Knight Therapeutics Announces Regulatory Submission of Pemigatinib in Brazil

Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for pemigatinib to ANVISA, the Brazilian health regulatory agency, under the rare diseases approval pathway, for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Marketing authorization applications for pemigatinib have also been submitted previously in Colombia, Mexico and Argentina.

"This milestone demonstrates Knight's commitment to providing innovative therapies for important unmet healthcare needs in Latin America," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

Cholangiocarcinoma is the malignant neoplasm of the primary biliary tract, being the intrahepatic type localized in the biliary duct ramifications inside the liver. This kind of tumor is considered rare, and more than 50% of the patients are diagnosed in advanced disease stages.

In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute pemigatinib (Pemazyre ^® ) as well as tafasitamab (sold as Monjuvi ^® in the United States and Minjuvi ^® in Europe) in Latin America.

In July 2023, ANVISA granted regulatory approval in Brazil for Minjuvi ^® in combination with lenalidomide followed by tafasitamab monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL due to low-grade lymphoma, who are not eligible for autologous stem cell transplantation (ASCT). Upon obtaining the marketing authorization from ANVISA, Knight submitted an application for pricing approval to the Drugs Market Regulation Chamber ("CMED") which establishes maximum prices allowed for drugs sold in Brazil. The commercial launch of Minjuvi ^® is dependent upon the outcome of the pricing approval process which could take up to two years. Knight has also submitted marketing authorization applications for tafasitamab in Colombia, Mexico and Argentina.

About Pemigatinib (Pemazyre ^® )

Pemigatinib is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The FDA approval in the USA is based on a multicenter, open-label, single-arm, multicohort, phase 2 study (FIGHT-202), that evaluated the safety and antitumor activity of pemigatinib in patients with previously treated, locally advanced or metastatic intrahepatic cholangiocarcinoma with and without FGFR2 fusions or rearrangements, in patients aged 18 years or older with disease progression following at least one previous treatment.

The overall response rate was 36%, with 2.8% of patients having a complete response and 34% having a partial response. Median duration of response was 9.1 months. The most common adverse reactions occurring in 20% or more of patients who received pemigatinib are hyperphosphatemia, alopecia, diarrhea, fatigue, dysgeusia, nausea and stomatitis.

Pemigatinib is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, pemigatinib is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, pemigatinib is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre ^® is marketed by Incyte in the United States, Europe and Japan.

Pemazyre ^® is a trademark of Incyte Corporation.

About Tafasitamab (Minjuvi ^® )

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi ^® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Please see the U.S. full Prescribing Information for Monjuvi for important safety information.

In Europe, Minjuvi ^® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, 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).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational uses have not been established in pivotal trials.

Minjuvi ^® and Monjuvi ^® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi ^® in the U.S., and marketed by Incyte under the brand name Minjuvi ^® in Region Europe, the United Kingdom and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States.

XmAb ^® is a registered trademark of Xencor, Inc.

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.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, 2022, 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.

References

K Abou-Alfa et al. (2020). Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. The Lancet Oncology VOLUME 21, ISSUE 5, P671-684, MAY 2020. DOI:https://doi.org/10.1016/S1470-2045(20)30109-1

Banales, J., Cardinale, V., Carpino, G. et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 13, 261–280 (2016). https://doi.org/10.1038/nrgastro.2016.51

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

News Provided by GlobeNewswire via QuoteMedia

Knight Therapeutics GUD:CA Medical Device Investing

GUD:CA

Medtronic receives FDA approval for Inceptiv closed-loop spinal cord stimulator

Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Investing in Cardiovascular MedTech Companies

Cardiovascular diseases remain the leading global cause of death, taking an estimated 17.9 million lives annually, based on data from the World Health Organisation. Over 80 percent of these deaths are due to heart attacks and strokes, while one-third of them occur in people under seventy years of age.

Efforts to address the core risk factors associated with cardiovascular diseases are coinciding with recent innovations in medical technology, which have been critical in not only preventing and managing them but also increasing the survival rate.

