Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company" or the "Group")

Interim Results for the six months ended 31 December 2024

31 March 2025: Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, announces its unaudited interim results for the six months ended 31 December 2024.

Highlights

Financial

-     Operating profit of £1.9 million before R&D, exceptional and fundraising costs (FY2024 H1: £0.5 million operating loss pre-R&D and exceptional costs).

-     Cash position of £21.7 million at 31 December 2024 (30 June 2024: £12.9 million).

-     Financial turnaround progressing with H1 revenues of £34.0 million (FY2024 H1: £33.6 million), 4% growth on a constant currency basis (FY2024 H2: 2% growth).

-     Second consecutive period of half year growth with improved operating margin.

-     Continued focus on cost control, with total administrative expenses reduced by 9.7% against comparative period.

Operational

-     Increase of 5% in volume of units sold reflecting a recovery in manufacturing capacity and improved ability to meet market demand.

-     Submission of Marketing Authorisation Application for Grass MATA MPL in November 2024.

-     First patient treated in the G308 Phase III trial to evaluate long-term efficacy and safety of Grass MATA MPL in paediatric patients.

-     Positive interim analysis data from the Phase I/IIa VLP Peanut PROTECT Trial showing up to 48% reduction in wheal size after skin-prick testing compared to 8% in placebo, indicating significant potential efficacy of the product.

Manuel Llobet, CEO at Allergy Therapeutics, commented: "We enter 2025 with clear positive momentum across all aspects of our business. Our return to first-half growth and strengthened financial foundation give us renewed confidence to advance our strategic priorities. The submission of our Marketing Authorisation Application for Grass MATA MPL in Germany and the start of our paediatric G308 trial mark significant progress in our grass allergy programme. Simultaneously, the encouraging interim data from our VLP Peanut programme demonstrating meaningful reductions in skin sensitivity reinforce the transformational potential of this innovative vaccine candidate. With these developments, we are well positioned to deliver on our commitment to transform patient care in allergy while building sustainable value."

Financial Review

Revenue for the six months ended 31 December 2024 was £34.0 million (FY2024 H1: £33.6 million) representing 1% growth on a reported basis, or more than 4% on a constant* currency basis. Revenue has now grown for two consecutive half year periods, when compared to the equivalent periods in the prior financial year, demonstrating that the Group's financial recovery continues. Further, the volume of units sold increased by 5%, indicating a recovery in manufacturing output, with the growth primarily driven by a rebuild of the diagnostic portfolio.

Cost of sales increased slightly to £13.2 million (FY2024 H1: £13.1 million) in line with the higher sales volumes and maintaining broadly the same gross margin of 61%.

Sales, marketing and distribution costs were lower than the prior period at £9.3 million (FY2024 H1: £10.2 million) mainly as a result of streamlined marketing and promotional activity. Administrative expenses reduced to £10.4 million (FY2024 H1: £11.6 million) as a result of continued successful cost control initiatives.

The Group made an operating profit pre-R&D, exceptional and fundraising costs of £1.9 million (FY2024 H1: £0.5 million operating loss pre-R&D and exceptional costs).

Research and development costs reduced to £7.6 million (FY2024 H1: £11.4 million) mainly due to the prior period including the peak activity of the Group's pivotal G306 Phase III trial of Grass MATA MPL which successfully met its primary endpoint during H1 of FY2024.

There were no exceptional costs in this or the prior period, however there was a total fundraising charge of £2.9 million (FY2024 H1: £nil), this includes £0.4 million of transaction costs associated with the warrants issued to Hayfin Healthcare Opportunities ("Hayfin"), a £2.9 million accounting loss due to the revaluation of the Hayfin warrants to fair value at the reporting date, partially offset by a £0.4 million accounting gain on modification of the Loan Facility provided by SkyGem Acquisition Limited and Southern Fox Investments Limited (together the "Shareholder Lenders").

The operating loss was £8.6 million (FY2024 H1: £11.9 million), and the loss before tax was £11.4 million (FY2024 H1: £14.9 million). The finance expense for the period was £3.0 million (FY2024 H1: £3.2 million) mainly comprising interest expenses on the shareholder loan and Hayfin facility. Tax was a credit of £0.3 million (FY2024 H1: £0.7 million tax charge) relating to movements in the Group's liability for uncertain tax positions and tax payable by the overseas subsidiaries.

