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Poxel Interim / Quarterly Report 2019

Sep 24, 2019

1606_ir_2019-09-24_01d0247b-18db-4c77-8c63-e5542d2ff33c.pdf

Interim / Quarterly Report

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Société anonyme (limited liability company) with capital of €518,295.54 Registered office: 259/261 Avenue Jean Jaurès – Immeuble le Sunway – 69007 Lyon, France 510 970 817 Lyon Trade & Companies Register

INTERIM FINANCIAL REPORT

AT 30 JUNE 2019

CONTENTS

1. Certification by the person responsible for the interim financial report 3
2. Activity report at 30 June 2019 4
3. Condensed interim financial statements under IFRS at 30 June 2019 7
4. Limited report of the Statutory Auditors on the 2019 interim information 36

1. CERTIFICATION BY THE PERSON RESPONSIBLE FOR THE INTERIM FINANCIAL REPORT

1.1. Person responsible for the interim financial report

  1. Thomas Kuhn, Chief Executive Officer of Poxel.

1.2 Certification by the person responsible

(Article 222-3 – 4° of the AMF General Regulations)

"I certify, to the best of my knowledge, that the condensed financial statements for the previous halfyear have been prepared in accordance with the applicable accounting standards, and give a true and fair view of the assets, financial position and earnings of the Company, and that the appended interim activity report gives a fair view of significant events occurring during the first half-year, their impact on the interim financial statements, the main transactions between related parties and a description of the main risks and uncertainties for the remaining half-year".

Lyon, 26 August 2019

Thomas Kuhn, Chief Executive Officer of Poxel.

2. ACTIVITY REPORT AT 30 JUNE 2019

2.1. Highlights of the first half-year of 2019

Creation of a subsidiary in the United States

In January 2019, the Company created a subsidiary in the United States ("POXEL Inc"), domiciled in Burlington, Massachusetts. This subsidiary is wholly owned by Poxel SA. It has total capital of 1 dollar.

Capital increases

The Board of Directors' meeting of 24 January 2019 definitively awarded 24,150 shares to the Group's employees. This amount corresponds to the fully vested shares under the performance linked to the first tranche of 126,500 bonus performance shares awarded to employees at the Board of Directors' meeting of 25 January 2018.

In addition, on 21 March 2019, one employee exercised 1,690 BSPCE warrants, granting entitlement to subscribe to 33,800 ordinary shares at a price of €2.50, representing a capital increase of €676 alongside an issue premium of €83,824.

Lastly, the Board of Directors' meeting of 20 June 2019 decided on the issuance of 3,600 free shares for employees, subject to the same conditions as those awarded on 24 January 2019 and the issuance of 225,000 stock options for employees, with a strike price of €7.04.

The share capital thus stands at €518,295.54 at 30 June 2019, divided into 25,914,777 shares, each with a par value of €0.02.

2.2. Activity and results of the Group

Partnership activity

Sumitomo

The Company continued the Phase 3 TIMES programme for Imeglimin in Japan. The external costs incurred by the Company as part of this programme were re-invoiced to Sumitomo and recognised as net sales, according to the progress of the TIMES programme.

Roivant Sciences

The agreement signed with Roivant Sciences continued in the first half of 2019. The Company participated in the financing of this programme according to the conditions stated in the contract.

Details of the accounting principles used to recognise these two agreements are given under Note 18 in Chapter 3 of this report.

Research and development activity

The Company made significant progress in the Imeglimin phase III TIMES programme for the treatment of type 2 diabetes in Japan in the first half of 2019. The Company announced positive phase III results for the 24-week TIMES 1 and 16-week TIMES 3 portion of the trial. Phase III data for the 52-week TIMES

2 and 36-week open-label portion of the TIMES 3 trial are expected to be reported in the fourth quarter of 2019.

The Company also made progress in the clinical development of its two drug candidates for the treatment of NASH. A Phase IIa trial for PXL770 was initiated in the first half of 2019. The results are expected in the first half of 2020. The Company also announced positive results of a Phase Ia study for PXL065, which evaluated the administration of incremental single doses. The Company is preparing for a Phase Ib study for PXL065, which will evaluate the administration of incremental multiple doses, and is expected to be initiated in the third quarter of 2019.

Human resources

Over the half-year, the Group continued to strengthen its clinical and administrative teams, to support its development. The average consolidated workforce in the first half of 2019 is 44 employees, compared to 34 employees in the first half of 2018.

Results

The Group reported turnover of €23,169,000 at 30 June 2019 compared with €37,463,000 at 30 June 2018.

R&D costs amounted to €25,742,000 for the first half of 2019, compared with €28,920,000 at 30 June 2018. These costs mainly reflect the Imeglimin TIMES programme for which expenses of €16.6 million were exposed during the half-year.

The research tax credit calculated for the first half of 2019 stands at €1,578,000, compared with €1,478,000 at 30 June 2018.

General overheads were €4,868,000 for the first half of 2019, compared with €3,614,000 at 30 June 2018. This increase reflects the continued efforts to increase the Company's workforce and the associated resources.

The Group had an operating expense of -€5,864,000, compared with an operating income of €6,406,000 at 30 June 2018.

Financial income stood at €71,000 compared with €850,000 at 30 June 2018. It consists primarily of income from investments and currency gains.

Net expense stood at -€5,792,000, compared with a net income of €7,256,000 at 30 June 2018.

Cash

Cash at 30 June 2019 was €49,761,000, compared with €66,737,000 at 31 December 2018. The change in cash is due to:

  • operating cash flows of -€11,690,000;
  • investment flows of +€282,000;
  • funding flows of -€5,568,000;

2.3. Trends and prospects

The financial resources available to the Company at 30 June 2019 means it can continue the development of studies and clinical trials for the Imeglimin, PXL770 and PXL065 programmes.

During the second half-year, the Company intends to:

  • continue to advance the phase III TIMES programme for Imeglimin in Japan; complete phase III results should be reported in the fourth quarter of 2019,
  • continue to advance the phase 2a study for PXL770 with results expected in the first half of 2020. Initiate a PK/PD study in the third quarter of 2019 for this drug candidate with results expected in the fourth quarter of 2019,
  • initiate a phase 1b study for PXL065 in the third quarter of 2019 with results expected in the fourth quarter of 2019,
  • continue the development of its portfolio of drug candidates. In addition, the Company may source new opportunities externally through continued business development efforts.

2.4. Events occurring after the end of the half-year

The Company announced in July 2019 the positive results of a study performed by Metavant, conducted with type 2 diabetic patients presenting stages 3b/4 chronic kidney failure. These results demonstrated that Imeglimin had a favourable tolerance and safety profile and that the pharmacokinetic and pharmacodynamic data were consistent with previous Poxel data.

2.5. Risk factors and transactions between related parties

2.5.1 Risk factors

The risks for the Company are set out in Chapter 4, "Risk factors" of the Company's 2018 Registration Document. No significant change in the assessment of these risks has been identified by the Company.

2.5.2 Transactions between related parties

Transactions between related parties are the same type as those presented in Chapter 19, "Related party transactions" of the 2018 Registration Document. No significant transactions were entered into with a director or member of the Board of Directors during the first half of 2019.

3. CONDENSED INTERIM FINANCIAL STATEMENTS UNDER IFRS AT 30 JUNE 2019

3.1. Statement of financial position

30/06/2019 31/12/2018
POXEL Notes
Statement of financial situation €K €K
ASSETS
Intangible assets 6 16,578 16,577
Tangible assets 7 1,903 296
Other non-current financial assets 8 207 372
Deferred tax assets 22
Total non-current assets 18,689 17,246
Trade payables and other accounts 9 12,916 14,262
Other receivables 9 9,721 7,271
Tax asset due 22
Cash and cash equivalents 10 49,761 66,737
Total current assets 72,398 88,270
Total assets 91,087 105,516
LIABILITIES
Equity
Capital 12 518 517
Issue and contribution premiums 12 128,080 127,996
Translation adjustment reserve 12 -6 -5
Reserves -71,975 -86,251
Results -5,792 13,525
Total equity 50,825 55,782
Non-current liabilities
Commitments to staff 15 345 279
Non-current financial debts 14 1,549 359
Non-current liabilities 1,894 638
Current liabilities
Current financial debts 14 8,807 13,873
Provisions 16 18
Trade payables and other accounts 17.1 21,975 20,742
Tax and social security debts 17.2 1,090 1,129
Liabilities on contract 17.3 6,497 13,334
Current liabilities 38,368 49,096
Total liabilities 91,087 105,516

