- Development of Prima System in France on track and continued implantation in the United States with sustained progress in dry-AMD;
- Implanted patients introduced with new smart transparent glasses with improved algorithms;
- Preparation underway for PRIMAVERA pivotal study, key step towards Prima System marketing authorization
- Targeted allocation of cash to clinical programs and R&D for maximum value creation;
- 2019 closing cash position: € 6.8 million.
Paris, France, February 13, 2020 – 7.00 AM CET - Pixium Vision (FR0011950641 - PIX), a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced today its 2019 financial results. Auditing of these results is ongoing. The Board of Directors of Pixium Vision approved the annual results at the meeting held on February 12, 2020.
Lloyd Diamond, Chief Executive Officer of Pixium Vision, stated: “Pixium Vision made significant and exciting progress in 2019, including the implementation of the upgraded version of the Prima System, Prima 2, and its first in human clinical data. The Prima System is now equipped with second generation glasses combining natural residual vision with prosthetic vision. These glasses are currently under study in all implanted patients in France and the United States. The first, very encouraging, clinical data are expected to be reported by the end of Q1 2020.” Lloyd Diamond added: “Controlling our costs allows us to allocate as much of our financial resources as possible to our clinical and R&D efforts with the aim of creating significant value. Thanks to impressive results of the ongoing feasibility studies, our priority in 2020 is to start the PRIMAVERA pivotal study, and the Pixium Vision team is fully committed to this key step in bringing the Prima System to market.”
2019 full year financial results – Summary
|P&L 2019 – Highlights|
|In thousand euros||2019||2018||Change|
|Revenue / other revenues||1,782.5||1,598.3||12%|
|Recurring Operating expenses||(9,650.4)||(9,372.3)||-3%|
|Cost of Goods Sold||0||(41.2)||NS|
|Research and Development||(6,533.6)||(6,183.6)||-6%|
|Marketing & Communication||(49.6)||(101.8)||50%|
|General and Administrative||(3,067.3)||(3,045.7)||-1%|
|Recurring Operating income||(7,868.0)||(7,774.0)||-1%|
|Non-recurring items / share-based payment||(1,002.1)||(4,520.5)||>100%|
|Total profit / (loss)||(9,623.5)||(13,522.6)||29%|
|Earnings / (Loss) per share||(0.44)||(0.73)|
|Cash-flow statement summary|
|in thousand euros||2019||2018|
|Opening cash and cash equivalents||15,629.4||10,531.6|
|(Decrease) / Increase in cash position||(8,837.9)||5,097.8|
|O/W net cash flows from operating activities||(8,288.1)||(7,450.3)|
|O/W net cash flows from investing activities||(28.3)||9.0|
|O/W net cash flows from financing activities||(521.5)||12,539.1|
|Closing cash and cash equivalents||6,791.5||15,629.4|
Key developments in 2019
In 2019, Pixium Vision continued the development of its Prima System in the management of the dry form of Age-Related Macular Degeneration (AMD). In France, the majority of patients included in the feasibility study achieved results that exceeded expectations. Indeed, the Prima System allows these patients to read letters and letter sequences after a few months of rehabilitation. In parallel, Pixium Vision has finalized the development of the Prima 2 smart glasses. Equipped with a high-resolution camera, a more powerful embedded algorithm, these transparent glasses combine residual peripheral natural vision with central prosthetic vision. They provide patients with greater comfort in using the Prima System on a daily basis. All patients today benefit from this equipment with very encouraging initial results. The first reported clinical results with these upgraded glasses are expected in the course of the first quarter of 2020. Based on these results, Pixium Vision will continue to prepare the implementation of the PRIMAVERA pivotal clinical study, a required step towards CE marking, FDA approval and commercialization. The start of this study is expected before the end of 2020.
In the United States, Pixium Vision recently announced the implantation of a first patient. The two research centers in Pittsburgh and Miami are actively recruiting patients. As with patients in France, initial results show that the implant and surgical procedure are well tolerated without side effects and without impact on residual natural peripheral vision. All patients in this study will benefit directly from the upgraded Prima System glasses. The Company is assessing the possibility of pursuing development in the United States and Europe in parallel, which could accelerate the regulatory process in the US.
