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MarketScreener Homepage  >  Equities  >  Euronext Paris  >  GenSight Biologics S.A.    SIGHT   FR0013183985

GENSIGHT BIOLOGICS S.A.

(SIGHT)
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GenSight Biologics S A : 2020 Half-Year Financial Report

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07/30/2020 | 02:50am EDT

HALF-YEAR FINANCIAL REPORT

JUNE 30, 2020

TABLE OF CONTENTS

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

3

ACTIVITY REPORT

25

TRANSACTIONS BETWEEN RELATED PARTIES

29

RISK FACTORS

31

STATUTORY AUDITORS' REVIEW REPORT

ON THE 2020 HALF-YEAR FINANCIAL INFORMATION

33

DECLARATION BY THE PERSON RESPONSIBLE

FOR THE 2020 HALF-YEAR FINANCIAL REPORT

35

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 1

CONDENSED HALF-YEAR CONSOLIDATED

FINANCIAL STATEMENTS

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 3

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As of December 31,

As of June 30,

In thousands of euros

Notes

2019

2020

ASSETS

Non-current assets

Intangible assets

4

154

144

Property, plant and equipment

5

4,228

3,772

Other non-current financial assets

7

336

338

Total non-current assets

4,718

4,254

Current assets

Trade accounts receivable

846

2

Other current assets

8

7,669

6,068

Cash and cash equivalents

9

19,250

16,831

Total current assets

27,765

22,899

TOTAL ASSETS

32,483

27,152

4 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

As of December 31,

As of June 30,

In thousands of euros

Notes

2019

2020

LIABILITIES

Shareholders' equity

Share capital

10

821

821

Premiums related to the share capital

128,130

128,142

Reserves

(86,495)

(115,337)

of wich cumulative translation adjustment

(22)

(10)

Net income (loss)

(30,710)

(14,078)

Total shareholders' equity attributable to equity holders of the

11,746

(453)

Company

Non-current liabilities

Corporate bonds - non-current portion

11.1

3,732

3,146

Borrowings from Banks - non-current portion

11.2

-

4,625

Conditional advances - non-current portion

11.3

3,633

3,732

Lease liability - non-current portion

6

2,763

2,473

Other financial liabilities - non-current portion

-

325

Non-current provisions

103

98

Total non-current liabilities

10,231

14,399

Current liabilities

Corporate bonds - current portion

11.1

889

1,469

Lease liability - current portion

6

563

582

Trade accounts payable

12.1

7,139

8,745

Current provisions

22

22

Other current liabilities

12.2

1,893

2,388

Total current liabilities

10,506

13,206

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

32,483

27,152

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 5

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

CONDENSED CONSOLIDATED STATEMENT OF INCOME (LOSS)

For the six-month period ended June 30,

In thousands of euros

Notes

2019

2020

Operating income

Revenues

14

-

700

Other income

15

2,466

2,578

Total operating income

2,466

3,278

Operating expenses

Research and development

16.1

16,105

11,964

General and administrative

16.2

3,113

3,985

Sales and marketing

16.3

411

944

Total operating expenses

19,629

16,893

Operating profit (loss)

(17,164)

(13,615)

Financial income

18

41

70

Financial expenses

18

(220)

(533)

Financial income (loss)

(179)

(463)

Income tax

(1)

-

Net income (loss)

(17,344)

(14,078)

Basic and diluted earnings (loss) per share

22

(0.63)

(0.43)

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (LOSS)

For the six-month period ended June 30,

In thousands of euros

2019

2020

Net income (loss)

(17,344)

(14,078)

Actuarial gains and losses on employee benefits, net of income tax

(10)

23

Foreign currency translation differences, net of income tax

-

6

Total comprehensive income (loss)

(17,354)

(14,049)

6 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

For the six-month period ended June 30,

In thousands of euros

Notes

2019

2020

Cash flows from operating activities

Net income (loss)

(17,344)

(14,078)

Operating activities

Amortization and depreciation

4-5-6

557

480

Retirement pension obligations

10

18

Expenses related to share-based payments

17.4

1,071

1,789

Other financial items

147

453

Operating cash flows before change in working capital

(15,558)

(11,338)

Accounts receivable

-

844

Accounts payable, net of prepayments

(1,577)

1,626

Other receivables

(2,238)

1,637

Other current liabilities

(90)

496

Change in working capital

(3,905)

4,603

Net cash flows from operating activities

(19,464)

(6,734)

Cash flows from investment activities Acquisitions of property, plant and equipment Acquisitions of intangible assets Acquisitions/reimbursement of non-current financial assets Acquisitions/reimbursement of current financial assets Sales of property, plant and equipment

Net cash flows from investing activities

5

(65)

(2)

4

(7)

-

170

(50)

-

-

-

-

98

(52)

Cash flows from financing activities

New borrowings obtained

11.3

-

4,625

Interests paid

18

-

(276)

Repayment of obligations under finance leases

6

(354)

(362)

Other financial liabilities

-

330

Treasury shares

(170)

49

Subscription of share warrants

-

12

Capital increases, net of transaction costs

7,906

-

Net cash flows from financing activities

7,380

4,377

Increase/(decrease) in cash and cash equivalents

(11,986)

(2,410)

Cash and cash equivalents at beginning of the period

26,241

19,250

Effect of changes in exchange rates on cash and cash equivalents

(1)

(9)

Cash and cash equivalents at end of period

14,253

16,831

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 7

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

Share Capital

Premiums

Reserves

Net income

Total

In thousands of euros, except

Number

Amount

related to the

(loss)

Shareholders'

share capital

Equity

for number of shares

of shares

Balance at January 1, 2019

24,802,973

620

112,135

(55,432)

(33,453)

23,870

Net income (loss) for the

-

-

-

-

(17,344)

(17,344)

period

Cumulative translation

-

-

-

-

-

-

adjustment

Other comprehensive income

-

-

-

(10)

-

(10)

Total comprehensive income

-

-

-

(10)

(17,344)

(17,354)

(loss)

Allocation of prior period net

-

-

-

(33,453)

33,453

-

income (loss)

Allocation to reserves

-

-

-

-

-

-

Capital increase by issuance

3,921,568

98

7,902

-

-

8,000

of ordinary shares

Capital increase transaction

-

-

(94)

-

-

(94)

costs

Capital increases related to

263,750

7

(7)

-

-

-

acquisition of free shares

Treasury shares

-

-

-

(166)

-

(166)

Share-based payments

-

-

-

1,071

-

1,071

Balance at June 30, 2019

28,988,291

725

119,936

(87,990)

(17,344)

15,328

Balance at January 1, 2020

32,827,362

821

128,130

(86,495)

(30,710)

11,746

Net income (loss) for the

-

-

-

-

(14,078)

(14,078)

period

Cumulative translation

-

-

-

-

-

-

adjustment

Other comprehensive income

-

-

-

29

-

29

Total comprehensive income

-

-

-

29

(14,049)

(14,049)

(loss)

Allocation of prior period net

-

-

-

(30,710)

30,710

-

income (loss)

Allocation to reserves

-

-

-

-

-

-

Capital increase by issuance of

-

-

-

-

-

-

ordinary shares

Capital increase transaction

-

-

-

-

-

-

costs

Capital increases related to

-

-

-

-

-

-

acquisition of free shares

Subscription of share warrants

-

-

12

-

-

12

Treasury shares

-

-

-

49

-

49

Share-based payments

-

-

-

1,789

-

1,789

Balance at June 30, 2020

32,827,362

821

128,142

(115,337)

(14,049)

(453)

8 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1: General information about the Company

Founded in 2012, GenSight Biologics S.A. (hereinafter referred to as "GenSight Biologics" or the "Company" and together with its subsidiary as the "Group") is a clinical-stage biotechnology group discovering and developing novel therapies for neurodegenerative retinal diseases and diseases of the central nervous system. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from severe degenerative retinal diseases. The Group focus is in ophthalmology where it develops product candidates to restore eyesight to patients suffering from retinal diseases that would otherwise lead to blindness.

