Pixium Vision announces its 2018 annual results and provides
business update
- PRIMA clinical performance exceeded initial expectations in
advanced dry-AMD;
- Positive feasibility study results to enable the European
pivotal trial, the next step to market for PRIMA;
- Significant reduction in 2018 Operating cash consumption;
- 2018 closing cash position: € 15.6 million.
Paris, France, February 8, 2019
– 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 2018 financial results. The
board of directors of Pixium Vision approved the annual results at
the meeting held on February 7, 2019.
Khalid Ishaque, Chief Executive Officer
Pixium Vision stated: “The clinical safety and performance
achieved to date with PRIMA in patients with advanced dry-AMD,
exceeded the initial expectations. Beyond eliciting light
perception in the central area of the retina that had no remaining
perception, PRIMA enabled patients to progressively identify
letters and sequence of letters. These positive results support the
decision to no longer pursue any IRIS® system development, and
exclusively focus all our efforts on unlocking PRIMA’s broader
potential and value, both for vision loss patients, as well as our
shareholders.” Khalid Ishaque added: “2018 was a
pivotal year with PRIMA, focused on R&D and clinical efforts,
delivering remarkable first clinical results, along with lowering
our overall cost base, while maintaining our financial flexibility.
The 2019 key goal is to initiate the European pivotal clinical
trial with PRIMA. The team is energized to successfully execute
this key next development phase for PRIMA on the path to
market.”
2018 annual results –
Summary
|
P&L 2018 – Highlights |
|
|
| In thousand
euros |
2018 |
|
|
2017 Adjusted* |
|
2017 |
|
|
Revenue / other revenues |
1,598.3 |
|
|
2,535.3 |
|
|
2,535.3 |
|
| Operating
expenses |
(9,124.4 |
) |
|
(13,597.7 |
) |
|
(15,201.5 |
) |
|
Cost of Goods Sold |
(41.2 |
) |
|
(1,124.4 |
) |
|
(1,253.9 |
) |
|
Research and Development |
(6,183.6 |
) |
|
(7,817.4 |
) |
|
(8,486.2 |
) |
|
Marketing & Communication |
(101.8 |
) |
|
(530.7 |
) |
|
(530.7 |
) |
|
General and Administrative |
(2,797.9 |
) |
|
(4,125.2 |
) |
|
(4,930.6 |
) |
| Adjusted
Operating income |
(7,526.1 |
) |
|
(11,062.4 |
) |
|
- |
|
| Operating
income |
(12,294.4 |
) |
|
(12,666.1 |
) |
|
(12,666.1 |
) |
|
Net profit |
(13,571.1 |
) |
|
(13,541.9 |
) |
|
(13,541.9 |
) |
|
Earnings per share |
(0.73 |
) |
|
(1.02 |
) |
|
(1.02 |
) |
(*) Adjusted operating income: The operating
income was adjusted for non-cash items related to charge for
share-based compensation and loss of value registered in 2018.
|
Cash-flow statement summary |
| in thousand
euros |
|
2018 |
|
2017 |
|
|
Opening cash and cash equivalents |
|
10,531.6 |
|
14,244.2 |
|
|
(Decrease) / Increase in cash position |
|
5,097.8 |
|
(3,712.6 |
) |
|
O/W net cash flows from operating activities |
|
(7,450.3 |
) |
(11,480.7 |
) |
|
O/W net cash flows from investing activities |
|
9.0 |
|
(402.3 |
) |
|
O/W net cash flows from financing activities |
|
12,539.1 |
|
8,170.4 |
|
|
Closing cash and cash equivalents |
|
15,629.4 |
|
10,531.6 |
|
Business update
In 2018, Pixium Vision continued to develop its
PRIMA bionic vision system, including the subretinal and wireless
photovoltaic implantable microchip, initially for treatment of
advanced dry form of Age-related macular degeneration (AMD). In
France, all 5 patients planned in the feasibility trial were
successfully implanted. In the separate FDA approved Early
Feasibility Study, in the United States, recruitment is now fully
active. Pixium Vision recently announced 6-month results that
exceeded initial expectations for the five patients successfully
implanted in France: all implanted patients confirmed light
perception with PRIMA from atrophic central retina; with
rehabilitation, majority of the patients progress to identify
letters and sequences of letters. The adverse events, mainly
non-serious, were successfully treated, and the device and
procedure preserved the residual natural peripheral visual acuity.
