Earnings Release • Jan 29, 2016
Earnings Release
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Paris, France. January 29th, 2016. 7:00 CET – The board of directors of Pixium Vision (FR0011950641 – PIX), chaired by Bernard Gilly, met on January 28, 2016 to approve the 2015 financial results released today.
Khalid Ishaque, CEO of Pixium Vision, said "Our progress has continued to gather momentum particularly in the second half of 2015 with approvals of the clinical trial of IRIS® II in France and in Austria. We continued to expand clinical research partnerships with centers of excellence in several countries, thus laying solid foundations for future growth." Khalid Ishaque added: "2016 will be transformational for Pixium Vision with the expected CE mark approval of IRIS® II in Retinitis Pigmentosa. In parallel we are planning the first human implant of PRIMA, our second generation miniaturized wireless implant, better suited for Age Related Macular Degeneration (AMD). We remain committed to bring meaningful innovations in bionic vision restoration to patients blinded by retinal dystrophies and enabling greater independence, autonomy and quality of daily living."
| P&L summary | ||
|---|---|---|
| in thousand euros | 2015 | 2014 |
| Revenue / other revenues | 3,293.3 | 2,426.6 |
| Research and Development | (15,169.0) | (10,963.0) |
| General and Administrative | (3,823.9) | (3,111.4) |
| Operating income | (15,696.5) | (11,647.8) |
| Net profit | (15,644.4) | (11,611.3) |
| Earnings per share | (€1.23) | (€1.18) |
| in thousand euros | 2015 | 2014 |
|---|---|---|
| Opening cash and cash equivalents | 42,131.7 | 9,420.2 |
| (Decrease) / Increase in cash position | (17,777.9) | 32,711.5 |
| O/W net cash flows from operating activities | (15,532.1) | (8,389.5) |
| Closing cash and cash equivalents | 24,353.8 | 42,131.7 |
Audit procedures are in progress
Pixium Vision is the only company in the world to develop in parallel two distinct retinal bionic implant platforms. IRIS® II, the company's first system, targeting retinitis pigmentosa, and PRIMA, the second generation miniaturized wireless implant, better suited for Age Related Macular Degeneration (AMD) will allow the company to address an estimated market of more than 4 million patients1 in Europe and North America.
Over the last quarter of 2015, the company made significant progress on IRIS® II, its technologically advanced epi-retinal bionic system equipped with an innovative asynchronous bioinspired2 image sensor. IRIS® II is the first epi-retinal device to be equipped with 150 electrodes worldwide. Over the period, Pixium Vision opened two additional clinical centers and an additional three are in process of approval. In December 2015, the company received the approval from the French regulatory authority ANSM to initiate clinical study for patients who have lost sight due to retinitis pigmentosa. The company has also received the Austrian approval. Further national approvals are expected in the coming months.
In early 2016, the company announced positive preclinical safety and feasibility data for PRIMA, its second generation bionic system. Stanford University, demonstrated thermal safety of near infrared stimulation3 of PRIMA in a well-established animal model for retinal damage assessment in laser treatment. PRIMA meets the required standards as the temperature increase is more than 4 times below the recommended thermal safety limit of 2°C4 .
In parallel, the Vision Institute in Paris (Institut de la Vision), demonstrated that PRIMA electrically activated the ganglion cell layers (surface of the retina where the optic nerve starts) well within the optical safety limits5 in a primate retina where photoreceptors had been previously removed.