The Company has incurred losses and negative cash flows from operations since its inception and shareholders' equity amounts to €(453) K as of June 30, 2020 as a result of several financing rounds. The Group anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its product candidates in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates.

The Group's future operations are highly dependent on a combination of factors, including: (i) the success of its research and development; (ii) regulatory approval and market acceptance of the Group's proposed future products; (iii) the timely and successful completion of additional financing; and (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies.

Note 2: Significant events during the period

On April 6, 2020, GenSight Biologics provided an update on the impact of COVID-19 on its operations.

The REVERSE and RESCUE Phase III trials of LUMEVOQ® (GS010) for the treatment of Leber Hereditary Optic Neuropathy (LHON) are completed, and patients have been transferred to long-termfollow-up for an additional 3-year period. As of today, 10 out of 61 patients are due to attend their first annual follow-up visit (at Year 3 after injection) in the coming weeks and months. Given the follow-up nature of these visits and the stability of patients with no safety concern, delaying some of these visits is an acceptable precautionary measure, which should have no impact on the conduct of the trial, and will be properly documented and reported to regulators.

The strategic manufacturing partner (CDMO) for LUMEVOQ® maintained its operations and has indicated that no delay is currently expected in the planned activities to support the filing to the European Medicines Agency (EMA) in Europe.

GenSight Biologics held a pre-submission meeting with the EMA on March 19, 2020, as planned, in the form of a teleconference. The Company remains on track for regulatory filing in Europe (MAA filing with EMA) in Q3 2020, with potential approval in H2 2021.

The REFLECT Phase III trial of LUMEVOQ® is fully recruited with a primary endpoint at 78 weeks. Although some on-site visits are being postponed, the Company is closely partnering with clinical sites, and investigators continue to assess the safety of all patients remotely, in accordance with regulators' guidelines. Safety monitoring is an absolute priority and will not be disrupted. Most patients are due to make their 78-week visit in the near future, and some may be delayed as a result. This will be properly documented and reported to regulators, as well as pre-specified in the Statistical Analysis Plan (SAP), in agreement with biostatisticians, before database lock. Accordingly, GenSight Biologics foresees limited impact on the trial and no consequence on the primary endpoint other than a possible delay in data availability from Q1 to Q2 2021, which will be confirmed as soon as possible. The regulatory filing target with the FDA in the US remains H2 2021.

The PIONEER Phase I/II clinical trial of GS030, combining gene therapy and optogenetics for the treatment of retinitis pigmentosa (RP), has fully completed recruitment of the second cohort. In order to protect patients, the Company and investigators have together decided to delay recruiting new patients into the third cohort until the COVID-19 situation has improved, as RP is a chronic disease, and does not require an urgent treatment. In the interim, the six patients in the first two cohorts are being remotely monitored for safety aspects by investigators. Consequently, recruitment may take longer than expected; this limited impact will be more precisely assessed as soon as possible.

A patient was treated with LUMEVOQ® under a first Temporary Authorization for Use (ATU) granted by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM) in December 2019. A second patient was treated early 2020, and several additional ATUs have been requested and are being reviewed by the ANSM. GenSight Biologics expects any delay to be overcome as soon as patients can get normal access to treatment sites, with no material impact on the related revenues expected in 2020; this will be more precisely assessed as soon as the situation improves. In addition, the Company is currently discussing with the ANSM the possibility to broaden individual named patient ATUs to a cohort ATU as soon as feasible to further facilitate access to LUMEVOQ® for patients in Europe.

On April 14, 2020, GenSight Biologics announced that the independent Data Safety Monitoring Board (DSMB) completed its second planned safety review of the ongoing PIONEER

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 9

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Phase I/II clinical trial of GS030, GenSight's novel product combining gene therapy and optogenetics for the treatment of Retinitis Pigmentosa (RP). The DSMB confirmed the absence of any safety issues for the second cohort of three subjects, who each received a single intravitreal injection of 1.5e11 vg (viral genomes) and used a wearable optronic visual stimulation device after the injection. The DSMB recommended moving forward as planned without any modification in the protocol and recruiting the third cohort of three subjects who are to receive the maximal dose of 5e11 vg.

On April 15, 2020, GenSight Biologics announced the completion of the pre-submission meeting with the European Medicines Agency (EMA) for the Company's lead product LUMEVOQ® (GS010; lenadogene nolparvovec). The EMA pre- submission meeting is a procedural milestone in the preparation of a marketing authorization application (MAA). Based on its successful conclusion, GenSight Biologics confirms its intention to submit the MAA for LUMEVOQ® in September 2020. LUMEVOQ® is the gene therapy developed by the Company for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare blinding disease marked by sudden, irreversible vision loss. The pivotal trials for LUMEVOQ® in Europe, RESCUE and REVERSE, were completed in 2019; patients from those trials have been invited to participate in a long-termfollow-up study.

Note 3: Accounting principles and compliance

3.1 Preliminary remarks

The condensed half-year consolidated financial statements (the "Financial Statements") present the operations of GenSight Biologics as of June 30, 2020. GenSight Biologics S.A. is a public limited company whose head office is located at 74 rue du Faubourg St. Antoine, 75012 Paris.

The condensed half-year consolidated financial statements for the six months ended June 30, 2020 have been prepared under the responsibility of the management of GenSight Biologics, they have been approved on July 29, 2020 by the Board of Directors.

The presented condensed financial statements are expressed in thousands of euros, unless stated otherwise.

The Reporting date for the condensed consolidated accounting statements is June 30 and covers a six- month period. The individual statements of the consolidated subsidiary are

prepared at the same Reporting date, i.e. June 30, and covers the same period.

3.2 Accounting principles and Statement of compliance

International accounting standards include International Financial Reporting Standards (IFRS), International Accounting Standards (IAS), as well as the interpretations issued by the Standing Interpretations Committee (SIC), and the International Financial Reporting Interpretations Committee (IFRIC).

The IFRS as adopted by the European Union differ in certain aspects with the IFRS published by the IASB. Nevertheless, the Group ensured that the financial information for the periods presented would not have been substantially different if it had applied IFRS as published by the IASB.

The notes to the condensed consolidated financial statements at June 30, 2020 were prepared in accordance with IAS 34

  • Interim Financial Reporting, as endorsed by the European Union, which requires the disclosure of selected notes only. The condensed financial statements do not include all disclosures required for annual financial statements and should therefore be read in conjunction with the consolidated financial statements for year ended December 31, 2019.

