Interim / Quarterly Report • Jul 22, 2022
Interim / Quarterly Report
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A French société anonyme (limited company) with share capital of €3,521,707.98 Registered office: 74 rue du Faubourg Saint-Antoine, 75012 Paris Paris Trade and Companies Register No. 538 797 655
I – PRESENTATION OF THE COMPANY & MAJOR EVENTS
II - RISK FACTORS
III – CONSOLIDATED FINANCIAL STATEMENTS FIRST HALF 2022
IV – ACTIVITY REPORT
Pixium Vision, a bioelectronics company that specialises in sensorial neuromodulation, was created in December 2011 based on the collaborative work of several scientific teams from prestigious and academic institutions, such as the French Institut de Vision (UPMC, CNRS, INSERM), the Quinze-Vingts National Ophthalmology Medical Centre and Stanford University in California.
Pixium's mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium is an advanced clinical stage company that specialises in neuromodulation to treat vision disorders. Its Prima system is leveraging a cutting edge wireless sub-retinal neurostimulation micro implant with stateof-the-art augmented reality smart glasses driven by proprietary artificial intelligence-ready algorithms.
We are initially focusing our Prima System on the AMD market because we believe that the Prima System has the potential to offer benefits to AMD patients, including restoring functional vision in areas the photoreceptors have degenerated, and allowing patients to combine their remaining natural peripheral vision with the bionic vision from the Prima System. In our feasibility study in France, or the European Feasibility Study, that we started in November 2017, our Prima System achieved successful elicitation of light perception in the central retinal area in all subjects.
After the encouraging results of improvements in visual acuity demonstrated by the European Feasibility Study, in November 2020, we commenced a pivotal registration study in Europe, or the PRIMAvera study, and expect initial 12-month data in late 2023. We expect the PRIMAvera study will be the basis for the CE marking of our device in Europe under the MDR as early as late 2024. The European Feasibility Study, which we commenced in November 2017 and reported 6, 12, 18, 24 and 36 month follow up data in 2021 is still ongoing and we expect to report further results in late 2022. In January 2020 we completed our first implantation of a patient in a feasibility study in the United States, or the United States Feasibility Study, which is intended to support our regulatory filing with the FDA. We expect that the Prima System will be classified as a Class III implantable medical device, and will therefore require submission and approval of a premarket approval, or PMA, application. We intend to discuss with the regulatory authorities in Europe and the United States the structure of our required PMA application and pathway to marketing approval.
The four main causes of impaired vision are cataracts, glaucoma, diabetic retinopathy and diseases involving photoreceptor degeneration such as AMD; retinitis pigmentosa, or RP; and Stargardt disease. Our technologies currently focus on the disorders resulting from degeneration of photoreceptors, specifically nonexudative, or dry, AMD, which is the leading form of blindness among the aging. There is currently no approved retinal implant for dry AMD that is intended to restore vision. Based on third party research as well as primary market research conducted by us, we believe the potential dry AMD market in the European Union and the United States combined is approximately \$19 billion, and may grow an additional 10% by 2030. Many degenerative diseases of the retina, whether of genetic origin or age-related, result from the progressive or acute degeneration of photoreceptor cells: the retina can no longer convert light stimuli into electrical signals. This degeneration of photoreceptor cells leaves the other retinal cells, whether ganglion cells or the inner retina cells, functional. Consequently, when these inner retinal cells are electrically stimulated, a visual signal can still be transmitted through the optic nerve to the brain. Our goal is to restore this visual stimulus through the Prima System, our bionic vision system for the treatment of retinal dystrophies, to allow ganglion cells and/or the inner retina cells to communicate visual information to the brain.
The Prima System uses a wireless sub-retinal neurostimulation micro-implant developed in cooperation with Stanford University. It is injected under the retina using a patented implant placement instrument. The implant has photovoltaic properties, receiving visual information and at the same time is powered by pulsed near infrared light transmitted through a digital projector that is integrated into the smart glasses. A pocket computer, equipped with proprietary algorithms and artificial intelligence, processes and simplifies images captured in the environment to extract useful information that is then projected, using near infrared light generated by an integrated light source, onto the wireless sub-retinal micro-implant. Our wireless subretinal neurostimulation micro implant then electrically stimulates the surviving nerve cells of the retina, which transmit visual stimulation to the brain via the optic nerve.
In our European Feasibility Study of five patients with advanced dry AMD, as recently reported in Nature Communications,
the Prima System exceeded its primary endpoint in all subjects. The primary efficacy endpoint was improvement in visual perception in the central visual field, measured using the OCTOPUS visual field measurement with the Prima System on as compared to when the Prima System was turned off. Patients have experienced a marked improvement in their vision, gaining on average 0.7 logMAR (an improvement of seven lines on a standard visual acuity chart), and all patients improving from a low of 0.5 logMAR (corresponding to five lines) to a high of 0.9 logMAR (corresponding to nine lines). The primary safety endpoint was the number and severity of device and procedure related serious adverse events at 18 and 36 months followup. Patients in this study have been monitored for 36 months and the Prima System was generally well tolerated in this study. Two patients experienced procedure related serious adverse events, with one instance of ocular hypertension and one instance of superior-temporal retinal detachment, and both have resolved. We expect to report further results on this study in late 2022.
In November 2020, we commenced our PRIMAvera pivotal study to confirm the safety and the efficacy of the Prima System and to support the CE marking of our device in Europe. In the PRIMAvera study we are actively enrolling patients in 14 leading hospitals in France, Germany and the United Kingdom, with the intention to expand to additional hospitals in Spain, Italy and the Netherlands (in these three countries, the PRIMAvera study has started but patients have not been implanted with the Prima System yet). We expect to enroll 38 patients in the PRIMAvera study, an open-label, baseline-controlled, nonrandomized, multi-center, prospective, single-arm pivotal trial. The primary efficacy endpoint is at least 72% of patients achieving proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months, and the primary safety endpoint is the number and severity of device and procedure related serious adverse events at 12 months follow-up. As there is no comparative product with similar performance or mechanism of action to the Prima System, the PRIMAvera study does not have a pre-defined threshold for the safety endpoints. Instead, the safety data collected during the trial will be discussed with the trial's independent data safety monitoring board and assessed in relation to the measured visual improvement. Secondary endpoints include quality of life outcomes. The study includes three years of follow-up, with an evaluation of the primary endpoints at 12 months post-implantation. We expect to report initial 12-month data from this study in late 2023. If successful, we intend the PRIMAvera study to serve as the basis for the CE mark of our Prima System in Europe.
We conduct our studies through several leading research and vision institutions, including Stanford University, UPMC Eye Center and Bascom Palmer Eye Institute, providing us with access to top-tier research groups, high-quality facilities for preclinical tests of our devices and easier access to patients to conduct clinical trials. We have signed exclusive license agreements with Stanford University and CRNS and the Université de Bordeaux, granting us access to several patents for our Prima System.
Major events in the first half of 2022 include:
On 27 January 2022, Pixium Vision announced the publication in Nature Communications of peer-reviewed clinical data demonstrating the clinical benefit of the Prima System in Dry AMD patients
On 29 March 2022, Pixium Vision announced FDA approval of clinical trial expansion of Prima System US feasibility study to Stanford University.
On 24 June 2022, Pixium Vision expands its Board of Directors with the appointment of Anja Krammer and August Moretti.
The risk factors to which the Company is exposed are described in Appendix 1 to the 2021 Universal Registration Document that was filed on 30 April 2022 with the French Financial Markets Authority (AMF). Management's assessment of the nature and level of risks has not changed during the last half-year.
The 2021 annual report is available on the Group's website: https://www.pixium-vision.com/fr/2022/04/rapport-annuel-2021/ III – CONSOLIDATED FINANCIAL STATEMENTS FIRST HALF 2022
BALANCE SHEET
| (in thousands of euros) | Note | 30/06/2022 | 31/12/2021 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 4 | 1,162 | 1,341 |
| Property, plant and equipment | 5 | 261 | 300 |
| Use rights | 6 | 837 | 989 |
| Non-current financial assets | 7 | 84 | 54 |
| Deferred tax assets | – | – | |
| Total non-current assets | 2,344 | 2,684 | |
| Current assets | |||
| Inventories and work in progress | 8 | – | – |
| Research Tax Credit | 9 | 2,599 | 1,615 |
| Other current assets | 10 | 1,055 | 825 |
| Cash and cash equivalents | 11 | 7,221 | 14,505 |
| Total current assets | 10,874 | 16,945 | |
| TOTAL ASSETS | 13,218 | 19,629 | |
| LIABILITIES | |||
| Shareholders' equity | 12 | ||
| Share capital | 3,522 | 3,521 | |
| Additional paid-in capital | 4,048 | 24,063 | |
| Reserves* | (1,429) | (10,799) | |
| Currency translation differences | (95) | (41) | |
| Profit/(loss)* | (5,614) | (10,930) | |
| Total shareholders' equity | 431 | 5,814 | |
| Non-current liabilities | |||
| Non-current financial liabilities | 13 | 6,110 | 6,500 |
| Non-current lease liabilities | 17 | 580 | 730 |
| Non-current provisions* | 15 | 94 | 102 |
| Total non-current liabilities | 6,784 | 7,333 | |
| Current liabilities | |||
| Current financial liabilities | 13 | 2,274 | 1,588 |
| Current provisions | 16 | 0 | 8 |
| Trade payables, related accounts and other current liabilities | 18 | 3,121 | 3,398 |
| Current lease liabilities | 17 | 320 | 315 |
| Derivative financial instruments | 14 | 287 | 1,174 |
| Total current liabilities | 6,002 | 6,482 | |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 13,218 | 19,629 |
| At 30 June | ||||
|---|---|---|---|---|
| (in thousands of euros) | Note | 2022 | 2021 | |
| Operating revenue | 19 | |||
| Net sales | – | – | ||
| Research Tax Credit | 983 | 851 | ||
| Grants | 61 | 105 | ||
| Other revenues | 0 | 844 | ||
| Total revenues | 1,044 | 1,801 | ||
| Operating expenses | 20 | |||
| Research and development* | (4,086) | (3,687) | ||
| General and administrative expenses | (3,062) | (2,944) | ||
| Total expenses | (7,149) | (6,631) | ||
| Operating income | (6,105) | (4,830) | ||
| Financial revenue | 829 | – | ||
| Financial expenses* | (339) | (715) | ||
| Financial income | 22 | 490 | (715) | |
| Pre-tax current income | (5,614) | (5,546) | ||
| Corporate income tax | – | – | ||
| Net income | (5,614) | (5,546) | ||
| Net earnings per share | 24 | (0.12) | (0.12) | |
| Diluted earnings per share | 24 | (0.12) | (0.12) | |
| Other non-transferable comprehensive income | ||||
| Actuarial gains/(losses) on pension plans** | 17 | 7 | ||
| Change in fair value valuation | 31 | (26) | ||
| Total profit/(loss) for the period | (5,566) | (5,564) |
* Interest expense for the year ended 30 June 2021 has been restated in accordance with the IFRIC decision on IAS 19, as described in Note 2
** Actuarial gains/(losses) on pension assets for the year ended 30 June 2021 have been restated in accordance with the IFRIC decision on IAS 19, as described in Note 2.