2016 is an important year for Pixium Vision and the company anticipates a rich news flow:
| H1 2016 | IRIS® II |
• First human implants for IRIS® II equipped with 150 electrodes and an innovative asynchronous image sensor ATIS6 • Initiate FDA process for approval • Mid 2016: IRIS® II CE mark approval |
|---|---|---|
| PRIMA | • Preclinical safety results • FDA pre IDE |
|
| IRIS® II |
• IRIS® II launch in Europe |
|
| H2 2016 | PRIMA | • First in Human implantation in feasibility study • Preparation of AMD pivotal clinical study |
1Retinitis Pigmentosa (RP) and Age related Macular Degeneration (AMD)
2 How Neuromorphic Image Sensors Steal Tricks from the Human Eye – IEEE Spectrum 26 November 2015
3Retinal safety of near infrared radiation in photovoltaic restoration of sight – Biomedical Optics Express Vol. 7, Issue 1, pp. 13-21 (2016)
4 Required standards for active implanted medical devices in chronic use at a power level that allow in-vivo stimulation
5 Validation of photovoltaic subretinal implants on ex-vivo blind non-human primate retinas PH. Prevot, S. Picaud
6ATIS – Asynchronous Time Image Sensor, a bioinspired neuromorphic image sensor
Total revenues amounted respectively to €2.43 million and €3.30 million in 2014 and 2015. Other revenues are composed of proceeds of the research tax credit – CIR – (respectively €2.0 million and €2.26 million in 2014 and 2015) and €0.9 million in grants related to the SIGHT AGAIN and Graphene projects in 2015. The CIR increase in 2015 is related to a continued R&D effort, notably with the preclinical, clinical and regulatory expenses of IRIS® II and the industrial and preclinical development of PRIMA.
In 2015, Research & Development expenses amounted to €15.17 million against €10.96 million a year earlier. These efforts, in line with the company's development plan executing in parallel developments of two major bionic vision restoration platforms, and mainly driven by sub-contracting, collaboration and consultant expenses related to the preclinical, clinical and regulatory work on IRIS® II and the industrial and preclinical development of PRIMA. The increased R&D spend is also related to the increase in R&D staff to 32 from 26 over the period.
General and administrative expenses amounted to €3.11 million and €3.82 in 2014 and 2015 respectively. This increase is mainly related to the fact that 2015 is the first full year where Pixium Vision bears the cost of being a listed company (Communication, travels), the move in the company's new premises and the implementation of board attendance fees.
Consequently, the net loss amounted to €11.61 million and €15.64 million in 2014 and 2015 respectively. The loss per issued share (weighted average number of shares outstanding over the period) amounted to (€1.18) and (€1.23) respectively in 2014 and 2015.
The use of cash flows from operating activities amounted to €8.39 million and €15.53 million respectively in 2014 and 2015. The increase is mainly related to the company's continued R&D efforts (preclinical, clinical and regulatory expenses of IRIS® II and the start of industrial and preclinical development of PRIMA) and its development.
Net cash flow from financing activities amounted to €53,032 in 2015 compared to €42.9 million a year earlier. In June 2014, the company was successfully publically listed on Euronext and raised €39.5 million in gross proceeds. The company closed 2015 with net cash position of €24.4 million against €42.1 million a year earlier.
Pierre Kemula, CFO [email protected] +33 1 76 21 47 68
Pixium Vision's Mission is to create a world of bionic vision for those who have lost their sight enabling them to regain partial perception and greater autonomy and improved quality of daily living. Pixium Vision is the only company today developing in parallel 2 innovative bionic retinal implant systems, which incorporate active implantable prostheses intended to treat and compensate for blindness resulting from the degeneration of retinal photoreceptor cells. The Company harnesses the rapid advances in neuroscience, neuromorphic visual processing, microelectronics / nanoelectronics, optoelectronics, neurobiology and intelligent software algorithms. These bionic systems are intended for blind people whose optic nerve remains functional. Pixium Vision's bionic vision systems are associated with a surgical intervention as well as a rehabilitation period.
European Clinical trials are currently underway with IRIS® , the company's first bionic vision system. Patients have tolerated their implants well so far and improvements in visual perception have been observed. Pixium Vision has filed IRIS's CE mark dossier at the end of 2015 and expects CE mark approval by mid-2016.
Pixium Vision is in parallel, also developing PRIMA, a sub retinal wireless implant platform currently in preclinical studies. The Company plans to begin clinical trials with PRIMA in Europe in 2016.
The company is EN ISO 13485 certified.
Pixium Vision maintains close collaborations with academic and research partnerships spanning across the prestigious Vision Institute in Paris, the Hansen Experimental Physics Laboratory at Stanford University, as well as several global scientific, medical, clinical, and technology experts, resulting also in strong intellectual property portfolio.
Pixium Vision is listed on Euronext (Compartment C) in Paris. ISIN: FR0011950641; Mnemo: PIX IRIS® is a trademark of Pixium-Vision SA For more information, please visit www.pixium-vision.com
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 R15-069 on September 23, 2015 which can be found on the websites of the AMF - AMF (www.amffrance.org) and of Pixium Vision (www.pixium-vision.com).