In 2019, Pixium Vision continued its efforts to control its operational cash burn, which was stable compared to 2018 despite research and development efforts to finalize and produce the new Prima System glasses. The Company has also partially secured its financing through the establishment of a bond contract that gives the possibility, under certain conditions, to raise up to € 10 million.
2020 operational outlook
Pixium Vision will prepare the PRIMAVERA pivotal study of the Prima System, building on the clinical results with the new transparent smart glasses. This study is expected to start by the end of 2020 and will be a major step in the clinical development of the Prima System in Dry-AMD. In the United States, recruitment under an early feasibility study is actively ongoing and should allow implantations to be finalized during the first half of the year.
2019 full-year financial results
In 2019, the Company did not generate sales.
Total revenues are mainly composed of the Crédit Impôt Recherche (CIR) research tax credit, which amounted to €1.72 million (€1.32 million in 2018). The CIR is related to continued R&D efforts, notably with the clinical and regulatory expenses on the Prima System. The increase in CIR in 2019 highlights the sustained R&D efforts of Pixium Vision. In all, total revenues amounted to €1.78 million in 2019 compared with €1.60 million in 2018.
Research & Development (R&D) recurring expenses amounted to €6.53 million in 2019 versus €6.18 million in 2018. In 2019, Pixium Vision increased its investments in the development of the Prima System, especially in newly designed intelligent transparent glasses as well as in the manufacturing of the first system for the patients already in clinical studies. R&D expenses also reflect the continuous effort of Pixium Vision in running the feasibility clinical studies. R&D accounted for two-third of overall recurring expenses in 2019.
General & Administrative (G&A) recurring expenses amounted to €3.07 million in 2019 compared with €3.05 million in 2018. It highlights the sustained efforts to control the overall expenses and to focus spending on R&D and value creation.
Marketing & Communication expenses amounted to €49,559, very limited due to no commercial activities.
The Company has chosen to report its Recurring Operating Result to improve the readability of the recurring operating items. Non-recurring items or items with no cash impact are excluded from the Recurring Operating Result which amounted to a loss of €7.87 million (versus a loss of €7.77 million in 2018).
Non-recurring items amounted to €1.00 million in 2019 (vs. €4.52 million in 2018) including the leaving costs associated with the departure of the former CEO and non-cash share-based payments. In 2018, the Company booked value losses following the impairment of tangible and intangible IRIS®-related assets, partially offset by a reduction in share-based payment.
Operating Income amounted to a loss of €8.87 million (vs. a loss of €12.29 million in 2018), and the Net Result to a loss of €9.62 million (vs. a loss of €13.52 million in 2018). In 2019, the Company recognized a financial charge of €1.00 million (vs. €0.98 million in 2018) mainly due to interest payment of the venture loan signed with Kreos Capital in September 2016. No Income Tax was recorded in 2018. Net Loss per issued share (weighted average number of shares outstanding over the period of 22.3m in 2019 and 18.5m in 2018) amounted to (€0.44) in 2019 compared to (€0.73) in 2018.
Cash consumption from operating activities increased by 11% in 2019 to €8.29 million compared with €7.45 million in 2018. The increase in company’s R&D efforts to support the development of the Prima System as well as indemnities paid to the former CEO lead to the uptake in cash consumption. Excluding non-recurring items, cash consumption related to G&A is stable.
