Anglo American’s Mogalakwena PGM mine completes IRMA audit

SEATTLE, March 13, 2025 (GLOBE NEWSWIRE) — Today the Initiative for Responsible Mining Assurance (IRMA) released the audit report of Anglo American’s Mogalakwena PGM complex against the IRMA Standard for Responsible Mining. Independent audit firm ERM–CVS assessed Mogalakwena at IRMA 50 when measuring its performance against the Standard’s best practice social and environmental criteria.

IRMA 50 means that ERM–CVS verified that the operations at least substantially met all 40 critical requirements of the IRMA Standard, as well as at least 50% of the Standard’s criteria in each of the four principle areas: social responsibility, environmental responsibility, business integrity and planning for positive legacies. The full audit reports are available on the Mogalakwena audit page on the IRMA website.

The information stakeholders need to decide what’s going well — and what may require more attention.

“This report demonstrates that mines can point to transparent, independent evaluations of their environmental and social performance,” said Aimee Boulanger, Executive Director of IRMA. “Through detailed IRMA audit reports, mining companies, communities and companies that purchase mined materials can gain the information they need, to decide what’s going well — and what may require more attention — at specific mines.”

As the IRMA Standard is recognized and adopted around the globe, these audits are steps in a deepening dialogue between mining companies and those affected by their operations. Because the process is still evolving, the results should be reviewed and interpreted accordingly.

“An increasing number of community members and workers are engaging in IRMA audits, and they’re using the audit reports to communicate directly with the mining company about their priorities for improvement,” Ms. Boulanger said. “If readers find results inconsistent with their experience, we encourage them to share their perspectives with IRMA and the company so that we can improve the audit review process and support continuing improvement at the site—as community members and NGOs have already done in this case.”

“We are always looking to improve not only mining practices, but also IRMA's system. IRMA's improvements, and being transparent about how we need to improve, is built into our system and a measure of its success,” said Ms. Boulanger.

Craig Miller, CEO of Anglo American Platinum said, “This milestone at Mogalakwena is significant in our overall adoption of IRMA. It enables us to promote transparency and best practice in sustainability, while adding value to our global customers by helping them meet the increasing expectations for responsibly mined materials in an efficient and credible way. With IRMA 50, we have accomplished our sustainable mining plan target of having all our mining operations assured against a recognised responsible mining standard by 2025.”

Including Mogalakwena, 23 industrial–scale mines worldwide are within the IRMA independent assessment system. After an initial self–assessment, a participating mine engages a third–party audit firm — trained and approved by IRMA — to conduct a detailed independent evaluation, including on–site visits to the mine and nearby communities. Following the release of the initial audit, a shorter surveillance audit checks on the mine’s performance. Three years after the initial audit, the operation is fully audited again (Note: The first mines audited in the IRMA system have had extensions to this timeline due to Covid delays and launch–phase learning; updated full reviews will be required to maintain or increase achievement scores.)

The independent IRMA system is the only global mining standard that provides equal power to the public sector (communities and Indigenous rights holders, mine workers, and environmental and human rights advocates) alongside the private sector (mining companies, mined materials purchasers and investors).

For More Information:


GLOBENEWSWIRE (Distribution ID 9393841)

Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
FDA PMA Application Review Nearing Conclusion
Positioned for U.S. Commercial Launch in March 2025

Mont–Saint–Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the fourth quarter and financial year 2024.  

Recent Financial and Operating Highlights

  • Revenue for the fourth quarter of 2024 was €1.3 million, which excludes €0.6 million of deferred revenue
  • Revenue for the full year 2024 was €4.5 million, which excludes €0.6 million of deferred revenue
  • Gross margin for the fourth quarter of 2024 was 73%
  • At December 31, 2024, cash and financial assets were €85.6 million, compared to €57.7 million at December 31, 2023
  • Assembled U.S. executive leadership team with deep industry experience
  • Full U.S. commercial organization, including sales, marketing, and market access teams, in place

“2024 was a transformative year for Nyxoah. We reported best–in–class outcomes from our DREAM pivotal study, completed our PMA submission with the FDA for Genio, and built a world–class U.S. commercial organization,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “We believe an approval is still expected by the end of the first quarter, and we look forward to launching this innovative therapy to the millions of Americans suffering from moderate to severe OSA.”

