|
Belgium
(State or other jurisdiction of
incorporation or organization) |
| |
3841
(Primary Standard Industrial
Classification Code Number) |
| |
Not applicable
(I.R.S. Employer
Identification Number) |
|
|
Jonathan L. Kravetz, Esq.
John T. Rudy, Esq. Mintz, Levin, Cohn, Ferris, Glovksy & Popeo, P.C. One Financial Center Boston, MA 02111 (617) 542 6000 |
| |
Philippe Remels
NautaDutilh BV/SRL Chaussée de La Hulpe 120 1000 Brussels, Belgium +32 2 566 80 00 |
| |
Shayne Kennedy, Esq.
Latham & Watkins LLP 650 Town Center Drive 20th Floor Costa Mesa, CA 92626 (714) 540 1235 |
|
| | | | | ii | | | |
| | | | | ii | | | |
| | | | | iii | | | |
| | | | | iii | | | |
| | | | | 1 | | | |
| | | | | 9 | | | |
| | | | | 10 | | | |
| | | | | 12 | | | |
| | | | | 66 | | | |
| | | | | 68 | | | |
| | | | | 69 | | | |
| | | | | 70 | | | |
| | | | | 71 | | | |
| | | | | 73 | | | |
| | | | | 90 | | | |
| | | | | 131 | | | |
| | | | | 147 | | | |
| | | | | 149 | | | |
| | | | | 152 | | | |
| | | | | 166 | | | |
| | | | | 168 | | | |
| | | | | 184 | | | |
| | | | | 193 | | | |
| | | | | 194 | | | |
| | | | | 194 | | | |
| | | | | 194 | | | |
| | | | | 195 | | | |
| | | | | F-1 | | |
(In thousands, except per share data)
|
| |
Years Ended December 31
|
| |
Three Months Ended
March 31 |
| ||||||||||||||||||
|
2020
|
| |
2019
|
| |
2021
|
| |
2020
|
| ||||||||||||||
|
€
|
| |
€
|
| |
€
|
| |
€
|
| ||||||||||||||
Revenue
|
| | | | 69 | | | | | | — | | | | | | 185 | | | | | | — | | |
Cost of goods sold
|
| | | | (30) | | | | | | — | | | | | | (52) | | | | | | — | | |
Gross Profit
|
| | | | 39 | | | | | | — | | | | | | 133 | | | | | | — | | |
General and administrative expenses
|
| | | | (7,522) | | | | | | (4,226) | | | | | | (1,818) | | | | | | (1,178) | | |
Research and development expenses
|
| | | | (473) | | | | | | (630) | | | | | | (852) | | | | | | (7) | | |
Clinical expenses
|
| | | | (1,053) | | | | | | (848) | | | | | | (342) | | | | | | (177) | | |
Manufacturing expenses
|
| | | | (460) | | | | | | (489) | | | | | | (901) | | | | | | (62) | | |
Quality assurance and regulatory expenses
|
| | | | (227) | | | | | | (227) | | | | | | (325) | | | | | | (25) | | |
Patent fees and related
|
| | | | (123) | | | | | | (267) | | | | | | (674) | | | | | | (58) | | |
Therapy development income / (expenses)
|
| | | | (1,864) | | | | | | (902) | | | | | | (548) | | | | | | (352) | | |
Other operating expenses
|
| | | | 459 | | | | | | (126) | | | | | | 4 | | | | | | (191) | | |
Operating loss for the period
|
| | | | (11,224) | | | | | | (7,715) | | | | | | (5,323) | | | | | | (2,050) | | |
Financial income
|
| | | | 62 | | | | | | 71 | | | | | | 4 | | | | | | 19 | | |
Financial expense
|
| | | | (990) | | | | | | (740) | | | | | | (325) | | | | | | (336) | | |
Loss for the period before taxes
|
| | | | (12,152) | | | | | | (8,384) | | | | | | (5,644) | | | | | | (2,367) | | |
Taxes
|
| | | | (93) | | | | | | (70) | | | | | | (25) | | | | | | (13) | | |
Loss for the period
|
| | | | (12,245) | | | | | | (8,454) | | | | | | (5,669) | | | | | | (2,380) | | |
Loss attributable to equity holders
|
| | | | (12,245) | | | | | | (8,454) | | | | | | (5,669) | | | | | | (2,380) | | |
Currency translation differences
|
| | | | (58) | | | | | | 168 | | | | | | (70) | | | | | | 272 | | |
Total Comprehensive loss for the period, net of tax
|
| | | | (12,303) | | | | | | (8,286) | | | | | | (5,739) | | | | | | (2,108) | | |
Loss attributable to equity holders
|
| | | | (12,303) | | | | | | (8,286) | | | | | | (5,739) | | | | | | (2,108) | | |
Basic and diluted Loss Per Share
|
| | | | (0.677) | | | | | | (0.568) | | | | | | (0.256) | | | | | | (0.151) | | |
| | |
As of March 31
|
| ||||||||||||
| | |
Actual
|
| |
As Adjusted(1)
|
| | ||||||||
(In thousands)
|
| |
2021
|
| |
2021
|
| | ||||||||
Cash and cash equivalents
|
| | | € | 86,207 | | | | | € | 152,043 | | | | ||
Total assets
|
| | | | 110,650 | | | | | | 176,486 | | | | ||
Total equity attributable to shareholders
|
| | | | 91,503 | | | | | | 157,339 | | | | ||
Total liabilities
|
| | | | 19,147 | | | | | | 19,147 | | | |
| | |
As of March 31, 2021
|
| |||||||||
(in thousands)
|
| |
Actual
|
| |
As Adjusted
|
| ||||||
Cash and cash equivalents
|
| | | € | 86,207 | | | | | € | 152,043 | | |
Capital and Reserves | | | | | | | | | | | | | |
Capital
|
| | | | 3,798 | | | | | | 4,272 | | |
Share premium
|
| | | | 150,986 | | | | | | 216,348 | | |
Share based payment reserve
|
| | | | 2,650 | | | | | | 2,650 | | |
Currency translation reserve
|
| | | | 79 | | | | | | 79 | | |
Retained Earnings
|
| | | | (66,010) | | | | | | (66,010) | | |
Total equity
|
| | | | 91,503 | | | | | | 157,339 | | |
Non-current debt | | | | ||||||||||
Secured
|
| | | | 2,737 | | | | | | 2,737 | | |
Unsecured
|
| | | | 7,794 | | | | | | 7,794 | | |
Total non-current debt
|
| | | | 10,531 | | | | | | 10,531 | | |
Current debt | | | | ||||||||||
Secured
|
| | | | 475 | | | | | | 475 | | |
Unsecured
|
| | | | 8,141 | | | | | | 8,141 | | |
Total current debt
|
| | | | 8,616 | | | | | | 8,616 | | |
Total debt
|
| | | | 19,147 | | | | | | 19,147 | | |
Total capitalization
|
| | | | 110,650 | | | | | | 176,486 | | |
| | |
As of March 31, 2021
|
| |||||||||
|
Per Ordinary Share
|
| |||||||||||
Assumed initial public offering price
|
| | | | | | | | | € | 26.50 | | |
Historical net tangible book value per ordinary share
|
| | | € | 3.36 | | | | | | | | |
Increase in net tangible book value per ordinary share attributable investors participating in the offering
|
| | | | 2.27 | | | | | | | | |
As adjusted net tangible book value per ordinary share after the offering
|
| |
|
| | | | 5.63 | | | |||
Dilution in as adjusted net tangible book value per ordinary share to new investors participating in the offering
|
| | | | | | | | | € | 20.87 | | |
| | |
Ordinary Shares
Purchased |
| |
Total
Consideration |
| |
Average
Price Per |
| |||||||||||||||||||||
|
Number
|
| |
Percent
|
| |
Amount
(in millions) |
| |
Percent
|
| |
Ordinary
Share |
| |||||||||||||||||
Existing shareholders
|
| | | | 22,107,609 | | | | | | 88.9% | | | | | $ | 171,793,266 | | | | | | 66.4% | | | | | $ | 10.83 | | |
Investors participating in this offering
|
| | | | 2,760,000 | | | | | | 11.1 | | | | | | 86,831,808 | | | | | | 33.6 | | | | | | 31.46 | | |
Total
|
| | | | 24,867,609 | | | | | | 100% | | | | | $ | 258,625,074 | | | | | | 100% | | | | | $ | 10.39 | | |
| | |
Three Months Ended
March 31 |
| |
Year-Over-Year
Change |
| | | | | | | ||||||||||||||||||
(in Thousands)
|
| |
2021
|
| |
2020
|
| |
Euro
Change |
| |
% Change
|
| | | ||||||||||||||||
Revenue
|
| | | € | 185 | | | | | € | — | | | | | € | 185 | | | | | | — | | | | | ||||
Cost of goods sold
|
| | | | (52) | | | | | | — | | | | | | (52) | | | | | | — | | | | | ||||
Gross Profit
|
| | | | 133 | | | | | | — | | | | | | 133 | | | | | | — | | | | | ||||
General and administrative expenses
|
| | | | (1,818) | | | | | | (1,178) | | | | | | (640) | | | | | | 54.3% | | | | | ||||
Research and development expenses
|
| | | | (852) | | | | | | (7) | | | | | | (845) | | | | | | * | | | | | ||||
Clinical expenses
|
| | | | (342) | | | | | | (177) | | | | | | (165) | | | | | | 93.2% | | | | | ||||
Manufacturing expenses
|
| | | | (901) | | | | | | (62) | | | | | | (839) | | | | | | * | | | | | ||||
Quality assurance and regulatory expenses
|
| | | | (325) | | | | | | (25) | | | | | | (300) | | | | | | * | | | | | ||||
Patents fees & related expenses
|
| | | | (674) | | | | | | (58) | | | | | | (616) | | | | | | * | | | | | ||||
Therapy development expenses
|
| | | | (548) | | | | | | (352) | | | | | | (196) | | | | | | 55.7% | | | | | ||||
Other operating income/(expenses)
|
| | | | 4 | | | | | | (191) | | | | | | 195 | | | | | | (102.1)% | | | | | ||||
Operating loss for the period
|
| | | | (5,323) | | | | | | (2,050) | | | | | | (3,273) | | | | | | 159.7% | | | | | ||||
Financial income
|
| | | | 4 | | | | | | 19 | | | | | | (15) | | | | | | (78.9)% | | | | | ||||
Financial expense
|
| | | | (325) | | | | | | (336) | | | | | | (11) | | | | | | (3.3)% | | | | | ||||
Loss for the period before taxes
|
| | | | (5,644) | | | | | | (2,367) | | | | | | (3,277) | | | | | | 138.4% | | | | | ||||
Taxes
|
| | | | (25) | | | | | | (13) | | | | | | (12) | | | | | | 92.3% | | | | | ||||
Loss for the period
|
| | | | (5,669) | | | | | | (2,380) | | | | | | (3,289) | | | | | | 138.2% | | | | |
| | |
For the year ended
December 31 |
| |
Year-Over-Year
Change |
| ||||||||||||||||||
(in Thousands)
|
| |
2020
|
| |
2019
|
| |
Euro Change
|
| |
% Change
|
| ||||||||||||
Revenue
|
| | | € | 69 | | | | | € | — | | | | | € | 69 | | | | | | — | | |
Cost of goods sold
|
| | | | (30) | | | | | | — | | | | | | (30) | | | | | | — | | |
Gross Profit
|
| | | | 39 | | | | | | — | | | | | | 39 | | | | | | — | | |
General and administrative expenses
|
| | | | (7,522) | | | | | | (4,226) | | | | | | (3,296) | | | | | | (78.0)% | | |
Research and development expenses
|
| | | | (473) | | | | | | (630) | | | | | | 157 | | | | | | 24.9% | | |
Clinical expenses
|
| | | | (1,053) | | | | | | (848) | | | | | | (205) | | | | | | (24.2)% | | |
Manufacturing expenses
|
| | | | (460) | | | | | | (489) | | | | | | 29 | | | | | | 5.9% | | |
Quality assurance and regulatory expenses
|
| | | | (227) | | | | | | (227) | | | | | | — | | | | | | — | | |
Patents fees & related expenses
|
| | | | (123) | | | | | | (267) | | | | | | 144 | | | | | | 53.9% | | |
Therapy development expenses
|
| | | | (1,864) | | | | | | (902) | | | | | | (962) | | | | | | 106.7% | | |
Other operating income/(expenses)
|
| | | | 459 | | | | | | (126) | | | | | | 585 | | | | | | 464.3% | | |
Operating loss for the period
|
| | | | (11,224) | | | | | | (7,715) | | | | | | (3,509) | | | | | | (45.5)% | | |
Financial income
|
| | | | 62 | | | | | | 71 | | | | | | (9) | | | | | | (12.7)% | | |
Financial expense
|
| | | | (990) | | | | | | (740) | | | | | | (250) | | | | | | (33.8)% | | |
Loss for the period before taxes
|
| | |
|
(12,152)
|
| | | | | (8,384) | | | | |
|
(3,768)
|
| | | |
|
(44.9)%
|
| |
Taxes
|
| | | | (93) | | | | | | (70) | | | | | | (23) | | | | | | (32.9)% | | |
Loss for the period
|
| | | | (12,245) | | | | | | (8,454) | | | | | | (3,791) | | | | | | (44.8)% | | |
(in Thousands)
|
| |
Contractual
Advances |
| |
Advances
received |
| |
Amounts
reimbursed |
| |||||||||
Total | | | | € | 7,627 | | | | | € | 7,627 | | | | | € | 519 | | |
| | |
For the three months ended
March 31 |
| | | | |||||||||
(in Thousands)
|
| |
2021
|
| |
2020
|
| | ||||||||
Net cash used in operating activities
|
| | | € | (4,159) | | | | | € | (1,197) | | | | ||
Net cash used in investing activities
|
| | | | (1,775) | | | | | | (1,777) | | | | ||
Net cash used in / generated from financing activities
|
| | | | (104) | | | | | | 24,838 | | | | ||
Movement in cash and cash equivalents
|
| | | | (6,038) | | | | | | 21,864 | | | | ||
Effect of exchange rates on cash and cash equivalents
|
| | | € | (55) | | | | | € | 155 | | | |
(in Thousands)
|
| |
For the year ended December 31
|
| |||||||||
|
2020
|
| |
2019
|
| ||||||||
Net cash used in operations
|
| | | € | (7,015) | | | | | € | (5,965) | | |
Net cash used in investing activities
|
| | | | (10,693) | | | | | | (5,795) | | |
Net cash from financing activities
|
| | | | 104,176 | | | | | | 733 | | |
Effects of exchange rate changes
|
| | | | (23) | | | | | | 77 | | |
Change in cash and cash equivalents
|
| | | € | 86,445 | | | | | € | (10,950) | | |
(in Thousands)
|
| |
2020
|
| |
2019
|
| ||||||||||||||||||||||||||||||||||||
|
Lease
Liability |
| |
Financial
