GENFIT Reports First Half-Year 2024 Financial Results and
Provides Corporate Update
- Cash and
cash equivalents totaled €61.6 million as of June 30, 2024,
excluding the €48.7 million milestone invoiced in June 2024
(received in August 2024) upon first sale of Ipsen’s Iqirvo®
(elafibranor) in the U.S. for the treatment of Primary Biliary
Cholangitis (PBC)
- €59.0
million in revenues, including the €48.7 million milestone invoiced
in June 2024
- Positive
opinion from the European Medicines Agency Committee in July 2024,
with final decision on marketing authorization for Iqirvo
anticipated in the second half of 2024, clearing the path to an
additional €26.5 million milestone payment expected upon Iqirvo’s
pricing and reimbursement approval in three European
countries
Lille (France), Cambridge (Massachusetts, United
States), (Zurich, Switzerland); September 19, 2024
– GENFIT (Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to improving the lives of
patients with rare and life-threatening liver diseases, today
announced its first half-year 2024 financial results and provided a
corporate update.
Pascal Prigent, CEO of GENFIT, commented:
“The approval of Iqirvo in the United States
was a very significant milestone for the entire GENFIT team. We are
proud to have developed elafibranor from its initial discovery
through late-stage trials and are thrilled to now see it prescribed
to U.S. patients. We believe Iqirvo can potentially address a
significant unmet need for people living with PBC. Following the
positive CHMP opinion in July 2024, we also anticipate a final
decision on authorization in Europe by the end of the
year.”
Mr. Prigent continued, “We believe the
recent approval in the U.S. of Iqirvo demonstrates our robust drug
development capabilities and, along with our strong financial
position enabled by our partnership with Ipsen, we are well
positioned to continue to develop innovative therapies for
challenging and underserved liver conditions that are
life-threatening.”
I. 1H24 Business
highlights1
PBC
Accelerated approval of Ipsen’s
Iqirvo®2 (elafibranor) was granted on June
10, 2024 by the U.S. Food and Drug Administration (U.S. FDA), as a
first-in-class treatment for PBC in combination with
ursodeoxycholic acid (UDCA) in adults with an inadequate response
to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Following Ipsen’s commercial launch in the U.S.
in June 2024, first royalty invoicing began and a €48.7 million
milestone payment was made.
On July 25, 2024, Ipsen announced an
“encouraging early start for Iqirvo in the U.S.” and
indicated that “50% of Healthcare Professionals surveyed one
week post launch were very likely to prescribe Iqirvo”. Ipsen
also reported “early positive coverage determinations from
commercial and government payer segments”3.
On July 26, 2024, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency's
(EMA) issued a positive opinion for the treatment of PBC in
combination with ursodeoxycholic acid (UDCA) in adults with an
inadequate response to UDCA or as a monotherapy in patients unable
to tolerate UDCA.
Acute on-Chronic Liver Failure (ACLF)
franchise
The UNVEIL-IT®2 Phase 2 trial for
VS-01 progressed, with the opening of several new clinical
investigation sites and geographic expansion into the U.S. However,
the initial uptake of recruitment was below our expectations, and
we have been working closely with investigators to address this. As
a result, we have modified our protocol to better account for the
logistics of the care for these patients, as well as their many
comorbidities. We feel that the latest version of the protocol
addresses the initial challenges and should allow us to maintain
our timeline of having preliminary results before the end of the
year. We will monitor the impact of the implementation of the new
protocol and will update this guidance as appropriate.
During the EASL congress in June 2024, GENFIT
presented blood and peritoneal metabolomics data suggesting that
VS-01 actively captures metabolites associated with ACLF. Data
indicating that NTZ (nitazoxanide) directly protects from
stress-induced cell death to alleviate liver damage in preclinical
models of ACLF were also presented.
June 2024 also marked the start of a research
collaboration between GENFIT and the European Foundation for the
Study of Chronic Liver Failure (EF CLIF), reinforcing our
leadership in advancing the understanding of ACLF.
MASH diagnostics
In June 2024, new European Clinical Practice
Guidelines on managing metabolic dysfunction-associated steatotic
liver disease (MASLD) recognized NIS2+®2 as a key tool
for detecting at-risk MASH4. This highlights the
potential of our technology in identifying those who may benefit
from emerging MASH treatments.
Corporate governance updates
Following the death of Mr. Xavier Guille des
Buttes in April 2024, Vice-Chairman of the Board of Directors, the
composition of the Board of Directors of the Company changed. In
accordance with the succession plan, Mr. Éric Baclet become
Vice-Chairman of the Board of Directors. He was also appointed
Chairman of the Nominations and Compensation Committee. Mr.
