Exhibit 99.1

CONTENT

 

I – FIRST HALF 2019 INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS			2
II – MANAGEMENT DISCUSSION & ANALYSES			24
III – INFORMATION REGARDING RELATIONSHIPS WITH RELATED PARTIES			29
IV – RISK FACTORS			30

 

1

I – FIRST HALF OF 2019 CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

INTERIM CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION

(thousands of euros)

 

		Note		6/30/2019				12/31/20181
ASSETS
Intangible assets					23				29
Right-of-use assets related to leases		14			22,060				—
Property, plant, and equipment					20,905				20,219
Other non-current financial assets		4			6,144				6,033
Total non-current assets					49,131				26,281
Inventories					2,082				1,566
Other current assets		5			28,183				21,131
Cash and cash equivalents		6			107,265				122,770
Total current assets					137,531				145,468
TOTAL ASSETS					186, 662				171,749
		Note		6/30/2018				12/30/20181
LIABILITIES
Shareholders’ equity
Share capital		7			3,616				3,016
Premiums related to the share capital		7			605,223				539,292
Reserves		7			(412,702	)			(254,946	)
Net (loss)		7			(79,810	)			(166,076	)
Total shareholders’ equity					116,327				121,286
Non-current liabilities
Long-term financial debt		8			1,003				1,278
Long-term lease debt		14			21,038				—
Non-current provisions					1,620				1,536
Other non-current liabilities					873				4,105
Total non-current liabilities					24,533				6,919
Current liabilities
Short-term financial debt		8			572				1,201
Short-term lease debt		14			3,162				—
Current provisions					595				1,270
Supplier accounts payable		9			22,308				28,567
Other current liabilities		9			19,164				12,506
Total current liabilities					45,801				43,543
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY					186,662				171,749

 

1	The financial statements as of June 30, 2019 were prepared using the modified retrospective method of IFRS 16 accounting standard, requiring no restatement of the comparative period.

 

2

INTERIM CONDENSED CONSOLIDATED STATEMENT OF INCOME (LOSS)

(thousands of euros, except per share information)

 

				Six months ended June 30,
		Note		2019				20182
Operating income
Revenues		10			—				—
Other income		10			7,062				7,283
Total income					7,062				7,283
Operating expenses
Cost of goods sold					—				—
Research and development		11			(52,238	)			(49,946	)
Sales and marketing		11			(8,327	)			(9,728	)
General and administrative		11			(25,825	)			(21,135	)
Total expenses					(86,389	)			(80,809	)
Operating (loss)					(79,327	)			(73,526	)
Financial revenues		13			491				1,813
Financial expenses		13			(966	)			(360	)
Financial (loss) profit					(475	)			1,452
Income tax					(8	)			—
Net (loss)					(79,810	)			(72,074	)
Basic and diluted earnings per share (€/share)					(2.43	)			(2.60	)

 

2	The financial statements as of June 30, 2019 were prepared using the modified retrospective method of IFRS 16 accounting standard, requiring no restatement of the comparative period.

 

3

INTERIM CONDENSED CONSOLIDATED STATEMENTS

OF COMPREHENSIVE INCOME (LOSS)

(thousands of euros)

 

		Six months ended June 30
		2019				20183
Net (loss)			(79,810	)			(72,074	)
Actuarial gains and losses on employee benefits, net of corporate tax			150				72
Gain (Loss) directly recognized in shareholders’ equity			150				72
Other comprehensive income (loss)			8				(1,566	)
Total comprehensive (loss)			(79,652	)			(73,568	)

In accordance with IAS 1 Presentation of Financial Statements (2007) (IAS 1), the Group, as defined in Note 1, presents a combined statement of other elements of comprehensive income or loss.

Other comprehensive income mainly includes, as of June 30, 2019 and 2018, the change in consolidated translation reserves.

 

3	The financial statements as of June 30, 2019 were prepared using the modified retrospective method of IFRS 16 accounting standard, requiring no restatement of the comparative period.

 

4

INTERIM CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

(thousands of euros)

 

		Note				6/30/2019				6/30/20184
Net profit (loss) for the period							(79,810	)			(72,074	)
Reconciliation of the net profit (or loss) and the cash used for the operating activities:
Amortization and depreciation							2,437				162
Retirement pension obligations							233				190
Expenses related to share-based compensation							8,040				16,758
Other elements							515				242
Operating cash flows before change in working capital							(68,584	)			(54,722	)
Inventories							(516	)			—
Customer accounts receivable							—				1,262
Other current assets							(7,420	)			(10,163	)
Supplier accounts payable							(5,945	)			2,811
Other current and non-current liabilities							5,296				(4,357	)
Change in working capital requirement							(8,585	)			(10,448	)
Net cash flow used in operating activities							(77,170	)			(65,170	)
Cash flows used in investing activities
Acquisitions of property, plant, and equipment							(2,117	)			(498	)
Acquisitions of intangible assets							1				(10	)
Acquisitions of non-current financial assets							16				(171	)
Net cash flows from investment activities							(2,100	)			(679	)
Cash flows from financing activities
Increase in conditional advances							—				—
(Decrease) in conditional advances							(904	)			(648	)
Treasury shares							34				(12	)
Capital increases, net of transaction costs							66,531				132,460
Repayment of lease liabilities							(1,403	)			—
Interest paid on lease liabilities							(521	)			—
Other cash flows related to financing activities							(27	)			(135	)
Net cash flows used in financing activities							63,710				131,666
(Decrease) in cash							(15,560	)			65,817
Cash and cash equivalents at beginning period							122,770				137,880
Impact of exchange rate fluctuations							55				(1,452	)
Cash and cash equivalents at the close of the period			6				107,265				202,245

 

4	The financial statements as of June 30, 2019 were prepared using the modified retrospective method of IFRS 16 accounting standard, requiring no restatement of the comparative period.