Debt |
| |
Trade &
Other Payable |
| |
Other
Commitments* |
| |
Lease
Liability |
| |
Financial
Debt |
| |
Trade &
Other Payable |
| |||||||||||||||||||||||
Less than 1 year
|
| | | € | 560 | | | | | € | 632 | | | | | € | 5,313 | | | | | € | 1,450 | | | | | | 353 | | | | | € | 392 | | | | | € | 3,658 | | |
1 – 5 years
|
| | | | 2,186 | | | | | | 4,987 | | | | | | — | | | | | | 1,570 | | | | | | 709 | | | | | | 2,871 | | | | | | 547 | | |
5+ years
|
| | | | 895 | | | | | | 4,620 | | | | | | — | | | | | | — | | | | | | 38 | | | | | | 11,470 | | | | | | — | | |
Total | | | | € | 3,640 | | | | | € | 10,239 | | | | | € | 5,313 | | | | | € | 3,020 | | | | | € | 1,100 | | | | | | 14,733 | | | | | | 4,205 | | |
Categories
|
| |
AHI Range
|
|
Normal Range
|
| | <5 Events Per Hour | |
Mild OSA
|
| | 5-14 Events Per Hour | |
Moderate OSA
|
| | 15-30 Events Per Hour | |
Severe OSA
|
| | >30 Events Per Hour | |
| | |
Population aged
30 – 69 years |
| |
Prevalence of
moderate-to- severe OSA in 30 – 69Y old population |
| |
Percentage of
moderate-to- severe OSA in 30 – 69Y old population |
| |||||||||
United States | | | | | | | | | | | | | | | | | | | |
United States
|
| | | | 163,246,772 | | | | | | 23,678,109 | | | | | | 14.50% | | |
INITIAL TARGET MARKETS | | | | | |||||||||||||||
European Countries | | | | | | | | | | | | | | | | | | | |
Germany
|
| | | | 43,751,645 | | | | | | 14,393,964 | | | | | | 32.90% | | |
Spain
|
| | | | 26,158,266 | | | | | | 4,233,728 | | | | | | 16.20% | | |
Netherlands
|
| | | | 9,050,266 | | | | | | 2,582,583 | | | | | | 28.50% | | |
Belgium
|
| | | | 5,917,763 | | | | | | 931,859 | | | | | | 15.7% | | |
Switzerland
|
| | | | 4,518,615 | | | | | | 1,654,232 | | | | | | 36.60% | | |
Australia and New Zealand | | | | | | | | | | | | | | | | | | | |
Australia
|
| | | | 12,110,362 | | | | | | 581,348 | | | | | | 4.8% | | |
New Zealand
|
| | | | 2,256,063 | | | | | | 68,590 | | | | | | 3.0% | | |
Total Initial Target Markets | | | | | |||||||||||||||
Total
|
| | | | 103,762,980 | | | | | | 24,446,304 | | | | | | 23.56% | | |
Outcome
|
| |
Baseline (n=22)
|
| |
6-months (n=22)
|
| |
Mean
Difference (95% CI) |
| |
P-value
|
|
AHI, events/hour
|
| |
23.7 ± (12.2)
|
| |
12.9 ± (10.1)
|
| |
10.8 ± (14.6 to 7.0)
|
| | <0.0001 | |
ODI, events/hour
|
| |
19.1 ± (11.2)
|
| | 9.8 ± (6.9) | | |
9.3 ± (13.1 to 5.5)
|
| | <0.0001 | |
FOSQ-10 | | |
15.3 ± (3.3)
|
| | 17.2 ± (3.0) | | | 1.9 ± (0.4 to 3.4) | | | 0.0157 | |
ESS | | |
11.0 ± (5.3)*
|
| | 8.0 ± (5.4) | | | 3.0 ± (5.7 to 0.8) | | | 0.0113 | |
SaO2<90%, % time
|
| | 5.0 ± (6.0) | | | 2.1 ± (3.0) | | | 2.9 ± (4.6 to 1.3) | | | 0.0015 | |
Arousal Index, events per hour
|
| |
28.7 ± (11.5)
|
| | 16.0 ± (8.0) | | |
12.7 ± (16.6 to 8.9)
|
| | <0.0001 | |
Sleep efficiency (%)
|
| |
84.0 ± (10.8)
|
| | 87.3 ± (8.9) | | |
3.2 ± (0-01 to 6.4)
|
| | 0.0494 | |
Responder rate (Sher Criteria) at 6-month
|
| |
11 patients out of 22 (50%)
|
| |
NA
|
| | | |
Name
|
| |
Age
|
| |
Position(s)
|
|
Robert Taub | | |
74
|
| | Non-Executive Director (Chairman of the Board of Directors) | |
Janke Dittmer, Ph.D. | | |
44
|
| | Non-Executive Director | |
Kevin Rakin | | |
60
|
| | Non-Executive Director | |
Donald Deyo | | |
61
|
| | Non-Executive Director | |
Pierre Gianello, M.D. | | |
64
|
| | Non-Executive Director | |
Jan Janssen | | |
56
|
| | Non-Executive Director | |
Jürgen Hambrecht, Ph.D. | | |
74
|
| | Non-Executive Director | |
Olivier Taelman | | |
50
|
| | Executive Director (Chief Executive Officer) | |
Name
|
| |
Age
|
| |
Position(s)
|
|
Olivier Taelman | | |
50
|
| | Chief Executive Officer and Executive Director | |
Fabian Suarez Gonzalez(1) | | |
47
|
| | Chief Financial Officer | |
| | |
Annual Fixed
Fee (€) |
| |||
Chairman – Non-Executive Director
|
| | | | 50,000 | | |
Independent Director
|
| | | | 25,000 | | |
Non-Executive Director
|
| | | | 25,000 | | |
Additional fee for Audit Committee Member
|
| | | | 2,500 | | |
Additional fee for Remuneration Committee Member
|
| | | | 2,500 | | |
Additional fee for Science & Technology Committee Member
|
| | | | 2,500 | | |
| | |
Fees Earned (€)
|
| |||
MINV SA
(Management company of Robert Taub) |
| | | | 50,000 | | |
Robert Taub
(Executive chairman until September 21, 2020; non-executive chairman as of September 21, 2020) |
| | | | 27,260 | | |
Janke Dittmer
(Non-executive director) |
| | | | 0 | | |
Jürgen Hambrecht
(Non-executive director as of September 21, 2020) |
| | | | 8,384 | | |
Kevin Rakin
(Non-executive director) |
| | | | 8,384 | | |
MedTech Execs LLC
(Non-executive director until September 21, 2020) (Management company of Donald Deyo) |
| | | | 9,025 | | |
Donald Deyo
(Non-executive director as of September 21, 2020) |
| | | | 11,877 | | |
Pierre Gianello
(Employee and non-executive director) |
| | | | 90,958 | | |
Jan Janssen
(Non-executive director) |
| | | | 7,685 | | |
Name
|
| |
Warrant Awards
|
| ||||||||||||
|
Number of
Ordinary Shares Underlying Warrants |
| |
Warrant
Exercise Price per Ordinary Share Underlying Warrant (€) |
| |
Warrant
Expiration Date |
| ||||||||
Donald Deyo
|
| | | | 27,000 | | | | | | 5.17 | | | |
November 3, 2021
|
|
Pierre Gianello
|
| | | | 6,000 | | | | | | 5.17 | | | |
December 9, 2021
|
|
Kevin Rakin
|
| | | | 27,000 | | | | | | 5.17 | | | |
November 3, 2021
|
|
Short-term incentive plan: yearly performance bonus / yearly success fee
|
| |||
Main provisions
|
| |
Short description
|
|
Performance cycle | | | One calendar year | |
Target bonus | | | NA | |
Performance criteria and corresponding payout levels | | |
One or more performance criteria (objectives) are determined.
For each performance criterion, a target and corresponding payout level are determined:
1. If target is reached: full payout 2. If target is not reached: no payout |
|
Calculation of bonus / success fee | | | The total bonus / success fee is composed of the sum of the payout levels related to the various performance criteria (if more than one) | |
Payment modalities | | | Payment in cash 100% of the bonus / success fee is paid at once |
|
Long-term incentive plan: share option plans | | |||
Main provisions | | | Short description | |
Frequency of offer | | | No pre-set frequency | |
Performance cycle | | | NA | |
Target number of offered share options | | | NA | |
Exercise price | | | Value of underlying shares at date of offer of share options | |
Exercise period | | |
1. Share option plans issued prior to 2020: five years from date of offer of share options
2. Share option plan issued in 2020: ten years from issue of share options
|
|
Performance criteria and corresponding offering levels | | | NA | |
Short-term incentive plan: yearly performance bonus / yearly success fee
|
| |||
Main provisions
|
| |
Short description
|
|
Calculation of number of offered share options
|
| | NA | |
Vesting | | | Vesting in three tranches: 1/3 of offered share options vests upon offer 1/3 of offered share options vests on first anniversary of offer 1/3 of offered share options vests on second anniversary of offer |
|
Retention | | | NA | |
| | |
Compensation
(€) |
| |||
Base salary
|
| | | | 262,538 | | |
Performance bonus
|
| | | | 40,000 | | |
Pension contributions
|
| | | | 19,860 | | |
Company car
|
| | | | 11,632 | | |
Health insurance contributions
|
| | | | 1,903 | | |
Exit Value (€)
|
| |
Compensation payment
(in % of the Exit Value, excl. VAT) |
| |||
< 65,000,000
|
| | | | 0% | | |
≥ 65,000,000 < 300,000,000
|
| | | | 0.35% | | |
≥ 300,000,000
|
| | | | 0.50% | | |
Name
|
| |
Warrant Awards
|
| ||||||||||||
|
Number of
Ordinary Shares Underlying Warrants |
| |
Warrant
Exercise Price (€) |
| |
Warrant
Expiration Date |
| ||||||||
Olivier Taelman
|
| | | | 500 | | | | | | 11.93 | | | |
December 23, 2024
|
|
| | | | | 133,000 | | | | | | 6.52 | | | | July 29, 2024 | |
| | | | | 16,500 | | | | | | 11.93 | | | | April 7, 2025 | |
| | | | | 320,000 | | | | | | 11.94 | | | |
February 21, 2030
|
|
Fabian Suarez Gonzalez(1)
|
| | | | 25,000 | | | | | | 5.17 | | | | June 13, 2022 | |
|
Name of
Warrants Plan |
| |
Number of
Warrants Issued |
| |
Number of
Warrants lapsed, exercised or no longer available for grant |
| |
Number of
Warrants outstanding |
| |
Issue
date |
| |
Expiration
date |
| |
Exercise
Price Warrant (€) |
| |
Number
and type of Shares issuable per ESOP Warrant |
| |
Aggregate
number and type of Shares issuable upon execise of outstanding Warrants |
|
|
2013 Share
Incentive Plan |
| |
640
|
| |
499
|
| |
141
|
| |
05/03/2013
12/23/2014 |
| |
05/03/2023
12/23/2024 |
| |
2,585.51(1)
5,966.59(2) |
| |
500
Ordinary Shares |
| |
70,500
Ordinary Shares |
|
|
2016
Warrants Plan |
| |
1,500
|
| |
1,065
|
| |
435
|
| |
11/03/2016
|
| |
11/03/2026
|
| |
2,585.32(1)
|
| |
500
Ordinary Shares |
| |
217,500
Ordinary Shares |
|
|
2018
Warrants Plan |
| |
525
|
| |
206
|
| |
319
|
| |
12/12/2018
|
| |
12/12/2028
|
| |
3,259.91(3)
5,966.59(2) |
| |
500
Ordinary Shares |
| |
159,500
Ordinary Shares s |
|
|
2020
Warrants Plan |
| |
550,000
|
| | | | |
550,000
|
| |
02/21/2020
|
| |
02/21/2030
|
| |
11.94
|
| |
1 Ordinary
Share |
| |
550,000
Ordinary Shares |
|
| | | | | | | | | | | | | | | | | | | | | |
Total
|
| |
997,500
Ordinary Shares |
|
Name of beneficial owner
|
| |
Number of
Ordinary Shares Beneficially Owned |
| |
Percentage of Ordinary Shares
Beneficially Owned |
| ||||||||||||
|
Before
Offering |
| |
After
Offering |
| ||||||||||||||
3% or Greater Shareholders: | | | | | | | | | | | | | | | | | | | |
Cochlear Investments Pty Ltd(1)
|
| | | | 3,947,617 | | | | | | 17.86% | | | | | | 15.87%(14) | | |
Entities affiliated with Gilde Healthcare(2)
|
| | | | 3,153,822 | | | | | | 14.27% | | | | | | 12.68% | | |
Robert Taub(3)
|
| | | | 2,817,470 | | | | | | 12.74% | | | | | | 11.33% | | |
TOGETHER Partnership(4)
|
| | | | 2,503,500 | | | | | | 11.32% | | | | | | 10.07% | | |
Jürgen Hambrecht(5)
|
| | | | 1,047,029 | | | | | | 4.74% | | | | | | 4.21% | | |
Resmed Inc.(6)
|
| | | | 794,235 | | | | | | 3.59% | | | | | | 3.19%(15) | | |
BNP Paribas Asset Management SA(7)
|
| | | | 664,380 | | | | | | 3.01% | | | | | | 2.67% | | |
Executive Officers and Directors: | | | | | | | | | | | | | | | | | | | |
Robert Taub(3)
|
| | | | 2,817,470 | | | | | | 12.74% | | | | | | 11.33% | | |
Janke Dittmer
|
| | | | — | | | | | | — | | | | | | — | | |
Kevin Rakin(8)
|
| | | | 117,940 | | | | | | * | | | | | | * | | |
Donald Deyo(9)
|
| | | | 45,000 | | | | | | * | | | | | | * | | |
Pierre Gianello(10)
|
| | | | 6,000 | | | | | | * | | | | | | * | | |
Name of beneficial owner
|
| |
Number of
Ordinary Shares Beneficially Owned |
| |
Percentage of Ordinary
Shares Beneficially Owned |
| ||||||||||||
|
Before
Offering |
| |
After
Offering |
| ||||||||||||||
Jan Janssen
|
| | | | — | | | | | | — | | | | | | — | | |
Jürgen Hambrecht(5)
|
| | | | 1,047,029 | | | | | | 4.74% | | | | | | 4.21% | | |
Olivier Taelman(11)
|
| | | | 470,000 | | | | | | 2.08% | | | | | | 1.85% | | |
Fabian Suarez Gonzalez(12)
|
| | | | 42,883 | | | | | | * | | | | | | * | | |
All current directors and executive management as a group
(9 persons)(13) |
| | | | 4,546,322 | | | | | | 20.52% | | | | | | 18.25% | | |
|
Date
|
| |
Transaction
|
| |
Increase
(reduction) of share capital (€) |
| |
Number
of shares issued |
| |
Class of
shares issued |
| |
Issue
price per Share / Par value per Share (€, rounded) |
| |
Resulting
share capital (€) |
| |
Existing shares
|
|
|
6/29/2016
|
| |
Capital Increase(1)
|
| |
719,224.50
|
| |
7,032
|
| |
Preferred B shares
|
| |
2,585.32 /
102.28 |
| |
2,004,255.29
|
| |
Total: 19,336
7,637 common shares 4,061 preferred A shares 7,638 preferred B shares |
