Isotechnika Reports Third Quarter 2011 Financial Results

Trades on Toronto Stock Exchange - (TSX:ISA)

EDMONTON, Nov. 10, 2011 /CNW/ - Isotechnika Pharma Inc. (TSX:ISA) today announced financial results for the third quarter ended September 30, 2011.

The Company's financial and operational resources in the third quarter ended September 30, 2011, were focused primarily on the planning phase for the Phase 3 program for the lead indication for voclosporin, the prevention of rejection following kidney transplantation. The Company has been actively engaged in the preparatory clinical work required prior to the enrolment of the patients.  These activities include the selection of clinical trial sites, obtaining non-disclosure agreements with all parties, working with the data management Contract Research Organization ("CRO") to develop the electronic documents to be used by the clinical trial sites, and developing the project plans and processes with the Company's CRO and other providers. Alongside the regulatory and clinical preparations, another key process step is having active pharmaceutical ingredient (API) ready to be administered to patients.  A new batch of voclosporin has been ordered from the manufacturer, and is expected to be ready for patient use in the first half of 2012.

The Company, in October 2011, received positive Scientific Advice from the European Medicines Agency (EMA) on the proposed phase 3 clinical trial protocol for voclosporin.  Receipt of positive Scientific Advice ensures a clear regulatory path forward in the European Union.  The Company is currently awaiting a similar outcome with the United States Food and Drug Administration (FDA) so it can finalize its phase 3 clinical plans.

Financial Results

The Company reported consolidated net income of $2.2 million or $0.013 per common share for the three months ended September 30, 2011, as compared to a consolidated net loss of $3.5 million or $0.025 per common share for the same period in 2010. For the nine months ended September 30, 2011, the consolidated net income was $4.07 million or $0.024 per common share compared to a consolidated net loss of $3.2 million or $0.024 per common share for the comparable period in 2010.

The net income for the three months ended September 30, 2011 included an unrealized non-cash gain of $3.0 million on derivative financial instruments compared to loss of $1.9 million on derivative financial instruments for the three months ended September 30, 2010. The unrealized gains (losses) resulted from the required accounting treatment for derivatives in financial instruments under International Financial Reporting Standards ("IFRS").  Pursuant to the Distribution and License Agreement ("DDL") with ILJIN Life Science Co., Ltd. ("ILJIN") which the Company signed on January 28, 2011, ILJIN is entitled to acquire a fixed number of common shares for a fixed US dollar price per share on the first and second anniversary dates of the DDL.  In accordance with IFRS an obligation to issue shares for a price that is not fixed in the Company's functional currency, must be classified as a derivative asset or liability and measured at fair value with changes recognized in the statement of operations and comprehensive income (loss) as it arises. This requirement resulted in the Company recording a gain of $3.0 million.  The Company recorded a loss on derivative financial liability of $1.9 million for the three months ended September 30, 2010 to reflect the fair value of the embedded financial derivative component of the 3SBio Inc. convertible debenture that was outstanding at September 30, 2010.

Revenue increased to $555,000 for the third quarter of 2011, compared to $272,000 for the same period in 2010. The Company recorded revenue of $838,000 for the nine months ended September 30, 2011, as compared to $3.2 million for the same period in 2010. The decrease in revenue for the nine months ended September 30, 2011 primarily reflects less amortization of deferred revenue to licensing and research and development revenues in 2011.

Research and development expenditures were consistent at $771,000 in the third quarter of 2011, compared to $694,000 in the third quarter of 2010.  The Company incurred net research and development expenditures of $2.6 million for the nine months ended September 30, 2011, as compared to $3.1 million for the same period in 2010.

Corporate and administration decreased to $682,000 for the third quarter of 2011, compared to $779,000 for the third quarter of 2010. The Company incurred corporate and administration expenses of $2.0 million for the nine months ended September 30, 2011, as compared with $2.2 million for the same period in fiscal 2010.

The Company, as at September 30, 2011, had $7.6 million in cash and cash equivalents compared to $8.4 million at June 30, 2011 and $6.3 million at December 31, 2010.

For further discussion of the Company's financial results for the three and nine month periods ended September 30, 2011, the unaudited interim consolidated financial statements and the Management's Discussion and Analysis for the third quarter ended September 30, 2011 are accessible on the Company's website at www.isotechnika.com or at www.sedar.com.

We seek Safe Harbour.

Isotechnika Pharma Inc.
Interim Consolidated Statement of Operations and Comprehensive Income (Loss) (unaudited)


(in thousands of Canadian dollars)

         Three months ended      Nine months ended
    September 30,
2011
$
  September 30,
2010
$
  September 30,
2011
$
  September 30,
2010
$
Revenue                
                 
Licensing revenue   67   67   239   896
Research and development revenue   28   196   104   2,189
Contract services   14   9   49   137
Other   446   -   446   -
                 
    555   272   838   3,222
Expenses                
Research and development, net   771   694   2,632   3,118
Corporate and administration   682   779   2,047   2,186
Amortization of property and equipment   176   202   538   625
Royalty expense   -   -   138   -
Amortization of  intellectual property   64   34   181   288
Contract services   12   9   40   43
                 
    1,705   1,718   5,576   6,260
                 
Loss before the undernoted   (1,150)   (1,446)   (4,738)   (3,038)
                 
Other income (expense)                
Interest income   2   3   5   7
Interest on convertible debenture   -   (7)   -   (7)
Foreign exchange gain (loss)   340   (101)   (26)   (101)
Gain on derivative financial asset   3,050   -   8,831   -
Loss on convertible debenture derivative liability   -   (1,925)   -   (1,925)
                 
    3,392   (2,030)   8,810   (2,026)
                 
Net income (loss) from continuing operations   2,242   (3,476)   4,072   (5,064)
                 
Net income from discontinued operation   -   -   -   1,900
                 
Net income (loss) for the period   2,242   (3,476)   4,072   (3,164)
                 
Comprehensive income (loss) for the period   2,242   (3,476)   4,072   (3,164)
                 
Earnings (loss) per share                
Basic and diluted net income (loss) per common share - continuing operations   0.013   (0.025)   0.024   (0.038)
Basic and diluted net income per common share - discontinued operation   -   -   -   0.014
Basic and diluted net income (loss) per common share   0.013   (0.025)   0.024   (0.024)

 

 

 

SOURCE Isotechnika Pharma Inc.

For further information:

Dr. Robert Foster 
President & CEO
780-487-1600 (247)
rfoster@isotechnika.com
      Mr. Dennis Bourgeault
Chief Financial Officer
780-487-1600 (226)
dbourgeault@isotechnika.com

 

Profil de l'entreprise

Isotechnika Pharma Inc.

Renseignements sur cet organisme


FORFAITS PERSONNALISÉS

Jetez un coup d’œil sur nos forfaits personnalisés ou créez le vôtre selon vos besoins de communication particuliers.

Commencez dès aujourd'hui .

ADHÉSION À CNW

Remplissez un formulaire d'adhésion à CNW ou communiquez avec nous au 1-877-269-7890.

RENSEIGNEZ-VOUS SUR LES SERVICES DE CNW

Demandez plus d'informations sur les produits et services de CNW ou communiquez avec nous au 1‑877-269-7890.