| At 30 June | |||
|---|---|---|---|
| (in thousands of euros) | Note | 2022 | 2021 |
| Cash flows from operating activities | |||
| Net income for the period* | (5,614) | (5,446) | |
| Reconciliation of net profit to cash flows used in operating activities | |||
| Amortization and depreciation of intangible and tangible assets | 215 | 260 | |
| Increase in provisions, net of reversals* | (16) | (42) | |
| Expenses on share-based payments | 21 | 196 | 139 |
| Retirement benefit obligations* | 15 | 17 | 7 |
| Unwinding of conditional advances | 301 | 298 | |
| Leases | 176 | 161 | |
| Other items | (892) | 315 | |
| Operating cash flows before change in working capital requirements | (5,617) | (4,408) | |
| Inventories | – | – | |
| Other receivables | (1,213) | (1,091) | |
| Trade payables | (294) | (355) | |
| Other current liabilities | (60) | (260) | |
| Net cash flows from operating activities | (7,064) | (6,115) | |
| Acquisitions/Disposals of property, plant and equipment | (25) | (33) | |
| Acquisitions of intangible assets | – | – | |
| Acquisitions (decrease) of financial assets | (1) | 0 | |
| Net cash flows from investment activities | (27) | (32) | |
| Capital increase | 12 | – | 6,250 |
| Costs paid in relation to equity transactions | (10) | (406) | |
| (BSA share warrant subscription) | – | – | |
| Exercise of share warrants (BSA) and founders' warrants (BSPCE) | – | 20 | |
| Increase/(Decrease) in repayable advances | – | – | |
| Increase/(Decrease) in financial debt | (17) | 1 | |
| Payment of lease liabilities | (169) | (152) | |
| Net cash flows from financing activities | (196) | 5,713 | |
| Effect of exchange rate changesvariations on cash | 4 | – | |
| Opening cash and cash equivalents | 14,505 | 10,566 | |
| Closing cash and cash equivalents | 7,221 | 10,131 | |
| (Decrease)/Increase in cash position | (7,284) | (435) |
* Net income, provision allowances net of reversals and pension obligations for the year ended 30 June 2021 have been restated in accordance with the IFRIC decision on IAS 19, as described in Note 2.
| Share capital | |||||||
|---|---|---|---|---|---|---|---|
| (in thousands of euros) | Number of shares |
Amount | Additional paid-in capital |
Reserves | Currency translation differences |
Profit/(loss) | Total equity |
| at 31 December 2020* | 43,967,034 | 2,638 | 13,415 | (2,356) | - | (9,134) | 4,563 |
| Appropriation of prior result | (9,134) | 9,134 | – | ||||
| Capital increase | 14,719,599 | 883 | 7,130 | (13) | 8,000 | ||
| Net income | (10,930) | (10,930) | |||||
| Fees recorded in diminution of issuance premium |
(1,115) | (1,115) | |||||
| Issue of warrants | 71 | 71 | |||||
| Neutralisation of treasury shares | (36) | (36) | |||||
| ORNAN 2019 | 5,797 | 5,797 | |||||
| BSA 2021 | (1,235) | (1,235) | |||||
| Change in fair value valuation | 31 | 31 | |||||
| Actuarial gains/(losses) | 6 | 6 | |||||
| Share-based payments | 486 | 486 | |||||
| Change in repayable advances** | 216 | 216 | |||||
| Impact of change | (41) | (41) | |||||
| At 31 December 2021 | 58,686,633 | 3,521 | 24,063 | (10,799) | (41) | (10,930) | 5,814 |
| Appropriation of prior result | (10,930) | 10,930 | – | ||||
| Capital increase | 8,500 | 0 | (0) | – | |||
| Allocation of issue premium to regulated reserves |
(20,000) | 20,000 | – | ||||
| Net income | (5,614) | (5,614) | |||||
| Fees recorded in diminution of issuance premium |
(10) | (10) | |||||
| Neutralisation of treasury shares | 29 | 29 | |||||
| ORNAN 2019 | (5) | (5) | |||||
| Change in fair value valuation | 57 | 57 | |||||
| Actuarial gains/(losses) | 17 | 17 | |||||
| Share-based payments | 196 | 196 | |||||
| Impact of change | (54) | (54) | |||||
| At 30 June 2022 | 58,695,133 | 3,521 | 4,048 | (1,429) | (95) | (5,614) | 431 |
*The balance at 1 January 2021 has been restated in accordance with the IFRIC decision on IAS 19, as described in greater detail in Note 3 of the consolidated financial statements at December 31, 2021.
**Impact of the correction to conditional advances (see Note 3.10 of the consolidated financial statements at December 31, 2021)
The Company is described in Chapter I of this document along with the major events of the first half of 2022. Subsequent events are described in Note 28 of this chapter.
As at 30 June 2022, the scope consolidation comprises two entities, the parent company, Pixium Vision SA, a French société anonyme (limited company) whose registered office is at 74 rue du Faubourg Saint Antoine, 75012 Paris, and a subsidiary, Pixium Vision LLC, which was incorporated on 16 November 2017 and is domiciled in the State of Delaware, USA.
Pixium Vision SA owns 100% of the share capital of the subsidiary, which is fully consolidated in the consolidated financial statements.
The condensed consolidated financial statements present the operations of the Pixium Vision Group (the "Group") as at 30 June 2022.
The condensed consolidated financial statements as at 30 June 2022 have been prepared under the responsibility of the management of Pixium Vision. The condensed consolidated financial statements were approved by the Company's Board of Directors at its meeting on 20 July 2022.
The Company's condensed consolidated financial statements are presented in thousands of euros, unless stated otherwise.
International standards include the International Financial Reporting Standards (IFRS), the International Accounting Standards (IAS) and the interpretations of the Standing Interpretations Committee (SIC) and the International Financial Reporting Interpretations Committee (IFRIC).
The IFRS standards as adopted by the European Union differ in certain respects from the IFRS standards published by the IASB. However, the Group has ensured that the financial information for the periods presented would not have been materially different if the IFRS standards as published by the IASB had been applied.
All standards adopted by the European Union are available on the following website: https://www.efrag.org/Endorsement
The condensed consolidated financial statements as at 30 June 2020 are prepared in accordance with IAS 34 – Interim Financial Reporting, as adopted by the European Union, which permits presenting a selection of explanatory notes.
The accompanying notes do not contain all information required for complete annual financial statements and should be read in conjunction with the 2021 consolidated financial statements.
These financial statements are a set of financial statements in addition to the Company's historical financial statements, which are prepared in accordance with French accounting principles.
The Group's business is not subject to significant seasonal variations.
The condensed consolidated financial statements are prepared in accordance with the accounting principles and policies applied by the Group to the 2021 financial statements (described in Note 3 to the consolidated financial statements as at 31 December 2021) and in accordance with the standards and interpretations in force on 1 January 2022.
The European Union has adopted the following standards, which are of mandatory application for the Company for its financial year beginning on 1 January 2022 and which have no material impact on the Company's consolidated financial statements:
These amendments apply prospectively and are mandatory for accounting periods beginning on or after 1 January 2022. They update a reference to the Conceptual Framework without changing the accounting requirements for business combinations.
This amendment does not apply to the Company.
These amendments apply retrospectively as from 1 January 2022. They delete the exception to the general principle in paragraph 17(e) of IAS 16, which prohibits an entity from deducting from the cost of an item of property, plant and equipment the net proceeds generated during the operational testing of the asset. The proceeds from the sale of such assets must be recognised in the income statement.
This amendment does not apply to the Company.
These amendments apply retrospectively as from 1 January 2022. They clarify the costs that a company should include in determining whether a contract is onerous and, in particular, that the costs of fulfilling a contract include both incremental costs, such as the costs of direct labour and materials, and the allocation of other costs that relate directly to the contract, such as the allocation of depreciation expense for an item of property, plant and equipment used inter alia in fulfilling the contract.
This amendment does not apply to the Company.
The main standards concerned are:
IFRS 9: these amendments clarify that fees should be included in the 10% test for derecognition of financial liabilities;
IFRS 16: these amendments modify illustrative example 13 to remove the illustration of payments from the lessor in connection with leasehold improvements;
IFRS 1 and IAS 41, to which minor amendments not applicable to the Company have been made.
In April 2021, the IFRS IC issued a decision on accounting for the costs of configuring or customising software used in Software as a Service (SaaS) mode.
The Company has identified its various SaaS contracts and completed an analysis of the various types of costs incurred in order to identify costs whose initial treatment has been impacted by this decision. Based on its analysis, the Company has concluded that the customisation and configuration costs do not meet the IAS 38 criteria for capitalisation (i.e. the Company does not control the SaaS solution). Therefore, these costs are expensed as they are incurred.
At the end of the first half of 2021, the IAS Board endorsed the IFRIC's interpretation of IAS 19 on attributing employee benefits to periods of service. In particular, it clarifies the attribution periods to be taken into account in determining the cost of the benefits.
In France, the IFRIC's clarifications have resulted in a change in the method for measuring obligations to pay end-of-career bonuses under collective agreements that cap these bonus rights and/or define them by length of service brackets.
