Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“
Innate” or the “
Company”) today
reported its consolidated financial results for the six months
ended
June 30, 2021. The consolidated financial
statements are attached to this press release.
“In the first half of 2021, we had two key
advancements in our portfolio – encouraging new lacutamab data in a
subtype of cutaneous T-cell lymphoma, mycosis fungoides, and new
data from our proprietary, multi-specific NK cell engager platform,
ANKET™. These progressions have set the stage for delivering both
near and long-term value, while also highlighting the strength and
depth of our core R&D efforts,” said
Mondher Mahjoubi, Chief Executive Officer of Innate
Pharma. “We look forward to the continued progress of our
pipeline, including the upcoming monalizumab presentation at ESMO
and our lacutamab clinical trial program, in addition to advancing
our early-stage R&D activities. These important efforts will
help to progress the next wave of innovation at Innate.”
Webcast and conference call will be held today at 2:00 p.m.
CEST (8:00 a.m. ET)Access to live webcast:
https://edge.media-server.com/mmc/p/bi2jkpjrParticipants may also
join via telephone by registering in advance of the event at
http://emea.directeventreg.com/registration/3774818.Upon
registration, participants will be provided with dial-in numbers, a
direct event passcode and a unique registrant ID that they may use
10 minutes prior to the event start to access the call.This
information can also be found on the Investors section of the
Innate Pharma website, www.innate-pharma.com. A replay of the
webcast will be available on the Company website for 90 days
following the event. |
Financial highlights for the first half of
2021:
The key elements of Innate’s financial position
and financial results as of and for the six-month period ended June
30, 2021 are as follows:
- Cash, cash
equivalents, short-term investments and financial assets amounting
to €159.4 million (€m) as of June 30, 2021 (€190.6m as of
December 31, 2020).
- Revenue and other
income amounted to €15.7m in the first half of 2021 (€36.7m in the
first half of 2020) and mainly comprise of:
- Revenue from
collaboration and licensing agreements, which mainly resulted from
the partial or entire recognition of the proceeds received pursuant
to the agreements with AstraZeneca and Sanofi and which are
recognized on the basis of the percentage of completion of the
works performed by the Company under such agreements:
- (i) Revenue from
collaboration and licensing agreements for monalizumab decreased by
€13.5m to €6.1m in the first half of 2021 (€19.6m in the first half
of 2020), due to lower costs in connection with the collaboration
works performed relating to the trials’ maturity;
- (ii) Revenue from
collaboration and licensing agreements for IPH5201 are nil for the
first half of 2021 (€8.7m in the first half of 2020), due to the
Company having fulfilled all of its commitments on preclinical work
related to the start of Phase 1 of the IPH5201 program as of
December 31, 2020.
- Revenue from
invoicing of research and development (R&D) costs for
avdoralimab (IPH5401) and IPH5201 are €1.2m the first half of 2021
(€1.1m in the first half of 2020), or an increase of €0.1m, or 11%,
between the first half of 2020 and the first half of 2021.
- Government funding
for research expenditures of €6.4m in the first half of 2021 (€6.9m
in the first half of 2020).
- Operating expenses
are €41.1m in the first half of 2021 (€46.0m in the first half of
2020), of which 53.0% (€21.8m) are related to R&D.
- R&D expenses
decreased by €9.7m to €21.8m in the first half of 2021 (€31.5m in
the first half of 2020). This change mainly results from a decrease
in depreciation and amortization expenses allocated to R&D, and
a decrease in direct R&D expenses relating to Lumoxiti
following the end of the transition period with AstraZeneca in
September 2020 and the return of commercialization rights in the
U.S. and Europe, as well as the end of recruitment in trials
evaluating avdoralimab in oncology.
- Selling, general
and administrative (SG&A) expenses increased by €4.8m to €19.3m
in the first half of 2021 (€14.5m in the first half of 2020)
primarily as a result of the provision for charges booked as
of June 30, 2021 relating to the payment of $6.2m (€5.2m as of June
30,2021) to be made to AstraZeneca on April 30, 2022. In the full
year results 2020 announcement2, the Company reported a contingent
liability of up to $12.8m in its consolidated financial statements,
which was linked to the split of certain manufacturing costs. As
part of the termination and transition agreement, effective on June
30, 2021, Innate and AstraZeneca agreed to split the manufacturing
costs, and Innate will pay $6.2m on April 30, 2022.
