Bioniche Life Sciences Inc. Reports Q2, Fiscal 2013 Results

-Animal Health product sales revenues are 14% ahead of Fiscal 2012 on a year-to-date basis-

(all figures are in Canadian dollars unless otherwise noted)

BELLEVILLE, ON, Feb. 6, 2013 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for the second quarter of its 2013 fiscal year (ended December 31, 2012).

"The return of global rights to our Phase III human health bladder cancer product - Urocidin™ - from Endo in December was a significant event in the life of the Company," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "We are already in discussions with new potential partners for the technology and are actively strategizing around a new clinical plan to advance the product to registration, bearing in mind that we will be unable to meet with regulatory authorities until after the end of March, when clinical sponsorship is returned to us from Endo."

The Company continues to invest in several late-stage development projects and in facilities where commercial products will be made," added Mr. McRae. "These intensive resource allocations have impacted our corporate burn rate, but this will be alleviated as new products reach the market over the next 12 to 18 months. To sustain the Company through this period, additional financial resources will be required and management is in discussions with potential new investors."

Fiscal 2013 Second Quarter Financial Results Highlights

Revenues from the sale of Animal Health products were $8.8 million in the quarter, as compared to $7.4 million in the same period in Fiscal 2012 - a 19% increase. On a year-to-date basis, Animal Health product revenues have reached $15.4 million, compared to $13.5 million in Fiscal 2012. This represents growth of 14% year-over-year. Consolidated revenues for the quarter were 8% higher compared to the same period last year and 4% higher on a year-to-date basis, in spite of a decline in research collaboration revenue.

Gross margins were 50% in Q2, Fiscal 2013, compared to 52% in the second quarter of last year. The margins are 52% on a year-to-date basis, versus 51% in the first six months of Fiscal 2012.

The Company generated Earnings (Loss) Before Interest, Taxes, Depreciation and Amortization (EBITDA) - before research and development expenses and income taxes - of $1.0 million for Q2, Fiscal 2013, as compared to $0.9 million for the same period in Fiscal 2012. On a year-to-date basis, the EBITDA amount to $0.9 million as compared to $0.6 million at the six-month point in Fiscal 2012. This increase relates to increased Animal Health revenues and reduced administration expenses, partially offset by reduced collaborative research revenues.

Cash and cash equivalents amounted to $8.7 million at December 31, 2012, as compared $20.0 million at June 30, 2012. A further $15.0 million was available to the Company at December 31, 2012 through trade and other receivables and inventories. At June 30, 2012, $14.6 million was available through these sources.

At December 31, 2012, the Company's working capital totalled $16.9 million as compared to working capital of $27.5 million 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 December 31, 2012 was $4.7 million, as compared to cash used in operations of $3.0 million in the same period in Fiscal 2012. On a year-to-date basis, cash flow used in operations was $9.7 million, versus $7.0 million after the first six months of Fiscal 2012. The average monthly burn rate for the Company was $1.4 million, vs. $1.1 million for the same six-month period in Fiscal 2012. Cash requirements to support financing have increased the average monthly burn rate by $0.3 million compared to last year.

"The Company remains committed to reducing the average monthly burn rate as it completes the development and commercialization of several new products," said Mr. Brian Ford, Chief Financial Officer of Bioniche Life Sciences Inc. "However, there will be some short-term expenditures incurred to support new product launches and to advance the Urocidin data package for regulators, including Health Canada. The Company expects to conclude one or more partnering deals related to its core technologies, which could involve up-front payments to the Company that would offset the burn rate. The Company remains committed to neutralizing the burn rate and developing sustainable positive cash flows by the end of Fiscal 2014."

Administrative expenses were $1.9 million in Q2, Fiscal 2013, as compared to $2.5 million in the same quarter last year. On a year-to-date basis, administrative expenses were $4.3 million in Fiscal 2013 versus $5.0 million in the first six months of Fiscal 2012. Marketing, selling and distribution expenses were $1.9 million in Q2, Fiscal 2013, as compared to $1.6 million in the same quarter last year, or $3.7 million this year versus $3.3 million last year on a year-to-date basis. The additional expenditure in this category is related to increased staffing to support the launch and promotion of several new Animal Health products.

