Pixium Vision announces its financial results for 2020 and provides a business update Paris Stock Exchange:PIX

(MENAFN- GlobeNewsWire - Nasdaq)

Pixium Vision announces its financial results for 2020 and provides a business update

• Cash position at 31 December 2020: €10.6 million
• Cash runway to end of 2021
• PRIMAvera European pivotal study of Prima System initiated in Q4 2020

Paris, 19 February 2021 – 7.00 a.m. CET - Pixium Vision (FR0011950641 - PIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independently, announces its financial results for 2020. The 2020 financial statements were approved by Pixium Vision's Board of Directors at its meeting on 18 February 2021.

Lloyd Diamond, CEO of Pixium Vision commented 'We continued in 2020 to deliver on our plan of transitioning Pixium Vision from a research project to a commercially oriented company. We progressed our innovative Prima System to the last step of clinical development in Europe by initiating the PRIMAvera pivotal study and strengthened our presence in the US in anticipation of increasing clinical development in this key market. We are well positioned to continue development of the Prima System through these important stages, having successfully extended our cash runway to end of 2021

2020 annual results - Excerpts

Update on Pixium Vision's business

Pixium Vision made important clinical and business progress in 2020. The company reported positive follow-up data from the French feasibility trial of the Prima System in patients with dry age-related macular degeneration (AMD). The follow-up, from 18 to 24 months after implantation, showed that that the Prima System sustainably elicited light perception in all four dry AMD patients and had a favorable safety profile. The second-generation transparent glasses, enabling the combination of natural peripheral vision and prosthetic vision, greatly benefited patients and their visual acuity.

These results paved the way for the initiation of the PRIMAvera pivotal study in Q4 2020, the last clinical step before seeking market approval in Europe. Pixium Vision continues clinical development in the US and has now implanted two patients with the Prima System in its US feasibility study.

Pixium Vision completed the transfer of its shares to Euronext Growth Paris. This provides a regulatory framework that is better adapted to SMEs and reduces listing costs, while enabling the company to continue to benefit from the advantages of the financial markets.

The scientific leadership of Pixium Vision was strengthened with two key appointments. Lisa Olmos de Koo, M.D., a retinal surgent and Associated Professor of Ophthalmology at University of Washington, was appointed Chief Medical Advisor. Ophthalmologist Sandra Montezuma, M.D., Associate Professor in the Department of Ophthalmology and Visual Neurosciences of the University of Minnesota who brings extensive expertise in providing medical and surgical care for all retina diseases, was appointed Clinical Advisor.

Pixium Vision successfully hosted a key opinion leader KOL event on the Prima System for atrophic dry-AMD, featuring presentations by José-Alain Sahel, M.D., University of Pittsburgh School of Medicine, and Lisa Olmos de Koo. The KOLs discussed the current treatment landscape and unmet medical need in treating patients and the event attracted great interest from US investors and analysts.

Analysis of 2020 results

In financial year 2020, the Group did not generate any sales.

Operating revenue is comprised of a Research Tax Credit (CIR) in the amount of €1.38 million (€1.72 million in 2019). The Research Tax Credit was generated by the Group's ongoing R & D efforts, particularly its clinical and regulatory expenses for the Prima System. The decrease in the Research Tax Credit in 2020 was due to various refundable advances and grants received during the period that were deducted from the expenses included in the calculation of the Research Tax Credit. Grants recognised in operating revenue are mainly for the 'SIGHT AGAIN' project, for which the Group received the last two amounts of aid provided for under the contract, as well as the recognition as a grant of the economic benefit under the State-guaranteed loan obtained from the BPI and the CIC. In 2020, total operating revenue was €2.09 million, compared to €1.78 million in 2019.

Current Research and Development (R & D) expenses totalled €5.56 million, compared to €6.53 million the previous year. In 2020, due to the health measures adopted by the government, Pixium Vision was obliged to suspend its R & D activities for several months, in particular its feasibility studies in France and the United States, which were resumed in June 2020. The Group nevertheless continued to prepare the application package for the PRIMAvera pivotal study and received ANSM approval in November 2020. In the second half of the year, the Group primarily incurred expenses to produce the Prima systems in order to optimally prepare for the launch of its PRIMAvera study in Europe. Current R & D expenses accounted for 58% of total current expenses.

Current general and administrative (G & A) expenses totalled €4.10 million in 2020, compared to €3.07 million in 2019. General and administrative expenses increased by 33.7% in 2020, mainly due to the costs the Group incurred for legal services in preparation for its combination with the US company Second Sight Medical Products, Inc.

In 2020, the Group did not recognise any marketing and sales expenses .

In order to provide a clearer picture of Pixium Vision's operations, the Company also publishes its current operating income . This balance is adjusted for non-recurring items and items with no impact on the Group's cash position. Current operating income was a loss of €7.57 million (compared to a loss of €7.87 million in 2019).

Non-current items totalled €0.9 million in 2020 (compared to €1.0 million in 2019). These items consist of expenses calculated in relation to share-based payments for an amount of €0.43 million, compared to €0.37 million a year earlier. In 2020, the Group recognised an impairment loss of €0.45 million on its intangible assets, in connection with patents it decided not to maintain or that had fallen into the public domain. It should be noted that, in 2019, the Group had recognised as a non-current item the severance payment of €0.56 million made to its previous Chief Executive Officer.

Operating income was a loss of €8.45 million, which is lower than in 2019 (€8.87 million). Total income was a loss of €9.13 million (compared to a loss of €9.62 million in 2019). In 2020, the Group recognised financial expenses of €0.7 million (compared €1.0 million in 2019). This decrease was due to the Group's exit from the Kreos Capital bond financing mechanism in September 2020. The Group did not recognise corporate income tax expense for 2020. The loss per share is €0.27 and €0.44 for shares issued in financial years 2020 and 2019, respectively.

Net cash outflow from operating activities fell by 9% in 2020 to €6.9 million, compared to €8.3 million in 2019. The drop in net cash outflow is due to the suspension of feasibility studies and the lower production rate of the Prima systems during the second quarter of 2020. Excluding non-recurring items, cash outflow on administrative expenses rose in the fourth quarter, particularly in connection with the combination with Second Sight Medical Products, Inc.

Net cash flows from financing activities totalled €10.5 million in 2020. They reflect primarily the €7.3 million capital increase with pre-emptive subscription rights completed in July 2020, the drawdown of two ORNAN bond tranches of €1.25 million each under its agreement with ESGO, the €2.5 million State-guaranteed loan obtained, and the last grants and refundable advances received for the 'SIGHT AGAIN' project for a total of €2.7 million. In addition, the Group exited the Kreos Capital bond financing mechanism in September 2020.

In total, Pixium Vision ended 2020 with a net cash position of €10.6 million, compared to €6.8 million a year earlier.

Contacts

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 and a rehabilitation period.

Pixium Vision is conducting clinical feasibility studies of its Prima system, its miniaturised wireless sub-retinal implant, in patients who have lost their sight due to retinal degeneration associated with the dry form of Age-Related Macular Degeneration (AMD). Pixium Vision works closely with world-renown academic partners, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, USA. The company is EN ISO 13485 certified. Pixium Vision has been qualified as an 'Innovative Company' by Bpifrance.

For more information:

Follow us on @PixiumVision ;

MENAFN19022021004107003653ID1101626427