Jean-François Tiné joined the Audit Committee. In May 2024, the
Board of Directors appointed Ms. Katherine Kalin as member of the
ESG Committee.
II. 2H24 and beyond: key milestones and
outlook
PBC
Following the positive CHMP recommendation, the European
Commission is expected to take a final decision on marketing
authorization for Iqirvo in the second half of 2024. After the
€13.3 million milestone payment received in February 2024 and the
€48.7 million milestone payment received in August 2024, a €26.5
million milestone payment is expected to be received upon Iqirvo’s
pricing and reimbursement approval in three European countries.
Over the Summer of 2024, Iqirvo's competitive
landscape evolved as expected, reinforcing confidence in our
revenue projections. We intend to provide royalty revenue forecasts
once additional information is received from our commercial partner
Ipsen5.
ACLF franchise
Previous guidance is reiterated:
- VS-01-ACLF: Phase 2 interim data
readout still targeted for 2H24, taking into account the
implementation of the new protocol
- NTZ in ACLF: reformulation and
Phase 2 under preparation with a proof-of-concept study initiation
targeted for 1H25
- SRT-015: First-in-Human study
initiation targeted 1Q25
- CLM-022: preclinical Proof of
Concept expected to be obtained by end of 2024
- VS-02-HE: completion of
Investigational New Drug (IND) enabling studies expected in
2025
Other indications
Previous guidance is reiterated:
- Cholangiocarcinoma (CCA): The
GNS561 Phase 1b/2a clinical trial is currently ongoing and
preliminary data from Phase 1b is targeted by the end of 2024
- VS-01 Urea Cycle Disorder (UCD) and
Organic Acidemia (OA): Following completion of the non-clinical
feasibility study, we plan to develop formulation optimization for
specific pediatric implementation and conduct IND enabling
nonclinical studies with a target to complete such non-clinical
studies in 2024.
MASH Diagnostics
The first-ever approved drug for MASH was
approved in early 2024 and we anticipate that this should increase
the focus on diagnosis over the coming years and the need for a
non-invasive test such as NIS2+.
III. 1H24 Financial highlights
Cash and cash equivalents
As of June 30, 2024, GENFIT had €61.6 million in
cash and cash equivalents compared with €77.8 million as of
December 31, 2023. Cash and cash equivalents as of June 30, 2024
exclude the €48.7 million milestone invoiced in June 2024 upon
first sale of Ipsen’s Iqirvo® (elafibranor) in the U.S. for the
treatment of PBC, as this balance was received in August 2024.
We expect that our existing cash and cash
equivalents will enable us to fund our operating expenses and
capital expenditure requirements until at least the start of the
fourth quarter of 2025. This is based on current assumptions and
programs and does not include exceptional events. This estimation
includes our expectations to receive future milestone revenue,
subject to approval by applicable regulatory authorities and
European commercial launches of elafibranor in PBC by Ipsen,
representing a total of approximately €26.5 million.
In the first half of 2024, cash utilization is
mainly the result of our research and development efforts, notably
for Elative, our Phase 3 clinical trial of elafibranor in PBC
(approved by the FDA in June 2024); UNVEIL-IT, our Phase 2 clinical
trial of VS-01 in ACLF; GNS561, as part of our cholangiocarcinoma
program; NTZ, as part of our ACLF program; and SRT-015, also as
part of our ACLF program.
Revenues and other income
Revenues and other income amounted to €61.2
million in the first half of 2024, compared to €15.4 million in the
first half of 2023.
Substantially all revenue is attributable to our
Collaboration and License Agreement with Ipsen and related
Transition Services Agreement. Revenue growth is due to a €48.7
million milestone invoiced to Ipsen in June 2024 following the
first commercial sale of Iqirvo in the U.S. The milestone was
collected in August 2024.
Operating expenses
Operating expenses amounted to €30.0 million in
the first half of 2024 (compared to €34.7 million in the first half
of 2023).
Substantially all of the decrease in operating
expenses is due to research and development expenses, which
amounted to €19.0 million in the first half of 2024 (compared to
€25.6 million in the first half of 2023).
Specifically, there was a decrease in:
- Contracting costs which amounted to
€7.8 million in the first half of 2024 (compared to €14.4 million
in the first half of 2023), primarily reflecting decreased
activities related to Elative, following the FDA approval in June
2024, and
- Other expenses (maintenance, fees,
travel and other taxes) which amounted to €2.8 million in the first
half of 2024 (compared to €3.3 million in the first half of 2023),
reflecting decreased activity as previously noted.
Financial results
For the half-year ended June 30, 2024, financial
income amounted to a loss of €0.9 million, compared to a loss of
€1.1 million for the same period in 2023.
Net loss
The first half of 2024 resulted in a net profit
of €30.3 million, compared with a net loss of €20.9 million in the
first half of 2023.
