Quantum Genomics : Universal Registration Document 2021

Quantum Genomics S.A.

Public limited company (SA) with capital of 10,972,353.99 euros

Registered office: 33 rue Marbeuf, 75008 Paris

Paris TCR 487 996 647

UNIVERSAL REGISTRATION DOCUMENT 2021

The universal registration document was approved on 29 April 2022 by the AMF (French Financial Markets Authority) as the competent authority under Regulation (EU) 2017/1129.

The AMF approves this document after verifying that the information contained therein is complete, consistent and understandable. The universal registration document will have the following approval number: R. 22-016.

This approval should not be considered as a favourable opinion on the issuer that is the subject of the universal registration document.

The universal registration document may be used for the purpose of an offer to the public of financial securities or the listing for trading of financial securities on a regulated market if it is supplemented by an operation note and, where appropriate, a summary and its amendment(s). In that case, the note relative to the securities, the summary and all amendments made to the universal registration document since its approval will be approved separately in accordance with the second subparagraph of article 10 (3) of Regulation (EU) 2017/1129.

The universal registration document will be valid until 28 April 2023 and, during that period and at the latest at the same time as the operation note and under the conditions of articles 10 and 23 of Regulation (EU) 2017/1129, will be supplemented by an amendment in the event of significant developments or material errors or inaccuracies.

Copies of this universal registration document are available free of charge from Quantum Genomics, 33 rue Marbeuf, 75008 Paris, as well as on the websites of Quantum Genomics (www.quantum-genomics.com) and of the AMF (www.amf-france.org).

Table of contents

1. RESPONSIBLE INDIVIDUALS, INFORMATION FROM THIRD PARTIES,

	EXPERT REPORTS AND APPROVAL BY THE COMPETENT AUTHORITY....	9
1.1	Individuals responsible for the information........................................................................	9
1.2	Statement by the responsible individual.............................................................................	9
1.3	Expert declaration and declarations of interests .................................................................	9
1.4	Information from third parties............................................................................................	9
1.5	Declaration relative to the competent authority approving the document ..........................	9

2.	STATUTORY AUDITOR...............................................................................................	9
2.1	Information relating to the statutory auditors .....................................................................	9
2.2	Information on the possible resignation or non-reappointment of statutory auditors .......	10
3.	RISK FACTORS............................................................................................................	10
3.1	Risks related to regulatory approval and marketing of our candidate drugs.....................	11
	3.1.1 Specific risk related to pre-clinical studies and clinical trials*............................	11
	3.1.2 Risk related to drug coverage and reimbursement...............................................	12
	3.1.3 Risk of not obtaining a Marketing Authorisation (MA) ......................................	13
	3.1.4 Risk related to the support for the products by the medical community,
		prescribers and third-party payers .......................................................................	14
3.2	Risks related to intellectual property rights......................................................................	15
	3.2.1 Risk related to non-compliance with patents and other intellectual rights by third
		parties*................................................................................................................	15
	3.2.2 Risk related to the development of products already covered by patents and
		intellectual property rights held by third parties* ................................................	16
	3.2.3 Risk of loss of licence agreement........................................................................	16
	3.2.4 Risk related to the inability to protect the confidentiality of its information and
		know-how ...........................................................................................................	17
3.3	Financial Risks.................................................................................................................	17
	3.3.1	Liquidity risk*.....................................................................................................	17
	3.3.2	Dilution risk* ......................................................................................................	21
	3.3.3 Risk related to historical losses and projected losses...........................................	22
3.4	Risks related to the company's activities .........................................................................	22
	3.4.1 Risk related to the imposition of liability, in particular with regard to product
		liability*..............................................................................................................	22
	3.4.2 Risk related to the competitive environment .......................................................	23
	3.4.3 Risk related to the Covid 19 health crisis ............................................................	23
	3.4.4	Governance organisation risk..............................................................................	24
3.5	Risks related to dependence on third parties ....................................................................	24
	3.5.1 Risk of dependence on current and future partnerships* .....................................	24
	3.5.2 Risks related to partnerships and subcontracting.................................................	26
	3.5.3 Risk linked to dependence on suppliers of raw materials and essential materials
		............................................................................................................................	27
	3.5.4 Risk related to the need to attract and retain key personnel and scientific advisors
		............................................................................................................................	28
3.6	Insurance and risk coverage .............................................................................................	28
4.	INFORMATION CONCERNING THE ISSUER.......................................................	29
4.1	Corporate name and trade name of the Company ............................................................	29
4.2	Location and registration number of the Company and legal entity identifier..................	29
4.3	Incorporation date and duration of the Company .............................................................	29
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4.4	Registered office, legal form and regulations applicable to the Company .......................	29
5.	OVERVIEW OF ACTIVITIES ....................................................................................	29
5.1	Main activities..................................................................................................................	29
	5.1.1 General presentation of the Company .................................................................	29
	5.1.2	Company pipeline ...............................................................................................	36
5.2	Key markets .....................................................................................................................	38
	5.2.1	Arterial Hypertension market..............................................................................	38
	5.2.2	Heart failure ........................................................................................................	43
5.3	Significant events in the development of the Company's activities .................................	45
5.4	Description of the strategy and objectives........................................................................	47

