(all figures are in Canadian dollars unless otherwise
noted)
BELLEVILLE, ON,
Sept. 26, 2014 /CNW/ - Bioniche Life
Sciences Inc. (TSX: BNC) today announced financial results for its
fiscal year ended June 30, 2014.
Major accomplishments for the fiscal year
include:
- Positioning Bioniche as a focused, human therapeutics company
with a late-stage asset for bladder cancer for which the Company is
now preparing for the filing of a Biologics License Application
(BLA), projected to be submitted prior to March 31, 2015;
- The sale of the Animal Health business unit for proceeds of
$61 million, representing 16.7 times
the unit's Fiscal 2013 profit before income taxes;
- Initiation of a sales process of the Company's vaccine
business, including the Econiche® technology and a state-of-the-art
Vaccine Manufacturing Centre (VMC);
- Repayment of $50.3 million of
high-cost secured and unsecured debt, and renegotiation of interest
and principal payments due on the remaining debt associated with
the VMC;
- Execution of additional cost reduction and revenue generation
initiatives, including ASX delisting, employee position reduction,
elimination of non-essential patent and trademark costs, and sale
of non-core assets; and
- Extension of the Company's cash runway to a minimum of 15
months, including the proceeds of the recently completed equity
financing.
"Fiscal 2014 was a year of major transition for
Bioniche Life Sciences Inc.," said Dr. Michael Berendt, Chief Executive Officer and
Chief Scientist. "The Company is now focused to fully capitalize on
our late stage bladder cancer therapeutic. We have clarified the
regulatory approval path forward with the U.S. Food and Drug
Administration (FDA) and are targeting the filing of a BLA with the
FDA in the first quarter of calendar 2015. I am looking forward to
addressing our shareholders at our upcoming Annual General Meeting
in November, to provide a comprehensive review of the past year, as
well as to discuss our vision for the Company going forward."
Fiscal 2014 Financial Results
Highlights
The Company's continuing operations recorded
revenue of $185 in Fiscal 2014,
compared to $82 in Fiscal 2013. This
revenue was derived from rental income related to the lease of
production and office space at the Company's Belleville campus. In Fiscal 2013, revenue was
entirely derived from research collaboration activity related to a
license, development and supply agreement with Endo Pharmaceuticals
Inc. (Endo). The Endo agreement was terminated in Fiscal 2013.
Fiscal year-end cash amounted to $10.5 million at June 30,
2014, as compared to $4.2
million at June 30, 2013.
The Company's total assets at June 30, 2014 were $33.5
million, as compared to $61.5
million at June 30, 2013.
The Company's consolidated cash flow used in
operations after changes in non-cash working capital for the year
ended June 30, 2014 was $17.7 million, as compared to cash used in
operations of $13.3 million in Fiscal
2013. The average monthly burn rate was $1.5
million for Fiscal 2014, as compared to $1.1 million for Fiscal 2013. The monthly burn
increased by $0.4 million primarily
due to increased financial charges and severances related to
restructuring activities.
Administrative expenses for continuing
operations were $6.2 million in
Fiscal 2014, in line with the $6.0
million incurred in Fiscal 2013. Marketing and
selling expenses were $0.5 million in
Fiscal 2014, as compared to $0.9
million in Fiscal 2013.
Interest and financial expenses include both
non-cash and cash interest components. For the year ended
June 30, 2014, financial expenses
dropped to $3.1 million from
$8.6 million in Fiscal 2013. This
substantial reduction relates to the extinguishment of a
significant amount of corporate debt upon the sale of the Animal
Health business and to a change in the estimate of debt related to
One Health's Econiche® product.
Net research and development (R&D)
expenditures for continuing operations in Fiscal 2014 were
$9.4 million, as compared to
$12.4 million in Fiscal 2013. This
includes the continued investment in the staffing and
infrastructure associated with the GMP pilot plant for the
production of the Company's MCNA bladder cancer therapeutic.
The Company incurred a non-cash impairment
charge of $19.8 million in Fiscal
2014 (compared to $3.7 million in
Fiscal 2013), related to the Company's VMC in Belleville, an asset that is being offered for
sale.
The basic and fully diluted net income per Share
for the Company's continuing operations for Fiscal 2014 was
($0.32) compared to a loss per Share
of ($0.32) in Fiscal 2013.
