GENFIT: Reports Full-Year 2018 Financial Results: cash position of €207.2m as of 12.31.2018
GENFIT: Reports Full-Year 2018 Financial Results:
cash position of €207.2m as of 12.31.2018
GENFIT achieved significant development milestones in 2018:
- Completed enrollment of interim analysis cohort for phase 3 RESOLVE-IT trial in NASH
- Announced positive results in phase 2 trial of elafibranor in PBC
- Entered into licensing agreement with LabCorp® for NASH diagnostic
- Launched a U.S. phase 2 investigator-initiated trial of nitazoxanide in patients with NASH-induced fibrosis
Cash position of €207.2 million as of December 31, 2018, compared to €273.8 million as of December 31, 2017
Lille (France), Cambridge (Massachusetts, United States), February 4, 2019 - GENFIT (Euronext: GNFT - ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announces its annual financial results for 2018. A summary of the consolidated financial statements is included below.
Jean-François Mouney, Chairman & CEO of GENFIT, commented: "The lead programs in our clinical and diagnostic pipeline, in particular the later-stage ones in NASH and PBC, have moved forward considerably and met our corporate 2018 milestones. We completed enrollment for the interim analysis cohort of our phase 3 RESOLVE-IT trial of elafibranor in NASH, achieved positive results in the phase 2 trial of elafibranor in PBC and accomplished significant milestones in the regulatory and commercial development of our biomarker program, leading to the signature of a licensing agreement with LabCorp® in early January this year. Our objective with this agreement is, in particular, to expand access to NIS4, GENFIT's non-invasive in vitro diagnostic test, in order to identify NASH patients who should be considered for therapeutic intervention. Our program to reposition nitazoxanide in liver fibrosis took shape with the launch of a U.S. phase 2 trial in patients with NASH induced fibrosis. Additional pre-clinical research results completed in 2018 suggest that elafibranor is uniquely positioned as a backbone for combination therapies in NASH, including with our nitazoxanide program.
Finally, we believe our strong cash position allows GENFIT substantial flexibility as we prepare for a potential conditional marketing authorization for elafibranor in NASH in 2020."
Key 2018 R&D Developments
January 2018
- GENFIT announced the official launch of elafibranor in pediatric NASH, following an agreement from the U.S. Food and Drug Administration (FDA) on the Company's pediatric study plan (PSP).
April 2018
- GENFIT announced completion of the target recruitment for the interim analysis cohort of the phase 3 RESOLVE-IT trial of elafibranor in NASH.
- GENFIT also announced the positive outcome from the 24-month pre-planned safety review by the Data Safety Monitoring Board (DSMB) in the RESOLVE-IT phase 3 clinical trial with elafibranor.
June 2018
- GENFIT announced new preclinical study results suggesting that elafibranor has anti-tumor development activity in the context of NAFLD/NASH-induced hepatocellular carcinoma (HCC).
August 2018
- GENFIT announced the achievement of the full enrollment in the phase 2 trial of elafibranor in PBC ,a major milestone
October 2018
- GENFIT presented new data at the annual AASLD conference confirming:
- the diagnostic performance of its NIS4 algorithm in identifying, in a non-invasive way, NASH patients eligible to therapeutic intervention.
- elafibranor's potential as cornerstone drug in combination therapies for NASH; and
- elafibranor's potential in treating hepatic cancer (HCC)
December 2018
- GENFIT announced the initiation of a phase 2 investigator-initiated clinical trial evaluating nitazoxanide) in patients with NASH-induced fibrosis.
- GENFIT also announced positive results from its phase 2 trial of elafibranor in PBC.
- Elafibranor met the primary endpoint of the Phase 2 clinical trial, which was the change at week 12 in serum alkaline phosphatase (ALP) from baseline. Both elafibranor doses demonstrated significant decrease in mean ALP: -48% for 80 mg -41% for 120 mg with +3% increase for placebo leading to highly significant treatment effect versus placebo: -52% for 80 mg (p<0.001) and -44% for 120 mg (p<0.001).
- On the composite endpoint of the responder rate for patients achieving serum ALP <1.67xUpper Limit of Normal (ULN), an ALP decrease >15%, and total bilirubin (TB) <ULN, elafibranor achieved the substantially higher response rates of 67% for 80 mg and 79% for 120 mg as compared to 6.7% for placebo (p=0.001 and p<0.001, respectively).