As medical technologies associated with the diagnosis and treatment of cardiovascular disease continue to evolve, medical technology companies provide an opportunity for investors to create wealth through health.

Keep reading...Show less

Contacts:
Jeff Trauring	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-505-0159	+1-763-505-4626

Condensed Consolidated Statements of Income (unaudited)
	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	10,345				$	10,710
Costs and operating expenses:
Cost of revenues (a)		6,040		58.4	%		6,437		60.1	%
Selling, general and administrative expenses (b)		1,731		16.7	%		1,646		15.4	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Research and development expenses		331		3.2	%		346		3.2	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Total costs and operating expenses		8,682		83.9	%		9,147		85.4	%
Operating income		1,663		16.1	%		1,563		14.6	%
Interest income		279					146
Interest expense		(363	)				(300	)
Other income/(expense) (d)		10					(46	)
Income before income taxes		1,589					1,363
Provision for income taxes (e)		(281	)				(46	)
Equity in earnings/(losses) of unconsolidated entities		23					(25	)
Net income		1,331					1,292
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest		4					3
Net income attributable to Thermo Fisher Scientific Inc.	$	1,328		12.8	%	$	1,289		12.0	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	3.47				$	3.34
Diluted	$	3.46				$	3.32
Weighted average shares:
Basic		382					386
Diluted		384					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%
Cost of revenues adjustments (a)		15		0.1	%		41		0.4	%
Selling, general and administrative expenses adjustments (b)		19		0.2	%		8		0.1	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Adjusted operating income (non-GAAP measure)	$	2,278		22.0	%	$	2,330		21.8	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	1,328				$	1,289
Cost of revenues adjustments (a)		15					41
Selling, general and administrative expenses adjustments (b)		19					8
Restructuring and other costs (c)		29					112
Amortization of acquisition-related intangible assets		551					606
Other income/expense adjustments (d)		(11	)				46
Provision for income taxes adjustments (e)		50					(171	)
Equity in earnings/losses of unconsolidated entities		(23	)				25
Adjusted net income (non-GAAP measure)	$	1,959				$	1,956

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	3.46				$	3.32
Cost of revenues adjustments (a)		0.04					0.10
Selling, general and administrative expenses adjustments (b)		0.05					0.02
Restructuring and other costs (c)		0.08					0.29
Amortization of acquisition-related intangible assets		1.44					1.56
Other income/expense adjustments (d)		(0.03	)				0.12
Provision for income taxes adjustments (e)		0.13					(0.44	)
Equity in earnings/losses of unconsolidated entities		(0.06	)				0.06
Adjusted EPS (non-GAAP measure)	$	5.11				$	5.03

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	1,251				$	729
Purchases of property, plant and equipment		(347	)				(458	)
Proceeds from sale of property, plant and equipment		4					6
Free cash flow (non-GAAP measure)	$	908				$	277

Business Segment Information	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions)	2024			Revenues		2023			Revenues

Revenues
Life Sciences Solutions	$	2,285		22.1	%	$	2,612		24.4	%
Analytical Instruments		1,687		16.3	%		1,723		16.1	%
Specialty Diagnostics		1,109		10.7	%		1,108		10.3	%
Laboratory Products and Biopharma Services		5,723		55.3	%		5,763		53.8	%
Eliminations		(460	)	-4.4	%		(496	)	-4.6	%
Consolidated revenues	$	10,345		100.0	%	$	10,710		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	840		36.8	%	$	836		32.0	%
Analytical Instruments		400		23.7	%		421		24.4	%
Specialty Diagnostics		294		26.5	%		280		25.3	%
Laboratory Products and Biopharma Services		744		13.0	%		793		13.8	%
Subtotal reportable segments		2,278		22.0	%		2,330		21.8	%
Cost of revenues adjustments (a)		(15	)	-0.1	%		(41	)	-0.4	%
Selling, general and administrative expenses adjustments (b)		(19	)	-0.2	%		(8	)	-0.1	%
Restructuring and other costs (c)		(29	)	-0.3	%		(112	)	-1.0	%
Amortization of acquisition-related intangible assets		(551	)	-5.3	%		(606	)	-5.7	%
Consolidated GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%