Fiscal 2014 Financial Results Highlights -
Discontinued Operations (Animal Health)
In the fourth quarter of the year ended
June 30, 2013, the Company completed
the divestiture of its Animal Health business unit on April 15, 2014. Animal Health was a reportable
segment for business and reporting purposes. At June 30, 2013, the Animal Health business was
classified as held for sale and as a discontinued operation.
Revenues for this business unit in Fiscal 2014,
which includes sales until April 15,
2014, were $23.9 million, as
compared to $31.5 million in Fiscal
2013, with a profit in Fiscal 2014 of $48.1
million, which includes a gain on the sale of the business
of $44.5 million, as compared to a
profit of $3.3 million in Fiscal
2013.
The basic and fully diluted earnings per Share
for this business unit in Fiscal 2014 was $0.36, as compared to basic and fully diluted
earnings per Share of $0.03 in Fiscal
2013.
Fiscal 2014 Summary
The Company has total Common Shares outstanding
at September 26, 2013 of 167,630,221.
In addition, the Company has 36,541,812 outstanding Warrants and
8,734,213 outstanding Options, exchangeable for one Common Share
upon exercise.
More information on the Company's year-end
financial results is available in the Company's Fiscal 2014
Management's Discussion and Analysis which will be available on
www.SEDAR.com.
Corporate Updates
MCNA Regulatory Activities
The Company, working with a top-tier global
regulatory consulting firm, is currently actively preparing for the
filing of a Biologics License Application (BLA) with the FDA,
projected to be submitted prior to March 31,
2015. In addition, an Orphan Drug Designation request has
been submitted in the U.S., which, if granted, will provide the
Company with a 7-year period of market exclusivity in the U.S., as
well as a waiver of certain filing fees associated with a BLA,
which could be in excess of $2.5
million. The opportunity to obtain marketing authorization
of MCNA from regulatory agencies in geographic regions beyond the
U.S. and Canada is also being
explored.
MCNA Partnering Activities
The Company's near-term ability to file a BLA in
the U.S., which represents the most important global market for
MCNA, has had a significant and positive impact on the Company's
ability to generate partnering interest and engage potential
partners with strong commercial capabilities and experience. A
number of potential partners have executed confidentiality
agreements and are actively reviewing and evaluating the MCNA
program via access to the Company's confidential electronic data
room. The Company is conducting a thorough and structured
partnering process and is seeking to explore multiple strategic
options over the upcoming months. The Company has formally mandated
a consulting firm to conduct a full U.S. commercial assessment of
MCNA, including market research and a pricing/market access
assessment, to validate its internal estimates, and to provide a
robust U.S. sales forecast and product valuation. This external
commercial assessment will be key in supporting the Company's
strategic decisions related to the potential future partnering of
MCNA. .
VMC Sale Process
The VMC and related Econiche® vaccine technology
have been put up for sale. These assets are being actively brokered
by PharmaBioSource, a specialized U.S. merchant bank, engaged by
the Company to find a qualified buyer for the VMC and the entire
Belleville campus. The Company is
currently in discussions, and meeting, with interested parties.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a late clinical
stage Canadian biopharmaceutical company focused on the
development, manufacturing, marketing and licensing/acquisition of
proprietary and innovative therapies for the global human health
market. The Company's primary goal is to develop and commercialize
products that advance human 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" and
"forward-looking information" within the meaning of applicable
securities laws that reflect the Company's current expectation
regarding future events, including, without limitation, the
proposed use of proceeds and the timing and completion of the
Offering. Forward-looking statements and information are
necessarily based upon a number of estimates and assumptions that,
while, considered reasonable by management, are inherently subject
to significant business, economic and competitive uncertainties and
contingencies. Readers are cautioned that any such forward-looking
statements and information are not guarantees and there can be no
assurance that such statements and information will prove to be
accurate, and actual results and future events could differ
materially from those anticipated in such statements and
information. These forward-looking statements and information
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. The Company
expressly disclaims any intention or obligation to update or revise
any forward-looking statements and information whether as a result
of new information, future events or otherwise. All written and
oral forward-looking statements and information attributable to us
or persons acting on our behalf are expressly qualified in their
entirety by the foregoing cautionary statements.
SOURCE Bioniche Life Sciences Inc.