|
|
10/05/2018
|
| |
Capital Increase(2)
|
| |
159,014.44
|
| |
1,534
|
| |
Preferred B2
shares |
| |
3,259.91 /
103.66 |
| |
2,163,269.73
|
| |
Total: 20,870
7,637 common shares 4,061 preferred A shares 7,638 preferred B shares 1,534 preferred B2 shares |
|
|
11/07/2018
|
| |
Capital Increase
|
| |
318,028.88
|
| |
3,068
|
| |
Preferred B2
shares |
| |
3,259.91 /
103.66 |
| |
2,481,296.61
|
| |
Total: 23,938
7,637 common shares 4,061 preferred A shares 7,638 preferred B shares 4,602 preferred B2 shares |
|
|
2/21/2020
|
| |
Share
Consolidation (as described below) |
| |
NA
|
| |
NA
|
| |
NA
|
| |
NA
|
| |
2,481,296.61
|
| |
29,758
common shares |
|
|
2/21/2020
|
| |
Capital
Increase (as further described below) |
| |
435,372
|
| |
4,200
|
| |
common shares
|
| |
5,966.59 /
103.66 |
| |
2,916,670.61
|
| |
33,958
common shares |
|
|
2/21/2020
|
| |
Share Split
with a ratio of 500:1 (as described below) |
| |
NA
|
| |
NA
|
| |
common shares
|
| |
NA
|
| |
2,916,670.61
|
| |
16,979,000
common shares |
|
|
9/07/2020
|
| |
Exercise of
ESOP Warrants |
| |
7,645.10
|
| |
44,500
|
| |
common shares
|
| |
5.17 / 0.1718
|
| |
2,924,315.71
|
| |
17,023,500
common shares |
|
|
9/21/2020
|
| |
Capital increase
|
| |
755,981.68
|
| |
4,400,359
|
| |
common shares
|
| |
17 / 0.1718
|
| |
3,680,297.39
|
| |
21,423,859
common shares |
|
|
9/29/2020
|
| |
Capital increase
|
| |
111,712.95
|
| |
650,250
|
| |
common shares
|
| |
17 / 0.1718
|
| |
3,792,010.34
|
| |
22,074,109
common shares |
|
|
10/28/2020
|
| |
Exercise of
ESOP Warrants |
| |
4,037.30
|
| |
23,500
|
| |
common shares
|
| |
5.17 / 0.1718
|
| |
3,796,047.64
|
| |
22,097,609
common shares |
|
|
2/22/2021
|
| |
Exercise of
ESOP Warrants |
| |
1,718.00
|
| |
10,000
|
| |
common shares
|
| |
5.17 / 0.1718
|
| |
3,797,765.64
|
| |
22,107,609
common shares |
|
Underwriter
|
| |
Number of Shares
|
| |||
Piper Sandler & Co.
|
| | | | | | |
Stifel, Nicolaus & Company, Incorporated
|
| | | | | | |
Cantor Fitzgerald & Co.
|
| | | | | | |
Bank Degroof Petercam SA/NV
|
| | | | | | |
Total
|
| | | | 2,760,000 | | |
| | |
Per Share
|
| |
Without Option
|
| |
With Option
|
| |||||||||
Public offering price
|
| | | $ | | | | | $ | | | | | $ | | | |||
Underwriting discounts and commissions
|
| | | $ | | | | | $ | | | | | $ | | | |||
Proceeds, before expenses, to us
|
| | | $ | | | | | $ | | | | | $ | | | |
Expense
|
| |
Amount
|
| |||
SEC registration fee
|
| | | $ | 10,910.00 | | |
Nasdaq initial listing fee
|
| | | | 150,000.00 | | |
FINRA filing fee
|
| | | | 15,500.00 | | |
Printing expenses
|
| | | | 120,000.00 | | |
Legal fees and expenses
|
| | | | 1,900,000.00 | | |
Accounting fees and expenses
|
| | | | 675,000.00 | | |
Miscellaneous costs
|
| | | | 590,000.00 | | |
Total
|
| | | $ | 3,461,410.00 | | |
| Audited Consolidated Financial Statements for the Years Ended December 31, 2020 and 2019 | | | | | | | |
| | | | | F-2 | | | |
| | | | | F-3 | | | |
| | | | | F-4 | | | |
| | | | | F-5 | | | |
| | | | | F-6 | | | |
| | | | | F-7 | | | |
|
Unaudited Condensed Consolidated Interim Financial Statements as of March 31, 2021 and for the Three Month Periods Ended March 31, 2021 and 2020
|
| | | | | | |
| | | | | F-46 | | | |
| | | | | F-47 | | | |
| | | | | F-48 | | | |
| | | | | F-49 | | | |
| | | | | F-50 | | |
| | |
As of December 31
|
| |||||||||
|
2020
|
| |
2019
|
| ||||||||
ASSETS | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | |
Property, plant and equipment
|
| | | € | 713 | | | | | € | 322 | | |
Intangible assets
|
| | | | 15,853 | | | | | | 5,734 | | |
Right of use assets
|
| | | | 3,283 | | | | | | 1,066 | | |
Deferred tax asset
|
| | | | 32 | | | | | | 21 | | |
Other long-term receivables
|
| | | | 91 | | | | | | 78 | | |
| | | | € | 19,972 | | | | | € | 7,221 | | |
Current assets | | | | | | | | | | | | | |
Inventory
|
| | | | 55 | | | | | | — | | |
Other receivables
|
| | | | 1,644 | | | | | | 2,108 | | |
Other current assets
|
| | | | 109 | | | | | | 11 | | |
Cash and cash equivalents
|
| | | | 92,300 | | | | | | 5,855 | | |
| | | | € | 94,108 | | | | | € | 7,974 | | |
Total assets
|
| | | € | 114,080 | | | | | € | 15,195 | | |
EQUITY AND LIABILITIES | | | | | | | | | | | | | |
Capital and reserves | | | | | | | | | | | | | |
Common shares
|
| | | | 3,796 | | | | | | 1,122 | | |
Preferred shares
|
| | | | — | | | | | | 1,359 | | |
Share premium
|
| | | | 150,936 | | | | | | 47,668 | | |
Share based payment reserve
|
| | | | 2,650 | | | | | | 420 | | |
Currency translation reserve
|
| | | | 149 | | | | | | 207 | | |
Retained Earnings
|
| | | | (60,341) | | | | | | (48,415) | | |
Total equity attributable to shareholders
|
| | | € | 97,190 | | | | | € | 2,361 | | |
LIABILITIES | | | | | | | | | | | | | |
Non-current liabilities | | | | | | | | | | | | | |
Financial debt
|
| | | | 7,607 | | | | | | 7,146 | | |
Lease liability
|
| | | | 2,844 | | | | | | 735 | | |
Pension Liability
|
| | | | 37 | | | | | | 30 | | |
Other payables
|
| | | | — | | | | | | 547 | | |
| | | | € | 10,488 | | | | | € | 8,458 | | |
Current liabilities | | | | | | | | | | | | | |
Financial debt
|
| | | | 616 | | | | | | 378 | | |
Lease liability
|
| | | | 473 | | | | | | 340 | | |
Trade payables
|
| | | | 1,190 | | | | | | 1,385 | | |
Other payables
|
| | | | 4,123 | | | | | | 2,273 | | |
| | | | € | 6,402 | | | | | € | 4,376 | | |
Total liabilities
|
| | | € | 16,890 | | | | | € | 12,834 | | |
Total equity and liabilities
|
| | | € | 114,080 | | | | | € | 15,195 | | |
| | |
For the year ended
December 31 |
| |||||||||
|
2020
|
| |
2019
|
| ||||||||
Revenue
|
| | | € | 69 | | | | | € | — | | |
Cost of goods sold
|
| | | | (30) | | | | | | — | | |
Gross Profit
|
| | | € | 39 | | | | | € | — | | |
General and administrative expenses
|
| | | | (7,522) | | | | | | (4,226) | | |
Research and development expenses
|
| | | | (473) | | | | | | (630) | | |
Clinical expenses
|
| | | | (1,053) | | | | | | (848) | | |
Manufacturing expenses
|
| | | | (460) | | | | | | (489) | | |
Quality assurance and regulatory expenses
|
| | | | (227) | | | | | | (227) | | |
Patents Fees & Related
|
| | | | (123) | | | | | | (267) | | |
Therapy Development expenses
|
| | | | (1,864) | | | | | | (902) | | |
Other operating income/ (expenses)
|
| | | | 459 | | | | | | (126) | | |
Operating loss for the period
|
| | | € | (11,224) | | | | | € | (7,715) | | |
Financial income
|
| | | | 62 | | | | | | 71 | | |
Financial expense
|
| | | | (990) | | | | | | (740) | | |
Loss for the period before taxes
|
| | | € | (12,152) | | | | | € | (8,384) | | |
Income Taxes
|
| | | | (93) | | | | | | (70) | | |
Loss for the period
|
| | | € | (12,245) | | | | | € | (8,454) | | |
Other comprehensive loss | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss (net of tax) | | | | | | | | | | | | | |
Currency translation differences
|
| | | | (58) | | | | | | 168 | | |
Total comprehensive loss for the year, net of tax
|
| | | € | (12,303) | | | | | € | (8,286) | | |
Loss attributable to equity holders
|
| | | € | (12,303) | | | | | € | (8,286) | | |
Basic Loss Per Share
|
| | | € | (0.677) | | | | | € | (0.568) | | |
Diluted Loss Per Share
|
| | | € | (0.677) | | | | | € | (0.568) | | |
| | |
Attributable to owners of the parent
|
| |||||||||||||||||||||||||||||||||||||||
| | |
Common
Shares |
| |
Preferred
Shares |
| |
Share
premium |
| |
Share based
payment reserve |
| |
Currency
translation reserve |
| |
Retained
earnings |
| |
Total
|
| |||||||||||||||||||||
Balance at January 1, 2019
|
| | | € | 1,122 | | | | | € | 1,359 | | | | | € | 47,668 | | | | | € | 80 | | | | | € | 39 | | | | | € | (39,967) | | | | | € | 10,301 | | |
Loss for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (8,454) | | | | | | (8,454) | | |
Other comprehensive income for the
year |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 168 | | | | | | — | | | | | | 168 | | |
Total comprehensive income/(loss) for the year
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | | € | 168 | | | | | € | (8,454) | | | | | € | (8,286) | | |
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | 340 | | | | | | — | | | | | | 6 | | | | | | 346 | | |
Balance at December 31, 2019
|
| | | € | 1,122 | | | | | € | 1,359 | | | | | € | 47,668 | | | | | € | 420 | | | | | € | 207 | | | | | € | (48,415) | | | | | € | 2,361 | | |
Balance at January 1, 2020
|
| | | € | 1,122 | | | | | € | 1,359 | | | | | € | 47,668 | | | | | € | 420 | | | | | € | 207 | | | | | € | (48,415) | | | | | € | 2,361 | | |
Loss for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (12,245) | | | | | | (12,245) | | |
Other comprehensive loss for the year
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | (58) | | | | | | | | | | | | (58) | | |
Total comprehensive loss for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | € | (58) | | | | | € | (12,245) | | | | | € | (12,303) | | |
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | 2,230 | | | | | | — | | | | | | 319 | | | | | | 2,549 | | |
Conversion of preferred shares to common
shares |
| | | | 1,359 | | | | | | (1,359) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| |
Issuance of shares for cash
|
| | | | 1,304 | | | | | | — | | | | | | 108,857 | | | | | | — | | | | | | — | | | | | | — | | | | | | 110,161 | | |
Conversion convertible loan
|
| | | | 11 | | | | | | — | | | | | | 989 | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,000 | | |
Transaction cost
|
| | | | — | | | | | | — | | | | | | (6,578) | | | | | | — | | | | | | — | | | | | | — | | | | | | (6,578) | | |
Total transactions with owners of the company recognized directly in equity
|
| | | € | 2,674 | | | | | | (1,359) | | | | | € | 103,268 | | | | | € | 2,230 | | | | | | — | | | | | € | 319 | | | | | € | 107,132 | | |
Balance at December 31, 2020
|
| | | € | 3,796 | | | | | | — | | | | | € | 150,936 | | | | | € | 2,650 | | | | | € | 149 | | | | | € | (60,341) | | | | | € | 97,190 | | |
| | |
For the year ended
December 31 |
| |||||||||
|
2020
|
| |
2019
|
| ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | | | | | | | | | | | | | |
Loss before tax for the year
|
| | | € | (12,152) | | | | | € | (8,384) | | |
Adjustments for: | | | | | | | | | | | | | |
Finance income
|
| | | | (62) | | | | | | (71) | | |
Finance expenses
|
| | | | 990 | | | | | | 740 | | |
Depreciation and impairment of property, plant and equipment and right-of-use assets
|
| | | | 620 | | | | | | 433 | | |
Share-based payment transaction expense
|
| | | | 2,549 | | | | | | 346 | | |
Pension-related expenses
|
| | | | 7 | | | | | | 30 | | |
Other non-cash items
|
| | | | (134) | | | | | | 70 | | |
Cash generated before changes in working capital
|
| | | € | (8,182) | | | | | € | (6,836) | | |
Changes in working capital: | | | | | | | | | | | | | |
Increase in Inventory
|
| | | | (55) | | | | | | — | | |
Decrease/(Increase) in other receivables
|
| | | | 365 | | | | | | (1,385) | | |
Increase in Trade and other payables
|
| | | | 1,109 | | | | | | 2,342 | | |
Cash generated from changes in operations
|
| | | € | (6,763) | | | | | € | (5,879) | | |
Interests received
|
| | | | 3 | | | | | | 8 | | |
Interests paid
|
| | | | (151) | | | | | | (33) | | |
Income tax paid
|
| | | | (104) | | | | | | (61) | | |
Net cash used in operating activities
|
| | | € | (7,015) | | | | | € | (5,965) | | |
CASH FLOWS FROM INVESTING ACTIVITIES | | | | | | | | | | | | | |
Purchases of property, plant and equipment
|
| | | | (562) | | | | | | (51) | | |
Capitalization of intangible assets
|
| | | | (10,118) | | | | | | (5,734) | | |
Increase of long-term deposits
|
| | | | (13) | | | | | | (10) | | |