 

5

INTERIM CONDENSED STATEMENT OF CHANGES

IN CONSOLIDATED SHAREHOLDERS’ EQUITY

(thousands of euros)

 

		Shares of common Stock
		Number of shares (Note 7)				Amount				Premiums related to the share capital				Reserve				Profit (loss)				Total shareholders’ equity
At January 1, 2018			24 990 822				2,499				406,709				(131,592	)			(147,693	)			129,923
Net (loss)			—				—				—				—				(72,074	)			(72,074	)
Foreign exchange translation			—				—				—				(1,566	)			—				(1,566	)
Profit (loss) directly recognized in shareholders’ equity			—				—				—				72				—				72
Total profit (loss) directly recognized in shareholders’ equity			—				—				—				(1,494	)			(72,074	)			(73,568	)
Allocation of prior (loss)			—				—				—				(147,693	)			147,693				—
Increase in capital			5 015 530				502				131,821				—				—				132,323
Treasury shares			—				—				—				(650	)			—				(650	)
Issue of share warrants			—				—				138				—				—				138
Share-based payments			—				—				—				16,758				—				16,758
At June 30, 2018			30 006 352				3,001				538,668				(264,671	)			(72,074	)			204,924
At January 1, 2018			24 990 822				2,499				406,709				(131,592	)			(147,693	)			129,923
Net (loss)			—				—				—				—				(166,076	)			(166,076	)
Foreign exchange translation			—				—				—				(683	)			—				(683	)
Profit (loss) directly recognized in shareholders’ equity			—				—				—				19				—				19
Total profit (loss) directly recognized in shareholders’ equity			—				—				—				(665	)			(166,076	)			(166,740	)
Allocation of prior (loss)			—				—				—				(147,693	)			147,693				—
Increase in capital			5 166 955				517				132,419				—				—				132,936
Treasury shares			—				—				—				(900	)			—				(900	)
Issue of share warrants			—				—				164				—				—				164
Share-based payments			—				—				—				25,904				—				25,904
At December 31, 2018			30 157 777				3,016				539,292				(254,946	)			(166,076	)			121,286
At January 1, 2019			30 157 777				3,016				539,292				(254,946	)			(166,076	)			121,286
Net (loss)			—				—				—				—				(79,810	)			(79,810	)
Foreign exchange translation			—				—				—				8				—				8
Profit (loss) directly recognized in shareholders’ equity			—				—				—				150				—				150
Total profit (loss) directly recognized in shareholders’ equity			—				—				—				158				(79,810	)			(79,652	)
Allocation of prior (loss)			—				—				—				(166,076	)			166,076				—
Increase in capital			6 000 000				600				65,931				—				—				66,531
Treasury shares			—				—				—				122				—				122
Share-based payments			—				—				—				8,040				—				8,040
At June 30, 2019			36 157 777				3,616				605,223				(412,702	)			(79,810	)			116,327

 

6

NOTES TO THE INTERIM CONDENSED FINANCIAL STATEMENTS

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin^®. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT^®, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin^®.

Viaskin^® Peanut

The Company’s lead product candidate, Viaskin^® Peanut, has completed a global Phase III program for the treatment of peanut-allergic patients 4 to 11 years of age. In October 2018, the Company announced its submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for Viaskin^® Peanut for the treatment of peanut allergy in children 4 to 11 years of age. On December 19, 2018, the Company announced that, after discussions with the FDA, the Company voluntarily withdrew its Biologics License Application (“BLA”) for Viaskin^® Peanut in children 4 to 11 years of age. On August 7, 2019, the Company announced the submission of its BLA to the FDA for Viaskin^® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.

In August 2017, the Company initiated Part A of the EPITOPE (EPIT^® in Toddlers with Peanut Allergy) trial, a Phase III trial of Viaskin^® Peanut in peanut-allergic toddlers ages one to three. EPITOPE is a two-part, pivotal Phase III clinical trial assessing the safety and efficacy of Viaskin^® Peanut 250 µg for the treatment of peanut-allergic toddlers one to three years of age. In September 2018, the Company announced that the independent data safety and monitoring board (“DSMB”) completed its review of Part A of EPITOPE and recommended that the dose of Viaskin^® Peanut 250 µg be evaluated in Part B. On October 26, 2018, the Company announced that the first patient was enrolled in Part B of EPITOPE. This trial is the second Phase III clinical program currently investigating the use of Viaskin^® Peanut for the treatment of patients with peanut allergy.

