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8-K - CURRENT REPORT - Tribute Pharmaceuticals Canada Inc.tbuff_8k.htm
EXHIBIT 99.1
 
 
Press Release
Source: Tribute Pharmaceuticals
Canada Inc.
 
Tribute Pharmaceuticals Reports First Quarter 2014 Results
 & Schedules First Quarter 2014 Conference Call

MILTON, ONTARIO--(Marketwired - May 15, 2014) - Tribute Pharmaceuticals Canada Inc. (OTCQB:TBUFF) ("Tribute" or the "Company"), a specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada and the U.S., today announced financial results for its first quarter ending March 31, 2014. In this press release, all dollar amounts are expressed in Canadian currency - unless otherwise noted - and results are reported in accordance with United States generally accepted accounting principles (U.S. GAAP).

Recent Highlights:

As announced by the Company in a press release issued on May 13, 2014, Tribute entered into an exclusive license and supply agreement with Faes Farma, S.A. (“Faes”), a Spanish pharmaceutical company, for the exclusive right to sell Bilastine, a product for the treatment of Allergic Rhinitis and Chronic Idiopathic Urticaria (hives) in Canada. The exclusive license is inclusive of prescription and non-prescription rights for Bilastine, as well as adult and paediatric presentations in Canada. Sales of Bilastine are subject to receiving regulatory approval from Health Canada.

First Quarter 2014 Highlights:

- Revenues increased 2.1% for the quarter ended March 31, 2014 compared to the same period in 2013;

- Gross profit was up 3.5% for the quarter ended March 31, 2014 compared to the same period in 2013;

- Licensed domestic product net sales, which includes the Company’s promoted products Soriatane® and Bezalip® SR, increased 20.2% for the quarter ended March 31, 2014 compared to the same period in 2013;
 
- Excluding the initial Cambia® wholesaler and pharmacy pipeline stocking program implemented during the first quarter of 2013, as part of the initial launch of Cambia® to general practitioners, other domestic product sales increased 30.2% for the quarter ended March 31, 2014 compared to the same period in 2013;
 
- IMS Health, an audited third party provider of sales data, reported a 182.3% increase in total prescriptions written for Cambia® during the quarter ended March 31, 2014 compared to the same period in 2013, and a 27.5% increase compared to the fourth quarter;
 
- International product sales increased by $132,600 or 40.0% for the quarter ended March 31, 2014 compared to the same period in 2013; and

- Tribute to compete in the $120 million dollar Canadian antihistamine market upon the approval by Health Canada of Bilastine, recently licenses from Faes Farma of Spain.
 
 
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“We are pleased with our performance in the first quarter of 2014,” said Rob Harris, President and CEO of Tribute. “Domestic sales trends for Cambia®, Soriatane® and Bezalip® SR all improved, and international product sales further progressed as well. With Tribute’s recently expanded sales force now established, our objectives for upcoming quarters are to continue boosting sales of all our promoted products in Canada while also introducing new products in this market. For our internally developed proprietary products NeoVisc and Uracyst, we will continue to look for new international distribution agreements as we also strive to secure additional European patents for Uracyst.”

Mr. Harris added, “With the IND for Bezalip® SR recently cleared by the FDA, we will also continue to make a concerted effort alongside JSB-Partners to find an optimal transaction partner in the U.S. In view of these near term goals, our primary mission remains the same: increase revenues through organic growth and business development efforts, as well as significantly reduce losses.”
 
Review of First Quarter 2014 Operating Results:

Total net revenues for the three-month period ended March 31, 2014 increased by 2.1% to $3,493,600 compared to $3,422,200 during the same period in 2013. The increase in sales was attributable to an increase in licensed domestic product net sales of $382,700 or 20.2%, and international product sales of $132,600 or 40.0%, which was partially offset by a decrease in other domestic product sales of $364,400 or 33.2%, as well as royalty and licensing revenues of $79,600.

Gross profit for the three-month period ended March 31, 2014 increased by 3.5% to $1,734,600 compared to $1,675,900 during same period in 2013. Underlying improvements in gross profit were due to additional gross profit of $258,200 from licensed domestic product net sales. Serving as a partial offset was a decrease in gross profit from other domestic product sales and international product sales of $119,800 and from royalty and licensing revenue of $79,600.