- Revenue from
distribution agreement are nil in the first half of 2021 (net gain
of €0.9m in the first half of 2020). As of June 30, 2021,
following the end of the transition period relating to the
commercialization of Lumoxiti in the U.S. on September 30, 2020,
the Company recognized net sales of Lumoxiti for the first half of
2021 for an amount of €1.0m.
- A net financial
gain of €1.7m in the first half of 2021 (net financial loss of
€2.0m in the first half of 2020), principally as a result of the
decrease in fair value of certain of our financial instruments due
to the negative impact of the COVID-19 outbreak on the financial
markets in the first half of 2020.
- A net loss of
€23.7m for the first half of 2021 (net loss of €10.3m for the first
half of 2020).
The table below summarizes the IFRS consolidated
financial statements as of and for the six months ended June 30,
2021, including 2020 comparative information.
In thousands of euros, except for data per
share |
June 30, 2021 |
June 30, 2020 |
Revenue and other
income |
15,686 |
36,745 |
Research and development
expenses |
(21,794) |
(31,499) |
Selling, general and
administrative expenses |
(19,321) |
(14,490) |
Operating
expenses |
(41,115) |
(45,989) |
Net income / (loss) distribution agreements |
— |
896 |
Operating income (loss) |
(25,428) |
(8,348) |
Net
financial income (loss) |
1,709 |
(1,986) |
Income tax expense |
— |
— |
Net income (loss) |
(23,719) |
(10,334) |
Weighted average number of shares ( in thousands) : |
78,998 |
78,892 |
- Basic income (loss) per
share |
(0.30) |
(0.13) |
- Diluted income (loss) per
share |
(0.30) |
(0.13) |
|
|
June 30, 2020 |
December 31,2020 |
Cash, cash equivalents and
financial assets |
159,402 |
190,571 |
Total assets |
266,217 |
307,423 |
Total shareholders’
equity |
133,561 |
155,976 |
Total financial debt |
16,502 |
19,087 |
Pipeline highlights:
Lacutamab (anti-KIR3DL2
antibody):
- In June 2021, the Company announced
promising preliminary data from its Phase 2 TELLOMAK trial, in
which lacutamab demonstrated a 35% overall global response rate in
patients with mycosis fungoides (MF) that express KIR3DL2 (cohort
2). This first trial data set also established safety and
demonstrated skin improvement. Lacutamab reached the pre-determined
threshold to advance to stage 2 (six confirmed responses). These
results were presented in an oral presentation at the 16th
International Conference on Malignant Lymphoma (16-ICML).
- In the second half of the year, the Company will initiate two
parallel clinical trials to study lacutamab in patients with
KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma
(PTCL):
- Phase 1b trial: a Company-sponsored Phase 1b
clinical trial to evaluate lacutamab as a monotherapy in patients
with KIR3DL2-expressing relapsed PTCL.
- Phase 2 KILT (anti-KIR in T Cell Lymphoma)
trial: The Lymphoma Study Association (LYSA) plans to
initiate an investigator-sponsored, randomized trial to evaluate
lacutamab in combination with chemotherapy GEMOX (gemcitabine in
combination with oxaliplatin) versus GEMOX alone in patients with
KIR3DL2-expressing relapsed/refractory PTCL.
ANKET™ (Antibody-based NK cell Engager
Therapeutics):
- In June 2021, the Company presented
new data on its next-generation NK cell engager platform, ANKET, at
the Federation of Clinical Immunology Societies (FOCIS) meeting.
Specifically, Innate shared data from its tetra-specific ANKET
molecule, which is the first NK cell engager technology to engage
two NK cell activating receptors (NKp46 and CD16), a cytokine
receptor (IL-2Rb) and a tumor antigen via a single molecule. In
preclinical studies, the tetra-specific ANKET demonstrated in vitro
the ability to induce human NK cell proliferation, cytokine
production and cytolytic activity against cancer cells expressing
the targeted antigen. The tetra-specific ANKET also demonstrated in
vivo anti-tumor efficacy in several tumor models, allowing
regression of established tumors as well as control of metastasis,
associated with increased NK cell infiltration, cytokine and
chemokine production at the tumor site. ANKET also showed a
pharmacodynamic effect, low systemic cytokine release and a
manageable safety profile in non-human primates.