The positive interim results enable Pixium Vision to design and
implement the multicenter pivotal clinical study in Europe,
required for CE mark on the path to market.
The sub-retinal PRIMA Bionic Vision System is
intended to address the significant unmet medical need globally for
more than 5 million1 people with advanced atrophic dry-AMD and
associated loss of central vision, for whom there is no proven or
curative therapeutic treatment at this time.
Positive results from PRIMA feasibility study
and its potential for value creation, initially being evaluated in
the dry form of AMD, also contributed to the company’s decision to
no longer pursue further development of its IRIS® system and
exclusively focus resources in development of PRIMA with its
broader potential. Consequently, the company recorded impairment of
tangible and intangible assets as well as inventories related to
the IRIS® system.
In 2018, implementation of the restructuring
plan enabled Pixium Vision to successfully reduce its operating
cash consumption by more than € 4 million, or 35% as compared to
2017. Investments in R&D were preserved and accounted for more
than two-thirds of operational expenditures. Pixium Vision also
secured additional financing through a capital increase and the use
of an equity line. The latter was renewed at the end of 2018. In
summary, Pixium Vision maintains financial flexibility to pursue
the development of PRIMA.
2019 operational outlook
In 2019, thanks to the positive results of the
feasibility study, Pixium Vision will prepare the European pivotal
clinical study, expected to begin by the end of the current fiscal
year. This trial will be a major milestone in the clinical
development plan of PRIMA in advance dry-AMD. Separately for the
clinical and regulatory pathway in the USA, recruitment is now
fully active for the Early Feasibility Study approved by the FDA
and implantations are expected during the first half of the
year.
2018 full-year annual
results
In 2018, the Company did not generate sales.
Total revenues are mainly
composed of the Crédit Impôt Recherche (CIR) research tax credit,
which amounted to €1.32 million (€2.06 million in 2017). The CIR is
related to a continued R&D effort, notably with the clinical
and regulatory expenses on PRIMA. The decrease in CIR in 2018 is
due to the cash payment of a refundable advance from “Sight Again”.
Excluding this payment, the CIR would have been stable year on year
showing unchanged eligible R&D expenses among a significant
drop of charges. 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
€1.60 million in 2018 compared with €2.53 million in 2017.
Research & Development
(R&D) expenses amounted to €6.18 million in
2018 versus €7.82 million a year earlier. In 2018, Pixium Vision
maintained its investments in the development of its bionic vision
system PRIMA aiming to pursue both the technical development of
PRIMA and running the feasibility clinical studies. The drop in
R&D expenses is explained by not renewed regulatory and
clinical spending following 2017 milestones achievement.
General & Administrative
(G&A) expenses amounted to €2.80 million in 2018
compared with €4.13 million in 2017. The decrease by more than 30%
is the consequence of the cost cutting plan and the focus to
R&D expenses. Lowered rentals costs, as well as dropped
communication and consultancy fees are the main sources of cost
savings.
Cost of Goods Sold and
Marketing & Communication expenses amounted
respectively to €41,172 and €101,829 in 2018 since there is no
commercial activities.
The Company has chosen to report its
Adjusted Operating Result to improve the
readability of the recurring operating items. Non-recurring items
with no cash impact are excluded from the Adjusted
Operating Result which amounted to a loss of €7.53 million
(versus a loss of €11.06 million in 2017). The tight control in
operating expenses explained the improvement by 32% of the adjusted
Operating Result.
Non-recurring items amounted to €4.77 million of
which €5.48 million corresponds to the impairment of tangible and
intangible IRIS®-related assets, partially offset by the
share-based payment. The non-recurring items are non-cash
items.
Net Operating Income amounted
to a loss of €12.29 million (vs. a loss of €12.67 million in 2017),
and the Net Profit to a loss €13.57 million (vs. a
loss of €13.54 million in 2017). In 2018, the Company booked a
financial charge of €1.28 million (vs. €0.88 million in 2017)
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) amounted to (€0.73) in 2018 compared
to (€1.02) in 2017.
Cash consumption from operating
activities dropped by 35% in 2018 to €7.45 million
compared with €11.48 million in 2017. Cash consumption was mainly
related to the company’s R&D efforts to support the development
of the PRIMA bionic vision system. The drop of cash consumption is
mainly due to reduced non-R&D expenses.
