Innate Pharma SA 6-K, filed Sep 8, 2020
Innate Pharma SA (IPHA)
About this 6-K
Innate Pharma SA filed this 6-K on September 8, 2020.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of report: For the month of September 2020
Commission File Number: 001-39084
Innate Pharma S.A.
(Translation of registrant's name into English)
Innate Pharma S.A.
117 Avenue de Luminy—BP 30191
13009 Marseille, France
+ 33 (0) 4 30 30 30
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
EXHIBIT INDEX
| Exhibit | Description | |||
| 99.1 | Press Release dated September 8, 2020 | |||
| 99.2 | Half Year Financial Report 2020 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Innate Pharma S.A. | |||
| Date: September 8, 2020 | By: | /s/ Laure-Hélène Mercier | |
| Name: | Laure-Hélène Mercier | ||
| Title: | Chief Financial Officer | ||
EXHIBIT 99.1
Innate Pharma Reports First Half 2020 Financial Results and Business Update
- Innate resumed enrollment of lacutamab TELLOMAK Phase 2 clinical trial for patients with Sézary syndrome and mycosis fungoides
- Monalizumab Phase 3 study expected to initiate in the second half of 2020, triggering $50 million milestone payment
- Innate to explore avdoralimab in inflammation beyond COVID-19
- Cash position of €184.6 million1 as of June 30, 2020
MARSEILLE, France, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today reported its consolidated financial results for the six months ended June 30, 2020. The consolidated financial statements are attached to this press release.
“In the first half of 2020, Innate has made meaningful progress across its portfolio, quickly resuming enrollment in the lacutamab Phase 2 study, TELLOMAK, for patients with Sézary syndrome and mycosis fungoides,” commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “In the second half of the year, our partner, AstraZeneca, expects to initiate the Phase 3 clinical study for monalizumab in combination with cetuximab in IO-pretreated patients with recurrent or metastatic head and neck squamous cell cancer. This represents a significant clinical and financial milestone, as we progress our first Phase 3 asset and advance a promising, potentially first-in-class treatment for a patient population that needs novel, effective and tolerable therapies. More broadly, we continue to execute on our long-term strategy, transitioning into a global commercial-stage biotech company as we assume full US commercial responsibilities for Lumoxiti by the end of the year.”
| Webcast and conference call will be held today at 2:00pm CEST (8:00am ET) Webcast access: https://edge.media-server.com/mmc/p/ptr5apbo or Dial in numbers: France: +33 (0)1 70 70 07 81 US only: + 1 877 870 9135 Standard International: +44 (0) 2071 928338 Conference ID: 7368163 The presentation and access to the live webcast will be available on Innate Pharma’s website 30 minutes ahead of the conference. A replay will be available on Innate Pharma’s website after the conference call. |
1 Including short term investments (€16.0 million) and non-current financial instruments (€36.9 million)
Financial highlights for the first half of 2020:
The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2020 are as follows:
- Cash, cash equivalents, short-term investments and financial assets amounting to €184.6 million (€m) as of June 30, 2020 (€255.9m as of December 31, 2019).
- Revenue and other income amounted to €36.7m in the first half of 2020 (€59.2m in the first half of 2019) and mainly comprise of:
- Revenue from collaboration and licensing agreements, which mainly resulted from the spreading of the upfront and opt-in payments received from AstraZeneca (LSE/STO/NYSE: AZN):
- (i) Revenue from collaboration and licensing agreements for monalizumab decreased by €4.7m to €19.6m in the first half of 2020 (€24.3m in the first half of 2019), due to a catch up on the period of a non material decrease in the collaboration budget; and
- (ii) Revenue from collaboration and licensing agreements for IPH5201 decreased by €13.8m to €8.7m in the first half of 2020 (€22.5m in the first half of 2019), primarily due to an extension of the recognition period of such revenue after the renewal in November 2019 of the collaboration with AstraZeneca for 12 months.
- Revenue from invoicing of research and development (R&D) costs for avdoralimab (IPH5401) and IPH5201 was €1.1m the first half of 2020 (€4.4m in the first half of 2019), after IPH5201 transitioned to Phase 1, which is carried out and paid by AstraZeneca.
- Government funding for research expenditures of €6.9m in the first half of 2020 (€7.6m in the first half of 2019).
- Revenue from collaboration and licensing agreements, which mainly resulted from the spreading of the upfront and opt-in payments received from AstraZeneca (LSE/STO/NYSE: AZN):
- Operating expenses of €46.0m in the first half of 2020 (€45.9m in the first half of 2019), of which 68.5% (€31.5m) are related to R&D.
- R&D expenses decreased by €5.1m to €31.5m in the first half of 2020 (€36.6m in the first half of 2019), following the completion of regulatory work for certain pipeline programs, including the Lumoxiti filing in Europe and the Phase 1 transition of IPH5201 to AstraZeneca.
- Selling, general and administrative (SG&A) expenses increased by €5.2m to €14.5m in the first half of 2020 (€9.3m in the first half of 2019) primarily as a result of the structuration of the US subsidiary and commercialization of Lumoxiti.
- The Lumoxiti distribution agreement generated a net income of €0.9m in the first half of 2020 (net loss of €3.8m in the first half of 2019) primarily as a result of the transition of commercial costs from AstraZeneca to Innate Pharma.
- A net financial loss of €2.0m in the first half of 2020 (net financial income of €3.8m in the first half of 2019), principally as a result of the decrease in fair value of certain of our financial instruments due to the negative impact of the COVID-19 outbreak on the financial markets.
- A net loss of €10.3m for the first half of 2020 (net income of €13.2m for the first half of 2019).
The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2020, including 2019 comparative information.
| In thousands of euros, except for data per share | June 30, 2020 | June 30, 2019 | ||
| Revenue and other income | 36,745 | 59,155 | ||
| Research and development | (31,499) | (36,584) | ||
| Selling, general and administrative | (14,490) | (9,295) | ||
| Total operating expenses | (45,989) | (45,879) | ||
| Net income (loss) from distribution agreements | 896 | (3,820) | ||
| Operating income (loss) | (8,348) | 9,456 | ||
| Net financial income (loss) | (1,986) | 3,784 | ||
| Income tax expense | - | - | ||
| Net income (loss) | (10,334) | 13,240 | ||
| Weighted average number of shares outstanding (in thousands) | 78,892 | 63,988 | ||
| Basic income (loss) per share | (0.13) | 0.21 | ||
| Diluted income (loss) per share | (0.13) | 0.20 | ||
| | ||||
| June 30, 2020 | December 31, 2019 | |||
| Cash, cash equivalents and financial asset | 184,614 | 255,869 | ||
| Total assets | 333,066 | 401,361 | ||
| Shareholders’ equity | 207,764 | 217,416 | ||
| Total financial debt | 18,817 | 18,723 | ||
Pipeline highlights:
Lacutamab (IPH4102, anti-KIR3DL2 antibody):
- In June 2020, the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on the TELLOMAK Phase 2 clinical trial, which evaluates the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas.
- In Europe, regulatory agencies in Spain and Germany have also lifted the partial clinical hold on the TELLOMAK trial, enabling the Company to resume recruitment of the trial in these countries in addition to France, the United Kingdom and the United States.
- Innate expects to start sharing data from this trial for mycosis fungoides in 2021 and Sézary syndrome in 2022.
- In addition, the Company announced its plan to resume development of lacutamab in peripheral t-cell lymphomas (PTCL).
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
- At the May ASCO20 Virtual Scientific Conference, efficacy data was presented from a Phase 2 expansion cohort investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”, “Cohort 2”). Those data showed an overall response rate in line with previously reported data and a manageable safety profile.
- As previously announced, the advancement of monalizumab into a Phase 3 randomized clinical trial evaluating monalizumab in combination with cetuximab in patients suffering from R/M SCCHN is expected in the second half of 2020.
- Following review of longer patient follow-up and maturing survival data from Cohort 2, and following discussions with AstraZeneca, the Company has agreed to amend the agreement. It will now receive a $50 million payment upon AstraZeneca’s dosing of the first patient in the Phase 3 trial, and a $50 million payment after the interim analysis demonstrates the combination meets a pre-defined threshold of clinical activity. All other potential development and commercial milestones related to the agreement remains unchanged. The Company is planning to present updated and longer term Cohort 2 data at a future scientific conference.
- During the second quarter of 2020, the Company expanded a Phase 2 expansion cohort (“Cohort 3”), exploring the combination of monalizumab, cetuximab and durvalumab in IO-naïve patients with R/M SCCHN, from 20 to 40 patients. Recruitment for Cohort 3 is complete, and the Company now expects to publish data in 2021.
Avdoralimab in Oncology (IPH5401, anti-C5aR antibody):
- Avdoralimab is currently being tested in a Phase 1 dose escalation and expansion study (STELLAR-001) in combination with durvalumab in three expansion cohorts: 1) NSCLC patients with secondary resistance to prior immuno-oncology (IO) treatment; 2) IO-naïve HCC patients; and 3) IO-pretreated HCC patients. Based on the data from our cohort expansions in NSCLC and IO-naïve HCC, the Company has made the decision to stop enrollment in STELLAR-001.