- GENFIT provided an update in December on the positive outcome from the 30-month pre-planned safety review by the DSMB in the RESOLVE-IT phase 3 clinical trial with elafibranor.
January 2019
- GENFIT announced it had signed a licensing agreement with LabCorp® to expand access to its NIS4 test for the identification and monitoring of patients with NASH and significant fibrosis in the clinical research market. The objective of this test is to provide these actors with a non-invasive diagnostic tool to identify and monitor patients with NASH and advanced stage fibrosis.
Other Corporate Events
- On June 12, 2018, the Company, through the endowment fund it founded, The NASH Education Program(TM), organized the first International NASH Day, which garnered significant interest from the international scientific and medical communities, patients and media.
Full-Year 2018 Financial Results (consolidated IFRS accounts) (*)
A summary of the key aspects of GENFIT's 2018 annual results are:
- Cash, cash equivalents and other current financial assets of €207.2 million at December 31, 2018 (€273.8 million at December 31, 2017) in a context of a significant increase in operating expenses relating to the progression of the R&D pipeline;
- Operating income of €7.5 million (€6.9 million at December 31, 2017) essentially from the Research Tax Credit, which amounted to €7.3 million for 2018 compared with €6.5 million in 2017;
- Operating expenses of €77.0 million (€63.6 million in 2017) of which 87% represented R&D expenses. The increase in operating expenses is due to:
- the increase in contracted R&D expenses resulting from the progression of the R&D program pipeline, of which the majority related to expenses for the phase 3 elafibranor trial in NASH, and to a lesser extent, the phase 2 trial of elafibranor in PBC and the launch of the phase 2 trial of nitazoxanide;
- an increase in payroll expense, resulting mainly from changes in employee profiles, salary increases, and the increase in headcount (from 125 at December 31, 2017 to 148 at December 31, 2018); and
- an increase in other operating expenses in particular relating to intellectual property expenses and fees and expenses in the preparation for the commercialization of elafibranor in NASH.
- As a result of changes in revenues and expenses, a net loss of €79.5 million at December 31, 2018 (€55.7 million in 2017) (*).
(*) In the context of the preparation of its 2018 consolidated financial statements, the Company adjusted the financial statements previously published for the 2017 fiscal year under IFRS. These changes do not affect the cash position or the operating results, and are related to the application of IFRS to deferred taxes on the OCEANE bonds issued in October 2017. The corrections lead mainly to a decrease in the consolidated net loss of €2.9 million. More information is provided on Appendix 2.
- Net cash flows from operations in 2018 and 2017 were €(56.1) million and €(49.9) million respectively, mainly due to the increase in the Group's R&D activities;
- Net cash flows from investment activities were €(4.0) million in 2018 compared to €(2.9) million in 2017 ; this change is mainly due to the additional amount allocated to the liquidity agreement ;
- Net cash flows from financing activities in 2018 and 2017 amounted to, €(6.5) million and €174.3 million, respectively, following the issuance in 2017 of convertible bonds (OCEANE) due October 16, 2022 in a private placement to institutional investors for a nominal amount of approximately €180 million.
Year ended | |||
(in € millions) | 2017/12/31 (*) | 2018/12/31 | |
Revenues and other income | 6.9 | 7.5 | |
Research and development expenses | (54.2) | (67.0) | |
General and administrative expenses | (9.4) | (9.8) | |
Operating loss | (56.7) | (69.5) | |
Net loss | (55.7) | (79.5) | |
Net cash flows used in operating activities | (49.9) | (56.1) | |
Net cash flows used in investment activities | (2.9) | (4.0) | |
Net cash flows provided by / (used in ) financing activities | 174.3 | (6.5) | |
Increase / (decrease) in cash and cash equivalents | 121.5 | (66.6) | |
Cash, cash equivalents and current financial assets | 273.9 | 207.2 |
(*)In the context of the preparation of its 2018 consolidated financial statements, the Company adjusted the financial statements previously published for the 2017 fiscal year under IFRS. More information is provided on Appendix 2 below.
The summary IFRS consolidated financial statements for the year ended December 31, 2018 are presented in the appendix at the end of this press release. The 2018 annual consolidated financial statements are available on the "Investors" page of the GENFIT website.
