Ondine Biopharma Announces 2007 Year End Financial Results VANCOUVER, March 25 /CNW/ - Ondine Biopharma Corporation (the "Company"
or "Ondine", TSX: OBP; AIM: OBP) a medical technology company developing
photodisinfection based products, today announced its financial results for
the year ended December 31, 2007. "2007 was a year in which we continued to make great strides forward on
several fronts, including the validation of our Periowave(TM)
Photodisinfection System for the treatment of periodontal diseases," said
Carolyn Cross, President and CEO of Ondine. "To date, over 10,000 patients
have been treated, with clinicians reporting excellent outcomes compared to
the gold standard of scaling and root planing alone. We are also very pleased
to be able to state that there have been no reported adverse events associated
with the treatment. Looking beyond the current oral applications of Ondine's
technology, our belief is that Photodisinfection may be able to address the
growing need for non-antibiotic options for eradicating resistant 'superbugs'
including methicillin/multiple-resistant Staphylococcus aureus (MRSA). Our
Photodisinfection technology has been cleared to market in Canada and in
Europe for eradication of potentially pathogenic microorganisms (including
MRSA) in the nose - a primary source of MRSA in hospital-acquired infections. We expect to initiate further clinical programs in MRSA decolonization and
disinfection in 2008. Finally, Ondine is actively pursuing strategic
partnerships for current and future applications which will allow the Company
to exploit the full potential of Photodisinfection while remaining focused on
its core strength of technology development."
2007 Results and Recent Developments FINANCIAL RESULTS - For the year ended December 31, 2007 (the "Current Year") the
Company recorded a loss of $13.16 million, or $0.24 per common
share, compared with a loss of $11.96 million, or $0.25 per common
share, for the year ended December 31, 2006 (the "Prior Year"). Product sales revenue for Periowave(TM) laser base stations and
treatment kits, the Company's first commercially available
photodisinfection ("PDD") product, for the Current Year was
$1.61 million generating a gross margin of $0.82 million (51%)
compared to product sales of $1.62 million and gross profit margin
of $0.60 million (37%) for the Prior Year.
REGULATORY AND PRODUCT DEVELOPMENTS
MRSA Program - A Health Canada license was received for decolonization of
pathogenic bacteria such as MRSA in the nose. This license
represents the first application of the Company's PDD technology
outside the oral cavity to receive regulatory clearance in Canada. The Company plans to initiate a clinical study for this indication
for marketing and regulatory purposes during 2008;
- A nanotechnology-based photosensitizer was developed, jointly with
UCL Business PLC, which dramatically enhances antimicrobial
lethality at very small unit doses. The Company owns exclusive
rights to worldwide patent applications covering this
nanotechnology-based photosensitizer technology, with potential
widespread antimicrobial indications including eradication of MRSA
from the nose and other areas, treatment of conditions such as
periodontal diseases, otitis externa, nailbed fungus and the
disinfection of burns and wounds; and
- On March 6, 2008, the Company announced the results from two
research studies from its MRSA program will be presented at the
Society for General Microbiology's 162nd Meeting held March 31 -
April 3, 2008 in Edinburgh, Scotland. The studies provide detailed
results of Ondine's photodisinfection system in the eradication of
Staphylococcus aureus, a bacterium which secretes potent cell
wall-bound virulence factors that enhance host tissue destruction.
