Spectral announces fourth quarter and fiscal 2012 results
27 Março 2013 - 10:50AM
OTC Markets
Spectral Diagnostics Inc., (TSX:SDI) (OTCQX:
DIAGF), a Phase III company
developing the first theranostic treatment for patients with septic
shock, today
announced its audited financial results for the fourth quarter and
year ended
December 31, 2012.
2012 Highlights:
- Continued enrolling patients into the Company's Phase III
EUPHRATES trial at
a per site rate that is higher than previous sepsis trials.
Directed by the
Company's Endotoxin Activity Assay (EAA™), which is the only
FDA-cleared
diagnostic for the risk of developing sepsis, Spectral's EUPHRATES
trial is
currently targeted to enroll 306 evaluable patients at up to 60
sites in North America. Contingent
on maintaining current
enrolment rates and timely site start ups, the trial should be
fully enrolled by
the end of 2014.
- As of March 25, 2013, 100
patients have been
randomized into Spectral's EUPHRATES trial.
- Announced an exclusive distribution agreement with Toray
International Italy S.r.l. - a
subsidiary of Toray Industries, Inc. -
to sell the Company's Endotoxin Activity Assay in combination with
Toraymyxin in
Saudi Arabia and Turkey. The expansion of commercial
jurisdictions with
Toray further confirms the outstanding market opportunity for the
Company's
unique theranostic treatment for septic shock.
- Subsequent to year end, announced that the first interim
analysis has been
conducted on the initial 76 randomized patients in its EUPHRATES
trial. The Data
and Safety Monitoring Board (DSMB), consisting of experts in the
fields of
critical care medicine, infectious disease, nephrology,
biostatistics and
regulatory affairs, reviewed the totality of the data set for
evidence of safety
concerns, such as adverse events and/or adverse device effects,
related to the
use of the Toraymyxin cartridge. The results from the first interim
safety
analysis by the DSMB state that there are no safety issues to date
concerning
the application of the Toraymyxin cartridge to patients in the
EUPHRATES trial.
In addition, the results state that the EUPHRATES clinical protocol
appears to
be defining the correct target patient population for this
study.
- Concluded the reporting period with approximately $10.5
million in cash, cash equivalents and short- term
investments.
- Subsequent to year end, on March 7,
2013, the
Company announced it entered into a private placement agreement
with Toray
Industries, Inc. Under the terms of the private placement, Spectral
will issue
16,666,667 common shares in the capital of the Company to Toray at
a price of
$0.30 per common share, for gross
proceeds of $5 million. On
March 18, 2013
the Company announced that other investors had subscribed for an
additional
$ 0.6 million under the same terms,
bringing the
total private placement gross proceeds to $5.6
million. The net proceeds of the private placement will be
used to
continue to support the Company's EUPHRATES clinical trial and for
general
operating purposes. Immediately after the closing of the private
placement,
Toray's investment will represent approximately 12.6% of the issued
and
outstanding common shares of Spectral, calculated on a non-diluted
basis.
Closing of the private placement is expected at the beginning of
April, 2013 and
is subject to the approval of the Toronto Stock
Exchange.
"2012 was a very important year for the
Company," said Dr. Paul Walker,
President and CEO of Spectral
Diagnostics. "We made crucial and significant progress with our
Phase III sepsis
asset and consequently we are now potentially less than a year away
from our
second planned interim analysis of the trial data."
The second interim analysis will occur after 184
randomized
patients have been followed for 28 days. At the second analysis,
the trial's
DSMB will advise Spectral on the trial's safety, efficacy or
futility, with
stopping rules in place for efficacy and futility. A sample size
recalculation
will be done if necessary. Management remains on track to disclose
information
from the second interim analysis in the first half of 2014.
Financial Review
Revenue for the three months ended December 31, 2012 was $647,000
compared to $628,000 for the same
period in the
preceding year. For the year ended December
31,
2012, revenue was $2,589,000
compared to
$2,430,000 for the same period in
2011.
Revenue was positively impacted by the revised
terms of certain
EAA™ distribution agreements that took effect during 2012.
Conversely, revenues
were negatively impacted by the increased strength of the Canadian
dollar
compared to the U.S. dollar and the Euro. It is anticipated that
revenue in 2013
will be consistent with levels achieved in 2012.
For the quarter ended December 31,
2012, the Company reported a loss of $2,067,000 compared to a loss of $1,940,000 for the corresponding period in 2011.
For the
year ended December 31, 2012,
Spectral reported a
loss of $8,543,000 compared to
$6,713,000 for the same period in
2011. The Company's loss
was greater for the three and twelve months of 2012 due to higher
costs for its
EUPHRATES trial.