- Progress was made in the
IPH6101/SAR443579 collaboration with Sanofi, resulting in the
decision announced in January 2021 that Sanofi will transition
IPH6101/SAR443579 into investigational new drug (IND)-enabling
studies. IPH6101 is a NKp46-based NK cell engager (NKCE) using
Innate’s proprietary multi-specific antibody format (Gauthier et
al. Cell 2019). The decision triggered a €7 million milestone
payment from Sanofi to Innate. In addition, in January 2021, a
GLP-tox study was initiated for the IPH6101/SAR443579 program.
- The Company will present further
ANKET data at the European Society for Medical Oncology (ESMO)
Congress 2021 on September 18, 2021.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- On September 17, 2021, AstraZeneca
will present a late-breaker abstract on the COAST Phase 2 trial,
highlighting progression-free survival (PFS) results for novel
durvalumab combinations with potential new medicines, including
Innate’s lead partnered asset, monalizumab, and AstraZeneca’s
oleclumab, an anti-CD73 monoclonal antibody, in unresectable, Stage
III non-small cell lung cancer at the ESMO Congress 2021.
- The Company expects to publish data
this year from the Phase 2 expansion cohort (‘cohort 3’), exploring
the combination of monalizumab, cetuximab and durvalumab in
first-line IO naïve patients with R/M SCCHN.
Avdoralimab (IPH5401, anti-C5aR
antibody):
- In July 2021, the Company announced
that FORCE (FOR COVID-19
Elimination), the investigator-sponsored, Phase 2
clinical trial evaluating the safety and efficacy of avdoralimab,
in COVID-19 patients with severe pneumonia, did not meet its
primary endpoints in all three cohorts of the trial. Results from
this trial, including translational data, are planned to be
submitted for publication. The Company’s COVID-19 activities were
covered by public funding from the French government.
- Following a
strategic review, the Company will now solely pursue avdoralimab in
bullous pemphigoid, an inflammatory disease, through an
investigator-sponsored study and stop further development in all
other indications.
Corporate Update:
- Bpifrance informed
Innate that its permanent representative at Innate’s Supervisory
Board, Ms. Maylis Ferrere will be replaced by Mr. Olivier Martinez,
Senior Investment Director in the Life Sciences Investments
Department of the Direction of Innovation of Bpifrance, who has
been Observer of Innate’s Supervisory Board since 2010.
- Announced on May
28, 2021, Novo Nordisk A/S, represented by Marcus Schindler, M.D.,
decided not to seek re-election to the Supervisory Board due to Dr.
Schindler’s new role as Executive Vice President Research &
Early Development and Chief Scientific Officer of Novo Nordisk A/S.
Novo Nordisk A/S remains a shareholder in the Company but no longer
has a seat on its Supervisory Board.
About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage
oncology-focused biotech company dedicated to improving treatment
and clinical outcomes for patients through therapeutic antibodies
that harness the immune system to fight cancer.
Innate Pharma’s broad pipeline of antibodies
includes several potentially first-in-class clinical and
preclinical candidates in cancers with high unmet medical need.
Innate is a pioneer in the understanding of
Natural Killer cell biology and has expanded its expertise in the
tumor microenvironment and tumor-antigens, as well as antibody
engineering. This innovative approach has resulted in a diversified
proprietary portfolio and major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb, Novo
Nordisk A/S, Sanofi, and a multi-products collaboration with
AstraZeneca.
Headquartered in Marseille, France with a US
office in Rockville, MD, Innate Pharma is listed on Euronext Paris
and Nasdaq in the US.
Learn more about Innate Pharma at
www.innate-pharma.com
Information about Innate Pharma
shares:
ISIN codeTicker
codeLEI |
FR0010331421Euronext: IPH Nasdaq: IPHA9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking
information and risk factors:
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995. The use of
certain words, including “believe,” “potential,” “expect” and
“will” and similar expressions, is intended to identify
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 anticipated. These risks and uncertainties
include, among other things, the uncertainties inherent in research
and development, including related to safety, progression of and
results from its ongoing and planned clinical trials and
preclinical studies, review and approvals by regulatory authorities
of its product candidates, the Company’s commercialization efforts,
the Company’s continued ability to raise capital to fund its
development and the overall impact of the COVID-19 outbreak on the
global healthcare system as well as the Company’s business,
financial condition and results of operations. For an additional
discussion of risks and uncertainties which could cause the
company's actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque")
section of the Universal Registration Document filed with the
French Financial Markets Authority (“AMF”), which is available on
the AMF website http://www.amf-france.org or on Innate Pharma’s
website, and public filings and reports filed with the U.S.