All the texts adopted by the European Union are available on the European Commission's website: https://ec.europa. eu/info/law/international-accounting-standards-regulation- ec-no-1606-2002/amending-and-supplementary-acts/acts- adopted-basis-regulatory-procedure-scrutiny-rps_en

The condensed consolidated financial statements were prepared in accordance with the accounting principles and methods used by the Group for the 2019 financial statements and described in note 2 to consolidated financial statements for the year ended December 31, 2019. Furthermore, the condensed consolidated financial statements were prepared in compliance with other standards and interpretations in force as of January 1, 2020, described below.

Changes in accounting policies

In the current year, the Group has applied a number of amendments to IFRS Standards and Interpretations issued by the IASB that are effective for an annual period that begins on or after January 1, 2020. Their adoption has not had any material impact on the disclosures or on the amounts reported in these financial statements.

Amendments to IFRS 3

Definition of a business

Conceptual Framework

Amendments to References to the Conceptual Framework in IFRS Standards

Amendments to IAS 1 and IAS 8

Definition of material

Amendments to IFRS 9, IAS 39 et IFRS 7

Interest rates (IBOR)

10 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

At the date of authorisation of these financial statements, the Group has not applied the following new and revised IFRS

Standards that have been issued but are not yet effective and in some cases had not yet been adopted by the EU:

IFRS 17

Insurance Contracts

The directors do not expect that the adoption of the Standards listed above will have a material impact on the financial statements of the Group in future periods.

3.3 Consolidation scope and methods

On April 28, 2017 the Group incorporated GenSight Biologics Inc. in the United States. As 100% of the voting rights and ownership interests are held by the Group, GenSight Biologics Inc. is fully consolidated.

3.4 Going-concern

Since its incorporation, the Company has funded its activities through several equity financings, grants, conditional advances and Research Tax Credit. Since the end of 2019, the Company started to generate revenues from the sale of LUMEVOQ® (GS010), since the National Drug Safety Agency (ANSM) granted a number of named patient Temporary Authorizations for Use ("ATU nominative") for LUMEVOQ®. To date Management expects operating losses to continue for the foreseeable future. The Company continues to actively prepare for the launch of LUMEVOQ® in Europe in Q4 2021 and in the United States in 2022, if approved by regulatory authorities.

As of June 30, 2020, the level of consolidated Cash and Cash equivalent amounted to €16.8 million.

As described in Note 24 related to subsequent events, the Company received in July 2020 the remaining €2.1 million from Bpifrance related to the PGE (State-backed loan) and an additional conditional advance in July 2020 from Bpifrance for an amount of €1.1 million.

In addition, and as mentioned in Note 24, the Company has amended certain terms and conditions of the bond agreement with Kreos Capital and intend to draw down the second tranche of €4 million before July 31, 2020.

Further to this, the Company expects to continue to generate revenues with ATUs going forward and prior to a possible commercial launch in Europe in Q4 2021.

Based on these assumptions, the Company has sufficient net working capital to meet its obligations until mid-2021. However, in the event of an escalation or rebound of the COVID-19 pandemic in France, the Company may face uncertainties regarding its ability to be granted expected ATUs and therefore to generate related revenues.

The condensed half-year consolidated financial statements have been prepared on a going concern basis assuming that the Company will either be successful in its additional financing assumptions or that the Company will modify its operating plans, in particular by delaying or limiting the scope of its research and development programs. However, no assurance can be given at this time as to whether the Company will be able to achieve these financing objectives, particularly in relation to the revenues from ATUs.

3.5 Use of estimates

In the course of preparing its interim financial statements, GenSight Biologics' management made estimates, judgments and assumptions impacting the application of accounting principles and methods as well as the carrying value of assets and liabilities and income and expense items. The main sources of uncertainty with respect to key estimates and judgments made were identical to those applied in the consolidated financial statements for the year ended December 31, 2019, except regarding the following: The issue which had been raised with one of our key suppliers with which contractual relationship ended during 2019 has been resolved. The amount booked as a liability corresponds to the amount due to the supplier and is no longer an estimate.

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 11

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Note 4: Intangible assets

The intangible assets are broken down as follows:

As of December 31,

As of June 30,

In thousands of euros

2019

2020

Patents, licenses, trademarks

275

275

Software

18

18

Total historical cost

293

293

Accumulated amort. of patents, licenses and trademarks

127

135

Accumulated depreciation of software packages

12

14

Accumulated amortization and depreciation

139

149

Net total

154

144

An intangible asset was recognized at December 31, 2013 as a

€0.41 per ordinary share, issued as consideration for the

result of the license agreement signed with Novartis. The initial

license. There has been no recognition of impairment losses

recognition cost amounted to €275 K and was determined

in application of IAS 36 Impairment of Assets over the periods

by reference to the fair value of the 670,588 ordinary shares,

presented.

Note 5: Property, plant and equipment

Changes in PPE gross book values and accumulated depreciation for the full year 2019 are presented in the following table:

As previously

IFRS 16

Increase

Decrease

Currency

As of

reported at

impact

translation

December 31,

In thousands of euros

December 31,

adjustment

2019

2018

Technical equipment and installations

586

-

27

-

2

615

IFRS 16 - Right-of-use - Building

-

3,653

-

-

44

3,696

Leasehold improvement

976

-

2

-

6

984

Office and computer equipment

172

-

31

-

-

203

IFRS 16 - Right-of-use - Others

-

19

-

-

-

19

Furniture

495

-

8

-

3

507

Total gross property, plant and equipment

2,229

3,672

69

-

55

6,025

Accumulated depreciation of technical

227

-

102

-

-

329

equipment and installations

IFRS 16 - Right-of-usee - Building

-

612

-

-

(1)

611

Accumulated depreciation of leasehold

248

-

110

-

-

358

improvement

Accumulated depreciation of office and

124

-

36

-

-

161

computer equipment

IFRS 16 - Right-of-use - Others

-

9

-

-

-

9

Accumulated depreciation of furniture

234

-

96

-

-

330

Total accumulated depreciation

833

621

344

-

(1)

1,797

Total net property, plant and equipment

1,396

3,051

(274)

-

54

4,228

12 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Changes in PPE gross book values and accumulated depreciation as of June 30, 2020 are presented in the following table:

As at

Increase

Decrease

Currency

As of June 30,

In thousands of euros

December 31,

translation

2020

2019

adjustment

Technical equipment and installations

615

2

-

-

618

IFRS 16 - Right-of-use - Building

3,696

-

-

7

3,704

Leasehold improvement

984

-

-

1

985

Office and computer equipment

203

-

-

-

203

IFRS 16 - Right-of-use - Others

19

-

-

-

19

Furniture

507

-

-

1

508

Total gross property, plant and equipment

6,025

2

-

9

6,037

Accumulated depreciation of technical equipment and

329

47

-

-

375

installations

IFRS 16 - Right-of-usee - Building

611

309

-

2

918

Accumulated depreciation of leasehold improvement

358

55

-

-

413

Accumulated depreciation of office and computer

161

16

-

-

177

equipment

IFRS 16 - Right-of-use - Others

9

4

-

-

13

Accumulated depreciation of furniture

330

39

-

-

369

Total accumulated depreciation

1,797

470

-

2

2,265

Total net property, plant and equipment

4,228

(468)

-

11

3,772

Note 6: IFRS 16 - Leases

The main impacts on the balance sheet and the income statement resulting from the application of the IFRS 16 standard as of June 30, 2020 are the following:

Balance sheet

Right-of-use

As of December 31,

New contracts

Amortization

Currency

As of June 30,

2019

translation

2020

adjustment

Right-of-use - Buildings

3,085

-

(309)

9

2,785

Right-of-use - Others

11

-

(4)

-

7

Net value of the righ-of-use

3,096

-

(313)

9

2,792

(1) The weighted average marginal debt ratio used to value the lease debts at the date of transition is 5.0%.

