Knight Therapeutics Reports Fourth Quarter and Year-End 2022 Results

 

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading Pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

 

Financial information as at and for the year ended December 31, 2022 is unaudited.

 

  2022 Highlights  

 

Financials

 
  • Revenues were $293,563, an increase of $50,085 or 21% over prior year.
  •  
  • Gross margin of $138,061 or 47% of revenues compared to $115,412 or 47% of revenues in prior year.
  •  
  • Adjusted EBITDA 1 was $54,032, an increase of $16,027 or 42% over prior year.
  •  
  • Net loss on financial assets measured at fair value through profit or loss of $20,677.
  •  
  • Net loss was $29,892, compared to net income of $15,675 in prior year.
  •  
  • Cash inflow from operations was $40,481, compared to a cash inflow from operations of $44,618 in prior year.
  •  

Corporate Developments

 
  • Entered into a five-year secured loan of $52,416 (US$38,500) loan denominated in select LATAM currencies with International Finance Corporation ("IFC").
  •  
  • Executed a settlement agreement with former controlling shareholders of GBT and received $6,030 (US$4,600).
  •  
  • Launched a NCIB in July 2022 to purchase up to 7,988,986 common shares of the Company over the next 12 months.
  •  
  • Purchased 5,649,189 common shares through Knight's through Normal Course Issuer Bid ("NCIB") at an average price of $5.34 for an aggregate cash consideration of $30,069.
  •  
  • Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
  •  
  • Hired Leopoldo Bosano as VP Manufacturing and Operations.
  •  

Products

 
  • Launched Lenvima ® , Halaven ® and Rembre ® in Colombia in Q1-22.
  •  
  • Entered into exclusive license and supply agreements with Rigel Pharmaceuticals to commercialize fostamatinib in LATAM in May 2022.
  •  
  • Entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO ® oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI ® oral/IV (palonosetron) in Canada in May 2022.
  •  
  • Relaunched AKYNZEO ® in Canada, Brazil and Argentina, and ALOXI ® oral/IV in Canada in second half of 2022.
  •  
  • Transferred marketing authorization of Exelon ® (rivastigmine) and assumed commercial activities in Brazil, Colombia, Argentina, Mexico, Chile, Peru, Ecuador, Canada and re-launched Exelon ® in Brazil and certain other LATAM countries.
  •  
  • Submitted tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) to ANVISA for regulatory approval in Brazil and Colombia in Q4-22 and Argentina in Q1-23.
  •  
  • In-license three branded generics products for key territories in LATAM.
  •  
  • Obtained regulatory approval for Palbocil ® (palbociclib) in Argentina in Q4-22.
  •  
  • Submitted two branded generic products (palbociclib and pomalidomide) for regulatory approval in Chile and Colombia in Q4-2022.
  •  

Subsequent Event

 
  • Purchased an additional 1,279,900 common shares through NCIB for an aggregate cash consideration of $6,577.
  •  

_______________________

 

   1 Adjusted EBITDA is a non-GAPP measure, refer to the definitions below in section "Non-Gaap measures" for additional details  

 

"I am excited to announce that we delivered another record year in 2022, with revenues of over $290,000, an increase of 21% over last year and record adjusted EBITDA of over $54,000, an increase of 42% over last year. This growth was generated by the full year effect of Exelon ® and the continued performance of our recent launches, including Lenvima ® , Halaven ® and Rembre ® in Colombia. While delivering on record results, we have completed the transfer of the commercial activities to Knight for Exelon ® and Akynzeo ® in our key markets. We continued to advance our pipeline with the regulatory submission of tafasitamab in Brazil, Colombia and Argentina as well as two branded generic products in Chile and Colombia. In addition, to the in-licensing of Akynzeo ® , we have expanded our pipeline portfolio in our key Latin America markets with fostamatinib and three branded generic products," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

 

 

 

  SELECT FINANCIAL RESULTS REPORTED UNDER IFRS  
[In thousands of Canadian dollars]

 

[Unaudited]

 
                                                                                                                                      
     Change      Change  
   Q4-22   Q4-21   $ 1     %   2    YTD-22   YTD-21   $ 1     %   2  
         
Revenues   81,655    58,273    23,382   40 %   293,563    243,478   50,085   21 %
Gross margin   36,888    28,195    8,693   31 %   138,061    115,412   22,649   20 %
Operating expenses 4   67,938    42,829    (25,109 ) 59 %   179,105    128,244   (50,861 ) 40 %
Net (loss) income   (15,188    )   (8,301 )   (6,887 ) 83 %   (29,892    )   15,675 N/A N/A
EBITDA 3   13,330    4,101    9,229   225 %   53,541    35,865   17,676   49 %
Adjusted EBITDA 3   13,821    5,696    8,125   143 %   54,032    38,005   16,027   42 %
 

   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 EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions in section "Non-Gaap measures" for additional details  
  4 Operating expenses include selling and marketing expenses, general and administrative  expenses, research and development expenses, amortization and impairment of non current   assets  

 

  SELECT FINANCIAL RESULTS AT CONSTANT CURRENCY  
[In thousands of Canadian dollars]

 

[Unaudited]

 
                                                                                                         
   Q4-22    Q4-21    Variance    YTD-22    YTD-21    Variance  
   Excluding impact of IAS 29   3  
   Constant Currency   3     $   1     %   2     Constant Currency   3     $   1     %   2  
         
Revenues   83,806     58,370   25,436   44 %   291,770   243,731   48,039   20 %
Gross margin   41,931     29,692   12,239   41 %   150,359   120,694   29,665   25 %
Operating expenses 4   46,173     42,509   (3,664 ) 9 %   151,158     124,865     (26,293 ) 21 %
EBITDA 3   13,330     4,258   9,072   213 %   53,541     36,376   17,165   47 %
Adjusted EBITDA 3   13,821     5,884   7,937   135 %   54,032     38,551   15,481   40 %
 

   1 A positive variance represents a positive impact to adjusted EBITDA and a negative variance represents a negative impact to adjusted EBITDA  
  2 Percentage change is presented in absolute values  
  3 Financial results at constant currency and excluding impact of IAS 29, EBITDA and adjusted EBITDA are non GAAP measures, refer to the specific sections for additional details  
  4 Operating expenses include selling and marketing expenses, general and administrative expenses, research  and development expenses, amortization and impairment of non-current   assets  

 

  SELECT BALANCE SHEET ITEMS  
[In thousands of Canadian dollars]

 

[Unaudited]

 
                                                        
     Change  
   12-31-22      12-31-21      $    %   1  
     
Cash, cash equivalents and marketable securities   172,674     149,502    23,172     15 %
Trade and other receivables   151,669     103,875    47,794     46 %
Inventory   92,489     72,397    20,092   28 %
Financial assets   176,563     192,443    (15,880 ) 8 %
Accounts payable and accrued liabilities   108,730     65,590    43,140   66 %
Bank loans   70,072     35,927    34,145     95 %
 

   1 Percentage change is presented in absolute values  

 

  Revenues: For the quarter ended December 31, 2022, excluding the impact of hyperinflation, revenues increased by $27,448 or 49% compared to the same period in prior year. The increase in revenues excluding the impact of hyperinflation is explained by the following:

 
                                        
   Excluding impact of IAS 29   3  
   Q4-22    Q4-21    Change  
  Therapeutic Area    $    $     $   1    %   2  
Oncology/Hematology   29,343   23,534   5,809 25 %
Infectious Diseases   32,744   20,211   12,533 62 %
Other Specialty   21,760   12,613   9,147 73 %
  Total    83,806   56,358   27,448 49 %
 

   1 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  
  3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.  

 
  •   Oncology/hematology : The increase in revenues of $5,809 is driven by growth in our key promoted brands, including new launches of Lenvima® and Halaven® in Colombia in Q1-22, the growth of key promoted products including Lenvima® and Trelstar® and the assumption of commercial activities of Akynzeo® in Brazil and Canada. This increase is offset by a reduction in revenues of our branded generics products due to their lifecycle including the market entrance of new competitors.
  •  
  •   Infectious disease: The portfolio grew by approximately $15,900, excluding the impact of the planned transition and termination of the Gilead Amendment. This growth is due to an increase in patient treatments as our markets reduce COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for Ambisome® ("MOH Contract"). Knight recorded $7,500 in revenues, which represents 40% of the expected deliveries under the MOH contract in Q4-22 and the balance of the contract is expected to be delivered in the first six months of 2023
  •  
  •   Other specialty : The growth is mainly due to the incremental revenue of $5,092 due to the change in accounting treatment of Exelon® from net profit transfer from Novartis to revenues with related cost of sales upon the transition of commercial activities to Knight as well as the timing of purchases of products by certain customers.
  •  

For the year ended December 31, 2022, excluding the impact of hyperinflation, revenues increased by $52,532 or 22% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation is explained by the following:

 
                                        
   Excluding impact of IAS 29   3  
   YTD-22    YTD-21    Change  
  Therapeutic Area    $    $     $   1    %   2  
Oncology/Hematology   105,464   89,079   16,385 18 %
Infectious Diseases   116,530   101,650   14,880 15 %
Other Specialty   69,776   48,509   21,267 44 %
  Total    291,770   239,238   52,532 22 %
 

  1 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
3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details

 
  •   Oncology/hematology : The increase in revenues of $15,960 is driven by growth in our key promoted brands, including the launches of Lenvima ® and Halaven ® in Colombia in Q1-22, the continued growth of key promoted products including Lenvima ® , Halaven ® and Trelstar ® and the assumption of commercial activities of Akynzeo ® in Brazil and Canada. This increase is offset by a reduction in revenues of our branded generics products due to their lifecycle including the market entrance of new competitors.
  •  
  •   Infectious disease : The portfolio grew by approximately $29,080 due to increase in patient treatments as our markets reduce COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for Ambisome ® ("MOH Contract"). Knight recorded $7,500 in revenues, which represents 40% of the expected deliveries under the MOH contract in Q4-22 and the balance of the contract is expected to be delivered in the first six months of 2023. The growth is offset by an estimated $14,200 due to lower demand for certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19 as well as the planned transition and termination agreement of the Gilead Amendment effective July 1, 2022.
  •  
  •   Other specialty : The increase is mainly driven by the timing of the acquisition of Exelon ® as well as a change in the accounting treatment of Exelon ® . The full year effect of the Exelon ® transaction executed on May 26, 2021, represents an incremental revenue of $15,282. The change in accounting treatment from net profit transfer from Novartis to recognition of revenues with related cost of sales upon transition of commercial activities to Knight led to an increase of $6,427 in revenues.
  •  

  Gross margin: For the quarter ended December 31, 2022, gross margin as a percentage of revenues was 45% compared to 48% in the same prior year period. The decrease in the gross margin, as a percentage of revenues, is explained by the impact of hyperinflation. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 50% in Q4-22 and 51% in Q4-21.

