NIOX GROUP PLC

("NIOX" or the "Company" 
and, together with its subsidiaries, the "Group")

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2025

Oxford, UK - 30 September 2025: NIOX Group plc (AIM: NIOX), a company engaged in the design, development, and commercialisation of medical devices for the diagnosis, monitoring and management of asthma and COPD, today announces its unaudited interim results for the six months ended 30 June 2025 ("H1 2025").

Financial highlights

·    Revenue growth of 20% (21% on a constant currency basis) to £25.2 million (H1 2024: £21.0 million).

·    Clinical¹ revenue growth of 8% (9% on a constant currency basis) to £20.0 million (H1 2024: £18.5 million).

·    Research² revenue up 108% (108% on a constant currency basis) to £5.2 million (H1 2024: £2.5 million), driven by unforecasted increases in clinical trial activity using FeNO testing for asthma and COPD.

·    Adjusted EBITDA³ of £9.2 million up 30% (H1 2024: £7.1 million), reflecting strong operational leverage driven by higher sales and a broadly flat cost base.

·    Adjusted EBITDA margin 36.5% (H1 2024: 33.8%).

·    Adjusted basic earnings per share of 2.26p up 31% (H1 2024: 1.73p).

·    Cash generated from operations of £7.0 million (H1 2024: £6.0 million).

·    Strong balance sheet with cash of £11.8 million as of 30 June 2025 (30 June 2024: £21.5 million, before £21.0 million returned by way of tender offer, 31 December 2024: £10.9 million), notwithstanding the payment of a £5.0 million dividend in June 2025. Cash at 31 August 2025: £13.2 million.

Financial progress

¹ Clinical revenue represents sales to physicians and hospitals for use in clinical practice.

² Research revenue is from pharmaceutical companies and contract research organisations (CROs) for use in clinical studies.

³ Earnings before interest, tax, depreciation, amortisation and share-based payment expenses. See note 12 for reconciliation.

⁴ Excludes depreciation, amortisation and share-based payment expenses. See note 12 for reconciliation.

Operational highlights

·      Continued adoption and increased penetration of FeNO testing as part of routine practice globally, supported by new NICE guidelines in the UK, increased tender wins in China and expansion into Japanese community clinics.

·      A final dividend for the financial year ended 31 December 2024 of 1.25 pence per share (equating to a return of cash of £5.0 million) was paid on 16 June 2025.

·      Development of our next-generation device, the NIOX PRO®, is progressing well and remains on track for initial launch in late 2025.

Jonathan Emms, NIOX's Chief Executive, said: "NIOX has delivered another excellent half year, with revenues up 20% to £25.2 million and adjusted EBITDA up 30% to £9.2 million. Both the clinical and research businesses performed strongly, with research sales more than doubling, significantly exceeding the forecasts provided by the CROs. This surge in demand has been met effectively thanks to the exceptional support of our supply chain partners. Meanwhile, our core clinical business continues to benefit from high levels of recurring revenue.

Trading in July and August has continued on a strong trajectory, and we remain debt-free, with £13.2 million of cash as of 31 August 2025, enabling us to invest in future growth while supporting our progressive dividend policy. Given the strong performance of our research business, we are comfortably in line with revenue and adjusted EBITDA consensus expectations for 2025. We remain well-positioned to deliver sustained revenue growth, strong cash generation and attractive shareholder returns in the years ahead."  

Contacts

About NIOX

Our mission is to improve asthma diagnosis, monitoring and management of both asthma and COPD by providing greater patient access to FeNO testing. Asthma and COPD are two of the biggest healthcare issues globally, with more than 600 million sufferers combined, many of whom are undiagnosed or are misdiagnosed. NIOX is engaged in the design, development, and commercialisation of medical devices for the measurement of FeNO, a precise biomarker for Type-2 inflammation, which is present in asthma and COPD. Our market-leading device, NIOX VERO®, is increasingly recognised by healthcare professionals as an important tool to improve the diagnosis, monitoring and management of asthma and COPD. NIOX VERO® is also the device of choice by leading clinical research organisations for respiratory studies.

NIOX provides products and services via its direct sales organisation and extensive distributor network in 50 countries. For more information, please visit www.niox.com

Forward-looking statements

This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of NIOX. The use of terms such as "may", "will", "should", "expect", "anticipate", "project", "estimate", "intend", "continue", "target" or "believe" and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. NIOX undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

OPERATING REVIEW  

Introduction

NIOX delivered a strong performance in the first half of 2025, with revenues increasing by 20% (21% at constant currency) to £25.2 million (H1 2024: £21.0 million). Adjusted EBITDA grew by 30% to £9.2 million (H1 2024: £7.1 million), reflecting both top-line growth and improved operating efficiency.

Business Review

NIOX remains the market leader in point-of-care FeNO testing for the diagnosis, monitoring and management of asthma and COPD. The NIOX VERO® device is approved and reimbursed in most major markets globally.

