GUD Knight Therapeutics Inc

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, 2023. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2023 Highlights

Financial results

• Revenues were $328,199, an increase of $34,636 or 12% over prior year.
• Revenues excluding IAS 29 were $343,138, an increase of $51,368 or 18% over prior year.
• Gross margin was $152,652 or 47% compared to $138,061 or 47% in prior year.
• Adjusted EBITDA1 was $60,075, an increase of $6,043 or 11% over prior year.
• Adjusted EBITDA per share1 was $0.59, an increase of $0.11 or 23% over prior year.
• Net loss on financial assets measured at fair value through profit or loss was $10,224.
• Net loss was $16,835, compared to $29,892 in prior year.
• Cash inflow from operations was $35,939, a decrease of $9,061 or 20% over prior year.

Corporate developments

• Launched a NCIB in July 2023 to purchase up to 5,999,524 common shares of the Company over the next 12 months.
• Purchased 11,125,288 common shares through Knight’s NCIB at an average price of $4.82 for aggregate cash consideration of $53,479.
• In January 2024, Henrique Dias and Melanie Groleau were promoted to Global VP Marketing and Global VP Medical and Clinical, respectively.

ProductsQ1-23

• Submitted marketing authorization for Minjuvi® (tafasitamab) in combination with lenalidomide in Argentina.
• Launched Palbocil® (palbociclib) in Argentina.
• Obtained regulatory approval for Bapocil® (palbociclib) in Chile.

Q2-23

• Submitted Pemazyre® (pemigatinib) for regulatory approval in Argentina and Mexico.
• Submitted Minjuvi® (tafasitamab) for regulatory approval in Mexico.
• Submitted Rembre® (dasatinib) and Karfib® (carfilzomib) for regulatory approval in Chile.
• Obtained regulatory approval for Xetrane® (pomalidomide) in Chile.

Q3-23

• Submitted marketing authorization for Tavalisse® (fostamatinib) in Colombia and Mexico.
• Obtained regulatory approval for Minjuvi® (tafasitamab) in Brazil.
• In-licensed a branded generic molecule in Oncology/Hematology for Brazil.

Q4-23

• In-licensed QelbreeTM (viloxazine) for Canada.
• Obtained price approval from CMED for Minjuvi® (tafasitamab) in Brazil.
• Submitted marketing authorization for Pemazyre® (pemigatinib) in Brazil.

Subsequent to year-end

• 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 Bijuva® (estradiol and progesterone) and Imvexxy® (estradiol vaginal inserts) in Canada.

“I am excited to announce that we have delivered ten consecutive years of record revenues and have delivered record EBITDA since 2019. For 2023, we reported revenues of over $343 million, a growth of 18%, and adjusted EBITDA of over $60 million, a growth of 11%. While delivering on record results, we made significant progress in advancing and expanding our product pipeline. We submitted five products, Minjuvi®, Pemazyre®, Tavalisse®, Rembre® and Karfib®, for regulatory approval across multiple territories and received the regulatory approval of Minjuvi® in Brazil, Palbocil® and Xetrane® in Chile and Karfib® in Colombia. In addition, we are launching four products, Imvexxy® and Bijuva® in Canada, Minjuvi® in Brazil and Palbocil® in Argentina. Further to advancing our product pipeline, we expanded our portfolio with the in-licensing of three additional products, a branded generic molecule in Oncology/Hematology for Brazil, QelbreeTM for Canada and IPX203 for Canada and Latin America.

Looking ahead we will remain focused on our strategy of building a profitable pan-American (ex US) company commercializing both innovative and branded generic pharmaceuticals products. With our strong foundation and unique platform, we are poised to be the partner of choice for Canada and Latin America,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

1 Adjusted EBITDA and Adjusted EBITDA per share are non-GAAP measures. Refer to the definitions in section "Non-GAAP Measures" for additional details.

SELECT FINANCIAL RESULTS REPORTED UNDER IFRS[In thousands of Canadian dollars]
					Change								Change
	Q4-23		Q4-22		$1		%2		YTD-23		YTD-22		$1		%2
Revenues	74,197		81,655		(7,458	)	9	%	328,199		293,563		34,636		12	%
Gross margin	34,215		36,888		(2,673	)	7	%	152,652		138,061		14,591		11	%
Gross margin %	46	%	45	%					47	%	47	%
Operating expenses4	43,558		67,938		24,380		36	%	155,542		179,105		23,563		13	%
Net loss	(24,326	)	(15,188	)	(9,138	)	60	%	(16,835	)	(29,892	)	13,057		44	%
EBITDA3	12,001		13,330		(1,329	)	10	%	60,019		53,541		6,478		12	%
Adjusted EBITDA3	12,057		13,821		(1,764	)	13	%	60,075		54,032		6,043		11	%
Adjusted EBITDA per share3	0.12		0.12		—		—		0.59		0.48		0.11		23	%

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, adjusted EBITDA and adjusted EBITDA per share are non-GAAP measures. Refer to section “Non-GAAP measures” for additional details.4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization of intangible assets and impairment of non-current assets.