3.2. Income statement

POXEL
Statement of comprehensive income
Notes 30/06/2019
€K
30/06/2018
€K
Turnover 18 23,169 37,463
Research and development expenses
Research and development expenses 19.1 -25,742 -28,920
Subsidies 19.1 1,578 1,478
General and administrative expenses 19.2 -4,868 -3,614
Operating income -5,864 6,406
Financial expenses 21 -26 -15
Financial income 21 116 223
Foreign exchange gains and losses 21 -19 641
Pre-tax income -5,792 7,256
Income expense 22
Net income -5,792 7,256
Earnings per share Notes 30/06/2019 30/06/2018
Weighted average number of shares in circulation 25,896,723 24,087,916
Earnings per share (€/share) 23 (0.22) 0.30
Diluted earnings per share (€/share) 23 (0.22) 0.28

3.3. Statement of comprehensive income

POXEL - IFRS
Statement of comprehensive income
Notes 30/06/2019 30/06/2018
€K €K
Income(loss) for the year -5,792 7,256
Actuarial gains and losses (non-recyclable) 15 -31 -15
Consolidation translation adjustments (recyclable) -1 5
Tax effects linked to these elements
Other comprehensive income (net of tax) -31 -10
Comprehensive income -5,824 7,246

3.4. Changes in equity

Capital
Number
of shares
Capital Premiums
linked to capital
Reserves
and
income(loss)
Other
comprehensive
income
Equity
POXEL
Changes in equity
€K €K €K €K
At 31 December 2017 23,127,428 463 106,951 -88,021 -65 19,327
Net income 30 June 2018 7,256 7,256
Other comprehensive income -10 -10
Comprehensive income 7,256 -10 7,246
Share issue (1) 1,439,399 29 12,158 12,187
Subscription of BSA share subscription warrants 41 41
Share-based payments 956 956
Treasury shares 19 19
Capital increase costs -15 -15
At 30 June 2018 24,566,827 491 119,135 -79,790 39,761
At 31 December 2018 25,856,827 517 127,996 -72,667 -65 55,782
Net income 30 June 2019 -5,792 -5,792
Other comprehensive income -31 -31
Comprehensive income -5,792 -31 -5,824
Share issue (1) 24,150
Subscription of BSA share subscription warrants 33,800 1 84 85
Share-based payments 741 741
Treasury shares 41 41
At 30 June 2019 25,914,777 518 128,080 -77,677 -96 50,825

(1) In 2019, the capital increase corresponds to the definitive award of 24,150 bonus shares and the exercise of BSPCE founder warrants leading to the creation of 33,800 shares at the price of €2.5 per share (see notes 12 and 13). In 2018, the capital increase corresponds to:

  • the equity investment by Roivant, with the creation of 1,431,399 shares at a price of €8.50,

  • the exercise of 400 BSPCE founder warrants (giving entitlement to 8,000 shares, at the price of €2.5 per share) by employees.

3.5. Cash flow statement

POXEL - IFRS Notes 30/06/2019 30/06/2018
Cash flow statement €K €K
Cash flows generated by operational activities
Net income -5,792 7,256
(-) Elimination of amortisation of intangible assets 6 -1 -1
(-) Elimination of depreciation of tangible assets 7 -196 -23
(-) Provisions
(-) Reversals of provisions
15-16
16
-35
18
-27
(-) Expense related to share-based payments 13 -741 -956
(+) Interest expenses
(-) Interest income 116 223
(-) Subsidy transferred to profit/loss 14.2 -11 -15
Self-financing capacity before net cost of financial debt and tax -4,942 8,056
(-) Change in working capital requirement 6,748 -20,732
Cash flows generated by operating activities -11,690 28,788
Cash flows generated by investment
Acquisition of intangible assets 6 -3 -5
Acquisition of tangible assets 7 -51 -169
(+) Interests received 130 229
Other investment flows 8 206 -2
Cash flows related to investment activities 282 53
Cash flows linked to financing activities
Capital increase + issue premium net of fees (1) 12 85 12,172
Subscription of BSA share subscription warrants 12 41
(-) Paid interests -4
Debt on Roivant contract 14.4 -5,408
Repayments of loans and conditional advances 14.1/14.2 -98 -85
Repayment of rental debts
Cash flows linked to financing activities
14.3 -143
-5,568
12,128
Impact of currency price fluctuations
Increase (Decrease of cash) -16,976 40,969
Cash and cash equivalents at beginning of year (including current bank borrowings) 66,737 53,412
Cash and cash equivalents at year end (including current bank
borrowings)
49,761 94,381
Increase (Decrease of cash) -16,976 40,969

(1) In 2019, the capital increase and issue premium net of fees corresponds to the exercise of 1,690 BSPCE founder warrants by employees (+€85,000).

In 2018, this same heading corresponds to the capital increase subscribed by Roivant Sciences (€12,166,892) after deduction of charges incurred in preparing this transaction (€14,678), as well as the exercise of 400 BSPCE warrants by employees (€19,840).

3.6. Detailed analysis of changes in WCR (working capital requirement)

Breakdown of the change in WCR 30/06/2019 30/06/2018
Trade receivables and other accounts (net of depreciations of trade receivables) -1,346 3,379
Other receivables 2,450 2,143
Trade payables and related accounts -1,233 -16,177
Tax and social security payables 39 159
Liabilities on contract 6,838 -10,236
Total changes 6,748 -20,732

3.7. Notes to the interim financial statements

Note 1: Presentation of activity and significant events

The attached consolidated financial statements at 30 June 2019 and the related notes, or financial statements, present the Group's activities. Each of these fiscal years cover a period of six months from 1 January to 30 June.

1.1 Information about the Company and its activity

Created in 2009 following a spin-off from Merck Serono, POXEL is a limited company incorporated under French law, with registered office located 259 Avenue Jean Jaurès, 69007 LYON, registered in the Trade and Companies Register of Lyon under number 510 970 817 RCS, hereafter referred to as the "Company" or "the Group" if its subsidiaries are included) develops innovative molecules for the treatment of metabolic diseases, such as type 2 diabetes and non-alcoholic steatohepatitis (NASH).

Apart from the year of its creation and during the fiscal year ended 31 December 2018, the Company has reported operating losses each year. These losses are the result of internal and external research and development expenses, specifically related to the undertaking of numerous pre-clinical and clinical trials, primarily in connection with the development of Imeglimin. In October 2017, the Company signed an initial strategic partnership agreement with Sumitomo Dainippon Pharma for the development and marketing of Imeglimin, a drug candidate for the treatment of Type 2 diabetes, in Japan, China and eleven other countries in Asia. A second strategic partnership was signed in February 2018 with Roivant Sciences for the development and marketing of Imeglimin in the United States, Europe and other countries not covered by the agreement with Sumitomo Dainippon Pharma. On 30 August 2018 the Company signed a strategic agreement with DeuteRx for the acquisition of PXL065, a drug candidate in clinical development for the treatment of NASH, as well as other programmes for the treatment of metabolic, specialty and rare diseases.

The Company's future development depends on a combination of several factors, which include (i) the success of its research and development operations, (ii) the continuation of the partnership agreements entered into by the Company, (iii) obtaining the statutory authorisations and acceptance by the market of future products to be offered by the Company, (iv) obtaining the necessary financing and (v) the development of competing products by other companies. Consequently, the Company may, in the short/medium term, fund its operations through new partnerships for the development and marketing of its drug candidates and the issue of new equity instruments.

1.2 Cut-off date

The financial statements were prepared under the responsibility of the Company's Management and were adopted and authorised for publication by the Board of Directors' meeting of 26 August 2019.

Note 2: Principles for preparing the accounts and statement of compliance

The unaudited interim condensed consolidated financial statements as at 30 June 2019 and for the six months ended 30 June 2018 and 2019 as well as the attached notes (the "unaudited interim condensed consolidated financial statements") were drawn up under the responsibility of the Company's Management in accordance with the predicate assumptions of going concern, with the Company's loss-making situation explained by the innovative nature of the developed products, involving a research and development phase over several years.

The unaudited interim condensed consolidated financial statements were prepared in accordance with IAS 34, interim financial information, published by the International Accounting Standards Board ("IASB").

