SUMMARY FINANCIAL INFORMATION AND MANAGEMENT'S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

June 15, 2022

Statement of Management Responsibility

The following "Summary Financial Information and Management's Discussion and Analysis of Financial Condition and Results of Operations" ("MD&A") for the three- and six-month periods ended April 30, 2022 and April 30, 2021 was prepared by management of Avivagen Inc. ("Avivagen" or the "Corporation") and approved for issuance by the Board of Directors on June 15, 2022 (the "Issue Date"). Unless otherwise indicated, all results within this MD&A are presented in Canadian Dollars.

Management is responsible for ensuring that processes are in place to provide sufficient knowledge to support the representations made in these filings. The Audit Committee and Board of Directors provide an oversight role with respect to all public financial disclosures and filings by the Corporation, and have reviewed this MD&A and the accompanying financial statements.

The Chief Executive Officer (the "CEO"), and the Chief Financial Officer (the "CFO"), in accordance with National Instrument 52-109, have both certified that they have reviewed the financial statements and this MD&A (the "filings") and that, based on their knowledge having exercised reasonable diligence, that:

  1. the filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the filings; and
  2. the financial statements together with the other financial information included in the filings fairly present in all material respects the financial condition, financial performance and cash flows of the Corporation, as of the date of and for the period presented in the filings.

Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement, on a cost-effective basis, the disclosure controls and procedures and internal control over financial reporting as defined in National Instrument 52-109Certification of Disclosure in Issuers' Annual and Interim Filings (NI 52-109) will result in additional risks to the quality, reliability, transparency and timeliness of interim filings, annual filings, and other reports provided under securities legislation.

In contrast to the certification required for non-venture issuers under NI 52-109, the Corporation does not include any representations relating to the establishment and maintenance of disclosure controls and procedures and internal control over financial reporting, as defined in NI 52-109. In particular, the CEO and CFO filing this MD&A are not making any representations relating to the establishment, effectiveness, and/or maintenance of:

  1. Controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the Corporation in its filings or other reports filed or submitted under securities legislation is recorded, processed, summarized and/or reported within the time periods specified in securities legislation; and
  2. A process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer's International Financial Reporting Standards ("IFRS") reporting.

This MD&A discusses material changes in the Corporation's financial condition, results of operations, and cash flows for the three- and six-month periods ended April 30, 2022. This MD&A also includes an assessment of the Corporation's exposure to credit and liquidity risk as well as its ability to continue operating as a going concern as at April 30, 2022. Such discussion and comments on liquidity, going concern assessments, and capital resources should be read in conjunction with the interim financial statements dated April 30, 2022 and related notes which have been prepared in accordance with IFRS. The reader should also refer to the Corporation's Annual Information Form dated January 18, 2022, Risk Factor section (the "AIF Risk Factors"), which risk factors are incorporated herein by reference. To the extent there is any conflict between the AIF Risk Factors and risks identified in this MD&A, the risks identified in this MD&A will govern.

This discussion and the comments contained hereunder include both historical information and forward- looking information. Statements including expressions such as "anticipate", "believe", "estimate", "expect", "foresee", "intend", "plan", "will", and similar expressions are forward-looking statements. The forward- looking statements are not historical facts but reflect the Corporation's current assumptions and expectations regarding future events. The forward-looking information, which is generally information stated to be anticipated, expected, or projected by the Corporation, involves known and unknown risks, uncertainties and other factors that may cause the actual results and performance of the Corporation to

Page 1 of 24

SUMMARY FINANCIAL INFORMATION AND MANAGEMENT'S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

be materially different from any future results and performance expressed or implied by such forward- looking information.

Forward-looking statements in this MD&A include, without limitation:

