Salute e Benessere
ONWARD Reports 2022 Full Year Financial and Operating Results
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
EINDHOVEN, the Netherlands, LAUSANNE, Switzerland & BOSTON, MA USA, March 27, 2023 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces its 2022 financial and operating results. The full Annual Report is available here , on the Company's website in the Investors section ( https://ir.onwd.com ), and on the website of the Netherlands Authority for the Financial Markets ( www.afm.nl ).
“I am proud of the volume and significance of our team's achievements as we prepare for commercialization of our first therapy in late 2023 or early 2024,” said Dave Marver, CEO of ONWARD. “We announced positive top-line results from our Up-LIFT pivotal study evaluating the use of our external ARC-EX Therapy to restore upper extremity function after spinal cord injury (SCI) and positive interim outcomes from our studies evaluating the use of our implantable ARC-IM Therapy to better regulate blood pressure after SCI. We also made progress in the development of the ARC-IM system to restore motor function, including the evaluation of our ARC-BCI platform, designed to augment ARC-IM Therapy to enable more natural movement. This first-of-its-kind system adds a brain-computer interface (BCI) that records a person's intention to move and directs our spinal cord stimulation platform to enable that movement with ARC-IM Therapy.
We added impactful talent to our Board of Directors and leadership team over the past 12 months. These new additions will help ONWARD scale and reach its vast potential. We are now implementing the operational and commercial capabilities required to successfully launch our first therapy.
We expect several important milestones in 2023, including the first-in-human use of the ARC-IM Lead, the commencement of mobility studies for both SCI and Parkinson's disease, the first-in-human use of the ARC-BCI platform to restore upper extremity function, the publication of detailed results from our Up-LIFT pivotal study, and regulatory clearance and first commercial sale of the ARC-EX device. It is an exciting time to be at ONWARD, and we are deeply motivated by the imperative to help people with SCI, their caregivers, and others with paralysis and movement disabilities.”
The Company's financial and operating highlights for 2022 and early 2023 include the following:
Innovation and Clinical Development:
Science and Intellectual Property (IP):
Corporate:
Financial:
“We expect our current cash to propel operations through the end of 2024, providing us a sound financial base as we grow the Company and prepare for commercial operations in 2023,” commented Lara Smith Weber, CFO of ONWARD.
Full Year Financial Summary:
Total Revenues & Other Income
Other Income, mainly grant income, increased to EUR 2.1M (2021: EUR 1.4M) following an increase in US Defense Advanced Research Projects Agency (DARPA) funding and new grants received from the European Innovation Council (EIC) and SMEs Executive Agency (EISMEA) and Eurostars. The new grants support work on BCIs to reverse upper- and lower-limb paralysis as well as closed-loop control of blood pressure for people with SCI.
Total Operating Expenses
Total Operating expenses increased during 2022 by EUR 4.2M to EUR 34.2M (2021: EUR 30.0M). As part of this, Research & Development expenses increased from EUR 10.6M in 2021 to EUR 13.1M in 2022, driven by advancements made with the ARC-EX and ARC-IM platforms. Additionally, Clinical expenses increased from EUR 4.8M in 2021 to EUR 5.7M in 2022, primarily due to the completion of the Up-LIFT and LIFT Home clinical trials. Marketing and Market Access expenses increased from EUR 1.5M in 2021 to EUR 2.0M in 2022 and include preparations for launch in the US and Europe, as well as attendance at key events to raise awareness of ARC Therapy among key customer groups. General and Administrative expenses were stable, decreasing slightly from EUR 10.7M in 2021 to EUR 10.6M in 2022.
Net Finance Expense
Net Finance expense decreased from EUR 5.7M in 2021 to EUR 1.5M in 2022. The 2021 expense included the interest on the Company's sources of funding from our innovation loan from Rijksdienst voor Ondernemend (RVO, a Dutch government funding vehicle for entrepreneurial ventures), our convertible loan (CLA), and the accrued dividend of preference A shares. Both the CLA and preference A shares converted to ordinary shares in October 2021. The 2022 expense is related to the innovation loan from RVO NL plus bank interest paid on our positive cash balance.
Net Loss for the Period
The Company realized a Net Loss for the period of EUR 32.8 million vs. EUR 34.3 million in 2021. The decrease is driven by a lower Net Finance expense (see above).
Net Cash Position
The Company ended the year with a net cash position of EUR 61.8M (2021: EUR 89.4M), comprising of cash and cash equivalents of EUR 41.8M and fixed term deposits of EUR 20.0M. Cash outflow from operating activities increased from EUR 19.9M in 2021 to EUR 26.7M in 2022 due to higher operating costs, partially offset by a decrease in non-cash adjustments (relating to share-based compensation and net finance costs) and a positive change in working capital.
Outlook
ONWARD expects to achieve several important milestones in 2023:
Conference Call & Webcast
ONWARD will host a conference call with live webcast on March 28, 2023, at 2:00 PM CEST / 08:00 AM EDT. The webcast can be accessed on the News and Events page of the Company's website or by clicking here . A webcast replay will be available after the call at the same location.
The Company's Annual Report 2022 is available here , on the Company's website in the Investors section ( https://ir.onwd.com ), and on the website of the Netherlands Authority for the Financial Markets ( www.afm.nl ).
About ONWARD Medical
ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injuries. ONWARD's work builds on more than a decade of basic science and preclinical research conducted at the world's leading neuroscience laboratories. ONWARD's ARC Therapy, which can be delivered by implantable (ARC-IM) or external (ARC-EX) systems, is designed to deliver targeted, programmed spinal cord stimulation to restore movement and other functions in people with spinal cord injury, ultimately improving their quality of life.
ONWARD has received eight Breakthrough Device Designations from the US FDA encompassing both ARC-IM and ARC-EX. ARC-EX is an external, non-invasive platform consisting of a stimulator and wireless programmer. Positive top-line data were reported in 2022 from the Company's first pivotal study, called Up-LIFT, evaluating the ability of transcutaneous ARC Therapy to improve upper extremity strength and function. The Company is now preparing marketing approval submissions for the US and Europe. ARC-IM consists of an implantable pulse generator and lead placed near the spinal cord. The Company completed the first-in-human use of the ARC-IM neurostimulator and reported positive interim clinical outcomes for ARC-IM Therapy for improved blood pressure regulation following SCI in 2022.
ONWARD is headquartered in Eindhoven, the Netherlands. It maintains a Science and Engineering Center in Lausanne, Switzerland, and has a growing US presence in Boston, Massachusetts. The Company has an academic partnership with .NeuroRestore, a collaboration between EPFL, the Swiss Federal Institute of Technology in Lausanne, and Lausanne University Hospital (CHUV). For additional information about the Company, please visit ONWD.com . To access our 2023 Financial Calendar, please visit IR.ONWD.com .
For Company Enquiries:
info@onw d.com
For Media Enquiries:
MC Services AG
US: Laurie Doyle, P: +1 339 832 0752
Europe: Dr. Johanna Kobler, Katja Arnold, Kaja Skorka P: +49 89 210 228 0
media@onwd.com
For Investor Enquiries:
investors@onwd.com
Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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