Surgical Innovations Group plc

("Surgical Innovations", the "Group" or the "Company")

Half-year Report

Interim results for the six months ended 30 June 2024

Surgical Innovations Group plc (AIM: SUN), the designer, manufacturer and distributor of innovative medical technology for minimally invasive surgery, reports its unaudited financial results for the six-month period ended 30 June 2024 ("2024 H1").

Commercial and Operational Highlights

Financial Highlights

¹ Adjusted EBITDA, adjusted operating (loss)/ profit and adjusted EPS are stated before deducting non-recurring exceptional costs of £0.30m (2023 H1: £0.01) and share based payment costs of nil (2023 H1 £0.02m).

² Net debt is presented Pre-IFRS 16 and equals cash less bank debt

Current Trading and Outlook

Jonathan Glenn, Chairman of Surgical Innovations Group Plc, said: "I am pleased with the progress Surgical Innovations has made over the first half of this financial year. We have continued to grow revenues and have delivered an adjusted EBITDA profit in the period.

"The operational plan implemented is expected to deliver cost benefits in the second half of the year and positions the business for increased profitability in 2025. The strength of SI-branded products remains robust, though challenges in the UK market are likely to persist over the near term. However, additional new product introductions and the realignment of the sales structure are anticipated to improve the UK business. In the first half, OEM sales were boosted by the clearing of backorders and will return to more normalised levels in the second half. Modest revenue and margin improvements are expected to materialise in Q4 and continue into 2025.

Investor briefing

David Marsh, Chief Executive Officer, and Chris Martin, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on the new date of Monday 14 October 2024 at 4:00 p.m. BST.

The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9:00 a.m. the day before the meeting or at any time during the live presentation. Investors can sign up to Investor Meet Company for free and add to meet Surgical Innovations Group plc via: https://www.investormeetcompany.com/surgical-innovations-group-plc/register-investor 

Investors who already follow Surgical Innovations Group plc on the Investor Meet Company platform will automatically be invited.

For further information please contact:

About Surgical Innovations Group plc

Strategy

The Group specialises in the design, manufacture, sale and distribution of innovative, high quality medical products, primarily for use in minimally invasive surgery. Our product and business development is guided and supported by a key group of nationally and internationally renowned surgeons across the spectrum of minimally invasive surgical activity.

We design, manufacture and source our branded port access systems, surgical instruments and retraction devices which are sold directly in the UK home market through our subsidiary, Elemental Healthcare ("Elemental"), and exported widely through a global network of trusted distribution partners. Many of our products in this field are based on a "resposable" concept, in which the products are part reusable, part disposable, offering a high quality and environmentally responsible solution at a cost that is competitive against fully disposable alternatives.

Elemental also has exclusive UK distribution for a select group of specialist products employed in laparoscopy, bariatric and metabolic surgery, hernia repair and breast reconstruction.

In addition, we design and develop medical devices for carefully selected OEM partners. We have a number of long-term relationships with key partners including the design, development and manufacture of the FIX8 device for Advanced Medical Solutions plc ("AMS") and more recently for a new collaboration with robotic surgery company, CMR Surgical Limited ("CMR"), to design and develop an access device for their unique instrumentation.

We aim for our brands to be recognised and respected by healthcare professionals in all major geographical markets in which we operate and provide, by development, partnership or acquisition, a broad portfolio of cost effective, procedure specific surgical instruments and implantable devices that offer reliable solutions to genuine clinical needs in the operating theatre environment.

Operations

The Group currently employs approximately 80 people across one site in Leeds in the UK. Elemental was acquired by the Group on 1 August 2017 and provides direct sales representation in the UK home market and a range of third-party products for UK distribution. Elemental was originally based in Berkshire and was successfully relocated in 2021, with all operations now located at the Leeds site.