The national collective agreement for the metallurgy industry, which applies to the Group's French employees, caps these rights and includes length of service brackets.
The Group has restated the comparable information presented, which therefore differs from previously published information. The retrospective impact of the change of policy at the beginning of the first period presented has been recognised in equity in accordance with the provisions of IAS 8. A breakdown of the full impact is provided below.
| Note | At 30 June |
IFRIC IAS 19 impact |
At 30 June |
|
|---|---|---|---|---|
| 2021 | 2021* | |||
| Research and development | (3,692) | 4.8 | (3,687) | |
| of which Wages and salaries | (1,775) | 4.8 | (1,770) | |
| General and administrative expenses | (2,945) | 0.5 | (2,944) | |
| of which Wages and salaries | (668) | 0.5 | (668) | |
| Total expenses | 20 | (6,637) | 5.3 | (6,631) |
| Operating income | (4,836) | 5.3 | (4,830) | |
| Financial expenses | 22 | (716) | 0.2 | (715) |
| of which Oother financial expenses | (0.3) | 0.2 | (0.2) | |
| Pre-tax current income | (5,551) | 5.5 | (5,546) | |
| Net income | (5,551) | 5.5 | (5,546) | |
| Earnings per share | 24 | |||
| — Net earnings per share | (0.12) | - | (0.12) | |
| — Diluted earnings per share | (0.12) | - | (0.12) |
Impact on other non-recyclable items of comprehensive income
| in thousands of € | Note | At 30 June |
IFRIC IAS 19 impact |
At 30 June |
|---|---|---|---|---|
| 2021 | 2021* | |||
| Net income | (5,551) | 5.5 | (5,546) | |
| Actuarial gains/(losses) on pension plans Other non-transferable comprehensive |
7 | (0.5) | 7.5 | |
| income | (19.2) | (0.5) | (18.6) | |
| Total profit/(loss) for the period | (5,570) | 6 | (5,564) |
| in thousands of € | Note | At 30 June |
IFRIC IAS 19 impact |
At 30 June |
|---|---|---|---|---|
| 2021 | 2021* | |||
| LIABILITIES | ||||
| Shareholders' equity | ||||
| Reserves | (11,477) | 80 | (11,398) | |
| Profit/(loss) | (5,551) | 5.5 | (5,546) | |
| Total shareholders' equity | 12 | 3,383 | 85 | 3.468 |
| Non-current liabilities | ||||
| Non-current provisions | 15 | 180 | (85) | 95.3 |
| Total non-current liabilities | 8,108 | (85) | 8,023 | |
| TOTAL LIABILITIES AND SHAREHOLDERS' | - | |||
| EQUITY | 16,437 | 16,437 |
| in thousands of € | Note | At 30 June |
IFRIC IAS 19 impact |
At 30 June |
|---|---|---|---|---|
| 2021 | 2021* | |||
| Cash flows from operating activities | ||||
| Net income for the period | (5,551) | 5.5 | (5,546) | |
| Retirement benefit obligations | 7 | (0.5) | 7.5 | |
| Operating cash flows before change in working capital requirements |
(4,408) | - | (4,408) |
Since inception, our operation has been financed primarily through the sales of our ordinary shares and warrants, from the issuance of convertible notes, and the receipt of research as well as clinical grants. Our consolidated financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and the satisfaction of liabilities within the normal course of business. We are subject to the risks and uncertainties associated with a business with no revenues and that is developing a novel medical device, including limitations on our operating resources. We have incurred recurring operating losses and negative operating cash flows since inception and expect to continue to do so in the near future.
The company's financial statements have been prepared on a going concern basis, taking into account the following elements:
If the conditions precedent are not met, the company may not be able to realize its assets and liabilities and pay its debts in the normal course of business. As a result, this situation gives rise to a significant going concern uncertainty.
In preparing these consolidated financial statements, management has made judgements and estimates that affect the application of the Company's accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revised estimates are applied prospectively.
Estimates and judgments are continuously evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.
The main estimates and judgements made by management relate to:
Intangible assets break down as follows:
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Patents, licences, trademarks | 10,499,989 | 10,499,989 |
| Software | 217,988 | 217,988 |
| Total historical cost | 10,717,977 | 10,717,977 |
| Accumulated amortisation of patents, licenses, trademarks | 4,289,615 | 4,111,072 |
| Accumulated amortisation of software | 217,988 | 217,988 |
| Impairment losses | 5,048,350 | 5,048,350 |
| Accumulated amortisation | 9,555,952 | 9,377,410 |
| Net total | 1,162,024 | 1,340,567 |
Amortisation expense totalled to €179,000 at the end of June 2022 and €386,000 for the year ending 31 December 2021. These expenses are recognised as general and administrative expenses.
As part of our annual intangible asset review, the Company hasn't booked additional impairment in 2022.
| (Amounts in euros) | 01/01/2022 | Increase | Decrease | 30/06/2022 |
|---|---|---|---|---|
| Industrial and laboratory equipment | 1,274,075 | 7,877 | – | 1,281,952 |
| Building fixtures and fittings | 500,693 | – | – | 500,693 |
| IT equipment | 262,552 | 15,211 | – | 277,763 |
| Office furniture | 307,558 | 2,342 | – | 309,899 |
| Non-current assets in progress | – | – | – | – |
| Other property, plant and equipment | – | – | – | – |
| Gross total | 2,344,877 | 25,430 | – | 2,370,307 |
| Accumulated amortisation of industrial and laboratory equipment |
1,056,071 | 16,074 | – | 1,072,145 |
| Accumulated amortisation of building fixtures and fittings | 463,831 | 29,613 | – | 493,444 |
| Accumulated amortisation of IT equipment | 219,132 | 12,589 | – | 231,721 |
| Accumulated amortisation of office furniture | 297,741 | 6,740 | – | 304,481 |
| Accumulated amortisation of other property, plant and equipment |
– | – | – | – |
| Impairment losses | 7,680 | – | – | 7,680 |
| Total accumulated amortisation | 2,044,455 | 65,015 | – | 2,109,470 |
| Net total | 300,422 | (39,584) | – | 260,837 |
Depreciation expense totalled to €65,000 at the end of June 2022 (€134,000 at the end of December 2021), of which €56,000 was charged to research and development expenses (€117,000 in 2021) and €8,000 was charged to general and administrative expenses (€18,000 in 2021).
The table below breaks down use rights by category:
| (Amounts in euros) | Real estate | Other assets | Total |
|---|---|---|---|
| At 30 June 2022 | |||
| Contracts (1) | 1,580,718 | 102,268 | 1,682,986 |
| Contractual amendments | 229,551 | (10,608) | 218,943 |
| Gross total | 1,810,269 | 91,661 | 1,901,929 |
| Amortisation | 1,010,894 | 54,047 | 1,064,941 |
| Net total | 799,375 | 37,614 | 836,989 |
| (1) See Note 3.14 "Leases" of the consolidated financial statements at December 31, 2021 | |||
| (Amounts in euros) | Real estate | Other assets | Total |
| At 31 December 2021 | |||
| Contracts (1) | 1,580,718 | 102,268 | 1,682,986 |
| Contractual amendments | 221,871 | (10,608) | 211,263 |
| Gross total | 1,802,589 | 91,661 | 1,894,249 |
| Amortisation | 859,019 | 46,328 | 905,347 |
| Net total | 943,570 | 45,333 | 988,902 |
(1) See Note 3.14 "Leases" of the consolidated financial statements at December 31, 2021
The components of lease liabilities are presented in Note 17.
Amortisation expense of rights of use totalled to €160,000 at the end of June 2022 (€294,000 at the end of December 2021), of which €126,000 was charged to research and development expenses (€236,000 in 2021) and €24,000 was charged to general and administrative expenses (€58,000 in 2021).
| (Amounts in euros) | 01/01/2022 | Increase | Decrease | 30/06/2022 |
|---|---|---|---|---|
| Deposits and guarantees | 80,694 | 1,344 | – | 82,038 |
| Financing guarantees | – | – | – | – |
| Gross total | 80,694 | 1,344 | – | 82,038 |
| (Amounts in euros) | 01/01/2020 | Allowances | Reversals | 30/06/2022 |
| Provisions, deposits and guarantees | (26,369) | 28,295 | – | 1,926 |
| Total provisions | – | – | – | – |
| Net total | 54,325 | 28,295 | – | 83,964 |
| (Amounts in euros) | 01/01/2021 | Increase | Decrease | 31/12/2021 |
|---|---|---|---|---|
| Deposits and guarantees | 78,364 | 2,330 | – | 80,694 |
| Financing guarantees | – | – | – | – |
| Gross total | 78,364 | 2,330 | – | 80,694 |
| (Amounts in euros) | 31/12/2021 | Allowances | Reversals | 31/12/2021 |
| Provisions, deposits and guarantees | – | – | (26,369) | (26,369) |
| Total provisions | – | – | – | – |
| Net total | 78,364 | 2,330 | (26,369) | 54,325 |
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Raw materials | – | 3,215 |
| Finished goods | – | – |
| Total historical cost | – | 3,215 |
| Depreciation of inventories and work in progress |
– | (3,215) |
| Total net value of inventories and work in progress | – | – |
In 2022, the Company scrapped all items associated with the IRIS system, which had been fully impaired in previous years, in accordance with IAS 36.
The Company qualifies for the provisions of Articles 244 quater B and 49 septies F of the French Tax Code on the research tax credit. In accordance with the principles described in Note 3.13 of the notes to the IFRS financial statements prepared at 31 December 2021, the research tax credit is recognised in "Other revenues" in the year to which the qualifying research expenses relate according to IAS 20.
