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MARSEILLE, France--(BUSINESS WIRE)--Mar 23, 2023--
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today reported its consolidated financial results 1 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:
Participants may also join via telephone using the registration link below:
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):
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)
IPH6501 (proprietary)
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
IPH5201 (anti-CD39), partnered with AstraZeneca:
IPH5301 (anti-CD73):
Avdoralimab (anti-C5aR1):
Preclinical assets:
Corporate Update:
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:
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 ® ( A ntibody-based NK cell E ngager T herapeutics) 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:
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:
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:
Post period event
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/20230322005782/en/
CONTACT: Investors & Media
Innate Pharma
Henry Wheeler
Tel.: +33 (0)4 84 90 32 88
henry.wheeler@innate-pharma.frNewcap
Arthur Rouillé
Tel.: +33 (0)1 44 71 00 15
innate@newcap.eu
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SOURCE: Innate Pharma SA
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PUB: 03/23/2023 02:00 AM/DISC: 03/23/2023 02:01 AM
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