Reports record-high revenues since inception

MONTREAL, March 20, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company”), a pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2024. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2024 Highlights

Financial results

  • Revenues were $371,304, an increase of $43,105 or 13% over the prior year. The increase was driven by the growth of our key promoted products, the impact of hyperinflation in Argentina, partly offset by declines of our mature products and the depreciation of select LATAM currencies.
  • Gross margin was $174,405 or 47% of revenues compared to $152,652 or 47% of revenues in prior year.
  • Operating income was $7,397 compared to an operating loss of $2,890 in prior year.
  • Net income was $4,332, compared to a net loss $16,835 in prior year.
  • Earnings per share was $0.04, compared to a loss per share of $0.16 in prior year.
  • Cash inflow from operations was $36,280, an increase of $341 or 1% over prior year.
Non-GAAP measures

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  • Adjusted Revenues1 were $365,412, an increase of $22,274 or 6% or an increase of $29,439 or 9% on a constant currency1 basis, driven by the growth of our key promoted products partly offset by declines of our mature products.
  • Adjusted Gross margin1 was $173,496 or 47% of Adjusted Revenues1 compared to $166,190 or 48% of Adjusted Revenues1 in prior year.
  • Adjusted EBITDA1 was $57,783, a decrease of $2,292 or 4% over prior year.
  • Adjusted EBITDA per share1 was $0.58, a decrease of $0.01 or 2% over prior year driven by investments on our new launches and pipeline offset by the impact of the common shares purchased through the NCIB.
Corporate developments

  • Launched a NCIB in July 2024 to purchase up to 5,312,846 common shares of the Company over the next 12 months.
  • Purchased 1,619,167 common shares through Knight's NCIB at an average price of $5.53 for aggregate cash consideration of $8,956.
Products

  • In-licensed Crexont® (carbidopa and levodopa extended-release capsules) for Canada and Latin America.
  • Entered into an exclusive supply and distribution agreement for Jornay PMTM (methylphenidate HCI extended-release capsules) for Canada and Latin America.
  • In-licensed two branded generic products molecule for key territories in LATAM.
  • Submitted Tavalisse® (fostamatinib) for ANVISA approval in Brazil.
  • Submitted QelbreeTM (viloxazine extended-release capsules) for Health Canada approval.
  • Obtained regulatory approval for Karfib® (carfilzomib) in Colombia.
  • Obtained regulatory approval for Minjuvi® (tafasitamab) in Mexico.
  • Obtained regulatory approval for Jornay PMTM (methylphenidate HCI extended-release capsules) in Canada.
  • Obtained regulatory approval for Tavalisse® (fostamatinib disodium hexahydrate) in Mexico.
  • Obtained regulatory approval for Pemazyre® (pemigatinib) in Brazil.
  • Launched Minjuvi® (tafasitamab) in Brazil.
  • Launched Imvexxy® (estradiol vaginal inserts) and Bijuva® (estradiol and progesterone) in Canada.
____________________

1 Adjusted Revenues, revenues at constant currency, Adjusted Gross Margin, Adjusted EBITDA and Adjusted EBITDA per share are non-GAAP measures and do not have any standardized meaning under GAAP. As a result, the information presented may not be comparable to similar measures presented by other companies. Refer to section Financial Results under Non-GAAP measures for additional details.

Subsequent to year-end

  • In-licensed Onicit® (palonosetron) for Mexico, Brazil, and select LATAM countries.
  • Obtained regulatory approval for Pemazyre® (pemigatinib) in Mexico.
  • Submitted Tavalisse® (fostamatinib disodium hexahydrate) for ANMAT approval in Argentina.
  • Entered into an asset purchase agreement with Endo Operations Limited and Paladin Pharma Inc., to acquire the Paladin business for an upfront payment of $120,000, including inventory valued at $20,000. Furthermore, Knight may pay up to an additional US$15,000 upon achieving certain sales milestones. The transaction is expected to close in the middle of 2025.
  • Up to March 10, 2025, the Company purchased additional 605,400 common shares through Knight's NCIB at an average purchase price of $5.53 for an aggregate cash consideration of $3,346.
"I am excited to announce that we have delivered another year of record-high revenues since the inception of Knight. We reported adjusted revenues1 of over $365 million, a growth of 6%, and adjusted EBITDA1 of approximately $58 million. Our key promoted products grew by 16% over the prior year and delivered a 3-year CAGR of more than 30%. We made significant progress in advancing and expanding our pipeline, with new products, multiple product submissions and approvals and three product launches. Subsequent to the year-end, we announced the acquisition of Paladin in Canada. The Paladin acquisition is synergistic, adds a profitable portfolio and critical mass and significantly increases the size of our business in Canada while bringing a stable source of cash flow that will help fund our growth in Canada and Latin American,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