Selling, general and administrative expenses for the three-month period ended March 31, 2014 were $3,222,700 compared to $2,949,600 for the same period in 2013. The increase of $273,100 or 9.3% is primarily due to a significant investment in the expansion of the Company’s sales force and marketing expenses to grow its existing products, and an increase in business development expenses including $245,200 related to the development and licensing costs associated with Bezalip® SR in the U.S.

Net loss for the three-month period ended March 31, 2014 was $3,288,200, compared to a net loss of $2,716,800 for same period in 2013. This equates to a loss of $0.06 per share compared to a loss of $0.06 per share for the same period in 2013.

Excluding non-operating income of $1,509,800 for the three-month period ended March 31, 2014 (compared to $1,428,400 for the same period in 2013), the net loss from operations was $1,778,400 compared to the prior period net loss from operations of $1,603,200. The increase in the operational loss of $175,100 or 10.9% represents higher selling, general and administrative costs offset in part by increases in product margins.

The introduction of Cambia® at the pharmacy level in the first quarter of 2013 resulted in $534,800 in revenues to accommodate wholesaler and pharmacy initial stocking requirements. Excluding this one-time event, the growth rate for other domestic product sales in the first quarter of 2014 compared to the same period in 2013 would have been $170,400 or an increase of 30.2% and an adjusted overall growth for total revenue of $606,200 or 21.0%. Excluding gross profit associated with the initial Cambia® buy-in in the first quarter of 2013, the adjusted gross profit in that period was $1,174,200. This represents an increase in the gross profit of $560,500 or 47.7% for first quarter of 2014 compared to the same period in the prior year. Excluding the initial Cambia® stocking, the net loss before taxes for the three month period ended March 31, 2013 was $3,533,400. This represents an adjusted decrease in the net loss of $245,200 or 6.9% for the three month period ended March 31, 2014 compared to the same period in the prior year.

On August 8, 2013, SWK Funding LLC ("SWK"), a wholly-owned subsidiary of SWK Holdings Corporation entered into a credit agreement (the "Credit Agreement") pursuant to which the lenders party thereto provided to Tribute a term loan in the principal amount of US$6,000,000 (the "Loan") which may be increased by an additional US$2,000,000 at the Company's request on or before December 31, 2014. In connection with this loan, Tribute exercised its rights under its loan and security agreement with MidCap Financial LLC ("MidCap") to prepay the outstanding balance of the Company's term loan with MidCap. On February 4, 2014, pursuant to the terms of the Credit Agreement, SWK advanced the Company the remaining US$2,000,000 in available funds. All terms under the Credit Agreement apply to the additional loan.

The Company’s cash and cash equivalents position amounted to $3,073,300 at March 31, 2014 compared to $2,813,500 at December 31, 2013.

As previously announced on May 8, 2014, the Company will host a conference call on Thursday, May 15, 2014 at 11:00 AM EDT (8:00 AM PST) to review and discuss the Company's results for its first quarter ending March 31, 2014.

To join the conference call, use the dial-in information below. When prompted, ask for the "Tribute Pharmaceuticals Call" and/or be prepared to provide the conference ID.

Date:
05/15/2014
Time:
11:00 AM Eastern
Conference Line Dial-In (Canada & U.S.):
877-407-0782
International Dial-In:
201-689-8567
Conference ID#:
13581986
 
http://www.investorcalendar.com/IC/CEPage.asp?ID=172736

 
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Dial in at least 10 minutes before the call to ensure timely participation. A playback will be available until 11:59 PM May 29, 2014. To listen to the conference call playback, please call     1-877-660-6853 within Canada and the United States or 1-201-612-7415 if calling internationally.
 
About Tribute Pharmaceuticals Canada Inc.

Tribute is a Canadian specialty pharmaceutical company focused on the acquisition, licensing, development and management of pharmaceutical and healthcare products with its primary focus on the Canadian and U.S. market. Tribute markets Cambia®** (diclofenac potassium for oral solution), Bezalip® SR* (bezafibrate), Soriatane®* (acitretin), NeoVisc® (1.0% sodium hyaluronate solution) Uracyst® (sodium chondroitin sulfate solution 2%), and Collatamp® G*** (gentamicin-impregnated collagen) in the Canadian market. Additionally, NeoVisc and Uracyst are commercially available and are sold globally through various international partnerships.