Fourth Quarter and Full Year 2024 Results

Revenue

In the fourth quarter of 2024, the Company began recording a portion of the selling price for a Genio system related to disposable patches as deferred revenue and recognized €0.6 million in the quarter. Due to this deferral, reported revenue was €1.3 million for the fourth quarter ending December 31, 2024, and €4.5 million for the full year. Had the Company not recorded deferred revenue for its disposable patches, total revenue for the fourth quarter would have €1.9 million, up 46% versus the third quarter of 2024. Likewise, revenue for the full year 2024 would have been €5.1 million, up 18% from €4.3 million in 2023. The increase in full year revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.

Cost of Goods Sold

Cost of goods sold was €0.3 million for the three months ending December 31, 2024, representing a gross profit of €0.9 million, or gross margin of 73%. This compares to total cost of goods sold of €0.7 million in the fourth quarter of 2023, for a gross profit of €1.1 million, or gross margin of 60%.

For the full year ending December 31, 2024, total cost of goods sold was €1.5 million, representing a gross profit of €3.0 million, or gross margin of 66%. This compares to total cost of goods sold of €1.7 million for the full year of 2023, for a gross profit of €2.7 million, or gross margin of 62%.

Research and Development
For the fourth quarter ending December 31, 2024, research and development expenses were €11.7 million, versus €7.3 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, research and development expenses were €34.3 million, versus €26.7 million for the full year of 2023. The increase in research and development expenses was primarily driven by higher R&D activities and clinical expenses.

Selling, General and Administrative
For the fourth quarter ending December 31, 2024, selling, general and administrative expenses were €8.1million, versus €4.9 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, selling, general and administrative expenses were €28.5 million, versus €21.7 million for the full year of 2023. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system in Europe and scale up of the Company.

Operating Loss
Total operating loss for the fourth quarter and full year 2024 was €18.3 million and €58.8 million, respectively, versus €10.8 million and €45.1 million in the fourth quarter and full year 2023, respectively. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.

Cash Position
As of December 31, 2024, cash and financial assets totaled €85.6 million, compared to €57.7 million on December 31, 2023.

Annual Report 2024
Nyxoah is currently finalizing the financial statements for the year ended December 31, 2024. The Company’s independent auditor has confirmed that their audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the accounting information included in this press release. The complete consolidated financial statements for the year ended December 31, 2024 as well as the complete audit report related to the audit of the consolidated financial statements will be included in the 2024 Annual Report which the Company aims to publish on or around March 20, 2025. When published, the Nyxoah Annual Report for the financial year 2024 will be available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Thursday, March 13, 2025, beginning at 1:00pm CET / 8:00am ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q4 and FY 2024 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah's Q4 and FY 2024 Earnings Call. After registering, an email will be sent, including dial–in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

The archived webcast will be available for replay shortly after the close of the call.

CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)

 

For the three months ended December 31,

 

For the twelve months ended December 31,

 

2024

 

2023

 

2024

 

2023

Revenue 

1 263

 

1 824

 

4 521

 

4 348

Cost of goods sold 

(335)

 

(726)

 

(1 552)

 

(1 656)

Gross profit 

928

 

€ 1 098

 

2 969

 

€ 2 692

Research and Development Expense 

(11 752)

 

(7 321)

 

(34 325)

 

(26 651)

Selling, General and Administrative Expense 

(8 065)

 

(4 893)

 

(28 461)

 

(21 687)

Other income/(expense) 

578

 

279

 

1 008

 

544

Operating loss for the period 

€(18 311)

 

€(10 837)

 

€(58 809)

 

€(45 102)

Financial income 

2 832

 

582

 

7 447

 

4 174

Financial expense 

410

 

(964)

 

(5 070)

 

(3 729)

Loss for the period before taxes 

€(15 069)

 

€(11 219)

 

€(56 432)

 

€(44 657)

Income taxes

(2 080)

 

326

 

(2 804)

 

1 445

Loss for the period 

€(17 149)

 

€(10 893)

 

€(59 236)

 

€(43 212)

 

 

