EINDHOVEN, the Netherlands & LAUSANNE, Switzerland–(BUSINESS WIRE)–ONWARD Medical N.V. (Euronext: ONWD), the medical know-how firm creating modern therapies to revive motion, independence, and well being in individuals with spinal wire harm, at this time pronounces its annual monetary and working outcomes for the yr ended December 31, 2021. The Firm additionally offers a enterprise replace for Q1 2022.
The corporate additional pronounces the publication of its statutory annual accounts for the monetary yr ended December 31, 2021, ready in accordance with Worldwide Monetary Reporting Requirements (IFRS-EU), as drawn up and authorised by the Board and included within the Firm’s annual report (the Annual Report).
The total Annual Report is on the market on the Firm’s web site within the Buyers part (https://ir.onwd.com) and the web site of the Netherlands Authority for the Monetary Markets (www.afm.nl).
The Firm’s Monetary and Working highlights for 2021 embrace the next:
- Awarded Breakthrough Machine Designation from the US Food and Drug Administration (FDA) for the Firm’s ARCIM Remedy centered on restoration of regular blood strain and trunk management for individuals with spinal wire harm (SCI). That is the Firm’s third such designation.
- Accomplished enrollment in its Up-LIFT pivotal research in December, forward of expectations and in lower than 12 months regardless of COVID-related challenges. Up-LIFT is the primary large-scale pivotal trial of non-invasive spinal wire stimulation know-how.
- Accomplished improvement of the preliminary era of its ARCIM know-how platform in preparation for first-in-human use of its IPG and Lead household, anticipated to happen in 2022 as a part of the HeMon Research.
- Raised EUR 30 million by a pre-initial public providing (IPO) convertible word financing.
- Raised EUR 80 million in an IPO on Euronext Brussels and Euronext Amsterdam in October, believed to be the most important early-stage medtech IPO in European historical past.
The Firm reported an Working Lack of EUR 34.3 million for 2021 vs. EUR 20.0 million in 2020. The Firm’s year-end steadiness for money and money equivalents elevated to EUR 89.4 million on December 31, 2021 vs. EUR 6.4 million on December 31, 2020.
“Regardless of difficult circumstances that impacted companies worldwide, we executed strongly in opposition to our major aims in 2021”, stated Dave Marver, CEO of ONWARD. “We demonstrated wonderful progress in R&D by finishing our implantable machine platform, and in Scientific/Regulatory by finishing enrollment within the Up-LIFT Research forward of expectations and receiving our third Breakthrough Machine Designation award from the FDA. Lastly, we efficiently accomplished two necessary financings, together with a big IPO that attracted a high-quality group of traders from the US, Europe, and internationally. We anticipate our sturdy money place from these financings to offer runway by the tip of 2024, however we are going to proceed to discover choices to lift much more capital and improve liquidity by financing actions.”
2021 Monetary Abstract
|
EUR thousands and thousands |
2021 |
2020 |
||
|
Whole Grant Earnings |
1.4 |
|
0.8 |
|
|
Whole Working Bills |
(30.0) |
|
(16.3) |
|
|
Science bills |
(2.7) |
|
(1.1) |
|
|
Analysis & Improvement bills |
(7.9) |
|
(5.8) |
|
|
Scientific & Regulatory bills |
(4.8) |
|
(2.8) |
|
|
Advertising & Market Entry bills |
(1.5) |
|
(0.4) |
|
|
Patent Charges & Associated bills |
(1.4) |
|
(1.2) |
|
|
High quality Assurance bills |
(1.0) |
|
(0.4) |
|
|
Basic & Administrative bills |
(10.7) |
|
(4.7) |
|
|
Working Loss for the Interval |
(28.6) |
|
(15.5) |
|
|
Internet Finance expense |
(5.7) |
|
(4.5) |
|
|
Internet Loss for the Interval |
(34.3) |
|
(20.0) |
|
|
|
|
|
|
|
|
Fundamental (and diluted) Earnings per Share (in EUR) |
(3.62) |
|
(5.56) |
|
|
|
|
|
|
|
|
Money place on the finish of the yr |
89.4 |
|
6.4 |
|
|
Curiosity Bearing Loans |
(11.5) |
|
(41.8) |
|
|
Fairness |
82.7 |
|
(32.1) |
Grant Earnings
Grant earnings elevated by EUR 0.6 million vs. 2020, totaling EUR 1.4 million in 2021 and pushed primarily by proceeds from a DARPA grant that commenced in October 2020. ONWARD is a part of a analysis consortium eligible to obtain as much as USD 36 million as a part of the DARPA Bridging the Hole+ program.
