TORONTO, ONTARIO -- (Marketwired) -- 03/05/14 -- 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™, 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™, 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™, 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™ 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
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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
----------------------------------------------------------------------------
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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
----------------------------------------------------------------------------
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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
--------------- ---------------
Contacts:
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0536
ir@trimelpharmaceuticals.com