 

For the year ended December 31, 2022, there was no significant difference in gross margin, as a percentage of revenues, compared to the same prior year period. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 52% for year ended December 31, 2022 compared to 50% in prior year. The increase in the gross margin is explained by the change in product mix including the full year effect of the acquisition of Exelon ® .

 

  Selling and marketing: For the quarter ended December 31, 2022, S&M increased by $2,111 or 17%. Excluding the impact of IAS 29, the increase was $3,162 or 27% driven by an increase in compensation expenses including severance cost of $1,116 due to certain restructuring activities, an increase in selling and marketing activities related to key promoted products including spend on Exelon ® and Akynzeo ® as well as certain variable costs such as logistics fees due to higher sales.

 

For the year ended December 31, 2022, S&M increased by $9,396 or 24%. Excluding the impact of IAS 29, the increase is $9,827 or 26% mainly driven by an increase in compensation expenses including severances of $1,146, an increase in selling and marketing activities related to key promoted products including the spend on Exelon® and Akynzeo as well as certain variable costs such as logistics fees due to higher sales.

 

  General and administrative: For the quarter ended on December 31, 2022, there was no significant variation in General and administrative expenses. For the year ended December 31, 2022, G&A increased by $4,852 or 14%. Excluding the impact of IAS 29, the increase is $3,721 or 11%, mainly driven by an increase in compensation expense certain consulting and professional fees offset by the lower costs related to the long-term incentive plan.

 

  Research and development expenses : For the quarter ended on December 31, 2022, there was no significant variation in Research and development expenses. For the year ended December 31, 2022, R&D increased by $2,063 or 16%. Excluding the impact of IAS 29, the increase is $1,653 or 14%, mainly driven by an increase in compensation expenses and medical initiatives.

 

  Amortization of intangible assets: For the year ended December 31, 2022, amortization of intangible assets increased by $10,566 or 26%, mainly explained by the amortization of $11,667 related to the full year effect of the acquisition of Exelon®.

 

  Impairment of non-current assets : Under hyperinflation accounting, non-monetary assets including property plant and equipment, right-of-use assets and intangible assets are adjusted by the inflation index and converted back to Canadian Dollar ("CAD") at the closing rate of the reporting period. During a period where the inflation index is higher than devaluation of the Argentine peso relative to the CAD, the value of the non-monetary assets increases when converted to CAD. During 2022, the increase in the value of non-monetary assets in Argentina due to hyperinflation accounting, resulted in an impairment of $21,654. The loss represents a write-down of certain right-of-use assets, property, plant and equipment in Argentina, and intangible assets related to branded generics intellectual property to its recoverable amount.

 

In addition, during 2022, the Company recorded an additional impairment loss of $2,330 representing the write-down of the upfront and certain milestones payments made under certain product license agreements as a result of changes in commercial expectations.
Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter and year ended December 31, 2022, interest income was $4,263 and $10,632, an increase of 94% or $2,067 and 44% or $3,250 respectively, compared to the same period in prior year due to higher interest rates on cash and marketable securities as well as interest earned on strategic loans.

 

  Interest expense: The increase for the quarter and year ended December 31, 2022, is due to the increase of the Certificados de Depositos Interfinancieros (Brazil interbank lending rate) ("CDI") and Indicador Bancario de Referencia (Colombia interbank lending rate) ("IBR") rates throughout 2022, partially offset by lower average loan balance due to partial repayment of Itaú Unibanco Brasil and Bancolombia bank loans.

 

In December 2022, the Company entered into a loan with IFC for an amount of $52,416 denominated in BRL, COP, CLP and MXN with interest rates ranging between 7.86% and 15.83% ("IFC Loan"). The interest expense on bank loans is expected to increase in 2023 due the IFC Loan as well as any future increases in variable interest rates.

 

  Adjusted EBITDA: For the quarter ended December 31, 2022, adjusted EBITDA increased by $8,125 or 143%. The growth in adjusted EBITDA is driven by an increase in gross margin of $8,693, offset by an increase in operating expenses.

 

For the year ended December 31, 2022 adjusted EBITDA increased by $16,027 or 42%. The growth in adjusted EBITDA is driven by an increase in gross margin of $22,649 offset by an increase in operating expenses.

 

  Net loss or income: For the quarter ended December 31, 2022, net loss was $15,188 compared to net loss of $8,301 for the same period last year. The increase in net loss mainly resulted from the above-mentioned items and (1) an increase in income tax recovery of $1,824 in the fourth quarter of 2022 due to the recognition of certain deferred tax assets as well as (2) a higher net gain on the revaluation of financial assets measured at fair value through profit or loss of $8,824 in the fourth quarter of 2022 versus a net gain of $2,300 in the prior year period mainly due to unrealized gains on revaluation of the strategic fund investments resulting from positive mark-to-market adjustments as a result of the increase in the share prices of one of the publicly-traded equities held by one of the funds, (3) foreign exchange loss of $1,633 versus a loss of $3,485 in the prior year period due to appreciation of the CAD versus the US dollar, and (4) a other expense for the quarter ended December 31, 2022 increase by $2,285 compared to the same period in prior year mainly due to the increase in a provision related to certain import tax claims.

 

For the year ended December 31, 2022, net loss was $29,892 compared to net income of $15,675 in prior year. The variance mainly resulted from the above-mentioned items and (1) an income tax recovery of $17,125 in 2022 due to the recognition of certain deferred tax assets due to timing differences related to our financial assets, impairment of certain non-current assets and certain intercompany transactions, compared to a prior year income tax recovery of $8,985, (2) a lower net loss on the revaluation of financial assets measured at fair value through profit or loss of $20,677 in 2022 versus a net gain of $18,944 in prior year mainly due to unrealized losses on revaluation of the strategic fund investments as a result of the decline in the share prices of the publicly-traded equities held by our strategic fund investments due to general market conditions, as well as (3) foreign exchange gain of $7,442 versus a loss of $3,737 in the prior year period due to appreciation of the US dollar compared to CAD in 2022, and (4) gain of $6,030 as a result of execution of settlement agreement and general release with the former shareholders of GBT, partially offset by expense due to the change in an accounting provision for a potential liability.

 

  Cash, cash equivalents and marketable securities : As at December 31, 2022, Knight had $172,674 in cash, cash equivalents and marketable securities, including $18,961 [USD 14,000] pledged as restricted cash collateral under the IFC Loan. The increase of $23,172 or 15% as compared to December 31, 2022 primarily relates to cash generated through operating activities and funds received under the IFC Loan offset by cash outflows from shares purchased through the NCIB, the in-licensing of AKYNZEO ® and ALOXI ® from Helsinn as well as fostamatinib from Rigel, repayments on bank loans and foreign exchange gain on cash and cash equivalents.

 

  Financial assets: As at December 31, 2022, financial assets were at $176,563, a decrease of $15,880 or 8%, as compared to the prior year, mainly due to a negative mark-to-market adjustments of $23,325 driven mostly by the decline in the share prices of the publicly-traded equities held by our strategic fund investments due to general market conditions, fund distributions of $6,478, decrease in equity investments and derivatives of $1,918 mainly due to disposal of Medimetriks offset by capital calls of $6,307, loans issued of $2,723 and foreign exchange gains of $6,245.

 

  Bank Loans: As at December 31, 2022, bank loans were at $70,072, an increase of $34,145 or 95% as compared to the prior period, mainly due to the IFC loan offset by loan repayments.

 

  Product Updates  

 

   Commercial Execution   

 

In the first quarter of 2022, Knight launched three products in Colombia in Oncology/Hematology namely Lenvima® for differentiated thyroid cancer and unresectable hepatocellular carcinoma, Halaven ® for metastatic breast cancer and soft tissue sarcoma and Rembre ® , a branded generic product, for chronic myeloid leukemia.

 

As at March 22, 2023, the marketing authorizations of Exelon ® for Brazil, Colombia, Argentina, Mexico, Chile, Peru, Ecuador and Canada were transferred to Knight. In addition, Knight has assumed the commercial activities of Exelon ® in Colombia in Q2-22, Brazil, Argentina & Chile in Q3-22 and Mexico, Peru, Ecuador & Canada in Q4-22.

 

On May 12, 2022, Knight entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO ® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI ® oral/IV (palonosetron) in Canada. Knight has assumed commercial activities and re-launched AKYNZEO ® in Brazil and Argentina in July 2022 and in Canada in Q4-22.

 

On July 1, 2022, Knight has entered into a transition and termination agreement with Gilead for a portfolio of HIV and HCV products ("Gilead Amendment"). The portfolio is currently distributed by Knight in one or more of the following countries: Colombia, Peru, Ecuador, Bolivia and Paraguay. As part of the Gilead Amendment, Knight distributes the products under a mutually agreed amended commercial and financial terms, until the earlier of April 30, 2023 and the completion of the regulatory, logistical and commercial transition on a per country and product basis. The Gilead Amendment does not impact any products distributed by the Company on behalf of Gilead in Brazil.

 

   Advancing our pipeline portfolio   

 

Knight submitted tafasitamab (sold as Monjuvi ® in the United States and Minjuvi ® in Europe) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) for regulatory approval to ANVISA in Brazil in October 2022, INVIMA in Colombia in December 2022 and ANMAT in Argentina in January 2023. Knight expects to submit tafasitamab in other key LATAM countries in the first half of 2023.