Working Bills
Working bills elevated by EUR 13.7 million vs. 2020, totaling EUR 30 million in 2021. The rise was pushed primarily by a EUR 8.2 million improve in worker prices, with full-time equal (FTE) staff growing from 55 in 2020 to 76.9 in 2021. EUR 2.4 million of the worker price improve might be attributed to extra FTEs whereas EUR 5.8 million might be attributed to share-based cost expense resulting from accelerated vesting of the Firm’s Worker Funding Plan on the date of the Firm’s IPO.
Consulting companies and different prices related to analysis and improvement of the Firm’s therapies elevated by EUR 0.4 million vs. 2020. Actions to drive enrollment within the Firm’s Up-LIFT pivotal trial and different medical research associated prices contributed to a rise of EUR 1.4 million vs. 2020. The Firm additionally incurred an incremental EUR 0.4 million for advertising and market entry actions within the US and Europe. The Firm’s 2021 IPO and the incremental prices of working as a public firm added EUR 2.4 million not incurred in 2020. These prices embrace uncapitalized consulting and authorized bills referring to the IPO and assuring compliance with monetary regulatory necessities.
Working Loss for the Interval
The Firm’s Working Loss for the interval elevated by EUR 13 million, pushed by the rise in Working Bills.
Internet Loss for the Interval
The Firm realized a Internet Loss for the interval of EUR 34.3 million vs. EUR 20 million in 2020. EUR 13.0 million of this improve might be attributed to the Working Loss for the interval. A further EUR 1.2 million is because of a rise within the Firm’s Internet Finance Expense, pushed primarily by a rise in Curiosity Expense.
Money Place
Money and money equivalents elevated by EUR 83 million vs. 2020. The year-end steadiness was EUR 89.4 million on December 31, 2021 vs. EUR 6.4 million on December 31, 2020.
Internet money utilized in working actions was EUR 19.9 million vs. EUR 12.9 million in 2020. The rise was pushed by the rise within the Working Loss for the interval.
The corporate invested EUR 2.3 million in belongings in 2021, a EUR 2.2 million improve vs. 2020. The rise was pushed primarily by IPO-related license charges paid and capitalized as intangible belongings.
The Firm efficiently raised EUR 110 million by investing actions in 2021. EUR 80 million was raised by way of the IPO on Euronext Brussels and Euronext Amsterdam, preceded by a pre-IPO convertible word financing of EUR 30 million. The money generated was offset by capitalized IPO charges paid within the quantity of EUR 4.6 million. Internet money generated from financing actions was EUR 105.3 million in 2021 vs. EUR 4.4 in 2020.
Curiosity Bearing Loans
The lower in Curiosity Bearing Loans from EUR 41.8 million in 2020 to EUR 11.5 million in 2021 was primarily attributable to the conversion of the Firm’s choice A shares into peculiar shares instantly previous the IPO.
Fairness
The optimistic Fairness place of the Firm as of December 31, 2021 was EUR 82.7 million, a rise of EUR 114.8 million vs. December 31, 2020. This improve resulted from the proceeds from the IPO (EUR 80 million), the conversion of the convertible word into peculiar shares (EUR 31 million), the conversion of choice A shares into peculiar shares (EUR 34 million) and the accelerated vesting of the Worker Funding Plan (EUR 8.5 million). The rise was offset by the Internet Loss for the interval (EUR 34.3 million) and the entire paid and unpaid capitalized IPO charges (EUR 4.9 million).
Q1 2022 Enterprise Replace and 2022 Outlook
The Firm’s money steadiness was EUR 83 million as of March 31, 2022, reflecting a money burn of EUR 6.4 million throughout Q1 2022. That is in alignment with expectations that present money readily available will gas operations by the tip of 2024.
In January, the Firm was awarded 9 new patents in collaboration with main analysis universities. The Firm now has over 320 issued or pending patents worldwide.
In February, the Firm’s know-how was leveraged to allow individuals with probably the most extreme type of spinal wire accidents to stroll and stand once more. This breakthrough was printed in Nature Medication and featured by media shops across the globe.
In March, the Firm enrolled the primary contributors within the LIFT House Research, a trial designed to review the protection and efficiency of its ARCEX Remedy within the house setting.
In March, the Firm was added to Euronext Brussels’ Bel-Small Index.
