By $3,731,973 or $0.08 per share for fiscal year 2011. Also for fiscal 2011, the Company reported net earnings from discontinued operation of $3,115,542. At the end of the quarter, cash, short?term investments and long?term investments stood at $8,883,528.
Highlights of the Fourth Quarter 2011
On August 17, 2011, DiagnoCure announced that Health Canada
had granted regulatory approval for the PROGENSA® PCA3 assay
to Gen?Probe, the Company's commercial partner for the
prostate cancer PCA3 biomarker.
On November 7, 2011, Gen?Probe reported that it had received
notice from the FDA that the FDA had concluded a panel review
was no longer necessary in connection with the PMA for the
PROGENSA® PCA3 assay, based on recent discussions between the
FDA and the company with respect to product labeling and
related issues. Gen? Probe mentioned that it expected to work
interactively with the FDA to address outstanding issues
related to the PROGENSA® PCA3 assay PMA. In December, during
an investor presentation, Gen?Probe stated that it views this
situation as a positive one and that the company is preparing
for a launch of its PROGENSA® PCA3 assay in the first half of
2012.
Total revenues for 2011 were $1,306,012 compared with
$1,340,590 for 2010. In 2011, royalty revenues amounted to
$659,120 compared with $645,067 for 2010. Royalty revenues
from Gen?Probe increased by
$8,996, to $605,288 for 2011, from $596,292 for 2010. Without
taking into account the effect of the exchange rate
variation, royalty revenues from Gen?Probe have increased by
8%, to US$622,217 for 2011 from US$578,493 for 2010. Also in
2011, DiagnoCure recorded royalties of $44,244 from Scimedx,
related to ImmunoCytTM / uCyt+TM,
compared with $48,775 for 2010. Following the agreement
signed with Signal Genetics, Diagnocure recorded its first
PrevistageTM GCC royalties of $9,588 in the
fourth quarter of 2011. In 2011, DiagnoCure sold clinical
samples to Signal Genetics to support their lung cancer
testing R&D for an amount of
$82,632. There were no sales of samples in 2010. Pursuant to
the amendment agreement signed with Gen?
Probe on April 29, 2009, DiagnoCure recorded an annual
payment, that is, $502,491 for 2011 compared with
$539,031 for 2010. This difference is attributable to the
exchange rate variation since the Company received
US$500,000 for 2010 and for 2011.
Interest income decreased by $94,723 for 2011, to $61,769,
from $156,492 for 2010. The decrease is attributable to
timing and cash received and the use of funds.
Operating expenses decreased by $1,418,170, to $5,147,062 for
2011, from $6,565,232 for 2010. This decrease is mostly
attributable to the postponement of the second phase of the
Vitar clinical study, the restructuring charges incurred in
2010 and to the gain on foreign exchange. Based on the above,
for the fiscal year 2011,
DiagnoCure recorded a net loss from continuing operation of
$3,731,973 or $0.08 per share, compared with
$4,972,574 or $0.12 per share, for the same period of 2010.
Total revenues for the fourth quarter of 2011 were $358,996
compared with $307,475 for the same period of
2010. In the fourth quarter of 2011, royalty revenues
amounted to $141,951 compared with $154,203 for the
corresponding period of 2010. Royalty revenues from Gen?Probe
decreased by $766 to $125,344 for the fourth quarter of 2011,
from $126,110 for the same period of 2010. Without taking
into account the effect of the exchange rate variation,
royalty revenues from Gen?Probe have increased by 2%, to
US$126,240 for the fourth quarter of 2011, from US$123,783
for the same period of 2010. Also in the fourth quarter of
2011, DiagnoCure recorded royalties of $7,019 from Scimedx,
related to ImmunoCytTM / uCyt+TM,
compared with $28,093 for the same period of 2010. Following
the agreement signed with Signal Genetics, Diagnocure
recorded its first PrevistageTM GCC royalties of
$9,588 in the fourth quarter of 2011. In the fourth quarter
of 2011, DiagnoCure sold clinical samples to Signal Genetics
to support their lung cancer testing R&D for an amount of
$82,632. There were no sales of samples for the same period
of 2010. Pursuant to the amendment agreement signed with Gen?
Probe on April 29, 2009, DiagnoCure recorded a portion of the
annual payment, that is, $123,800 for the fourth quarter of
2011, compared with $131,088 for the same period of 2010.
Interest income decreased by $15,338, to $10,611 for the
fourth quarter of 2011, from $25,949 for the same period of
2010. The decrease is attributable to timing and cash
received and the use of funds.
