Bioniche Life Sciences Inc. Reports Q2, Fiscal 2013 Results

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Feb 06, 2013, 05:00 ET

-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 Urocidin^TM 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