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Press release from CNW Group

Bioniche Life Sciences Inc. Reports Fiscal 2012 Year-End Results

Wednesday, September 12, 2012

Bioniche Life Sciences Inc. Reports Fiscal 2012 Year-End Results17:53 EDT Wednesday, September 12, 2012- Animal Health product sales revenues increase by 10% over Fiscal 2011 -(all figures are in Canadian dollars unless otherwise noted)BELLEVILLE, ON, Sept. 12, 2012 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its fiscal year ended June 30, 2012."During the course of its history, Bioniche Life Sciences Inc. has evolved from a modest animal health business with a focus on researching and developing alternatives to antibiotics in food producing animals to a three-pronged business (Animal Health, Human  Health and Food Safety) with consistent revenues, successful commercialization of internally developed technologies, late-stage human clinical development, top-of-the-line production facilities in both animal and human health, and significant potential for future growth and value creation," said Graeme McRae, President & CEO. "The evolution of the Company continues as many of our R&D projects are nearing the end of their development cycle and approaching the marketplace. The next five years will be particularly important in this respect, as several significant technologies become commercialized globally."Fiscal 2012 Financial Results HighlightsConsolidated revenues related to Bioniche Animal Health product sales for the fiscal year were $29.8 million, as compared to $27.3 million in Fiscal 2011. Gross margins were 50% for the year ended June 30, 2012, as compared to 51% in the year ended June 30, 2011. This reduction in margins is largely the result of cost increases relative to sales processes, and in particular, products acquired through licensing and distribution agreements, many of them introduced over the last 2 quarters of the year ended June 30 2012. These margins are expected to improve progressively as the markets for these new products grow over the next year.In addition to product sales revenues, the Company recorded research collaboration income of $2.0 million in Fiscal 2012, as compared to $3.1 million in Fiscal 2011. This is related to certain reimbursements by the Endo Health Solutions Inc. (Endo), with whom the Company has a license, development and supply agreement for its human bladder cancer therapy, UrocidinTM. Total revenues from all sources for Fiscal 2012 were $31.8 million, as compared to $34.6 million in Fiscal 2011. The difference in revenues was largely due to a non-recurring milestone payment of US$4 million that was received from Endo in November, 2010, which is included in the Fiscal 2011 revenues.The Company generated Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) - before research and development expenses - of $0.3 million, as compared to $4.4 million in Fiscal 2011.Fiscal year-end cash, cash equivalents and short-term investments amounted to $20.0 million at June 30, 2012, as compared to $15.4 million at June 30, 2011. At June 30, 2012, the Company's net working capital totaled $27.5 million, compared to net working capital of $22.9 million at June 30, 2011.The Company's cash flow used in operations for the year ended June 30, 2012 was $14.7 million, as compared to cash used in operations of $12.9 million in 2011. A $4.0 million milestone offset the cash flow used in operations in Fiscal 2011, where no milestone revenue was recorded in Fiscal 2012. Further, minor variations in income and changes in non-cash working capital balances affected the cash flow used in operations in Fiscal 2012. The average monthly burn rate was $1.4 million for Fiscal 2012, vs. $1.1 million for Fiscal 2011. In the year ahead, the Company expects to reduce the average monthly burn rate progressively throughout the year as it completes the development and commercialization of several new products. The Company's goal is to neutralize its burn rate and develop sustainable cash flows in Fiscal 2014.The value of the Company's Property, Plant and Equipment has increased to $40.1 million at June 30, 2012, compared to $37.6 million at June 30, 2011. This increase reflects an ongoing investment in the Animal Health and Food Safety Vaccine Manufacturing Centre at the Company's corporate headquarters in Belleville, Ontario. This facility has been undergoing commissioning and validation to meet North American production standards."The Vaccine Manufacturing Centre initially was constructed to produce EconicheTM," said Mr. McRae. "Sales of EconicheTM have been limited to date, as there is presently no mandatory requirement for cattlemen in Canada to vaccinate their animals, nor do they receive any compensation or incentive to do so.  