Securities and Exchange Commission (“SEC”), including the Company’s
Annual Report on Form 20-F for the year ended December 31, 2020,
and subsequent filings and reports filed with the AMF or SEC, or
otherwise made public, by the Company.
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 Innate Pharma in any
country.
For
additional information, please contact: |
|
|
Investors |
Media |
Henry Wheeler |
Tracy Rossin (Global/US) |
Tel.: +33 761 88 38 74 |
Tel.: +1 240 801 0076 |
Henry.Wheeler@innate-pharma.fr |
Tracy.Rossin@innate-pharma.com |
|
ATCG Press Marie Puvieux (France)Tel. : +33 (0)9
81 87 46 72 |
|
innate-pharma@atcg-partners.com |
Summary of Interim Condensed Consolidated
Financial Statements and Notes as of JUNE 30, 2021Interim Condensed
Consolidated Statements of Financial Position(in thousand
euros)
|
June 30, 2021 |
December 31, 2020 |
Assets |
|
|
|
|
|
Current assets |
|
|
Cash and cash equivalents |
103,980 |
136,792 |
Short-term investments |
15,341 |
14,845 |
Trade receivables and others |
10,368 |
21,814 |
Total current assets |
129,688 |
173,451 |
|
|
|
Non-current assets |
|
|
Intangible assets |
45,193 |
46,289 |
Property and equipment |
10,891 |
11,694 |
Non-current financial assets |
40,081 |
38,934 |
Other non-current assets |
210 |
147 |
Trade receivables and others - non-current |
34,753 |
29,821 |
Deferred tax asset |
5,400 |
7,087 |
Total non-current assets |
136,528 |
133,972 |
|
|
|
Total assets |
266,217 |
307,423 |
Liabilities |
|
|
|
|
|
Current liabilities |
|
|
Trade payables and others |
17,026 |
29,538 |
Collaboration liabilities – current portion |
7,489 |
1,832 |
Financial liabilities – current portion |
2,017 |
2,142 |
Deferred revenue – current portion |
10,464 |
11,299 |
Provisions - current portion |
5,623 |
676 |
Total current liabilities |
42,619 |
45,488 |
|
|
|
Non-current liabilities |
|
|
Collaboration liabilities – non-current portion |
38,445 |
44,854 |
Financial liabilities – non-current portion |
14,485 |
16,945 |
Defined benefit obligations |
3,879 |
4,177 |
Deferred revenue – non-current portion |
27,602 |
32,674 |
Provisions - non-current portion |
226 |
221 |
Deferred tax liabilities |
5,400 |
7,087 |
Total non-current liabilities |
90,037 |
105,959 |
|
|
|
Shareholders’ equity |
|
|
Share capital |
3,952 |
3,950 |
Share premium |
373,043 |
372,130 |
Retained earnings |
(220,431) |
(156,476) |
Other reserves |
715 |
355 |
Net income (loss) |
(23,719) |
(63,983) |
Total shareholders’ equity |
133,561 |
155,976 |
|
|
|
Total liabilities and shareholders’ equity |
266,217 |
307,423 |
Interim Condensed Consolidated Statements of
Income (loss) (in thousand euros)
|
June 30, 2021 |
June 30, 2020 |
|
|
|
Revenue from collaboration and
licensing agreements |
8,304 |
29,841 |
Government financing for
research expenditures |
6,368 |
6,904 |
Lumoxiti Sales |
1,015 |
— |
|
|
|
Revenue and other income |
15,686 |
36,745 |
|
|
|
Research and development
expenses |
(21,794) |
(31,499) |
Selling, general and
administrative expenses |
(19,321) |
(14,490) |
|
|
|
Operating expenses |
(41,115) |
(45,989) |
|
|
|
Net income / (loss)
distribution agreements |
— |
896 |
|
|
|
Operating income (loss) |
(25,428) |
(8,348) |
|
|
|
Financial income |
3,490 |
2,446 |
Financial expenses |
(1,781) |
(4,431) |
|
|
|
Net financial income (loss) |
1,709 |
(1,986) |
|
|
|
Net income (loss) before tax |
(23,719) |
(10,334) |
|
|
|
Income tax expense |
— |
— |
