GENFIT : 2016 Results: Cash position at end of period at €152M and significant advances in the Company's pipeline

8 februari 2017

2016 Results: Cash position at end of period at €152M and significant advances in the Company's pipeline

• 2016 results reflect the significant acceleration of the Phase 3 RESOLVE-IT study in elafibranor in NASH
• Major scientific advances in the other programs: biomarkers, liver fibrosis and TGFTX1
• Active recruitment of patients in the Phase 2 study in PBC and launch of a Phase 2 study of a new drug candidate in liver fibrosis planned for 2017

Lille (France), Cambridge (Massachusetts, United States), February 8, 2017 - GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical group at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces its financial results for 2016.  A summary of the consolidated financial statements is included in this press release.  The full year 2016 consolidated financial statements are available from the "Investors" page of the GENFIT website.

Jean-François Mouney, Chairman & CEO of GENFIT, commented:

"Our 2016 financial results mainly reflect the significant acceleration of the RESOLVE-IT study of elafibranor in NASH, which will expand considerably in 2017.  They also reflect the efforts and scientific advances realized in other important programs in our pipeline such as our NASH biomarkers program, our liver fibrosis program and our TGFTX1 (RORgt) program.

Thanks to the capital increases carried out during the year, we have a cash position of slightly more than €150 million.  We are therefore able to continue our investments in our programs in accordance with our plans without incurring any pressing constraints and keeping open our options for potential partnerships.

2016 was also a particularly eventful year on the regulatory front, punctuated in particular by:
- FDA approval to launch a Phase 2 study of elafibranor in PBC;
-The positive opinion of the EMA on the Paediatric Investigtation Plan for elafibranor in NAFLD/NASH.

We should therefore be in a position to announce in 2017 the operational launch or other important milestones for the Company, including:
- end of recruitment of patients in the RESOLVE-IT study, for the first stage of the study, which, if the intermediary results are satisfactory, could lead to Subpart H conditional marketing authorization during the second half of 2019 or the first half of 2020;
- implementation of the regulatory pathway for our biomarkers for NASH diagnosis;
- active recruiting of patients in the Phase 2 study of elafibranor in PBC;
- launch of a Phase 2 study with a new candidate in liver fibrosis.

We're also actively exploring combination therapies for the treatment of NASH.

The coming years should allow GENFIT to make a decisive contribution in bringing treatments to patients with unmet needs due to lack of or insufficient treatment options, whether they suffer from NASH, PBC or liver fibrosis of various origins.

These patients share the risk of rapidly evolving into liver cirrhosis and for some, face considerable cardiovascular complications. Because the public health risks are serious, we also intend to do our part in NASH disease awareness destined to inform these patients, their families but also the medical profession with the ramp-up of The NASH Education Program in 2017."

Main financial results:

Key aspects of the full year 2016 results are:

• cash and cash equivalents and current financial instruments of €152.4 million at December 31, 2016 (€60.1 million at December 31, 2015) reinforced by several capital raises during the period in a context of a significant increase in current and projected operating expenses relating to the progression of the R&D portfolio. At the same date, net cash amounted to €146 million (€54.4 million at December 31, 2015);
   
• Operating income of €6.8 million (€4.4 million at  December 31, 2015) essentially from :
  • the Research Tax Credit, which amounted to €6.0 million in 2016 compared with €3.7 million in 2015;
  • industrial revenues of €0.28 million in 2016 compared with €0.53 million in 2015.
     
• Operating expenses of €40.9 million in 2016 (€22.0 million in 2015) of which 80% represented R&D expenses. The increase in operating expenses is mainly due to the :
  • increase in contracted research and development activities conducted by third parties resulting from the progression of the R&D program pipeline, of which the majority relate to expenses for the Phase 3 study of elafibranor in NASH;
  • increase in personnel expenses due to an increase in headcount (from 97 at December 31, 2015 to 119 at December 31, 2016) and changes in compensation and bonuses awarded to personnel in accompanying the development of the Group in 2016.
     
• As a result of changes in revenues and expenses, a net loss of €33.7 million at December 31, 2016 (€17.1 million at December 31, 2015).