Additionally, the Company has not yet achieved a conditional license for the vaccine in the U.S. market, and the Company is just beginning to access ex-North American markets. Beyond EconicheTM, the Company expects to manufacture other vaccine products, including internally developed products, such as our Rhodococcus equi vaccine for horses, and to offer manufacturing services for companies seeking high quality production."Added Mr. McRae, "We are continuing to the next level of validation in the facility, which will allow the production of vaccines for sale in European and Asian markets, where premium pricing is available. It will take approximately 6-12 months of additional validation work to achieve this Good Manufacturing Practices (GMP) compliance."EconicheTM U.S. Regulatory StatusThe Company continues to pursue the registration of its E. coli O157 cattle vaccine in the United States. Subsequent to the February, 2008 notice from the United States Department of Agriculture (USDA) that the data for its E. coli O157 cattle vaccine "meets the 'expectation of efficacy' standard" and is eligible for a conditional license, there has been little progress.  Ongoing discussions revealed significant additional requirements which the Company has decided are not justifiable in terms of cost and time for a conditional license.  The Company is consequently focused on developing a critical path agreement with the USDA for a full license.  In the interim, research permits are an option for any U.S. customers wanting access to the Canadian vaccine.Additional Fiscal 2012 Financial Results HighlightsAdministrative expenses were $10.6 million in Fiscal 2012, as compared to $10.8 million at June 30, 2011. Marketing, selling and distributed expenses were $7.4 million in Fiscal 2012, as compared to $6.9 million in Fiscal 2011. The additional expenditure in this category is related to increased staffing to support the launch and distribution of several new Animal Health products.Research and development (R&D) expenditures were $20.5 million in Fiscal 2012, as compared to $21.0 million in Fiscal 2011. R&D resources are focused on the advancement of certain development programs in Animal Health and Food Safety. Additionally, there is continued investment in the staffing and infrastructure associated with the GMP production of the Company's UrocidinTMbladder cancer treatment that is in Phase III clinical testing. Endo has assumed financial responsibility for the external costs of clinical activities as they relate to UrocidinTM, and the Company is focusing its human clinical development activities for the underlying technology - Mycobacterial Cell Wall-DNA Complex (MCC) - on other indications. Until such time as the Company's Vaccine Manufacturing Centre in Belleville is making commercial product, the carrying costs associated with this facility are also accounted for under R&D.The Company's financing activities provided $22.4 million during the year ended June 30, 2012 from the closing of the debt financing with Capital Royalty Partners of US$20.million, as compared to the $38.0 million in Fiscal 2011, primarily from the concurrent share offerings netting $26.0 million and from loan advances to fund the Vaccine Manufacturing Centre of $9.8 million.The basic and fully-diluted net loss per share for Fiscal 2012 is ($0.24), as compared to a net loss per share of ($0.14) in Fiscal 2011. Total Common Shares outstanding at June 30, 2012 were 103,574,370, as compared to 102,108,692 at June 30, 2011.More information on the Company's year-end financial results is provided in the Company's Fiscal 2012 Management's Discussion and Analysis dated September 12, 2012.Fiscal 2012 Year-End Results Conference CallThe Company will discuss its year-end results during a:Conference Call & Audio Web CastWednesday, September 19, 20127:00 p.m. (Eastern)To participate in the conference call from North America, call (888) 231-8191 or (647) 427-7450.To participate in the conference call from Australia, call 1-800-287-011.In order to join this conference call, all participants will be required to provide the topic, Company name or conference ID number: 25364133.A listen-only audio web cast will be available at:http://event.on24.com/r.htm?e=510747&s=1&k=D5EE4A57B99BADE02CE30C5FCD8791EBA replay of the conference call will be available until September 24, 2012 at midnight by calling 1-855-859-2056 (passcode: 25364133#).The web cast will be available for replay using the above link until September 19, 2013.About Bioniche Life Sciences Inc.Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focussed on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.Bioniche Life Sciences Inc. has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2011. For more information, please visit www.Bioniche.com.Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Bioniche Life Sciences Inc.Amalgamated under the laws of OntarioCONSOLIDATED STATEMENT OF FINANCIAL POSITION As at(thousands of Canadian dollars) June 30,2012$June 30,2011$July 1,2010$ASSETSCurrent    Cash and cash equivalents 20,02015,35311,070Other current financial assets —1,493—Trade and other receivables 6,7876,4608,601Income taxes receivable —25463Inventories 7,7768,5236,582Prepayments 1,0811,067788  35,66433,15027,104Non-current    Property, plant and equipment 40,13437,58225,330Intangible assets 5,2066,3066,500Goodwill 456456456Other non-current receivables 1831,7561,156Deferred tax assets 509539494Total assets 82,15279,78961,040LIABILITIES AND SHAREHOLDERS' EQUITY    Current    Trade and other payables 6,7138,5209,716Income taxes payable 94——Current portion of long-term debt 997700256Current portion of repayable government assistance 3661,049960  8,17010,26910,932Non-current    Long-term debt 25,4382,7172,525Repayable government assistance 30,92126,38721,889Employee benefit liability 1,8751,808—Deferred government incentives ——2,382  66,40441,18137,728Shareholders' equity    Share capital 126,354125,63096,677Other paid-in capital 9,3278,7718,813Deficit (118,807)(94,619)(82,094)Foreign currency translation reserve (1,126)(1,174)(84)Total shareholders' equity 15,74838,60823,312Total liabilities and shareholders' equity 82,15279,78961,040Bioniche Life Sciences Inc.CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS For the years ended June 30(thousands of Canadian dollars, except share and per share amounts) 2012$2011$    REVENUES   Sales 29,81127,366Licensing —4,046Research collaborations 1,9863,146  31,79734,558EXPENSES   Cost of sales 14,91613,441Administration 10,55510,840Marketing and selling 7,3956,897Financial expenses (income) 3,163(2,029)Foreign exchange gain (413)(879)  35,61628,270(Loss) income before research and development expenses and other items (3,819)6,288Research and development expenses 20,54921,031Less: government assistance (289)(1,954)Loss before income taxes (24,079)(12,789)Income tax expense (recovery) 109(281)Net loss for the year (24,188)(12,508)    OTHER COMPREHENSIVE INCOME (LOSS)Exchange difference on translation of foreign operations 48(1,090)    Total comprehensive loss for the year (24,140)(13,598)    Basic and fully diluted net loss per share (0.24)(0.14)    Weighted-average number of common shares outstanding 102,818,00988,896,923Bioniche Life Sciences Inc.CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended June 30(thousands of Canadian dollars) 2012$2011$OPERATING ACTIVITIES   Net loss for the year (24,188)(12,508)Items not affecting cash and other reconciling items:    Depreciation of property, plant and equipment 1,5111,384 Amortization of intangible assets 1,092881 Unrealized foreign exchange loss (gain) 248(1,530) Accreted interest on government incentives and repayable government assistance 2,354(2,118) Related party transaction —20 Stock-based compensation expense 553619 Employee share ownership plan 875836 Employee future benefit 671,808 Impairment of intangible assets 268— Deemed government assistance (7)(61) Amortization of deferred government incentives —(1,005) Deferred future income taxes 39(69) Other 11  (17,187)(11,742)Net change in non-cash working capital balances 2,530(1,145)Cash (used in) operating activities (14,657)(12,887)INVESTING ACTIVITIES   Proceeds on settlement of other non-current receivables —100Proceeds (purchase) of other current financial assets 1,493(1,493)Proceeds on disposal of property, plant and equipment 15103Purchases of intangible assets (260)(687)Purchases of property, plant and equipment (4,286)(18,912)Cash used in investing activities (3,038)(20,890)FINANCING ACTIVITIES   Proceeds from repayable government assistance on account of property, plant and equipment —1,496Proceeds from repayable government assistance 1,2309,342Proceeds from long-term debt 22,728500Payment of financing fees (545)—Proceeds from shares issued 630,587Payment of share issuance costs —(2,969)Proceeds from deferred government incentives —691Repayment of repayable government assistance (91)(960)Redemption of shares (156)(173)Repayment of finance lease obligations (439)(431)Repayment of long-term debt (371)(24)Cash provided by financing activities 22,36238,059Net increase in cash and cash equivalents during the year 4,6674,283Cash and cash equivalents, beginning of year 15,35311,070Cash and cash equivalents, end of year 20,02015,353  SOURCE: Bioniche Life Sciences Inc.For further information: Jennifer Shea, Vice-President, Communications, Investor & Government Relations Bioniche Life Sciences Inc. Telephone: (613) 966-8058; from Australia: 0011 1 613-966-8058 Cell: (613) 391-2097; from Australia: 0011 1 613-391-2097 Jennifer.Shea@Bioniche.com