Dental Program - A 510(k) submission to the United States Food and Drug
Administration (FDA) seeking clearance to market the Periowave(TM)
System in the United States was filed in October. The Company was
subsequently advised by the Center for Devices and Radiological
Health ("CDRH") branch of the FDA that the Company's device was
classified as Class III (Premarket Approval), an automatic
designation since no substantially equivalent system has been
previously marketed. Final determination of the regulatory pathway
is subject to continued evaluation by FDA of Ondine's submission
as well as other information that may be required;
- Health Canada licenses were received for endodontics (root canal);
peri-implantitis, which includes peri-mucositis; and gingivitis
applications of the Company's Periowave(TM) PDD system;
- Regulatory clearance was received from the European Commission for
the treatment of peri-implantitis and for endodontics using the
Company's Periowave(TM) PDD system;
- A meta-analysis (statistical review of pooled clinical trial data)
was completed on the use of the Periowave(TM) PDD system for the
treatment of gum disease. Among other data, the meta-analysis
found that Periowave(TM) used in a re-treatment protocol (six
weeks apart) produced 2.3 times more clinically relevant ((greater
than or equal to)2 mm) pocket depth reductions than the gold
standard of and root planning (SRP) alone (p(less than)0.0001);
and
- Dr. Tim Rose was appointed chairman of Ondine's Clinical Advisory
Board (CAB) and Dr. Angelo Mariotti was appointed a member of
Ondine's CAB.
CORPORATE DEVELOPMENTS - The Company moved its US-based R&D facilities to a new facility in
Bothell, Washington. The expanded facility in Bothell, which
includes a microbiology laboratory, provides the basis for
accelerated product development in both the oral care and MRSA
sectors;
- The Company closed its office in York, Pennsylvania and
transferred the marketing and sales functions to its head office
in Vancouver, British Columbia and to the new facility in Bothell. York-based Jacqueline Walker, formerly Chief Operating Officer,
and Tom Leonardi, formerly Vice President of Sales and Marketing
of Ondine Biopharma (U.S.A.) Inc., left to pursue opportunities
outside of the Company;
- A non-brokered private placement financing was completed in
December 2007 raising aggregate net proceeds of $6.96 million; and
- In February of 2008 the Company cancelled its exclusive
distribution agreement with Henry Schein Canada, Inc. (formerly
Henry Schein Ash Arcona Inc.) for the Canadian market and intends
to work with them on a non-exclusive basis.
Financial Review Consolidated statements of operations for the fourth quarter (unaudited -
in thousands except per share amounts): -------------------------------------------------------------------------
Three months ended
December 31,
2007 2006
$ $
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Revenue
Product sales 128 659
Cost of sales 75 421
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Gross Margin 53 238
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Expenses
Research and development 1,096 1,635
General and administration 917 1,073
Marketing and sales 713 1,028
Depreciation and amortization 53 73
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(2,779) (3,809)
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Other
Interest income 55 135
Foreign exchange loss (52) (41)
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3 94
-------------------------------------------------------------------------
Loss before income taxes (3,477)
Income tax recovery (expense) (11) 13
-------------------------------------------------------------------------
Loss for the period (2,734) (3,464)
Unrealized gain on short-term investments 1 -
-------------------------------------------------------------------------
Comprehensive loss for the period (2,733) (3,464)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per common share (0.05) (0.07)
-------------------------------------------------------------------------
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Weighted average number of shares outstanding 56,345 51,553
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For the quarter ended December 31, 2007 (the "Current Quarter") the
Company recorded a loss of $2.73 million or $0.05 per common share compared
with a loss of $3.46 million or $0.07 per common share during the quarter
ended December 31, 2006 (the "Prior Quarter"). Product sales of our laser
consoles and treatment kits during the Current Quarter amounted to
$0.12 million with a gross margin of $0.05 million (41%) compared to product
sales of $0.66 million and a gross margin of $0.24 million (36%) during the
Prior Quarter. There were no sales during the three months ended March 31, 2006 in the
Prior Year as the Company commenced sales of its first product, Periowave(TM),
in April of 2006. The improvement in gross margin during the Current Year, as