The following table summarizes the Consolidated Statement of Operations under IFRS for the 2016 fiscal year, with comparative figures for the 2015 fiscal year.

		Year ended
(in € thousands, except earnings per share data)		2015/12/31	2016/12/31
Revenues and other income
Revenue		527	284
Other income		3 831	6 499
Revenues and other income		4 358	6 783
Operating expenses and other operating income (expenses)
Research & development expenses		(16 360)	(32 959)
General & administrative expenses		(5 630)	(7 938)
Other operating income		2	(2)
Other operating expenses		(47)	(42)
Operating loss		(17 676)	(34 158)
Financial revenue		642	729
Financial expenses		(100)	(203)
Financial income		542	526
Income tax		(0)	(35)
Net loss		(17 135)	(33 667)

The summary IFRS consolidated financial statements at December 31, 2016 as well as the management discussion of the results, are presented in the appendix at the end of this document.

Main developments in the R&D pipeline programs during the second half 2016

Elafibranor

Elafibranor is GENFIT's lead pipeline product. Elafibranor is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH).

NASH is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer. Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.

Elafibranor is currently being evaluated in this disease in a Phase 3 clinical trial RESOLVE-IT in patients who have continued to be recruited and treated during the course of the second half of 2016.

Subject to satisfactory clinical results obtained during the first stage of this study in a first group of approximately 1,000 patients, which GENFIT anticipates can be recruited by the Summer of 2017 and the authorization of the regulatory agencies, a conditional marketing authorization could be obtained for elafibranor in NASH during the course of the second half of 2019 or first half of 2020.

During the second half 2016, GENFIT also received the approval of European Medicines Agency's Paediatric Committee of GENFIT's Paediatric Investigation Plan (PIP) for elafibranor in the treatment of NAFLD (Non-Alcoholic Fatty Liver Disease), including NASH. Following the opinion of the Committee, GENFIT began its first PIP juvenile toxicology studies.

GENFIT also received the approval of the Food and Drug Administration (FDA) to launch a Phase 2 study evaluating elafibranor in Primary Biliary Cholangitis (PBC), a new indication.

PBC is a rare, chronic disease, with unmet need and only two molecules having orphan drug designation approved to date. This disease is characterized by the gradual destruction of the bile ducts in the liver which can inhibit the liver's ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis. Current treatments only cure a fraction of the patient population, and/or generate important side effects such as pruritus, which is a major and well-known symptom already affecting most PBC patients.

Following this approval, GENFIT launched a multicenter, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of elafibranor after 12 weeks of treatment in patients with PBC and inadequate response to ursodeoxycholic acid. The primary objective is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase (ALP) in these patients, based on relative change versus placebo. The first patient is expected to be recruited in Spring 2017.

Potential combination therapies using elafibranor in NASH with compounds from other GENFIT programs, compounds already marketed in other indications or compounds in development in NASH are also being evaluated by GENFIT.

NASH biomarker program (BMGFT03)

In order to propose an alternative to the standard method of diagnosing NASH patients, which consists of carrying out costly and invasive liver biopsies, GENFIT is researching, through the BMGFT03 program, new biomarkers allowing for the identification, without biopsy, of NASH patients to be treated with elafibranor or other relevant drug.

In particular, GENFIT demonstrated the interest of miRNAs as new NASH biomarkers, and seeks to optimize their diagnostic value in combination with other clinical, biochemical and/or imaging variables. GENFIT has filed several patent applications on algorithms linking certain miRNAs to other typical biochemical variables.

The RESOLVE-IT Phase 3 trial is an essential element in the clinical validation required for FDA approval in the United States and CE marking in Europe, and also for the distribution of these new diagnostic tools.

In addition to RESOLVE-IT, GENFIT launched a large scale validation and qualification program for the same tools in other cohorts in order to measure the level of circulating miRNAs in thousands of NAFLD patients (NASH and non-NASH) and their performance in the diagnosis of liver lesions - as well as their evolution.

As such, during the second half 2016, GENFIT signed a first collaboration agreement with Antwerp University Hospital, Belgium through which the Company has access to a cohort of obese patients as well as related liver biopsies and blood samples. The first analyses from the validation sought from this cohort confirmed the predictive nature of the miRNAs identified by GENFIT as NASH biomarkers.