  • Statements about the Corporation's expectations with respect to future purchase orders, registrations (see below), revenues, expenses, commitments, contingencies, assets, and liabilities;
  • The Corporation's intention to pursue additional funds through government funding, long-term debt or equity financings or to refinance existing long-term debt or obligations;
  • The ability of the Corporation's products to reduce the development of antibiotic resistant pathogens that are widely thought to occur as a result of food animal production and can threaten human health or to replace antibiotics in food-animal applications;
  • The expectation that the Corporation will expand or maintain its patent portfolio;
  • The Corporation's expectations as to the potential size of various markets;
  • The ability to market and sell human, livestock, or companion animal supplements or applications;
  • The Corporation's long term goals and expectations with respect to its products and the application thereof;
  • The Corporation's planned efforts with respect to regulatory approval in additional jurisdictions, the expected timing of such approval processes and the funding required for such processes;
  • The Corporation's plans to expand into additional geographic markets;
  • The Corporation's plans to obtain and retain distributors, agents, and other consultants;
  • The continuation of operations and the anticipated success of the Corporation's joint venture with Mimi's Rock Corp. and the expected benefits to the Corporation anticipated therefrom, if any, and the ability of the joint venture to operate as a going concern;
  • The impacts of the COVID-19 pandemic on current and future operations;
  • The impact of the ongoing Russia-Ukraine war on the financial results of the Corporation;
  • The expected impacts on the Corporation of future IFRS accounting pronouncements; and
  • The Corporation's estimates and judgments with respect to projected future financial results.

In addition to the AIF Risk Factors, potential risks and uncertainties include, without limitation:

  • The uncertainties inherent in the early revenue stage of the Corporation and the development of biotechnology products for use in livestock, companion animals, and humans;
  • The ability to continue as a going concern;
  • The need for significant additional funding;
  • The need to repay current debt, accounts payable, and loans from government agencies;
  • The need to fulfill various commitments in future periods;
  • Extensive government regulation of the Corporation's products;
  • The ability of the Corporation to obtain and retain third-party regulatory support;
  • The success of Corporation-sponsored and customer-sponsored product trials;
  • The ability of the Corporation to obtain and enforce patent protection;
  • The risk of product liability claims and product recalls;
  • The Corporation's sensitivity to unfavourable publicity and consumer perception;
  • The political and legal risk associated with the Corporation's major markets being located outside of Canada;
  • The Corporation's dependence on international advisors, distributors, agents, warehouses, and consultants;
  • The volatility of the Corporation's share price;
  • The Corporation's susceptibility to global economic stress, including: inflation, deglobalization, supply chain pressures, and the macroeconomic impact of the ongoing Russia-Ukraine war;
  • Rapid developments in technology and acquisition of future technology, including developments by competitors;
  • The Corporation's limitations and potential defects on internal controls over financial reporting and disclosure controls and procedures;
  • The introduction of products to market;
  • Protection of intellectual property and trade secrets;
  • Dependence on key employees, management, and consultants;
  • Dependence on partners for development, regulatory and commercial advancement of products;

Page 2 of 24

SUMMARY FINANCIAL INFORMATION AND MANAGEMENT'S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

  • Significant portions of revenue from a single client;
  • Current and future impairment of assets and inventories;
  • Reliance on a sole source for manufacturing for its primary product;
  • Reliance on third parties for sales, marketing, and distribution of products;
  • All of the Corporation's inventories being held in trust outside of Canada;
  • Potential future expected credit losses;
  • Revenues recorded which are subject to variable consideration;
  • Outbreaks of virus or disease that impact humans and/or livestock animals worldwide could have a negative impact on the Corporation and its customers; and
  • The ability of the Corporation to obtain purchase orders for its products, which may be cancelled or not fulfilled for many reasons.

The COVID-19 pandemic has spread across the globe and is impacting worldwide economic activity. Conditions surrounding the pandemic continue to rapidly evolve and government authorities have implemented emergency measures to mitigate the spread of the virus. The Corporation's business, operations and financial condition could be materially adversely affected by the COVID-19 pandemic or the outbreak of other epidemics, pandemics or other health crises. However, as conditions surrounding the pandemic continue to evolve, the Corporation may in the future experience unexpected negative impacts from the COVID-19 pandemic. Such impacts could include, with respect to its operations, its suppliers' operations and its customers' operations, forced closures, mandated social distancing, isolation and/or quarantines, impacts of declared states of emergency, public health emergency and similar declarations and could include other increased government regulations, a material reduction in demand for the Corporation's products, reduced sales, higher costs for new capital, licencing delays, increased operating expenses, delayed performance of contractual obligations, product shipping delays, and potential supply and staff shortages, all of which would be expected to negatively impact the business, financial condition and results of operations of the Corporation and its ability to satisfy its obligations and to continue as a going concern. The risks to the Corporation of such public health crises also include risks to employee and consultant health and safety and a slowdown or temporary suspension of operations in the Corporation's facility or a supplier's facilities. Should an employee, consultant, or visitor in the Corporation's facility or a supplier's facilities become infected with a serious illness that has the potential to spread rapidly, this could place the Corporation's workforce at risk.