Net cash outflow from financing activities amounted to €0.52 million in 2019. Cash outflow resulted from the reimbursement of the venture loan signed with Kreos Capital, partly offset by cash inflows from the equity line and the drawdown of the first tranche of the convertible note (“ORNAN 2019”) signed with ESGO. Pixium Vision closed 2019 with a net cash position of €6.79 million compared with €15.63 million in 2018.
|Pixium Vision |
Chief Financial Officer
+33 1 76 21 47 68
|Media relations |
+33 6 27 74 74 49
|Investor relation |
Guillaume van Renterghem
+33 6 69 99 37 83
Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as: Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
For more information: http://www.pixium-vision.com/fr
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Registration Document filed with the AMF under number D.10-0364 on April 18, 2019 which can be found on the websites of the AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
The risk factors affecting the Company are presented in Chapter 4 of the Annual Report filed on April 18th, 2019 by the French Financial Markets Authority (AMF) under number D.19-0364.
To the best of the Company’s knowledge, the assessment of risks has not changed since the filing of its Annual Report.
The registration document is available on the company’s website:
During 2019, major developments include:
- On January 8, 2019, Pixium Vision announced its wireless PRIMA chip successfully met the interim study endpoints for dry age-related macular degeneration.
- On February 8, 2019, Pixium Vision announced its 2018 Annual results and provided business update.
- On March 7, 2019, Pixium Vision highlighted conclusions of its KOL meeting: Experts confirm Prima's promises and potential to treat Dry-AMD.
- On April 19, 2019, Pixium Vision reported cash position as of March 31, 2019.
- On April 25, 2019, Pixium Vision announced change in governance.
- On May 2, 2019, Lloyd Diamond appointed Chief Executive Officer of Pixium Vision.
- On May 29, 2019, Pixium Vision highlighted its latest progress and achievements in its annual general meeting 2019.
- On July 18, 2019, Pixium Vision announced sustained success of its Prima System after 12 months in dry age-related macular degeneration patients.
- On July 25, 2019, Pixium Vision announced its H1 2019 financial results and provided business update.
- On October 3, 2019, Sofinnova Partners Re-joined Board of Directors.
- On October 4, 2019, Pixium Vision provided clarification on Omnes Capital shareholding unchanged since end 2017.
- On October 24, 2019, Pixium Vision reported cash position as of September 30, 2019.
- On October 29, 2019, Proposed transfer of the listing of Pixium Vision’s share to the Euronext Growth Paris market.
- On November 6, 2019, Pixium Vision announced a financing agreement for a maximum amount of €10 million issuing a first tranche of €1.25 million, for the development of its Prima System.
- On November 10, 2019, Pixium Vision presented the 12 months data of its Dry-AMD Prima System at the 11th Eye and Chip World Research Congress on Artificial Vision, Dearborn, MI, USA.
- On December 2, 2019, Pixium Vision and partners published paper on photovoltaic subretinal prosthesis PRIMA in Nature Biomedical Engineering.
- On December 23, 2019, Pixium Vision notified on threshold crossing following passive dilution.
After 31 December 2019 major developments were:
·On January 13, 2020, Pixium Vision announced the successful implantation of its Prima System in the first patient in the USA.
Comparison of 2019 and 2018 annual results
|(Amounts in euros)||As of 31 December|
|Research Tax Credit||1,718,149||1,322,986||1,322,986|
|Costs of goods sold||–||(41,172)||(41,172)|
|Research and Development||(6,562,662)||(5,678,011)||(5,678,011)|
|Sales and Marketing||(49,559)||(101,829)||(101,829)|
|Total non-recurring expenses||(69,463)||(5,482,656)||(5,482,656)|
|Financial profit / (loss)||(1,005,822)||(981,551)||(1,276,688)|
|Current profit / (loss)||(9,875,913)||(13,275,976)||(13,571,113)|
|Other non-transferable comprehensive income|
|Actuarial gains / (losses) on pension plans||(6,116)||48,528||48,528|
|Fair value valuation*||258,494||(295,137)||–|
|Total profit / (loss) for the year||(9,623,535)||(13,522,585)||(13,522,585)|
|Weighted average number of shares||22,338,681||18,523,505||18,523,505|
|Net earnings per share||(0.44)||(0.73)||(0.73)|
|Diluted earnings per share||(0.44)||(0.73)||(0.73)|
* Changes in fair value of BSA Kreos which were recognized in financial expenses are now recognized in Other non-transferable comprehensive income.