SELECT FINANCIAL RESULTS AT CONSTANT CURRENCY
	Q4-23		Q4-22		Variance				YTD-23		YTD-22		Variance
	Excluding impact of IAS 291
			ConstantCurrency1		$2		%3				ConstantCurrency1		$2		%3
Revenues	88,402		89,038		(636	)	1	%	343,138		305,499		37,639		12	%
Gross margin	42,439		43,920		(1,481	)	3	%	166,190		157,265		8,925		6	%
Gross margin %	48	%	49	%					48	%	51	%
Operating expenses4	50,903		47,230		(3,673	)	8	%	162,787		155,277		(7,510	)	5	%
EBITDA1	12,001		14,129		(2,128	)	15	%	60,019		57,326		2,693		5	%
Adjusted EBITDA1	12,057		14,636		(2,579	)	18	%	60,075		57,833		2,242		4	%
Adjusted EBITDA per share1	0.12		0.13		(0.01	)	7	%	0.59		0.51		0.09		17	%

1 Financial results at constant currency, excluding the impact of hyperinflation, 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.4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization of intangible assets and impairment of non-current assets.

SELECT BALANCE SHEET ITEMS[In thousands of Canadian dollars]
					Change
	12-31-23		12-31-22		$		%1
Cash, cash equivalents and marketable securities	161,825		172,674		(10,849	)	6	%
Trade and other receivables	141,684		151,118		(9,434	)	6	%
Inventory	91,834		92,489		(655	)	1	%
Financial assets	128,369		176,563		(48,194	)	27	%
Accounts payable and accrued liabilities	90,617		108,730		(18,113	)	17	%
Bank loans	61,866		70,072		(8,206	)	12	%

1 Percentage change is presented in absolute values.

Revenues: For the quarter ended December 31, 2023, excluding the impact of hyperinflation, revenues increased by $4,596 or 5% compared to the same period in prior year. The appreciation of select LATAM currencies led to an increase in revenues of $5,232 in Q4-23 compared to Q4-22. The revenues by therapeutic areas are as follows:

	Excluding impact of IAS 293
					Change
Therapeutic Area	Q4-23		Q4-22		$1		%2
Oncology/Hematology	34,373		29,343		5,030		17	%
Infectious Diseases	35,012		32,744		2,268		7	%
Other Specialty	19,017		21,719		(2,702	)	12	%
Total	88,402		83,806		4,596		5	%

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 $7,114 primarily due to continued growth of key promoted products including Lenvima®, Trelstar®, Palbocil® launched in Argentina in Q1-23, as well as the growth and assumption of commercial activities of Akynzeo® in Brazil, Argentina and Canada in 2022. The increase was offset by a reduction of approximately $2,084 in revenues for our mature and branded generics products due to their lifecycle including the entrance of new competitors.

• Infectious Diseases: The increase in the infectious disease portfolio was driven by the appreciation of select LATAM currencies and the growth of Cresemba®. Knight delivered $4,800 in Q4-23 and $7,000 in Q4-22 under the AmBisome® MOH Contract. However, there was no significant variance in the total revenues of AmBisome® between Q4-23 and Q4-22.

• Other Specialty: The decrease in the other specialty portfolio was primarily driven by the purchasing patterns of certain customers.

For the year ended December 31, 2023, excluding the impact of hyperinflation, revenues increased by $51,368 or 18% compared to the same period in prior year. The appreciation of select LATAM currencies led to an increase in revenues of $13,729 in 2023 compared to 2022.

	Excluding impact of IAS 293
	YTD-23		YTD-22		Change
Therapeutic Area	$		$		$1		%2
Oncology/Hematology	122,736		105,464		17,272		16	%
Infectious Diseases	140,671		116,530		24,141		21	%
Other Specialty	79,731		69,776		9,955		14	%
Total	343,138		291,770		51,368		18	%

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 the definitions in the section "Non-GAAP Measures" for additional details.

