QUEBEC CITY, Jan. 16, 2012 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company that develops and commercializes highvalue cancer diagnostic tests, today reported financial and operation results for the fourth quarter 2011 and fiscal year ended October 31, 2011. The Company announced a net loss from continuing operations of $715,749 or $0.01 per share for the fourth quarter ending October 31, 2011, and a net loss of $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.
Results for the Fiscal Year Ended October 31, 2011
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.
Results of the Fourth Quarter 2011
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.
Financial Data
| For the periods of | Three months ended October 31 | Years ended October 31 | ||
| 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 |
Consolidated Balance Sheets
| 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 |
About DiagnoCure
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 GenProbe; a PMA application was filed with the FDA. For more information, visit www.diagnocure.com.
Forwardlooking statements
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.
