Knight Therapeutics Reports First Quarter 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 first quarter ended March 31, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

  Q1 2022 Highlights  

Financials

• Revenues were $63,807, an increase of $17,738 or 39% over the same period in prior year.
 
• Gross margin of $32,477 or 51% compared to $20,580 or 45% in the same period in prior year.
 
• Adjusted EBITDA ¹ was $13,312, an increase of $7,732 or 139% over the same period in prior year.
 
• Net loss on financial assets measured at fair value through profit or loss of $16,363, of which $16,281 was unrealized.
 
• Net loss was $18,811, compared to net income of $3,558 in the same period in prior year.
 
• Cash inflow from operations was $12,879, compared to a cash inflow from operations of $17,207 in the same period in prior year.
 

Corporate Developments

• Purchased 1,734,305 common shares through Knight's Normal Course Issuer Bid ("NCIB") at an average price of $5.29 for an aggregate cash consideration of $9,183.
 
• Hired Leopoldo Bosano as VP Manufacturing and Operations.
 

Products

• Launched Lenvima ^® (lenvatinib) and Rembre ^® (dasatinib) in Colombia in February 2022.
 
• Launched Halaven ^® (eribulin mesylate) in Colombia in March 2022.
 

Subsequent Events

• Entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA for AKYNZEO ^® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI ^® oral/IV (palonosetron) in Canada.
 
• 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.
 
• Purchased an additional 893,414 common shares through NCIB for an aggregate cash consideration of $4,760.
 

"I am excited to report that in the first quarter of 2022 Knight's revenues increased by $17,738 or 39%. In addition to the acquisition of Exelon ^® , we had revenue growth across all our therapeutic areas driven by market penetration of our key promoted brands and an increase in patient treatments due to reduced COVID-19 restrictions. On the business development front, we entered into an exclusive license, distribution and supply agreements with Helsinn in our key territories", said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc. "As we look to the balance of 2022, we will continue to execute on revenue and EBITDA growth as well as adding new products through business development."

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

 
SELECT FINANCIAL RESULTS  
[In thousands of Canadian dollars]

  SELECT BALANCE SHEET ITEMS  
[In thousands of Canadian dollars]

  Revenues: For the quarter ended March 31, 2022, excluding the impact of hyperinflation, revenues increased by $17,752 or 39% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation is explained as following:

• An increase in revenues of $7,059 driven by the acquisition of Exelon ^® .
 
• The remainder of the increase is driven by the growth and market penetration of our key promoted brands as well as an increase in patient treatments as our markets reduce COVID-19 restrictions.
 

  Gross margin: For the quarter ended March 31, 2022, gross margin increased from 45% to 51% explained by a change in product mix as well as the acquisition of Exelon ^® and related revenues recorded as a net profit transfer.

  Selling and marketing: For the quarter ended March 31, 2022, selling and marketing expenses increased by $2,077 or 27% driven by an increase in certain variable costs such as logistics fees, compensation as well as an increase in selling and marketing activities related to key promoted products and Exelon ^® .

  General and administrative: For the quarter ended March 31, 2022, general and administrative expenses increased by $1,750 or 25% driven by increase in compensation and certain consulting and professional fees.

  Amortization of intangible assets: For the quarter ended March 31, 2022, amortization of intangible assets increased by $5,986 due to the acquisition of Exelon ^® .   

  Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended March 31, 2022, interest income was $1,480, a decrease of 26% or $518, compared to the same period in prior year due to a lower average cash and marketable securities balances and loan balance.

  Interest expense: For the quarter ended March 31, 2022, interest expense was $1,111, an increase of $451 or 68%, compared to the same period in prior year due to higher interest rates.

  Adjusted EBITDA: For the quarter ended March 31, 2022, adjusted EBITDA increased by $7,732 or 139%. The growth in adjusted EBITDA is driven by an increase in gross margin of $11,897, offset by an increase in operating expenses.

