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Knight Therapeutics Reports First Quarter 2021 Results

MONTREAL, May 14, 2021 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (TSX: GUD) (“Knight” or “the Company”), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2021. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

Q1 2021 Highlights

Financials

  • Revenues were $46,069, an increase of $230 or 1% over prior year.
  • Gross margin generated of $20,580 or 45% compared to $19,860 or 43% in prior year.
  • Adjusted EBITDA1 was $5,580, an increase of $2,383 or 75% over prior year.
  • Interest income generated of $1,998 a decrease of $2,651 or 57% over prior year.
  • Net income was $3,558 compared to net loss of $9,477 in prior year.
  • Cash inflow from operations was $17,207 compared to cash outflow of $21,167 in prior year.

Corporate Developments

  • Promoted Amal Khouri to Chief Business Officer.
  • Purchased 3,557,340 common shares through a Normal Course Issuer Bid (“NCIB”) for an average cost of $18,592.

Products        

  • Launched Ibsrela™ in Canada for the treatment of Irritable Bowel Syndrome with Constipation (“IBS-C”).

Strategic Investments

  • Disposed of 315,600 common shares of Medexus for total proceeds of $2,624.
  • Received distributions of $4,336 from strategic fund investments and realized a gain of $3,031.

Key Subsequent Events

  • Entered into a definitive agreement with Novartis to acquire the exclusive rights to manufacture, market and sell Exelon® in Canada and LATAM for an upfront payment of USD 168,000 ($211,2602) and a milestone payment of up to USD 12,000 ($15,0902).
  • Shareholders re-elected James C. Gale, Jonathan Ross Goodman, Samira Sakhia, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
  • Announced leadership change with Samira Sakhia assuming role of CEO and Jonathan Goodman assuming role of Executive Chairman effective September 1, 2021.
  • Purchased 512,271 common shares through its NCIB for an aggregate cost of $2,695.

“We are continuing to execute on multiple fronts. I am excited to report that our key launch brands in Latin America, including Cresemba®, Halaven®, Lenvima®, Trelstar® and Nerlynx® in Canada grew 116% compared to the prior year quarter.   We continue to progress on our integration activities and have commenced implementation of our ERP, CRM and HR and learning management systems. On the business development front, we executed on another transformational transaction with the acquisition of Exelon® from Novartis for Canada and Latin America, said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc. “I am humbled and honored to be leading talented Knights in Canada and across Latin America as we continue to execute on our strategy of acquiring, in-licensing and developing innovative medicines and high quality treatments for Latin America and Canada.”

1
Adjusted EBITDA is not defined terms under IFRS, refer to the definitions below for additional details.
2Converted to CAD using the closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction

SELECT FINANCIAL RESULTS & BALANCE SHEET ITEMS

[In thousands of Canadian dollars]

      Change
  Q1-21    Q1-20    $1 %2
         
Revenues 46,069   45,839   230   1 %
Gross margin 20,580   19,860   720   4 %
Selling and marketing 7,613   10,114    2,501   25 %
General and administrative 7,082   8,418    1,336   16 %
Research and development 2,818   2,749    (69 ) 3 %
Amortization of intangible assets 5,302   6,039    737   12 %
Operating loss (2,235 ) (7,460 ) 5,225   70 %
Interest income (1,998 ) (4,649 ) (2,651 ) 57 %
Interest expense 660   1,147   487   42 %
Foreign exchange loss 4,201   4,907   706   14 %
Net income (loss) 3,558   (9,477 ) 13,035   N/A
Basic net earnings (loss) per share 0.028   (0.013 ) 0.041   N/A
Adjusted EBITDA3 5,580   3,197   2,383   75 %
         
1 A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
2 Percentage change is presented in absolute values
3 Adjusted EBITDA is a non-IFRS measure, refer to section “Non-IFRS measure: EBITDA and Adjusted EBITDA” for additional details
      Change
  03-31-21 12-31-20 $   %1
         
Cash, cash equivalents and marketable securities 382,381 392,225 (9,844 ) 3 %
Trade and other receivables               104,310               116,510 (12,200 ) 10 %
Inventory               55,044               56,505 (1,461 ) 3 %
Financial assets 193,922                193,955 (33 ) 0 %
Accounts payable and accrued liabilities 45,693 44,828 865   2 %
Bank loans 38,192 51,770 (13,578 ) 26 %
1 Percentage change is presented in absolute values

Revenue: For the quarter ended March 31, 2021, revenues increased by $230 or 1% as a result of an increase in sales from new product launches, partially offset by the depreciation in the LATAM currencies. Excluding the impact of hyperinflation and under constant currency, revenues would have increased by $4,123, which is mainly attributable to the launch of Cresemba®, Lenvima®, Halaven®, Nerlynx® and certain BGx products as well as Trelstar®, which Knight began commercializing in April 2020.