The table below presents the condensed
Consolidated Statement of Operations under the International
Financial Reporting Standards (IFRS) for the first half of 2024,
with comparative figures for the first half of 2023.
| |
Half-year ended |
|
(in € thousands, except earnings per share data) |
2023/06/30 |
2024/06/30 |
|
|
|
|
|
Revenues and other income |
|
|
|
Revenue |
11,482 |
58,973 |
| Other
income |
3,893 |
2,226 |
|
Revenues and other income |
15,374 |
61,199 |
|
|
|
|
|
Operating expenses and other operating income
(expenses) |
|
|
|
Research and development expenses |
(25,630) |
(18,984) |
| General and
administrative expenses |
(9,105) |
(10,564) |
| Marketing and
market access expenses |
(520) |
(390) |
| Reorganization
and restructuring income (expenses) |
633 |
0 |
| Other operating
expenses |
(52) |
(39) |
| |
|
|
|
Operating income (loss) |
(19,299) |
31,222 |
|
|
|
|
| Financial
income |
1,748 |
1,546 |
| Financial
expenses |
(2,890) |
(2,419) |
|
Financial profit (loss) |
(1,141) |
(873) |
|
|
|
|
|
Net profit (loss) before tax |
(20,440) |
30,349 |
|
|
|
|
| Income tax
benefit (expense) |
(414) |
(39) |
| |
|
|
| Net profit
(loss) |
(20,854) |
30,311 |
|
|
|
|
|
Basic and diluted earnings (loss) per share |
|
|
|
Basic earnings (loss) per share (€/share) |
(0.42) |
0.61 |
| Diluted earnings
(loss) per share (€/share) |
(0.42) |
0.53 |
Further information is provided in the condensed
consolidated financial statements at June 30, 2024 under the IFRS
and the management discussion of the results are provided in the
appendix of this press release. The condensed consolidated
financial statements as well as the statutory auditors' report on
those financial statements are included in the 2024 Half Year
Business and Financial Report available on the “Investors” page of
the GENFIT website.
We encourage investors to take into
consideration all the information presented in our 2023 Annual
Report on Form 20-F (“Form 20-F”) filed with the U.S. Securities
Exchange Commission and the 2023 Universal Registration Document
filed under D.24-0246 with the French Autorité des Marchés
Financiers (AMF) on April 5, 2024 and the 2024 Half-Year
Business and Financial Report before deciding to invest in Company
shares; these documents are available on GENFIT’s website:
www.genfit.com and on the website of the AMF (www.amf-france.org).
This includes, in particular, the risk factors described in Item 3
of the Form 20-F (and the contents of this section) and section 2
of the 2023 Universal Registration Document, as well as the update
provided in section 2.5 of the 2024 Half-Year Business and
Financial Report, of which the realization may have (or has had in
some cases) material adverse effect on the Group and its activity,
financial situation, results, development or perspectives, and
which are of importance in the investment decision-making
process.
|
|
Half-year Consolidated Financial Results at June 30,
2024
|
|
|
|
|
The Condensed Consolidated Statements of
Financial Position, Statements of Operations and Statements of Cash
Flow of the Group were prepared in accordance with the IFRS.
The limited review procedures on the condensed
consolidated financial statements have been performed. The
half-year consolidated financial statements for the period ended
June 30, 2024 were approved by the Board of Directors on September
18, 2024.
The condensed consolidated financial statements
as well as the notes to the consolidated financial statements for
the period ended June 30, 2024 and the statutory auditor’s report
on the consolidated financial statements are included in the Half
Year Business and Financial Report at June 30, 2024 available on
the “Investors” page of the GENFIT website.
All financial information (unless indicated
otherwise) is presented in thousands of euros (€).
