Quarterly Report • Sep 8, 2017
Quarterly Report
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| 1 | HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – JUNE 30, 2017 |
3 |
|---|---|---|
| 2 | ACTIVITY REPORT | 19 |
| A. | Operating income | 20 |
| B. | Operating expenses | 20 |
| 1. Research and Development | 20 | |
| 2. General and Administrative | 20 | |
| C. | Financial income (loss) | 21 |
| D. | Net income (loss) | 21 |
| E. | Non-current assets | 21 |
| F. | Current assets | 21 |
| G. | Changes in shareholder's equity | 22 |
| H. | Analysis of cash flow | 22 |
| 3 | TRANSACTIONS BETWEEN RELATED PARTIES | 23 |
| 4 | RISK FACTORS | 25 |
| 5 | STATUTORY AUDITORS' REVIEW REPORT ON THE 2017 HALF-YEAR FINANCIAL INFORMATION |
27 |
| 6 | DECLARATION BY THE PERSON RESPONSIBLE FOR THE 2017 HALF-YEAR FINANCIAL REPORT |
29 |
| As of December 31, | As of June 30, | ||
|---|---|---|---|
| (Amounts in K€) | Note | 2016(1) | 2017 |
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 4 | 204 | 194 |
| Property, plant and equipment | 5 | 858 | 899 |
| Other non-current financial assets | 6 | 103 | 80 |
| Total non-current assets | 1,165 | 1,173 | |
| Current assets | |||
| Trade accounts receivable | 30 | — | |
| Other current assets | 7 | 4,053 | 9,281 |
| Cash and cash equivalents | 8 | 53,982 | 63,618 |
| Total current assets | 58,066 | 72,898 | |
| TOTAL ASSETS | 59,231 | 74,071 |
(1) The condensed consolidated balance sheet as of December 31, 2016 corresponds to GenSight Biologics SA's, as the company had no consolidated subsidiary as this date.
| As of December 31, | As of June 30, | |||
|---|---|---|---|---|
| (Amounts in K€) | Note | 2016(1) | 2017 | |
| LIABILITIES | ||||
| Shareholders' equity | 9 | |||
| Share capital | 485 | 588 | ||
| Premiums related to the share capital | 91,230 | 112,088 | ||
| Reserves | (16,293) | (36,294) | ||
| Net income (loss) | (22,082) | (10,113) | ||
| Total shareholders' equity | 53,340 | 66,269 | ||
| Non-current liabilities | ||||
| Conditional advances - non-current portion | 10 | 2,922 | 2,701 | |
| Non-current provisions | 11 | 73 | 62 | |
| Total non-current liabilities | 2,995 | 2,763 | ||
| Current liabilities | ||||
| Conditional advances - current portion | 10 | — | — | |
| Trade accounts payable | 1,734 | 3,944 | ||
| Other current liabilities | 12 | 1,161 | 1,095 | |
| Total current liabilities | 2,895 | 5,039 | ||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 59,231 | 74,071 |
(1) The condensed consolidated balance sheet as of December 31, 2016 corresponds to GenSight Biologics SA's, as the company had no consolidated subsidiary as this date.
| For the six-month period ended June 30, | ||||
|---|---|---|---|---|
| (Amounts in K€) | Note | 2016(1) | 2017 | |
| Operating income | ||||
| Revenues | — | — | ||
| Other income | 14 | 1,874 | 1,988 | |
| Total Operating Income | 1,874 | 1,988 | ||
| Operating expenses | ||||
| Research and development | 15 | 8,601 | 7,699 | |
| General and administration | 15 | 2,593 | 4,377 | |
| Total Operating expenses | 11,194 | 12,076 | ||
| Operating income (loss) | (9,320) | (10,088) | ||
| Financial income | 17 | 18 | 14 | |
| Financial expenses | 17 | (14) | (39) | |
| Financial income (loss) | 4 | (25) | ||
| Income tax | — | — | ||
| Net income (loss) | (9,316) | (10,113) | ||
| Basic/Diluted earnings per share (€ / share) | 20 | (0.68) | (0.51) |
(1) The condensed consolidated statements of income (loss) as of June 30, 2016 corresponds to GenSight Biologics SA's, as the company had no consolidated subsidiary as this date.
| For the six-month period ended June 30, | ||||
|---|---|---|---|---|
| (Amounts in K€) | 2016(1) | 2017 | ||
| Net income (loss) | (9,316) | (10,113) | ||
| Actuarial gains and losses on employee benefits, net of income tax | 19 | 24 | ||
| Foreign currency translation differences, net of income tax | — | 2 | ||
| Total comprehensive income (loss) | (9,297) | (10,086) |
(1) The condensed consolidated statements of income (loss) as of June 30, 2016 corresponds to GenSight Biologics SA's, as the company had no consolidated subsidiary as this date.
