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Press release from CNW Group

Bioniche Life Sciences Inc. Reports Q1, Fiscal 2013 Results

Wednesday, November 07, 2012

Bioniche Life Sciences Inc. Reports Q1, Fiscal 2013 Results20:36 EST Wednesday, November 07, 2012-quarterly revenues consistent with last year; margin on animal health product sales improves to 54%-(all figures are in Canadian dollars unless otherwise noted)BELLEVILLE, ON, Nov. 7, 2012 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for the first quarter of its 2013 fiscal year (ended September 30, 2012)."The Company continues to invest in several late-stage development projects and in facilities where commercial products will be made," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "We are nearing commercialization of some important products in the next 12 to 18 months and this requires an intensive resource allocation. Once these products reach the marketplace, we expect the new revenues will neutralize the corporate burn rate."Further to the Company's news release of Monday, November 5, 2012, the Company continues to discuss with its licensing partner, Endo Pharmaceuticals, potential next steps for the Urocidin™ clinical program following the discontinuation of the current Phase III clinical trial in non-muscle-invasive bladder cancer. Urocidin™ remains a valuable asset and the Company is committed to ensuring that this valuable product becomes commercialized.Fiscal 2013 First Quarter Financial Results HighlightsRevenues from the sale of Animal Health products increased by $0.5 million in the quarter, offset by a decrease in collaborative research revenue of $0.6 million. Animal Health revenues out of Canada, which includes sales into South America, declined by 17% compared to the same quarter last year due to the timing of sales orders. Sales in the United States increased 30% over the same quarter last year primarily from the introduction of new products. Sales in Australia and Europe also saw modest increases. Consolidated revenues for the quarter were $6.7 million, as compared to $6.8 million in the same period in Fiscal 2012.The cost of sales related to product sales in the Animal Health business unit has decreased by 2% in Q1, Fiscal 2013 from the same quarter in Fiscal 2012. This decrease is directly related to increased sales from new products. Gross margins were 54.2% in Q1, Fiscal 2013, compared to 49.8% in the first quarter of last year.The Company generated Earnings (Loss) Before Interest, Taxes, Depreciation and Amortization (EBITDA) - before research and development expenses - of ($107,000) for Q1, Fiscal 2013, as compared to ($242,000) for the same period in Fiscal 2012.Cash, cash equivalents and short-term investments amounted to $14.4 million at September 30, 2012, as compared to $9.6 million in the same period last year and $20.0 million at June 30, 2012. A further $14 million was available to the Company at September 30, 2012 through trade and other receivables and inventories. In the same period last year, $14.6 million was available through these sources.At September 30, 2012, the Company's net working capital totalled $21.2M as compared to working capital of $27.5M at June 30, 2012, reflecting the decrease in cash primarily used to invest in late-stage development and commercialization activities.The Company's cash flow used in operations for the quarter ended September 30, 2012 was $5.0 million, as compared to cash used in operations of $3.9 million in the same period in Fiscal 2012. As a result, the average monthly burn rate for Q1, Fiscal 2013 was $1.8 million, vs. $1.2 million for the same quarter in Fiscal 2012."The Company remains committed to reducing the average monthly burn rate progressively throughout the year as it completes the development and commercialization of several new products," said Mr. Brian Ford, Chief Financial Officer of Bioniche Life Sciences Inc. "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 $40.2 million at September 30, 2012, compared to $40.1 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 is undergoing validation to meet global GMP production standards.Administrative expenses were $2.3 million in Q1, Fiscal 2013, as compared to $2.5 million in the same quarter last year. Marketing, selling and distribution expenses were $1.8 million in Q1, Fiscal 2013, as compared to $1.8 million in the same quarter last year. 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 for Q1, Fiscal 2013 were $4.3 million, as compared to $4.8 million in the same quarter last year. 