There were 919 press releases posted in the last 24 hours and 167,871 in the last 365 days.

Knight Reports 2018 Fourth Quarter and Year End Results

/EIN News/ -- MONTREAL, March 14, 2019 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a Canadian specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2018. All dollar amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2018 Highlights 

Financial Results

  • Revenues were $12,500, an increase of $3,866 or 45% over prior year.
  • Realized net gain on financial assets measured at fair value through profit or loss of $6,444.
  • Net income was $24,079, an increase of $6,835 or 40% versus prior year.

Corporate Developments

  • Received notices of reassessment from Canada Revenue Agency and Quebec Revenue Agency of $23,340 and $18,242 respectively, related to the sale of Knight’s Priority Review Voucher.
  • Accepted the resignation of Dr. Sarit Assouline and appointed Nancy Harrison on the Board of Directors.

Products

  • Received regulatory approval and launched Probuphine® for the treatment of opioid drug dependence in Canada.
  • Received regulatory approval from Health Canada for Iluvien® for the treatment of diabetic macular edema.
  • Submitted Netildex™ for approval and received a Notice of Non-Compliance ("NON") from Health Canada.
  • Entered into an exclusive licensing agreement with Ardelyx Inc. to commercialize tenapanor in Canada.
  • Entered into a licensing agreement with TherapeuticsMD, Inc. ("TXMD") to commercialize TX-004HR and
    TX-001HR in Canada and Israel.
  • Entered into a distribution, license and supply agreement with Jaguar Health Inc. ("Jaguar") to commercialize Mytesi® in Canada and Israel.
  • Entered into an out-licensing agreement with Pharma Consulting Group S.A. ("Biopas") for the commercial rights of Impavido® in Colombia, Peru, Ecuador and Paraguay.

Strategic Lending

  • Received an early repayment of US$22,757 from Medimetriks Pharmaceutical Inc. ("Medimetriks") including payment of principal of US$20,000.
  • Received US$4,460 as a partial repayment from 60⁰ Pharmaceuticals, LLC ("60P") and loaned an additional US$2,100.
  • Received $3,188 as full loan repayment and early repayment fee from Profound Medical Inc. ("Profound").
  • Received $1,305 from Pediapharm Inc. "(Pediapharm") as full loan repayment.
  • Converted $500 Antibe Therapeutics Inc. debenture into 2,489,899 common shares subsequently sold for $1,011.

Strategic Investments

  • Acquired an additional 754,716 common shares of Crescita Therapeutics Inc. through a rights offering at $0.53 per share.
  • Invested US$20,000 in common shares of TXMD at a price of US$5.10 per share.
  • Invested US$900 in common shares of Jaguar at a price of US$0.60 per share.
  • Received distributions of $6,769 from strategic fund investments and realized a gain of $1,879. 

Key Subsequent Events

  • Entered into a licensing agreement with Puma Biotechnology, Inc. ("Puma") to commercialize NERLYNX® in Canada.
  • Entered into a strategic financing agreement with Moksha8, Inc. ("Moksha8"), a specialty pharmaceutical company in Brazil and Mexico, for a loan of up to US$25,000 of which US$10,000 was issued.
  • Entered into a secured loan agreement with Triumvira Immunologics ("Triumvira") for US$5,000 for the development of its novelty T cell technology and obtained the exclusive rights to commercialize Triumvira’s future products in select countries.
  • Medison’s board of directors declared and approved dividends of $4,153, payable to Knight. 

“During the past year we made significant progress in building a specialty pharmaceutical company in Canada and select international markets. We expanded our product portfolio with the in-licensing of five innovative products offering novel treatment options in women’s health, oncology and gastroenterology,” said Jonathan Ross Goodman, CEO of Knight. “Looking ahead, the talented team at Knight and myself remain fully dedicated and committed to both the patients and the shareholders we serve. We will continue to work tirelessly to make a meaningful difference in the lives of patients and in the process deliver healthy returns to our shareholders.”

