Welcome!

News Feed Item

Trimel Provides Corporate Update and Second Quarter 2014 Financial Results

- Natesto(TM) Receives FDA Approval

TORONTO, ONTARIO -- (Marketwired) -- 07/30/14 -- Trimel Pharmaceuticals Corporation (TSX: TRL) today provided an overview of its corporate accomplishments and reported financial results for the three month period ended June 30, 2014.

Corporate Highlights

Natesto™ Approval

On May 28, 2014, the United States Food and Drug Administration approved Natesto™ (testosterone nasal gel), for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism).

Tefina™ Phase II Results

Also on May 28, 2014, Trimel announced positive top-line results of its Phase II clinical trial evaluating the efficacy and safety of Tefina™, a "use-as-required" testosterone nasal gel for the treatment of Female Orgasmic Disorder ("FOD"). Women treated with Tefina™ 0.6 mg reported a 35% increase in the average number of orgasms versus placebo (p=0.0013) and 58% of women had at least one orgasm, compared to 43% of women in the placebo group. Tefina™ 0.6 mg also showed a statistically significant (p=0.017) improvement in distress over placebo.

Estrace® Acquisition

On July 16, 2014, the Company announced that it has acquired from Shire plc the Canadian rights for Estrace® (17-beta estradiol), a product indicated for the treatment of symptomatic relief of menopausal symptoms. Estrace® has been available on the Canadian market for 39 years and generated revenues of USD$9.9 million in 2013 within a hormone replacement therapy ("HRT") market valued at USD$100 million and grew by 6% in 2013. It is anticipated that Estrace® will contribute significantly to the Company's earnings before interest, tax, depreciation, and amortization ("EBITDA") and future cash flows.

Private Placement

On July 30, 2014 the Company completed a private placement of 28,801,000 common shares of the Company at a price of CDN$0.62 per share for gross proceeds of CDN$17,856,620.

The Company has used the full net proceeds from the private placement to repay a significant portion of a convertible promissory note previously issued to First Generation Capital Inc. ("First Generation"), a company affiliated with Mr. Ian Ihnatowycz, the Chairman of the Board of Directors of the Company. Following this repayment, First Generation has advised that it intends to convert a portion of the note into a total of 8,945,796 common shares after August 21, 2014. Following such conversion, First Generation would hold approximately 23.7% of the company's common shares, thereby maintaining its current securityholding percentage. The indebtedness remaining under the note (expected to equal approximately US$4.1 million) following such conversion and repayment would remain outstanding in accordance with the terms of the note and no longer be convertible into common shares after such time.

As a result of the transactions noted above, the Company has received an additional USD$5.0 million from its senior secured lender pursuant to the terms and conditions of its applicable senior credit facility.

Financial Results for the Three Months Ended June 30, 2014 (All values in U.S. dollars)

Research and Development ("R&D") expenses were $4.1 million and $6.9 million respectively for the three months ended June 30, 2014 and 2013. The variance is primarily due to costs related to the filing of the Natesto™ new drug application ("NDA") that were incurred during the 2013 period. The decrease in Natesto™ related expenses is offset by higher Tefina™ clinical trial costs in 2014 as this study progressed to its completion during the quarter.

Trimel incurred General and Administrative ("G&A") expenses of $1.5 million and $2.4 million respectively for the three months ended June 30, 2014 and 2013. The decrease in spending was primarily attributable to lower salaries, benefits and share-based compensation, and 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 months ended June 30, 2014, the Company incurred a net loss of $0.05 per share as compared to a net loss of $0.07 per share for the same 2013 period.

At June 30, 2014, the Company had total assets of $22.4 million, as compared to $28.1 million at December 31, 2013 and total liabilities of $9.0 million at June 30, 2014, as compared to $14.5 million at December 31, 2013. The $5.8 million decrease in assets is primarily due to the $5.8 million decrease in cash during the period as it was used to fund current activities. The $5.6 million decrease in total liabilities was primarily impacted by $4.25 million milestone obligation paid to M&P Patent AG and payments related to the Company's debt facility, offset by a $2.5 million Natesto™ milestone accrual that was made in the second quarter of 2014.