Net cash used in investing activities
|
| | | € | (10,693) | | | | | € | (5,795) | | |
CASH FLOWS FROM FINANCING ACTIVITIES | | | | | | | | | | | | | |
Payment of principal portion of lease liabilities
|
| | | | (479) | | | | | | (341) | | |
Repayment of other loan
|
| | | | (63) | | | | | | (82) | | |
Recoverable cash advance received
|
| | | | 190 | | | | | | 1,196 | | |
Repayment of recoverable cash advance
|
| | | | (55) | | | | | | (40) | | |
Proceeds from convertible loan
|
| | | | 1,000 | | | | | | — | | |
Proceeds from issuance of shares, net of transaction costs
|
| | | | 103,583 | | | | | | — | | |
Net cash generated from financing activities
|
| | | € | 104,176 | | | | | € | 733 | | |
Movement in cash and cash equivalents
|
| | | € | 86,468 | | | | | € | (11,027) | | |
Effect of exchange rates on cash and cash equivalents
|
| | | | (23) | | | | | | 77 | | |
Cash and cash equivalents at January 1
|
| | | € | 5,855 | | | | | € | 16,805 | | |
Cash and cash equivalents at December 31
|
| | | € | 92,300 | | | | | € | 5,855 | | |
|
IT equipment
|
| | 3 years | |
|
Furniture and office equipment
|
| | 5 to 15 years | |
|
Laboratory equipment
|
| | 15 years | |
|
Leasehold improvements
|
| | The shorter of lease term and 10 years | |
| | |
2020 rates
|
| |
2019 rates
|
| ||||||||||||||||||
Currency
|
| |
Closing
|
| |
Average
|
| |
Closing
|
| |
Average
|
| ||||||||||||
NIS
|
| | | | 3.92758 | | | | | | 3.92330 | | | | | | 3.87700 | | | | | | 3.99220 | | |
AUD
|
| | | | 1.58636 | | | | | | 1.65548 | | | | | | 1.60102 | | | | | | 1.61057 | | |
USD
|
| | | | 1.22239 | | | | | | 1.15189 | | | | | | — | | | | | | — | | |
| | |
Change in foreign
exchange rate |
| |
Effect on loss (before tax)
|
| |
Effect on pretax equity
|
| |||||||||||||||||||||||||||||||||
|
NIS
|
| |
USD
|
| |
AUD
|
| |
NIS
|
| |
USD
|
| |
AUD
|
| ||||||||||||||||||||||||||
2020
|
| | | | 5% | | | | | | 12 | | | | | | -4 | | | | | | 55 | | | | | | 83 | | | | | | -7 | | | | | | 208 | | |
| | | | | -5% | | | | | | -12 | | | | | | 4 | | | | | | -61 | | | | | | -91 | | | | | | 8 | | | | | | -230 | | |
2019
|
| | | | 5% | | | | | | 11 | | | | | | — | | | | | | 39 | | | | | | 71 | | | | | | — | | | | | | 127 | | |
| | | | | -5% | | | | | | -11 | | | | | | — | | | | | | -43 | | | | | | -77 | | | | | | — | | | | | | -141 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||||||||||||||||||||||||||||||||
|
Lease
Liability |
| |
Financial
Debt |
| |
Trade &
Other Payable |
| |
Other
Commitments* |
| |
Lease
Liability |
| |
Financial
Debt |
| |
Trade &
Other Payable |
| |||||||||||||||||||||||
Less than 1 year
|
| | | | 560 | | | | | | 632 | | | | | | 5,313 | | | | | € | 1,450 | | | | | | 353 | | | | | | 392 | | | | | | 3,658 | | |
1-5 years
|
| | | | 2,185 | | | | | | 4,987 | | | | | | — | | | | | | 1,570 | | | | | | 709 | | | | | | 2,871 | | | | | | 547 | | |
5+ years
|
| | | | 895 | | | | | | 4,620 | | | | | | — | | | | | | — | | | | | | 38 | | | | | | 11,470 | | | | | | — | | |
TOTAL
|
| | | | 3,640 | | | | | | 10,239 | | | | | | 5,313 | | | | |
€
|
3,020
|
| | | | | 1,100 | | | | | | 14,733 | | | | | | 4,205 | | |
(in EUR 000)
|
| |
Carrying value
|
| |
Fair value
|
| ||||||||||||||||||
|
2020
|
| |
2019
|
| |
2020
|
| |
2019
|
| ||||||||||||||
Financial Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Other long-term receivables (level 3)
|
| | | | 91 | | | | | | 78 | | | | | | 91 | | | | | | 78 | | |
Trade and other receivables (level 3)
|
| | | | 1,644 | | | | | | 2,107 | | | | | | 1,644 | | | | | | 2,107 | | |
Other current assets (level 3)
|
| | | | 109 | | | | | | 11 | | | | | | 109 | | | | | | 11 | | |
Cash and cash equivalents (level 1)
|
| | | | 92,300 | | | | | | 5,855 | | | | | | 92,300 | | | | | | 5,855 | | |
Financial liabilities | | | | | | | | | | | | | | | | | | | | | | | | | |
Financial debt (level 3)
|
| | | | 313 | | | | | | 376 | | | | | | 250 | | | | | | 321 | | |
Lease liability (level 3)
|
| | | | 3,317 | | | | | | 1,075 | | | | | | 3,317 | | | | | | 1,075 | | |
Recoverable cash advances (level 3)
|
| | | | 7,910 | | | | | | 7,148 | | | | | | 7,910 | | | | | | 7,148 | | |
Trade and other payables (level 3)
|
| | | | 5,313 | | | | | | 4,205 | | | | | | 5,313 | | | | | | 4,205 | | |
(in EUR 000)
|
| |
Furniture and
office equipment |
| |
Leasehold
improvements |
| |
Laboratory
equipment |
| |
Total
|
| ||||||||||||
Gross value | | | | | | | | | | | | | | | | | | | | | | | | | |
Opening Gross value
|
| | | | 439 | | | | | | 190 | | | | | | 133 | | | | |
|
762
|
| |
Additions
|
| | | | 48 | | | | |
|
—
|
| | | | | 3 | | | | | | 51 | | |
Gross value at 31/12/2019
|
| | | | 487 | | | | | | 190 | | | | | | 136 | | | | | | 813 | | |
Additions
|
| | | | 178 | | | | | | 358 | | | | | | 26 | | | | | | 562 | | |
Gross value at 31/12/2020
|
| | | | 665 | | | | | | 548 | | | | | | 162 | | | | | | 1,375 | | |
Depreciation | | | | | | | | | | | | | | | | | | | | | | | | | |
Opening accumulated depreciation
|
| | | | (283) | | | | | | (72) | | | | | | (37) | | | | | | (392) | | |
Depreciation charge
|
| | | | (64) | | | | | | (24) | | | | | | (12) | | | | | | (100) | | |
Depreciation at 31/12/2019
|
| | |
|
(347)
|
| | | |
|
(96)
|
| | | |
|
(49)
|
| | | | | (492) | | |
Depreciation charge
|
| | | | (83) | | | | | | (74) | | | | | | (12) | | | | | | (169) | | |
Depreciation at 31/12/2020
|
| | | | (430) | | | | | | (170) | | | | | | (61) | | | | | | (661) | | |
Opening Exchange differences
|
| | | | (3) | | | | | | 2 | | | | | | 2 | | | | | | 1 | | |
Exchange differences
|
| | | | (1) | | | | | | — | | | | | | — | | | | | | (1) | | |
Exchange differences at 31/12/2020
|
| | | | (4) | | | | | | 2 | | | | | | 2 | | | | | | — | | |
Net book value at 31/12/2019
|
| | | | 137 | | | | | | 96 | | | | | | 89 | | | | | | 322 | | |
Net book value at 31/12/2020
|
| | | | 231 | | | | | | 380 | | | | | | 103 | | | | | | 713 | | |
(in EUR 000)
|
| |
Development
Cost |
| |
Patents and
licenses |
| |
Total
|
| |||||||||
Cost | | | | | | | | | | | | | | | | | | | |
Opening Gross value
|
| | | | — | | | | | | — | | | | | | — | | |
Additions
|
| | | | 5,311 | | | | | | 335 | | | | | | 5,646 | | |
Gross value at 31/12/2019
|
| | | | 5,311 | | | | | | 335 | | | | | | 5,646 | | |
Additions
|
| | | | 9,874 | | | | | | 256 | | | | | | 10,130 | | |
Gross value at 31/12/2020
|
| | | | 15,185 | | | | | | 591 | | | | | | 15,776 | | |
Amortization | | | | | | | | | | | | | | | | | | | |
Opening amortization
|
| | | | — | | | | | | — | | | | | | — | | |
Amortization
|
| | | | — | | | | | | — | | | | | | — | | |
Amortization at 31/12/2019
|
| | | | — | | | | | | — | | | | | | — | | |
Amortization
|
| | | | — | | | | | | — | | | | | | — | | |
Amortization at 31/12/2020
|
| | | | — | | | | | | — | | | | | | — | | |
Opening Exchange differences
|
| | | | 88 | | | | | | — | | | | | | 88 | | |
Exchange differences
|
| | | | (11) | | | | | | — | | | | | | (11) | | |
Exchange differences at 31/12/2020
|
| | |
|
77
|
| | | | | — | | | | |
|
77
|
| |
Net book value at 31/12/2019
|
| | | | 5,399 | | | | | | 335 | | | | | | 5,734 | | |
Net book value at 31/12/2020
|
| | | | 15,262 | | | | | | 591 | | | | | | 15,853 | | |
(in EUR 000)
|
| |
Building
|
| |
Motor
vehicles |
| |
Total
|
| |||||||||
Gross value | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 1,131 | | | | | | 192 | | | | | | 1,323 | | |
Addition
|
| | | | — | | | | | | — | | | | | | — | | |
Gross value at 31/12/2019
|
| | | | 1,131 | | | | | | 192 | | | | | | 1,323 | | |
Addition
|
| | | | 3,194 | | | | | | 233 | | | | | | 3,427 | | |
Disposal
|
| | | | (1,207) | | | | | | (23) | | | | | | (1,230) | | |
Gross value at 31/12/2020
|
| | | | 3,117 | | | | | | 402 | | | | | | 3,519 | | |
Depreciation | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | — | | | | | | — | | | | | | — | | |
Depreciation of the year
|
| | | | (281) | | | | | | (52) | | | | | | (333) | | |
Depreciation at 31/12/2019
|
| | | | (281) | | | | | | (52) | | | | | | (333) | | |
Depreciation of the year
|
| | | | (383) | | | | | | (68) | | | | | | (451) | | |
Disposal
|
| | | | 470 | | | | | | 11 | | | | | | 481 | | |
Depreciation at 31/12/2020
|
| | | | (194) | | | | | | (109) | | | | | | (303) | | |
Opening exchange difference
|
| | | | 76 | | | | | | — | | | | | | 76 | | |
Exchange difference
|
| | | | (9) | | | | | | — | | | | | | (9) | | |
Exchange difference at 31/12/2020
|
| | | | 67 | | | | | | — | | | | | | 67 | | |
Net carrying value at 31/12/2019
|
| | | | 926 | | | | | | 140 | | | | | | 1,066 | | |
Net carrying value at 31/12/2020
|
| | | | 2,990 | | | | | | 293 | | | | | | 3,283 | | |
(in EUR 000)
|
| | | | | | |
As at January 1, 2019 – Adoption of IFRS 16
|
| | | | 1,323 | | |
Addition
|
| | | | — | | |
Accretion of interest
|
| | | | 17 | | |
Payments
|
| | | | (341) | | |
Exchange difference
|
| | | | 76 | | |
Net carrying value at 31/12/2019
|
| | | | 1,075 | | |
Addition
|
| | | | 3,427 | | |
Disposal
|
| | | | (743) | | |
Accretion of interest
|
| | | | 47 | | |
Payments
|
| | | | (479) | | |
Exchange difference
|
| | | | (10) | | |
Net carrying value at 31/12/2020
|
| | | | 3,317 | | |
Non-Current
|
| | | | 735 | | |
Current
|
| | | | 340 | | |
Net carrying value at 31/12/2019
|
| | | | 1,075 | | |
Non-Current
|
| | | | 2,844 | | |
Current
|
| | | | 473 | | |
Net carrying value at 31/12/2020
|
| | | | 3,317 | | |
(in EUR 000)
|
| |
31/12/2020
|
| |
31/12/2019
|
| ||||||
Depreciation expense of right-of-use assets
|
| | | | 451 | | | | | | 333 | | |
Interest charge on lease liabilities
|
| | | | 47 | | | | | | 17 | | |
Rent expenses (note 0)
|
| | | | 89 | | | | | | 115 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Recoverable cash advance receivable
|
| | | | — | | | | | | 1,100 | | |
R&D Incentive receivable (Australia)
|
| | | | 951 | | | | | | 495 | | |
VAT receivable
|
| | | | 607 | | | | | | 153 | | |
Current tax receivable
|
| | | | (3) | | | | | | 30 | | |
Other
|
| | | | 89 | | | | | | 330 | | |
Total Other receivables
|
| | | | 1,644 | | | | | | 2,108 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Short term deposit
|
| | | | 28 | | | | | | 28 | | |
Three months term deposit
|
| | | | 6 | | | | | | 363 | | |
Current accounts
|
| | | | 92,266 | | | | | | 5,463 | | |
Petty Cash
|
| | | | — | | | | | | 1 | | |
Total Cash and cash equivalents
|
| | | | 92,300 | | | | | | 5,855 | | |
(Number of shares(1) except otherwise stated)
|
| |
Common
Shares |
| |
Preferred
Shares |
| |
Total of
Shares |
| |
Par value
(EUR) |
| |
Share
Capital |
| |
Share
Premium |
| ||||||||||||||||||
January 1, 2019 (adjusted for share split in
2020) |
| | | | 6,728,500 | | | | | | 8,150,000 | | | | | | 14,879,000 | | | | | | 0.17 | | | | | | 2,481 | | | | | | 47,668 | | |
December 31, 2019 (adjusted for share split
in 2020) |
| | | | 6,728,500 | | | | | | 8,150,000 | | | | | | 14,879,000 | | | | | | 0.17 | | | | | | 2,481 | | | | | | 47,668 | | |
February 21, 2020 – Conversion of preferred shares to common shares
|
| | | | 8,150,000 | | | | | | (8,150,000) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
February 21, 2020 – Capital increase
|
| | | | 2,100,000 | | | | | | — | | | | | | 2,100,000 | | | | | | 0.21 | | | | | | 436 | | | | | | 24,624 | | |
September 7, 2020 – Exercise warrants
|
| | | | 44,500 | | | | | | — | | | | | | 44,500 | | | | | | 0.17 | | | | | | 8 | | | | | | 222 | | |
September 21, 2020 – IPO
|
| | | | 4,335,000 | | | | | | — | | | | | | 4,335,000 | | | | | | 0.17 | | | | | | 745 | | | | | | 72,950 | | |
September 21, 2020 – Convertible loan
|
| | | | 65,359 | | | | | | — | | | | | | 65,359 | | | | | | 0.17 | | | | | | 11 | | | | | | 989 | | |
