- Sanofi collaboration for Natural Killer cell engager
therapeutics expanded to B7-H3 ANKET® program and two
additional targets, with €25 million payment
- Encouraging preliminary TELLOMAK Phase 2 efficacy data for
lacutamab in advanced cutaneous T cell lymphoma in Sézary syndrome
and mycosis fungoides
- First patient dosed in monalizumab PACIFIC-9 Phase 3 lung
cancer clinical trial with $50M payment from AstraZeneca
- Cash position of €136.6 million2 as of December 31, 2022
(not including the €25 million payment from Sanofi), anticipated
cash runway into mid 2025
- 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 results1 for the year ending December 31,
2022. The consolidated financial statements are attached to this
press release.
“In 2022 we made important progress in our pipeline, both on our
clinical and preclinical projects as well as maintaining a strong
financial position. We’re continuing to see encouraging efficacy
signals for our proprietary program lacutamab in advanced cutaneous
T cell lymphomas. In the meantime, our innovative R&D pipeline
progression was marked by the expansion of our partnership with
Sanofi to develop new NK Cell Engager Therapeutics from our ANKET®
platform, including solid tumors. The Sanofi collaboration is an
example of how we use partnerships to build value at Innate, also
underlined by our partnership with AstraZeneca for monalizumab
which is in a Phase 3 trial for non-small cell lung cancer,”
said Mondher Mahjoubi, Chief Executive Officer of Innate
Pharma. “As we look to progress our pipeline in house or with
partnerships, we look forward to new milestones in 2023 with
important inflection points, including final readouts from the
TELLOMAK Phase 2 trial with lacutamab and further updates for our
ANKET® assets.”
Webcast and conference call
will be held today at 2:00pm CET (9:00am EDT)
Access to live webcast:
https://events.q4inc.com/attendee/611394672
Participants may also join via
telephone using the registration link below:
https://registrations.events/direct/Q4E60253
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.
1 This press release contains financial
data approved by the Executive Board based on our consolidated
financial statements for the year ended December 31, 2022. The
audit is in progress at the date of this communication.
2 Including short term investments
(€17.3m) and non-current financial instruments (€35.1m).
Pipeline highlights:
Lacutamab (IPH4102, anti-KIR3DL2
antibody):
- Innate continues to see progress for lacutamab with final data
from the TELLOMAK Phase 2 trial for both mycosis fungoides and
Sézary syndrome expected in H2 2023.
- In preliminary results confirming clinical activity and a
favorable safety profile in patients with mycosis fungoides (MF)
who were previously treated with at least two lines of systemic
therapy, lacutamab produced a global objective response rate (ORR)
of 28.6% (95% confidence interval [CI]: 13.8-50.0) in the
KIR3DL2-expressing MF patients (n=21), including 2 complete
responses and 4 partial responses (EORTC-CLTG (European
Organisation for Research and Treatment of Cancer - Cutaneous
Lymphoma Tumours Group) 2022 meeting - September 2022).
- In a preliminary analysis, lacutamab demonstrated clinical
activity and a favorable safety profile in heavily pretreated,
post-mogamulizumab patients with advanced Sézary syndrome. In the
Intention To Treat (ITT) population (n=37), the global ORR was
21.6% (8/37). ORR in the blood was 37.8% (95% CI: 24.1-53.9), with
21.6% (8/37) achieving complete response (CR). ORR in the skin was
35.1% (95% CI: 21.8-51.2). In the Evaluable for Efficacy (EES)
population (n=35), global objective response rate (ORR) was 22.9%
(8/35). ORR in the blood was 40.0% (95% CI: 25.6-56.4) and ORR in
the skin was 37.1% (95% CI: 23.2 53.7) (2022 ASH (American
Society Hematology) Annual Meeting - December 2022).
- Two parallel clinical trials to study lacutamab in patients
with KIR3DL2-expressing, relapsed/refractory peripheral T-cell
lymphoma (PTCL) are ongoing. Initial PTCL data are expected in H2
2023.
- Phase 1b trial: a Company-sponsored Phase 1b clinical
trial to evaluate lacutamab as a monotherapy in patients with
KIR3DL2-expressing relapsed PTCL. A poster on the trial design was
presented at the ESMO (European Society for Medical Oncology) 2022
conference.
- 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):
ANKET® is Innate’s proprietary platform for developing
next-generation, multi-specific NK cell engagers to treat certain
types of cancer. Innate’s pipeline includes four public drug
candidates born from the ANKET® platform: IPH6101 (CD123-targeted),
IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific
IPH6501 (CD20-targeted). Several other undisclosed proprietary
preclinical targets are being explored.
IPH6101, IPH6401 and IPH62 (partnered with Sanofi)
- The Phase 1/2 clinical trial by Sanofi is progressing well,
evaluating IPH6101/SAR’579, the first NKp46/CD16-based
CD123-targeted ANKET® platform NK cell engager, in patients with
relapsed or refractory acute myeloid leukemia (AML), B-cell acute
lymphoblastic leukemia or high-risk myelodysplastic syndrome.