| For the six-month period ended June 30, | |||
|---|---|---|---|
| (Amounts in K€) | Note | 2016(1) | 2017 |
| Cash flows from operating activities | |||
| Net profit (loss) | (9,316) | (10,113) | |
| Reconciliation of net profit (loss) and the cash used for operating activities | |||
| Amortization and depreciation | 99 | 107 | |
| Retirement pension obligations | 16 | 13 | |
| Expenses related to share-based payments | 16 | 1,434 | 2,175 |
| Other financials items | 5 | 20 | |
| Operating cash flows before change in working capital | (7,761) | (7,799) | |
| Accounts receivable | 8 | 30 | |
| Accounts payable, net of prepayments | (1,663) | (1,191) | |
| Other receivables | (1,441) | (1,949) | |
| Other current liabilities | 8 | (303) | |
| Change in working capital | (3,087) | (3,412) | |
| Net cash flows from operating activities | (10,849) | (11,211) | |
| Cash flows from investment activities | |||
| Acquisitions of property, plant, and equipment | (146) | (139) | |
| Acquisitions of intangible assets | (1) | — | |
| Acquisitions/reimbursement of non-current financial assets | 8 | 24 | |
| Acquisitions/reimbursement of current financial assets | - | 120 | |
| Net cash flows from investment activities | (139) | 5 | |
| Cash flows from financing activities | |||
| Conditional advances received | — | — | |
| Treasury shares | — | (120) | |
| Warrants issuance | — | 216 | |
| Capital increases, net of transaction costs | 9 | — | 20,745 |
| Net cash flows from financing activities | — | 20,840 | |
| (Decrease)/Increase in cash and cash equivalents | (10,988) | 9,634 | |
| Cash and cash equivalents at the beginning of the period | 30,060 | 53,982 | |
| Effect of changes in exchange rates on Cash and cash equivalents | — | 1 | |
| Cash and cash equivalents at the close of the period | 19,072 | 63,618 |
(1) The condensed consolidated statement of cash flows as of June 30, 2016 corresponds to GenSight Biologics SA's, as the company had no consolidated subsidiary as this date.
| Share Capital | Premiums | Reserves | Net income | Total | ||
|---|---|---|---|---|---|---|
| (Amounts in K€) | Number of shares |
Amount | related to the share capital |
(loss) | Shareholders' Equity |
|
| At January 1, 2016(1) | 13,609,122 | 340 | 49,796 | (7,156) | (13,654) | 29,326 |
| Net income (loss) | — | — | — | — | (9,316) | (9,316) |
| Other comprehensive income |
— | — | — | 19 | — | 19 |
| Total comprehensive income (loss) |
— | — | — | 19 | (9,316) | (9,297) |
| Allocation of prior period net income (loss) |
— | — | — | (13,654) | 13,654 | — |
| Share-based payments | — | — | — | 1,434 | — | 1,434 |
| At June 30, 2016(1) | 13,609,122 | 340 | 49,796 | (19,356) | (9,316) | 21,464 |
| At January 1, 2017 | 19,409,701 | 485 | 91,230 | (16,293) | (22,082) | 53,340 |
| Net income (loss) | — | — | — | — | (10,113) | (10,113) |
| Other comprehensive income |
— | — | — | 27 | — | 27 |
| Total comprehensive income (loss) |
— | — | — | 27 | (10,113) | (10,086) |
| Allocation of prior period income (loss) |
— | — | — | (22,082) | 22,082 | — |
| Capital increase by issuance of Ordinary shares |
3,750,000 | 94 | 22,406 | — | — | 22,500 |
| Capital increase transaction costs |
— | — | (1,755) | — | — | (1,755) |
| Capital increases related to exercises of warrants |
374,552 | 9 | 206 | — | — | 216 |
| Treasury shares | — | — | — | (120) | — | (120) |
| Share-based payments | — | — | — | 2,175 | — | 2,175 |
| At June 30, 2017 | 23,534,253 | 588 | 112,088 | (36,294) | (10,113) | 66,269 |
(1) The condensed consolidated statement of change in shareholder's equity as of June 30, 2016 corresponds to GenSight Biologics SA's, as the company had no consolidated subsidiary as this date.
Founded in 2012, GenSight Biologics (hereinafter referred to as 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.
On June 23, 2017, the company operated a capital increase whose gross proceeds amounted to €22.5 million, by means of a private placement reserved to a category of persons, US and European institutional investors specialized in healthcare and biotechnology. The majority of the new shares were allocated to US investors. This increase corresponds to 3,750,000 new shares, par value €0.025 each.
The funds raised will be allocated to prepare for the commercial launch of GS010 in Europe and the United States, notably initiating marketing and market access activities, as well as the establishment of a marketing infrastructure. The funds will strengthen the cash position of the Company and enhance the Company's financial visibility until Q1 2019.
On January 31, 2017, GenSight Biologics announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the Company's product candidate GS030 for the treatment of retinitis pigmentosa.
On February 21, 2017, GenSight Biologics announced that enrollment in REVERSE, a Phase III clinical trial of GS010 in the treatment of Leber's Hereditary Optic Neuropathy (LHON), has been successfully completed.