  Net loss or income: For the quarter ended March 31, 2022, net loss was $18,811 compared to net income of $3,558 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss on the revaluation of financial assets measured at fair value through profit or loss of $16,363 versus a net gain of $9,473 in the same period in prior year, mainly due to unrealized losses and gains on revaluation of the strategic fund investments, offset by (2) an income tax recovery of $3,501 due to the recognition of certain deferred tax assets compared to an income tax expense of $869 in the same period in prior period.   

  Cash, cash equivalents and marketable securities : As at March 31, 2022, Knight had $156,396 in cash, cash equivalents and marketable securities, an increase of $6,894 or 5% as compared to December 31, 2021. The variance is primarily due to cash inflows from operating activities, offset by the shares repurchased through NCIB.

  Financial assets: As at March 31, 2022, financial assets were at $169,392, a decrease of $23,051 or 12%, as compared to the prior year, mainly due to negative mark-to-market adjustments of $16,660 driven mainly by the decline in the share prices of the publicly-traded equities of our strategic fund investments. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

  Bank Loans: As at March 31, 2022, bank loans were at $41,025, an increase of $5,098 or 14% as compared to the prior period, due to appreciation of the Brazilian Real and Colombian Peso versus Canadian Dollar.

  Product Updates  

Knight obtained regulatory approval and launched Lenvima ^® , Halaven ^® and Rembre ^® in Colombia during the first quarter of 2022. Lenvima ^® , the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, is indicated for the treatment of radioiodine refractory differentiated thyroid cancer ("RR-DTC") and unresectable hepatocellular carcinoma ("u-HCC") and was launched in February 2022. Halaven ^® injection is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatments for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven® is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed and who have already been treated with an anthracycline, unless deemed unsuitable. Knight launched Halaven ^® in Colombia in March 2022. In addition, Rembre ^® is indicated for treatment of chronic myeloid leukemia with positive Philadelphia chromosome (Ph+) and was launched in February 2022.

Subsequent to the quarter Knight entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA for AKYNZEO ^® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI ^® oral/IV (palonosetron) in Canada. AKYNZEO ^® oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO ^® oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. ALOXI ^® solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI ^® oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

  NCIB  

For the three-month period ended March 31, 2022, the Company purchased 1,734,305 common shares at an average price of $5.29 for an aggregate cash consideration of $9,183 of which $2,520 remains to be settled as at March 31, 2022. Subsequent to quarter-end up to May 10, 2022, the Company purchased an additional 893,414 common shares at an average purchase price of $5.33 for an aggregate cash consideration of $4,760.

  Financial Outlook Update  

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 2022, Knight has updated its guidance and expects to generate $260 to $270 million in revenue, an increase of $5 million on the upper end of the range. 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 at May 11, 2022
 
• discontinuation of certain distribution agreements
 
• Exelon ^® marketing authorization transfer to Knight in May 2022 in Colombia and in June 2022 in Brazil
 
• recording revenue related to Akynzeo ^® and Aloxi ^® following transition period from Helsinn's current licensees
 
• 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.

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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 first quarter ended March 31, 2022, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

  Date: Thursday, May 12, 2022
Time: 8:30 a.m. ET
Telephone : Toll Free: 1-855-669-9657 or International 1-412-317-0790
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  

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  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 owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. 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:  

  IMPACT OF HYPERINFLATION  
[In thousands of Canadian dollars]

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

  NON-GAAP MEASURES  
[In thousands of Canadian dollars]

  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 and in interpreting the effect of the GBT Transaction on the Company. 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.

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

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

Adjustments include the following:

• With the adoption of IFRS 16, the lease payments of Knight are not reflected in operating expenses. The IFRS 16 adjustment approximates the cash outflow related to leases of Knight.
 
• Acquisition costs relate to costs incurred on legal, consulting and advisory fees for the acquisition of GBT and the acquisition of products.
 
• Other non-recurring expenses relate to expenses incurred by Knight that are not due to, and are not expected to occur in, the ordinary course of business.
  
  
 

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

  INTERIM CONSOLIDATED BALANCE SHEETS  
[In thousands of Canadian dollars]

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

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

  INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS  

[In thousands of Canadian dollars]