TGFTX1 program (RORgt )

As part of ambitious efforts to diversify the portfolio of GENFIT's proprietary drug candidates for the treatment of autoimmune, inflammatory and fibrotic diseases, GENFIT has invested these last three years in the design and optimization of novel RORgt inverse agonists.

RORgt is a lineage commitment factor for several classes of leukocytes that produce and secrete interleukin 17 (IL-17), an important regulatory factor in the immune system. Dysregulation and pathologic roles of IL-17 signaling were reported in many systemic diseases that concern hundreds of millions of patients around the world, including but not limited to chronic inflammatory and autoimmune diseases such as psoriasis, multiple sclerosis, rheumatoid arthritis, COPD, neutrophilic asthma, fibrotic chronic liver diseases and certain cancers.

During the course of the second half 2016, GENFIT crossed a critical development path in validation of drug candidates that will enter the path of regulatory pre-IND studies. These candidates are highly potent and selective against other members of the ROR nuclear receptor family, and interfere with IL-17 production in human blood leukocytes. GENFIT expects to begin these studies in Spring 2017.

Main corporate developments

Capital raises

During the second half 2016, GENFIT carried out a private placement, immediately followed by a rights issue with preferential subscription rights to existing shareholders, which allowed the Company to raise gross proceeds respectively of, €33.9 million and €44.6 million (the total demand for the second transaction was approximately €155 million).

The €78.5 million in gross proceeds raised provided GENFIT with additional means to fund its strategy, and more specifically to:

• continue the development of the Phase 3 clinical program for elafibranor in NASH, in particular, through the RESOLVE-IT pivotal study;
• continue the development of the related biomarkers program (BMGFT03);
• initiate the pediatric study of elafibranor in NASH;
• commence clinical development of elafibranor in PBC;
• progress its other proprietary research programs and in particular, programs targeting fibrosis; and
• prepare market access for elafibranor in NASH by reinforcing different teams within the Company.

Human resources

In line with its development, in 2016, GENFIT increased headcount by 22 new employees in particular to reinforce its clinical development teams dedicated to the RESOLVE-IT study and the launch of the Phase 2 study in PBC. At December 31, 2016, GENFIT Group headcount was 119 employees. Additional recruitments are planned in 2017.

In July 2016, GENFIT opened a secondary establishment in Paris, with 150m ² of office space for new employees based in Ile-de-France (Paris region).

In December 2016, the Executive Board used the 25 ^th and 26 ^th authorizations of the June 21, 2016 Extraordinary Shareholders Meeting to grant stock options and free shares to its employees and officers.  The exercise of the stock options and the definitive grant of the free shares put in place in 2016 are subject to collective internal and external performance conditions evaluated over a period of three years, reflecting the mid-term interests of GENFIT.

Launch of The NASH Education Program ^TM , a not-for-profit endowment fund

In order to significantly contribute to the global effort that must be engaged to increase NASH disease awareness, GENFIT created in November 2016, a not-for-profit endowment fund, The NASH Education Program ^TM , whose purpose is to develop and fund disease awareness activities aimed at the medical community and general public.

In particular, this endowment fund will draw on the data generated by the NASH patient registry developed since July 2016 by Pinnacle Clinical Research Center in San Antonio, Texas (United States), with the financial assistance of GENFIT. The proactive follow-up of the patients participating in the registry will allow for the collection and dissemination of crucial information in improving knowledge about the disease, and in particular, the co-morbidities related to NASH.

Main upcoming events:

• Leerink 6th Annual Global Healthcare Conference, February 15-16, 2017, New York, NY USA
• Barclay's Capital Global Healthcare Conference, March 14-16, 2017, Miami, FL USA
• NASH Summit 2017, April 4-6, 2017, Cambridge, MA - USA
• The International Liver Congress ^TM 2017, April 19-23, 2017, Amsterdam, The Netherlands

APPENDICES

GENFIT

Consolidated Annual

Financial Results

At December 31, 2016

The Statements of Financial Position, Statements of Operations and Statements of Cash Flow of the Group were prepared in accordance International Financial Reporting Standards (IFRS).