The general accounting standards were applied in accordance with the underlying assumptions, namely (i) going concern principle, (ii) comparability principle implying the consistency of accounting methods from one fiscal year to another (iii) time period and matching principles and in accordance with the general rules governing the preparation and presentation of consolidated financial statements in accordance with the International Financial Reporting Standards ("IFRS"). The unaudited interim condensed consolidated financial statements do not include all the required disclosures for the annual financial statements and must therefore be read together with the consolidated financial statements for the financial year ended 31 December 2018.

The results of transactions for the six-month period ended 30 June 2019 are not necessarily indicative of the results expected for the financial year ended 31 December 2019 or for any other interim period or any future year.

With the exception of the number of shares and amounts per share, all amounts are expressed in thousands of euros, unless otherwise indicated. Some amounts may be rounded up for the calculation of the financial information contained in the unaudited interim condensed consolidated financial statements. Consequently, the totals found in some tables may not correspond to the exact amount of the previous figures.

Accounting methods

The condensed consolidated financial statements were prepared by applying the same methods and accounting methods as those applied by the Group at 31 December 2018, with the exception of the adoption of the following specific accounting principles, applicable at 1 January 2019:

  • IFRS 16 Leases
  • IFRIC 23 Uncertainty over Income Tax Treatments,
  • Amendments to IAS 28 Long-term interests in Associates and Joint Ventures,
  • Amendments to IAS 19 Employee benefits,
  • Annual improvements to the cycle of IFRS 2015-2017 standards,
  • Amendments to IFRS 9 Financial Instruments.

The changes had no impact on the interim condensed consolidated financial statements, with the exception of IFRS 16.

IFRS 16 was published in January 2016. It replaces IAS 17, Leases, IFRIC 4 "Determining whether an agreement contains a lease", SIC-15 "Operating leases-incentives" and SIC-27 "Evaluating the substance of transactions in the legal form of a lease". IFRS 16 states the principles for recognising, evaluating, and presenting information applicable to leases and requires lessors to recognise all leases according to a unique model on the balance sheet similar to the recognition of finance leases according to IAS 17. The standard includes two recognition exemptions for tenants (leases for "low value" assets and short-term leases, under 12 months). At the date of entry into force of a lease, the lessor records a liability for lease payments (in other words the rental liability) and an asset representing the right to use the underlying assets during the term of the lease (in other words the asset with a right of use). Lessors are required to record interests payable as a lease liability on a separate line and amortisation expense as an asset linked to the right of use. Changes to the presentation of operating lease expenses lead to a corresponding increase in cash flows from operating activities and a decrease in cash flows from financing activates.

According to the new standard, the Group has determined the term of the lease, including the option of extension or termination agreed by the lessor. These options were assessed at the start of a lease and required judgement from Management. The evaluation of the liability pursuant to the rental at the current value of rental payments is still required by using an appropriate discount rate in accordance with IFRS 16. The discount rate corresponds to the interest rate implied in the lease or, if it can be determined, the additional borrowing rate on the date of the start of the lease. The additional borrowing rate can significantly impact the net current value of the asset linked to the right to use and the liability under the recognised leases, a situation that requires judgement.

Tenants re-evaluate the liability of the lease at the occurrence of certain events (for example, change of lease term, change of future lease payments resulting from a change of index or of the rate used to determine such payments). The lessor generally recognises the amount of the revaluation of the lease liability as adjustment of the asset linked to the right of use.

Transition to IFRS 16

The Group has decided to adopt IFRS 16 by applying the simplified retrospective method to contracts previously recognised as leases. Consequently, leases are no longer recognised in the balance sheet as at 1 January 2019 and the comparative information is no longer restated.

These liabilities are evaluated at the current value of the remaining rental payments, discounted by using the lessor's marginal borrowing rate at 1 January 2019. The asset linked to right of use is measured at an amount equal to the rental liability, adjusted for the amount of any advance payments or accrued in relation to this lease recorded in the statement of financial position immediately before the date of first application.

In accordance with IFRS 16, the company applies the following principles:

  • Application of a single discount rate to assets with similar characteristics; and
  • Use of the exemption proposed by the standard on leases for which the terms of the lease expire within 12 months from the transition date.

The Company excludes the initial direct costs of the asset evaluation linked to the right of use on the date of the initial request.

This standard requires lessors to recognise, for all eligible lease agreements, all remaining lease payments in the form of:

  • On the asset side, a right of use, as a tangible asset;

  • On the liability side, as a debt linked to leases, recognised as a financial liability.

The application of this standard as of 1 January 2019 led to an increase in the Company's financial liability of €1,709,000 and an increase in property, plant and equipment of €1,709,000 (see note 6). The weighted average marginal borrowing rate applied by the Company to the liabilities linked to leases, recognised in the consolidated financial statements at 1 January 2019 was 2.5%.

The reconciliation between liabilities under leases recognised at 1 January 2019 and the commitments under non-cancellable leases disclosed at 31 December 2018 is broken down as follows:

Amounts in €K
Off-balance sheet commitments relating to leases at 31 December
2018
1,042
Exemption - 14
Difference of term * 859
Discount - 162
Other - 16
Debt under leases at 1 January 2019 1,709

* For off-balance sheet commitments at 31 December 2018, the commitment relating to commercial leases were retained for the period going from the last renewal date while in the context of IFRS 16, the retained period extends until the end of the nine-year period. The table below presents the interim consolidated income statements as if IAS 17 were still applied, with respect to the same statement after the application of IFRS 16.

Amounts in €K As reported Impact of IFRS 16 Without IFRS 16
Turnover 23,169 23,169
Research and development expenses -25,742 -25,742
Subsidies 1,578 1,578
General and administrative expenses -4,868 2 -4,866
Operating income -5,864 2 -5,862
Financial expenses -26 15 -11
Financial income 116 116
Foreign exchange gains and losses -19 14 -5
Pre-tax income (loss) -5,792 31 -5,761
Income expense
Pre-tax income (loss) -5,792 31 -5,761

IFRS 16 has an impact on the consolidated statements of interim consolidated cash flows for the halfyear ended 30 June 2019.

At 30 June 2019
Amounts in €K As reported Impact of
IFRS 16
Without IFRS
16
Cash flows generated by operating activities -11,690 -143 -11,833
Cash flows generated by investment 282 282
Cash flows generated by funding activities -5,568 143 -5,425
Increase (Decrease of cash) -16,976 -16,976
Cash at beginning of year 66,737 66,737
Cash at year end 49,761 49,761
Increase (Decrease of cash) -16,976 -16,976

2.2 Use of judgements and estimates

When preparing the financial statements in accordance with IFRS, estimates, judgements and assumptions have been made by the Company's management; they were able to allocate the amounts reported in respect of assets and liabilities, contingent liabilities on the preparation date of the financial statements, and amounts reported in respect of income and expenses for the year.

These estimates are based on the going concern assumption, and on information available at the time they are made. They are continuously assessed on the basis of past experience, and various other factors considered reasonable, which form the basis of the assessments of the book value of assets and liabilities. Estimates may be reviewed if the circumstances on which they were based change, or in the light of new information. Actual results may differ materially from such estimates according to different assumptions or conditions.

When preparing these interim financial statements, the main judgements made by senior management, along with the main assumptions used, were identical to those applied when preparing the financial statements for the year ended 31 December 2018.

2.3 Change in accounting methods

The Group applies IFRS 16 "Leases" since 1 January 2019. With the exception of the new text identified above, the Company made no other change in accounting policies compared to the financial year ended 31 December 2018.

Note 3: Scope of consolidation

The consolidated financial statements include, by way of full consolidation, the financial statements of those subsidiaries over which the Group has exclusive control, whether directly or indirectly. The Group considers that it has exclusive control over an entity when it has the ability to steer the entity's operational and financial policies in order to obtain economic benefit.

After elimination of internal results and transactions, full consolidation allows account to be taken of all the assets, liabilities and income statement items of the Companies concerned, where the share of income and shareholders' equity accruing to Group companies (Group share) is separate from that relating to the interests of other shareholders (non-controlling interests). All material transactions between the consolidated companies and the internal income of the consolidated entity (including dividends) are eliminated.

Intra-group transactions and balances are also eliminated. The financial statements of the subsidiary are prepared over the same reference period as those of the parent company, on the basis of consistent accounting methods.

On the publication date of these financial statements, the Company wholly owned two subsidiaries which are fully consolidated;

Consolidation method % of control / interest
Company Country 31 December 2018 30 June 2019 31 December 2018 30 June 2019
POXEL S.A. France Consolidating company Consolidating company
POXEL
JAPAN
Japan FC FC 100% 100%
POXEL INC USA NA FC NA 100%

Note 4: Highlights

4.1: Highlights of the first half of 2019

Capital increases

On 24 January 2019, the Company recorded the definitive award of 24,150 bonus shares, representing a capital increase of €483 taken from the reserves.