Net cash flow from financing
activities amounted to €12.54 million in 2018. Cash inflow
resulted in the capital increase achieved in the first half of
2018, the equity line financing and the receipt of “Sight Again”
refundable advance. In parallel, Pixium Vision reimbursed the
venture loan signed with Kreos Capital. Pixium Vision closed 2018
with a net cash position of €15.63 million
compared with €10.53 million a year earlier.
Contacts
|
Pixium Vision Didier
Laurens, CFOinvestors@pixium-vision.com+33 1 76 21 47 68 |
Media
RelationsNewcap MediaAnnie-Florence Loyer
- afloyer@newcap.fr +33 1 44 71 00 12 / +33 6 88 20 35 59Léa
Jacquin - ljacquin@newcap.fr +33 1 44 71 94 94 |
US Investor RelationsICRDavid
Clairdavid.clair@icrinc.com+1 646 277 12 66 |
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 in
clinical stage with PRIMA, its sub-retinal miniature photovoltaic
wireless implant system, designed 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
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, PA. The company is EN
ISO 13485 certified and qualifies as “Entreprise Innovante” by
Bpifrance.
For more information, please visit:
www.pixium-vision.com;And follow us on: @PixiumVision;
www.facebook.com/pixiumvision
www.linkedin.com/company/pixium-vision
Disclaimer:
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
Appendices
Risk factors
The risk factors affecting the Company are
presented in Chapter 4 of the Annual Report filed on March 26th,
2018 by the French Financial Markets Authority (AMF) under number
D.18-0185. 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:http://www.pixium-vision.com/fr/investisseurs/financial-reports-and-documents
During 2018, major developments include:
- On January 4, 2018, Pixium Vision received FDA
approval to begin human clinical study of its PRIMA retinal implant
in the US.
- On January 25, 2018, Pixium Vision completed
world’s first activation in human of PRIMA bionic vision
system.
- On February 8, 2018, Pixium Vision announced
its 2017 annual results and provides business update.
- On March 13, 2018, Pixium Vision announced
successful activations with PRIMA, its breakthrough Bionic Vision
System, in the first three patients with atrophic dry-AMD.
- On April 11, 2018, Pixium Vision reported Q1
2018 cash position.
- On April 11, 2018, Pixium Vision launched a
€10.6 million right issue to support the advances in clinical
development of PRIMA, its breakthrough bionic vision system.
- On May 3, 2018, Pixium Vision announced the
significant success of its €10.6 million right issue.
- On June 27, 2018, annual general meeting and
board of directors of June 27, 2018.
- On July 10, 2018, Pixium Vision completed
implantation of PRIMA in five patients with atrophic dry-amd as
expected for the feasibility clinical trial in France.
- On July 26, 2018, Pixium Vision announced H1
2018 financial results and provided an update on its
activities.
- On August 1, 2018, Pixium Vision restructured
its bond financing facility with Kreos Capital.
- On August 30, 2018, Pixium Vision achieved
successful activation of its photovoltaic PRIMA implant in all five
study patients with dry age-related macular degeneration.
- On September 18, 2018, Pixium Vision announced
the presentation of the first clinical results with PRIMA, its
wireless implant, in patients with atrophic dry-AMD.
- On September 24, 2018, Pixium Vision announced
positive review of the first results with PRIMA, its wireless
subretinal implant, in patients with atrophic dry-AMD.
- On October 25, 2018, Pixium Vision reported
cash position as of September 30, 2018.
- On October 30, 2018, Pixium Vision reported
positive data with PRIMA, its wireless retinal implant, at the
annual meeting of the American Academy of Ophthalmology.
- On December 13, 2018, Pixium Vision awarded
Galien prize 2018 for research with prima system for dry-AMD.
- On December 24, 2018 - Pixium Vision
established a new equity line financing with Kepler Cheuvreux.
After 31 December 2018 major
developments were:
- On January 8, 2019, Pixium Vision announced
its wireless PRIMA chip successfully met the interim study
endpoints for dry age-related macular degeneration.