Condensed Consolidated Statement of Financial Position
Assets
| |
As of |
|
(in € thousands) |
2023/12/31 |
2024/06/30 |
|
Current assets |
|
|
|
Cash and cash equivalents |
77,789 |
61,645 |
| Current trade and
others receivables |
32,707 |
71,044 |
| Other current
assets |
2,615 |
3,690 |
| Inventories |
4 |
4 |
|
Total - Current assets |
113,115 |
136,384 |
|
Non-current assets |
|
|
|
Intangible assets |
48,761 |
46,946 |
| Property, plant
and equipment |
7,872 |
8,059 |
| Other non-current
financial assets |
4,125 |
3,388 |
| Deferred tax
assets |
0 |
0 |
|
Total - Non-current assets |
60,758 |
58,393 |
|
Total - Assets |
173,872 |
194,777 |
Shareholders’ equity and liabilities
| |
As of |
|
(in € thousands) |
2023/12/31 |
2024/06/30 |
|
Current liabilities |
|
|
|
Current convertible loans |
415 |
413 |
| Other current
loans and borrowings |
7,510 |
7,605 |
| Current trade
and other payables |
18,799 |
22,159 |
| Current deferred
income and revenue |
11,692 |
6,095 |
| Current
provisions |
40 |
40 |
| Other current
tax liabilities |
23 |
118 |
|
Total - Current liabilities |
38,480 |
36,430 |
|
Non-current liabilities |
|
|
|
Non-current convertible loans |
52,206 |
53,233 |
| Other
non-current loans and borrowings |
10,047 |
6,553 |
| Non-current
deferred income and revenue |
3,755 |
0 |
| Non-current
employee benefits |
978 |
1,026 |
| Deferred tax
liabilities |
455 |
171 |
|
Total - Non-current liabilities |
67,441 |
60,983 |
|
Shareholders' equity |
|
|
|
Share capital |
12,459 |
12,477 |
| Share
premium |
445,261 |
446,490 |
| Retained
earnings (accumulated deficit) |
(361,870) |
(391,461) |
| Currency
translation adjustment |
996 |
(452) |
| Net profit
(loss) |
(28,894) |
30,311 |
|
Total - Shareholders' equity |
67,951 |
97,363 |
|
Total - Shareholders' equity & liabilities |
173,872 |
194,777 |
| |
|
|
Condensed Consolidated Statement of Operations
| |
Half-year ended |
|
(in € thousands, except earnings per share data) |
2023/06/30 |
2024/06/30 |
|
|
|
|
|
Revenues and other income |
|
|
|
Revenue |
11,482 |
58,973 |
| Other income |
3,893 |
2,226 |
|
Revenues and other income |
15,374 |
61,199 |
|
|
|
|
|
Operating expenses and other operating income
(expenses) |
|
|
|
Research and development expenses |
(25,630) |
(18,984) |
| General and
administrative expenses |
(9,105) |
(10,564) |
| Marketing and
market access expenses |
(520) |
(390) |
| Reorganization
and restructuring income (expenses) |
633 |
0 |
| Other operating
expenses |
(52) |
(39) |
| |
|
|
|
Operating income (loss) |
(19,299) |
31,222 |
|
|
|
|
| Financial
income |
1,748 |
1,546 |
| Financial
expenses |
(2,890) |
(2,419) |
|
Financial profit (loss) |
(1,141) |
(873) |
|
|
|
|
|
Net profit (loss) before tax |
(20,440) |
30,349 |
|
|
|
|
| Income tax
benefit (expense) |
(414) |
(39) |
|
|
|
|
|
Net profit (loss) |
(20,854) |
30,311 |
| |
|
|
| Basic and diluted
earnings (loss) per share |
|
|
| Basic earnings
(loss) per share (€/share) |
(0.42) |
0.61 |
|
Diluted earnings (loss) per share (€/share) |
(0.42) |
0.53 |
Condensed Statement of Cash Flows
| |
Half-year ended |
Half-year ended |
|
(in € thousands) |
2023/06/30 |
2024/06/30 |
|
|
|
|
|
Cash flows from operating activities |
|
|
|
+ Net profit (loss) |
(20,854) |
30,311 |
| |
|
|
| Reconciliation of
net loss to net cash used in operating activities |
|
|
| Adjustments
for: |
|
|
| + Depreciation
and amortization on tangible and intangible assets |
835 |
854 |
| + Impairment and
provisions |
(396) |
105 |
| + Expenses
related to share-based compensation |
274 |
334 |
| - Loss (gain) on
disposal of property, plant and equipment |
(52) |
(62) |
| + Net finance
expenses (revenue) |
763 |
542 |
| + Income tax
expense (benefit) |
414 |
39 |
| + Other non-cash
items |
1,199 |
1,687 |
|
|
|
|
|
Operating cash flows before change in working
capital |
(17,817) |
33,809 |
|
|
|
|
| Decrease
(increase) in trade receivables and other assets |
(4,858) |
(39,413) |
| (Decrease)
increase in trade payables and other liabilities |
(2,398) |
(5,572) |
|
|
|
|
|
Change in working capital |
(7,256) |
(44,984) |
|
|
|
|
| Income tax
paid |
0 |
(12) |
|
|
|
|
|
Net cash flows provided by (used in) in operating
activities |
(25,074) |
(11,187) |
|
|
|
|
|
Cash flows from investment
activities |
|
|
|
|
|
|
| - Acquisition net
of cash acquired (Versantis intangible) |
0 |
0 |
| - Acquisition of
other intangible assets |
(2,000) |
0 |
| - Acquisition of
property, plant and equipment |
