Positive independent market research data on PCA3
QUEBEC CITY, Sept. 6, 2012 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR), a
Quebec life sciences company that develops and commercializes
high-value cancer diagnostic tests, today reported financial and
operation results for its third quarter 2012. The Company announced a
net loss from continuing operations of $606,049 or $0.01 per share for
the third quarter ending July 31, 2012, compared to a net loss of
$892,216 or 0.03$ per share for the same quarter of 2011. At the end of
the quarter, cash, short-term investments and long-term investments
stood at $6,487,969.
Third Quarter 2012 Highlights
On June 14, a few months after its FDA's approval, LifeSci Advisors,
LLC, a leading provider of investment research and investor relations
services in the life sciences sector, published positive independent
market research data on the PCA3 assay. The survey, which was conducted
among 273 practicing urologists who answered questions about their
expected use of the PCA3 assay in men suspected of having prostate
cancer, showed that interest in this test is high in the urologist's
community. Almost half of the responding urologists indicated their
intent to test their patients with this assay, 47% reported that they
may use it, and only 4% did not expect to use the test.
The PCA3 test continues to be highly profiled at major medical meetings,
while the debate in the clinical community on the most effective way to
screen for prostate cancer continues. At the end of May, when the US
Preventive Services Task Force (USPSTF) issued its final recommendation
issued against the routine use of prostatespecific antigen (PSA) for
screening for prostate cancer, the American Urological Association
(AUA) publicly criticized it while a debate of leading urologists
highlighted the value of the PCA3 test, which incidentally was featured
in no less than 14 presentations at the last AUA meeting.
At the end of the quarter, Gen-Probe, our exclusive licensee for PCA3's
diagnostic applications was acquired and became a wholly-owned
subsidiary of Hologic Inc. that now operates under the name Hologic
Gen-Probe. The transaction closed on August 1, 2012; the medium and
long-term impact on PCA3 sales has yet to be fully determined.
Third Quarter 2012 Results
The Company' financial statements for the period ended July 31, 2012
have been prepared in accordance with IAS 34, Interim Financial
Reporting, International Financial Reporting Standards (IFRS).
Comparative unaudited consolidated condensed financial statements for
2011 have been adjusted to reflect the Company's adoption of IFRS on a
retrospective basis, effective November 1, 2010.
Total revenues for the third quarter of 2012 were $709,754 compared with
$292,073 for the same period of 2011. In the third quarter of 2012,
royalty revenues amounted to $142,102 compared with $168,273 for the
corresponding period of 2011. Royalty revenues from Gen-Probe decreased
by $18,182 to $136,843 for the third quarter of 2012, from $155,025 for
the same period of 2011. This decrease is attributable to sales in
Europe reflecting the general softness in the European markets due to
austerity measures. Royalty revenues from Scimedx, related to ImmunoCytTM / uCyt+TM, decreased by $7,989 to $5,259 for the third quarter of 2012, from
$13,248 for the same period of 2011. In the third quarter of 2012,
DiagnoCure provided to a subsidiary of Signal Genetics R&D services
related to the PrevistageTM GCC Colorectal Cancer Staging test for an amount of $567,652, for a
total in accounts receivable of $707,012. We have been advised that
Signal Genetics has closed its laboratory in Pennsylvania on July 31,
2012, and is no longer performing the Previstage test. As of July 31st, Signal Genetics has not made the royalty payment required for the
second calendar quarter of 2012. While we intend to enforce our rights
under our agreements with Signal Genetics, there can be no assurance
that Signal Genetics will pay us any further amounts under the R&D
agreement, or any royalties due. Pursuant to FDA approval of the
PROGENSA® PCA3 test on February 15, 2012, DiagnoCure didn't record
revenues in the third quarter of 2012, compared with $123,801 for the
third quarter of 2011. The 2009 amended agreement with Gen-Probe
contained an FDA submission milestone that had to be paid on January 31st of each year until said milestone was reached. As a result of the
PROGENSA® PCA3 test having been approved, all the conditions in the
amendment have been met. Accordingly, DiagnoCure recorded the full 2012
payment as revenues in the second quarter of 2012.
Operating expenses increased by $131,514, to $1,315,803 for the third
quarter of 2012 from $1,184,289 for the same period of 2011. This
increase is mainly attributable to the R&D services performed in
support to the PrevistageTM GCC Colorectal Cancer Staging Test. Total operating expenses increased
primarily as a result of the following:
Research and development expenses, net of investment tax credits,
increased by $187,122, to $755,819 for the third quarter of 2012 from
$568,697 for the same period of 2011. This increase in research and
development expenses is attributable to the R&D services provided in
relation with the PrevistageTM GCC Colorectal Cancer Staging test.
General and administrative expenses decreased by $63,748, to $516,995
for the third quarter of 2012 from $580,743 for the same period of
2011. This decrease is attributable to reduction in professional fees
and stock-based compensation expenses allowance.
Selling and business development expenses increased by $23,044, to
$67,319 for the third quarter of 2012 from $44,275 for the same period
of 2011. This increase is attributable to professional fees.
Based on the above, for the third quarter of 2012, DiagnoCure recorded a
net loss from continued operations of $606,049 or $0.01 per share,
compared with $892,216 or $0.03 per share for the same period of 2011.
||For the Third Quarter Ended July 31|
Operating expenses (before stock-based compensation and amortization)
Net loss from continuing operations (before stock-based compensation and
Net loss from continuing operations
Basic and diluted loss per share:
Weighted average number of common shares outstanding
Consolidated Statements of Financial Position
As of July 31, 2012
As of October 31, 2011
Cash, cash equivalents, temporary and long-term investments
Conference call with investors
Investors and financial analysts wishing to participate to the
"DiagnoCure Q3 2012 Earnings Announcement" conference call to be held
today, September 6, 2012 at 4:30 p.m. (EDT) shall dial the toll-free
number 1-888-231-8191, and provide the conference ID number: 11370258.
The event will also be webcasted live on DiagnoCure's website at www.diagnocure.com, through the hyperlink under the "Presentations" page of the
"Investors" tab. A replay of the audio conference will be available on
September 10, 2012.
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 has also granted a worldwide exclusive
license agreement to Gen-Probe, now a wholly-owned subsidiary of
Hologic Inc. (HOLX:NASDAQ) operating as Hologic Gen-Probe, for the
development and commercialization of a third-generation prostate cancer
test using PCA3, DiagnoCure's proprietary molecular biomarker.
Gen-Probe's PROGENSA® PCA3 test is commercialized in Europe under CE
mark and is approved for commercialization in Canada and the United
States. For more information, visit www.diagnocure.com.
This release contains forwardlooking 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,
forwardlooking 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 forwardlooking 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
forwardlooking statements contained herein unless required by the
applicable securities laws and regulations.
SOURCE DIAGNOCURE INC.