On 21 March 2019, an employee exercised 1,690 BSPCE corresponding to 33,800 ordinary shares, at a strike price of €2.5, representing a capital increase of €676 together with a share premium of €83,824.

The share capital thus stands at €518,295.84 at 30 June 2019, divided into 25,914,777 shares, each with a par value of €0.02.

Creation of a subsidiary in the United States

On 2 January 2019, the Company created a subsidiary in the United States ("POXEL Inc"), domiciled in Burlington, Massachusetts. This subsidiary is wholly owned by Poxel SA. It has total capital of 1 dollar.

4.2: Post-balance-sheet date events

None.

Note 5: Sector-specific information

The Group operates in a single segment: the development of innovative molecules for the treatment of metabolic diseases, including Type 2 diabetes and non-alcoholic steatohepatitis (NASH).

Poxel SA owns a subsidiary in Japan since 2018 as well as a subsidiary in the United States since 2019, which had no significant activity to report at the balance sheet date. Most of the assets and operating

results presented are located in France. The Group's performance is now evaluated at consolidated level.

In 2019, 99% of the Group's revenues came from Sumitomo Dainippon Pharma.

In 2018, the Group's revenues came from two clients: 78% from Sumitomo Dainippon Pharma and 22% from Roivant Science GMBH.

Note 6: Intangible assets

GROSS VALUES OF INTANGIBLE ASSETS
(Amounts in €K)
Software Products
portfolio
Total
Statement of financial position at 31 December 2017 2 2
Capitalisation of development costs
Acquisition 5 5
Disposal
Transfer
Statement of financial position at 30 June 2018 7 7
Statement of financial position at 31 December 2018 9 16,572 16,580
Capitalisation of development costs
Acquisition 3 3
Disposal
Transfer
Statement of financial position at 30 June 2019 11 16,572 16,583
DEPRECIATION AND AMORTISATION
Statement of financial position at 31 December 2017 2 2
Increase 1 1
Decrease
Statement of financial position at 30 June 2018 3 3
Statement of financial position at 31 December 2018 4 4
Increase 1 1
Decrease
Statement of financial position at 30 June 2019 5 5
NET BOOK VALUES
At 31 December 2018 5 16,572 16,577
At 30 June 2019 6 16,572 16,578

Due to the risks and uncertainties related to the research and development process, the six intangible asset criteria are not deemed to have been met for any of the development projects in progress. Accordingly, all costs incurred by the Company are recognised as expenses.

Note 7: Tangible assets

GROSS VALUES OF TANGIBLE ASSETS
(Amounts in €K)
Premises Fixtures
&
Fittings
IT
equip
ment
Furnit
ure
and
other
Total Includin
g rights
of use
Statement of financial position at 31 December 2017 111 92 51 254
Acquisition 113 24 33 169
Disposal/scrapping
Transfer
Statement of financial position at 30 June 2018 224 115 84 423
Statement of financial position at 31 December 2018 239 125 103 467
First application of IFRS 16 1,698 3 8 1,709 1,709
Acquisition 43 13 10 28 94 43
Disposal/scrapping
Transfer
Statement of financial position at 30 June 2019 1,741 254 135 139 2,269 1,752
DEPRECIATION AND AMORTISATION
Statement of financial position at 31 December 2017 27 53 31 111
Increase 7 16 23
Decrease
Statement of financial position at 30 June 2018 34 70 31 134
Statement of financial position at 31 December 2018 47 81 43 170
Increase 159 14 22 1 196 159
Decrease
Statement of financial position at 30 June 2019 159 61 102 44 366 159
NET BOOK VALUES
At 31 December 2018 192 44 60 296
At 30 June 2019 1,581 193 33 96 1,903 1,592

There was no recognition of impairment losses pursuant to the IAS 36 standard.

Note 8: Other non-current financial assets

Non-current financial assets consist of the following:

OTHER NON-CURRENT FINANCIAL ASSETS
(Amounts in €K)
30/06/2019 31/12/2018
Liquidity contract cash portion 119 78
Deposits relating to operating leases 88 93
Other deposits 201
Total 207 372

Note 9: Trade and other receivables

Trade receivables (€12,916,000) are made up of €12,760,000 for the re-invoicing to Sumitomo Dainippon Pharma of research costs incurred as part of the Phase 3 programme for Imeglimin in Japan, which are adjusted on an ongoing basis as project costs are incurred.

The other receivables are broken down as follows:

OTHER RECEIVABLES
(Amounts in €K)
30/06/2019 31/12/2018
Research tax credit 5,117 3,539
Value added tax 546 937
Supplier liabilities 2,243 1,219
Pre-paid expenses 1,309 1,081
Other tax receivable 382 382
Receivable credit 77 81
Other 46 32
Total other receivables 9,721 7,271

All other current assets have a maturity of less than one year.

At 30 June 2019, the receivable was estimated on the basis of the research expenses incurred on that date and eligible for research tax credit.

Prepaid expenses relate to current expenses.

Note 10: Cash and cash equivalents

The cash and cash equivalents item is broken down as follows:

CASH AND CASH EQUIVALENTS
(Amounts in €K)
30/06/2019 31/12/2018
Bank accounts 19,949 7,292
Term deposits 29,812 59,445
Total cash and cash equivalents 49,761 66,737

Cash and cash equivalents net of financial debts (see note 14) amounted to €39,405,000 at 30 June 2019 and €52,506,000 at 31 December 2018

Note 11: Financial assets and liabilities and effects on income

The Company's assets and liabilities are valued as follows at 31 December 2018 and at 30 June 2019:

(Amounts in €K) 30/06/2019 Value - statement of financial position
under IFRS 9
Balance sheet items Value
Statement
of financial
position
Fair
value (3)
Fair value
through
profit or
loss
Loans and
receivables
(2)
Debts at
amortised
cost (1)
Non-current financial assets 207 207 207
Trade receivables and related accounts 12,916 12,916 12,916
Other receivables 9,721 9,721 9,721
Cash and cash equivalents 49,761 49,761 49,761
Total assets 72,605 72,605 49,761 22,844
Current financial debts 8,807 8,807 8,807
Non-current financial debts 1,549 1,549 1,549
Trade payables and related accounts 21,975 21,975 21,975
Total liabilities 32,330 32,330 32,330
(Amounts in €K) 31/12/2018 Value - statement of financial position
under IFRS 9
Balance sheet items Value
Statement
of financial
position
Fair
value (3)
Fair value
through
profit or
loss
Loans and
receivables
(2)
Debts at
amortised
cost (1)
Non-current financial assets 372 372 372
Trade receivables and related accounts 14,262 14,262 14,262
Other receivables 7,271 7,271 7,271
Cash and cash equivalents 66,737 66,737 66,737
Total assets 88,643 88,643 66,737 21,906
Current financial debts 13,873 13,873 13,873
Non-current financial debts 359 359 359
Trade payables and related accounts 20,742 20,742 20,742
Total liabilities 34,973 34,973 34,973

(1) The book value of debts at amortised cost was considered a reasonable estimate of fair value.

(2) The fair value of loans and receivables corresponds to the value shown in the balance sheet (value at the transaction date, subject to impairment test at each closing).

(3) The fair value of financial assets recognised at fair value through the income statement (such as the SICAV) is determined on the basis of the level 1 valuation of the fair value and corresponds to a market value.

Note 12: Capital

Capital issued

The capital stands at €518,295.54 divided into 25,914,777 ordinary shares, each fully paid-up and with a par value of €0.02 after recognition of capital transactions carried out in the first half of 2019.

In 2018, the different transactions that had an impact on the capital are presented in Note 4.1.

Table of changes in share capital

Date Nature of operations Number of shares constituting
the capital
Capital
movement in
€K
Issue
premium in
€K
At 31 December 2018 25,856,827 517 127,996
January 2019 Capital increase costs 24,150
March 2019 BSA/BSPCE subscriptions 33,800 1 84
At 30 June 2019 25,914,777 518 128,080

Distribution of dividends

The company did not distribute any dividends in the first half of 2019.