Research and development (R&D) expenditures for Q2, Fiscal 2013 were $4.2 million, as compared to $4.7 million in the same quarter last year. For the six months ending December 31, 2012, R&D expenditures were $8.5 million versus $9.5 million for the same period 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 UrocidinTM bladder 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 Vaccine Manufacturing Centre continues to undergo GMP validation, a process which is expected to be completed this Spring.

The Company incurred financing expenses of $3.2 million during the first six months of Fiscal 2013 as a result of its US$20 million debt financing with Capital Royalty Partners. This compares to financing expenses of $0.2 million in the same period of Fiscal 2012.

The basic and fully-diluted net loss per share for Q2, Fiscal 2013 is ($0.05), as compared to a net loss per share of ($0.04) in the same period last year. Total Common Shares outstanding at December 31, 2012 were 104,005,809, as compared to 102,749,670 at December 31, 2011.

The Company has incurred significant losses and has an accumulated deficit of $130.6 million as at December 31, 2012, including a current loss of $5.1 million for the second quarter of Fiscal 2013 ($11.8 million year-to-date, as compared to $8.5 million in the first six months of Fiscal 2012). 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 December 31, 2012.

The Company expects to finance its future expenditures by obtaining additional financing and the exploration of new partnering agreements on marketed products and/or 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, or potentially dispose of certain assets.

Company representatives will discuss the Q2, Fiscal 2013 (half-year) results during a:

Conference Call & Audio Webcast
February 11, 2013
5:00 p.m. EST

To participate in the conference call from North America, call (888) 231-8191 (conference ID: 89590179). To participate in the conference call from Australia, call 1-800-287-011 (conference ID: 89590179).

A listen-only audio webcast will be available at:

http://event.on24.com/r.htm?e=565698&s=1&k=FC5CA7D17AD739E05E3C798EDD7E10ED

A replay of the conference call will be available until February 18, 2013 at midnight by calling 1-855-859-2056 (passcode: 89590179).

The webcast will be available for replay using the above link until February 11, 2014.

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 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

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(Unaudited - see going concern uncertainty)
 
As at December 31, 2012 June 30, 2012
(thousands of Canadian dollars) $ $
ASSETS
Current  
   
Cash and cash equivalents   8,734 20,020
Trade and other receivables   7,134 6,787
Inventories   7,822 7,776
Prepayments   552 1,081
    24,242 35,664
Non-current      
Property, plant and equipment   40,397 40,134
Intangible assets   4,936 5,206
Goodwill   456 456
Other non-current receivables   140 183
Deferred tax assets   271 509
Total assets   70,442 82,152
       
LIABILITIES AND SHAREHOLDERS' EQUITY      
Current      
Trade and other payables   5,325 6,713
Income taxes payable   176 94
Current portion of long-term debt   1,003 997
Current portion of repayable government
  assistance  
866 366
    7,370 8,170
Non-current      
Long-term debt   25,412 25,438
Repayable government assistance   31,382 30,921
Employee benefit liability   1,937 1,875
    66,101 66,404
Shareholders' equity      
Share capital   126,516 126,354
Other paid-in capital   9,528 9,327
Deficit   (130,595) (118,807)
Foreign currency translation reserve   (1,108) (1,126)
Total shareholders' equity   4,341 15,748
Total liabilities and shareholders' equity   70,442 82,152

Bioniche Life Sciences Inc.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(Unaudited - see going concern uncertainty)
 
