, 2007, December 31, 2007, March 31, 2008, June 30 2008 and September
30, 2008, respectively.
Accordingly,
the Company recognized a loss of $68,281 in its consolidated statement of
operations for the nine months ended September 30, 2008 which reflects the
increase in the Company’s obligation to its warrant holders to its aggregate
fair value at September 30, 2008.
Transaction
costs associated with the issuance of the Warrants recorded as a warrant expense
in the Company’s consolidated statements of operations for the nine months ended
September 30, 2008 and 2007 were nil and $170,081, respectively.
A summary
of the Warrants issued during the nine months ended September 30, 2008 and the
total number of warrants outstanding as of that date are set forth
below:
|
|
Number
of warrants outstanding
|
|
|
Weighted
average exercise price
|
|
|
|
|
|
|
$
|
|
Outstanding,
December 31, 2007
|
|
|
110,578
|
|
|
|
55.00
|
|
Granted
|
|
|
—
|
|
|
|
—
|
|
Forfeited
|
|
|
—
|
|
|
|
—
|
|
Outstanding,
September 30, 2008 *
|
|
|
110,578
|
|
|
|
46.25
|
|
* -
during 2008, the exercise price of the warrants were revised from $55.00 to
$46.25 as a result of
the
Bridge Loan agreements announced earlier
in the year.
Loss per
share, basic and diluted, is computed using the treasury method. Potentially
dilutive shares have not been used in the calculation of loss per share as their
inclusion would be anti-dilutive.
14.
|
RELATED
PARTY TRANSACTIONS
|
The
following are the Company’s related party transactions:
TLC
Vision and Diamed
On June
25, 2003, the Company entered into agreements with TLC Vision Corporation, TLC
Vision, and Diamed to issue grid debentures in the maximum aggregate principal
amount of $12,000,000 in connection with the funding of the Company’s MIRA-1 and
related clinical trials. $7,000,000 of the aggregate principal amount was
convertible into shares of the Company’s common stock at a price of $24.6255 per
share, and $5,000,000 of the aggregate principal amount was
non-convertible.
The
$5,000,000 portion of the $12,000,000 commitment which was not convertible into
the Company’s common stock was not advanced and the commitment was terminated
prior to the completion of the Company’s initial public offering of shares of
its common stock. During the years ended December 31, 2004 and 2003, the Company
issued grid debentures in an aggregate principal amount of $4,350,000 and
$2,650,000 to TLC Vision and Diamed, respectively, under the convertible portion
of the grid debentures. On December 8, 2004, as part of the corporate
reorganization relating to the Company’s initial public offering, the Company
issued 7,106,454 shares of its common stock to TLC Vision and Diamed, upon
conversion of $7,000,000 of aggregate principal amount of convertible debentures
at a conversion price of $24.6255 per share. Collectively, at September 30,
2008, the two companies have a combined 35.6% equity interest in the Company on
a fully diluted basis.
In the
third quarter of 2008, the Company finalized an agreement with Diamed in which
the Company sold to Diamed 113 Octo Nova pumps which had been purchased for
commercial purposes but never used and four Octo Nova pumps previously used for
training purposes for $136,800. The carrying value of these pumps had previously
been fully provided for in the fourth quarter of 2007 when the Company
terminated all RHEO
™
Systems related activities. Diamed paid the Company $86,800 for the pumps
purchased and applied the remaining $50,000 against minimum royalty payments due
to Hans Stock and Dr. Brunner. Revenue for the nine months ended September 30,
2008 included $136,800 related to this transaction.
Asahi
Medical
The
Company entered into a distributorship agreement, referred to as the
Distribution Agreement, effective October 20, 2006, with Asahi Medical. The
Distribution Agreement replaced the 2001 distributorship agreement between Asahi
Medical and the Company, as supplemented and amended by the 2003, 2004 and 2005
Memoranda. Pursuant to the Distribution Agreement, the Company had
distributorship rights to Asahi Medical's Plasmaflo filter and Asahi Medical's
second-generation polysulfone Rheofilter filter on an exclusive basis in the
United States, Mexico and certain Caribbean countries, collectively referred to
as Territory 1-a, on an exclusive basis in Canada, on an exclusive basis in
Colombia, Venezuela, New Zealand and Australia, collectively referred to as
Territory 2, and on a non-exclusive basis in Italy.
On
January 28, 2008, the Company disclosed that it was engaged in discussions with
Asahi Medical to terminate the Distribution Agreement. The Company and Asahi
Medical have terminated substantially all of their obligations under the
Distribution Agreement effective February 25, 2008, or the Termination
Agreement. Pursuant to the Termination Agreement, the Company and
Asahi Medical have agreed to a mutual release of claims relating to the
Distribution Agreement, other than any claims relating to certain provisions of
the Distribution Agreement which survived its termination.
The
Company received free inventory from Asahi Medical for purposes of the RHEO-AMD
trial, the LEARN, or Long-term Efficacy in AMD from Rheopheresis in North
America, trials and related clinical studies. The Company has accounted for this
inventory at a value equivalent to the cost the Company has paid for the same
filters purchased from Asahi Medical for purposes of commercial sales to the
Company’s customers. The value of the free inventory received from Asahi Medical
was nil and $384,660 for the nine months ended September 30, 2008 and 2007,
respectively.
Mr.
Hans Stock
On
February 21, 2002, the Company entered into an agreement with Mr. Stock as a
result of his assistance in procuring a distributorship agreement for the filter
products used in the RHEO™ System from Asahi Medical. Mr. Stock agreed to
further assist the Company in procuring new product lines from Asahi Medical for
marketing and distribution by the Company. The agreement will remain effective
for a term consistent with the term of the distributorship agreement with Asahi
Medical, and Mr. Stock will receive a 5% royalty payment on the purchase of the
filters from Asahi Medical.
The
Company reversed $48,022 previously accrued for royalties on filters, as all
filters for which the royalty was due had been disposed of subsequent to the
termination of RHEO
™
Systems related activities. Included in due to stockholders at September 30,
2008 and December 31, 2007 are nil and $48,022, respectively, due to Mr. Stock
for filter products.
On June
25, 2002, the Company entered into a consulting agreement with Mr. Stock for the
purpose of procuring a patent license for the extracorporeal applications in
ophthalmic diseases for that period of time in which the patent was effective.
Mr. Stock was entitled to 1.0% of total net revenue from the Company’s
commercial sales of products sold in reliance and dependence upon the validity
of the patent’s claims and rights in the United States. The Company agreed to
make advance consulting payments to Mr. Stock of $50,000 annually, payable on a
quarterly basis, to be credited against any and all future consulting payments
payable in accordance with this agreement. Due to the uncertainty of future
royalty payment requirements, all required payments to date have been
expensed.
On August
6, 2004, the Company entered into a patent license and royalty agreement with
Mr. Stock to obtain an exclusive license to U.S. Patent No. 6,245,038. The
Company is required to make royalty payments totaling 1.5% of product sales to
Mr. Stock, subject to minimum advance royalty payments of $12,500 per quarter.
The advance payments are credited against future royalty payments to be made in
accordance with the agreement. This agreement replaces the June 25, 2002
consulting agreement with Mr. Stock which provided for a royalty payment of 1%
of product sales. On May 19, 2008, the patent license and royalty agreement with
Mr. Stock was terminated by Mr. Stock as a result of non-payment of minimum
license fees due at March 31, 2008 and December 31, 2007 of $25,000 and $12,500,
respectively. As such, no amounts were accrued for license fees for Mr. Stock in
the three months ended September 30, 2008. Included in due to stockholders at
September 30, 2008 and December 31, 2007 are nil and $12,500, respectively, due
to Mr. Stock for royalties as any amounts due were applied by Diamed against
amounts due to the Company for Octo Nova pumps purchased by Diamed from the
Company.
Other
On June
25, 2003, the Company entered into a reimbursement agreement with Apheresis
Technologies, Inc., or ATI, pursuant to which employees of ATI, including Mr.
John Cornish, one of the Company’s stockholders and its former Vice President,
Operations, provided services to the Company and ATI was reimbursed for the
applicable percentage of time the employees spent working for the Company.
Effective April 1, 2005, the Company terminated its reimbursement agreement with
ATI, as a result of which termination the Company no longer compensated ATI in
respect of any salary paid to, or benefits provided to, Mr. Cornish by ATI.
Until April 1, 2005, Mr. Cornish did not have an employment contract with the
Company and received no direct compensation from the Company. On April 1, 2005,
Mr. Cornish entered into an employment agreement with the Company under which he
received an annual base salary of $106,450, representing compensation to him for
devoting 80% of his time to the business and affairs of the Company. Effective
June 1, 2005, the Company amended its employment agreement with Mr. Cornish such
that he began to receive an annual base salary of $116,723, representing
compensation to him for devoting 85% of his time to the business and affairs of
the Company. Effective April 13, 2006, the Company further amended its
employment agreement with Mr. Cornish such that his annual base salary was
decreased to $68,660 in consideration of his devoting 50% of his time to the
business and affairs of the Company. In light of the Company's current financial
situation, and in connection with the indefinite suspension of its RHEO™ System
clinical development program and the sale of SOLX, the Company terminated the
employment of Mr. Cornish effective January 4, 2008.
During
the three months and nine months ended September 30, 2008 and 2007, ATI made
available to the Company, upon request, the services of certain of ATI’s
employees and consultants on a per diem basis. During the three
months and nine months ended September 30, 2008, the Company paid ATI nil
and $21,666 respectively, under this arrangement (2007 – $17,036 and
$63,692, respectively). Included in accounts payable and accrued
liabilities at September 30, 2008 and December 31, 2007 are nil and $20,004,
respectively, due to ATI.
In March
2008, the Company sold substantially all of its fixed assets located in Florida
to ATI for their book value of $8,000. Included in amounts receivable at
September 30, 2008 is $2,111 due from ATI; the balance of $5,889 has been
expensed with ATI and applied to the amount due from ATI.
Effective
January 1, 2004, the Company entered into a rental agreement with Cornish
Properties Corporation, a company owned and managed by Mr. Cornish, pursuant to
which the Company leases space from Cornish Properties Corporation at $2,745 per
month. The original term of the lease extended to December 31, 2005. On November
8, 2005, as provided for in the rental agreement, the Company extended the term
of the rental agreement with Cornish Properties Corporation for another year,
ending December 31, 2006. On December 19, 2006, the Company extended the term of
the rental agreement with Cornish Properties Corporation for another year,
ending December 31, 2007, at a lease payment of $2,168 per month which has now
expired.
On
November 30, 2006, the Company announced that Mr. Elias Vamvakas, the Chairman,
Chief Executive Officer and Secretary of the Company, had agreed to provide the
Company with a standby commitment to purchase convertible debentures of the
Company, or the Convertible Debentures, in an aggregate maximum amount of
$8,000,000, referred to as the Total Commitment Amount. Pursuant to
the Summary of Terms and Conditions, executed and delivered as of November 30,
2006 by the Company and Mr. Vamvakas, during the 12-month commitment term
commencing on November 30, 2006, upon no less than 45 days’ written notice by
the Company to Mr. Vamvakas, Mr. Vamvakas was obligated to purchase Convertible
Debentures in the aggregate principal amount specified in such written notice. A
commitment fee of 200 basis points was payable by the Company on the undrawn
portion of the Total Commitment Amount. Any Convertible Debentures purchased by
Mr. Vamvakas would have carried an interest rate of 10% per annum and would have
been convertible, at Mr. Vamvakas’ option, into shares of the Company’s common
stock at a conversion price of $13.50 per share. The Summary of Terms and
Conditions further provided that if the Company closes a financing with a third
party, whether by way of debt, equity or otherwise, and there are no Convertible
Debentures outstanding, then the Total Commitment Amount was to be reduced
automatically upon the closing of the financing by the lesser of: (i) the Total
Commitment Amount; and (ii) the net proceeds of the financing. On February 6,
2007, the Company raised gross proceeds in the amount of $10,016,000 in a
private placement of shares of its common stock and warrants. The Total
Commitment Amount was therefore reduced to zero, thus effectively terminating
Mr. Vamvakas’ standby commitment. No portion of the standby commitment was ever
drawn down by the Company, and the Company paid Mr. Vamvakas a total of $29,808
in commitment fees in February 2007.
Marchant,
a firm indirectly beneficially owned as to approximately 32% by Mr. Vamvakas and
members of his family, introduced the Company to the lenders of the (i)
$3,000,000 aggregate principal amount Original Bridge Loan that the Company
secured and announced on February 19, 2008; (ii) the $300,000
aggregate principal amount Additional Bridge Loan I secured and announced on May
5, 2008; and (iii) the $3,403,500 aggregate principal amount Additional Bridge
Loan II secured and announced on July 28, 2008. The Company also has
retained Marchant in connection with the proposed private placement of
$2,173,000 of OccuLogix’s common stock, announced by the Company on July 28,
2008, for which Marchant will be paid $750,000 representing approximately 17% of
the gross aggregate proceeds of such private placement and bridge loans by
Canadian investors. Marchant has been paid $180,000 and subject
to obtaining any and all requisite stockholder and regulatory approvals, will be
paid a further $88,800 in cash and $481,200 in the form of equity securities of
the Company. (See Note 22 A – Subsequent Events.)
In March
2007, Veris Health Sciences Inc., or Veris negotiated new payment terms with the
Company, and it was agreed that payment for treatment sets shipped subsequent to
March 2007 must be received within 180 days of shipment. From April 2007 to
December 31, 2007, the Company sold a total of 816 treatment sets to Veris, for
a total amount of $172,992, plus applicable taxes. The sale of these treatment
sets was not recognized as revenue during the year ended December 31, 2007 based
on Veris’ payment history with the Company and the new 180-day payment terms
agreed by Veris and the Company. In October 2007, the Company met with the
management of Veris and, based on discussions with Veris, the Company believes
that Veris will not be able to meet its financial obligations to the Company.
Therefore, during the year ended December 31, 2007, the Company recorded an
allowance for doubtful accounts of $172,992 against the total amount due from
Veris for the purchase of these treatment sets. As at September 30, 2008
and December 31, 2007, the allowance for doubtful accounts was
$172,992.
On
January 25, 2007, the Company entered into a consulting agreement with Dr.
Michael Lemp for the purpose of procuring consulting services as OcuSense’s
Chief Medical Officer. Dr. Lemp is entitled to $100,000 per annum to be paid at
the end of each month and a $99 monthly expense reimbursement
stipend. Dr. Lemp will be available to OcuSense on an average of 20
hours a week or 1,000 hours per year. Dr. Lemp also served as a member of the
board of directors of OcuSense until October 6, 2008.
On
January 1, 2007, the Company adopted the provisions of FASB Interpretation No.
48, “Accounting for Uncertainty in Income Taxes – An Interpretation of FASB
Statement No. 109,” or FIN No. 48. FIN No. 48 addresses the determination of
whether tax benefits claimed or expected to be claimed on a tax return should be
recorded in the financial statements. Under FIN No. 48, the Company
may recognize the tax benefit from an uncertain tax position only if it is more
likely than not that the tax position will be sustained on examination by the
taxing authorities, based on the technical merits of the
position. The tax benefits recognized in the financial statements
from such a position should be measured based on the largest benefit that has a
greater than 50% likelihood of being realized upon ultimate settlement. FIN No.
48 also provides guidance on de-recognition, classification, interest and
penalties on income taxes and accounting in interim periods and requires
increased disclosure.
As a
result of the implementation of the provisions of FIN No. 48, the Company
recognized a reduction to the January 1, 2007 deferred tax liability balance in
the amount of $4.6 million with a corresponding reduction to accumulated
deficit.
As of
January 1, 2007, the Company had unrecognized tax benefits of $24.8
million which, if recognized, would favorably affect the Company’s
effective tax rate.
When
applicable, the Company recognizes accrued interest and penalties related to
unrecognized tax benefits as other expense in its consolidated statements of
operations, which is consistent with the recognition of these items in prior
reporting periods. As of January 1, 2007, the Company did not have any liability
for the payment of interest and penalties.
The
Company does not expect a significant change in the amount of its unrecognized
tax benefits within the next 12 months. Therefore, it is not expected that the
change in the Company’s unrecognized tax benefits will have a significant impact
on the results of operations or financial position of the Company.
However,
the completion of the reorganization transactions on October 6, 2008 makes it
more likely than not that the Company incurred a change of control for purposes
of Section 382 for US Income Taxes. (See Note 22 A – Subsequent Events.) Rules
under Section 382 of the U.S. Income Tax Code substantially reduce the Company’s
ability to utilize prior tax losses. Accordingly, income tax benefits of
$2,304,938, representing the excess of income tax benefits previously recognized
and the income tax benefit applicable to the equivalent of one year’s losses
deductible in accordance with Section 382 and benefits related to
unrestricted losses under Section 382(h) of the U.S. Income Tax Code, were
reversed and reported as an income tax expense.