Viaskin^® Milk

The Company is developing its second product candidate, Viaskin^® Milk, for the treatment of cow’s milk protein allergy (“CMPA”), in children two to 17 years of age, which received fast track designation from the FDA in September 2016. In November 2014, the Company initiated a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin^® Milk in 198 patients with Immunoglobulin E (“IgE”) mediated CMPA, which the Company refers to as the Milk Efficacy and Safety (“MILES”) trial. In June 2015, the Company announced completion of Part A of the MILES trial, or Phase I, and it launched Part B, or Phase II, in October 2015. In February 2018, the Company announced preliminary results from Part B of the MILES trial. Following analyses of the data, the 300 µg dose was identified as the dose with the greatest observed clinical activity for children (intent-to-treat, p=0.042). The Company believes these preliminary results support further advancement of the Viaskin^® Milk program and intends to discuss findings with regulatory authorities to determine the design of future clinical trials. All patients in the open-label extension trial were switched to the 300 µg dose for treatment of up to 24 months.

Viaskin^® Egg

The Company is also working on a third product candidate, Viaskin^® Egg, for the treatment of patients suffering from hen’s egg allergy. Preclinical development for Viaskin^® Egg commenced in the first half of 2015 and is currently ongoing.

Other Viaskin^® application

In addition to the Company’s development programs in food allergies, it is exploring the use of its Viaskin^® technology for the treatment of inflammatory and autoimmune diseases with high unmet medical need. Human proof-of-concept trials with Viaskin^® in Eosinophilic Esophagitis (“EoE”) and as a booster vaccination against Bordetella pertussis (whooping cough) in healthy adults have been completed. The Company’s other earlier stage research programs include vaccination for respiratory syncytial virus, as well as potential treatments for celiac disease and type I diabetes.

 

7

 

Major events during the first half of 2019

 

1.

FINANCING

On April 8, 2019, the Company announced the settlement and delivery of an underwritten global offering of an aggregate of 6,000,000 ordinary shares reserved to specified categories of investors in (i) an offering of 2,447,500 ordinary shares in the form of 4,895,000 American Depositary Shares (“ADSs”) in the United States, Canada and certain other countries outside Europe, at an offering price of $6.75 per ADS (on the basis of an exchange rate of $1.1233 = €1.00), and (ii) a private placement of 3,552,500 ordinary shares in Europe (including France), at an offering price of €12.02 per ordinary share. Each ADS represents the right to receive one-half of one ordinary share. The gross proceeds to the Company from the global offering were approximately $81.0 million (approximately €72.1 million), before deducting underwriting commissions and estimated offering expenses.

 

2.	CLINICAL PROGRAMS

Viaskin^® Peanut

On February 13, 2019, the Company announced that it expects to submit its BLA to the FDA for Viaskin^® Peanut for the treatment of peanut-allergic children 4 to 11 years of age in the third quarter of 2019.

On August 7, 2019, the Company announced the submission on August 6, 2019 of its BLA to the FDA for Viaskin^® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.

 

3.	CHANGE IN THE GROUP’S BOARD MEMBERS AND EXECUTIVE MANAGEMENT

On January 3, 2019, the Company announced the following changes to its leadership team as the Company strengthens its organizational competencies in the development of the Viaskin^® platform:

 

•

DBV’s Chief Scientific Officer (CSO), Dr. Hugh Sampson, assumed the role of interim Chief Medical Officer (CMO) effective on January 3, 2019. Dr. Sampson succeeded Dr. Lucia Septien-Velez. As CSO and during his time as interim CMO, Dr. Sampson led both the scientific and medical teams at the Company and reports to Daniel Tassé, Chief Executive Officer of DBV Technologies.

 

•

Julie O’Neill was engaged to direct all product development, manufacturing, supply chain, quality assurance, and end-to-end process optimization at the Company. She directly advises Daniel Tassé. Julie, who was appointed to DBV’s Board of Directors in 2017, continues to serve as a director, while overseeing the submission of the Viaskin® Peanut BLA in children 4 to 11 years of age.

 

•

Alan Kerr, Senior Vice President, Head of Global Regulatory Affairs of DBV Technologies, reports to the Company’s CEO, Daniel Tassé effective from January 3, 2019.

On March 5, 2019, the Company also provided an update on leadership and operational changes:

 

•

Charles Ruban, former Chief Operating Officer, who oversaw regulatory, product development and commercial operations, resigned from the Company, effective March 15, 2019.

 

•

Laurent Martin, former Chief Development Officer, resigned from his regulatory and product development role, effective March 15, 2019. Mr. Martin continues to serve as DBV’s Pharmacien Responsable (Responsible Pharmacist) in accordance with applicable regulations in France while a search for a replacement is planned. Mr. Martin’s primary responsibilities were taken by Julie O’Neill, DBV’s manufacturing and operations leader, who oversees product development, manufacturing, supply chain, quality assurance, and end-to-end process optimization at the Company.

On March 5, 2019, the board of directors appointed existing board member, Michel de Rosen, as Non-Executive Chairman of the board. Mr. de Rosen succeeds the Company’s co-founder, Dr. Benhamou, who retired from his position as DBV’s Non-Executive Chairman and board member. Dr. Benhamou joined the Company’s Scientific Advisory Board on March 5, 2019. In addition, Daniel Tassé, CEO of DBV Technologies, has been appointed to the Board of Directors to replace Pierre-Henri Benhamou. This appointment was approved by the Annual General Meeting of Shareholders held on May 24, 2019.

 

8

 

On May 14, 2019, the Company announced that its Deputy Chief Executive Officer and Principal Financial Officer, David Schilansky, has decided to leave the company by the end of August 2019. While a new Chief Financial Officer search is underway, DBV will not fill the Deputy CEO role following David Schilansky’s departure. Sébastien Robitaille has been appointed to serve as the Company’s interim Chief Financial Officer and Principal Financial Officer, effective as of August 31, 2019.