(thousands of Canadian dollars)   Common
shares
$
  Preferred
shares
Series I
$
  Total Share
Capital
$
  Other
paid-in
Capital
$
  Deficit
$
  Foreign
currency
translation
reserve
$
  Total
$
Balance, June 30, 2012   126,354     126,354   9,327   (118,807)   (1,126)   15,748
Net loss for the period           (11,788)     (11,788)
Exchange difference on
  translation of foreign
  operations
            18   18
Issued under employee share
  ownership plan
  142     142         142
Fair value of stock options
 vested
        201       201
Shares issued to Directors   19     19         19
Options exercised   1     1         1
Balance, December 31, 2012   126,516     126,516   9,528   (130,595)   (1,108)   4,341
Balance, June 30, 2011   125,469   161   125,630   8,771   (95,687)   (1,174)   37,540
Net loss for the period           (8,547)     (8,547)
Exchange difference on
  translation of foreign
  operations
            26   26
Issued under employee share
  ownership plan
  419     419         419
Fair value of stock options
 vested
        404       404
Share redemption     (161)   (161)   5       (156)
Options issued to a consultant         1       1
Options exercised   2     2   (1)       1
Balance, December 31, 2011   125,890     125,890   9,180   (104,234)   (1,148)   29,688

Bioniche Life Sciences Inc.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(Unaudited - see going concern uncertainty)
 
For the three and six months ended December 31
(thousands of Canadian dollars, except share and per share amounts)
  2012
$
2011
$
2012
$
2011
$
           
REVENUES          
Product   8,793 7,358 15,388 13,480
Research collaborations   8 757 82 1,451
    8,801 8,115 15,470 14,931
EXPENSES          
Cost of sales   4,379 3,504 7,400 6,577
Administrative   1,928 2,461 4,266 4,954
Marketing and selling   1,886 1,562 3,713 3,334
Financial expenses   1,636 (2) 3,154 225
Foreign exchange loss (gain)   (69) (93) 220 (526)
    9,760 7,432 18,753 14,564
Income before research and development expenses and
 income taxes
  (959) 683 (3,283) 367
Research and development expenses, gross   4,210 4,679 8,526 9,499
Less: government assistance   (247) (173) (345) (372)
Loss before income taxes   (4,922) (3,823) (11,464) (8,760)
Income tax expense (recovery)   195 208 324 (213)
Net loss for the period   (5,117) (4,031) (11,788) (8,547)
OTHER COMPREHENSIVE (LOSS) INCOME
Exchange difference on translation of foreign operations
  (79) (241) 18 26
Total comprehensive loss for the period   (5,196) (4,272) (11,770) (8,521)
Basic and diluted net loss per share   (0.05) (0.04) (0.11) (0.08)
Weighted-average number of common shares
 outstanding
  103,848,063 102,613,484 103,791,122 102,443,797

Bioniche Life Sciences Inc.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited - see going concern uncertainty)
 
For the six months ended December 31          
(thousands of Canadian dollars)   2012
$
    2011
$
OPERATING ACTIVITIES          
Net loss for the period   (11,788)     (8,547)
Items not affecting cash and other reconciling items:          
  Depreciation of property, plant and equipment   735     734
  Amortization of intangible assets   751     486
  Unrealized foreign exchange gain   (372)     (331)
  Finance expense on government incentives, long-term debt
  and repayable government assistance 
  1,539     195
  Stock-based compensation expense   201     404
  Shares issued to directors   19     -
  Employee share ownership plan   144     419
  Employee future benefit   62     58
  Deemed government assistance   -     (7)
  Write off of intangible asset   -     143
  Deferred income taxes   107     (153)
  Other   -     1
    (8,602)     (6,598)
Net change in non-cash working capital balances   (1,114)     (384)
Cash used in operating activities   (9,716)     (6,982)
INVESTING ACTIVITIES          
Purchases of property, plant and equipment   (284)     (3,672)
Proceeds on disposal of other current financial asset   -     1,493
Proceeds on disposal of property, plant and equipment   5     7
Purchases of intangible assets   (481)     (36)
Cash used in investing activities   (760)     (2,208)
FINANCING ACTIVITIES          
Proceeds from repayable government assistance   -     1,230
Proceeds on exercise of stock options   1     1
Redemption of shares   -     (156)
Repayment of repayable government assistance   (320)      
Repayment of finance lease obligations   (228)     (210)
Repayment of long-term debt   (263)     (174)
Cash provided by (used in) financing activities   (810)     691
Net decrease in cash and cash equivalents during the period   (11,286)     (8,499)
Cash and cash equivalents, beginning of period   20,020     15,353
Cash and cash equivalents, end of period   8,734     6,854
       

 

SOURCE Bioniche Life Sciences Inc.



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