|
|
|
Net income (loss) |
(23,719) |
(10,334) |
|
|
|
- Basic income (loss) per
share |
(0.30) |
(0.13) |
- Diluted income (loss) per
share |
(0.30) |
(0.13) |
Interim Condensed Consolidated Statements of Cash
Flow(in thousand euros)
|
June 30, 2021 |
June 30, 2020 |
Net income (loss) |
(23,719) |
(10,334) |
Depreciation and amortization, net |
2,168 |
6,719 |
Employee benefits costs |
268 |
264 |
Change in provision for
charges |
4,952 |
142 |
Share-based compensation
expense |
853 |
824 |
Change in valuation allowance
on financial assets |
(1,031) |
2,536 |
Gains (losses) on financial
assets |
(443) |
(48) |
Change in valuation allowance
on financial instruments |
(170) |
425 |
Gains on assets and other
financial assets |
(86) |
(758) |
Interest paid |
160 |
173 |
Other profit or loss items
with no cash effect |
(1,476) |
(373) |
Operating cash flow before change in working
capital |
(18,524) |
(430) |
Change in working capital |
(12,638) |
(57,595) |
Net cash generated from / (used in) operating
activities: |
(31,162) |
(58,025) |
Acquisition of intangible assets, net |
(33) |
(9,306) |
Acquisition of property and
equipment, net |
(240) |
(544) |
Purchase of non-current
financial instruments |
— |
(3,000) |
Disposal of property and
equipment |
2 |
36 |
Purchase of other assets |
(63) |
(52) |
Interest received on financial
assets |
86 |
758 |
Net cash generated from / (used in) investing
activities: |
(247) |
(12,108) |
Proceeds from the exercise / subscription of equity
instruments |
61 |
3 |
Repayment of borrowings |
(1,127) |
(1,029) |
Net interest paid |
(160) |
(173) |
Net cash generated / (used in) from financing
activities: |
(1,226) |
(1,199) |
Effect of the exchange rate changes |
(178) |
(13) |
Net increase / (decrease) in cash and cash
equivalents: |
(32,813) |
(71,345) |
Cash and cash equivalents at the beginning of the year: |
136,792 |
202,887 |
Cash and cash equivalents at the end of the six-months
period: |
103,980 |
131,542 |
Revenue and other incomeThe
following table summarizes operating revenue for the periods under
review:
In thousands of euros |
June 30, 2021 |
June 30, 2020 |
Revenue from collaboration and licensing agreements |
8,304 |
29,841 |
Government funding for
research expenditures |
6,368 |
6,904 |
Lumoxiti sales |
1,015 |
— |
Revenue and other income |
15,686 |
36,745 |
Revenue from collaboration and licensing
agreements
Revenue from collaboration and licensing
agreements decreased by €21.5 million, or 72.2%, to €8.3 million
for the six months ended June 30, 2021, as compared to
revenues from collaboration and licensing agreements of €29.8
million for the six months ended June 30, 2020. These revenues were
derived principally from our agreements with AstraZeneca and Sanofi
and are recognized on the basis of the percentage of completion of
the works performed by the Company.
The evolution for the first half of 2021 is
mainly due to:
-
Revenue related to monalizumab decreased by €13.5 million, or
69.0%, to €6.1 million for the six months ended June 30, 2021, as
compared to €19.6 million for the six months ended June 30, 2020.
This decrease mainly results from lower costs in connection with
the collaboration works performed relating to the trials’
maturity.
As of June 30, 2021, the deferred revenue
related to monalizumab was €20.7 million (€10.5 million as
“Deferred revenue—Current portion” and €10.2 million as “Deferred
revenue—Non-current portion).