The audit procedures on the consolidated financial statements have been performed. The consolidated financial statements for the year ended December 31, 2016 were approved by the Executive Board on February 1, 2017. These statements were reviewed by the Supervisory Board on February 7, 2017 and will be submitted for approval to the Shareholders' General Meeting on June 16, 2017.

The full consolidated financial statements as well as the notes to the consolidated financial statements for the year ended December 31, 2016 are available on GENFIT's website. GENFIT's annual financial report, included in the registration document, will be available on GENFIT's website in April 2017.

Consolidated Statement of Financial Position

ASSETS		As of
(in € thousands)		2015/12/31	2016/12/31
Non-current assets
Intangible assets		563	668
Property, plant & equipment		1 324	3 010
Non current trade & others receivables		7	0
Other non-current financial assets		612	541
Total - Non-current assets		2 505	4 219
Current assets
Inventories		28	14
Current trade & others receivables		5 998	8 394
Other current financial assets		31	174
Other current assets		585	1 137
Cash & cash equivalents		60 111	152 277
Total - Current assets		66 753	161 996
Total - Assets		69 258	166 214
EQUITY & LIABILITIES		As of
(in € thousands)		2015/12/31	2016/12/31
Shareholders' equity
Share capital		5 990	7 792
Share premium		118 038	237 305
Retained earnings		(51 492)	(68 654)
Currency translation adjustment		15	21
Net loss		(17 135)	(33 667)
Total shareholders' equity - Group share		55 416	142 797
Non-controlling interests		0	0
Total - Shareholders' equity		55 416	142 797
Non-current liabilities
Non-current loans & borrowings		4 482	5 004
Non-current deferred income and revenue		5	3
Non-current employee benefits		743	849
Total - Non-current liabilities		5 229	5 855
Current liabilities
Current loans & borrowings		1 223	1 248
Current trade & other payables		7 292	16 146
Current deferred income and revenue		29	1
Current provisions		69	167
Total - Current liabilities		8 613	17 562
Total - Equity & liabilities		69 258	166 214

Statement of Operations

		Year ended
(in € thousands, except earnings per share data)		2015/12/31	2016/12/31
Revenues and other income
Revenue		527	284
Other income		3 831	6 499
Revenues and other income		4 358	6 783
Operating expenses and other operating income (expenses)
Research & development expenses		(16 360)	(32 959)
General & administrative expenses		(5 630)	(7 938)
Other operating income		2	(2)
Other operating expenses		(47)	(42)
Operating loss		(17 676)	(34 158)
Financial revenue		642	729
Financial expenses		(100)	(203)
Financial income		542	526
Income tax		(0)	(35)
Net loss		(17 135)	(33 667)
Attributable to owners of the Company		(17 135)	(33 667)
Attributable to non-controlling interests		0	0
Basic / diluted loss per share attributable to shareholders of Genfit
Basic earnings per share (€/share)		(0.71)	(1.25)

Statement of Cash Flows

		Year ended	Year ended
(in € thousands)		2015/12/31	2016/12/31
Cash flows from operating activities
+ Net loss		(17 135)	(33 667)
Reconciliation of net loss and of the cash used for operating activities
Adjustments for:
+ Amortization		327	630
+ Depreciation & impairment charges		237	186
- Expenses related to share-based compensation		2 012	11
- Gain / (loss) on disposal of property, plant & equipment		²3	0
- Net finance expenses / (revenue)		(27)	45
- Income tax expense		0	35
+ Other non-cash items		10	(338)
Operating cash flows before change in working capital		(14 572)	(33 098)
Change in:
Decrease (+) / increase (-) in inventories		219	14
Decrease (+) / increase (-) in trade receivables & other assets		946	(2 942)
Decrease (-) / increase (+) in trade payables & other liabilities		(1 462)	8 828
Change in working capital		(298)	5 900
Income tax paid		0	(28)
Net cash flows provided by (used in) operating activities		(14 870)	(27 226)
Cash flows from investment activities
- Acquisition of property, plant & equipment		(790)	(2 036)
+ Proceeds from disposal of property, plant & equipment		2	(0)
- Acquisition of financial instruments		(16)	(51)
+ Proceeds from sale of financial instruments		4 300	0
- Acquisition of subsidiary, net of cash acquired		0	0
Net cash flows provided by (used in) investing activities		3 496	(2 086)
Cash flows from financing activities
+ Proceeds from issue of share capital (net)		2	121 007
+ Proceeds from subscription / exercise of share warrants		267	50
+ Proceeds from new loans & borrowings		807	1 500
- Repayments of loans & borrowings		(1 609)	(1 034)
- Financial interests paid (including finance lease)		13	(43)
Net cash flows provided by (used in) financing activities		(520)	121 480
Increase / (decrease) in cash & cash equivalents		(11 894)	92 167
Cash & cash equivalents at the beginning of the period		72 005	60 111
Cash & cash equivalents at the end of the period		60 111	152 277