- Preclinical data showing the control of AML cells by a
trifunctional NKp46-CD16a-NK cell engager targeting CD123 were
published in Nature Biotechnology in January 2023.
- On July 21, 2022, the Company announced that its partner Sanofi
had made the decision to progress IPH6401/SAR’514, a BCMA-targeting
NK cell engager into investigational new drug (IND)-enabling
studies. Selection of IPH6401/SAR’514 triggered a €3M milestone
payment to Innate.
- As announced on December 19, 2022, Sanofi licensed IPH62, a NK
cell engager program targeting B7-H3 from Innate’s ANKET® platform.
Sanofi also have the option to add up to two additional ANKET®
targets. Upon candidate selection, Sanofi will be responsible for
all development, manufacturing and commercialization. Under the
terms of the agreement, Innate received a €25m upfront payment and
is eligible for up to €1.35bn total in preclinical, clinical,
regulatory and commercial milestones plus royalties on potential
net sales.
IPH6501 (proprietary)
- Progress continues toward a Phase 1 clinical trial in 2023 for
the proprietary CD20 targeted tetra-specific ANKET®, IPH6501.
- An October 2022 edition of Cell Reports Medicine described the
development of Innate’s fit-for-purpose ANKET® antibody-based
tetra-specific molecule to harness the antitumor functions of NK
cells, boosting their capacity to proliferate, to accumulate at the
tumor site and to kill tumor cells.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- Innate continues to see progress for monalizumab in the early
non-small cell lung cancer (NSCLC) setting, with the ongoing Phase
3 PACIFIC-9 study run by AstraZeneca. The study is evaluating
durvalumab (anti-PD-L1) in combination with monalizumab 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).
- On April 29, 2022, Innate announced a $50 million milestone
payment from AstraZeneca was triggered for dosing the first patient
in the PACIFIC-9 Phase 3 clinical trial.
- Detailed results from the randomized AstraZeneca-sponsored
Phase 2 COAST clinical trial, including monalizumab data in
combination with durvalumab, were published in the Journal of
Clinical Oncology in April 2022. The results were initially
presented during the European Society for Medical Oncology (ESMO)
Congress 2021. The results of the interim analysis showed
monalizumab in combination with durvalumab reduced the risk of
disease progression by 58% (improved progression-free survival
(PFS) with a hazard ratio of 0.42) and improved objective response
rate (ORR) compared to durvalumab alone in patients with
unresectable, Stage III NSCLC who had not progressed after
concurrent CRT. The Journal of Clinical Oncology publication
includes exploratory subgroup analysis.
- Partner AstraZeneca presented data from Phase 2 NeoCOAST
randomized trial in resectable, early-stage NSCLC at the 2022
American Association for Cancer Research (AACR) Annual Meeting and
ESMO 2022 congress. The presentations highlighted improved disease
responses with durvalumab in combination with monalizumab,
oleclumab or danvatirsen, when compared to durvalumab alone. The
follow-up randomized Phase 2 clinical trial, NeoCOAST-2, is
enrolling patients with resectable, stage IIA-IIIB NSCLC to receive
neoadjuvant durvalumab combined with chemotherapy and either
oleclumab or monalizumab, followed by surgery and adjuvant
durvalumab plus oleclumab or monalizumab.
- On August 1, 2022, Innate announced that a planned futility
interim analysis of the Phase 3 INTERLINK-1 study sponsored by
AstraZeneca did not meet a pre-defined threshold for efficacy. The
Company announced that, based on the result and the recommendation
of an Independent Data Monitoring Committee, the study was to be
discontinued. There were no new safety findings. AstraZeneca plan
to share the data in due course. The INTERLINK-1 study evaluated
monalizumab in combination with cetuximab vs. cetuximab in patients
with recurrent or metastatic squamous cell carcinoma of the head
and neck who have been previously treated with platinum-based
chemotherapy and PD-(L)1 inhibitors.
IPH5201 (anti-CD39), partnered with
AstraZeneca:
- The MATISSE Phase 2 clinical trial conducted by Innate in
neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking
monoclonal antibody developed in collaboration with AstraZeneca,
has started and is awaiting first patient dosed.
- In August 2022 Innate received a $5 million milestone payment
from AstraZeneca and will be responsible for conducting the study.
AstraZeneca and Innate will share study costs and AstraZeneca will
supply clinical trial drugs.
- Preclinical data supporting the rationale for the Phase 2
development in NSCLC were presented at the 2022 ESMO
Immuno-Oncology (IO) Annual Congress in December.
- AstraZeneca conducted a Phase 1 trial in solid tumors with
IPH5201 alone or in combination with durvalumab and presented a
poster entitled “IPH5201 as Monotherapy or in Combination with
Durvalumab in Advanced Solid Tumours” at the 2022 ESMO IO Annual
Congress in December.
IPH5301 (anti-CD73):
- The investigator-sponsored CHANCES Phase 1 trial of IPH5301, in
collaboration with Institut Paoli-Calmettes is ongoing. 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. The design of the Phase 1 study was
highlighted at the 2022 ESMO IO congress in December.