compared to the Prior Year, is primarily due to higher treatment kit sales
during the Current Year. Sales during the Current Year include a $0.27 million
sale of Periowave(TM) laser base stations and treatment kits to a distributor
in Germany as an initial order and a $0.22 million sale of Periowave(TM) laser
base stations to the Radcliffe Foundation who donated them to certain
universities and colleges across Canada. The balance of product sales revenue
for the Current Year consisted primarily of laser base stations and treatment
kit sales to the Company's distributor in Canada. Sales revenue for the Prior
Year included sales of laser base stations to the Canadian distributor as the
distributor built up its inventory to meet expected demand. Sales in the Prior
Quarter included sales of laser base stations to the Company's Canadian
distributor, which did not occur in the Current Quarter as the Canadian
distributor's level of laser base station inventory during the Current Quarter
was sufficient to meet demand. The Company is seeing additional market
acceptance for its products in Canada. Information obtained from the Company's
Canadian distributor shows an increase of 259% in the average number of
treatment kits sold per month during 2007, when compared to that average
during 2006. Although the Company is seeing increasing market acceptance for
Periowave(TM), its sales to date have been limited and there is not sufficient
sales history to reasonably predict future demand, including the full impact
of seasonality on its sales. The Company expects that the summer months will
generally be a slower sales period and this may have a negative impact on
third quarter sales. In addition, substantially all of the Company's sales in
Canada are to one distributor. Sales by the Company to its distributor are not
necessarily reflective of the distributor's sales to dental offices. Until the
Company has adequate sales history to accurately forecast demand on an ongoing
basis, the fluctuations in the distributor's inventory levels could
significantly impact sales in future quarters. The increase in loss during the Current Year, when compared to the Prior
Year, was primarily due to increases in operating costs which were partially
offset by the increase in gross margin as described above. The increases in
operating costs occurred in general and administration (G&A) and in marketing
and sales (M&S). Research and Development (R&D) expenses for the Current Year were
$5.71 million compared to $5.71 million during the Prior Year. During the
Current Year the Company continued to invested in research and development
programs on potential new applications of the Company's PDD technology,
incurred costs in connection with a number of ongoing clinical studies in
Canada and at University College London Hospital in the United Kingdom on the
use of Periowave(TM) for the treatment of periodontitis, and incurred costs in
connection with the preparation and filing of its submission to the FDA for
Periowave(TM). In addition, the Company currently has underway research
programs at University College London on potential new applications of PDD,
principally for the non-antibiotic treatment of MRSA and other topical
infections. During the Current Year, the Company was successful in expanding
the scope of its license in Canada for the use of its Periowave(TM) PDD system
to include the treatment of other indications in the oral cavity and for the
decolonization of pathogenic bacteria, such as MRSA, in the nose. G&A expenses for the Current Year were $4.24 million compared to
$3.93 million during the Prior Year as additional administrative staff and
administrative facilities were added at the beginning of 2007 to support the
increase in the Company's activities. During the Current Year, as compared to
the Prior Year, the Company incurred an increase in consulting fees in
connection with general corporate matters, an increase in investor relations
costs, and costs associated with an office in York, PA, which has now been
closed. These increases were partially offset by a decrease in stock-based
compensation costs due to the forfeiture of unvested stock options and a
reduction in travel costs. M&S expenses for the Current Year were $3.71 million compared to
$3.03 million during the Prior Year. M&S expenses during the Current Year, as
compared to the Prior Year, increased primarily due to the Current Year
including costs incurred in connection with market research studies and plans
for the United States market and for the development of marketing materials
and telemarketing activities in the Canadian market, higher advertising and
promotional costs, primarily in connection with activities in Europe, and an
increase in staff costs due principally to an increase in sales staff. The Company incurred a foreign exchange loss of $0.28 million during the
Current Year, compared to a loss of $0.04 million during the Prior Year,