Avdoralimab in Inflammation:
- Targeting C5a/C5aR has been demonstrated scientifically and through positive clinical trials in some complement-driven inflammatory diseases.
- The Company is pursuing investigator-sponsored trials in chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP) where the C5aR1 pathway has been shown to be strongly involved in the physiopathology of the disease.
- Both trials are expected to start in the second half of 2020.
Innate’s COVID-19 efforts:
- Innate has been conducting R&D programs in partnership with several French-based hospitals and academic centers in an effort to advance the scientific understanding of COVID‑19:
- FORCE (FOR COVID-19 Elimination): in April, the Company announced an investigator-sponsored trial named FORCE (FOR COVID-19 Elimination). FORCE is a randomized, double-blind Phase 2 clinical trial which aims to further explore avdoralimab in COVID-19 patients with severe pneumonia and is currently ongoing.
- The Phase 2 trial is supported by an exploratory translational study, EXPLORE, which suggests that patients who progress towards severe COVID-19 disease exhibit an increase activation of the C5a/C5aR1 pathway.
- Results from the EXPLORE study were published online in Nature on July 29, 2020.
- ImmunONCOVID-20: a controlled, randomized, study, sponsored by Centre Léon Bérard, Lyon, is exploring the potential efficacy of monalizumab, a potentially first-in-class immune checkpoint inhibitor, and avdoralimab, amongst other treatment arms, against COVID‑19 in cancer patients with mild symptoms and pneumonia respectively.
- Recruitment update: study recruitment for both clinical studies had declined due to improving conditions in France. However, due to the recent increase in COVID-19 cases and the Company opening new centers in France, enrolment is starting to resume in the FORCE trial. ImmunONCOVID-20 is currently suspended. The Company continues to closely monitor the situation and is also assessing the feasibility to expand its exploration of avdoralimab in COVID-19 into other geographies.
- FORCE (FOR COVID-19 Elimination): in April, the Company announced an investigator-sponsored trial named FORCE (FOR COVID-19 Elimination). FORCE is a randomized, double-blind Phase 2 clinical trial which aims to further explore avdoralimab in COVID-19 patients with severe pneumonia and is currently ongoing.
- In August, the Company announced it obtained €6.8m in public funding from the French government for its COVID-19 R&D activities. This funding is part of the government’s PSPC-COVID call for COVID-19 related projects and will enable the Company to cover the development of its current COVID-19 activities, which began in March 2020, including the EXPLORE COVID-19 translational research study and its two Phase 2 clinical trials, FORCE and ImmunONCOVID-20.
IPH5201 (anti-CD39 antibody), partnered with AstraZeneca:
- In February 2020, the multicenter, open-label, dose-escalation Phase 1 trial started, which is evaluating IPH5201 as monotherapy or in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73) in advanced solid tumors. Following the dosing of the first patient on March 9, 2020, AstraZeneca made a $5m milestone payment to Innate pursuant to Innate’s collaboration agreement with AstraZeneca and Innate made a €2.7m milestone payment to Orega Biotech SAS pursuant to Innate’s licensing agreement with Orega Biotech SAS.
Lumoxiti, a first-in-class marketed product in-licensed from AstraZeneca for the treatment of relapsed or refractory hairy cell leukemia:
- In January, the Company announced the European Medicines Agency (EMA) accepted the filing of the Marketing Authorization Application (MAA) for Lumoxiti.
- In March 2020, the Biologics License Application for Lumoxiti was transitioned from AstraZeneca to Innate. The transition of the full US commercial operations is on track to be completed in 2020.
- Relapsed or refractory hairy cell leukemia (HCL) is a rare disease, and approximately 380 HCL patients in the US have received at least two lines of prior systemic therapy, making them eligible for Lumoxiti treatment. Prior to Lumoxiti, no new therapeutic had been approved for HCL in over 20 years. The COVID-19 pandemic has limited face-to-face interactions with oncology healthcare professionals regarding Lumoxiti. Furthermore, it has caused delays to treatment initiations for potential Lumoxiti patients. As a result, the rate of new Lumoxiti patients has slowed, which is expected to impact 2020 sales.
Corporate Update:
- In July 2020, Dr. Joyson Karakunnel was appointed as Executive Vice President and Chief Medical Officer (CMO). Dr. Pierre Dodion, CMO since 2014, retired from this position. Dr. Karakunnel comes to the Company with deep experience in immuno-oncology, and a proven track record in drug development. Most recently, Dr. Karakunnel served as CMO and Senior Vice President at Tizona Therapeutics, where he led the development of the company’s biotherapeutics pipeline.
Post period event:
- On August 11, 2020, the Company announced that it has obtained funding from Bpifrance Financement as part of the program established by the French government to support the development of therapeutic solutions with a preventative or curative aim for COVID-19. This funding, in a maximum aggregate amount of €6.8 million, consists of (i) an advance reimbursable only upon technical and commercial success and (ii) a non-reimbursable grant. This funding will be received in four consecutive tranches. The first tranche of €1.7m was received at signing, and the three remaining tranches will be received upon achievement of certain clinical milestones, particularly around the FORCE Phase 2 trial
- On September 7, 2020, the Company signed an amendment to the monalizumab collaboration and license agreement concluded with AstraZeneca in 2015. Following review of longer patient follow-up and maturing survival data from Cohort 2, and following discussions with AstraZeneca, the Company has agreed to amend the agreement. It will now receive a $50 million payment upon AstraZeneca’s dosing of the first patient in the Phase 3 trial, and a $50 million payment after the interim analysis demonstrates the combination meets a pre-defined threshold of clinical activity. All other potential development and commercial milestones related to the agreement remains unchanged. The Company is planning to present updated and longer term Cohort 2 data at a future scientific conference. The Phase 3 trial evaluating monalizumab is expected to commence in the second half of 2020.
About Innate Pharma:
Innate Pharma S.A. is a commercial 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 commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia. 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 has been 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.
Based in Marseille, France, 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, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.
For additional information, please contact:
| Investors Innate Pharma Tel.: +33 (0)4 30 30 30 30 investors@innate-pharma.com | Media Innate Pharma Tracy Rossin (Global/US) Tel.: +1 240 801 0076 Tracy.Rossin@innate-pharma.com ATCG Press Marie Puvieux (France) Tel.: +33 (0)9 81 87 46 72 innate-pharma@atcg-partners.com |
Summary of Interim Condensed Consolidated Financial Statements and Notes as of June 30, 2020
Interim Condensed Consolidated Statements of Financial Position
(in thousand euros)
| June 30, 2020 | December 31, 2019 | |
| Assets | ||
| Cash and cash equivalents | 131,542 | 202,887 |
| Short-term investments | 16,199 | 15,978 |
| Trade receivables and others - current | 15,948 | 18,740 |
| Total current assets | 163,689 | 237,605 |
| Intangible assets | 95,215 | 96,968 |
| Property and equipment | 12,434 | 11,672 |
| Non-current financial assets | 36,872 | 37,005 |
| Trade receivables and others - non-current | 23,447 | 16,737 |
| Other non-current assets | 141 | 89 |
| Deferred tax assets | 1,269 | 1,286 |
| Total non-current assets | 169,377 | 163,756 |
| Total assets | 333,066 | 401,361 |
| Liabilities | ||
| Trade payables and others | 26,544 | 49,504 |
| Collaboration liabilities – Current portion | 12,012 | 21,304 |
| Financial liabilities – Current portion | 2,035 | 2,130 |
| Deferred revenue – Current portion | 41,581 | 48,770 |
| Provisions – Current portion | 171 | 114 |
| Total current liabilities | 82,345 | 121,822 |
| Collaboration liabilities – Non current portion | - | - |
| Financial liabilities – Non-current portion | 16,781 | 16,593 |
| Defined benefit obligations | 4,155 | 3,760 |
| Deferred revenue – Non-current portion | 20,491 | 40,342 |
| Provisions – Current portion | 262 | 142 |
| Deferred tax liabilities | 1,269 | 1,286 |
| Total non-current liabilities | 42,958 | 62,123 |
| Share capital | 3,946 | 3,941 |
| Share premium | 370,440 | 369,617 |
| Retained earnings | (155,719) | (134,912) |
| Other reserves | (568) | (472) |
| Net income (loss) | (10,334) | (20,759) |
| Total shareholders’ equity | 207,764 | 217,416 |
| Total liabilities and shareholders’ equity | 333,066 | 401,361 |
Interim Condensed Consolidated Statements of Income (loss)
(in thousands euros)
| June 30, 2020 | June 30, 2019 | |
| Revenue from collaboration and licensing agreements | 29,841 | 51,588 |
| Government financing for research expenditures | 6,904 | 7,567 |
| Revenue and other income | 36,745 | 59,155 |
| Research and development expenses | (31,499) | (36,584) |
| Selling, general and administrative expense | (14,490) | (9,295) |
| Operating expenses | (45,989) | (45,879) |
| Net income / (loss) distribution agreements | 896 | (3,820) |
| Operating income (loss) | (8,348) | 9,456 |
| Financial income | 2,446 | 5,717 |
| Financial expenses | (4,431) | (1,933) |
| Net financial income (loss) | (1,986) | 3 784 |
| Net income (loss) before tax | (10,334) | 13,240 |
| Income tax expense | - | - |
| Net income (loss) | (10,334) | 13,240 |
| - Basic income (loss) per share | (0,13) | 0,21 |