Avdoralimab
(anti-C5aR1):
- The Company has decided to discontinue the development of
avdoralimab in bullous pemphigoid. The Company will continue to
evaluate out-licensing as a potential next step.
Preclinical assets:
- Fueling the R&D engine, the Company continues to develop
different approaches for the treatment of cancer utilizing its
antibody engineering capabilities to deliver novel assets, with its
innovative ANKET® platform and continuing to explore Antibody Drug
Conjugates (ADC) formats.
- During the period, the Company received from AstraZeneca a
notice that it will not exercise its option to license the four
preclinical programs covered in the "Future Programs Option
Agreement". This option agreement was part 2018 multi-term
agreement between AstraZeneca and Innate. Innate regained full
rights to further develop the four preclinical molecules.
Corporate Update:
- On May 3, 2022 Innate announced the commencement of an
At-The-Market (ATM) program, pursuant to which it may, from time to
time, offer and sell to eligible investors a total gross amount of
up to $75 million American Depositary Shares (“ADS”). Each ADS
representing one ordinary share of Innate. As of December 31, 2022,
the balance available under our May 2022 sales agreement remains at
$75 million.
- Dr Sally Bennett was appointed as new member of the Supervisory
Board in May 2022. She was appointed as a member of the Audit
Committee. On the same date it was announced that Mr Patrick
Langlois decided to resign from his mandate of Supervisory Board
member of Innate Pharma.
- In January 2023, Mrs Claire de Saint Blanquat, Vice President
Legal and Corporate Affairs, and Mr Henry Wheeler, Vice President
Investor Relations and Communications, were appointed to the
Leadership Team.
Financial highlights for 2022:
The key elements of Innate’s financial position and financial
results as of and for the year ended December 31, 2022 are as
follows:
- Cash, cash equivalents, short-term investments and financial
assets amounting to €136.6 million (€m) as of December 31, 2022
(€159.7m as of December 31, 2021), including financial instruments
amounting to €35.1m (€39.9m as of December 31, 2021). Cash, cash
equivalents as of December 31, 2022 do not include the €25.0
million payment received from Sanofi in March 2023.
- As of December 31, 2022, financial liabilities amount to €42.3m
(€44.3m as of December 31, 2021). In August 2022, the Company
obtained an extension for a period of five year (starting in 2022)
with a one-year grace period (2023) of its State-Guaranted Loans
(Prêts Garantis par l’Etat “PGE”) from Société Générale (€20.0m)
and BNP Paribas (€8.7m).
- Revenue and other income from continuing operations amounted to
€57.7m in 2022 (2021: €24.7m). It mainly comprises revenue from
collaboration and licensing agreements (€49.6m in 2022 vs €12.1m in
2021), and research tax credit (€7.9m in 2022 vs €10.3m in 2021,
-23.1%):
- 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 increased by €14.9m to €22.4m in 2022 (€7.5m in 2021).
This change mainly results from the transaction price increase of
€13.4m ($14.0m) triggered by the launch of the “PACIFIC-9” Phase 3
trial announced on April 29, 2022. This change in the transaction
price generated a €12.6 million favorable cumulative adjustment in
the revenue related to monalizumab agreements for the first half of
2022, partially offset by effects of the decrease in direct
monalizumab research and development costs over the period as
compared to the first half of 2021, in connection with the Phase 1
& 2 trials maturity;
- (ii) Revenue related to IPH5201 for the year ended 2022
amounted to €4.7m and results from the entire recognition in
revenue of the $5.0m milestone payment received in August 2022 from
AstraZeneca following the signature on June 1, 2022 of an amendment
to the initial contract signed in October 2018. This amendment sets
the terms of the collaboration following AstraZeneca’s decision to
advance IPH5201 to a Phase 2 study;
- (iii) During 2022 first semester, the Company received from
AstraZeneca a notice that it will not exercise its option to
license the four preclinical programs covered in the "Future
Programs Option Agreement". This option agreement was part of the
2018 multi-term agreement between AstraZeneca and the Company under
which the Company received an upfront payment of $20.0m (€17.4m).
Innate has now regained full rights to further develop the four
preclinical molecules. Consequently, the entire initial payment of
$20.0m, or €17.4m was recognized as revenue in 2022.
- (iv) During 2022 first semester, the Company was informed of
Sanofi's decision to advance IPH6401/SAR'514 into investigational
new drug (IND)-enabling studies. As such, Sanofi has selected a
second multispecific antibody engaging NK cells as a drug
candidate. This selection triggered a €3.0m milestone payment from
Sanofi. This amount was received by the Company on September 9,
2022.
- 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) and to the decrease in
personnel expenses allocated to research and development
operations. In addition, there was a decrease in public
subcontracting included in the calculation of the CIR. This
decrease is the consequence of the end of the doubling of public
subcontracting expenses eligible for the CIR since January 1, 2022,
partly offset by an increase in private subcontracting expenses
with accredited suppliers.