September 29, 2020 – Exercise warrants
|
| | | | 650,250 | | | | | | — | | | | | | 650,250 | | | | | | 0.17 | | | | | | 112 | | | | | | 10,943 | | |
October 28, 2020 – Exercise
warrants |
| | | | 23,500 | | | | | | — | | | | | | 23,500 | | | | | | 0.17 | | | | | | 4 | | | | | | 117 | | |
December 31, 2020 (adjusted for share split
in 2020) |
| | | | 22,097,609 | | | | | | — | | | | | | 22,097,609 | | | | | | 0.17 | | | | | | 3,796 | | | | | | 157,514 | | |
Number of shares (after share split) warrants give right to across all plans
|
| |
2020
|
| |
2019
|
| ||||||
Outstanding at January 1
|
| | | | 1,143,500 | | | | | | 1,012,000 | | |
Granted
|
| | | | 567,000 | | | | | | 246,000 | | |
Forfeited/Cancelled
|
| | | | (635,000) | | | | | | (114,500) | | |
Exercised
|
| | | | (68,000) | | | | | | 0 | | |
Outstanding at December 31
|
| | | | 1,007,500 | | | | | | 1,143,500 | | |
Exercisable at December 31
|
| | | | 1,007,500 | | | | | | 968,503 | | |
Number of shares (after share split) warrants give right to for Plan 2013
|
| |
2020
|
| |
2019
|
| ||||||
Outstanding at January 1
|
| | | | 208,000 | | | | | | 269,500 | | |
Granted
|
| | | | 500 | | | | | | 0 | | |
Forfeited/Cancelled
|
| | | | (83,500) | | | | | | (61,500) | | |
Exercised
|
| | | | (44,500) | | | | | | 0 | | |
Outstanding at December 31
|
| | | | 80,500 | | | | | | 208,000 | | |
Exercisable at December 31
|
| | | | 80,500 | | | | | | 208,000 | | |
Number of shares (after share split) warrants give right to for Plan 2016
|
| |
2020
|
| |
2019
|
| ||||||
Outstanding at January 1
|
| | | | 742,500 | | | | | | 742,500 | | |
Granted
|
| | | | 0 | | | | | | 0 | | |
Forfeited/Cancelled
|
| | | | (501,500) | | | | | | 0 | | |
Exercised
|
| | | | (23,500) | | | | | | 0 | | |
Outstanding at December 31
|
| | | | 217,500 | | | | | | 742,500 | | |
Exercisable at December 31
|
| | | | 217,500 | | | | | | 695,500 | | |
Number of shares (after share split) warrants give right to for Plan 2018
|
| |
2020
|
| |
2019
|
| ||||||
Outstanding at January 1
|
| | | | 193,000 | | | | | | 0 | | |
Granted
|
| | | | 16,500 | | | | | | 246,000 | | |
Forfeited/Cancelled
|
| | | | (50,000) | | | | | | (53,000) | | |
Exercised
|
| | | | 0 | | | | | | 0 | | |
Outstanding at December 31
|
| | | | 159,500 | | | | | | 193,000 | | |
Exercisable at December 31
|
| | | | 159,500 | | | | | | 65,000 | | |
Number of shares warrants give right to for Plan 2020
|
| |
2020
|
| |||
Outstanding at January 1
|
| | | | 0 | | |
Granted
|
| | | | 550,000 | | |
Forfeited/Cancelled
|
| | | | 0 | | |
Exercised
|
| | | | 0 | | |
Outstanding at December 31
|
| | | | 550,000 | | |
Exercisable at December 31
|
| | | | 550,000 | | |
Total
|
| |
2020
|
| |
2019
|
| |
2018
|
| |||||||||
Exercisable Warrants at December 31
|
| | | | 550,915 | | | | | | 1,940 | | | | | | 1,807 | | |
Shares representing the Exercisable Warrants at December 31
|
| | | | 1,007,500 | | | | | | 1,143,500 | | | | | | 1,012,000 | | |
Weighted average exercise price per share
|
| | | | 9.17 | | | | | | 5.26 | | | | | | 5.17 | | |
| | |
Plan 2016
(grant 2018) |
| |
Plan 2018
(grant 2019) |
| |
Plan 2013
(grant 2020) |
| |
Plan 2018
(grant 2020) |
| |
Plan 2020
(grant 2020) |
| |||||||||||||||
Return Dividend
|
| | | | 0% | | | | | | 0% | | | | | | 0% | | | | | | 0% | | | | | | 0% | | |
Expected volatility
|
| | | | 66.92% | | | | | | 56.32% | | | | | | 56.32% | | | | | | 56.32% | | | | | | 56.32% | | |
Risk-free interest rate
|
| | | | 0.35% | | | | | | -0.20% | | | | | | -0.20% | | | | | | -0.20% | | | | | | -0.20% | | |
Expected life
|
| | | | 3 | | | | | | 3 | | | | | | 3 | | | | | | 3 | | | | | | 3 | | |
Exercise price
|
| | | | 5.17 | | | | | | 6.52 | | | | | | 11.94 | | | | | | 11.94 | | | | | | 11.94 | | |
Stock price
|
| | | | 1.09 | | | | | | 10.24 | | | | | | 10.20 | | | | | | 10.20 | | | | | | 10.20 | | |
Fair value
|
| | | | 0.10 | | | | | | 5.30 | | | | | | 3.31 | | | | | | 3.31 | | | | | | 3.31 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Recoverable cash advances – Non-current
|
| | | | 7,419 | | | | | | 6,874 | | |
Recoverable cash advances – Current
|
| | | | 491 | | | | | | 274 | | |
Total Recoverable cash advances
|
| | | | 7,910 | | | | | | 7,148 | | |
Other loan – Non-current
|
| | | | 188 | | | | | | 272 | | |
Other loan – Current
|
| | | | 125 | | | | | | 104 | | |
Total Other loan
|
| | | | 313 | | | | | | 376 | | |
Non-current
|
| | | | 7,607 | | | | | | 7,146 | | |
Current
|
| | | | 616 | | | | | | 378 | | |
Total Financial debt
|
| | | | 8,223 | | | | | | 7,524 | | |
(in EUR 000)
|
| |
Contractual
Advances |
| |
Advances
received |
| |
Amounts
reimbursed |
| |||||||||
Sleep apnea device (6472)
|
| | | | 1,600 | | | | | | 1,600 | | | | | | 420 | | |
First Articles (6839)
|
| | | | 2,160 | | | | | | 2,160 | | | | | | 84 | | |
Clinical Trial (6840)
|
| | | | 2,400 | | | | | | 2,400 | | | | |
|
—
|
| |
Activation chip improvements (7388)
|
| | | | 1,467 | | | | | | 1,467 | | | | | | 15 | | |
Total | | | | | 7,627 | | | | | | 7,627 | | | | | | 519 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Recoverable cash advances received
|
| | | | 7,627 | | | | | | 7,437 | | |
Amounts to be reimbursed (2 times)
|
| | | | 15,254 | | | | | | 14,874 | | |
Amounts reimbursed at year-end (interests included)
|
| | | | (582) | | | | | | (517) | | |
Total Recoverable cash advances (undiscounted)
|
| | | | 14,672 | | | | | | 14,357 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Contract 6472
|
| | | | 1,421 | | | | | | 1,296 | | |
Contract 6839
|
| | | | 2,214 | | | | | | 2,115 | | |
Contract 6840
|
| | | | 2,592 | | | | | | 2,232 | | |
Contract 7388
|
| | | | 1,683 | | | | | | 1,505 | | |
Total Recoverable cash advances
|
| | | | 7,910 | | | | | | 7,148 | | |
Non-current
|
| | | | 7,419 | | | | | | 6,874 | | |
Current
|
| | | | 491 | | | | | | 274 | | |
Total Recoverable cash advances
|
| | | | 7,910 | | | | | | 7,148 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
As of January 1
|
| | | | 7,148 | | | | | | 5,357 | | |
Advances received
|
| | | | 190 | | | | | | 1,196 | | |
Advances reimbursed (excluding interests)
|
| | | | (55) | | | | | | (40) | | |
Initial measurement and re-measurement
|
| | | | (145) | | | | | | 60 | | |
Discounting impact
|
| | | | 772 | | | | | | 575 | | |
As of December 31
|
| | |
|
7,910
|
| | | |
|
7,148
|
| |
Fair Value of Liabilities as of end of 2020 (in EUR 000)
|
| |
Variation of revenue projections
|
| |||||||||||||||
Variation of discount rates*
|
| | | | -25% | | | | | | 0% | | | | | | 25% | | |
-25%
|
| | | | 8,787 | | | | | | 9,099 | | | | | | 9,281 | | |
0%
|
| | | | 7,567 | | | | | | 7,910 | | | | | | 8,114 | | |
+25%
|
| | | | 6,566 | | | | | | 6,922 | | | | | | 7,138 | | |
(in EUR 0000029
|
| |
2020
|
| |
2019
|
| ||||||
Payables
|
| | | | 815 | | | | | | 1,174 | | |
Invoices to be received
|
| | | | 375 | | | | | | 211 | | |
Total Trade payables
|
| | | | 1,190 | | | | | | 1,385 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Total other non-current payables
|
| | | | — | | | | | | 547 | | |
Holiday pay accrual
|
| | | | 376 | | | | | | 243 | | |
Salary
|
| | | | 382 | | | | | | 381 | | |
Accrued expenses
|
| | | | 1,244 | | | | | | 687 | | |
Other
|
| | | | 2,121 | | | | | | 962 | | |
Total Other current payables
|
| | | | 4,123 | | | | | | 2,273 | | |
(in EUR 000)
|
| |
2020
|
| |||
Purchases of goods and services
|
| | | | 85 | | |
Inventory movement
|
| | | | (55) | | |
Cost of goods sold
|
| | | | 30 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Staff costs
|
| | | | 3,015 | | | | | | 1,327 | | |
Consulting and contractors’ fees
|
| | | | 2,883 | | | | | | 1,733 | | |
Legal fees
|
| | | | 201 | | | | | | 42 | | |
Rent
|
| | | | 89 | | | | | | 115 | | |
Facilities
|
| | | | 116 | | | | | | 67 | | |
Depreciation and amortization expense
|
| | | | 599 | | | | | | 415 | | |
ICT
|
| | | | 234 | | | | | | 151 | | |
Travel
|
| | | | 134 | | | | | | 186 | | |
Other expenses
|
| | | | 251 | | | | | | 190 | | |
Total General and Administrative expenses
|
| | | | 7,522 | | | | | | 4,226 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Staff costs
|
| | | | 1,304 | | | | | | 1,252 | | |
Consulting and contractors’ fees
|
| | | | — | | | | | | 11 | | |
Outsourced developments
|
| | | | 1,717 | | | | | | 1,054 | | |
Depreciation and amortization expense
|
| | | | 20 | | | | | | 16 | | |
Travel
|
| | | | 4 | | | | | | 33 | | |
Other
|
| | | | 21 | | | | | | 9 | | |
Capitalized costs
|
| | | | (2,593) | | | | | | (1,745) | | |
Total Research and development expenses
|
| | | | 473 | | | | | | 630 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Staff costs
|
| | | | 1,531 | | | | | | 921 | | |
Consulting and contractors’ fees
|
| | | | 748 | | | | | | 474 | | |
Clinical activities
|
| | | | 1,731 | | | | | | 1,190 | | |
Travel
|
| | | | 51 | | | | | | 182 | | |
Other
|
| | | | 255 | | | | | | 114 | | |
Capitalized costs
|
| | | | (3,263) | | | | | | (2,033) | | |
Total Clinical expenses
|
| | |
|
1,053
|
| | | | | 848 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Staff costs
|
| | | | 1,211 | | | | | | 613 | | |
Consulting and contractors’ fees
|
| | | | — | | | | | | — | | |
Manufacturing
|
| | | | 2,427 | | | | | | 1,071 | | |
Travel
|
| | | | 25 | | | | | | 41 | | |
Other
|
| | | | 139 | | | | | | 87 | | |
Capitalized costs
|
| | | | (3,342) | | | | | | (1,323) | | |
Total Manufacturing expenses
|
| | | | 460 | | | | | | 489 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Implantable stimulator
|
| | | | 1,660 | | | | | | 686 | | |
Activation chip
|
| | | | 228 | | | | | | 67 | | |
Disposable patch
|
| | | | 102 | | | | | | 113 | | |
External stimulator
|
| | | | 69 | | | | | | 37 | | |
Other
|
| | | | 368 | | | | | | 168 | | |
Capitalized costs
|
| | | | (2,254) | | | | | | (800) | | |
Total | | | |
|
173
|
| | | | | 271 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Staff costs
|
| | | | 641 | | | | | | 353 | | |
Consulting and contractors’ fees
|
| | | | 291 | | | | | | 400 | | |
QA & regulatory
|
| | | | 542 | | | | | | 148 | | |
Travel
|
| | | | — | | | | | | 27 | | |
Capitalized costs
|
| | | | (1,247) | | | | | | (701) | | |
Total Quality Assurance and Regulatory expenses
|
| | | | 227 | | | | | | 227 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Recoverable cash advances | | | | | | | | | | | | | |
— Initial measurement and re-measurement
|
| | | | 147 | | | | | | (61) | | |
R&D Incentives (Australia)
|
| | | | 1,000 | | | | | | 425 | | |
Capitalization of R&D Incentive
|
| | | | (573) | | | | | | (493) | | |
Other income/(expenses)
|
| | | | (115) | | | | | | 3 | | |
Total Other Operating Income/(Expenses)
|
| | | | 459 | | | | | | (126) | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Salaries
|
| | | | 4,577 | | | | | | 3,625 | | |
Social charges
|
| | | | 562 | | | | | | 518 | | |
Fringe benefits
|
| | | | 104 | | | | | | 153 | | |
Defined contribution plan
|
| | | | 249 | | | | | | 258 | | |
Holiday pay
|
| | | | 273 | | | | | | 99 | | |
Share-based payment (see note 13)
|
| | | | 2,548 | | | | | | 346 | | |
Other
|
| | | | 138 | | | | | | 127 | | |
Total employee benefits
|
| | | | 8,451 | | | | | | 5,126 | | |
General and administrative expenses
|
| | | | 3,015 | | | | | | 1,327 | | |
Research & Development costs
|
| | | | 1,304 | | | | | | 1,252 | | |
Clinical expenses
|
| | | | 1,531 | | | | | | 921 | | |
Operation & Manufacturing expenses
|
| | | | 1,211 | | | | | | 613 | | |
QA expenses
|
| | | | 641 | | | | | | 353 | | |
Other expenses (therapy development, patents, etc.)