| - Diluted income (loss) per share | (0,13) | 0,20 |
Interim Condensed Consolidated Statements of Cash Flows
(in thousand euros)
| June 30, 2020 | June 30, 2019 | |
| Net income (loss) | (10,334) | 13,240 |
| Depreciation and amortization, net | 6,719 | 6,826 |
| Employee benefits costs | 264 | 318 |
| Change in provision for charges | 142 | (70) |
| Share-based compensation expense | 824 | 1,975 |
| Change in valuation allowance on financial assets | 2,536 | (2,308) |
| Gains (losses) on financial assets | (48) | (90) |
| Change in valuation allowance on financial instruments | 425 | (101) |
| Gains on assets and other financial assets | (758) | (1069) |
| Interest paid | 173 | 44 |
| Other profit or loss items with no cash effect | (373) | (317) |
| Operating cash flow before change in working capital | (430) | 18,448 |
| Change in working capital | (57,595) | 41,187 |
| Net cash generated from / (used in) operating activities: | (58,025) | 59,635 |
| Acquisition of intangible assets, net | (9,306) | (64,130) |
| Acquisition of property and equipment, net | (544) | (738) |
| Purchase of non-current financial instruments | (3,000) | - |
| Disposal of property and equipment | 36 | - |
| Disposal of other assets | - | 1 |
| Purchase of other assets | (52) | - |
| Disposal of non-current financial instruments | - | 2,000 |
| Interest received on financial assets | 758 | 1069 |
| Net cash generated from / (used in) investing activities: | (12,108) | (61,798) |
| Increase in capital, net | 3 | 1 |
| Repayment of borrowings | (1,029) | (729) |
| Net interest paid | (173) | (44) |
| Net cash generated / (used in) from financing activities: | (1,199) | (772) |
| Effect of the exchange rate changes | (13) | (3) |
| Net increase / (decrease) in cash and cash equivalents: | (71,345) | (2,938) |
| Cash and cash equivalents at the beginning of the year: | 202,887 | 152,314 |
| Cash and cash equivalents at the end of the six-months period: | 131,542 | 149,376 |
Revenue and other income
The following table summarizes operating revenue for the periods under review:
| In thousands of euro | June 30, 2020 | June 30, 2019 |
| Revenue from collaboration and licensing agreements | 29,841 | 51,588 |
| Government funding for research expenditures | 6,904 | 7,567 |
| Revenue and other income | 36,745 | 59,155 |
Revenue from collaboration and licensing agreements
Revenue from collaboration and licensing agreements decreased by €21.7 million, or 42.2%, to €29.8 million for the six months ended June 30, 2020, as compared to revenues from collaboration and licensing agreements of €51.6 million for the six months ended June 30, 2019. This revenue mainly results from the spreading of the upfront and opt-in payments received from AstraZeneca for monalizumab and IPH5201. This spreading is based on the completion of the work the Company executed in relation to these agreements.
The evolution for the first half of 2020 is mainly due to:
- Revenue related to monalizumab decreased by €4.7 million, or 19.2%, to €19.6 million for the six months ended June 30, 2020, as compared to €24.3 million for the six months ended June 30, 2019. This change mainly resulted from the decrease of the budget in one of the clinical trials carried out by the Company in the context of the collaboration with AstraZeneca. Whereas not material at the global scale, its impact is entirely recognized on the period under review.
As of June 30, 2020, the deferred revenue related to monalizumab was €40.0 million (€24.0 million as “Deferred revenue—Current portion” and €16.0 million as “Deferred revenue—Non-current portion”). - Revenue related to IPH5201 decreased by €13.8 million, or 61.2%, to €8.7 million for the six months ended June 30, 2020, as compared to €22.5 million for the six months ended June 30, 2019. The collaboration completion was initially planned in December 2019; the recognition period of the revenue was therefore planned on a fifteen months period from October 2018. During the fourth quarter of 2019, it was agreed that the collaboration between AstraZeneca and the Company relating to IPH5201 will be extended for twelve months. The recognition period of the revenue was extended accordingly for the deferred revenue as of September 30, 2019, resulting in a fall of the portion recognized in revenue for the six-months ended June 30, 2020, as compared to the portion recognized in revenue for the six-months ended June 30,2019.
As of June 30, 2020, the deferred revenue related to IPH5201 was €4.7 million, classified as “Deferred revenue—Current portion”.
- Invoicing of research and development costs: Pursuant to our agreements with AstraZeneca, clinical costs for the ongoing Phase 1 trial of avdoralimab are equally shared between Innate Pharma and AstraZeneca and research and development costs related to IPH5201 are fully borne by AstraZeneca, resulting in periodic settlement invoices. These costs are invoiced back on a quarterly basis.
- Revenue from invoicing of research and development costs for the six months ended June 30, 2020 decreased by €3.3 million, or 75%; to €1.1 million, as compared to €4.4 million for the six months ended June 30, 2019. This mainly resulted from a decrease in the costs relating to IPH5201 invoiced back to AstraZeneca following the transition of the program to Phase 1 trial, which is carried out by AstraZeneca.
Government funding for research expenditures
Government financing for research expenditures decreased by €0.7 million, or 8.8%, to €6.9 million for the six months ended June 30, 2020 as compared to €7.6 million the six months ended June 30, 2019. This change is mainly due to a decrease in amortization of the acquired licenses eligible to research tax credit (monalizumab and IPH5201).
The research tax credit is calculated as 30% of the amount of research and development expenses, net of grants received, eligible for the research tax credit for the six months ended June 30, 2020 and 2019. Following the loss of the SME status under European Union criteria as of December 31, 2019, the CIR for the tax year 2020 will be imputable on the tax expense of the following three tax years, or refunded if necessary at the end of this delay.
Operating expenses
The table below presents our operating expenses for the six months periods ended June 30, 2020 and 2019:
| In thousands of euros | June 30, 2020 | June 30, 2019 |
| Research and development | (31,499) | (36,584) |
| Selling, general and administrative | (14,490) | (9 295) |
| Total operating expenses | (45,989) | (45,879) |
Research and development expenses
Research and development (“R&D”) expenses decreased by €5.1 million, or 13.9%, to €31.5 million for the six months ended June 30, 2020, as compared to €36.6 million for the six months ended June 30, 2019, representing a total of 68.5% and 79.7% of the total operating expenses, respectively. R&D expenses include direct R&D expenses (subcontracting costs and consumables), depreciation and amortization, and personnel expenses.
Direct expenses decreased by €5.2 million, or 24.8%, to €15.9 million for the six months ended June 30, 2020, as compared to €21.1 million for the six months ended June 30, 2019. This decrease is mainly explained by (i) the decrease in expenses relating to Lumoxiti, as a result of the completion in 2019 of work carried out for regulatory purposes, including for the regulatory filing in Europe, (ii) a decrease in costs relating to programs transitioning to clinics (IPH5201 and IPH5301) which were partially offset by (iii) an increase in expenses relating to the lacutamab program of which the clinical program Tellomak started in June 2019.
Depreciation and amortization expenses are comparable, decreased by €0.2 million, or 3.2% to €6.1 million for the six months ended June 30, 2020, as compared to €6.3 million for the six months ended June 30, 2019.
Personnel expenses including share-based payments compensation of our employees and consultants allocated to R&D were €8.0 million for the six months ended June, 2020, as compared to €7.8 million for the six months ended June 30, 2019.
Selling, general and administrative expenses
Selling, general and administrative (“SG&A”) expenses increased by €5.2 million, or 55.9%, to €14.5 million for the six months ended June 30, 2020, as compared to €9.3 million for the six months ended June 30, 2019, representing a total of 31.5% and 20.3% of the total operating expenses, respectively.
Personnel expenses increased by €2.3 million, or 56.6%, to €6.4 million for the six months ended June 30, 2020 as compared to €4.1 million for the six months ended June 30, 2019. This increase mainly resulted from the recruitments completed during the second half of 2019 and the first half of 2020 for our US subsidiary, including staff allocated to the commercialization of Lumoxiti and the Company general structuring process.
Non-scientific advisory and consulting expenses mostly consist of auditing, accounting, taxation and legal fees. Non-scientific advisory and consulting expenses increased by €1.8 million, or 76.2%, to €4.1 million for the six months ended June 30, 2020 as compared to €2.3 million for the six months ended June 30, 2019, primarily as a result of expenses related to the commercialization of Lumoxiti and the structuring of our US subsidiary, as well as certain insurance costs following the listing of the shares of the Company on the Nasdaq stock exchange in October 2019.
Net income (loss) from distribution agreements
When product sales are performed by a partner in the context of collaboration or transition agreements, the Company must determine if the partner acts as an agent or a principal. The Company concluded that AstraZeneca acts as a principal in the context of the production and commercialization of Lumoxiti. Consequently, the global inflows and outflows received from or paid to AstraZeneca are presented on a single line in the statement of income of Innate Pharma. This amount does not include the R&D costs which are recognized as R&D operating expenses.