The growth in revenues excluding the impact of hyperinflation is explained by the following:

• Oncology/Hematology: The oncology/hematology portfolio grew by approximately $27,380 primarily due to continued growth of key promoted products including Lenvima®, Trelstar®, Palbocil® launched in Argentina in Q1-23, as well as the growth and assumption of commercial activities of Akynzeo® in Brazil, Argentina and Canada in 2022. The increase was offset by a reduction of approximately $ 10,108 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 approximately $31,897 excluding the impact of the planned transition and termination agreement with Gilead for a portfolio of HIV and HCV products. The increase was driven by the growth of our key promoted products including AmBisome® and Cresemba® as well as higher demand for Impavido®. The increase included $18,200 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 ("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 and it is expected that $16,500 will be delivered in 2024 starting in March 2024, which would bring total expected sales of $18,900 to MOH in 2024.
• Other Specialty: The increase in the other specialty portfolio was primarily driven by the transition of commercial activities for Exelon® from Novartis to Knight resulting in the change in accounting treatment from net profit transfer to revenues with related cost of sales.

 

Gross margin: For the quarter ended December 31, 2023, gross margin, as a percentage of revenues, was 46% compared to 45% in Q4-22. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 48% in Q4-23 and 50% in Q4-22. The decrease was driven by the change in product mix.

For the year ended December 31, 2023 and 2022, gross margin, as a percentage of revenues, was 47%. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 48% in 2023 and 52% in 2022. Exelon® was recorded as a net profit transfer from Novartis for Brazil and Colombia in H1-22. If Knight had reported revenues and related cost of sales for Exelon® instead of a net profit transfer, the Adjusted Gross Margin in both 2023 and 2022 would have been 48% and 50%, respectively. The decrease in the Adjusted Gross Margin was due to the change in product mix.

Selling and marketing (“S&M”) expenses: For the quarter ended December 31, 2023, S&M expenses were $10,816, a decrease of $3,586 or 25%, compared to the same period in prior year. Excluding the impact of IAS 29, the decrease was $702 or 5%. There was no significant variance in S&M expenses.

For the year ended December 31, 2023, S&M expenses decreased by $2,195 or 5%. Excluding the impact of IAS 29, S&M expenses increased by $1,923 or 4%. The increase was driven by compensation expenses, certain variable costs such as logistics fees which increased as a function of higher revenues, as well as increased selling and marketing activities related to key promoted products, including Akynzeo® which was relaunched in Brazil in Q3-22 and Canada in Q4-22.

General and administrative (“G&A”) expenses: For the quarter ended December 31, 2023, G&A expenses were $8,109, a decrease of $2,227 or 22%, compared to the same period in prior year. Excluding the impact of IAS 29, G&A expenses decreased by $535 or 5%. For the year ended December 31, 2023, G&A expenses were $37,414, a decrease of $$2,736 or 7%. Excluding the impact of IAS 29, G&A expenses increased by $1,181 or 3%. There were no significant variances in G&A expenses.

Research and development (“R&D”) expenses: For the quarter ended December 31, 2023, R&D expenses were $4,258, an increase of $118 or 3%, compared to the same period in prior year. Excluding the impact of IAS 29, the increase was $2,518 or 62%. The increase was driven by an expansion in our product development activities for pipeline products. Knight invested $1,947 in Q4-23, an increase of $1,838 versus Q4-22 on its pipeline.

For the year ended December 31, 2023, R&D expenses increased by $2,794 or 19%. Excluding the impact of IAS 29, R&D expenses increased by $6,204 or 45%. The increase was driven by an expansion on product development activities in connection with our pipeline products and medical initiatives related to key promoted products, including Akynzeo® which was relaunched in Brazil in Q3-22 and in Canada in Q4-22. Knight invested $2,492 in 2023, an increase of $2,236 versus the prior year on its pipeline products. All costs related to development activities have been expensed which typically include regulatory submissions, analytical method transfers, stability studies and bio-equivalence studies.

Amortization of intangible assets: For the quarter and year ended December 31, 2023, amortization of intangible assets decreased by $6,041 and $6,702, respectively. Excluding the impact of IAS 29, the decrease in amortization was $5,407 and $5,534, respectively. The decrease was driven by a reduction of the net book value of the intangible assets including the impairment recorded in 2022.

Impairment of non-current assets: For the quarter and year ended December 31, 2023, the Company recorded an impairment charge of $9,260. The impairment was mainly driven by Exelon®. The book value of the intangible asset of Exelon® is accounted in US dollars and revalued from US dollars to Canadian dollars 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 and a resulting impairment loss.

For the year ended December 31, 2022, the company recorded an impairment charge of $21,654. 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. 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 ended December 31, 2023, interest income decreased by $1,182 or 28% compared to the same period in prior year mainly driven by a reduction in the outstanding balance of strategic loans offset by the increase in the interest rates on cash and marketable securities.

For the year ended December 31, 2023, interest income increased by $1,943 or 18%, compared to prior year. The increase was driven by higher interest rates on cash and marketable securities.