The change in this Research Tax Credit during the last two financial years is shown below:
| Change in research tax credit receivable (in euros) | Amount |
|---|---|
| Receivable at 01/01/2021 | 1,383,023 |
| Operating revenue | 1,615,488 |
| Payment received | (1,400,288) |
| Receivable at 31/12/2021 | 1,615,488 |
| Receivable at 01/01/2022 | 1,615,488 |
| Operating revenue | 983,205 |
| Payment received | – |
| Receivable at 30/06/2022 | 2,598,693 |
Other current assets break down as follows:
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Suppliers, advances and deposits | 117,656 | 95,101 |
| State, VAT | 441,404 | 329,025 |
| Liquidity agreement | 49,058 | 57,228 |
| Prepaid expenses | 437,115 | 312,510 |
| Other | 8,859 | 30,759 |
| Net total | 1,054,092 | 824,624 |
The cash and cash equivalents item break down as follows:
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Cash | 7,221,243 | 14,504,880 |
| Term deposits | – | – |
| Net total | 7,221,243 | 14,504,880 |
As of 31 December 2022, the share capital totalled to €3,521,707.98 (three million five hundred and twenty-one thousand seven hundred and seven euros and ninety-eight cents). It is divided into 58,695, 133 fully subscribed and paid-in shares with a nominal value of €0.06 each.
This number excludes free shares (AGAs), authorised and unissued stock options (SOs), share warrants (BSAs) and founders' warrants (BSPCEs) granted to certain investors and individuals who may or may not be Group employees.
All the shares give their owners the right to a proportional share of the net income and net assets of the Company.
| - €€ | Share capital | Additional paid in capital |
Number of shares |
|---|---|---|---|
| At 31 December 2020 | 2,638,022 | 13,414,980 | 43,967,034 |
| Share warrants (BSA)/Founders' warrants (BSPCE) | - | 51,217 | 337,988 |
| ORNAN 2019 | 384,339 | 5,026,690 | 6,067,670 |
| Free shares (AGA) | 13,006 | - | 216,773 |
| Capital increase (July 2021) | 485,830 | 6,805,657 | 8,097,168 |
| Warrants (BSA 2021 US) | - | (1,235,312) | - |
| At 31 December 2021 | 3,521,198 | 24,063,232 | 58,686,633 |
| Stock warrants/Founders' warrants | |||
| ORNAN 2019 | (5,250) | ||
| Free shares (AGA) | 510 | 8,500 | |
| Expenses deducted from the issue premium | (10,000) | ||
| Allocation of retained earnings to additional paid-in capital | (20,000,000) | ||
| At 30 June 2022 | 3,521,708 | 4,047,982 | 58,695,133 |
In 2022, in order to receive European and French grants, and in accordance with the requirements of the French Commercial Code, the Company reclassified €20 million losses recognised in retained earnings as additional paid-in capital.
In July 2021, the Company completed a private placement restricted to US investors for a gross amount of €8 million (including costs of €1.2 million) and issued a total of 4,615,386 warrants (4,048,584 warrants were attached to the 8,097,168 ordinary shares issued at the time the private placement restricted to US investors was completed (measured at a fair value of €1.23 million on 12 July 2021) and 566,802 warrants were issued to H.C. Wainwright & Co, as placement agent of the private placement. Each warrant confers the right to subscribe for one ordinary share of the Company at an exercise price of €1.24 and may be exercised at any time until 15 July 2026. The warrants were issued electronically in bearer form, were detached upon issue and are freely negotiable. Warrants are not listed on Euronext Growth market or on any other stock exchange. The warrants issued to H.C. Wainwright & Co have been accounted for as a share-based payment for investment services in accordance with IFRS 2. As these warrants vest immediately and are exercisable, their fair value on the award date (€176,000) was recognised as general and administrative expenses.
The Group has issued share warrants (BSAs), founders' warrants (BSPCEs), stock options (SOs) and free shares (AGAs) as follows:
| Type | Date | Total number of instruments originally issued |
Number of instruments exercised |
Number of lapsed instruments |
Number of outstanding instruments |
Number of potential shares (*) |
|---|---|---|---|---|---|---|
| BSAs | ||||||
| BSA 2013 | 18/03/2013 | 1,978,020 | (1,871,903) | 0 | 106,117 | 18,393** |
| 2015 BSAs** | 23/06/2015 | 33,333 | 0 | 33,333 | 0 | 0 |
| New 2016 Kreos BSAs | 27/06/2017 | 140,935 | 0 | 0 | 140,935 | 422,805*** |
| 2018 Kreos BSAs | 25/07/2018 | 1 | 0 | 0 | 1 | 167,084** |
| HCW BSAs | 12/07/2021 | 566,802 | 0 | 0 | 566,802 | 566,802 |
| 2021 US BSAs** | 12/07/2021 | 4,048,584 | 0 | 0 | 4,048,584 | 4,048,584 |
| BSA 2021 | 26/11/2021 | 731,670 | 0 | 0 | 731,670 | 731,670 |
| AGAs | ||||||
| AGA 2019-02 | 12/12/2019 | 375,000 | (191,616) | (55,802) | 127,582 | 127,582** |
| AGA 2020 | 17/02/2021 | 17,000 | (8,500) | 0 | 8,500 | 8,500 |
| AGA 2022-1 | 17/02/2022 | 959,763 | 0 | (22,425) | 937,338 | 937,338 |
| SO 2019-01 | 02/10/2019 | 1,107,818 | 0 | 0 | 1,117,982 | 1,117,982** |
|---|---|---|---|---|---|---|
| SO 2019-02 | 12/12/2019 | 50,000 | 0 | 0 | 50,807 | 50,807** |
| SO 2020 | 23/07/2020 | 353,795 | 0 | 0 | 353,795 | 353,795 |
| Total | 10,362,721 | (2,072,019) | (111,560) | 8,190,113 | 8,551,342 |
(*) Instruments issued before 17/6/2014 (date of the one-for-six reverse stock split of the Group's shares) have been adjusted accordingly. (**) The number of potential shares was adjusted following the capital increases of 7 May 2018 and 6 July 2020, in accordance with the statutes
on BSA warrants and BSPCE warrants (implementation of legal measures to protect the holders of securities), and in accordance with the adjustment clauses of the free share and stock option plan.
(***) See New 2016 Kreos BSAs in the general exercise requirements below.
The characteristics of these plans are described in greater detail in Note 21.
In March 2013, the Board approved the BSA 2013 grant pursuant to which 1,978,020 warrants were originally issued entitling originally the holder to subscribe to one ordinary share before the one-for-six (6) reverse stock split decision taken at the time of the IPO. These warrants were granted to consultants of the Company. These warrants became fully vested and exercisable following the IPO in France of the Company in June 2014 and expire ten years from the grant date.
In February 2014, the Board approved the BSA 2013 grant pursuant to which 820,000 warrants were originally issued entitling the holder to purchase one ordinary share before the one-for-six (6) reverse stock split decision taken at the time of the IPO. These warrants were granted to consultants of the Company. These warrants became fully vested and exercisable following the IPO of the Company in June 2014. The warrants may be exercised at any time for up to ten full years from the award date.
On 17 December 2014, the Board approved the BSA 2014 grant pursuant to which 40,000 warrants were originally issued entitling the holder to subscribe to one ordinary share. The warrants were granted to consultants of the Company. These warrants vest ratably over three years from the grant date. The expiration date of the BSA 2014 was seven years from the grant date and the BSA 2014 lapse on 17 December 2021.
In June 2015, the Board approved the BSA 2015 grant pursuant to which 33,333 warrants were originally issued entitling the holder to subscribe to one ordinary share. The warrants were granted to an officer of the Company. These warrants vest ratably over three years from the grant date and expire seven years from the grant date.
In July 2021, in connection with the private placement restricted to US investors, the Company issued 566,802 warrants to H.C Wainwright & Co, as placement agent for the private placement. Each warrant confers the right to subscribe for one ordinary share of the Company at an exercise price of €1.24 and may be exercised at any time until 15 July 2026.
In July 2021, in connection with the private placement reserved for US investors, the Company issued 4,048,584 warrants (2021 US share warrants) which were attached to the 8,097,168 ordinary shares issued to US investors. Each warrant entitles the holder to subscribe for one ordinary share of the Company at an exercise price of €1.24 and may be exercised at any time until 15 July 2026.
In July 2021, the Board approved the BSA 2021 grant pursuant to which 731,670 warrants were issued entitling the holder to subscribe to one ordinary share. The warrants were granted to a consultant of the Company. The vesting period is three years from the first anniversary of the grant date (award of 25% at the end of the first year and the balance at the rate of 1/36th per month of continued presence as from the first anniversary of the grant date).
In March 2013, the Board approved the BSPCE Plan pursuant to which 2,000,517 warrants were originally issued entitling the holder to purchase one ordinary share before the one-for-six (6) reverse stock split decision taken at the time of the IPO. These warrants were granted to employees and officers of the Company. These warrants became fully vested and exercisable following the IPO of the Company in June 2014. The warrants may be exercised at any time for up to ten full years from the award date.
In October 2013, the Board approved the BSPCE Plan pursuant to which 824,859 warrants were originally issued entitling the holder to purchase one ordinary share before the one-for-six (6) reverse stock split decision taken at the time of the IPO. These warrants were granted to employees and officers of the Company. These warrants became fully vested and exercisable following the IPO of the Company in June 2014. The warrants may be exercised at any time for up to ten full years from the award date.
SOs
In February 2014, the Board approved the BSPCE Plan pursuant to which 2,809,933 warrants were originally issued entitling the holder to purchase one ordinary share before the one-for-six (6) reverse stock split decision taken at the time of the IPO. These warrants were granted to employees and officers of the Company. These warrants became fully vested and exercisable following the IPO of the Company in June 2014. The warrants may be exercised at any time for up to ten full years from the award date.
The remaining BSPCE were exercised during 2021 and there exists no more BSPCE exercisable.
In July 2019, the Board granted 20,000 free shares to a single beneficiary under the AGA 2019-1 plan entitling the holder to obtain one of our ordinary shares. These shares vest over a two-year period and have a one-year lock-up period. These shares are not subject to any performance targets. In July 2021, the Board recorded the definitive allocation of the AGA 2019- 1 and the issuance of an aggregate of 20,000 ordinary shares.
In December 2019, the Board granted 375,000 free shares under the AGA 2019-2 plan to employees and officers of the Company entitling originally the holder to obtain one of our ordinary shares. These shares are subject to the following performance conditions:
These conditions are independent and each one is a condition for 50% of the award.. These shares vest over a two-year period and have a one-year lock-up period.
On 8 April 2021, the Board recorded the completion of the first performance condition before 31 March 2021.