Key 2019 Events
- February 12, 2019: Frankfurt European Midcap Event (Frankfurt, Germany)
- February 25-26, 2019: Global NASH Congress (London, UK)
- February 27-March 1, 2019: Leerink Annual Global Heathcare Conference (New York, NY - USA)
- March 12-14, 2019: Barclays Global Healthcare Conference (Miami, FL - USA)
APPENDIX 1
Annual Consolidated
Financial Results
at December 31, 2018
The Statements of Financial Position, Statements of Operations and Statements of Cash Flow of the Company 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 period ended December 31, 2018 were approved by Board of Directors on February 4, 2019 and will be submitted to the shareholders at the Shareholders' Meeting on June 13, 2019.
The full consolidated financial statements as well as the notes to the consolidated financial statements for the period ended December 31, 2018 are available on GENFIT's website under the "Investors" tab. The annual financial report, included in the registration document, will be available on GENFIT's website before the end of April 2019.
Consolidated Statement of Financial Position
ASSETS | As of | ||
(in € thousands) | 2017/12/31 (*) | 2018/12/31 | |
Non-current assets | |||
Intangible assets | 636 | 796 | |
Property, plant and equipment | 6 324 | 7 764 | |
Non-current trade and others receivables | 1 921 | 1 489 | |
Other non-current financial assets | 729 | 1 313 | |
Deferred tax assets | 0 | 0 | |
Total - Non-current assets | 9 611 | 11 362 | |
Current assets | |||
Inventories | 4 | 4 | |
Current trade and others receivables | 7 955 | 8 794 | |
Other current financial assets | 31 | 0 | |
Other current assets | 1 761 | 2 078 | |
Cash and cash equivalents | 273 820 | 207 240 | |
Total - Current assets | 283 572 | 218 116 | |
Total - Assets | 293 183 | 229 478 | |
SHAREHOLDERS' EQUITY AND LIABILITIES | As of | ||
(in € thousands) | 2017/12/31 (*) | 2018/12/31 | |
Shareholders' equity | |||
Share capital | 7 792 | 7 796 | |
Share premium | 251 932 | 251 554 | |
Accumulated deficit | (102 531) | (158 897) | |
Currency translation adjustment | (8) | 6 | |
Net loss | (55 728) | (79 521) | |
Total shareholders' equity - Group share | 101 457 | 20 939 | |
Non-controlling interests | 0 | 0 | |
Total - Shareholders' equity | 101 457 | 20 939 | |
Non-current liabilities | |||
Non-current convertible loans | 154 539 | 159 176 | |
Other non-current loans and borrowings | 6 978 | 7 255 | |
Non-current deferred income and revenue | 2 | 1 | |
Non-current employee benefits | 936 | 1 085 | |
Deferred tax liabilities | 2 165 | 1 773 | |
Total - Non-current liabilities | 164 620 | 169 291 | |
Current liabilities | |||
Current convertible loans | 1 329 | 1 312 | |
Other current loans and borrowings | 1 834 | 1 848 | |
Current trade and other payables | 23 580 | 35 974 | |
Current deferred income and revenue | 1 | 1 | |
Current provisions | 361 | 112 | |
Total - Current liabilities | 27 106 | 39 248 | |
Total - Shareholders' equity & liabilities | 293 183 | 229 478 |
(*)In the context of the preparation of its 2018 consolidated financial statements, the Company adjusted the financial statements previously published for the 2017 fiscal year under IFRS. More information is provided on Appendix 2 below.
Statement of Operations
Year ended | |||
(in € thousands, except earnings per share data) | 2017/12/31(*) | 2018/12/31 | |
Revenues and other income | |||
Revenue | 118 | 69 | |
Other income | 6 737 | 7 425 | |
Revenues and other income | 6 856 | 7 494 | |
Operating expenses and other operating income (expenses) | |||
Research and development expenses | (54 189) | (67 024) | |
General and administrative expenses | (9 421) | (9 793) | |
Other operating income (expenses) | 60 | (162) | |
Operating loss | (56 695) | (69 484) | |
Financial income | 642 | 728 | |
Financial expenses | (3 096) | (11 118) | |
Financial loss | (2 453) | (10 391) | |
Net loss before tax | (59 148) | (79 875) | |
Income tax expense | 3 420 | 354 | |
Net loss | (55 728) | (79 521) | |
Attributable to owners of the Company | (55 728) | (79 521) | |
Attributable to non-controlling interests | 0 | 0 | |
Basic and diluted loss per share | |||
Basic loss per share (€/share) | (1.79) | (2.55) |
(*)In the context of the preparation of its 2018 consolidated financial statements, the Company adjusted the financial statements previously published for the 2017 fiscal year under IFRS. More information is provided on Appendix 2 below.
