PARIS--(BUSINESS WIRE)--Regulatory News:
Pixium Vision (FR0011950641 - PIX) (Paris:PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, today announces its revenues and cash position for the third quarter of 2017 and an operational update on the Company. Pixium’s cash position, as of September 30, 2017, is €13.4 million. The Company also announced sales of €0.1 million from a successful commercial implant of its IRIS®II system.
“Pixium Vision has achieved a number of additional milestones in the last few weeks. This includes the French regulatory approval for PRIMA, our miniaturized wireless sub-retinal implant to be evaluated for vision loss from atrophic dry age-related macular degeneration (atrophic dry AMD). With this next generation bionic vision system (BVS), Pixium Vision is entering a new phase of its development,” said Khalid Ishaque, Chief Executive Officer of Pixium Vision. “The PRIMA BVS is designed using the state of the art technology available, to offer significant potential to also treat atrophic dry AMD, a growing and unmet medical need. The implementation of an equity line financing with Kepler Cheuvreux brings visibility to Pixium among US and European financial markets to ensure execution through PRIMA’s initial clinical evaluation phases.’
|9-month revenues (*)|
|In K euros||30/09/2017||30/09/2016|
|Other revenues (**)||1,625.9||1,925.7|
(*): unaudited ; (**) of which Research Tax Credit
|9-month Cash and Cash Equivalent|
|In K euros||30/09/2017||30/09/2016|
|Cash and Cash equivalent at January 1st||14,244.2||24,353.8|
|(Decrease) / Increase in Cash position||(820.3)||(7,015.7)|
|Of which cash from operating activities||(8,413.3)||(8,851.5)|
|Of which cash from investing activities||(361.5)||(119.7)|
|Of which cash from financing activities||7,954.4||1,955.5|
|Cash and Cash equivalent||13,423.8||17,338.1|
During the first 9 months of 2017, total revenues amounted to €1.7 million, including €0.1 million of net sales from its IRIS®II system. Other revenues totaled €1.6 million, including €1.3 million from Research Tax Credit (CIR) and €0.3 million as subsidies from the Key Step 1 (EC01) of the “Sight Again” research project. The Research Tax Credit represents the ongoing efforts invested by Pixium in developing its BVS. Eligible expenses to CIR had decreased following the IRIS®II CE mark in July 2016.
Use of net cash flow from operating activities at September 30, 2017 amounted to €8.4 million compared to €8.9 million for the first 9-month of 2016. During the third quarter 2017, Pixium Vision received €1.7 million for Research Tax Credit (vs. €2.3 million in Q3 2016). Operating expenses focused on the continued development of PRIMA and the cost accrued in the regulatory process in Europe and in the USA. Beyond R&D expenses, sales & marketing expenses focused on selected countries for company’s commercial deployment with a first successful commercial implant in Spain. Lastly, G&A costs continue to be kept under control. In all, the lower cash consumption from operations improved by almost €1.0 million in the first 9 months of 2017 compared to the same period last year and adjusted from Research Tax Credit payment.
During the first 9 months of 2017, investments amounted €0.4 million vs. €0.1 million in 2016. The increase is linked to a €0.2 million given as guarantee of the venture loan signed with Kreos following the drawdown of €8 million.
As at September 30, 2017, net cash flow from financing activities reached €7.9 million. Pixium Vision received net proceeds, respectively €3.7 and €3.9 million, from the planned drawdown of the venture loan signed in September 2016 with Kreos Capital.
As at September 30, 2017, the cash and cash equivalent of Pixium Vision amounted to €13.4 million compared to €17.3 million as of September 30, 2016.
PRIMA, next generation of Bionic Vision System, First-in-Human implants
The PRIMA Bionic Vision System, a miniaturized, totally wireless, sub-retinal photovoltaic implant (chip of 2 millimeters and 30 microns thick, equipped with 378 electrodes) is designed to treat vision loss from advanced dry form of Age-Related Macular Degeneration (atrophic dry AMD) and also outer retinal dystrophies like Retinitis Pigmentosa. Pixium Vision recently received approval from French regulatory authorities for PRIMA to start a clinical trial to evaluate the device, initially aiming to treat the atrophic dry form of AMD, in France. With aging population dynamics, atrophic dry AMD, or geographic atrophy, is a leading cause of irreversible vision loss. This advanced form of AMD has no approved treatment, and thus is a significant unmet medical need that affects over 4 million people in Europe and the USA.
Pixium Vision aims to implant the first eligible subject in the first-in-human feasibility study of PRIMA by the end of the year. The clinical study, titled, “Feasibility study of compensation for blindness with the PRIMA system in patients with dry age related macular degeneration”, is designed to evaluate the tolerance of PRIMA and to demonstrate the evoked central visual perception among patients who have lost their sight due to atrophic dry-AMD. The study will recruit five patients with an interim evaluation at a 6-month follow-up and longer-term follow-up at 36 months.
In parallel, Pixium Vision continues to actively pursue constructive discussions with the US Food and Drug Administration (FDA), to prepare a clinical feasibility study with PRIMA in the US.
Pixium Vision announced positive interim 6-month follow-up safety and performance results of its epi-retinal IRIS®II. It also announced its decision to halt implantations due to shorter than expected life span of the implant. Pixium Vision awaits regulatory authorization to resume the halted clinical study and reimplantations (as the device was designed to be exchangeable), in order to evaluate the proposed corrective actions potentially extending the life span of the device. Pixium Vision expects results from this evaluation after 15 to 18 months.
Establishing an Equity Line Financing
On October 23, Pixium Vision established an equity line financing. Kepler Cheuvreux provided a full and firm commitment to subscribe to 2,000,000 shares (representing, for information purposes, an issued capital of €6.2 million1), at its own initiative over a timeframe not exceeding 24 months, provided that the contractual conditions are fulfilled. The shares will be issued based on the lowest of the daily volume-weighted average price of the two trading days preceding each issuance, minus a maximum discount of 7.5%. Pixium Vision retains the option of suspending or terminating this agreement at any time.
This financing provides Pixium Vision additional visibility to financially support the development of PRIMA through the initial clinical evaluation phases in EU and US.
Next Event: 2017 Annual Results on February 8th, 2018
ABOUT PIXIUM VISION
Pixium Vision’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 Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period. Following the CE mark for its first bionic retinal implant systems, IRIS®II, Pixium Vision has been authorized to start clinical study in Human for PRIMA, a sub-retinal miniaturized wireless implant system. No human clinical data on PRIMA is yet available. Pixium Vision collaborates closely with academic and research partners spanning across the prestigious Vision research institutions including the Institut de la Vision in Paris, the Hansen Experimental Physics Laboratory at Stanford University, and Moorfields Eye Hospital in London. The company is EN ISO 13485 certified.
Pixium Vision is qualified “Entreprise Innovante” par Bpifrance
Pixium Vision is listed on Euronext Paris (Compartment C). Pixium Vision shares are eligible for the French tax incentivized PEA-PME and FCPI investment vehicles.
Pixium Vision is included in the Euronext CAC All Shares index
Euronext ticker: PIX - ISIN: FR0011950641 – Reuters: PIX.PA – Bloomberg: PIX:FP
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 R16-033 on April 28, 2016 which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA
1 On the basis of the average price of Pixium Vision share during the last 20 days of trading as at October 19, 2017