On June 14, 2017, the company reported additional promising clinical trial results with GS010 after 96 weeks of follow-up in its Phase I/II study. These results confirm the long-term positive sustained visual acuity gain after 2 years with a single intravitreal injection of GS010 in patients with Leber's Hereditary Optic Neuropathy (LHON), especially in those with less than 2 years of disease onset.
On April 28, 2017, the Company created its first subsidiary, GenSight Biologics Inc., registered and located in the United States of America. This US-based subsidiary is held at 100% by GenSight Biologics S.A. and is fully consolidated.
These financial statements are therefore the first consolidated financial statements of the group thus formed.
The financial information as at June 30, 2016 and December 31, 2016 corresponds to the information previously published and includes only business flows unique to the parent company GenSight Biologics S.A., which had no equity interest in a subsidiary over the periods in question.
The presented condensed financial statements are expressed in thousands of euros, unless stated otherwise. The Reporting date forthecondensedconsolidatedaccounting statements is June 30, and covers a six- month period. The individual statements of consolidated subsidiaries are prepared at the same Reporting date, i.e. June 30, and cover the same period.
The semi-annual condensed consolidated financial statements as of June 30, 2017 have been approved on July 27, 2017 by the Board of Directors.
In compliance with European regulation n° 1606 / 2002 adopted on July 19, 2002 by the European Parliament and the European Council, the Group's consolidated financial statements for the year ending December 31, 2016 were prepared in accordance with International Financial Reporting Standards (IFRS), as endorsed by the European Union on the date of preparation.
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. 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 notes to the condensed consolidated financial statements at June30,2017were prepared in accordancewith IAS34– 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, 2016.
All the texts adopted by the European Union are available on the European Commission's website: http://ec.europa.eu/internal\_ market/accounting/ias/index\_fr.htm IFRS
The condensed consolidated financial statements were prepared in accordance with the accounting principles and methods used by the Group for the 2016 financial statements and described in note 3 to consolidated financial statements for the year ended December 31, 2016. Furthermore, the condensed consolidated financial statements were prepared in compliance with other standards and interpretations in force as of January 1, 2017, with the exception of the application of the new standards and interpretations described below.
The mandatory standards, amendments and interpretations published by the IASB and applicable as of January 1, 2017 are listed below:
• The IASB also issued various amendments and clarifications to IAS7, IAS12, IAS28 and IFRS10, IAS40, IFRS2, IFRS4 and IFRS15.The company is still intheprocessof assessingwhether there will be a material change to its financial statements upon adoption of these amendments.
A review of these amendments showed that their application had a non-material impact on the Group's interim financial statements, which – consequently – were notrestated.
Subsidiaries under the exclusive control of the Group are consolidated using the full consolidation method. When the accounting policies applied by subsidiaries are not consistent with those used by the Group, the necessary changes are made to the financial statements of those companies to make them compatible with the accounting policies adopted by the Group.
The Consolidated Financial Statements are presented in euros, which is also the functional currency of the parent Company GenSight Biologics S.A. The statements of financial position of consolidated entities having a functional currency different from the euro are translated into euros at the closing exchange rate (spot exchange rate at the statement of financial position date), and the statements of income, statements of comprehensive income and statement of cash flow of such consolidated entities are translated at the average period to date exchange rate. The resulting translation adjustments are included in equity under the caption "Cumulative translation adjustment" in the consolidated statement of changes in equity.
Foreign currency transactions are converted to euros at the rate of exchange applicable on the transaction date. At period-end, foreign currency monetary assets and liabilities are converted at the rate of exchange prevailing on that date. The resulting exchange gains or losses are recorded in the Consolidated Statement of Income in "Financial income (loss)".
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 respectto key estimates and judgments made were identical to those applied in the consolidated financial statements for the year ended December 31, 2016.
GENSIGHT – Half-Year Financial Report 2017 – June 30, 2017 – 9
The intangible assets are broken down as follows:
| As of December 31, |
As of June 30, |
|
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Patents, licenses, trademarks | 275 | 275 |
| Software | 10 | 10 |
| Total historical cost | 285 | 285 |
| Accumulated amort. of patents, licenses, and trademarks |
72 | 81 |
| Accumulated depreciation of softwage packages |
10 | 10 |
| Accumulated amortization and depreciation |
82 | 91 |
| Net total | 204 | 194 |
An intangible asset was recognized at December 31, 2013 as a result of the license agreement signed with Novartis. The initial recognition cost amounted to €275 K and was determined by reference to the fair value of the 670,588 ordinary shares, €0.41 per ordinary share, issued as consideration for the license.
There has been no recognition of impairment losses in application of IAS 36 Impairment of Assets over the periods presented.