_____________________

1 Adjusted revenues and adjusted EBITDA are non-GAAP measures and do not have any standardized meaning under GAAP. As a result, the information presented may not be comparable to similar measures presented by other companies. Refer to Section - Financial Results under Non-GAAP measures for additional details.

SELECT FINANCIAL RESULTS REPORTED UNDER IFRS

[In thousands of Canadian dollars]

   Change  Change
 Q4-24Q4-23$1 %2YTD-24YTD-23$1 %2
         
Revenues96,864 74,197 22,667 31% 371,304 328,199 43,105 13% 
Gross margin40,352 34,215 6,137 18% 174,405 152,652 21,753 14% 
Gross margin %42% 46%   47% 47%   
Selling and marketing14,576 10,816 (3,760)35% 53,861 46,279 (7,582)16% 
General and administrative10,741 8,109 (2,632)32% 45,488 37,414 (8,074)22% 
Research and development7,365 4,258 (3,107)73% 23,304 17,549 (5,755)33% 
Amortization of intangible assets10,630 11,115 485 4% 44,355 45,040 685 2% 
Impairment of non-current assets- 9,260 9,260 100% - 9,260 9,260 100% 
Operating expenses43,312 43,558 246 1% 167,008 155,542 (11,466)7% 
         
Operating income (loss)(2,960)(9,343)6,383 68% 7,397 (2,890)10,287 356% 
         
Net income (loss)10,735 (24,326)35,061 144% 4,332 (16,835)21,167 126% 
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.

Revenues: For the quarter ended December 31, 2024, revenues increased by $22,667 or 31% compared to the same period in prior year, of which $17,003 is explained by the Hyperinflation Impact1. Excluding IAS 29, the increase was $5,664 or 6%, driven by the growth of our key promoted products partly offset by declines in our mature products and the depreciation of select LATAM currencies.

For the year ended December 31, 2024, revenues increased by $43,105 or 13% compared to the prior year, of which $20,831 is explained by the Hyperinflation Impact1. Excluding IAS 29, the increase was $22,274 or 6%, and was driven by the growth of our key promoted products partly offset by declines of our mature products and the depreciation of select LATAM currencies.

The table below provides revenues by therapeutic areas.

   Change  Change
Therapeutic AreaQ4-24Q4-23$%YTD-24YTD-23$%
Oncology/Hematology35,77126,0539,71837%140,837114,62626,21123%
Infectious Diseases40,54531,0809,46530%150,986136,66214,32410%
Other Specialty20,54817,0643,48420%79,48176,9112,5703%
Total96,86474,19722,66731%371,304328,19943,10513%
_________________________

1 The Hyperinflation Impact is due to the application of IAS 29 in Argentina. Refer to Section - Hyperinflation for additional details.

The increase in revenues is explained by the following:

  • Oncology/Hematology: For the quarter ended December 31, 2024, the oncology/hematology portfolio increased by $9,718 or 37%, of which $9,768 is due to the Hyperinflation Impact1. Excluding IAS 29, the oncology/hematology portfolio decreased by $50. Revenues from our key promoted products increased by $5,781 or 42% on a constant currency2 basis driven by the growth of Lenvima®, Akynzeo®, Trelstar® and the launch of Minjuvi® in Brazil. This growth was offset by a decline in our mature and branded generics products due to their lifecycle and the market entrance of new competitors.

    For the year ended December 31, 2024, the oncology/hematology portfolio increased by $26,211 or 23% of which $11,336 is due to the Hyperinflation Impact1. Excluding IAS 29, the oncology/hematology portfolio increased by $14,875 or 12%. Our key promoted brands grew by $23,831 or 49% on a constant currency2 basis driven by the growth of Lenvima®, Akynzeo®, Trelstar® and the launch of Minjuvi® in Brazil. This growth was partially offset by a decline in our mature and branded generics products due to their lifecycle and the market entrance of new competitors and the impact of LATAM currencies depreciation.