 

In December 2022, Knight obtained the regulatory approval for Palbocil ® (palbociclib) in Argentina. Knight launched Palbocil ® in Argentina in March 2023 and filed for regulatory approval for Bapocil ® (palbociclib) in Colombia and Chile in Q4-2022. Palbocil ® is indicated for the treatment of patients with hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women or fulvestrant in patients with disease progression after prior endocrine therapy.

 

In addition, during the fourth quarter of 2022, Knight also submitted a branded generic of for regulatory approval in Chile and Colombia. Furthermore, the Company has in-licensed three branded generic products for our key markets in Latin America.

 

  NCIB  

 

On July 12, 2022, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2022 NCIB"). Under the terms of the 2022 NCIB, Knight may purchase for cancellation up to 7,988,986 common shares of the Company which represented 10% of its public float as at June 30, 2022. The 2022 NCIB commenced on July 14, 2022 and will end on the earlier of July 13, 2023 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 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.

 

For the year ended December 31, 2022, the Company purchased 5,649,189 (2021: 12,321,864) common shares at an average price of $5.34 (2021: $5.23) for aggregate cash consideration of $30,069 (2021: $64,415). Subsequent to December 31, 2022, the Company purchased an additional 1,279,900 common shares at an average purchase price of $5.14 for an aggregate cash consideration of $6,577.

 

  Financial Outlook  

 

Knight provides guidance on revenues 1 on a non-GAAP basis. This is due to both the difficulty in predicting Argentinian inflation rates and its IAS 29 impact.

 

For fiscal 2023, Knight expects to report $280 to $300 million in revenue and adjusted EBITDA, as a percentage of revenues, between 13% to 15% of revenue. The guidance is based on a number of assumptions, including but not limited to the following:

 
  • no revenues for business development transactions not completed as of March 22, 2023
  •  
  • discontinuation of certain distribution agreements
  •  
  • no interruptions in supply whether due to global supply chain disruptions or general manufacturing issues
  •  
  • no new generic entrants on our key pharmaceutical brands
  •  
  • no unforeseen changes to government mandated pricing regulations
  •  
  • successful commercial execution on product listing arrangements with HMOs, insurers, key accounts, and public payers
  •  
  • successful execution and uptake of newly launched products
  •  
  • no significant restrictions or economic shut down due to the COVID-19 pandemic
  •  
  • foreign currency exchange rates remaining within forecasted ranges
  •  

Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Refer to the risks and assumptions referred to in the Forward-Looking Statements section of this news release for further details.

 

"Our team has been successfully executing on our pan-American ex US strategy and has built a profitable business with a unique platform and a strong foundation from where to continue growing over the long term.  We ended 2022 by delivering record revenues and adjusted EBITDA as a result of growing the current portfolio as well as adding new products that leverage our existing infrastructure. Looking ahead, while we will face headwinds with the entrance of new competitors on certain of our banded generic products as well as incur investments related to promoted products, Knight is expected to continue to generate strong cash flows from operations and with over $150,000 of cash and $175,000 of financial assets, we remain well positioned to execute on our mission to acquire, in-license, develop and commercialize pharmaceutical products in Latin America and Canada." said Jonathan Ross Goodman, Executive Chairman of Knight Therapeutics Inc.

 

__________________________

 

   1 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to the definitions in section "Non-Gaap measures" for additional details  

 

  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 23, 2023
Time: 8:30 a.m. ET
Telephone : Toll Free: 1-888-256-1007 or International 1-647-484-0475
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 pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. 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, 2021 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:  

 
                        
  Investor Contact:    
Knight Therapeutics Inc.   
Samira Sakhia   Arvind Utchanah
President & Chief Executive Officer   Chief Financial Officer
T: 514.484.4483   T. +598.2626.2344
F: 514.481.4116   
Email: info@knighttx.com    Email: info@knighttx.com  
Website: www.gud-knight.com    Website: www.gud-knight.com  
 

  
 

 

  Financial Results  

 

  Impact of Hyperinflation  

 

The Company applies IAS 29, Financial Reporting in Hyperinflation Economies, as the Company's Argentine subsidiaries use 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. After applying for the effects of translation, the statement of income is converted using the closing foreign exchange rate of the month. The Company restated the revenues and operating expenses of each of the following months in the year ended December 31 using the following general price indexes:

 

[Unaudited]

 
                                       
   January    February    March    April    May    June    July    August    September    October    November    December  
  2022   1.88 1.79 1.68 1.58 1.51 1.43 1.33 1.25 1.17 1.10 1.05 1.00
  2021   1.45 1.40 1.34 1.28 1.24 1.20 1.17 1.14 1.10 1.06 1.04 1.00
 

If the Company did not apply IAS 29, the effect on the Company's operating (loss) income would be as follows:

 

[Unaudited]

 
                                                                                                                                                                                                                                   
   Q4-22    YTD-22  
   Reported under
IFRS
 
  Excluding impact of
IAS 29
  1  
  Variance    Reported under
IFRS
 
  Excluding impact of
IAS 29
  1  
  Variance   
    $   2     %   3     $   2    %   3   
         
Revenues 81,655   83,806    (2,151 ) 3 % 293,563   291,770    1,793   1 %
Cost of goods sold 44,767   41,875    (2,892 ) 7 % 155,502   141,411    (14,091 ) 10 %
  Gross margin    36,888     41,931     (5,043 ) 12 %   138,061     150,359     (12,298 ) 8 %
  Gross margin (%)    45    %    50    %      47    %    52    %    
         
  Expenses          
Selling and marketing 14,402   15,073    671   4 % 48,474   48,083    (391 ) 1 %
General and administrative 10,336   10,083    (253 ) 3 % 40,150   37,451    (2,699 ) 7 %
Research and development 4,140   4,043    (97 ) 2 % 14,755   13,733    (1,022 ) 7 %
Amortization of intangible assets 17,156   16,724    (432 ) 3 % 51,742   49,561    (2,181 ) 4 %
Impairment of non-current assets 21,904   250    (21,654 ) n/a 4 23,984   2,330    (21,654 ) n/a 4
  Operating loss    (31,050    )    (4,242    )    (26,808 ) n/a 4   (41,044    )    (799    )    (40,245 ) n/a 4
 

   1 Financial results excluding the impact of hyperinflation is a non-GAAP measure. Refer to section "Non-GAAP measures" for additional details.  
  2 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.  
  3 Percentage change is presented in absolute values.  
  4 Percentage change not relevant.  

 

[Unaudited]

 
                                                                                                                                                                                                                   
   Q4-21    YTD-21  
   Reported under
IFRS
 
  Excluding impact of
IAS 29
  1  
  Variance    Reported under
IFRS
 
  Excluding impact of
IAS 29
  1  
  Variance  
    $   2     %   3     $   2     %   3  
         
Revenues 58,273   56,358    1,915   3 % 243,478   239,238    4,240   2 %
Cost of goods sold 30,078   27,724    (2,354 ) 8 % 128,066   120,409    (7,657 ) 6 %
  Gross margin    28,195     28,634     (439 ) 2 %   115,412     118,829     (3,417 ) 3 %
  Gross margin (%)    48    %    51    %      47    %    50    %    
         
  Expenses          
Selling and marketing 12,291   11,911    (380 ) 4 % 39,078   38,256    (822 ) 2 %
General and administrative 10,002   9,795    (207 ) 2 % 35,298   33,730    (1,568 ) 5 %
Research and development 3,496   3,087    (409 ) 13 % 12,692   12,080    (612 ) 5 %
Amortization of intangible assets 17,040   16,355    (685 ) 4 % 41,176   38,824    (2,352 ) 6 %
  Operating loss    (14,634    )    (12,514    )    (2,120 ) 17 %   (12,832    )    (4,061    )    (8,771 ) 216 %
 

   1 Financial results excluding the impact of hyperinflation is a non-GAAP measure. Refer to section "Non-GAAP measures" for additional details.  
  2 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.  
  3 Percentage change is presented in absolute values.  

 

  Impact of LATAM Foreign Exchange volatility  

 

The Company records its transactions and balances in the respective functional currencies of its subsidiaries. Generally, for the LATAM subsidiaries, the functional currency is the local currency in the country where the entity operates. In order to convert a foreign-denominated transaction to the functional currency, the exchange rate prevailing at the date of the transaction is used. Furthermore, upon consolidation, for all subsidiaries with a functional currency other than CAD, the respective statements of income are translated using the average exchange rates for the period. The table below summarizes the average foreign exchange rates used for the conversion of selected LATAM currencies:

 

[Unaudited]

 
                                             
  Rates    Q4-22    Q3-22    Q2-22    Q1-22    Q4-21    Q3-21    Q2-21    Q1-21  
BRL 3.87 4.02 3.85 4.12 4.44 4.15 4.30 4.32
ARS 118.9 103.6 92.3 84.1 79.7 77.2 76.46 69.9
COP 3,550 3,363 3,074 3,093 3,080 3,058 3,012 2,812
CLP 674 712 660 639 656 614 583 572
 

The below table summarizes the variances quarter over quarter for selected LATAM currencies:

 
                                                                             
  Variance (%)   1    Q4-22    Q3-22    Q2-22    Q1-22    Q4-21    Q3-21    Q2-21    Q1-21  
BRL 4 % -4 % 7 % 7 % -7 % 3 % 0 % -4 %
ARS -15 % -12 % -10 % -6 % -3 % -1 % -9 % -14 %
COP -6 % -9 % 1 % 0 % -1 % -2 % -7 % 0 %
CLP 5 % -8 % -3 % 3 % -7 % -5 % -2 % 2 %
 

  1   Negative percentage represents a depreciation of the currency while a positive variance represents an appreciation of the currency.  

 

  Impact  

 

Exchange rate fluctuations of LATAM currencies impact the Company's results in two ways:

 
  1. Transactional impact: certain product purchases and operating expenses are denominated in foreign currencies (mainly USD, EURO and CHF); and,
  2.  
  3. Translational impact: translation of local LATAM functional currency operating results to reporting currency in CAD.
  4.  