On 2 December 2021, the Board decided to waive the second performance condition attached to the second tranche of the initial allocation and to extend the vesting period of the second tranche of one year, until 12 December 2022.
On 16 December 2021, the Board recorded the definitive allocation of the first tranche of the AGA 2019-2 and the issuance of an aggregate of 139,960 ordinary shares.
In December 2019, the Board granted 56,250 free shares to a single beneficiary under the AGA 2019-3 plan entitling originally the holder to obtain one of our ordinary shares. These shares vest over two years and are not subject to any performance conditions and have a one-year lock-up period. On 16 December 2021, the Board recorded the definitive allocation of the AGA 2019-3 and the issuance of an aggregate of 56,813 ordinary shares.
In February 2021, the Board granted 17,000 free shares to a single beneficiary under AGA 2020 plan entitling originally the holder to obtain one of our ordinary shares. These shares are subject to the following performance conditions:
These conditions are independent and each one is a condition for 50% of the award. These shares vest over a one-year period and have a one-year lock-up period.
On 8 April 2021, the Board recorded the completion of the first performance condition before 31 March 2021. On 2 December 2021, the Board decided to waive the second performance condition attached to the second tranche and to extend the vesting period of this second tranche of one year, until 17 February 2023. The vesting of the first tranche remains unchanged and will come to an end on 17 February 2022, subject to the continued presence of the beneficiary.
On 17 February 2022, the Board granted 959,763 free shares under the AGA 202129-1 plan to employees and officers of the Company entitling originally the holder to obtain one of our ordinary shares. These shares are not subject to any performance conditions. The award of the AGA 2022-2 free performance shares will be divided into three tranches (Tranche 1, Tranche 2 and Tranche 3), representing, respectively, 25%, 50% and 25% of the total award, and will vest if the conditions stated below, as well as the performance conditions specific to each tranche, which are independent, are fulfilled within the deadlines specified below:
• Tranche 1 (representing 25% of the award): implantation of all patients in the US feasibility study ("Performance Condition 1") to be achieved by 31 December 2022 ("Performance Condition 1 Deadline");
In addition, the vesting of the AGA 2022-1 free performance shares will be conditioned on (i) the beneficiary's presence in the Company (or in an Affiliate) throughout the Vesting Period and (ii) the existence of sufficient reserves to allow the vesting of the shares to be issued or in existence at the expiry of the Vesting Period, regardless of whether the Performance Conditions have been met.
The duration of the Vesting Period for the AGA 2022-1 free performance shares has been set at two (2) years and will, therefore, end on 17 February 2024, and will be followed by a one (1)-year Lock-up Period, which will end on 17 February 2025.
In October 2019, the Board granted 1,107,818 stock options to the Company's CEO. These stock options entitled the holder originally to purchase one ordinary share. Twenty percent of these options do not contain any performance targets and vest in May 2020. Forty percent of these options do not contain any performance targets and vest ratably over a three-year term starting May 2020. The remaining (40% of the initial allocation) contain various performance targets that must be achieved by May 2023 and vest ratably over three years as from May 2020. Vested stock options may be exercised at any time for up to seven full years from award date.
In December 2019, the Board granted 50,000 stock options to a single beneficiary. These stock options entitled the holder originally to purchase one ordinary share. A tranche of 25% of the options vest at the end of the first year while the remainder vest ratably over a three-year term starting with the first anniversary. All options will vest and will be exercisable on the fourth anniversary of the award. Vested stock options may be exercised at any time for up to seven full years from award date.
In July 2020, the Board awarded 353,795 stock options to the Company's CEO. These stock options entitle the holder to purchase one ordinary share. A fraction of the stock options (20%) awarded will vest on 23 July 2020 without any performance conditions. Forty percent of these options do not contain any performance targets and vest ratably over a three-year term starting with the first anniversary. The remaining (40% of the initial allocation) contain various performance targets that must be achieved by May 2023 and vest ratably over three years as from the first anniversary. All the options will vest and will be exercisable on the fourth anniversary of the award, provided the defined performance conditions are met. Vested stock options may be exercised at any time for up to seven full years from award date.
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Repayable advances | 5,774,318 | 5,473,683 |
| State-guaranteed loan | 2,077,608 | 2,026,612 |
| ORNAN 2019 | 525,900 | 586,600 |
| Other borrowings and financial liabilities | 6,579 | 1,457 |
| Total financial assets and liabilities | 8,384,405 | 8,088,352 |
| LT | 6,110,011 | 6,500,295 |
| ST | 2,274,393 | 1,588,057 |
The contractual maturity of the financial liabilities represents as follows 30 June 2022:
| (Amounts in euros) | At 30 June 2022 | <1 year | 1 to 5 years | <5 years |
|---|---|---|---|---|
| Repayable advances | 5,774,318 | 1,250,000 | 4,524,318 | - |
| State-guaranteed loan | 2,077,608 | 491,914 | 1,585,694 | - |
| ORNAN 2019 | 525,900 | 525,900 | - | - |
| Other borrowings and financial liabilities | 6,579 | 6,579 | - | - |
| Total financial assets and liabilities | 8,384,405 | 2,274,393 | 6,110,011 | - |
| (Amounts in euros) | At 31 December 2021 |
<1 year | 1 to 5 years | <5 years |
|---|---|---|---|---|
| Repayable advances | 5,473,683 | 500,000 | 4,973,683 | - |
| State-guaranteed loan | 2,026,612 | 500,000 | 1,526,612 | - |
| ORNAN 2019 | 586,600 | 586,600 | - | - |
| Other borrowings and financial liabilities | 1,457 | 1,457 | - | - |
| Total financial assetsliabilities | 8,088,352 | 1,588,057 | 6,500,295 | - |
Bpifrance Financement granted Pixium Vision a repayable advance in connection with its contribution to the "SIGHT AGAIN" competitiveness cluster fundamental R&D project.
This advance of a maximum amount of €5,225,680 breaks down as follow:
In the second half of 2022, Pixium Vision requested a repayment schedule extension form Bpifrance. The Bpifrance steering committee accepted the Company's request and agreed to postpone the repayment date by two years, i.e. the first repayment instalment will be due on 30 June 2024. As a result, the Company did not repay the first instalment of €500,000 due on 30 June 2022.
Because the Company had not yet received the amendment to the contract by 30 June 2022, the treatment of repayable advances remains unchanged in these financial statements.
After acceptance of the postponement of the repayment dates, the repayable advance will be reimbursed in accordance with the following timetable projected:
For a total of €5,850,000.
After the repayable advance has been fully repaid, Pixium Vision may be required to make additional payments over a period of two years of up to € 2,490,000 once its total sales reaches €100,000,000.
The difference in the value of the repayable advance depending on the rates used is recognised as a grant (IAS 20.10A). The repayable advance is discounted at a rate of 11.5%, using the bond financing set up with Kreos Capital as a reference. When the amendment is received from Bpifrance, the Company will assess the impact of this deferred repayment on its accounting treatment.
The portion of repayable advances to be repaid in more than one year is recognised as non-current liabilities, and the portion to be repaid within one year is recognised as current liabilities as prepaid income.
The impact of "unwinding" discounted advances is shown in financial expenses. (See Note 22)
Repayments are owed in case the project is successful. In the event of failure, a contractual revision clause allows the financial returns to be adjusted, if applicable.
The table below shows the breakdown of debts reported on the balance sheet for each repayable advance instalment:
| (Amounts in euros) | First instalment paid when the contract is signed |
Key stage 1 | Key stage 2 | Key stage 3 | Key stage 4 | Total |
|---|---|---|---|---|---|---|
| Opening balance sheet debt 1/1/2022 | 187,495 | 1,990,171 | 920,716 | 821,920 | 1,553,381 | 5,473,683 |
| (+) receipts | – | – | – | – | – | – |
| (-) repayments | – | – | – | – | – | – |
| Prepaid income upon receipt | – | – | – | – | – | – |
| Compound interest | 10,298 | 109,307 | 50,569 | 45,143 | 85,317 | 300,635 |
| (+) / (–) other movements | – | – | – | – | – | – |
| Balance sheet debt 30/6/2022 | 197,793 | 2,099,478 | 971,285 | 867,063 | 1,638,698 | 5,774,318 |
| LT | 4,524,318 | |||||
| ST | 1,250,000 | |||||
| Prepaid income recognised as grants | ||||||
| Prepaid income recognised as other current liabilities |
||||||
| (+) / (–) other movements | ||||||
| Interest rate | 4.57% | 5.69% | 6.48% | 7.55% | 9.03% | – |
| Discount rate | 11.5% | 11.5% | 11.5% | 11.5% | 11.5% | – |
| Maturity in years | 0–14 | 0–12 | 0–11 | 0–10 | 0–9 | – |
Interest rate: calculated based on the repayment schedule.
Discount rate: the market rate applied for Pixium Vision.
| First instalment paid when the contract is |
||||||
|---|---|---|---|---|---|---|
| (Amounts in euros) | signed | Key stage 1 | Key stage 2 | Key stage 3 | Key stage 4 | Total |
| Opening balance sheet debt 1/1/2021 | 177,498 | 1,884,053 | 871,622 | 778,094 | 1,470,553 | 5,181,819 |
| (+) receipts | – | – | – | – | – | – |
| (-) repayments | – | – | – | – | – | – |
| Prepaid income upon receipt | – | – | – | – | – | – |
| Compound interest | 14,855 | 170,246 | 84,018 | 82,667 | 156,235 | 508,021 |
| (+) / (–) other movements(*) | (4,858) | (64,128) | (34,924) | (38,841) | (73,407) | (216,158) |
| Balance sheet debt 31/12/2021 | 187,495 | 1,990,171 | 920,716 | 821,920 | 1,553,381 | 5,473,683 |
| LT | 4,973,683 | |||||
| ST | 500,000 | |||||
| Prepaid income recognised as grants | – | – | – | – | – | – |
| Prepaid income recognised as other current liabilities |
– | – | – | – | – | – |
| (+) / (–) other movements | – | – | – | – | – | – |
| Interest rate | 4.57% | 5.69% | 6.48% | 7.55% | 9.03% | – |
| Discount rate | 11.5% | 11.5% | 11.5% | 11.5% | 11.5% | – |
| Maturity in years | 0–14 | 0–12 | 0–11 | 0–10 | 0–9 | – |
Interest rate: calculated based on the repayment schedule.
