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Trimel Reports Fourth Quarter and Full Year 2013 Financial Results

TORONTO, ONTARIO -- (Marketwired) -- 03/06/14 -- Trimel Pharmaceuticals Corporation (TSX:TRL) today provided an overview of its corporate accomplishments and reported financial results for the three and twelve month periods ended December 31, 2013.

2013 Corporate Accomplishments

During 2013, numerous accomplishments were achieved in the advancement of Trimel's business. The Company successfully raised gross proceeds of $46 million in connection with its April 2013 offering which also allowed for an expansion of its shareholder base. The Company's first New Drug Application, for the novel male testosterone replacement therapy CompleoTRT(TM), was filed with the U.S. Food and Drug Administration in April 2013. The independence and expertise of the Board of Directors was strengthened with the addition of Dr. Lorne Tyrrell, Mr. Matthew Pfeffer, and Mr. Ian Ihnatowycz as directors. The Company re-negotiated its agreement with M&P Patent AG which resolved certain matters in dispute, strengthened the relationship, and provided non-exclusive rights in important commercial markets Trimel previously did not have access to. Lastly, Trimel also saw the completion of the enrolment phase for the Phase II clinical trial for Tefina(TM), a product being developed for the treatment of Female Orgasmic Disorder which is estimated to effect up to one in five women worldwide.

Financial Results for the Three and Twelve Months Ended December 31, 2013

For the three and twelve month periods ended December 31, 2013, Trimel incurred Research and Development ("R&D") expenses of US$8.9 million and US$22.7 million respectively as compared to US$4.1 million and US$17.2 million for the comparable 2012 periods. The increase in R&D expenses for the three and twelve month periods ended December 31, 2013 versus the comparable 2012 periods reflects the favourable settlement of arbitration matters with a technology partner during the fourth quarter or 2013 for $4.25 million.

Trimel incurred General and Administrative expenses of US$2.3 million and US$9.9 million for the three and twelve month periods ended December 31, 2013 respectively as compared to US$3.0 million and US$10.1 million for the comparable 2012 periods. The decrease in expense for the three month period ended December 31, 2013, as compared to the same 2012 period, is primarily attributable to lower share based compensation. The decrease in expense for the twelve month period ended December 31, 2013, as compared to the equivalent 2012 period, is primarily attributable to lower share based compensation expense offset partially by higher professional fees associated with arbitration matters that were resolved during 2013.

For the three and twelve month periods ended December 31, 2013, the Company incurred a net loss of US$0.07 and US$0.25 per share respectively, as compared to US$0.09 and US$0.32 per share for the comparable 2012 periods.

As at December 31, 2013, the Company had total assets of US$28.1 million as compared to US$16.9 million at December 31, 2012 and total liabilities of US$14.5 million at December 31, 2013 as compared to US$12.2 million at December 31, 2012. The Company's average monthly burn rate during the 2013 fourth quarter was approximately $2.0 million.

The information set out above is in summary form. Readers are encouraged to review the Company's annual information form, financial statements (and accompanying notes), together with management's discussion and analysis available on SEDAR at www.sedar.com and on the Company's website at www.trimelpharmaceuticals.com.

About Trimel

Trimel is a specialty pharmaceutical company developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. An NDA for CompleoTRT(TM), a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has been accepted for review by the FDA for regulatory approval in the United States. For more information, please visit www.trimelpharmaceuticals.com.

Notice regarding forward-looking statements:

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including that CompleoTRT(TM) may not be approved by the FDA or that any approval may be delayed, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 5, 2014 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.


                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
                CONSOLIDATED STATEMENT OF FINANCIAL POSITION                
                      AS AT DECEMBER 31, 2013 AND 2012                      
                        (expressed in U.S. Dollars)                         
                                                                            
                                   ASSETS                                   
                                                                            
                                                     2013              2012 
                                         ----------------- -----------------
                                                                            
CURRENT                                                                     
 Cash                                    $     18,111,145  $      9,216,999 
 Restricted cash                                   23,505            25,128 
 Inventory                                      1,913,772                 - 
 Prepaids and other assets                      1,582,924         1,095,256 
                                         ----------------- -----------------
                                               21,631,346        10,337,383 
                                                                            
NON-CURRENT ASSETS                                                          
 Property and equipment, net                    3,273,196         3,026,160 
 Intangible assets                              3,216,800         3,562,600 
                                         ----------------- -----------------
TOTAL ASSETS                             $     28,121,342  $     16,926,143 
                                         ----------------- -----------------
                                                                            
                                                                            
                                LIABILITIES                                 
                                                                            
CURRENT                                                                     
 Accounts payable and accrued                                               
  liabilities                            $      9,864,079  $      4,844,608 
 Current portion of capital lease                                           
  obligation                                            -           140,551 
 Current portion of long-term debt, net                                     
  of issuance costs                             2,834,639         2,425,562 
                                         ----------------- -----------------
                                               12,698,718         7,410,721 
                                                                            
