- Monalizumab progressing to Phase 3 PACIFIC-9 lung cancer
clinical trial in partnership with AstraZeneca
- First CD123 tri-specific ANKETTM starts Phase 1 study by
Sanofi
- Lacutamab encouraging MF data and PTCL study starts
- Cash position of €159.7 million1 as of December 31,
2021
- Conference call to be held today at 2:00 p.m. CET / 9:00
a.m. EDT
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today reported its
consolidated financial results for the year ending December 31,
2021. The consolidated financial statements are attached to this
press release.
“Throughout 2021, we made key progress across our portfolio –
announcing promising data with our proprietary pipeline as well as
the start of a new pivotal study by our partner AstraZeneca with
our most advanced pipeline asset, monalizumab. Highlights from our
pipeline included the encouraging lacutamab data in a subtype of
cutaneous T-cell lymphoma, mycosis fungoides (MF), and the
initiation of trials of the product in the broader indications of
peripheral T-cell lymphomas (PTCL). We also showed further
validation with our multi-specific NK cell engager platform,
ANKETTM, including the start of a Phase 1 trial with Sanofi,”
said Mondher Mahjoubi, Chief Executive Officer of Innate
Pharma. “The value in Innate is the strength and depth of our
core R&D efforts, as we look to progress our pipeline in house,
or with partnerships. We look forward to new milestones in the
coming year including readouts from the lacutamab program, further
progress in our early-stage R&D activities in ANKETTM and the
adenosine franchise and not least in continued development of
monalizumab.”
Webcast and conference call
will be held today at 2:00pm CET (9:00am EDT)
Access to live webcast:
https://event.on24.com/wcc/r/3577447/6B0C866D3C3BB7A70F1BAAD02F7320D2
Participants may also join via
telephone using the dial-in details below:
France: 0805 620 704
United States: 1 844 200 6205 / 1
646 904 5544
United Kingdom: 44 208 0682 558 /
44 808 189 648
All other locations: +1 929 526
1599
Access code: 834852
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.
Pipeline highlights:
Lacutamab (IPH4102, anti-KIR3DL2
antibody):
- The Company announces the opening of a new mycosis fungoides
(MF) all-comers cohort in the TELLOMAK study. The all-comers cohort
will recruit both KIR3DL2 expressors and non-expressors to explore
the correlation between the level of KIR3DL2 expression and
treatment outcomes utilizing a formalin-fixed paraffin embedded
(FFPE) assay as a companion diagnostic. The KIR3DL2 non-expressing
Cohort 3 has been closed to recruitment. As per the Simon 2-stage
design, the number of responses to move to stage 2 was not reached,
as such, recruitment into this cohort is stopped. Cohort 3 included
KIR3DL2 non-expressing patients assigned via a KIR3DL2
immunohistochemistry assay for use on frozen biopsy samples and as
a tool for stratification.
- In June 2021, the Company announced preliminary data from its
Phase 2 TELLOMAK trial, in which lacutamab demonstrated a 35%
overall global response rate in patients with 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).
- Two parallel clinical trials to study lacutamab in patients
with KIR3DL2-expressing, relapsed/refractory peripheral T-cell
lymphoma (PTCL) are ongoing:
- 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) initiated 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 December 2021, the Company announced that the first patient
was dosed in a Phase 1/2 clinical trial by Sanofi, evaluating
IPH6101/SAR443579, the first NKp46/CD16‑based NK cell engager, in
patients with relapsed or refractory acute myeloid leukemia (R/R
AML), B-cell acute lymphoblastic leukemia (B-ALL) or high
risk-myelodysplastic syndrome (HR-MDS). The purpose of the dose
escalation and dose expansion study, which is sponsored by Sanofi,
is to evaluate the safety, pharmacokinetics, pharmacodynamics and
initial clinical activity of IPH6101/SAR443579, Innate’s lead
ANKETTM asset, in various CD123-expressing hematological
malignancies. The start of the trial has triggered a milestone
payment from Sanofi to Innate.
- In November 2021, Innate Pharma in collaboration with Sanofi,
presented preclinical data from Innate’s proprietary,
multi-specific NK cell engager platform, ANKETTM, at the Society
for Immunotherapy of Cancer (SITC). Data on IPH6101/SAR443579,
using Innate’s proprietary multi-specific antibody format (Gauthier
et al. Cell 2019) that targets CD123 on acute myeloid leukemia
(AML) cells and co-engages NKp46 and CD16a on NK cells was
presented. In preclinical studies, IPH6101/SAR443579 demonstrated
potent antitumor activity against AML cell lines, including those
resistant to ADCC by a comparator anti-CD123 antibody.
IPH6101/SAR443579 also promoted strong and specific NK-cell
activation and induced cytokine secretion only in the presence of
AML target cells. In addition, IPH6101/SAR443579 had sustained
pharmacodynamic effects in non-human primates, combining efficient
depletion of CD123-expressing cells with minor systemic cytokine
release in comparison to T-cell engagers. As expected, it also had
a favorable safety profile.