Discussion of the 2016 annual results

Revenue and other income

The Company's revenue and other income results, in particular, from its revenues, government grants, other operating income and, mainly the research tax credit.

Revenues and other income amounts to €6,783k for 2016 compared to €4,358k for the previous year representing an increase of 56%, broken down as follows:

Revenue and other income		Year ended
(in € thousands)		2015/12/31	2016/12/31
Revenues		527	284
Other income		3 831	6 499
TOTAL		4 358	6 783

Revenues

Revenues totaled €284k for 2016 compared to €527k for the previous year, or a decrease of 46%. The decrease in revenues between the two periods is mainly due to the end of the research phase shared by the scientific teams of both parties in the collaborative research alliance with Sanofi, which expired in May 2015.

Other income

Other income		Year ended
(in € thousands)		2015/12/31	2016/12/31
Government grants		12	411
Research tax credit		3 705	5 964
Other operating income		114	124
TOTAL		3 831	6 499

Other income, which includes government grants, other operating income, and the Research Tax Credit, totaled €6,499k in 2016 compared with €3,831k in the previous year, or an increase of 70%. This increase is mainly due to the Research Tax Credit, which amount to €5,964k in 2016 compared to €3,705 in 2015, in the context of an increase in 2016 of expenses of contracted research and development activities conducted by third parties registered with respect to the progression of the RESOLVE-IT Phase 3 clinical study (see in particular, (ii) "operating expenses and other operating income by destination" below).

Operating expenses and other operating income by destination

The tables below break down operating expenses by destination into research and development expenses on the one hand, and general and administrative expenses on the other, for the years ended December 31, 2016 and 2015.

Operating expenses and other operating income (expenses)	Year ended		Of which:
	2015/12/31		Raw materials	Contracted	Employee	Other	Depreciation,	Gain / (loss)
			& consumables	research &	expenses	expenses	amortization	on disposal of
			used	development		(maintenance, fees,	& impairment	property, plant
				activities		travel, taxes.)	charges	& equipment
				conducted by
(in € thousands)				third parties
Research & development expenses		(16 360)	(1 863)	(5 389)	(6 289)	(2 356)	(459)	(3)
General & administrative expenses		(5 630)	(68)	(0)	(2 840)	(2 675)	(46)	0
Other operating income		2	0	0	0	1	0	1
Other operating expenses		(47)	0	0	0	(43)	(2)	(2)
TOTAL		(22 034)	(1 930)	(5 390)	(9 130)	(5 074)	(508)	(3)
Operating expenses and other operating income (expenses)	Year ended		Of which:
	2016/12/31		Raw materials	Contracted	Employee	Other	Depreciation,	Gain / (loss)
			& consumables	research &	expenses	expenses	amortization	on disposal of
			used	development		(maintenance, fees,	& impairment	property, plant
				activities		travel, taxes.)	charges	& equipment
				conducted by
(in € thousands)				third parties
Research & development expenses		(32 959)	(1 894)	(19 187)	(7 334)	(3 876)	(667)	0
General & administrative expenses		(7 938)	(91)	(0)	(4 321)	(3 395)	(131)	0
Other operating income		(2)	0	0	0	0	0	(2)
Other operating expenses		(42)	0	0	0	(44)	(0)	2
TOTAL		(40 941)	(1 985)	(19 187)	(11 656)	(7 315)	(799)	(0)

