Isotechnika reports full year and fourth quarter 2009 financial results
EDMONTON, March 24 /CNW/ - (ISA:TSX): Isotechnika Pharma Inc. has released its financial results for the fourth quarter and year ended December 31, 2009 and provided a review of the Company's operational and scientific highlights for 2009 and to the current date:
2009 Scientific and Operating Updates
- Completed the Plan of Arrangement with Paladin Labs Inc. ("Paladin")
which created a strategic partnership for the future
commercialization of voclosporin in Canada, Mexico, Central and South
America, Israel and South Africa. This arrangement provided
Isotechnika Pharma with gross proceeds of $7 million upon completion
and $4.35 million in supported R&D funding over 12 months commencing
June 18, 2009.
- Partner Lux Biosciences, Inc. ("Lux") announced positive results from
their LUMINATE Phase 2/3 clinical trial program showing that
voclosporin had a clinically significant effect on ocular
inflammation and a safety profile consistent with its expected use in
non-infectious uveitis involving the posterior segment of the eye.
- Reported positive 12 month follow up data from the Phase 2b PROMISE
trial evaluating voclosporin in de novo kidney transplant patients.
As a dose ranging study, the Phase 2b trial was successful in meeting
the primary endpoint demonstrating non-inferiority in biopsy proven
acute rejection (BPAR) episodes as compared to tacrolimus control in
all three dose groups at six months and also demonstrated an improved
safety profile versus tacrolimus.
- Reported positive Phase 3 ESSENCE trial data evaluating voclosporin
in moderate to severe psoriasis patients. ESSENCE successfully met
the primary endpoint of superiority to placebo in the proportion of
patients achieving a score of "clear" or "almost clear" in the Static
Physician's Global Assessment (SPGA) at 12 weeks of treatment. The
full data set was presented at the Canadian Dermatology Association
84th Annual Conference held in Vancouver, B.C., July 1 - 5, 2009.
- Discovered a portfolio of non-immunosuppressive cyclosporine analogue
molecules (NICAMs) with potent cyclophilin inhibition without binding
to calcineurin. Cyclophilin inhibition has garnered considerable
attention as a novel therapy in the treatment of a wide range of
diseases including hepatitis C, stroke, and chronic neurological
disorders such as Parkinson's, Lou Gehrig's, and Alzheimer's.
- Partner Lux commenced and completed a First-in-Man (Phase 1) study
with LX214, a proprietary topical ophthalmic solution containing
voclosporin as the active ingredient. Results from this open-label
pilot efficacy study of the company's potential best-in-class therapy
for dry eye indicated that randomized, double-masked, placebo-
controlled data from 30 healthy volunteers showed LX214 to be well
tolerated at the two doses (0.02% and 0.2%) studied, with safety and
tolerability measurements indistinguishable from placebo.
- Repaid $13 million USD loan issued by Oxford Finance Corporation and
Silicon Valley Bank.
Subsequent Scientific and Operating Updates
- Partner, Lux, filed a New Drug Application (NDA) with the U.S. Food
and Drug Administration (FDA) and a Market Authorization Application
(MAA) with the European Medicines Agency (EMA) for voclosporin, under
the proposed brand name, LUVENIQ(TM). Voclosporin is proposed for the
treatment of non-infectious uveitis involving the posterior segment
of the eye, a leading cause of vision loss and long-term disability
and the fourth leading cause of legal blindness in the industrialized
world. If the submissions are approved in the U.S. and Europe, the
Company will receive milestone payments of $7.04 million USD and
$3.52 million USD, respectively, from Lux. Isotechnika Pharma will
also receive royalty payments on sales of voclosporin for uveitis.
- Isotechnika Labs, has amended its agreement with Paladin Labs
concerning its remaining stake in the revenue stream from the
Isodiagnostika business sold to Paladin on June 18, 2009. Under the
agreement, Isotechnika Labs was entitled to receive a revenue stream
equivalent to 88 percent of the net profits of Isodiagnostika through
to June 18, 2016. This amendment resulted in a one time up front
payment of $1.65 million with an additional amount up to $350,000
payable by January 31, 2011, based on Isodiagnostika sales in 2010.
- The Company announced that it received a research and development
contribution from the National Research Council of Canada Industrial
Research Assistance Program for its NICAM platform.
- The Company appointed Mr. Doug Goss as Chairman of the Board. He
replaces Mr. Jonathan Goodman who has resigned effective today due to
recently announced business transactions at Paladin. Mr. Goodman
stated, "In Paladin's efforts to expand internationally, over the
last 3 weeks, Paladin has acquired interests in two companies,
SpePharm in Amsterdam and Pharmaplan in South Africa. As part of
those transactions, I am to become a Board member of both companies
and simply don't have the bandwidth to continue in my role at
Isotechnika. Paladin remains Isotechnika's largest shareholder and I
have full confidence in my replacement, Doug Goss, who has a stellar
reputation in the legal community coupled with a great business
mind." "After 4 years of being corporate secretary, I am pleased to
become Chairman of the Board", stated Mr. Goss. "The Company remains
focused on unlocking shareholder value through commercialization of
voclosporin for uveitis through our partner Lux while seeking a
development partner for voclosporin in transplantation."