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. Further, 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 incurred financial expenses of $1.5 million (including non-cash financial expenses of $737,000) during Q1, Fiscal 2013 as a result of its US$20 million debt financing with Capital Royalty Partners. This compares to financial expenses of $0.2 million in the same quarter of Fiscal 2012.The basic and fully-diluted net loss per share for Q1, Fiscal 2013 is ($0.06), as compared to a net loss per share of ($0.04) in the same period last year. Total Common Shares outstanding at September 30, 2012 were 103,738,712, as compared to 102,375,477 at September 30, 2011.The Company has incurred significant losses and has an accumulated deficit of $125.5 million as at September 30, 2012, including a current loss of $6.7 million for the first quarter of Fiscal 2013. The Company's committed cash obligations and expected level of expenditures for the next twelve months exceed its committed resources of funds and funds available as at September 30, 2012.The Company expects to finance its future expenditures by obtaining additional financing and the exploration of new partnering agreements on technologies under development. If the Company is unable to accomplish either of these initiatives, which are outside of management's control, the Company will be required to curtail its development activities and operations.More information on the Company's year-end financial results is provided in the Company's Q1, Fiscal 2013 Management's Discussion and Analysis dated November 7, 2012.Annual and Special Meeting of ShareholdersThe Company held its Annual and Special Meeting of Shareholders in Belleville, Ontario today. At the meeting, shareholders voted in favour of electing the following individuals as members of the Board of Directors:-Dr. Stanley Alkemade-Mr. Albert Beraldo-Mr. Rod Budd-Dr. Margaret Cunningham-Dr. James Johnson-Mr. Graeme McRae-Mr. Nick Photiades-Mr. James Rae-Mr. Lyle VancliefDr. Armen Aprikian remains an Observer on the Board.The shareholders also voted in favour of the appointment Ernst & Young, LLP, Chartered Accountants, as auditors of the Corporation.Further, the shareholders voted in favour of an increase in the maximum number of Common Shares available to be issued under the Group Registered Retirement Savings and Employee Savings Plan ("Savings Plans") to 10,000,000.The shareholders voted in favour of an increase in the maximum number of Common Shares available to be issued to pay outside directors to 1,400,000.The shareholders voted in favour of a new Shareholders' Rights Plan. The Plan was originally approved in 2006 by the Toronto Stock Exchange and the shareholders. As the Plan had expired, a new Plan had to be approved.Finally, the shareholders voted in favour of re-approval of the Amended and Restated Stock Option Plan. This Plan was approved by the shareholders in 2009 and requires re-approval by the shareholders every three years. The Stock Option Plan is a means by which the Company can compensate eligible persons for their contributions to the performance of the Company.Other Meeting HighlightsDuring the meeting, additional information was presented to shareholders, including the following highlights:The Animal Health business unit has an objective of reaching $60 million in product sales revenues in Fiscal 2016.The Company's Sin Susto™ canine calming product is expected to be launched in North America in January, 2013.The Company is talking with the University of Ottawa about potential human applications for Sin Susto™.The Company's Animal Health and Food Safety Vaccine Manufacturing Centre in Belleville, Ontario is expected to be fully validated to Good Manufacturing Practice (GMP) standards by the spring of 2013.The Company is seeking a distribution partner in Japan for Econiche®.The Company's second canine oncology product in development - Oncocidin™ - is expected to be launched in Q1, Fiscal 2014.The Company has filed new patents around Mycobacterial Cell Wall-DNA Complex (MCC) in October, 2011.A possible future indication for MCC is in human palliation following chemotherapy.The Company's R. equi vaccine for horses is undergoing proof of concept studies at the Gluck Equine Research Centre in Kentucky, where the protocol involves vaccinating mares to protect foals.About Bioniche Life Sciences Inc.Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused 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.For more information, please visit 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 OntarioCONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION[Unaudited - see going concern uncertainty] As at(thousands of Canadian dollars) September30, 2012$June 30,2012$ASSETSCurrent   Cash and cash equivalents 14,40920,020Trade and other receivables 6,0246,787Inventories 7,9607,776Prepayments 1,0651,081  29,45835,664Non-current   Property, plant and equipment 40,21740,134Intangible assets 5,0095,206Goodwill 456456Other non-current receivables 145183Deferred tax assets 375509Total assets 75,66082,152    LIABILITIES AND SHAREHOLDERS' EQUITY   Current   Trade and other payables 6,5736,713Income taxes payable 8894Current portion of long-term debt 1,015997Current portion of repayable government assistance 616366  8,2928,170Non-current   Long-term debt 24,84225,438Repayable government assistance 31,27330,921Employee benefit liability 1,9061,875  66,31366,404Shareholders' equity   Share capital 126,425126,354Other paid-in capital 9,4299,327Deficit (125,478)(118,807)Foreign currency translation reserve (1,029)(1,126)Total shareholders' equity 9,34715,748Total liabilities and shareholders' equity 75,66082,152Bioniche Life Sciences Inc.  CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY[Unaudited - see going concern uncertainty](thousands of Canadiandollars)CommonShares$ PreferredSharesSeries I$ Total ShareCapital$ Otherpaid-inCapital$ Deficit$ Foreigncurrencytranslationreserve$ Total$Balance, June 30, 2012 126,354 — 126,354 9,327 (118,807) (1,126) 15,748Net loss for the period— — — — (6,671) — (6,671)Exchange difference on translation of foreign operations— — — — — 97 97Issued under employee share ownership plan70 — 70 — — — 70Options exercised1 — 1 — — — 1Fair value of stock options vested— — — 102 — — 102Balance, September 30, 2012126,425 — 126,425 9,429 (125,478) (1,029) 9,347              Balance, June 30, 2011 125,469 161 125,630 8,771 (94,619) (1,174) 38,608Net loss for the period— — — — (4,509) — (4,509)Exchange difference on translation of foreign operations— — — — — 267 267Issued under employee share ownership plan209 — 209 — — — 209Options issued to a consultant— — — 1 — — 1Fair value of stock options vested— — — 213 — — 213Share redemption— (161) (161) 5 — — (156)Balance, September 30, 2011125,678 — 125,678 8,990 (99,128) (907) 34,633Bioniche Life Sciences Inc.CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS [unaudited - see going concern uncertainty]For the three months ended September 30(thousands of Canadian dollars, except share and per share amounts) 2012$2011$    REVENUES   Product 6,5956,123Research collaborations 74693  6,6696,816EXPENSES   Cost of sales 3,0213,073Administration 2,3382,489Marketing and selling 1,8271,771Financial expenses 1,518227Foreign exchange loss (gain) 289(433)  8,9937,127Loss before research and development expenses and income taxes (2,324)(311)Research and development expenses 4,3164,820Less: government assistance (98)(199)Loss before income taxes (6,542)(4,932)Income tax expense (recovery) 129(421)Net loss for the period (6,671)(4,511)OTHER COMPREHENSIVE INCOMEExchange difference on translation of foreign operations 97267Total comprehensive loss for the period (6,574)(4,244)Basic and diluted net loss per Share (0.06)(0.04)Weighted-average number of Common Shares outstanding 103,734,182102,274,109Bioniche Life Sciences Inc.CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS [unaudited - see going concern uncertainty]For the three months ended September 30(thousands of Canadian dollars) 2012$2011$OPERATING ACTIVITIES   Net loss for the period (6,671)(4,511)Items not affecting cash and other reconciling items:    Depreciation of property, plant and equipment 367355 Amortization of intangible assets 444243 Unrealized foreign exchange gain (466)(99) Finance expense on government incentives, long-term debt   and repayable government assistance  737217 Stock-based compensation expense 102214 Employee share ownership plan —208 Employee future benefit 3123 Unrealized loss on other current financial assets —20 Deemed government assistance —(7) Deferred income taxes 129(361) Other —1  (5,327)(3,697)Net change in non-cash working capital balances 345(237)Cash used in operating activities (4,982)(3,934)INVESTING ACTIVITIES   Purchases of property, plant and equipment (124)(2,766)Proceeds on disposal of property, plant and equipment —2Purchases of intangible assets (247)(3)Cash used in investing activities (371)(2,767)FINANCING ACTIVITIES   Proceeds from repayable government assistance —1,230Proceeds on exercise of stock options 1—Redemption of shares —(156)Repayment of repayable government assistance (35)—Repayment of finance lease obligations (108)(118)Repayment of long-term debt (116)(29)Cash provided by financing activities (258)927Net decrease in cash and cash equivalents during the period (5,611)(5,774)Cash and cash equivalents, beginning of period 20,02015,353Cash and cash equivalents, end of period 14,4099,579 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