Interest expense: For the quarter and year ended December 31, 2023, interest expense increased by $1,797 or 78% and $5,888 or 89%, respectively, compared to the same periods in prior year. The increase was driven by the higher average loan balance resulting from the International Finance Corporation ("IFC") loan which closed in December 2022 and higher variable interest rates, partially offset by principal repayments of Itaú Unibanco Brasil, Bancolombia and IFC bank loans.

Adjusted EBITDA: For the three-month period ended December 31, 2023, adjusted EBITDA decreased by $1,764. The decrease in adjusted EBITDA was driven by an increase in operating expenses mainly due to higher research and development expenses driven by an expansion in our product development activities behind our pipeline and medical initiatives related to key promoted products, offset by an increase in gross margin (excluding impact of IAS 29) of $508.

For the year ended December 31, 2023, adjusted EBITDA increased by $6,043 or 11%. The growth in adjusted EBITDA was driven by an increase in gross margin (excluding impact of IAS 29) of $15,831, offset by an increase in our S&M, G&A and R&D expenses.

Net loss: For the quarter ended December 31, 2023, the net loss was $24,326 compared to a net loss of $15,188 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 $7,878 versus a net gain of $8,824 in the same period in prior year mainly driven by realized and unrealized gains and losses in the fair value of financial assets, (2) 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, compared to a foreign exchange loss of $1,663 in Q4-22 mainly driven by the appreciation of the CAD versus the US dollar, and (3) income tax recovery of $1,826 in Q4-23 and $7,947 in Q4-22 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.

For the year ended December 31, 2023, the net loss was $16,835 compared to a net loss of $29,892 in the 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 $10,224 compared to a net loss of $20,677 in the prior year mainly driven by realized and unrealized gains and losses in the fair value of financial assets, (2) a foreign exchange loss of $15,169 in 2023 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, versus a foreign exchange gain of $7,442 in 2022 mainly driven by the appreciation of the US dollar, offset by (3) income tax recovery of $5,153 in 2023 and $14,068 in 2022 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.

Cash, cash equivalents and marketable securities: As at December 31, 2023, Knight had $161,825 in cash, cash equivalents and marketable securities, a decrease of $10,849 or 6% as compared to December 31, 2022. The variance is mainly due to the repurchase of common shares through the NCIB, principal repayments on bank loans and the settlement of other balances payable mainly due to sales and regulatory milestones on certain products including Akynzeo® and Aloxi®, partially offset by cash inflows from operating activities and proceeds from repayments of strategic loans and disposal of certain investments including Moksha8 and Medimetriks.

Financial assets: As at December 31, 2023, financial assets were at $128,369, a decrease of $48,194 or 27%, as compared to December 31, 2022, driven by a decrease of funds of $23,455 mainly due to the decline in share prices of publicly-traded equities held by our strategic fund investments, a decrease in loan and other receivables of $22,386 mainly from Moksha8 loan payments, and decrease of equity investments and derivatives of $2,352 mainly due to the disposal of certain warrants and equities including Moksha8 and Medimetriks. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Accounts payable and accrued liabilities: As at December 31, 2023, accounts payable and accrued liabilities were at $90,617, a decrease of $18,113 or 17%, as compared to December 31, 2022, mainly driven by payments for purchase of inventory.

Bank Loans: As at December 31, 2023, bank loans were at $61,866, a decrease of $8,206 or 12%, as compared to December 31, 2022, due to repayments partially offset by accrued interest, appreciation of select LATAM currencies, as well as the final tranche of the IFC loan received in Q1-23.

"I am extremely proud of our accomplishments over the last decade that led not only to record results but also a robust balance sheet. We built a profitable business that generates a healthy level of cash flow from operations. We ended the year with over $161 million in cash and marketable securities and over $128 million in financial assets and a conservative debt level under $62 million. In addition, since inception of our NCIB program, we have returned to shareholders over $239 million at an average price $5.70 per share.

The strong platform and balance sheet will allow us to confidently pursue our strategy, invest in our product pipeline, and deliver long-term value to our shareholders," said Arvind Utchanah, Chief Financial Officer of Knight Therapeutics Inc.

Product Updates

Regulatory submissions, approvals and product launches

Minjuvi® (tafasitamab)Knight submitted the marketing authorization applications for Minjuvi® in Mexico and Argentina, 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). Knight received the regulatory approval for Minjuvi® in Brazil which was launched commercially in 2024.

Pemazyre® (pemigatinib)Knight submitted the marketing authorization applications for Pemazyre® in Argentina, Mexico and Brazil for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

FostamatinibKnight submitted marketing authorization applications for fostamatinib in Brazil, Mexico and Colombia, for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment, for regulatory approval.

