FDA Approval of the First Molecular Prostate Cancer Test
QUEBEC CITY, June 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 the second quarter 2012 ended April 30, 2012. The Company announced a net loss from continuing operations of $270,147 or $0.01 per share for the second quarter ending April 30, 2012, compared to a net loss of $1,072,224 or 0.02$ per share for the same quarter of 2011. At the end of the quarter, cash, short-term investments and long-term investments stood at $7,407,058.
Second Quarter 2012 Highlights
On February 15, the US Food and Drug Administration (FDA) approved
Gen-Probe's PROGENSA® PCA3 assay (Prostate Cancer Antigen 3), the first
molecular test for prostate cancer to help determine the need for
repeat prostate biopsies in men who have had a previous negative
biopsy. "This FDA approval marks a significant milestone achievement
for the company and should generate significant long-term royalty
revenues for our Company", states Dr. Fradet, President and Chief
Medical Officer of DiagnoCure.
- On February 29, DiagnoCure reported that the PROGENSA® PCA3 prostate cancer diagnostic test had been featured in seven (7) presentations by leading professors and researchers at the 27th annual European Association of Urology (EAU) in Paris and on May 25, in at least 14 presentations during the 107th American Urological Association (AUA) meeting held in Atlanta, Georgia. Notably, during this last meeting, the value of PCA3 testing was highlighted during a debate on the new USPSFT recommendation on prostate cancer screening.
Second Quarter 2012 Results
The Company' financial statements for the period ended April 30, 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 second quarter of 2012 were $1,063,131 compared with $310,907 for the same period of 2011. In the second quarter of 2012, royalty revenues amounted to $173,264 compared with $187,106 for the corresponding period of 2011. Royalty revenues from Gen-Probe increased by $4,823 to $168,663 for the second quarter of 2012, from $163,840 for the same period of 2011. Royalty revenues from Scimedx, related to ImmunoCytTM / uCyt+TM, decreased by $18,665 to $4,601 for the second quarter of 2012, from $23,266 for the same period of 2011. In the second quarter of 2012, DiagnoCure provided R&D services to Signal Genetics related to the PrevistageTM GCC Colorectal Cancer Staging Test for an amount of $387,267. Pursuant to the amendment signed with Gen-Probe on April 29, 2009, and the FDA approval of the PROGENSA® PCA3 test, DiagnoCure recorded the annual payment, that is, $502,600 in the second quarter of 2012, compared with $123,801 for the same period of 2011 that was representing only a portion of the annual payment. The 2009 amended agreement with Gen-Probe contains an FDA submission milestone to be paid on January 31st of each year until the said milestone is reached. As Gen-Probe received the FDA approval for the PROGENSA® PCA3 test on February 15, 2012, DiagnoCure recorded the full payment in revenues in the second quarter of 2012 given that all the conditions in the amendment were met.
Operating expenses decreased by $75,668, to $1,335,347 for the second quarter of 2012 from $1,411,015 for the same period of 2011. This decrease is mainly attributable to amortization of intangible assets. Total operating expenses decreased primarily as a result of the following:
- Research and development expenses, net of investment tax credits, decreased by $26,400, to $694,950 for the second quarter of 2012 from $721,350 for the same period of 2011. This decrease in research and development expenses is attributable to the decrease in intangible amortization. Without the intangible amortization expenses, the research and development expenses, net of investment tax credits increased by $64,898 mainly attributable to the R&D services performed in support to the PrevistageTM GCC Colorectal Cancer Staging Test.
- General and administrative expenses decreased by $58,363, to $562,700 for the second quarter of 2012 from $621,063 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 $38,056, to $91,867 for the second quarter of 2012 from $53,811 for the same period of 2011. This increase is attributable to professional fees.
Based on the above, for the second quarter of 2012, DiagnoCure recorded a net loss from continuing operation of $270,147 or $0.01 per share, compared with $1,072,224 or $0.02 per share, for the same period of 2011.
For the Second Quarter
Ended April 30
Operating expenses (before stock-based compensation and
Net profit (loss) from continuing operations (before stock-based
compensation and amortization)
|Net loss before income taxes from continuing operations||(272,216)||(1,100,108)|
|Future income taxes||2,069||27,884|
|Net loss from continuing operations||(270,147)||(1,072,224)|
|Basic and diluted loss per share:||(0.01)||(0.02)|
|Weighted average number of common shares outstanding||43,033,471||
Consolidated Statements of Financial Position
|As of April 30|
|Cash, cash equivalents, temporary and long-term investments||7,407,058||4,706,383|
Conference call with investors
Investors and financial analysts wishing to participate to the "DiagnoCure Q2 2012 Earnings Announcement" conference call to be held today, June 6, 2012 at 4:30 p.m. (EST) shall dial the toll-free number 1-888-231-8191, and provide the conference ID number: 85202071.
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 June 11, 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 (NASDAQ: GPRO) for the development and commercialization of a second-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 now approved for commercialization in Canada and the United States. For more information, visit www.diagnocure.com.
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.
SOURCE DIAGNOCURE INC.