In 2019, the Company generated no sales.
Other revenues amounted to respectively €1.78 million and €1.60 million, for the years ended 2019 and 2018. These amounts mainly include the Research Tax Credit (CIR) reaching respectively €1.72 million and €1.32 million for the financial years 2019 and 2018. The increase in the CIR in 2019 reflects the ongoing R&D efforts in the development of the Prima System.
The French tax authorities grant research tax credits to businesses as an incentive to carry out technical and scientific research. Businesses with eligible expenditure (research carried out in France or, since 1 January 2005, within the European Community or any State party to the agreement on the European Economic Area having signed a tax treaty with France containing a mutual administrative assistance clause) benefit from a tax credit, which they may offset against corporation tax due for the financial year in which the expenses have been incurred and the three subsequent financial years. Where applicable, they may request reimbursement of any surplus tax credit amounts. Only research expenses are considered in the calculation of the research tax credit.
The Company has not capitalized R&D expenses in 2019 and 2018. Therefore, research tax credit amounts relating to its research programs have been recorded in full into operating income over the period.
Operating expenses amounted to €9.65 million and €9.37 million respectively for the years ended 2019 and 2018. In 2019, the operating expenses amount mainly corresponds to Research and Development activities, which are recorded as expenses, as well as General and Administrative expenses.
Research and Development expenses
Research and Development costs notably include:
- personnel costs, incorporating direct and indirect costs for teams involved in research and development activities;
- subcontracting, collaboration and consulting costs. These encompass the costs incurred for preclinical and clinical trials, patent filing and maintenance fees, fees payable to scientific and clinical experts and costs relating to regulatory and quality assurance matters;
- the purchase of research supplies, incorporating consumables and design and production costs;
- amortization and depreciation charges on the patents and equipment used in research and development projects.
Research and development costs break down as follow:
|R&D expenses (Amounts in euros)||31/12/2019||31/12/2018|
|Subcontractors, collaboration and consultants||1,752,147||1,531,793|
|Amortization of right of use2||236,180||–|
|Conferences, travel expenses||129,020||109,374|
|Amortization, depreciation and provisions||243,017||381,334|
|Various - Service delivery3||298,824||–|
Research and Development expenditure amounted to €6.56 million for the financial year 2019, compared to €5.68 million for the financial year 2018. In 2019, Staff costs are including a charge related to share-based payment of €29,075 compared to reversal of provision of €0.5 million in 2018.
General & Administrative Expenses
G&A are mainly made up of administrative personnel costs, external costs such as legal, audit and consultancy fees and communication, hospitality, rental and travel costs.
The split of G&A costs is as follows:
|General and administrative (Amounts in euros)||31/12/2019||31/12/2018|
|Amortization of right of use (2)||67,639||–|
|Communication, travel and entertainment expenses||434,468||390,583|
|Postal and telecommunication costs||57,734||50,632|
|Administrative supplies and equipment leases||21,597||22,634|
|Amortization, depreciation and provisions||243,412||561,811|
|Various - Service delivery (3)||60,015||–|
In 2019, staff costs included the booking of a share-related payment charge of €348,768 compared to a reversal of provision in 2018 of €0.60 million. Furthermore, the Company received €248k related to a reimbursement of social charges linked to overpaid social taxes on share-based payment plan of 2014. The Company also booked an exceptional charge of €562k linked to the leaving cost of its former CEO in May 2019.
D&A dropped in 2019 following the loss of value booked in 2018 on patents related to IRIS®.
Marketing and Communication expenses
Marketing expenses are mainly made up of personnel costs, communication costs and travel costs. The split of “Marketing and Communication” costs is as follows:
|Marketing & Communication (Amounts in euros)||31/12/2019||31/12/2018|
|Communication, travel and entertainment expenses||2,541||43,439|
Cost of goods sold
These expenses are broken down as follows:
|Cost of goods sold (Amounts in euros)||31/12/2019||31/12/2018|
|Purchase of raw materials, supplies and other consumables||–||4,430|
|Change in inventory||–||32,081|
Following the drop of its IRIS® II program as decided in 2018, the Company is not booking manufacturing charges anymore.