All
federal income tax returns for the Company and its subsidiaries remain open
since their respective dates of incorporation due to the existence of net
operating losses. The Company and its subsidiaries have not been, nor
are they currently, under examination by the Internal Revenue Service or the
Canada Revenue Agency.
State and
provincial income tax returns are generally subject to examination for a period
of between three and five years after their filing. However, due to
the existence of net operating losses, all state income tax returns of the
Company and its subsidiaries since their respective dates of incorporation are
subject to re-assessment. The state impact of any federal changes
remains subject to examination by various states for a period of up to one year
after formal notification to the states. The Company and its
subsidiaries have not been, nor are they currently, under examination by any
state tax authority.
|
|
September
30, 2008
$
|
|
|
December 31,
2007
$
|
|
Due
(from)/to
|
|
|
|
|
|
|
TLC
Vision Corporation
|
|
|
15,517
|
|
|
|
(2,708
|
)
|
Other
stockholders
|
|
|
—
|
|
|
|
35,522
|
|
|
|
|
15,517
|
|
|
|
32,814
|
|
The
balance due from TLC Vision is related to computer and administrative support
provided by TLC Vision. All amounts have been expensed during the nine months
ended September 30, 2008 and 2007 and included in general and administrative
expenses. The balance due to other stockholders includes outstanding royalty
fees payable to Mr. Hans Stock.
17.
PREPAID EXPENSES
|
|
September
30, 2008
$
|
|
|
December 31,
2007
$
|
|
Prepaid
insurance
|
|
|
110,610
|
|
|
|
427,063
|
|
Tear
samples and lab cards
|
|
|
2,451
|
|
|
|
—
|
|
Prepaid
regulatory fees
|
|
|
15,460
|
|
|
|
—
|
|
Other
fees and services
|
|
|
49,337
|
|
|
|
54,058
|
|
|
|
|
177,858
|
|
|
|
481,121
|
|
18.
|
OTHER
NON-CURRENT ASSETS
|
|
|
September
30, 2008
$
|
|
|
December 31,
2007
$
|
|
Other
non-current assets
|
|
|
249,504
|
|
|
|
—
|
|
Other
non-current assets represent professional fees that will become capital costs of
the reorganization transactions which were closed October 6, 2008. (See Note 22
A – Subsequent Events.)
19. ACCRUED
LIABILITIES
|
|
September
30, 2008
$
|
|
|
December 31,
2007
$
|
|
Due
to professionals
|
|
|
367,611
|
|
|
|
475,044
|
|
Due
to clinical trial sites
|
|
|
123,342
|
|
|
|
136,681
|
|
Due
to clinical trial specialists
|
|
|
60,711
|
|
|
|
116,359
|
|
Product
development costs
|
|
|
350,763
|
|
|
|
277,521
|
|
Due
to employees and directors
|
|
|
55,545
|
|
|
|
66,804
|
|
Sales
and capital taxes payable
|
|
|
16,333
|
|
|
|
26,820
|
|
Corporate
compliance
|
|
|
144,931
|
|
|
|
246,675
|
|
Obligation
to repay advances received
|
|
|
183,065
|
|
|
|
—
|
|
Severances
(restructuring charges)
|
|
|
1,919,570
|
|
|
|
1,312,721
|
|
Cash
with restricted use
|
|
|
200,000
|
|
|
|
—
|
|
Miscellaneous
|
|
|
40,253
|
|
|
|
214,826
|
|
|
|
|
3,462,124
|
|
|
|
2,873,451
|
|
The
following sets out a continuity of the Company’s liability for restructuring
costs for the nine months ended September 30, 2008 and 2007:
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
Accrued
liability for severances - beginning of period
|
|
|
1,312,721
|
|
|
|
―
|
|
Restructuring
charges incurred in the period
|
|
|
1,029,646
|
|
|
|
―
|
|
Restructuring
charges funded by the issuance of options
|
|
|
(74,128
|
)
|
|
|
―
|
|
Foreign
exchange adjustment
|
|
|
(34,442
|
)
|
|
|
―
|
|
Paid
in the period
|
|
|
(314,227
|
)
|
|
|
―
|
|
Accrued
liability for severances - end of period
|
|
|
1,919,570
|
|
|
|
―
|
|
In
accordance with SFAS No. 146, “Accounting for Costs Associated with Exit or
Disposal Activities,” or SFAS No. 146, the Company recognized a total of
$1,029,646 and nil in restructuring charges during the nine months ended
September 30, 2008 and 2007, respectively, reflecting the termination of
employment on June 30, 2008 of Tom Reeves, formerly the Company's President
and Chief Operating Officer, and the fair value of options modified for former
executives. (See Note 12 (b) – CAPITAL STOCK-Stock-based compensation.) With the
suspension of the Company’s RHEO™ System clinical development program, and the
resulting winding down of the RHEO-AMD study, and the Company’s disposition
of SOLX on December 19, 2007, the Company has reduced its workforce
considerably. During 2007, the Company implemented a number of structural and
management changes consistent with the termination of its focus on the RHEO™
System. The restructuring charges of $1,312,721 recorded in the fourth quarter
of 2007 consist solely of severance and benefit costs related to the termination
of certain of the Company’s employees at the Company’s Palm Harbor and
Mississauga offices.
20.
|
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
The net
change in non-cash working capital balances related to operations consists of
the following:
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
Amounts
receivable, net
|
|
|
345,606
|
|
|
|
(197,986
|
)
|
Inventory
|
|
|
―
|
|
|
|
(61,784
|
)
|
Prepaid
expenses
|
|
|
271,908
|
|
|
|
(46,787
|
)
|
Deposit
|
|
|
(11,238
|
)
|
|
|
(10,600
|
)
|
Other
current assets
|
|
|
(249,504
|
)
|
|
|
17,600
|
|
Accounts
payable
|
|
|
(758,156
|
)
|
|
|
243,097
|
|
Accrued
liabilities
|
|
|
588,674
|
|
|
|
938,684
|
|
Deferred
revenue
|
|
|
97,444
|
|
|
|
―
|
|
Due
to stockholders
|
|
|
(17,297
|
)
|
|
|
83,646
|
|
Accrued
interest payable
|
|
|
305,255
|
|
|
|
―
|
|
|
|
|
572,692
|
|
|
|
965,870
|
|
The
following table lists those items that have been excluded from the consolidated
statements of cash flows as they relate to non-cash transactions and additional
cash flow information:
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
Non-cash
financing activities
|
|
|
|
|
|
|
Warrant
issued in part payment of placement fee
|
|
|
—
|
|
|
|
97,222
|
|
Free
inventory
|
|
|
—
|
|
|
|
418,303
|
|
|
|
|
|
|
|
|
|
|
Additional
cash flow information
|
|
|
|
|
|
|
|
|
Interest
paid
|
|
|
—
|
|
|
|
11,180
|
|
21.
|
SEGMENTED
INFORMATION
|
As a
result of the acquisition of SOLX and OcuSense during 2006
,
the Company had three
reportable segments: retina, glaucoma and point-of-care. The retina segment was
in the business of commercializing the RHEO™ System which was used to perform
the Rheopheresis™ procedure, a procedure that selectively removes molecules from
plasma, which is designed to treat Dry AMD. The Company began limited
commercialization of the RHEO™ System in Canada in 2003 and provided support to
its sole customer in Canada, Veris, in its commercial activities in Canada. The
Company obtained investigational device exemption clearance from the FDA to
commence RHEO-AMD, its clinical study of the RHEO™ System. On November 1, 2007,
the Company announced an indefinite suspension of the RHEO™ System clinical
development program for Dry AMD following a comprehensive review of the
respective costs and development timelines associated with the products in the
Company’s portfolio and, in particular, the impact if the Company is unable to
raise additional capital.
The
glaucoma segment of the Company was in the business of providing treatment for
glaucoma with the use of the components of the SOLX Glaucoma System which are
used to provide physicians with multiple options to manage intraocular pressure.
The Company was seeking to obtain 510(k) approval to market the components of
the SOLX Glaucoma System in the United States. The Company acquired the glaucoma
segment in the acquisition of SOLX on September 1, 2006; therefore, no amounts
are shown for the segment in periods prior to September 1, 2006. On December 19,
2007, the Company sold all of the issued and outstanding shares of the capital
stock of SOLX. All revenue and expenses related to the Company’s glaucoma
segment, prior to the December 19, 2007 closing date, have therefore been
included in discontinued operations on its consolidated statements of operations
for the nine months ended September 30, 2008 and 2007.
The
point-of-care segment is made up of the TearLab™ business which is currently
developing technologies that enable eyecare practitioners to test, at the
point-of-care, for highly sensitive and specific biomarkers in tears using
nanoliters of tear film.
The
accounting policies of the segments are the same as those described in
significant accounting policies. Inter-segment sales and transfers are minimal
and are accounted for at current market prices, as if the sales or transfers
were to third parties.
The
Company’s reportable units are strategic business units that offer different
products and services. They are managed separately, because each business unit
requires different technology and marketing strategies. The business units’
managements were acquired or developed individually. OcuSense’s management was
retained at the time of acquisition.
The
Company’s business units are as follows:
|
|
Retina
|
|
|
Point-of-care
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Three
months ended September 30, 2008
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
23,900
|
|
|
|
—
|
|
|
|
23,900
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
1,945
|
|
|
|
—
|
|
|
|
1,945
|
|
Operating
charges before the following
|
|
|
191,226
|
|
|
|
1,311,935
|
|
|
|
1,503,161
|
|
Restructuring
charges
|
|
|
74,128
|
|
|
|
—
|
|
|
|
74,128
|
|
Amortization
|
|
|
776
|
|
|
|
334,400
|
|
|
|
335,176
|
|
Loss
from continuing operations
|
|
|
(244,175)
|
)
|
|
|
(1,646,335)
|
)
|
|
|
(1,890,510)
|
)
|
Interest
income
|
|
|
16,200
|
|
|
|
1,746
|
|
|
|
17,946
|
|
Interest
expense
|
|
|
(169,540)
|
)
|
|
|
—
|
|
|
|
(169,540)
|
)
|
Amortization
of deferred finance charges
|
|
|
(48,000)
|
)
|
|
|
—
|
|
|
|
(48,000)
|
)
|
Changes
in fair value of warrant obligation Changes in fair value of warrant
obligation
|
|
|
(68,281)
|
)
|
|
|
—
|
|
|
|
(68,281)
|
)
|
Other
income (expense), net
|
|
|
93,999
|
|
|
|
37,656
|
|
|
|
131,655
|
|
Minority
interest
|
|
|
—
|
|
|
|
1,393,410
|
|
|
|
1,393,410
|
|
Recovery
of income taxes
|
|
|
—
|
|
|
|
(1,649,632)
|
|
|
|
(1,649,632)
|
|
Net
loss
|
|
|
(419,797)
|
|
|
|
(1,863,155)
|
|
|
|
(2,282,952)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine
months ended September 30, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
158,300
|
|
|
|
—
|
|
|
|
158,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
26,501
|
|
|
|
—
|
|
|
|
26,501
|
|
Operating
charges before the following
|
|
|
2,242,124
|
|
|
|
3,745,071
|
|
|
|
5,988,145
|
|
Restructuring
charges
|
|
|
1,029,646
|
|
|
|
—
|
|
|
|
1,029,646
|
|
Amortization
|
|
|
16,209
|
|
|
|
946,611
|
|
|
|
961,870
|
|
Loss
from continuing operations
|
|
|
(3,156,180)
|
)
|
|
|
(4,691,682)
|
)
|
|
|
(7,847,862)
|
)
|
Interest
income
|
|
|
63,782
|
|
|
|
4,713
|
|
|
|
68,495
|
|
Interest
expense
|
|
|
(305,256)
|
)
|
|
|
—
|
|
|
|
(305,256)
|
)
|
Amortization
of deferred finance charges
|
|
|
(180,000)
|
)
|
|
|
—
|
|
|
|
(180,000)
|
)
|
Changes
in fair value of warrant obligation
|
|
|
(68,281)
|
)
|
|
|
—
|
|
|
|
(68,281)
|
)
|
Impairment
of investments
|
|
|
(450,072)
|
)
|
|
|
—
|
|
|
|
(450,072)
|
|
Other
income (expense), net
|
|
|
114,163
|
|
|
|
37,730
|
|
|
|
151,893
|
|
Minority
interest
|
|
|
—
|
|
|
|
1,964,540
|
|
|
|
1,964,540
|
|
Recovery
of income taxes
|
|
|
—
|
|
|
|
(430,465)
|
|
|
|
(430,465)
|
|
Net
loss
|
|
|
(3,981,844)
|
|
|
|
(3,115,164)
|
|
|
|
(7,097,008)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets as at September 30, 2008
|
|
|
1,915,285
|
|
|
|
11,529,513
|
|
|
|
13,444,798
|
|
The
Company’s business units were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Three
months ended September 30, 2007 – as restated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,287,411
|
|
|
|
|
|
|
|
—
|
|
|
|
2,287,411
|
|
|
|
|
3,206,466
|
|
|
|
|
|
|
|
1,426,117
|
|
|
|
4,632,583
|
|
|
|
|
641,479
|
|
|
|
|
|
|
|
775,402
|
|
|
|
1,416,881
|
|
Impairment
of intangible asset
|
|
|
20,923,028
|
|
|
|
|
|
|
|
—
|
|
|
|
20,923,028
|
|
Loss
from continuing operations
|
|
|
(27,058,384
|
)
|
|
|
|
|
|
|
(2,201,519
|
)
|
|
|
(29,259,903
|
)
|
|
|
|
113,733
|
|
|
|
|
|
|
|
23,404
|
|
|
|
137,137
|
|
Interest
and accretion expense
|
|
|
(226
|
)
|
|
|
|
|
|
|
(362
|
)
|
|
|
(588
|
)
|
Changes
in fair value of warrant obligation
|
|
|
856,969
|
|
|
|
|
|
|
|
—
|
|
|
|
856,969
|
|
Other
income (expense), net
|
|
|
(23,653
|
)
|
|
|
|
|
|
|
17,960
|
|
|
|
(5,693
|
)
|
|
|
|
—
|
|
|
|
|
|
|
|
217,436
|
|
|
|
217,436
|
|
|
|
|
8,202,962
|
|
|
|
|
|
|
|
246,226
|
|
|
|
8,449,188
|
|
Loss
from continuing operations
|
|
|
(17,908,599
|
)
|
|
|
—
|
|
|
|
(1,696,855
|
)
|
|
|
(19,605,454
|
)
|
Loss
from discontinued operations
|
|
|
—
|
|
|
|
(1,082,842
|
)
|
|
|
—
|
|
|
|
(1,082,842
|
)
|
|
|
|
(17,908,599
|
)
|
|
|
(1,082,842
|
)
|
|
|
(1,696,855
|
)
|
|
|
(20,688,296
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine
months ended September 30, 2007 – as restated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
90,000
|
|
|
|
|
|
|
|
—
|
|
|
|
90,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,352,807
|
|
|
|
|
|
|
|
—
|
|
|
|
2,352,807
|
|
|
|
|
9,842,801
|
|
|
|
|
|
|
|
3,546,421
|
|
|
|
13,389,222
|
|
|
|
|
720,257
|
|
|
|
|
|
|
|
2,280,809
|
|
|
|
3,001,066
|
|
Impairment
of intangible asset
|
|
|
20,923,028
|
|
|
|
|
|
|
|
—
|
|
|
|
20,923,028
|
|
Loss
from continuing operations
|
|
|
(33,748,893
|
)
|
|
|
|
|
|
|
(5,827,230
|
)
|
|
|
(39,576,123
|
)
|
|
|
|
519,783
|
|
|
|
|
|
|
|
49,026
|
|
|
|
568,809
|
|
Interest
and accretion expense
|
|
|
(7,458
|
)
|
|
|
|
|
|
|
(784
|
)
|
|
|
(8,242
|
)
|
Changes
in fair value of warrant obligation
|
|
|
1,633,700
|
|
|
|
|
|
|
|
—
|
|
|
|
1,633,700
|
|
Other
income (expense), net
|
|
|
(35,315
|
)
|
|
|
|
|
|
|
21,682
|
|
|
|
(13,633
|
)
|
|
|
|
—
|
|
|
|
|
|
|
|
783,447
|
|
|
|
783,447
|
|
|
|
|
10,273,942
|
|
|
|
|
|
|
|
1,341,607
|
|
|
|
11,615,549
|
|
Loss
from continuing operations
|
|
|
(21,364,241
|
)
|
|
|
—
|
|
|
|
(3,632,252
|
)
|
|
|
(24,996,493
|
)
|
Loss
from discontinued operations
|
|
|
—
|
|
|
|
(3,267,891
|
)
|
|
|
—
|
|
|
|
(3,267,891
|
)
|
|
|
|
(21,364,241
|
)
|
|
|
(3,267,891
|
)
|
|
|
(3,632,252
|
)
|
|
|
(28,264,384
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets as at September 30, 2007
|
|
|
17,493,302
|
|
|
|
31,417,560
|
|
|
|
13,155,891
|
|
|
|
62,066,753
|
|
22. SUBSEQUENT
EVENTS
|
A)
|
Reorganization
transactions
|
On
October 6, 2008, the Company announced that it had completed a series of
reorganization transactions that included those transactions which the Company
had presented to its shareholders in the proxy circular prepared for the
September 30, 2008 shareholders meeting and which were approved by the Company’s
stockholders at the Annual and Special Meeting of Stockholders on September 30,
2008. The transactions that were completed were as follows:
i.
|
A
private placement, or PIPE, transaction for $2,173,000 in which the
Company issued 869,200 common shares of OccuLogix at a per share price of
$2.50.
|
ii.
|
OccuLogix
prepaid $7,021,978 representing the aggregate of all of the outstanding
bridge loans plus related accrued interest, in which the amounts
outstanding were converted into 3,304,511 shares of common stock of
OccuLogix at a per share price of $2.125. Under this repayment, since
OccuLogix met the condition of having closed a PIPE for aggregate
gross proceeds of at least $1,000,000, the Company was able to repay the
bridge loans in full by issuing to the lenders, shares of its common
stock, in an aggregate amount equal to the amount of outstanding principal
and accrued interest, at a 15% discount to the price paid by the PIPE
investors or $2.125 per share.
|
iii.
|
OccuLogix
acquired the remaining ownership interest (44.03% of remaining outstanding
shares after the cashless exercise of all outstanding OcuSense warrants,
49.9% on a fully diluted basis) in OcuSense that it did not already own,
by way of a merger of OcuSense and a newly incorporated, wholly-owned
subsidiary of OccuLogix. As merger consideration, the Company
issued an aggregate of 3,169,938 shares of its common stock to the
minority stockholders of OcuSense.
|
iv.
|
At
the completion of the reorganization transactions, the Company paid the
remaining $570,000 of the commission owing for placement agency services
rendered by Marchant Securities Inc., or Marchant. Marchant received
$88,800 in cash and $481,200 of value in OccuLogix’s common stock at a per
share price of $2.50 as payment for these amounts owing. Marchant is a
firm that is indirectly beneficially owned as to approximately 32% by Mr.