Karfib® (carfilzomib)Knight submitted the marketing authorization application for Karfib® in Chile for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more previous lines of therapy. Subsequent to year-end, Knight obtained the regulatory approval for Karfib® in Colombia, and is expected to be launched in H2 2024.

Rembre® (dasatinib)Knight submitted the marketing authorization application for Rembre® in Chile, for the treatment of chronic myeloid leukemia with positive Philadelphia chromosome (Ph+).

Palbocil® and Bapocil® (palbociclib)Knight launched Palbocil® in Argentina and obtained the regulatory approval for Bapocil® in Chile. The drug 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.

Xetrane® (polalidomide)Knight obtained the regulatory approval for Xetrane® in Chile, for the treatment of adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy, in combination with dexamethasone.

Bijuva® (estradiol and progesterone) and Imvexxy® (estradiol vaginal inserts)Subsequent to year end, Knight launched Bijuva® and Imvexxy® in Canada. Bijuva® is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause. Imvexxy® is indicated for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy® is competing in the VVA market which was over 90 million dollars in 2023 and grew at a CAGR of 9% since 2020, according to IQVIA.

Expansion of Pipeline

Knight expanded its pipeline with the in-licensing of one branded generic and two Innovative Drugs. In Q3 2023, Knight in-licensed a branded generic molecule in Oncology/Hematology for Brazil. Currently no branded generic has launched against the Innovative Drug which is estimated to have generated over $170,000 in revenues in 2023, according to IQVIA.

In Q4 2023, Knight in-licensed QelbreeTM (viloxazine) for Canada. QelbreeTM is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent, a nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder ("ADHD"). QelbreeTM is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of 4 pivotal trials,1-4 QelbreeTM was approved by the US Food and Drug Administration in 2021 for the treatment of children 6-17 years of age and in 2022 for the treatment of adults. QelbreeTM is also currently being studied in several phase 4 clinical trials5, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 20236). A second phase 4 clinical trial7 in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial8 is studying the impact of QelbreeTM on co-morbid mood symptoms prevalent in patients with ADHD. QelbreeTM is the first new non-stimulant to enter the market in over 10 years and will represent a new option in this segment that continues to have a significant unmet medical need. QelbreeTM is expected to compete in the non-stimulant market for ADHD valued at over $80,000, according to IQVIA. Knight expects to submit QelbreeTM for regulatory approval in H2-2024.

Subsequent to year-end, Knight in-licensed IPX203 for Canada and Latin America. IPX203 is a novel, oral formulation of carbidopa/levodopa ("CD/LD") extended-release capsules designed for the treatment of Parkinson’s disease. IPX203 contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. IPX203 was studied in the RISE-PD clinical study which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients. The RISE-PD study met its primary and secondary endpoints and showed that treatment with IPX203 demonstrated statistically significant improvement in daily “Good On” time with fewer doses of IPX203 compared with immediate-release carbidopa-levodopa (least squares mean, 0.53 hours; 95% CI, 0.09-0.97). In that study, IPX203 was dosed an average of three times per day versus 5 times per day for immediate-release carbidopa-levodopa9. IPX203 is expected to compete in a market valued at over $50,000 in Canada and over $120,000 in Brazil, according to IQVIA.

“These recent deals illustrate our focused approach to building on the strong platform and capabilities that we have, specifically, in oncology and CNS, as well as our strategy to build a balanced portfolio that includes innovative products as well as branded generics and therapies for acute conditions as well as chronic diseases,” said Amal Khouri, Chief Business Officer of Knight Therapeutics Inc. “In the four years since the acquisition of Grupo Biotoscana, our team has added 13 new products to our portfolio and will continue to build on that momentum to further rejuvenate our portfolio and accelerate the growth of our business.”

Corporate Updates

Normal Course Issuer Bid

On July 12, 2023, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB (“2023 NCIB”). Under the terms of the 2023 NCIB, Knight may purchase for cancellation up to 5,999,524 common shares of the Company which represented 10% of its public float as at June 30, 2023. The 2023 NCIB commenced on July 14, 2023 and will end on the earlier of July 13, 2024 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. During the year ended December 31, 2023, the Company purchased 11,125,288 (2022: 5,649,189) common shares at an average price of $4.82 (2022: $5.34) for aggregate cash consideration of $53,479 (2022: $30,069).

Financial Outlook

Knight provides guidance on revenues10 on a non-GAAP basis. This is due to both the difficulty in predicting Argentinian inflation rates and its IAS 29 impact.