-
Revenue related to IPH5201 are nil for the six months ended June
30, 2021, as compared to €8.7 million for the six months ended June
30, 2020. As of December 31, 2020, since the Company had fulfilled
all of its commitments on preclinical work related to the start of
Phase 1 of the IPH5201 program, the initial payment of $50.0
million and the milestone payment of $5.0 million were fully
recognized in revenue. Consequently, the Company has not recognized
any revenue related to the spreading of the milestone received from
the agreement with AstraZeneca on IPH5201 as of June 30, 2021.
-
Invoicing of research and development costs: Pursuant to our
agreements with AstraZeneca, clinical costs for the ongoing Phase 1
trial of avdoralimab are equally shared between Innate Pharma and
AstraZeneca and research and development costs related to IPH5201
are fully borne by AstraZeneca, resulting in periodic settlement
invoices. These costs are invoiced back on a quarterly basis.
Revenue from invoicing of research and development costs for the
six months ended June 30, 2021 increased by €0.1 million, or 11%,
to €1.2 million, as compared to €1.1 million for the six months
ended June 30, 2020.
Government funding for research
expenditures
Government financing for research expenditures
decreased by €0.5 million, or 7.8%, to €6.4 million for the
six months ended June 30, 2021 as compared to €6.9 million the six
months ended June 30, 2020. This change is mainly due to (i) a
decrease in amortization of the acquired licenses (monalizumab and
IPH5201) and decrease in eligible private subcontracting costs
included in research tax credit calculation, in connection with the
decrease in R&D subcontracting over the period; (ii) partly
offset by an increase in grants of €1.3 million in connection with
the recording in revenue of the first relative repayable advance
tranche paid to the Company and pursuant to the BPI financing
contract signed in August 2020. This payment was received by the
Company at contract signing. This financing contract was set up as
part of the program set up by the French government to help develop
a therapeutic solution with a preventive or curative aim against
COVID-19. As of June 30, 2021, this financing is considered by
the Company to be non-refundable, in accordance with the terms of
the agreement, in light of the technical and commercial failure of
the project based on the results of the Phase 2 "FORCE" trial
evaluating avdoralimab in COVID-19, published on July 6, 2021.
The research tax credit is calculated as 30% of
the amount of research and development expenses, net of grants
received, eligible for the research tax credit for the six months
ended June 30, 2021 and 2020. Following the loss of the SME status
under European Union criteria since December 31, 2019, the CIR for
the tax year 2021 will be imputable on the tax expense of the
following three tax years, or refunded if necessary at the end of
this delay.
Lumoxiti Sales
As of June 30, 2021, following the end of the
transition period relating to the commercialization of Lumoxiti in
the United States on September 30, 2020, the Company recognized net
sales of Lumoxiti for the first half of 2021 for an amount of €1.0
million.
Operating expenses
The table below presents our operating expenses
for the six months periods ended June 30, 2021 and 2020:
In thousands of euros |
June 30, 2021 |
June 30, 2020 |
Research and development expenses |
(21,794) |
(31,499) |
General
and administrative expenses |
(19,321) |
(14,490) |
Operating expenses |
(41,115) |
(45,989) |
Research and development
expenses
Research and development (“R&D”) expenses
decreased by €9.7 million, or 30.8%, to €21.8 million for the six
months ended June 30, 2021, as compared to €31.5 million for the
six months ended June 30, 2020, representing a total of 53.0% and
68.5% of the total operating expenses, respectively. R&D
expenses include direct R&D expenses (subcontracting costs and
consumables), depreciation and amortization, and personnel
expenses.
Direct expenses decreased by €3.8 million, or
23.8%, to €12.1 million for the six months ended June 30, 2021, as
compared to €15.9 million for the six months ended June 30, 2020.
This decrease is mainly explained by (i) a decrease of €1.4 million
in expenses relating to Lumoxiti, which is explained by the end of
the transition period with AstraZeneca in September 2020 and the
decision taken by the Company to return commercial rights in the
United States and in Europe notified in December 2020, (ii) a
decrease of €1.7 million in expenses relating to the avdoralimab
program in connection with the decision taken by the Company at the
end of the first half of 2020 to stop recruitment in trials
evaluating avdoralimab in oncology, and (iii) a €0.7 million
decrease in expenses relating to monalizumab in connection with the
maturity of clinical trials falling within the scope of the
collaboration with AstraZeneca.