The risk factors affecting the Company are presented in Chapter 4 of the Document de Référence filed on 23 September 2015 by the French Financial Markets Authority (AMF) under number R15-069.
To the best of the Company's knowledge, the assessment of risks has not changed since the filing of its Document de Référence.
The registration document is available on the company's website:
http://www.pixium-vision.com/fr/investisseurs/financial-reports-and-documents
On 24 June 2015, Pixium Vision announced the appointment of James A. Reinstein to its Board of Directors. Mr. Reinstein joins as an independent board member. Mr. Reinstein was previously President and Chief Executive Officer at Aptus Endosystems Inc. until its sale to Medtronic. Aptus Endosystems was a medical device company engaged in developing and manufacturing advanced technology for treatment of aortic disease;
On 9 July 2015, Pixium Vision announced the appointment of Karine Chevrie as Regulatory Affairs and Quality Director. Karine will lead the teams in charge of Regulatory Affairs and Quality to conduct the regulatory process prior to the commercial launches of the company's products;
After December 31st 2015 major developments were:
• On 7 January 2016 Pixium Vision announced that new positive preclinical thermal safety and feasibility data for PRIMA, its second generation bionic vision system, were published and presented.
P&L
| at 31st December | |||
|---|---|---|---|
| 2015 | 2014 | ||
| (in euros) | |||
| Revenue | |||
| Other revenues | 3,296,305 | 2,426,576 | |
| Total revenues | 3,296,305 | 2,426,576 | |
| Operating expenses | |||
| Research and Development | (15,168,971) | (10,962,963) | |
| General Expenses | (3,823,871) | (3,111,421) | |
| Total expenses | (18,992,843) | ( 14,074,384) | |
| Operating income | (15,696,537) | (11,647,808) | |
| Financial income | 247,797 | 82,277 | |
| Financial expenses | (195,687) | (45,753) | |
| Financial profit (/loss) | 52,110 | 36,525 | |
| Current profit (/loss) before tax | (15,644,427) | (11,611,283) | |
| Corporation tax | - | - | |
| Net Result | (15,644,427) | (11 611 283) | |
| Other non-transferable comprehensive income | |||
| Actuarial gains (/losses) on pension plans | (34,216) | (26,075) | |
| Total profit (/loss) for the year | (15,678,643) | (11,637,358) | |
| Weighted average number of shares | 12,731,795 | 9,804,490 | |
| Net earnings per share | (1.23) | (1.18) | |
| Diluted earnings per share | (1.23) | (1.18) |
The Company was in research and development (R&D) during the two financial years under consideration and did not generate any sales.
Total revenues amounted respectively to €2,426,576 and €3,296,305 in 2014 and 2015. Other revenues are composed of proceeds of the research tax credit (respectively 2,004,974€ and 2,261,854€ in 2014 and 2015) and 908,745€ related to SIGHT AGAIN and Graphene grants in 2015. The CIR increased between 2014 and 2015 is related to the application of a wider eligible expenses base in 2015, as the Company incurred increased R&D spend in 2015, notably with the clinical and regulatory costs for IRIS® II and the industrialization and preclinical development of the PRIMA program.
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 taken into account in the calculation of the research tax credit.
The Company has not capitalized R&D expenses in 2014 and 2015. As a consequence, research tax credit amounts relating to its research programs have been taken in full to operating income over the period.
