9/13/2012 11:00:40 AM
BELLEVILLE, ON, Sept. 12, 2012 /PRNewswire/ - 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 Highlights
Consolidated 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 Status
The 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 Highlights
Administrative 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 Call
The Company will discuss its year-end results during a:
Conference Call & Audio Web Cast
Wednesday, September 19, 2012
7:00 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=D5EE4A57B99BADE02CE30C5FCD8791EB
A 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 Ontario | CONSOLIDATED STATEMENT OF FINANCIAL POSITION | | | As at
(thousands of Canadian dollars) |
| June 30,
2012
$ |
June 30,
2011
$
|
July 1,
2010
$
| ASSETS
Current |
|
|
|
| |
Cash and cash equivalents
|
|
20,020
|
15,353
|
11,070
| |
Other current financial assets
|
|
|
1,493
|
| |
Trade and other receivables
|
|
6,787
|
6,460
|
8,601
| |
Income taxes receivable
|
|
|
254
|
63
| |
Inventories
|
|
7,776
|
8,523
|
6,582
| |
Prepayments
|
|
1,081
|
1,067
|
788
| |
|
|
35,664
|
33,150
|
27,104
| | Non-current |
|
|
|
| |
Property, plant and equipment
|
|
40,134
|
37,582
|
25,330
| |
Intangible assets
|
|
5,206
|
6,306
|
6,500
| |
Goodwill
|
|
456
|
456
|
456
| |
Other non-current receivables
|
|
183
|
1,756
|
1,156
| |
Deferred tax assets
|
|
509
|
539
|
494
| |
Total assets
|
|
82,152
|
79,789
|
61,040
| | LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
| | Current |
|
|
|
| |
Trade and other payables
|
|
6,713
|
8,520
|
9,716
| |
Income taxes payable
|
|
94
|
|
| |
Current portion of long-term debt
|
|
997
|
700
|
256
| |
Current portion of repayable government assistance
|
|
366
|
1,049
|
960
| |
|
|
8,170
|
10,269
|
10,932
| | Non-current |
|
|
|
| |
Long-term debt
|
|
25,438
|
2,717
|
2,525
| |
Repayable government assistance
|
|
30,921
|
26,387
|
21,889
| |
Employee benefit liability
|
|
1,875
|
1,808
|
| |
Deferred government incentives
|
|
|
|
2,382
| |
|
|
66,404
|
41,181
|
37,728
| | Shareholders' equity |
|
|
|
| |
Share capital
|
|
126,354
|
125,630
|
96,677
| |
Other paid-in capital
|
|
9,327
|
8,771
|
8,813
| |
Deficit
|
|
(118,807)
|
(94,619)
|
(82,094)
| |
Foreign currency translation reserve
|
|
(1,126)
|
(1,174)
|
(84)
| |
Total shareholders' equity
|
|
15,748
|
38,608
|
23,312
| |
Total liabilities and shareholders' equity
|
|
82,152
|
79,789
|
61,040
|
Bioniche 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
|
| 29,811 |
27,366
| |
Licensing
|
| |
4,046
| |
Research collaborations
|
| 1,986 |
3,146
| |
|
| 31,797 |
34,558
| | EXPENSES |
|
|
| |
Cost of sales
|
| 14,916 |
13,441
| |
Administration
|
| 10,555 |
10,840
| |
Marketing and selling
|
| 7,395 |
6,897
| |
Financial expenses (income)
|
| 3,163 |
(2,029)
| |
Foreign exchange gain
|
| (413) |
(879)
| |
|
| 35,616 |
28,270
| |
(Loss) income before research and development expenses and other items
|
| (3,819) |
6,288
| |
Research and development expenses
|
| 20,549 |
21,031
| |
Less: 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 |
| 102,818,009 |
88,896,923
|
Bioniche 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
|
|
1,511
|
1,384
| |
|
Amortization of intangible assets
|
|
1,092
|
881
| |
|
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
|
|
553
|
619
| |
|
Employee share ownership plan
|
|
875
|
836
| |
|
Employee future benefit
|
|
67
|
1,808
| |
|
Impairment of intangible assets
|
|
268
| | |
|
Deemed government assistance
|
|
(7)
|
(61)
| |
|
Amortization of deferred government incentives
|
| |
(1,005)
| |
|
Deferred future income taxes
|
|
39
|
(69)
| |
|
Other
|
|
1
|
1
| |
|
|
(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
|
| |
100
| |
Proceeds (purchase) of other current financial assets
|
|
1,493
|
(1,493)
| |
Proceeds on disposal of property, plant and equipment
|
|
15
|
103
| |
Purchases 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
|
| |
1,496
| |
Proceeds from repayable government assistance
|
|
1,230
|
9,342
|
Proceeds from long-term debt
|
|
|
|
|
|
|
|