Recurring Operating income / loss
Recurring Operating loss is stable at €7.88 million in 2019 compared with a loss of €7.77 million in 2018.
Operating income / loss
The Company posted an operating loss of €8.87 million in 2019 versus an operating loss of €12.94 million in 2018. The 2018 operating result was negatively impacted by a non-recurring item of €5.86 million related to the impairment and exceptional amortization of IRIS® program.
Financial result amounted to a loss of €1.01 million in 2019. This loss is related to the interest payment of the venture loan signed with Kreos Capital in September 2016. Other financial expenses consist mainly of foreign exchange losses on US dollars and British pounds’ purchases.
Financial income consists mainly of the remuneration of term deposits and other short to mid-term investments.
Having posted a loss, the Company did not record any corporate income tax.
Net profit/loss for the period and net earnings/losses per share
The Company posted net loss of €9.88 million and €13.28 million respectively for 2019 and 2018.
The loss per issued share amounted to (€0.44) and (€0.73) respectively in 2019 and 2018.
Cash Flow Statement
(Amounts in euros)
|As of 31st December|
|Cash flows from operating activities|
|Profit / (loss) for the half year||(9,875,913)||(13,571,113)|
|Reconciliation of net profit to cash flows used in operating activities|
|Depreciation, amortization and impairment||517,741||6,159,600|
|Loss of value on disposals||–||638,297|
|Non-cash charge for share-based compensation||370,843||(1,090,889)|
|Retirement benefit obligations||27,216||33,492|
|Cash flows from operating activities||(8,273,611)||(7,634,385)|
|(Increase) / Decrease in trade receivables||(5,472)||–|
|Other current assets||110,329||708,719|
|(Increase) / Decrease in trade payables||(140,941)||(238,463)|
|Other current liabilities||21,562||(346,023)|
|Net cash flows from operating activities||(8,288,132)||(7,450,339)|
|Acquisitions of property, plant and equipment||(34,059)||(31,112)|
|Acquisitions of Intangible assets||–||–|
|Acquisitions of financial holdings||5,801||40,157|
|Net cash flows from investing activities||(28,258)||9,045|
|Increase / (Decrease) of refundable advances||–||879,000|
|Increase / (Decrease) of financial debt||(2,224,816)||(2,408,287)|
|Payment of Lease debt||(331,030)||–|
|Share capital Increases||2,031,179||14,033,727|
|Net cash flows from financing activities||(521,533)||12,539,117|
|Opening cash and cash equivalents||15,629,424||10,531,602|
|Closing cash and cash equivalents||6,791,500||15,629,424|
|(Decrease) / Increase in cash position||(8,837,924)||5,097,822|
Cash flows from operating activities
Cash flows used in operating activities increased by 11% in 2019 to €8.29 million versus €7.45 million in 2018. The higher cash consumption results from the enhanced R&D efforts dedicated to the Prima System as well as leaving costs from the former CEO. Excluding, non-recurring items, the cash consumption from operating activities is under tight control.
Cash flows from investing activities
Cash flows from investing activities is not significant.
Cash flows from financing activities
Net cash flow from financing activities amounted to € (0.52) million in 2019. This includes the reimbursement (interest and principal) of the venture loan signed with Kreos Venture, partially offset by use of an Equity Line and the drawdown of the first tranche of a newly signed convertible note (“ORNAN2019”) with ESGO in November 2019. Pixium Vision closing cash position was €6.79 million in 2019 compared with €15.63 million in 2018.
|(Amounts in euros)||As of 31st December|
|Property, plant and equipment||484,378||706,107|
|Right of use||1,324,356||–|
|Non-current financial assets||336,625||336,356|
|Total non-current assets||4,506,744||3,665,799|
|Stocks and work in progress||–||–|
|Other current assets||2,310,076||2,126,120|
|Cash & cash equivalents||6,791,500||15,629,424|
|Total current assets||9,107,048||17,755,544|
|Profit / (loss)||(9,875,913)||(13,571,113)|
|Total shareholders' equity||3,700,398||11,354,591|
|Total non-current liabilities||7,033,185||8,022,976|
|Trade account payables||843,010||983,951|
|Other current liabilities||1,488,563||1,016,110|
|Total current liabilities||2,880,209||2,043,776|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||13,613,792||21,421,343|
Total assets amounted to €13.61 million as of 31 December 2019 compared with €21.42 million a year earlier.