61 |
(737) |
| + Proceeds from
disposal of / reimbursement of property, plant and equipment |
62 |
78 |
| - Acquisition of
financial instruments |
9 |
(28) |
| ‘+Proceeds from
disposal of financial instruments |
4,500 |
0 |
|
|
|
|
|
Net cash flows provided by (used in ) investment
activities |
2,682 |
(687) |
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
| + Proceeds from
issue of share capital (net) |
0 |
0 |
| + Proceeds from
new loans and borrowings net of issue costs |
0 |
0 |
| - Repayments of
loans and borrowings |
(464) |
(3,143) |
| - Payments on
lease debts |
(530) |
(545) |
| - Financial
interests paid (including finance lease) |
(1,106) |
(1,073) |
| + Financial
interests received |
337 |
535 |
|
|
|
|
|
Net cash flows provided by (used in ) financing
activities |
(1,764) |
(4,225) |
|
|
|
|
|
Increase (decrease) in cash and cash
equivalents |
(24,155) |
(16,100) |
|
|
|
|
| Cash and cash
equivalents at the beginning of the period |
136,001 |
77,789 |
| Effects of
exchange rate changes on cash |
(20) |
(43) |
| |
|
|
|
Cash and cash equivalents at the end of the
period |
111,826 |
61,645 |
|
|
Discussion of the 2024 half-year results
|
|
|
|
|
Comments on the condensed statement of net income for the
periods ended June 30, 2023 and June 30, 2024
(1) Revenue and other
income
The Company’s revenue and other income mainly
comprises revenue, the research tax credit, and other operating
revenue.
| |
Half-year ended |
|
(in € thousands) |
2023/06/30 |
2024/06/30 |
|
Revenues |
11,482 |
58,973 |
| CIR tax
credit |
3,547 |
2,108 |
| Government
grants and subsidies |
82 |
21 |
|
Other operating income |
263 |
97 |
|
TOTAL |
15,374 |
61,199 |
For the half-year ended June 30, 2024, total
revenues and other income amounted to €61,199, compared with
€15,374 for the same period in 2023.
Revenues
For the half-year ended June 30, 2024, revenue
amounted to €58,973 compared with €11,482 for the same period in
2023.
Revenue is primarily composed of:
-
Licensing Agreement (Ipsen). In December 2021, GENFIT and Ipsen
entered into an exclusive licensing agreement for elafibranor
(marketed as Iqirvo), a Phase 3 asset evaluated in PBC, as part of
a long-term global partnership ("Collaboration and License
Agreement").
-
During the first six months of 2024:
-
€48.7 million was attributable to a milestone invoiced to Ipsen in
June 2024 following the first commercial sale of Iqirvo/elafibranor
in the U.S.
-
€9.3 million was attributable to the partial recognition of
deferred revenue as noted in Note 20 - "Deferred income and
revenue".
-
€0.2 million was attributable to royalty revenue from U.S. sales of
Iqirvo.
-
During the first six months of 2023:
-
€8.2 million was attributable to the partial recognition of
deferred revenue as noted in Note 20 - "Deferred income and
revenue".
-
Transition Services Agreement (Ipsen). GENFIT and Ipsen entered
into the Transition Services Agreement and Part B Transition
Services Agreement, signed in April 2022 and September 2023
respectively, in order to facilitate the transition of certain
services related to the Phase 3 Elative clinical trial until the
complete transfer of the responsibility of the trial to Ipsen.
-
During the first six months of 2024, services provided under this
contract generated €0.8 million in revenue.
-
During the first six months of 2023, services provided under this
contract generated €3.2 million in revenue.
Research Tax Credit
(CIR)
During the first six months of 2024, the CIR
amounted to €2,108 in 2024 including €177 of legally required
related interest, (€3,547 for the same period in 2023), due to a
reduction in eligible research and development expenses.
The CIR receivable amounted to €7,738 as of June
30, 2024, which comprises balances from 2023 onward (compared to
€12,200 for the same period in 2023). Previously withheld balances
from 2021 and 2022 have since been reimbursed on May 28, 2024 in
the amount of €6,570 which includes legally required related
interest of €177.
We were subject to a tax audit by the French tax
authorities on our tax returns or operations subject to review on
the 2019 and 2020 periods (including the CIR claimed for these
periods), which started on December 10, 2021 and is still ongoing
at the date of this document.
Other operating
income
During the first six months of 2024, the Group
recognized €97 in “Other operating income” (€263 for the same
period in 2023), mainly comprised of exchange gains on trade
receivables.