Vamvakas and members of his family. (See Note 14 – Related Party
Transactions.)
|
v.
|
At
the completion of the reorganization transactions, OccuLogix had reached
agreement with the majority of its senior management in which the senior
management agreed to forego a fixed percentage of their cash severance
entitlement in exchange for 1,101,636 stock options under the OccuLogix
Stock Option Plan exercisable into common shares of OccuLogix. The number
of options that each senior manager received was based on the cash
severance entitlement being foregone divided by a Black-Scholes valuation
of the options assuming the same price per share of OccuLogix common stock
applicable to the PIPE and Minority Shareholders investors in the
reorganization transactions. These options will vest immediately and will
have a 10 year life. The exercise price of these options are $2.63 which
equals the fair market value of OccuLogix’s common stock on NASDAQ on the
day of the completion of the reorganization transactions. The calculation
of the number of options provided to senior managers took into account the
impact of the exercise price of the options being greater than the price
per share applicable to the PIPE and Minority Shareholders investors in
the reorganization transactions.
|
vi.
|
In connection with
the completion of the reorganization transactions, the Company issued an
aggregate of 188,401,858 shares of its common stock resulting in the
Company’s total and outstanding share capital to consist of 245,707,733
shares of common stock. Immediately after the close of the reorganization
transactions, OccuLogix made an amendment to the Company’s
Amended
and Restated Certificate of Incorporation in order to provide for a
recapitalization in which the issued and outstanding shares of the
Company’s common stock underwent a reverse split in a ratio of 1:25.
Subsequent to the reverse split, the Company’s total and outstanding share
capital was 9,828,409 shares of common stock. As explained in Note 1, the
effect of the reverse stock split has been reflected retroactively in
these financial statements for each period
presented.
|
B)
NASDAQ listing
On
October 30, 2008, the Company announced that it had been notified by the NASDAQ
Listing and Hearing Council, or the Listing Council, that OccuLogix had
demonstrated compliance with both the $1.00 minimum bid price rule and the
requirement to maintain stockholders’ equity in the minimum amount of
$2,500,000. The Listing Council confirmed that the listing review is
now closed and that the Company’s securities will remain listed on the NASDAQ
Capital Market.
This
represented the culmination of ongoing dialogue and communications with the
NASDAQ Listing Qualifications Panel and the Listing Council subsequent to the
Company’s receipt on September 18, 2007, of a letter from NASDAQ indicating
that, for the previous 30 consecutive business days, the bid price of the
Company’s common stock closed below the minimum $1.00 per share requirement for
continued inclusion under Marketplace Rule 4450(e)(5).
C) ARS
In a
letter from Credit Suisse Securities dated September 18, 2008, the Company was
informed that Credit Suisse’s records indicate that the Company may be eligible
as an “Individual Investor” of Credit Suisse to have Credit Suisse repurchase
those ARS, that had been purchased by the Company through Credit Suisse prior to
February 14, 2008. The term “Individual Investor” was defined by a recent ARS
settlement by Credit Suisse with the New York Attorney General’s Office and the
North American Securities Administrators Association in which 10 firms including
Credit Suisse accepted as a result of enforcement actions.
In a
letter and Offer to Purchase for Cash from Eligible customers ARS from Credit
Suisse dated October 2, 2008, the Company was again informed that Credit
Suisse’s records indicate that the Company may be an eligible customer and may
therefore be eligible to have Credit Suisse purchase the ARS purchased by the
Company through Credit Suisse at a value equal to their principal amount plus
accrued interest.
On
October 15, 2008, Credit Suisse informed the Company that it had wired to the
Company $503,622 representing the purchase by Credit Suisse of $500,000
principal and accrued interest balance of the Alesco Preferred Funding Ltd.
ARS.
On
October 24, 2008, Credit Suisse informed the Company that it had wired to the
Company $481,148 representing the purchase by Credit Suisse of $475,000
principal and accrued interest balance of the Class V Funding II, Ltd.
ARS.
On
November 7, 2008, Credit Suisse informed the Company that it had wired to the
Company $502,085 representing the purchase by Credit Suisse of $500,000
principal and accrued interest balance of the Reservoir Funding Ltd
ARS.
On
November 10, 2008, Credit Suisse informed the Company that it had wired to the
Company $425,000 plus accrued interest representing the purchase by Credit
Suisse of $425,000 principal and accrued interest balance of the Juniper
High-Grade CDO III Ltd ARS.
The ARS
investments are classified as available-for-sale under SFAS No.133 which states
that where an impairment of an available-for-sale investment has been reported,
this impairment can only be reversed when a recovery or gain of the amount
reflected as an impairment charge has been realized. At September 30, 2008,
Credit Suisse had not yet purchased any of the Company’s outstanding ARS and as
such the Company has not reported the recovery of the impairment charge and
continues to reflect the ARS at $413,678, consistent with the fair value
reported by the Company in its June 30, 2008 financial statements. Since the ARS
will be purchased by Credit Suisse in the fourth quarter, the ARS have been
reported as current assets.
ITEM
2.
|
MA
NAGEM
ENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
|
Overview
On
October 7, 2008, we effected a 1-for-25 reverse split of our common stock. See
“—Recent Developments”. Historical share numbers and prices throughout this
Quarterly Report on Form 10-Q are split-adjusted.
We are an
ophthalmic therapeutic company founded to commercialize innovative treatments
for age-related eye diseases. Previously, the Company operated three business
divisions, being Retina, Glaucoma and Point-of-care. Currently, Point-of-care is
the Company’s sole operating business.
Until
November 1, 2007, when we announced the suspension of the Company’s RHEO™ System
clinical development program, the Company’s Retina division had been in the
business of developing and commercializing the RHEO™ System, a treatment for dry
age-related macular degeneration. We had conducted a pivotal clinical study, the
MIRA-1 study, which, if successful, was expected to support our application to
the U.S. Food and Drug Administration, or the FDA, to obtain approval to market
the RHEO™ System in the United States. The MIRA-1 study did not meet its primary
efficacy endpoint, and the FDA required us to conduct an additional study of the
RHEO™ System, the RHEO-AMD study, which was commenced in early 2007, was
suspended on November 1, 2007 and is now nearly wound down.
In
anticipation of the delay in the commercialization of the Company’s RHEO™ System
in the U.S. as a result of the failure of the MIRA-1 study to meet its primary
efficacy endpoint and the FDA’s requirement of us to conduct the RHEO-AMD study,
we accelerated our diversification plans. On September 1, 2006, we acquired
Solx, Inc., or SOLX, a Boston University Photonics Center-incubated company that
has developed a system for the treatment of glaucoma. SOLX was the Company’s
Glaucoma division until we disposed of it in December 2007.
On
November 30, 2006, also as part of our accelerated diversification plans, we
acquired 1,754,589 shares of the Series A Preferred Stock of OcuSense, Inc., or
OcuSense, then representing 50.1% of the capital stock, on a fully diluted
basis, of OcuSense (57.62% of the capital stock of OcuSense, measured on an
issued and outstanding basis). The total purchase price was $8,000,000, of which
the Company paid $2,000,000 on November 30, 2006 and paid another $2,000,000 on
January 3, 2007. The third $2,000,000 installment of the purchase price was
payable upon the attainment by OcuSense of the first of two developmental
milestones and was paid by the Company on June 15, 2007. The last $2,000,000
installment of the purchase price was payable upon the attainment by OcuSense of
the second of the two developmental milestones and was paid by the Company on
March 31, 2008.
On
October 6, 2008, the Company acquired the minority ownership interest in
OcuSense that it did not already own by issuing to the minority stockholders of
OcuSense an aggregate of 3,169,938 shares of the Company’s common stock. The
acquisition of the minority ownership interest in OcuSense was effected pursuant
to a statutory merger of OcuSense Acquireco, Inc., or Merger Sub, a wholly-owned
subsidiary of the Company, with and into OcuSense, with the separate corporate
existence of Merger Sub ceasing and OcuSense continuing as the surviving
corporation. Today, OcuSense is a wholly-owned subsidiary of the Company. The
quantum of the merger consideration was based on a full-enterprise valuation of
OcuSense of $18,000,000, determined in good faith by the respective boards of
directors of the Company and OcuSense, and a deemed value of $2.50 per share of
the Company’s common stock, which was reflective of the per share average
trading price of the Company’s common stock on NASDAQ during the period of
negotiation of the merger consideration (and, as it turned out, on the date of
closing of the acquisition).
Following
the closing of the acquisition, Elias Vamvakas stepped down as the Company’s
Chief Executive Officer, and Eric Donsky, OcuSense’s Chief Executive Officer and
a director of OcuSense, became the Company’s Chief Executive Officer. Mr.
Vamvakas remains the Company’s Chairman of the Board.
OcuSense
is a San Diego-based company that is developing technologies that will enable
eye care practitioners to test, at the point-of-care, for highly sensitive and
specific biomarkers using nanoliters of tear film. OcuSense’s first product is a
hand-held tear film test for the measurement of osmolarity, a quantitative and
highly specific biomarker that has shown to correlate with dry eye disease, or
DED. The test is known as the TearLab™ test for DED. The anticipated innovation
of the TearLab™ test for DED will be its ability to measure precisely and
rapidly certain biomarkers in nanoliter volumes of tear samples, using
inexpensive hardware. Historically, eye care researchers have relied on
expensive instruments to perform tear biomarker analysis. In addition to their
cost, these conventional systems are slow, highly variable in their measurement
readings and not categorized as waived by the FDA under regulations promulgated
under the Clinical Laboratory Improvement Amendments, or CLIA.
There are
estimated to be more than 30 million people with DED in the U.S. alone, and this
condition is estimated to account for up to one-third of all visits to U.S.
doctors. DED is often seen as a result of aging, diabetes, prostate cancer
therapy, HIV, autoimmune diseases such as Sjögren’s syndrome and rheumatoid
arthritis, LASIK surgery, contact lens wear and menopause and as a side effect
of hormone replacement therapy. Numerous commonly prescribed and
over-the-counter medications also can cause, or contribute to, the manifestation
of DED.
There are
approximately 15 million Americans who suffer from contact lens-induced DED, and
10-15% of these patients revert to frame wear annually due to dryness and
discomfort. There are approximately 1.2 million LASIK procedures performed in
the U.S. each year, and about 50% of patients experience DED post-operatively.
Osmolarity testing could provide optometrists with a tool to identify patients
at risk for dropping out of contact lens wear early in disease progression so
that they may be treated, and osmolarity testing could be an invaluable
pre-operative screen used to determine which LASIK patients should be treated
prior to surgery in order to improve post-operative outcomes.
The
TearLab™ test for DED consists of the following three components: (1)
the TearLab™ disposable, which is a single-use microfluidic labcard; (2) the
TearLab™ pen, which is a hand-held device that interfaces with the TearLab™
disposable; and (3) the TearLab™ reader, which is a small desktop unit that
allows for the docking of the TearLab™ disposable and the TearLab™ pen and
provides a quantitative reading for the operator. The operator of the TearLab™
test for DED, most likely a technician, will collect the tear sample from the
patient’s eye in the TearLab™ disposable, using the TearLab™ pen, and then place
the TearLab™ disposable into the TearLab™ reader. The TearLab™ reader then will
display an osmolarity reading to the operator. Following the completion of the
test, the TearLab™ disposable will be discarded and a new TearLab™ disposable
will be readied for the next test. The entire process, from sample to answer,
should require approximately two minutes or less to complete.
On April
4, 2008, we announced that OcuSense had validated successfully the beta
prototype of the TearLab™ test for DED. On April 8, 2008, we further announced
that OcuSense had received company-wide certification to ISO 13485:2003. The
successful validation of the beta prototype and the achievement of ISO
certification represented the attainment of significant milestones.
Since
then, the TearLab™ test for DED has received CE mark approval, enabling the
commercialization of the product in the member states of the European Union and
all other countries that recognize the CE mark. Currently, OcuSense is party to
multi-year exclusive agreements with four European distributors, pursuant to
which the TearLab™ test for DED is being distributed in the United Kingdom, the
Republic of Ireland, Germany, Spain and Italy. The Company has plans to expand
OcuSense’s distribution network in Europe during the coming months.
On
October 29, 2008, we announced that OcuSense has submitted its application to
the FDA for 510(k) clearance for the TearLab™ test for DED. The Company expects
to release, at the upcoming joint meeting of the American Academy of
Ophthalmology and the European Society of Ophthalmology, top-line data from the
three-site, 234-patient clinical trial that had been conducted in support of
OcuSense’s 510(k) application. At the present time, the Company anticipates that
OcuSense will seek the CLIA waiver during the latter half of 2009.
Recent
Developments
On
October 6, 2008, the Company completed the acquisition of the minority ownership
interest in OcuSense that it did not already own by issuing to the minority
stockholders of OcuSense an aggregate of 3,169,938 shares of the Company’s
common stock. See “—Overview”. On that same day, the Company completed a private
placement of 869,200 shares of its common stock for gross aggregate proceeds of
$2,173,000, referred to as the Private Placement, and pre-paid, in full, its
$6,703,500 aggregate principal amount bridge loan, or the Bridge Loan, and paid
$481,200 of the commission remaining owing for placement agency services
rendered by Marchant Securities Inc., or Marchant. The Company pre-paid the
Bridge Loan (plus accrued but unpaid interest) by issuing to the lenders thereof
an aggregate of 3,304,511 shares of its common stock, at a per share price of
$2.125, and issued to Marchant an aggregate of 192,480 shares of the Company’s
common stock in payment of $481,200 of the commission remaining owing to
Marchant.
On
October 7, 2008, the Company filed, with the Secretary of State of the State of
Delaware, a Certificate of Amendment to its Amended and Restated Certificate of
Incorporation, as amended, in order to (i) provide for a recapitalization in
which the issued and outstanding shares of the Company’s common stock was
reverse split in a ratio of 1:25, referred to as the Reverse Split, and (ii)
upon the effectiveness of the Reverse Split, decrease the number of authorized
shares of the Company’s common stock from 500,000,000 to 40,000,000. The Reverse
Split took effect on The NASDAQ Capital Market and the Toronto Stock Exchange on
October 9, 2008. Currently, the Company’s issued and outstanding share capital
consists of 9,828,409 shares of common stock.
On
October 30, 2008, we announced that the Company has regained compliance with
NASDAQ’s $1.00 minimum bid price rule and NASDAQ’s requirement to maintain
stockholders’ equity in the minimum amount of $2,500,000. NASDAQ confirmed that
the listing review of the Company is now closed and that our securities will
remain listed on The NASDAQ Capital Market.