Operating expense amounted to €14,074,384 and €18,992,843 respectively, in the financial years ended 31 December 2014 and 31 December 2015. These amounts correspond:
Research and development costs notably include:
Research and development costs break down as follow:
| 31/12/2015 | 31/12/2014 | |
|---|---|---|
| Personnel cost | 3,200,178 | 3,466,157 |
| Subcontracting, joint work and consulting costs | 5,313,527 | 4,415,617 |
| Research supplies | 3,650,288 | 1,521,253 |
| Rental costs | 1,308,357 | 394,039 |
| Medical conventions, travel costs | 253,857 | 214,246 |
| License fees | 192,934 | 141,785 |
| Charges to provisions and depreciation/amortization | 900,963 | 772,002 |
| Other | 348,866 | 37,865 |
| Total net | 15,168,971 | 10,962,963 |
R&D expenses amounted to €15,168,971 in 2015 against €10,962,963 in 2014. This increase was essentially related to:
• an increase in headcount. The Company expanded its R&D staff in 2015 to 32 at December 31st , 2015 from 26 a year earlier;
Overheads 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 overhead costs is as follows:
| 31/12/2015 | 31/12/2014 | |
|---|---|---|
| Personnel cost | 1,716,532 | 2,118,856 |
| Fees | 371,679 | 335,982 |
| Rental expenses | 328,370 | 127,167 |
| Insurance | 17,635 | 18,432 |
| Communication, hospitality and travel | 880,579 | 307,607 |
| Postal and telecommunication | 107,687 | 80,013 |
| Administrative supplies | 49,009 | 26,362 |
| Other | 353,380 | 91,002 |
| Total net | 3,823,871 | 3,111,421 |
General and administrative expenses totaled €3,111,421 and €3,823,871 in 2014 and 2015 respectively. This increase is mainly driven by the fact that 2015 is the first full year where Pixium Vision bears the cost of being a listed company with the increase in communication expense. This increase is partially compensated by the decrease in personnel cost over the period, related to a non-recurring booking of a 837,287 euros non-cash IFRS2 expense related to the allocation of free shares at the end of 2014.
The Company posted an operating loss of €11,647,808 in 2014 versus an operating loss of €15,696,537 in 2015.
Financial profit amounted to €36,525 in 2014 and €52,110 in 2015.
Financial income is mainly derived from interest on time deposits accounts. For both financial years, financial losses related exclusively to foreign exchange losses on component purchased in dollars and British pounds.
Having posted a loss for the two financial years under consideration, the Company did not book any corporate income tax.
The Company posted net losses of €11,611,283 and €15,644,427 respectively for 2014 and 2015.
The loss per issued share (weighted average number of shares outstanding over the period) amounted to (€1.18) and (€1.23) respectively in 2014 and 2015.
| (in euros) | At 31 December | ||
|---|---|---|---|
| 2015 | 2014 | ||
| Cash flows from operating activities | |||
| Profit (/loss) for the financial year | (15,644,427) | (11,611,283) | |
| Reconciliation of net profit to cash flows used in operating activities: |
|||
| Depreciation, amortization and impairment | 1,144,092 | 812,722 | |
| Non-cash charge for share-based compensation | 75,784 | 1,201,376 | |
| Retirement benefit obligations | 38,782 | 22,175 | |
| Cash flows from operating activities | (14,385,768) | (9,575,010) | |
| Other receivables | (593,770) | (827,969) | |
| Trade payables | 429,934 | 350,670 | |
| Other current liabilities | (982,460) | 1,662,777 | |
| Net cash flows from operating activities | (15,532,064) | (8,389,532) | |
| Cash flows from investing activities | |||
| Acquisitions of property, plant and equipment | (1,960,662) | (264,669) | |
| Acquisitions of intangible assets | (145,140) | (1,507,677) | |
| Acquisitions of financial holdings | (193,067) | 1,265 | |
| Net cash flows from investing activities | (2,298,868) | (1,771,081) | |
| Cash flow from financing activities: | |||
| Increase (decrease) of refundable advances | (2,677) | 166,943 | |
| Treasury stocks | 32,793 | (181,697) | |
| Issuance of share warrants | 22,317 | - | |
| Share capital increases | 600 | 42,886,904 | |
| Net cash flow from financing activities: | 53,032 | 42,872,151 | |
| Opening cash and cash equivalents | 42,131,728 | 9,420,190 | |
| Closing cash and cash equivalents | 24,353,828 | 42,131,728 | |
| (Decrease) / Increase in cash position | (17,777,900) | 32,711,537 |
Cash flows used in operating activities amounted to €8,389,532 and €15,532,064 respectively in 2014 and 2015. The increase is related to the 2015 ramp up of R&D expenses notably with the continuation of the clinical trials on IRIS® , the regularity filing of IRIS® II and the industrialization and preclinical development of PRIMA.
Cash flows used in investing activities amounted to €1,771,081 and €2,298,868 respectively in 2014 and 2015.