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 13

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Lease liability

As of December 31,

New

Repayments

Currency

Change

As of June 30,

2019

contracts

translation

2020

adjustment

Lease liability - Buildings

2,763

-

-

9

(299)

2,473

Lease liability - Others

-

-

-

-

-

-

Total

2,763

-

-

9

(299)

2,473

Lease liability - Buildings

552

-

(277)

1

299

575

Lease liability - Others

11

-

(4)

-

-

7

Total current

563

-

(281)

1

299

582

Total

3,326

-

(281)

10

-

3,055

The interests on lease financing amounted to €81K during the first half of 2020.

Note 7: Other non-current financial assets

The non-current financial assets correspond to the deposits paid to the lessor for the registered offices of the Group in Paris and New York.

Note 8: Other current assets

The other current assets are broken down as follows:

As of December 31,

As of June 30,

In thousands of euros

2019

2020

Prepayments

135

121

Research tax credit

4,242

2,296

Other taxes receivable

1,019

1,032

Liquidity contract

273

323

Prepaid expenses

2,000

1,898

Other Trade Receivables

-

398

Total

7,669

6,068

Other taxes receivable essentially refers to VAT receivables.

Research Tax Credit

As of June 30, 2020, prepaid expenses were primarily

The following table shows the changes in the Research Tax

manufacturing costs, rental, scientific collaborations and travel

Credit during the six-month period ended June 30, 2020:

expenses.

Amounts in K€

Other Trade Receivables include a €282 K subsidy to be received from Bpifrance Financement, related to Sight Again contract, as well as €108 K to be received related to the sublease of our New York premises. The €282 K were received on July 7, 2020.

Opening balance sheet receivable

4,242

as of January 1, 2020

Other operating income

2,296

Payment received

4,242

Closing balance sheet receivable

2,296

as of June 30, 2020

14 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Note 9: Cash and cash equivalents

Cash and cash equivalents items are broken down as follows:

As of December 31,

As of June 30,

In thousands of euros

2019

2020

Cash

19,250

16,831

Cash equivalents

-

-

Total cash and cash equivalent as reported in the statements of financial

19,250

16,831

position

Bank overdrafts

-

-

Total net cash and cash equivalents as reported in the statements of cash flows

19,250

16,831

The Group does not hold any short-term investment and all of its cash balances are cash at hand deposits with high-credit quality financial institutions.

Note 10: Capital

The share capital as of June 30, 2020 amounts to €820,684.05. It is divided into 32,827,362 fully authorized, subscribed and paid-up ordinary shares with a nominal value of €0.025.

As of June 30, 2020, the Company held 99,079 treasury shares for an amount of €284,356.73.

Note 11: Financial liabilities

11.1 Bond financing

In December 2019, GenSight Biologics obtained committed financing in the form of a bond financing of up to €12 million from Kreos Capital VI (UK) Limited and issued a drawdown notice thereunder for the first tranche of €6 million, including a €4.2 million straight bond issuance and a €1.8 million convertible bonds issuance.

The financial transaction is structured as follows:

  • a capital increase for a total amount of €9 million representing 3,799,071 new shares subscribed for €4 million by Sofinnova Crossover I and for €5 million by Strategic International Group Limited, a wholly owned subsidiary of 3SBio Inc. (the "3SBio-Sofinnova Transaction"); and
  • subject to the realization of the 3SBio-Sofinnova Transaction described above, a bond issuance for a maximum amount of €10 million divided in 2 tranches as follows:
    • a first tranche (the "Tranche A") in the form of:
      • a bond issuance subscribed by Kreos Capital VI (UK) Limited for an amount of €6 million including €1.8 million subscribed by Kreos Capital VI (Expert Fund) LP in the form of convertible bonds, and
      • a concurrent issuance of share warrants for an amount the potential exercise of which would represent €1.2 million subscribed by Kreos LP; and
  • a second tranche, exercisable, subject to the realization of a Qualifying Financing, at the Company's option until September 1, 2020, in the form of:
    • a bond issuance subscribed by Kreos UK for an amount of €4 million including a maximum amount of €1.2 million susceptible to be subscribed at its election by Kreos LP in the form of convertible bonds, and
    • a concurrent issuance of share warrants for an amount the potential exercise of which would represent €300 K.

The Company has the option to issue additional bonds similar to the bonds described above (assimilables) to Kreos UK for an amount of €2 million.

The convertible loan notes were issued on December 19, 2019 at an issue price of €2.245 per note. The notes are convertible into ordinary shares of the Company at any time between the date of issue of the notes and their settlement date. On issue, the loan notes were convertible at a ratio of 1/2.245 shares per 1 convertible note. The conversion price is at a 10% discount to the volume weighted average share price of the ordinary shares for the 3 days period prior to the Board Meeting date, ie. December 16, 17 and 18, 2019.

If the notes have not been converted, they will be redeemed on May 1, 2023 at par. Interest of 9.25% per cent will be paid annually up until that settlement date.

11.2 Borrowings from Banks

GenSight Biologics has contracted over the period presented

  • €6.8 million non-dilutive loan from a bank syndicate formed with Crédit Industriel et Commercial (CIC), BNP Paribas and BPIfrance, in the form of a state-guaranteed loan (Prêt Garanti par l'État). As of June 2020, we have received the funds from CIC and BNP Paribas for €2.5 million and €2.1 million, respectively. The remaining €2.1 million were received from BPIfrance on July 10, 2020.

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 15

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

11.3 Conditional advances

The table below presents the changes in conditional advances that occurred during the presented periods:

In thousands of euros

Balance as of January 1, 2019

3,441

Receipts

-

Repayments

-

Accrued interest

191

Other

-

Balance as of December 31, 2019

3,633

Non-current portion

3,633

Current portion

-

11.4 Maturity dates

In thousands of euros

Balance as of January 1, 2020

3,633

Receipts

-

Repayments

-

Accrued interest

99

Other

-

Balance as of June 30, 2020

3,732

Non-current portion

3,732

Current portion

-

Maturity dates of financial liabilities as of December 31, 2019 are as follows:

In thousands of euros

Gross amount

Less than one year

One to five years

More than five years

Conditional advances

3,633

-

3,050

583

Corporate bonds

4,621

889

3,732

-

Lease Liability

3,326

563

2,340

423

Total financial liabilities

11,580

1,452

9,122

1,006

Maturity dates of financial liabilities as of June 30, 2020 are as follows:

In thousands of euros

Gross amount

Less than one year

One to five years

More than five years

Conditional advances

3,732

-

3,303

429

Corporate bonds

4,615

1,469

3,146

-

Borrowings from Banks

4,625

-

4,625

-

Lease Liability

3,055

582

2,449

24

Other financial liabilities

325

-

325

-

Total financial liabilities

16,352

2,051

13,848

453

Note 12: Account payables and other current liabilities

12.1 Account payables and related payables

With respect to accounts payable and related payables, no discounting effect has been recognized to the extent that

amounts did not represent payables on terms longer than one year at the end of each period presented.