Changes in PPE gross book values and accumulated depreciation are presented in the following table:
| (Amounts in K€) | As of January 1, 2017 |
Increase | Decrease | As of June 30, 2017 |
|---|---|---|---|---|
| Technical equipment and installations | 687 | 41 | 728 | |
| Leasehold improvement | 143 | 39 | 182 | |
| Office and computer equipment | 102 | 18 | 120 | |
| Furniture | 256 | 41 | 297 | |
| Total gross property, plant and equipment | 1,188 | 139 | — | 1,327 |
| Accumulated depreciation of technical equipment and installations |
108 | 27 | 135 | |
| Accumulated depreciation of leasehold improvement | 67 | 31 | 98 | |
| Accumulated depreciation of office and computer equipment |
62 | 13 | 75 | |
| Accumulated depreciation of furniture | 93 | 26 | 119 | |
| Total accumulated depreciation | 330 | 98 | — | 427 |
| Total net property, plant and equipment | 858 | 41 | — | 899 |
The non-current financial assets correspond to the deposit paid to the lessor for the registered offices of the Company.
| As of December 31, |
As of June 30 |
|
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Guarantee deposits | 103 | 80 |
| Total non-current financial assets |
103 | 80 |
The decrease in guarantee deposits as of June 30, 2017 relates to the amendment made on April 25, 2017 to the lease contract for the head office in Paris, France. Pursuant to the new terms and conditions, less square meters are used and as a result, both the rental fees and the guarantee deposit have been reduced accordingly.
At the end of the period, the Group has not yet entered into an office lease contract for its US-based subsidiary.
The other current assets are broken down as follows:
| As of December 31, |
As of June 30, |
|
|---|---|---|
| (Amounts in K€) | 2016 | 2016 |
| Prepayments | 133 | 3,531 |
| Research tax credit | 2,930 | 4,898 |
| Other taxes receivable | 398 | 465 |
| Liquidity contract | 151 | 31 |
| Prepaid expenses | 442 | 346 |
| Other receivable | — | 10 |
| Total | 4,053 | 9,281 |
• The significant increase in prepayments primarily refers to an advance payment of €3.5 million to the supplier in charge of manufacturing the lead product GS010 (Novasep). This payment primarily corresponds to reservation fees to secure the process characterization as well as the manufacturing of process performance qualification (PPQ) and first commercial batches.
• The following table shows the changes in the Research Tax Credit receivable during the six-month period ended June 30, 2017:
| Amounts in k€ |
|
|---|---|
| Opening balance sheet receivable as of January 1, 2017 |
2,930 |
| Other operating income | 1,968 |
| Payment received | — |
| Closing balance sheet receivable as of June 30, 2017 |
4,898 |
Cash, cash equivalents and short-term investments items are broken down as follows:
| As of December 31, |
As of June, 30 |
|
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Cash | 53,982 | 63,618 |
| Cash equivalents | — | — |
| Total cash and cash equivalent as reported in the statements of financial position |
53,982 | 63,618 |
| Bank overdrafts | — | — |
| Total net cash and cash equivalents as reported in the statements of cash flows |
53,982 | 63,618 |
The share capital as of June 30, 2017 amounts to €588,356.33. It is divided into 23,534,253 fully authorized, subscribed and paidup ordinary shares with a nominal value of €0.025.
The table below shows the changes occurred in the share capital during the six-month period ended June 30, 2017:
| (Amounts in K€) | Share Capital | Share premium | Number of shares |
|---|---|---|---|
| Balance as of January 1, 2017 | 485 | 91,230 | 19,409,701 |
| Capital increase by issuance of ordinary shares | 94 | 22,406 | 3,750 |
| Less cost of issuance of shares | — | (1,755) | — |
| Issue of shares upon exercise of subscription warrants(1) | 9 | 206 | 375 |
| Total as of June 30, 2017 | 588 | 112,088 | 23,534,253 |
(1) The share premium includes eitherthe subscription price of non-employee warrants and the exercise price in excess of the share nominal value for employee and non-employee warrants.
All the changes relating to employee warrants, non-employee warrants and performance shares, as well as their impact on the profit and loss for the period are detailed in Note 16.
The other movement amounting to €(240) K in the table refers to the balance sheet reclassification between deferred revenue and conditional advances relating to the discount effect of the last receipts.
The following table shows the changes in conditional advances that occurred during the six-month period ended June 30, 2017:
| (Amounts in K€) | |
|---|---|
| Balance as of January 1, 2017 | 2,922 |
| Receipts | — |
| Repayments | — |
| Unwinding ofthe discount | 19 |
| Other | (240) |
| Balance as of June 30, 2017 | 2,701 |
| Non-current portion | 2,701 |
| Current portion | — |
Maturity dates of financial liabilities as of June 30, 2017, are as follows:
| (Amounts in K€) | Gross amount | Less than one year | One to five years | More than five years |
|---|---|---|---|---|
| Non-current conditional advances | 2,701 | — | 550 | 2,151 |
| Trade accounts payable | 3,944 | 3,944 | — | — |
| Total financial liabilities | 6,645 | 3,944 | 550 | 2,151 |
Non-current provisions are exclusively composed of employee benefits relating to a compensation payable to French employees upon their retirement – Indémnités de Fin de Carrière (IFC).