- In June 2021, the Company presented new data on its ANKETTM
platform, at the Federation of Clinical Immunology Societies
meeting. Specifically, Innate shared data from its tetra-specific
ANKETTM 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 ANKETTM
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
ANKETTM 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.
ANKETTM also showed a pharmacodynamic effect, low systemic cytokine
release and a manageable safety profile in non-human primates.
- In January 2021, it was announced that Sanofi will transition
IPH6101/SAR443579 into investigational new drug (IND)-enabling
studies. 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.
- IPH64, the other drug candidate of the research collaboration
with Sanofi is progressing and the Company look forward to updates
on this asset.
- The Company’s proprietary tetra-specific ANKETTM IPH65 is
progressing to IND enabling studies.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- In March 2022, the Phase 2 NeoCOAST study assessing the safety
and efficacy of neoadjuvant durvalumab in combination with
chemotherapy and oleclumab or monalizumab and adjuvant treatment in
participants with resectable, early-stage non-small cell lung
cancer (NSCLC) has been accepted for an oral presentation on 11
April 2022 at the Annual Meeting 2022 of the American Association
for Cancer Research.
- In February 2022, AstraZeneca initiated a Phase 3 clinical
trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination
with monalizumab (anti-NKG2A) or AstraZeneca’s oleclumab
(anti-CD73) in patients with unresectable, Stage III NSCLC who have
not progressed following definitive platinum-based concurrent
chemoradiation therapy (CRT).
- In December 2021, the Company presented data from the Phase 2
expansion cohort (‘cohort 3’), exploring the triplet combination of
monalizumab, cetuximab and durvalumab in the first-line treatment
of patients with recurrent or metastatic head and neck squamous
cell cancer (R/M HNSCC) at the European Society for Medical
Oncology (ESMO) Immuno-Oncology Congress 2021. After a median
follow-up of 16.3 months, preliminary data suggest anti-tumor
activity in the triplet of monalizumab, cetuximab and durvalumab in
first-line treatment of R/M HNSCC. As of August 1, 2021, 40
patients were enrolled. Thirteen patients had a confirmed response
with a 32.5% overall response rate (95% confidence interval (CI):
20-48), including three complete responses. Seven out of 13
responders were still on treatment. Median duration of response was
not yet reached (95% CI: 7.1-not available). The survival rate at
12 months was 58.6% (95% CI: 45-77) and the median overall survival
was 15 months (95% CI: 11.4 - not available).
- In September 2021, AstraZeneca commenced a Phase 2 clinical
study, NeoCOAST-2, that includes a treatment arm with durvalumab in
combination with chemotherapy and monalizumab in resectable,
early-stage NSCLC.
- In September 2021, AstraZeneca presented a late-breaker
abstract on the randomized COAST Phase 2 trial in patients with
unresectable, Stage III NSCLC at the ESMO Congress. The
presentation highlighted progression-free survival (PFS) and
overall response rate (ORR) results for durvalumab in combination
with monalizumab, Innate’s lead partnered asset, and oleclumab,
AstraZeneca’s anti-CD73 monoclonal antibody. After a median
follow-up of 11.5 months, the results of an interim analysis showed
a 10-month PFS rate of 72.7% for durvalumab plus monalizumab,
versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC
patients following chemoradiation therapy. The results also showed
an increase in the primary endpoint of confirmed ORR for durvalumab
plus monalizumab over durvalumab alone (36% vs. 18%).
IPH5201 (anti-CD39), partnered with
AstraZeneca:
- AstraZeneca is conducting a Phase 1 trial in solid tumors with
IPH5201 alone or in combination with durvalumab (anti-PD-L1). The
data is expected to be presented in 2023. Innate is in discussions
with AstraZeneca on potential next steps for this program.
IPH5301 (anti-CD73):
- In March 2022, The Institut Paoli-Calmettes announced that the
first patient had been dosed in the investigator-sponsored Phase 1
trial of IPH5301 (CHANCES). The trial will be conducted in two
parts, Part 1, the dose escalation, followed by a Part 2 safety
expansion study cohort. Part 2 will evaluate IPH5301 in combination
with chemotherapy and trastuzumab in HER2+ cancer patients.
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. Data in bullous pemphigoid is
now expected in 2024.
Corporate Update:
- In February 2022, Mrs Tracy Rossin, VP, Global Head of
Communications, decided to pursue another opportunity outside the
Company. Mr Henry Wheeler, Vice President of Investor Relations,
who joined Innate in June 2021 is now responsible for Investor
Relations and Communications.
- In January 2022, Mr Nicola Beltraminelli PhD was appointed as
Vice President, Chief Development Officer of Innate responsible for
non-clinical development. Mrs Frederique Brune, Vice President
Development CMC and Supply Chain decided to pursue another
opportunity outside the company. Mr Beltraminelli brings more than
20 years of biotech experience to the role, and specifically in the
development of biologic products from early discovery to GMP
manufacture. Most recently, Mr Beltraminelli served as Chief
Technical Officer at Lysogene, where he led the CMC activities for
two late-stage assets.