  Constant Currency  

 

Financial results at constant currency 1 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 financial results at constant currency is considered to be a non-GAAP 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 from the functional currencies to CAD using the conversion rates in effect during the current period. Furthermore, with respect to Argentina, the Company excludes the impact of hyperinflation and translates the results at the average exchange rate in effect for each of the periods.

 

______________________________

 

   1 Financial results at constant currency are non-GAAP measure, refer to section "Non-GAAP measures" for additional details.  

 

[Unaudited]

 
                                                                                                                                                                                                                                                                     
   Q4-22    Q4-21    Variance    YTD-22    YTD-21    Variance  
   Excluding impact of IAS 29   1  
   Constant Currency   2     $   3     %   4     Constant Currency   2     $   3     %   4  
Revenues   83,806    58,370    25,436   44 %   291,770    243,731    48,039   20 %
Cost of goods sold   41,875    28,678    (13,197 ) 46 %   141,411    123,037    (18,374 ) 15 %
  Gross margin    41,931    29,692    12,239   41 %   150,359    120,694    29,665   25 %
  Gross margin (%)     50      %     51    %       52      %     50    %    
         
  Expenses          
Selling and marketing   15,073    12,223    (2,850 ) 23 %   48,083    38,715    (9,368 ) 24 %
General and administrative   10,083    10,289    206   2 %   37,451    34,458    (2,993 ) 9 %
Research and development   4,043    3,193    (850 ) 27 %   13,733    12,264    (1,469 ) 12 %
Amortization of intangible assets   16,724    16,804    80   0 %   49,561    39,428    (10,133 ) 26 %
Impairment of non-current assets   250      (250 ) 100 %   2,330      (2,330 ) 100 %
  Operating (loss) income    (4,242    )   (12,817 )   8,575   67 %   (799    )   (4,171 )   3,372   81 %
  EBITDA   5    13,330    4,258    9,072   213 %   53,541    36,376    17,165   47 %
  Adjusted EBITDA   5    13,821    5,884    7,937   135 %   54,032    38,551    15,481   40 %
 

   1 Financial results excluding the impact of hyperinflation is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.
   2 Financial results at constant currency are non-GAAP measure, refer to section "Non-GAAP measures" for additional details.
   3 A positive variance represents a positive impact to net income and a negative variance represents a negative impact to net income.
   4 Percentage change is presented in absolute values.
   5 Financial results at constant currency, EBITDA and adjusted EBITDA are non-GAAP measures, refer to section "Non-GAAP measures" and "Reconciliation to adjusted EBITDA" for additional details.  

 

The financial results under IFRS reconcile to the financial results at constant currency as follows:

 

[Unaudited]

 
                                                                                                                                                                     
   Q4-21    YTD-21  
  Reported under IFRS    IAS 29 Adjustment    Constant Currency Adjustment    Constant Currency   1    Reported under IFRS    IAS 29 Adjustment    Constant Currency Adjustment    Constant Currency   1  
Revenues 58,273   (1,915 ) 2,012   58,370   243,478   (4,240 ) 4,493   243,731  
Cost of goods sold 30,078   (2,354 ) 954   28,678   128,066   (7,657 ) 2,628   123,037  
  Gross margin   28,195   439   1,058   29,692   115,412   3,417   1,865   120,694  
         
  Expenses          
Selling and marketing 12,291   (380 ) 312   12,223   39,078   (822 ) 459   38,715  
General and administrative 10,002   (207 ) 494   10,289   35,298   (1,568 ) 728   34,458  
Research and development 3,496   (409 ) 106   3,193   12,692   (612 ) 184   12,264  
Amortization of intangible assets 17,040   (685 ) 449   16,804   41,176   (2,352 ) 604   39,428  
  Operating loss   (14,634 ) 2,120   (303 ) (12,817 ) (12,832 ) 8,771   (110 ) (4,171 )
 

  1 F   inancial results at constant currency   are   non-   GAAP   measure, refer to section "   Non-GAAP measures   " for additional details   .  

 

  
 

 

  Consolidated Statement of (Loss) Income  

 

[In thousands of Canadian dollars]

 

[Unaudited]

 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
     Change      Change  
   Q4-22   Q4-21    $   1     %   2    YTD-22   YTD-21    $   1     %   2   
          
Revenues   81,655    58,273    23,382   40 %   293,563    243,478    50,085   21 %  
Cost of goods sold   44,767    30,078    (14,689 ) 49 %   155,502    128,066    (27,436 ) 21 %  
  Gross margin    36,888    28,195    8,693   31 %   138,061    115,412    22,649   20 %  
  Gross margin (%)     45      %     48    %       47      %     47    %      
           
  Expenses            
Selling and marketing   14,402    12,291    (2,111 ) 17 %   48,474    39,078    (9,396 ) 24 %  
General and administrative   10,336    10,002    (334 ) 3 %   40,150    35,298    (4,852 ) 14 %  
Research and development   4,140    3,496    (644 ) 18 %   14,755    12,692    (2,063 ) 16 %  
Amortization of intangible assets   17,156    17,040    (116 ) 1 %   51,742    41,176    (10,566 ) 26 %  
Impairment of non-current assets   21,904      (21,904 ) 100 %   23,984      (23,984 ) 100 %  
  Operating (loss) income    (31,050    )   (14,634 )   (16,416 ) 112 %   (41,044    )   (12,832 )   (28,212 ) 220 %  
           
Interest income on financial instruments measured at amortized cost   (1,922    )   (725 )   1,197   165 %   (4,072    )   (2,446 )   1,626   66 %  
Other interest income   (2,341    )   (1,471 )   870   59 %   (6,560    )   (4,936 )   1,624   33 %  
Interest expense   2,293    1,331    (962 ) 72 %   6,600    3,618    (2,982 ) 82 %  
Other (income) expense   1,964    (321 )   (2,285 ) 712 %   (4,025    )   (128 )   3,897   3045 %  
Net loss (gain) on financial assets measured at fair value through profit or loss   (8,824    )   (2,300 )   6,524   284 %   20,677    (18,944 )   (39,621 ) 209 %  
Foreign exchange (gain) loss   1,663    3,485    1,822   52 %   (7,442    )   3,737    11,179   299 %  
Gain on hyperinflation   (748    )   (209 )   539   258 %   (2,262    )   (423 )   1,839   435 %  
  Income (loss) before income taxes    (23,135    )   (14,424 )   (8,711 ) 60 %   (43,960    )   6,690    50,650   757 %  
           
  Income tax            
Current   882    (2,642 )   (3,524 ) 133 %   3,057    (1,349 )   (4,406 ) 327 %  
Deferred   (8,829    )   (3,481 )   5,348   154 %   (17,125    )   (7,636 )   9,489   124 %  
  Income tax recovery    (7,947    )   (6,123 )   1,824   30 %   (14,068    )   (8,985 )   5,083   57 %  
  Net (loss) income for the period    (15,188    )   (8,301 )   (6,887 ) 83 %   (29,892    )   15,675    (45,567 ) 291 %  
           
           
Basic and diluted net (loss) earnings per share (0.13 ) (0.07 )   (0.07 ) 99 %   (0.26    )   0.13    (0.39 ) 307 %  
           
  EBITDA   3    13,330    4,101    9,229   225 %   53,541    35,865    17,676   49 %  
  Adjusted EBITDA   3    13,821    5,696    8,125   143 %   54,032    38,005    16,027   42 %  
           
 

  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   EBITDA and a   djusted EBITDA is a non-   GAAP   measure, refer to section "Non-   GAAP   measures"   and "Reconciliation to adjusted EBITDA"   for additional details   .  

 

 

 
                                                                        
  Revenues    Q4-22 vs Q4-21      
      
    Q4-22    Q4-21    Q4-21    Change  
    Excluding impact of IAS 29   3    Excluding impact of IAS 29   3    Constant Currency   4    Excluding impact of IAS 29   3  

   Therapeutic Area    $    $    $     $   1    %   2  
  Oncology/Hematology   29,343   23,534   23,876    5,809 25 %
  Infectious Diseases   32,744   20,211   21,393    12,533 62 %
  Other Specialty   21,719   12,613   13,101    9,106 72 %
   Total    83,806   56,358   58,370    27,448 49 %
    1 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  
  3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.  
  4 Revenues at constant currency is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details  
  For the quarter ended December 31, 2022, excluding the impact of hyperinflation, revenues increased by $27,448 or 49% compared to the same period in prior year. The increase in revenues excluding the impact of hyperinflation is explained by the following:

  •   Oncology/Hematology: The increase in revenues of $5,809 is driven by growth in our key promoted brands, including new launches of Lenvima ® and Halaven ® in Colombia in Q1-22, the growth of key promoted products including Lenvima ® and Trelstar ® and the assumption of commercial activities of Akynzeo ® in Brazil and Canada. This increase is offset by a reduction in revenues of our branded generics products due to their lifecycle including the market entrance of new competitors.

    Infectious Diseases: The infectious disease portfolio grew by approximately $15,900, excluding the impact of the planned transition and termination of the Gilead Amendment. This growth is due to an increase in patient treatments as our markets reduce COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for Ambisome ® ("MOH Contract"). Knight recorded $7,500 in revenues, which represents 40% of the expected deliveries under the MOH contract in Q4-22 and the balance of the contract is expected to be delivered in the first six months of 2023.