Comparison of 2018 and 2017 annual results
|
(Amounts in euros) |
|
As at 31st December |
|
2018 |
|
2017adjusted* |
2017Reported |
|
Revenues |
|
|
|
|
|
Net sales |
|
– |
|
100,000 |
|
100,000 |
|
|
Research Tax Credit |
|
1,322,986 |
|
2,057,327 |
|
2,057,327 |
|
|
Grants |
|
236,338 |
|
288,923 |
|
288,923 |
|
|
Other revenues |
|
38,980 |
|
89,075 |
|
89,075 |
|
|
Total revenues |
|
1,598,304 |
|
2,535,325 |
|
2,535,325 |
|
|
Operating expenses |
|
|
|
|
|
Costs of goods sold |
|
(41,172 |
) |
(1,124,412 |
) |
(1,253,929 |
) |
|
Research and Development |
|
(6,183,557 |
) |
(7,817,392 |
) |
(8,486,206 |
) |
|
Sales and Marketing |
|
(101,829 |
) |
(530,718 |
) |
(530,718 |
) |
|
General expenses |
|
(2,797,881 |
) |
(4,125,221 |
) |
(4,930,629 |
) |
|
Total expenses |
|
(9,124,440 |
) |
(13,597,744 |
) |
(15,201,483 |
) |
|
Adjusted operating income * |
|
(7,526,136 |
) |
(11,062,419 |
) |
– |
|
|
Share-based compensation |
|
1,090,889 |
|
(1,603,739 |
) |
– |
|
|
Exceptional Amortization |
|
(376,522 |
) |
– |
|
– |
|
|
Impairment |
|
(5,482,656 |
) |
– |
|
– |
|
|
Operating income |
|
(12,294,425 |
) |
(12,666,158 |
) |
(12,666,158 |
) |
|
Financial income |
|
15,008 |
|
61,413 |
|
61,413 |
|
|
Financial expenses |
|
(1,291,696 |
) |
(937,188 |
) |
(937,188 |
) |
|
Financial profit / (loss) |
|
(1,276,688 |
) |
(875,776 |
) |
(875,776 |
) |
|
Current profit / (loss) before tax |
|
(13,571,113 |
) |
(13,541,934 |
) |
(13,541,934 |
) |
|
Corporation tax |
|
– |
|
– |
|
– |
|
|
Net result |
|
(13,571,113 |
) |
(13,541,934 |
) |
(13,541,934 |
) |
|
Other non-transferable comprehensive income |
|
|
|
|
|
Actuarial gains / (losses) on pension plans |
|
48,528 |
|
7,002 |
|
7,002 |
|
|
Total profit / (loss) for the half year |
|
(13,522,585 |
) |
(13,534,931 |
) |
(13,534,931 |
) |
|
Weighted average number of shares |
|
18,523,505 |
|
13,267,646 |
|
13,267,646 |
|
|
Net earnings per share |
|
(0.73 |
) |
(1.02 |
) |
(1.02 |
) |
|
Diluted earnings per share |
|
(0.73 |
) |
(1.02 |
) |
(1.02 |
) |
(*) Adjusted operating income: The operating
income was adjusted for non-cash items related to charge for
share-based compensation and loss of value registered in 2018.
Total revenues
In 2018, the Company
generated no sales.
Other revenues amounted to
respectively €1.60 million and €2.53 million, for the years ended
2018 and 2017. These amounts include the Research Tax Credit (CIR)
reaching respectively €1.32 million and €2.11 million for the
financial years 2018 and 2017. Pixium Vision has also booked in
2018 a product related to refundable advance from “Sight Again”
project.
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 2018 and 2017. Therefore, research tax credit amounts relating
to its research programs have been recorded in full into operating
income over the period.
Operating expenses
Operating expenses amounted to €9.12 million and
€13.60 million respectively for the years ended 2018 and 2017. In
2018, the operating expenses amount mainly correspond to Research
and Development activities, which are recorded as expenses, as well
as general and administration expenses. Following the halt in
IRIS®II program, the "cost of goods sold" as well as “Marketing
& Communication” were significantly reduced.