The Company had a net cash outflow of $5.2 million for the three months ended June 30, 2014 and had $12.3 million of cash at June 30, 2014. The Company's average monthly burn rate during the three months ended June 30, 2014 was approximately US$1.7 million as compared to approximately $3.1 million for the three months ended June 30, 2013 after excluding certain payments made during the second quarter of 2013 (NDA filing fee for Natesto™, a milestone payment made to a technology partner and an inventory prepayment). The Company believes it has sufficient resources to fund its ongoing activities into 2015, depending on the timing of further clinical activities and barring unforeseen events. The Company's average monthly burn rate is a non-GAAP financial measure with no standard meaning under IFRS, which management uses to further evaluate the Company's results of operations in each reporting period.

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.

Conference Call Details

Shareholders are reminded of the conference call to discuss the Company's second quarter results to be held on July 31, 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 Wednesday, August 6, 2014 by dialling 905-694-9451 or 1-800-408-3053, using access code: 8161397#.

About Trimel

Trimel is a specialty pharmaceutical company involved in the sale, distribution, and development of products with a focus in men's health, women's health, and respiratory medicine. Natesto™, a product utilizing Trimel's licensed nasal gel technology, has been approved for sale in the United States by the FDA. 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 with respect to the performance of Estrace®, 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 JUNE 30, 2014
                                 UNAUDITED
                        (expressed in U.S. Dollars)

                                   ASSETS
                                                    June 30,   December 31,
                                                        2014           2013
                                              ------------------------------

CURRENT
  Cash                                          $ 12,289,692   $ 18,111,145
  Restricted cash                                     23,417         23,505
  Inventory                                        3,758,254      1,913,772
  Prepaids and other assets                          700,779      1,582,924
  Assets classified as held for sale                 107,135              -
                                              ------------------------------
                                                  16,879,277     21,631,346

NON-CURRENT ASSETS
  Property and equipment, net                      2,407,046      3,273,196
  Intangible assets                                3,068,900      3,216,800
                                              ------------------------------
TOTAL ASSETS                                    $ 22,355,223   $ 28,121,342
                                              ------------------------------


                                LIABILITIES

CURRENT
  Accounts payable and accrued liabilities       $ 5,678,088    $ 9,864,079
  Current portion of long-term debt, net of
   issuance costs                                  2,874,046      2,834,639
                                              ------------------------------
                                                   8,552,134     12,698,718

LONG-TERM
  Long-term debt, net of issuance costs              349,999      1,827,082
  Derivative financial instrument                     49,008         20,977
                                              ------------------------------
TOTAL LIABILITIES                                $ 8,951,141   $ 14,546,777
                                              ------------------------------


                            SHAREHOLDERS' EQUITY

Share capital                                    129,211,443    119,741,040
Warrants                                           1,039,705      1,039,705
Contributed surplus                                8,284,868      7,987,237
Accumulated other comprehensive (loss)            (1,539,663)    (1,639,862)
Deficit                                         (123,592,271)  (113,553,555)
                                              ------------------------------
TOTAL SHAREHOLDERS' EQUITY                        13,404,082     13,574,565
                                              ------------------------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY      $ 22,355,223   $ 28,121,342
                                              ------------------------------


                     TRIMEL PHARMACEUTICALS CORPORATION
  CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
         FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2014 AND 2013
                                 UNAUDITED
                        (expressed in U.S. Dollars)

                     For the three months ended   For the six months ended
                              June 30,                    June 30,
                             2014          2013          2014          2013
                    --------------------------------------------------------
EXPENSES
  Research and
   development        $ 4,139,357   $ 6,917,920   $ 6,849,318  $ 11,792,337
  General and
   administrative       1,531,071     2,361,902     2,806,136     5,764,213
                    --------------------------------------------------------
  Total operating
   expenses             5,670,428     9,279,822     9,655,454    17,556,550
                    --------------------------------------------------------