In March, the Firm confirmed its money runway by the tip of 2024. The Firm believes its sturdy money place will mitigate the influence of world provide chain challenges which will have an effect on sure improvement packages. At the moment and barring unanticipated occasions, the Firm believes it has mitigated the danger of additional impacts to essential parts.
In March, the Firm added choices to acquire rights to novel Mind-Backbone Interface and Parkinson’s illness IP developed by its analysis companions at EPFL and Lausanne College Hospital (CHUV).
Constructing on progress proven in Q1, 2022, the Firm expects to attain a number of necessary milestones through the the rest of 2022:
- Completion of the Up-LIFT Pivotal Research for the Firm’s ARCEX Remedy
- Launch of prime line knowledge from the Up-LIFT Pivotal Research for the Firm’s ARCEX Remedy
- Completion of the LIFT House Research for the Firm’s ARCEX Remedy
- Launch of prime line knowledge from the LIFT House Research for the Firm’s ARCEX Remedy
- First-in-human use of the Firm’s ARCIM IPG
- Graduation of the HeMon Feasibility Research for the Firm’s ARCIM Remedy
“We demonstrated regular and constant execution (and related information stream) in Q1 2022”, stated Dave Marver, CEO of ONWARD. “Our drive to execute will proceed through the the rest of 2022, with a number of value-driving milestones anticipated, together with prime line knowledge from the Firm’s first pivotal trial and first-in-human use of our novel, proprietary, purpose-built neuromodulation platform.”
Convention Name & Webcast
ONWARD will host a convention name with dwell webcast at this time at 4 pm CET / 10 am ET. The webcast could also be accessed on the Occasions web page of the corporate’s web site or by clicking right here. A replay of the webcast will likely be obtainable on the ONWARD web site.
To be taught extra about ONWARD’s ARC Remedy and the corporate’s imaginative and prescient to revive motion, independence and well being in individuals with spinal wire harm, please go to ONWD.com.
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014).
About ONWARD
ONWARD is a medical know-how firm creating modern therapies to revive motion, independence, and well being in individuals with spinal wire harm. ONWARD’s work builds on greater than a decade of primary science and preclinical analysis carried out on the world’s main neuroscience laboratories. ONWARD’s ARC Remedy, which might be delivered by implantable (ARCIM) or exterior (ARCEX) programs, is designed to ship focused, programmed stimulation of the spinal wire to revive motion and different capabilities in individuals with spinal wire harm, in the end bettering their high quality of life. ONWARD has acquired three Breakthrough Machine Designations from the FDA encompassing each ARCIM and ARCEX. The corporate’s first FDA pivotal trial, referred to as Up-LIFT, accomplished enrollment in December 2021 with 65 topics worldwide.
ONWARD is headquartered on the Excessive Tech Campus in Eindhoven, the Netherlands. It maintains a major workforce in Lausanne, Switzerland and has a rising U.S. presence in Boston, Massachusetts, USA. For added details about the corporate, please go to ONWD.com. To entry our 2022 Monetary Calendar, please go to IR.ONWD.com.
The Firm is listed on Euronext Brussels and Euronext Amsterdam as of 21 October 2021 below the ONWD ticker with worldwide securities identification quantity NL0015000HT4.
Disclaimer
Sure statements, beliefs and opinions on this press launch are forward-looking, which mirror the Firm or, as acceptable, the Firm administrators’ present expectations and projections about future occasions. By their nature, forward-looking statements contain a lot of dangers, uncertainties and assumptions that would trigger precise outcomes or occasions to vary materially from these expressed or implied by the forward-looking statements. These dangers, uncertainties and assumptions may adversely have an effect on the result and monetary results of the plans and occasions described herein. A large number of things together with, however not restricted to, adjustments in demand, competitors and know-how, could cause precise occasions, efficiency or outcomes to vary considerably from any anticipated improvement. Ahead wanting statements contained on this press launch relating to previous traits or actions shouldn’t be taken as a illustration that such traits or actions will proceed sooner or later. Because of this, the Firm expressly disclaims any obligation or endeavor to launch any replace or revisions to any forward-looking statements on this press launch on account of any change in expectations or any change in occasions, circumstances, assumptions or circumstances on which these forward-looking statements are based mostly. Neither the Firm nor its advisers or representatives nor any of its subsidiary undertakings or any such individual’s officers or staff ensures that the assumptions underlying such forward-looking statements are free from errors nor does both settle for any duty for the longer term accuracy of the forward-looking statements contained on this press launch or the precise incidence of the forecasted developments. You shouldn’t place undue reliance on forward-looking statements, which communicate solely as of the date of this press launch.
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