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 cash |
22,614 |
|
23,505 |
|
|
Inventory |
2,179,094 |
|
1,913,772 |
|
|
Prepaids and other assets |
1,716,208 |
|
1,582,924 |
|
|
21,425,434 |
|
21,631,346 |
|
|
|
|
|
|
| NON-CURRENT ASSETS |
|
|
|
|
|
Property and equipment, net |
2,582,675 |
|
3,273,196 |
|
|
Intangible assets |
3,142,850 |
|
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 costs |
2,846,946 |
|
2,834,639 |
|
|
7,285,849 |
|
12,698,718 |
|
|
|
|
|
|
| LONG-TERM |
|
|
|
|
|
Long-term debt, net of issuance costs |
1,092,120 |
|
1,827,082 |
|
|
Derivative financial instrument |
41,676 |
|
20,977 |
|
| TOTAL LIABILITIES |
$ 8,419,645 |
|
$ 14,546,777 |
|
|
|
|
|
|
|
|
|
|
|
| SHAREHOLDERS' EQUITY |
|
|
|
|
|
|
| Share capital |
129,211,443 |
|
119,741,040 |
|
| Warrants |
1,039,705 |
|
1,039,705 |
|
| Contributed surplus |
8,058,386 |
|
7,987,237 |
|
| Accumulated other comprehensive income (loss) |
(3,445,938 |
) |
(1,639,862 |
) |
| Deficit |
(116,132,282 |
) |
(113,553,555 |
) |
| TOTAL SHAREHOLDERS' EQUITY |
18,731,314 |
|
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 |
|
|
|
|
|
|
Trimel Pharmaceuticals CorporationKenneth G. HowlingChief
Financial Officer416 679 0536ir@trimelpharmaceuticals.com
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