Clinical sales, comprising sales to physicians and hospitals for clinical use, grew by 8% (9% at constant currency) to £20.0 million (H1 2024: £18.5 million). Recurring revenues from consumables used in routine FeNO testing continue to account for over 90% of clinical sales, supporting high revenue visibility and a resilient business model.

Growth was geographically broad-based. On a constant currency basis:

·      APAC sales were up 10%, supported by continued strong demand in Japan and China.

·      EMEA sales grew by 8%, driven by our continued focus on Primary Care and new customer education initiatives in the UK.

·      Americas sales rose by 7%, with untapped potential in the US market representing a significant growth opportunity.

Our experience consistently shows that testing volumes are highest in markets with the greatest FeNO awareness. Accordingly, we remain committed to supporting ongoing education initiatives and local partnerships to raise awareness and adoption.

Research sales are derived from pharmaceutical companies and contract research organisations (CROs) using NIOX® for FeNO testing in clinical studies. These sales more than doubled in the period to £5.2 million (H1 2024: £2.5 million) due to increased clinical trial activity involving FeNO testing for both asthma and COPD, which was not forecasted by the CROs. Research revenues can fluctuate as demand is ultimately determined by pharmaceutical companies' investment in clinical trials.

Strategic Focus

In the US, we are focused on accelerating the penetration of FeNO testing through a revised go-to-market strategy. Historically, our reliance on external sales partners has not delivered the desired results. To address this, we are establishing a small direct sales capability. Under this hybrid model, a dedicated direct sales team will target high-priority geographies and customer segments, while lower-priority areas will continue to be supported by e-marketing initiatives and carefully selected external partners. Alongside this, our existing inside sales team will focus on supporting existing customers and driving growth in recurring revenues. This NIOX-led, focused approach is expected to deliver more consistent growth and is a key strategic step.

Investments

The development of our next-generation clinical device, the NIOX PRO®, progressed well during this period. We previewed the device at the European Respiratory Society conference in September, and we were encouraged by the positive feedback we received. We remain on track for an initial commercial launch in late 2025.

Capitalised development expenditure for the NIOX PRO® in H1 was £0.7 million (H1 2024: £0.2 million), bringing the cumulative spend to date to £1.6 million. Total investment in the development of this device is expected to be approximately £2.5 million, with the majority of costs incurred by the end of 2025.

Separately, we plan to invest £0.5 million in the second half of the year to continue the early-stage development of MyNO®, our home-use FeNO device. These costs will be expensed in the income statement in the period as planned, as costs cannot be capitalised until technical feasibility is demonstrated. While MyNO® is not expected to generate near-term revenue, it represents a longer-term opportunity aligned with the growing trend toward home monitoring.

To support future sensor demand and strengthen supply chain resilience, we previously signed a Letter of Intent with our sensor manufacturer to invest in expanded manufacturing capacity. Preparatory work is currently in progress, and we anticipate incurring capital expenditure of approximately £1.0 million in 2026.

Beyond Air

Under the existing agreement, NIOX is entitled to receive a 5% royalty on net sales of Beyond Air's LungFit® PH device in the United States, up to a maximum of $6.0 million. Royalties began accruing in Q4 2024 and are expected to build steadily as product adoption increases. Royalties earned in the period amounted to £0.1 million (H1 2024: £nil).

Outlook

Trading during July and August continued ahead of management expectations, driven in particular by strong research sales.

As of 31 August 2025, the Group held a cash balance of £13.2 million and remained debt-free. Strong cash generation continues to support the Group's progressive dividend policy. The Board remains committed to returning excess cash to shareholders in the medium term while continuing to invest in future growth and product innovation.

The Board expects results for the full year to be comfortably in line with current revenue and adjusted EBITDA consensus expectations. With over 90% of the Group's revenues denominated in currencies other than Sterling, exchange rate movements may cause reported revenue growth rates at actual exchange rates to differ from those at constant currency. However, the impact on EBITDA remains minimal due to the natural hedging between revenue and cost bases across regions

Looking forward, the Group remains committed to driving sustainable growth in its core clinical business, which remains the main revenue and profit driver. In the US, the Group is implementing changes to its go-to-market strategy. This initiative will involve a transition period through the remainder of 2025, with a more focused approach delivering benefits in late 2026. As previously reported, and despite continued momentum, the visibility of future research demand remains limited.

The Group is well-positioned to deliver sustained revenue growth, strong cash generation and attractive shareholder returns in the years ahead.

Jonathan Emms

Chief Executive Officer

FINANCIAL REVIEW

The first half of 2025 marked another period of strong performance for NIOX, driven by sustained demand for FeNO testing. Continued uptake by our customers has supported robust revenue growth and a corresponding increase in adjusted EBITDA.

¹ Earnings before interest, tax, depreciation, amortisation and share-based payment expenses. Adjusted EBITDA reconciles to operating profit as shown in note 12.

² On 9 April 2020, the Group announced that the development and commercialisation agreement with AstraZeneca was terminating and as such, the results of the COPD business are classified as a discontinued operation.