primarily due to the decrease in the value of its cash and cash equivalents
denominated in United States dollars as a result of a decrease during the last
nine months of 2007 in the value of the United States dollar in relation to
the value of the Canadian dollar. The Company's R&D activities are conducted
primarily in the United States and accordingly a substantial portion of its
expenses are incurred in United States dollars. The decrease in loss during the Current Quarter, when compared to the
Prior Quarter, was primarily due to decreases in operating costs which were
partially offset by the decrease in gross margin as described above. The
decreases in operating costs occurred in R&D, G&A, and M&S. R&D expenses for the Current Quarter were $1.10 million compared to
$1.63 million during the Prior Quarter. During the Current Quarter the Company
continued to invest in research and development programs on potential new
applications of the Company's PDD technology and incurred costs in connection
with the preparation of its submission to the FDA. The decrease in R&D
expenses during the Current Quarter, as compared to the Prior Quarter, was
primarily due to a reduction in clinical trial costs, as substantially all
patient visits had been completed by the beginning of the quarter, and lower
salaries and benefits costs due to a reduction in staff. G&A expenses for the Current Quarter were $0.92 million compared to
$1.07 million during the Prior Quarter. The decrease in G&A expenses during
the Current Quarter, as compared to the Prior Quarter, was primarily due to
lower salaries and benefits due to a reduction in staff and a reduction in
travel costs. These decreases were partially offset by an increase in general
corporate consulting and professional fees. M&S expenses for the Current Quarter were $0.71 million compared to
$1.03 million during the Prior Quarter. M&S expenses during the Current
Quarter, as compared to the Prior Quarter, decreased primarily due to a
reduction in advertising and promotions activities. As at December 31, 2007 the Company had cash, cash equivalents and short
term investments totaling $10.15 million compared with $15.50 million as at
December 31, 2006. During the Current Year the Company used cash of
approximately $11.9 million for its operating activities, $4.93 million was
provided by its investing activities, and $6.99 million was provided by the
issuance of common shares and warrants, including $6.96 million, being the net
proceeds raised in a non-brokered private placement that closed in December
2007. As at December 31, 2007 the Company had 61,027,675 common shares
outstanding.
About Periowave(TM) Periowave(TM) is a photodisinfection system commercialized by Ondine that
utilizes low-intensity lasers and microbiological stains to target and destroy
microbial pathogens and reduce the symptoms of disease. The photodisinfection
technology was developed by Professor Michael Wilson and colleagues at the
Eastman Dental Institute, University College London, and licensed to Ondine by
UCL Business plc, University College London. Periowave(TM) is currently
approved in Canada and the European Union for several oral indications. Additional information about Periowave(TM) is available at www.periowave.com About Ondine Biopharma Corporation Ondine is developing non-antibiotic therapies for the treatment of a
broad spectrum of bacterial, fungal and viral infections. The Company is
focused on creating and commercializing leading edge products utilizing its
patented light-activated technology. Photodisinfection provides broad-spectrum
antimicrobial efficacy without encouraging the formation and spread of
antibiotic resistance. The Company is headquartered in Vancouver,
British Columbia, Canada, with a research laboratory in Bothell, Washington,
USA, and an international office in St. Michael, Barbados. For additional
information, please visit the Company's website at: www.ondinebiopharma.com.
Forward-Looking Statements: Certain statements contained in this release containing words like
"believe", "intend", "may", "expect" and other similar expressions, are
forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to differ materially from those
projected in the Company's forward-looking statements include the following:
market acceptance of our technologies and products; our ability to obtain
financing; our financial and technical resources relative to those of our
competitors; our ability to keep up with rapid technological change;
government regulation of our technologies; our ability to enforce our
intellectual property rights and protect our proprietary technologies; the
ability to obtain and develop partnership opportunities; the timing of
commercial product launches; the ability to achieve key technical milestones
in key products and other risk factors identified from time to time in the
Company's filings.
The TSX Exchange has not reviewed and does not accept responsibility for
the adequacy or accuracy of this release.