Operating expenses in 2016 amounted to € (40,941)k in 2016 compared to €(22,034)k in 2015, or an 86% increase. They include, in particular:

      ·         research and development expenses, which include the wages and salaries paid to the research staff (€7,334k in 2016 compared to €6,289k in 2015), the cost of consumables and contracted research and development activities conducted by third parties (particularly clinical and pharmaceutical representing €19,187k in 2016 compared to €5,389k in 2015), and expenses related to intellectual property. These research and development expenses amounted to €32,959k in 2016 compared with €16,360k in 2015, or 80% and 74% of operating expenses, respectively.

2016 saw an increase in clinical development expenses related to the progression of the Phase 3 RESOLVE-IT study evaluating elafibranor in NASH while 2015 was a transitional year in this respect, punctuated by the end of the GOLDEN 505 Phase 2b pivotal study and the launch, at the very end of the year of the RESOLVE-IT Phase 3 pivotal study. Other programs also generated contracted research and development activities conducted by third parties in 2016 and in 2015, but in smaller amounts than those related to the development of elafibranor because they are at an earlier stage in their development. Changes in expenses for research personnel are mainly related to the increase in headcount (89 compared to 74) and the impact of bonuses granted to these employees for their implication in the Group's development, and in particular, related to the implementation of an incentive plan in 2016.

      ·         General and administrative expenses, which include the costs of personnel not assigned to research (€4,321k in 2016 compared to €2,840k in 2015), and the administrative and commercial costs. These general and administrative expenses amounted to €7,938k in 2016 compared with €5,630k in 2015, or 19% and 26% of operating expenses, respectively.

Changes in expenses for personnel not assigned to research is mainly related to an increase in headcount (30 compared to 23) and the impact of bonuses granted to these employees for their implication in the Group's development, and in particular, related to the implementation of an incentive plan in 2016.

Operating expenses and other operating income by type

Broken down by type instead of by destination, operating expenses mainly included the following:

 

Contracted research and development activities conducted by third parties

 

Contracted research & development activities conducted by third parties		Year ended
(in € thousands)		2015/12/31	2016/12/31
Research & development expenses		(5 389)	(19 187)
General & administrative expenses		(0)	(0)
Other operating income		0	0
Other operating expenses		0	0
TOTAL		(5 390)	(19 187)

Contracted research and development activities conducted by third parties amounted to €(19,187)k in 2016 compared with €(5,390)k in 2015, corresponding to a 256% increase, which is mainly due to the progression of the launch of Phase 3 clinical study (RESOLVE-IT) in elafibranor.

Employee expenses

Employee expenses				Year ended
(in € thousands)			2015/12/31		2016/12/31
Research & development expenses			(6 289)		(7 334)
General & administrative expenses			(2 840)		(4 321)
Other operating income			0		0
Other operating expenses			0		0
TOTAL			(9 130)		(11 656)

Employee expenses excluding share-based compensation amounted to €(11,645)k in 2016 compared to €(7,118)k in 2015, or a 64% increase mainly to an increase in headcount (119 compared to 97) and the impact of bonuses granted to these employees for their implication in the Group's development.

 

The amount recognized as share-based compensation (share warrants (BSAs), redeemable share warrants (BSAARs), stock options (SO) and free shares (AGA)) free of any impact on cash flow went from €2,012k in 2015 to €11k in 2016. Included in the amount for 2016 are the expenses related to the December 2016 SO and AGA plans. For more information, see note 6.21 - "Financial revenue and expenses" to the consolidated financial statements for the year ended December 31, 2016 available on GENFIT's website.