Note 13: Share subscription warrants, stock options and Founder warrants

Share subscription warrants ("BSA")

The table below summarises the data relating to plans for stock options issued, along with the assumptions used for their valuation under IFRS2:

Adopted assumptions - calculation of fair value under IFRS 2
Type Number
of issued
warrants
Number
of
expired
options
Number
of
exercised
options
Number of
options
outstanding
Maximum
number
of shares
to be
issued*
Underlying
fair value*
Fair
value of
the
warrant*
Maturity Strike
price
in*
Exercise
period
Volatility Risk
free
rate
Total valuation
IFRS2
(Black&Scholes)
inK
Directors' BSA 4,500 0 4,500 0 0 €3.33 €1.50 5 years €3.33 10 years 45% 3.5% 135
BSA 31/10/2012 2,500 0 0 2,500 50,000 €4.23 €2.04 5 years €4.00 10 years 52% 2.2% 72
BSA 31/10/2012 2,500 0 0 2,500 50,000 €8.00 €5.16 4.5 years €4.00 10 years 55% 1.8% 228
BSA 25-07-2014 42,500 0 0 42,500 42,500 €8.20 €5.16 6 years €4.00 10 years 57% 0.0% 219
BSA 16-06-2015 42,500 0 0 42,500 42,500 €13.57 €6.77 6 years €9.37 10 years 57% 0.0% 288
BSA 16-06-2015 240,000 0 0 240,000 240,000 €13.57 €6.46 6 years €9.62 10 years 57% 0.1% 1,551
BSA 29-01-2016 42,500 0 0 42,500 42,500 €9.07 €2.84 6 years €9.05 10 years 53% 0.2% 121
BSA 29-01-2016 42,500 0 0 42,500 42,500 €9.07 €2.84 6 years €9.05 10 years 53% 0.2% 121
BSA 29-01-2016 42,500 0 0 42,500 42,500 €12.23 €5.19 6 years €9.26 10 years 53% 0.0% 220
BSA 27-01-2017 62,500 0 0 62,500 62,500 €6.76 €2.66 5.5 years €7.17 10 years 53% 0.0% 166
BSA 30-06-2017 25,000 0 0 25,000 25,000 €6.61 €2.64 5.5 years €6.90 10 years 53% 0.0% 66
BSA 2018 90,000 0 0 90,000 90,000 # €6.74 €2.84 5.5 years €6.60 10 years 53% 0.1% 256
BSA 2019 120,000 0 0 120,000 120,000 # €5.16 €0.00 6 years €5.16 10 years 53% 0.0%
759,500 0 4,500 755,000 850,000

* After dividing the par value by 20

Those warrants issued prior to the division of the par value by 20, effective in March 2014, are convertible into 20 ordinary shares. Consequently, the fair value of the underlying asset, the fair value of the warrant and the exercise price were adjusted in order to take this into account.

The exercise price for grants made after the IPO is based on the average share price over the 20 days preceding the grant.

The exercise rights for each plan vest as follows:

  • The exercise rights for "Directors' Warrants" vest annually by one-third on each grant anniversary date.
  • The exercise rights for "BSA 31/10/2012" vest immediately on the date on which they are granted by the General Meeting of Shareholders.
  • The exercise rights for "BSA 25/07/2014" vest annually by one-third on each grant anniversary date.
  • Exercise rights for warrants issued in 2016 vest one year after the grant date.
  • In 2017:
    • o The exercise rights for the warrants issued in January 2017 vest by one third on the first anniversary date of the grant.
    • o The exercise rights for the warrants issued in June 2017 vest in full on the first anniversary date of the grant.
  • The exercise rights for the warrants issued in January 2018 and 2019 vest in full on the first anniversary date of the grant.

The exercise of the warrants issued is not subject to a performance condition. However, it is subject to a continued employment condition.

These plans are known as "equity settled". The Company has no commitment to redeem these instruments with employees should said employees leave, or should a particular event not occur.

Stock options

The table below summarises the data relating to plans for stock options issued, along with the assumptions used for their valuation under IFRS2:

Award date Type Number
of
issued
stock
options
Number
of
expired
options
Number
of
exercised
options
Number of
options
outstanding
Maximum
number
of shares
to be
issued
Underlying
fair value
Fair
value
of the
warrant
Maturity Strike
price
in €
Exercise
period
Volatility Risk
free
rate
Total valuation
IFRS2
(Black&Scholes)
in €K
BOD of 31 March 2016 Stock options 80,000 0 0 80,000 80,000 €12.55 €5.88 5.5 years €12.55 10 years 53% 0.0% 471
BOD of 23 November 2016 Stock options 150,000 0 0 150,000 150,000 €6.47 €3.15 6 years €6.47 10 years 53% 0.0% 472
BOD of 27 January 2017 Stock options 12,500 0 0 12,500 12,500 €6.76 €3.15 5.5 years €6.76 10 years 53% 0.0% 39
BOD of 27 January 2017 Stock options 185,000 0 0 185,000 185,000 €6.76 €3.27 6 years €6.76 10 years 53% 0.0% 605
BOD of 30 June 2017 Stock options 97,500 5,000 0 92,500 92,500 €6.61 €3.20 6 years €6.61 10 years 53% 0.0% 312
BOD of 25 January 2018 Stock options 215,000 7,500 0 207,500 207,500 €6.74 €3.27 6 years €6.79 10 years 53% 0.2% 679
BOD of 27 September 2018 Stock Options 2018-2 130,000 0 0 130,000 130,000 €6.82 €3.31 6 years €6.82 10 years 53% 0.1% 430
BOD of 24 January 2019 Stock options 40,000 0 0 40,000 40,000 €5.16 €2.50 5.5 years €5.16 10 years 53% 0.0% 100
At 30 June 2019 910,000 12,500 0 897,500 897,500
Underlying
fair value
Fair
value
of the
warrant
Maturity Strike
price
in €
Exercise
period
Adopted assumptions - calculation of fair value under IFRS 2
Volatility
Risk
free
rate
Total valuation
IFRS2
(Black&Scholes)
in €K

Exercise rights for stock options vest:

  • annually by one-third for stock options granted in 2016;
  • for stock options granted in 2017:
    • o one year after the grant date for the 12,500 stock options granted by the Board of Directors on 27 January;

  • o annually by one-third for the 185,000 stock options granted by the Board of Directors on 27 January;
  • o annually by one-third for the 97,500 stock options granted by the Board of Directors on 30 June (given the award date, no expense has been recognised in this half-year in this respect);
  • annually by one-third for stock options granted in 2018;
  • on the first anniversary date of the award for the stock options awarded by the Board of Directors in January 2019.

The exercise of the warrants issued is not subject to a performance condition. However, it is subject to a continued employment condition.

These plans are known as "equity settled". The Company has no commitment to redeem these instruments with employees should said employees leave, or should a particular event not occur.

Furthermore, the Board of Directors of 20 June 2019 decided to issue 225,000 stock options for employees, with an exercise price of €7.04. At 30 June 2019, these employees were not yet informed of the terms and conditions of the award. These stock options are therefore not considered as awarded on the closing date and are not included in the expense for share-based payments at 30 June 2019.

Founder warrants ("BSPCE" or "BCE")

The table below summarises the data relating to plans for stock options issued, along with the assumptions used for their valuation under IFRS2:

Adopted assumptions - calculation of fair value under IFRS 2
Award date Type Number
of issued
warrants
Number
of
expired
options
Number
of
exercised
options
Number of
options
outstanding
Maximum
number
of shares
to be
issued*
Underlying
fair value*
Fair
value of
the
warrant*
Maturity Strike
price
in €*
Exercise
period
Volatility Risk
free
rate
Total valuation
IFRS2
(Black&Scholes)
in €K
BOD of 20 June 2010 BCE 10-06-2010-1 5,000 2,750 560 0 0 €3.33 €1.77 5 years €2.50 10 years 45% 3.5% 177
BOD of 17 December 2010 BCE 10-06-2010-2 3,000 0 3,000 0 0 €3.33 €1.72 4.5 years €2.50 10 years 45% 3.73% 103
BOD of 20 September 2011 BCE 10-06-2010-2 1,500 0 1,500 30,000 €3.74 €2.00 3.5 years €2.50 10 years 50% 4.0% 60
BOD of 12 March 2014 BCE 31-10-2012 5,000 0 2,300 2,700 54,000 €8.00 €5.58 4.5 years €3.20 10 years 55% 1.80% 558
BOD of 29 July 2016 BSPCE 29-07-2016 45,000 45,000 0 0 €7.53 €3.30 5.5 years €8.45 10 years 53% 0.00% 99
BOD of 31 March 2017 BSPCE 31-03-2017 100,000 0 0 100,000 100,000 €6.76 €2.63 6 years €5.91 10 years 53% 0.00% 263
BOD of 30 June 2017 BSPCE 2017-2 177,500 15,000 0 162,500 162,500 €6.61 €3.04 6 years €7.26 10 years 53% 0.00% 532
BOD of 21 September 2017 BSPCE 2017-3 15,000 0 0 15,000 15,000 €5.76 €2.72 6 years €6.01 10 years 53% 0.0% 41
At 30 June 2019 352,000 62,750 5,860 281,700 361,500

* After dividing the par value by 20

Those warrants issued prior to the division of the par value by 20, effective in March 2014, are convertible into 20 ordinary shares. Consequently, the fair value of the underlying asset, the fair value of the warrant and the exercise price were adjusted in order to take this into account.

