Knight Therapeutics : 2024 Annual Report Annual Information

Published: 2025-03-20 11:54:18 ET GUD.TO

KNIGHT THERAPEUTICS INC.

ANNUAL INFORMATION FORM

Fiscal year ended December 31, 2024

March 19, 2025

TABLE OF CONTENTS

Contents

GLOSSARY OF ABBREVIATIONS

CORPORATE STRUCTURE

GENERAL DEVELOPMENT OF THE BUSINESS

Overview

Three Year History

DESCRIPTION OF THE BUSINESS

Knight's Focus

The Innovative Drug Industry

Branded Generic Industry

Pharmaceutical Markets in which Knight Operates

The Canadian Pharmaceutical Market

Key LATAM Pharmaceutical Markets

Environmental Matters

THE CORPORATION'S STRATEGY

Growth Strategy

Commercial Strategy

BUSINESS OF THE CORPORATION

Sources of Product Opportunities

Knight's Product Portfolio

Sales and Marketing

Manufacturing and Distribution

Competition

Licensing and Intellectual Property

Potential Liability and Insurance

Knight's Fund Investment Portfolio

Knight's Strategic Loans

Personnel and Employees

RISKS FACTORS

Risk Factors Related to our Business and Industry

Risk Factors Related to the Common Shares

DIVIDEND RECORD AND POLICY

CAPITAL STRUCTURE

MARKET FOR SECURITIES

DIRECTORS AND OFFICERS

Cease Trade Orders, Bankruptcies, Penalties or Sanctions

Committees of the Board of Directors and their Responsibilities

Audit Committee Disclosure

LEGAL PROCEEDINGS

101

INTERESTS OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS

101

MATERIAL CONTRACTS

101

TRANSFER AGENT AND REGISTRAR

101

INTEREST OF EXPERTS

101

ADDITIONAL INFORMATION

102

SCHEDULE "A" AUDIT COMMITTEE CHARTER

103

Cautionary Note Regarding Forward Looking Statements

Any statements made in this annual information form ("AIF") that are not statements of historical fact or that refer to estimated or anticipated future events are forward-looking statements. The Corporation has based its forward-looking statements on management's beliefs and assumptions based on information available to its management at the time these statements are made. Such forward-looking statements reflect the Corporation's current perspective of our business, future performance, existing trends and information as of the date of this AIF. These include, but are not limited to, the Corporation's beliefs about future revenue and expense levels and growth rates, prospects related to its strategic initiatives and business strategies, including the integration of, and synergies associated with, strategic acquisitions, express or implied assumptions about government regulatory action or inaction, anticipated product approvals and launches, business initiatives and product development activities, assessments related to clinical trial results, product performance and competitive environment, and anticipated financial performance. Without limiting the generality of the foregoing, words such as "may", "will", "expect", "believe", "anticipate", "intend", "could", "would", "estimate", "preliminary", "continue", or "pursue", or the negative or other variations thereof or comparable terminology, are intended to identify forward-looking statements. The statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict, including but not limited to cross-border trade risks including the impositions of tariffs and other trade restrictions measures, the ongoing conflicts between Ukraine and Russia, as well as in the Middle East, inflation and interest rates, currency exchange fluctuations, volatility in financial markets and banking system, disruptions in the global supply chain, changes in laws and regulations, and the climate change. The Corporation cautions the reader that these statements are based on certain assumptions, risks and uncertainties, many of which are beyond the Corporation's control, including but not limited to the ongoing conflicts between Ukraine and Russia, as well as in the Middle East, inflation and interest rates, currency exchange fluctuations, volatility in financial markets and banking system, disruptions in the global supply chain, changes in laws and regulations, and the climate change on the business operations, financial results and on the supply chain. In addition, certain important factors may affect the Corporation's actual operating results and could cause such results to differ materially from those expressed or implied by forward-looking statements. The Corporation believes the risks and uncertainties discussed under the section entitled "Risks Related to Knight's Business" and other risks and uncertainties detailed herein and from time to time in the Corporation's SEDAR+ filings, may cause its actual results to vary materially from those anticipated in any forward-looking statement. The Corporation disclaims any obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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GLOSSARY OF ABBREVIATIONS

In this AIF, unless the context otherwise requires, the following terms shall have the meanings set forth below:

Abbreviation

Entity

60P

60⁰ Pharmaceuticals, LLC

Abir

Abir Therapeutics Ltd.

Antibe

Antibe Therapeutics Inc.

Ardelyx

Ardelyx, Inc.

BMS

Bristol-Myers Squibb

Crescita

Crescita Therapeutics Inc.