Maturity dates of accounts payables as of June 30, 2020 are as follows:

In thousands of euros

Gross amount

Less than one year

One to five years

More than five years

Trade accounts payable

8,745

8,745

-

-

16 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

12.2 Other current liabilities

The following table provides the detail of other current liabilities for the presented periods:

In thousands of euros Employee-related payable Other taxes liabilities Deferred revenue Other current liabilities

Total

As of December 31,

As of June 30,

2019

2020

1,265

1,869

625

483

-

36

3

-

1,893

2,388

Note 13: Financial instruments recognized in the consolidated statements of financial position and related effect on the consolidated statement of income (loss)

The nature of the financial instruments as at December 31, 2019 and June 30, 2020 is as follows:

Book value on

Fair value

At amortized

Fair Value

In thousands of euros

the statement of

through profit

cost(2)

financial position

and loss(1)

As of December 31, 2019

Financial assets

Non-current financial assets

336

-

336

336

Current financial assets

273

273

-

273

Accounts receivable and related receivables

846

-

846

846

Cash and cash equivalents

19,250

-

19,250

19,250

Total financial assets

20,705

273

20,432

20,705

Financial liabilities

Bond financing

4,621

-

4,621

4,621

Conditional advances

3,633

-

3,633

3,633

Lease liability - Buildings

3,315

-

3,315

3,315

Lease liability - Others

11

-

11

11

Accounts payable and related payables

7,139

-

7,139

7,139

Total financial liabilities

18,719

-

18,719

18,719

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 17

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Book value on

Fair value

At amortized

Fair Value

In thousands of euros

the statement of

through profit

cost(2)

financial position

and loss(1)

As of June 30, 2020

Financial assets

Non-current financial assets

338

-

338

338

Current financial assets

322

322

-

322

Accounts receivable and related receivables

2

-

2

2

Other trade receivables

396

-

396

396

Cash and cash equivalents

16,831

-

16,831

16,831

Total financial assets

17,889

322

17,567

17,889

Financial liabilities

Bond financing

4,615

-

4,615

4,615

Conditional advances

3,732

-

3,732

3,732

Borrowings from banks

4,625

-

4,625

4,625

Lease liability - Buildings

3,048

-

3,048

3,048

Lease liability - Others

7

-

7

7

Other financial liabilities

325

-

325

325

Accounts payable and related payables

8,745

-

8,745

8,745

Total financial liabilities

25,097

-

25,097

25,097

  1. The fair value of financial assets classified as fair value through profit and loss corresponds to the market value of the assets.
  2. The book amount of financial liabilities measured at amortized cost was deemed to be a reasonable estimation of fair value.

Note 14: Income

Total income as of June 30, 2020 solely comes from the second named patient Temporary Authorization for Use ("ATU nominative") for LUMEVOQ™ (GS010) granted by the National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM) to the CHNO of the Quinze-Vingts in January 2020. The price per patient was set at €700 K by the Group (€350 K per eye).

Should our commercial price set at a lower price than the one used for the ATU, the Company will have to reimburses the Health Insurance for the overpayment received during the ATU phase.

18 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Note 15: Other income

Other income is detailed in the table below:

As of June 30,

In thousands of euros

2019

2020

Research tax credit

2,466

2,296

Subsidies

-

282

Total

2,466

2,578

Note 16: Operating expenses

16.1 Research and development expenses

The table below shows the breakdown of research and development expenses by cost nature for the periods presented:

As of June 30,

In thousands of euros

2019

2020

Personnel expenses(1)

2,347

2,017

Sub-contracting, collaboration

12,257

9,004

and consultants

Licensing and intellectual

191

150

property

Offices cost

534

15

Travel and entertainment

366

204

expenses

Depreciation and amortization

404

208

expense

Other

7

366

Total R&D expenses

16,105

11,964

  1. Includes €608 K and €468 K related to share-based compensation expense as of June 30, 2019 and 2020 respectively.

16.2 General and administrative expenses

The table below shows the breakdown of general and administrative expenses by cost nature for the periods presented:

As of June 30,

In thousands of euros

2019

2020

Personnel expenses(1)

1,419

2,706

Professional Fees

593

604

Communication and travel

404

301

expenses

Offices cost

37

(83)

Office furniture and small

59

39

equipment

Postal and telecommunication

9

7

expenses

Depreciation and amortization

133

216

expense

Attendance fees

82

105

Insurance

24

23

Others

353

67

Total G&A expenses

3,113

3,985

  1. Includes €370 K and €1,272 K related to share-based compensation expense as of June 30, 2019 and 2020 respectively.

16.3 Sales and Marketing expenses

The table below shows the breakdown of sales and marketing expenses by cost nature for the periods presented:

As of June 30,

In thousands of euros

2019

2020

Personnel expenses(1)

227

225

Professional Fees

110

499

Communication and travel

40

7

expenses

Offices cost

6

62

Depreciation and amortization

18

56

expense

Others

10

95

Total S&M expenses

411

944

  1. Includes €93 K and €49K related to share-based compensation expense as of June 30, 2019 and 2020, respectively.

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 19

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

16.4 Personnel expenses

The Group was employing 25 people on permanent contract as of June 30, 2020 compared with 28 as of June 30, 2019. The following table shows the nature of costs included in personnel expenses:

As of June 30, 2019

As of June 30, 2020

In thousands of euros

R&D

G&A

S&M

TOTAL

R&D

G&A

S&M

TOTAL

Wages and salaries

1,301

779

110

2,190

941

745

108

1,793

Social contributions

301

186

7

494

487

613

52

1,151

Service cost (employee benefit)

128

81

16

225

109

73

15

197

Pensions - IAS 19 Service cost

9

3

1

13

13

3

2

18

Share-based payments

608

370

93

1,071

468

1,272

49

1,789

Total

2,347

1,419

227

3,993

2,017

2,706

225

4,948

Note 17: Share-based payments

The Board of Directors has been authorized by the general meeting of the shareholders to grant employee warrants (Bons de Souscription de Parts de Créateur d'Entreprise or "BCE"), non- employee warrants (Bons de Souscription d'Actions or "BSA") and performance shares (Attributions Gratuites d'Actions or "AGA").

17.1 Employee warrants (BCE)

Details regarding the main characteristics of employee warrants (BCE), non-employee warrants (BSA), performance shares (AGA), and stock options (SO) granted before January 1, 2020 are presented in Note 18 of the 2019 Consolidated Financial Statements.

Changes in the balances of employee warrants (BCE) are as follows during the period:

BCE 2013-02

BCE 2014-06

BCE 2015-06

Total

Balance outstanding at January 1, 2020

123,720

60,000

482,582

666,302

Granted during the period

-

-

-

-

Exercised during the period

-

-

-

-

Forfeited during the period

-

-

-

-

Balance outstanding at June 30, 2020

123,720

60,000

482,582

666,302

Of which exercisable

123,720

60,000

482,582

666,302

17.2 Non-employee warrants (BSA)

With the authorization of the General Meeting of Shareholders on June 11, 2019, the Board of Directors granted 40,000 BSA 2020 have been granted on January 28, 2020 and may be exercised by the beneficiary on the basis of the following vesting schedule:

• up to 1/4 on the date of the grant

  • the remaining 75% becoming exercisable up to 1/36 per month from the date of grant; and
  • at the latest within 7 years from the date of grant.

