REGISTERED NUMBER: 09520509 (England and Wales)

JENAVALVE PRODUCTION LIMITED

FINANCIAL STATEMENTS

FOR THE YEAR ENDED 31 DECEMBER 2024

Page

Company Information

1

Statement of Financial Position

2

Notes to the Financial Statements

3

to

6

DIRECTOR:

J T Kilcoyne

REGISTERED OFFICE:

Unit 9a Astley Way

Astley Lane Industrial Estate

Swillington

Leeds

LS26 8XT

REGISTERED NUMBER:

09520509 (England and Wales)

SENIOR STATUTORY AUDITOR:

Tara Bellamy FCA

AUDITORS:

Duncan & Toplis Audit Limited, Statutory Auditor

4 Henley Way

Doddington Road

Lincoln

Lincolnshire

LN6 3QR

FIXED ASSETS

Property, plant and equipment

4

229,435

166,977

CURRENT ASSETS

Inventories

1,310,152

2,097,152

Debtors

5

503,871

1,262,492

Cash at bank and in hand

461,191

126,730

2,275,214

3,486,374

CREDITORS

Amounts falling due within one year

6

538,566

387,699

NET CURRENT ASSETS

1,736,648

3,098,675

TOTAL ASSETS LESS CURRENT LIABILITIES

1,966,083

3,265,652

CAPITAL AND RESERVES

Called up share capital

8

100

100

Capital contribution reserve

9

21,321,398

20,821,398

Retained earnings

9

(19,355,415

)

(17,555,846

)

SHAREHOLDERS' FUNDS

1,966,083

3,265,652

The financial statements have been prepared and delivered in accordance with the provisions applicable to companies subject to the small companies regime.

In accordance with Section 444 of the Companies Act 2006, the Statement of Income and Retained Earnings has not been delivered.

The financial statements were approved by the director and authorised for issue on 11 September 2025 and were signed by:

J T Kilcoyne - Director

1.	STATUTORY INFORMATION

Jenavalve Production Limited is a private company, limited by shares , registered in England and Wales. The company's registered number and registered office address can be found on the Company Information page.

The presentation currency of the financial statements is the Pound Sterling (£).

2.	ACCOUNTING POLICIES

Basis of preparing the financial statements

These financial statements have been prepared in accordance with Financial Reporting Standard 102 "The Financial Reporting Standard applicable in the UK and Republic of Ireland" including the provisions of Section 1A "Small Entities" and the Companies Act 2006. The financial statements have been prepared under the historical cost convention.

Revenue

Revenue is measured at the fair value of the consideration received or receivable net of VAT and trade discounts. The policies adopted for the recognition of revenue are as follows:

Sale of goods

Revenue from the sale of 'The Trilogy System' is recognised when significant risks and rewards of ownership of the goods have transferred to the buyer, the amount of turnover can be measured reliably, it is probable that the economic benefits associated with the transaction will flow to the company and the costs incurred or to be incurred in respect of the transaction can be measured reliably. This is usually on dispatch of the goods.

Tangible fixed assets

Tangible fixed assets are measured at cost less accumulated depreciation. Depreciation is provided at the following annual rates in order to write off each asset over its estimated useful life.

Land and buildings - straight line over 5 years

Plant and machinery etc - straight line over 3 - 7 years

Inventories

Inventories are valued at the lower of cost and estimated selling price after making due allowance for obsolete and slow moving items. Costs include all cost attributed to the production of each product, including wages and overheads, on an absorption costing basis. Provisions are made for reject products and products still subject to final quality control approval at the year end with an estimated value based on average yield rates.

Taxation

Taxation for the year comprises current and deferred tax. Tax is recognised in the Statement of Income and Retained Earnings, except to the extent that it relates to items recognised in other comprehensive income or directly in equity.

Current or deferred taxation assets and liabilities are not discounted.

Current tax is recognised at the amount of tax payable using the tax rates and laws that have been enacted or substantively enacted by the statement of financial position date.

Deferred tax

Deferred tax is recognised in respect of all timing differences that have originated but not reversed at the statement of financial position date.

Timing differences arise from the inclusion of income and expenses in tax assessments in periods different from those in which they are recognised in financial statements. Deferred tax is measured using tax rates and laws that have been enacted or substantively enacted by the year end and that are expected to apply to the reversal of the timing difference.

Unrelieved tax losses and other deferred tax assets are recognised only to the extent that it is probable that they will be recovered against the reversal of deferred tax liabilities or other future taxable profits.

Foreign currencies

Assets and liabilities in foreign currencies are translated into sterling at the rates of exchange ruling at the statement of financial position date. Transactions in foreign currencies are translated into sterling at the rate of exchange ruling at the date of transaction. Exchange differences are taken into account in arriving at the operating result.

Pension costs and other post-retirement benefits

The company operates a defined contribution pension scheme. Contributions payable to the company's pension scheme are charged to the income statement in the period to which they relate.

Going concern

The Company, JenaValve Production Limited, continues to develop its product in support of the clinical trials and premarket approval application of the ALIGN-AR Trilogy system with the United States Food and Drug Administration. In May 2021, the parent company, JenaValve Technology Inc, obtained Conformite European, (CE Mark) for products manufactured by the Company, who subsequently commenced the intercompany supply of products made available for full commercial operations in selected European countries, including Germany, Austria, and Italy. Consequently, revenue is now being generated by the Company. Despite this development, the Company remains reliant upon the financial support of its parent company, JenaValve Technology Inc.