FINANCE COSTS, NET
  Interest on long-
   term debt and
   other financing
   costs                  179,786       369,723       356,498       658,378
  Interest income         (29,514)      (36,940)      (49,157)      (41,083)
  Foreign exchange
   (gain)/ loss         1,632,069      (471,406)       48,002      (468,036)
  Change in fair
   value of
   derivative
   financial
   instrument               7,220       (10,947)       27,919      (146,914)
                    --------------------------------------------------------
                        1,789,561      (149,570)      383,262         2,345
                    --------------------------------------------------------
TOTAL EXPENSES          7,459,989     9,130,252    10,038,716    17,558,895
                    --------------------------------------------------------
NET LOSS             $ (7,459,989) $ (9,130,252) $(10,038,716) $(17,558,895)
                    --------------------------------------------------------
                    --------------------------------------------------------

OTHER COMPREHENSIVE INCOME
(LOSS), NET OF INCOME TAX
Items that may be
 reclassified
 subsequently to
 profit or loss:
  Foreign currency
   translation
   adjustment           1,906,275    (1,403,787)      100,199    (1,530,274)
                    --------------------------------------------------------
TOTAL COMPREHENSIVE
 LOSS FOR THE PERIOD $ (5,553,714) $(10,534,039) $ (9,938,517) $(19,089,169)
                    --------------------------------------------------------
                    --------------------------------------------------------
Basic and diluted
 weighted average
 shares outstanding   163,126,438   132,555,004   158,947,911   112,108,917

Basic and diluted
 net loss per common
 share                    $ (0.05)      $ (0.07)      $ (0.06)      $ (0.16)


                     TRIMEL PHARMACEUTICALS CORPORATION
 CONDENSED INTERIM CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
               FOR THE SIX MONTHS ENDED JUNE 30, 2014 AND 2013
                                  UNAUDITED
                         (expressed in U.S. Dollars)

                                                                Contributed
                          Notes Share capital       Warrants        surplus
                               ---------------------------------------------

Balance, January 1, 2013         $ 78,214,661    $ 3,452,607    $ 4,318,927

Net loss for the period                     -              -              -

Cumulative translation
 adjustment                                 -              -              -

----------------------------------------------------------------------------

Total comprehensive loss
 for the period                             -              -              -

Common shares, net of
 share issuance costs              41,526,379              -              -

Share based compensation                    -              -      1,000,556
----------------------------------------------------------------------------
Balance as at June 30,
 2013                           $ 119,741,040    $ 3,452,607    $ 5,319,483
----------------------------------------------------------------------------

Balance, January 1, 2014        $ 119,741,040    $ 1,039,705    $ 7,987,237

Net loss for the period                     -              -              -

Cumulative translation
 adjustment                                 -              -              -

----------------------------------------------------------------------------

Total comprehensive loss
 for the period                             -              -              -

Common shares, net of     8
 share issuance costs               9,470,403              -              -

Share based compensation  11                -              -        297,631
----------------------------------------------------------------------------
Balance as at June 30,
 2014                           $ 129,211,443    $ 1,039,705    $ 8,284,868
----------------------------------------------------------------------------


                                  Accumulated
                                        other
                                comprehensive
                          Notes  income (loss)       Deficit          Total
                               ---------------------------------------------

Balance, January 1, 2013            $ 362,920  $ (81,598,627)   $ 4,750,488

Net loss for the period                     -    (17,558,895)   (17,558,895)

Cumulative translation
 adjustment                        (1,530,274)             -     (1,530,274)

----------------------------------------------------------------------------

Total comprehensive loss
 for the period                    (1,530,274)   (17,558,895)   (19,089,169)

Common shares, net of
 share issuance costs                       -              -     41,526,379

Share based compensation                    -              -      1,000,556
----------------------------------------------------------------------------
Balance as at June 30,
 2013                            $ (1,167,354) $ (99,157,522)  $ 28,188,254
----------------------------------------------------------------------------