 

 

 

 

 

 

Loss attributable to equity holders 

€(17 149)

 

€(10 893)

 

€(59 236)

 

€(43 212)

 

 

 

 

 

 

 

 

Other comprehensive income/(loss) 

 

 

 

 

 

 

 

Items that may not be subsequently reclassified to profit or loss (net of tax) 

 

 

 

 

 

 

 

Remeasurements of post–employment benefit obligations, net of tax

11

 

81

 

11

 

81

Items that may be subsequently reclassified to profit or loss (net of tax)

 

 

 

 

 

 

 

Currency translation differences 

545

 

(32)

 

766

 

(120)

Total other comprehensive income/(loss)

556

 

€(39)

 

€777

 

€(39)

Total comprehensive loss for the year, net of tax 

€(16 151)

 

€ (10 844)

 

€(58 459)

 

€(43 251)

Loss attributable to equity holders 

€(16 151)

 

€ (10 844)

 

€(58 459)

 

(43 251)

 

 

 

 

 

 

 

 

Basic loss per share (in EUR) 

€(463)

 

€(379)

 

€(1 809)

 

€(1 545)

Diluted loss per share (in EUR) 

€(463)

 

€(379)

 

€(1 809)

 

€(1 545)

CONSOLIDATED BALANCE SHEET (unaudited)
(in thousands)

 

 

 

As at December 31

 

 

 

2024

 

2023

ASSETS

 

 

 

 

 

Non–current assets

 

 

 

 

 

Property, plant and equipment

 

 

4 753

 

4 188

Intangible assets

 

 

50 381

 

46 608

Right of use assets

 

 

3 496

 

3 788

Deferred tax asset

 

 

76

 

56

Other long–term receivables

 

 

1 617

 

1 166

 

 

 

€ 60 323

 

€ 55 806

Current assets

 

 

 

 

 

Inventory

 

 

4 716

 

3 315

Trade receivables

 

 

3 382

 

2 758

Other receivables

 

 

2 774

 

3 212

Other current assets

 

 

1 656

 

1 318

Financial assets

 

 

51 369

 

36 138

Cash and cash equivalents

 

 

34 186

 

21 610

 

 

 

€ 98 083

 

€ 68 351

Total assets

 

 

€ 158 406

 

€ 124 157

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

Share capital and reserves

 

 

 

 

 

Share capital

 

 

6 430

 

4 926

Share premium

 

 

314 345

 

246 127

Share based payment reserve

 

 

9 300

 

7 661

Other comprehensive income

 

 

914

 

137

Retained loss

 

 

(217 735)

 

(160 829)

Total equity attributable to shareholders

 

 

€ 113 254

 

€ 98 022

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Non–current liabilities

 

 

 

 

 

Financial debt

 

 

18 725

 

8 373

Lease liability

 

 

2 562

 

3 116

Pension liability

 

 

 

9

Provisions

 

 

1 000

 

185

Deferred tax liability

 

 

19

 

9

Contract liability

 

 

472

 

Other liabilities

 

 

845

 

 

 

 

€ 23 623

 

€ 11 692

Current liabilities

 

 

 

 

 

Financial debt

 

 

248

 

364

Lease liability

 

 

1 118

 

851

Trade payables

 

 

9 505

 

8 108

Current tax liability

 

 

4 317

 

1 988

Contract liability

 

 

117

 

Other liabilities

 

 

6 224

 

3 132

 

 

 

€ 21 529

 

€ 14 443

Total liabilities

 

 

€ 45 152

 

€ 26 135

Total equity and liabilities

 

 

€ 158 406

 

€ 124 157

About Nyxoah
Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery–free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best–in–class outcomes for reducing OSA burden.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

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; receipt of FDA approval; entrance to the U.S. market; 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. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20–F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that the Company files with the SEC. 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:

Nyxoah
John Landry – CFO
[email protected]

For Media
United States
FINN Partners – Glenn Silver
[email protected]

Belgium/France
Backstage Communication – Gunther De Backer
[email protected]

International/Germany
MC Services – Anne Hennecke
nyxoah@mc–services.eu

Attachment


GLOBENEWSWIRE (Distribution ID 1001053522)