We recognized a net profit of €0.9 million from the Lumoxiti distribution agreement in the six months ended June 30, 2020, as compared to a net loss of €3.8 million in the six months ended June 30, 2019, which reflected revenue from sales of Lumoxiti in the period, less administrative and selling expenses associated with the sales revenue allocated to us. This €4.7 million change primarily resulted from a decrease in the commercial costs invoiced by AstraZeneca, as a result of the transfer of the commercial activities from AstraZeneca to the Company. It also includes a one-time positive true-up relating to the rebates applied to the gross sales generated over the whole period of commercialization.
Financial income (loss), net
We recognized a net financial loss of €2.0 million in the six months ended June 30, 2020 as compared to a net financial income of €3.8 million in the six months ended June 30, 2019. This €5.8m decrease mainly resulted from the decrease in fair value of certain of our financial instruments (net loss of €2.5 million as compared to a net gain of €2.3 million for the six months ended June 30, 2020 and 2019, respectively). Such decrease in fair value of certain of our financial instruments resulted from the negative impact of the COVID-19 outbreak on the financial markets.
Balance sheet items
Cash, cash equivalents, short-term investments and non-current financial assets amounted to €184.6m as of June 30, 2020, as compared to €255.9m as of December 31, 2019. Net cash as of June 30, 2020 amounted to €145.7m (€216.7m as of December 31, 2019). Net cash is equal to cash, cash equivalents and short-term investments less current financial liabilities.
The other key balance sheet items as of June 30, 2020 are:
- Deferred revenue of €62.1m (including €20.5m booked as ‘Deferred revenue – non-current portion’) and collaboration liabilities of €12.0m relating to the remainder of the initial payment received from AstraZeneca not yet recognized as revenue or not yet refunded;
- Receivables from the French government amounting to €23.4m in relation to the research tax credit for 2019 and the six-month period ended June 30, 2020;
- Intangible assets for a net book value of €95.2m, mainly corresponding to the rights and licenses relating to the acquisition of the monalizumab, IPH5201, avdoralimab, and Lumoxiti;
- Shareholders’ equity of €207.8m, including the net loss of the period of €10.3m;
- Financial liabilities of €18.8m (€18.7m as of December 31, 2019).
Cash-flow items
As of June 30, 2020, cash and cash equivalents amounted to €131.5m, compared to €202.8m as of December 31, 2019, corresponding in a decrease of €71.3m.
The net cash flow generated during the period under review mainly results from the following:
- Net cash flow used by operations of €58.0 million for the six months ended June 30, 2020 as compared to net cash flows generated by operations of €59.6 million for the six months ended June 30, 2019. As a reminder, Innate Pharma received from AstraZeneca payments of €87.7 million and €21.1 million received in January 2019 in relation to monalizumab and IPH5201 agreements, respectively. In April 2020, Innate Pharma received €4.6 million payment from AstraZeneca following the dosing of the first patient in the IPH5201 Phase 1 clinical trial.
- Net cash flow used in investing activities of €12.8 million, which mainly resulted from (i) a €13.4 million ($15.0 million) additional consideration paid 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 relating to IPH5201 following the dosing of a first patient in a Phase 1 clinical trial 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 of the rebate relating to the acquisition of Lumoxiti (€7.0 million).
- Net cash flows used in financing activities for an amount of €1.2 million.
Post period events
- On August 11, 2020, the Company announced that it has obtained funding signed a financing contract with BPIfrance Financement as part of the program established by the French government to support the development of therapeutic solutions with a preventative or curative aim for COVID-19 This funding, in a maximum aggregate amount of €6.8 million, consists of (i) an advance reimbursable only upon technical and commercial success and (ii) a non-reimbursable grant. This funding will be received in four consecutive tranches. The first tranche of €1.7m was received at signing, and the three remaining tranches will be received upon achievement of certain clinical milestones, particularly around the FORCE Phase 2 trial.
- On September 7, 2020, the Company signed an amendment to the monalizumab collaboration and license agreement concluded with AstraZeneca in 2015. Following review of longer patient follow-up and maturing survival data from Cohort 2, and following discussions with AstraZeneca, the Company has agreed to amend the agreement. It will now receive a $50 million payment upon AstraZeneca’s dosing of the first patient in the Phase 3 trial, and a $50 million payment after the interim analysis demonstrates the combination meets a pre-defined threshold of clinical activity. All other potential development and commercial milestones related to the agreement remains unchanged. The Company is planning to present updated and longer term Cohort 2 data at a future scientific conference. The Phase 3 trial evaluating monalizumab is expected to commence in the second half of 2020.
Nota
The interim consolidated financial statements for the six-month period ended June 30, 2019 have been subject to a limited review by our Statutory Auditors and were approved by the Executive Board of the Company on September 7, 2020. They were reviewed by the Supervisory Board of the Company on September 7, 2020. They will not be submitted for approval to the general meeting of shareholders.
Risk factors
Risk factors identified by the Company are presented in section 3 of the universal registration document (“Document d’Enregistrement Universel”) submitted to the French stock-market regulator, the “Autorité des Marchés Financiers”, on April 20, 2020 (AMF number D.20-0352). The main risks and uncertainties the Company may face in the six remaining months of the year are the same as the ones presented in the registration document available on the internet website of the Company. In addition, an update of the risks related to the current health crisis of COVID-19 is presented in note G) of the half-year management review as of June 30, 2020. Not only may these risks and uncertainties occur during the six months remaining in the financial year but also in the years to come.
Related party transactions:
Transactions with related parties during the periods under review are disclosed in Note 19 to the interim condensed consolidated financial statements prepared in accordance with IAS 34. No material transaction was concluded with a member of the executive committee or the Supervisory Board following the date of the 2019 registration document.
Exhibit 99.2


HALF-YEAR FINANCIAL REPORT
JUNE 30, 2020
INNATE PHARMA S.A.
French société anonyme governed by an Executive Board and a Supervisory Board
with a share capital of 3,945,638.55 euros composed of
78,898,264 ordinary shares, and 14,507 preferred shares with a nominal value of 0.05 euros each
Registered office: 117, Avenue de Luminy, F-13009 Marseille, France
Registered with the Company and Trade Register of Marseille under number 424 365 336
The following interim condensed consolidated financial statements have been approved by the Executive Board of the Company on September 7, 2020, and have been subject to a limited review by our Statutory Auditors. They have been examined by the Supervisory Board of the Company on September 7, 2020.
SUMMARY
| INNATE PHARMA AT A GLANCE | 4 |
| HALF-YEAR MANAGEMENT REVIEW | 5 |
| A. Revenue and other income | 6 |
| B. Operating expenses | 7 |
| C. Balance sheet items | 10 |
| D. Cash-flow items | 10 |
| E. Key events since January 1, 2020 | 11 |
| F. Nota | 11 |
| G. Main risks and uncertainties for the remaining six months of the fiscal year | 11 |
| H. Related party transactions | 13 |
| INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 | 14 |
| A. Interim Condensed Consolidated Statements of Financial Position (amounts in thousands of euro) | 14 |
| B. Interim Condensed Consolidated Statements of Income (Loss) (amounts in thousands of euro, except share and per share amounts) | 15 |
| C. Interim Condensed Consolidated Statements of Comprehensive Income (Loss) (amounts in thousands of euro) | 16 |
| D. Interim Condensed Consolidated Statements of Cash Flows (amounts in thousands of euro) | 17 |
| E. Interim Consolidated Statement of Changes in Shareholders’ Equity (amounts in thousands of euro, except share data) | 19 |
| F. Interim Condensed Notes to the Consolidated Financial Statements | 20 |
| STATUTORY AUDITORS' REVIEW REPORT ON THE HALF-YEARLY FINANCIAL INFORMATION | 39 |
| DECLARATION BY THE PERSON RESPONSIBLE FOR THIS HALF-YEAR FINANCIAL REPORT | 40 |
Innate Pharma | Half-year financial report June 30, 2020 | 3 |
| INNATE PHARMA AT A GLANCE |
INNATE PHARMA AT A GLANCE
Innate Pharma SA (the “Company” and, with its subsidiaries, the “Group”), is a biotechnology company focused on the discovery, development and marketing of first-rate therapeutic antibodies intended to exploit the immune system for the treatment of indications in oncology with a significant unmet medical need.
The Company has extensive experience in research and development in immuno-oncology. She was a pioneer in understanding the biology of NK cells (natural killer cells) and subsequently expanded her expertise in the fields of the tumor microenvironment, tumor antigens and antibodies. The Company has built, internally and as part of its development strategy, a broad and diversified portfolio comprising an approved product, three products candidates for clinical treatment and a solid preclinical pipeline. The Company has also established collaborations with leaders in the biopharmaceutical sector, such as AstraZeneca and Sanofi.
Since its creation, the Company has suffered losses due to its research and development ("R&D") activities. The first half of 2020 generated a net loss of 10,334 thousand euros. As of June 30, 2020, shareholders' equity amounted to 207,764 thousand euros. Subject to receiving new milestone payments related to its collaboration agreements, the Company expects to incur additional losses until, if necessary, it can generate significant revenues from its product candidates in development.
The future business of the Company is highly dependent on a combination of factors, including: (i) the success of its research and development activities; (ii) regulatory approval and market acceptance of the Company's future product candidates; (iii) timely and successful completion of the additional funding; and (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies. As a result, the Company is, and should continue to be funded in the short and medium term, through collaborative arrangements for the development and commercialization of its drug candidates and through the issuance of new equity instruments.