Net non-current assets stood at €4.51 million, and €3.67 million respectively at 31 December 2019 and 2018.
This includes non-current intangible, tangible and financial assets as well as the Right of Use as calculated following the IFRS 16 first application:
- Intangible assets amounted to €2.36 million and €2.62 million at 31 December 2019 and 2018 respectively mainly consisting of amortization of patents acquired from Intelligent Medical Implant. The decrease corresponds to the amortization of acquired patents and to the impairment on a few of them.
- Tangible assets amounted to €0.48 million and €0.71 million at 31 December 2019 and 2018 respectively and are mainly made up of machinery and laboratory equipment. Depreciation explains the drop in value from one year to the other.
- The right of use of €1.32 million at 31 December 2019 represent the cost of rentals, mainly facilities, over the full rental period.
- Non-current financial assets amounted to €0.34 million at 31 December 2019, flat compared with 2018. These assets are related to the security deposit paid to the landlord of the Company’s premises as well as deposit linked with the venture loan signed with Kreos Capital.
Net current assets amounted to €9.11 million and €17.76 million at 31 December 2019 and 2018 respectively.
Net current assets comprise:
·Other current assets:
|(Amounts in euros)||31/12/2019||31/12/2018|
|Deposits and advances||72,181||76,537|
|State, Research Tax Credit and CICE||1,692,137||1,323,412|
|Product to be received||260,000||–|
As of December 31, 2019, other current assets consist mainly of the research tax credit receivable for €1.69 million. The product to be received of €260,000 booked in 2019 equals to the subvention from the “Sight Again” project and the closure of the EC03
In 2018, the differed charges mostly comprised the rental expenses.
·cash on hand, time deposits and transferable securities, breaking down as follows:
|(Amounts in euros)||31/12/2019||31/12/2018|
|Money market funds (SICAV)||–||–|
Shareholders’ equity stood at €3.70 million and €11.35 million respectively at 31 December 2019 and 2018:
- €86.63 million in share capital and issue premiums as of 31 December 2019 (€85.01 million as of 31 December 2018);
- Reserves, including previous losses of €73.05 million in 2019
- 2019 loss of €9.88 million.
Non-current liabilities are composed of venture loan, refundable advances and retirement benefit liabilities in accordance with IAS 19. Non-current liabilities increased in 2019 dropped following the reimbursement of the venture loan. Non-current liabilities amounted to €7.03 million (vs. €8.02 million in 2018). Non-current provisions are composed of pension obligations.
This heading mainly incorporates operating liabilities, i.e.:
- Current provisions: €0.26 million as of 31 December 2019 represents the subvention related to EC03 of the “Sight Again” project and covers the risk linked with this subvention.
- Short-term debt related to rentals: €0.29 million as of 31 December 2019.
- trade payables: €0.84 million as of 31 December 2019 (€0.98 million as of 31 December 2018);
- social security liabilities: €0.98 million as of 31 December 2019 (€0.98 million as of 31 December 2018);
- tax liabilities: €33,749 as of 31 December 2019 (€9,611 as of 31 December 2018);
- Short-term debt: €0.47 million as of 31 December 2019 (€6,967 as of 31 December 2018). As of 31 December 2019, the Company booked 43 ORNAN not converted, resulting from the first tranche of the contract signed with European Select Growth Opportunities Fund (ESGO).
1 In 2019, lease expenses correspond to unfunded leases
2 Linked with IFRS 16 ruling
3 Service delivery linked to leases