- Operating expenses from continuing operations amounted to
€74.1m in 2022 (2021: €72.5m, +2.2%):
- General and administrative (G&A) expenses from continuing
activities amounted to €22.4m in 2022 (2021: €25.5m, -12.1%). This
variation results cumulatively from (i) a decrease in wages mainly
resulting from restructuring costs and higher annual bonuses level
in 2021, (ii) a decrease in non-scientific advisory fees and (iii)
a decrease in other general and administrative expenses.
- Research and development (R&D) expenses from continuing
activities amounted to €51.7m in 2022 (2021: €47.0m, 9.9%). This
variation mainly results from (i) an increase in direct research
and development expenses (clinical and non-clinical) and (ii) an
increase in other indirect research and development expenses,
mainly linked to non-scientific and scientific fees.
- The avdoralimab intangible asset (anti-C5aR rights) total
impairment of €41.0m (non-cash expense) following the Company’s
decision to stop avdoralimab development in bullous pemphigoid
indication in inflammation.
- A net financial income of €0.5m in 2022 (2021: €2.3m
gain).
- A net loss from Lumoxiti discontinued operations of €0.1m in
2022 (2021: net loss of €7.3m, -98.2%). This decrease mainly
resulted from the Settlement Amount of $6.2m (€5.5m as of December
31, 2021) paid to AstraZeneca in April 2022 for an amount of €5.9m
under the Termination and Transition agreement.
- A net loss of €58.1m in 2022 (2021: net loss of €52.8m).
The table below summarizes the IFRS consolidated financial
statements as of and for the year ended December 31, 2022,
including 2021 comparative information.
In thousands of euros, except for data
per share
December 31, 2022
December 31, 2021
Revenue and other income
57,674
24,703
Research and development
(51,663)
(47,004)
Selling, general and administrative
(22,436)
(25,524)
Total operating expenses
(74,099)
(72,528)
Operating income (loss) before
impairment
(16,425)
(47,825)
Impairment of intangible asset
(41,000)
—
Operating income (loss) after
impairment
(57,425)
(47,825)
Net financial income (loss)
(546)
2,347
Income tax expense
—
—
Net income (loss) from continuing
operations
(57,972)
(45,478)
Net income (loss) from discontinued
operations
(131)
(7,331)
Net income (loss)
(58,103)
(52,809)
Weighted average number of shares
outstanding (in thousands)
79,640
79,543
Basic income (loss) per share
(0.73)
(0.66)
Diluted income (loss) per share
(0.73)
(0.66)
Basic income (loss) per share from
continuing operations
(0.73)
(0.57)
Diluted income (loss) per share from
continuing operations
(0.73)
(0.57)
Basic income (loss) per share from
discontinued operations
—
(0.09)
Diluted income (loss) per share from
discontinued operations
—
(0.09)
December 31, 2022
December 31, 2021
Cash, cash equivalents and financial
asset
136,604
159,714
Total assets
207,863
267,496
Shareholders’ equity
54,151
107,440
Total financial debt
42,251
44,251
About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage biotechnology
company developing immunotherapies for cancer patients. Its
innovative approach aims to harness the innate immune system
through therapeutic antibodies and its ANKET®
(Antibody-based NK cell Engager
Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab,
developed in advanced form of cutaneous T cell lymphomas and
peripheral T cell lymphomas, monalizumab developed with AstraZeneca
in non small cell lung cancer, as well as ANKET® multi-specific NK
cell engagers to address multiple tumor types.
Innate Pharma is a trusted partner to biopharmaceutical
companies such as Sanofi and AstraZeneca, as well as leading
research institutions, to accelerate innovation, research and
development for the benefit of patients.
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 and
follow us on Twitter and LinkedIn.