20 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Changes in the balances of the non-employee warrants (BSA) are as follows during the period:

BSA 2013-02

BSA 2015-06

BSA 2016

BSA 2017

BSA 2018

BSA 2019

BSA 2020

Total

Balance outstanding

293,040

121,000

158,000

165,000

20,000

105,000

-

862,040

at January 1, 2020

Granted during the

-

-

-

-

-

-

40,000

40,000

period

Exercised during the

-

-

-

-

-

-

-

-

period

Forfeited during the

-

-

-

-

-

-

-

-

period

Balance outstanding

293,040

121,000

158,000

165,000

20,000

105,000

40,000

902,040

at June 30, 2020

Of which exercisable

293,040

121,000

158,000

161,563

13,750

46,250

14,167

807,769

17.3 Free shares (AGA)

With the authorization of the General Meeting of Shareholders on April 12, 2018, the Board of Directors granted 1,020,000 free shares (AGA 2018) on January 28, 2020:

  • 567,500 AGA 2018 may be fully acquired by Key Managers, including Mr. Gilly, subject to (i) a one year acquisition period from the date of grant and (ii) achievement of the performance criteria described below no later than January 28, 2022:
    • 283,750 of these free shares will be acquired upon the approval with the European Medicines Agency (EMA) of the application for market authorization (MA) at the European level of the LUMEVOQ® (GS010);
    • 283,750 of these free shares will be acquired upon the filing with the Food and Drug Administration (FDA) of the

application for Biologics License Application (BLA) for the LUMEVOQ® (GS010).

  • 452,500 AGA 2018 will be fully acquired on January 28, 2021 (one year after their grant date).

Changes in the balances of free shares (AGA) are as follows during the period:

AGA 2018

Balance outstanding at January 1, 2020

1,005,000

Granted during the period

1,020,000

Vested during the period

-

Forfeited during the period

(115,000)

Balance outstanding at June 30, 2020

1,910,000

17.4 Reconciliation with P&L share-based expenses

As of June 30, 2019

As of June 30, 2020

In thousands of euros

R&D

G&A

S&M

TOTAL

R&D

G&A

S&M

TOTAL

Non-Employee Warrants (BSA)

14

28

-

41

58

28

-

85

Employee Warrants (BCE)

(41)

18

-

(22)

-

-

-

-

Performance Shares (AGA)

420

318

93

831

282

699

49

1,030

Free Share (AGA)

42

4

-

45

128

546

-

674

Stock Options (SO)

173

3

-

176

-

-

-

-

Share-based payments

608

370

93

1,071

468

1,272

49

1,789

expense

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 21

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

Note 18: Financial income and expenses

The financial income and expenses are broken down as follows:

As of June 30,

In thousands of euros

2019

2020

Foreign exchange gains

41

70

Other

-

-

Financial income

41

70

Foreign exchange losses

(78)

(81)

Accrued interests

(94)

(99)

Amortized cost (Effective

-

(272)

Interest Method)

Finance cost on employee

(1)

-

benefits

Interest expenses from Leases

(47)

(81)

Other

-

-

Financial expenses

(220)

(533)

Financial income (loss)

(179)

(463)

Foreign exchange gains and losses primarily arise from the purchase of services labeled in U.S. dollars.

The accrued interests on conditional advances received from Bpifrance Financement. have been calculated on the basis of a rate of 5.56%/year.

Interest expenses from Leases reflect interest on the lease liability deriving from the first application of IFRS 16 new standard.

Amortized costs (Effective Interest Method) reflect the interests paid on the bonds financing contracted with Kreos Capital in December 2019.

Note 19: Income tax

Taking into account its stage of development which prevents management from making sufficiently financial forecasts, the Group does not recognize deferred tax assets.

Taking into account the tax regulations, the Company had tax losses to be carried forward with no time limit for a total amount of €144 million at December 31, 2019.

Note 20: Commitments and contingent liabilities

Commitments existing as of December 31, 2019 have not changed significantly at the end of the reporting period.

Note 21: Relationships with related parties

The Group did not conclude any new significant transactions with related parties during the period.

Note 22: Earnings per share

The basic earnings per share is calculated by dividing the net income for the period attributable to the shareholders of the Company by the weighted average number of common shares outstanding during the period. All outstanding ordinary shares have been taken into consideration for purposes of calculating basic earnings per share. The weighted average number of shares was 27,590,756 and 32,827,362 in June 2019 and June 2020 respectively.

The diluted earnings per share is calculated by dividing the net income for the period attributable to shareholders of the Company by the weighted average number of shares outstanding plus any potentially dilutive shares not yet issued from share-based compensation plans (see Note 17).

Dilution is defined as a reduction of earnings per share or an increase of loss per share. When the exercise of outstanding share options and warrants decreases loss per share, they are considered to be anti-dilutive and excluded from the calculation of loss per share. Thus, basic and diluted earnings (loss) per share are equal as all equity instruments issued, representing 4,814,644 potential additional ordinary shares, have been considered anti-dilutive.

As of June 30,

In thousands of euros

2019

2020

Net income (loss) of the reporting period

(17,344)

(14,078)

Adjusted weighted average number of outstanding shares

27,590,756

32,827,362

Basic and diluted earnings (loss) per share in euros

(0.63)

(0.43)

Note 23: Management of financial risks

Note 24: Subsequent events

The assessment of risks has not substantially changed since the Company filed its 2019 Universal Registration Document. The document is available on the company's website:

ht t ps://w w w. gensight - biologic s . com/wp - content / uploads/2020/04/GENSIGHT_URD_2019_VA_vDEF.pdf

GenSight Biologics has obtained a €6.8 million non-dilutive loan from a bank syndicate formed with Crédit Industriel et Commercial (CIC), BNP Paribas and BPIfrance, in the form of a state-guaranteed loan (Prêt Garanti par l'État). As of June 30, 2020, we have received the funds from CIC and BNP Paribas

22 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS

for €2,5 million and €2.1 million, respectively. The remaining €2.1 million were received from BPIfrance on July 10, 2020.

In parallel with this financing, GenSight has amended certain terms and conditions of the bond agreement with Kreos Capital which was announced by the Company on December 20, 2019 and which included two main tranches (the "Kreos Transaction"). The first tranche of €6 million in straight and convertible bonds was drawn in December 2019 ("Tranche A"). The second tranche of €4 million in straight and convertible bonds was available to be drawn through September 2020, conditioned on GenSight obtaining a qualifying financing ("Tranche B"). Following the grant of the PGE and the amount of revenues anticipated to be generated from Autorisations Temporaires d'Utilisation payantes ("ATUs"), the parties have agreed that Tranche B may be drawn in the coming weeks under more flexible conditions and no longer conditioned to the initial qualifying financing. Although the total amount of €4 million for Tranche B remains unchanged, the proportion between straight bonds and convertible bonds has been amended to include additional convertible bonds B and fewer straight bonds B, as further described below. Kreos also agreed to extend the interest-only period to December 2020. The Kreos Transaction

also provided for a possible third tranche of €2 million which could be made available at a later date.