LONG-TERM                                                                   
 Long-term debt, net of issuance costs          1,827,082         4,561,686 
 Derivative financial instrument                   20,977           203,248 
                                         ----------------- -----------------
TOTAL LIABILITIES                        $     14,546,777  $     12,175,655 
                                         ----------------- -----------------
                                                                            
                                                                            
                            SHAREHOLDERS' EQUITY                            
                                                                            
Share capital                                 119,741,040        78,214,661 
Warrants                                        1,039,705         3,452,607 
Contributed surplus                             7,987,237         4,318,927 
Accumulated other comprehensive income                                      
 (loss)                                        (1,639,862)          362,920 
Deficit                                      (113,553,555)      (81,598,627)
                                         ----------------- -----------------
TOTAL SHAREHOLDERS' EQUITY                     13,574,565         4,750,488 
                                         ----------------- -----------------
TOTAL LIABILITIES AND SHAREHOLDERS'                                         
 EQUITY                                  $     28,121,342  $     16,926,143 
                                         ----------------- -----------------
                                                                            
                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
           CONSOLIDATED STATEMENT OF LOSS AND COMPREHENSIVE LOSS            
               FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012               
                        (expressed in U.S. Dollars)                         
                                                                            
                                            For the year ended December 31, 
                                                     2013              2012 
                                         ----------------- -----------------
EXPENSES                                                                    
 Research and development                $     22,680,609  $     17,240,969 
 General and administrative                     9,896,688        10,147,650 
                                         ----------------- -----------------
 Total operating expenses                      32,577,297        27,388,619 
                                                                            
FINANCE COSTS, NET                                                          
 Interest on long-term debt and other                                       
  financing costs                               1,112,912           635,247 
 Interest income                                 (116,289)          (14,060)
 Foreign exchange loss/(gain)                  (1,116,721)           30,730 
 Change in fair value of derivative                                         
  financial instrument                           (182,271)           94,158 
                                         ----------------- -----------------
                                                 (302,369)          746,075 
                                         ----------------- -----------------
TOTAL EXPENSES                                 32,274,928        28,134,694 
                                         ----------------- -----------------
LOSS BEFORE INCOME TAXES                      (32,274,928)      (28,134,694)
                                                                            
(RECOVERY OF) INCOME TAXES                                                  
 Current                                                -           (53,036)
 Deferred                                        (320,000)          (57,945)
                                         ----------------- -----------------
                                                 (320,000)         (110,981)
                                         ----------------- -----------------
NET LOSS                                 $    (31,954,928) $    (28,023,713)
                                         ----------------- -----------------
                                         ----------------- -----------------
                                                                            
OTHER COMPREHENSIVE LOSS, NET OF INCOME                                     
 TAX                                                                        
Items that may be reclassified                                              
 subsequently to profit or loss:                                            
 Foreign currency translation adjustment       (2,002,782)          284,238 
                                         ----------------- -----------------
TOTAL COMPREHENSIVE LOSS                 $    (33,957,710) $    (27,739,475)
                                         ----------------- -----------------
                                         ----------------- -----------------
Basic and Diluted Weighted Average                                          
 Shares Outstanding                           130,351,557        86,663,082 
                                                                            
Basic and Diluted Net Loss per Common                                       
 Share                                   $          (0.25) $          (0.32)
                                                                            
                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
          CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY         
               FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012               
                         (expressed in U.S. Dollars)                        
                                                                 Contributed
                              Share capital        Warrants          surplus
                            --------------- ---------------- ---------------
                            --------------- ---------------- ---------------
                                                                            
Balance, January 1, 2012     $   67,430,241  $    2,413,367   $    1,610,972
                                                                            
Net loss for the year                     -               -                -
                                                                            
Cumulative translation                                                      
 adjustment                               -               -                -
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss                                                    
 for the year                             -               -                -
                                                                            
Units, net of issuance                                                      
 costs                           10,728,722       1,002,882                -
                                                                            
Broker warrants issued as                                                   
 part of long-term debt                   -          36,823                -
                                                                            
Conversion of warrants                5,698            (465)               -
                                                                            
Conversion of options                50,000               -                -
                                                                            
Share based compensation                  -               -        2,707,955
----------------------------------------------------------------------------
Balance as at December 31,                                                  
 2012                        $   78,214,661  $    3,452,607   $    4,318,927
----------------------------------------------------------------------------
----------------------------------------------------------------------------
                                                                            
Balance, January 1, 2013     $   78,214,661  $    3,452,607   $    4,318,927
                                                                            
Net loss for the year                     -               -                -
                                                                            
Cumulative translation                                                      
 adjustment                               -               -                -
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss                                                    
 for the year                             -               -                -
                                                                            
Common shares, net of share                                                 
 issuance costs                  41,526,379               -                -
                                                                            
Warrant expiry, net of tax                -      (2,412,902)       2,092,902
                                                                            
Share based compensation                  -               -        1,575,408
----------------------------------------------------------------------------
Balance as at December 31,                                                  
 2013                        $  119,741,040  $    1,039,705   $    7,987,237
----------------------------------------------------------------------------
----------------------------------------------------------------------------
                                                                            