Information about Innate Pharma shares:
ISIN code
FR0010331421
Ticker code
Euronext: IPH Nasdaq: IPHA
LEI
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. 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, 2021,
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, 2022
Consolidated Statements of
Financial Position
(in thousand euros)
December 31, 2022
December 31, 2021
Assets
Cash and cash equivalents
84,225
103,756
Short-term investments
17,260
16,080
Trade receivables and others - current
38,346
18,420
Total current assets
139,831
138,256
Intangible assets
1,556
44,192
Property and equipment
8,542
10,174
Non-current financial assets
35,119
39,878
Other non-current assets
149
148
Deferred tax assets
8,568
5,028
Trade receivables and others -
non-current
14,099
29,821
Total non-current assets
68,033
129,241
Total assets
207,863
267,496
Liabilities
Trade payables and others
20,911
28,573
Collaboration liabilities – Current
portion
10,223
7,418
Financial liabilities – Current
portion
2,102
30,748
Deferred revenue – Current portion
6,560
12,500
Provisions – Current portion
1,542
647
Total current liabilities
41,338
79,886
Collaboration liabilities – Non current
portion
52,988
32,997
Financial liabilities – Non-current
portion
40,149
13,503
Defined benefit obligations
2,550
2,975
Deferred revenue – Non-current portion
7,921
25,413
Provisions – Current portion
198
253
Deferred tax liabilities
8,568
5,028
Total non-current liabilities
112,374
80,169
Share capital
4,011
3,978
Share premium
379,637
375,220
Retained earnings
(272,213
)
(219,404
)
Other reserves
819
456
Net income (loss)
(58,103
)
(52,809
)
Total shareholders’ equity
54,151
107,440
Total liabilities and shareholders’
equity
207,863
267,496
Consolidated Statements of Income (loss)
(in thousand euros)
December 31, 2022
December 31, 2021
Revenue from collaboration and licensing
agreements
49,580
12,112
Government financing for research
expenditures
8,035
12,591
Sales
59
Revenue and other income
57,674
24,703
Research and development expenses
(51,663
)
(47,004
)
Selling, general and administrative
expenses
(22,436
)
(25,524
)
Operating expenses
(74,099
)
(72,528
)
Operating income (loss) before
impairment of intangible assets
(16,425
)
(47,825
)
Impairment of intangible assets
(41,000
)
—
Operating income (loss) after
impairment of intangible assets
(57,425
)
(47,825
)
Financial income
4,775
6,344
Financial expenses
(5,321
)
(3,997
)
Net financial income (loss)
(546
)
2,347
Net income (loss) before tax
(57,972
)
(45,478
)
Income tax expense
—
—
Net income (loss) from continuing
operations
(57,972
)
(45,478
)
Net income (loss) from discontinued
operations
(131
)
(7,331
)
Net income (loss)
(58,103
)
(52,809
)
Net income (loss) per share:
(in € per share)
- basic income (loss) per share
(0.73
)
(0.66
)
- diluted income (loss) per share
(0.73
)
(0.66
)
- Basic income (loss) per share from
continuing operations
(0.73
)
(0.57
)
- Diluted income (loss) per share from
continuing operations
(0.73
)
(0.57
)
- Basic income (loss) per share from
discontinued operations
—
(0.09
)
- Diluted income (loss) per share from
discontinued operations
—
(0.09
)
Consolidated Statements of Cash
Flows
(in thousand euros)
December 31, 2022
December 31, 2021
Net income (loss)
(58,103
)
(52,809
)
Depreciation and amortization
45,405
4,596
Employee benefits costs
365
437
Provisions for charges
839
4
Share-based compensation expense
4,249
2,617
Change in valuation allowance on financial
assets
1,372
(987
)
Gains (losses) on financial assets
(912
)
(1,136
)
Change in valuation allowance on financial
assets
118
(55
)
Gains (losses) on assets and other
financial assets
—
(367
)
Interest paid
—
312
Other profit or loss items with no cash
effect
15
(1,185
)
Operating cash flow before change in
working capital
(6,652
)
(48,573
)
Change in working capital
(12,502
)
(9,884
)
Net cash generated from / (used in)
operating activities:
(19,154
)
(58,457
)
Acquisition of intangible assets, net
(587
)
(401
)
Acquisition of property and equipment,
net
(535
)
(929
)
Acquisition of non-current financial
assets
—
—
Disposal of property and equipment
—
7
Disposal of other assets
—
40
Acquisition of other assets
(1
)
(1
)
Disposal of non-current financial
instruments
3,000
—
Interest received on financial assets
—
367
Net cash generated from / (used in)
investing activities:
1,877
(917
)
Proceeds from the exercise / subscription
of equity instruments
198
499
Proceeds from borrowings
—
28,700
Repayment of borrowings
(2,026
)
(2,069
)
Net interest paid
—
(312
)
Net cash generated from financing
activities:
(1,828
)
26,818
Effect of the exchange rate changes
(428
)
(483
)
Net increase / (decrease) in cash and
cash equivalents:
(19,531
)
(33,037
)
Cash and cash equivalents at the beginning
of the year:
103,756
136,792
Cash and cash equivalents at the end of
the year :
84,225
103,756
Revenue and other income
The following table summarizes operating revenue for the periods
under review:
In thousands of euro
December 31, 2022
December 31, 2021
Revenue from collaboration and licensing
agreements
49,580
12,112
Government financing for research
expenditures
8,035
12,591
Other income
59
—
Revenue and other income
57,674
24,703
Revenue from collaboration and licensing agreements
Revenue from collaboration and licensing agreements from
continuing operations increased by €37.5 million, to €49.6 million
for the year ended December 31, 2022, as compared to €12.1 million
for the year ended December 31, 2021. 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 2022 is mainly due to:
- A €14.9 million increase in revenue related to monalizumab to
€22.4 million for the year ended December 31, 2022, as compared to
€7.5 million for the year ended December 31, 2021. This increase is
mainly explained by the transaction price increase of €13.4 million
($14.0 million) triggered by the launch of the “PACIFIC-9” Phase 3
trial on April 28, 2022. This change in the transaction price
generated a €12.6 million favorable cumulative adjustment in the
revenue related to monalizumab agreements over the period. As of
December 31, 2022, the deferred revenue related to monalizumab
amounts to €14.5 million (€6.6 million as “Deferred revenue—Current
portion” and €7.9 million as “Deferred revenue—Non-current
portion”).