The exercise price for grants made after the IPO is based on the average share price over the 20 days preceding the grant.

The exercise rights for all the BSPCE warrants vest annually by one-third on each grant anniversary date.

Exercise of the warrants is not subject to a performance condition. However, it is subject to a continued employment condition.

These plans are known as "equity settled". The Company has no commitment to redeem these instruments with employees should said employees leave, or should a particular event not occur.

Bonus shares

Award date Type Number
of expired
bonus
shares
Number of
definitively
granted bonus
shares
Number of
bonus shares
in circulation
Maximum
number of
shares to be
issued
BOD of 25 January 2018 Bonus shares 126,500 22,516 24,150 79,834 79,834
BOD of 24 January 2019 Bonus shares 240,000 0 0 240,000 240,000
At 30 June 2019 366,500 22,516 24,150 319,834 319,834

The Board of Directors' meetings of 25 January 2018 and 24 January 2019 granted 126,500 and 240,000 bonus shares respectively to employees.

For the 2018 plan, the final award of bonus shares is made annually, by one third on each anniversary date of the award. For the 2019 plan, the final bonus share award is made on the second anniversary date of the award for tranches 1 and 2 and on the third anniversary of the award for tranche 3.

For these two plans, each annual tranche is subject to one presence condition and to three performance conditions, the achievement of each of which grants entitlement to one-third of the annual tranche:

  • two annual performance conditions not related to market conditions, such that the total number of shares granted will depend on the level of achievement of the conditions for 2018, 2019 and 2020 (25 January 2018 plan) and 2019, 2020 and 2021 (24 January 2019 plan). For each of these conditions, the likelihood of achieving the objective is estimated by management. To determine the expense recognised at 30 June 2018 and 2019, the number of free shares that the Company expects to award was defined on the basis of an estimate by management.
  • an annual performance condition linked to market conditions, and reflected in the assessment of fair value.

The Board meeting of 24 January 2019 amended the performance conditions attached to 2019 and 2020 of the 2018 plan, aligning them on the conditions of the 2019 plan. In accordance with IFRS 2.27 B43, as this amendment increases the fair value of awarded equity instruments, its effects lead to the recognition of marginal fair value, equal to the difference between the fair value of the amended equity and the fair value of the original equity instrument, both measured on the amendment date of the transaction.

For the two plans, the fair value of options subject to the market-linked condition was determined using the Monte Carlo model. The modalities of the assessment used in estimating the fair value of the options are specified below:

  • the share price used is equal to the share price on the grant date;
  • the risk-free rate is determined using the average life of the instruments;
  • volatility was determined using a sample of listed companies in the biotechnology sector, on the instrument subscription date, and over a period equivalent to the life of the option.

These plans are known as "equity settled". The Company has no commitment to redeem these instruments with employees should said employees leave, or should a particular event not occur.

Furthermore, the Board of Directors' meeting of 20 June 2019 decided on the issue of 3,600 bonus shares in favour of employees, subject themselves to conditions such as those awarded on 24 January 2019. At 30 June 2019, these employees were not yet informed of the terms and conditions of the award. These bonus shares are therefore not considered as awarded on the closing date and are not included in the expense for share-based payments at 30 June 2019.

Type Grant date Number
of
options
outstandi
ng
Plan cost
under
IFRS 2
Cumulati
ve
expense
at
01/01/20
18
Expense
at 30
June
2018
Cumulati
ve
expense
at 30
June
2018
Expense
at 30
June
2019
Cumulati
ve
expense
at 30
June
2019
Directors' BSA BOD of 5 July 2010 0 135 135 135 135
BSA 31/10/2012 BOD of 20 February 2013 2,500 72 72 72 72
BSA 31/10/2012 BOD of 12 March 2014 2,500 228 228 228 228
BSA 25-07-2014 BOD of 08 January 2015 42,500 219 219 219 219
BSA 16-06-2015 BOD of 29 April 2015 42,500 288 273 15 288 288
BSA 16-06-2015 BOD of 07 May 2015 240,000 1,551 1,551 1,551 1,551
BSA 29-01-2016 BOD of 29 January 2016 42,500 121 105 8 113 1 121
BSA 29-01-2016 BOD of 29 January 2016 42,500 121 105 8 113 1 121
BSA 29-01-2016 BOD of 31 March 2016 42,500 220 181 21 202 6 220
BSA 27-01-2017 BOD of 27 January 2017 62,500 166 154 12 166 166
BSA 30-06-2017 BOD of 30 June 2017 25,000 66 33 33 66 66
BSA 2018 BOD of 25 January 2018 90,000 256 107 107 20 256
BSA 2019 BOD of 24 January 2019 120,000
Total - BSA 755,000 3,443 3,056 205 3,261 28 3,443

Details of the expense recognised in accordance with IFRS 2 at 30 June 2018 and 2019:

Type Grant date Number
of
options
outstandi
ng
Plan cost
under
IFRS 2
Cumulati
ve
expense
at
01/01/20
18
Expense
at 30
June
2018
Cumulati
ve
expense
at 30
June
2018
Expense
at 30
June
2019
Cumulati
ve
expense
at 30
June
2019
BCE 10-06-2010-1 BOD of 20 June 2010 0 177 177 177 177
BCE 10-06-2010-2 BOD of 17 December 2010 0 103 103 103 103
BCE 10-06-2010-2 BOD of 20 September 2011 1,500 60 60 60 60
BCE 31-10-2012 BOD of 12 March 2014 2,700 558 558 558 558
BSPCE 29-07-2016 BOD of 29 July 2016 0 99 134 -35 99 99
BSPCE 31-03-2017 BOD of 31 March 2017 100,000 263 122 58 180 25 241
BSPCE 2017-2 BOD of 30 June 2017 162,500 532 161 160 320 73 466
BSPCE 2017-3 BOD of 21 September 2017 15,000 41 7 12 19 6 34
Total - BSPCE 281,700 1,832 1,321 195 1,516 104 1,738
Type Grant date Number
of options
outstandi
ng
Plan cost
under
IFRS 2
Cumulativ
e expense
at
01/01/20
18
Expense
at 30 June
2018
Cumulativ
e expense
at 30 June
2018
Expense
at 30 June
2019
Cumulativ
e expense
at 30 June
2019
Stock options BOD of 31 March 2016 80,000 471 451 19 471 471
Stock options BOD of 23 November
2016
150,000 472 302 66 368 26 451
Stock options BOD of 27 January 2017 12,500 39 36 3 39 39
Stock options BOD of 27 January 2017 185,000 605 342 99 441 41 566
Stock options BOD of 30 June 2017 92,500 312 96 95 191 43 277
Stock options BOD of 25 January 2018
BOD of 27 September
207,500 679 174 174 112 495
Stock options 2018 130,000 430 130 199
Stock options BOD of 24 January 2019 40,000 100 41 41
Total - Stock Options 897,500 3,108 1,228 456 1,684 393 2,540

Type Grant date Number
of
options
outstandi
ng
Plan cost
under
IFRS 2
Cumulati
ve
expense
at
01/01/20
18
Expense
at 30
June
2018
Cumulati
ve
expense
at 30
June
2018
Expense
at 30
June
2019
Cumulati
ve
expense
at 30
June
2019
Bonus shares BOD of 25 January 2018 79,834 520 101 101 87 378
Bonus shares BOD of 24 January 2019 240,000 693 129 129
Total - Bonus shares 319,834 1,213 101 101 216 507
Number
of options
outstandi
ng
Plan cost
under
IFRS 2
Cumulativ
e expense
at
01/01/20
18
Expense
at 30 June
2018
Cumulativ
e expense
at 30 June
2018
Expense
at 30 June
2019
Cumulativ
e expense
at 30 June
2019
Grand total 2,254,034 9,596 5,605 956 6,562 741 8,228

At closing on 30 June 2019, total expense linked to the BSA warrants, BSPCE warrants, stock-options and bonus shares amount to €741,000 (of which €358,000 in research and development expenses and €384,000 in general and administrative expenses).