- In January 2022, Innate Pharma announced that it had obtained
€28.7M in non-dilutive financing in the form of State Guaranteed
Loans from Société Générale and BNP Paribas. The two agreements
were signed and funds received in December 2021.
- In November 2021, Jen Butler, Head of Global Commercial and US
General Manager left her position at the Company.
- In June 2021, Bpifrance informed Innate that its permanent
representative at Innate’s Supervisory Board, Mrs Maïlys 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.
- Frederic Lombard was appointed as Chief Financial Officer on
April 1, 2021. Mr Lombard has more than 20 years of financial
experience in the pharmaceutical industry, holding senior finance
roles at Ipsen, AstraZeneca and Novartis. Laure-Hélène Mercier,
Executive Vice President, Chief Financial Officer and member of the
Executive Board, decided to step down from her position, after
leading the Company through more than 14 years of growth, including
an initial public offering in the US. She left the Company on
January 2022.
Financial highlights for 2021:
The key elements of Innate’s financial position and financial
results as of and for the year ended December 31, 2021 are as
follows:
- Cash, cash equivalents, short-term investments and financial
assets amounting to €159.7 million2 (€m) as of December 31, 2021
(€190.6m as of December 31, 2020), including non-current financial
instruments amounting to €39.9m (€38.9m as of December 31,
2020).
- As of December 31, 2021, financial liabilities amount to €44.3m
(€19.1m as of December 31, 2020). This change is mainly linked to
proceeds relating to State-Guaranteed Loans (Prêts Garantis par
l’Etat “PGE”) of €28.7m from Société Générale (€20.0m) and BNP
Paribas (€8.7m) collected by the Company on December 2021.
- Revenue and other income from continuing operations3 amounted
to €24.7m in 2021 (2020: €69.8m, -64.6%). It mainly comprises
revenue from collaboration and licensing agreements (€12.1m in 2021
vs €56.2m in 2020, -78.4%), and research tax credit (€10.3m in 2021
vs €13.1m in 2020, -21.2%):
- Revenue from collaboration and licensing agreement with
AstraZeneca amounted to €9.1m in 2021 (€49.0m in 2020, -81.4%) and
mainly resulted from (i) the spreading of the upfront and opt-in
payments received from AstraZeneca and (ii) the invoicing to
AstraZeneca of certain fees for the work performed by Innate for
the partnered programs. The variation between the two periods is
notably explained by the (i) decrease in direct monalizumab
research and development costs over the period, in connection with
the Phase 1 & 2 trials maturity, and (ii) the absence of
revenue relating to IPH5201 in 2021, the Company having fulfilled
all of its commitments on preclinical work related to the start of
Phase 1 as of December 31,2020.
- Revenue of €3.0m from Sanofi following the initiation of a
GLP-tox Study and the launching of the first Phase 1 clinical trial
in humans in relapsed of refractory AML with IPH6101/SAR443579,
respectively in January and December 2021.
- The variation in the research tax credit mainly results from a
decrease in the amortization for the intangible assets related to
acquired licenses (monalizumab and IPH5201).
- Operating expenses from continuing operations amounted to
€72.5m in 2021 (2020: €68.7m, +5.6%):
- General and administrative (G&A) expenses from continuing
activities amounted to €25.5m in 2021 (2020: €19.0m, +34.4% 4).
This increase results cumulatively from (i) an increase in wages
mainly resulting from restructuring costs and higher annual bonuses
level in 2021, (ii) an increase in non-scientific advisory fees and
(iii) an increase in other general and administrative
expenses.
- Research and development (R&D) expenses from continuing
activities amounted to €47.0m in 2021 (2020: €49.7m, -5.4%). This
variation mainly results from a (i) decrease in depreciation and
amortization of intangible assets acquired by the Company (IPH5201,
fully amortized since December 2020, and monalizumab) partly offset
by (ii) an increase in direct research and development expenses
(clinical and non-clinical).
- A net financial income of €2.3m in 2021 (2020: €1.9m
loss).
- A net loss from Lumoxiti discontinued operations of €7.3m in
2021 (2020 : net loss of €63.2m, -88.4%) mainly resulting from the
Settlement Amount of $6.2m5 (€5.5m as of December 31, 2021) to be
paid to AstraZeneca on April 30, 2022, as part of the Termination
and Transition agreement effective as of June 30, 2021. The net
loss in 2020 mainly resulted from the full impairment of Lumoxiti
rights following the Company decision to return the marketing
rights of Lumoxiti in the United States and in Europe to
AstraZeneca.
- A net loss of €52.8m in 2021 (2020: net loss of €64.0m).
The table below summarizes the IFRS consolidated financial
statements as of and for the year ended December 31, 2021,
including 2020 comparative information.