Forbion

Forbion Capital Partners

KTE or GBT

Knight Therapeutics Europe S.A. (former Biotoscana Investments Inc.)

Genesys

Genesys Capital Management Inc.

HarbourVest

HarbourVest Partners LLC

Knight,

the Corporation or

Knight Therapeutics Inc.

the Company

Knight International

Knight Therapeutics International S.A.

Knight USA

Knight Therapeutics (USA) Inc.

Medimetriks

Medimetriks Pharmaceuticals, Inc.

M8 Pharmaceuticals, Inc.

NEMO II

New Emerging Medical Opportunities Fund II Ltd.

NEMO III

New Emerging Medical Opportunities Fund III Ltd.

NeurAxon

NeurAxon Inc.

Origin

Origin BioMed Inc.

Paladin

Paladin Labs Inc.

Profound

Profound Medical Inc.

Puma

Puma Biotechnology, Inc.

Sanderling

Sanderling Ventures, LLC

Sectoral

Sectoral Asset Management Inc.

Synergy

Synergy CHC Corp.

Teralys

Teralys Capital

Triumvira

Triumvira Immunologics Inc.

TVM

TVM Capital GmbH

TXMD

TherapeuticsMD, Inc

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Abbreviation

Currency

ARS

Argentine Peso

BOB

Bolivian Boliviano

BRL

Brazilian Real

C$ or $

Canadian Dollar

CHF

Swiss Franc

CLP

Chilean Peso

COP

Colombian Peso

EUR

Euro

MXN

Mexican Peso

PEN

Peruvian Sol

PYG

Paraguayan Guarani

US$ or USD

U.S. Dollar

UYU

Uruguayan Peso

Abbreviation

Territory

CAN

Canada

LATAM

Latin America

U.S.

United States of America

Abbreviation

Other

ACEMI

Colombian Association of HMOs

ADHD

Attention-Deficit Hyperactivity Disorder

Artificial Intelligence

API

Active pharmaceutical ingredient

ANMAT

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (Argentina's health

authority regulatory agency)

ANS

National Health Agency in Brazil

ANVISA

Agencia Nacional de Vigilancia Sanitaria (Brazil's health authority regulatory agency)

ARCSA

Ministry of Health in Ecuador

ASCT

Autologous stem cell transplantation

B3 S.A. - Brasil, Bolsa, Balcão

CADTH

Canadian Agency for Drugs and Technologies in Health

CAGR

Compound Annual Growth Rate

CBCA

Canada Business Corporations Act

CEO

Chief Executive Officer

COFEPRIS

Comisión Federal para la Protección contra Riesgos Sanitarios (Mexico's health authority regulatory

agency)

Common Share

Common share of Knight Therapeutics Inc.

CMED

Câmara de Regulação do Mercado de Medicamentos

CMO

Contract manufacturing organization

CNFP

Ecuador's National Council for setting and Review of Prices for Medicines for Human Use

CNS

Central nervous system

CRA

Canada Revenue Agency

CTD

Common Technical Document

DIGEMID

Directorate General of Medicines, Supplies and Drugs in Peru

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DLBCL

Diffuse large B-cell lymphoma

eCTD

Electronic Common Technical Document

EMA

European Medicines Agency

ESG

Environmental, social and governance

FDA

U.S. Food and Drug Administration

FGFR2

Fibroblast growth factor receptor 2

Financial Statements

Annual audited consolidated financial statements

Formulary

An official list of drugs established by a provincial government or a private insurance plan, the cost

of which will be reimbursed by them for the benefit of eligible patients

Generic Drug/ Gx

A drug that, in comparison with an Innovative Drug, contains identical amounts of the identical

medicinal ingredients, in comparable dosage forms, but does not necessarily contain the same non-

medicinal ingredients and which is interchangeable with the said Innovative Drug

GMP

HER2

HIV

HMO

HTA

IBS-C

IFRS

IFC

IMC

IMPI

IMSS

INESSS Innovative Drug

INSABI

INVIMA

Good Manufacturing Practices, which are the standards established by health authorities under which drugs can be developed, manufactured, packaged, analyzed, stored and shipped

Human epidermal growth factor receptor 2 Human immunodeficiency virus infection Health Maintenance Organization Health Technology Assessment

Irritable Bowel Syndrome with Constipation International Financial Reporting Standards International Finance Corporation Innovative Medicines Canada

Mexican Intellectual Property Office Mexican Social Security Institute

Institut national d'excellence en santé et services sociaux

A drug that usually enjoys proprietary barriers to entry, including regulatory or patent derived market exclusivity, novelty or brand differentiation