                               Accumulated                                  
                                     other                                  
                             comprehensive                                  
                             income (loss)         Deficit            Total 
                            --------------- --------------- ----------------
                            --------------- --------------- ----------------
                                                                            
Balance, January 1, 2012     $      78,682  $  (53,574,914)  $   17,958,348 
                                                                            
Net loss for the year                    -     (28,023,713)     (28,023,713)
                                                                            
Cumulative translation                                                      
 adjustment                        284,238               -          284,238 
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss                                                    
 for the year                      284,238     (28,023,713)     (27,739,475)
                                                                            
Units, net of issuance                                                      
 costs                                   -               -       11,731,604 
                                                                            
Broker warrants issued as                                                   
 part of long-term debt                  -               -           36,823 
                                                                            
Conversion of warrants                   -               -            5,233 
                                                                            
Conversion of options                    -               -           50,000 
                                                                            
Share based compensation                 -               -        2,707,955 
----------------------------------------------------------------------------
Balance as at December 31,                                                  
 2012                        $     362,920  $  (81,598,627)  $    4,750,488 
----------------------------------------------------------------------------
----------------------------------------------------------------------------
                                                                            
Balance, January 1, 2013     $     362,920  $  (81,598,627)  $    4,750,488 
                                                                            
Net loss for the year                    -     (31,954,928)     (31,954,928)
                                                                            
Cumulative translation                                                      
 adjustment                     (2,002,782)              -       (2,002,782)
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss                                                    
 for the year                   (2,002,782)    (31,954,928)     (33,957,710)
                                                                            
Common shares, net of share                                                 
 issuance costs                          -               -       41,526,379 
                                                                            
Warrant expiry, net of tax               -               -         (320,000)
                                                                            
Share based compensation                 -               -        1,575,408 
----------------------------------------------------------------------------
Balance as at December 31,                                                  
 2013                        $  (1,639,862) $ (113,553,555)  $   13,574,565 
----------------------------------------------------------------------------
----------------------------------------------------------------------------
                                                                            
                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
                    CONSOLIDATED STATEMENT OF CASH FLOWS                    
               FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012               
                        (expressed in U.S. Dollars)                         
                                                                            
                                                       2013            2012 
                                             --------------- ---------------
                                                                            
CASH FLOWS FROM OPERATING ACTIVITIES                                        
--------------------------------------------                                
Net loss for the year                        $  (31,954,928) $  (28,023,713)
Items not requiring an outlay of cash:                                      
 Adjustment for foreign exchange (gain)/loss     (1,148,602)        210,078 
 Amortization of intangible assets                  295,800         295,800 
 Depreciation of property and equipment             870,705         687,889 
 Interest on long-term debt and other                                       
  financing costs                                 1,112,912         635,247 
 Change in fair value of derivative                                         
  financial instrument                             (182,271)         94,158 
 Share based compensation                         1,575,408       2,707,955 
 Intangible asset write-off                          50,000               - 
 Loss on disposal of property and equipment          49,331               - 
 Deferred income tax liability                            -         (57,898)
 Recovery of deferred income tax                   (320,000)              - 
 Income tax provision                                     -         (53,036)
Net changes in non-cash working capital                                     
 items related to operating activities:                                     
 Inventory                                       (1,913,772)              - 
 Prepaids and other assets                         (977,790)       (734,228)
 Accounts payable and accrued liabilities         5,069,637       1,108,512 
Income taxes received (paid)                              -         (22,876)
                                             --------------- ---------------
                                                (27,473,570)    (23,152,112)
                                             --------------- ---------------
                                                                            
CASH FLOWS FROM FINANCING ACTIVITIES                                        
--------------------------------------------                                
Proceeds from issuance of common shares and                                 
 warrants, net of financing costs                41,526,379      11,731,604 
Proceeds from long-term debt financing, net                                 
 of financing costs                                       -       6,914,379 
Proceeds from exercise of warrants                        -           5,233 
Proceeds from exercise of options                         -          50,000 
Payment of long-term debt obligations            (2,750,000)              - 
Payment of capital lease obligations               (136,451)       (400,669)
Interest paid                                      (643,025)       (346,419)
                                             --------------- ---------------
                                                 37,996,903      17,954,128 
                                             --------------- ---------------
                                                                            
CASH FLOWS FROM INVESTING ACTIVITIES                                        
--------------------------------------------                                
Acquisition of property and equipment              (891,575)       (136,941)
Proceeds from sale of property and equipment          3,219           2,833 
Restricted cash                                           -         (25,128)
                                             --------------- ---------------
                                                   (888,356)       (159,236)
                                             --------------- ---------------
                                                                            
                                                                            
NET INCREASE/(DECREASE) IN CASH FOR THE YEAR     10,783,580      (5,567,298)
                                                                            
Exchange (loss)/gain on cash                       (740,831)         45,594 
                                                                            
CASH BEGINNING OF YEAR                            9,216,999      14,528,625 
                                             --------------- ---------------
                                                                            
CASH END OF YEAR                             $   18,111,145  $    9,216,999 
                                             --------------- ---------------

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