For further information on Tribute visit the Company's website: http://www.tributepharma.com.

Tribute Pharmaceuticals' Forward Looking Statement

This press release contains certain forward-looking statements about Tribute as defined in the Private Securities Litigation Reform Act of 1995, which statements can be identified by the use of forward-looking terminology, such as "may", "will", "expect", "intend", "anticipate", "estimate", "predict", "plan" or "continue" or the negative thereof or other variations thereon or comparable terminology referring to future events or results. Forward-looking statements, by their nature, are subject to risks and uncertainties, Tribute actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including, but not limited to, statements regarding our expectations regarding clinical trials, the timing of clinical results, development timelines, regulatory filings and submissions for our product candidates and the approval of the products by the regulatory authorities, general economic conditions, the ability of Tribute to successfully integrate operations, and the timing of expenditures and expansion opportunities, any of which could cause actual results to vary materially from current results or anticipated future results. See Tribute reports filed with the Canadian Securities Regulatory Authorities and the U.S. Securities and Exchange Commission including Tribute’s Form 10-K for the fiscal year ended December 31, 2013, which contains for cautionary statements identifying important risk factors with respect to such forward-looking statements, including certain risks and uncertainties that could cause actual results to differ materially from results referred to in any forward-looking statements. Tribute assumes no obligation to update the information contained in this press release to update forward-looking statements to reflect changed assumptions, the occurrence of anticipated events or changes in future operating results, financial condition or business over time.

*Bezalip®SR and Soriatane® are registered trademarks and under license from Actavis Group PTC ehf
**Cambia® is a registered trademark and under license from Depomed, Inc.
***Collatamp G® is a registered trademark and under license EUSA Pharma (Europe) Limited.

For further information on Tribute, visit http://www.tributepharma.com.

Contact:
Tribute Pharmaceuticals Canada Inc.
Scott Langille
CFO
905-876-3166
scott.langille@tributepharma.com

Investor Relations
Kevin Fickle
President, Nuwa Group LLC
Phone: (925) 330-8315
Email: Kevin@nuwagroup.com

 
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TRIBUTE PHARMACEUTICALS CANADA INC.

CONDENSED INTERIM BALANCE SHEETS
(Expressed in Canadian dollars)
(Unaudited)
 
   
As at
March 31,
2014
   
As at
December 31,
2013
 
ASSETS
           
Current
           
Cash and cash equivalents
  $ 3,073,341     $  2,813,472  
Accounts receivable, net of allowance of $nil
    1,656,851          591,766  
Inventories
    1,103,932          1,044,831  
Taxes recoverable
    122,410          651,791  
Loan receivable
    15,814          15,814  
Prepaid expenses and other receivables
    174,922          165,886  
Current portion of debt issuance costs, net     119,140         91,100  
Total current assets
    6,266,410          5,374,660  
Property, plant and equipment, net
    1,076,093          1,089,919  
Intangible assets, net
    9,481,581          9,717,173  
Goodwill
    3,599,077          3,599,077  
Debt issuance costs, net
    342,194          253,712  
Total assets
  $ 20,765,355     $ 20,034,541  
                 
LIABILITIES
               
Current
               
Accounts payable and accrued liabilities
  $ 3,092,100     $ 3,284,756  
Current portion of long term debt
    345,728       204,700  
Warrant liability
    4,499,402       2,966,714  
Other current liability
    103,488       38,156  
Total current liabilities
    8,040,718       6,494,326  
Long term debt
    7,849,090       5,640,102  
Total liabilities
    15,889,808       12,134,428  
                 
Contingencies and commitments
               
                 
SHAREHOLDERS’ EQUITY
               
Capital Stock
               
AUTHORIZED
               
Unlimited   Non-voting, convertible redeemable and retractable preferred shares with no par value
               