Revenue

NIOX® revenues for the period were £25.2 million (H1 2024: £21.0 million), which include clinical sales of £20.0 million (H1 2024: £18.5 million) and research sales of £5.2 million (H1 2024: £2.5 million). NIOX® clinical revenue represents sales to physicians and hospitals for use in clinical practice, while research revenue is from pharmaceutical companies and contract research organisations (CROs) for use in clinical studies.

A significant portion of the increase in NIOX® revenue was associated with the growth in research sales due to increased clinical trial activity involving FeNO testing for both asthma and COPD. The increase in clinical revenue is attributable primarily to increased testing volumes in Japan and China.

Gross profit

Gross profit on NIOX® sales was £17.7 million (H1 2024: £15.2 million), with a gross margin of 70% (H1 2024: 72%).

Gross margin was lower than the prior period due to a higher proportion of lower margin, device-heavy research sales.

Administrative expenses

Administrative expenses increased to £4.9 million (H1 2024: £4.1 million) primarily due to higher labour costs, plus one-off costs associated with the withdrawn Keensight bid of £0.3 million.

Earnings per share

Basic profit per share for the period was 1.43p (H1 2024: 1.04p) and diluted profit per share for the period was 1.39p (H1 2024: 0.97p) reflecting a profit for the period of £5.9 million (H1 2024: £4.4 million).

Excluding the impact of depreciation, amortisation and share-based payment expenses, adjusted basic profit per share for the period was 2.26p (H1 2024: 1.73p) reflecting an adjusted profit for the period of £9.3 million (H1 2024: £7.3 million). See note 6.

Statement of financial position

Net assets as at 30 June 2025 increased to £64.4 million (31 December 2024: £59.5 million) largely as a result of lower current liabilities and a higher cash balance.

Current liabilities as at 30 June 2025 were £6.0 million (31 December 2024: £8.1 million). The decrease is mainly due to lower trade and other payables, particularly a reduction in accruals following the payment of annual bonuses.

Cash flow

The Group's cash position (including cash and cash equivalents) increased from £10.9 million as at 31 December 2024 to £11.8 million as at 30 June 2025. The Group has no debt.

Cash generated from operations during the period aggregated £7.0 million (H1 2024: £6.0 million), of which £nil (H1 2024: £0.9 million) was used in discontinued operations. The increase in cash generation is due to the increased profitability of the Group.

A dividend totalling £5.0 million (H1 2024: £4.2 million) was paid to shareholders in the period.

Exchange differences on cash and cash equivalents arose as a result of the translation of foreign currency balances at the beginning and end of the relevant period. The exchange loss for the period was £0.2 million (H1 2024: £0.1 million).

Sarah Duncan

Chief Financial Officer

PRINCIPAL RISKS AND UNCERTAINTIES

NIOX has considered the principal risks and uncertainties facing the Group for the first six months of 2025 and does not consider them to have changed materially from those set out on pages 32 to 33 of the 2024 annual report and accounts, which is available on the Group's website. A summary of these risks and uncertainties is as follows:

Cyber security

If the Group fails to sufficiently detect, monitor, or respond to cyber-attacks against its systems, this may result in disruption of service, compromise of sensitive data, financial loss and reputational damage.

Supply Chain

The Group relies on third parties for the supply of key materials, finished products and services, including shipping. Some materials may only be available from one source, and regulatory requirements may make substitution costly and time-consuming.

Geopolitical developments such as trade disputes, tariffs, sanctions or regional instability may impact these risks by disrupting markets, restricting the movement of goods and services, or increasing costs.

Commercial success

The Group's competitors, some of whom have considerably greater financial and human resources, may develop more effective products, launch similar products at a lower price or be able to compete more effectively in the markets targeted by the Group.

The Group may face issues selling its products if there is no payer coverage or inclusion of these products by health insurance schemes, or if large payers that currently cover FeNO testing shift to a negative coverage policy.

Compliance with healthcare regulations

The Group must comply with complex regulations in relation to the marketing of its devices. These regulations are strictly enforced. Failure by the Group (or its commercial partners) to comply with relevant legislation and regulations in the countries in which it operates may result in criminal and civil proceedings against the Group.

Foreign exchange fluctuations

Foreign exchange fluctuations may adversely affect the Group's results and financial condition. The Group records its transactions and prepares its financial statements in British pound sterling, but a significant proportion of its cash flows are in United States dollars, Swedish krona, euros and Chinese yuan.

Staff retention

Failure to attract, retain and develop people could lead to a lack of critical skills, knowledge and experience, which could hinder both daily operations and growth potential.

CONDENSED INTERIM CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 30 JUNE 2025

The notes below are an integral part of these condensed interim consolidated financial statements.

CONDENSED INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2025

The notes below are an integral part of these condensed interim consolidated financial statements.

Jonathan Emms                                                                       Sarah Duncan

Chief Executive Officer                                                              Chief Financial Officer
NIOX Group plc                                                                         NIOX Group plc

Registered number: 05822706