Further information

Further details of the Group's businesses are available on the following websites:

www.sigroupplc.com

www.surginno.com

www.elementalhealthcare.co.uk

Investors and others can register to receive regular updates by emailing [email protected]

Surgical Innovations Group plc

Chairman's Statement

For the six-month period ended 30 June 2024

Market and Financial Overview

Trading in the first half of the year increased 9% to £6.17m (2023 H1: £5.65m). This was predominantly as a result of strong SI-branded and OEM sales, however the UK saw an overall drop in revenue with some significant headwinds especially in the early part of 2024. 

In Europe, Canada and the UK, our investment in training and the development of marketing tools to promote the sustainability message has proven successful, resulting in strong sales growth in these regions. In Europe, this effort has led to an impressive underlying sales increase of 28%, driving revenue to £0.89m in 2024 H1, up from £0.69m in 2023 H1.

The USA has seen a 15% increase bringing revenue to £0.63m in 2024 H1, up from £0.55m in the same period the previous year. This growth has been primarily driven by sales of scissors and instruments, with access devices beginning to gain traction.

APAC revenues showed modest growth of 2% over the previous year, reaching £0.54m. In 2024 H1, purchasing slowed due to stocking orders in India and Japan in 2023. However, this trend has normalized in 2024 H2, with India in particular, seeing some significant account conversions to drive disposable sales.

The UK faced a challenging start to the year, with H1 revenues falling 8% to £2.74m. Sales were adversely affected by NHS industrial action and changes in NHSSC inventory management. Additionally, the shift away from lower-margin, time consuming products has allowed focus on key distribution and SI branded devices.  SI Branded products grew 17% to £1.02m up from £0.87m in H1 2023.

ROW has experienced robust growth, up 23% from the previous year, with sales of £0.28m, largely driven by our new Canadian partner who has embraced our sustainability messaging. Significant account conversions are planned for H2 and are expected to further support growth in this region.

OEM revenues increased by 63%, reaching £1.1m, primarily due to clearing backorders. Increasing supply chain and labour costs have impacted margins. Revenues from OEM are expected to normalise in H2.

Commercial or underlying margins of 34.4% have reduced in H1 by 3.5% compared to 2023 FY margins (2023 H1: 40.53%, 2023 FY: 37.87%). This reflects significant inflationary increases in material costs. While commercial margins have declined, the reported gross margin of 32.9%, which includes the net cost of manufacturing, is in line with 2023 H1 and has improved by 4.2% on the 2023 FY margins (2023 H1: 33.0%; 2023 FY: 28.7%). This is the result of operational improvements in efficiency and manning levels and less disruption within our supply chain.  

A number of customer price increases have been implemented in H1 with further rises planned in H2 as fixed term customer agreements are renewed. This, together with continuing operational improvements, will help maintain gross margins in H2.

Other operating expenses increased to £2.47m (2023 H1: £2.17m). The increase is due to one-off costs relating to a restructuring programme across the business. Excluding the effect of non-recurring items, operating expenses were on a par with 2023 H1 at £2.16m. Other operating expenses in 2024 H2 are expected to reduce from 2024 H1 as the benefits from the re-structure begin to be fully realised.

The Group generated an adjusted EBITDA profit for the period of £0.19m (2023 H1: £0.09m). The full effect of the savings from the restructuring, actions on price and further operational efficiencies will deliver improved profitability in H2.

Adjusted operating loss before tax for the period (before non-recurring items and share based payment charges) was £0.13m (2023 H1: £0.28m loss). The reported net loss before taxation amounted to £0.49m against a net loss of £0.37m in 2023 H1.

There was no reported tax charge/credit in the period (2023 H1: nil). In terms of deferred tax, the Group continues to hold substantial corporation tax losses on which management takes a cautious view, and consequently, the Group does not recognise a corresponding deferred tax asset.

Adjusted net earnings per share amounted to a loss of £0.020p (2023 H1: £0.037p loss). The net total comprehensive income for the period amounted to a loss of £0.49m (2023 H1: loss of £0.37m).