The activity of the Company is not subject to seasonal effects.
As of June 30, 2020, the Company owned two wholly-owned subsidiaries: Innate Pharma, Inc., based in the United States, and Innate Pharma France SAS, based in France.
Innate Pharma is based in Marseille, France and listed on Euronext in Paris, and had 247 employees as of June 30, 2020.
Learn more about Innate Pharma at www.innate-pharma.com.
Innate Pharma | Half-year financial report June 30, 2020 | 4 |
| HALF-YEAR MANAGEMENT REVIEW |
| Revenue and other income |
HALF-YEAR MANAGEMENT REVIEW
The key elements of Innate Pharma’s financial results for the first half of 2020 are as follows:
· Cash, cash equivalents and financial assets (current and non-current) amounting to €184.6m (million euros) as of June 30, 2020 (€255.9m as of December 31, 2019). At the same date, the financial liabilities amounted to €18.8m, including €16.8m of non-current liabilities (€18.7m as of December 31, 2019, including €16.6m of non-current financial liabilities).
· Revenue and other income amounting to €36.7m (€59.2m for the first half of 2019). This amount mainly results from collaboration and licensing revenue (€28.3m) and from research tax credit (€6.7m). Revenue from collaboration and licensing agreements mainly result from the agreements with AstraZeneca/Medimmune.
· Operating expenses amounting to €46.0m (€45.9m for the first half of 2019), of which 68.5% are related to research and development. Research and development expenses amount to €31.5m compared to €36.6m for the first half of 2019 and decrease by €5.3m, which mainly results from a fall in expenses relating to Lumoxiti. During the first half of 2019, AstraZeneca invoiced the Company for expenses in relation to the generation of additional data on Lumoxiti for regulatory purposes, including for the regulatory filing in Europe. Selling, general and administrative expenses amounting to €14.5 million (€9.3 million for the first half of 2019), increasing by €5.3 million, mainly resulting from the costs engaged for the commercialization of Lumoxiti and the structuring of our US subsidiary.
· A net loss for the first half of 2020 amounting to €10.3m compared to net income of €13.2m for the first half of 2019.
Note on change of accounting standards during the period
Application of the following amended standards is mandatory for the first time for the financial period beginning on January 1, 2020 and, as such, they have been adopted by the Company:
· Amendments to IFRS 3 “Definition of a business”, published on October 22, 2018.
· Amendments to IAS 1 and IAS 8 relating to the definition of materiality, published on October 31, 2018.
· Amendments to IAS 39, IFRS 7 and IFRS 9 relating to the interest rate benchmark reform.
· Conceptual framework for financial reporting and modification to references to conceptual framework in IFRS standards.
Those amended standards have no impact on the interim condensed consolidated financial statements.
Application of the following amended standard is mandatory for the first time for the financial period beginning on June 1, 2020:
· Covid-19-Related Rent Concessions Amendment to IFRS 16
The Company has not early adopted this amendment.
Innate Pharma | Half-year financial report June 30, 2020 | 5 |
HALF-YEAR MANAGEMENT REVIEW |
Revenue and other income |
| A. | Revenue and other income |
Revenue and other income resulted from collaboration and licensing agreements and government financing for research expenditure. Revenue and other income decreased by €22.4 million, or 37.9%, to €36.7 million for the six months ended June 30, 2020, as compared to revenue and other income of €59.2 million for the six months ended June 30, 2019.
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Revenue from collaboration and licensing agreements | 29,841 | 51,588 |
| Government funding for research expenditures | 6,904 | 7,567 |
| Revenue and other income | 36,745 | 59,155 |
Revenue from collaboration and licensing agreements
Revenue from collaboration and licensing agreements decreased by €21.7 million, or 42.2%, to €29.8 million for the six months ended June 30, 2020, as compared to revenues from collaboration and licensing agreements of €51.6 million for the six months ended June 30, 2019. These revenues were derived principally under our agreements with AstraZeneca and are set forth in the table below:
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Proceeds from collaboration and licensing agreements | 28,349 | 46,770 |
| of which monalizumab agreement | 19,636 | 24,293 |
| of which IPH5201 agreement | 8,713 | 22,478 |
| Invoicing of R&D costs (IPH5201 and avdoralimab agreements) | 1,090 | 4,418 |
| Exchange gains on collaboration agreement | 402 | 400 |
| Revenue from collaboration and licensing agreements | 29,841 | 51,588 |
Proceeds from collaboration and licensing agreements
Proceeds from collaboration and licensing agreements result from the partial recognition of the proceeds received in the context of the agreements with AstraZeneca for monalizumab and IPH5201 and which are recognized on the basis of the percentage of completion of the works performed by the Company.
For monalizumab, these amounts result from the partial recognition of the $250 million non-refundable upfront payment received in June 2015 and the $100 million milestone regarding the exercise of the option received in October 2018.
For IPH5201, revenue related to the partial recognition of the $50.0 million non-refundable upfront payment received from AstraZeneca in October 2018 and the $5.0m milestone payment received in March 2020.
The amounts not yet recognized in revenue are classified as deferred revenue.
Proceeds related to monalizumab:
Revenue related to monalizumab decreased by €4.7 million, or 19.2%, to €19.6 million for the six months ended June 30, 2020, as compared to €24.3 million for the six months ended June 30, 2019. This variance mainly results from the decrease of the budget of one of the clinical trials carried out by the Company in the context of the collaboration. This decrease is not material at the global scale of but its impact is entirely recognized on the period.
As of June 30, 2020, the deferred revenue related to monalizumab is €40.0 million (€24.0 million as “Deferred revenue—Current portion” and €16.0 million as “Deferred revenue—Non-current portion”).
Proceeds related to IPH5201:
Revenue related to IPH5201 decreased by €13.8 million, or 61.2%, to €8.7 million for the six months ended June 30, 2020, as compared to €22.5 million for the six months ended June 30, 2019.
Innate Pharma | Half-year financial report June 30, 2020 | 6 |
| HALF-YEAR MANAGEMENT REVIEW |
| Operating expenses |
The collaboration was initially planned to terminate in December 2019. The recognition period of the revenue was therefore planned on a fifteen months period from October 2018. During the fourth quarter of 2019, the involvement of the Company in the collaboration was extended by twelve months. The recognition period of the revenue was extended accordingly for the deferred revenue remaining as of September 30, 2019, resulting in a fall of the portion recognized in revenue over each period.
As of June 30, 2020, the deferred revenue related to monalizumab is €4.7 million, classified as “Deferred revenue—Current portion”.
Invoicing of research and development costs:
Pursuant to our agreements with AstraZeneca, clinical costs for the ongoing Phase I trial of avdoralimab are equally shared between Innate Pharma and AstraZeneca and research and development costs related to IPH5201 are fully borne by AstraZeneca, resulting in periodic settlement invoices. These costs are invoiced back on a quarterly basis.
Revenue from invoicing of research and development costs for the six months ended June 30, 2020 is €1.1 million compared to €4.4 million for the six months ended June 30, 2019. The €3.3 million, or 75%, fall between the first half of 2019 and the first half of 2020 mainly results from a €3.0 million decrease of the research and development costs relating to IPH5201 invoiced back to AstraZeneca following the transition of the program at the clinical stage which is carried out by AstraZeneca.
Government financing for research expenditures
Government financing for research expenditures decreased by €0.7 million, or 8.8%, to €6.9 million for the six months ended June 30, 2020 as compared to €7.6 million the six months ended June 30, 2019. This change is primarily a result of a decrease in the research tax credit of €0.8 million, which is mainly due to a fall in amortization of the acquired licenses (monalizumab and IPH5201) and decrease of the rate applied to the staff costs to determine operating costs (43% instead of 50%). The impact of these elements on the research tax credit amounts to €0.6 and €0.1 million, respectively.
The table below details government funding for research expenditures for the six months ended June 30, 2020 and 2019.
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Research tax credits | 6,733 | 7,494 |
| Grants | 171 | 73 |
| Government financing for research expenditures | 6,904 | 7,567 |
The research tax credit is calculated as 30% of the amount of research and development expenses, net of grants received, eligible for the research tax credit for the six months ended June 30, 2020 and 2019.
| B. | Operating expenses |
The table below presents our operating expenses for the six months periods ended June 30, 2020 and 2019:
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Research and development | (31,499) | (36,584) |
| Selling, general and administrative | (14,490) | (9 295) |
| Total operating expenses | (45,989) | (45,879) |
Innate Pharma | Half-year financial report June 30, 2020 | 7 |
| HALF-YEAR MANAGEMENT REVIEW |
| Operating expenses |
Research and development expenses (R&D)
Our R&D expenses in the periods presented primarily relate to activities for our clinical programs. Our research and development expenses are broken down as set forth in the table below:
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Monalizumab | (2,112) | (2,192) |
| Lacutamab | (5,003) | (2,918) |
| Advoralimab | (3,654) | (2,805) |
| Lumoxiti(1) | (1,797) | (6,456) |
| Sub-total programs in clinical development | (12,566) | (14,371) |
| Sub-total programs in preclinical development | (3,333) | (6,774) |
| Total direct research and development expenses | (15,899) | (21,145) |
| Personnel expenses (including share-based payments) | (8,021) | (7,808) |
| Depreciation and amortization | (6,145) | (6,348) |
| Other expenses | (1,434) | (1,283) |
| Personnel and other expenses | (15,60) | (15,439) |
| Total research and development expenses | (31,499) | (36,584) |
R&D expenses decreased by €5.1 million, or 13.9%, to €31.5 million for the six months ended June 30, 2020, as compared to R&D of €36.6 million for the six months ended June 30, 2019.