- A €4.7 million revenue increase in revenue related to IPH5201
for the year ended December 31, 2022 resulting from the entire
recognition in revenue of the $5.0 million milestone payment
received from AstraZeneca following an amendment in June 2022 to
the initial contract signed in October 2018. This amendment sets
the terms of the collaboration following AstraZeneca’s decision to
advance IPH5201 to a Phase 2 study. The Company will conduct the
study. Both parties will share the external cost related to the
study and incurred by the Company and AstraZeneca will provide
products necessary to conduct the clinical trial.
- During the 2022 first semester, the Company received from
AstraZeneca a notice that it will not exercise its option to
license the four preclinical programs covered in the "Future
Programs Option Agreement". This option agreement was part of the
2018 multi-term agreement between AstraZeneca and the Company under
which the Company received an upfront payment of $20.0 million
(€17.4m). Innate has now regained full rights to further develop
the four preclinical molecules. Consequently, the entire initial
payment of $20.0 million, or €17.4 million was recognized as
revenue over the period.
- A €1.0 million increase in revenue from the collaboration and
research license agreement with Sanofi, to €4.0 million for the
year ended December 31, 2022, as compared to €3.0 million for the
year ended December 31, 2021. During the period, the Company
announced the decision taken by Sanofi to advance IPH6401/SAR'514
towards regulatory preclinical studies for a new investigational
drug. This decision triggered a milestone payment of €3.0 million
fully recognized in revenue. This amount was received by the
Company on September 9, 2022.
- A €0.2 million decrease in revenue from invoicing of research
and development costs to €1.4 million for the year ended December
31, 2022, as compared to €1.6 million for the year ended December
31, 2021.
Government funding for research expenditures
Government funding for research expenditures decreased by €4.6
million, or 36.2%, to €8.0 million for the year ended December 31,
2022, as compared to €12.6 million for the year ended December 31,
2021. This change is primarily a result of a decrease in the
research tax credit of €2.4 million, which is mainly due to (i) a
decrease in eligible expenses in the research tax credit
calculation and (ii) a provision following the tax inspection
carried out in 2022 by the French tax authorities and recognized as
a deduction from the 2022 research tax credit. This provision is
based on estimated amounts and adjustments not disputed by the
Company.
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 Small and Mid-size Enterprise (SME) status
under European Union criteria as of December 31, 2022.
Consecutively, the Company is eligible for the early repayment by
the French treasury of the 2021 research tax credit during the
fiscal year 2023. The 2021 research tax credit (€10.3m) was
received by the Company in November 2022.
Operating expenses
The table below presents our operating expenses from continuing
operations for the years ended December 31, 2022 and 2021:
In thousands of euros
December 31, 2022
December 31, 2021
Research and development expenses
(51,663)
(47,004)
Selling, general and administrative
expenses
(22,436)
(25,524)
Operating expenses
(74,099)
(72,528)
Research and development expenses
Research and development (“R&D”) expenses from continuing
operations increased by €4.7 million, or 9.9%, to €51.7 million for
the year ended December 31, 2022, as compared to €47.0 million for
the year ended December 31, 2021. This increase over the period is
mainly due to an increase in indirect research and development
expenses resulting from an increase of €3.9 million in personnel
and other expenses in line with an increase in scientific and
non-scientific fees related to research and development operations.
In addition, direct research and development expenses increased by
€0.8 million over the period due to the significant increase in
expenses relating to non-clinical development programs, partly
offset by the decrease in expenses relating to clinical programs.
Research and development expenses represented a total of 69.7% and
64.8% of operating expenses for years ended December 31, 2022 and
December 31, 2021, respectively.
Direct research and development expenses increased by €0.8
million, or 2.8%, to €27.5 million for the year ended December 31,
2022, as compared to direct research and development expenses of
€26.7 million for the year ended December 31, 2021. This increase
is mainly due to: (i) a €5.0 million increase in expenses related
to preclinical development programs relating notably to IPH6501,
partly offset by a €4.3 million decrease in expenses related to the
Company's clinical programs. This decrease in clinical program
expenses mainly results from a €2.9 million decrease in expenses
relating to the avdoralimab program and a €2.4 million decrease in
expenses relating to the lacutamab program, partly offset by a €1.1
million increase in expenses related to IPH5201.
Also, as of December 31, 2022, the collaboration liabilities
relating to monalizumab and the agreements signed with AstraZeneca
in April 2015, October 2018 and September 2020 amounted to €63.2
million, as compared to collaborations liabilities of €40.4 million
as of December 31, 2021. This increase of €22.8 million mainly
results from the additional payment of $50.0 million (€47.7
million) made by AstraZeneca in June 2022 triggered by the
treatment of the first patient in a second Phase 3 trial
“PACIFIC-9” evaluating monalizumab in April 2022. This additional
payment has been treated as an increase of the collaboration
commitment ("collaboration liabilities" in the consolidated
statements of financial position) for an amount of $36.0 million
(€34.3 million) in connection to the Phase 3 study co-funding
commitment made by the Company and notified to AstraZeneca in July
2019. This increase was partially offset by payments made in 2022
to AstraZeneca related to the co-funding of the monalizumab
program, including the Phase 3 INTERLINK-1 and PACIFIC-9
trials.
