Inventiva : H1 2021 Interim Financial Report

INVENTIVA S.A.

1. joint-stockcompany (société anonyme) with a share capital of 386,593.61euros Registered office: 50, rue de Dijon, 21121 Daix, France
   Dijon Trade and Companies Register 537 530 255

INTERIM FINANCIAL REPORT

FOR THE SIX MONTHS ENDED JUNE 30, 2021

		Table of contents
1. Interim Financial Report .............................................................................	2
1.1. General overview of activities .....................................................................................	2
1.2. Significant events in first-half 2021 ............................................................................	2
1.3. Recent events and prospects ........................................................................................	5
1.4.	Risk factors ..................................................................................................................	8
1.5.	Earnings analysis .........................................................................................................	9
1.6. Analysis of the financial situation .............................................................................	15
2. Cash flow and equity..................................................................................	18
2.1. Cash and cash equivalents .........................................................................................	18
2.2.	Cash flow analysis .....................................................................................................	21
2.3. Anticipated sources of funds .....................................................................................	23
3. Interim condensed consolidated financial statements.............................	24
Note 1. Company information ..............................................................................................	29
Note 2. Basis of preparation for the consolidated financial statements................................	32
Note 3.	Accounting principles ..............................................................................................	34
Note 4.	Notes to the consolidated balance sheet...................................................................	36
Note 5.	Notes to the income statement .................................................................................	49
Note 6.	Other financial information......................................................................................	56

Definitions

In this half-yearly report (the Interim Financial Report), and unless otherwise specified, the terms Inventiva or the Company are taken to mean the company Inventiva S.A. with its registered office at 50, rue de Dijon, 21121 Daix, France, and which is listed with the Dijon Trade and Companies Register under number 537 530 255 and its subsidiary, 100% owned, Inventiva Inc. with its registered office at 10-34 44th Dr, Long Island, 11101 New York, USA, created in January 2021.

A glossary defining certain terms used in this Interim Financial Report is given in the 2020 Universal Registration Document (the 2020 Universal Registration Document).

Forward-looking information

This Interim Financial Report contains information about the Company's objectives and development priorities. This information is sometimes identified by the usage of the future, the conditional or terms such as "consider", "anticipate", "think", "aim", "expect", "understand", "should", "seek", "estimate", "believe", "wish", "can" or, where applicable, the negative form of these same terms, or any other variants or similar terminology. The reader's attention is drawn to the fact that these objectives and development priorities are dependent on circumstances or facts that cannot be certain to occur or materialize. These objectives and development priorities are not historical data and should not be interpreted as a guarantee that the facts or data will occur, that the assumptions will be proven correct or that the objectives will be achieved. By their very nature, these objectives might not be achieved and any representations or information given in this Interim Financial Report may prove to be incorrect. The Company has no obligation whatsoever to update this information, subject to the applicable regulations and, in particular, the General Regulation of the French Financial Markets Authority (Autorité des marchés financiers - AMF).

Market and competitive position

This Interim Financial Report also contains information about the Company's activities and the markets on which it operates. This information comes from studies or surveys carried out internally or externally. Other information contained in this Interim Financial Report is available to the general public. The Company considers that all of this information is reliable but it has not been verified by an independent expert. The Company cannot guarantee that a third party using different methods to gather, analyze or calculate market data would obtain the same results.

Rounding of figures

Certain figures (including data expressed in thousands or millions of euros or dollars) and the percentages presented in this Interim Financial Report have been rounded up or down. Accordingly, totals given may vary slightly from those obtained by adding the exact (unrounded) values of those same figures.

Abbreviations

Certain figures are given in thousands or millions of euros and are indicated as € thousand or € million respectively.

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1. Interim Financial Report

1.1. General overview of activities

Since the Company's founding, most of its resources have gone into research and development (R&D), particularly in order to develop:

• the lanifibranor clinical program in a Phase III NATIVE clinical study for patients suffering from non-alcoholic steatohepatitis ("NASH"), for which the positive results of Phase IIb were announced in June 2020 and Breakthrough Therapy and Fast Track designations were granted by the U.S. Food and Drug Administration ("FDA") in October 2020 and September 2019, respectively;
• the odiparcil clinical program, for which the positive results of the Phase IIa clinical study in the treatment of type VI mucopolysaccharidoses, or MPS VI, were announced in December 2019 and the "Fast Track" designation was granted by the FDA in October 2020;
• to a lesser extent, the Company's pre-clinical product portfolio, notably in the field of oncology.

In November 2020, the Company decided to focus its clinical activities on the development of lanifibranor for the treatment of NASH. As part of this decision, the Company is considering any available options to optimize the development of odiparcil for the treatment of MPS VI treatment and, during this period, has suspended all MPS-related research and development activities.

These research and development activities are presented in further detail in Chapter 1 Business activities and markets of the 2020 Universal Registration Document.

Changes in research and development costs are detailed in section 1.5.2 "Operating expenses" below.

1.2. Significant events in first-half 2021

1.2.1. Operations and product portfolio

The 2020 Universal Registration Document describes the Company's main clinical and pre-clinical programs. The significant events linked to the programs that took place in the first six months of 2021 are as follows:

Lanifibranor

Design of its Phase III clinical study with lanifibranor in NASH

On January 5, 2021, the Company has announced the details of the Phase III clinical trial with its lead drug candidate lanifibranor for the treatment of NASH following the end-of-phase II meeting with the FDA and the receipt of the Scientific Advice letter from the European Medicines Agency ("EMA") . The phase III trial design and clinical strategy have been discussed with both regulatory authorities and the following key points can be confirmed:

• Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on a 72-week histology analysis;
• Use of a primary composite endpoint combining NASH resolution and fibrosis improvement;
• Adequacy of long-term use to be established after 72 weeks.

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