For fiscal 2024, Knight expects to generate between $335 million to $350 million in revenues and adjusted EBITDA to be approximately 17% of revenues. 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 March 20, 2024
• no unforeseen termination to our license, distribution & supply 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 material increase in provisions for inventory or trade receivables
• foreign currency exchange rates with the exception of Argentina remaining similar to 2023
• inflation 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.

Conference Call Notice 

Knight will host a conference call and audio webcast to discuss its fourth quarter and year ended December 31, 2023, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, March 21, 2024Time: 8:30 a.m. ETTelephone: Toll Free: 1-888-664-6383 or International 1-416-764-8650Webcast: www.knighttx.com or WebcastThis 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.knighttx.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.knighttx.com or www.sedarplus.ca.

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, 2023 as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether because 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: IR@knighttx.com		Email: IR@knighttx.com
Website: www.knighttx.com		Website: www.knighttx.com

References:

1. Nasser A et al. (2020). A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children. Clinical Therapeutics, 42(8), 1452-1466. DOI: https://doi.org/10.1016/j.clinthera.2020.05.021
2. Nasser A et al. (2021). Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. Clinical Therapeutics, 43(4), 684-700. DOI: https://doi.org/10.1016/j.clinthera.2021.01.027
3. Nasser A et al. (2021). A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit/Hyperactivity Disorder. Journal of Clinical Psychopharmacology, 41(4), 370-380. DOI: 10.1097/JCP.0000000000001404
4. Nasser A et al. (2022). A Phase III, Randomized, Double‑Blind, Placebo‑Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended‑Release Capsules in Adults with Attention‑Deficit/Hyperactivity Disorder. CNS Drugs, 36(8), 897-915. DOI: https://doi.org/10.1007/s40263-022-00938-w
5. US National Library of Medicine. (2021, March 8 - ). Open-label study of SPN-812 administered with psychostimulants in children and adolescents with ADHD (ADHD). Identifier NCT04786990. https://clinicaltrials.gov/study/NCT04786990
6. Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms. (2023, September 10). Retrieved from https://ir.supernus.com/node/13856/pdf
7. US National Library of Medicine. (2021, March 4 - ). Evaluation of SPN-812 (viloxazine extended-release capsule) in preschool-age children with ADHD. Identifier NCT04781140. https://clinicaltrials.gov/study/NCT04781140
8. Presented during Supernus Pharmaceuticals R&D Day; October 18, 2023
9. Hauser RA et al. JAMA Neurol. 2023 Oct 1;80(10):1062-1069.
10. Revenues excluding the impact of IAS 29 is a non-GAAP measure. Refer to the definitions in section “Non-GAAP measures” for additional details.

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:

	Q4-23								YTD-23
	Reportedunder IFRS		Excludingimpact ofIAS 291		Variance				Reportedunder IFRS		Excludingimpact ofIAS 291		Variance
					$2		%3						$2		%3
Revenues	74,197		88,402		(14,205	)	16	%	328,199		343,138		(14,939	)	4	%
Cost of goods sold	39,982		45,963		5,981		13	%	175,547		176,948		1,401		1	%
Gross margin	34,215		42,439		(8,224	)	19	%	152,652		166,190		(13,538	)	8	%
Gross margin (%)	46	%	48	%					47	%	48	%
Expenses
Selling and marketing	10,816		14,371		3,555		25	%	46,279		50,006		3,727		7	%
General and administrative	8,109		9,548		1,439		15	%	37,414		38,632		1,218		3	%
Research and development	4,258		6,561		2,303		35	%	17,549		19,937		2,388		12	%
Amortization of intangible assets	11,115		11,163		48		—		45,040		44,952		(88	)	—
Impairment of intangible assets	9,260		9,260		—		—		9,260		9,260		—		—
Operating income (loss)	(9,343	)	(8,464	)	(879	)	10	%	(2,890	)	3,403		(6,293	)	185	%

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 on net income (loss) due to the application of IAS 29 and a negative variance represents a negative impact on net income (loss) due to the application of IAS 29.3 Percentage change is presented in absolute values.

	Q4-22								YTD-22
	Reportedunder IFRS		Excludingimpact ofIAS 291		Variance				Reportedunder IFRS		Excludingimpact ofIAS 291		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	)	8662	%	23,984		2,330		(21,654	)	929			%
Operating loss	(31,050	)	(4,242	)	(26,808	)	632	%	(41,044	)	(799	)	(40,245	)	5037			%

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 on net income (loss) due to the application of IAS 29 and a negative variance represents a negative impact on net income (loss) due to the application of IAS 29.3 Percentage change is presented in absolute values.