The Company and Bpifrance Financement have had recent discussions to debate over the possibility to consider the expenses in the scope of the Sight Again project raised by the Company until the end of November 2019; i.e. the original date of expiration of the contract. The Company has been informed by Bpifrance Financement on July 2, 2020 that they agreed to cover for the expenses raised during the 3rd and 4th key step with an additional conditional advance of €1,139 K, which have been received on July 7, 2020.

In addition, it has also been decided that the beneficiary contract would be amended, notably with the following conditions:

  • the repayment schedule will be delayed by 2 years, therefore, the first repayment deadline is now June 30, 2024 instead of June 30, 2022.
  • Implementation of a minimum reimbursement of €819 K, representing 20% of the total conditional advances received by the Company.

The updated contract has not been received by the Company yet.

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 23

ACTIVITY REPORT

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 25

ACTIVITY REPORT

Preliminary remarks

This activity report discussed hereafter the main operations of GenSight Biologics as of June 30, 2020.

The interim condensed financial statements the Company as of June 30, 2020 have been prepared by the Management as a going concern regarding assumptions and hypothesis mentioned in the Note 3.4 "Going concern" of the interim condensed consolidated financial statements.

A. OPERATING INCOME

Our operating income consists of revenues and other income.

Income

As described in our Press Release relating to the update on our operations in the context of COVID-19 released on April 6, 2020, a second patient has been treated under a Temporary Authorization for Use (ATU) granted by the French National Drug Safety Agency early 2020. However, the COVID-19 situation has delayed the review and approval by the ANSM of the additional ATU's requested before the lockdown, and therefore, no additional patient could be treated before the end of the semester.

The Company still considers that, within the current situation, it will be able to overcome this delay and does not expect any impact on the related revenues for 2020.

Income as of June 30, 2020 therefore solely comes from the named patient Temporary Authorization for Use ("ATU nominative") for LUMEVOQ® (GS010) granted by the National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM) to the CHNO of the Quinze-Vingts early 2020. The price per patient was set at €700K by the Group (€350K per eye).

Other income

The other income is composed of research tax credit, as well as a subsidy from BpiFrance related to the "Sight Again" contract.

Research Tax Credit

The expenditures taken into account for the calculation of the credit tax research only involve research expenses.

This credit meets the definition of a government grant as defined in IAS 20 Accounting for Government Grants and Disclosure of Government Assistance. As no research and development expenditure is capitalized before obtaining a marketing authorization, this credit related to a research program is entirely recorded as operating income.

We have requested the reimbursement of the 2019 Research tax credit in the amount of €4,242 K which has been received in May 2020.

Subsidy

In addition to the conditional advance mentioned in Note 24 of our condensed half-year consolidated financial statements, the Company has recognized a non-refundable subsidy from Bpifrance Financement in connection with its development its product candidate using its optogenetics technology platform, GS030.

As of June 30,

In thousands of euros

2019

2020

Research tax credit

2,466

2,296

Subsidies

-

282

Total

2,466

2,578

B. OPERATING EXPENSES

1. Research and Development

Our research and development expenses consist principally of external costs, such as manufacturing expenses, startup fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical studies, costs related to acquiring and manufacturing clinical study materials and costs related to collaborations.

As of June 30,

In thousands of euros

2019

2020

Personnel expenses(1)

2,347

2,017

Sub-contracting, collaboration

12,257

9,004

and consultants

Licensing and intellectual

191

150

property

Offices cost

534

15

Travel and entertainment

366

204

expenses

Depreciation and amortization

404

208

expense

Other

7

366

Total R&D expenses

16,105

11,964

  1. Includes €608 K and €468 K related to share-based compensation expense as of June 30, 2019 and 2020 respectively.

From the first half of 2019 to the first half of 2020, the total amount spent by the group for research and development

26 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

ACTIVITY REPORT

activity strongly decreased from €16,105 K to €11,964 K, or a decrease of 25.7%. The drop has been primarily driven by:

  • a €330K decrease in personnel expenses, coming from a €140K decrease in share-based compensation expense and the decrease of the headcount dedicated to Research and Development, from 21 to 18 in June 2019 and June 2020, respectively.
  • a €2.4 million decrease in Chemistry Manufacturing and Control costs, mainly related to LUMEVOQ® (GS010) whose the majority of costs related to the preparation for the Marketing approval has been spent in 2019.
  • a €1.3 million decrease in clinical trials, mainly related to mainly related to the end of Rescue and Reverse trials, as well as our Reflect trial for which several key milestones were achieved during the first semester of 2019 and whose last patient has been treated on July 2, 2019, therefore, there has been fewer patient follow-up visits and related costs during the first semester of 2020.
  • a €0.6 million decrease in device engineering, related to the design and manufacturing costs of the Goggles for the Pioneer trial of GS030. This decrease is explained by the strategical decision of the Company to mainly focus its

resources on the preparation of the Marketing Approval for LUMEVOQ® (GS010).

All the decreases described above have been partially offset by a rise of €0.5 million in Regulatory and Quality services expenses. This inflation derives from the consulting costs involved by the preparation of the filling with the EMA planned for Q3 of this year.

2. General and Administrative

Our general and administrative expenses consist primarily of salaries and related costs for personnel and travel expenses for our employees in executive, operational, finance, legal and human resources functions, facility-related costs, as well as audit, legal, regulatory and tax-related services associated with maintaining compliance with Euronext Paris listing and AMF requirements, director and officer insurance premiums, and corporate communications and investor relations costs.

During the period presented, our general and administrative expenses increased from €3,113 K as of June 30, 2019, to €3,985 K as of June 30, 2020.

Our general and administrative expenses are broken down as follows:

As of June 30,

In thousands of euros

2019

2020

Personnel expenses(1)

1,419

2,706

Professional Fees

593

604

Communication and travel expenses

404

301

Offices cost

37

(83)

Office furniture and small equipment

59

39

Postal and telecommunication expenses

9

7

Depreciation and amortization expense

133

216

Attendance fees

82

105

Insurance

24

23

Others

353

67

Total G&A expenses

3,113

3,985

(1) Includes €370 K and €1,272 K related to share-based compensation expense as of June 30, 2019 and 2020 respectively.

The increase in our general and administrative expenses (28% or €0.9 million) from year to year mainly results from the increase of €0.9 million in share-based compensation.

3. Sales and Marketing

Sales and marketing expenses consist primarily of professional fees, communication and branding fees and personnel costs.

If and when we believe that regulatory approval of the first product candidate appears likely, we anticipate an increase in payroll and related expenses as a result of our preparation for commercial operations.

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 27

ACTIVITY REPORT

As of June 30,

In thousands of euros

2019

2020

Personnel expenses(1)

227

225

Professional Fees

110

499

Communication and travel

40

7

expenses

Offices cost

6

62

Depreciation and amortization

18

56

expense

Others

10

95

Total S&M expenses

411

944

  1. Includes €93 K and €49K related to share-based compensation expense as of June 30, 2019 and 2020, respectively.

During the period presented, our sales and marketing expenses strongly increased from €411 K as of June 30, 2019, to €943 K as of June 30, 2020.

The increase primarily derives from the professional fees. The Group has initiated the deployment of its pre-launch roadmap activities for LUMEVOQ® (GS010), mainly focused on our commercial model as well as payer landscape analysis.

