Bioniche Reports Fiscal 2010 Year-End Results
- revenues for the year - including licensing payments - total $45.9 million -
(all figures are in Canadian dollars unless otherwise noted)
BELLEVILLE, ON, Sept. 10 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2010 fiscal year ended June 30, 2010.
"Fiscal 2010 represents a banner year for our Company, in which we executed a license, development and supply agreement for our proprietary product, Urocidin(TM), for the treatment of non-muscle-invasive bladder cancer," stated Graeme McRae, Chairman, President & CEO of Bioniche Life Sciences Inc. "The up-front payment of US$20 million, combined with three milestone payments received to date totaling US$14 million, and revenues from animal health product sales, have resulted in total revenues of $45.9 million."
"The loss per share was reduced from $0.15 in Fiscal 2009 to $0.02 this year," added Mr. McRae.
Bioniche has the potential to receive up to US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones under the license agreement with Endo Pharmaceuticals Inc. (NASDAQ: ENDP). Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.
Urocidin(TM) is a patented intravesical formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently undergoing Phase III clinical testing. As reported by the Company on August 19, 2010, a protocol for an additional clinical trial - expected to begin enrolling patients in 2010 - is currently being finalized. Details of this new protocol, when finalized, will be made publicly available via the U.S. National Institutes of Health clinical trial registration service at http://www.clinicaltrials.gov. Concurrently, 12-month data from the ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial with Urocidin(TM) for non-muscle-invasive bladder cancer refractory to current therapy are undergoing thorough analysis. This process is expected to be completed in the near-term.
More information on the Company's year-end financial results is provided in the Company's Fiscal 2010 Management's Discussion and Analysis dated September 9, 2010.
Fiscal 2010 Financial Results Highlights
Consolidated revenues related to Bioniche Animal Health product sales for the fiscal year were $27 million, as compared to $33 million in Fiscal 2009. This 19% decrease is primarily attributed to the economic recession in some markets, which impacted the sales of livestock reproduction products and performance horse products. In spite of these recessionary challenges, the Animal Health business unit continued to generate Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA). It should be noted that this is before Research and Development expenditures of $8.6 million, as compared to $12.2 million in Fiscal 2009.
The increase in the value of the Canadian dollar versus the U.S. dollar over the course of the fiscal year also contributed to the decline in revenues over Fiscal 2009.
As previously noted, beyond product sales revenues, the Company recorded licensing revenue of $1.5 million in Fiscal 2010 (there was no such revenue in Fiscal 2009), reflecting the amortization of the up-front payment by Endo upon signing of the Urocidin(TM) license, development and supply agreement. The total up-front payment received, C$22.3 million, will be recognized over 15 years, which is the term over which the Company maintains substantive contractual obligations (per Canadian Generally Accepted Accounting Principles - GAAP). Milestone revenue of C$14.8 million earned under the same agreement was also recognized to income during Fiscal 2010.
Fiscal year-end cash and cash equivalents amounted to $11 million, as compared to $6 million at June 30, 2009. At June 30, 2010, the Company's net working capital totalled $16.3 million, excluding the current portion of non-refundable deferred licensing revenue, as compared to negative working capital of ($0.5 million) at June 30, 2009.
Research and development expenditures increased in Fiscal 2010 by $4.6M over Fiscal 2009, or 34%. This increase relates to ongoing expenditures for the Urocidin(TM) clinical development program, as well as the reintroduction of certain development programs in animal health that were deferred in Fiscal 2009 due to cash constraints.
The majority of research and development costs can be attributed to the ongoing Phase III clinical program for the Company's Urocidin(TM) bladder cancer treatment and to an increased focus on the development of animal health reproduction products and vaccines. Going forward, Endo has assumed financial responsibility for the external costs of clinical activities as they relate to Urocidin(TM), and the Company intends to refocus its development activities for MCC on other indications.
The basic and fully-diluted net loss per share for Fiscal 2010 was ($0.02) compared to a net loss per share of ($0.15) in Fiscal 2009. Total common shares outstanding at June 30, 2010 were 72,890,247, as compared to 71,681,147 for the corresponding period in Fiscal 2009.