Discount rate: the market rate applied for Pixium Vision.
(*) In 2021, the Company adjusted the calculation of repayable advances in line with the change in repayment schedule.
On 31 July 2020, the Company received a state guaranteed loan of €2.5 million that bears interest at rates between 1% and 2.5%. The Company has the option to repay the full balance and any accrued interest within one year or to pay the interest only in year one and defer the principal payments to be paid in equal instalments over 5 years starting September 2022. The Company has elected to pay the loan back over 5 years beginning in September 2022. There are no covenants or collateral associated with this debt.
The difference in the value of the State-guaranteed loan is depending on the rates used is recognised as a grant (IAS 20.10A). The State-guaranteed loan is discounted at a rate of 8.0% with reference to the market rate applicable in 2020.
The portion of the repayable advances State-guaranteed loan to be repaid in more than one year is recognised as non-current liabilities, and the portion to be repaid within one year is recognised as current liabilities within prepaid income.
The impact of "unwinding" discounted advances is shown in financial expenses. (See Note 22)
On 5 November 2019, the Company signed a financing contract with European Select Growth Opportunities Fund (ESGO) for a maximum of €10 million of convertible notes (ORNAN 2019) for term of 30 months. The Company also drew down of the first tranche of notes for €1.25 million, consisting of 125 convertible notes of €0.01 million each.
On 31 December 2019, 82 of these notes were converted for 1,617,961 shares, resulting in an increase of additional paid in capital of approximately €0.82 million. The remaining €0.42 million is included in the current portion of bonds and convertible debt on the Company's consolidated balance sheet as of 31 December 2019. These notes were converted into approximately 535,000 shares, \$0.07 (€0.06) par value ordinary shares in February 2020 bringing the outstanding balance on this tranche to zero as of 31 December 2020.
In February 2020, the Company drew down the second tranche of €1.25 million, consisting of 125 convertible notes of €0.01 million each. In April 2020, a portion of these notes were converted for approximately 915,000 ordinary shares. In May 2020, all of the remaining notes were converted for approximately 944,000 ordinary shares, bringing the outstanding balance of the second tranche to zero as of 31 December 2020.
In May 2020, the Company drew down the third tranche of €1.25 million, consisting of 125 convertible notes of €0.01 million each. In December 2020, a portion of these notes were converted for approximately 2,453,000 ordinary shares. In January 2021, all of the remaining notes were converted for approximately 43,000 ordinary shares.
In January 2021, the Company drew down the fourth tranche of €1.25 million, consisting of 125 convertible notes of €0.01 million each. In March 2021, all of the notes were converted for approximately 1,709,000 ordinary shares.
In March 2021, the Company drew down the fifth and the sixth tranche of €1.0 million each, consisting of 100 convertible notes of €0.01 million each. In March 2021, a portion of these notes were converted for approximately 1,209,000 ordinary shares. In April, all of the remaining notes were converted for approximately 143,000 ordinary shares.
In April 2021, the Company drew down the seventh tranche of €1.5 million, consisting of 150 convertible notes of €0.01 million each. At end of July 2021, all of the remaining notes were converted for approximately 1,487,000 ordinary shares.
In May 2021, the Company drew down the eighth and last tranche of €1.5 million, consisting of 150 convertible notes of €0.01 million each. As of 31 December 2021 a portion of these notes were converted for approximately 1,477,000 ordinary shares. In 2022 no bonds were converted. The remaining 50 convertible notes that have not yet been converted are included in the Company's consolidated balance sheet at their fair value for €0.5 million as of 30 June 2022.
The notes contain certain non-financial covenants which restrict the ability of the Company to pay dividends, issue additional stock or dispose of certain assets without the permission of the investor.
The convertible notes are zero-coupon notes with a 1-year duration from the date of the tranche's respective drawdown to convert the note into ordinary shares. At conversion, the issuer can redeem either (i) in new shares, and/or (ii) in cash for the full or partial amount of the conversion. At the maturity date, ORNAN 2019 for which no conversion notice will have sent shall be redeemed by the Company at its principal amount in cash.
On 27 June 2017 and 27 September 2016, the Company issued 140,935 stock warrants (the New 2016 Kreos BSAs) to Kreos Capital to Kreos Capital in connection with the entry into the Venture Loan Agreement in replacement of stock warrants issued on 27 September 2016 at the time of the entry into the Venture Loan Agreement which were concomitantly waived and. These warrants were abandoned and cancelled simultaneously. Each New 2016 Kreos BSA warrant (or BSA) gives rights to subscribe for N shares equal to the following formula: N = 1,100,000 / P / [Number of New BSA2016- KREOS] where P is equal to the lower of (i) €7.81, (ii) in the assumption of a new Initial Public Offering ("IPO") at a price lower than this amount, or (iii) any future issue of Transferable Securities at a lower exercise price than this amount in connection with a fund raising. In any event, the maximum number of shares to be issued was capped at 422,805.
Following the capital increase carried out in the first half of 2018 at a price of €1.87, each New 2016 Kreos BSA confers the right to subscribe for N = 4.1738 shares, i.e. 588,235 shares. However, under the issue contract for the New 2016 Kreos BSAs, at 31 December 2018, the maximum number of shares to be created is 422,805 for a capital increase of €25,368.30. T, the subscription price "P" of the New 2016 Kreos BSAs which is currently €0.5 on the basis of the subscription price used for the capital increases, which was definitively completed on 7 May 2018 and 6 July 2020.
Following the 2018 capital increase referred to above, which was carried out at a price of €1.87, the 140,935 New 2016 Kreos BSAs should have conferred the right to subscribe for 588,235 shares, a number higher than the maximum of 422,805 shares. Consequently, the Board of Directors decided to issue a 2018 Kreos BSA share warrant conferring initially the right to subscribe for 165,430 ordinary shares with a value of €0.06, corresponding to the difference between the number of shares to be subscribed and the maximum number of shares authorized under the New 2016 Kreos BSAs. Following the completion of the 2020 capital increase, the subscription price of the 167,084 shares obtained by exercising the 2018 KREOS is now €1.85.
The value of the KREOS BSA warrants is recognised at fair value in derivative financial instruments as a liability on the balance sheet. As at 30 June 2022, the KREOS BSA warrants were valued at €1,695, compared to €59,047 as at 31 December 2021.
In July 2021, in connection with the private placement restricted to US investors, the Company issued 4,048,584 warrants, which were attached to the 8,097,168 ordinary shares issued to US investors. Each warrant entitles the holder to subscribe for one ordinary share of the Company at an exercise price of €1.24 and may be exercised at any time until 15 July 2026.
The terms and conditions of the warrants require the Company to pay a net cash settlement if it fails to deliver the shares to the holders. In accordance with IAS 32, this instrument is defined as a derivative and has been classified as a liability, with subsequent changes in fair value recognised as a financial gain or loss.
The warrants were issued electronically in bearer form, were detached upon issue and are freely negotiable. Warrants are not listed on Euronext Growth market or on any other stock exchange.
Non-current provisions comprise primarily pension liabilities due in more than one year.
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Pension liabilities | 94,223 | 102,429 |
| Other provisions | – | – |
| Net total | 94,223 | 102,429 |
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| At 31 December 2021 | (102,429) | (97,302) |
| Cost of services rendered (operating expense) | (8,423) | (10,666) |
| Interest expense (financial expense) | (563) | (326) |
| Actuarial losses/gains | 17,192 | 5,865 |
| At 30 June 2022 | 94,223 | (102,429) |
The following assumptions have been used to estimate retirement obligations for all categories of employees:
| 30/06/2022 | 31/12/2021 | |
|---|---|---|
| Social security contribution rate |
45% | 45% |
| Salary increase rate | 3% | 2% |
| Discount rate | 3.20% | 1.10% |
– Retirement age: 67 years
– Collective agreement: National collective agreement for engineers and management employees in the metallurgy industry
The discount rates are taken from the Bloomberg F66710Y IND Euros Composite Zero Coupon Yield AA index.
There were no retirements from the Group during 2022.
At end-June 2022, current provisions totalled €441, compared to €7,957 euros in 2021, and represent provisions for social charges.
| (Amounts in euros) | Non-current | Current | Total |
|---|---|---|---|
| At 30 June 2022 | |||
| Lease liabilities - real estate | 563,249 | 298,168 | 861,416 |
| Lease liabilities - other | 16,766 | 21,427 | 38,194 |
| Total - Lease liabilities | 580,015 | 319,595 | 899,610 |
| (Amounts in euros) | Non-current | Current | Total |
|---|---|---|---|
| At 31 December 2021 | |||
| Lease liabilities - real estate | 709,319 | 289,804 | 999,122 |
| Lease liabilities - other | 20,530 | 25,241 | 45,771 |
| Total - Lease liabilities | 729,849 | 315,044 | 1,044,893 |
| (Amounts in euros) | 2022 |
|---|---|
| N +1 | 313,559 |
| N +2 | 227,344 |
| N +3 | 131,322 |
| N +4 | 127,734 |
| N +5 | 99,651 |
| Over 5 years | – |
| Total | 899,610 |
No discounting was applied to trade payables because none of the amounts had payment terms exceeding one year at the end of each period presented.
Other current liabilities include short-term debts to employees and social security and tax authorities.
| (Amounts in euros) | 30/06/2022 | 31/12/2021 |
|---|---|---|
| Trade payables | 1,624,536 | 1,911,453 |
| Social security liabilities | 964,287 | 943,342 |
| Tax liabilities | 42,112 | 36,956 |
| Prepaid income | 430,733 | 483,101 |
| Other payables | 59,264 | 22,770 |
| Net total | 3,120,931 | 3,397,621 |
The Group recognised prepaid income of €0.65 million corresponding to the economic benefit mainly from the preferential interest rate applied to the State-guaranteed loan. The proceeds are recognised as a grant over the entire repayment period of the State-guaranteed loan, i.e. over a period of six years. (See Note 19)
| (Amounts in euros) | 30/06/2022 | 30/06/2021 |
|---|---|---|
| Sales | – | – |
| Research Tax Credit | 983,205 | 851,313 |
| Grants | 60,818 | 105,192 |
| Other revenues | (227) | 844,459 |
| Net total | 1,043,797 | 1,800,964 |
Research Tax Credit. In the first half of 2022, we recognised a research tax credit of €0.98 million, compared to €0.85 million for the first half of 2021.