Unlimited   Common shares with no par value
               
ISSUED
               
Common shares 51,581,238  (2013 – 51,081,238)
    20,159,102       19,947,290  
Additional paid-in capital options
    2,404,022        2,286,890  
Accumulated other comprehensive loss
    (103,488 )     (38,156 )
Deficit
    (17,584,089 )     (14,295,911 )
Total shareholders’ equity
    4,875,547        7,900,113  
Total liabilities and shareholders’ equity
  $ 20,765,355     $ 20,034,541  
 
 
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TRIBUTE PHARMACEUTICALS CANADA INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS AND
COMPREHENSIVE (LOSS) AND DEFICIT
(Expressed in Canadian dollars)
(Unaudited)

For the Periods Ended March 31,

   
2014
   
2013
 
Revenues
           
Licensed domestic product net sales
  $ 2,276,383     $ 1,893,640  
Other domestic product sales
    734,779       1,099,162  
International product sales
    463,978       331,338  
Royalty and licensing revenues
    18,414       98,040  
Total revenues
    3,493,554       3,422,180  
                 
Cost of sales
               
Licensor sales and distribution fees
    1,413,043       1,288,479  
Cost of products sold
    345,864       457,763  
Total cost of sales
    1,758,907       1,746,242  
Gross Profit
    1,734,647       1,675,938  
Expenses
               
Selling, general and administrative
    3,222,661       2,949,604  
Amortization
    290,352       329,572  
Total operating expenses
    3,513,013       3,279,176  
(Loss) from operations
    (1,778,366 )     (1,603,238 )
                 
Non-operating income (expenses)
               
Gain on derivative instrument
    200,000       -  
Change in warrant liability
    (1,411,774 )     (1,317,041 )
Accretion expense
    (31,118 )     (24,245 )
Interest expense
    (267,292 )     (87,858 )
Interest income
    372       725  
(Loss) and comprehensive (loss) before tax
    (3,288,178 )     (3,031,657 )
Deferred income tax recovery
    -       (314,900 )
Net (loss) for the period
    (3,288,178 )     (2,716,757 )
Unrealized loss on derivative instrument, net of tax
    (103,488 )     -  
Net loss and comprehensive loss for the period
  $ (3,391,666 )   $ (2,716,757 )
Deficit, beginning of period
    (14,295,911 )     (7,723,556 )
Deficit, end of period
    (17,584,089 )     (10,440,313 )
Loss Per Share                         -        Basic
  $ (0.06 )   $ (0.06 )
-  Diluted
  $ (0.06 )   $ (0.06 )
Weighted Average Number of Common Shares Outstanding               -       Basic
    51,420,127       43,535,459  
-  Diluted
    51,420,127       43,535,459  

 
 
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TRIBUTE PHARMACEUTICALS CANADA INC.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Expressed in Canadian dollars)
(Unaudited)

For the Periods Ended March 31,
 
   
2014
   
2013
 
Cash flows from (used in) operating activities
           
Net (loss)
  $ (3,288,178 )   $ (2,716,757 )
Items not affecting cash:
               
Deferred income tax recovery
    -       (314,900 )
Amortization
    295,128       344,305  
Change in warrant liability
    1,411,774       1,317,041  
Stock-based compensation
    117,133       174,487  
Accretion expense
    31,118       24,245  
Paid in  common shares for services
    211,812       -  
Change in non-cash operating assets and liabilities
    (796,497 )     (2,534,179 )
Cash flows (used in) operating activities
    (2,017,710 )     (3,705,758 )
Cash flows (used in) investing activities
               
Additions to property, plant and equipment
    (4,353 )     -  
Payment of contingent liabilities
    -       (460,000 )
Increase in patents and licensing agreements
    (16,593 )     -  
Cash flows (used in) investing activities
    (20,946 )     (460,000 )
Cash flows from (used in) financing activities
               
Financing costs deferred
    (128,181 )     -  
Long term debt issued
    2,211,000       -  
Units issued
    -       4,662,700  
Long term debt repayment
    -       (330,652 )
Share issuance costs
    -       (403,727 )
Cash flows from financing activities
    2,082,819       3,928,321  
Changes in cash and cash equivalents
    44,163       (237,437 )
Change in cash due to changes in foreign exchange
    215,706       55,417  
Cash and cash equivalents, beginning of period
    2,813,472       2,283,868  
Cash and cash equivalents, end of period
  $ 3,073,341     $ 2,101,848  
 
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