Ondine Biopharma Corporation
Incorporated under the laws of British Columbia CONSOLIDATED BALANCE SHEETS As at December 31 (expressed in Canadian dollars)
-------------------------------------------------------------------------
2007 2006
$ $
-------------------------------------------------------------------------
ASSETS
Current
Cash and cash equivalents 4,540,245 4,522,877
Short-term investments 5,606,836 10,980,656
Accounts receivable 653,448 762,250
Inventories 570,561 746,404
Prepaid expenses and deposits 526,520 570,213
-------------------------------------------------------------------------
Total current assets 11,897,610 17,582,400
Capital assets 991,606 810,527
Intangible assets 114,714 71,204
-------------------------------------------------------------------------
13,003,930 18,464,131
-------------------------------------------------------------------------
------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 1,873,860 1,714,361
Income taxes payable 30,765 49,290
Current portion of deferred tenant inducement 42,374 11,700
Future income tax 67,026 66,064
-------------------------------------------------------------------------
Total current liabilities 2,014,025 1,841,415
Deferred tenant inducement, net of current
portion 145,967 31,224
-------------------------------------------------------------------------
Total liabilities 2,159,992 1,872,639
------------------------------------------------------------------------- Shareholders' equity
Share capital 51,193,823 45,453,690
Contributed surplus 3,467,847 1,801,209
Deficit (43,816,528) (30,663,407)
Accumulated other comprehensive loss (1,204) -
-------------------------------------------------------------------------
Total shareholders' equity 10,843,938 16,591,492
-------------------------------------------------------------------------
13,003,930 18,464,131
-------------------------------------------------------------------------
------------------------------------------------------------------------- Ondine Biopharma Corporation CONSOLIDATED STATEMENTS OF LOSS
AND COMPREHENSIVE LOSS For the years ended December 31 (expressed in Canadian dollars)
-------------------------------------------------------------------------
2007 2006
$ $
-------------------------------------------------------------------------
REVENUE
Product sales 1,605,485 1,619,209
Cost of sales 784,838 1,015,092
-------------------------------------------------------------------------
Gross margin 820,647 604,117
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EXPENSES
Research and development 5,714,608 5,708,908
General and administration 4,243,368 3,929,721
Marketing and sales 3,709,383 3,030,371
Depreciation and amortization 371,744 244,041
-------------------------------------------------------------------------
(14,039,103) (12,913,041)
-------------------------------------------------------------------------
Other
Interest income 335,002 431,549
Foreign exchange loss (276,236) (35,217)
-------------------------------------------------------------------------
58,766 396,332
-------------------------------------------------------------------------
Loss before income taxes (13,159,690) (11,912,592)
Income tax recovery (expense) 2,168 (50,504)
-------------------------------------------------------------------------
Loss for the year (13,157,522) (11,963,096)
Unrealized gain on short-term investments 3,197 -
-------------------------------------------------------------------------
Comprehensive loss for the year (13,154,325) (11,963,096)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per common share (0.24) (0.25)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number of common shares
outstanding 55,084,943 47,907,443
-------------------------------------------------------------------------
------------------------------------------------------------------------- Ondine Biopharma Corporation CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (expressed in Canadian dollars)
-------------------------------------------------------------------------
Share Contributed
Number of Capital Surplus
Common Shares $ $
-------------------------------------------------------------------------
Balance, December 31, 2005 43,812,143 34,045,959 1,158,104
Common shares issued for cash
during the year for:
Exercise of warrants 3,945,878 1,578,351 -
Exercise of options 121,972 30,493 -
Equity financing, net of
issue costs 6,250,000 9,095,152 -
Exercise of over allotment
option 462,500 681,780 -
Stock-based compensation - - 665,060
Reallocation of contributed
surplus arising from
stock-based compensation
on exercise of stock
options - 21,955 (21,955)
Loss for the year - - -
-------------------------------------------------------------------------
Balance, December 31, 2006 54,592,493 45,453,690 1,801,209
Transitional adjustment to
beginning balance on
adoption of new accounting
policy - - -
Common shares issued for
