(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
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
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
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.
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
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.
For further information:
Donald Olds, Chief Operating Officer
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058