In thousands of euros, except for data
per share
December 31, 2021
December 31, 2020(1)
Revenue and other income
24,703
69,773
Research and development
(47,004)
(49,708)
Selling, general and administrative
(25,524)
(18,986)
Total operating expenses
(72,528)
(68,694)
Operating income (loss)
(47,825)
1,079
Net financial income (loss)
2,347
(1,908)
Income tax expense
—
—
Net income (loss) from continuing
operations
(45,478)
(829)
Net income (loss) from discontinued
operations
(7,331)
(63,155)
Net income (loss)
(52,809)
(63,984)
Weighted average number of shares
outstanding (in thousands)
79,543
78,935
Basic income (loss) per share
(0.66)
(0.81)
Diluted income (loss) per share
(0.66)
(0.81)
Basic income (loss) per share from
continuing operations
(0.57)
(0.01)
Diluted income (loss) per share from
continuing operations
(0.57)
(0.01)
Basic income (loss) per share from
discontinued operations
(0.09)
(0.80)
Diluted income (loss) per share from
discontinued operations
(0.09)
(0.80)
December 31, 2021
December 31, 2020
Cash, cash equivalents and financial
asset
159,714
190,571
Total assets
267,496
307,423
Shareholders’ equity
107,440
155,976
Total financial debt
44,251
19,087
(1) The 2020 comparatives have been
restated to consider the impact of classifying the Lumoxiti
business as discontinued operations in 2021.
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 code Ticker code LEI
FR0010331421
Euronext: IPH Nasdaq: IPHA
9695002Y8420ZB8HJE29
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.
Summary of Consolidated Financial Statements
and Notes as of December 31, 2021
Consolidated Statements of
Financial Position
(in thousand euros)
December 31, 2021
December 31, 2020
Assets
Cash and cash equivalents
103,756
136,792
Short-term investments
16,080
14,845
Trade receivables and others - current
18,420
21,814
Total current assets
138,256
173,451
Intangible assets
44,192
46,289
Property and equipment
10,174
11,694
Non-current financial assets
39,878
38,934
Other non-current assets
148
147
Deferred tax assets
5,028
7,087
Trade receivables and others -
non-current
29,821
29,821
Total non-current assets
129,241
133,972
Total assets
267,496
307,423
Liabilities
Trade payables and others
28,573
29,539
Collaboration liabilities – Current
portion
7,418
1,832
Financial liabilities – Current
portion
30,748
2,142
Deferred revenue – Current portion
12,500
11,299
Provisions – Current portion
647
676
Total current liabilities
79,886
45,488
Collaboration liabilities – Non current
portion
32,997
44,854
Financial liabilities – Non-current
portion
13,503
16,945
Defined benefit obligations
2,975
4,177
Deferred revenue – Non-current portion
25,413
32,674
Provisions – Current portion
253
221
Deferred tax liabilities
5,028
7,087
Total non-current liabilities
80,169
105,959
Share capital
3,978
3,950
Share premium
375,219
372,131
Retained earnings
(219,404)
(156,476)
Other reserves
456
355
Net income (loss)
(52,809)
(63,984)
Total shareholders’ equity
107,440
155,976
Total liabilities and shareholders’
equity
267,496
307,423
Consolidated Statements of Income
(loss)
(in thousand euros)
December 31, 2021
December 31, 2020(1)
Revenue from collaboration and licensing
agreements
12,112
56,155
Government financing for research
expenditures
12,591
13,618
Revenue and other income
24,703
69,773
Research and development expenses
(47,004)
(49,708)
Selling, general and administrative
expenses
(25,524)
(18,986)
Operating expenses
(72,528)
(68,694)
Operating income (loss)
(47,825)
1,079
Financial income
6,344
4,855
Financial expenses
(3,997)
(6,763)
Net financial income (loss)
2,347
(1,908)
Net income (loss) before tax
(45,478)
(829)
Income tax expense
—
—
Net income (loss) from continuing
operations
(45,478)
(829)
Net income (loss) from discontinued
operations
(7,331)
(63,155)
Net income (loss)
(52,809)
(63,984)
Net income (loss) per share:
(in € per share)
- basic income (loss) per share
(0.66)
(0.81)
- diluted income (loss) per share
(0.66)
(0.81)
- Basic income (loss) per share from
continuing operations
(0.57)
(0.01)
- Diluted income (loss) per share from
continuing operations
(0.57)
(0.01)
- Basic income (loss) per share from
discontinued operations
(0.09)
(0.80)
- Diluted income (loss) per share from
discontinued operations
(0.09)
(0.80)
(1) The 2020 comparatives have been
restated to consider the impact of classifying the Lumoxiti
business as discontinued operations in 2021.