On May 24, 2019, the Company also announced that Viviane Monges, who has 30 years of global pharmaceutical leadership experience in financial operations, has been appointed to the Board of Directors and Audit Committee. DBV’s Board of Directors now includes nine directors, including four women.

On June 26, 2019, the Company announced the appointment of Pharis Mohideen, M.D., as its CMO, effective July 22, 2019. Dr. Mohideen serves as a member of the Executive Committee and reports to Daniel Tassé. Effective as of Dr. Mohideen’s start date, Dr. Hugh Sampson, who assumed the role of interim CMO in early 2019, continued to serve as CSO.

 

4.	OTHER KEY EVENTS

A class action complaint was filed on January 15, 2019, in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint alleges that the Company and its former Chief Executive Officer, its current Chief Executive Officer and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.

The plaintiff seeks unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and December 19, 2018. The Company believes that the allegations contained in the complaint are without merit and intend to defend the case vigorously. However, whether or not the plaintiff’s claims are successful, this type of litigation is often expensive and diverts management’s attention and resources, which could adversely affect the operation of the Company’s business. If the Company is ultimately required to pay significant defense costs, damages or settlement amounts, such payments could adversely affect its operations.

The Company may be the target of similar litigation in the future. Any future litigation could result in substantial costs and divert management’s attention and resources, which could cause serious harm to the Company’s business, operating results and financial condition. The company maintains liability insurance; however, if any costs or expenses associated with this or any other litigation exceed its insurance coverage, the Company may be forced to bear some or all of these costs and expenses directly, which could be substantial.

Note 2: General principles and statement of compliance

 

1.

SCOPE OF CONSOLIDATION

The company DBV Technologies Inc. was incorporated in Delaware on April 7, 2015 (the “US subsidiary”). The share capital of this US subsidiary is 100% owned by DBV Technologies S.A. (“DBV Technologies”).

The company DBV Australia Pty Ltd. was incorporated in New South Wales, Australia on July 3, 2018 (the “Australian subsidiary”). The share capital of this Australian subsidiary is 100% owned by DBV Technologies S.A. (“DBV Technologies”).

The company DBV Canada Ltd. was incorporated in Ottawa, Ontario on August 13, 2018 (the “Canadian subsidiary”). The share capital of this Canadian subsidiary is 100% owned by DBV Technologies S.A. (“DBV Technologies”).

The company DBV Pharma was incorporated in Paris on December 21, 2018 (the “French subsidiary”). The share capital of this French subsidiary is 100% owned by DBV Technologies S.A. (“DBV Technologies”).

 

9

2.

GENERAL PRINCIPLES

The interim consolidated condensed financial statements (the “Financial Statements”) present the operations of DBV Technologies S.A. and its subsidiaries (the “Group”) as of June 30, 2019. DBV Technologies is a Corporate French venture under French law (société anonyme) and has its registered offices located at 177/181 avenue Pierre Brossolette, 92120 Montrouge (France).

The interim condensed consolidated financial statements at June 30, 2019 have been prepared under the responsibility of the management of DBV Technologies. These interim condensed financial statements were approved by the Board of Directors of the Company on September 20, 2019.

The interim condensed consolidated financial statements of the Group are expressed in thousands of euros unless stated otherwise.

For consolidation purposes, DBV Technologies and its subsidiaries have prepared individual financial statements for the period ended June 30, 2019.

 

3.

STATEMENT OF COMPLIANCE

International accounting standards include International Financial Reporting Standards (“IFRS”), International Accounting Standards (“IAS”), as well as the interpretations issued by the Standing Interpretations Committee (“SIC”), and the International Financial Reporting Interpretations Committee (“IFRIC”).

Those Financial Statements have been prepared in accordance with IFRS as issued by the International Accounting Standard Board (“IASB”) and whose application is mandatory for the year beginning January 1, 2019. Comparative figures are presented for December 31, 2018 and June 30, 2018.

Due to the listing of the Company’s ordinary shares on the Euronext Paris and in accordance with the European Union’s regulation No. 1606/2002 of July 19, 2002, Financial Statements of the Group are also prepared in accordance with IFRS, as adopted by the European Union (“EU”).

The Financial Statements at June 30, 2019 were prepared in accordance with IAS 34 - Interim Financial Reporting, which requires the disclosure of selected explanatory notes only.

The condensed financial statements do not include all disclosures required for annual financial statements and should therefore be read in conjunction with the consolidated financial statements for the year ended December 31, 2018.

The Group is not subject to significant seasonal effects.

Note 3: Accounting principles and methods used at June 30, 2019

These condensed consolidated financial statements are prepared using the same accounting policies and methods as those applied by DBV Technologies at December 31, 2018 (described in Note 3 of the consolidated accounts as of December 31, 2018 published) and in accordance with other standards and interpretations that came into effect on January 1, 2019.

The following Standards, amendments to standards and interpretations, which are mandatorily effective for annual periods beginning on or after January 1st, 2019 were adopted by the Company:

 

•

IFRS 16 – Leases;

 

•

Amendments to IFRS 9 - Prepayment features with negative compensation;

 

•

Amendments to IAS 28 - Long-term Interests in Associates and Joint Ventures;

 

•

Amendments to IAS 19 - Plan Amendment, Curtailment or Settlement;

 

•

IFRIC 23 - Uncertainty over Income Tax Treatments;

 

•

Annual Improvements to IFRS Standards 2015–2017 Cycle.