At 31 December 2024, the Group had cash of £21.7 million (30 June 2024: £12.9 million) and debt of £37.5 million (30 June 2024: £23.1 million). The operating cash outflow was £7.7 million (FY2024 H1: £10.8 million) an improvement of 29% reflecting the improving operational performance. The investing outflow was £1.4 million (FY2024 H1: £1.8 million), offset by an inflow of £17.8 million (FY2024 H1: £11.2 million) from the net proceeds of financing activities.

On 15 October 2024 the Group strengthened its cash position (and increased its debt) with a new £40m facility from Hayfin. As previously announced the Hayfin Facility comprises a £20 million committed five-year term loan and £20 million uncommitted incremental facility. As part of these financing arrangements, the Company has also issued to Hayfin 131,603,616 warrants to subscribe for new ordinary shares, representing approximately 2.7% of the issued share capital of the Company, with a nominal exercise price of 0.1 pence per warrant and exercisable for a period of ten years from the date of issue. The Hayfin £20 million loan is subject to an upfront arrangement fee and has a variable interest rate based on SONIA plus 9.5% per annum with interest payable based on Company selected interest periods.

Also on 15 October 2024, the Group secured additional support from its Shareholder Lenders, through an amendment to the Loan Facility. The total facility was increased from £40 million to £50 million and its term extended to October 2030. The Shareholder Facility has been amended ("the Amended Shareholder Facility") to be unsecured and rank behind the Hayfin Facility. In addition, interest under the Amended Shareholder Facility will no longer be paid and instead interest will be rolled up into capital.

As at 31 December 2024 there was an undrawn but uncommitted balance of £27.5 million remaining on the Amended Shareholder Facility. With the £20 million uncommitted Hayfin funding, the Group has access to a total £47.5 million of uncommitted facilities to continue to drive the business forward. The Group expects that additional funding will be required during Q4 FY2025 onwards for trading, working capital, capital expenditure and continuing R&D programmes.

The Directors have applied the going concern principle in preparing the interim results for the six months ended 31 December 2024.

Clinical Update

Grass MATA MPL Programme

Grass MATA MPL, the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate for allergic rhinoconjunctivitis due to grass pollen, achieved a key milestone in its clinical development with the submission of its Marketing Authorisation Application to the Paul Ehrlich Institut in Germany in November 2024.

This submission follows the successful completion of the pivotal Phase III G306 trial in adults, which demonstrated a highly statistically significant reduction in Combined Symptom & Medication Score of -20.3% (p≤0.0002) compared to placebo over the peak pollen season.

Building on this, in November 2024, the Group initiated G308, an industry-first long-term subcutaneous allergen-specific immunotherapy Phase III trial in paediatric subjects with grass induced allergic rhinitis.

VLP Peanut Programme

The clinical development of VLP Peanut, the Group's innovative short-course peanut allergy vaccine candidate administered via subcutaneous injection, continues to progress through the Phase I/IIa PROTECT trial. This trial is evaluating maximum safe and tolerated doses while assessing biomarker efficacy in peanut allergic patients.

Interim analysis of the first two cohorts of peanut allergic patients has shown promising results. Treatment with VLP Peanut resulted in a meaningful dose-dependent reduction in skin sensitivity to peanut allergen, with up to 48% reduction in wheal size after skin-prick test compared to an 8% reduction in placebo-treated patients. Further, a comparison of the biomarker profile between treatment and placebo points to VLP Peanut driving a reduction in allergic response to the major peanut allergen, Ara h2.

These findings are supported by pre-clinical research published in the Journal of Allergy and Clinical Immunology in collaboration with Imperial College London, which demonstrated beneficial tolerogenic properties and reduced allergenicity in cells from peanut-allergic individuals.

The hypo-allergic safety profile observed to date supports the potential of the product as a transformative treatment option for peanut allergy sufferers.

Outlook

In the second half of the financial year, we expect further sales growth when compared to H2 2024 and we expect overall sales for the full year to show growth over the corresponding period ended 30 June 2024. The Group is continuing with cost control initiatives but is undertaking selective investments such as launch readiness for its new Grass MATA MPL product should MAA approval be received during FY2026.