The following table shows the changes in the provision during the six-month period ended June 30, 2017:
| (Amounts in K€) | |
|---|---|
| As of December 31, 2016 | 73 |
| Costs of services rendered (operating expense) |
13 |
| Interest expense | 0 |
| Benefit paid | — |
| Actuarial gain (loss) | (24) |
| As of June 30, 2017 | 62 |
The underlying actuarial assumptions are similar to the one used at end ofDecember 2016, with the exception ofthe discountrate: 1.67% corresponding to the iBoxx Corporates AA 10+ index as of June 30, 2017.
The following table provides the detail of other current liabilities forthe presented periods:
| As of December 31, |
As of June 30 |
|
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Employee-related payable | 1,103 | 827 |
| Other taxes liabilities | 17 | 15 |
| Deferred revenues from subsidies |
33 | 254 |
| Other current liabilities | 7 | 0 |
| Total other current liabilities | 1,161 | 1,095 |
| (Amounts in K€) | Book value on the statement of financial position |
Fair value through profit and loss(1) |
Loans and receivables(2) |
At amortized cost(3) |
Fair Value |
|---|---|---|---|---|---|
| As of June 30, 2017 | |||||
| Financial assets | |||||
| Non-current financial assets | 80 | — | — | 80 | 80 |
| Cash and cash equivalent | 63,618 | 63,618 | — | — | 63,618 |
| Total financial assets | 63,697 | 63,618 | — | 80 | 63,697 |
| Financial liabilities | |||||
| Conditional advances (non-current portion) | 2,701 | — | — | 2,701 | 2,701 |
| Accounts payable and related payables | 3,944 | — | — | 3,944 | 3,944 |
| Total financial liabilities | 6,645 | — | — | 6,645 | 6,645 |
(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 fair value of loans and receivables corresponds to the value reported in the statement of financial position meaning the value at the transaction date and then tested for impairment on each reporting date.
(3) The book amount of financial liabilities measured at amortized cost was deemed to be a reasonable estimation of fair value.
| As of June 30, | ||
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Research tax credit (see note 7) |
1,825 | 1,968 |
| Subsidies | 49 | 20 |
| Total Operating Income | 1,874 | 1,988 |
The table below shows the breakdown of research and development expenses by cost nature forthe periods presented:
| As of June 30, | ||
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Personnel expenses(1) | 1,853 | 1,672 |
| Sub-contracting, collaboration and consultants |
4,991 | 4,848 |
| Licensing and intellectual property |
1,057 | 114 |
| Offices cost | 260 | 271 |
| Travel and entertainment expenses |
314 | 551 |
| Depreciation and amortisation expense |
62 | 88 |
| Other | 65 | 154 |
| Total R&D expenses | 8,601 | 7,699 |
(1) Includes €539Kand €306Krelated to share-based compensation expense as of June 30, 2016 and 2017 respectively.
The table below shows the breakdown of research and development expenses by cost nature forthe periods presented:
| As of June 30, | ||
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Personnel expenses(1) | 1,690 | 2,944 |
| Professional Fees | 191 | 573 |
| Communication and travel expenses |
387 | 520 |
| Offices cost | 168 | 116 |
| Equipment rental | 11 | 8 |
| Office furniture and small equipment |
28 | 30 |
| Postal and telecommunication expenses |
23 | 19 |
| Depreciation and amortisation expense |
37 | 19 |
| Attendance fees | 28 | 65 |
| Insurances | 21 | 35 |
| Others | 8 | 47 |
| Total G&A expenses | 2,593 | 4,377 |
(1) Includes €896 K and €1,869 K related to share-based compensation expense as of June 30, 2016 and 2017 respectively.
The Group was employing 29 permanent people as of June 30, 2017 to compare with 26 as of June 30, 2016.
The following table shows the nature of costs included in personnel expenses:
| As of June 30, 2016 | As of June 30, 2017 | |||||
|---|---|---|---|---|---|---|
| (Amounts in K€) | R&D | G&A | TOTAL | R&D | G&A | TOTAL |
| Wages and salaries | 1,006 | 561 | 1,568 | 1,087 | 786 | 1,874 |
| Social contributions | 294 | 232 | 526 | 267 | 287 | 555 |
| Service cost (employee benefit) | 14 | 1 | 16 | 12 | 1 | 13 |
| Share-based payments | 538 | 896 | 1,434 | 306 | 1,869 | 2,175 |
| Total | 1,853 | 1,690 | 3,544 | 1,672 | 2,944 | 4,616 |
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"), nonemployee warrants (Bons de Souscription d'Actions or "BSA") and performance shares (Attributions Gratuites d'Actions or"AGA").