(2) Operating expenses by
destination
The tables below break operating expenses down
by destination, mainly into research and development expenses,
general and administrative expenses, and marketing and market
access expenses.
| |
Half-year ended |
Of which : |
| |
2023/06/30 |
Raw |
Contracted |
Employee |
Other |
Depreciation, |
Gain / |
| |
|
materials |
research and |
expenses |
expenses |
amortization |
(loss) on |
| |
|
and |
development |
|
(maintenance, |
and |
disposal of |
| |
|
consumables |
activities |
|
fees, travel, |
impairment |
property, |
| |
|
used |
conducted by |
|
taxes…) |
charges |
plant and |
|
(in € thousands) |
|
|
third parties |
|
|
|
equipment |
|
Research and development income (expenses) |
(25,630) |
(1,040) |
(14,367) |
(6,299) |
(3,251) |
(705) |
33 |
| General and
administrative expenses |
(9,105) |
(162) |
(96) |
(3,919) |
(4,645) |
(283) |
0 |
| Marketing and
market access expenses |
(520) |
(2) |
(1) |
(275) |
(236) |
(6) |
0 |
| Reorganization
and restructuring income (expenses) |
633 |
0 |
0 |
0 |
0 |
633 |
0 |
|
Other operating income (expenses) |
(52) |
0 |
0 |
0 |
(75) |
3 |
20 |
|
TOTAL |
(34,673) |
(1,204) |
(14,464) |
(10,492) |
(8,207) |
(358) |
52 |
| |
Half-year ended |
Of which : |
| |
2024/06/30 |
Raw |
Contracted |
Employee |
Other |
Depreciation, |
Gain / |
| |
|
materials |
research and |
expenses |
expenses |
amortization |
(loss) on |
| |
|
and |
development |
|
(maintenance, |
and |
disposal of |
| |
|
consumables |
activities |
|
fees, travel, |
impairment |
property, |
| |
|
used |
conducted by |
|
taxes…) |
charges |
plant and |
|
(in € thousands) |
|
|
third parties |
|
|
|
equipment |
|
Research and development expenses |
(18,984) |
(1,056) |
(7,838) |
(6,610) |
(2,806) |
(675) |
0 |
| General and
administrative expenses |
(10,564) |
(152) |
(69) |
(4,380) |
(5,778) |
(185) |
0 |
| Marketing and
market access expenses |
(390) |
(2) |
0 |
(295) |
(89) |
(3) |
0 |
| Reorganization
and restructuring expenses |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other operating income (expenses) |
(39) |
0 |
0 |
0 |
(102) |
0 |
62 |
|
TOTAL |
(29,977) |
(1,210) |
(7,907) |
(11,284) |
(8,774) |
(863) |
62 |
For the half-year ended June 30, 2024 operating
expenses amounted to €29,977 (€34,673 for the same period in
2023).
They include the following:
Research and development
expenses
For the first six months of 2023, research and
development expenses totaled €25.6 million. These expenses were
comprised of €14.4 million in contracted research and development
conducted by third parties, €6.3 million in employee expenses, €3.3
million in other expenses, €0.7 million in depreciation,
amortization and impairment charges and €1.0 million in raw
materials and consumables.
For the first six months of 2024, research and
development expenses totaled €19.0 million. These expenses were
comprised of €7.8 million in contracted research and development
conducted by third parties, €6.6 million in employee expenses, €2.8
million in other expenses, €0.7 million in depreciation,
amortization and impairment charges and €1.1 million in raw
materials and consumables.
The decrease of €6.6 million in contracted
research and development conducted by third parties is mainly due
to:
-
Decreasing costs related to the Elative product candidate (approved
by the FDA in the US in June 2024 and marketed under the name
Iqirvo) of €7.4 million,
-
Increasing costs related to the SRT-015 product candidate of €0.5
million, and
-
Increasing costs related to the VS-01 product candidate of €0.3
million.
The increase of €0.3 million in employee
expenses, consisting of wages, salaries, social security, pension
costs and share-based compensation paid to employees in the
research and development function, relates primarily to the
increase in workforce (from 96 to 106 employees at June 30, 2023
and 2024, respectively).
The decrease of €0.5 million in other expenses
is mainly due to decreasing costs related to maintenance costs of
€0.3 million and decreasing costs related to consultants of €0.2
million.
General and administrative
expenses
For the first six months of 2023, general and
administrative expenses totaled €9.1 million. These expenses were
mainly comprised of €3.9 million in employee expenses and €4.6
million in other expenses.
For the first six months of 2024, general and
administrative expenses totaled €10.6 million. These expenses were
mainly comprised of €4.4 million in employee expenses and €5.8
million in other expenses.
The increase of €0.5 million in employee
expenses in the general and administrative function was mainly due
to the increase in workforce (from 56 to 61 employees at June 30,
2023 and 2024, respectively).