As at
September 30, 2008 and December 31, 2007, the Company had investments in four
separate asset-backed ARS, or ARS, in the aggregate principal amount of
$1,900,000 currently yielding an average return of 3.471% per annum. With the
liquidity problems in the global credit and capital markets, the Company’s ARS
have experienced multiple failed auctions since 2007. Although the Company
continued to receive payments of interest on its ARS, we did not know when we
would be able to convert these investments into cash. As a result of a recent
settlement agreement among the New York Attorney General’s Office, the North
American Securities Administrators Association and Credit Suisse (USA) LLC, or
Credit Suisse, the financial institution through which the Company had purchased
its ARS, subsequent to September 30, 2008, the Company had the opportunity to
have Credit Suisse purchase from the Company, for full value plus accrued
interest, all of the Company’s outstanding ARS. Credit Suisse has since
purchased all of these ARS at the Company’s original cost of $1,900,000, plus
accrued interest, when each of these securities came up for
auction.
As a
result of the Private Placement, the Bridge Loans, and the purchase by Credit
Suisse of the principal of, and the accrued interest on, the ARS outstanding at
September 30, 2008, management believes that the Company’s cash and cash
equivalents will be sufficient to meet its operating activities and other
demands until approximately June 2009.
RESULTS
OF OPERATIONS
Continuing
and Discontinued Operations
On
December 20, 2007, we announced the sale of SOLX to SOLX Acquisition, Inc., or
SOLX Acquisition, a company wholly owned by Doug P. Adams, the founder of SOLX
and who, until the closing of the sale, had been serving as an executive officer
of the Company in the capacity of President & Founder, Glaucoma
Division. The results of operations of SOLX have been included in
discontinued operations in the Company’s consolidated statements of operations
for the nine months ended September 30, 2008 and 2007.
Revenue,
Cost of Sales and Gross Margin from Continuing Operations
|
|
Three
Months Ended September 30,
|
|
|
Nine
Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retina
revenue
|
|
|
23,900
|
|
|
|
—
|
|
|
|
N/M
|
*
|
|
|
158,300
|
|
|
|
90,000
|
|
|
|
75
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retina
cost of sales
|
|
|
1,945
|
|
|
|
2,287,411
|
|
|
|
(99.9
|
%)
|
|
|
26,501
|
|
|
|
2,352,807
|
|
|
|
(98.9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retina
gross margin (loss)
|
|
|
21,955
|
|
|
|
(2,287,411
|
)
|
|
|
N/M
|
*
|
|
|
131,799
|
|
|
|
(2,262,807
|
)
|
|
|
N/M
|
*
|
Percentage
of retina revenue
|
|
|
91.9
|
%
|
|
|
N/M
|
*
|
|
|
|
|
|
|
83.3
|
%
|
|
|
N/M
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*N/M
– Not meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
Retina
Revenue
The key
components of the RHEO™ System consist of (1) a Rheofilter filter, a Plasmaflo
filter, and tubing which, together, comprise a disposable treatment set, and (2)
an Octo Nova pump.
The
Company owned consignment inventory of 400 disposable treatment sets held by
Macumed AG, a company based in Switzerland. During the three months and nine
months ended September 30, 2008, Macumed consumed a total of 75 and 123
treatment sets, respectively, at a negotiated price of $150 per treatment set,
resulting in revenue of $11,300 and $18,500, respectively. In addition, Macumed
purchased two Octo Nova pumps at $1,500 per pump, resulting in $3,000 in revenue
in the three months and nine months ended September 30,
2008.
In the
third quarter of 2008, the Company completed an agreement with Diamed
Medizintechnik GmbH, or Diamed, in which the Company agreed to sell to Diamed
113 Octo Nova pumps which had been purchased for commercial use and never used
and four Octo Nova pumps previously used for training purposes. These pumps had
previously been fully provided for in the fourth quarter of 2007 when the
Company suspended all RHEO™ System-related activities. The sale of these pumps
resulted in revenues of $9,600 and $136,800 in the three months and nine months
ended September 30, 2008, respectively.
Revenue
for the nine months ended September 30, 2007 resulted from the sale to
Macumed AG of a total of 600 treatment sets at a negotiated price of $150 per
treatment set.
Retina Cost of
Sales
Cost of
sales includes costs of goods sold and royalty costs. Our cost of goods sold for
the nine months ended September 30, 2007 consists primarily of freight and
shipping costs.
Cost of
sales for the three months and nine months ended September 30, 2008 includes
royalty fees of nil and $25,000, respectively, payable to Dr. Brunner and
Mr. Stock. Cost of sales for the three months ended September 30,
2008 related to Octo Nova pumps which were supplied from an inventory that
had been written down to nil during the nine months ended September 30, 2007 as
a result of the decision to suspend all RHEO™ System-related
activities. Accordingly, there was no additional cost of sales
recorded in the period.
Cost of
sales for the three months ended September 30, 2007 includes $25,000 in royalty
fees payable to Dr. Brunner and Mr. Stock and a charge of $2,261,705 which
reflects the write-down of the value of our commercial inventory of pumps to nil
as of September 30, 2007.
Cost of
sales for the nine months ended September 30, 2007 includes $75,000 in royalty
fees payable to Dr. Brunner and Mr. Stock, freight charges on the treatment sets
sold and delivered to Macumed AG and Veris Health Sciences Inc., during the
nine-month period and a charge of $2,261,705 which reflects the write-down of
the value of our commercial inventory of pumps to nil as of September 30,
2007.
Retina Gross
Margin
During
the three months and nine months ended September 30, 2008, gross margin was
$21,955 and $131,799, respectively, reflecting low sales, nil-value
items sold and fixed royalty fees of $25,000.
During
the three and nine months ended September 30, 2007, gross margin (loss) was
($2,287,411) and ($2,262,807), respectively reflecting low sales, fixed royalty
fees of $75,000 and the write-down in the value of commercial inventory of
$2,261,705.
Operating
Expenses – Continuing Operations
|
|
Three
Months Ended September 30,
|
|
|
Nine
Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
General
and administrative
|
|
|
947,830
|
|
|
|
2,471,586
|
|
|
|
(62
|
%)
|
|
|
3,817,886
|
|
|
|
7,868,264
|
|
|
|
(51
|
%)
|
Clinical
and regulatory
|
|
|
671,612
|
|
|
|
3,076,010
|
|
|
|
(78
|
%)
|
|
|
2,507,792
|
|
|
|
7,204,181
|
|
|
|
(65
|
%)
|
Sales
and marketing
|
|
|
218,895
|
|
|
|
501,868
|
|
|
|
(56
|
%)
|
|
|
629,337
|
|
|
|
1,499,843
|
|
|
|
(58
|
%)
|
Impairment
of intangible asset
|
|
|
—
|
|
|
|
20,923,028
|
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
20,923,028
|
|
|
|
N/M
|
*
|
Restructuring
charges
|
|
|
74,128
|
|
|
|
—
|
|
|
|
N/M
|
*
|
|
|
1,029,646
|
|
|
|
—
|
|
|
|
N/M
|
*
|
Operating
expense from continuing operations
|
|
|
1,912,465
|
|
|
|
26,972,492
|
|
|
|
(93
|
%)
|
|
|
7,979,661
|
|
|
|
37,313,316
|
|
|
|
(79
|
%)
|
Discontinued
operations expense from continuing operations
|
|
|
—
|
|
|
|
1,927,652
|
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
5,840,848
|
|
|
|
N/M
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,912,465
|
|
|
|
28,900,144
|
|
|
|
(93
|
%)
|
|
|
7,797,661
|
|
|
|
43,154,164
|
|
|
|
(82
|
%)
|
*N/M
– Not meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and Administrative Expenses
General
and administrative expenses decreased by $4,050,378 or 51% during the nine
months ended September 30, 2008, as compared with the corresponding period in
fiscal 2007, due to the indefinite suspension of our RHEO™ System clinical
development program. Employee costs, other than stock-based compensation,
decreased by $874,939 reflecting the impact of the restructuring activities in
the latter part of 2007 reducing employee costs in 2008. Stock-based
compensation expense decreased by $701,445, from $733,667 for the nine months
ended September 30, 2007 to $32,221 for the nine months ended September 30,
2008, and reflects the forfeiture of unvested stock options previously granted
to terminated employees. In addition, amortization of intangible assets expense
decreased by $1,760,753, from $2,664,153 for the nine months ended September 30,
2007 to $903,400 for the nine months ended September 30, 2008, and
was primarily due to the impairment of RHEO™
System intangible assets
at September 30, 2007.
We are
continuing to focus our efforts on achieving an orderly refocus on ongoing
activities by reviewing and improving upon our existing business processes and
cost structure.
Clinical
and Regulatory Expenses
Clinical
and regulatory expenses decreased by $4,696,389 or 65% during the nine months
ended September 30, 2008, as compared with the corresponding prior year period,
due to the indefinite suspension of our RHEO™ System clinical development
program. Clinical expense for retina activity of $133,580 for the nine months
ended September 30, 2008 represents expenses incurred to close clinics and to
support ongoing obligations for patient support. Clinical expense for retina
activity during the nine months ended September 30, 2007 was
$4,309,979.
OcuSense
clinical expenditures for the nine months ended September 30, 2008 and 2007 were
$2,367,532 and $2,894,202, respectively. The decrease of $526,670 or 18.2%
reflects the maturing stage of OcuSense technological development in that the
development in the nine months ended September 30, 2008 was of a nature that
could be carried out in-house, whereas the development in the corresponding
period was completed primarily in contracted facilities.
In March
2008, we announced that OcuSense had validated the prototype of the
TearLab
TM
test
for DED and received company-wide certification to ISO 13485:2003. These
achievements allowed the Company to move forward with clinical trials and attain
the CE Mark in Europe, in advance of commercialization.
Sales
and Marketing Expense
Sales and
marketing expenses decreased by $870,506 or 58% during the nine months ended
September 30, 2008, as compared with the prior period in fiscal
2007.
Retina
sales and marketing expense for the nine months ended September 30, 2008 was a
recovery of $82,168 compared to an expense of $1,352,167 during the previous
year, a decline of $1,434,335. This decline is due in general to the
indefinite suspension of our RHEO™ System clinical development program and, in
particular, to a decline in ordinary compensation paid of $2,352 in the
nine months ended September 30, 2008, as compared to $127,091 paid in the nine
months ended September 30, 2007, and to stock-based compensation expense
which declined by $328,112, from $263,746 for the nine months ended September
30, 2007 to a recovery of $64,366 for the nine months ended September 30,
2008.
Sales and
marketing expense for OcuSense increased by $481,662 in the nine months ended
September 30, 2008 when compared with the prior year period in fiscal 2007. This
increase reflects an increased focus on building awareness of the TearLab
TM
test for DED prior
to commercialization.
The
cornerstone of our sales and marketing strategy to date has been to increase
awareness of our products among eye care professionals and, in particular, the
key opinion leaders in the eye care professions. We are presently primarily
focused on commercialization in Europe and developing plans to do the same in
North America. We will continue to develop and execute our conference and podium
strategy to ensure visibility and evidence-based positioning of the TearLab™
test for DED among eye care professionals.
Restructuring
Charges
In
accordance with SFAS No. 146, “Accounting for Costs Associated with Exit or
Disposal Activities”, or SFAS No. 146, we recognized a total of $1,029,646 and
nil in restructuring charges during the nine months ended September 30, 2008 and
2007, respectively, reflecting the termination of employment on June 30, 2008 of
Tom Reeves, the Company's former President and Chief Operating Officer, and
the option expense for options modified under termination agreements of former
executives.
The
Company recognized a total of $74,128 and nil in restructuring charges during
the three months ended September 30, 2008 and 2007, respectively, reflecting the
option expense for options modified under termination agreements of former
executives.
The table
below details the activity affecting the Company’s restructuring liability
during the nine months ended September 30, 2008 and 2007.
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
Accrued
liability for severances - beginning of period
|
|
|
1,312,721
|
|
|
|
―
|
|
Restructure
costs incurred in the period
|
|
|
1,029,646
|
|
|
|
―
|
|
Restructure
cost funded by the issuance of option
|
|
|
(74,128
|
)
|
|
|
|
|
Foreign
exchange adjustment
|
|
|
(34,442
|
)
|
|
|
―
|
|
Paid
in the period
|
|
|
(314,227
|
)
|
|
|
―
|
|
Accrued
liability for severances - end of period
|
|
|
1,919,570
|
|
|
|
―
|
|
Other
Income (Expenses) of Continuing Operations
|
|
Three
Months Ended September 30,
|
|
|
Nine
months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
Interest
income
|
|
|
17,946
|
|
|
|
137,137
|
|
|
|
(87%
|
)
|
|
|
68,495
|
|
|
|
568,809
|
|
|
|
(88%
|
)
|
Changes
in fair value of warrant obligation
|
|
|
(68,281
|
)
|
|
|
856,969
|
|
|
|
(108%
|
)
|
|
|
(68,281
|
)
|
|
|
1,633,700
|
|
|
|
(104%
|
)
|
Interest
expense
|
|
|
(169,540
|
)
|
|
|
(588
|
)
|
|
|
N/M*
|
|
|
|
(305,256
|
)
|
|
|
(8,242
|
)
|
|
|
N/M*
|
|
Amortization
of finance costs
|
|
|
(48,000
|
)
|
|
|
―
|
|
|
|
N/M*
|
|
|
|
(180,000
|
)
|
|
|
―
|
|
|
|
N/M*
|
|
Iimpairment
of investments
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
(450,072
|
)
|
|
|
―
|
|
|
|
N/M*
|
|
Other
|
|
|
131,655
|
|
|
|
(5,693
|
)
|
|
|
N/M*
|
|
|
|
151,893
|
|
|
|
(13,633
|
)
|
|
|
N/M*
|
|
Minority
interest
|
|
|
1,393,410
|
|
|
|
217,436
|
|
|
|
541%
|
|
|
|
1,964,540
|
|
|
|
783,447
|
|
|
|
148%
|
|
|
|
|
1,257,190
|
|
|
|
1,205,261
|
|
|
|
4%
|
|
|
|
1,181,319
|
|
|
|
2,964,082
|
|
|
|
(60%
|
)
|
*N/M
– Not meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
Income
Interest
income consists of interest income earned in the current period and the
corresponding prior period as a result of the Company’s cash and short-term
investment position following the raising of capital and debt.
Changes
in Fair Value of Obligation under Warrants and Warrant Expense
On
February 6, 2007, pursuant to the Securities Purchase Agreement between the
Company and certain institutional investors, the Company issued five-year
warrants exercisable into an aggregate of 106,838 shares of the Company’s common
stock to these investors. On February 6, 2007, the Company also issued a
five-year warrant exercisable into an aggregate of 3,740 shares of the Company’s
common stock to Cowen and Company, LLC in part payment of the placement fee
payable to Cowen and Company, LLC for the services it had rendered as the
placement agent in connection with the private placement of the Company’s shares
of common stock and warrants. The per share exercise price of the warrants is
$46.25, subject to adjustment, and the warrants became exercisable on August 6,
2007. All of the terms and conditions of the warrants issued to Cowen and
Company, LLC (other than the number of shares of the Company's common stock into
which the warrant is exercisable) are identical to those of the warrants issued
to the institutional investors. The Company accounts for the warrants in
accordance with the provisions of SFAS No. 133 along with related interpretation
EITF 00-19 “Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company’s Own Stock” or EITF 00-19.
Based on the provisions
of EITF 00-19, the Company determined that the warrants issued during the nine
months ended September 30, 2007 do not meet the criteria for classification as
equity. Accordingly, the Company has classified the warrants as a current
liability as at September 30, 2007. The estimated fair value was determined
using the Black-Scholes option-pricing model. In addition, SFAS No. 133 requires
the Company to record the outstanding warrants at fair value at the end of each
reporting period resulting in an adjustment to the recorded liability of the
derivative, with any gain or loss recorded in earnings of the applicable
reporting period. The Company therefore estimated the fair value of the warrants
as at September 30, 2008 and determined the aggregate fair value to be $68,281,
an increase of $68,281 from the nominal value calculated as at December 31,
2007.
Changes
in fair value of obligation under warrants and warrant expense of $1,633,700 for
the nine months ended September 30, 2007 includes transaction costs associated
with the issuance of the warrants of $170,082 and a gain of $1,803,782 which
reflects the decrease in the fair value of the warrants as at September 30, 2007
over the initial measurement of the fair value of the warrants on the date of
issuance.
