Trimel Pharmaceuticals Corporation

TSX : TRL


Trimel Pharmaceuticals Corporation

May 08, 2014 17:29 ET

Trimel Provides Corporate Update and First Quarter 2014 Financial Results

TORONTO, ONTARIO--(Marketwired - May 8, 2014) - Trimel Pharmaceuticals Corporation (TSX:TRL) today provided an overview of its corporate accomplishments and reported financial results for the three month period ended March 31, 2014.

2014 Corporate Developments

As previously communicated, the Food and Drug Administration's ("FDA") review of CompleoTRT™ is progressing and is in its final stages. Barring any unforeseen circumstances, the Company expects to obtain a final decision regarding marketing approval in late May 2014.

With respect to the ongoing Phase II clinical trial for Tefina™, a product being developed for the treatment of Female Orgasmic Disorder, the last patient enrolled in the study has now completed the applicable treatment protocol. Full database lock is scheduled to occur on May 9, 2014. The Company anticipates receiving top-line results from the study by the end of May 2014.

During the 2014 first quarter, the Company successfully raised net proceeds of CAD $10.5 million (US$9.5 million) from a private placement which closed on February 21, 2014. In connection with the private placement, the Company issued 14,829,676 common shares at a price of CAD$0.711 per share.

Shareholder Meeting and Earnings Call

Shareholders are advised that an annual general and special meeting of shareholders will occur on June 12, 2014 at 11:00 a.m. (Toronto time) at The Toronto Region Board of Trade, First Canadian Place, 77 Adelaide Street West, Toronto, Ontario. Shareholders of record as of May 6, 2014 shall be entitled to vote on all matters at the meeting, and a detailed management information circular and voting materials will be mailed to shareholders shortly. If shareholders have not received their materials by June 1, 2014, they are encouraged to follow up directly with their brokers at such time.

Additionally, shareholders are reminded of the conference call to discuss the Company's first quarter results to be held on May 9, 2014 at 8:30 a.m. (Toronto time). To access the call live, please dial 416-340-2216 or 1-866-223-7781. Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays. A replay of the conference call will be available until 7:00 p.m. (Toronto time) on Friday, May 16, 2014 by dialing 905-694-9451 or 1-800-408-3053, using access code: 6382379#.

Financial Results for the Three Months Ended March 31, 2014

For the three month period ended March 31, 2014, Trimel incurred Research and Development ("R&D") expenses of US$2.7 million, as compared to US$4.9 million for the comparable 2013 period. Higher R&D expenses for the 2013 first quarter reflected CompleoTRT™ expenses associated with the NDA submission in April 2013, a $2.0 million time-based milestone payment which became due on March 31, 2013, and development materials and mould prototypes for CompleoTRT™. First quarter 2014 R&D expenses were impacted by higher Tefina™ clinical trial costs as this study progressed to its completion in April 2014.

Trimel incurred General and Administrative expenses of US$1.3 million for the three month period ended March 31, 2014, as compared to US$3.4 million for the comparable 2013 period. The decrease in spending was primarily attributable to lower legal fees related to arbitration, corporate and intellectual property matters. The arbitration matters were settled pursuant to a December 21, 2013 agreement.

For the three month period ended March 31, 2014, the Company incurred a net loss of US$0.02 per share, as compared to a net loss of US$0.09 per share for the comparable 2013 period.

At March 31, 2014, the Company had total assets of US$27.2 million, as compared to US$28.1 million at December 31, 2013 and total liabilities of US$8.4 million at March 31, 2014, as compared to US$14.6 million at December 31, 2013. The US$6.2 million decrease in total liabilities was primarily impacted by a US$4.25 million milestone obligation paid to M&P Patent AG, payments related to the Company's debt facility and payments related to the purchase of CompleoTRT™ inventory.

The Company had a net cash outflow of US$0.6 million for the three months ended March 31, 2014. After adjusting this net cash outflow for the US$9.5 million private placement and the US$4.25 million milestone payment to M&P Patent AG which was accrued at the end of fiscal 2013 and paid on January 2, 2014, the Company's burn rate during the 2014 first quarter was approximately US$5.85 million, or an average of US$1.95 million per month. The Company believes it has sufficient resources to fund its ongoing activities through 2014, depending on the timing of further clinical activities and barring unforeseen events.