As at December 31, 2018, Knight had over $787,000 in cash, cash equivalents and marketable securities. From this strong cash position, Knight will focus on the disciplined execution of its strategy to continue building a Canadian and “rest of world” specialty pharmaceutical company.  This will be achieved through the in-licensing and acquisitions of pharmaceutical products for the Canadian and select international markets as well as through corporate acquisitions at a fair price. Knight is also focused on finding the right strategic partners in Latin America, the Middle East and Africa to further our “rest of world” strategy. Furthermore, Knight will continue to pursue deals such as strategic loans and or equity investments to secure rights to innovative pipeline assets including early stage products.

Financial Results 

  Q4-18 Q4-17 Change
  2018   2017 Change
       $1   %2      $1   %2
                 
Revenues 3,888 2,544 1,344 53% 12,500 8,634 3,866 45%
Gross margin 3,364 2,056 1,308 64% 10,195 7,049 3,146 45%
Operating expenses 4,001 3,266 (735) 23% 14,046 14,326 280 2%
Interest income3 5,944 7,783 (1,839) 24% 20,934 26,300 (5,366) 20%
Share of net income of associate 114 341 (227) 67% 555 854 (299) 35%
Net income 221 7,145 (6,924) 97% 24,079 17,244 6,835 40%
Basic earnings per share 0.002 0.050 (0.048) 96% 0.169 0.121 (0.048) 40%


1 A positive variance represents a positive impact to net income and a negative variance represents a negative impact to net income
2 Percentage change is presented in absolute values
3 Includes the sum of " interest income on financial instruments measured and amortized costs" and "other interest income" as presented in the 2018 statement of income under IFRS 9.  Refer to 2018 audited financial statements of Knight for further details.

Revenue: Increase due to timing and growth of Impavido® sales and growth in Movantik® sales.

Gross margin: Increase attributable to revenues and change in product mix. 

Operating expenses: There is no significant variance in the year while the Q4-18 increase is due to transactional professional fees and timing of certain expenses. 

Interest income: Interest income was driven by the sum of interest income and interest accretion. Interest income (excluding accretion) for Q4-18 was $5,944, an increase of 3% or $162 compared to prior year while interest income (excluding accretion) for YTD-18 was $20,934, an increase of $16 compared to prior year. The variances in interest income are explained by an increase in the average cash, cash equivalents, and marketable securities balances and an increase in interest rates, offset by a lower average loan balance. 

Net gain on financial assets measured at fair value through profit or loss: A net loss of $6,717 was recorded in Q4-18 explained by the unrealized loss on revaluations of Knight’s financial assets measured at fair value through profit or loss. For fiscal year 2018, a net gain of $7,632 was recorded on financial assets measured at fair value through profit or loss explained mainly by (i) realized gains on disposal of equity investments: $2,978 (ii) realized gains on recognition of day 1 gains and the early repayments of the Medimetriks, Profound and Pediapharm loans: $1,723 (iii) realized gains on distributions from the strategic fund investments: $1,879 (iv) net unrealized gains on the fair value revaluation of certain financial assets: $1,052. 

Net income: Net income for the quarter was driven by the above-mentioned items as well as a foreign exchange gain of $2,716 from the relative gain on certain U.S. dollar denominated financial assets. Similarly, net income for the twelve-month period was impacted by (i) other income of $1,979 due to the early repayment of fees on the Medimetriks, Profound and Pediapharm loans, (ii) share of net income of associate of $555, and (iii) a foreign exchange gain of $4,147 from the relative gains on certain U.S. dollar denominated financial assets.

Product Updates

Over the past year, the Company advanced its product pipeline with the Canadian regulatory approval of two products.  Knight launched Probuphine® for the management of opioid dependence and expects to launch Iluvien® for the treatment of diabetic macular edema later in 2019. Furthermore, Knight submitted Netildex™ for the treatment of inflammatory ocular conditions of the anterior segment of the eye for regulatory approval in Canada. During Q4-18, Knight received a NON for Netildex™ and will be responding to Health Canada’s concerns.

Furthermore, Knight expanded its product pipeline with the in-licensing of multiple innovative pharmaceutical products. Knight entered into an exclusive licensing agreement with TXMD for the commercial rights of TX-004HR (marketed as Imvexxy™ in the U.S.) and TX-001HR (marketed as BIJUVA™ in the U.S.) for Canada and Israel. The products treat the symptoms associated with menopause and are expected to be submitted for regulatory approval in Canada in 2019. In addition, Knight expanded its gastrointestinal portfolio with the exclusive commercial rights of tenapanor in Canada and Mytesi® for Canada and Israel. Tenapanor, marketed as Ibsrela™ for IBS-C (irritable bowel syndrome with constipation) is pending regulatory approval in the U.S. Tenapanor is also being evaluated in a Phase 3 study for hyperphosphatemia. Knight expects to submit a NDS for Ibsrela™ in 2019.