Institute of Health for the Wellbeing

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia's health authority regulatory agency)

IQVIA

IQVIA Holdings, Inc. a leading pharmaceutical market research organization

IRP

International Reference Pricing

ISP

Instituto de Salud Publica de Chile (Public Health Institute of Chile)

MD&A

Management Discussion and Analysis

NAV

Net Asset Value

NCIB

Normal Course Issuer Bid

NCPMMD

National Price Commission of Pharmaceuticals and Medical Devices

OTC

Over-the-counter medicines sold directly to a consumer without a prescription from a healthcare

professional

PAMI

Public health insurance agency in Argentina

PBS

Colombian Formulary of Drugs

pCODR

Pan-Canadian Oncology Review

pCPA

Pan-Canadian Pharmaceutical Alliance

PFIC

Passive Foreign Investment Company

PMPRB

Patented Medicine Prices Review Board, an independent quasi-judicial body that oversees pricing

of patented pharmaceuticals in Canada

PhRMA

Pharmaceutical Research and Manufacturers of America association

PRV

Priority Review Voucher

QRA

Quebec Revenue Agency

sNDA

Supplemental New Drug Application

TPD

Health Canada's Therapeutic Products Directorate

TSX

Toronto Stock Exchange, a Canadian senior equities market

TSX-V

TSX Venture Exchange, a Canadian equities market

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CORPORATE STRUCTURE

Knight Therapeutics Inc. ("Knight", the "Company" or the "Corporation") was incorporated under the CBCA on November 1, 2013. On February 28, 2014, the Corporation ceased to be a wholly-owned subsidiary of Paladin immediately following a court approved plan of arrangement under Section 192 of the CBCA, and its Common Shares were listed on the TSX-V the same day. On April 29, 2014, the Corporation's Common Shares were up- listed from the TSX-V to the TSX. The articles of the Corporation have been amended several times, and most recently the Corporation amalgamated with NeurAxon Inc. on January 1, 2015. The Corporation's registered offices are located at 3400 De Maisonneuve Blvd. W., Suite 1055, Montreal, Québec H3Z 3B8.

On November 29, 2019, Knight completed the acquisition of a 51.2% interest in Biotoscana Investments S.A. (renamed Knight Therapeutics Europe S.A. and hereinafter referred as "KTE") from a controlling shareholder group that included Advent International and Essex Woodlands, among others. The remaining 48.8% of GBT, which was publicly-held and traded on B3 S.A. - Brasil, Bolsa, Balcão ("B3"), Brazil's main stock exchange through Brazilian Depository Receipts and on the Luxembourg Stock Exchange, was acquired in August 2020.

Please see below an organizational chart showing the intercorporate relationships of Knight as at December 31, 2024. Knight wholly-owns Knight International, Knight USA, KTE and its subsidiaries.

Subsidiary

Jurisdiction of Incorporation

Percent ownership

Biotoscana Farma S.A.

Argentina

100%

Laboratorio LKM S.A.

Argentina

100%

Laboratorio LKM Bolivia S.A.

Bolivia

100%

UM - Industria e Distribuidora de Medicamentos Ltda.

Brazil

100%

United Medical Ltda.

Brazil

100%

11718991 Canada Inc.

Canada

100%

Laboratorio Biotoscana Farma S.p.A.

Chile

100%

Laboratorio LKM Chile S.p.A.

Chile

100%

Biotoscana Farma S.A.

Colombia

100%

Biotoscana Colveh 1 S.A.S

Colombia

100%

Biotoscana Colveh 2 S.A.S

Colombia

100%

Biotoscana Colveh 3 S.A.S

Colombia

100%

Biotoscana Colveh 4 S.A.S

Colombia

100%

Knight Therapeutics USA Inc.

Delaware

100%

Biotoscana Ecuador S.A.

Ecuador

100%

LKM Laboratorios Ecuador S.A.

Ecuador

100%

Knight Therapeutics Europe S.A.

Grand Dutchy of Luxembourg

100%

Grupo Biotoscana de Especialidad S.A. de C.V.

México

100%

Grupo Biotoscana Panamá S.A.

Panamá

100%

Laboratorio LKM Paraguay S.A.

Paraguay

100%

Biotoscana Farma de Perú S.A.C.

Perú

100%

Grupo Biotoscana S.L.U.

Spain

100%

Latin American Pharma Company ETVE S.L.U.

Spain

100%

Knight Therapeutics International S.A.

Uruguay

100%

Biotoscana Uruguay S.A.

Uruguay

100%

GBT - Grupo Biotoscana S.A.