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) |
31/12/2018 |
31/12/2017 |
|
Staff costs |
2,722,565 |
2,384,750 |
|
|
Subcontractors, collaboration and consultants |
1,531,793 |
2,833,885 |
|
|
Research supplies |
608,530 |
1,084,473 |
|
|
Lease of real property |
606,192 |
988,122 |
|
|
Conferences, travel expenses |
109,374 |
157,184 |
|
|
License fees |
160,391 |
(2,831 |
) |
|
Amortization, depreciation and provisions |
381,334 |
291,603 |
|
|
Other |
63,377 |
80,207 |
|
|
Net total |
6,183,557 |
7,817,392 |
|
Research and development expenditure amounted to
€6.18 million for the financial year 2018, compared to €7.82
million for the financial year 2017. This decrease is mainly due
the drop of subcontractors involved in pre-clinical development of
PRIMA as well as the end of IRIS®II clinical trial.
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) |
31/12/2018 |
31/12/2017 |
|
Staff costs |
923,208 |
1,822,235 |
|
Fees |
579,057 |
656,910 |
|
Lease of real property |
120,044 |
238,722 |
|
Insurance |
49,088 |
54,686 |
|
Communication, travel and entertainment expenses |
390,583 |
581,534 |
|
Postal and telecommunication costs |
50,632 |
60,057 |
|
Administrative supplies and equipment leases |
22,634 |
32,933 |
|
Amortization, depreciation and provisions |
561,811 |
567,441 |
|
Other |
100,824 |
110,703 |
|
Net total |
2,797,881 |
4,125,221 |
General and administrative expenses totalled
€2.80 million and €4.13 in 2018 and 2017 respectively. The drop is
due to the implementation of cost-saving plan in early 2018.
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:
|
Selling and marketing (Amounts in euros) |
31/12/2018 |
31/12/2017 |
|
Staff costs |
30,890 |
253,363 |
|
Fees |
22,785 |
150,033 |
|
Communication, travel and entertainment expenses |
43,439 |
60,005 |
|
Others |
4,715 |
67,316 |
|
Net total |
101,829 |
530,718 |
Cost of goods sold
The Company incurred residual expenses in the
manufacturing of the bionic vision system IRIS®II. As the Company
recorded one sale of IRIS®II in 2017, the whole cost of goods sold
was recognized in the P&L. These expenses are broken down as
follows:
|
Cost of goods sold (Amounts in euros) |
31/12/2018 |
31/12/2017 |
|
Staff costs |
– |
876,764 |
|
|
Purchase of raw materials, supplies and other consumables |
4,430 |
643,312 |
|
|
Subcontractors, collaboration and consultants |
– |
35,157 |
|
|
Change in inventory |
36,742 |
(596,955 |
) |
|
Amortization, depreciation and provisions |
– |
103,340 |
|
|
Others |
– |
62,794 |
|
|
Net total |
41,172 |
1,124,412 |
|
Adjusted Operating income /
loss
Adjusted Operating losses is reduced by 32% to
€7.53 million in 2018 compared with a loss of €11.06 million in
2017.
Operating income /
loss
The Company posted an operating loss of €12.29
million in 2018 versus an operating loss of €12.67 million in 2017.
The operating result is negatively impacted by a non-recurring item
of a €5.86 million impairment and exceptional amortization of IRIS®
program. This charge is partially offset by a reversal of €1.09
million share-based payment.
Financial
result
Financial result amounted to a loss of €1.28
million in 2018. 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
dollars and British pounds’ purchases.
Financial income consists mainly of the
remuneration of term deposits and other short to mid-term
investments.
Corporation
tax
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 losses of €13.57 million
and €13.54 million respectively for 2018 and 2017.
The loss per issued share amounted to (€0.73)
and (€1.02) respectively in 2018 and 2017.