Personnel and other expenses allocated to research and
development increased by €3.9 million, or 19.2%, to €24.2 million
for the year ended December 31, 2022, as compared to an amount of
€20.3 million for the year ended December 31, 2021. This increase
is due to (i) a €3.0 million increase in other expenses related to
the €1.3 million increase in non-scientific fees and the €1.0
million increase in scientific fees allocated to research and
development, mainly explained by the increase in the use of
external medical and regulatory experts, as well as (ii) the €1.2
million increase in staff costs allocated to research and
development. This increase is mainly explained by the increase of
€1.7 million share-based payments expenses in connection with the
implementation of a company savings plan remunerated in free shares
and (ii) the elimination of the non-transferability discount in the
initial valuation of free performance share plans being
acquired.
General and administrative expenses
General and administrative (“G&A”) expenses from continuing
operations decreased by €3.1 million, or 12.1% to €22.4 million for
the year ended December 31, 2022 as compared to €25.5 million for
the year ended December 31, 2021. G&A expenses represented a
total of 30.3% and 35.2% of the total operating expenses for the
years ended December 31, 2022 and 2021, respectively.
Personnel expenses, which includes the compensation paid to our
employees and consultants, decreased by €0.7 million, or 6.0%, to
€10.2 million for the year ended December 31, 2022, as compared to
personnel expenses of €10.9 million for the year ended December 31,
2021. This decrease mainly results from a decrease in wages of €0.6
million, mainly resulting from restructuring costs and higher
annual bonuses level in 2021 as compared to 2022. This decrease is
completed by the decrease in share-based payments of €0.1
million.
Non-scientific advisory and consulting expenses mostly consist
of auditing, accounting, legal and hiring services. These expenses
decreased by €0.9 million, or 16.9%, to €4.2 million for the year
ended December 31, 2022, as compared to an amount of €5.1 million
for the year ended December 31, 2021. This decrease results mainly
from (i) an increase of €0.9 million in fees for strategic
consulting and implementation of the "At-the-Market" capital
increase program, offset by (ii) a decrease of legal assistance
costs, support costs by external service providers in the context
of compliance with the Sarbanes-Oxley (SOX) Act and costs relating
to the American subsidiary.
Other general and administrative 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 €1.6 million
or 16.5% to €8.0 million for the year ended December 31,2022, as
compared to an amount of €9.5 million for the year ended December
31, 2021. This decrease related notably to the reversals of
provisions for charges in connection with restructuring costs
linked to the abandonment of the Company's commercial activities,
as well as reversals of tax provisions, both within the 2021
financial year. These elements are completed by a net position of
more favorable commercial exchange gains over the 2022 financial
year.
Impairment of intangible
assets
As of December 31, 2022, impairment of intangible assets is
linked to the full depreciation of the avdoralimab intangible asset
(anti-C5aR rights acquired from Novo/Nordisk A/S) for an amount of
€41.0 million (non-cash expense) following Company’s decision to
stop the development of avdoralimab in bullous pemphigoid ("BP")
indication in inflammation.
Financial income (loss),
net
We recognized a net financial loss of €0.5 million for the year
ended December 31, 2022, as compared to €2.3 million net financial
gain for the year ended December 31, 2021. This change results
mainly from the change in the fair value of certain financial
instruments (net loss of €1.6 million in 2022 as compared to a €1.1
million gain in 2021) and a net foreign exchange gain of €0.8
million in 2022 as compared to a net foreign exchange loss of €1.2
million in 2021.
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 €7.2 million, or -98.2%, to a
€0.1 million net loss for the year ended December 31, 2022, as
compared to a a €7.3 million net loss for the year ended December
31, 2021. As a reminder, for the year ended the December 31, 2021,
the net loss mainly resulted from the provision in connection with
the Settlement Amount of $6.2m (€5.5m as of December 31, 2021) to
be paid to AstraZeneca on April 30, 2022 under the Termination and
Transition agreement. That amount was paid in 2022 by the Company
in April 2022 for €5.9 million ($6.2 million).
Balance sheet items
Cash, cash equivalents, short-term investments and financial
assets (current and non-current) amounted to €136.6 million as of
December 31, 2022, as compared to €159.7 million as of December 31,
2021. Net cash as of December 31, 2022 (cash, cash equivalents and
current financial assets less current financial liabilities)
amounted to €99.4 million (€89.1 million as of December 31,
2021).