Grants Grant proceeds recognised in the first half of 2022 totalled €0.06 million, consisting primarily of grants in connection with the State-guaranteed loan, in accordance with IAS 20.
In 2021, we received €0.9 million other revenues for contractual indemnities paid by Second Sight Medical Product Inc. (SSMP). These payments were made following SSMP's unilateral termination of the memorandum of understanding between the two companies (effective 5 January 2021).
Research and development expenses break down as follows:
| R&D expenses (Amounts in euros) | 30/06/2022 | 30/06/2021*. |
|---|---|---|
| Wages and salaries* | 2,341,367 | 1,770,269 |
| Subcontracting, collaboration and consultants | 923,896 | 1,108,325 |
| Research supplies | 264,062 | 289,415 |
| Leases (1) | 1,895 | 13,874 |
| Amortisation of use rights | 126,056 | 113,713 |
| Conferences, travel expenses | 141,557 | 78,027 |
| Licence fees | 43,833 | 90,054 |
| Provisions and amortisation allowances | 56,606 | 57,780 |
| Miscellaneous - Services provided (2) | 160,606 | 144,053 |
| Impairment losses | – | – |
| Other | 26,213 | 21,367 |
| Net total | 4,086,091 | 3,686,877 |
(1) Lease expenses correspond to non-capitalised leases
(2) Service contracts associated with leases
* Including the impact of the IAS 19 change (Note 3: IFRIC May 2021 – IAS 19 Retirement Benefits)
At 30 June 2022, Research and development expenses totalled to €4.1 million compared with €3.7 million the previous year. This increase of €0.4 million is primarily due to the reinforced research and development teams, particularly in the clinical field, to provide support for the increased activity in connection with the PRIMAvera study.
In 2021, research and development expenses amounted to €7.3 million compared to €6.2 million one year earlier. The increase of €1,1 million is mainly related to strengthening of its clinical team and the opening of several centers in Europe as part of its PRIMAvera study.
A breakdown of general and administrative expenses by type is shown below:
| General and administrative (Amounts in euros) | 30/06/2022 | 30/06/2021*. |
|---|---|---|
| Wages and salaries* | 725,879 | 668,073 |
| Fees | 1,585,683 | 1,679,801 |
| Leases (1) | 12,806 | 16,126 |
| Amortisation of use rights | 33,538 | 26,902 |
| Insurance | 24,919 | 23,400 |
| Communication, travel and entertainment expenses | 311,487 | 159,767 |
| Postage and telecommunication costs | 48,844 | 44,479 |
| Administrative supplies and equipment leases | 7,409 | 12,671 |
| Provisions and amortisation allowances | 187,050 | 226,684 |
| Miscellaneous - Services provided (2) | 34,466 | 27,793 |
| Other | 90,344 | 58,750 |
| Net total | 3,062,425 | 2,944,445 |
(1) Lease expenses correspond to non-capitalised leases
(2) Service contracts associated with leases
* Including the impact of the IAS 19 change (Note 3: IFRIC May 2021 – IAS 19 Retirement Benefits)
In June 2022, general and administrative expenses amounted to €3.1 million compared to €2.9 million in 2021. The increase in expenses has primarily incurred for legal and accounting services to analyse and prepare various financing options, such as convertible bonds and private placements with French or international investors on Euronext Growth or on a foreign stock exchange.
At end June 2022, the Group employed 43 persons, compared to 35 in 2021.
Payroll expense breaks down as follows:
| Payroll expense (Amounts in euros) | 30/06/2022 | 30/06/2021 |
|---|---|---|
| Wages and salaries | 1,978,040 | 1,580,165 |
| Social contributions | 824,077 | 651,170 |
| Pension liability expenses* | 8,986 | 5,496 |
| Share-based payments | 196,225 | 139,115 |
| Net total | 3,007,327 | 2,381,945 |
* Including the impact of the IAS 19 change (Note 3: IFRIC May 2021 – IAS 19 Retirement Benefits)
Share-based payments relate to all financial instruments (BSA warrants/BSPCE warrants/free shares (AGA)/SOs) awarded to employees, members of the Board of Directors and scientific advisors. The BSA warrants in connection with the Kreos bonds do not come within the category covered by IFRS 2. They are included at fair value as a liability on the statement of financial position in the "Derivative financial instruments" item. (See Note 14.)
The expense representing the benefit awarded is recognised on a straight-line basis as a payroll expense over the vesting period.
The amount of the annual accounting expense in connection with all share-based payments breaks down as follows:
| 30/06/2022 | 30/06/2021 | |||||
|---|---|---|---|---|---|---|
| In euros | R&D | G&A | Total | R&D | G&A | Total |
| BSAs | 0 | 37,776 | 37,776 | 0 | 0 | 0 |
| BSA HCW ‑ Award of 12/07/2021 | 0 | 0 | 0 | 0 | 0 | 0 |
| BSA ‑ Award of 26/11/2021 | 0 | 37,776 | 37,776 | 0 | 0 | 0 |
| AGAs | 119,222 | 6,224 | 125,446 | 49,547 | 11,939 | 61,486 |
| AGA-01– Award of 24/07/2019 | 0 | 0 | 0 | 7,428 | 0 | 7,428 |
| AGA-02– Award of 12/12/2019 | 0 | 0 | 0 | 42,119 | 11,939 | 54,058 |
| AGA-03– Award of 12/12/2019 | 0 | 0 | 0 | 0 | 0 | 0 |
| AGA ‑ Award of 17/02/2021 | 3,341 | 0 | 3,341 | 0 | 0 | 0 |
| AGA ‑ Award of 17/02/2022 | 115,880 | 6,224 | 122,104 | 0 | 0 | 0 |
| SOs | 996 | 32,007 | 33,003 | 2,008 | 75,621 | 77,629 |
| SO ‑ Award of 02/10/2019 | 0 | 20,611 | 20,611 | 0 | 48,273 | 48,273 |
| SO ‑ Award of 12/12/2019 | 996 | 0 | 996 | 2,008 | 0 | 2,008 |
| SO ‑ Award of 23/07/2020 | 0 | 11,395 | 11,395 | 0 | 27,348 | 27,348 |
| Total | 120,218 | 76,007 | 196,225 | 51,556 | 87,559 | 139,115 |
The key features of the plans are shown in the tables below:
| BSAs | |||||||
|---|---|---|---|---|---|---|---|
| Award date (CA) | 18/03 | 23/06 | 12/07 | 26/11 | |||
| 2013 | 2015 | 2021 | 2021 | ||||
| Vesting period | 4 years | 4 years | – | – | |||
| Contractual duration | 10 years | 7 years | 5 years | 7 years | |||
| Average expected duration of instrument | 6 years | – | – | – | |||
| Total number of instruments | 18,393 | 34,666 | 566,802 | 731,670 | |||
| at end-2021 (*) | |||||||
| Instrument/share ratio (*) | 1 | 1 | 1 | 1 | |||
| Strike price (€) (*) | €0.06 | €5.99 | €1.24 | €0.93 | |||
| Evaluation model used | Black and Scholes | ||||||
| Fair value of share at award date (*) | €0.06 | €0.00 | €0.99 | €0.85 | |||
| Expected volatility (1) | 45.0% | 45.0% | 62.70% | 60.40% | |||
| Expected dividends | – | – | – | ||||
| Performance conditions | N/A | N/A | N/A | N/A | |||
| Fair value of option (*) | €0.03 | €2.00 | €0.31 | €0.25 |
| AGAs 2019 |
AGAs 2020 |
AGAs 2022 |
SOs 2019 |
SOs 2020 |
|||
|---|---|---|---|---|---|---|---|
| Award date (CA) | 12/12 2019 |
17/02 2021 |
17/02 2022 |
02/10 2019 |
12/12 2019 |
23/07 2020 |
|
| Vesting period | 1 year | 1 year | 2 years | 4 years | 4 years | 4 years | |
| Contractual duration | – | – | - | 7 years | 7 years | 7 years | |
| Average expected duration of instrument | – | – | - | 6 years | 6 years | 6 years |
| Total number of instruments as at 30/06/2022 (*) |
139,954 | 17,000 | 937,338 | 1,117,982 50,000 | 353,795 | |
|---|---|---|---|---|---|---|
| Instrument/share ratio (*) | 1 | 1 | 1 | 1 | 1 | 1 |
| Strike price (€) (*) | N/A | N/A | N/A | €1.09 | €0.62 | €0.55 |
| Evaluation model used | Black and Scholes | |||||
| Fair value of share at award date (*) | €0.98 | €1.04 | €0.72 | €1.01 | €0.63 | €0.53 |
| Expected volatility (1) | – | – | - | 52.11% | 56.95% | 65.60% |
| Expected dividends | – | – | - | – | – | – |
| Performance conditions | N/A | N/A | YES | YES | N/A | YES |
| Fair value of option (*) | €0.98 | €1.04 | €0.72 | €0.42 | €0.28 | €0.28 |
(*) In order to provide clearer comparability between the instruments and the same conversion ratio, instruments issued before 17/06/2014 (the date of the six-for-one reverse stock split of the Group's shares) have been adjusted accordingly (number, strike price, share value, etc.).
(1) Based on the historical volatility of a panel of comparable companies.
Detailed information on the number of options by category and strike price is provided in Note 12.2.
| Financial income and expenses (Amounts in euros) | 30/06/2022 | 30/06/2021*. |
|---|---|---|
| Financial revenue | 829,489 | – |
| Fair value 2021 US BSAs | 829,489 | – |
| Financial expenses | (339,068) | (715,389) |
| Interest on loans and debts | (378,964) | (368,062) |
| Leases | (16,094) | (20,093) |
| Reversal of daily loss on ORNAN JVs | 65,950 | (327,070) |
| Other financial expenses* | (9,960) | (163) |
| Net total | (339,068) | (715,520) |
* Including the impact of the IAS 19 change (Note 3: IFRIC May 2021 – IAS 19 Retirement Benefits)
In 2022, financial income comprises the change in the fair value of the 2021 US BSA warrants in the amount of €829,489.