cash during the year for:
Exercise of options 100,000 25,000 -
Private placement of units
(net of issue costs) 6,335,182 5,697,133 1,267,036
Stock-based compensation - - 417,602
Reallocation of contributed
surplus arising from
stock-based compensation
on exercise of stock
options - 18,000 (18,000)
Loss for the year - - -
Unrealized gain on
short-term investments - - -
-------------------------------------------------------------------------
Balance, December 31, 2007 61,027,675 51,193,823 3,467,847
-------------------------------------------------------------------------
-------------------------------------------------------------------------
(expressed in Canadian dollars)
-------------------------------------------------------------------------
Accumulated
Other Total
Comprehensive Shareholders'
Deficit Loss Equity
$ $ $
-------------------------------------------------------------------------
Balance, December 31, 2005 (18,700,311) - 16,503,752
Common shares issued for cash
during the year for:
Exercise of warrants - - 1,578,351
Exercise of options - - 30,493
Equity financing, net of
issue costs - - 9,095,152
Exercise of over allotment
option - - 681,780
Stock-based compensation - - 665,060
Reallocation of contributed
surplus arising from
stock-based compensation
on exercise of stock
options - - -
Loss for the year (11,963,096) - (11,963,096)
-------------------------------------------------------------------------
Balance, December 31, 2006 (30,663,407) - 16,591,492
Transitional adjustment to
beginning balance on
adoption of new accounting
policy 4,401 (4,401) -
Common shares issued for
cash during the year for:
Exercise of options - - 25,000
Private placement of units
(net of issue costs) - - 6,964,169
Stock-based compensation - - 417,602
Reallocation of contributed
surplus arising from
stock-based compensation
on exercise of stock
options - - -
Loss for the year (13,157,522) - (13,157,522)
Unrealized gain on
short-term investments - 3,197 3,197
-------------------------------------------------------------------------
Balance, December 31, 2007 (43,816,528) (1,204) 10,843,938
-------------------------------------------------------------------------
------------------------------------------------------------------------- Ondine Biopharma Corporation CONSOLIDATED STATEMENTS OF CASH FLOWS For the years ended December 31 (expressed in Canadian dollars)
-------------------------------------------------------------------------
2007 2006
$ $
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OPERATING ACTIVITIES
Loss for the year (13,157,522) (11,963,096)
Add items not affecting cash:
Depreciation and amortization 371,744 244,041
Stock-based compensation 417,602 665,060
Unrealized loss on short-term investments - 4,401
Gain on redemption of short-term
investments - (16,411)
Deferred tenant inducement (6,583) (11,700)
Future income tax expense 962 66,064
Changes in non-cash working capital items
relating to operations:
Accounts receivable 108,802 (576,123)
Inventory 175,843 (622,164)
Prepaid expenses and deposits 43,693 293,192
Accounts payable and accrued liabilities 159,499 1,078,984
Income taxes payable (18,525) (6,314)
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Cash used in operating activities (11,904,485) (10,844,066)
-------------------------------------------------------------------------
FINANCING ACTIVITIES
Issuance of common shares and warrants,
net of issue costs 6,989,169 11,385,776
-------------------------------------------------------------------------
Cash provided by financing activities 6,989,169 11,385,776
-------------------------------------------------------------------------
INVESTING ACTIVITIES
Short-term investments 5,377,017 1,632,795
Purchase of capital assets (368,159) (591,133)
Acquisition of intangible asset (76,174) (74,812)
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Cash provided by investing activities 4,932,684 966,850
-------------------------------------------------------------------------
Net increase in cash and cash equivalents 17,368 1,508,560
Cash and cash equivalents, beginning of year 4,522,877 3,014,317
-------------------------------------------------------------------------
Cash and cash equivalents, end of year 4,540,245 4,522,877
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-------------------------------------------------------------------------For further information: Carolyn Cross, President and Chief Executive
Officer, Ondine Biopharma Corporation, (604) 669-0555,
ccross(at)ondinebiopharma.com; Christina Bessant, Investor Relations, The
Equicom Group Inc., (416) 815-0700 ext. 269, cbessant(at)equicomgroup.com;
Irma Gomez-Dib, Media & Investors Relations, FD International, (212) 850-5761,
Irma.gomez-dib(at)fd.com; Canaccord Adams Ltd, Nominated Adviser & Broker,
Neil Johnson, Ryan Gaffney, +4420 7050 6500
(OBP OBP.) END
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