The other key balance sheet items as of December 31, 2022
are:
- Deferred revenue of €14.5 million (including €7.9 million
booked as ‘Deferred revenue – non-current portion’) and
collaboration liabilities of €63.2 million (including €53.0 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 and PACIFIC-9 Phase 3
trials;
- Intangible assets for a net book value of €1.6 million, mainly
corresponding to the rights and licenses relating to the
acquisitions of monalizumab (€44.2 million as of December 30,
2021); variation between the two periods is mainly explained by the
avdoralimab intangible asset full impairment;
- Current receivables of €38.3 million, mainly resulting from the
French government in relation to the research tax credit for 2022
(€9.2 million) and 2019 (€16.8 million);
- Non-current receivables from the French government mainly
resulting from the research tax credit 2020 (€13.0 million) for a
total amount of €14.1 million;
- Shareholders’ equity of €54.2 million, including the net loss
of the period of €58.1 million;
- Financial liabilities amounting to €42.3 million (€44.3 million
as of December 31, 2021). In August 2022, the Company obtained an
extension for a period of five year with a one-year grace period
(2023) of its State-Guaranteed Loans (Prêts Garantis par l’Etat
“PGE”) from Société Générale (€20.0m) and BNP Paribas (€8.7m).
Cash-flow items
The net cash flow used over the year ended December 31, 2022
amounted to €19.5 million, compared to a net cash flow used of
€33.0 million for the year ended December 31, 2021.
The net cash flow used during the period under review mainly
results from the following:
- Net cash used from operating activities of €19.2 million,
mainly explained by the net cash consumption of operating
activities less the receipts (i) of 47.7 million ($50.0 million)
and €4.6 million ($5.0 million) in June 2022 and August 2022,
respectively, under the monalizumab agreement and the amendment to
the IPH5201 collaboration and option agreement, (ii) the collection
of €3.0 million received from Sanofi under the 2016 agreement and
following Sanofi's decision to advance IPH6401/SAR'514 into
regulatory preclinical studies for an investigational new drug and
(iii) the 2021 research tax credit repayment of €10.3 million in
November 2022. Theses proceeds are partly offset by the €5.9
million payment made to AstraZeneca in April 2022 pursuant the
Lumoxiti Termination and Transition Agreement. As a reminder, net
cash used from operating activities in 2021 included 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 2022 and 2021
proceeds and payments, net cash flows used by operating activities
for the year ended December, 2022 increased by €10.4 million. This
increase is mainly explained by the increase in the Company's
research and development activities, notably related to
pre-clinical trials, and also by higher cash outflows related to
the re-invoicing of costs to AstraZeneca for the Phase 3 trials
evaluating monalizumab (INTERLINK-1 and PACIFIC-9) in accordance
with the Company's co-financing commitments. Also, net cash flow
consumed by operating activities in connection with the Lumoxiti
discontinued operation amounted to €5.1 million for the year ended
December 31,2022 as compared to €3.6 million for the year 2021.
This increase is mainly linked to the payment made to AstraZeneca
in April 2022 for an amount of €5.9 million pursuant the Lumoxiti
Termination and Transition Agreement.
- Net cash used in investing activities for an amount of €1.9
million, mainly composed of a disposal of a non-current financial
instrument which generated a net cash collection of €2.9 million
partially offset by acquisitions of property, plant and equipment
and intangible assets for €1.1 million. Net cash flows consumed by
investing activities in connection with the Lumoxiti discontinued
operation are nil for year ended December 31, 2022 and December 31
2021, respectively.
- Net cash flows from financing activities for an amount of €1.8
million. As a reminder, 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 (€20.0m) and BNP Paribas (€8.7m). The funds
related to these two PGEs were received by the Company on December
27 and 30, 2021 respectively. In August 2022, the Company obtained
an extension for a period of five year with a one-year grace period
(starting in 2024) of its State-Guaranted Loans (Prêts Garantis par
l’Etat “PGE”) from Société Générale (€20.0m) and BNP Paribas
(€8.7m). Loan repayments amounted to €2.0 million for the year
ended December 31, 2022 compared to €2.1 million for the year ended
December 31, 2021. In addition, net cash flow from financing
activities related to Lumoxiti discontinued operation are nil for
year ended December 31, 2022 and 2021, respectively.
Post period event
- On December 19, 2022, the Company announced that it had entered
into a research collaboration and license agreement with Genzyme
Corporation, a wholly-owned subsidiary of Sanofi (“Sanofi”)
pursuant to which the Company granted Sanofi an exclusive license
on the Innate Pharma's B7-H3 ANKET® program and options on two
additional targets. Once selected, Sanofi will be responsible for
all development, manufacturing and marketing. The closing of the
transaction was subject to the authorization of the American
authorities in accordance with the Hart Scott Rodino Act of 1976.
This clearance was obtained on January 24, 2023, the date on which
the collaboration was effective. Under the terms of the
collaboration and research license agreement, the Company is
eligible from the effective date of the contract for an initial
payment of €25.0 million. This amount was received by the Company
in March 2023.
Nota
This press release contains financial data approved by the
Executive Board on March 22, 2023 based on our consolidated
financial statements for the year ended December 31, 2022. The
audit is in progress at the date of this communication.
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, 2022 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230322005783/en/
Investors & Media
Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
henry.wheeler@innate-pharma.fr
Newcap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15
innate@newcap.eu
Innate Pharma (EU:IPH)
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