Interest
Expense
On
February 19, 2008, May 5, 2008 and July 28, the Company announced that it had
secured bridge loans in an aggregate principal amount of $6,703,500 (less
transaction costs paid of approximately $180,000) from a number of private
parties. The loan earned interest at a rate of 12% per annum and has a 180-day
term initially, which subsequently was extended to 270 days. The Company had
pledged its shares of the capital stock of OcuSense as collateral for these
bridge loans. Interest expense for the three months and nine months ended
September 30, 2008 of $169,540 and $305,256, respectively, was due to the
lenders. The bridge loans, plus accrued interest, were prepaid on
October 6, 2008.
Amortization
of Finance Costs
Finance
costs for the nine months ended September 30, 2008 reflect amortization of the
$180,000 paid to Marchant Securities Inc., or Marchant, a related party, for
introducing the Company to the bridge loan lenders who participated in the
February 19, 2008 bridge financing. The finance costs were amortized
over the initial term of the bridge financing.
Impairment
of Investments
As at
September 30, 2008 and December 31, 2007, the Company had investments in the
aggregate principal amount of $1,900,000 consisting of investments in four
separate asset-backed ARS, currently yielding an average return of 3.471%
per annum. Contractual maturities for these ARS are greater than eight years
with an interest rate reset date for these investments averaging approximately
every 43 days. Historically, the carrying value of ARS approximated fair
value due to the frequent resetting of the interest rates. With the liquidity
issues experienced in the global credit and capital markets, the Company’s ARS
have experienced multiple failed auctions. During 2008, although the Company
continued to earn and receive interest on these investments at the maximum
contractual rate, the estimated fair value of these ARS were no longer believed
to approximate par value. Refer to Note 9 to the Notes to Consolidated Financial
Statements for discussion regarding the Company’s method to determine the fair
value of its investment in ARS.
Although
the Company continued to receive payment of interest earned on these securities,
the Company did not previously know when it would be able to convert these
investments into cash. Accordingly, management had classified these
investments as a non-current asset on its consolidated balance sheets as at
December 31, 2007 and at March 30, 2008 and June 30, 2008. In accordance
with a recent settlement agreement among the New York Attorney General’s Office,
the North American Securities Administrators Association and Credit Suisse, the
financial institution through which the Company had purchased its ARS,
subsequent to September 30, 2008, Credit Suisse purchased all of the
Company’s ARS at the Company’s original cost of $1,900,000, plus accrued
interest, when each of these securities came up for auction.
The ARS
investments are classified as Available for Sale under SFAS 115, “Accounting for
Certain Investments in Debt and Equity”, or SFAS 115, which states that where an
impairment of an Available for Sale investment has been reported, this
impairment can only be reversed when a recovery or gain of the amount reflected
as an impairment charge has been realized.
At September 30, 2008,
Credit Suisse had not yet purchased any of the Company’s outstanding ARS and as
such the Company has not reported the recovery of the impairment charge and
continues to reflect the ARS at $413,678, which is consistent with the fair
value reported by the Company in its June 30, 2008 financial statements. Since
the ARS were purchased by Credit Suisse in the fourth quarter, the ARS have been
reported as current assets.
Other
Other
income for the nine months ended September 30, 2008 of $151,893 includes a
foreign exchange gain of $107,163 and a non-recurring gain of $48,023 reflecting
prior RHEO
TM
System
royalty commitments which will not be paid.
Other
expense for the nine months ended September 30, 2007 consists of a one-time
charge of $9,274 paid to one of our suppliers for carrying excess inventory on
our behalf. Other expenses also include a net foreign exchange loss resulting
from exchange rate fluctuations on the Company’s foreign currency transactions
and miscellaneous tax expenses during the nine-month period.
.
Minority
Interest
|
|
Three
months ended September 30,
|
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
Minority
share of results from operation
|
|
|
1,393,410
|
|
|
|
217,436
|
|
|
|
1,175,974
|
|
|
|
2,168,359
|
|
|
|
913,738
|
|
|
|
1,254,621
|
|
Increment
on completion of the Alpha milestone
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
(130,291
|
)
|
|
|
130,291
|
|
Increment
on completion of the Beta milestone
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
(203,819
|
)
|
|
|
―
|
|
|
|
(203,819
|
)
|
Total
for the period
|
|
|
1,393,410
|
|
|
|
217,436
|
|
|
|
1,175,974
|
|
|
|
1,964,540
|
|
|
|
783,447
|
|
|
|
1,181,093
|
|
Minority
stockholder’s share of net losses from operation for the nine months ended
September 30, 2008 of $2,168,359 was offset by $203,819 to reflect a minority
increment for the beta milestone payment to OcuSense. Minority share
of net loss from operation for nine months ended September 30, 2007 of $913,738
was offset by $130,291 to reflect a minority increment for the alpha milestone
payment to OcuSense. These transactions are specific to the
acquisition of OcuSense. The increment represents the minority stockholders’
ownership percentage of the variance between the actual milestone payments made
and the original fair value of the milestone payments reported when the Company
acquired its initial ownership interest in OcuSense. No future milestone
payments remain to be paid.
Discontinued
Operations
On
December 19, 2007, the Company sold to SOLX Acquisition all of the issued and
outstanding shares of the capital stock of SOLX, which had been the Glaucoma
division of the Company prior to the completion of this transaction. The
consideration for the purchase and sale of all of the issued and outstanding
shares of the capital stock of SOLX consisted of: (i) on the closing
date of the sale, the assumption by SOLX Acquisition of all of the liabilities
of the Company related to SOLX’s business, incurred on or after December 1,
2007, and the Company’s obligation to make a $5,000,000 payment to the former
stockholders of SOLX due on September 1, 2008 in satisfaction of the outstanding
balance of the purchase price of SOLX; (ii) on or prior to February 15, 2008,
the payment by SOLX Acquisition of all of the expenses that the Company had paid
to the closing date, as they related to SOLX’s business during the period
commencing on December 1, 2007; (iii) during the period commencing on the
closing date and ending on the date on which SOLX achieves a positive cash flow,
the payment by SOLX Acquisition of a royalty equal to 3% of the worldwide net
sales of the SOLX 790 Laser and the SOLX Gold Shunt, including next-generation
or future models or versions of these products; and (iv) following the date on
which SOLX achieves a positive cash flow, the payment by SOLX Acquisition of a
royalty equal to 5% of the worldwide net sales of these products. In order to
secure the obligation of SOLX Acquisition to make these royalty payments, SOLX
granted to the Company a subordinated security interest in certain of its
intellectual property. No value was assigned to the royalty payments since
the determination of worldwide net sales of SOLX’s products is subject to
significant uncertainty.
The sale
transaction described above established fair values for certain of the Company’s
acquisition-related intangible assets and goodwill. Accordingly, the Company
performed an impairment test of these assets at December 1, 2007. Based on this
analysis, during the year ended December 31, 2007, the Company recognized a
non-cash goodwill impairment charge of $14,446,977 and an impairment charge of
$22,286,383 to record its acquisition-related intangible assets at their fair
value as of December 31, 2007. As at September 30, 2008 and December 31, 2007,
the value of both of these assets associated with SOLX was nil and nil,
respectively.
The
Company’s results of operations related to discontinued operations for the nine
months ended September 30, 2008 and 2007 are as follows:
|
|
Three
months ended September 30,
|
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
―
|
|
|
|
15,225
|
|
|
|
―
|
|
|
|
176,125
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
―
|
|
|
|
13,423
|
|
|
|
―
|
|
|
|
111,397
|
|
Royalty
costs
|
|
|
―
|
|
|
|
6,250
|
|
|
|
―
|
|
|
|
21,233
|
|
Total
cost of goods sold
|
|
|
―
|
|
|
|
19,673
|
|
|
|
―
|
|
|
|
132,630
|
|
|
|
|
―
|
|
|
|
(4,448)
|
|
|
|
―
|
|
|
|
43,495
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
―
|
|
|
|
965,986
|
|
|
|
―
|
|
|
|
3,003,944
|
|
Clinical
and regulatory
|
|
|
―
|
|
|
|
776,105
|
|
|
|
―
|
|
|
|
2,141,355
|
|
Sales
and marketing
|
|
|
―
|
|
|
|
185,561
|
|
|
|
―
|
|
|
|
695,549
|
|
|
|
|
―
|
|
|
|
1,927,652
|
|
|
|
―
|
|
|
|
5,840,848
|
|
|
|
|
―
|
|
|
|
(1,932,100
|
)
|
|
|
―
|
|
|
|
(5,797,353
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and accretion expense
|
|
|
―
|
|
|
|
(222,374
|
)
|
|
|
―
|
|
|
|
(632,158
|
)
|
Other
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
(9,301
|
)
|
|
|
|
―
|
|
|
|
(222,374
|
)
|
|
|
―
|
|
|
|
(641,459
|
)
|
Loss
from discontinued operations before income taxes
|
|
|
―
|
|
|
|
(2,154,474
|
)
|
|
|
―
|
|
|
|
(6,438,812
|
)
|
Recovery
of income taxes
|
|
|
―
|
|
|
|
1,071,632
|
|
|
|
―
|
|
|
|
3,170,921
|
|
Loss
from discontinued operations
|
|
|
―
|
|
|
|
(1,082,842
|
)
|
|
|
―
|
|
|
|
(3,267,891
|
)
|
Recovery
of Income Taxes
|
|
Three
months ended September 30,
|
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
|
|
|
|
As
restated
|
|
|
|
|
Recovery
of income taxes from continuing operations
|
|
|
(1,649,632
|
)
|
|
|
8,449,188
|
|
|
|
(120%
|
)
|
|
|
(430,465
|
)
|
|
|
11,615,549
|
|
|
|
(104%
|
)
|
Recovery
of income taxes from discontinued operations
|
|
|
—
|
|
|
|
1,071,632
|
|
|
|
N/M*
|
|
|
|
—
|
|
|
|
3,170,921
|
|
|
|
N/M*
|
|
Recovery
of income taxes
|
|
|
(1,649,632
|
)
|
|
|
9,520,820
|
|
|
|
(117%
|
)
|
|
|
(430,465
|
)
|
|
|
14,786,470
|
|
|
|
(103%
|
)
|
Recovery
of income taxes from continuing operations decreased by $10,098,820 and
$12,046,014 during the three and nine months ended September 30, 2008,
respectively, as compared with the prior periods in 2007. The decreases are due
primarily to the impact of the impairment of all RHEO™ System intangible assets
in the nine months ended September 30, 2007 resulting in the elimination of all
related deferred tax liabilities. The elimination of RHEO™ System-related
deferred tax liabilities reduces to nil and nil the amortization of RHEO™
System-related deferred tax liabilities during the three and nine months ended
September 30, 2008, respectively, as compared to amortization of RHEO™
System-related deferred tax liabilities of $154,507 and $466,400 during the
three and nine months ended September 30, 2007, respectively. The elimination of
the RHEO™ System-related deferred tax liability resulted in a one-time recovery
of income taxes of $7,529,390 for the three months and nine months periods ended
September 31, 2007. There were no comparable amounts for the same
periods in 2008. In addition, due to the elimination of RHEO™ System-related
deferred tax liabilities, the amount of losses benefited related to RHEO™ System
activities were $0 and $0 during the three and nine months ended September
30, 2008, respectively, as compared to a benefit for applicable tax losses of
$673,563 and $2,278,154 reported relating to RHEO™ System activities during the
three and nine months ended September 30, 2007, respectively. As a result of the
completion of the reorganization transactions on October 6, 2008, it was more
likely than not that the Company incurred a change in control for purposes of
Section 382 of the U.S. Income Tax Code. Accordingly, income tax
benefits of $2,304,938, representing the excess of income tax benefits
previously recognized and the income tax benefit applicable to unrestricted
losses and the equivalent of one year’s losses deductible in accordance
with Section 382 of the U.S. Income Tax Code, were reversed and reported as
an income tax expense. Offsetting these decreases are increases in the recovery
of income taxes of $411,084 and $558,369 relating to increased OcuSense losses
benefited during the three and nine months ended September 30, 2008,
respectively, representing increased costs incurred by OcuSense in its
efforts to achieve its beta milestone and in its focus on commercialization and
clinical trial activities.
To date,
the Company has recognized income tax benefits in the aggregate amount of $1.6
million associated with the recognition of the deferred tax asset from the
availability of net operating losses in the United States which may be utilized
to reduce taxes in future years. The benefits associated with the balance of the
net operating losses are subject to a full valuation allowance since it is not
more likely than not that these losses can be utilized in future years. A
portion of the Company’s net operating losses may, however, be subject to annual
limitations as a result of the Company’s initial public offering and prior
changes of control. Accordingly, until a formal analysis of the effect of the
changes of control is performed, a portion of the income tax benefits recognized
to date may be affected.
Recovery
of income taxes for the three and nine months ended September 30, 2008 and 2007
also includes the amortization of the deferred tax liability which was recorded
based on the difference between the fair value of intangible assets acquired and
their tax bases. The amounts recorded during the three and nine months ended
September 30, 2008, as compared with the corresponding periods in fiscal 2007
did not change. The deferred tax recorded upon the acquisition of OcuSense of
$5,158,155 represents the difference between the fair value of the intangible
assets acquired by the Company upon its acquisition of OcuSense and their
respective tax bases. The deferred tax liability is being amortized over an
average period of 10 years, the estimated weighted-average useful life of the
intangible assets.
Liquidity
and capital resources
( in
thousands)
|
|
September
30,
|
|
|
December
31,
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
2,107,932
|
|
|
$
|
2,235,832
|
|
|
$
|
(127,900
|
)
|
Cash
restricted in use
|
|
|
200,000
|
|
|
|
—
|
|
|
|
200,000
|
|
Short-term
investments
|
|
|
413,678
|
|
|
|
—
|
|
|
|
413,678
|
|
Total
cash and cash equivalents and short-term investments
|
|
$
|
2,721,610
|
|
|
$
|
2,235,832
|
|
|
$
|
485,778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage
of total assets
|
|
|
(58.4%)
|
|
|
|
(6.5%)
|
|
|
|
|
|
Working
capital (deficiency)
|
|
$
|
(8,105,060
|
)
|
|
$
|
(996,862
|
)
|
|
$
|
(7,108,198
|
)
|
In
December 2004, the Company raised $67,200,000 of gross cash proceeds (less
issuance costs of $7,858,789) in an initial public offering of shares of its
common stock. Immediately prior to the offering, the primary source of the
Company’s liquidity was cash raised through the issuance of
debentures.
On
February 6, 2007, the Company raised gross proceeds in the amount of $10,016,000
(less issuance costs of $871,215 in a private placement of shares of its common
stock and warrants.
On
February 19, 2008, we announced that the Company secured a bridge loan in an
aggregate principal amount of $3,000,000 (less transaction costs of $180,000)
from a number of private parties. The loan bore interest at a rate of 12% per
annum and had a 180-day term initially, which subsequently was extended to 270
days. The repayment of the loan was secured by a pledge by the Company of its
shares of the capital stock of OcuSense.
On May 5,
2008, we announced that the Company secured an additional bridge loan in an
aggregate principal amount of $300,000 from a number of private parties. The
terms of the additional bridge loan were substantially the same as those of the
$3,000,000 aggregate principal amount bridge loan announced on February 19,
2008.
On July
28, 2008, we announced that the Company secured a second additional bridge
loan in an aggregate principal amount of $3,403,500 from a number of private
parties. The terms of that additional bridge loan were substantially the same as
those of the $3,000,000 aggregate principal amount bridge loan announced on
February 19, 2008.
All of
these bridge loans, plus accrued interest, were prepaid on October 6,
2008.
On
October 6, 2007, we announced that the Company closed a private placement of
shares of its common stock, at a price of $2.50 per share, for gross aggregate
proceeds of $2,173,000.
Including
prior periods, cumulatively to the end of 2007, cash has been primarily utilized
to finance increased infrastructure costs, to accumulate inventory and to fund
costs of the MIRA-1, LEARN and RHEO-AMD trials and other clinical trials and to
acquire SOLX and OcuSense in line with our diversification strategy.
In 2008, as a result of
the suspension of the Company’s RHEO™ System clinical trial development program,
and the consequent winding-down of the RHEO-AMD study, and the Company’s
disposition of SOLX, our cash resources were used, and we expect that they will
continue to be used, to continue the product development of OcuSense’s TearLab™
test for DED and to conduct the clinical trials that will be required for the
TearLab™ test for DED.
As at
September 30, 2008 and December 31, 2007, the Company had investments in the
aggregate principal amount of $1,900,000 consisting of investments in four
separate ARS, currently yielding an average return of 3.471% per annum.
Contractual maturities for these ARS were greater than eight years with an
interest rate reset date for these investments averaging approximately every
43 days. Historically, the carrying value of ARS approximated fair value
due to the frequent resetting of the interest rates. With the liquidity issues
experienced in the global credit and capital markets, the Company’s ARS have
experienced multiple failed auctions. During 2008, although the Company
continued to earn and receive interest on these investments at the maximum
contractual rate, the estimated fair value of these ARS were no longer believed
to approximate par value. Refer to Note 9 to the Notes to Consolidated Financial
Statements for discussion regarding the Company’s method to determine the fair
value of its investment in ARS.