|
| | | | 749 | | | | | | 660 | | |
Total employee benefits
|
| | | | 8,451 | | | | | | 5,126 | | |
| | |
As at December 31,
|
| |||||||||
|
2020
|
| |
2019
|
| ||||||||
General & Administration
|
| | | | 9 | | | | | | 5.8 | | |
IP & Trademark
|
| | | | — | | | | | | 1.0 | | |
Research & Development
|
| | | | 10.8 | | | | | | 10.6 | | |
Clinical & Regulatory Affairs
|
| | | | 23.2 | | | | | | 8.2 | | |
Quality Assurance & Regulatory
|
| | | | 7.9 | | | | | | 5.9 | | |
Operations
|
| | | | 15 | | | | | | 9.0 | | |
Therapy Development (including the sales team)
|
| | | | 6 | | | | | | 2.0 | | |
Total
|
| | | | 71.9 | | | | | | 42.5 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Net defined benefit liability at the beginning of the year
|
| | | | 30 | | | | | | 13 | | |
Defined benefit cost included in profit or loss
|
| | | | 93 | | | | | | 90 | | |
Total remeasurement included in OCI
|
| | | | — | | | | | | — | | |
Employer contributions
|
| | | | (77) | | | | | | (73) | | |
Transfer reserves (terminated participants)
|
| | | | (9) | | | | | | — | | |
Net defined benefit liability at the end of the year
|
| | | | 37 | | | | | | 30 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Gross defined benefit liability at the beginning of the year
|
| | | | 209 | | | | | | 118 | | |
Current service cost
|
| | | | 90 | | | | | | 90 | | |
Interest cost
|
| | | | 1 | | | | | | 2 | | |
Taxes on contributions
|
| | | | (8) | | | | | | (1) | | |
Transfer reserves (terminated participants)
|
| | | | (60) | | | | | | — | | |
Actuarial loss due to change in financial assumptions
|
| | | | 16 | | | | | | — | | |
Gross defined benefit liability at the end of the year
|
| | | | 248 | | | | | | 209 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Fair value plan assets at the beginning of the year
|
| | | | 179 | | | | | | 106 | | |
Interest income
|
| | | | 2 | | | | | | 1 | | |
Employer contributions
|
| | | | 77 | | | | | | 73 | | |
Taxes on contributions
|
| | | | (8) | | | | | | (1) | | |
Transfer reserves (terminated participants)
|
| | | | (55) | | | | | | — | | |
Actuarial gain on fair value of the plan assets
|
| | | | 16 | | | | | | — | | |
Fair value plan assets at the end of the year
|
| | | | 211 | | | | | | 179 | | |
| | |
2020
|
| |
2019
|
| ||||||
Active members
|
| | | | 14 | | | | | | 8 | | |
Inactive members
|
| | | | — | | | | | | — | | |
Average age
|
| | | | 43 | | | | | | 48 | | |
| | |
2020
|
| |
2019
|
|
Discount rate
|
| |
0.1%
|
| |
0.6%
|
|
Inflation rate
|
| |
2%
|
| |
2%
|
|
Salary increase (in excess of inflation)
|
| |
0%
|
| |
0%
|
|
Withdrawal rate based on age (between)
|
| |
1.5% and 8.50%
|
| |
1.5% and 8.50%
|
|
(in EUR 000)
|
| |
2020
|
| |||
Increase of 0,25% in the discount rate
|
| | | | (2) | | |
Decrease of 0,25% in the discount rate
|
| | | | 2 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Interests
|
| | | | 3 | | | | | | 8 | | |
Exchange differences
|
| | | | 59 | | | | | | 63 | | |
Total Financial income
|
| | | | 62 | | | | | | 71 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Recoverable cash advances, Discounting
|
| | | | 772 | | | | | | 575 | | |
Interest and bank charges
|
| | | | 151 | | | | | | 33 | | |
Interest on lease liabilities
|
| | | | 47 | | | | | | 17 | | |
Exchange differences
|
| | | | 20 | | | | | | 115 | | |
Total Financial expense
|
| | | | 990 | | | | | | 740 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Current tax
|
| | | | (104) | | | | | | (61) | | |
Deferred tax Income/(Expense)
|
| | | | 11 | | | | | | (9) | | |
Total Income Tax Expenses
|
| | | | (93) | | | | | | (70) | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Pre-Tax Book Income /(loss)
|
| | | | (12,152) | | | | | | (8,384) | | |
Company Statutory Income Tax Rate
|
| | | | 25.00% | | | | | | 29.58% | | |
Income Tax at Company Statutory Tax Rate:
|
| | | | 3,038 | | | | | | 2,480 | | |
Unrecognized DTA on tax losses and temporary differences
|
| | | | (2,681) | | | | | | (2,132) | | |
Nondeductible expenses
|
| | | | (488) | | | | | | (426) | | |
Foreign Tax Rate Differential
|
| | | | 58 | | | | | | 38 | | |
Other temporary differences
|
| | | | (20) | | | | | | (30) | | |
Income Tax at Company Effective Tax Rate
|
| | | | (93) | | | | | | (70) | | |
Company Effective Income Tax Rate
|
| | | | (0.77)% | | | | | | (0.83)% | | |
| | |
2020
|
| |
2019
|
| ||||||
As at December 31, after conversion and share split | | | | | | | | | | | | | |
Outstanding common shares at year-end
|
| | | | 22,097,609 | | | | | | 6,728,500 | | |
Weighted average number of common shares outstanding
|
| | | | 18,097,988 | | | | | | 6,728,500 | | |
Number of Shares resulting of the exercise of outstanding
warrants |
| | | | 1,007,500 | | | | | | 1,143,500 | | |
| | |
2020
|
| |
2019
|
| ||||||
Loss of year attributable to common holders (in EUR)
|
| | | | (12,245,000) | | | | | | (3,823,000) | | |
Loss of year attributable to preferred holders (in EUR)
|
| | | | 0 | | | | | | (4,631,000) | | |
Loss of year attributable to equity holders (in EUR)
|
| | | | (12,245,000) | | | | | | (8,454,000) | | |
Weighted average number of common shares outstanding
(in units) |
| | | | 18,097,988 | | | | | | 6,728,500 | | |
Basic earnings per share in EUR (EUR/unit)
|
| | | | (0.677) | | | | | | (0.568) | | |
Diluted earnings per share in EUR (EUR/unit)
|
| | | | (0.677) | | | | | | (0.568) | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Expense
|
| | | | 89 | | | | | | 115 | | |
Total | | | | | 89 | | | | | | 115 | | |
(in EUR 000)
|
| |
2020
|
| |
2019
|
| ||||||
Short-term remuneration & compensation
|
| | | | 337 | | | | | | 612 | | |
Share based payment
|
| | | | 1,576 | | | | | | 231 | | |
Total | | | | | 1,913 | | | | | | 843 | | |
| | |
12/31/2020
|
| |
12/31/2019
|
| ||||||||||||||||||||||||
(in EUR 000)
|
| |
R&D
Collaboration |
| |
Consulting
services |
| |
Board
remuneration |
| |
Consulting
services |
| |
Board
remuneration |
| |||||||||||||||
Cochlear
|
| | | | 1,300 | | | | | | — | | | | | | — | | | | | | 839 | | | | | | — | | |
Noshaq
|
| | | | — | | | | | | 10 | | | | | | — | | | | | | — | | | | | | — | | |
MINV SA
|
| | | | — | | | | | | 50 | | | | | | — | | | | | | 79 | | | | | | — | | |
Man & Science S.A
|
| | | | — | | | | | | 44 | | | | | | — | | | | | | 6 | | | | | | — | | |
Christopher Smith
|
| | | | — | | | | | | — | | | | | | — | | | | | | 9 | | | | | | 11 | | |
Medtech Execs LLC
|
| | | | — | | | | | | — | | | | | | 9 | | | | | | — | | | | | | 31 | | |
Robert Taub
|
| | | | — | | | | | | — | | | | | | 28 | | | | | | — | | | | | | — | | |
Kevin Rakin
|
| | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | — | | |
Donald Deyo
|
| | | | — | | | | | | — | | | | | | 12 | | | | | | — | | | | | | — | | |
Pierre Gianello
|
| | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | — | | |
Jan Janssen
|
| | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | — | | |
Jurgen Hambrecht
|
| | | | — | | | | | | — | | | | | | 9 | | | | | | — | | | | | | — | | |
Total | | | | | 1,300 | | | | | | 104 | | | | | | 90 | | | | | | 935 | | | | | | 42 | | |
| | |
As of March 31
2021 |
| |
As of December 31
2020 |
| ||||||
ASSETS | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | |
Property, plant and equipment
|
| | | € | 852 | | | | | € | 713 | | |
Intangible assets
|
| | | | 17,247 | | | | | | 15,853 | | |
Right of use assets
|
| | | | 3,158 | | | | | | 3,283 | | |
Deferred tax asset
|
| | | | 41 | | | | | | 32 | | |
Other long-term receivables
|
| | | | 91 | | | | | | 91 | | |
| | | | € | 21,389 | | | | | € | 19,972 | | |
Current assets | | | | | | | | | | | | | |
Inventory
|
| | | | 106 | | | | | | 55 | | |
Trade Receivables
|
| | | | 185 | | | | | | | | |
Other receivables
|
| | | | 1,699 | | | | | | 1,644 | | |
Other current assets
|
| | | | 1,064 | | | | | | 109 | | |
Cash and cash equivalents
|
| | | | 86,207 | | | | | | 92,300 | | |
| | | | € | 89,261 | | | | | € | 94,108 | | |
Total assets
|
| | | € | 110,650 | | | | | € | 114,080 | | |
EQUITY AND LIABILITIES | | | | | | | | | | | | | |
Capital and reserves | | | | | | | | | | | | | |
Common shares
|
| | | | 3,798 | | | | | | 3,796 | | |
Share premium
|
| | | | 150,986 | | | | | | 150,936 | | |
Share-based payment reserve
|
| | | | 2,650 | | | | | | 2,650 | | |
Currency translation reserve
|
| | | | 79 | | | | | | 149 | | |
Retained earnings
|
| | | | (66,010) | | | | | | (60,341) | | |
Total equity attributable to shareholders
|
| | | € | 91,503 | | | | | € | 97,190 | | |
LIABILITIES | | | | | | | | | | | | | |
Non-current liabilities | | | | | | | | | | | | | |
Financial debt
|
| | | | 7,757 | | | | | | 7,607 | | |
Lease liability
|
| | | | 2,737 | | | | | | 2,844 | | |
Pension Liability
|
| | | | 37 | | | | | | 37 | | |
| | | | € | 10,531 | | | | | € | 10,488 | | |
Current liabilities | | | | | | | | | | | | | |
Financial debt
|
| | | | 658 | | | | | | 616 | | |
Lease liability
|
| | | | 475 | | | | | | 473 | | |
Trade payables
|
| | | | 2,802 | | | | | | 1,190 | | |
Other payables
|
| | | | 4,681 | | | | | | 4,123 | | |
| | | | € | 8,616 | | | | | € | 6,402 | | |
Total liabilities
|
| | | € | 19,147 | | | | | € | 16,890 | | |
Total equity and liabilities
|
| | | € | 110,650 | | | | | € | 114,080 | | |
| | |
For the three months ended March 31
|
| |||||||||
|
2021
|
| |
2020
|
| ||||||||
Revenue
|
| | | € | 185 | | | | | € | — | | |
Cost of goods sold
|
| | | | (52) | | | | | | — | | |
Gross Profit
|
| | |
€
|
133
|
| | | | € | — | | |
General and administrative expenses
|
| | | | (1,818) | | | | | | (1,178) | | |
Research and development expenses
|
| | | | (852) | | | | | | (7) | | |
Clinical expenses
|
| | | | (342) | | | | | | (177) | | |
Manufacturing expenses
|
| | | | (901) | | | | | | (62) | | |
Quality assurance and regulatory expenses
|
| | | | (325) | | | | | | (25) | | |
Patents fees & related
|
| | | | (674) | | | | | | (58) | | |
Therapy development expenses
|
| | | | (548) | | | | | | (352) | | |
Other operating income / (expenses)
|
| | | | 4 | | | | | | (191) | | |
Operating loss for the period
|
| | | € | (5,323) | | | | | € | (2,050) | | |
Financial income
|
| | | | 4 | | | | | | 19 | | |
Financial expense
|
| | | | (325) | | | | | | (336) | | |
Loss for the period before taxes
|
| | | € | (5,644) | | | | | € | (2,367) | | |
Income taxes
|
| | | | (25) | | | | | | (13) | | |
Loss for the period
|
| | | € | (5,669) | | | | | € | (2,380) | | |
Other comprehensive loss | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
(net of tax) |
| | | | | | | | | | | | |