Gross margin: For the quarter ended March 31, 2021, the gross margin increased from 43% to 45% compared to the same period in the prior year due to lower inventory provision and product mix, partially offset by re-negotiation of certain license agreements and the depreciation of the LATAM currencies. The gross margin would have been 47%, an increase of 2%, from 45% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: The decrease of $2,501 or 25% for the quarter ended March 31, 2021 compared to the same period in the prior year is due to $1,133 of expected credit loss that was recorded in Q1 20 compared to none in Q1 21 and $783 due to the depreciation of the LATAM currencies.

General and administrative: For the quarter ended March 31, 2021, the general and administrative expenses decreased by $1,336 or 16% as compared to the same period in prior year driven by $671 in savings due to restructuring activities and $789 due to the depreciation of the LATAM currencies.

Amortization of intangible assets: For the quarter ended March 31, 2021, amortization of intangible assets decreased by $737, or 12%, mainly explained by the depreciation in the LATAM currencies partially offset by the amortization of intangible assets acquired during 2020.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter, interest income was $1,998, a decrease of 57% or $2,651 compared to the same prior year period due to a decrease in interest rates, the average cash and marketable securities balances and a lower average loan balance.

Interest expense: The interest expense relates to interest incurred on bank loans. For the quarter ended March 31, 2021 interest expenses was $660, a decrease of $487 or 42% compared to the same period in the prior year due to decrease in the average loan balance outstanding.

Adjusted EBITDA: For the three-month period ended March 31, 2021, adjusted EBITDA was $5,580, an increase of $2,383 or 75% compared to the same period last year. The variance is explained by the above mentioned increase in gross margin and decrease in operating expenses.

Net income or loss: For the quarter ended March 31, 2021, net income was $3,558 compared to a net loss of $9,477 for the same period last year. The variance mainly resulted from the above-mentioned items as well as a net gain on the revaluation of financial assets measured at fair value through profit or loss of $9,473 in the first quarter of 2021 versus a loss of $6,730 in the prior year period.

Cash, cash equivalents and marketable securities: As at March 31, 2021, Knight had $382,381 in cash, cash equivalents and marketable securities, a decrease of $9,844 or 3% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the shares repurchased through NCIB, the bank loans repaid by Knight offset by cash generated from operating activities.

Financial assets: There is no significant variance for financial assets. However, given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets. More specifically, an investment held within Sectoral Asset Management (“Sectoral”) fund, Atea Pharmaceutics Inc (“Atea”), announced in October 2020, the closing of its initial public offering at a public offering price of USD 24 per share. The shares held by Sectoral are subject to a 180-day lockup period. As at March 31, 2021, Atea’s share price closed at USD 61.75 compared to USD 41.78 as at December 31, 2020. As at May 12, 2021, Atea’s share price closed at USD 19.74 Should the share price of Atea remain at this level, the Company would record a loss of approximately $15.2M.

Bank Loans: As at March 31, 2021, bank loans were at $38,192, a decrease of $13,578 as compared to the prior period, mainly due to loan repayment of $8,848 and a further decrease of $4,854 due to the foreign exchange revaluation.

Product Updates

On March 1, 2021 the Company launched Ibsrela™ (tenapenor) for the treatment of IBS-C. The Company entered into an exclusive licensing agreement with Ardelyx to commercialize Ibsrela™ in Canada in March 2018. Ibsrela™ is a first-in-class small molecule treatment for IBS-C. Ardelyx received regulatory approval for Ibsrela™ from the US FDA in September 2019. On April 17, 2020, the Company announced that Ibsrela™ was approved by Health Canada.