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 products for human and animal health markets worldwide. The fully-integrated company employs 211 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. 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 Ontario
CONSOLIDATED BALANCE SHEETS
(see going concern uncertainty)
As at June 30 2010 2009
(thousands of Canadian dollars) $ $
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ASSETS
Current
Cash and cash equivalents 11,070 5,950
Accounts receivable 8,601 3,720
Income taxes receivable 63 -
Future income tax assets 197 -
Inventories 6,668 5,408
Prepaid expenses and deposits 793 569
Restricted cash - 1,227
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27,392 16,874
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Long-term
Property, plant and equipment 16,584 9,494
Intangible assets 6,500 6,792
Goodwill 456 456
Long-term accounts receivable 1,156 1,025
Future income tax assets 51 -
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52,139 34,641
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Revolving credit facility - 4,448
Accounts payable and accrued liabilities 9,716 11,607
Income and other taxes payable - 321
Deferred government incentives - 342
Current portion of long-term debt and
obligations under capital leases 256 635
Current portion of repayable government assistance 960 -
Current portion of non-refundable deferred
licensing revenue 1,486 -
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12,418 17,353
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Long-term
Long-term debt 1,341 1,149
Obligations under capital leases 1,184 1,225
Repayable government assistance 6,965 2,476
Deferred government incentives 2,382 3,335
Non-refundable deferred licensing revenue 19,353 -
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43,643 25,538
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Shareholders' equity
Share capital 96,677 95,855
Other paid-in capital 8,700 8,539
Deficit (96,881) (95,291)
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8,496 9,103
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52,139 34,641
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Commitments and contingencies
Subsequent event
Bioniche Life Sciences Inc.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
(see going concern uncertainty)
(thousands of Canadian dollars, except share amounts)
Preferred Preferred
shares - shares -
Common shares Series 1 Series II
# $ # $ # $
-------------------------------------------------------------------------
Balance, June 30,
2008 65,782,510 83,982 167 161 9,000,000 8,799
Net loss for
the year - - - - - -
Issued under
employee share
ownership plan 1,171,916 593 - - - -
Fair value of stock
options vested - - - - - -
Directors'
remuneration 161,672 113 - - - -
Warrants issued in
connection with
the revolving
credit facility - - - - - -
Revolving credit
facility principal
payments made
in shares 4,565,049 1,967 - - - -
Special warrants
expired - - - - - -
Options issued to
a consultant - - - - - -
Write-off of
employee share
purchase loan - 240 - - - -
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Balance, June 30,
2009 71,681,147 86,895 167 161 9,000,000 8,799
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Other
Special paid-in
warrants capital Deficit Total
$ $ $ $
------------------------------------------------------------
Balance, June 30,
2008 2,174 6,056 (84,791) 16,381
Net loss for
the year - - (10,500) (10,500)
Issued under
employee share
ownership plan - - - 593
Fair value of stock
options vested - 247 - 247
Directors'
remuneration - - - 113
Warrants issued in
connection with
the revolving
credit facility - 61 - 61
Revolving credit
facility principal
payments made
in shares - - - 1,967
Special warrants
expired (2,174) 2,174 - -
Options issued to
a consultant - 1 - 1
Write-off of
employee share
purchase loan - - - 240
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Balance, June 30,
2009 - 8,539 (95,291) 9,103
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Preferred Preferred
shares - shares -
Common shares Series 1 Series II
# $ # $ # $
-------------------------------------------------------------------------
Balance, June 30,
2009 71,681,147 86,895 167 161 9,000,000 8,799
Net loss for
the year - - - - - -
Issued under
employee share
ownership plan 639,176 464 - - - -
Fair value of stock
options vested - - - - - -
Directors'
remuneration 278,495 103 - - - -
Warrants exercised 211,429 165 - - - -
Options exercised 80,000 90 - - - -
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Balance, June 30,
2010 72,890,247 87,717 167 161 9,000,000 8,799
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Other
Special paid-in
warrants capital Deficit Total
$ $ $ $
------------------------------------------------------------
Balance, June 30,