Personnel and other expenses allocated to
R&D decreased by €5.9 million, or (37.9%), to €9.7 million for
the six months ended June 30, 2021, as compared to an amount of
€15.6 million for the six months ended June 30, 2020. This decrease
is mainly explained by the decrease in depreciation and
amortization expenses allocated to R&D for €4.7 million in
connection with the decrease in depreciation expenses relating to
the licenses acquired and concerning (i) Lumoxiti for €2.0 million
(intangible asset fully depreciated as of December 31, 2020), (ii)
IPH5201 for €1.8 million (intangible asset fully amortized as of
December 31, 2020) and (iii) monalizumab for €0.7 million, in
connection with the extension of the estimated end date of the
program clinical studies.
Selling, general and administrative
expenses
Selling, general and administrative (“SG&A”)
expenses increased by €4.8 million, or 33.3%, to €19.3 million for
the six months ended June 30, 2021, as compared to €14.5 million
for the six months ended June 30, 2020, representing a total of
47.0% and 31.5% of the total operating expenses, respectively.
Personnel expenses are stable, to €6.4 million
for the six months ended June 30, 2021 as compared to €6.4 million
for the six months ended June 30, 2020.
Non-scientific advisory and consulting expenses
mostly consist of auditing, accounting, taxation and legal fees as
well as consulting fees in relation to business strategy and
operations and hiring services. Non-scientific advisory and
consulting expenses decreased by €0.8 million, or (19.9%), to €3.3
million for the six months ended June 30, 2021 as compared to €4.1
million for the six months ended June 30, 2020, primarily as a
result of expenses related to the commercialization of Lumoxiti and
the structuring of our U.S subsidiary in the first semester of
2020.
Selling, general and administrative expenses
include the provision for charges relating to the payment of $6.2
million (€5.2 million as of June 30, 2021) to be made on April 30,
2022 to AstraZeneca under the Lumoxiti transition and termination
agreement effective as of June 30, 2021. The provision thus
constituted is presented under “Provision - current portion” in the
consolidated balance sheet.
Following the December 2020 announcement, Innate
and AstraZeneca have successfully executed the Lumoxiti termination
and transition agreement. The companies are currently in a
transition period, in which Innate will remain the Biologics
License Application (BLA) holder in the U.S until September 30,
2021. AstraZeneca will reimburse Innate for all Lumoxiti related
costs and expenses, and Innate will remit proceeds from net sales
to AstraZeneca. In the full year results 2020 announcement, the
Company reported a contingent liability of up to $12.8 million in
its consolidated financial statements, which was linked to the
split of certain manufacturing costs. As part of the termination
and transition agreement, Innate and AstraZeneca agreed to split
the manufacturing costs, and Innate will pay $6.2 million on April
30, 2022.
The rise in other expenses mainly results from
insurance costs, which increase following the listing of the
Company on the Nasdaq.
Net income (loss) from distribution
agreements
During the transition period which ended on
September 30, 2020, Lumoxiti products were commercialized in the
U.S by AstraZeneca who is the owner of the regulatory approval. The
Company concluded that it did not meet the criteria for being
principal under IFRS 15 during the transition period. Consequently,
the net result resulting from all Lumoxiti marketing’s operations
was disclosed in the item line “Net income / (loss) from
distribution agreements.” The Company recognized a €896 thousand
net gain for the six months ended June 30, 2020, corresponding to
production and marketing costs, net of sales proceeds, as invoiced
by AstraZeneca in relation to Lumoxiti distribution agreement for
the period.
Financial income (loss),
net
We recognized a net financial gain of €1.7
million in the six months ended June 30, 2021 as compared to a net
financial loss of €2.0 million in the six months ended June 30,
2020. This €3.7 million increase mainly resulted from the decrease
in fair value of certain of our financial instruments (net gain of
€1.0 million as compared to a net loss of €2.5 million for the six
months ended June 30, 2021 and 2020, respectively). Such decrease
in fair value of certain of our financial instruments resulted from
the negative impact of the COVID-19 outbreak on the financial
markets in the first half of 2020.
Balance sheet items
Cash, cash equivalents, short-term investments
and non-current financial assets amounted to €159.4 million as of
June 30, 2021, as compared to €190.6 million as of
December 31, 2020. Net cash as of June 30, 2021 amounted to
€117.3 million (€149.5 million as of December 31, 2020). Net
cash is equal to cash, cash equivalents and short-term investments
less current financial liabilities.