On April 23, 2021, the Company announced that it has entered into a definitive agreement to acquire the exclusive rights to manufacture, market and sell Exelon®, indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease, in Canada and Latin America (“Territory”). In addition, the Company obtained an exclusive license to use the intellectual property and the Exelon trademark in the Territory. At closing, Knight will pay USD 168,000 ($211,2601) in cash and may pay up to USD 12,000 ($15,0901) upon the achievement of certain conditions. For the year ended December 31, 2020, Exelon® sales in the Territory were approximately USD 47,000.

The closing of this transaction is subject to the completion of the anti-trust clearance process in Brazil. In conjunction with closing, Knight will enter into a transition service agreement until transfer of marketing authorization, on a country by country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country by country basis.

NCIB

On July 10, 2020, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch an additional NCIB (‘2020 NCIB”). Under the terms of the 2020 NCIB, Knight may purchase for cancellation up to 10,856,710 common shares of the Company which represented 10% of its public float as at July 6, 2020. The 2020 NCIB commenced on July 14, 2020 and will end on the earlier of July 13, 2021 or when the Company completes its maximum purchases under the 2020 NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 2020 NCIB. Under Knight’s automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods. During the three-month period ended March 31, 2021, the Company purchased 3,557,340 common shares, for an aggregate cash consideration of $18,592, of which $44 remains to be settled as at March 31, 2021. Subsequent to the quarter, the Company purchased an additional 512,271 common shares, for an aggregate cash consideration of $2,695.

1 Converted using the March 31, 2021 closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction.


Conference Call Notice 

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

Date: Friday, May 14, 2021
Time: 8:30 a.m. ET
Telephone: : Toll Free 888-506-0062 or International 973-528-001
Webcast: www.gud-knight.com or Webcast
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.gud-knight.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 Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. 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, 2020 as filed on www.sedar.com. 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:

IMPACT OF HYPERINFLATION

[In thousands of Canadian dollars]

The Company applies IAS 29, Financial Reporting in Hyperinflation Economies, as the Company’s Argentine subsidiaries used the Argentine Peso as their functional currency. IAS 29 requires that the financial statements of an entity whose functional currency is the currency of a hyperinflationary economy be adjusted based on an appropriate general price index to express the effects of inflation. If the Company did not apply IAS 29, the effect on the Company’s operating income would be as follows:

Q1-21

  Reported
under IFRS 
  Excluding impact
of IAS 29
  Variance
$1   %2
         
Revenues 46,069   46,082   (13 ) 0 %
Cost of goods sold 25,489   24,376   (1,113 ) 5 %
Gross margin 20,580   21,706   (1,126 ) 5 %
Gross margin (%) 45%   47%      
         
Expenses        
Selling and marketing 7,613   7,614   1   0 %
General and administrative 7,082   6,874   (208 ) 3 %
Research and development 2,818   2,770   (48 ) 2 %
Amortization of intangible assets 5,302   5,086   (216 ) 4 %
Operating loss (2,235 ) (638 ) (1,597 ) 250 %
A positive variance represents a positive impact to net income due to the application of IAS 29 and a negative variance represents a negative impact to net income due to the application of IAS 29
2 Percentage change is presented in absolute values

CONSTANT CURRENCY
[In thousands of Canadian dollars]

Financial results at constant currency allow results to be viewed without the impact of fluctuations in foreign currency exchange rates thereby facilitating the comparison of results period over period. The presentation of results under constant currency is considered to be a non-GAPP measure and does not have any standardized meaning under GAAP. As a result, the information presented may not be comparable to similar measures presented by other companies.

Financial results at constant currency are obtained by translating the prior period results at the average foreign exchange rates in effect during the current period. Furthermore, with respect to Argentina, for both Q1-20 and Q1-21, the Company excludes the impact of hyperinflation and translates the results at the average exchange rate in effect for each of the periods.