The financial statements have been prepared on the going concern basis which assumes that JenaValve Technology Inc., and its investors will support the Company for the foreseeable future in order to ensure that the Company can meet its obligations as they fall due. The parent company continues to primarily fund its operations through the sale of debt and equity securities and in March 2024 secured funding to provide sufficient capital to facilitate its continued operation, and that of its subsidiary holdings, over the 2024 financial year and beyond. Additionally, in July 2024, Edwards Lifesciences entered into an agreement and plan of merger to acquire JenaValve Technology, Inc. Concurrently, the parties entered into a promissory note agreement to loan JenaValve up to $75.0 million should the merger not close within 90 days, amongst certain other conditions. Through July 2025, Edwards has advanced $60 million under the note agreement. The parent company's consolidated financial statements do not include any adjustments related to recoverability and classification of assets, or the amounts and classification of liabilities, or any other adjustments that might be necessary should the parent company be able to continue as a going concern. As such, the directors are satisfied that the Company remains a going concern.

3.	EMPLOYEES AND DIRECTORS

The average number of employees during the year was 64 (2023 - 62 ) .

4.	PROPERTY, PLANT AND EQUIPMENT

Plant and

Land and

machinery

buildings

etc

Totals

£

£

£

COST

At 1 January 2024

405,979

472,694

878,673

Additions

32,795

104,774

137,569

At 31 December 2024

438,774

577,468

1,016,242

DEPRECIATION

At 1 January 2024

371,300

340,396

711,696

Charge for year

23,841

51,270

75,111

At 31 December 2024

395,141

391,666

786,807

NET BOOK VALUE

At 31 December 2024

43,633

185,802

229,435

At 31 December 2023

34,679

132,298

166,977

5.

DEBTORS

2024

2023

£

£

Amounts falling due within one year:

Trade debtors

321,120

50,640

Amounts owed by group undertakings

4,400

992,000

Other debtors

88,351

129,852

413,871

1,172,492

Amounts falling due after more than one year:

Other debtors

90,000

90,000

Aggregate amounts

503,871

1,262,492

Amounts owed from group undertakings are unsecured, interest free and repayable on demand.

6.

CREDITORS: AMOUNTS FALLING DUE WITHIN ONE YEAR

2024

2023

£

£

Trade creditors

219,105

119,248

Amounts owed to group undertakings

52,481

14,950

Taxation and social security

63,001

53,591

Other creditors

203,979

199,910

538,566

387,699

Amounts owed to group undertakings are unsecured, interest free and repayable on demand.

7.	LEASING AGREEMENTS

Total financial commitments, guarantees and contingencies which are not included in the statement of financial position amount to £100,091 (2023: £182,231).

8.	CALLED UP SHARE CAPITAL

Allotted, issued and fully paid:

Number:

Class:

Nominal

2024

2023

value:

£

£

100

Ordinary A

£1

100

100

9.

RESERVES

Capital

Retained

contribution

earnings

reserve

Totals

£

£

£

At 1 January 2024

(17,555,846

)

20,821,398

3,265,552

Deficit for the year

(1,799,569

)

-

(1,799,569

)

Contribution in the year

-

500,000

500,000

At 31 December 2024

(19,355,415

)

21,321,398

1,965,983

The capital contribution reserve relates to funding received from the parent entity which is not classified as a loan nor has it been received in exchange for share capital.

Retained earnings represents cumulative profit and losses.

10.	DISCLOSURE UNDER SECTION 444(5B) OF THE COMPANIES ACT 2006

The Report of the Auditors was unqualified.

Tara Bellamy FCA (Senior Statutory Auditor)

for and on behalf of Duncan & Toplis Audit Limited, Statutory Auditor

11.	CONTINGENT LIABILITIES

The company has a short leasehold for their business premises. Upon termination of the lease the company is required to return the building to its original condition, including internal layout and repainting of all walls. The cost of this cannot be reliably estimated but is not expected to exceed the £90,000 which has previously been paid as a deposit.

12.	PENSION COMMITMENTS

Assets of the company's pension scheme are held separately in an independently administered fund. At the financial reporting date the company had pension commitments of £18,328 (2023: £15,165)

13.	RELATED PARTY DISCLOSURES

The following balances and transactions relate to JenaValve Production Limited and other companies within the group.

Related Party

Related Person

During the year 2024

During the year 2023

Sales

Purchases

Sales

Purchases

JenaValve Technology Inc. (USA)

Parent Company

1,724,400

84,510

2,247,300

31,000

JenaValve Technology GmbH (Germany)

Fellow Subsidiary Company

2,068,560

269,428

1,540,125

143,699

Related Party

Related Person

Year end 2024

Year end 2023

Debtors

Creditors

Debtors

Creditors

JenaValve Technology Inc. (USA)

Parent Company

4,400

52,481

864,000

-

JenaValve Technology GmbH (Germany)

Fellow Subsidiary Company

-

-

128,000

14,950

14.	ULTIMATE PARENT COMPANY