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Knight Therapeutics Reports First Quarter 2024 Results

MONTREAL, May 09, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 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 $86,604, an increase of $4,007 or 5% over the same period in prior year driven by the growth of our key promoted products offset by our mature branded generic products. Gross margin was $41,699 or 48% compared to $40,762 or 49% in the same period in prior year. Adjusted EBITDA1 was $13,589, a decrease of $4,648 or 25% over the same period in prior year reflecting higher marketing spend for the launches of Imvexxy®, Bijuva® and Minjuvi® as well as development costs on our pipeline products. Adjusted EBITDA per share1 was $0.13, a decrease of $0.04 or 24% over the same period in prior year. Net loss on financial assets measured at fair value through profit or loss was $16,267 driven mainly by unrealized losses on the valuation of certain private investments in our strategic funds. Net loss was $4,546, compared to $3,937 in the same period in prior year. Cash inflow from operations was $30,881, an increase of $26,565 or 616% over the same period in prior year driven by operating results and a decrease in working capital. Corporate developments Promoted Henrique Dias and Melanie Groleau to Global VP Marketing and Global VP Medical and Clinical, respectively. Products In-licensed IPX203 (carbidopa and levodopa extended-release capsules) for Canada and Latin America. Submitted fostamatinib for ANVISA approval in Brazil. Obtained regulatory approval for Karfib® (carfilzomib) in Colombia. Launched Minjuvi® (tafasitamab) in Brazil. Launched Imvexxy® (estradiol vaginal inserts) and Bijuva® (estradiol and progesterone) in Canada. Subsequent to quarter-end Entered into exclusive supply and distribution agreement for JORNAY PM® (methylphenidate HCI extended-release capsules) for Canada and Latin America. 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. "I am pleased to report that for the three months ended March 31, 2024, revenues were over $86 million, a growth of 5% over the same period prior year. In addition, we are investing for the future growth of our portfolio with the launch of three products and the in-licensing of two products for Canada and Latin America. We launched Bijuva® and Imvexxy® in Canada and Minjuvi® in Brazil. Furthermore, we have strengthened our neurology portfolio with the addition of QelbreeTM, IPX203 and JORNAY PM® and will be leveraging our infrastructure behind Exelon®," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc. SELECTED FINANCIAL RESULTS REPORTED UNDER IFRS[In thousands of Canadian dollars]       Change   Q1-24 Q1-23 $1   %2           Revenues 86,604   82,597     4,007   5 % Gross margin 41,699   40,762     937   2 % Gross margin % 48 % 49 %     Selling and marketing 12,649   10,665     (1,984 ) 19 % General and administrative 10,538   9,106     (1,432 ) 16 % Research and development 4,980   4,187     (793 ) 19 % Amortization of intangible assets 10,872   11,171     299   3 % Operating expenses 39,039   35,129     (3,910 ) 11 %           Net loss (4,546 ) (3,937 )   (609 ) 15 % 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. SELECTED FINANCIAL RESULTS EXCLUDING IAS 291[In thousands of Canadian dollars]   Q1-24 Q1-23 Change         $2   %3                 Revenues 85,795   82,667     3,128   4 %   Gross margin 40,695   41,386     (691 ) 2 %   Gross margin (%) 47 % 50 %                       Selling and marketing 12,493   10,713     (1,780 ) 17 %   General and administrative 10,212   8,887     (1,325 ) 15 %   Research and development 4,840   4,102     (738 ) 18 %   Amortization of intangible assets 10,846   11,125     279   3 %   Operating expenses 38,391   34,827     (3,564 ) 10 %               EBITDA1 13,589   18,237     (4,648 ) 25 %   Adjusted EBITDA1 13,589   18,237     (4,648 ) 25 %   Adjusted EBITDA per share1 0.13   0.17     (0.04 ) 24 %   1 Financial results excluding the impact of IAS 29, EBITDA, adjusted EBITDA and adjusted EBITDA per share are non-GAAP measures. Refer to section "Non-GAAP measures" for additional details. 2 A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss). 3  Percentage change is presented in absolute values. RevenuesFor the quarter ended March 31, 2024, revenues were $85,795, an increase of $3,128 or 4% mainly driven by a growth of $7,163 or 13% from our promoted innovative products offset by the decline on our mature branded generic portfolio. The table below provides revenues by therapeutic area.   