Cash Flow Statement
|
(Amounts in euros) |
As at 31st December |
|
2018 |
|
2017 |
|
|
|
Cash flows from operating activities |
|
|
|
|
Profit / (loss) for the half year |
(13,571,113 |
) |
(13,541,934 |
) |
|
|
Reconciliation of net profit to cash flows used in
operating activities |
|
|
|
|
Depreciation, amortization and impairment |
6,159,600 |
|
935,637 |
|
|
|
Loss of value on disposals |
638,297 |
|
- |
|
|
|
Provisions |
(143,616 |
) |
187,331 |
|
|
|
Government grants |
(198,838 |
) |
(289,592 |
) |
|
|
Financial results |
538,682 |
|
241,530 |
|
|
|
Non-cash charge for share-based compensation |
(1,090,889 |
) |
1,603,739 |
|
|
|
Retirement benefit obligations |
33,492 |
|
3,545 |
|
|
|
Cash flows from operating activities |
(7,634,385 |
) |
(10,859,743 |
) |
|
|
Inventories |
59,813 |
|
(596,955 |
) |
|
|
(Increase) / Decrease in trade receivables |
– |
|
30,060 |
|
|
|
Other current assets |
708,719 |
|
(75,493 |
) |
|
|
(Increase) / Decrease in trade payables |
(238,463 |
) |
(70,445 |
) |
|
|
Other current liabilities |
(346,023 |
) |
91,921 |
|
|
|
Net cash flows from operating activities |
(7,450,339 |
) |
(11,480,655 |
) |
|
|
Acquisitions of property, plant and equipment |
(31,112 |
) |
(191,404 |
) |
|
|
Acquisitions of Intangible assets |
– |
|
– |
|
|
|
Acquisitions of financial holdings |
40,157 |
|
(210,873 |
) |
|
|
Net cash flows from investing activities |
9,045 |
|
(402,277 |
) |
|
|
Increase / (Decrease) of refundable advances |
879,000 |
|
– |
|
|
|
Increase / (Decrease) of financial debt |
(2,408,287 |
) |
7,651,134 |
|
|
|
Treasury stocks |
34,677 |
|
66,994 |
|
|
|
Share capital Increases |
14,033,727 |
|
452,233 |
|
|
|
Net cash flows from financing activities |
12,539,117 |
|
8,170,360 |
|
|
|
Opening cash and cash equivalents |
10,531,602 |
|
14,244,174 |
|
|
|
Closing cash and cash equivalents |
15,629,424 |
|
10,531,602 |
|
|
|
(Decrease) / Increase in cash position |
5,097,822 |
|
(3,712,572 |
) |
|
Cash flows from operating
activities
Cash flows used in operating activities amounted
to €7.45 million and €11.48 million respectively in 2018 and 2017.
The significant drop in cash consumption results in the success of
the cost-reduction plan implemented as from beginning of 2018.
Cash flows from investing activities
Cash flows used in investing activities is not
significant.
Cash flows from financing activities
Net cash flow from financing activities amounted
to €12.54 million in 2018 to be compared to €8.17 million in
2017.
This increase is explained by the successful
capital increase held in 2018 as well as the used of the Equity
Line signed in October 2017 with Kepler Cheuvreux. In 2018, the
Company also received €0.88 million as a refundable advance from
the “Sight Again” R&D project. The cash-in has been partially
offset by the repayment of €2.41 million of the venture loan signed
with Kreos Venture.
Balance Sheet
|
(Amounts in euros) |
Note |
|
|
31/12/2018 |
31/12/2017 |
|
ASSETS |
|
|
|
|
Non-current Assets |
|
|
|
|
Intangible assets |
4 |
2,623,337 |
|
7,679,574 |
|
|
Property, plant and equipment |
5 |
706,107 |
|
1,567,341 |
|
|
Non-current financial assets |
6 |
336,356 |
|
402,223 |
|
|
Total non-current assets |
|
3,665,799 |
|
9,649,139 |
|
|
Current assets |
|
|
|
|
Stocks and work in progress |
7 |
– |
|
909,126 |
|
|
Receivables |
|
– |
|
– |
|
|
Other current assets |
8 |
2,126,120 |
|
2,800,553 |
|
|
Cash & cash equivalents |
9 |
15,629,424 |
|
10,531,602 |
|
|
Total current assets |
|
17,755,544 |
|
14,241,281 |
|
|
TOTAL ASSETS |
|
21,421,343 |
|
23,890,420 |
|
|
LIABILITIES |
|
|
|
|
Shareholders' equity |
10 |
|
|
|
Share capital |
|
1,296,382 |
|
816,005 |
|
|
Additional paid-in-capital |
|
83,717,369 |
|
70,164,019 |
|
|
Retained earnings |
|
(60,088,048 |
) |
(45,601,973 |
) |
|
Profit / (loss) |
|
(13,571,113 |
) |
(13,541,934 |
) |
|
Total shareholders' equity |
|
11,354,591 |
|
11,836,118 |
|
|
Non-current liabilities |
|
|
|
|
Refundable advances |
11 |
2,358,623 |
|
1,486,758 |
|
|
Venture loan |
12 |
5,510,954 |
|
7,643,731 |
|
|
Non-current provisions |
13 |
153,399 |
|
171,576 |
|
|
Total non-current liabilities |
|
8,022,976 |
|
9,302,065 |
|
|
Current liabilities |
|
|
|
|
Current provisions |
14 |
43,715 |
|
184,190 |
|
|
Trade account payables |
15 |
983,951 |
|
1,222,414 |
|
|
Other current liabilities |
16 |
1,016,110 |
|
1,345,633 |
|
|
Total current liabilities |
|
2,043,776 |
|
2,752,237 |
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
|
21,421,343 |
|
23,890,420 |
|
Assets
Total assets amounted to €21.42 million as at 31
December 2018 compared with €23.89 million a year earlier.