2009 - 8,539 (95,291) 9,103
Net loss for
the year - - (1,590) (1,590)
Issued under
employee share
ownership plan - - - 464
Fair value of stock
options vested - 240 - 240
Directors'
remuneration - - - 103
Warrants exercised - (61) - 104
Options exercised - (18) - 72
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Balance, June 30,
2010 - 8,700 (96,881) 8,496
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Bioniche Life Sciences Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(see going concern uncertainty)
Years ended June 30
(thousands of Canadian dollars, except share and per share amounts)
2010 2009
$ $
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REVENUES
Sales 26,993 33,281
Licensing 16,203 -
Research collaborations 1,820 -
Gain on disposal of intangible assets 883 -
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45,899 33,281
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EXPENSES
Cost of sales (excluding amortization) 12,729 14,432
Administration 6,841 6,109
Marketing and selling 6,264 6,096
Other expenses - 863
Financial expenses 726 2,465
Amortization of property, plant and equipment 1,080 1,343
Amortization and write-down of intangible assets 813 897
Foreign exchange loss (gain) 505 (191)
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28,958 32,014
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Income before research and development
expenses and other items 16,941 1,267
Research and development expenses, gross 17,922 13,315
Repayable government assistance 3,884 -
Less: government assistance, net (3,181) (1,862)
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Loss before income taxes (1,684) (10,186)
Provision for income tax (recovery) expense 94 314
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Net loss and comprehensive loss for the year (1,590) (10,500)
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Basic and fully diluted net loss per share (0.02) (0.15)
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Weighted-average number of common shares
outstanding 72,239,959 70,313,509
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Bioniche Life Sciences Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(see going concern uncertainty)
Years ended June 30 2010 2009
(thousands of Canadian dollars) $ $
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OPERATING ACTIVITIES
Net loss for the year (1,590) (10,500)
Add (deduct) non cash items:
Amortization 1,841 2,140
Accreted interest on discounted receivables
and interest-free loans and amortization
of financial expenses 471 1,472
Write-off of intangible assets 52 100
Unrealized foreign exchange loss (gain) (47) 244
Deemed government assistance (81) (284)
Stock-based compensation expense 240 487
Warrants issued to consultants - 1
Repayable government assistance 3,884 -
Licensing revenue (1,447) -
Amortization of deferred government incentive (1,689) -
Future income taxes (248) -
Employee share ownership plan 528 533
Gain on sale of intangible assets (883) -
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1,031 (5,807)
Decrease (increase) in restricted cash 1,227 (1,227)
Net change in non-cash working capital balances (7,960) 4,068
Net change in non-refundable deferred
licensing revenue 22,286 -
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Cash provided by (used in) operating activities 16,584 (2,966)
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INVESTING ACTIVITIES
Government incentives received on account
of property, plant and equipment 1,098 80
Proceeds on sale of intangible assets 606 -
Proceeds on disposal of property, plant
and equipment 21 -
Purchases of intangible assets (521) -
Purchases of property, plant and equipment (7,789) (1,405)
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Cash used in investing activities (6,585) (1,325)
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FINANCING ACTIVITIES
Proceeds from government assistance 1,706 3,409
Payment of financing fees - debt (2,117) (11)
Proceeds from exercise of stock options 72 -
Proceeds from exercise of warrants 104 -
Proceeds from deferred government incentives 407 121
Proceeds from revolving credit facility - 31,475
Repayment of revolving credit facility (4,416) (28,448)
Repayment of capital lease obligations (292) (298)
Repayment of long-term debt (343) (407)
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Cash provided by (used in) financing activities (4,879) 5,841
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Net increase in cash and cash equivalents
during the year 5,120 1,550
Cash and cash equivalents, beginning of year 5,950 4,400
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Cash and cash equivalents, end of year 11,070 5,950
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SOURCE Bioniche Life Sciences Inc.
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