Uruguay

100%

All dollar amounts herein are expressed in thousands of Canadian dollars (unless otherwise indicated) except for share and per share amounts. All other currencies are in thousands (unless otherwise indicated).

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GENERAL DEVELOPMENT OF THE BUSINESS

Overview

Knight was founded in 2014 to become a leading rest of world specialty pharmaceutical company focused on acquiring, in licensing, out-licensing, marketing, and commercializing pharmaceuticals products in Canada, Latin America and select international markets. Since founding, Knight has been focused on building a portfolio of innovative products through in-licensing or acquiring product rights. Knight operates in the fast-growing Latin American countries, through its wholly-owned subsidiaries - United Medical, Biotoscana Farma and Laboratorio LKM, in market segments such as oncology and hematology, infectious diseases, and other specialty therapeutic areas. Knight is currently present in Canada and 10 Latin American countries.

Since inception, the Corporation has raised gross proceeds of $685,128 through issuance of 109,298,800 Common Shares at prices ranging from $3.50 to $10.00. As at March 10, 2025, the Corporation has acquired under its NCIB programs a total of 44,318,873 Common Shares at an average price of $5.69 for total cash proceeds of $252,116. The details of the NCIB programs are as follows:

Launch Date

Status

Common Shares

Average Price ($)

Total Cash

Acquired

Consideration ($)

July 11, 2019

Completed

12,053,693

7.14

86,094

July 14, 2020

Completed

6,193,169

5.33

32,991

July 14, 2021

Completed

10,267,956

5.25

53,869

July 14, 2022

Completed

7,785,625

4.99

38,871

July 14, 2023

Completed

5,999,524

4.87

29,231

July 15, 2024

Active

2,018,906

5.48

11,059

Total

44,318,873

5.69

252,116

Knight has committed to invest over $126,000 with nine life sciences debt or equity fund managers all of which can leverage their broad life sciences industry experience and existing relationships with key life science companies to help secure product rights for the Corporation. During 2019, Knight determined that while the fund strategy has been financially successful, the strategy has not been successful from a business development perspective as it led to only two product license agreements. Consequently, Knight has no plans to invest in any new venture capital funds. Since the inception and up to December 31, 2024, the Corporation has invested $160,192 in strategic funds and received distributions of $144,117. Furthermore, as at December 31, 2024, the fund investments were recorded at their fair value of $92,024 and Knight has approximately $5,9361 of unfunded commitments that may be called over the life of the funds. The maximum remaining life of the funds varies between one to six years.

Knight has also invested over $170,000 through strategic debt financing to over a dozen companies with the objective of deploying capital in low risk, fair return opportunities while helping to secure Canadian and select international product rights. As at December 31, 2024, Knight has advanced a cumulative total amount of $13,910 (US$10,091) and has a loan receivable balance of $21,116 (US$13,862) from two strategic loans outstanding.

During 2024, Knight continued to advance its pipeline and build its product portfolio. The Corporation launched Minjuvi® (tafasitamab) in Brazil as well as Imvexxy® (estradiol vaginal inserts) and Bijuva® (estradiol and progesterone) in Canada. The Company also in-licensed Crexont® (carbidopa and levodopa extended-release capsules) and Jornay PMTM (methylphenidate HCI extended-release capsules) for Canada and Latin America. Furthermore, in 2024, Knight obtained regulatory approval for Jornay PMTM (methylphenidate HCI extended-

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release capsules) in Canada, Karfib® (carfilzomib) in Colombia, Minjuvi® (tafasitamab) & Tavalisse® (fostamatinib disodium hexahydrate) in Mexico, Pemazyre® (pemigatinib) in Brazil, and submitted QelbreeTM (viloxazine extended-release capsules) for Health Canada and fostamatinib for regulatory approval in Brazil.

Subsequent to year-end, in March 2025, Knight entered into a definitive Asset Purchase Agreement with Endo Operations Limited ("Endo") and Paladin Pharma Inc. ("Paladin" and, together with Endo, the "Sellers"), to acquire the assets used by the Sellers to conduct their international pharmaceuticals business, which is primarily operated through Canada-based specialty pharmaceutical company Paladin. Upon closing, Knight will make an upfront payment of $120,000 in cash, including inventory valued at $20,000. In addition, Knight may pay future contingent payments of up to US$15,000 upon achieving certain sales milestones. The closing of the transaction is subject to the satisfaction of customary regulatory approvals including anti-trust clearance in Canada and is expected to occur in the middle of 2025. The acquisition of Paladin´s assets adds critical mass and expands the size of the Company´s business in Canada while adding a portfolio of cash flow generating products that will help fund Knights' growth in Canada and Latin America.