Although
the Company continued to receive payment of interest earned on these securities,
the Company did not previously know when it would be able to convert these
investments into cash. Accordingly, management had classified these
investments as a non-current asset on its consolidated balance sheets as at
December 31, 2007 and at March 30, 2008 and June 30, 2008. In accordance
with a recent settlement agreement among the New York Attorney General’s Office,
the North American Securities Administrators Association and Credit Suisse, the
financial institution through which the Company had purchased its ARS,
subsequent to September 30, 2008, Credit Suisse purchased from the Company all
of the Company’s ARS at the Company’s original cost of $1,900,000, plus accrued
interest, when each of these securities came up for auction.
The ARS
investments are classified as Available for Sale under SFAS No. 115 which states
that where an impairment of an Available for Sale investment has been reported,
this impairment can only be reversed when a recovery or gain of the amount
reflected as an impairment charge has been realized. At September 30, 2008,
Credit Suisse had not yet purchased any of the Company’s outstanding ARS and as
such the Company has not reported the recovery of the impairment charge and
continues to reflect the ARS at $413,678, which is consistent with the fair
value reported by the Company in its June 30, 2008 financial statements. Since
the ARS were purchased by Credit Suisse in the fourth quarter, the ARS have been
reported as current assets.
Having
received the principal of, and the accrued interest on its ARS, management
believes that the Company’s cash and cash equivalents will be sufficient to meet
its operating activities and other demands until approximately June
2009.
Changes
in Cash Flows
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
|
|
|
(6,305,142
|
)
|
|
|
(13,301,135
|
)
|
|
|
6,995,993
|
|
Cash
provided (used) in investing activities
|
|
|
(346,257
|
)
|
|
|
4,503,649
|
|
|
|
(4,849,906
|
)
|
Cash
provided by financing activities
|
|
|
6,523,500
|
|
|
|
9,201,735
|
|
|
|
(2,678,235
|
)
|
Net
(decrease) increase in cash and cash
equivalents period
|
|
|
(127,899
|
)
|
|
|
404,249
|
|
|
|
(532,148
|
)
|
Cash
Used in Operating Activities
Net cash
used to fund our operating activities during the nine months ended September 30,
2008 was $6,305,142. Net loss during the nine-month period was
$7,097,008. The non-cash sources which comprise a portion of the net loss during
that period consist primarily of the amortization of intangible assets,
fixed assets, patents and trademarks, the provision for obligation under
warrants, the impairment of investments, stock-based compensation and prepaid
finance charges in the aggregate total of $1,753,249. Additional non-cash
amounts which comprise a portion of the net loss during that period include
deferred tax charges of ($430,465) and minority interest share of losses of
$1,964,540.
The net
change in non-cash working capital balances related to operations for the nine
months ended September 30, 2008 and 2007 consists of the following:
Cash
provided (used)
|
|
Nine
months ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
$
|
|
|
$
|
|
Amounts
receivable, net
|
|
|
345,606
|
|
|
|
(197,986
|
)
|
Inventory
|
|
|
|
|
|
|
(61,784
|
)
|
Prepaid
expenses
|
|
|
272,008
|
|
|
|
(46,787
|
)
|
Deposit
|
|
|
(11,238
|
)
|
|
|
(10,600
|
)
|
Other
current assets
|
|
|
(249,504
|
)
|
|
|
17,600
|
|
Accounts
payable
|
|
|
(758,156
|
)
|
|
|
243,097
|
|
Accrued
liabilities
|
|
|
588,674
|
|
|
|
938,684
|
|
Deferred
revenue
|
|
|
97,444
|
|
|
|
—
|
|
Due
to stockholders
|
|
|
(17,297
|
)
|
|
|
83,646
|
|
Accrued
interest payable
|
|
|
305,255
|
|
|
|
—
|
|
|
|
|
572,692
|
|
|
|
965,870
|
|
·
|
Amounts
receivable decrease is due to receipts for matters related to the sale of
SOLX.
|
·
|
The
decline in prepaid expenses results primarily from a decline in prepaid
insurance costs attributable to discontinued activities and the
elimination of advances related to the RHEO™ System clinical
trials.
|
·
|
Other
current assets represent finance costs which will be capitalized with
future finance transactions.
|
·
|
Accounts
payable decreased due primarily to payment for clinical trial services
which were suspended in the fourth quarter of
2007.
|
·
|
Accrued
liabilities increased primarily due to an increase to the accrual of
$955,518 in restructuring charges and the receipt of a $250,000 advance to
be utilized to offset the cost of certain OcuSense TearLab™ tests, offset
by liabilities paid in the period.
|
·
|
In
addition, accrued liabilities increased in the period by $200,000 relating
to cash restricted in use.
|
·
|
Increase
in deferred revenue reflects $5,044 received from a customer for the
future sale of consignment inventory and $92,400 received as an advance
payment for products.
|
·
|
Decrease
in amounts due to stockholders is primarily attributable an decrease of
$48,023 in the amount due to Mr. Stock net of a decrease of an amount due
from a stockholder on the receipt of $25,000 due from a minority
shareholder of OcuSense.
|
·
|
Increase
in accrued interest payable reflects interest accrued on the bridge
financing.
|
Cash
Used in Investing Activities
Net cash
used in investing activities for the nine months ended September 30, 2008 was
$346,257. Cash used in investing activities during the period consists of
$50,686 used to acquire fixed assets and $95,571 used to protect and maintain
patents and trademarks. It also includes cash restricted in use of $200,000
which the Company does not have access to.
Net cash
provided by investing activities for the nine months ended September 30, 2007
was $4,503,649 and resulted from cash earned from the net sale of short-term
investments of $7,785,000. Cash used in investing activities during the period
also consisted of cash in the amount of $190,341 used to acquire fixed assets
and cash in the amount of $91,010 used to protect and maintain patents and
trademarks. Additional cash used in investing activities included cash of
$3,000,000 paid by the Company to the former stockholders of SOLX on September
1, 2007 in partial satisfaction of the purchase price of SOLX.
Cash
Provided by Financing Activities
During
2008, the Company secured bridge financing in an aggregate principal amount of
$6,703,500, which debt was prepaid in full on October 6, 2008. In addition, on
October 6, 2008, the Company closed a private placement of shares of its common
stock, at a price of $2.50 per share, for gross aggregate proceeds of
$2,173,000.
Net cash
provided by financing activities for the nine months ended September 30, 2007
was $9,201,735 which is made up of gross proceeds in the amount of $10,016,000
raised in the February 2007 private placement of shares of the Company’s common
stock and warrants, less issuance costs of $871,215 which includes the fair
value of the warrant issued to Cowen and Company, LLC of $97,222 issued in part
payment of the placement fee owed to Cowen and Company, LLC. Cash provided by
financing activities also includes cash received in the amount of $2,228 from
the exercise of options to purchase shares of common stock of the Company,
offset by additional share issuance costs of $42,500 in respect of the shares
issued to the former stockholders of SOLX in part payment of the purchase price
of SOLX.
Financial
Condition
Having received the
principal of, and the accrued interest on its ARS, management believes that the
Company’s cash and cash equivalents will be sufficient to meet its operating
activities and other demands until approximately June 2009.
Our
forecast of the period of time through which our financial resources will be
adequate to support our operations is a forward-looking statement and involves
risks and uncertainties. Actual results could vary as a result of a number of
factors. We have based this estimate on assumptions that may prove to be wrong,
and we could utilize our available capital resources sooner than we currently
expect. Our future funding requirements will depend on many factors, including
but not limited to:
|
·
|
the
cost and results of continuing development of OcuSense’s TearLab™ test for
DED;
|
|
·
|
the
cost and results, and the rate of progress, of the clinical trials of the
TearLab™ test for DED that will be required to support OcuSense’s
application to obtain a CLIA waiver from the
FDA;
|
|
·
|
OcuSense’s
ability to obtain 510(k) approval and a CLIA waiver from the FDA for the
TearLab™ test for DED and the timing of such approval, if
any;
|
|
·
|
whether
government and third-party payers agree to reimburse treatments using the
TearLab™ test for DED;
|
|
·
|
the
costs and timing of building the infrastructure to market and sell the
TearLab™ test for DED;
|
|
·
|
the
costs of filing, prosecuting, defending and enforcing any patent claims
and other intellectual property rights;
and
|
|
·
|
the
effect of competing technological and market
developments.
|
At the
present time, our only product is the TearLab™ test for DED, and we cannot begin
commercialization of our product in the United States until we receive FDA
approval. At this time, we do not know when we can expect to begin to generate
revenues from the TearLab™ test for DED in the United States.
We will
need additional capital in approximately June 2009, and our prospects for
obtaining it are uncertain. On October 9, 2007, we announced that the Board had
authorized management and the Company’s advisors to explore the full range of
strategic alternatives available to enhance shareholder value, including, but
not limited to, the raising of capital through the sale of securities, one or
more strategic alliances and the combination, sale or merger of all or part of
the Company. For some time prior to the October 9, 2007 announcement, the
Company had been seeking to raise additional capital. The Company’s
capital-raising efforts culminated in the $6,703,500 bridge financing and the
private placement of $2,173,000 amount of shares of the Company’s common stock.
These transactions took an amount of time, consumed resources of the Company and
required an effort on the part of management that were disproportionately large,
relative to the total amount of the capital raise.
Additional
capital may not be available on terms favorable to us, or at all. In addition,
future financings could result in significant dilution of existing stockholders.
However, unless we succeed in raising additional capital, we anticipate that we
will be unable to continue our operations beyond approximately June
2009.
RECENT
ACCOUNTING PRONOUNCEMENTS
In
September 2006, the Financial Accounting Standards Board, or FASB, issued
Statement of Financial Accounting Standards, or SFAS, No. 157, “Fair Value
Measurements”, or SFAS No. 157. This standard defines fair value, establishes a
framework for measuring fair value in accounting principles generally accepted
in the United States of America and expands disclosure about fair value
measurements. This statement applies to other accounting standards that require
or permit fair value measurements and, accordingly, does not require any new
fair value measurement. SFAS No. 157 is effective for fiscal years beginning
after November 15, 2007 and interim periods within those fiscal years. In
December 2007, FASB agreed to a one-year deferral of SFAS No. 157’s fair value
measurement requirements for non-financial assets and liabilities that are not
required or permitted to be measured at fair value on a recurring basis. The
Company adopted SFAS No. 157 on January 1, 2008, which had no effect
on the Company’s consolidated financial statements. Refer to Note 8, “Fair value
measurements” for additional information related to the adoption of SFAS
No. 157.
In
February 2007, FASB issued Statement No. 159, “The Fair Value Option
for Financial Assets and Financial Liabilities—Including an amendment of FASB
Statement No. 115,” or SFAS No. 159. SFAS No. 159 expands the use of fair
value accounting but does not affect existing standards which require assets or
liabilities to be carried at fair value. Under SFAS No. 159, a company may elect
to use fair value to measure accounts and loans receivable, available-for-sale
and held-to-maturity securities, equity method investments, accounts payable,
guarantees and issued debt. Other eligible items include firm commitments for
financial instruments that otherwise would not be recognized at inception and
non-cash warranty obligations where a warrantor is permitted to pay a third
party to provide the warranty goods or services. If the use of fair value is
elected, any upfront costs and fees related to the item must be recognized in
earnings and cannot be deferred (
e.g.
, debt issue costs). The
fair value election is irrevocable and generally made on an
instrument-by-instrument basis, even if a company has similar instruments that
it elects not to measure based on fair value. At the adoption date, unrealized
gains and losses on existing items for which fair value has been elected are
reported as a cumulative adjustment to beginning retained
earnings.
Subsequent
to the adoption of SFAS No. 159, changes in fair value are recognized in
earnings. SFAS No. 159 is effective for fiscal years beginning on or after
November 15, 2007 and is required to be adopted by the Company in the first
quarter of fiscal 2008. The adoption of SFAS No. 159 has not had a material
impact on the Company’s results of operations and financial
position.
On June
14, 2007, FASB ratified EITF 07-3, "Accounting for Non-Refundable Advance
Payments for Goods or Services to Be Used in Future Research and Development
Activities", or EITF 07-3. EITF 07-3 requires that all non-refundable advance
payments for R&D activities that will be used in future periods be
capitalized until used. In addition, the deferred research and development costs
need to be assessed for recoverability. EITF 07-3 is applicable for fiscal years
beginning after December 15, 2007 and is to be applied prospectively without the
option of early application. The adoption of EITF 07-3 has not had a
material impact on the Company’s results of operations and financial
position.
On
December 4, 2007, FASB issued SFAS No. 141(R) (revised 2007), “Business
Combinations”, or SFAS No. 141(R), and SFAS No. 160, “Non-controlling Interests
in Consolidated Financial Statements”, or SFAS No. 160. Effective for fiscal
years beginning after December 15, 2008, the standards will improve, simplify,
and converge internationally the accounting for business combinations and the
reporting of non-controlling interests in consolidated financial
statements.
SFAS No.
141(R) improves reporting by creating greater consistency in the accounting and
financial reporting of business combinations, resulting in more complete,
comparable and relevant information for investors and other users of financial
statements. To achieve this goal, the new standard: requires the
acquiring entity in a business combination to recognize all (and only) the
assets acquired and liabilities assumed in the transaction; establishes the
acquisition date fair value as the measurement objective for all assets acquired
and liabilities assumed; and requires the acquirer to disclose to investors and
other users all of the information they need to evaluate and understand the
nature and financial effect of the business combination.
SFAS No.
160 improves the relevance, comparability, and transparency of financial
information provided to investors by requiring all entities to report
non-controlling (minority) interests in subsidiaries in the same way - as equity
in the consolidated financial statements. Moreover, SFAS 160 eliminates the
diversity that currently exists in accounting for transactions between an entity
and non-controlling interests by requiring they be treated as equity
transactions.
Early
adoption of SFAS No. 141(R) and SFAS No. 160 is prohibited. Management is
currently evaluating the requirements of these standards and has not yet
determined the impact, if any, on the Company’s consolidated financial
statements.
In
March 2008, FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities - An Amendment of FASB Statement
No. 133”, or SFAS No. 161. SFAS No. 161 enhances the required
disclosures regarding derivatives and hedging activities, including disclosures
regarding how an entity uses derivative instruments, how derivative instruments
and related hedged items are accounted for under SFAS No. 133, “Accounting
for Derivative Instruments and Hedging Activities”, and how derivative
instruments and related hedged items affect an entity’s financial position,
financial performance and cash flows. SFAS No. 161 is effective for fiscal
years beginning after November 15, 2008. Management is currently evaluating
the requirements of SFAS No. 161 and has not yet determined its impact, if
any, on the Company’s financial statements.
In June
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles”, or SFAS No. 162. SFAS No. 162 identifies the
sources of accounting principles and the framework for selecting the principle
used in the preparation of financial statements presented in conformity with
U.S. GAAP. SFAS No. 162 will be effective 60 days following the SEC’s approval
of the Public Company Accounting Oversight Board amendment to AU Section 411,
“
The Meaning of
Present
Fairly in Conformity with Generally Accepted Accounting Principles”. The
adoption of SFAS No. 162 is not expected to have any impact on the Company’s
consolidated financial statements.
ITEM
3. QUAN
TIT
ATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
Currency
Fluctuation and Exchange Risk
All of
our sales are in U.S. dollars or are linked to the U.S. dollar, while a portion
of our expenses are in Canadian dollars and Australian dollars. We cannot
predict any future trends in the exchange rate of the Canadian dollar or
Australian dollar against the U.S. dollar. Any strengthening of the Canadian
dollar or Australian dollar in relation to the U.S. dollar would increase the
U.S. dollar cost of our operations and would affect our U.S. dollar measured
results of operations. We do not normally engage in any hedging or other
transactions intended to manage these risks. In the future, we may undertake
hedging or other similar transactions or invest in market risk sensitive
instruments if we determine that would be advisable to offset these
risks.
Subsequent
to September 30, 2008, the Company purchased sufficient Canadian and Australian
dollars to meet its forecasted operational spending requirements in those
currencies into the first quarter of 2009.
Interest
Rate Risk
The
primary objective of our investment activity is to preserve principal while
maximizing interest income we receive from our investments, without increasing
risk. We believe this will minimize our market risk.