All BCE granted may be exercised by the beneficiary on the basis ofthe following vesting schedule:
| BCE 2013-02 | BCE 2013-02 | BCE 2014-06 | BCE 2015-06 | |
|---|---|---|---|---|
| Date of grant | July 8, 2013 | April 9, 2014 | December 3, 2014 | July 8, 2015 |
| Plan expiration date | July 7, 2023 | April 8, 2024 | December 2, 2024 | July 7, 2025 |
| Number of warrants initially granted | 892,000 | 193,800 | 60,000 | 733,298 |
| Share entitlement per warrant | 1 | 1 | 1 | 1 |
| Exercise price | €0.025 | €0.025 | €0.025 | €3.275 |
| Valuation method | Black & Scholes | |||
| Expected volatility | 42.50% | 42.50% | 75.21% | 76.49% |
| Expected dividend | 0.00% | 0.00% | 0.00% | 0.00% |
| Fair value per warrant | €0.44 | €0.44 | €2.15 | €5.56 |
| BCE 2013-02 | BCE 2014-06 | BCE 2015-06 | Total | |
|---|---|---|---|---|
| Balance outstanding at January 1, 2017 | 780,478 | 60,000 | 733,298 | 1,573,776 |
| Granted during the period | — | — | — | — |
| Exercised during the period | (311,120) | — | (64,432) | (375,552) |
| Forfeited during the period | — | — | (96,867) | (96,867) |
| Balance outstanding at June 30, 2017 | 469,358 | 60,000 | 571,999 | 1,101,357 |
| Of which exercisable | 469,358 | 60,000 | 273,563 | 802,921 |
BSA 2013-02 and BSA 2015-06 granted may be exercised by the beneficiary on the basis ofthe following vesting schedule:
• atthe latest within 10 years from the date of grant.
BSA 2016 granted may be exercised by the beneficiary on the basis ofthe following vesting schedule:
| BSA 2013-02 | BSA 2013-02 | BSA 2015-06 | BSA 2016 | |
|---|---|---|---|---|
| Date of grant | July 8, 2013 | April 9, 2014 | July 8, 2015 | July 26, 2016 |
| Plan expiration date | July 7, 2023 | April 8, 2024 | July 7, 2025 | July 25, 2026 |
| Number of warrants initially granted | 328,000 | 33,000 | 121,000 | 205,000 |
| Exercise price | €0.025 | €0.025 | €3.275 | €8.08 |
| Share entitlement per warrant | 1 | 1 | 1 | 1 |
| Valuation method | Black & Scholes | |||
| Expected volatility | 42.50% | 42.50% | 76.49% | 62.46% |
| Expected dividend | 0.00% | 0.00% | 0.00% | 0.00% |
| Subscription price per warrant | €0.08 | €0.08 | €0.25 | €0.65 |
| Fair value per warrant (subscription price deducted) |
€0.36 | €0.36 | €5.31 | €2.94 |
Changes in the balances of Non-employee warrants (BSA)
| BSA 2013-02 | BSA 2015-06 | BSA 2016 | Total | |
|---|---|---|---|---|
| Balance outstanding at January 1, 2017 | 293,040 | 121,000 | 205,000 | 619,040 |
| Granted during the period | — | — | — | — |
| Exercised during the period | — | — | — | — |
| Forfeited during the period | — | — | (47,000) | (47,000) |
| Balance outstanding at June 30, 2017 | 293,040 | 121,000 | 158,000 | 572,040 |
| Of which exercisable | 293,040 | 57,979 | — | 351,019 |
The AGA 2016 performance shares granted on July 26, 2016, may be fully acquired at the end of an acquisition period of one year.
In addition, the acquisition of performance shares by Key Managers, including Mr. Gilly, is subordinate to the achievement of the following performance criteria at the latest on July 26, 2018:
Details and main characteristics of the performance shares (AGA) granted to date
| AGA 2016 | |
|---|---|
| Date of grant | July 26, 2016 |
| Number of Performance shares initially granted |
766,000 |
| Vesting period (in Years) | 1 |
| Grant date Fair-value | €8.08 |
| Performance conditions | Yes |
Changes in the balances of performance shares (AGA)
| Total | |
|---|---|
| Balance outstanding at January 1, 2017 | 763,000 |
| Granted during the period | — |
| Exercised during the period | — |
| Forfeited during the period | (125,000) |
| Balance outstanding at June 30, 2017 | 638,000 |
| As of June 30, 2016 | As of June 30, 2017 | ||||||
|---|---|---|---|---|---|---|---|
| (Amounts in K€) | R&D | G&A | TOTAL | R&D | G&A | TOTAL | |
| Non-Employee Warrants (BSA) | 80 | 116 | 195 | 266 | 85 | 351 | |
| Employee Warrants (BCE) | 459 | 780 | 1,239 | (148) | 267 | 120 | |
| Performance Shares (AGA) | — | — | — | 187 | 1,517 | 1,704 | |
| Share-based payments expense | 538 | 896 | 1,434 | 306 | 1,869 | 2,175 |
The financial income and expenses are broken down as follows:
| As of June 30, | ||
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Income from cash equivalents | 1 | |
| Foreign exchange gains | 17 | 14 |
| Financial income | 18 | 14 |
| Foreign exchange losses | (9) | (20) |
| Unwinding ofthe discount on conditional advances |
(4) | (19) |
| Finance cost on employee benefits |
(1) | (0) |
| Other | (0) | — |
| Financial expenses | (14) | (39) |
| Total | 4 | (25) |
Foreign exchange gains and losses primarily arise from the purchase of services labelled in U.S. dollars.