Subsequent to 2018, Knight advanced its oncology portfolio with the license agreements for the Canadian exclusive rights to commercialize NERLYNX® (neratinib) a novel treatment for breast cancer patients, and Triumvira Immunologics Inc.’s future products for Canada, Israel, Mexico, Colombia and TAC01-CD19 for Israel, Mexico, Brazil and Colombia (“Triumvira Products”).

Strategic Lending and Investment Updates 

On February 8, 2018, Knight received US$4,460 as a partial repayment of the 60P loan and subsequently lent an additional US$2,100 at an interest rate of 15%. As consideration for the additional loan, Knight obtained the commercial rights of Arakoda™ for the prophylaxis of malaria in patients aged 18 years and older for the territory of Latin America.

On February 15, 2019, the Company announced a strategic financing agreement with Moksha8, a specialty pharmaceutical company operating in Brazil and Mexico, the two largest pharmaceutical markets in Latin America. Under the terms of the agreement, Knight may loan up to US$25,000 in working capital funding and US$10,000 was issued at closing. The loan bears interest at 15% per annum and matures five years from the issuance date. The Company may issue up to an additional US$100,000 for corporate development and the acquisition of product licenses in Latin America. In conjunction with the strategic financing agreement, Knight received warrants at an exercise price of US$0.01 each representing 5% of the fully diluted shares of Moksha8.

On February 20, 2019, the Company entered into a U$5,000 secured loan agreement with Triumvira for the development of its novelty T cell technology. The loan bears interest at 15% per annum and matures on February 20, 2020. In addition, as part of this strategic financing transaction, Knight received warrants to purchase 3.5% of Triumvira’s fully diluted common shares and the commercial rights to the Triumvira Products.

Conference Call Notice 

Knight will host a conference call and audio webcast to discuss its fourth quarter and year end results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, March 14, 2019
Time: 8:30 a.m. EST
Telephone: 1-877-223-4471 or 647-788-4922
Webcast: www.gudknight.com or https://preview.tinyurl.com/y3wtsj4e
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.
Replay: An archived replay will be available for 30 days at www.gudknight.com 

About Knight Therapeutics Inc.  

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for the Canadian and select international markets. Knight Therapeutics Inc.’s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company’s web site at www.gud-knight.com or www.sedar.com.

Forward-Looking Statement

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2018. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

CONTACT INFORMATION:

Knight Therapeutics Inc.
Samira Sakhia
President and Chief Financial Officer
T: 514-678-8930
F: 514-481-4116
info@gudknight.com
www.gudknight.com  

CONSOLIDATED BALANCE SHEETS
[In thousands of Canadian dollars]
 
As at December 31, 2018 2017
     
ASSETS    
     
Current    
Cash and cash equivalents 244,785 496,460
Marketable securities 445,003 232,573
Trade and other receivables 11,756 9,176
Inventories 1,136 1,224
Other current financial assets 14,030 58,848
Income taxes receivable 821 792
Total current assets 717,531 799,073
     
Marketable securities 97,274 36,000
Property and equipment 794 633
Intangible assets 17,475 12,576
Other financial assets 113,314 76,988
Investment in associate 79,145 75,983
Deferred income tax assets 2,959 4,730
Other receivable 23,340
Total assets 1,051,832 1,005,983
     
LIABILITIES AND SHAREHOLDERS’ EQUITY    
     
Current    
Accounts payable and accrued liabilities 6,100 5,025
Income taxes payable 10,705 7,599
Other balances payable 197 1,354
Deferred other income 183 282
Total current liabilities 17,185 14,260
     
Deferred other income 167
Other balances payable 4,615 348
Total liabilities 21,800 14,775
     