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
CONDENSED INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT MARCH 31, 2014
UNAUDITED
(expressed in U.S. Dollars)
ASSETS
March 31, December 31,
2014 2013
CURRENT
Cash$ 17,507,518 $ 18,111,145
Restricted cash22,614 23,505
Inventory2,179,094 1,913,772
Prepaids and other assets1,716,208 1,582,924
21,425,434 21,631,346
NON-CURRENT ASSETS
Property and equipment, net2,582,675 3,273,196
Intangible assets3,142,850 3,216,800
TOTAL ASSETS$ 27,150,959 $ 28,121,342
LIABILITIES
CURRENT
Accounts payable and accrued liabilities$ 4,438,903 $ 9,864,079
Current portion of long-term debt, net of issuance costs2,846,946 2,834,639
7,285,849 12,698,718
LONG-TERM
Long-term debt, net of issuance costs1,092,120 1,827,082
Derivative financial instrument41,676 20,977
TOTAL LIABILITIES$ 8,419,645 $ 14,546,777
SHAREHOLDERS' EQUITY
Share capital129,211,443 119,741,040
Warrants1,039,705 1,039,705
Contributed surplus8,058,386 7,987,237
Accumulated other comprehensive income (loss)(3,445,938)(1,639,862)
Deficit(116,132,282)(113,553,555)
TOTAL SHAREHOLDERS' EQUITY18,731,314 13,574,565
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$ 27,150,959 $ 28,121,342
TRIMEL PHARMACEUTICALS CORPORATION
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013
UNAUDITED
(expressed in U.S. Dollars)
2014 2013
EXPENSES
Research and development $ 2,709,961 $ 4,874,417
General and administrative 1,275,065 3,402,311
Total operating expenses 3,985,026 8,276,728
FINANCE COSTS, NET
Interest on long-term debt and other financing costs 176,712 288,655
Interest income (19,643 ) (4,143 )
Foreign exchange (gain)/ loss (1,584,067 ) 3,370
Change in fair value of derivative financial instrument 20,699 (135,967 )
(1,406,299 ) 151,915
TOTAL EXPENSES 2,578,727 8,428,643
LOSS BEFORE INCOME TAXES (2,578,727 ) (8,428,643 )
INCOME TAXES - -
NET LOSS $ (2,578,727 ) $ (8,428,643 )
OTHER COMPREHENSIVE LOSS, NET OF INCOME TAX
Items that may be reclassified subsequently to profit or loss:
Foreign currency translation adjustment (1,806,076 ) (126,487 )
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD $ (4,384,803 ) $ (8,555,130 )
Basic and diluted weighted average shares outstanding 154,722,955 90,796,762
Basic and diluted net loss per common share $ (0.02 ) $ (0.09 )
TRIMEL PHARMACEUTICALS CORPORATION
CONDENSED INTERIM CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)
FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013
UNAUDITED
(expressed in U.S. Dollars)
Share capital Warrants Contributed surplus Accumulated
other
comprehensive
income
(loss)
Deficit Total
Balance, January 1, 2013 $ 78,214,661 $ 3,452,607 $ 4,318,927 $ 362,920 $ (81,598,627 ) $ 4,750,488
Net loss for the period - - - - (8,428,643 ) (8,428,643 )
Cumulative translation adjustment - - - (126,487 ) - (126,487 )
Total comprehensive loss for the period - - - (126,487 ) (8,428,643 ) (8,555,130 )
Share based compensation - - 477,545 - - 477,545
Balance as at March 31, 2013 $ 78,214,661 $ 3,452,607 $ 4,796,472 $ 236,433 $ (90,027,270 ) $ (3,327,097 )
Balance, January 1, 2014 $ 119,741,040 $ 1,039,705 $ 7,987,237 $ (1,639,862 ) $ (113,553,555 ) $ 13,574,565
Net loss for the period - - - - (2,578,727 ) (2,578,727 )
Cumulative translation adjustment - - - (1,806,076 ) - (1,806,076 )
Total comprehensive loss for the period - - - (1,806,076 ) (2,578,727 ) (4,384,803 )
Common shares, net of share issuance costs 9,470,403 - - - - 9,470,403
Share based compensation - - 71,149 - - 71,149
Balance as at March 31, 2014 $ 129,211,443 $ 1,039,705 $ 8,058,386 $ (3,445,938 ) $ (116,132,282 ) $ 18,731,314
TRIMEL PHARMACEUTICALS CORPORATION
CONDENSED INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013
UNAUDITED
(expressed in U.S. Dollars)
2014 2013
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss for the period $ (2,578,727 ) $ (8,428,643 )
Items not requiring an outlay of cash:
Adjustment for foreign exchange (gain)/loss (1,250,269 ) 63,742
Amortization of intangible assets 73,950 73,950
Depreciation of property and equipment 635,799 170,414
Interest on long-term debt and other financing costs 176,712 288,655
Change in fair value of derivative financial instrument 20,699 (135,967 )
Share based compensation 71,149 477,545
Net changes in non-cash working capital items related to operating activities:
Inventory (265,322 ) -
Prepaids and other assets (137,696 ) (158,947 )
Accounts payable and accrued liabilities (5,404,597 ) 3,561,219
Provisions - (7,784 )
(8,658,302 ) (4,095,816 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common shares, net of financing costs 9,470,403 -
Financing costs, long-term debt (35,757 ) -
Payment of long-term debt obligations (750,000 ) (500,000 )
Payment of capital lease obligations - (103,705 )
Interest paid (78,836 ) (130,311 )
8,605,810 (734,016 )
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of property and equipment (27,103 ) (34,796 )
Proceeds from sale of property and equipment - 1,015
(27,103 ) (33,781 )
NET DECREASE IN CASH FOR THE PERIOD (79,595 ) (4,863,613 )
Exchange (loss) on cash (524,032 ) (144,542 )
CASH BEGINNING OF PERIOD 18,111,145 9,216,999
CASH END OF PERIOD $ 17,507,518 $ 4,208,844

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