Currency translation differences
|
| | | | (70) | | | | | | 272 | | |
Total comprehensive loss for the year, net of tax
|
| | | € | (5,739) | | | | | € | (2,108) | | |
Loss attributable to equity holders
|
| | | € | (5,739) | | | | | € | (2,108) | | |
Basic Loss Per Share
|
| | | € | (0.256) | | | | | € | (0.151) | | |
Diluted Loss Per Share
|
| | | € | (0.256) | | | | | € | (0.151) | | |
| | |
Attributable to owners of the parent
|
| |||||||||||||||||||||||||||||||||||||||
As of and for the three months ended March 31, 2021 |
| |
Common
Shares |
| |
Preferred
Shares |
| |
Share
premium |
| |
Share
based payment reserve |
| |
Currency
translation reserve |
| |
Retained
earnings |
| |
Total
|
| |||||||||||||||||||||
Balance at January 1, 2021
|
| | | € | 3,796 | | | | | | — | | | | | € | 150,936 | | | | | € | 2,650 | | | | | € | 149 | | | | | € | (60,341) | | | | | € | 97,190 | | |
Loss for the period
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | | | (5,669) | | | | | | (5,669) | | |
Other comprehensive loss for the period
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (70) | | | | | | — | | | | | | (70) | | |
Total comprehensive loss for the period
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | € | (70) | | | | | € | (5,669) | | | | | € | (5,739) | | |
Issuance of shares for cash
|
| | | | 2 | | | | | | — | | | | | | 50 | | | | | | — | | | | | | — | | | | | | — | | | | | | 52 | | |
Total transactions with owners of the Company recognized directly in equity
|
| | | € | 2 | | | | | | — | | | | | € | 50 | | | | | | — | | | | | | — | | | | | | — | | | | | € | 52 | | |
Balance at March 31, 2021
|
| | | € | 3,798 | | | | | | — | | | | | € | 150,986 | | | | | € | 2,650 | | | | | € | 79 | | | | | € | (66,010) | | | | | € | 91,503 | | |
As of and for the three months ended March 31, 2020 |
| |
Common
Shares |
| |
Preferred
Shares |
| |
Share
premium |
| |
Share
based payment reserve |
| |
Currency
translation reserve |
| |
Retained
earnings |
| |
Total
|
| |||||||||||||||||||||
Balance at January 1, 2020
|
| | | € | 1,122 | | | | | € | 1,359 | | | | | € | 47,668 | | | | | € | 420 | | | | | € | 207 | | | | | € | (48,415) | | | | | € | 2,361 | | |
Loss for the period
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (2,380) | | | | | | (2,380) | | |
Other comprehensive income for the period
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 272 | | | | | | — | | | | | | 272 | | |
Total comprehensive income/(loss) for the period
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | € | 272 | | | | | € | (2,380) | | | | | € | (2,108) | | |
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | 147 | | | | | | — | | | | | | 50 | | | | | | 197 | | |
Issuance of shares for cash
|
| | | | 436 | | | | | | — | | | | | | 24,624 | | | | | | — | | | | | | — | | | | | | — | | | | | | 25,060 | | |
Transaction cost
|
| | | | — | | | | | | — | | | | | | (96) | | | | | | — | | | | | | — | | | | | | — | | | | | | (96) | | |
Conversion of preferred shares to common shares
|
| | | | 1,359 | | | | | | (1,359) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Total transactions with owners of the Company
recognized directly in equity |
| | | € | 1,795 | | | | | | (1,359) | | | | | € | 24,528 | | | | | € | 147 | | | | | | — | | | | | € | 50 | | | | | € | 25,161 | | |
Balance at March 31, 2020
|
| | | € | 2,917 | | | | | | — | | | | | € | 72,196 | | | | | € | 567 | | | | | € | 479 | | | | | € | (50,745) | | | | | € | 25,414 | | |
| | |
For the three months ended March 31
|
| |||||||||
|
2021
|
| |
2020
|
| ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | | | | | | | | | | | | | |
Loss before tax for the period
|
| | | € | (5,644) | | | | | € | (2,367) | | |
Adjustments for: | | | | | | | | | | | | | |
Finance income
|
| | | | (4) | | | | | | (19) | | |
Finance expenses
|
| | | | 325 | | | | | | 336 | | |
Depreciation and impairment of property, plant and equipment and right-of-use assets
|
| | | | 375 | | | | | | 128 | | |
Share-based payment transaction expense
|
| | | | — | | | | | | 197 | | |
Other non-cash items
|
| | | | 3 | | | | | | 111 | | |
Cash used before changes in working capital
|
| | | € | (4,945) | | | | | € | (1,614) | | |
Changes in working capital: | | | | | | | | | | | | | |
Increase in inventory
|
| | | | (51) | | | | | | — | | |
Increase in trade receivables
|
| | | | (185) | | | | | | — | | |
Decrease/(increase) in other receivables
|
| | | | (1,010) | | | | | | 402 | | |
Increase in trade and other payables
|
| | | | 2,170 | | | | | | 35 | | |
Cash used for changes in operations
|
| | | € | (4,021) | | | | | € | (1,177) | | |
Interests received
|
| | | | 1 | | | | | | 2 | | |
Interests paid
|
| | | | (105) | | | | | | (5) | | |
Income tax paid
|
| | | | (34) | | | | | | (17) | | |
Net cash used in operating activities
|
| | | € | (4,159) | | | | | € | (1,197) | | |
CASH FLOWS USED IN INVESTING ACTIVITIES | | | | | | | | | | | | | |
Purchases of property, plant and equipment
|
| | | | (169) | | | | | | (84) | | |
Capitalization of intangible assets
|
| | | | (1,606) | | | | | | (1,694) | | |
Increase of long-term deposits
|
| | | | — | | | | | | 1 | | |
Net cash used in investing activities
|
| | | € | (1,775) | | | | | € | (1,777) | | |
CASH FLOWS USED IN / GENERATED FROM FINANCING ACTIVITIES
|
| | | | | | | | | | | | |
Payment of principal portion of lease liabilities
|
| | | | (135) | | | | | | (105) | | |
Repayment of other loan
|
| | | | (21) | | | | | | (21) | | |
Proceeds from issuance of shares, net of transaction costs
|
| | | | 52 | | | | | | 24,964 | | |
Net cash used in/generated from financing activities
|
| | | € | (104) | | | | | € | 24,838 | | |
Movement in cash and cash equivalents
|
| | | € | (6,038) | | | | | € | 21,864 | | |
Effect of exchange rates on cash and cash equivalents
|
| | | | (55) | | | | | | 155 | | |
Cash and cash equivalents at January 1
|
| | | € | 92,300 | | | | | € | 5,855 | | |
Cash and cash equivalents at March 31
|
| | | € | 86,207 | | | | | € | 27,874 | | |
| | |
Carrying value
|
| |
Fair value
|
| ||||||||||||||||||
(in EUR 000)
|
| |
As at
March 31, 2021 |
| |
As at
December 31, 2020 |
| |
As at
March 31, 2021 |
| |
As at
December 31, 2020 |
| ||||||||||||
Financial Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Other long-term receivables (level 3)
|
| | | | 91 | | | | | | 91 | | | | | | 91 | | | | | | 91 | | |
Trade and other receivables (level 3)
|
| | | | 1,884 | | | | | | 1,644 | | | | | | 1,884 | | | | | | 1,644 | | |
Other current assets (level 3)
|
| | | | 1,064 | | | | | | 109 | | | | | | 1,064 | | | | | | 109 | | |
Cash and cash equivalents (level 1)
|
| | | | 86,207 | | | | | | 92,300 | | | | | | 86,207 | | | | | | 92,300 | | |
Financial liabilities | | | | | | | | | | | | | | | | | | | | | | | | | |
Financial debt (level 3)
|
| | | | 292 | | | | | | 313 | | | | | | 268 | | | | | | 250 | | |
Recoverable cash advances (level 3)
|
| | | | 8,123 | | | | | | 7,910 | | | | | | 8,123 | | | | | | 7,910 | | |
Trade and other payables (level 3)
|
| | | | 7,484 | | | | | | 5,313 | | | | | | 7,484 | | | | | | 5,313 | | |
(in EUR 000)
|
| |
Development
Cost |
| |
Patents and licenses
|
| |
Total
|
| |||||||||
Cost | | | | | |||||||||||||||
Opening Gross value at 01/01/2020
|
| | | | 5,311 | | | | | | 335 | | | | | | 5,646 | | |
Additions
|
| | | | 1,653 | | | | | | 56 | | | | | | 1,709 | | |
Gross value at 03/31/2020
|
| | | | 6,964 | | | | | | 391 | | | | | | 7,355 | | |
Opening Gross value at 01/01/2021
|
| | | | 15,185 | | | | | | 591 | | | | | | 15,776 | | |
Additions
|
| | | | 1,598 | | | | | | — | | | | | | 1,598 | | |
Gross value at 03/31/2021
|
| | | | 16,783 | | | | | | 591 | | | | | | 17,374 | | |
Amortization | | | | | | | | | | | | | | | | | | | |
Opening amortization at 01/01/2020
|
| | | | — | | | | | | — | | | | | | — | | |
(in EUR 000)
|
| |
Development
Cost |
| |
Patents and licenses
|
| |
Total
|
| |||||||||
Amortization
|
| | | | — | | | | | | — | | | | | | — | | |
Amortization at 03/31/2020
|
| | | | — | | | | | | — | | | | | | — | | |
Opening amortization at 01/01/2021
|
| | | | — | | | | | | — | | | | | | — | | |
Amortization
|
| | | | (211) | | | | | | — | | | | | | (211) | | |
Amortization at 03/31/2021
|
| | | | (211) | | | | | | — | | | | | | (211) | | |
Opening Exchange differences at 01/01/2020
|
| | | | 88 | | | | | | — | | | | | | 88 | | |
Exchange differences
|
| | | | (15) | | | | | | — | | | | | | (15) | | |
Exchange differences at 03/31/2020
|
| | |
|
73
|
| | | | | — | | | | |
|
73
|
| |
Opening Exchange differences at 01/01/2021
|
| | |
|
77
|
| | | | | — | | | | |
|
77
|
| |
Exchange differences
|
| | | | 7 | | | | | | — | | | | | | 7 | | |
Exchange differences at 03/31/2021
|
| | |
|
84
|
| | | | | — | | | | |
|
84
|
| |
Net book value at 03/31/2020
|
| | | | 6,037 | | | | | | 391 | | | | | | 7,428 | | |
Net book value at 03/31/2021
|
| | | | 16,656 | | | | | | 591 | | | | | | 17,247 | | |
|
(in EUR 000)
|
| |
As of March 31,
2021 |
| |
As of December 31,
2020 |
| ||||||
R&D incentive receivable (Australia)
|
| | | | 1,222 | | | | | | 951 | | |
VAT receivable
|
| | | | 398 | | | | | | 607 | | |
Current tax receivable
|
| | | | 28 | | | | | | (3) | | |
Other
|
| | | | 51 | | | | | | 89 | | |
Total other receivables
|
| | | | 1,699 | | | | | | 1,644 | | |
(in EUR 000)
|
| |
As of March 31,
2021 |
| |
As of December 31,
2020 |
| ||||||
Prepaid transaction costs
|
| | | | 915 | | | | | | — | | |
Other prepaid
|
| | | | 149 | | | | | | 109 | | |
Total other current assets
|
| | | | 1,064 | | | | | | 109 | | |
(in EUR 000)
|
| |
As of March 31,
2021 |
| |
As of December 31,
2020 |
| ||||||
Short term deposit
|
| | | | 28 | | | | | | 28 | | |
Three months term deposit
|
| | | | 6 | | | | | | 6 | | |
Current accounts
|
| | | | 86,173 | | | | | | 92,266 | | |
Total cash and cash equivalents
|
| | |
|
86,207
|
| | | | | 92,300 | | |
(Number of shares (1) except otherwise stated) |
| |
Common
Shares |
| |
Preferred
Shares |
| |
Total of
Shares |
| |
Par value
(EUR) |
| |
Share
Capital |
| |
Share
Premium |
| ||||||||||||||||||
January 1, 2020 (adjusted for share split in 2020)
|
| | |
|
6,728,500
|
| | | |
|
8,150,000
|
| | | |
|
14,879,000
|
| | | |
|
0.17
|
| | | |
|
2,481
|
| | | |
|
47,668
|
| |
February 21, 2020 – Conversion
of preferred shares to common shares |
| | | | 8,150,000 | | | | | | (8,150,000) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
February 21, 2020 – Capital increase
|
| | | | 2,100,000 | | | | | | — | | | | | | 2,100,000 | | | | | | 0.21 | | | | | | 436 | | | | | | 24,624 | | |