    Other Specialty: The increase in revenues is mainly due to incremental revenue of $5,092 due to the change in accounting treatment of Exelon ® from net profit transfer from Novartis to revenues with related cost of sales upon the transition of commercial activities to Knight as well as the timing of purchases of products by certain customers.
  •  
All the pharmaceutical products sold by Knight are categorized as either innovative or BGx products. The description of each portfolio are as follows:

Innovative Portfolio : The portfolio consists of the pharmaceutical products with innovative molecules and includes both in-licensed products such as Lenvima ® , Cresemba ® , Halaven ® , Trelstar ® , Akynzeo ® , Ambisome ® as well as products owned (or partially owned) by Knight such as Exelon ® and Impavido ® . The categories of the portfolio are as follows:
  • Innovation – Promoted portfolio: consists of products on which the Company invest in commercial activities such as sales force promotion and products that require medical activities.
  •  
  • Innovative – Mature: consists of products that require lower level of promotional activities and/or products that have reached their peak market capture potential.
  •  
  • Innovative – Discontinued: consists of products that the company has stopped commercializing or is in the process of discontinuing sales.
  •  
BGx Portfolio : The portfolio consists of branded generic products which are pharmaceutically equivalent to an innovative molecule. The branded generics are given a brand name to differentiate the product from ordinary generics or other branded generics. The Company's branded generic portfolio currently primarily consists of products manufactured at our facilities in Argentina for commercialization in Argentina and the rest of Latin America (excluding Brazil and Mexico). The categories of portfolio are as follows:

  • BGx New Launches: consists of branded generic pharmaceutical products in the first three years of launch.
  •  
  • BGx Mature: consists of products which have been launched for more than three years.
  •  
  • BGx – Discontinued: consists of products that the company has stopped commercializing or is in the process of discontinuing sales.
  •  
During the quarter ended December 31, 2022, excluding the impact of IAS 29 the Company generated $68,404 or 82% of total revenues from its innovative portfolio and $15,402 or 18% of total revenues from its BGx portfolio.
 

 

 
                                                                                                     
    Q4-22    Q4-21    Change  
    Excluding impact of IAS 29   3    Excluding impact of IAS 29   3    Excluding impact of IAS 29   3  

   Product portfolio    $    $     $   1     %   2  
  Innovative – Promoted   54,270   26,127   28,143   108 %
  Innovative – Mature   13,399   9,199   4,200   46 %
  Innovative – Discontinued   735   3,547   (2,812 ) 79 %
   Total Innovative    68,404   38,873   29,531   76 %
  BGx - New Launches   2,999   2,730   269   10 %
  BGx – Mature   11,661   12,814   (1,153 ) 9 %
  BGx – Discontinued   742   1,941   (1,199 ) 62 %
   Total BGx    15,402   17,485   (2,083 ) 12 %
   Total    83,806   56,358   27,448   49 %
   1 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
3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.
4 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  
 
 

 

 
                                                                                         
    Change   
    Excluding impact of IAS 29   3  

 
   Product portfolio     $   1     %   2   
  Innovative – Promoted   28,143   108 %  
  • Incremental revenues of $5,092 related to the change in accounting treatment from net profit transfer to recognition of revenues and cost of sales of Exelon ®
  •  
  • Incremental revenues of $7,500 related to the Ambisome ® MOH Contract
  •  
  • Incremental revenues from launches of Lenvima ® and Halaven ® Colombia in Colombia in Q1-22
  •  
  • Continued growth of key promoted products including Lenvima ® , Cresemba ® and Trelstar ®
  •  
  Innovative - Mature   4,200   46 %  
  • Due to growth of Impavido® in certain markets and timing of sales of certain products
  •  
  Innovative - Discontinued   (2,812 ) 79 %  
  • Due to planned transition and termination agreement of the Gilead Amendment effective July 1, 2022
  •  
   Total Innovative     29,531     76    %   
  BGx - New Launches   269   10 %  
  • Due to the launch of Rembre® in Colombia and Dolufevir® in Argentina
  •  
  BGx - Mature   (1,153 ) 9 %  
  • Due to lifecycle of products including entrance of new competition
  •  
  BGx - Discontinued   (1,199 ) 62 %  
  • Discontinuation of the products at the end of their lifecycle
  •  
   Total BGx     (2,083    )    12    %   
   Total     27,448     49    %   
   1 Percentage change is presented in absolute values
2 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.  
 
 

 

 
                                                                
   YTD-22 vs YTD-21      
    YTD-22    YTD-21    YTD-21    Change  
    Excluding impact of IAS 29   3    Excluding impact of IAS 29   3    Constant Currency   4    Excluding impact of IAS 29   3  

   Therapeutic Area    $    $    $     $   1    %   2  
  Oncology/Hematology   105,464   89,079   89,505    16,385 18 %
  Infectious Diseases   116,530   101,650   106,640    14,880 15 %
  Other Specialty   69,776   48,509   47,586    21,267 44 %
   Total    291,770   239,238   243,731    52,532 22 %
    1 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
3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.
  4 Revenues at constant currency is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details
  4 Revenues at constant currency is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details  


For the twelve-month period ended December 31, 2022, excluding the impact of hyperinflation, revenues increased by $52,532 or 22% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation is explained by the following:

  •   Oncology/Hematology: The increase in revenues of $15,960 is driven by growth in our key promoted brands, including the launches of Lenvima ® and Halaven ® in Colombia in Q1-22, the continued growth of key promoted products including Lenvima ® , Halaven ® and Trelstar ® and the assumption of commercial activities of Akynzeo® in Brazil and Canada. This increase is offset by a reduction in revenues of our branded generics products due to their lifecycle including the market entrance of new competitors.

    Infectious Diseases: The infectious disease portfolio grew by approximately $29,080 due to increase in patient treatments as our markets reduce COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for Ambisome ® ("MOH Contract"). An incremental revenue of $7,500 representing 40% of the expected deliveries under the MOH contract was recorded in Q4-22 and the balance of the contract is expected to be delivered in the first six months of 2023. The growth is offset by an estimated $14,200 due to lower demand for certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19 as well as the planned transition and termination agreement of the Gilead Amendment effective July 1, 2022.
  •  
  •   Other Specialty: The revenues increase is mainly driven by the timing of the acquisition of Exelon® as well as a change in the accounting treatment of Exelon®. The full year effect of the Exelon® transaction executed on May 26, 2021, represents an incremental revenue of $15,282. The change in accounting treatment from net profit transfer from Novartis to recognition of revenues with related cost of sales upon transition of commercial activities to Knight led to an increase of $6,427 in revenues.
  •  
 

 

 
                                                                                                       
  During the year ended December 31, 2022, excluding the impact of IAS 29, the Company generated revenues of $228,003 or 78% of total revenues from its innovative portfolio and $63,767 or 22% of total revenues from its BGx portfolio.  
 
    YTD-22    YTD-21    Change  
    Excluding impact of IAS 29   3    Excluding impact of IAS 29   3    Excluding impact of IAS 29   3  

   Product portfolio    $    $     $   1     %   2  
  Innovative - Promoted   170,391   120,127   50,264   42 %
  Innovative - Mature   49,209   41,998   7,211   17 %
  Innovative - Discontinued   8,403   13,389   (4,986 ) 37 %
   Total Innovative    228,003   175,514   52,489   30 %
  BGx - New Launches   12,091   7,115   4,976   70 %
  BGx - Mature   47,744   49,772   (2,028 ) 4 %
  BGx - Discontinued   3,932   6,837   (2,905 ) 42 %
   Total BGx    63,767   63,724   43   0

%

   Total    291,770   239,238   52,532   22 %
    1 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 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  
  3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.  
 
 
 

 

 
                                                                                        
    Change   
    Excluding impact of IAS 29   3  

 
   Product portfolio    $   1     %   2   
  Innovative - Promoted   50,264   42 %  
  • Incremental revenues of $15,282 related to the full year effect of acquisition of Exelon® and $6,427 related to the change in accounting treatment from net profit transfer to recognition of revenues and cost of sales
  •  
  • Incremental revenues of $7,500 related to the Ambisome® MOH Contract
  •  
  • Incremental revenues from launches of Lenvima® and Halaven® Colombia in Colombia in Q1-21
  •  
  • Continued growth of key promoted products including Lenvima®, Cresemba® and Trelstar®
  •  
  Innovative - Mature   7,211   17 %  
  • Due to growth of Impavido® in certain markets and timing of sales of certain products
  •  
  Innovative - Discontinued   (4,986 ) 37 %  
  • Due to planned transition and termination agreement of the Gilead Amendment effective July 1, 2022
  •  
   Total Innovative     52,489     30    %   
  BGx - New Launches   4,976   70 %  
  • Due to launch of Rembre® in Colombia in Q1-22 and continued growth of Dolufevir® in Argentina
  •  
  BGx - Mature   (2,028 ) 4 %  
  • Due to lifecycle of products including entrance of new competition
  •  
  BGx - Discontinued   (2,905 ) 42 %  
  • Discontinuation of the products at the end of their lifecycle
  •  
   Total BGx     43     0    %   
   Total     52,532     22    %   
   
  1 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 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
3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.  
  
 
 

 

 
                        
  
  Gross margin     Q4-22 vs Q4-21   
  • Under IFRS, for the quarter ended December 31, 2022, gross margin, as a percentage of revenues, decreased from 48% in Q4-21 to 45% in Q4-22. The decrease in the gross margin, as a percentage of revenues, is explained by the impact of hyperinflation. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 50% in Q4-22 and 51% in Q4-21.
  •  
  YTD-22 vs YTD-21   
  • For the year ended December 31, 2022, there was no significant difference in gross margin, as a percentage of revenues, compared to the same prior year period. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 52% for year ended December 31, 2022 compared to 50% in prior year. The increase in the gross margin is explained by the change in product mix including the full year effect of the acquisition of Exelon®.
  •  
  Selling and marketing     Q4-22 vs Q4-21   
  • For the quarter ended December 31, 2022, S&M increased by $2,111 or 17%. Excluding the impact of IAS 29, the increase is $3,162 or 27% driven by an increase in compensation expenses including severance cost of $1,116 due to certain restructuring activities, an increase in selling and marketing activities related to key promoted products including spend on Exelon® and Akynzeo® as well as certain variable costs such as logistics fees due to higher sales.
  •  
  YTD-22 vs YTD-21   
  • For the twelve-month period ended December 31, 2022, S&M increased by $9,396 or 24%. Excluding the impact of IAS 29, the increase is $9,827 or 26% mainly driven by an increase in compensation expenses including severances of $1,146, an increase in selling and marketing activities related to key promoted products including the spend on Exelon® and Akynzeo as well as certain variable costs such as logistics fees due to higher sales.
  •  
  General and administrative     Q4-22 vs Q4-21   
  • No significant variance
  •  
  YTD-22 vs YTD-21   
  • For the twelve-month period ended December 31, 2022, G&A increased by $4,852 or 14%. Excluding the impact of IAS 29, the increase is $3,721 or 11%, mainly driven by an increase in compensation expense certain consulting and professional fees offset by the lower costs related to the long-term incentive plan.
  •  
  Research and development expenses  