The increase in the interest expense resulting from the unwinding of the discount on conditional advances is related to the additional conditional advances received in July 2016. The interest expense (unwinding of the discount) has been calculated on the basis of a discountrate of1.44%and is offset by a€20Ksubsidy recognized as "otherincome", in accordance with IAS 20 – Government grants.
Commitments existing as of December 31, 2016 have not changed significantly at the end of the reporting period, with the exception ofthe following:
• On May 2017, the office lease contract the Group entered on January, 2015 relating to its headquarters in Paris, France, has been amended. The amendment consisted especially in a decreased rent as the Group is using less office space. The associated services (reception, printers and IT, access to meeting rooms…) have also been revised accordingly.
• Car rental contracts have either been terminated or transferred during the period so that at end of June 2017, there is no remaining commitment.
The table belowshows theminimumcontractualfuture payments relating to these contracts as of June 30, 2017:
| (Amounts in K€) | As of June 30, 2017 |
|---|---|
| 2017 | 267 |
| 2018 | 533 |
| 2019 | 533 |
| 2020 | 533 |
| 2021 | 533 |
| 2022 | 533 |
| 2023 | 533 |
| Total | 3,467 |
In addition, the Group also entered into a new services contract with "Passage de l'innovation" in connection with HR, legal and IP services. According to the contract terms and conditions, the annual cost is fixed at €187 K and each party can terminate the contract after a six-month notice period. Thus, the commitment related forthe second part of 2017 amounts to €94 K.
As of June 30, 2017, the Group has not yet entered into a binding office lease agreement for its US-based subsidiary.
The Group did not conclude any new significanttransactions with related parties during the period.
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. Preferred shares had the same rights and dividends as ordinary shares for purposes of calculating earnings per share. As a result, all outstanding ordinary and preferred shares have been taken into consideration for purposes of calculating basic earnings per share. The weighted average number of shares was 13,609,120 and 19,738,721 in June 2016 and June 2017 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 sharebased compensation plans (see Note 16).
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 2,311,398 potential additional ordinary shares, have been considered antidilutive.
| As of June 30, | |||
|---|---|---|---|
| 2016 | 2017 | ||
| Net income (loss) of the reporting period (in k€) |
(9,316) | (10,113) | |
| Adjusted weighted average number of outstanding shares |
13,609,120 | 19,738,721 | |
| Basic and diluted earnings (loss) per share (in Euros) |
(0.68) | (0.51) |
The assessment of risks has not substantially changed since the Company filed its 2016 registration document. The registration document is available on the company's website: http://www.gensight-biologics.com/uploads/Modules/ InvestorsDocumentation
No significant events, that would have a material impact on the half-year consolidated financial statements occurred subsequent to June 30, 2017.
Our operating income consists of revenues and other income. To date, we have not generated any revenue from the sale of our products. The other income is mainly composed of research tax credit.
The expenditures taken into account for the calculation of this credit 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 2016 Research tax creditin the amount of €2,930 K which had not yet been received at the date of this half-year financial report.
| As of June 30, | |||
|---|---|---|---|
| (Amounts in K€) | 2016 | 2017 | |
| Research tax credit (see note 7) |
1,825 | 1,968 | |
| Subsidies | 49 | 20 | |
| Total Operating Income | 1,874 | 1,988 |
From the first half of 2016 to the first half of 2017, the total amount spent by the group for research and development activity decreased from €8,601 K to €7,699 K , or a decrease of -10%.
Our research and development expenses consist principally of external costs, such as manufacturing expenses, non-clinical studies, 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, | ||
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Personnel expenses(1) | 1,853 | 1,672 |
| Sub-contracting, collaboration and consultants |
4,991 | 4,848 |
| Licensing and intellectual property |
1,057 | 114 |
| Offices cost | 260 | 271 |
| Travel and entertainment expenses |
314 | 551 |
| Depreciation and amortisation expense |
62 | 88 |
| Other | 65 | 154 |
| Total R&D expenses | 8,601 | 7,699 |
(1) Includes €539Kand €306Krelated to share-based compensation expense as of June 30, 2016 and 2017 respectively.
The decreased expenditures from half year to half year resulted from:
During the period presented, our general and administrative expenses increased from €2,593 K as of June 30, 2016, to €4,377 K as of June 30, 2017.
Our general and administrative expenses are broken down as follows:
| As of June 30, | |||
|---|---|---|---|
| (Amounts in K€) | 2016 | 2017 | |
| Personnel expenses(1) | 1,690 | 2,944 | |
| Professional Fees | 191 | 573 | |
| Communication and travel expenses |
387 | 520 | |
| Offices cost | 168 | 116 | |
| Equipment rental | 11 | 8 | |
| Office furniture and small equipment |
28 | 30 | |
| Postal and telecommunication expenses |
23 | 19 | |
| Depreciation and amortisation expense |
37 | 19 | |
| Attendance fees | 28 | 65 | |
| Insurances | 21 | 35 | |
| Others | 8 | 47 | |
| Total G&A expenses | 2,593 | 4,377 |
(1) Includes €896 K and €1,869 K related to share-based compensation expense as of June 30, 2016 and 2017 respectively.