Consolidated Statements of Cash
Flows
(in thousand euros)
December 31, 2021
December 31, 2020
Net income (loss)
(52,809)
(63,984)
Depreciation and amortization
4,596
56,797
Employee benefits costs
437
216
Provisions for charges
4
604
Share-based compensation expense
2,617
2,475
Change in valuation allowance on financial
assets
(987)
577
Gains (losses) on financial assets
(1,136)
1,256
Change in valuation allowance on financial
assets
(55)
372
Gains (losses) on assets and other
financial assets
(367)
(962)
Interest paid
312
341
Other profit or loss items with no cash
effect
(1,185)
(254)
Operating cash flow before change in
working capital
(48,573)
(2,562)
Change in working capital
(9,884)
(49,206)
Net cash generated from / (used in)
operating activities:
(58,457)
(51,767)
Acquisition of intangible assets, net
(401)
(10,375)
Acquisition of property and equipment,
net
(929)
(907)
Acquisition of non-current financial
assets
—
(3,000)
Disposal of property and equipment
7
9
Disposal of other assets
40
—
Acquisition of other assets
(1)
(59)
Interest received on financial assets
367
962
Net cash generated from / (used in)
investing activities:
(917)
(13,370)
Proceeds from the exercise / subscription
of equity instruments
499
48
Proceeds from borrowings
28,700
1,360
Repayment of borrowings
(2,069)
(2,245)
Net interest paid
(312)
(341)
Net cash generated from financing
activities:
26,818
(1,177)
Effect of the exchange rate changes
(483)
219
Net increase / (decrease) in cash and
cash equivalents:
(33,037)
(66,096)
Cash and cash equivalents at the beginning
of the year:
136,792
202,887
Cash and cash equivalents at the end of
the year :
103,756
136,792
Revenue and other income
The following table summarizes operating revenue for the periods
under review:
In thousands of euro
December 31, 2021
December 31, 2020(1)
Revenue from collaboration and licensing
agreements
12,112
56,155
Government financing for research
expenditures
12,591
13,618
Revenue and other income
24,703
69,773
(1) The 2020 comparatives have been
restated to consider the impact of classifying the Lumoxiti
business as discontinued operations in 2021.
Revenue from collaboration and licensing agreements
Revenue from collaboration and licensing agreements from
continuing operations decreased by €44.0 million, or 78.4%, to
€12.1 million for the year ended December 31, 2021, as compared to
€56.2 million for the year ended December 31, 2020. Revenue from
collaboration and licensing agreements mainly results from the
spreading of the initial payments and the exercise of options
related to the agreements signed with AstraZeneca in April 2015 and
October 2018, on the basis of the completion of work that the
Company is committed to carry out. The evolution in 2021 is mainly
due to:
- A €26.1 million decrease in revenue related to monalizumab to
€7.5 million for the year ended December 31, 2021, as compared to
€33.6 million for the year ended December 31, 2020. This decrease
is mainly explained by the decrease in direct monalizumab research
and development costs over the period, in connection with the Phase
1 & 2 trials maturity. As of December 31, 2021, the deferred
revenue related to monalizumab amounts to €20.2 million (€12.1
million as “Deferred revenue—Current portion” and €8.0 million as
“Deferred revenue—Non-current portion”).
- A €13.4 million decrease in revenue related to IPH5201. Nil for
the year ended December 31, 2021, as compared to €13.4 million for
the year ended December 31, 2020. As a reminder, as of December 31,
2020, the Company having 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.
- A €0.9 million decrease in revenue from invoicing of research
and development costs to €1.6 million for the year ended December
31, 2021, as compared to €2.5 million for the year ended December
31, 2020. Pursuant to our agreements with AstraZeneca, research and
development costs related to avdoralimab in oncology are equally
shared between us and AstraZeneca and research and development
costs related to IPH5201 are fully borne by AstraZeneca. The
decrease between the two periods is mainly explained by the
decrease in research and development costs relating to IPH5201
re-invoiced to AstraZeneca following the transition of the program
in Phase 1 clinical trial, supported AstraZeneca.
- A €4.0 million decrease in revenue from collaboration and
research license agreement with Sanofi, to €3.0 million for the
year ended December 31, 2021, as compared to €7.0 million for the
year ended December 31, 2020. In January 2021, a GLP-tox study was
initiated for the IPH6101/SAR443579 program. Additionally, in
December, 2021, the Company announced that the first patient was
dosed in a Phase 1 clinical trial launched by Sanofi in humans with
IPH6101/SAR443579 in relapsed or refractory AML. These trials
triggered two milestone payments from Sanofi to Innate, planned in
the research collaboration between the two companies, fully
recognized in revenue as of December 31, 2021. As a reminder, in
December 2020, Sanofi informed the Company of its intention to
advance IPH6101/SAR443579 into investigational new drug
(IND)-enabling studies. This decision triggered a milestone payment
of €7.0 million from Sanofi to the Company, fully recognized in
revenue as of December 31, 2020.
Government funding for research expenditures
Government funding for research expenditures decreased by €1.0
million, or 7.5%, to €12.6 million for the year ended December 31,
2021, as compared to €13.6 million for the year ended December 31,
2020. This change is primarily a result of a decrease in the
research tax credit of €2.8 million, which is mainly due to a
decrease in the amortization expense relating to the intangible
assets related to the acquired licenses (see R&D expenses).