Statement of Cash Flows
Year ended | Year ended | ||
(in € thousands) | 31/12/2017 | 31/12/2018 | |
Cash flows from operating activities | |||
+ Net loss | (55 728) | (79 521) | |
Reconciliation of net loss to net cash used in operating activities | |||
Adjustments for: | |||
+ Amortization | 1 226 | 1 819 | |
+ Depreciation and impairment charges | 186 | (208) | |
+ Expenses related to share-based compensation | 278 | 787 | |
- Gain / (loss) on disposal of property, plant and equipment | 8 | (2) | |
+ Net finance expenses | 2 296 | 10 971 | |
+ Income tax expense | (3 420) | (354) | |
+ Other non-cash items | 17 | 0 | |
Operating cash flows before change in working capital | (55 137) | (66 507) | |
Change in: | |||
Decrease / (increase) in inventories | 10 | (0) | |
Increase in trade receivables and other assets | (2 106) | (724) | |
Increase in trade payables and other liabilities | 7 364 | 11 056 | |
Change in working capital | 5 268 | 10 332 | |
Income tax paid | 13 | 93 | |
Net cash flows used in operating activities | (49 856) | (56 081) | |
Cash flows from investment activities | |||
- Acquisition of property, plant and equipment | (2 800) | (2 938) | |
+ Proceeds from disposal of property, plant and equipment | 15 | 3 | |
- Acquisition of financial instruments | (163) | (1 050) | |
+ Proceeds from sale of financial instruments | 0 | 0 | |
- Acquisition of subsidiary, net of cash acquired | 0 | 0 | |
Net cash flows used in investment activities | (2 948) | (3 986) | |
Cash flows from financing activities | |||
+ Proceeds from issue of share capital (net) | 0 | 0 | |
+ Proceeds from subscription / exercise of share warrants | 37 | 37 | |
+ Proceeds from new loans and borrowings net of issue costs | 177 338 | 1 800 | |
- Repayments of loans and borrowings | (1 655) | (2 000) | |
- Financial interests paid (including finance lease) | (1 372) | (6 351) | |
Net cash flows provided by / (used in ) financing activities | 174 348 | (6 514) | |
Increase / (decrease) in cash and cash equivalents | 121 544 | (66 580) | |
Cash and cash equivalents at the beginning of the period | 152 277 | 273 820 | |
Cash and cash equivalents at the end of the period | 273 820 | 207 240 |
APPENDIX 2
Correction for Technical Errors on the Annual Consolidated
Financial Results for the year ended December 31, 2017
In the context of the preparation of its 2018 consolidated financial statements, and in accordance with IAS 8, the Company adjusted the financial statements previously published for the 2017 fiscal year with respect to the accounting for the OCEANE issuance.
These changes were approved by the Board of Directors at its meeting on February 4, 2019.
These changes have no impact on the operating results or the cash position, and the impacts on the consolidated statements of operations, consolidated statements of financial position and the consolidated statements of changes in equity are presented below.
The following table shows the impact on the Net Income (Loss) for the 2017 fiscal year, compared to previously published figures:
Year ended | Correction: | Correction: | Year ended | See | ||
2017/12/31 | proper effective | proper | 2017/12/31 | explanatory | ||
as published | interest rate of | accounting | as corrected | note below | ||
(in € thousands, except earnings per share data) | convertible loan | under IAS 12 | ||||
Revenues and other income | ||||||
Revenue | 118 | 118 | ||||
Other income | 6 737 | 6 737 | ||||
Revenues and other income | 6 856 | 0 | 0 | 6 856 | ||
Operating expenses and other operating income (expenses) | ||||||
Research and development expenses | (54 189) | (54 189) | ||||
General and administrative expenses | (9 421) | (9 421) | ||||
Other operating income (expenses) | 60 | 60 | ||||
Operating loss | (56 695) | 0 | 0 | (56 695) | ||
Financial income | 642 | 642 | ||||
Financial expenses | (2 168) | (928) | (3 096) | A | ||
Financial loss |
By: Nasdaq / GlobeNewswire
- 05 Feb 2019
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