Cash, cash equivalents and short-term
investments on hand at
December 31, 2012 were $10.5
million. Cash was used during the quarter ended December 31, 2012 to fund operations and for
working
capital purposes.
The total number of shares outstanding for the
Company was
113,883,394 as at December 31,
2012.
About Spectral Diagnostics
Spectral is a Phase III
company seeking U.S. FDA approval for its lead theranostics product
for the
treatment of severe sepsis with septic shock. Toraymyxin is a
therapeutic
hemoperfusion device that removes endotoxin, which can cause
sepsis, from the
bloodstream. Directed by the Company's Endotoxin Activity Assay
(EAA™), the only
FDA cleared diagnostic for the risk of developing sepsis.
Spectral's EUPHRATES
trial is the world's first theranostics trial in the area of
sepsis.
Toraymyxin has been approved for therapeutic use
in Japan and Europe, and
has been used safely and effectively on more than 100,000 patients
to date. In
March 2009, Spectral obtained the
exclusive
development and commercial rights in the U.S. for Toraymyxin, and
in November 2010, signed an exclusive
distribution agreement
for this product in Canada. More
than 250,000
patients are diagnosed with severe sepsis and septic shock in
North America each year,
representing a greater than
$1 billion market opportunity for
Spectral. Spectral
is listed on the Toronto Stock
Exchange under the
symbol SDI, and on the OTCQX under the symbol DIAGF. For more
information please
visit www.spectraldx.com
Forward-looking statement
Information in this news release that is not
current or
historical factual information may constitute forward-looking
information within
the meaning of securities laws. Implicit in this information,
particularly in
respect of the future outlook of Spectral and anticipated events or
results, are
assumptions based on beliefs of Spectral's senior management as
well as
information currently available to it. While these assumptions were
considered
reasonable by Spectral at the time of preparation, they may prove
to be
incorrect. Readers are cautioned that actual results are subject to
a number of
risks and uncertainties, including the availability of funds and
resources to
pursue R&D projects, the successful and timely completion of
clinical
studies, the ability of Spectral to take advantage of business
opportunities in
the biomedical industry, the granting of necessary approvals by
regulatory
authorities as well as general economic, market and business
conditions, and
could differ materially from what is currently expected.
The TSX has not reviewed and does not accept
responsibility for
the adequacy or accuracy of this statement.
Spectral Diagnostics
Inc.
Statement of
Financial Position |
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31
2012
|
|
|
December 31
2011 |
|
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
|
5,425 |
|
|
13,470 |
Short-term investment |
|
|
5,137 |
|
|
5,086 |
Trade and other receivables |
|
|
590 |
|
|
515 |
Inventories |
|
|
277 |
|
|
295 |
Prepayments |
|
|
226 |
|
|
407 |
|
|
|
11,655 |
|
|
19,773 |
Non-current assets |
|
|
|
|
|
|
Property, plant and
equipment |
|
|
497 |
|
|
419 |
Intangible assets |
|
|
434 |
|
|
459 |
|
|
|
931 |
|
|
878 |
|
|
|
|
|
|
|
Total
assets |
|
|
12,586 |
|
|
20,651 |
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Trade and other payables |
|
|
1,913 |
|
|
1,610 |
Deferred
revenue |
|
|
99 |
|
|
102 |
Total liabilities |
|
|
2,012 |
|
|
1,712 |
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
Share capital |
|
|
27,101 |
|
|
27,101 |
Contributed surplus |
|
|
3,864 |
|
|
3,864 |
Other equity reserves |
|
|
8,260 |
|
|
8,082 |
Deficit |
|
|
(28,651) |
|
|
(20,108) |
Total equity |
|
|
10,574 |
|
|
18,939 |
|
|
|
|
|
|
|
Total
liabilities and equity
|
|
|
12,586 |
|
|
20,651 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spectral Diagnostics
Inc.
Statement of
Loss and Comprehensive Loss
For the years ended December
31, 2012 and 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars, except for share and per
share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012 |
|
|
2011 |
|
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
Revenue |
|
|
2,589 |
|
|
2,430 |
|
|
|
|
|
|
|
Other income |
|
|
110 |
|
|
109 |
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
Changes in inventories of finished goods and
work-in-process
|
|
|
277 |
|
|
288 |
Raw materials and consumables used |
|
|
471 |
|
|
264 |
|
|
|
|
|
|
|
Employee benefits |
|
|
2,944 |
|
|
2,662 |
Consulting and professional fees |
|
|
4,619 |
|
|
3,047 |
Management services |
|
|
1,013 |
|
|
1,500 |
Regulatory and investor relations |
|
|
502 |
|
|
270 |
Travel and entertainment |
|
|
772 |
|
|
554 |
Depreciation and amortization |
|
|
216 |
|
|
316 |
Foreign exchange loss |
|
|
26 |
|
|
2 |
Other expenses |
|
|
473 |
|
|
414 |
|
|
|
11,313 |
|
|
9,317 |
|
|
|
|
|
|
|
Operating
loss |
|
|
(8,614) |
|
|
(6,778) |
|
|
|
|
|
|
|
Finance income |
|
|
71 |
|
|
65 |
|
|
|
|
|
|
|
Loss and
comprehensive loss for
the year |
|
|
(8,543) |
|
|
(6,713) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per common
share |
|
|
(0.08) |
|
|
(0.07) |
|
|
|
|
|
|
|
Weighted
average number of common shares
outstanding |
|
|
|
|
|
|
113,883,394 |
90,869,696 |
|
|
|
|
|
|
Spectral Diagnostics
Inc.