C. FINANCIAL LOSS

Our net financial loss increased to €(463) K as of June 30, 2020 from €(179) K as of June 30, 2019. Our financial expenses increased from €220 K to €533 K. The significant increase is primarily due to interest paid on the bond financing contracted with Kreos Capital in December 2019 for €272 K.

D. NET LOSS

The net loss amounts to €14,078 K as of June 30, 2020 from €17,344 K as of June 30, 2019. The basic and diluted loss per share (calculated with the adjusted weighted average number of outstanding shares during the period) amounted to €0.63 and €0.43 as of June 30, 2019 and 2020 respectively.

F. CURRENT ASSETS

Current assets amounted to €27,765 K as of December 31, 2019 and €22,899 K as of June 30, 2020. The decrease is essentially due to the usage of cash and cash equivalents during the first half of 2020, as well as the decrease of the Research Tax Credit receivable, whose reimbursement for the full year 2019 amount have been received as of the date of the present report.

G. CHANGES IN SHAREHOLDER'S EQUITY

The changes in shareholder's equity are primarily due to the losses of the half-year period. Thus, shareholder's equity amounted to €11,746 K as of December 31, 2019 and €(453) K as of June 30, 2020.

H. ANALYSIS OF CASH FLOW

As of June 30,

In thousands of euros

2019

2020

Net cash flows from operating

(19,464)

(6,734)

activities

Net cash flows from

98

(52)

investment activities

Net cash flows from financing

7,380

4,377

activities

The net cash flows from operating activities as of June 2020 amount to €(6.7) million and €(19.5) million as of June 2019. The significant change is explained by both the increase in the net result, from €(17,354) K as of June 2019 to €(14,078) K as of June 2020, mainly deriving from the increase in revenue and the strong decrease in R&D expenses; as well as the change in working capital related to operating activities (from a decrease of €3.9 million in June 2019 to an increase of €4.6 million in June 2020). The increase of the change in trade working capital observed during the first half of the year is mainly explained by the reimbursement of the Credit Tax Research in May 2020, the increase of the trade payables over the period and decrease of the account receivables.

E. NON-CURRENT ASSETS

Non-current assets are composed of intangible, tangible assets and non-current financial assets. They decreased over the period from €4,718 K as of December 31, 2019 to €4,254 K as of June 30, 2020, primarily from the amortization expense of the period.

The negative cash flows from investment activities are due to the acquisition of own shares as part of the liquidity contract.

The positive cash flows from financing activities are mainly due to the state-guaranteed loan (Prêt Garanti par l'État or PGE) obtained, of which €4,625 K have been received as of June 2020.

28 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

TRANSACTIONS BETWEEN RELATED PARTIES

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 29

TRANSACTIONS BETWEEN RELATED PARTIES

The Group did not conclude any new significant transactions with related parties during the period.

30 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

RISK FACTORS

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 31

RISK FACTORS

Risk factors are similar to those presented in the section 3 of the 2019 Universal Registration Document (pages 14 to 37) and did not change significantly during the first half-year of 2020.

This document is available on the Company's website: www.gensight-biologics.com.

32 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

STATUTORY AUDITORS' REVIEW REPORT ON THE 2020 HALF-YEAR FINANCIAL INFORMATION

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 33

STATUTORY AUDITORS' REVIEW REPORT ON THE 2020 HALF-YEAR FINANCIAL INFORMATION

BECOUZE

Deloitte & Associés

34, rue de Liège

6, place de la Pyramide

75008 Paris

92908 Paris La Défense cedex

S.A.S. au capital de 309 700 €

S.A.S. au capital de 2 188 160 €

323 470 427 RCS Angers

572 028 041 RCS Nanterre

GenSight Biologics

Société Anonyme

74, rue du faubourg Saint-Antoine

75012 PARIS

STATUTORY AUDITORS' REVIEW REPORT ON THE HALF-YEARLY FINANCIAL INFORMATION

Period from January 1 to June 30, 2020 To the Shareholders,

In compliance with the assignment entrusted to us by your bylaws and your Shareholders' Meeting and in accordance with the requirements of article L.451-1-2-III of the French Monetary and Financial Code ("code monétaire et financier"), we hereby report to you on:

  • the review of the accompanying condensed half-yearly consolidated financial statements of GenSight Biologics, for the period from January 1 to June 30, 2020,
  • the verification of the information presented in the half-yearly management report.

These half-year condensed consolidated financial statements were prepared under the responsibility of the Board of Directors on July 29, 2020 on the basis of the information available at that date in the evolving context of the crisis related to Covid-19 and of difficulties in assessing its impact and future prospects. Our role is to express a conclusion on these financial statements based on our review.

I. CONCLUSION ON THE FINANCIAL STATEMENTS

We conducted our review in accordance with professional standards applicable in France. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with professional standards applicable in France and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Based on our review, nothing has come to our attention that causes us to believe that the accompanying condensed half-yearly consolidated financial statements are not prepared, in all material respects, in accordance with IAS 34 - standard of the IFRSs as adopted by the European Union applicable to interim financial information.

  1. SPECIFIC VERIFICATION

We have also verified the information presented in the half-yearly management report commenting the condensed half-yearly consolidated financial statements subject to our review prepared on July 29, 2020.

We have no matters to report as to its fair presentation and consistency with the condensed half-yearly condensed consolidated financial statements.

Paris and Paris-La Défense, July 29, 2020

The Statutory Auditors

BECOUZE

DELOITTE & ASSOCIÉS

Fabien BROVEDANI

Stéphane LEMANISSIER

Partner

Partner

34 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

DECLARATION BY THE PERSON RESPONSIBLE FOR THE 2020 HALF-YEAR FINANCIAL REPORT

GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020 - 35

DECLARATION BY THE PERSON RESPONSIBLE FOR THE 2020 HALF-YEAR FINANCIAL REPORT

"I declare that, to the best of my knowledge, the summary consolidated financial statements for the ending semester have been prepared in accordance with applicable accounting standards and give a true and fair view of the assets and liabilities, financial position and profit and loss of the Company and all the other companies included in the scope of consolidation, and that this Half-year Activity Report includes a fair review of the important events which occurred during the first six months of the year, their impact on the half-year financial statements and the main transactions between related parties, together with a description of the principal risks and uncertainties that they face in the remaining six months of the year."

Paris, July 29, 2020

Bernard Gilly Chief Executive Officer

36 - GENSIGHT BIOLOGICS - Half-year Financial Report June 30, 2020

74, rue du Faubourg Saint-Antoine

75012 Paris, France

Disclaimer

Gensight Biologics SA published this content on 30 July 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 July 2020 05:50:09 UTC


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Financials
Sales 2020 12,5 M 14,5 M 14,5 M
Net income 2020 -16,7 M -19,4 M -19,4 M
Net cash 2020 16,7 M 19,5 M 19,5 M
P/E ratio 2020 -6,13x
Yield 2020 -
Capitalization 144 M 168 M 168 M
EV / Sales 2020 10,2x
EV / Sales 2021 9,55x
Nbr of Employees 25
Free-Float 97,8%
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Number of Analysts 3
Average target price 10,23 €
Last Close Price 3,64 €
Spread / Highest target 285%
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Managers
NameTitle
Bernard Jacques Alex Gilly Chief Executive Officer & Director
Michael S. Wyzga Chairman
Thomas Gidoin Chief Financial Officer
Magali Taiel Chief Medical Officer
Josť-Alain Sahel Director
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