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 fiscal year. The Company is
again eligible to the SME status under European Union criteria as
of December 31, 2021. Consecutively, the Company is eligible for
the early repayment by the French treasury of the 2021 research tax
credit during the fiscal year 2022.
Operating expenses
The table below presents our operating expenses from continuing
operations for the years ended December 31, 2021 and 2020:
In thousands of euros
December 31, 2021
December 31, 2020(1)
Research and development expenses
(47,004)
(49,708)
Selling, general and administrative
expenses
(25,524)
(18,986)
Operating expenses
(72,528)
(68,694)
(1) The 2020 comparatives have been
restated to consider the impact of classifying the Lumoxiti
business as discontinued operations in 2021.
Research and development expenses
Research and development (“R&D”) expenses from continuing
operations decreased by €2.7 million, or 5.4%, to €47.0 million for
the year ended December 31, 2021, as compared to €49.7 million for
the year ended December 31, 2020. This decrease mainly results from
a decrease of €5.1 million in research and development depreciation
and amortization of intangible assets acquired by the Company,
partly offset by an increase of €3.3 million in direct research and
development expenses (clinical and non-clinical). R&D expenses
represented a total of 64.8% and 72.4% of the total operating
expenses from continued operations for the years ended December 31,
2021 and 2020, respectively.
They include direct R&D expenses (subcontracting costs and
consumables), depreciation and amortization, and personnel
expenses. Direct R&D expenses increased by €3.3 million, or
14.0%, to €26.7 million for the year ended December 31, 2021, as
compared to €23.4 million for the year ended December 31, 2020.
This increase is mainly due to: (i) a €5.0 million increase in
expenses relating to the lacutamab program and (ii) a €1.5 million
increase in expenses related to non-clinical development program
relating notably to IPH65. These increases are partly offset by a
€1.9 million and €1.3 million decreases in expenses relating to the
monalizumab and avdoralimab programs, respectively.
Also, as of December 31, 2021, the collaboration liabilities
relating to monalizumab and the agreements signed with AstraZeneca
in April 2015, October 2018 and September 2020 amounted to €40.4m,
as compared to collaborations liabilities of €46.7m as of December
31, 2020. This decrease of €6.3m mainly results from the payments
made in 2021 to AstraZeneca relating to the co-funding of the
monalizumab program, including the INTERLINK-1 Phase 3 trial.
Personnel and other expenses allocated to R&D decreased by
€6.0 million, or 22.8%, to €20.3 million for the year ended
December 2021, as compared to an amount of €26.3 million for the
year ended December 31, 2020. This decrease is mainly due to the
decrease by €5.2 million in amortization relating to monalizumab
rights (extension of the depreciation horizon due to the extension
of the duration of certain clinical trials) and IPH5201 rights
(full amortization at December 31, 2020).
General and administrative expenses
General and administrative (“G&A”) expenses from continuing
operations increased by €6.5 million, or 34.4%6 to €25.5 million
for the year ended December 31, 2021 as compared to €19.0 million
for the year ended December 31, 2020. G&A expenses represented
a total of 35.2% and 27.6% of the total operating expenses for the
years ended December 31, 2021 and 2020, respectively.
Personnel expenses (including share-based compensation) include
the compensation paid to our employees and consultants, and
increased by €2.6 million, or 31.9%, to €10.9 million for the year
ended December 31, 2021, as compared to €8.3 million for the year
ended December 31, 2020. This increase mainly results from an
increase in wages of €2.0 million, mainly resulting from
restructuring costs and higher annual bonuses level in 2021. This
increase is completed by the increase in share-based payments of
€0.6 million.
G&A expenses also include non-scientific advisory and
consulting expenses which mostly consist of auditing, accounting,
legal and hiring fees. These expenses increased by €0.7 million, or
15.0%, to €5.1 million for the year ended December 31, 2021,
compared to an amount of €4.4 million for the year ended December
31, 2020. This increase results mainly from (i) an increase of
auditing and accounting fees, recruitment fees and investor
relation consultancy fees partly offset by (ii) a decrease of costs
related to the launch of the Company's new ERP in 2020 and the
support by external service providers in the context of compliance
with the Sarbanes-Oxley law following the listing of the Company in
the United States in October 2019.
Other G&A expenses relate to intellectual property, the
costs of maintaining laboratory equipment and our premises,
depreciation and amortization and other general, administrative
expenses. These expenses increased by €3.2 million or 51.5% to €9.5
million for the year ended December 31,2021, as compared to an
amount of €6.3 million for the year ended December 31, 2020. This
increase related notably to insurance costs, which increased in
fiscal year 2021, following the listing of the Company in the
United States in October 2019. It also includes increases related
to staff training (catch-up observed in 2021 following the impact
of COVID-19 in 2020) and local taxes.
