Pixium Vision announced today its 2017 financial results.
- The PRIMA system successfully elicited light perception, now in the first two AMD patients
- US FDA approved early feasibility study with PRIMA in atrophic dry-AMD
- Growth strategy focus on the development of PRIMA in AMD, a significant unmet medical need
- 2017 closing cash position: EUR 10.5M
Paris, France, February 8, 2018 – 7.00 AM CET - Pixium Vision (FR0011950641 - PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced today its 2017 financial results. The board of directors of Pixium Vision, chaired by Bernard Gilly, approved the annual results at a meeting on February 7, 2018.
“Key achievements for Pixium Vision include the approval in France and in the United States of the first in human clinical phase of breakthrough wireless photovoltaic sub-retinal technology, PRIMA for atrophic dry-AMD. This is in parallel with IRIS(R)II, which despite early lifetime exhaustion, showed positive 6-month results in Retinitis Pigmentosa.” said Khalid Ishaque, CEO of Pixium Vision. “We recently reached a major milestone with the world premiere successful PRIMA activations already in the first two subjects with atrophic dry Age-related Macular Degeneration. The early experience highlights PRIMA’s potential in dry-AMD and supports our strategic decision to postpone further developments on improving the IRIS(R)II implant lifetime, and to focus our growth strategy to further optimize and leverage the resources and acquired experience in artificial bionic vision development, in maximizing the potential and value creation with PRIMA.”
2017 annual results - Summary
P&L summary
in thousand euros 2017 2016
Revenue / other revenues (*) 2,535.3 2,515.9
Operating expenses (15,201.5) (15,014.7)
Cost of Goods Sold (1,253.9) (141.0)
Research and Development (8,486.2) (10,869.4)
Sales and Marketing (530.7) (6.7)
General and Administrative (4,930.6) (3,997.7)
Operating income (12,666.2) (12,498.9)
Net profit (13,541.9) (12,440.8)
Earnings per share (€1.02) (€0.98)
(*) O/W Research Tax Credit
Cash flow statement summary
in thousand euros 2017 2016
Opening cash and cash equivalents 14,244.2 24,353.8
(Decrease) / Increase in cash position (3,712.6) (10,109.7)
O/W net cash flows from operating activities (11,480.7) (11,860.8)
O/W net cash flows from investing activities (402.3) (148.5)
O/W net cash flows from financing activities 8,170.4 1,899.6
Closing cash and cash equivalents 10,531.6 14,244.2
Business update
In 2017, Pixium Vision made significant progress with its new generation implant PRIMA, a miniaturized photovoltaic wireless sub-retinal implant, to address a significant unmet medical need to compensate for severe vision loss from Atrophic Dry Age-related Macular Degeneration (dry-AMD). Pixium Vision finalised the pre-clinical development and in October 2017 obtained the authorisation to begin a first in human feasibility clinical trial in France in Atrophic dry-AMD[1]. The world’s first successful implantations and the activations about a month after with PRIMA have now been achieved in two subjects. Further communication will follow at the end of the recruitment of the 5 patients, and subsequently with 6-month follow-up results. This 36-month, 5-patient feasibility study is designed to evaluate the safety and function of the sub-retinal implant PRIMA in eliciting visual light perception with an interim 6-month follow-up enabling to decide proceeding with the pivotal clinical study in EU.
In parallel, Pixium Vision received the authorisation from the US Food and Drug Administration (US FDA) to start a feasibility study[2] in the United States and include 5 patients with Atrophic dry-AMD. The clinical trial should start in Q2 2018 at the University of Pittsburgh Medical Centre (UPMC), Pennsylvania.
The sub-retinal PRIMA Bionic Vision System is intended to address a significant potential unmet medical need for more than 4 million[3] people with Atrophic dry-AMD, in both Europe and in North America, for whom there is no proven therapeutic treatment.
Pixium Vision management, unanimously supported by the Board of Directors, has decided to adapt its strategy to focus available resources in the near term on the development of PRIMA. This also follows PRIMA’s first successful activations and the potential of maximizing value creation of this breakthrough technology, particularly in view of opportunities enabled by the FDA approval for starting feasibility study in the US. This strategic decision means Pixium Vision will focus its human and financial resources on the development of the PRIMA system and conducting clinical trials in Europe and in the United States initially for dry AMD. Consequently, for IRIS(R)II despite positive 6-month follow-up results, Pixium Vision will postpone developments to improve the implant’s lifetime, which would require important financial spend through to end 2019.
Following this strategic decision, Pixium Vision will adjust its operational spending to reduce its cash-burn. Pixium Vision will focus the spend in clinical studies with PRIMA for dry-AMD in Europe and the United States, and further development of the PRIMA system for the next clinical phase with a pivotal EU study.