The ongoing Russia-Ukraine war has, as at the Issue Date, had no direct impacts on the Corporation's financial results.

Corporation Overview

Avivagen is domiciled in Canada and is located at 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6. The Corporation is a life-sciences company that is developing and commercializing products that help support animal health, including antibiotic alternatives in livestock feeds. Avivagen discovered the source of β-carotene's overlooked, previously difficult-to-reproduce ability, independent of β-carotene's vitamin A activity, to support an animal's own health defences. The Corporation's unique proprietary technology, known as OxC-beta™(fully-oxidizedbeta-carotene) Technology, is based on Avivagen's utilization of the propensity of the β-carotene micronutrient to naturally undergo oxidation to generate a mixture of a polymeric compound and breakdown oxidation products, known as norisoprenoids, that have flavour and fragrance properties. This previously unrecognized mix of a polymeric compound and norisoprenoids, possesses a unique combination of health benefits that accounts for β-carotene's activity beyond being a source of vitamin A.

Avivagen has further discovered that the health benefits of the OxC-beta™ Technology afford the Corporation the opportunity to provide its lead product, OxC-beta™ Livestock, as an entirely new and novel, non-drug alternative product for in-feed antibiotics for livestock that are used for growth promotion and disease prevention. The use of antibiotics as growth promoters in the feedstock of cattle, swine and poultry has been banned for over 10 years in Europe. Their use has become a source of concern to health authorities, governments and consumers, leading them to demand changes now being supported by leading international food processors, retailers and restaurant chains. The OxC-beta™ Livestock product has completed multiple trials as a non-antibiotic feed additive that successfully helps optimize health and productivity in swine, poultry and dairy cattle. By enabling the removal of antibiotics from feeds, the OxC-beta™ Livestock product is expected to help reduce the development of antibiotic resistant pathogens that are widely thought to occur as a result of antibiotic use in food animal production and can threaten human health. Potential commercial opportunities also exist where in-feed antibiotic use

Page 3 of 24

SUMMARY FINANCIAL INFORMATION AND MANAGEMENT'S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

is either precluded, such as for dairy cattle during lactation, or is not applicable, such as for periparturient sows.

The health benefits observed in livestock have given rise to one of Avivagen's goals, which is to access the human supplement markets for OxC-beta™ Technology.

A milestone for the Corporation was the publication in April 2016 in the American Chemical Society's Journal of Agricultural and Food Chemistry of a peer-reviewed scientific publication "Discovery and Characterization of Carotenoid-Oxygen Copolymers in Fruits and Vegetables with Potential Health Benefits". The paper reported the important discovery that counterparts of fully oxidized beta carotene ("OxBC"), containing the β-carotene-oxygen copolymer and norisoprenoids of OxC-beta™ Livestock, occur naturally in a variety of foods at levels that are expected to beneficially affect health. This new knowledge is of major importance to the Corporation in gaining regulatory acceptance throughout the world for the use of the Corporation's OxC-betaTM Technology in animals and humans. The discovery also has provided the Corporation with the opportunity to expand its patent portfolio by filing for intellectual property protection for the natural forms and counterparts of OxBC.

The Corporation believes that OxC-beta™ Livestock in its food-animal applications has the potential, by supporting the animals' own immune system, to replace antibiotics used for growth promotion and in situations in which antibiotic use is precluded. Field trials have established that the product helps maintain health and, in this regard, thereby provides similar benefits to in-feed antibiotics. The Corporation is pursuing sales of OxC-beta™ Livestock in species such as poultry, swine and dairy cattle where data can be rapidly generated with a focus on jurisdictions with motivation to eliminate the use of antibiotics and/or that have lower regulatory hurdles for products of this nature. In pursuit of such sales, the Corporation has conducted confirmatory trials with livestock integrators and exploratory trials with universities or research institutes.