NON-GAAP MEASURES[In thousands of Canadian dollars]

The Company discloses non-GAAP measures and ratios 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 and adjusted EBITDA per share ratio 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. The 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 loss is converted using the closing foreign exchange rate of the month.

Revenues and Financial results at constant currency: Revenues and financial results at constant currency are obtained by translating the prior period revenues and 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 and results at the average exchange rate in effect for each of the periods.

Revenues and financial results at constant currency allow the 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 and 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.

Adjusted Gross Margin: Adjusted gross margin excludes the impact of IAS 29 and is adjusted to consider revenues and related cost of sales for Exelon® separately, rather than presenting as net profit transfer.

EBITDA: Operating income or loss adjusted to exclude amortization and impairment of non-current 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.

Adjusted EBITDA per share: Adjusted EBITDA over number of common shares outstanding at the end of the respective period.

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 acquisitions.
• 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.

 

Reconciliation to EBITDA, adjusted EBITDA and adjusted EBITDA per share

For the three-month period and year ended December 31, 2023, the Company calculated EBITDA and adjusted EBITDA as follows:

					Change								Change
	Q4-23		Q4-22		$1		%2		YTD-23		YTD-22		$1		%2
Operating income (loss)	(9,343	)	(31,050	)	21,707		70	%	(2,890	)	(41,044	)	38,154		93	%
Adjustments to operating income (loss):
Amortization of intangible assets	11,115		17,156		(6,041	)	35	%	45,040		51,742		(6,702	)	13	%
Impairment of non-current assets	9,260		21,904		(12,644	)	58	%	9,260		23,984		(14,724	)	61	%
Depreciation of property, plant and equipment and ROU assets	343		3,037		(2,694	)	89	%	5,357		10,879		(5,522	)	51	%
Lease costs (IFRS 16 adjustment)	(705	)	(836	)	131		16	%	(2,851	)	(2,750	)	(101	)	4	%
Impact of IAS 29	1,331		3,119		(1,788	)	57	%	6,103		10,730		(4,627	)	43	%
EBITDA	12,001		13,330		(1,329	)	10	%	60,019		53,541		6,478		12	%
Adjusted EBITDA	12,057		13,821		(1,764	)	13	%	60,075		54,032		6,043		11	%

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.

 

The Company calculated adjusted EBITDA per share as follows:

	Q4-23		Q4-22		YTD-23		YTD-22
Adjusted EBITDA	12,057		13,821		60,075		54,032
Adjusted EBITDA per share	0.12		0.12		0.59		0.48
Number of common shares outstanding at period end (in thousands)	101,170		112,206		101,170		112,206

Explanation of adjustments

Acquisition and transaction costs		Acquisition and transaction costs relate to costs incurred on legal, consulting and advisory feesfor the acquisitions.
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.

CONSOLIDATED BALANCE SHEETS[In thousands of Canadian dollars]
As at	12-31-2023		12-31-2022
ASSETS
Current
Cash and cash equivalents	58,761		71,679
Marketable securities	95,657		85,826
Trade receivables	88,722		94,890
Other receivables	7,427		11,290
Inventories	91,834		92,489
Prepaids and deposits	4,881		3,344
Other current financial assets	15,753		33,716
Income taxes receivable	2,080		2,385
Total current assets	365,115		395,619
Marketable securities	7,407		15,169
Prepaids and deposits	7,767		3,266
Right-of-use assets	6,190		5,827
Property, plant and equipment	11,669		16,806
Intangible assets	289,960		338,780
Goodwill	79,844		82,274
Other financial assets	112,616		142,847
Deferred tax assets	19,390		9,310
Other long-term receivables	45,535		44,938
	580,378		659,217
Total assets	945,493		1,054,836

CONSOLIDATED BALANCE SHEETS (continued)[In thousands of Canadian dollars]
As at	12-31-2023		12-31-2022
LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities	85,366		106,061
Lease liabilities	1,728		2,578
Other liabilities	1,046		5,793
Bank loans	17,850		17,674
Income taxes payable	1,182		2,274
Other balances payable	6,857		6,941
Total current liabilities	114,029		141,321
Accounts payable and accrued liabilities	5,251		2,669
Lease liabilities	5,497		5,050
Bank loans	44,016		52,398
Other balances payable	27,012		23,176
Deferred tax liabilities	2,817		4,365
Total liabilities	198,622		228,979
Shareholders’ equity
Share capital	540,046		599,055
Warrants	117		117
Contributed surplus	25,991		23,664
Accumulated other comprehensive income	29,829		41,266
Retained earnings	150,888		161,755
Total shareholders’ equity	746,871		825,857
Total liabilities and shareholders’ equity	945,493		1,054,836