5.5 Degree of issuer dependence on patents or licences, industrial, commercial or financial

	contracts or new manufacturing processes .......................................................................	48
5.6	Basis for the issuer's statement of its competitive position..............................................	48
	5.6.1 Products under development for the treatment of arterial hypertension ..............	49
	5.6.2 Products under development for the treatment of heart failure............................	50
5.7	Investments ......................................................................................................................	52
	5.7.1 Description of the main investments made by the Company...............................	52
	5.7.2 Description of the Company's investments in progress and their geographical
	location and the Company's planned investments...............................................	52
	5.7.3 Provide information on companies and joint ventures in which the issuer holds a
	fraction of the capital likely to have a significant impact on the assessment of its
	assets, liabilities, financial position or results......................................................	53
	5.7.4 Describe any environmental issues that may affect the issuer's use of its tangible
	fixed assets..........................................................................................................	53
6.	ORGANISATIONAL STRUCTURE ...........................................................................	53
6.1	Description of the Company ............................................................................................	53
6.2	List of major subsidiaries.................................................................................................	53
7.	REVIEW OF THE FINANCIAL SITUATION AND RESULTS ..............................	53
7.1	Financial position.............................................................................................................	53
	7.1.1 Statement of activity for the years ended 31 December 2021, 2020 and 2019 ....	53
	7.1.2 Explanation of future development prospects and R&D activities ......................	57
7.2	Operating profits ..............................................................................................................	59
	7.2.1 Operating profits for the years ended 31 December 2021, 2020, 2019 in IFRS ..	59
8.	CASH AND CAPITAL..................................................................................................	63
8.1	Information on the Company's capital .............................................................................	65
	8.1.1 Changes of capital and shareholders' equity as on 31 December 2021, 2020 and
	2019. ...................................................................................................................	65

8.2 Source and amount of the issuer's cash flows and description of cash flows for the years

	ended 31 December 2021, 2020 and 2019 (IFRS data) ....................................................	66
8.3	Information on the issuer's financing needs and financial structure.................................	68
	8.3.1	Conditional advances ..........................................................................................	69
	8.3.2	Liabilities for financial years 2019, 2020 and 2021 ............................................	70

8.4 Information on the existence of any restrictions on the use of capital that may have an

	impact on the issuer .........................................................................................................	70
8.5	Expected and required sources of funding for the Company to meet its commitments ....	71
9.	REGULATORY ENVIRONMENT .............................................................................	71
9.1	Regulatory environment for Research & Development of pharmaceuticals.....................	71
	9.1.1 Regulatory framework within the European Union.............................................	72
	9.1.2 Regulatory framework in the United States.........................................................	74
9.2	Regulatory environment for the pricing and reimbursement of medicines.......................	75
	9.2.1 France and Europe ..............................................................................................	76
	9.2.2 Context in the United States................................................................................	79
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9.3	Regulatory environment for foreign investments in France on biotech............................	79
9.4	Regulatory environment relating to data protection .........................................................	80
10.	INFORMATION ON TRENDS....................................................................................	81

10.1 Main trends affecting production, sales and inventory, costs and sale prices since the end

of last year........................................................................................................................

81

10.2 Known trends, uncertainties or demands or commitments or events reasonably likely to

	materially affect the issuer's outlook, at least for the current financial year ....................	81
11.	PROFIT FORECASTS OR ESTIMATES...................................................................	81

12. ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES AND

GENERAL MANAGEMENT.......................................................................................

82

12.1 Information concerning the members of the Company's administration and management

.........................................................................................................................................	82
12.1.1 Information on the management committee for the years ended 31 December
2021, 2020 and 2019...........................................................................................	82
12.1.2 Corporate officers and list of directorships on the date of the universal
registration document..........................................................................................	83
12.1.3 Corporate officers and list of directorships held for the 2020 financial year .......	86
12.1.4 Corporate officers and list of directorships held for the 2019 financial year .......	88
12.1.5 Declaration relative to the members of the management and the members of the
board of directors ................................................................................................	89

12.2 Conflicts of interest on the level of the administrative, management and supervisory

bodies and of the general management ............................................................................	89
13. REMUNERATION AND BENEFITS..........................................................................	89
Amount of remuneration paid and benefits in kind.......................................................................	89

13.1 Total amount of sums provisioned or recognised elsewhere by the issuer or its

subsidiaries for the purpose of payment of pensions, retirement or other benefits .........