    Furthermore, in Q3-24, a competitor in Brazil launched both a branded generic and a generic of Lenvima®. Knight and Eisai are collaborating to defend Lenvima®'s market exclusivity in Brazil. While we continue to challenge the generic entrants, the introduction of generics and branded generics will increase competitive pressures and negatively impact future sales and margins of Lenvima® in Brazil.

  • Infectious Diseases: For the quarter ended December 31, 2024, the infectious diseases portfolio increased by $9,465 or 30%, of which $4,992 is due to the Hyperinflation Impact1. Excluding IAS 29, the infectious diseases portfolio increased by $4,473 or 13% and $7,591 or 24% on constant currency2 basis. The increase is driven by the purchasing patterns of certain customers and the growth of Cresemba® across LATAM.

    For the year ended December 31, 2024, the infectious diseases portfolio increased by $14,324 or 10%, of which $5,797 is due to the Hyperinflation Impact1. Excluding IAS 29, the infectious diseases portfolio increased by $8,527 or 6% and $12,617 or 9% on constant currency2 basis driven by the growth of our key promoted products including Ambisome® and Cresemba®, partly offset by a decrease in the demand of Impavido®. In 2024, the Company delivered $24,800 of Ambisome® to the Ministry of Health of Brazil ("MOH”) compared to $25,200 in 2023.

    MOH Contract: The Company signed a contract with the MOH for Ambisome® in December 2022 ("2022 MOH Contract"). Knight delivered a total of $34,600 under the 2022 MOH Contract as follows: $7,000 in 2022, $25,200 in 2023 ($2,400 in Q1-23, $18,000 in Q2-23 and $4,800 in Q4-23) and $2,400 Q1-24. In December 2023, Knight signed a second contract with the MOH ("2024 MOH Contract") and has delivered $22,400 under this contract in 2024 as follows: $6,800 in Q1-24, $8,900 in Q2-24, $6,700 in Q3-24. The total MOH sales Ambisome® delivered in YTD-24 was $24,800. In January 2025, Knight signed a third contract with the MOH and it is expected that $22,400 will be delivered in 2025.

  • Other Specialty: For the quarter ended December 31, 2024, the other specialty portfolio increased by $3,484 or 20%, of which $2,243 is due to the Hyperinflation Impact1. Excluding IAS 29, the other specialty portfolio increased by $1,241 or 7% and $2,898 or 17% on constant currency2 basis mainly driven by the launch of Imvexxy® and Bijuva® in Canada.

    For the year ended December 31, 2024, the other specialty portfolio increased by $2,570 or 3%, of which $3,698 is due to the Hyperinflation Impact1. Excluding IAS 29, the other specialty portfolio decreased by $1,128 or 1%. On a constant currency2 basis, revenues increased by $621 or 1% mainly driven by the launch of Imvexxy® and Bijuva® in Canada offset by a decline in revenues from our mature branded generics products due to their lifecycle.

_____________________

1 The Hyperinflation Impact is due to the application of IAS 29 in Argentina. Refer to Section - Hyperinflation for additional details.

2 Revenues at constant currency is 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. Refer to Section - Financial Results under Non-GAAP measures for additional details.

Gross margin: For the quarter ended December 31, 2024, gross margin, as a percentage of revenues, was 42% compared to 46% in Q4-23. The decrease in the gross margin % is mainly explained by the Gross Margin Hyperinflation Impact1. Excluding IAS 29, the Adjusted gross margin %2 was 47% compared to 48% in Q4-23. There was no significant variance.

For the year ended December 31, 2024, gross margin, as a percentage of revenues, was 47% compared to 47% in YTD-23. There was no significant variance. Excluding IAS29, the Adjusted gross margin %2 was 47% compared to 48% in YTD-23. There was no significant variance.

Selling and marketing ("S&M”) expenses: For the quarter ended December 31, 2024, selling and marketing increased by $3,760 or 35%, of which $4,181 is explained by the Hyperinflation Impact1. The remaining variance was not significant.