The other key balance sheet items as of June 30,
2021 are:
-
Deferred revenue of €38.1 million (including €27.6 million booked
as ‘Deferred revenue – non-current portion’) and collaboration
liabilities of €45.9 million (including €38.4 million booked as
‘Collaboration liabilities - non-current portion’) relating to the
remainder of the initial payment received from AstraZeneca not yet
recognized as revenue or used as part of the co-financing of the
monalizumab program with AstraZeneca;
-
Receivables from the French government amounting to €34.8 million
in relation to the research tax credit for 2019 and 2020 and the
six-month period ended June 30, 2021;
-
Intangible assets for a net book value of €45.2 million, mainly
corresponding to the rights and licenses relating to the
acquisition of the monalizumab and avdoralimab;
-
Shareholders’ equity of €133.6 million, including the net loss of
the period of €23.7 million;
Cash-flow items
As of June 30, 2021, cash and cash equivalents
amounted to €104.0 million, compared to €136.8 million as of
December 31, 2020, corresponding in a decrease of €32.8
million.
The net cash flow generated during the period
under review mainly results from the following:
-
Net cash flow used by operations of €31.2 million for the six
months ended June 30, 2021 as compared to net cash flows used by
operations of €58.0 million for the six months ended June 30, 2020.
This change is mainly explained by the decrease in commercial
activities relating to Lumoxiti, in connection with the decision
taken by the Company in December 2020 to return the commercial
rights in the United States and in Europe to AstraZeneca.
-
Net cash flow used in investing activities of €0.2 million. The
Company has not made any investments in tangible, intangible or
significant financial assets during the first half of 2021.
As a reminder, our net cash flow used in
investing activities for the six months ended June 30, 2020 were
€12.1 million and were mainly driven by (i) a €13.4 million ($1.5
million) additional consideration paid to AstraZeneca regarding
Lumoxiti following the submission of the BLA to the European
Medicine Agency (EMA) in November 2019 (ii) a €2.7 million
additional consideration paid to Orega Biotech in April 2020
relating to IPH5201 following the dosing of a first patient in a
Phase I clinical trial and (iii) the acquisition of financial
assets for a net amount of €3.0 million. These items were partly
offset by the reimbursement by AstraZeneca of the rebate relating
to the acquisition of Lumoxiti (€7.0 million).
-
Net cash flows used in financing activities for the six months
ended June 30, 2021, are stable as compared to the six months ended
June 30, 2020. These amounted to €1.2 million and were mainly
related to repayments of financial liabilities.
Post period events
None.
Nota
The interim consolidated financial statements
for the six-month period ended June 30, 2021 have been subject to a
limited review by our Statutory Auditors and were approved by the
Executive Board of the Company on September 14, 2021. They
were reviewed by the Supervisory Board of the Company on
September 14, 2021. They will not be submitted for approval to
the general meeting of shareholders.
Risk factors
Risk factors identified by the Company are
presented in section 3 of the universal registration document
(“Document d’Enregistrement Universel”) submitted to the French
stock-market regulator, the “Autorité des Marchés Financiers”, on
April 27, 2021 (AMF number D.21-0361). The main risks and
uncertainties the Company may face in the six remaining months of
the year are the same as the ones presented in the universal
registration document available on the internet website of the
Company, except the risk described in the paragraph 3.4 “Risks
relating to the return of rights from Lumoxiti to Astrazeneca” of
the universal registration document, which is not relevant anymore
for the Company. An update of that risk is presented in note G) of
the half-year management review as of June 30, 2021. The risks that
are likely to arise during the remaining six months of the current
financial year could also occur during subsequent years.
Related party transactions:
Transactions with related parties during the periods under review
are disclosed in Note 19 to the interim condensed consolidated
financial statements for the period ended June 30, 2021 prepared in
accordance with IAS 34.
1 Including short term investments (€15.3
million) and non-current financial instruments (€40.1 million)
2 See note 18) of the consolidated financial
statements as of December 31, 2020
Innate Pharma (EU:IPH)
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Innate Pharma (EU:IPH)
過去 株価チャート
から 11 2023 まで 11 2024