Shareholders’ equity    
Share capital 761,844 761,490
Warrants 785 785
Contributed surplus 14,326 12,196
Accumulated other comprehensive income 20,955 20,907
Retained earnings 232,122 195,830
Total shareholders’ equity 1,030,032 991,208
Total liabilities and shareholders’ equity 1,051,832 1,005,983


CONSOLIDATED STATEMENTS OF INCOME
[In thousands of Canadian dollars, except for share and per share amounts]
 
  2018   2017 
     
Revenues 12,500   8,634  
Cost of goods sold 2,305   1,585  
Gross margin 10,195   7,049  
     
Expenses    
Selling and marketing 3,588   3,378  
General and administrative 8,467   8,198  
Research and development 1,991   2,750  
  (3,851 ) (7,277 )
     
Depreciation of property and equipment 87   8  
Amortization of intangible assets 1,845   1,621  
Interest income on financial instruments measured at amortized cost (16,114 ) (26,300 )
Other interest income (4,820 ) —   
Other income (1,979 ) (1,527 )
Net gain on financial assets —    (6,734 )
Impairment on financial assets —    1,621  
Net gain on financial instruments measured at fair value through profit or loss (7,632 ) —   
Share of net income of associate (555 ) (854 )
Foreign exchange (gain) loss (4,147 ) 3,689  
Income before income taxes 29,464   21,199  
     
Income tax expense    
Current 3,535   1,897  
Deferred 1,850   2,058  
Net income for the year 24,079   17,244  
     
Attributable to shareholders of the Company    
Basic earnings per share 0.17   0.12  
Diluted earnings per share 0.17   0.12  
     
Weighted average number of common shares outstanding    
Basic 142,827,616   142,763,730  
Diluted 143,275,010   143,416,666  


CONSOLIDATED STATEMENTS OF CASH FLOWS
[In thousands of Canadian dollars]
 
  2018   2017  
OPERATING ACTIVITIES    
Net income for the year 24,079   17,244  
Adjustments reconciling net income to operating cash flows:    
Deferred income tax 1,850   2,058  
Share-based compensation expense 2,170   3,038  
Depreciation and amortization 1,932   1,629  
Accretion of interest —    (5,382 )
Net gain on financial instruments (7,632 ) (6,734 )
Impairment on financial assets —    1,621  
Foreign exchange (gain) loss (4,147 ) 3,689  
Share of net income of associate (555 ) (854 )
Other income 168    (563 )
Deferred other income (266 ) (323 )
  17,599   15,423  
Changes in non-cash working capital and other items   3,050  
Other receivable (23,340 )  
Dividends from associate   4,984  
Cash (outflow) inflow from operating activities (5,739 ) 23,457  
     
INVESTING ACTIVITIES    
Purchase of marketable securities (531,401 ) (314,358 )
Purchase of intangibles (3,670 )    
Purchase of property and equipment (202 ) (126 )
Issuance of loans receivables (5,375 ) (20,112 )
Purchase of equities (27,919 ) (2,939 )
Investment in funds (27,169 ) (21,314 )
Proceeds on maturity of marketable securities 264,334   259,067  
Proceeds from repayments of loans receivable 41,112   38,835  
Proceeds from disposal of equities 31,207   12,872  
Proceeds from distribution of funds 6,769   8,083  
Cash outflow from investing activities (252,314 ) (39,992 )
     
FINANCING ACTIVITIES    
Proceeds from exercise of stock options 90   551  
Proceeds from contributions to share purchase plan 200   195  
Cash inflow from financing activities 290   746  
     
Decrease in cash and cash equivalents during the year (257,763 ) (15,789 )
Cash and cash equivalents, beginning of the year 496,460   514,942  
Net foreign exchange difference 6,088   (2,693 )
Cash and cash equivalents, end of the year 244,785   496,460  
     
Cash and cash equivalents 244,785   496,460  
Short-term marketable securities 445,003   232,573  
Long-term marketable securities 97,274   36,000  
Total cash, cash equivalents and marketable securities 787,062   765,033  

20170126-KnightL.jpg


EIN Presswire does not exercise editorial control over third-party content provided, uploaded, published, or distributed by users of EIN Presswire. We are a distributor, not a publisher, of 3rd party content. Such content may contain the views, opinions, statements, offers, and other material of the respective users, suppliers, participants, or authors.