  Q1-21 Q1-20 Variance Q1-20 Impact of FX on 2020
Excluding impact of IAS 29
  Constant
Currency
  $1   %2   $1   %2
               
Revenues 46,082   41,959   4,123   10 % 45,488   (3,529 ) 8 %
Cost of goods sold 24,376   22,045   (2,331 ) 11 % 25,015   2,970   12 %
Gross margin 21,706   19,914   1,792   9 % 20,473   (559 ) 3 %
Gross margin (%) 47%   47%       45%      
               
Expenses              
Selling and marketing 7,614   9,250   1,636   18 % 9,988   738   7 %
General and administrative 6,874   7,545   671   9 % 8,334   789   9 %
Research and development 2,770   2,632   (138 ) 5 % 2,721   89   3 %
Amortization of intangible assets 5,086   5,112   26   1 % 5,559   447   8 %
Operating loss (638 ) (4,625 ) 3,987   86 % (6,129 ) 1,504   25 %
EBITDA 5,160   1,018   4,142   407 % 1,217   (199 ) 16 %
Adjusted EBITDA 5,580   2,395   3,185   133 % 3,197   (802 ) 25 %
1 A positive variance represents a positive impact to net income and a negative variance represents a negative impact to net income
Percentage change is presented in absolute values

RECONCILIATION TO ADJUSTED EBITDA
[In thousands of Canadian dollars]

Non-IFRS measures: EBITDA and Adjusted EBITDA

The Company discloses non-IFRS measures that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the GBT Transaction on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

The Company uses the following non-IFRS measures:

EBITDA: Operating loss adjusted to exclude amortization and impairment of intangible assets, depreciation, PPA accounting adjustments, and the impact of IAS 29 (accounting under hyperinflation) but to include costs related to leases. In addition, EBITDA does not reflect the portion of GBT’s results attributable to the non-controlling interests.

Adjusted EBITDA: EBITDA adjusted for acquisition costs and non-recurring expenses.

Adjustments include the following:

  • With the adoption of IFRS 16, the lease payments of Knight are not reflected in operating expenses. The IFRS 16 adjustment approximates the cash outflow related to leases of Knight.
  • Acquisition costs relate to costs incurred on legal, consulting and advisory fees for the acquisition of GBT and products.
  • Other non-recurring expenses relate to expenses incurred by Knight that are not due to, and are not expected to occur in, the ordinary course of business. For the quarter ended March 31, 2021, Knight recorded one-time costs of $70 related to restructuring activities including severance to certain employees as part of restructuring and integration of GBT.

For the three-month period ended March 31, the Company calculated EBITDA and adjusted EBITDA as follows:

  Q1-21   Q1-20  
Operating loss (2,235 ) (7,460 )
Adjustments to operating loss:    
Amortization of intangible assets 5,302   6,039  
Depreciation of property, plant and equipment and ROU assets 1,406   1,724  
Lease costs (IFRS 16 adjustment) (694 ) (834 )
Impact of PPA accounting   632  
Impact of IAS 29 1,381   1,116  
EBITDA 5,160   1,217  
Acquisition and transaction costs 350   216  
Other non-recurring expenses 70   1,764  
Adjusted EBITDA 5,580   3,197  

INTERIM CONSOLIDATED BALANCE SHEETS
[In thousands of Canadian dollars]
[Unaudited]

As at

   
March 31, 2021 December 31, 2020
     
ASSETS    
Current    
Cash and cash equivalents 271,218 229,592
Marketable securities 111,163 147,316
Trade receivables 52,682 62,515
Other receivables 10,046 12,413
Inventories 55,044 56,505
Prepaids and deposits 2,007 2,214
Other current financial assets 40,069 34,431
Income taxes receivable 7,855 7,115
Total current assets 550,084 552,101
     
Marketable securities —  15,317
Prepaids and deposits 2,875 4,208
Right-of-use assets 3,623 4,035
Property, plant and equipment 22,476 22,127
Investment properties 1,414 1,539
Intangible assets 146,227 156,547
Goodwill 74,091 77,725
Other financial assets 153,853 159,524
Deferred income tax assets 2,137 2,432
Other long-term receivables 41,582 41,582
  448,278 485,036
Assets held for sale 2,433 2,539
Total assets 1,000,795 1,039,676

 

INTERIM CONSOLIDATED BALANCE SHEETS (continued)
[In thousands of Canadian dollars]
[Unaudited]

  March 31, 2021   December 31, 2020  
     
LIABILITIES AND EQUITY    
Current    
Accounts payable and accrued liabilities 45,385   44,512  
Lease liabilities 1,530   1,875  
Other liabilities 1,768   1,291  
Automatic share purchase plan liability 31,272    
Bank loans 38,192   51,770  
Income taxes payable 14,390   13,559  
Other balances payable 3,408   1,053  
Total current liabilities 135,945   114,060  
     