 

10

 

The impacts of the first-time application of IFRS 16 are described in detail in Note 3.1. The other amendments have not had any impact on the condensed consolidated financial statements as of June 30, 2019.

As of June 30, 2019, there is no difference between the IFRS published and mandated by the IASB and EU. As a result, the consolidated condensed Financial Statements as of and for the six month-period ended June 30, 2019, prepared in accordance with IFRS as published by the IASB, are the same than the ones prepared under as adopted by the EU and approved by the Board of directors on July 31, 2019, except for the subsequent events disclosure which has been updated.

The Company did not elect for early application of the new standards, amendments and interpretations which were adopted by the IASB but not mandatory as of January 1, 2019:

 

•

IFRS 17 – Insurance contracts

 

•

Amendments to IFRS 3 - Definition of a Business;

 

•

Amendments to IAS 1 and IAS 8 - Definition of Material.

 

•

Amendments to References to the Conceptual Framework in IFRS Standards;

Management is in the process of evaluating the impact of these standards and amendments application.

 

1.

IMPACT OF IFRS 16 APPLICATION ON JUNE 30, 2019 FINANCIAL STATEMENTS

IFRS 16 became applicable on January 1, 2019, requiring the Company to update its accounting policies on lease.

IFRS 16 aligns the balance sheet accounting treatment of operating leases on that of finance leases with the recognition of a liability for future lease payments, and of an asset for the associated rights of use. The lease term is defined contract by contract and corresponds to the firm period of the commitment taking into account the optional periods that are reasonably certain to be exercised.

The first-time application of IFRS 16 also lead to a change in presentation:

 

•

On the opening balance sheet: the recognition of an asset corresponding to the rights of use net of the existing debt as of December 31, 2018 related to the rent-free period and the recognition of a liability corresponding to lease obligations;

 

•

On the income statement: the lease expense previously recognized as a component of operating income is, under IFRS 16, recognized partly as depreciation expense within operating income, and partly within Financial expenses;

 

•

On the statement of cash flows: the lease payments previously presented within net cash provided used in operating activities is, under IFRS 16, presented within net cash used in financing activities to the extent that those payments are allocated to repayment of the lease liability.

For its transition method, the Group has elected to apply the simplified approach as of January 1, 2019. Prior-period comparative data will therefore not be restated at the transition date.

The Group has decided to apply the exemptions to lease with a term of less than 12 months and to leases of low value assets as soon as the new standard is effective.

Measurement of the right- of use asset

At the commencement date, the right- of- use asset is measured at cost and comprises:

 

•

The amount of the initial measurement of the lease liability, adjusted by the amount of any prepaid or accrued lease payments recognized in the statement of financial position immediately before the date of initial application;

 

•

Where relevant, any initial direct costs incurred by the lessee for the conclusion of the contract. These are incremental costs which would not have been incurred if the contract had not been concluded;

 

•

Estimated costs for restoration and dismantling of the leased asset according to the terms of the contract.

 

11

 

The majority of leases entered into by the Company are operating leases in which the Company is a lessee. The Group’s operating leases mainly relate to real estate assets and to a lesser extent to industrial equipment and company cars.

Following the initial recognition, the right-of-use asset must be depreciated over the useful life of the underlying assets on a straight-line basis over the term of the lease for the rent component.

In accordance with IAS 36 “Impairment of Assets”, right- of- use assets are tested for depreciation if there is an indication of impairment and at least once a year on December 31.

 

12

 

Measurement of the lease liability

At the commencement date, the lease liability is recognized for an amount equal to the present value of the lease payments over the lease term.

Amounts involved in the measurement of the lease liability are the contractual rents.

The lease liability is subsequently measured based on a process similar to the amortized cost method using the discount rate:

 

•

The liability is increased by the accrued interests resulting from the discounting of the lease liability, at the beginning of the lease period;

 

•

Less payments made.

The discount rate applied to each contract takes into account the remaining terms of the contracts from the date of first application, i.e. January 1, 2019, and the currency of each contract. The discount rates applied at the transition date are based on the Company’s marginal borrowing rate, to which is added a spread of its own which takes into account the nature and the total duration of the contract.

The discount rates and remaining term of the contracts determined by management are based on historical information and other factors considered reasonable in the circumstances.

The interest cost for the period as well as variable payments, not taken into account in the initial measurement of the lease liability and incurred over the relevant period are recognized as costs.

In addition, the lease liability may be remeasured in the following situations:

 

•

Change in the lease term;

 

•

Modification related to the assessment of the reasonably certain nature (or not) of the exercise of an option;

 

•

Adjustment to the rates and indices according to which the rents are calculated when rent adjustments occur.