   Q4-22 vs Q4-21   
  • No significant variance
  •  
  YTD-22 vs YTD-21   
  • For the twelve-month period ended December 31, 2022, R&D increased by $2,063 or 16%. Excluding the impact of IAS 29, the increase is $1,653 or 14%, mainly driven by an increase in compensation expenses and medical initiatives.
  •  
  Amortization of intangible assets  

   YTD-22 vs YTD-21   
  • For the year ended December 31, 2022, amortization of intangible assets increased by $10,566 or 26%, mainly explained by the amortization of $11,667 related to the full year effect of the acquisition of Exelon®.
  •  
  Impairment of non-current assets  

   YTD-22 vs YTD-21 and Q4-22 vs Q4-21   
  • Under hyperinflation accounting, non-monetary assets including property plant and equipment, right-of-use assets and intangible assets are adjusted by the inflation index and converted back to CAD at the closing rate of the reporting period. During a period where the inflation index is higher than devaluation of the Argentine peso relative to the CAD, the value of the non-monetary assets increases when converted to CAD.
  •  
  • During 2022, the increase in the value of non-monetary assets in Argentina due to hyperinflation accounting, resulted in an impairment of $21,654 (2021: Nil) of these assets which was recorded in "Impairment of non-current assets". The loss represents a write-down of certain right-of-use assets, property, plant and equipment in Argentina, and intangible assets related to branded generics intellectual property to its recoverable amount.
  •  
  • In addition, during 2022, the Company recorded an additional impairment loss of $2,330 representing the write-down of the upfront and certain milestones payments made under certain product license agreements as a result of changes in commercial expectations.
  •  
  
I nterest income  

   YTD-22 vs YTD-21 and Q4-22 vs Q4-21   
  • Includes "Interest income on financial instruments measured at amortized cost" and "Other interest income".
  •  
  • Primarily from interest earned on loans, cash and cash equivalents, marketable securities and accretion on loans receivable.
  •  
  • Interest income for Q4-22 was $4,263 and YTD-22 $10,632, an increase of 94% or $2,067 and 44% or $3,250, respectively, compared to the same period in prior year due to higher interest rates on cash and marketable securities as well as interest earned on loans.
  •  
  Interest Expense  

   Q4-22 vs Q4-21 and YTD-22 vs YTD-21   
  • The interest expense for Q4-22 and YTD-22 includes the interest expense on bank loans of $1,363 and $5,089 and interest expense of lease liabilities and other of $1,511 and $930 respectively.
  •  
  • Interest expense on banks loans for the Q4-22 and YTD-22 increased by $407 or 43% and by $2,364 or by 87% respectively, compared to the same periods in prior year, due to the increase of the CDI and IBR rates throughout 2022, partially offset by lower average loan balance due to partial repayment of Itaú Unibanco Brasil and Bancolombia bank loans. Refer to Section Liquidity and Capital Resources for further information on the bank loans.
  •  
  • The Company entered into a loan with IFC for an amount of $52,416 [USD 38,500] denominated in BRL, COP, CLP and MXN with interest rates ranging between 7.86% and 15.83% as at December 31, 2022. The interest expense on bank loans is expected to increase in 2023 due to the IFC loan as well as any future increases in variable interest rates.
  •  
  Other income (expense)  

   Q4-22 vs Q4-21   
  • Other expense for the three-month period ended December 31, 2022 increased by $2,285 or by 712% compared to the same period in prior year mainly due to the increase in a provision related to certain import tax claims.
  •  
  YTD-22 vs YTD-21   
  • Other income for the year ended December 31, 2022 increased by $3,897 or 3045%. The Company recorded a gain of $6,030 (US$4,600) upon execution of a settlement agreement and general release with the former shareholders of GBT. The settlement gain was partially offset by the increase in a provision related to certain import tax claims.
  •  
  Net gain or loss on financial assets measured at fair value through profit or loss  

   Q4-22 vs Q4-21   
  • Net gain on financial assets measured at fair value through profit and loss for Q4-22 was $8,824, mainly driven by unrealized gain on revaluation of our strategic fund investments resulting from positive mark-to-market adjustments as a result of the increase in the share prices of one of the publicly-traded equities held by one of the funds.
  •  
  YTD-22 vs YTD-21   
  • Net loss on financial assets measured at fair value through profit and loss for YTD-22 was $20,677, mainly driven by negative mark-to-market adjustments as a result of the decline in the share prices of the publicly-traded equities held by our strategic fund investments due to general market conditions.
  •  
 

 

 
       
  Foreign exchange gain or loss     Q4-22 vs Q4-21   
  • The foreign exchange loss in the three months ended Q4-22 and Q4-21 is mainly driven by the unrealized losses on revaluation of our financial assets including our cash balances as well as unrealized loss on intercompany balances due to the appreciation of the CAD vs. the USD.
  •  
  YTD-22 vs YTD-21   

  • The foreign exchange gains in YTD-22 are mainly driven by the unrealized gains on revaluation of our financial assets including our cash balances as well as intercompany balances due to the appreciation of the USD and EURO vs. the CAD, partially offset by the depreciation of the select LATAM currencies throughout the year.
  •  
  • The foreign exchange loss in Q4-21 and YTD-21 is mainly driven by the unrealized losses on revaluation of our financial assets including our cash balances due to the appreciation of the CAD vs. the USD and EURO.
  •  
 
  Gain or loss on hyperinflation   
  • Relates to gain on net monetary position (monetary assets less monetary liabilities) under hyperinflation accounting. Refer to "Impact of Hyperinflation" section for further details.
  •  
  Income tax expense   
  • The income tax recovery for Q4-22 and YTD-22 is driven by the recognition of certain deferred tax assets due to timing differences related to our financial assets, impairment of certain non-current assets and certain intercompany transactions.
  •  
  • The income tax recovery for Q4-21 and YTD-21 is driven by the recognition of certain deferred tax assets due tax losses generated, timing differences related to certain intercompany transactions, financial assets and impairment of certain non-current assets.
  •  
 

  
 

 

  Non-GAAP measures  

 

The Company discloses non-GAAP 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. Non-GAAP 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-GAAP measures:

 

  Revenues and Financial results excluding the impact of hyperinflation under IAS 29 : Revenues and financial results under IFRS are adjusted to remove the impact of hyperinflation under IAS 29. Impact of hyperinflation under IAS 29 is calculated by applying an appropriate general price index to express the effects of inflation. After applying the effects of translation, the statement of income is converted using the closing foreign exchange rate of the month.

 

  Revenues and Financial results at constant currency : Revenues/financial results at constant currency are obtained by translating the prior period revenues/financial results from the functional currencies to CAD using the conversion rates in effect during the current period. Furthermore, with respect to Argentina, the Company excludes the impact of hyperinflation and translates the revenues/results at the average exchange rate in effect for each of the periods.

 

Revenues/financial results at constant currency allow revenues/financial 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 revenues/financial results under constant currency is considered to be a non-GAAP 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.

 

  EBITDA: Operating income or loss adjusted to exclude amortization and impairment of long-lived assets, depreciation, purchase price allocation accounting adjustments, and the impact of IAS 29 (accounting under hyperinflation) but to include costs related to leases.

 

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

 

  Reconciliation to adjusted EBITDA  

 

For the three-month period and year ended December 31, 2022, the Company calculated EBITDA and adjusted EBITDA as follows:

 
                                                                                                                                                                                                          
[Unaudited]
     Change        Change  
   Q4-22    Q4-21   $ 1       %   2      YTD-22    YTD-21    $ 1       %   2    
  Operating loss    (31,050    )   (14,634 (16,416 ) 112 %   (41,044    )   (12,832 ) (28,212 ) 220 %
Adjustments to operating loss:                
Amortization of intangible assets   17,156    17,040 116   1 %   51,742    41,176   10,566   26 %
Impairment of non-current assets   21,904    21,904   100 %   23,984     23,984   100 %
Depreciation of property, plant and equipment and ROU assets   3,037    1,961 1,076   55 %   10,879    6,739   4,140   61 %
Lease costs (IFRS 16 adjustment)   (836    )   (874 38   4 %   (2,750    )   (3,016 ) 266   9 %
Impact of IAS 29   3,119    608 2,511   413 %   10,730    3,798   6,932   183 %
  EBITDA 3    13,330    4,101 9,229   225 %   53,541    35,865   17,676   49 %
Acquisition and transaction costs      0 %     432   (432 ) 100 %
Other non-recurring expenses   491    1,595 (1,104 ) 69 %   491    1,708   (1,217 ) 71 %
  Adjusted EBITDA 3    13,821    5,696 8,125   143 %   54,032    38,005   16,027   42 %
 

  1   A positive variance represents a positive impact to   EBITDA and adjusted EBITDA   and a negative variance represents a negative impact to   EBITDA and adjusted EBITDA  
2   Percentage change is presented in absolute values  
3   EBITDA and a   djusted   EBITDA   are   non-   GAAP   measure   s   , refer to section "   Non-GAAP measures   " for additional details  

 

  
 

 

   Explanation of adjustments   

 
    
  Acquisition costs   Acquisition and transaction costs relate to costs incurred on legal, consulting and advisory fees
for the acquisition of GBT and the acquisition of products.

During the year ended December 31, 2021 the Company incurred expenses of $432 related
to acquisition of Exelon® (Q4-21: Nil).

  Other non-recurring expenses   Other non-recurring expenses relate to expenses incurred by the Company that are not due to,
and are not expected to occur in, the ordinary course of business.

For the year ended December 31, 2022, the Company incurred non-recurring costs of $491
(Q4-22: $491) related to restructuring activities including severance to certain employees as
part of restructuring and integration of GBT.

For the year ended December 31, 2021, the Company incurred non-recurring costs of $1,708
(Q4-21: $1,595) related to restructuring activities including severance to certain employees as
part of restructuring and integration of GBT.
 