Other expenses

Other expenses (maintenance, fees, travel, taxes.)		Year ended
(in € thousands)		2015/12/31	2016/12/31
Research & development expenses		(2 356)	(3 876)
General & administrative expenses		(2 675)	(3 395)
Other operating income		1	0
Other operating expenses		(43)	(44)
TOTAL		(5 074)	(7 315)

Other expenses amount to €(7,315)k in 2016 compared to €(5,074)k in 2015. They include, in particular:

 

• "fees", which include legal, audit, and accounting fees, the fees of various advisors (press relations, investor relations, communication, IT), the external staff seconded to the Company (guard, security and reception), as well as the fees of some of its scientific advisers. This amount also includes Intellectual Property expenditures corresponding to fees incurred by the Company in connection with the registration and protection of its patents;
   
• expenses related to the rental, use, and maintenance of the Company's offices;
   
• expenses related to business travel and conferences, which essentially include the staff's travel expenses as well as the costs of participation in scientific, medical, financial, and business development conferences.

 

This change is mainly due to the faster pace of development of the Group's business and its stronger presence in the United States.

 

Financial income

 

Financial income totals €526k in 2016 compared to €542k in the previous year.

Net income

The year resulted in a net loss of €33,667k compared to a net loss of €17,135k in 2015.

Balance sheet items
At December 31, 2016, the total amount of the Group's Statement of Financial Position amounts to €166,214k compared to € 69,258k for the previous year.

At December 31, 2016, the Group had cash, cash equivalents and current financial instruments of €152,372k compared with €60,142 at December 31, 2015.

Non current assets

Non-current assets, which include goodwill and intangible, tangible, and financial assets, increased from €2,505k at December 31, 2015 to €4,294k at December 31, 2016. This increase is mainly due to investments made during the year (IT, telecommunications, renovations and scientific equipment).

Current assets

Current assets amount to €161,920k at December 31, 2016 compared to €66,753k as of December 31, 2015.

The change in trade and other receivables relates to receivables from the research tax credit for the 2014 and 2016 fiscal years. For the 2014 fiscal year, the French tax administration partially repaid in advance the research tax credit, after deduction as a precautionary measure, of the tax adjustment of €1,141k that the Company contests and which remain due.

The change in trade and other receivables corresponds to the increase in expenses recognized in advance related to current operating expenses.

Cash and cash equivalents increased from €60,111 thousand at December 31, 2015 to €152,277k at December 31, 2016, an increase of 153%. Available cash is mainly invested in highly liquid short-term investments presenting a low risk of change in value.

Cash & cash equivalents		As of
(in € thousands)		2015/12/31	2016/12/31
Short-term deposits		59 683	150 438
Cash & bank accounts		428	1 839
TOTAL		60 111	152 277

Shareholders' equity

At December 31, 2016, the amount of the Group's shareholders' equity totaled €142,797k compared to €55,416k as of December 31, 2015. 

The change in the Company's shareholders' equity is mainly due to three share capital increases carried out in 2016, and the year's loss, which reflects the Company's efforts in research and development, the completion of preclinical studies, and the clinical studies for elafibranor.

Non current liabilities

This mainly concerns the following liabilities reaching maturity in more than one year:

• conditional advances granted to GENFIT SA by BPI France for the purpose of financing the Company's research programs (for more information, see note 6.12.1.1 "Refundable and conditional advances" to the consolidated financial statements for the year ended December 31, 2016 available on GENFIT's website; and
• bank loans.

Current liabilities

This balance sheet item mainly includes liabilities reaching maturity in less than one year, such as conditional advances granted by BPI France to GENFIT, the development loan with a participation feature granted by BPI France, bank loans, trade payables, and social security expenses. Changes in current liabilities are essentially due to, as indicated above, the increase in contracted research and development activities. See also notes 6.13 "Trade and other payables" and 6.14 "Deferred income and revenue" to the consolidated financial statements for the year ended December 31, 2016 available on GENFIT's website.

Trade & other payables - Current		As of
(in € thousands)		2015/12/31	2016/12/31
Trade payables		5 275	13 341
Social security costs payables		1 832	2 562
Employee profit sharing		17	17
VAT payables		27	24
Taxes payables		129	187
Other payables		11	14
TOTAL		7 292	16 146

Cash flows

Consolidated statement of cash flows		Year ended
(in € thousands)		2015/12/31	2016/12/31
Cash flows from operating activities		(14 870)	(27 226)
Cash flows from investing activities		3 496	(2 086)
Cash flows from financial activities		(520)	121 480
Net increase / (decrease) in cash & cash equivalents		(11 894)	92 167

Cash flow from operating activities

In 2016, cash flow from operating activities amounted to €(27,226)k compared to €(14,870)k in 2015.