Balance, January 1, 2014         $ (1,639,862) $(113,553,555)  $ 13,574,565

Net loss for the period                     -    (10,038,716)   (10,038,716)

Cumulative translation
 adjustment                           100,199              -        100,199

----------------------------------------------------------------------------

Total comprehensive loss
 for the period                       100,199    (10,038,716)    (9,938,517)

Common shares, net of     8
 share issuance costs                       -              -      9,470,403

Share based compensation  11                -              -        297,631
----------------------------------------------------------------------------
Balance as at June 30,
 2014                            $ (1,539,663) $(123,592,271)  $ 13,404,082
----------------------------------------------------------------------------


                     TRIMEL PHARMACEUTICALS CORPORATION
           CONDENSED INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS
              FOR THE SIX MONTHS ENDED JUNE 30, 2014 AND 2013
                                 UNAUDITED
                        (expressed in U.S. Dollars)

                                                        2014           2013
                                              ------------------------------

CASH FLOWS FROM OPERATING ACTIVITIES
----------------------------------------------
Net loss for the period                        $ (10,038,716) $ (17,558,895)
Items not requiring an outlay of cash:
  Adjustment for foreign exchange (gain)/loss        220,411       (175,959)
  Amortization of intangible assets                  147,900        147,900
  Depreciation of property and equipment           1,078,511        412,561
  Interest on long-term debt and other
   financing costs                                   356,498        658,378
  Change in fair value of derivative financial
   instrument                                         27,919       (146,914)
  Share based compensation                           297,631      1,000,556
  Impairment of property and equipment                45,138          9,338
Net changes in non-cash working capital items
 related to operating activities:
  Inventory                                         (813,763)             -
  Prepaids and other assets                         (116,582)    (1,926,000)
  Accounts payable and accrued liabilities        (4,579,699)       383,458
Provisions                                                 -        (41,620)
                                              ------------------------------
                                                 (13,374,752)   (17,237,197)
                                              ------------------------------

CASH FLOWS FROM FINANCING ACTIVITIES
----------------------------------------------
Proceeds from issuance of common shares, net
 of financing costs                                9,470,403     41,526,379
Financing costs, long-term debt                      (70,907)             -
Payment of long-term debt obligations             (1,500,000)    (1,250,000)
Payment of capital lease obligations                       -       (140,551)
Interest paid                                       (180,274)      (319,602)
                                              ------------------------------
                                                   7,719,222     39,816,226
                                              ------------------------------

CASH FLOWS FROM INVESTING ACTIVITIES
----------------------------------------------
Acquisition of property and equipment, net of
 deposits                                            (58,838)      (245,611)
Proceeds from sale of property and equipment               -          2,812
                                              ------------------------------
                                                     (58,838)      (242,799)
                                              ------------------------------


NET (DECREASE)/INCREASE IN CASH FOR THE PERIOD    (5,714,368)    22,336,230

Exchange (loss) on cash                             (107,085)    (1,238,830)

CASH BEGINNING OF PERIOD                          18,111,145      9,216,999
                                              ------------------------------

CASH END OF PERIOD                              $ 12,289,692   $ 30,314,399
                                              ------------------------------

Contacts:
Kenneth G. Howling
Chief Financial Officer
416 679 0536
[email protected]

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
Sometimes I write a blog just to formulate and organize a point of view, and I think it’s time that I pull together the bounty of excellent information about Machine Learning. This is a topic with which business leaders must become comfortable, especially tomorrow’s business leaders (tip for my next semester University of San Francisco business students!). Machine learning is a key capability that will help organizations drive optimization and monetization opportunities, and there have been some...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"Storpool does only block-level storage so we do one thing extremely well. The growth in data is what drives the move to software-defined technologies in general and software-defined storage," explained Boyan Ivanov, CEO and co-founder at StorPool, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, provided some practical insights on what, how and why when implementing "software-defined" in the datacent...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Is advanced scheduling in Kubernetes achievable?Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, answered these questions and demonstrated techniques for implementing advanced scheduling. For example, using spot instances and co...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.