The increase of €1.2 million in other expenses
in the general and administrative function was mainly due to
increases in i) maintenance costs of €0.7 million, ii) consulting
costs of €0.2 million, iii) donations of €0.2 million, et iv)
recruiting fees of €0.1 million.
Marketing and market access
expenses
For the first six months of 2023, marketing and
market access expenses totaled €0.5 million. These expenses were
mainly comprised of €0.3 million in employee expenses and €0.2
million in other expenses.
For the first six months of 2024, marketing and
market access expenses totaled €0.4 million. These expenses were
mainly comprised of €0.3 million in employee expenses and €0.1
million in other expenses.
Marketing and market access expenses remained
stable period over period.
Reorganization and restructuring
income (expenses)
During the first half of 2023, the Group
reversed the entire remaining RESOLVE-IT® provision consisting of
unused building space, which are now in use. There was no
reorganization and restructuring expense in 2024.
(3) Financial income (expense)
For the half-year ended June 30, 2024, financial
income amounted to a loss of €0.9 million, compared to a loss of
€1.1 million for the same period in 2023.
For the first six months of 2024, this is
primarily the result of interest expense of €2.3 million, realized
and unrealized foreign exchange loss of €0.6 million, and €1.7
million in accrued and realized interest income.
For the first six months of 2024, this is
primarily the result of interest expense of €2.3 million, realized
and unrealized foreign exchange loss of €42 thousand, and €1.3
million in accrued and realized interest income.
(4) Net income (loss)
The first half of 2024 resulted in net profit of
€30,311 thousand compared with a net loss of €20,854 thousand in
the first half of 2023.
Comments on the Group’s Cash Flows for the periods ended June
30, 2023 and June 30, 2024.
As of June 30, 2024, cash and cash equivalents
amounted to €61,645.
Over the period, change in cash flow by type of
flow was as follows:
| |
|
Half-year ended |
|
(in € thousands) |
|
2023/06/30 |
2024/06/30 |
|
Cash flows provided by (used in) operating activities |
|
(25,074) |
(11,187) |
| Cash flows
provided by (used in) investment activities |
|
2,682 |
(687) |
|
Cash flows provided by (used in) financing activities |
|
(1,764) |
(4,225) |
|
|
|
(24,155) |
(16,100) |
(1) Cash flows provided by
(used in) operating activities
Cash flow used in operating activities amounted
to an outflow of €11,187 thousand for the half-year ended June 30,
2024 compared with an outflow of €25,074 thousand for the half-year
ended June 30, 2023.
In the first half of 2024, this amount mainly
stems from our research and development efforts; notably for
Elative, our Phase 3 clinical trial of elafibranor in PBC (approved
by the FDA in June 2024); UNVEIL-IT®, our Phase 2 clinical trial of
VS-01 in ACLF; GNS561, as part of its cholangiocarcinoma program;
and NTZ, as part of its ACLF program.
In the first half of 2023, this amount mainly
stems from our net loss of €20.9 million, which is largely the
result of our research and development efforts; notably for
Elative, our Phase 3 clinical trial of elafibranor in PBC;
UNVEIL-IT®, our Phase 2 clinical trial of VS-01 in ACLF; GNS561, as
part of its cholangiocarcinoma program; and NTZ, as part of its
ACLF program.
The change between the first half of 2024 and
2023 is further explained by the receipt of a milestone of €13.3
million from IPSEN in 2024 (incurred and recorded in 2023, upon the
acceptance of the new drug application filing with the FDA and the
filing of the marketing authorization application with the EMA for
the accelerated approval of elafibranor).
These cash flows reflect GENFIT’s business,
which requires significant research and development efforts, and
generates expenses that change in line with progress on the
Company’s research programs, net of its operating revenues.
(2) Cash flows provided by
(used in) investing activities
Cash flow used in investing activities amounted
to €-687 thousand in the first half of 2024, compared with €2,682
thousand in cash flow provided in the first half of 2023.
These cash flows include acquisitions, disposals
and repayments of fixed assets and financial assets.
(3) Cash flows provided by
(used in) financing activities
Cash flow used in financing activities amounted
to €-4,225 thousand in the first half of 2024, compared with
€-1,764 thousand in the first half of 2023.