103

14. FUNCTIONING OF THE ADMINISTRATIVE AND MANAGEMENT BODIES

	.......................................................................................................................................	103
14.1	Expiry date of current terms of office ............................................................................	103

14.2 Service contracts binding on members of the administrative and management bodies for

the financial years ended 31 December 2021, 2020 and 2019........................................

103

14.3 Information on the Audit Committee, Appointments and Remuneration Committee and

	the Scientific Committee for the years ended 31 December 2021, 2020 and 2019.........	103
	14.3.1	Audit committee................................................................................................	103
	14.3.2	Appointments and Remuneration Committee....................................................	104
	14.3.3 Scientific Committee and Steering Committees................................................	106
14.4	Corporate governance regime ........................................................................................	107

14.5 Potential governance impacts, including any changes to the board or membership of

	committees.....................................................................................................................	108
15.	EMPLOYEES ..............................................................................................................	108
15.1	Number of employees ....................................................................................................	108
15.2	Equity interests and stock options..................................................................................	109
15.3	Agreements providing for employee participation in the issuer's capital.......................	114
16.	MAIN SHAREHOLDERS ..........................................................................................	114
16.1	Shareholders holding more than 5% of the capital .........................................................	114
16.2	Existence of different voting rights ................................................................................	114
16.3	Ownership or control of the issuer .................................................................................	116
16.4	Agreement that could result in a change of control if implemented ...............................	116
17.	OPERATIONS WITH RELATED PARTIES...........................................................	117
17.1	Details of transactions with related parties for the 2021 financial year ..........................	117
17.2	Details of transactions with related parties for the 2020 financial year ..........................	121
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17.3

Details of transactions with related parties for the 2019 financial year ..........................

125

18. FINANCIAL INFORMATION CONCERNING THE ISSUER'S ASSETS,

FINANCIAL POSITION AND RESULTS ................................................................	128
18.1 Historical financial information .....................................................................................	128
18.1.1 IFRS restated financial statements for the years ended 31 December 2021, 31

		December 2020 and 31 December 2019............................................................	128
FINANCIAL STATEMENTS..................................................................................................	128
PROFIT AND LOSS ACCOUNT ..............................................................................................	128
STATEMENT OF COMPREHENSIVE INCOME ....................................................................	128
STATEMENT OF FINANCIAL POSITION .............................................................................	129
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY.............................................	130
CASH FLOW STATEMENT.....................................................................................................	131
NOTES TO THE FINANCIAL STATEMENTS ...................................................................	132
1.	Description of the Company's activity...........................................................................	132
2.	Preparation basis ............................................................................................................	132
	2.1.	Declaration of conformity .................................................................................	132
	2.2. Evolution of the accounting guidelines .............................................................	132
	2.3. Use of estimates and judgements ......................................................................	133
	2.4. Functional and presentation currency................................................................	133
	2.5.	Foreign currency transactions ...........................................................................	134
3.	Provisions for first application .......................................................................................	135
	3.1. Balance sheet reconciliation as of 1 January 2019 (IFRS transition date) .........	136

1. Balance sheet reconciliation as on 31 December 2019 (first comparative year)138
2. Balance sheet reconciliation as on 31 December 2020 (second comparative year)
   ..........................................................................................................................139
3. Reconciliation of comprehensive income for the year ended 31 December 2019
   ..........................................................................................................................140
4. Reconciliation of comprehensive income for the year ended 31 December 2020
   ..........................................................................................................................141
5. Reconciliation of the cash flow statement for the years ended 31 December 2019

		and 2020............................................................................................................	142
4.	Significant facts of the period ........................................................................................	143
5.	Events after the closing ..................................................................................................	144
6.	Sector information .........................................................................................................	145
7.	Operational data.............................................................................................................	145
	7.1.	Turnover ...........................................................................................................	145
	7.2.	Other income.....................................................................................................	147
	7.3.	Operational expenses ........................................................................................	148
	7.4.	Staff and personnel............................................................................................	149
8.	Financial result...............................................................................................................	153
9.	Income taxes ..................................................................................................................	153
	9.1.	Income tax expense...........................................................................................	154
	9.2.	Deferred tax assets not recognised ....................................................................	154
	9.3.	Tax uncertainties ...............................................................................................	155
10.	Earnings per share..........................................................................................................	155
	10.1. Basic earnings per share....................................................................................	155
	10.2.	Diluted earnings per share.................................................................................	155
11.	Intangible and tangible assets.........................................................................................	156
	11.1.	Intangible assets ................................................................................................	156
	11.2.	Tangible assets ..................................................................................................	157
	11.3.	Impairment tests................................................................................................	158

12.	Lease contract ................................................................................................................	158
13.	Non-current financial assets...........................................................................................	161
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