March 31, 2020 (adjusted for share split in 2020)
|
| | | | 16,979,000 | | | | | | — | | | | | | 22,097,609 | | | | | | 0.17 | | | | | | 3,796 | | | | | | 157,514 | | |
September 7, 2020 – Exercise warrants
|
| | | | 44,500 | | | | | | | | | | | | 44,500 | | | | | | 0,17 | | | | | | 8 | | | | | | 222 | | |
September 21, 2020 – IPO
|
| | | | 4,335,000 | | | | | | — | | | | | | 4,335,000 | | | | | | 0.17 | | | | | | 745 | | | | | | 72,950 | | |
September 21, 2020 – Convertible loan
|
| | | | 65,359 | | | | | | — | | | | | | 65,359 | | | | | | 0.17 | | | | | | 11 | | | | | | 989 | | |
September 29, 2020 – Exercise warrants
|
| | | | 650,250 | | | | | | — | | | | | | 650,250 | | | | | | 0.17 | | | | | | 112 | | | | | | 10,943 | | |
October 28, 2020 – Exercise warrants
|
| | | | 23,500 | | | | | | — | | | | | | 23,500 | | | | | | 0.17 | | | | | | 4 | | | | | | 117 | | |
December 31, 2020 (adjusted for share split in 2020)
|
| | |
|
22,097,609
|
| | | |
|
—
|
| | | |
|
22,097,609
|
| | | |
|
0.17
|
| | | |
|
3,796
|
| | | |
|
157,514
|
| |
February 22, 2021 – Capital increase
|
| | | | 10,000 | | | | | | — | | | | | | 10,000 | | | | | | 0.17 | | | | | | 2 | | | | | | 50 | | |
March 31, 2021 (adjusted for share split in 2020)
|
| | | | 22,107,609 | | | | | | — | | | | | | 22,107,609 | | | | | | 0.17 | | | | | | 3,798 | | | | | | 157,564 | | |
(in EUR 000)
|
| |
As of March 31, 2021
|
| |
As of December 31, 2020
|
| ||||||
Recoverable cash advances — Non-current
|
| | | | 7,590 | | | | | | 7,149 | | |
Recoverable cash advances — Current
|
| | | | 533 | | | | | | 491 | | |
Total recoverable cash advances
|
| | | | 8,123 | | | | | | 7,910 | | |
Other loan – Non-current
|
| | | | 167 | | | | | | 188 | | |
Other loan – Current
|
| | | | 125 | | | | | | 125 | | |
Total Other loan
|
| | | | 292 | | | | | | 313 | | |
Non-current
|
| | | | 7,757 | | | | | | 7,607 | | |
Current
|
| | | | 658 | | | | | | 616 | | |
Total Financial debt
|
| | | | 8,415 | | | | | | 8,223 | | |
(in EUR 000)
|
| |
Contractual
Advances |
| |
Advances
received |
| |
Amounts
reimbursed |
| |||||||||
Sleep apnea device (6472)
|
| | | | 1,600 | | | | | | 1,600 | | | | | | 420 | | |
First articles (6839)
|
| | | | 2,160 | | | | | | 2,160 | | | | | | 84 | | |
Clinical trial (6840)
|
| | | | 2,400 | | | | | | 2,400 | | | | |
|
—
|
| |
Activation chip improvements (7388)
|
| | | | 1,467 | | | | | | 1,467 | | | | | | 15 | | |
Total | | | | | 7,627 | | | | | | 7,627 | | | | | | 519 | | |
(in EUR 000)
|
| |
As of March 31,
2021 |
| |
As of December 31,
2020 |
| ||||||
Contract 6472
|
| | | | 1,464 | | | | | | 1,421 | | |
Contract 6839
|
| | | | 2,272 | | | | | | 2,214 | | |
Contract 6840
|
| | | | 2,659 | | | | | | 2,592 | | |
Contract 7388
|
| | | | 1,728 | | | | | | 1,683 | | |
Total recoverable cash advances
|
| | | | 8,123 | | | | | | 7,910 | | |
Non-current
|
| | | | 7,590 | | | | | | 7,419 | | |
Current
|
| | | | 533 | | | | | | 491 | | |
Total recoverable cash advances
|
| | | | 8,123 | | | | | | 7,910 | | |
(in EUR 000)
|
| |
2021
|
| |
2020
|
| ||||||
As of January 1
|
| | | | 7,910 | | | | | | 7,148 | | |
Initial measurement and re-measurement
|
| | | | (8) | | | | | | 100 | | |
Discounting impact
|
| | | | 220 | | | | | | 193 | | |
As of March 31, 2021
|
| | | | 8,123 | | | | | | 7,442 | | |
(in EUR 000)
|
| |
As of March 31,
2021 |
| |
As of December 31,
2020 |
| ||||||
Holiday pay accrual
|
| | | | 486 | | | | | | 376 | | |
Salary
|
| | | | 355 | | | | | | 382 | | |
Accrued expenses
|
| | | | 1,070 | | | | | | 1,244 | | |
Other
|
| | | | 2,769 | | | | | | 2,121 | | |
Total other payables
|
| | | | 4,680 | | | | | | 4,123 | | |
(in EUR 000)
|
| |
2021
|
| |
2020
|
| ||||||
Purchases of goods and services
|
| | | | 103 | | | | | | — | | |
Inventory movement
|
| | | | (51) | | | | | | — | | |
Total cost of goods sold
|
| | | | 52 | | | | | | — | | |
(in EUR 000)
|
| |
Total Cost
|
| |
Capitalized
|
| |
Operating expense
for the period |
| |||||||||
General and administrative expenses
|
| | | | 1,818 | | | | | | — | | | | | | 1,818 | | |
Research and development expenses
|
| | | | 852 | | | | | | — | | | | | | 852 | | |
Clinical expenses
|
| | | | 1,779 | | | | | | (1,437) | | | | | | 342 | | |
Manufacturing expenses
|
| | | | 1,116 | | | | | | (215) | | | | | | 901 | | |
Quality assurance and regulatory expenses
|
| | | | 458 | | | | | | (133) | | | | | | 325 | | |
Patents fees & related expenses
|
| | | | 674 | | | | | | — | | | | | | 674 | | |
Therapy development expenses
|
| | | | 548 | | | | | | — | | | | | | 548 | | |
Other operating expenses/(income)
|
| | | | (191) | | | | | | 187 | | | | | | (4) | | |
For the three months ended March 31, 2021
|
| | | | 7,054 | | | | | | (1,598) | | | | | | 5,456 | | |
(in EUR 000)
|
| |
Total Cost
|
| |
Capitalized
|
| |
Operating expense
for the period |
| |||||||||
General and administrative expenses
|
| | | | 1,178 | | | | | | — | | | | | | 1,178 | | |
Research and development expenses
|
| | | | 318 | | | | | | (311) | | | | | | 7 | | |
Clinical expenses
|
| | | | 745 | | | | | | (568) | | | | | | 177 | | |
Manufacturing expenses
|
| | | | 640 | | | | | | (578) | | | | | | 62 | | |
Quality assurance and regulatory expenses
|
| | | | 288 | | | | | | (263) | | | | | | 25 | | |
Patents fees & related
|
| | | | 114 | | | | | | (56) | | | | | | 58 | | |
Therapy development expenses
|
| | | | 352 | | | | | | — | | | | | | 352 | | |
Other operating expenses/(income)
|
| | | | 124 | | | | | | 67 | | | | | | 191 | | |
For the three months ended March 31, 2020
|
| | | | 3,759 | | | | | | (1,709) | | | | | | 2,050 | | |
(in EUR 000)
|
| |
For the three-month
period ended March 31, 2021 |
| |
For the three-month
period ended March 31, 2020 |
| ||||||
Staff costs
|
| | | | 366 | | | | | | 426 | | |
Consulting and contractors’ fees
|
| | | | 936 | | | | | | 431 | | |
Legal fees
|
| | | | 53 | | | | | | 22 | | |
Rent
|
| | | | 61 | | | | | | 36 | | |
Facilities
|
| | | | 24 | | | | | | 21 | | |
Depreciation and amortization expense
|
| | | | 161 | | | | | | 124 | | |
ICT
|
| | | | 112 | | | | | | 26 | | |
Travel
|
| | | | 25 | | | | | | 56 | | |
Other expenses
|
| | | | 80 | | | | | | 36 | | |
Total general and administrative expenses
|
| | | | 1,818 | | | | | | 1,178 | | |
(in EUR 000)
|
| |
For the three-month
period ended March 31, 2021 |
| |
For the three-month
period ended March 31, 2020 |
| ||||||
Staff costs
|
| | | | 414 | | | | | | 273 | | |
Outsourced developments
|
| | | | 238 | | | | | | 39 | | |
Depreciation and amortization expense
|
| | | | 184 | | | | | | 3 | | |
Travel
|
| | | | — | | | | | | 3 | | |
Other
|
| | | | 16 | | | | | | — | | |
Capitalized costs
|
| | | | — | | | | | | (311) | | |
Total research and development expenses
|
| | | | 852 | | | | | | 7 | | |
(in EUR 000)
|
| |
For the three-month
period ended March 31, 2021 |
| |
For the three-month
period ended March 31, 2020 |
| ||||||
Staff costs
|
| | | | 313 | | | | | | 179 | | |
Consulting and contractors’ fees
|
| | | | — | | | | | | — | | |
Manufacturing
|
| | | | 793 | | | | | | 404 | | |
Travel
|
| | | | — | | | | | | 23 | | |
Other
|
| | | | 10 | | | | | | 34 | | |
Capitalized costs
|
| | | | (215) | | | | | | (578) | | |
Total manufacturing expenses
|
| | | | 901 | | | | | | 62 | | |
| | |
2021
|
| |
2020
|
| ||||||
As at March 31, after conversion and share split | | | | | | | | | | | | | |
Outstanding common shares at year-end
|
| | | | 22,107,609 | | | | | | 16,979,000 | | |
Weighted average number of common shares outstanding
|
| | | | 22,101,766 | | | | | | 15,789,000 | | |
Number of Shares resulting of the exercise of outstanding warrants
|
| | | | 997,500 | | | | | | 1,007,500 | | |
| | |
2021
|
| |
2020
|
| ||||||
Loss of year attributable to equity holders (in EUR)
|
| | | | (5,669,000) | | | | | | (2,380,000) | | |
Weighted average number of common shares outstanding (in units)
|
| | | | 22,101,766 | | | | | | 15,789,000 | | |
Basic earnings per share in EUR (EUR/unit)
|
| | | | (0.256) | | | | | | (0.151) | | |
Diluted earnings per share in EUR (EUR/unit)
|
| | | | (0.256) | | | | | | (0.151) | | |
(in EUR 000)
|
| |
2021
|
| |
2020
|
| ||||||
Short-term remuneration & compensation
|
| | | | 69 | | | | | | 61 | | |
Share based payment
|
| | | | — | | | | | | — | | |
Total | | | | | 69 | | | | | | 61 | | |
| | |
As of March 31, 2021
|
| |
As of March 31, 2020
|
| ||||||||||||||||||||||||
(in EUR 000)
|
| |
R&D
Collaboration |
| |
Consulting
services |
| |
Board
remuneration |
| |
Consulting
services |
| |
Board
remuneration |
| |||||||||||||||
Cochlear
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Noshaq | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
MINV SA
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Man & Science S.A
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Medtech Execs LLC
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 3 | | |
Donald Deyo
|
| | | | — | | | | | | — | | | | | | 11 | | | | | | — | | | | | | — | | |
Robert Taub
|
| | | | — | | | | | | — | | | | | | 13 | | | | | | — | | | | | | — | | |
Kevin Rakin
|
| | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | — | | |
Pierre Gianello
|
| | | | — | | | | | | — | | | | | | 7 | | | | | | — | | | | | | — | | |
Jan Janssen
|
| | | | — | | | | | | — | | | | | | 7 | | | | | | — | | | | | | — | | |
Jurgen Hambrecht
|
| | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | — | | |
Total
|
| | | | — | | | | | | — | | | | | | 54 | | | | | | — | | | | | | 3 | | |
|
Piper Sandler
|
| |
Stifel
|
| |
Cantor
|
|
| | | |
Degroof Petercam
|
| | | |
|
Signature
|
| |
Title
|
| |
Date
|
|
|
/s/ Olivier Taelman
Olivier Taelman
|
| |
Chief Executive Officer and Executive Director
(Principal Executive Officer) |
| |
June 25, 2021
|
|
|
/s/ Fabian Suarez Gonzalez
Fabian Suarez Gonzalez, acting via ActuaRisk Consulting SRL
|
| |
Chief Financial Officer
(Principal Financial and Accounting Officer) |
| |
June 25, 2021
|
|
|
*
Robert Taub
|
| |
Chairman of the Board of Directors
|
| |
June 25, 2021
|
|
|
*
Janke Dittmer
|
| |
Director
|
| |
June 25, 2021
|
|
|
*
Kevin Rakin
|
| |
Director
|
| |
June 25, 2021
|
|
|
*
Donald Deyo
|
| |
Director
|
| |
June 25, 2021
|
|
|
Signature
|
| |
Title
|
| |
Date
|
|
|
*
Pierre Gianello
|
| |
Director
|
| |
June 25, 2021
|
|
|
*
Jan Janssen
|
| |
Director
|
| |
June 25, 2021
|
|
|
*
Jürgen Hambrecht
|
| |
Director
|
| |
June 25, 2021
|
|
|
/s/ Olivier Taelman
Name: Olivier Taelman
Title: Attorney-in-fact |
| | | | | | |