In the first half of 2024, these cash flows
mainly reflect financial interest received and paid. The decrease
is mainly explained by loan repayments for the period.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
committed to improving the lives of patients with rare,
life-threatening liver diseases whose medical needs remain largely
unmet. GENFIT is a pioneer in liver disease research and
development with a rich history and a solid scientific heritage
spanning more than two decades. Today, GENFIT has built up a
diversified and rapidly expanding R&D portfolio of programs at
various stages of development. The Company focuses on
Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes
five assets under development: VS-01, NTZ, SRT-015, CLM-022 and
VS-02-HE, based on complementary mechanisms of action using
different routes of administration. Other assets target other
serious diseases, such as cholangiocarcinoma (CCA), urea cycle
disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the
development of high-potential molecules from early to advanced
stages, and in pre-commercialization, was demonstrated with the
success of the 52-week Phase 3 Elative study evaluating elafibranor
in Primary Biliary Cholangitis (PBC). Elafibranor, a
'first-in-class' molecule developed by GENFIT from initial
discovery to the conclusion of a 52-week Phase 3 study, is now
marketed and commercialized in the United States by Ipsen under the
trademark Iqirvo® since June 2024.
Beyond therapies, GENFIT also has a diagnostic franchise, including
NIS2+® in Metabolic dysfunction-associated
steatohepatitis (MASH, formerly known as NASH for non-alcoholic
steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT
is headquartered in Lille, France and has offices in Paris
(France), Zurich (Switzerland) and Cambridge, MA (USA). The Company
is listed on the Nasdaq Global Select Market and on the Euronext
regulated market in Paris, Compartment B (Nasdaq and Euronext:
GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders,
acquiring an 8% stake in the Company's capital. For more
information, visit www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995 with respect
to GENFIT, including, but not limited to statements about GENFIT’s
corporate strategy and objectives, our ability to meet milestones
and receive payments from Ipsen, the potential of
Iqirvo®/elafibranor to receive marketing authorization
and successful launch and commercialization in PBC by Ipsen outside
the United States, the Iqirvo®/elafibranor competitive landscape,
anticipated timing for study enrollment and data readouts and
development plans for our pipeline programs, in particular for
VS-01 in ACLF and GNS561 in CCA, expected timing for potential
regulatory approvals and the impact of the development of our
programs, as well as our financial outlook including cash flow and
cash burn projections and business and R&D activity projections
for 2024 and beyond. The use of certain words, including “believe”,
“potential,” “expect”, “target”, “may”, “should” and “will” and
similar expressions, is intended to identify forward-looking
statements. Although the Company believes its expectations are
based on the current expectations and reasonable assumptions of the
Company’s management, these forward-looking statements are subject
to numerous known and unknown 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 others, the uncertainties
inherent in research and development, including in relation to
safety of drug candidates, cost of, progression of, and results
from, our ongoing and planned clinical trials, review and approvals
by regulatory authorities in the United States, Europe and
worldwide, of our drug and diagnostic candidates, potential
commercial success of elafibranor if approved, exchange rate
fluctuations, and our continued ability to raise capital to fund
our development, as well as those risks and uncertainties discussed
or identified in the Company’s public filings with the AMF,
including those listed in Chapter 2 "Risk Factors and Internal
Control" of the Company's 2023 Universal Registration Document
filed on April 5, 2024 (no. D.24-0246) with the Autorité des
marchés financiers ("AMF"), which is available on GENFIT's
website (www.genfit.fr) and the AMF's website (www.amf.org), and
those discussed in the public documents and reports filed with the
U.S. Securities and Exchange Commission ("SEC"), including the
Company’s 2023 Annual Report on Form 20-F filed with the SEC on
April 5, 2024 and subsequent filings and reports filed with the AMF
or SEC, including the Half-Year Business and Financial Report at
June 30, 2024 or otherwise made public, by the Company. In
addition, even if the results, performance, financial position and
liquidity of the Company and the development of the industry in
which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments
in future periods. These forward-looking statements speak only as
of the date of publication of this document. Other than as required
by applicable law, the Company does not undertake any obligation to
update or revise any forward-looking information or statements,
whether as a result of new information, future events or
otherwise.
CONTACT
GENFIT | Investors
Tel : + 33 3 20 16 40 00 | investors@genfit.com
GENFIT | Press relations
Stephanie BOYER | Tel : + 33 3 20 16 40 00
| stephanie.boyer@genfit.com
|
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com |
1 The Half Year Business and Financial
Report is available to the public and was filed with the French
Autorité des Marchés Financiers (French Financial Markets
Authority) and filed with the U.S. Securities and Exchange
Commission today. The condensed consolidated financial statements
are included in this press release and the complete financial
statements are included in the Half-Year Business and Financial
Report which is available on the “Investors” page of the GENFIT
website.
2 Iqirvo®, Elative®, NIS2+® and UNVEIL-IT®
are registered trademarks of GENFIT SA
3 www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/07/24211739/H1-2024-results-presentation.pdf
4 Metabolic dysfunction-associated
steatohepatitis
5 www.ipsen.com/investors/financial-calendar
(www.ipsen.com/event/ytd-2024-sales)
- GENFIT Reports First Half-Year 2024 Financial Results and
Provides Corporate Update
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