As at
September 30, 2008 and December 31, 2007, we had investments in the aggregate
principal amount of $1,900,000 which consist of investments in four separate
asset-backed ARS yielding an average return of 3.471% per annum. However,
as a result of market conditions, all of these investments have failed to settle
on their respective settlement dates and had been reset to be settled at future
dates with an average maturity of 43 days. Due to the current lack of
liquidity for asset-backed securities of this type, we concluded that the
carrying value of these investments was higher than its fair value as of
September 30, 2008 and December 31, 2007. Accordingly, these ARS have been
recorded at their estimated fair value of $413,678. We consider this to be an
other-than-temporary reduction in the fair value of these ARS. Accordingly, the
loss associated with these ARS of $450,072 for the nine months ended September
30, 2008 has been included as an impairment of investments in our consolidated
statement of operations for the nine months ended September 30, 2008. The
ARS were liquid as at September 30, 2007. As a result, the loss associated with
these ARS for the nine months ended September 30, 2007 was nil.
As a
result of a recent settlement agreement among the New York Attorney General’s
Office, the North American Securities Administrators Association and Credit
Suisse, the financial institution through which the Company had purchased its
ARS, subsequent to September 30, 2008, the Company had the opportunity to have
Credit Suisse purchase from the Company, for full value plus accrued interest,
all of the Company’s outstanding ARS. Credit Suisse has since purchased all of
these ARS at the Company’s original cost of $1,900,000, plus accrued interest,
when each of these securities came up for auction.
At
September 30, 2008, the Company had $2.1 million in cash and cash equivalents. A
change in the interest rate earned on these funds of 25 basis points (
i.e.
,
0.25%) would impact the
amount of interest earned by $5,250 per year.
ITEM
4.
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C
ONTR
OLS AND PROCEDURES
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(a) Disclosure
Controls and Procedures. The Company maintains disclosure controls and
procedures that are designed to ensure that information required to be disclosed
in the Company’s reports under the Securities Exchange Act of 1934, as amended,
or the Exchange Act, is recorded, processed, summarized and reported within the
time reports specified in the SEC’s rules and forms and that such information is
accumulated and communicated to the Company’s management, including our
principal executive officer, or the CEO, and our principal financial officer, or
the CFO, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and management necessarily is required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and
procedures.
In
assessing whether the Company’s disclosure controls and procedures and the
Company’s internal control over financial reporting were effective as at March
31, 2008 and December 31, 2007, management also considered the impact of the
restatement of its financial statements with respect to the method of
consolidation used to account for its investment in OcuSense, to the
consolidated financial statements for the fiscal years ended December 31, 2007
and 2006 and the three months ended March 31, 2008 as well as the Company’s
control environment.
Management
has concluded that due to the failure to account for the consolidation of
OcuSense under the variable interest entity model since the Company’s
acquisition of OcuSense on November 30, 2006, there was a material weakness in
its internal control over financial reporting as of December 31,
2007.
During
the period subsequent to December 31, 2007, the Company underwent significant
changes, including the termination of employment of most of its employees,
including finance department employees and senior executives. Despite the
reduced resources at our disposal, using our remaining internal resources and
engaging the services of outside consultants, we have focused our efforts on
ensuring, to the fullest extent possible, that the Company has and maintains
appropriate design and operating effectiveness of internal control over
financial reporting. However, as is the case for many small companies, the
Company may not have the resources to address fully complex financial accounting
matters.
As of the
end of the three-month period ended September 30, 2008, an evaluation of the
effectiveness of the Company’s disclosure controls and procedures (as defined in
Rule 13a-15(e) of the Exchange Act) was carried out by the CEO and the CFO.
Based on their evaluation, the CEO and the CFO have concluded that, as of the
end of that fiscal period, the Company’s disclosure controls and procedures are
effective to provide reasonable assurance of achieving the desired control
objectives.
(b) Changes
in Internal Control over Financial Reporting. During the three-month period
ended September 30, 2008, there were no changes in our internal control over
financial reporting that have materially affected, or are reasonably likely to
materially affect, our internal control over financial
reporting.
PART
II.
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OTHER
INFORMATION
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ITEM
1.
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L
EGA
L PROCEEDINGS
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We are
not aware of any material litigation involving us that is outstanding,
threatened or pending.
ITEM
1A. RISK F
ACT
ORS
Risk
Factors
Our
near-term success is highly dependent on the success of the TearLab™ test for
DED, and we cannot be certain that it will receive regulatory approval or be
successfully commercialized.
The
TearLab™ test for DED is currently our only product candidate. We are currently
seeking a 510(k) clearance, and we intend to seek a CLIA waiver, from the U.S.
Food and Drug Administration, or the FDA. Even if the TearLab™ test for DED
receives regulatory approval, it may never be successfully commercialized. If
the TearLab™ test for DED does not receive regulatory approval or is not
successfully commercialized, we may not be able to generate revenue, become
profitable or continue our operations. Any failure of the TearLab™ test for DED
to receive regulatory approval or to be successfully commercialized would have a
material adverse effect on our business, operating results, financial condition
and cash flows and could result in a substantial decline in the price of our
common stock.
Our
financial condition and history of losses have caused our auditors to express
doubt as to whether we will be able to continue as a going concern.
We have
prepared our consolidated financial statements on the basis that we will
continue as a going concern. However, we have sustained substantial losses for
each of the years ended December 31, 2005, 2006 and 2007. Our working capital
deficiency at September 30, 2008 is $8,105,060, which represents a
$7,108,198 increase in its working capital deficiency of $996,862 at
September 30, 2007. As a result of our history of losses and current financial
condition, there is substantial doubt about our ability to continue as a going
concern.
On
October 6, 2008, we completed a private placement of 869,200 shares of our
common stock for gross aggregate proceeds of $2,173,000, pre-paid in full our
$6,703,500 aggregate principal amount bridge loan by issuing to the lenders
thereof an aggregate of 3,304,511 shares of our common stock, at a per share
price of $2.125, and paid $481,200 of the commission remaining owing for
placement agency services by issuing aggregate of 192,480 shares of our common
stock. As a result of these transactions, and having received the principal of,
and the accrued interest on, our asset-backed auction rate securities, we
believe that our cash and cash equivalents will be sufficient to meet our
operating activities and other demands only until approximately June
2009.
Our
consolidated financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or the amounts and
classification of liabilities that might be necessary if we were not able to
continue as a going concern.
We
have incurred losses since inception and anticipate that we will incur continued
losses for the foreseeable future.
We have
incurred losses in each year since our inception in 1996. Our net losses for the
fiscal years ended December 31, 2003, 2004, 2005, 2006 and 2007 were $2.5
million, $21.8 million, $162.8 million, $82.2 million and $69.8 million,
respectively. The losses in 2007, 2006 and 2005 include a charge for impairment
of goodwill of $14.4 million, $65.9 million and $147.5 million, respectively. As
of September 30, 2008, we had an accumulated deficit of $365,385,988. Our losses
have resulted primarily from expenses incurred in research and development of
our product candidates from our discontinued businesses. We do not know when or
if we will receive regulatory approval for the TearLab™ test for DED or
successfully commercialize it in the United States. As a result, and because of
the numerous risks and uncertainties facing us, it is difficult to provide the
extent of any future losses or the time required to achieve profitability, if at
all. Any failure of our product candidate to obtain regulatory approval and any
failure to become and remain profitable would adversely affect the price of our
common stock and our ability to raise capital and continue
operations.
We
may not be able to raise the capital necessary to fund our
operations.
Since
inception, we have funded our operations through early private placements of our
equity and debt securities, early stage revenues, a successful initial public
offering, a private placement of shares of our common stock and warrants and, in
2008, bridge financing and another private placement of our common stock. We
will need additional capital in approximately June 2009, and our prospects for
obtaining it are uncertain. On October 9, 2007, we announced that our board of
directors had authorized management and the Company’s advisors to explore the
full range of strategic alternatives available to enhance shareholder value,
including, but not limited to, the raising of capital through the sale of
securities, one or more strategic alliances and the combination, sale or merger
of all or part of the Company. For some time prior to the October 9, 2007
announcement, the Company had been seeking to raise additional capital. The
Company’s capital-raising efforts culminated in the bridge financing and private
placement of 2008. These transactions took an amount of time,
consumed resources of the Company and required an effort on the part of
management that were disproportionately large, relative to the total amount of
the capital raise.
Additional
capital may not be available on terms favorable to us, or at all. In addition,
future financings could result in significant dilution of existing stockholders
and adversely affect the economic interests of existing stockholders. However,
unless we succeed in raising additional capital, we anticipate that we will be
unable to continue our operations beyond approximately June 2009. See “Risk
Factors—Risks Relating to Our Business—Our financial condition and history of
losses have caused our auditors to express doubt as to whether we will be able
to continue as a going concern.”
We
will face challenges in bringing the TearLab™ test for DED to market and may not
succeed in executing our business plan.
There are
numerous risks and uncertainties inherent in the development of new medical
technologies. In addition to our eventual requirement for additional capital,
our ability to bring the TearLab™ test for DED to market and to execute our
business plan successfully is subject to the following risks, among
others:
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Our
clinical trials may not succeed. Clinical testing is expensive and can
take longer than originally anticipated. The outcomes of clinical trials
are uncertain, and failure can occur at any stage of the testing. We could
encounter unexpected problems, which could result in a delay in the
submission of our application for the sought-after CLIA waiver from the
FDA or prevent its submission
altogether.
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We
may not receive either the 510(k) clearance or the CLIA waiver for the
TearLab™ test for DED from the FDA, in which case our ability to market
the TearLab™ test for DED in the United States will be hindered severely,
if not eliminated altogether.
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Our
suppliers and we will be subject to numerous FDA requirements covering the
design, testing, manufacturing, quality control, labeling, advertising,
promotion and export of the TearLab™ test for DED and other matters. If
our suppliers or we fail to comply with these regulatory requirements, the
TearLab™ test for DED could be subject to restrictions or withdrawals from
the market and we could become subject to
penalties.
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Even
if we succeed in obtaining the sought-after FDA approvals, we may be
unable to commercialize the TearLab™ test for DED successfully in the
United States. Successful commercialization will depend on a number of
factors, including, among other things, achieving widespread acceptance of
the TearLab™ test for DED among physicians, establishing adequate sales
and marketing capabilities, addressing competition effectively, the
ability to obtain and enforce patents to protect proprietary rights from
use by would-be competitors, key personnel retention and ensuring
sufficient manufacturing capacity and inventory to support
commercialization plans.
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If
we fail to obtain FDA clearance for the TearLab™ test for DED, or are subject to
regulatory enforcement action as a result of our failure to comply with
regulatory requirements, our commercial operations would be harmed.
We may
not obtain 510(k) clearance for the TearLab™ test for DED in a timely fashion,
or at all. Furthermore, any clearance of the TearLab™ test for DED
that we do receive may be conditioned upon certain limitations and restrictions
as to the product’s use or upon the completion of further studies. If
we do receive the 510(k) clearance that we are seeking, we will be subject
significant ongoing regulatory requirements, and if we fail to comply with these
requirements, we could be subject to enforcement action by the FDA or state
agencies, including:
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adverse
publicity, warning letters, fines, injunctions, consent decrees and civil
penalties;
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·
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repair,
replacement, refunds, recall or seizure of our
product;
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·
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operating
restrictions or partial suspension or total shutdown of
production;
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·
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delay
or refusal of our requests for 510(k) clearance or premarket approval of
new products or of new intended uses or modifications to our existing
product;
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·
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refusal
to grant export approval for our
products;
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·
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withdrawing
510(k) clearances or premarket approvals that have already been granted;
and
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If any of
these enforcement actions were to be taken by the government, our business could
be harmed.
In
addition to receiving 510(k) clearance of the TearLab™ test for DED, we will
required to demonstrate and maintain compliance with the FDA’s Quality System
Regulation, or the QSR, prior to marketing the product in the United States. The
QSR is a complex regulatory scheme that covers the methods and documentation of
the design, testing, control, manufacturing, labeling, quality assurance,
packaging, storage and shipping of our products. The FDA must determine that the
facilities which manufacture and assemble our products that are intended for
sale in the United States, as well as the manufacturing controls and
specifications for these products, are compliant with applicable regulatory
requirements, including the QSR. The FDA enforces the QSR through periodic
unannounced inspections. Our facilities have not yet been inspected by the FDA,
and we cannot assure you that we will pass any future FDA inspection. Our
failure, or the failure of our suppliers, to take satisfactory corrective action
in response to an adverse QSR inspection could result in enforcement actions,
including a public warning letter, a shutdown of our manufacturing operations, a
recall of our product, civil or criminal penalties or other sanctions, which
would significantly harm our available inventory and sales and cause our
business to suffer.
Our
patents may not be valid, and we may not be able to obtain and enforce patents
to protect its proprietary rights from use by would-be competitors. Patents of
other companies could require us to stop using or pay to use required
technology.
Our owned
and licensed patents may not be valid, and we may not be able to obtain and
enforce patents and to maintain trade secret protection for our technology. The
extent to which we are unable to do so could materially harm our
business.
We have
applied for, and intend to continue to apply for, patents relating to the
TearLab™ test for DED and related technology and processes. Such applications
may not result in the issuance of any patents, and any patents now held or that
may be issued may not provide adequate protection from competition. Furthermore,
it is possible that patents issued or licensed to us may be challenged
successfully. In that event, if we have a preferred competitive position because
of any such patents, any preferred position would be lost. If we are unable to
secure or to continue to maintain a preferred position, the TearLab™ test for
DED could become subject to competition from the sale of generic
products.
Patents
issued or licensed to us may be infringed by the products or processes of
others. The cost of enforcing patent rights against infringers, if such
enforcement is required, could be significant and the time demands could
interfere with our normal operations. There has been substantial litigation and
other proceedings regarding patent and other intellectual property rights in the
pharmaceutical, biotechnology and medical technology industries. We could become
a party to patent litigation and other proceedings. The cost to us of any patent
litigation, even if resolved in our favor, could be substantial. Some of our
would-be competitors may be able to sustain the costs of such litigation more
effectively than it can because of their substantially greater financial
resources. Litigation may also absorb significant management time.
Unpatented
trade secrets, improvements, confidential know-how and continuing technological
innovation are important to our future scientific and commercial success.
Although we attempt to, and will continue to attempt to, protect our proprietary
information through reliance on trade secret laws and the use of confidentiality
agreements with corporate partners, collaborators, employees and consultants and
other appropriate means, these measures may not effectively prevent disclosure
of our proprietary information, and, in any event, others may develop
independently, or obtain access to, the same or similar
information.
Certain
of our patent rights are licensed to us by third parties. If we fail to comply
with the terms of these license agreements, our rights to those patents may be
terminated, and we will be unable to conduct our business.
It is
possible that a court may find us to be infringing upon validly issued patents
of third parties. In that event, in addition to the cost of defending the
underlying suit for infringement, we may have to pay license fees and/or damages
and may be enjoined from conducting certain activities. Obtaining licenses under
third-party patents can be costly, and such licenses may not be available at
all.
We
may face future product liability claims.
The
testing, manufacturing, marketing and sale of therapeutic and diagnostic
products entail significant inherent risks of allegations of product liability.
Our past use of the RHEO™ System and the components of the SOLX Glaucoma System
in clinical trials and the commercial sale of those products may have exposed us
to potential liability claims. Our future use of the TearLab™ test for DED and
its commercial sale could expose us to liability claims also. All of such claims
might be made directly by patients, health care providers or others selling the
products. We carry clinical trials and product liability insurance to cover
certain claims that could arise, or that could have arisen, during our clinical
trials or during the commercial use of our products. We currently maintain
clinical trials and product liability insurance with coverage limits of
$5,000,000 in the aggregate annually. Such coverage, and any coverage obtained
in the future, may be inadequate to protect us in the event of successful
product liability claims, and we may not be able to increase the amount of such
insurance coverage or even renew it. A successful product liability claim could
materially harm our business. In addition, substantial, complex or extended
litigation could result in the incurrence of large expenditures and the
diversion of significant resources.
We
have entered into a number of related party transactions with suppliers,
creditors, stockholders, officers and other parties, each of which may have
interests which conflict with those of our public stockholders.
We have
entered into several related party transactions with our suppliers, creditors,
stockholders, officers and other parties, each of which may have interests which
conflict with those of our public stockholders.
If
we do not introduce new commercially successful products in a timely manner, our
products may become obsolete over time, customers may not buy our products and
our revenue and profitability may decline.
Demand
for our products may change in ways we may not anticipate because
of:
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•
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evolving
customer needs;
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•
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the
introduction of new products and technologies;
and
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•
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evolving
industry standards.
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Without
the timely introduction of new commercially successful products and
enhancements, our products may become obsolete over time, in which case our
sales and operating results would suffer. The success of our new product
offerings will depend on several factors, including our ability to:
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•
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properly
identify and anticipate customer
needs;
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•
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commercialize
new products in a cost-effective and timely
manner;
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•
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manufacture
and deliver products in sufficient volumes on
time;
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•
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obtain
and maintain regulatory approval for such new
products;
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differentiate
our offerings from competitors’
offerings;
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achieve
positive clinical outcomes;
and
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provide
adequate medical and/or consumer education relating to new
products.