Three Year History

Fiscal 2022

Corporate development

In Q3 2022, Knight executed a settlement agreement and general release ("Settlement Agreement") with the former shareholders of GBT. The Company made certain claims ("Claims") with respect to its indemnification rights under the purchase agreement for the acquisition of GBT. Under the Settlement Agreement, Knight received $6,030 (US$4,600) as settlement for the Claims.

Products

In January 2022, Knight announced that it obtained regulatory approval in Colombia from INVIMA for Halaven® and Lenvima®. Halaven® was approved for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatments for advanced cancer while Lenvima® was approved for the treatment of radioiodine refractory differentiated thyroid cancer and unresectable hepatocellular carcinoma. Knight launched Halaven® and Lenvima® in Colombia in Q1 2022.

On May 12, 2022, Knight announced that it entered into an agreement with Helsinn for the exclusive rights to commercialize Akynzeo® oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and Aloxi® oral/IV (palonosetron) in Canada.

Akynzeo® is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. Akynzeo® oral is approved and marketed in Canada, Brazil and Argentina. According to IQVIA, sales of Akynzeo® in Canada and Brazil were approximately $7 million in 2021. Aloxi® is a second generation 5-HT3 receptor antagonist with high receptor binding affinity and a duration of action up to 5 days after chemotherapy administration1,2. Aloxi® oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. Aloxi® injection is approved in Canada for use in adults and pediatric patients aged 2 to 17 years for the prevention of acute and delayed nausea and vomiting associated with emetogenic cancer chemotherapy. Knight assumed commercial activities and re-launched Akynzeo® in Brazil and Argentina in July 2022 and in

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Canada in Q4 2022.

On May 24, 2022, Knight announced that it entered into an agreement with Rigel for the exclusive rights to commercialize fostamatinib, an oral spleen tyrosine kinase inhibitor, in Latin America. Fostamatinib is commercially available in the U.S. under the brand name Tavalisse® and in Europe under the brand name Tavlesse® for the treatment of chronic immune thrombocytopenia.

Knight obtained the marketing authorization transfer of Exelon® from Novartis to Knight in Colombia, Brazil, and Mexico, and transferred Exelon®'s commercial activities from Novartis to Knight's affiliate in Colombia, Brazil, Argentina, Chile, Mexico, Peru, Ecuador and Canada.

Knight submitted the marketing authorization application for tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT to ANVISA in Brazil in October 2022, INVIMA in Colombia in December 2022 and ANMAT in Argentina in January 2023. The Company submitted pemigatinib to INVIMA in Colombia in December 2022.

In December 2022, Knight obtained the regulatory approval for Palbocil® (palbociclib) in Argentina and filed for regulatory approval for Bapocil® (palbociclib) in Colombia and Chile in Q4-2022. Palbocil® is indicated for the treatment of patients with hormone receptor 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.

In addition, during 2022, Knight also submitted a branded generic of products (pomalidomide) for regulatory approval in Chile and Colombia. Furthermore, up to December 2022, the Company in-licensed three branded generic products for our key markets in Latin America.

Bank loans

In December 2022, Knight obtained a five-year secured loan of $52,416 (USD 38,500) denominated in select LATAM currencies as follows: 104,800 BRL, 41,274,700 COP, 6,679,260 CLP, 48,346 MXN. The loan is secured by the shares of certain Knight's subsidiaries as well as a restricted cash collateral of 35% of the principal balance outstanding. The IFC loan matures on October 15, 2027, with principal repayments commencing on October 15, 2023. The principal and interest repayments are due on a semi-annual basis, except for the MXN tranche that is due on a monthly basis. The Company has the right to prepay the IFC Loan in exchange for a prepayment fee. The IFC loan include customary representations, warranties, affirmative and restrictive covenants as well as financial covenants. Refer to note 17 of the Financial Statements for further details.

Fiscal 2023

Products

Minjuvi® (tafasitamab)

Minjuvi® was submitted for regulatory approval in Colombia in Q4 2022, in Argentina in Q1 2023 and Mexico Q2 2023. In July 2023, Knight obtained ANVISA approval for Minjuvi®, under their rare disease designation according to Resolution RDC 205/2017 in combination with lenalidomide followed by Minjuvi® monotherapy for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. In addition, on October 16, 2023, Knight received Brazilian pricing approval for Minjuvi® from the Drugs Market Regulation Chamber ("CMED").

Disclaimer

Knight Therapeutics Inc. published this content on March 19, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 20, 2025 at 15:53:42.233.