For the year ended December 31, 2024, selling and marketing increased by $7,582 or 16%, of which $4,980 is explained by the Hyperinflation Impact1. Excluding IAS 29, selling and marketing increased by $2,602 or 5%. The increase was mainly driven by the marketing spend for the launches of Minjuvi® in Brazil, Imvexxy® and Bijuva® in Canada as well as pre-launch activities for Jornay PM™ in Canada.

General and administrative ("G&A”) expenses: For the quarter ended December 31, 2024, general and administrative increased by $2,632 or 32%, of which $1,809 is explained by the Hyperinflation Impact1. The remaining variance was not significant.

For the year ended December 31, 2024, general and administrative increased by $8,074 or 22%, of which $2,624 is explained by the Hyperinflation Impact1. Excluding IAS 29, general and administrative increased by $5,450 or 14%. The increase was mainly driven by structure and compensation expenses.

Research and development ("R&D”) expenses: For the quarter ended December 31, 2024, research and development expenses increased by $3,107 or 73%, of which $2,805 is explained by the Hyperinflation Impact1. The remaining variance was not significant.

For the year ended December 31, 2024, research and development increased by $5,755 or 33%, of which $3,040 is explained by the Hyperinflation Impact1. Excluding IAS 29, research and development increased by $2,715 or 14%. The increase was driven by product development activities in connection with our pipeline products and medical initiatives related to key promoted products. Knight invested $2,368 in 2024, an increase of $1,930 versus the prior year on its pipeline development activities. All costs related to development activities have been expensed which typically include regulatory submissions, analytical method transfers, stability studies and bioequivalence studies.

Impairment of non-current assets: In 2023, the impairment loss of $9,260 was mainly driven by Exelon®. The book value of the intangible asset of Exelon® is accounted in USD and revalued from USD to CAD at the end of every reporting period. The intangible of Exelon® is carried in the functional currency of USD and as such the related intangible is revalued from USD to CAD at the end of every reporting period. The appreciation of the USD versus the CAD from the acquisition date of Exelon® to the closing foreign exchange of 2023, has led to an increase in the value of the asset in CAD not offset by the cash flows projections, generating an impairment loss.

________________________

1 The Hyperinflation Impact and the Gross Margin Hyperinflation Impact are due to the application of IAS 29 in Argentina. Refer to Section - Hyperinflation for additional details.

2 Revenues at constant currency and Adjusted gross margin % are non-GAAP measures and do not have any standardized meaning under GAAP. As a result, the information presented may not be comparable to similar measures presented by other companies. Refer to Section - Financial Results under Non-GAAP measures for additional details.

Net income (loss)

For the quarter ended December 31, 2024, the net income was $10,735 compared to net loss $24,326 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net gain $8,317 on the revaluation of financial assets measured at fair value through profit or loss of versus a net loss of $7,878 in the same period in prior year, and (2) a foreign exchange gain of $1,740 in Q4-24 mainly driven by the depreciation of CAD vs USD, partially offset by losses on intercompany balances due to the depreciation of the BRL, compared to a foreign exchange loss of $9,007 in Q4-23 mainly driven by the unrealized losses due to the impact of the devaluation of the ARS on USD denominated payables held by Knight´s affiliate in Argentina and (3) income tax recovery of $2,860 in Q4-24 versus $1,826 in Q4-23.

For the year ended December 31, 2024, the net income was $4,332 compared to net loss $16,835 in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss of $11,435 on the revaluation of financial assets measured at fair value through profit or loss versus a net loss of $10,224 in prior year, (2) a foreign exchange loss of $4,194 in 2024, mainly driven by losses on intercompany balances due to the depreciation of the BRL and COP, compared to a foreign exchange loss of $15,169 in 2023, mainly driven by the the unrealized losses due to the impact of the devaluation of the ARS on USD denominated payables held by Knight´s affiliate in Argentina, offset by (3) a gain on hyperinflation of $9,226 versus $3,303 in prior year, and (4) income tax recovery of $2,280 in 2024 versus $5,153 in 2023.

SELECT BALANCE SHEET ITEMS

[In thousands of Canadian dollars]

   Change
 December 31, 2024December 31, 2023$%
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