   
 
 

 

   Adjusted EBITDA Q4-22 vs Q4-21   

 

For the three-month period ended December 31, 2022 adjusted EBITDA increased by $8,125 or 143%. The growth in adjusted EBITDA is driven by an increase in gross margin of $8,693 offset by an increase in operating expenses. Refer to above explanations for further details.

 

   Adjusted EBITDA YTD-22 vs YTD-21   

 

For the year ended December 31, 2022 adjusted EBITDA increased by $16,027 or 42%. The growth in adjusted EBITDA is driven by an increase in gross margin of $22,649 offset by an increase in operating expenses. Refer to above explanations for further details.

 

 

 

  Financial Condition  

 

  Impact of LATAM Foreign Exchange volatility  

 

The following table represents the quarter end closing rates used by Knight to convert the assets and liabilities on the balance sheet at the end of each reporting period.

 
                              
  Rates    Q4-22    Q3-22    Q2-22    Q1-22    Q4-21  
BRL 3.90 3.94 4.05 3.80 4.40
ARS 130.53 107.12 97.07 88.72 80.88
COP 3,584 3,322 3,205 3,012 3,195
CLP 629 703 718 631 671
 

 

 

The below table summarizes the variances quarter over quarter for selected LATAM currencies:

 
                                         
  Variance (%)   1    Q4-22    Q3-22    Q2-22    Q1-22  
BRL 1 % 3 % -7 % 14 %
ARS -22 % -10 % -9 % -10 %
COP -8 % -4 % -6 % 6 %
CLP 10 % 2 % -14 % 6 %
 

   1    Negative percentage represents a depreciation of the currency while a positive variance represents an appreciation of the currency  

 

  
 

 

  Consolidated Balance Sheets  
[In thousands of Canadian dollars]

 

[Unaudited]

 
                                                                                                                                                                                      
     Change  
  12-31-22   12-31-21   $    %   1  
     
  ASSETS        
  Current      
Cash and cash equivalents   71,679   85,963 (14,284 ) 17 %
Marketable securities   85,826   63,539 22,287   35 %
Trade receivables   94,890   55,388 39,502   71 %
Other receivables   12,930   5,056 7,874   156 %
Inventories   92,489   72,397 20,092   28 %
Prepaids and deposits   1,704   2,165 (461 ) 21 %
Other current financial assets   33,716   13,491 20,225   150 %
Income taxes receivable   2,385   6,970 (4,585 ) 66 %
  Total current assets    395,619   304,969 90,650   30 %
     
Marketable securities   15,169   15,169   0 %
Prepaids and deposits   4,355   3,046 1,309   43 %
Right-of-use assets   5,827   4,671 1,156   25 %
Property, plant and equipment   16,806   25,265 (8,459 ) 33 %
Investment properties    1,457 (1,457 ) 100 %
Intangible assets   338,780   350,299 (11,519 ) 3 %
Goodwill   82,274   75,403 6,871   9 %
Other financial assets   142,847   178,952 (36,105 ) 20 %
Deferred income tax assets   9,310   2,048 7,262   355 %
Other long-term receivables   43,849   43,431 418   1 %
   659,217   684,572 (25,355 ) 4 %
Assets held for sale    2,350 (2,350 ) 100 %
  Total assets    1,054,836   991,891 62,945   6 %
 

s 1   Percentage change is presented in absolute values  

 

  
 

 
                                                                                                                                                                                                      
     Change  
  12-31-22   12-31-21   $    %   1  
     
  LIABILITIES AND EQUITY      
  Current      
Accounts payable and accrued liabilities   106,061   65,309   40,752   62 %
Lease liabilities   2,578   1,614   964   60 %
Other liabilities   5,793   1,989   3,804   191 %
Bank loans   17,674   26,662   (8,988 ) 34 %
Income taxes payable   2,274   7,073   (4,799 ) 68 %
Other balances payable   6,941   2,655   4,286   161 %
  Total current liabilities    141,321   105,302   36,019   34 %
     
Accounts payable and accrued liabilities   2,669   281   2,388   850 %
Lease liabilities   5,050   3,417   1,633   48 %
Bank loans   52,398   9,265   43,133   466 %
Other balances payable   23,176   19,235   3,941   20 %
Deferred income tax liabilities   4,365   12,373   (8,008 ) 65 %
  Total liabilities    228,979   149,873   79,106   53 %
     
  Shareholders' Equity      
Share capital   599,055   628,854   (29,799 ) 5 %
Warrants   117   117    0 %
Contributed surplus   23,664   21,776   1,888   9 %
Accumulated other comprehensive income (loss)   41,266   (376 ) 41,642   11075 %
Retained earnings   161,755   191,647   (29,892 ) 16 %
  Total shareholders' equity    825,857   842,018   (16,161 ) 2 %
  Total liabilities and   shareholders'   equity    1,054,836   991,891   62,945   6 %
 

[Unaudited]

 

  1   Percentage change is presented in absolute values  

 

  
 

 
                     
 
12-31-22 vs 12-31-21  
  Cash and cash equivalents  

 
  • Cash and cash equivalents decreased by $14,284 or 17% mainly due to cash generated through operating activities and funds received under the IFC Loan offset by cash outflows from shares purchased through the NCIB, the in-licensing of AKYNZEO® and ALOXI® from Helsinn as well as fostamatinib from Rigel, repayments on bank loans and foreign exchange gain on cash and cash equivalents. Refer to section Liquidity and Capital Resources for more details.
  •  
  Trade receivables  

 
  • Trade receivables increased by $39,502 or 71%, mainly due to growth in revenues including the assumption of commercial activities of Exelon® and Akynzeo®, sale of Ambisome® under the MOH Contract, and the growth of our key promoted products.
  •  
  Other receivables (current)   
  • Other receivables increased by $7,874, or 156% mainly due to a receivable of $2,393 from sale of the Medimetriks investments, an increase in interest receivable of $2,965 and an increase in sales and other taxes receivable of $1,592.
  •  
  Inventories   
  • Inventories increased by $20,092, or 28% due to inventory purchases of $10,704 upon transfer of commercial activities of Exelon® and Akynzeo® as well as an increase in inventory levels across key promoted products including Ambisome® in anticipation of the 2023 deliveries of the MOH Contract.
  •  
  Other financial assets  
(current and long term)  
Other financial assets decreased by $15,880, or 85%, explained mainly by the following:


Loans and other receivable: increase of $5,023 mainly attributable to net loans issued
of $2,723 and foreign exchange gains of $1,734.

Equity investments and Derivatives: decrease of $1,918 or 24% driven mainly by the disposal of Medimetriks equity investments during the period and the revaluation of equity investments and derivatives.

Funds: decrease of $18,985 due to negative mark-to-market adjustments of $23,325 driven mostly by the decline in the share prices of the publicly-traded equities held by our strategic fund investments due to general market conditions, distributions received and receivable of $6,478, offset by capital calls of $6,307 and foreign exchange gains of $4,511.

  Income tax receivable   
  • Decrease is mainly due collection of tax refunds.
  •  
  Property, plant and equipment   
  • Property plant and equipment decreased by 8,459 or 33% mainly due to the impairment of certain property, plant and equipment in Argentina related to branded generics intellectual property.
  •  
  Intangible assets   
  • Intangible assets decreased by $11,519 or 3% mainly due to amortization and impairment charge during the period, offset by upfront payments and certain milestones primarily related to in-licensing of AKYNZEO® and ALOXI® from Helsinn, fostamatinib from Rigel and the appreciation of the USD vs. the CAD.
  •  
  Goodwill   
  • Increase due to the appreciation of certain LATAM currencies during the period.
  •  
  Deferred income tax asset   Increase is mainly explained by additional deferred tax assets recognized on tax losses generated in certain jurisdictions and certain temporary differences related to financial assets and change in temporary differences related to intercompany transactions.
 

 

 

 

 
                 
  12-31-22 vs 12-31-21  
  Other receivables (long-term)   
  • No significant variance.
  •  
  Accounts payable and accrued liabilities  
(current and long term)  
 
  • Increase in accounts payable and accrued liabilities balance by $43,140, or 64%, driven by:
    1. increase of $25,772 related to purchase of Exelon® & AKYNZEO® inventory driven by the transfer of the commercial activities to Knight and purchases of Ambisome® in anticipation of the MOH Contract deliveries of 2023;
    2.  
    3. higher payables due to inventory purchases of our key promoted products and, timing of accruals, payments to and purchases from certain suppliers.
    4.  
  •  
  Bank loans (current and long term)   
  • Increase in bank loans by $34,145 or 95% mainly due to a five-year loan from IFC denominated in select LATAM currencies of $51,478 and accrued interest, partially offset by loan repayments of $17,542.
  •  
  Income tax payable   
  • Decrease is mainly explained by the settlement of certain prior year income tax liabilities, instalments and lower current tax accruals in certain jurisdictions.
  •  
  Other balances payable (current and long term)   
  • Increase in other payables by $8,227 due to certain milestones mainly related to in-licensing of AKYNZEO® and ALOXI® from Helsinn, fostamatinib from Rigel and appreciation of the USD vs the CAD.
  •  
  Deferred income tax liability   
  • Decrease is mainly explained by the recognition of deferred income tax recovery on amortization of certain definite-life intangible assets acquired by the Company, the change in temporary difference related to intercompany transactions and certain impairment on intangible assets.
  •  
  Share capital   
  • Decrease due to the purchase of Knight's common shares though the NCIB, partially offset by share issuance under ESPP.
  •  
  Contributed surplus   
  • Increase related to share-based compensation expense.
  •  
 

  Liquidity and Capital Resources  

 

The Company's Investment Policy governs the investment activities relating to cash resources. An Investment Committee composed of representatives from management and the Board of Directors monitors compliance with said policy. The Company invests in strategic investments in the form of equity funds, debt funds, equity or liquid investment securities with varying terms to maturity, selected with regard to the expected timing of investments and expenditures for continuing operations and prevailing interest rates.

 

The Company believes that its existing cash, cash equivalents and marketable securities as well as cash generated from operations are sufficient to finance its current operations, working capital requirements and future product and corporate acquisitions. The table below sets forth a summary of cash flow activity and should be read in conjunction with our consolidated statements of cash flows.