Details on the volume in kilograms (kg) and revenues in Canadian dollars of OxC-beta™ Livestock 10% premix and companion animal products (excluding products sold by the joint venture) sold according to the geographic region of revenues are as follows:

Life-to-date

total:

Six-month

November 1,

2016 to

period ended

April 30,

April 30,

Volumes of OxC-beta™ Livestock sold by country:

2022

2022

Philippines

33,050 kg

3,150 kg

Mexico

2,775 kg

(825)1 kg

Thailand

1,425 kg

350 kg

Taiwan

1,535 kg

400 kg

Brazil

525 kg

400 kg

Malaysia

110 kg

-

China

100 kg

-

Total sales volumes (OxC-betaTM Livestock)

39,520 kg

3,475 kg

Total revenues (OxC-betaTM Livestock)

$

4,866,960

$

355,379

Total revenues (Vivamune, companion animal,

$

272,166

$

4,216

excluding joint venture)

Total revenues

$

5,139,126

$

359,595

Average price per kg of OxC-Beta™ Livestock (CAD)

$

123.15

$

102.27

Note 1: In the six-month period ended April 30, 2022, the Corporation recognized a return of 850kg of product or $89,658 in revenues recorded in prior accounting periods.

Page 4 of 24

SUMMARY FINANCIAL INFORMATION AND MANAGEMENT'S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Year ended

Year ended

Year ended

October 31,

October 31,

October 31,

Volumes of OxC-beta™ Livestock sold by country: 2021

2020

2019

Philippines

9,550 kg

7,250 kg

6,000 kg

Mexico

1,150 kg

2,450 kg

-

Thailand

725 kg

350 kg

-

Taiwan

656 kg

79 kg

200 kg

Brazil

-

125 kg

-

Malaysia

-

110 kg

-

China

-

-

100 kg

Total sales volumes (OxC-betaTM Livestock)

12,081 kg

10,364 kg

6,300 kg

Total revenues (OxC-betaTM Livestock)

$

1,279,697

$

1,148,967

$

896,345

Total revenues (Vivamune, companion animal,

$

16,294

$

28,890

$

81,106

excluding joint venture)

Total revenues

$

1,295,991

$

1,177,857

$

977,451

Average price per kg of OxC-Beta™ Livestock (CAD)

$

105.93

$

110.86

$

142.28

Year ended

Year ended

October 31,

October 31,

Volumes of OxC-beta™ Livestock sold by country:

2018

2017

Philippines

6,000 kg

1,100 kg

Mexico

-

-

Thailand

-

-

Taiwan

200 kg

-

Brazil

-

-

Malaysia

-

-

China

-

-

Total sales volumes (OxC-betaTM Livestock)

6,200 kg

1,100 kg

Total revenues (OxC-betaTM Livestock)

$

960,894

$

225,678

Total revenues (Vivamune, companion animal,

$

111,678

$

29,982

excluding Joint venture)

Total revenues

$

1,072,572

$

255,660

Average price per kg of OxC-Beta™ Livestock (CAD)

$

154.98

$

205.16

Life-to-date, the Corporation has sold 39,520kg of OxC-Beta™ Livestock, which is net of 850kg of product returns.

As at April 30, 2022 and the Issue Date, the Corporation has no unperformed performance obligations and is not a direct party to any current or outstanding purchase orders or revenue and sales contracts for the delivery of the Corporation's goods in future periods under IFRS 15 Revenue from Contracts with Customers.

OxC-beta™ Livestock

The Corporation believes that the total global animal feed production in Avivagen's target species of poultry, swine and cattle to which OxC-betaTM Livestock could be added is approximately 1 billion tons1. Asia, the Corporation's target market for initial commercialization, is the largest single region representing some 35% of total world animal feed consumption.

On May 30, 2022, the Corporation announced that it had signed a distribution agreement with Nong San Viet Co., Ltd., an entity based in Vietnam, to facilitate the expansion of the Corporation's market.

In February 2020, the Corporation signed a marketing and distribution agreement with INPHILCO, Inc., a corporation in the Philippines. This agreement does not replace the current and ongoing relationship Avivagen has with UNAHCO, Inc. The Corporation has completed the registration process with

INPHILCO.

1 1Alltech 2019 Annual Global Feed Survey, ALLTECH, Nicholasville, Kentucky, USA 40356

Page 5 of 24

This is an excerpt of the original content. To continue reading it, access the original document here.

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Avivagen Inc. published this content on 17 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 June 2022 12:52:02 UTC.