REGULATED INFORMATION
Nyxoah Issues First Half 2021 Financial Results
Mont-Saint-Guibert,
Highlights
- $97.8 million Nasdaq IPO gross proceeds
- On track to complete US DREAM trial enrollment
- €355 thousand revenue generated in
Europe , compared to no revenue for the six months ended June 30, 2020, driven mainly inGermany - Increased commercial activities in
Germany with 12 active accounts in Q2, up from 2 in Q1 2021 - Announced BETTER SLEEP study top-line results that showed primary safety and performance endpoints met, with statistically significant mean reduction in the AHI score in full patient population including Complete Concentric Collapse (“CCC”) patients
- To submit full BETTER SLEEP study data to a medical journal for publication and announce results following further analyses
- Integrated Vanderbilt University technology into our scientific and technology department pipelines including collaboration with US and German key opinion leaders
“In the first half of 2021, we kept pace with our initiatives to deliver significant new accomplishments. In less than 12 months, we completed our second IPO with a Nasdaq listing, further strengthening our balance sheet; made important gains in commercial activities in
First Half 2021 Results
For the six months ended | |||||
2021 | 2020 | ||||
(in thousands) | |||||
Revenue | € 355 | € − | |||
Cost of goods sold | (115) | − | |||
Gross profit | € 240 | € − | |||
General and administrative expenses | (4 777) | (2 400) | |||
Research and development expenses | (1 255) | (56) | |||
Clinical expenses | (631) | (509) | |||
Manufacturing expenses | (2 171) | (207) | |||
Quality assurance and regulatory expenses | (642) | (86) | |||
Patents fees & Related | (793) | (107) | |||
(1 502) | (761) | ||||
Other operating income / (expenses), net | (97) | 184 | |||
Operating loss for the period | € (11 628) | € (3 942) | |||
Financial income | 43 | 82 | |||
Financial expense | (899) | (416) | |||
Loss for the period before taxes | € (12 484) | € (4 276) | |||
Income taxes | (124) | (24) | |||
Loss for the period | € (12 608) | € (4 300) | |||
Loss attributable to equity holders | € (12 608) | € (4 300) | |||
Other comprehensive loss | |||||
Items that may be subsequently reclassified to profit or loss (net of tax) | |||||
Currency translation differences | 192 | (89) | |||
Total comprehensive loss for the year, net of tax | € (12 416) | € (4 389) | |||
Loss attributable to equity holders | € (12 416) | € (4 389) | |||
Basic Earnings Per Share (in EUR) | € (0.570) | € (0.262) | |||
Diluted Earnings Per Share (in EUR) | € (0.570) | € (0.262) |
Revenue
Revenue was €355 thousand for the six months ended
Cost of Goods Sold
Cost of goods sold was €115 thousand for the six months ended
General and Administrative Expenses. General and administrative expenses increased by €2.4 million, or 99 %, from €2.4 millionfor the six months ended
Research and Development Expenses. Before capitalization of €0.6 million for the six months ended
Clinical Expenses. Before capitalization of €3.1 million for the six months ended
Manufacturing Expenses. Before capitalization of €0.3 million for the six months ended
Quality Assurance and Regulatory Expenses. Before capitalization of €0.2 million for the six months ended
Patent Fees & Related Expenses. Before capitalization of €0.2 million for the six months ended
Therapy Development Expenses. Therapy development expenses increased by €0.7 million or 97 % from €0.8 million for the six months ended
Other Operating Income / (Expenses). The Company had other operating expenses of €0.1 million for the six months ended
Operating Loss
The Company realized a net loss of €12.6 million for the six months ended
Cash Position
Cash and cash equivalents totaled €79.2 million on
Net cash used in operations was €8.4 million for the six months ended
Net cash used in investing activities was €4.5 million for the six months ended
Net cash used in financing activities for the six months ended
Outlook for 2021
The Company’s business, operational, and clinical outlook for 2021 include the following expected milestones and goals:
- Begin marketing in
Switzerland with approved DRG, as well as additional European countries by the second half of 2021 - Ramp up EU revenue through dedicated sales team in Germany
- Open second independent manufacturing site in
Belgium - Complete DREAM pivotal trial enrollment in the fourth quarter of 2021
First half-year report 2021
Nyxoah’s financial report for the first half of 2021, including details of the unaudited condensed consolidated financial statements, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Conference ID: 7468474
USA: (844) 260-3718
Belgium: 0800 73264
International: (929) 517-0938
A question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events. The archived webcast will be available for replay shortly after the close of the call.
About
Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company has completed the BETTER SLEEP study in
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors 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 are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates 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, except if specifically required to do so by law or regulation. 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.
Contacts:
corporate@nyxoah.com
+32 (0)10 22 24 55
Gilmartin Group
IR@nyxoah.com
Attachment
- ENGLISH - 1H Results PR_FINAL
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