Non-current assets
Net non-current assets stood at €3.67 million,
and €9.65 million respectively at 31 December 2018 and 2017.
This includes non-current intangible, tangible
and financial assets:
- Intangible assets amounted to €2.62 million and €7.68 million
at 31 December 2018 and 2017 respectively mainly consisting of
amortization of patents acquired from Intelligent Medical Implant.
The decrease corresponds to the amortization of those acquired
patents and the booking of an impairment on some of
them.
- Tangible assets amounted to €0.71 million and €1.57 million at
31 December 2018 and 2017 respectively, are mainly made up of
machinery and laboratory equipment. The drop is due to the
accelerated amortization linked with the Company move is new
premises.
- Non-current financial assets amounted to €0.34 million and
€0.40 million as at 31 December 2018 and 2017. 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.
Current assets
Net current assets amounted to €17.76 million
and €14.24 million at 31 December 2018 and 2017 respectively.
Net current assets comprise:
|
(Amounts in euros) |
31/12/2018 |
31/12/2017 |
|
Deposits and advances |
76,537 |
101,140 |
|
State, Research Tax Credit and CICE |
1,323,485 |
2,133,406 |
|
VAT |
106,300 |
200,865 |
|
Liquidity agreement |
95,847 |
71,980 |
|
Differed charges |
470,709 |
287,696 |
|
Other |
53,242 |
5,465 |
|
Net total |
2,126,120 |
2,800,553 |
As at December 31st, 2018, other current assets
consist mainly of the research tax credit receivable for €1.32
million and the increase in advances and prepayment related to
R&D expenses incurred during the year. Prepaid expenses mainly
correspond to expenses related to rents, insurance and travel
expenses.
As at December 31st, 2018, the receivable
related to the Research Tax Credit was lower than in 2017 since the
Company booked a refundable advance of €0.88 million from “Sight
Again” R&D project. Excluding this payment, the CIR asset would
have been stable as compared with 2017 resulting in a stable
R&D eligible expense.
- cash on hand, time deposits and transferable securities,
breaking down as follows:
|
(Amounts in euros) |
31/12/2018 |
31/12/2017 |
|
Cash |
7,626,391 |
2,513,256 |
|
Term deposits |
8,003,033 |
8,018,346 |
|
Money market funds (SICAV) |
– |
– |
|
Net total |
15,629,424 |
10,531,602 |
Liabilities
Shareholders’ equity
Shareholders’ equity stood at €11.35 million and
€11.84 million respectively at 31 December 2018 and 2017:
- €85.01 million in share capital and issue premiums as at 31
December 2018 (€70.98 million as at 31 December 2017);
- Reserves, including previous losses of €60.09 million in
2018
- 2018 losses of €13.57 million.
Non-current liabilities
Non-current liabilities are composed of venture
loan, refundable advances and retirement benefit liabilities in
accordance with IAS 19. Non-current liabilities increased in 2018
dropped following the reimbursement of the venture loan.
Non-current liabilities amounted to €8.02 million (vs. €9.30
million in 2017) Refundable advances increased following the
payment of the refundable advance received from “Sight Again”.
Non-current provisions are composed of pension obligations.
Current liabilities
This heading mainly incorporates operating
liabilities, i.e.:
- Current provisions: €0.04 million as at 31 December 2018
represents the social charges incurred on free share plans.
- trade payables: €0.98 million as at 31 December 2018 (€1.22
million as at 31 December 2017);
- social security liabilities: €0.98 million as at 31 December
2018 (€1.29 million as at 31 December 2017);
- tax liabilities: €9,611 as at 31 December 2018 (€46,931 as at
31 December 2017);
1
http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30393-5/fulltext