The Group plans to meet with the US Food and Drug Administration in the coming months to present new data and discuss US specific registration requirements, including the design of US specific studies which is a standard requirement to expand the number of subjects treated with the new products.

The Group expects that additional funding will be required during Q4 FY2025 onwards and discussions are underway regarding the utilisation of the uncommitted facilities referenced in the Financial Review.

*Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year-on-year comparison excluding the effects of foreign exchange movements.

This announcement contains inside information for the purposes of the UK Market Abuse Regulations.

-  ENDS -

For further information, please contact:

Allergy Therapeutics

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

+44 (0)1903 845 820

Cavendish Capital Markets Limited (Nominated Adviser and Broker)

Geoff Nash/Giles Balleny/Seamus Fricker/Rory Sale

Nigel Birks Sales

+44 (0)20 7220 0500

ICR Healthcare

Mary-Jane Elliott/David Daley/Davide Salvi

+44 (0)20 3709 5700

[email protected]

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company, headquartered in the UK, focussed on the treatment and diagnosis of allergic disorders, including aluminium free immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third-party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. Its broad pipeline of products in clinical development includes vaccines for grass, tree, house dust mite and peanut. For more information, please see www.allergytherapeutics.com.

1. Interim financial information

The unaudited consolidated interim financial information is for the six months ended 31 December 2024. The financial information does not include all the information required for full annual financial statements and should be read in conjunction with the consolidated financial statements of the Group for the year ended 30 June 2024, which were prepared under International Financial Reporting Standards (IFRS) in issue as adopted by the UK and with those parts of the Companies Act 2006 that are relevant to the Group preparing its accounts in accordance with UK-adopted IFRS.

The interim financial information has not been audited nor has it been reviewed under ISRE (UK) 2410 (Revised) of the Financial Reporting Council. The financial information set out in this interim report does not constitute statutory accounts as defined in Section 434 of the Companies Act 2006.

2. Basis of preparation

As permitted, this interim report has been prepared in accordance with the AIM rules and not in accordance with IAS 34 "Interim Financial Reporting". The accounting policies adopted in this report are consistent with those in the annual financial statements for the year to 30 June 2024. There are no accounting standards that have become effective in the current period that would have a material impact upon the financial statements.

Going Concern

The unaudited consolidated interim financial information has been prepared on a going concern basis after considering the Group's and the Company's current cash position and reviewing budgets and cash flow forecasts for a period of at least 12 months from the date of approval of these financial statements.

On 15 October 2024 the Group entered into a £40 million secured senior loan facility (the "Hayfin Facility") with Hayfin Healthcare Opportunities LuxCo S.a.r.l., a fund advised by Hayfin Capital Management LLP. The Hayfin Facility consists of a committed £20 million five-year term loan which has been fully drawn and an additional uncommitted £20 million incremental facility.

Furthermore, following discussions with the major shareholders, SkyGem Acquisition and Southern Fox (together the "Shareholder Lenders"), the existing loan facility of £40 million (the "Shareholder Facility"), details of which were announced on 27 December 2023, was increased to £50 million and its term extended to October 2030. To date, £22.5 million has been drawn (net of repayments) and is outstanding under the Shareholder Facility, leaving an undrawn but uncommitted balance of £27.5 million. The Shareholder Facility has been amended ("the Amended Shareholder Facility") to be unsecured and rank behind the Hayfin Facility. In addition, interest under the Shareholder Facility will no longer be paid and instead interest will be rolled up into capital.

The Group continues to require funding for the foreseeable future, in particular to fund the ongoing R&D programme. With the £20 million committed Hayfin funding and £47.5 million of uncommitted facilities, from both Hayfin and the Shareholder Lenders, the Group has access to sufficient funding.

The Directors have prepared cash flow forecasts for the period to 31 March 2026 based on the arrangements in place for funding with Hayfin and representations provided by the Shareholder Lenders over the Group's ability to access funding under the Amended Shareholder Facility. These forecasts show that the Group has access to sufficient funds for the 12 month going concern review period.

3. Loss per share

The diluted loss per share does not differ from the basic loss per share as the exercise of share options would have the effect of reducing the loss per share and is therefore not dilutive under the terms of IAS 33.

4. Events after the balance sheet date

There were no disclosable events after the balance sheet date.