 

 

 

[Unaudited]

 
                                                                                                                                                                                                    
       Change   
 
  YTD   
 
   Change   
 
   Q4-22    Q4-21    $     %   1    2022    2021    $     %   1  
Net cash from operating activities   4,752    4,681   71   2 %   40,481    44,618   (4,137 ) 9 %
Net cash used in investing activities   (65,024    )   9,469   (74,493 ) 787 %   (63,079    )   (105,279 ) 42,200   40 %
Net cash from (used in) financing activities   29,858    (22,886 ) 52,744   230 %   1,762    (78,310 ) 80,072   102 %
Increase in cash and cash equivalents during the period   (30,414    )   (8,736 ) (21,678 ) 248 %   (20,836    )   (138,971 ) 118,135   85 %
Net foreign exchange difference   271    2,209   (1,938 ) 88 %   6,552    (4,658 ) 11,210   241 %
Cash and cash equivalents beginning of the period   101,822    92,490   9,332   10 %   85,963    229,592   (143,629 ) 63 %
Cash and cash equivalents, end of the period   71,679    85,963   (14,284 ) 17 %   71,679    85,963   (14,284 ) 17 %
Marketable securities 2 , end of the period   100,995    63,539   37,456   59 %   100,995    63,539   37,456   59 %
Cash and cash equivalents, and marketable securities 2 , end of the period   172,674    149,502   23,172   15 %   172,674    149,502   23,172   15 %
Cash and cash equivalents, net of bank loans   1,607    50,036   (48,429 ) 97 %   1,607    50,036   (48,429 ) 97 %
 

  1   Percentage change is presented in absolute   values   .  
2   Including marketable securities   pledged as restricted cash collateral under the IFC loan.  

 

  
 

 

 

 
                
   Q4-22     YTD-22  
  Net cash from operating activities   Primarily relates to cash generated through revenues and interest received, offset by operating expenses including salaries, research and development expenses, advertising and promotion costs, interest paid and other corporate expenses. Cash flows from operating activities exclude revenues and expenses not affecting cash, such as unrealized and realized gains or losses on financial assets, share based compensation expense, depreciation and amortization, unrealized foreign exchange gains or losses, hyperinflation gains, other income, deferred other income, and net changes in non-cash balances relating to operations.

  For the three-month period ended December 31, 2022, cash inflow from operations was $4,752. The net loss for the quarter plus adjustments of non-cash items such as depreciation, amortization and impairment is $6,280 which is offset by an increase in working capital of $1,528. The increase in the working capital is mainly due to the transition of commercial activities to Knight related to Exelon® and Akynzeo®. The working capital levels are expected to normalize during the first half of 2023.

Furthermore, the net cash from operating activities included an inflow of $2,287 related to net interest received mainly driven by the timing of maturity of marketable securities.

  For the year ended December 31, 2022, cash inflow from operations was $40,481. The net loss for the year plus adjustments of non-cash items such as non-cash items such as depreciation, amortization and impairment is $50,470 which is offset by an increase in working capital of $9,989. The increase in the working capital is mainly due to the transition of commercial activities to Knight related to Exelon® and Akynzeo®. The working capital levels are expected to normalize during the first half of 2023.

Furthermore, the net cash from operating activities included an inflow of $7,608 related to net interest received mainly driven by the timing of maturity of marketable securities as well as an inflow of $6,030 from the settlement with former shareholders of GBT.
  Net cash from investing activities   For the three-month period ended December 31, 2022, cash flows were mainly driven by:
  • net purchase of marketable securities of $57,418 driven by higher interest rates on GICs including the requirement under IFC loan for restricted cash collateral of 35% of loan balance outstanding;
  •  
  • distributions from life sciences funds of $577, offset by investment in funds of $531;
  •  
  • acquisition of intangibles and property and equipment of $6,653 mainly due to certain sales milestones payment;
  •  
  • proceeds from disposal of investments in Medimetriks of $1,742.
  •  
  For the year ended December 31, 2022, cash flows were mainly driven by:
  • net purchase of marketable securities of $36,825 driven by higher interest rates and requirement under IFC loan to have restricted cash collateral of 35% of loan balance outstanding;
  •  
  • acquisition of intangibles and property and equipment of $25,816 mainly due to upfront payments and certain milestones related to in-licensing of AKYNZEO® and ALOXI® from Helsinn as well as fostamatinib from Rigel, and
  •  
  • distributions from life sciences funds of $3,985, offset by investment in funds of $3,831;
  •  
  • issuance of additional strategic loan of $2,741 to Synergy, and
  •  
  • proceeds from disposal of investments in Medimetriks of $1,742.
  •  
  Net cash from financing activities   Cash flows from financing activities were mainly due to the repurchase of common shares through the NCIB, principal repayments on bank loans, principal repayments on lease liabilities, proceeds from bank loans and proceeds from the participation of employees and directors in the Company's share purchase plan.

 

 

 

The Company had the following indebtedness as at the end of the following periods:

 
                                                                                                           
  As at December 31, 2022       
[Unaudited]

     
   Currency of
debt
 
  Interest rate    Effective
interest rate
 
  Maturity    Current  
$  
  Non-current  
$  
  Total  
$  
  Banks         
Itaú Unibanco Brasil BRL 1.65% + CDI 13.36 % Dec 8, 2023   8,487      8,487  
Bancolombia COP 2.28% + IBR 8.07 % Oct 12, 2026   2,299    6,194    8,493  
Banco ICBC Argentina 1 ARS 77% 2 77% 2 N/A   344      344  
Banco Itaú Argentina 1 ARS 76% 3 76% 3 N/A   1,270      1,270  
IFC BRL 1.6% + CDI 15.83 % Oct 15, 2027   3,121    23,309    26,430  
IFC CLP 7.71 % 7.86 % Oct 15, 2027   1,202    9,198    10,400  
IFC COP 1.6% + IBR 13.29 % Oct 15, 2027   735    10,613    11,348  
IFC MXN 1.6% + TIIE 13.07 % Oct 15, 2027   216    3,084    3,300  
  Total Bank Loans        17,764    52,398    70,072  
 

  1   Overdraft balances  
2   Fixed rate renewed monthly  
3   Fixed rate renewed daily  

 

  
 

 
                                                                           
  As at December 31, 2021       
   Currency of
debt
 
  Interest rate    Effective
interest rate
 
  Maturity    Current  
$  
  Non-current  
$  
  Total  
$  
  Banks         
Itaú Unibanco Brasil BRL 1.65% + CDI 5.97 % Dec 8, 2023 15,028 15,028
Itaú Unibanco Brasil BRL 2.20% + CDI 11.35 % Dec 28, 2022 5,601 5,601
Bancolombia COP 2.28% + IBR 4.47 % Oct 12, 2026 2,448 9,265 11,713
Banco ICBC Argentina 1 ARS 42% 2 42 % N/A 694 694
Banco Itaú Argentina 1 ARS 40% 3 40 % N/A 2,891 2,891
Total Bank Loans      26,662 9,265 35,927
 

  1   Overdraft balances  
2   Fixed rate renewed monthly  
3   Fixed rate renewed daily  

 

 

 

  CONSOLIDATED STATEMENTS OF CASH FLOWS  

 

[In thousands of Canadian dollars]

 

[Unaudited]

 
                                                                                                                                                                                                                                                                                                                 
   Three months ended December 31,    Year ended December 31,  
   2022    2021    2022    2021  
  OPERATING ACTIVITIES      
  Net (loss) income for the period    (15,188    )   (8,301 )   (29,892    )   15,675    
Adjustments reconciling net income to operating cash flows:     
Depreciation and amortization   20,194    19,001    62,621    47,915    
Net gain (loss) on financial instruments   (8,824    )   (2,300 )   20,677    (18,944 )
Unrealized foreign exchange loss (gain)   (1,044    )   3,968    (8,479    )   2,881  
Loss on disposal and impairment of non-current assets   21,904    496    23,984    496    
Other operating activities   (10,762    )   (2,086 )   (18,441    )   (4,032 )
   6,280    10,778    50,470    43,991  
Changes in non-cash working capital and other items   (1,528    )   (6,097 )   (9,989    )   627  
  Cash inflow from operating activities    4,752    4,681    40,481    44,618  
     
  INVESTING ACTIVITIES      
Purchase of marketable securities   (100,995    )   3    (181,642    )   (47,892 )
Proceeds on maturity of marketable securities   43,577    90    144,817    146,986  
Investment in funds   (531    )   (5,466 )   (3,831    )   (16,429 )
Proceeds from distribution of funds   577    17,519    3,985    30,931  
Purchase of intangible assets   (4,407    )   (153 )   (22,931    )   (220,351 )
Other investing activities   (3,245    )   (2,524 )   (3,477    )   1,476  
  Cash (outflow) inflow from investing activities    (65,024    )   9,469    (63,079    )   (105,279 )
     
  FINANCING ACTIVITIES      
Repurchase of common shares through Normal Course Issuer Bid   (8,684    )   (23,508 )   (30,069    )   (64,415 )
Principal repayment on bank loans   (12,095    )   (5,688 )   (17,542    )   (20,599 )
Proceeds from bank loans   51,361    7,098    51,783    9,423  
Other financing activities   (724    )   (788 )   (2,410    )   (2,719 )
  Cash inflow (outflow) from financing activities    29,858    (22,886 )   1,762    (78,310 )
     
  (Decrease) in cash and cash equivalents during the period    (30,414    )   (8,736 )   (20,836    )   (138,971 )
Cash and cash equivalents, beginning of the period   101,822    92,490    85,963    229,592  
Net foreign exchange difference   271    2,209    6,552    (4,658 )
  Cash and cash equivalents, end of the period    71,679    85,963    71,679    85,963  
     
Cash and cash equivalents     71,679    85,963  
Short-term marketable securities     85,826    63,539  
Long-term marketable securities     15,169    
  Total cash, cash equivalents and marketable securities      172,674    149,502  
 

 

 

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News Provided by GlobeNewswire via QuoteMedia

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