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 

 Q4-18Q4-17Change
  2018  2017Change
    $1  %2   $1  %2
         
Revenues3,8882,5441,34453%12,5008,6343,86645%
Gross margin3,3642,0561,30864%10,1957,0493,14645%
Operating expenses4,0013,266(735)23%14,04614,3262802%
Interest income35,9447,783(1,839)24%20,93426,300(5,366)20%
Share of net income of associate114341(227)67%555854(299)35%
Net income2217,145(6,924)97%24,07917,2446,83540%
Basic earnings per share0.0020.050(0.048)96%0.1690.121(0.048)40%


1A positive variance represents a positive impact to net income and a negative variance represents a negative impact to net income
2Percentage change is presented in absolute values
3Includes 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 31,20182017
   
ASSETS  
   
Current  
Cash and cash equivalents244,785496,460
Marketable securities445,003232,573
Trade and other receivables11,7569,176
Inventories1,1361,224
Other current financial assets14,03058,848
Income taxes receivable821792
Total current assets717,531799,073
   
Marketable securities97,27436,000
Property and equipment794633
Intangible assets17,47512,576
Other financial assets113,31476,988
Investment in associate79,14575,983
Deferred income tax assets2,9594,730
Other receivable23,340
Total assets1,051,8321,005,983
   
LIABILITIES AND SHAREHOLDERS’ EQUITY  
   
Current  
Accounts payable and accrued liabilities6,1005,025
Income taxes payable10,7057,599
Other balances payable1971,354
Deferred other income183282
Total current liabilities17,18514,260
   
Deferred other income167
Other balances payable4,615348
Total liabilities21,80014,775
   
Shareholders’ equity  
Share capital761,844761,490
Warrants785785
Contributed surplus14,32612,196
Accumulated other comprehensive income20,95520,907
Retained earnings232,122195,830
Total shareholders’ equity1,030,032991,208
Total liabilities and shareholders’ equity1,051,8321,005,983


CONSOLIDATED STATEMENTS OF INCOME
[In thousands of Canadian dollars, except for share and per share amounts]
 
 2018  2017 
   
Revenues12,500 8,634 
Cost of goods sold2,305 1,585 
Gross margin10,195 7,049 
   
Expenses  
Selling and marketing3,588 3,378 
General and administrative8,467 8,198 
Research and development1,991 2,750 
 (3,851)(7,277)
   
Depreciation of property and equipment87 8 
Amortization of intangible assets1,845 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 taxes29,464 21,199 
   
Income tax expense  
Current3,535 1,897 
Deferred1,850 2,058 
Net income for the year24,079 17,244 
   
Attributable to shareholders of the Company  
Basic earnings per share0.17 0.12 
Diluted earnings per share0.17 0.12 
   
Weighted average number of common shares outstanding  
Basic142,827,616 142,763,730 
Diluted143,275,010 143,416,666 


CONSOLIDATED STATEMENTS OF CASH FLOWS
[In thousands of Canadian dollars]
 
 2018  2017  
OPERATING ACTIVITIES  
Net income for the year24,079 17,244 
Adjustments reconciling net income to operating cash flows:  
Deferred income tax1,850 2,058 
Share-based compensation expense2,170 3,038 
Depreciation and amortization1,932 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 income168  (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 securities264,334 259,067 
Proceeds from repayments of loans receivable41,112 38,835 
Proceeds from disposal of equities31,207 12,872 
Proceeds from distribution of funds6,769 8,083 
Cash outflow from investing activities(252,314)(39,992)
   
FINANCING ACTIVITIES  
Proceeds from exercise of stock options90 551 
Proceeds from contributions to share purchase plan200 195 
Cash inflow from financing activities290 746 
   
Decrease in cash and cash equivalents during the year(257,763)(15,789)
Cash and cash equivalents, beginning of the year496,460 514,942 
Net foreign exchange difference6,088 (2,693)
Cash and cash equivalents, end of the year244,785 496,460 
   
Cash and cash equivalents244,785 496,460 
Short-term marketable securities445,003 232,573 
Long-term marketable securities97,274 36,000 
Total cash, cash equivalents and marketable securities787,062 765,033