R&D expenses represented a total of 68.5% and 79.7% of the total operating expenses for the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, we had 164 employees in research and development functions, compared to 157 employees as of June 30, 2019.
Direct R&D expenses decreased by €5.2 million, or 25.0%, to €15.9 million for the six months ended June 30, 2020, as compared to an amount of €21.1 million for the six months ended June 30, 2019. This decrease is mainly explained by (i) the fall in expenses relating to Lumoxiti, resulting from the performance in 2019 of works in relation to the generation of additional data on Lumoxiti for regulatory purposes, including for the regulatory filing in Europe (ii) a decrease in the costs relating to the preclinical programs (iii) partly offset by a rise in expenses relating to the lacutamab program of which the clinical program Tellomak started in June 2019.
Personnel and other expenses allocated to R&D increased by €0.2 million, or 1.0%, to €15.6 million for the six months ended June 30, 2020, as compared to an amount of €15.4 million for the six months ended June 30, 2019.
Selling, general and administrative expenses:
Selling, general and administrative expenses increased by €5.2 million, or 55.9%, to €14.5 million for the six months ended June 30, 2020, as compared to selling, general and administrative expenses of €9.3million for the six months ended June 30, 2019. Selling, general and administrative expenses represented a total of 31.5% and 20.3% of the total operating expenses for the six months ended June 30, 2020 and 2019, respectively. The table below presents our selling, general and administrative expenses by nature for the six months ended June 30, 2020 and 2019:
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Personnel expenses (including shared-based payments) | (6,436) | (4,111) |
| Non scientific advisory and consulting | (4,109) | (2,332) |
| Other expenses(1) | (3,946) | (2,852) |
| Total selling, general and administrative expenses | (14,490) | (9,295) |
(1) Other expenses are related to intellectual property, maintenance costs for laboratory equipment and our premises, depreciation and amortization and other selling, general and administrative expenses.
Innate Pharma | Half-year financial report June 30, 2020 | 8 |
| HALF-YEAR MANAGEMENT REVIEW |
| Operating expenses |
Personnel expense includes the compensation paid to our employees, and increased by €2.3 million, or 56.6%, to €6.4 million for the six months ended June 30, 2020 as compared to personnel expenses of €4.1 million for the six months ended June 30, 2019. This increase mainly results from the recruitments completed during the second half of 2019 and the first half of 2020 by our US subsidiary, including the staff allocated to the commercialization of Lumoxiti. As of June 30, 2020, we had 74 employees in selling, general and administrative functions, compared to 43 employees as of June 30, 2019. This rise mainly results from the recruitments of our US subsidiary (23 employees as of June 30, 2020 to be compared to 2 employees as of June 30, 2019).
Non-scientific advisory and consulting expenses mostly consist of auditing, accounting, taxation and legal fees as well as consulting fees in relation to business strategy and operations and hiring services. Non-scientific advisory and consulting expenses increased by €1.8 million, or 76.2%, to €4.1 million for the six months ended June 30, 2020 as compared to €2.3 million for the six months ended June 30, 2019, primarily resulting from the expenses related to the commercialization of Lumoxiti and the structuring of our US subsidiary.
The rise in other expenses mainly results from the insurance costs, which increase by €0.8 million following the listing of the Company on the Nasdaq.
Net income (loss) from distribution agreements
We recognized a net profit of €0.9 million from the Lumoxiti distribution agreement in the six months ended June 30, 2020 (to be compared to a net loss of €3.8 million in the six months ended June 30, 2019), which reflected revenue from sales of Lumoxiti in the period, less administrative and selling expenses associated with the sales revenue allocated to us. This €4.7 million rise mainly results from decrease in the commercial costs invoiced by AstraZeneca, as a result of the transfer of the commercial activities from AstraZeneca to the Company. It also includes a one-time positive true-up relating to the rebates applied to the gross sales generated over the whole period of commercialization.
Financial income (loss), net
We recognized a net financial loss of €2.0 million in the six months ended June 30, 2020 as compared to a net financial income of €3.8 million in the six months ended June 30, 2019. This variance mainly results from the variance in fair value of our financial instruments (net gain of €2.3 million as compared to a net loss of €2.5 million for the six months ended June 30, 2019 and 2020, respectively). This results from the impact of the COVID health crisis on the financial markets.
The table below presents the components of our net financial income (loss) for the six months ended June 30, 2020 and 2019:
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Gains on financial assets | 343 | 893 |
| Change in valuation allowance on financial instruments | 173 | 2,309 |
| Foreign exchange gains | 1,929 | 2,511 |
| Other financial income | 1 | 5 |
| Financial income | 2,446 | 5,717 |
| Foreign exchange losses | (1,545) | (1,888) |
| Unrealized losses on financial assets | (2,712) | - |
| Interest on financial liabilities | (173) | (45) |
| Other financial expenses | (1) | - |
| Financial expenses | (4,431) | (1,933) |
| Net financial income (loss) | (1,986) | 3,784 |
Innate Pharma | Half-year financial report June 30, 2020 | 9 |
HALF-YEAR MANAGEMENT REVIEW |
Balance sheet items |
For the six months ended June 30, 2020 and 2019, the foreign exchange gains and losses mainly result from the variance of the exchange rate between the Euro and the U.S. dollar on U.S. dollar-denominated cash and cash equivalents and financial assets. Unrealized losses on financial assets relate to unquoted instruments.
| C. | Balance sheet items |
Cash, cash equivalents, short-term investments and non-current financial assets amounted to €184.6m as of June 30, 2020, as compared to €255.9m as of December 31, 2019. Net cash as of June 30, 2020 amounted to €145.7m (€216.7m as of December 31, 2019). Net cash is equal to cash, cash equivalents and short-term investments less current financial liabilities.
Since its incorporation in 1999, the Company has been primarily financed by revenue from its collaboration, licensing agreements (€420.5m in total, or $480.0m), and by issuing new shares (€306.4m in total excluding share-based payments and the costs the costs associated with capital increases). The Company has also benefited from the research tax credit (CIR) and fundings received from BPI France (ex-Oseo) in repayable advances not bearing interest and PTZI loan. As of June 30, 2020, the outstanding amount of repayable advances and PTZI loan amounts to €0.5m, of which €0.2m classified as current financial liabilities and €0.3m as non-current financial liabilities.
The Company also has bank borrowings of €14.6m as of June 30, 2020 and €3.8m of lease liabilities.
Regarding the CIR, the Company lost the status of SME at the end of the fiscal year 2019. Consequently, it does not benefit anymore from the immediate reimbursement of the CIR, which is now a debt towards the French government that will be settled against the corporate tax due in France for the three following years. The remaining portion of the tax credit not settled following this period will be reimbursed to the Company. Since its incorporation, the Company benefited of the CIR for a cumulative amount of €97.3 million, of which €80.6 million were reimbursed.
The other key balance sheet items as of June 30, 2020 are as follows:
· Deferred revenue of €62.1m (including €20,5m booked as ‘Deferred revenue – non-current portion’) and collaboration liabilities amounting to €12.0m relating to the remainder of the initial payment from AstraZeneca not yet recognized as revenue or not yet refunded;
· Receivables from the French government amounting to €23.4m in relation to the research tax credit for 2019 and the six-month period ended June 30, 2020;
· Intangible assets for a net book value of €95.2m, mainly corresponding to the rights and licenses relating to the acquisition of the monalizumab, IPH5201, avdoralimab, and Lumoxiti;
· Shareholders’ equity of €207.8m including the net loss for the period (€10.3m).
| D. | Cash-flow items |
As of June 30, 2020, cash and cash equivalents amounted to €131.5m, a decrease of €71.3m compared to December 31, 2019.
The following table sets forth cash flow data for the six months ended June 30, 2020 and 2019:
| in thousands of euro | June 30, 2020 | June 30, 2019 |
| Cash flows from / (used in) operating activities | (58,025) | 59,635 |
| Cash flows from / (used in) investing activities | (12,108) | (61,798) |
| Cash flows from / (used in) financing activities | (1,199) | (772) |
| Effect of the exchange rate changes | (13) | (3) |
| Net increase / (decrease) in cash and cash equivalents | (71,346) | (2,938) |
Cash flows from / (used in) operating activities:
Our net cash flow used by operations increased by €117.7 million to a net cash consumption of €58.0 million for the six months ended June 30, 2020 as compared net cash flows generated by operations of €59.6 million for the six months ended June 30, 2019. This variance is mainly explained by payments of €87.7 million and €21.1 million received in January 2019 from AstraZeneca in relation to monalizumab and IPH5201 agreements, respectively.