 

13

 

The following tables present the impacts of the first application of IFRS 16 on the opening balance sheet:

 

		Information December 31, 2018				First-time application of IFRS 16				Information January 1, 2019 with IFRS 16
ASSETS
Intangible assets			29				—				29
Right-of-use assets related to leases			—				23,792				23,792
Property, plant, and equipment			20,219				—				20,219
Other non-current financial assets			6,033				—				6,033
Total non-current assets			26,281				23,792				50,074
Total current assets			145,468				—				145,468
TOTAL ASSETS			171,749				23,792				195,542
		Information December 31, 2018				First-time application of IFRS 16				Information January 1, 2019 with IFRS 16
LIABILITIES
Shareholders’ equity
Total shareholders’ equity			121,286				—				121,286
Non-current liabilities
Long-term financial debt			1,278				—				1,278
Long-term lease debt			—				22,682				22,682
Non-current provisions			1,536				—				1,536
Other non-current liabilities			4,105				(1,546	)			2,559
Total non-current liabilities			6,919				21,136				28,055
Current liabilities
Short-term financial debt			1,201				—				1,201
Short-term lease debt			—				2,973				2,973
Current provisions			1,270				—				1,270
Supplier accounts payable			28,567				—				28,567
Other current liabilities			12,506				(317	)			12,189
Total current liabilities			43,543				2,656				46,200
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY			171,749				23,792				195,542

 

14

 

The following table present the reconciliation of lease liabilities on the date of transition with Off-Statement of Financial Position commitments at December 31, 2018:

 

(thousands of euros)
Commitments given under operating leases as of December 31, 2018			30,429
Effects of rental expenses not recognized into IFRS 16			(4,061	)
Other effects, including currency effects and rent-free periods			4,035
Lease debt before discounting			30,402
Effect of discounting			(4,748	)
Lease debt after discounting			25,655
Existing finance leases as of December 31, 2018			—
Lease debt as of January 1, 2019 after first-time application of IFRS 16			25,655

Commitments given at December 31, 2018 included €30,267 thousands under real estate’s leases and €163 thousands under industrial equipment and vehicles leases.

 

2.

GOING CONCERN

To date, the Company has not generated any product revenue and it continues to prepare for the potential launch of its Viaskin^® Peanut product candidate in North America in 2020, if approved. On August 7, 2019, the Company announced the submission on August 6, 2019 of its BLA to the FDA for Viaskin^® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.

The Company expects operating losses to continue for the foreseeable future. Current cash and cash equivalents are not projected to be sufficient to support the Company’s operating plan for the next 12 months despite additional funds raised in April 2019. The Company believes that its existing cash and cash equivalents will be sufficient to fund its operations until the first quarter of 2020.

As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. The Company expects to seek additional funds, most likely from equity and/or debt financings. However, no assurance can be given at this time as to whether the Company will be able to achieve these financing objectives on acceptable terms or at all.

If the Company does not achieve its financing objectives, the Company could scale back its operations, notably by delaying or reducing the scope of its research and development efforts.

The Company’s financial statements have been prepared on a going concern basis, assuming that it will be successful in its financing objectives. As such, no adjustment has been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should the Company not be able to continue as a going concern.

Refer to the liquidity risk disclosed in Note 23 to the financial statements for the year ended December 31, 2018.

 

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Note 4: Non-current financial assets

 

(thousands of euros)		6/30/2019				12/31/2018
Deposits			1,363				1,374
Pledged securities and other non-current financial assets			4,226				4,226
Liquidity contract			555				432
Total non-current financial assets			6,144				6,033

The non-current financial assets are composed of security deposits paid to premises’ lessors, of pledged securities not used as of June 30, 2019 and the liquidity contract.

Under the liquidity contract, 34,952 treasury shares were allocated as a reduction of Shareholders’ Equity as of June 30, 2019 with the cash balance being maintained in financial assets.

Note 5: Other current assets

Other current assets are broken down as follows:

 

(thousands of euros)		6/30/2019				12/31/2018
Research tax credit			16,802				10,829
Other tax claims			3,517				4,292
Other receivables			2,391				1,745
Prepaid expenses			5,474				4,265
Total other current assets			28,183				21,131

The other tax claims are primarily related to deductible VAT as well as the reimbursement of VAT that has been requested.

Prepaid expenses are comprised primarily of rental and insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

Research Tax Credit

The Company benefits from the provisions in Articles 244 quater B and 49 septies F of the French Tax Code related to the Research Tax Credit. In compliance with the principles described in Note 3.12 to the financial statements for the year ended December 31, 2018, the Research Tax Credit is posted to the accounts as “Other Income” during the year with which the eligible research expenditures are associated.

Research Tax Credits recorded over the last three fiscal years are presented as follows:

 

•

2017: €9.2 million (for 12 months) paid in 2018;

 

•

2018: €10.8 million (for 12 months), to be paid in 2019;

 

•

2019: €6.0 million (for 6 months), to be paid in 2020.

The Company recognized as other income a Research Tax Credit in the amount of €6.0 million at June 30, 2019 and €5.4 million at June 30, 2018.

Following a tax inspection led by the French tax authorities on fiscal years 2012, 2013 and 2014, the Company received on July 4, 2016 a proposition of adjustments primarily affecting the 2014 Research Tax credit. The proposed adjustment amounted to €0.9 million and had been accrued in the financial statements as of December 31, 2017.

 

16

 

On June 25, 2018, the Company received the final reassessment for €58 thousand. The accrual initially recognized for €0.9 million has been reversed in the December 31, 2018 financial statements.

A tax audit covering all the tax declarations for the period from January 1, 2015 to December 31, 2016, extended to December 31, 2017 for VAT, was conducted in the third quarter of 2018. The conclusions of this tax audit were received in November 2018 without major financial consequences for the Group.