Financial income (loss),
net
We recognized a net financial gain of €2.3 million for the year
ended December 31, 2021, as compared to €1.9 million net financial
loss for the year ended December 31, 2020. This change results
mainly from the change in the fair value of certain financial
instruments (loss of €0.6 million in 2020 as compared to a €1.1
million gain in 2021) and a net foreign exchange gain of €1.2
million in 2021 as compared to a net foreign exchange loss of €1.6
million in 2020.
Net loss from discontinued
operations
Further to the Company decision to terminate the Lumoxiti
Agreement in December 2020, a Termination and Transition Agreement
was negotiated and executed, effective as of June 30, 2021
terminating the Lumoxiti Agreement as well as Lumoxiti related
agreements (including the supply agreement, the quality agreement
and other related agreements) and transferring the U.S. marketing
authorization and distribution rights of Lumoxiti back to
AstraZeneca. The marketing authorization has been transferred back
to AstraZeneca which has reimbursed Innate for all Lumoxiti related
costs, expenses and benefited net sales.
Subsequently, operations related to Lumoxiti are presented as
discontinued operations from October 1, 2021.
As a consequence, net result from discontinued operations
relating to Lumoxiti decreased by €55.8m, or -88.4%, to a €7.3
million net loss for the year ended December 31, 2021, as compared
to a €63.2 million net loss for the year ended December 31, 2020.
Net loss for the year ended December 31, 2021 mainly resulting from
the Settlement Amount of $6.2m (€5.5m as of December 31, 2021) to
be paid to AstraZeneca on April 30, 2022, as part of the
Termination and Transition agreement. Net loss for the year ended
December 31, 2020 mainly resulted from the full impairment of
Lumoxiti rights following the Company’s decision to return the
marketing rights of Lumoxiti in the United States and in Europe to
AstraZeneca and the costs incurred for the marketing of Lumoxiti
and for our U.S subsidiary, including the related personnel
costs.
Balance sheet items
Cash, cash equivalents, short-term investments and financial
assets (current and non-current) amounted to €159.7 million as of
December 31, 2021, as compared to €190.6 million as of December 31,
2020. Net cash as of December 31, 2021 (cash, cash equivalents and
current financial assets less current financial liabilities)
amounted to €89.1 million (€149.5 million as of December 31,
2020).
The other key balance sheet items as of December 31, 2021
are:
- Deferred revenue of €37.9 million (including €25.4 million
booked as ‘Deferred revenue – non-current portion’) and
collaboration liabilities of €40.4 million (including €33.0 million
booked as ‘Collaboration liability – non-current portion’) relating
to the remainder of the initial payment received from AstraZeneca
with respect to monalizumab, not yet recognized as revenue or used
to co-fund the research and the development work performed by
AstraZeneca including co-funding of the monalizumab program with
AstraZeneca, notably the INTERLINK-1 Phase 3 trial;
- Deferred revenue of €17.4 million relating to the initial
payment for preclinical molecules, entirely classified as ‘Deferred
revenue – non-current portion’;
- Intangible assets for a net book value of €44.2 million, mainly
corresponding to the rights and licenses relating to the
acquisitions of monalizumab and avdoralimab (€46.3 million as of
December 30, 2020); variation between the two periods is mainly
explained by the amortization of monalizumab rights;
- Current receivables of €18.4 million, mainly resulting from the
French government in relation to the research tax credit for 2021
(€10.3 million).
- Non-current receivables from the French government in relation
to the research tax credit for 2019 and 2020 of €29.8 million;
- Shareholders’ equity of €107.4 million, including the net loss
of the period of €52.8 million;
- Financial liabilities amounting to €44.3 million (€19.1 million
as of December 31, 2020).
Cash-flow items
The net cash flow used over the year ended December 31, 2021
amounted to €33.0 million, compared to a net cash flow used of
€66.1 million for the year ended December 31, 2020.
The net cash flow used during the period under review mainly
results from the following:
- Net cash used from operating activities of €58.5 million,
mainly explained by the net cash consumption of operating
activities less the receipts for a total amount of €10.0 million
from Sanofi (in January, February and December 2021) in connection
with the IPH6101/SAR443579 agreement signed in 2016, following
Sanofi's decision at the end of 2020 to advance IPH6101/SAR443579
towards regulatory preclinical studies for a new investigational
drug, and the launch of the first related Phase 1 trial in December
2021. Restated for these receipts, net cash flows used by operating
activities for the year ended December, 2021 are down by €24.6
million. This decrease is mainly due to the discontinuation of
Lumoxiti-related activities in connection with the Company's
decision at the end of 2020 to return the commercial rights in the
United States and Europe to AstraZeneca, under the termination and
transition agreement signed in 2021. As a result, net cash flow
consumed by operating activities in connection with the Lumoxiti
discontinued operation amounted to €3.6 million for the year ended
December 31,2021 as compared to €22.4 million for the year
2020.