Note 14: Borrowing and financial debts

CURRENT AND NON-CURRENT FINANCIAL DEBTS
(Amounts in €K)
30/06/2019 31/12/2018
Repayable advances 215 359
Debt on leases 1,335
Non-current financial debts 1,549 359
Repayable advance 275 218
Debt on leases 289
Roivant contract 8,238 13,646
Bank charges 5 8
Current financial debts 8,807 13,873
Total financial debts 10,356 14,231

Breakdown of financial debts by due date

The due dates for financial debts break down as follows over the periods shown:

CURRENT AND NON-CURRENT FINANCIAL 30/06/2019
DEBTS
(Amounts in €K)
Gross
amount
Portion less than one
year
1 to 5
years
Over 5
years
Repayable advances 490 275 215
Debt on leases 1,623 289 1,075 259
Roivant contract 8,238 8,238
Bank charges 5 5
Total financial debts 10,356 8,807 1,290 259

CURRENT AND NON-CURRENT FINANCIAL

CURRENT AND NON-CURRENT FINANCIAL 31/12/2018
DEBTS
(Amounts in €K)
Gross
amount
Portion less than one
year
1 to 5
years
Over 5
years
Repayable advances 577 218 359
Roivant contract 13,646 13,646
Bank charges 8 8
Total financial debts 14,231 13,873 359

14.1 Debts to credit institutions

During the first half of 2019, the Company did not take out any loans with credit institutions.

14.2 Repayable advances and subsidies

The table below shows the change in repayable advance:

(Amounts in €K) PXL770 Imeglimin
(New
formulation)
Total
At 31 December 2017 43 692 736
(+) Receipt
(-) Repayment -40 -45 -85
Subsidies
Financial expenses 2 13 15
(+/-) Other movements
At 30 June 2018 5 660 666
At 31 December 2018 577 577
(+) Receipt
(-) Repayment -98 -98
Subsidies
Financial expenses 11 11
(+/-) Other movements
At 30 June 2019 490 490

Breakdown of repayable advances and subsidies by due date

(Amounts in €K) PXL770 Imeglimin (New
formulation)
Total
At 30 June 2019 490 490
Portion less than one year 275 275
Portion from 1 to 5 years 215 215
Portion over 5 years
(Amounts in €K) PXL770 Imeglimin (New
formulation)
Total
At 31 December 2018 577 577
Portion less than one
year 218 218
Portion from 1 to 5 years 359 359
Portion over 5 years

The advance relating to PXL770 was fully repaid in fiscal year 2018. The company did not obtain any new repayable advances during the first half of 2019, nor did it receive any additional payments in respect of existing advances.

14.3 Lease liabilities

At the first application of IFRS 16, the Group recognised a financial debt of €1,709,000 at 1 January 2019.

At 30 June 2019, the debt amounted to €1,623,000.

14.4 Obligation to participate in the financing of the Roivant development programme

CHANGE TO THE ROIVANT DEBT
(Amount in €K)
Roivant debt
At 31 December 2018 13,646
Receipt
Repayment -5.408
At 30 June 2019 8,238

Under the Roivant Sciences agreement, the Company received an initial payment of \$35 million and also committed to contribute financially to the development of Imeglimin in the United States and Europe in the amount of \$25 million. The portion of the initial payment which corresponds to the obligation to participate in the financing of the Roivant development programme was treated as a debt. The outstanding balance at the reporting date, of €8,238,000, was fully posted under current financial debts.

The contract stipulates that, until the full payment by the Company of its obligation to participate in the financing of the Roivant development programme, and in the event that the Company's immediately available cash, less the cash outflows stipulated within 30 days, is less than three times the amount of this residual obligation, for at least 10 consecutive days, the Company would be required to issue an irrevocable letter of credit undersigned by a leading bank in favour of Roivant, for the residual amount of such obligation calculated on that date. Roivant may present this letter of credit for payment if the Company fails to repay its obligation, or if the contract is terminated at the initiative of Roivant and under certain conditions. If the Company is unable to obtain the Letter of Credit, or if the latter is cancelled, then the sums owed by the Company to Roivant on that date will become immediately due.

Note 15: Commitments to staff

Commitments to staff are made up of the provision for pension rights, evaluated on the basis of the provisions of the applicable collective agreement, namely the collective agreement for the pharmaceutical industry. The main actuarial assumptions used to evaluate pension rights on retirement are as follows:

ACTUARIAL ASSUMPTIONS 30/06/2019 31/12/2018
Retirement age Voluntary retirement at 65/67 years
Collective agreements Pharmaceutical industry
Discount rate
(IBOXX Corporates AA)
0.77% 1.83%
Mortality table INSEE 2017 INSEE 2017
Salary adjustment rate 2% 2%
Turnover rate Low Low
Social security contribution rate 50% 50%

The provision for pensions has changed as follows:

COMMITMENTS TO STAFF
(Amounts in €K)
Retirement benefits
At 31 December 2018 279
Past service costs 32
Financial costs 3
Actuarial gains and losses 31
At 30 June 2019 345

Note 16: Provisions

The Company may be involved in judicial, administrative or regulatory procedures in the normal course of its activity. A provision is established by the Company if there is sufficient likelihood that such disputes will entail costs to be borne by the Company.

At 30 June 2019, no provision is recorded in the accounts (compared to the €18K at 31 December 2018, which was reversed for the period).

Note 17: Suppliers and other current liabilities

17.1. Suppliers and related accounts

TRADE PAYABLES AND RELATED ACCOUNTS
(Amounts in €K)
30/06/2019 31/12/2018
Trade payables 9,209 8,651
Invoices not received 12,765 12,091
Total trade payables and related accounts 21,975 20,742

There was no discounting of trade payables and related accounts since the amounts did not represent a maturity of more than one year at 30 June 2019.

17.2 Tax and social security debts

Tax and social security debts break down as follows:

TAX AND SOCIAL SECURITY PAYABLES
(Amounts in €K)
30/06/2019 31/12/2018
Staff and related accounts 440 510
Social security and other welfare bodies 605 394
Other taxes, duties and similar payments 45 225
Total tax and social security debts 1,090 1,129

17.3. Contract-related liabilities

CONTRACT-RELATED LIABILITIES
(Amounts in €K)
30/06/2019 31/12/2018
Deferred income - Sumitomo contract initial payment 4,807 12,077
Down-payments received 1,674 1,257
Derivative instruments 12
Other 4
Total contract-related liabilities 6,497 13,334

The deferred income relates to the initial payment received under the Sumitomo Dainippon Pharma contract, which is recognised in a staggered manner over the duration of the contract (see note 18).

Down-payments received relate to the re-invoicing to Sumitomo Dainippon Pharma of advances paid by the Company to the CRO in connection with the Phase 3 programme for Imeglimin.

The derivative instruments correspond to forward currency purchases with a fair value of €12,000 at 30 June 2019.

Note 18: Turnover

TURNOVER
(Amounts in €K)
30/06/2019 30/06/2018
Sumitomo contract 22,914 29,315
Roivant contract 155 8,148
Other 100
Total turnover 23,169 37,463

At 30 June 2019, the turnover is mainly linked (€22,914,000) to the contract signed with Sumitomo Dainippon Pharma in 2017.

In addition to these revenues from licensing, the operational income also includes grants detailed in the table above, recorded as a reduction of research and development costs.

Accounting treatment of the Roivant Sciences GmbH agreement:

On 9 February 2018, the Company entered into an exclusive agreement with Roivant Sciences GmbH ("Roivant") for the development and marketing of Imeglimin, an oral drug candidate developed by the Company for the treatment of Type 2 diabetes, in the United States, Europe and other countries not covered by the existing partnership in East and Southeast Asia between the Company and Sumitomo Dainippon Pharma. The agreement provides that prior to the marketing of Imeglimin, the parties may agree on a potential joint promotion agreement.