Accounts payable and accrued liabilities 308   316  
Lease liabilities 2,174   2,543  
Other balances payable 12,687   14,900  
Deferred income tax liabilities 20,206   21,616  
Total liabilities 171,320   153,435  
     
Shareholders’ Equity    
Share capital 641,461   694,351  
Warrants 117   117  
Contributed surplus 19,242   18,731  
Accumulated other comprehensive loss (12,552 ) (1,503 )
Retained earnings 181,207   174,545  
Total shareholders’ equity 829,475   886,241  
Total liabilities and shareholders’ equity 1,000,795   1,039,676  

INTERIM CONSOLIDATED STATEMENTS OF INCOME (LOSS)
[In thousands of Canadian dollars, except for share and per share amounts]
[Unaudited]

  Three months ended March 31,
 
  2021   2020  
     
Revenues 46,069   45,839  
Cost of goods sold 25,489   25,979  
Gross margin 20,580   19,860  
     
Expenses    
Selling and marketing 7,613   10,114  
General and administrative 7,082   8,418  
Research and development 2,818   2,749  
Amortization of intangible assets 5,302   6,039  
Operating loss (2,235 ) (7,460 )
     
Interest income on financial instruments measured at amortized cost (886 ) (3,383 )
Other interest income (1,112 ) (1,266 )
Interest expense 660   1,147  
Other income (112 ) (25 )
Net (gain) loss on financial instruments measured at fair value through profit or loss (9,473 ) 6,730  
Net loss on mandatory tender offer liability   487  
Realized gain on sale of asset held for sale   (2,948 )
Realized gain on automatic share purchase plan   (2,869 )
Foreign exchange loss 4,201   4,907  
Loss on hyperinflation              60   277  
Income (loss) before income taxes            4,427   (10,517 )
     
Income tax    
Current 648   3,001  
Deferred             221   (4,041 )
Income tax expense (recovery)             869   (1,040 )
Net income (loss) for the period            3,558   (9,477 )
     
Attributable to:    
Shareholders of the Company 3,558   (1,709 )
Non-controlling interests   (7,768 )
     
Attributable to shareholders of the Company    
Basic earnings (loss) per share 0.03   (0.01 )
Diluted earnings (loss) per share 0.03   (0.01 )
     
Weighted average number of common shares outstanding    
Basic 128,841,383   135,144,152  
Diluted 128,843,728   135,436,500  

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
[In thousands of Canadian dollars]
[Unaudited]

  Three months ended March 31,
 
  2021   2020   
OPERATING ACTIVITIES    
Net income (loss) for the period 3,558   (9,477 )
Adjustments reconciling net income to operating cash flows:    
Depreciation and amortization 6,708   7,763  
Net (gain) loss on financial instruments (9,473 ) 6,730  
Unrealized foreign exchange loss 4,657   4,907  
Other operating activities 1,452   (8,457 )
  6,902   1,466  
Changes in non-cash working capital and other items 10,628   (22,472 )
Interest payments on bank loans (323 ) (161 )
Cash inflow (outflow) from operating activities 17,207   (21,167 )
     
INVESTING ACTIVITIES    
Purchase of marketable securities (31,792 ) (13,415 )
Proceeds on maturity of marketable securities 83,156    76,446  
Proceeds from distribution of funds 4,336   2,090  
Other investing activities 220   70,909  
Cash inflow from investing activities 55,920   136,030  
     
FINANCING ACTIVITIES    
Repurchase of common shares through Normal Course Issuer Bid (18,549 ) (13,311 )
Principal repayment on bank loans (8,848 ) (731 )
Other financing activities (630 ) 11,168  
Cash outflow from financing activities (28,027 ) (2,874 )
     
Increase in cash and cash equivalents during the period 45,100   111,989  
Cash and cash equivalents, beginning of the period 229,592   174,268  
Net foreign exchange difference (3,474 ) 685  
Cash and cash equivalents, end of the period 271,218   286,942  
     
Cash and cash equivalents 271,218   286,942  
Short-term marketable securities 111,163   246,575  
Long-term marketable securities   59,061  
Total cash, cash equivalents and marketable securities 382,381   592,578  

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