In 2014, cash flows from investing activities were mainly driven by the acquisition of patents, trademarks and know-how €1.5 million as a result of a price difference of shares purchased from Intelligent Medical Implants AG assets. The subscription price of these IMI shares was fully paid through offset of debt held by holders of BSA IMI n°2.
In 2015, as a part of its expansion, the Company acquired technical equipment for €739,658, equipment of buildings and arrangement of premises for €911,448 and to a lesser extent, computer hardware and purchased software applications.
Net cash flow from financing activities amounted to €42,872,151 in 2014 and €53,032 in 2015 following the receipt in June and July 2014 of a gross amount of €44.4 million raised in the Company's IPO on Euronext, and to the exercising of BSA Tranche 2 share subscription warrants from the second round of financing in November 2013.
In 2015, the Company did not raise further capital.
| (in euros) | at 31 December | |||
|---|---|---|---|---|
| ASSETS | 2015 | 2014 | ||
| Non-current Assets | ||||
| Intangible assets | 8,822,379 | 9,259,093 | ||
| Property, plant and equipment | 2,071,510 | 627,307 | ||
| Non-current financial assets | 193,067 | 45,780 | ||
| Total non-current assets | 11,086,955 | 9,932,180 | ||
| Current assets | ||||
| Other current assets | 3,328,361 | 2,734,591 | ||
| Cash & cash equivalents | 24,353,828 | 42,131,728 | ||
| Total current assets | 27,682,189 | 44,866,319 | ||
| TOTAL ASSETS | 38,769,144 | 54,798,498 |
| At 31 December | ||
|---|---|---|
| LIABILITIES | 2015 | 2014 |
| Shareholders' equity | ||
| Share capital | 764,388 | 763,788 |
| Additional paid-in capital | 69,742,546 | 69,720,230 |
| Retained earnings | (19,906,480) | (8,369,557) |
| Profit / (loss) | (15,644,427) | (11,611,283) |
| Total shareholders' equity | 34,956,027 | 50,503,176 |
| Non-current liabilities | ||
| Refundable advances | 164,266 | 166,943 |
| Non-current provisions | 150,776 | 77,778 |
| Total non-current liabilities | 315,042 | 244,721 |
| Current liabilities | ||
| Trade account payables | 2,159,125 | 1,729,190 |
| Other current liabilities | 1,338,950 | 2,321,411 |
| Total current liabilities | 3,498,075 | 4,050,601 |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 38,769,144 | 54,798,498 |
Total assets amounted to €38,769,144 as at 31 December 2015 compared with €54,798,498 a year earlier.
Net non-current assets stood at €9,932,180 and €11,086,955 respectively at 31 December 2014 and 2015.
This includes non-current intangible, tangible and financial assets:
Net current assets amounted to €44,866,319 and €27,682,189 at 31 December 2014 and 2015 respectively. Net current assets comprise:
• cash on hand, time deposits and transferable securities, breaking down as follows:
(in euros)
| 31/12/2015 | 31/12/2014 | |
|---|---|---|
| Cash | 2,326,581 | 1,053,965 |
| Term deposits | 22,027,247 | - |
| Money market funds (SICAV) | - | 41,077,762 |
| Net total | 24,353,828 | 42,131,728 |
• other current assets, mainly incorporating the research tax credit and deductible VAT on purchases:
(in euros)
| 31/12/2015 | 31/12/2014 | |
|---|---|---|
| Deposits and advances | 186,940 | 38,930 |
| State, Research Tax Credit and CICE | 2,352,202 | 2,010,423 |
| VAT | 514,491 | 373,158 |
| Liquidity agreement | 118,417 | 109,232 |
| Other | 18,964 | 6,357 |
| Differed charges | 137,347 | 196,490 |
| Net total | 3,328,361 | 2,734,591 |
Shareholders' equity stood at €34,956,027 and €50,503,176 respectively at 31 December 2015 and 2014:
Non-current liabilities are composed of refundable advances of the SIGHT AGAIN project and retirement benefit liabilities in accordance with IAS 19. Non-current liabilities amount to €244,721 and €315,042 respectively at 31 December 2014 and 2015.
This heading mainly incorporates operating liabilities, i.e.:
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