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Moreover,
innovations generally will require a substantial investment in research and
development before we can determine the commercial viability of these
innovations and we may not have the financial resources necessary to fund these
innovations. In addition, even if we are able to successfully develop
enhancements or new generations of our products, these enhancements or new
generations of products may not produce revenue in excess of the costs of
development and they may be quickly rendered obsolete by changing customer
preferences or the introduction by our competitors of products embodying new
technologies or features.
We
rely on a single supplier of each of the key components of the TearLab™ test for
DED and are vulnerable to fluctuations in the availability and price of our
suppliers’ products and services.
We
purchase each of the key components of the TearLab™ test for DED from a single
third-party supplier. Our suppliers may not provide the components or other
products needed by us in the quantities requested, in a timely manner or at a
price we are willing to pay. In the event we were unable to renew our agreement
with our suppliers or they were to become unable or unwilling to continue to
provide important components in the required volumes and quality levels or in a
timely manner, or if regulations affecting the components were to change, we
would be required to identify and obtain acceptable replacement supply sources.
We may not be able to obtain alternative suppliers or vendors on a timely basis,
or at all, which could disrupt or delay, or halt altogether, our ability to
manufacture or deliver the TearLab™ test for DED. If any of these events should
occur, our business, financial condition, cash flows and results of operations
could be materially adversely affected.
We
face intense competition, and our failure to compete effectively could have a
material adverse effect on our results of operations.
We face
intense competition in the markets for ophthalmic products and these markets are
subject to rapid and significant technological change. We have numerous
competitors in the United States and abroad. Many of our competitors have
substantially more resources and a greater marketing scale than we do. If we are
unable to develop and produce or market our products to effectively compete
against our competitors, our operating results will materially
suffer.
If
we lose key personnel, or we are unable to attract and retain highly qualified
personnel on a cost-effective basis, it would be more difficult for us to manage
our existing business operations and to identify and pursue new growth
opportunities.
Our
success depends, in large part, upon our ability to attract and retain highly
qualified scientific, clinical, manufacturing and management personnel. In
addition, any difficulties retaining key personnel or managing this growth could
disrupt our operations. Future growth will require us to continue to implement
and improve our managerial, operational and financial systems, and to continue
to recruit, train and retain, additional qualified personnel, which may impose a
strain on our administrative and operational infrastructure. The competition for
qualified personnel in the medical technology field is intense. We are highly
dependent on our continued ability to attract, motivate and retain
highly-qualified management, clinical and scientific personnel.
Due to
our limited resources, we may not be able to effectively recruit, train and
retain additional qualified personnel. If we are unable to retain key personnel
or manage our growth effectively, we may not be able to implement our business
plan.
Furthermore,
we have not entered into non-competition agreements with our key employees. In
addition, we do not maintain “key person” life insurance on any of our officers,
employees or consultants. The loss of the services of existing personnel, the
failure to recruit additional key scientific, technical and managerial personnel
in a timely manner, and the loss of our employees to our competitors would harm
our research and development programs and our business.
If
we fail to establish and maintain proper and effective internal controls, our
ability to produce accurate financial statements on a timely basis could be
impaired, which would adversely affect our consolidated operating results, our
ability to operate our business and our stock price.
Ensuring
that we have adequate internal financial and accounting controls and procedures
in place to produce accurate financial statements on a timely basis is a costly
and time-consuming effort that needs to be re-evaluated frequently. Failure on
our part to maintain effective internal financial and accounting controls would
cause our financial reporting to be unreliable, could have a material adverse
effect on our business, operating results, financial condition and cash flows,
and could cause the trading price of our common stock to fall dramatically. Our
independent registered public accounting firm and we have found that, due to the
failure to account for the consolidation of OcuSense under the variable interest
entity model since our acquisition of OcuSense on November 30, 2006, there was a
material weakness in our internal control over financial reporting as of
December 31, 2007. As a result of this material weakness, our former chief
executive officer and our chief financial officer have determined that, as of
December 31, 2007, our internal controls over financial reporting were not
effective to provide reasonable assurance regarding the reliability of our
financial reporting and the preparation of financial statements for external
reporting in accordance with U.S. GAAP.
Maintaining
proper and effective internal controls will require substantial management time
and attention and may result in our incurring substantial incremental
expenses, including with respect to increasing the breadth and depth of our
finance organization to ensure that we have personnel with the appropriate
qualifications and training in certain key accounting roles and adherence to
certain control disciplines within the accounting and reporting function. Any
failure in internal controls or any additional errors or delays in our financial
reporting would have a material adverse effect on our business and results of
operations and could have a substantial adverse impact on the trading price of
our common stock.
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting to provide reasonable assurance regarding the
reliability of our financial reporting and the preparation of financial
statements for external purposes in accordance with U.S. GAAP. Our management
does not expect that our internal control over financial reporting will prevent
or detect all errors and all fraud. A control system, no matter how well
designed and operated, can provide only reasonable, not absolute, assurance that
the control system’s objectives will be met. As discussed in this Quarterly
Report on Form 10-Q, our management, together with our independent registered
public accounting firm, has identified a control deficiency in the past and may
identify additional deficiencies in the future.
We cannot
be certain that the actions we are taking to improve our internal controls over
financial reporting will be sufficient or that we will be able to implement our
planned processes and procedures in a timely manner. In future periods, if the
process required by Section 404 of the Sarbanes-Oxley Act of 2002 reveals
further material weaknesses or significant deficiencies, the correction of any
such material weaknesses or significant deficiencies could require additional
remedial measures which could be costly and time-consuming. In addition, we may
be unable to produce accurate financial statements on a timely basis. Any of the
foregoing could cause investors to lose confidence in the reliability of our
consolidated financial statements, which could cause the market price of our
common stock to decline and make it more difficult for us to finance our
operations and growth.
The
trading price of our common stock may be volatile.
The
market prices for, and the trading volumes of, securities of medical device
companies, such as ours, have been historically volatile. The market has
experienced, from time to time, significant price and volume fluctuations
unrelated to the operating performance of particular companies. The market price
of our common shares may fluctuate significantly due to a variety of factors,
including:
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•
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the
results of pre-clinical testing and clinical trials by us, our
collaborators and/or our
competitors;
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•
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technological
innovations or new diagnostic
products;
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•
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governmental
regulations;
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•
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developments
in patent or other proprietary
rights;
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•
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public
concern regarding the safety of products developed by us or
others;
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•
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comments
by securities analysts;
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•
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the
issuance of additional shares to obtain financing or for
acquisitions;
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•
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general
market conditions in our industry or in the economy as a whole;
and
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•
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political
instability, natural disasters, war and/or events of
terrorism.
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In
addition, the stock market has experienced extreme price and volume fluctuations
that have often been unrelated or disproportionate to the operating performance
of individual companies. Broad market and industry factors may seriously affect
the market price of companies’ stock, including ours, regardless of actual
operating performance. In the past, following periods of volatility in the
overall market and the market price of a particular company’s securities,
securities class action litigation has often been instituted against these
companies. This litigation, if instituted against us, could result in
substantial costs and a diversion of our management’s attention and
resources.
Because
we do not expect to pay dividends on our common stock, stockholders will benefit
from an investment in our common stock only if it appreciates in
value.
We have
never paid cash dividends on our common stock and have no present intention to
pay any dividends in the future. We are not profitable and do not expect to earn
any material revenues for at least several years, if at all. As a result, we
intend to use all available cash and liquid assets in the development of our
business. Any future determination about the payment of dividends will be made
at the discretion of our board of directors and will depend upon our earnings,
if any, our capital requirements, our operating and financial conditions and on
such other factors as our board of directors may deem relevant. As a result, the
success of an investment in our common stock will depend upon any future
appreciation in its value. There is no guarantee that our common stock will
appreciate in value or even maintain the price at which stockholders have
purchased their shares.
We
can issue shares of preferred stock that may adversely affect the rights of
holders of our common stock.
Our
certificate of incorporation authorizes us to issue up to 10,000,000 shares of
preferred stock with designations, rights, and preferences determined from time
to time by our board of directors. Accordingly, our board of directors is
empowered, without stockholder approval, to issue preferred stock with dividend,
liquidation, conversion, voting or other rights superior to those of holders of
our common stock. For example, an issuance of shares of preferred stock
could:
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•
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adversely
affect the voting power of the holders of our common
stock;
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•
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make
it more difficult for a third party to gain control of
us;
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•
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discourage
bids for our common stock at a
premium;
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•
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limit
or eliminate any payments that the holders of our common stock could
expect to receive upon our liquidation;
or
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•
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otherwise
adversely affect the market price or our common
stock.
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We may
issue shares of authorized preferred stock at any time in the
future.
ITEM
2.
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UNREG
ISTE
RED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
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None.
ITEM
3.
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DE
FAUL
TS UPON SENIOR
SECURITIES
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There has
not been any default upon our senior securities.
ITEM
4.
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SU
BMISS
ION OF MATTERS TO A VOTE OF SECURITY
HOLDERS
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On
September 30, 2008, the Company held its 2008 Annual and Special Meeting of
Stockholders, or the Stockholders Meeting. At the Stockholders Meeting, the
following matters were submitted to a vote of stockholders and were
approved:
1. The
following six individuals were nominated and elected to serve as directors of
the Company for the ensuing year:
2. The
holders of 1,717,321 shares of the Company’s common stock voted in favor of, the
holders of 17,355 shares of the Company’s common stock voted against, and the
holders of 512 shares of the Company’s common stock abstained with respect to,
the ratification of the selection of Ernst & Young LLP, independent
certified public accountants, to serve as independent auditors of the Company
for the fiscal year ending December 31, 2008.
3. The
holders of 1,692,020 of the Company’s common stock voted in favor of, the
holders of 44,750 shares of the Company’s common stock voted against, and the
holders of 818 shares of the Company’s common stock abstained with respect to,
the amendment to the Company’s Amended and Restated Certificate of Incorporation
in order to increase the number of authorized shares of the Company’s common
stock, from 75,000,000 to 500,000,000. (Note that these last two share numbers
are presented on a pre-reverse stock split basis.)
4. The
holders of 1,309,375 shares of the Company’s common stock voted in favor of, the
holders of 21,245 shares of the Company’s common stock voted against, and the
holders of 208 shares of the Company’s common stock abstained with respect to,
the approval and adoption of the Agreement and Plan of Merger and
Reorganization, dated April 22, 2008, by and among the Company, OcuSense
Acquireco, Inc. and OcuSense, as amended, pursuant to which the Company acquired
all of the issued and outstanding shares of OcuSense’s capital stock that the
Company did not already own in exchange for the issuance of an aggregate of
3,169,938 shares of the Company’s common stock to the minority stockholders of
OcuSense.
5. The
holders of 1,296,250 shares of the Company’s common stock voted in favor of, the
holders of 34,302 shares of the Company’s common stock voted against, and the
holders of 275 shares of the Company’s common stock abstained with respect to,
the approval and adoption of the Securities Purchase Agreement, dated as of May
19, 2008, by and among the Company, Marchant Securities Inc., or Marchant, and
the investors party thereto, as amended, pursuant to which the Company sold an
aggregate of 869,200 shares of its common stock to those investors for gross
aggregate proceeds to the Company of $2,173,000.
6. The
holders of 1,295,615 shares of the Company’s common stock voted in favor of, the
holders of 34,900 shares of the Company’s common stock voted against, and the
holders of 352 shares of the Company’s common stock abstained with respect to,
the pre-payment by the Company of its then outstanding $6,703,500 aggregate
principal amount bridge loan (plus accrued interest) by issuing to the lenders
of the bridge loan an aggregate of 3,304,511 shares of the Company’s common
stock.
7. The
holders of 1,295,553 shares of the Company’s common stock voted in favor of, the
holders of 34,815 shares of the Company’s common stock voted against, and the
holders of 460 shares of the Company’s common stock abstained with respect to,
the issuance to Marchant of 192,480 shares of the Company’s common stock in
payment of part of the commission then remaining owing for certain services
rendered by Marchant.
8. The
holders of 1,294,818 shares of the Company’s common stock voted in favor of, the
holders of 35,688 shares of the Company’s common stock voted against, and the
holders of 322 shares of the Company’s common stock abstained with respect to,
the extension of the terms of certain stock options of the Company issued under
the Company’s 2002 Stock Option Plan and held by current and former executives
of the Company and certain directors of the Company. However, of the number of
shares of the Company’s common stock indicated above as having been voted by
their respective holders in favor of this matter, 90,898 was subtracted from
such number since 90,898 shares of the Company’s common stock were held by
insiders of the Company at the close of business on August 6, 2008, the record
date for the Stockholders Meeting. Accordingly, the holders of 1,203,920 shares
of the Company’s common stock were deemed to have voted in favor of this
matter.
9. The
holders of 1,296,183 shares of the Company’s common stock voted in favor of, the
holders of 34,354 shares of the Company’s common stock voted against, and the
holders of 290 shares of the Company’s common stock abstained with respect to,
the increase in the share reserve under the Company’s 2002 Stock Option Plan by
53,544,000, from 6,456,000 to 60,000,000. (Note that these last three share
numbers are presented on a pre-reverse stock split basis.) However, of the
number of shares of the Company’s common stock indicated above as having been
voted by their respective holders in favor of this matter, 90,898 was subtracted
from such number since 90,898 shares of the Company’s common stock were held by
insiders of the Company at the close of business on August 6, 2008, the record
date for the Stockholders Meeting. Accordingly, the holders of 1,205,285 shares
of the Company’s common stock were deemed to have voted in favor of this
matter.
10. The
holders of 136,481 shares of the Company’s common stock voted in favor of, the
holders of 33,985 shares of the Company’s common stock voted against, and the
holders of 362 shares of the Company’s common stock abstained with respect to,
the further amendment to the Company’s Amended and Restated Certificate of
Incorporation in order to (i) provide for a recapitalization in which the issued
and outstanding shares of the Company’s common stock would be reverse split in a
ratio of up to 1:25, if at all, with the actual ratio and timing of such reverse
split to be determined by the Company’s board of directors in its sole
discretion, and (ii) decrease the number of authorized shares of the Company’s
common stock from 500,000,000 to a number equal to 500,000,000 multiplied by 50%
of the reverse split ratio, provided that the reverse split is effected. (Note
that this last share number, 500,000,000, is presented on a pre-reverse stock
split basis.)
ITEM
5.
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O
THE
R INFORMATION
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None.
2.1
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|
Form
of Plan of Reorganization (incorporated by reference to Exhibit 2.1 to the
Registrant’s Registration Statement on Form S-1/A No. 4, filed with the
Commission on December 6, 2004 (file no. 333-118024)).
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3.1
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Amended
and Restated Certificate of Incorporation of the Registrant as currently
in effect (incorporated by reference to Exhibit 10.4 to the Registrant’s
Registration Statement on Form S-1/A No. 3, filed with the Commission on
November 16, 2004 (file no. 333-118024)).
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3.2
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Amended
and Restated By-Laws of the Registrant as currently in effect
(incorporated by reference to Exhibit 10.4 to the Registrant’s
Registration Statement on Form S-1/A No. 3, filed with the Commission on
November 16, 2004 (file no. 333-118024)).
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2002
Stock Option Plan, as amended and restated on September 30,
2008.
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Amending
Agreement, dated as of October 6, 2008, between the Registrant and William
G. Dumencu, amending the Employment Agreement between the Registrant and
William G. Dumencu dated as of February 25, 2008.
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Termination
Agreement, dated as of October 6, 2008, between Suh Kim and the
Registrant, terminating the Employment Agreement between the Registrant
and Suh Kim dated as of March 12, 2007.
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Termination
Agreement, dated as of October 6, 2008, between Elias Vamvakas and the
Registrant, terminating the Employment Agreement between the Registrant
and Elias Vamvakas dated as of September 1, 2004.
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10.5
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Letter
Agreement, dated August 13, 2008, between 2600 Skymark Investments Inc,
and the Registrant, partially terminating the Lease between Penyork
Properties III Inc. and the Registrant dated October 17, 2005, as amended
by the Lease Amending Agreement between the Registrant and 2600 Skymark
Investments Inc. dated as of March 9, 2007.
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CEO’s
Certification required by Rule 13a-14(a) of the Securities Exchange Act of
1934.
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CFO’s
Certification required by Rule 13a-14(a) of the Securities Exchange Act of
1934.
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CEO’s
Certification of periodic financial reports pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, U.S.C. Section 1350.
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CFO’s
Certification of periodic financial reports pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, U.S.C. Section
1350.
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SIGNATURE
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.
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OccuLogix,
Inc.
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(Registrant)
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Date: November
10, 2008
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/s/
Eric Donsky
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Eric
Donsky
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Chief
Executive Officer
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63
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