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.
The increased expenditures between the two periods mainly resulted from:
Our net financial profit (loss) decreased to €(25) K as of June 30, 2017 from €4 K as of June 30, 2016. Our financial expenses increased from €14 K to €39 K primarily due to the foreign exchange losses related to the current accountwith the subsidiary GenSight Biologics Inc. but also to the unwinding of the discount on conditional advances with Bpifrance (Sight Again collaborative project).
The net loss amounts to €(10,113) K as of June 30, 2017 from €(9,316) K as of June 30, 2016. The basic and diluted loss per share (calculated with the adjusted weighted average number of outstanding shares during the period) amounted to €(0.68) and €(0.51) as of June 30, 2016 and 2017 respectively.
Non-current assets are composed of intangible, tangible assets and non-current financial assets. They remained stable over the period, amounting to €1,165 K as of December 31, 2016 and €1,173 K as of June 30, 2017. However, net tangible assets increased by €41 K due to the reconfiguration of premises and non-current financial assets decreased by €(24) K due to the decrease in guarantee deposits (cf. Note 6).
Current assets amounted to €58,066Kas of December 31, 2016 and €72,898 K as of June 30, 2017. This significant increase is essentially due to the capital increase that occurred on June 23, 2017 whose gross proceeds amounted to €22.5 million, the advance payment of €3.5 million to the supplier in charge of manufacturing the lead product GS010, and to the accumulated Research tax credit for 2016, still not reimbursed at the date of the present report.
The changes in shareholder's equity are primarily due the capital increase in June 2017 and losses of the half-year period. Thus, shareholder's equity amounted to €53,340 K as of December 31, 2016 and €66,269 K as of June 30, 2017.
| For the six-month period ended June 30, |
||
|---|---|---|
| (Amounts in K€) | 2016 | 2017 |
| Net cash flows from operating activities |
(10,849) | (11,211) |
| Net cash flows from investment activities |
(139) | 5 |
| Net cash flows from financing activities |
— | 20,840 |
The relative stability in cash flows from operating activities is due to an increase in trade accounts payable for €2.2 million, partly offset by the advance payment of €3.5 million to the supplier in charge of manufacturing the lead product GS010.
The positive cash flows from investment activities are due to the acquisition of own shares as part of the liquidity contract set up on the second half of 2016, following the 2016 IPO on Euronext Paris.
The positive cash flows from financing activities are due to the capital increase that occurred on June 23, 2017.
3
The Group did not conclude any new significanttransactions with related parties during the period.
Risk factors are similar to those presented in the section 4 of the 2016 Registration Document (pages 17 to 50) and did not change significantly during the first half-year of 2017. This Registration Document was registered on April 28, 2017, by The French "Autorité des Marchés Financiers" (AMF), with number R.17-0036 and was published on May 2, 2017.
T h i s d o c u m e n t i s a v a i l a b l e o n t h e C o m p a n y ' s website: www.gensight-biologics.com and the AMF's website : www.amf-france.org.
BECOUZE Deloitte & Associés 45, rue Boissière 106, cours Charlemagne 75116 Paris 69002 Lyon
Société Anonyme – 74 rue du Faubourg Saint-Antoine – 75012 PARIS
FOR THE PERIOD FROM JANUARY 1 TO JUNE 30, 2017
To the Shareholders,
In compliance with the assignment entrusted to us by your General Assembly 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 reportto you on:
These condensed half-yearly consolidated financial statements are the responsibility of the Board of Directors. Our role is to express a conclusion on these financial statements based on ourreview.
We conducted our review in accordance with professional standards applicable in France. A review of interim financial information consists ofmaking inquiries, primarily of persons responsible forfinancial and accountingmatters, and applying analytical and otherreview 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 materialrespects, in accordance with IAS 34 - standard of the IFRSs as adopted by the European Union applicable to interim financial information.
We have also verified the information presented in the half-yearly management report on the condensed half-yearly consolidated financial statements subjectto ourreview. We have no matters to report as to its fair presentation and consistency with the condensed half-yearly consolidated financial statements.
Paris and Lyon, July 28, 2017
The Statutory Auditors
BECOUZE DELOITTE & ASSOCIÉS Fabien BROVEDANI Dominique VALETTE
"I declare that,to the best ofmy knowledge,the summary consolidated financial statements forthe 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 fairreviewofthe important eventswhich occurred during the first sixmonths ofthe year,theirimpact on the half-yearfinancial statements and the main transactions between related parties,together with a description ofthe principalrisks and uncertainties thatthey face in the remaining six months ofthe year."
Paris, July 28, 2016
Bernard Gilly Chief Executive Officer
74, rue du Faubourg Saint-Antoine 75012 Paris, France
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