For the first half of 2024, cash used in operations was £0.49m (2023 FY: £0.26m generated, 2023 H1: £0.07m used). The outflow of £0.49m, however, does include £0.30m of non-recurring costs relating to the restructure. After continued investment into R&D of £0.16m (2023 FY: £0.40m, 2023 H1: £0.12m), capital expenditure of £0.04m (2023 FY: £0.28m, 2023 H1: £0.18m) and the financing costs of the existing bank loan and lease liabilities, the Group had available cash balances of £1.23m (31 Dec 2023: £2.21m).

The Directors have considered the available cash resources of the Group and the current internal anticipated forecasts and have a reasonable expectation that the Group have adequate resources. The Group is expected to continue to generate cash from operations over the next 12 months as the Group benefits from a lower cost base following restructuring, continues to improve operational efficiencies and reduce inventory. This will therefore provide ample support to continue in operational existence for the foreseeable future, considered to be at least 12 months from the date of approval of the financial statements. The covenant test for the period ending 30 June 2024 has been passed.

Market Outlook

The UK faced a challenging start to the year, primarily due to the NHSSC shifting to a 'Just-in-Time' model, which led to reduced inventory levels and lower purchasing activity. Purchasing levels have now normalised. Additionally, ongoing industrial action by junior doctors impacted the volume of elective surgery.

The strategic decision to withdraw from the low-margin, time-intensive synthetic hernia mesh business, allowing for a greater focus on own branded products and higher margin third-party opportunities has impacted sales. However, this has allowed the sales team to refocus on SI-Branded product resulting in significant revenue growth of 17%, rising from £0.87m in 2023 H1 to £1.02m in 2024 H1.

Elemental has expanded its portfolio by adding several third-party suppliers, some of which already generate revenue in the UK. While this is expected to have a modest impact on revenue in 2024, the effect will be more pronounced in 2025. Additionally, there is a pipeline of new third-party opportunities set for introduction in 2024 Q4 which, should the Company convert, will further contribute to revenue growth in 2025.

Sustainability messaging initiatives continue to drive sales across key markets, supported by ongoing investments in sales support, marketing, training, and the ongoing development of the financial and environmental calculator. These tools have proven highly effective in fostering growth. The increase in SI-branded product sales is largely driven by a strong focus on sustainability; this focus continues in H2 and significant account conversions in key markets will continue to drive growth into 2025.

The rollout of LogiTube is accelerating in the second half of the year, with key market launches in Europe, Canada, the Middle East, and Australia. Additionally, the rapid development of the Yelloport Elite XL cannula is enabling deeper penetration into the bariatric market, particularly for gastric bypass and gastric sleeve procedures. The cost-down project highlighted at YE 2023 continues to progress focusing on both material and design changes to improve manufacturing efficiencies.

Operational and Regulatory Activities

An operational improvement plan has been implemented to enhance manufacturing efficiency, reduce costs, and improve margins. The restructuring process is now complete, and the benefits are expected to be realised throughout the second half of the year, with a significant boost to profitability anticipated in 2025.

The new CFO brings extensive manufacturing expertise to the company, enhancing reporting accuracy and cost management. With a focus on improving financial control, the business is actively implementing cost controls to drive greater operational efficiency.

The regulatory pathway for the EU Medical Device Regulation ("MDR") remains on track, despite the transition deadline to MDR being revised, which has shifted the notified body's focus to more immediate priorities. The Company's Quality Management System, technical files, and microbiology data have been made MDR-compliant, successfully audited by BSI, and fully approved. Progress continues on the product technical files, with two out of three approved for MDR, while the final file is currently under clinical review. Additionally, the UKCA mark has been obtained, and the Medical Device Single Audit Program ("MDSAP") audit has been successfully completed.

Current Trading and Outlook

The operational plan implemented is expected to deliver cost benefits in the second half of the year and positions the business for increased profitability in 2025. The strength of SI-branded products remains robust, though challenges in the UK market are likely to persist over the near term. However, additional new  product introductions and the restructuring of the organisation, already implemented, are anticipated to improve the performance of the business going forward.

Jonathan Glenn

Chairman

30 September 2024