As at 30 June 2022, financial expenses consisted of interest calculated on the "Sight Again" repayable advance in the amount of €300,635, interest calculated on the State-guaranteed loan in the amount of €78,329, interest calculated on leases in the amount of €16,094 and an expense reversal of the valuation difference one-day loss of €65,950 corresponding to the difference between the fair value of the unconverted ORNAN 2019 bonds as at 30 June 2022 and their issue price.
Under IAS 24, related parties include parties with the ability to control or exercise significant influence over the reporting entity. All business transactions with related parties are entered into on arm's length terms.
The remuneration shown below, which was paid to the members of the Group's Board of Directors, was expensed during the periods presented (amounts in euros):
| Related-party transactions (Amounts in euros) 30/06/2022 |
30/06/2021 |
|---|---|
| ------------------------------------------------------------- | ------------ |
| Wages and salaries | 219,720 | 213,720 |
|---|---|---|
| Directors' fees | 30,000 | 30,000 |
| Benefits in kind and in cash | 74,659 | 63,074 |
| Share-based payments | 32,007 | 75,621 |
| Net total | 356,386 | 382,414 |
Net earnings per share are calculated by dividing the net profit attributable to holders of the Group's shares by the weighted average number of ordinary shares outstanding during the period.
| Earnings per share | 30/06/2022 | 30/06/2021*. |
|---|---|---|
| Net income for the period (in euros)* | (5,614,298) | (5,545,747) |
| Weighted average number of shares in circulation | 47,391,297 | 45,076,834 |
| Net earnings per share (in euros) | (0.12) | (0.12) |
* Including the impact of the IAS 19 change (Note 3: IFRIC May 2021 – IAS 19 Retirement Benefits)
Instruments giving deferred rights to equity (BSAs, BCEs, AGAs, SOs) are considered anti-dilutive as they lead to an increase in earnings per share. These instruments are presented in detail in Note 12.2. Therefore, diluted earnings per share are the same as net earnings per share.
Credit risk is linked to deposits with banks and financial institutions. The Company seeks to minimize the risk related to banks and financial institutions by placing cash deposits with highly rated financial institutions. The maximum level of the credit risk corresponds to the book value of the financial assets.
As outstanding receivables consist primarily of the research tax credit granted by the French government, the Company is not exposed to significant credit risk.
Several of the components, materials and services used in our products are available only from single suppliers, and substitutes for these items cannot be obtained easily or would require substantial design or manufacturing modifications. Any significant problem experienced by one or more of our sole source suppliers could result in a delay or interruption in the supply of components to us until that supplier cures the problem or an alternative source of the component is located and qualified. Even where we can usecould other qualify alternative suppliers, the substitution of suppliers may be at a higher cost and cause time delays that impede the production of our products and impact our ability to meet research and development and clinical objectives.
The Company currently operates exclusively in Europe and in the United States. Unanticipated events in foreign countries could disrupt our operations and impair the value of assets held.
| Fees paid to statutory auditors (Amounts in euros) |
30/06/2022 | 30/06/2021 |
|---|---|---|
| Audit standardsexpenses | 204,566 | 309,378 |
| Other audit expenses | – | – |
| Total | 204,566 | 309,378 |
In 2014, the Company entered into a worldwide exclusive licence agreement with the board of trustees of Leland Stanford Junior University (the "Stanford Licence"), which was amended in 2017 and in June and September 2021, concerning certain patents applicable to the Prima System. Under the Stanford Licence, the Company agreed to pay Stanford University a fee of \$100,000 upon the signature of the agreement, an annual licence maintenance fee of between \$15,000 and \$30,000 on the first six anniversaries of the effective date of the agreement, and of \$40,000 on the seventh and subsequent anniversaries, milestone payments totalling \$525,000 upon achieving certain regulatory developments, as well as royalties of between 2% and 3% on net sales of licensed products. Pixium Vision has already paid three milestones totalling \$325,000 in connection with the signature of the agreement, the Company becoming a listed company, and the first human trial in the licensed territory. In addition, under the September 2021 amendment, the Company also agreed to pay an additional one-time licence issue fee of \$30,000. The Stanford Licence is effective and exclusive, and includes the right to grant sublicences, subject to certain specified conditions, in the licensed field of use until 17 September 2033. The Company also agreed to pay Stanford University a portion of the consideration on all royalty-free sublicences for any licensed patents. The Company may terminate the Stanford Licence in its entirety for reasons of convenience by giving 30 days' written notice. Stanford University may terminate the licence for breach of certain provisions, subject to specific notice and cure periods.
In 2015, the Company entered into an exclusive worldwide licence agreement with CNRS, the University of Bordeaux and ESIEE (Paris Ile de France Chamber of Commerce and Industry) (the "CNRS Licence") concerning a patent family covering the configuration of microelectrode arrays for focal stimulation of living tissue applicable to the Prima System. Under this licence, the Company agreed to pay the University of Bordeaux a minimum annual fee of €30,000 as from January 2017. The CNRS Licence is effective and exclusive, and includes the right to grant sublicences, subject to certain specified conditions, for the life of the licensed patents. The Company is also required to pay the CNRS royalties of approximately 1% on direct net sales and a reduced royalty rate on sub-licensing revenues received in connection with the licensed patents (between 7.5% and 20% of sub-licensing revenues). The Company may terminate the CNRS Licence at any time by giving 30 days' written notice. The CNRS may terminate the licence for breach of certain provisions, subject to specific notice and cure periods.
On 14 July 2022, Pixium Vision announced that it had set up financing for a nominal amount of €30 million, and had drawn down a first tranche of €5.5 million.
Pixium Vision continued to make significant clinical and business progress in H1 2022, including continuing implanting patients in the European PRIMAvera pivotal trial evaluating the safety and efficacy of the Prima System in patients affected by dry Age-related Macular Degeneration (AMD), targeting the last implantation end of 2022.
The feasibility study in the US continued to make good progress and recently broadened its clinical centers to include Stanford Medicine. Implantations of all US patients in this study are expected to complete by the end of 2022.
In January 2022, peer reviewed data was published in Nature Communications demonstrating the clinical benefit of the PRIMA System in Dry AMD patients.
Despite the downturn on the financial markets, Pixium Vision was able to secure the financing as announced July 14, 2022. The Company is continuing to build on traction gained with global investors to secure its financing pipeline into the future.
| Income statement summary | |||
|---|---|---|---|
| In thousands of euros | H1 2022 | H1 2021 * | Change |
| Operating revenue | 1,043.8 | 1,801.0 | (42.0) % |
| Current operating expenses | (7,148.5) | (6,631.3) | +7.8 % |
| Research and Development | (4,086.1) | (3,686.9) | +10.8 % |
| General and administrative expenses | (3,062.4) | (2,944.4) | +4.0 % |
| Operating loss | (6,104.7) | (4,830.4) | +26.4 % |
| Net loss for the period | (5,614.3) | (5,545.7) | +1.2 % |
| Net earnings per share | (0.12) | (0.12) |
*H1 2021 restated: impact of change in IAS19 calculation (cf. note 3 IFRIC May 2021 – IAS19 Retirement Benefits of half year financial report 2022)
Operating revenue amounted to €1.0 million and is comprised of a Research Tax Credit (CIR) in the amount of €1.0 million.
Current Research and Development (R&D) expenses totalled €4.1 million, compared to €3.7 million the previous year. During the first half of 2022, Pixium Vision continued to strengthen its clinical team and opened several centers in Europe as part of its PRIMAvera study. In addition, the Group continued to develop and manufacture its Prima bionic vision system to ensure the progress of its ongoing clinical studies.
Current general and administrative (G&A) expenses totalled €3.1 million in H1 2022, compared to €2.9 million in H1 2021. General and administrative expenses increased by 4.0% in H1 2022, mainly due to the costs the Group incurred for legal services in preparation of various financing options such as convertible bonds, private placement with French or international investors on Euronext Growth or on a foreign stock exchange.
In H1 2022, the Group did not recognize any marketing and sales expenses.
Operating result presented a loss of €6.1 million, which is higher than in H1 2021 (€4.8 million). Net result was a loss of €5.6 million (compared to a loss of €5.5 million in H1 2021). The loss per share is €0.12 for both periods.
| Statement of cash flows summary | ||
|---|---|---|
| In thousands of euros | H1 2022 | H1 2021 |
| Opening cash and cash equivalents | 10,131.4 | 10,566.0 |
| (Decrease)/Increase in cash position | (7,283.6) | (434.5) |
| O/W net cash flows from operating activities | (7,064.1) | (6,115.4) |
| O/W net cash flows from investment activities | (26.8) | (32.0) |
| O/W net cash flows from financing activities | (196.4) | 5,712.9 |
| Closing cash and cash equivalents | 7,221.2 | 10,131.4 |
Net cash outflow from operating activities increased in H1 2022 to €7.1 million, compared to €6.1 million in H1 2021. The increase in net cash outflow reflects the continuation of the PRIMAvera study, the US feasibility study, as well as the spending associated with the preparation of financing options.
Net cash flows from financing activities totalled €(0.2) million which are mainly related to the repayment of lease liabilities under IFRS16 in H1 2022. In H1 2021, financing activities reflected primarily the drawdown of 5 ORNAN tranches for a total of €6.25 million in gross proceeds under its agreement with ESGO.
Pixium Vision ended H1 2022 with a net cash position of €7.2 million, compared to €10.1 million a year earlier.
Post-period, on July 14, 2022, Pixium Vision announced the implementation of a financing of a maximum nominal amount of €30 million, and the drawdown of a first tranche with a nominal value of €5.5 million.
I certify that, to my knowledge, the summary financial statements for the past half-year were prepared in accordance with applicable accounting standards and give a fair view of the assets, financial position and results of the Company at 30 June 2022, and that the half-year business report presents a fair overview of major events that occurred during the first six months of the year, their impact on the financial statements, the main transactions between related parties and a description of the principal risks and uncertainties for the remaining six months of the year.
Lloyd Diamond Chief Executive Officer 20 July 2022
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