Statement of
Changes in Equity
For the years ended December 31, 2012 and 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued
capital |
|
Contributed
surplus |
Share-based
compensation |
Warrants |
Deficit |
Total Equity |
|
|
Number |
$ |
$ |
$ |
$ |
$ |
$ |
Balance, January 1,
2011 |
|
80,550,061 |
17,538 |
3,696 |
2,722 |
5,311 |
(13,395) |
15,872 |
Private placement |
|
33,333,333 |
9,563 |
- |
- |
- |
- |
9,563 |
Loss and comprehensive loss for the year |
|
- |
- |
- |
- |
- |
(6,713) |
(6,713) |
Share-based compensation |
|
- |
- |
- |
217 |
- |
- |
217 |
Warrants expired |
|
|
|
168 |
|
(168) |
|
- |
Balance, December
31, 2011
|
|
113,883,394 |
27,101 |
3,864 |
2,939 |
5,143 |
(20,108) |
18,939 |
Loss and comprehensive loss for the year |
|
- |
- |
- |
- |
- |
(8,543) |
(8,543) |
Share-based
compensation |
|
- |
- |
- |
178 |
- |
- |
178 |
Balance,
December 31, 2012 |
|
113,883,394 |
27,101 |
3,864 |
3,117 |
5,143 |
(28,651) |
10,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spectral
Diagnostics
Inc.
Statement of Cash Flows
For the years ended December 31, 2012
and 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands of Canadian dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012 |
|
|
|
|
2011 |
|
|
|
|
$ |
|
|
|
|
$ |
Cash flow provided by (used
in) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
activities |
|
|
|
|
|
|
|
|
|
Loss and comprehensive loss
for the year |
|
|
|
(8,543) |
|
|
|
|
(6,713) |
Adjustments for: |
|
|
|
|
|
|
|
|
|
|
Depreciation on property, plant, and
equipment |
|
|
|
191 |
|
|
|
|
173 |
|
Amortization of intangible
assets |
|
|
|
25 |
|
|
|
|
143 |
|
Share-based compensation |
|
|
|
178 |
|
|
|
|
217 |
Changes in items of working capital
: |
|
|
|
|
|
|
|
|
|
|
Trade and other receivables |
|
|
|
(75) |
|
|
|
|
80 |
|
Inventories |
|
|
|
18 |
|
|
|
|
(86) |
|
Prepayments |
|
|
|
181 |
|
|
|
|
(376) |
|
Trade and other payables |
|
|
|
303 |
|
|
|
|
288 |
|
Deferred revenue |
|
|
|
(3) |
|
|
|
|
1 |
Net cash used in operating
activities |
|
|
|
(7,725) |
|
|
|
|
(6,273) |
|
|
|
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
|
|
|
|
|
Property, plant and equipment
expenditures |
|
|
|
(269) |
|
|
|
|
(66) |
Redemption of short-term
investment |
|
|
|
5,086 |
|
|
|
|
5,021 |
Purchase of
short-term
investment |
|
|
|
(5,137) |
|
|
|
|
(5,086) |
Net cash used in investing
activities |
|
|
|
(320) |
|
|
|
|
(131) |
|
|
|
|
|
|
|
|
|
|
Financing
activities |
|
|
|
|
|
|
|
|
|
Private
placement |
|
|
|
- |
|
|
|
|
9,563 |
Net cash provided by
financing activities |
|
|
|
- |
|
|
|
|
9,563 |
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash
and cash equivalents
|
|
|
|
(8,045) |
|
|
|
|
3,159 |
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents,
beginning of year |
|
|
|
13,470 |
|
|
|
|
10,311 |
Cash and cash
equivalents, end of year |
|
|
|
5,425 |
|
|
|
|
13,470 |
SOURCE: Spectral Diagnostics Inc.
For further information:
Anthony Businskas
Executive Vice President and CFO
416-626-3233 ext.
2200
Adam Peeler
Investor Relations
TMX Equicom
416-815-0700 ext.
225
apeeler@tmxequicom.com
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