This agreement provides that:

  • an initial payment of \$35 million (approximately €28 million) to the Company, in consideration of the licence and exclusive rights granted to Roivant Sciences GmbH. It was redeemed during the first half of 2018;
  • Payments related to the achievement of regulatory development and sales objectives, as well as double-digit royalties based on net sales achieved by Roivant, for which the percentage increases according to the level of sales;
  • Roivant's commitment to cover the development and marketing costs of Imeglimin;
  • The Company's contribution of \$25 million (approximately €20 million) to the development programme, paid to Roivant on a straight-line basis over two years (eight quarters, each with a payment of \$3.125 million). The first quarterly repayment was made by the company in May 2018, and the payment schedule runs until May 2020. At 30 June 2019, the corresponding debt amounts to €8,238,000 (see note 14.4).

The Company analyses the granted licence as performance obligation that has been immediately met.

The contract price comprises:

  • a fixed payment (upfront) of \$35 million;
  • the Company's commitment to contribute \$25 million to the financing of the development programme.

The contract price therefore corresponds to the net initial payment of the company's commitment towards Roivant, i.e., an amount of \$10 million was recorded in income in the fiscal year ended 31 December 2018. The milestone payments will be integrated into the price of the contract and therefore recognised in income when they become highly probable. The royalties collected in the framework of the operation of the licence by Roivant Sciences GmbH will be recognised to the extent that they become payable, i.e., when Roivant Sciences GmbH carries out sales.

This contract also provides for payments relating to the attainment of development and sales objectives. Since no stage had been completed at the time of closure, no such revenue is recognised in this respect at 30 June 2019.

Accounting treatment of the Sumitomo agreement:

In October 2017, the Company signed a partnership agreement with Sumitomo, under the terms of which the two companies will co-develop Imeglimin for the treatment of Type 2 diabetes in Japan. Sumitomo Dainippon Pharma will fund the Phase 3 costs and the commercialization costs.

This agreement provides that:

  • the Company benefits from an initial payment of €36,031,000 in remuneration of the licence and exclusive rights granted to Sumitomo Dainippon Pharma along with the co-development. It was collected in December 2017 and is non-refundable;
  • the Company benefits from reimbursement of the external development costs incurred in connection with Phase 3, under the conditions set out in the agreement.

The company considers the licence granted and the co-development as two separate performance obligations:

  • The performance obligation is met immediately for the licence, given that it is a static licence.
  • The performance obligation is satisfied continuously for the co-development. The nature of the services related to the co-development corresponds to research work. At 30 June 2019, the amount of the performance obligations still to be executed stands at €14,564,000 (compared with €36,190,000 at 31 December 2018).

The contract price is composed of fixed payments and variable consideration seen as highly likely, i.e. the initial payment and reimbursement of direct costs. The corresponding income thus incorporates the initial payment and repayments. The milestone payments will be integrated into the price of the contract when they become highly probable. The royalties collected in the framework of the operation of the license by Sumitomo Dainippon Pharma will be recognised to the extent that they become payable, i.e., when Sumitomo Dainippon Pharma carries out sales.

The transaction price was allocated to both performance obligations according to the residual method, given that the licence price is uncertain. The specific price of the co-development obligation was established on the basis of estimated costs to achieve the performance obligation, plus a margin in line with market practices. This meant that the entire transaction price was allocated to the codevelopment performance obligation. This allocation reflects the economics of the contract, since the highly likely payments aim to provide a reasonable margin for research and development work, given that the licence is essentially paid for via future amounts that are not highly likely at closing.

The income allocated to the research and development department is recognised by percentage of completion, based on an estimate of the internal and external direct costs, for the entire codevelopment phase, a method that best represents the progress of the work. The company expects to make a positive margin on this agreement.

This contract also provides for payments relating to the attainment of development and sales objectives. Since no stage had been completed at the time of closure, no such revenue is recognised in this respect at 30 June 2019.

Note 19 Details of income and expenditure by function

19.1 Research and Development

RESEARCH AND DEVELOPMENT
(Amounts in €K)
30/06/2019 30/06/2018
Subcontracting, studies and research 21,749 26,207
Staff costs 2,139 1,704
Share-based payments 358 309
Travel and Entertainment 316 283
Intellectual property fees 50 171
Remuneration of intermediaries Fees 984 212
Other Charges 145 35
Research and Development expenses 25,742 28,920
Research tax credit 1,578 1,478
Subsidies 1,578 1,478

The drop in subcontracting costs stems primarily from the TIMES programme in Japan, for which €15.5 million were incurred during the half-year, compared to €22.5 million in the first half of 2018.

The change in staff costs relates to the expansion of clinical research teams.

19.2 General and administrative expenses

GENERAL AND ADMINISTRATIVE EXPENSES
(Amounts in €K)
30/06/2019 30/06/2018
Remuneration of intermediaries Fees 1,818 1,017
Staff costs 1,369 994
Share-based payments 383 648
Travel and Entertainment 482 345
Other Charges 817 610
General and administrative expenses 4,868 3,614

The significant increase in fees is mainly linked to the support for the Group's development on its markets.

The change in staff costs relates to the expansion of teams other than R&D.

Note 20: Payroll

The average payroll for POXEL on 30 June 2018 and 2019 is given below:

PAYROLL 30/06/2019 30/06/2018
Executives 43 33
Non executives 1 1
Total payroll 44 34

Note 21: Net financial income and expenditure

FINANCIAL INCOME AND (EXPENSES)
(Amounts in €K)
30/06/2019 30/06/2018
Other financial expenses -26 -15
Financial income 116 223
Foreign exchange gains/(losses) -19 641
Total financial gains/(losses) 71 850

The financial income at 30 June 2018 and 2019 is primarily composed of:

  • currency gains and losses, linked to changes in the price of the yen and the dollar;
  • income from financial investments;
  • other financial expenses, corresponding to the effect of the accretion of repayable advances (€11,000) and the interest on debt linked to leases (€14,000).

Note 22: Income tax

At 31 December 2018 and 30 June 2019, the Company did not recognise any deferred tax assets in its tax loss carryforwards. Given its stage of development, the Company considers it is not in a position to make projections of its future taxable profits against which unused tax losses could be set off. There was no taxable profit at 30 June 2018 and 2019.

Note 23: Earnings per share

EARNINGS PER SHARE 30/06/2019 30/06/2018
Weighted average number of outstanding shares 25,896,723 24,087,916
Net income(loss) for the year (in €K) -5,792 7,256
Basic earnings per share (€/share) -
0.22
0.30
Diluted earnings per share (€/share) -
0.22
0.28

Basic earnings per share is calculated by dividing the net loss for Company shareholders by the weighted average number of ordinary shares in circulation during the year.

Diluted earnings per share is based on an average number of shares in circulation adjusted by the weighted average number of shares resulting from the potential exercise, during the year, of existing stock options or other dilutive instruments. The latter are considered as anti-diluting in 2019 because

they lead to an increase in earnings per share. This way, diluted loss per share at 30 June 2019 is identical to the basic loss per share.

Note 24: Related parties

No post-employment benefits are granted to members of the Board of Directors.

Remuneration for corporate officers 30/06/2019 30/06/2018
Fixed remuneration payable 190 167
Variable remuneration payable 88 77
Benefits in kind 4 8
Employee expenses 70 65
Attendance fees 209 167
Share-based payments 148 354
Consultancy fees 7
TOTAL 714 837

The methods for evaluating the benefit of share-based payments are given in Note 13.

Note 25: Off-balance sheet commitments

With the exception of the elements below, there has been no significant change in off-balance sheet commitments since 31 December 2018:

  • Accounting treatment of operating leases from 31 December 2018 to 1 January 2019 following the application of IFRS 16.
  • On 23 April 2019, the Company was notified by letter dated 19 April 2019 of the initiation by Merck Serono of an arbitration procedure to settle the difference in the interpretation of the contract between the Company and Merck Serono.

In the context of the application of this contract to the partnership agreement signed with Roivant in February 2018, the Company and Merck Serono have in fact a different interpretation of the basis used to calculate Poxel's income that should be subject to royalties. The Company, together with its advisers, consider that its interpretation is justified by substantiated legal arguments and that the probability of a cash outflow exceeding the settled amount of €1.2 million is low. This arbitration procedure does not challenge the Company's assessment of the risk inherent in this disagreement. Consequently, at 30 June 2019, the Company did not accrue a provision for this divergence, applied to the payments already received from Roivant at 30 June 2019, but treated it as a contingent liability.

4. LIMITED REPORT OF THE STATUTORY AUDITORS ON THE 2019 INTERIM INFORMATION (IN FRENCH)