Note 6: Cash and cash equivalents

The cash and cash equivalents items are broken down as follows:

 

(thousands of euros)		6/30/2019				12/31/2018
Cash			61,726				77,236
Cash equivalent term deposits			45,539				45,534
Total cash and cash equivalents as reported in the statement of financial position			107,265				122,770
Bank overdrafts			—				—
Total net cash and cash equivalents as reported in the statement of cash flows			107,265				122,770

Term deposits are immediately convertible into cash at no cost. They are measured using level 1 fair value measurements.

Note 7: Capital

The share capital as of June 30, 2019 is set at the sum of €3,615,777.70. It is divided into 36,157,777 fully authorized, subscribed and paid-up shares with a par value of €0.10.

This number does not include share warrants (Bons de Souscription d’Actions, “BSAs”), founders’ share warrants (Bons de Souscription de Parts de Créateur d’Entreprise, “BSPCEs”), stock options (“SO”) and performance shares (“AGA”) granted to certain investors and to certain natural persons, both employees and non-employees of the Company.

Over the six months period ended June 30, 2019, the capital increase of €600,000 is linked to the issuance of 6,000,000 ordinary shares pursuant to the global offering of April 2019 and the exercise of the underwriters’ option to purchase additional ordinary shares;

All the shares give their owners the right to a proportional share of the net income and net assets of the Company.

The impact of share-based payments on net income (or loss) is presented in Note 12.

 

17

 

Note 8: Financial liabilities

As of June 30, 2019, the Company had:

 

•

A conditional advance of €1,768,489, granted in 2013 by OSEO to the Company as part of a collaborative research and clinical development in mite allergy in young children. Following the interruption of the project in September 2017, the repayment has been rescheduled in 13 monthly repayments, starting on May 31, 2018. As of June 30, 2019, this advance has been fully repaid.

 

•

An interest-free Innovation loan of €3,000,000 granted in 2014 by BpiFrance to DBV Technologies to help finance the pharmaceutical development of Viaskin Milk. This amount was received in a single disbursement on November 27, 2014. The planned repayment is scheduled in 20 quarterly repayments of €150,000 each, starting on June 30, 2017.

In 2011, OSEO Innovation also granted to the Company a grant in the form of a conditional advance of €640,000 to finance the development of its program to treat the allergy to proteins in cow’s milk. This advance has been fully repaid as of June 30, 2018.

The portion of the conditional advances for terms over one year is classified as non-current liabilities, while the portion for terms of less than one year is classified as current liabilities.

The table below presents the details of the debts recorded on the statement of financial position by the type of conditional advance:

 

(thousands of euros)		3rd OSEO contract				4th OSEO contract				BPI advance				Total
At January 1, 2018			64				1,700				2,386				4,150
Receipts			—				—				—				—
Repayments			(64	)			(1,136	)			(600	)			(1,800	)
Other transactions			—				60				69				129
At December 31, 2018			—				624				1,854				2,479
Of which - Non-current portion															1,278
Of which - Current portion															1,201
At January 1, 2019			—				624				1,854				2,479
Receipts			—				—				—				—
Repayments			—				(632	)			(300	)			(932	)
Other transactions			—				8				21				29
At June 30, 2019			—				—				1,575				1,575
Of which - Non-current portion															1,003
Of which - Current portion															572
Stated interest rate			None				2,05%				None
Discount rate			0.4%-1.9%				1.5%-1.8%				3.20%
Maturity (in years)			0-3				7-9				2-7

 

18

 

Note 9: Supplier accounts payable and other current liabilities

 

1.

SUPPLIER ACCOUNTS PAYABLE AND RELATED PAYABLES

Supplier accounts payable and related payables are not discounted as amounts did not present payment terms longer than 1 year at the end of each fiscal year or period presented.

 

2.

OTHER CURRENT LIABILITIES

 

(thousands of euros)		6/30/2019				12/31/2018
Social security			13,238				6,343
Tax liabilities			203				448
Other debts			253				1,354
Deferred revenues			5,470				4,360
Total other current liabilities			19,164				12,506

The other liabilities include short-term debt to employees, as well as social welfare and tax agencies. Deferred revenues include subsidies, conditional advances and current part of deferred revenues from the collaboration agreement with Nestlé Health Science, which amounted to €5.4 million as of June 30, 2019.

Note 10: Operating Income

The operating income is broken down as follows:

 

		Six months ended June 30
(thousands of euros)		2019				2018
Revenues			—				—
Research tax credit			5,973				5,653
Subsidies			—				191
Other operating income			1,089				1,439
Total operating income			7,062				7,283

As of June 30, 2019 and June 30, 2018, other operating income is mainly composed by the portion of the upfront fee and milestones agreed under the contract with Nestlé Health Science, which are deferred over the performance obligation, using the same methods as those described in Note 3.12 to the consolidated financial statements for the year ended December 31, 2018.