Innate Pharma | Half-year financial report June 30, 2020 | 10 |
HALF-YEAR MANAGEMENT REVIEW |
Key events since January 1, 2020 |
Cash flows from / (used in) investing activities:
Our net cash flow used in investing activities for the six months ended June 30, 2020 were €12.8 million and mainly result from (i) a €13.4 million ($15 million) additional consideration paid to AstraZeneca regarding Lumoxiti following the submission of the BLA to the European Medicine Agency (EMA) in November 2019 (ii) a €2.7 million additional consideration paid to Orega Biotech in April 2020 relating to IPH5201 following the dosing of a first patient in a Phase I clinical trial and (iii) the acquisition of financial assets for a net amount of €3.0 million. These items are partly offset by the reimbursement by AstraZeneca of the rebate relating to the acquisition of Lumoxiti (€7.0 million, see Note 5).
Our net cash flow used in investing activities for the six months ended June 30, 2019 were €61.8 million and were mainly driven by the acquisition of intangible assets for €64.1 million. This amounts mainly consisted of (i) the payment of Lumoxiti rights to AstraZeneca ($50.0 million or €43.8 million), (ii) additional consideration payed to Novo Nordisk A/S for monalizumab rights ($15.0 million or €13.1 million) and (iii) the payment made to Orega Biotech for IPH5201 (anti-CD39) rights (€7.0 million).
Cash flows from / (used in) financing activities:
Our net cash flows used in financing activities for the six months ended June 30, 2020, increased by €0.4 million to €1.2 million as compared to net cash flows used in financing activities of €0.8 million for the six months ended June 30, 2019.
| E. | Key events since January 1, 2020 |
· In the first half of 2020, occured the COVID-19 health crisis. The Company has closely monitored and continues to monitor developments of the situation and has implemented a number of measures. Note G) to this half-year management report presents an update of the risk assessment related to the current health crisis linked to COVID-19 as set out in section 3 of the universal registration document filed with the Autorité des Marchés Financiers ("AMF") on April 24, 2020 (AMF number D.20-0352)
· On November 22, 2019, AstraZeneca submitted to the European Medicines Agency (EMA) the Marketing Authorization Application (MAA) relating to the commercialization of Lumoxiti in Europe. According to the agreement related to Lumoxiti with AstraZeneca, AstraZeneca is entitled to a $15.0 million milestone that was paid by the Company in January 2020. On January 2, 2020, the Company announced that the EMA has accepted the MAA submission for Lumoxiti. The EMA filling acceptance follows the U.S. Food and Drug Administration (FDA) approval of Lumoxiti in September 2018.
· On January 10, 2020, the Company signed an amendment to the lease for the “Le Virage” building in order to expand its premises. This amendment also extends the duration of the contractual commitment. The effective date of this addendum is January 15, 2020. Consequently, and following the application of IFRS 16 standard, the impact on the consolidated financial statements are the following: recognition of a new right-of-use asset of €1.2 million and a new lease liability of €1.1 million.
· On March 10, 2020, the Company announced the dosing of the first patient on March 9, 2020 in the IPH5201 Phase I clinical trial. AstraZeneca made a $5.0 million (€4.6 million) milestone payment to Innate under the companies’ October 2018 multi productoncology development collaboration. Innate made a €2.7 million milestone payment to Orega Biotech SAS pursuant to Innate’s exclusive licensing agreement.
| F. | Nota |
The interim condensed consolidated financial statements for the six-month period ended June 30, 2020 were established in accordance with IAS 34 standard adopted by European Union and have been subject to a limited review by our Statutory Auditors and were approved by the Executive Board of the Company on September 7, 2020. They were reviewed by the Supervisory Board of the Company on September 7, 2020. They will not be submitted for approval to the general meeting of shareholders.
| G. | Main risks and uncertainties for the remaining six months of the fiscal year |
Risk factors identified by the Company are presented in section 3 of the universal registration document (“Document d’Enregistrement Universel”) submitted to the French stock-market regulator, the “Autorité des Marchés Financiers”, on April 24, 2020 (AMF number D.20-0352). The main risks and uncertainties the Company may face in the six remaining months of the year are the same as the ones presented in the universal registration document available on the internet website of the Company. Not only may these risks and uncertainties occur during the six months remaining in the financial year but also in the years to come. However, during the first half of 2020, the COVID-19 health crisis occurred. The paragraph below presents an update of the risk assessment related to the current health crisis linked to the COVID-19 coronavirus as set forth in the universal registration document filed with the Autorité des Marchés Financiers ("AMF") on April 24, 2020 (AMF number D.20-0352) and in particular an update of the risk factor related to the COVID-19 coronavirus set forth in paragraph 3.8 of the same document.
Innate Pharma | Half-year financial report June 30, 2020 | 11 |
HALF-YEAR MANAGEMENT REVIEW |
Related party transactions |
The unit set up by the Company to monitor the COVID-19 coronavirus current health crisis and the risks and impacts on the Company is maintained and continues to meet regularly. It addresses the situation along the various lines described below. Despite our heightened vigilance, and given the evolving and unprecedented nature of this situation, even if certain risks are identified, we may not be able to identify and control all risks.
| · | Staff : |
Work organisation on our sites has been and is still being adapted to the changing situation, both internationally and locally, and in compliance with the health and safety measures dictated by the governments of the countries where the Company operates. During the lockdown period, the Company's on-site activity was focused on the opportunity to develop our drug candidates in indications related to COVID-19, in order to limit the number of persons on site and thus limit the exposure of personnel. The activities that can be carried out remotely have been maintained in their entirety thanks to the computer equipment that was already available within the Company. At the end of the lockdown period, research and development activities resumed in their entirety on-site within a short period of time. This lockdown episode resulted in a delay of several weeks, which was not significant given the nature of our activities. On the other hand, business travel by our staff was and still is reduced to the strict minimum, which essentially impacts relations with healthcare staff in hospital centers, whether it be for operations related to the conduct of our clinical trials or operations related to the marketing of Lumoxiti, as discussed below.
| · | Clinical Trials : |
The impact of the health crisis on the progress of ongoing clinical trials, whether conducted by the Company or by its institutional or industrial partners, remains uncertain for the coming months. Indeed, the situation varies from one country, region or even hospital center to another, in terms of the inclusion of new patients and the quality and completeness of the data from these trials. Although improvements have been observed, such as the resumption of the Phase I clinical trial evaluating IPH5201 by AstraZeneca, the recruitment of new patients is still limited in some of the hospitals participating in our clinical trials.
In addition, the Company has initiated a clinical development program in diseases related to COVID-19. The lack of knowledge of the pathologies related to this virus creates a risk related to the development of new drug candidates that is slightly higher than what the Company is generally aware of. It should be noted that the Company has obtained public funding (BPI - see note 21 to the condensed consolidated financial statements for the six months ended June 30, 2020) for this program under the PSCP-COVID call for projects.
| · | Marketing : |
Interactions with healthcare staff are still very constrained in the activities related to the commercialization of Lumoxiti. Also, the indolent and non-lethal nature of Hairy Cell Leukemia may encourage physicians to postpone or cancel treatment of patients. These factors induce a financial risk related to Lumoxiti's sales.
| · | Partnership : |
In the context of this health crisis, our partners may have to reorient their strategy or review the development priorities of their portfolio, which could impact our existing agreements and the progress of the relevant research and development programs or prevent us from entering into new agreements.
| · | Supply chain : |
Although no impact has been observed to date on the supply chain for key materials, including investigational or marketed drugs, the Company continues to closely monitor the suppliers involved and the situation in the various geographical areas where they operate or to which these materials transit.
| · | Finance : |
The occurrence of some or all of the risks listed here, or other risks related to the health crisis that have not yet been identified, could adversely affect the Company's operations, financial condition and prospects. For the first half of 2020, the Company's financial result shows a net financial loss of €2.0 million, compared to a net financial income of €3.8 million for the first half of 2019. This financial net loss is mainly due to the decrease in the fair value of certain of our financial instruments as a result of the impact of the COVID-19 health crisis on the financial markets.
Innate Pharma | Half-year financial report June 30, 2020 | 12 |
HALF-YEAR MANAGEMENT REVIEW |
Related party transactions |
| H. | Related party transactions |
Transactions with related parties during the periods under review are disclosed in Note 19 to the interim consolidated financial statements. No material transaction was concluded with a member of the executive committee or the Supervisory Board following the date of the 2019 registration document.