2018 operational outlook
In 2018, Pixium Vision will pursue the clinical development of PRIMA which has started following approval in France for the trial, received in October 2017. The first successful implantations have marked the start of the feasibility study leading to the 6-month follow-up results. In addition, following the authorization already received from the US FDA, a feasibility clinical study with PRIMA should also start with first implantations in the first half of 2018.
2017 full-year annual results
In 2017, Net Sales reached EUR 0.1 million generated by the sale of one bionic vision system (BVS) IRIS(R)II in Spain. In 2016, the Company did not generate sales.
Total revenues are mainly composed of the Credit Impot Recherche (CIR) research tax credit, which amounted to EUR 2.11 million (EUR 1.81 million in 2015). The CIR is related to a continued R&D effort, notably with the clinical and regulatory expenses on its two BVS, IRIS(R)II and PRIMA. The CIR increased in 2017, compared with 2016, mainly because of the increase of R&D expenses for the development of PRIMA, as well as the on-going clinical trial with IRIS(R)II. The Company accounted for a product linked with the refundable advance received in the framework of the “Sight Again” project. In all, total revenues amounted to EUR 2.53 million in 2017 compared with EUR 2.52 million in 2016.
Cost of Goods Sold reached EUR 1.25 million (vs. EUR 0.14 million in 2016). The increase of these costs is linked with the manufacturing of the implant IRIS(R)II and its visual processor as well as a full year effect. These charges were mainly considered as R&D expenses before IRIS®II received its CE Mark in July 2016.
Research & Development expenses amounted to EUR 8.49 million in 2017 versus EUR 10.87 million a year earlier. The reduction is explained by the transfer of charges related to IRIS(R)II manufacturing to Cost of Goods Sold. Pixium Vision additionally invested in the development of PRIMA its new generation bionic vision system. The goal was to obtain regulatory approval for the start of feasibility clinical studies with PRIMA, both in France and the US. The trial has already started in France. For IRIS®II, the Company focused spending related to the on-going multi-centric clinical trial.
Sales & Marketing expenses amounted to EUR 0.53 million in 2017 compared with EUR 0.07 million in 2016. Following the CE mark for the first device, IRIS(R)II, the Company started limited commercial activities at the end of 2016. Pixium vision recruited 3 employees to support the commercial efforts and significantly increased its presence at select conferences to market IRIS(R)II to ophthalmologists, retinal surgeons, and low-vision specialists. The limited commercial efforts were mainly focused in France, Germany and Spain.
General & Administrative expenses amounted to EUR 4.93 million in 2017 compared with EUR 4.00 million in 2016. The increase is mainly related to non-cash charges of EUR 0.89 million resulting from the valuation of a free share plan. Excluding this non-cash item, G&A expenses were kept under control, benefiting in particular from lower rental costs.
Net Operating Income amounted to a loss of EUR 12.67 million (vs. a loss of EUR 12.50 million in 2016), and the Net Profit to a loss EUR 13.54 million (vs. a loss of EUR 12.44 million in 2016). In 2017, the Financial charge increased significantly to EUR 0.88 million following the drawdown of 2 tranches of the venture loan signed with Kreos Capital in September 2016. This explains the increase in the Net loss in 2017 compared to 2016. No Income Tax was recorded in 2017. Net Loss per issued share (weighted average number of shares outstanding over the period) amounted to (EUR 1.00) compared to (EUR 0.98) in 2016.
Cash consumption from operating activities stabilized at EUR 11.48 million compared with EUR 11.33 million in 2016. Cash consumption was mainly related to the company’s R&D efforts to support the development of the PRIMA bionic vision system. The increase in regulatory expense to support the approval of clinical trials for PRIMA, both in France and in the US, as well as the sales and marketing efforts with IRIS®II following CE mark, explains the stable cash burn supported also by tight management of G&A expense.
Net cash flow from financing activities amounted to EUR 8.17 million in 2017, mainly from the drawdown of two tranches, EUR 4 million each, of the venture loan signed with Kreos Capital. Pixium Vision closed 2017 with a net cash position of EUR 10.53 million compared with EUR 14.24 million a year earlier.
[1] Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration. https://clinicaltrials.gov/ (NCT03333954)
[2] PRIMA US-Feasibility Study in Atrophic Dry AMD. https://clinicaltrials.gov/ (NCT03392324)
[3] http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30393-5/fulltext
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(R)II, Pixium Vision is now conducting a clinical study1 in Human with PRIMA, its new generation sub-retinal miniaturized photovoltaic wireless implant system, 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 spanning across the prestigious Vision research institutions including the Institut de la Vision in Paris, the Hansen Experimental Physics Laboratory at Stanford University, Moorfields Eye Hospital in London, and Institute of Ocular Microsurgery (IMO) in Barcelona. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” par Bpifrance.
For more information, please visit:
And follow us on:
@PixiumVision