Excluding impact of IAS 293       Change Therapeutic Area Q1-24 Q1-23 $1   %2 Oncology/Hematology 30,843 29,093   1,750   6 % Infectious Diseases 38,062 30,896   7,166   23 % Other Specialty 16,890 22,678   (5,788 ) 26 % Total 85,795 82,667   3,128   4 % 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 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details. The increase in revenues excluding the impact of hyperinflation is explained by the following: Oncology/Hematology: The oncology/hematology portfolio grew by approximately $4,600 primarily due to the growth of key promoted products including Lenvima®, Trelstar®, Akynzeo® and Palbocil® as well due to the launch of Minjuvi® in Brazil. The increase is offset by a reduction of approximately $2,850 in revenues of our mature and branded generics products due to their lifecycle including the entrance of new competitors.  Infectious Diseases: The infectious disease portfolio grew by $7,166 driven by the growth of our key promoted products including AmBisome® and Cresemba® partly offset by the timing of demand for certain products including Impavido®. The increase included $6,800 of incremental revenues related to the contract with MOH for AmBisome®.MOH Contract: The Company signed a contract with the Ministry of Health of Brazil for AmBisome® in December 2022 ("2022 MOH Contract"). Knight delivered a total of $34,600 under the 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 in Q1-24. In December 2023, Knight signed a new contract with the MOH ("2024 MOH Contract") and it is expected that $16,500 will be delivered in 2024 of which $6,800 was delivered in Q1-24. The total MOH sales for AmBisome® delivered in Q1-24 was $9,200. Other Specialty: The Other Specialty portfolio decreased by approximately $5,788 mainly due to advance purchases of Exelon® in Q1-23, due to the commercial transition from Novartis to Knight in certain countries as well as the purchasing patterns for certain products. Gross marginFor the quarter ended March 31, 2024, gross margin, as a percentage of revenues, was 48% compared to 49% in Q1-23. Excluding IAS 29, gross margin, as a percentage of revenues, was 47% in Q1-24 and 50% in Q1-23. The decrease in gross margin, as a percentage of revenues was due to product mix. Selling and marketing ("S&M") expenses: For the quarter ended March 31, 2024, S&M expenses were $12,649, an increase of $1,984 or 19%, compared to the same period in prior year. Excluding the impact of IAS 29, the increase was $1,780 or 17%. The increase was mainly due to the marketing spend for the launches of Imvexxy® and Bijuva® in Canada as well as Minjuvi® in Brazil. General and administrative ("G&A") expenses: For the quarter ended March 31, 2024, G&A expenses were $10,538 an increase of $1,432 or 16%, compared to the same period in prior year. Excluding the impact of IAS 29, G&A expenses increased by $1,325 or 15% driven by increase in structure and compensation expenses. Research and development ("R&D") expenses: For the quarter ended March 31, 2024, R&D expenses were $4,980, an increase of $793 or 19%, compared to the same period in prior year. Excluding the impact of IAS 29, the increase was $738 or 18%. The increase was driven by an increase in product development activities in connection with our pipeline products and medical initiatives related to key promoted products. Knight invested $587 in Q1-24, an increase of $575 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 bio equivalence studies. Adjusted EBITDA1For the three-month period ended March 31, 2024, adjusted EBITDA was $13,589, a decrease of $4,648 or 25%. The decrease in adjusted EBITDA was driven by an increase in operating expenses due to investments on new product launches and pipeline. Net lossFor the quarter ended March 31, 2024, the net loss was $4,546 compared to a net loss of $3,937 for the same period in prior year. The variance mainly resulted from the above-mentioned items and a net loss on the revaluation of financial assets measured at fair value through profit or loss of $16,267 versus a net loss of $11,847 in the same period in prior year mainly driven by unrealized losses in the fair value of financial assets, partly offset by (1) the foreign exchange gain of $1,934 in Q1-24 compared to a foreign exchange gain of $73 in Q1-23, and (2) income tax recovery of $2,598 in Q1-24 and $1,009 in Q1-23 mainly driven by the recognition of certain deferred tax assets due to tax losses generated in certain jurisdictions and timing differences related to our financial assets. SELECTED BALANCE SHEET ITEMS[In thousands of Canadian dollars]       Change   March 31, 2024 December 31, 2023 $ %1           Cash, cash equivalents and marketable securities 181,859