Financial results
For the fourth quarter ended December 31, 2009, the Company reported a significantly reduced consolidated net loss of $1.55 million or $0.01 per Common Share, as compared to a consolidated net loss of $4.84 million or $0.05 per Common Share for the same period in 2008. For the year ended December 31, 2009, the Company reduced its net consolidated loss to $7.96 million or $0.07 per Common Share, as compared to a consolidated net loss of $19.33 million or $0.18 per Common Share in 2008.
The reduction in the loss for the year ended December 31, 2009 when compared to 2008 was primarily due to a reduction of $5.91 million in research and development expenses, reduced corporate, administration and marketing expenses of $1.74 million and recording a net gain from the plan of arrangement with Paladin of $2.3 million.
Revenue decreased to $4.24 million for the year ended December 31, 2009, compared to $4.72 million for the year ended December 31, 2008. Revenue in 2009 was comprised of $500,000 of diagnostic royalty income, $1.08 million for product sales from the diagnostic division, $321,000 of contract services and product sales from the therapeutic division, $999,000 of research and development revenues and $1.34 million for licensing revenue. This compares to 2008, where revenue was comprised of $1.94 million for product sales from the diagnostic division, $2.2 million of contract services and product sales from the therapeutic division and $582,000 for licensing fees.
Net research and development expenses were $8.01 million for the year ended December 31, 2009, compared to $13.93 million for the year ended December 31, 2008. The decreased research and development expenses reflect decreased clinical trial activity as both the voclosporin Phase 2b kidney transplant and Phase 3 European/Canadian psoriasis trials were completed in 2009.
Corporate, administration and marketing expenses decreased to $3.78 million for the year ended December 31, 2009, compared to $5.52 million for the year ended December 31, 2008. The decrease reflected a general reduction in all corporate, administration and marketing costs which included reduced personnel numbers, reduced executive and director compensation and lower consulting fees incurred in 2009.
The Company, as at December 31, 2009, had $4.80 million in cash and cash equivalents. At December 31, 2009, other financial assets and liabilities were composed of accounts receivable of $770,000 and accounts payable and accrued liabilities of $2.14 million. Subsequent to the year end, the Company received gross proceeds of $1.65 million from Paladin resulting from the amendment of the terms of the research and development agreement. In addition the Company will receive monthly research and development payments of $329,000 from Paladin to June 30, 2010. The Company believes it has sufficient cash resources to continue its current planned operations until at least the fourth quarter of 2010. The Company will need to raise additional cash in the future.
The audited financial statements and the Management's Discussion and Analysis for the year ended December 31, 2009, are accessible on Isotechnika's Web site at www.isotechnika.com or on SEDAR at www.sedar.com.
We seek Safe Harbour.
Isotechnika Pharma Inc.
Consolidated Statements of Operations and Comprehensive Loss
For the periods ended December 31, 2009 and 2008
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(expressed in thousands of Canadian dollars, except per share amounts)
Three Months Ended Year Ended
December 31 December 31
(Unaudited)
2009 2008 2009 2008
$ $ $ $
Revenue
Contract services and
product sales 28 402 1,401 4,136
Licensing revenue 654 311 1,343 582
Research and development
revenues 762 - 999 -
Diagnostic royalty income 238 - 500 -
---------------------------------------------
1,682 713 4,243 4,718
---------------------------------------------
Expenses
Research and development 2,284 2,970 8,154 13,926
Less refundable research
and development tax credits (25) - (142) -
---------------------------------------------
2,259 2,970 8,012 13,926
Corporate, administration
and marketing 705 1,297 3,780 5,524
Interest and prepayment
costs on long-term debt - 510 1,077 902
Amortization of property
and equipment 219 260 933 1,160
Contract services and
product sales 29 170 603 2,574
Amortization and write-down
of intellectual property 80 416 402 546
Gain on disposal of equipment (1) - (45) (4)
---------------------------------------------
3,291 5,623 14,762 24,628
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Loss before the undernoted (1,609) (4,910) (10,519) (19,910)
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Other income (expense)
Net gain from plan of
arrangement - - 2,345 -
Investment income 4 109 40 706
Foreign exchange gain (loss) 51 (41) 178 (124)
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55 68 2,563 582
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Net loss for the period (1,554) (4,842) (7,956) (19,328)
Other comprehensive income - - - -
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Comprehensive loss for the
period (1,554) (4,842) (7,956) (19,328)
---------------------------------------------
---------------------------------------------
Basic and diluted loss per
share (0.01) (0.05) (0.07) (0.18)
---------------------------------------------
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%SEDAR: 00028600E
For further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., (780) 487-1600 (247), (780) 484-4105 (fax), [email protected]; Mr. Dennis Bourgeault, Chief Financial Officer, Isotechnika Pharma Inc., (780) 487-1600 (226), (780) 484-4105 (fax), [email protected]
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