- Net cash used in investing activities for an amount of €0.9
million. As a reminder, net cash flow used in investing activities
for the year ended December 31, 2020 amounted €13.4 million which
mainly resulted from (i) a €13.4 million ($15.0 million) additional
consideration paid, in January 2020, to AstraZeneca regarding
Lumoxiti following the submission of the Biologics License
Application to the European Medicine Agency (EMA) in November 2019
(ii) a €2.7 million additional consideration paid to Orega Biotech
in April 2020 regarding IPH5201 following the dosing of a first
patient in a Phase 1 clinical trial, in March 2020 and (iii) the
acquisition of financial assets for a net amount of €3.0 million.
Such items were partially offset by the reimbursement by
AstraZeneca in relation to the 2019 cost sharing mechanism for the
commercialization of Lumoxiti (€7.0 million). As a result, net cash
flows consumed by investing activities in connection with the
Lumoxiti discontinued operation were nil for year ended December
31, 2021 as compared to €6.6 million for year ended December 31
2020.
- Net cash flows from financing activities for an amount of €26.8
million. On January 5, 2022, the Company announced that it had
obtained a non-dilutive financing of €28.7 million in the form of
two State-Guaranteed Loans (Prêts Garantis “PGE”) from Société
Générale (€20.0 million) and BNP Paribas (€8.7 million). The funds
related to these two PGEs were collected by the Company on December
27 and 30, 2021 respectively. Loan repayments amounted to €2.1
million for the year ended December 31, 2021 compared to €2.2
million for the year ended December 31, 2020. In addition, net cash
flow from financing activities related to Lumoxiti discontinued
operation are nil for year ended December 31, 2021 and 2020,
respectively.
Post period event
- Between December 31, 2021, closing date of the financial year,
and March 23, 2022, closing date of the consolidated financial
statements by the Executive Board, the military operations in
Ukraine took place, which began on February 24, 2022 and the
sanctions taken against the Russia by many States having an impact
on the activity of many international groups and which will have an
impact on the world economy. As of March 23, 2022, closing date of
the consolidated financial statements, potential impacts of this
crisis, in general and more specifically on the Company's business
and financing, are unknown. The Company is closely monitoring
developments in the situation and is examining the appropriate
measures to be put in place. There is no impact on the consolidated
financial statements as of December 31, 2021.
Nota
The consolidated financial statements for the year ended
December 31, 2021 have been reviewed by our Statutory Auditors and
were closed by the Executive Board of the Company on March 23,
2022. They were reviewed by the Supervisory Board of the Company on
March 23, 2022. The statutory auditors’ report is in the process of
being issued.
Risk factors
Risk factors (“Facteurs de Risque”) identified by the Company
are presented in section 3 of the registration document (“Universal
Registration Document”) filed with the French Financial Markets
Authority (“Autorité des Marchés Financiers” or “AMF”), which is
available on the AMF website http://www.amf-france.org or on the
Company’s website as well as in the Risk Factors section of the
Company’s Annual Report on Form 20-F for the year ended December
31, 2020 filed with the U.S. Securities and Exchange Commission,
and subsequent filings and reports filed with the AMF or SEC, or
otherwise made public, by the Company.
1 Including short term investments
(€16.1m) and non-current financial instruments (€39.9m). Cash
position as of December 31, 2021 includes proceeds (€28.7m)
relating to State-Guaranteed Loans (Prêts Garantis par l’Etat
“PGE”) received in December 2021.
2 Cash and cash equivalents include
proceeds relating to State-Guaranteed Loans (Prêts Garantis par
l’Etat “PGE” - see below).
3 The 2020 comparatives have been restated
to consider the impact of classifying the Lumoxiti business as
discontinued operations in 2021.
4 Selling, general and administrative
expenses relating to Lumoxiti discontinued operations amounted to
€8.5m and €12.3m in 2021 and 2020 respectively. In 2021, these
expenses are mainly composed of the Settlement Amount of $6.2
million (€5.5 million as of December 31, 2021) to be paid on April
30, 2022 to AstraZeneca as part of the termination and transition
agreement. In 2020, these expenses mainly resulted from the costs
incurred for the marketing of Lumoxiti and for our U.S subsidiary,
including the related personnel costs.
5 As part of the communication of its 2020
consolidated financial statements, the Company had communicated on
a contingent liability estimated at a maximum of $12.8 million
related to the sharing of certain manufacturing costs.
6 Selling, general and administrative
expenses relating to Lumoxiti discontinued operations amounted to
€8.5m and €12.3m in 2021 and 2020 respectively. In 2021, these
expenses are mainly composed of the Settlement Amount of $6.2
million (€5.5 million as of December 31, 2021) to be paid on April
30, 2022 to AstraZeneca as part of the termination and transition
agreement. In 2020, these expenses mainly resulted from the costs
incurred for the marketing of Lumoxiti and for our U.S subsidiary,
including the related personnel costs.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220323006015/en/
For additional information:
Investors & Media
Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
henry.wheeler@innate-pharma.fr
ATCG Press Marie Puvieux (France) Tel. : +33 (0)9 81 87
46 72 innate-pharma@atcg-partners.com
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