CONSOLIDATED STATEMENTS OF LOSS[In thousands of Canadian dollars, except for share and per share amounts]
	Three months ended December 31,				Year ended December 31,
	2023		2022		2023		2022
Revenues	74,197		81,655		328,199		293,563
Cost of goods sold	39,982		44,767		175,547		155,502
Gross margin	34,215		36,888		152,652		138,061
Gross margin %	46	%	45	%	47	%	47	%
Expenses
Selling and marketing	10,816		14,402		46,279		48,474
General and administrative	8,109		10,336		37,414		40,150
Research and development	4,258		4,140		17,549		14,755
Amortization of intangible assets	11,115		17,156		45,040		51,742
Impairment of non-current assets	9,260		21,904		9,260		23,984
Operating loss	(9,343	)	(31,050	)	(2,890	)	(41,044	)
Interest income on financial instruments measured at amortized cost	(2,449	)	(1,922	)	(8,667	)	(4,072	)
Other interest income	(632	)	(2,341	)	(3,908	)	(6,560	)
Interest expense	4,090		2,293		12,488		6,600
Other income	(782	)	1,964		(2,905	)	(4,025	)
Net loss on financial assets measured at fair value through profit or loss	7,878		(8,824	)	10,224		20,677
Foreign exchange (gain) loss	9,007		1,663		15,169		(7,442	)
Gain on hyperinflation	(303	)	(748	)	(3,303	)	(2,262	)
Loss before income taxes	(26,152	)	(23,135	)	(21,988	)	(43,960	)
Income taxes
Current	722		882		3,973		3,057
Deferred	(2,548	)	(8,829	)	(9,126	)	(17,125	)
Income tax recovery	(1,826	)	(7,947	)	(5,153	)	(14,068	)
Net loss	(24,326	)	(15,188	)	(16,835	)	(29,892	)
Basic and diluted net loss per share	(0.23	)	(0.13	)	(0.16	)	(0.26	)
Basic and diluted weighted average number of common shares outstanding
Basic	103,718,322		112,865,984		107,465,978		114,890,252
Diluted	103,718,322		112,865,984		107,465,978		114,890,252

CONSOLIDATED STATEMENTS OF CASH FLOWS[In thousands of Canadian dollars]
	Three months ended December 31,				Year ended December 31,
	2023		2022		2023		2022
OPERATING ACTIVITIES
Net income (loss) for the period	(24,326	)	(15,188	)	(16,835	)	(29,892	)
Adjustments reconciling net income to operating cash flows:
Depreciation and amortization	11,458		20,194		50,397		62,621
Impairment of non-current assets	9,260		23,984		9,260		23,984
Net loss (gain) on financial instruments	7,878		(8,824	)	10,224		20,677
Unrealized foreign exchange (gain) loss	5,848		(1,044	)	7,405		(8,479	)
Other operating activities	2,535		(15,463	)	3,501		(18,441	)
	12,653		3,659		63,952		50,470
Changes in non-cash working capital and other items	5,290		2,979		(28,013	)	(5,470	)
Cash inflow from operating activities	17,943		6,638		35,939		45,000
INVESTING ACTIVITIES
Purchase of marketable securities	(94,241	)	(100,995	)	(331,909	)	(181,642	)
Proceeds on maturity of marketable securities	66,242		43,577		328,614		144,817
Investment in funds	(1,078	)	(531	)	(2,254	)	(3,831	)
Purchase of intangible assets	(1,281	)	(4,407	)	(9,008	)	(22,931	)
Other investing activities	28,457		(2,668	)	43,898		508
Cash inflow (outflow) from investing activities	(1,901	)	(65,024	)	29,341		(63,079	)
FINANCING ACTIVITIES
Repurchase of common shares through Normal Course Issuer Bid	(19,083	)	(8,684	)	(53,479	)	(30,069	)
Principal repayment of bank loans	(11,389	)	(12,095	)	(19,969	)	(17,542	)
Proceeds from bank loans	—		51,361		4,796		51,783
Other financing activities	(5,226	)	(2,610	)	(12,350	)	(6,929	)
Cash outflow from financing activities	(35,698	)	27,972		(81,002	)	(2,757	)
Increase (decrease) in cash and cash equivalents during the period	(19,656	)	(30,414	)	(15,722	)	(20,836	)
Cash and cash equivalents, beginning of the period	77,418		101,822		71,679		85,963
Net foreign exchange difference	999		271		2,804		6,552
Cash and cash equivalents, end of the period	58,761		71,679		58,761		71,679
Cash and cash equivalents					58,761		71,679
Marketable securities					103,064		100,995
Total cash, cash equivalents and marketable securities					161,825		172,674