(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines. Adjusted results in 2023 exclude $10 of charges for the sale of inventory revalued at the date of acquisition.
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, and charges/credits for changes in estimates of contingent acquisition consideration.
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, abandoned facility, and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $18 of net charges for pre-acquisition litigation and other matters.
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments.
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes, and the tax impacts from audit settlements.
Note:
Consolidated depreciation expense is $285 and $253 in 2024 and 2023, respectively.

Organic and Core organic revenue growth		Three months ended
		March 30, 2024
Revenue growth		-3%
Acquisitions		0%
Currency translation		0%
Organic revenue growth (non-GAAP measure)		-4%
COVID-19 testing revenue		-1%
Core organic revenue growth (non-GAAP measure)		-3%

Note:
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Balance Sheets (unaudited)

	March 30,		December 31,
(In millions)	2024		2023

Assets
Current assets:
Cash and cash equivalents	$	5,499	$	8,077
Short-term investments		1,751		3
Accounts receivable, net		7,931		8,221
Inventories		5,133		5,088
Other current assets		3,326		3,200
Total current assets		23,640		24,589
Property, plant and equipment, net		9,324		9,448
Acquisition-related intangible assets, net		16,048		16,670
Other assets		4,241		3,999
Goodwill		43,843		44,020
Total assets	$	97,095	$	98,726

Liabilities, redeemable noncontrolling interest and equity
Current liabilities:
Short-term obligations and current maturities of long-term obligations	$	4,451	$	3,609
Other current liabilities		9,486		10,403
Total current liabilities		13,937		14,012
Other long-term liabilities		6,378		6,564
Long-term obligations		31,157		31,308
Redeemable noncontrolling interest		119		118
Total equity		45,504		46,724
Total liabilities, redeemable noncontrolling interest and equity	$	97,095	$	98,726

Condensed Consolidated Statements of Cash Flows (unaudited)

	Three months ended
	March 30,			April 1,
(In millions)	2024			2023

Operating activities
Net income	$	1,331		$	1,292
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		837			859
Change in deferred income taxes		(253	)		(146	)
Other non-cash expenses, net		123			257
Changes in assets and liabilities, excluding the effects of acquisitions		(787	)		(1,533	)
Net cash provided by operating activities		1,251			729

Investing activities
Purchases of property, plant and equipment		(347	)		(458	)
Proceeds from sale of property, plant and equipment		4			6
Proceeds from cross-currency interest rate swap interest settlements		64			2
Acquisitions, net of cash acquired		—			(2,704	)
Purchases of investments		(1,758	)		(2	)
Other investing activities, net		7			14
Net cash used in investing activities		(2,030	)		(3,142	)

Financing activities
Net proceeds from issuance of debt		1,205			—
Net proceeds from issuance of commercial paper		—			1,027
Repayment of commercial paper		—			(523	)
Purchases of company common stock		(3,000	)		(3,000	)
Dividends paid		(135	)		(117	)
Other financing activities, net		110			20
Net cash used in financing activities		(1,821	)		(2,593	)

Exchange rate effect on cash		22			(31	)
Decrease in cash, cash equivalents and restricted cash		(2,578	)		(5,037	)
Cash, cash equivalents and restricted cash at beginning of period		8,097			8,537
Cash, cash equivalents and restricted cash at end of period	$	5,519		$	3,500

Free cash flow (non-GAAP measure)	$	908		$	277



Note:
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Knight Therapeutics Announces Regulatory Submission of Pemigatinib in Brazil

Cardiovascular healthcare technology market

Promising innovations

Investor takeaway

Latest News

Latest Press Releases

Related News

TOP STOCKS