 

19

 

Note 11: Operating expenses

The research and development expenses are broken down as follows:

 

		Six months ended June 30
(thousands of euros)		2019				2018
Research and development expenses
Personnel expenses			20,419				22,051
Sub-contracting, collaborations and consultants			25,624				21,023
Depreciation and amortization			2,670				489
Small equipment and supplies			1,946				2,581
Conferences, travel expenses			792				1,234
Rental5			333				965
Others			454				1,604
Total research and development expenses			52,238				49,946

The sales and marketing expenses are broken down as follows:

 

		Six months ended June 30
(thousands of euros)		2019				2018
Sales and marketing expenses
Personnel expenses			5,961				4,147
Fees			1,541				3,869
Depreciation and amortization			391				3
Marketing, tradeshows and travel expenses			342				1,692
Others			92				17
Total sales and marketing expenses			8,327				9,728

By nature, the breakdown of general and administrative expenses is as follows:

 

		Six months ended June 30
(thousands of euros)		2019				2018
General and administrative expenses
Personnel expenses			15,809				11,379
Fees			5,947				5,322
Depreciation and amortization			426				323
Insurance policies			1,071				726
Corporate communication and travel expenses			422				995
Rental5			164				582
Others			1,986				1,808
Total general and administrative expenses			25,825				21,135

 

5	As of June 30, 2019, rentals are composed of rents related to leases ending within less than 12 months and to leases of low value assets, excluded from the scope of application of IFRS 16 standard, and of rental expenses.

 

20

 

Personnel expenses

As of June 30, 2019, the average headcount of the Group was 322 employees, compared with 244 employees as of June 30, 2018.

Personnel expenses are broken down as follows:

 

		Six months ended June 30
(thousands of euros)		2019				2018
Wages and salaries			25,332				14,256
Social security contributions			7,138				4,556
Expenses for pension commitments			1,223				1,100
Employer contribution to bonus shares			455				906
Share-based payments			8,040				16,758
Total personnel expenses			42,188				37,577

Note 12: Share-based payments

The payments in shares of stock involve all the warrants (BSAs/BSPCEs), stock options and free shares granted to employees, non-employee members of the Board of Directors, scientific consultants, or service providers.

The warrants and stock options granted may be exercised at any time after a vesting period of between 0 and 4 years and become null and void after a period of 10 years from the date they are granted. The acquisition of the warrants by the recipients is not subject to market conditions.

The expense representing the benefit granted is recorded in the financial statements using the straight-line method as a personnel expense over the vesting period.

The acquisition of free shares and exercise of stock options depend on the existence of an employment contract or holding a corporate office between the recipient and the Company. Similarly, the exercise of the equity warrants depends on the existence of a directorship or consultant contract between the beneficiary and the Company.

For the six months ended June 30, 2019:

 

•

721,000 stock options were granted to the CEO and US employees with exercise prices between €14.58 and €16.99. Contingent upon the holders’ continued employment with the Company, these stock options can be vested over a four-year vesting period, on the basis of 25% one year after the grant and 12.5% every 6 months, The exercise will be subject to the following performance condition: approval of Viaskin Peanut by the United States Food and Drug Administration (FDA). The options will be forfeited 10 years after their grant;

 

•

One free shares plan was granted to French employees for a total of 100,000 shares. The definitive allocation of the free shares will only occur at the later of the following two dates: (i) expiry of the current vesting period as from their initial allocation and (ii) approval of Viaskin Peanut by the United States Food and Drug Administration (FDA) (performance condition). These free shares are subject to a 2 years’ retention period.

The definitive allocation of the free shares, subject to a presence requirement, will only occur at the later of the following two dates:

 

•

expiry of the current vesting period as from their initial allocation and

 

•

approval of Viaskin Peanut by the FDA (performance condition).

These free shares are subject to a 2 years’ retention period.

The IFRS 2 expense recorded for the six months ended June 30, 2019 amounts to €8.0 million compared to €16.8 million for the six months ended June 30, 2018.

 

21

 

As of June 30, 2019, the total number of ordinary shares that can be created through a full exercise or definitive acquisition, depending on the case, of all of securities giving access to the capital and instruments issued to date amounts to 3,712,444 at a weighted average exercise price of €34.07 (this weighted average exercise price does not include the 644,295 of potential shares resulting from the definitive acquisition of free shares).

Note 13: Financial revenue and expenses

The following table reflects financial revenue and expenses:

 

		Six months ended June 30
(thousands of euros)		2019				2018
Financial revenues			491				1,813
Financial expenses			(966	)			(360	)
Total			(475	)			1,452

The financial income is primarily composed of unrealized exchange effect of U.S.-dollar-denominated intercompany advances and capital gains on the disposal of investment securities.

Financial expenses primarily include financial interest related to lease obligations recognized in the balance sheet as part of the implementation of IFRS 16, foreign exchange losses and expenses related to the accretion of repayable advances.

Note 14: Lease contracts

Analysis of right-of-use assets by category of underlying property as of June 30, 2019 are broken down as follows:

 

(thousands of euros)		Real estate				Other assets				Total
At December 31, 2018			—				—				—
First application of IFRS 16			23,462				330				23,792
Addition of assets			—				—				—
Amortization expense			(1,624	)			(57	)			(1,681	)
Translation adjustments and other			(52	)			—				(52	)
At June 30, 2019			21,787				273				22,060

Analysis of maturities of lease liabilities as of June 30, 2019 are broken down as follows:

 

(thousands of euros)		6/30/2019
Less than one year			3,162
One to five years			13,773
More than five years			7,265
Total			24,200

As of June 30, 2019, the interest expense on lease liabilities amounted €521 thousand.

Note 15: Off balance sheet commitments

Except for the lease obligations presented in Notes 3.1 and 15, no significant changes occurred in contingent liabilities between December 31, 2018 and June 30, 2019.

 

22