This negative cash flow is a direct consequence of the industry in which GENFIT operates, which requires significant research and development efforts and generates costs that fluctuate based on the state of development of the Company's proprietary research programs. There is currently no corresponding revenue stream to offset said expenditures.

Cash flow from investment activities

Cash flow from investment activities was €(2,086)k in 2016 compared to €3,496k in 2015.

This change is mainly due to:

• financial assets restated as cash equivalents post-redemption ; these financial assets were negotiable medium-term notes and were sold, the available funds were thus used or placed in instruments that met the criteria for cash equivalents; and
• acquisition of capital assets.

Cash flow from financing activities

In the 2016 and 2015 fiscal years, cash flow from financing activities amounted to €121,480k and €(520)k, respectively. This significant change is mainly due to the absence of any share capital increases in 2015, and raising a total gross amount of €128.1 million via the following three transactions:

• A share capital increase via private placement in February 2016 with gross proceeds of €49.6 million;
• A share capital increase via private placement in October 2016, with gross proceeds of €33.9 million;
• A share capital increase with preferential subscription rights to existing shareholders in November 2016 with gross proceeds of €44.6 million.

Generally speaking, these transactions have enabled GENFIT to improve its financial position and continue deploying its development strategy, by giving it the means to maintain investment levels in research for its various ongoing programs and, in particular, for its drug candidate elafibranor.

The other elements of cash flow are:

• New loans and public financing

In 2016, the Company took out new loans in a total amount of €1,500k.

In 2015, the Company took out a new €500k loan with Crédit Industriel et Commercial and received €305k in connection with various financial aid initiatives for innovation and repayable advances.   

• Repayment of loans and public financing

In 2016, the Company repaid €133k in repayable and conditional advances and €892k in bank loans and a loan with a participation feature.

In 2015, the Company repaid €650k in repayable and conditional advances and €931.2k in bank loans and a loan with a participation feature.

Subsequent events to December 31, 2016

On January 27, 2017, the Company received an assessment notice in the amount of €1,479k relating to the tax dispute described in note 6.24 "Litigation and contingent liabilities" to the consolidated financial statements for the year ended December 31, 2016 available on GENFIT's website.

The Company intends to use all available remedies to contest this assessment notice, with the knowledge that the tax administration remains liable to the Company in an amount of €1,141k for the 2014 CIR.

Registration Document including the Annual Financial Report

The Group intends to file with the French Financial markets authority ( Autorité des Marchés Financiers ) a registration document including an annual financial report for 2016. This document should be available on the Company's website (www.genfit.com) in April 2017.

About GENFIT:

GENFIT is a biopharmaceutical company focused on the discovery and development of drug candidates in areas of high unmet medical needs corresponding to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT's R&D efforts are focused on bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) and more generally the gastro-intestinal arena. GENFIT's approach combines novel treatments and biomarkers. Its lead proprietary compound, elafibranor, is currently in a Phase 3 study. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 120 employees. GENFIT is a public company listed in compartment B of Euronext's regulated market in Paris (Euronext: GNFT - ISIN: FR0004163111). www.genfit.com

Forward Looking Statement / Disclaimer:

This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, including related to biomarkers, progression of, and results of clinical data from, the RESOLVE-IT trial, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding in particular, elafibranor in NASH and PBC, as well as other indications, and biomarkers, the success of any inlicensing strategies, the Company's continued ability to raise capital to fund its development, as well as those discussed or identified in the Company's public filings with the AMF, including those listed under Section 7 "Main Risks and Uncertainties"of the Company's Half Year 2016 Business and Financial Report, which is available on GENFIT's website (www.genfit.com) and on the website of the AMF (www.amf-france.org). Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in GENFIT in any country. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

CONTACT

GENFIT | Jean-François Mouney - Chairman & CEO | Ph. +333 2016 4000
MILESTONES - Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 - barabian@milestones.fr

---