Operating expenses decreased by $19,559, to $1,100,170 for
the fourth quarter of 2011, from $1,119,729 for the same
quarter of 2010. Based on the above, for the fourth quarter
of 2011, DiagnoCure recorded a net loss from continuing
operations of $715,749 or $0.01 per share, compared with
$560,186 or $0.01 per share, for the same period of 2010.
2
For the periods of | Three months ended October 31 | Years ended October 31 | ||
For the periods of | 2011 | 2010 | 2011 | 2010 |
$ | $ | $ | $ | |
Sales | 82,632 | ? | 82,632 | ? |
Revenue under research and license agreement | 265,753 | 281,526 | 1,161,611 | 1,184,098 |
Interest | 10,611 | 25,949 | 61,769 | 156,492 |
Total revenues | 358,996 | 307,475 | 1,306,012 | 1,340,590 |
Cost of sales | 2,462 | ? | 2,462 | ? |
Gross margin | 356,534 | 307,475 | 1,303,550 | 1,340,590 |
Operating expenses (before restructuring charges, stock?based compensation, and loss (gain) on foreign exchange) | 1,115,441 | 993,812 | 4,846,075 | 5,725,926 |
Net loss (before restructuring charges, stock?based compensation, and loss (gain) on foreign exchange) | (758,907) | (686,337) | (3,542,525) | (4,385,336) |
Restructuring charges | ? | ? | ? | 229,163 |
Stock?based compensation | 74,421 | 123,044 | 363,742 | 459,087 |
Loss (gain) on foreign exchange | (89,692) | 2,873 | (62,755) | 151,056 |
Net loss before income taxes | (743,636) | (812,254) | (3,843,512) | (5,224,642) |
Future income taxes | 27,887 | 252,068 | 111,539 | 252,068 |
Net loss from continuing operations | (715,749) | (560,186) | (3,731,973) | (4,972,574) |
Net earnings (loss) from discontinued operations | 269,664 | (581,717) | 3,115,542 | (3,844,843) |
Net loss | (446,085) | (1,141,903) | (616,431) | (8,817,417) |
Basic net earnings (loss) per share | ||||
From continuing operations | (0.01) | (0.01) | (0.08) | (0.12) |
From discontinued operations | 0.01 | (0.02) | 0.07 | (0.09) |
Basic net earnings (loss) per share | 0.00 | (0.03) | (0.01) | (0.21) |
Weighted average number of common shares outstanding | 42,993,274 | 42,968,755 | 42,993,274 | 42,968,755 |
As of October 31 | ||
2011 | 2010 | |
Cash, cash equivalents, temporary and long?term investments | 8,883,528 | 6,904,241 |
Total assets | 17,157,577 | 16,809,427 |
Shareholders' equity | 14,645,754 | 14,877,497 |
Number of Shares | 43,013,471 | 42,976,140 |
DiagnoCure (TSX: CUR) is a life sciences company that
develops and commercializes high?value cancer diagnostic
tests that increase clinician and patient confidence in
making critical treatment decisions. In 2008, the Company
launched the PrevistageTM GCC Colorectal Cancer
Staging Test through its U.S. CLIA laboratory, and granted
the worldwide exclusive rights to this test to Signal
Genetics in June 2011. The Company also has a strategic
alliance with Gen?Probe (NASDAQ: GPRO) for the development
and commercialization of a second?generation prostate cancer
test using PCA3, DiagnoCure's proprietary molecular
biomarker. The PROGENSA® PCA3 test is commercialized in
Europe under CE mark and was recently approved in Canada; in
the United States, the test is commercialized through
clinical laboratories using PCA3 analyte specific reagents
from Gen?Probe; a PMA application was filed with the FDA. For
more information, visit www.diagnocure.com.
3
This release contains forward?looking statements that involve
known and unknown risks, uncertainties and assumptions that
may cause actual results to differ materially from those
expected. By their very nature, forward?looking statements
are based on expectations and hypotheses and also involve
risks and uncertainties, known and unknown, many of which are
beyond DiagnoCure's control. As a result, investors are
cautioned not to place undue reliance on these
forward?looking statements. The forward?looking statements
regarding the outcome of research and development projects,
clinical studies and future revenues are based on management
expectations. In addition, the reader is referred to the
applicable general risks and uncertainties described in
DiagnoCure's most recent Annual Information Form under the
heading "Risk Factors". DiagnoCure undertakes no obligation
to publicly update or revise any forward?looking statements
contained herein unless required by the applicable securities
laws and regulations.
?30?
Chief Financial Officer Coordinator, Administration and
Communications
(418) 527?6100 (418) 527?6100 communications@diagnocure.com communications@diagnocure.com
4
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| Documents associés | |
| DiagnoCure announces Fourth Quarter 2011 and Year-End Results |