Innate Pharma | Half-year financial report June 30, 2020 | 13 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Consolidated Statements of Financial Position (amounts in thousands of euro) |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020
| A. | Interim Condensed Consolidated Statements of Financial Position (amounts in thousands of euro) |
| Note | June 30, 2020 | December 31, 2019 | |
| Assets | |||
| Current assets | |||
| Cash and cash equivalents | 4 | 131,542 | 202,887 |
| Short-term investments | 4 | 16,199 | 15,978 |
| Trade receivables and others | 5 | 15,948 | 18,740 |
| Total current assets | 163,689 | 237,605 | |
| Non-current assets | |||
| Intangible assets | 6 | 95,215 | 96,968 |
| Property and equipment | 7 | 12,434 | 11,672 |
| Non-current financial assets | 4 | 36,872 | 37,005 |
| Trade receivables and other–non-current | 5 | 23,447 | 16,737 |
| Other non-current assets | 141 | 89 | |
| Deferred tax assets | 17 | 1,269 | 1,286 |
| Total non-current assets | 169,377 | 163,756 | |
| Total assets | 333,066 | 401,361 | |
| Liabilities | |||
| Current liabilities | |||
| Trade payables and others | 8 | 26,544 | 49,504 |
| Collaboration liabilities – current portion | 13 | 12,012 | 21,304 |
| Financial liabilities – current portion | 9 | 2,035 | 2,130 |
| Deferred revenue – current portion | 13 | 41,581 | 48,770 |
| Provisions – current portion | 18 | 171 | 114 |
| Total current liabilities | 82,345 | 121,822 | |
| Non-current liabilities | |||
| Collaboration liabilities–non-current portion | 13 | - | - |
| Financial liabilities–non-current portion | 9 | 16,781 | 16,593 |
| Defined benefit obligations | 10 | 4,155 | 3,760 |
| Deferred revenue – non-current portion | 13 | 20,491 | 40,342 |
| Provisions – non-current portion | 18 | 262 | 142 |
| Deferred tax liabilities | 17 | 1,269 | 1,286 |
| Total non-current liabilities | 42,958 | 62,123 | |
| Shareholders’ equity | |||
| Share capital | 11 | 3,946 | 3,941 |
| Share premium | 11 | 370,440 | 369,617 |
| Retained earnings | (155,719) | (134,912) | |
| Other reserves | (568) | (472) | |
| Net income (loss) | (10,334) | (20,759) | |
| Total shareholders’ equity | 207,764 | 217,416 | |
| Total liabilities and shareholders’ equity | 333,066 | 401,361 |
Innate Pharma | Half-year financial report June 30, 2020 | 14 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
| Interim Condensed Consolidated Statements of Income (Loss) (amounts in thousands of euro, except share and per share amounts) |
| B. | Interim Condensed Consolidated Statements of Income (Loss) (amounts in thousands of euro, except share and per share amounts) |
| Note | June 30, 2020 | June 30, 2019 | |
| Revenue from collaboration and licensing agreements | 13 | 29,841 | 51,588 |
| Government financing for research expenditures | 13 | 6,904 | 7,567 |
| Revenue and other income | 36,745 | 59,155 | |
| Research and development expenses | 14 | (31,499) | (36,584) |
| Selling, general and administrative expenses | 14 | (14,490) | (9,295) |
| Operating expenses | (45,989) | (45,879) | |
| Net income (loss) from distribution agreements | 15 | 896 | (3,820) |
| Operating income (loss) | (8,348) | 9,456 | |
| Financial income | 16 | 2,446 | 5,717 |
| Financial expenses | 16 | (4,431) | (1,933) |
| Net financial income (loss) | (1,986) | 3,784 | |
| Net income (loss) before tax | (10,334) | 13,240 | |
| Income tax expense | 17 | - | - |
| Net income (loss) | (10,334) | 13,240 | |
| Net income (loss) per share | |||
| Weighted average number of shares | 78,892,031 | 63,987,582 | |
| (in € per share) | |||
| - Basic income (loss) per share | 20 | (0,13) | 0.21 |
| - Diluted income (loss) per share | 20 | (0,13) | 0.20 |
Innate Pharma | Half-year financial report June 30, 2020 | 15 |
|
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
|
Interim Condensed Consolidated Statements of Comprehensive Income (Loss) (amounts in thousands of euro) |
| C. | Interim Condensed Consolidated Statements of Comprehensive Income (Loss) (amounts in thousands of euro) |
| June 30, 2020 | June 30, 2019 | |
| Net income (loss) for the period | (10,334) | 13,240 |
| Items which will not reclassified in the consolidated statement of income (loss) | ||
| Actuarial gains and (losses) related to defined benefit obligations | (131) | (794) |
| Elements which will be reclassified in the consolidated statement of income (loss) | ||
| Foreign currency translation gain (loss) | (13) | (3) |
| Other comprehensive income (loss) | (144) | (797) |
| Total comprehensive income (loss) | (10,478) | 12,443 |
Innate Pharma | Half-year financial report June 30, 2020 | 16 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Consolidated Statements of Cash Flows (amounts in thousands of euro) |
| D. | Interim Condensed Consolidated Statements of Cash Flows (amounts in thousands of euro) |
| Note | June 30, 2020 | June 30, 2019 | |
| Net income (loss) | (10,334) | 13,240 | |
| Depreciation and amortization, net | 6, 7 | 6,719 | 6,826 |
| Employee benefits costs | 10 | 264 | 318 |
| Provisions for charges | 142 | (70) | |
| Share-based compensation expense | 14 | 824 | 1,975 |
| Change in valuation allowance on financial assets | 4 | 2,536 | (2,308) |
| Gains (losses) on financial assets | 4 | (48) | (90) |
| Change in valuation allowance on financial instruments | 4 | 425 | (101) |
| Gains on assets and other financial assets | (758) | (1,069) | |
| Interest paid | 173 | 44 | |
| Other profit or loss items with no cash effect | (373) | (317) | |
| Operating cash flow before change in working capital | (430) | 18,448 | |
| Change in working capital | (57,595) | 41,187 | |
| Net cash generated from / (used in) operating activities | (58,025) | 59,635 | |
| Acquisition of intangible assets, net | 5, 6 & 8 | (9,306) | (64,130) |
| Acquisition of property and equipment, net | 7,8 | (544) | (738) |
| Purchase of non-current financial instruments | 4 | (3,000) | - |
| Disposal of property and equipment | 4 | 36 | - |
| Disposal of other assets | - | 1 | |
| Purchase of other assets | (52) | - | |
| Disposal of non-current financial instruments | 4 | - | 2,000 |
| Interest received on financial assets | 16 | 758 | 1,069 |
| Net cash generated from / (used in) investing activities | (12,108) | (61,798) | |
| Proceeds from the exercise / subscription of equity instruments | 11 | 3 | 1 |
| Repayment of borrowings | 9 | (1,029) | (729) |
| Net interest paid | 9, 16 | (173) | (44) |
| Net cash generated / (used in) financing activities | (1,199) | (772) | |
| Effect of the exchange rate changes | (13) | (3) | |
| Net increase / (decrease) in cash and cash equivalents | (71,345) | (2,938) | |
| Cash and cash equivalents at the beginning of the year: | 4 | 202,887 | 152,314 |
| Cash and cash equivalents at the end of the six-month period | 4 | 131,542 | 149,376 |
Innate Pharma | Half-year financial report June 30, 2020 | 17 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Consolidated Statements of Cash Flows (amounts in thousands of euro) |
| Change in working capital | Note | June 30, 2020 | December 31, 2019 | Variance |
| Trade receivables and others (excluding rebates related to capital expenditures) | 5 | 39,394 | 28,716 | (10,678) |
| Deferred revenue - current and non-current portion | 13 | (62,072) | (89,112) | (27,040) |
| Trade payables and others (excluding payables related to capital expenditures) | 8 | (25,461) | (36,047) | (10,585) |
| Collaboration liabilities - current and non-current portion | 13 | (12,012) | (21,304) | (9,292) |
| Change in working capital | (60,151) | (117,746) | (57,595) |
| Change in working capital | Note | June 30, 2019 | December 31, 2018 | Variance |
| Trade receivables and others (excluding rebates related to capital expenditures) | 5 | 40,828 | 139,012 | 98,184 |
| Deferred revenue - current and non-current portion | 13 | (103,636) | (150,195) | (46,559) |
| Trade payables and others (excluding payables related to capital expenditures) | 8 | (28,042) | (34,662) | (6,620) |
| Collaboration liabilities - current and non-current portion | 13 | (27,838) | (31,656) | (3,818) |
| Change in working capital | (118,688) | (77,501) | 41,187 |
Innate Pharma | Half-year financial report June 30, 2020 | 18 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Consolidated Statement of Changes in Shareholders’ Equity (amounts in thousands of euro, except share data) |
| E. | Interim Consolidated Statement of Changes in Shareholders’ Equity (amounts in thousands of euro, except share data) |
| In thousands of euro, except for data share | Ordinary Shares |
Preferred Shares |
Share capital |
Share premium |
Retained earnings |
Other reserves |
Net income (loss) |
Total attributable to equity holders of the Company |
| December 31, 2018 | 63,932,655 | 6,931 | 3,197 | 299,932 | (137,840) | (1,099) | 3,049 | 167,240 |
| Restatement related to the first application of IFRS 16 | - | - | - | - | (121) | - | - | (121) |
| January 1, 2019 (after restatement)(1) | 63,932,655 | 6,931 | 3,197 | 299,932 | (137,961) | (1,099) | 3,049 | 167,119 |
| Net income | - | - | - | - | - | - | 13,240 | 13,240 |
| Actuarial gains on defined benefit obligations | - | - | - | - | - | (794) | - | (794) |
| Foreign currency translation loss | - | - | - | - | - | (3) | - | (3) |
| Total comprehensive income for the period | - | - | - | - | - | (797) | 13,240 | 12,443 |
| Allocation of prior period income | - | - | - | - | 3,049 | - | (3,049) | - |
| Exercise and subscription of equity instruments | 111,250 | 7,581 | 6 | (5) | - | - | - | 1 |
| Potential capital increase costs(2) | - | - | - | (274) | - | - | - | (274) |
| Shared-based payment | - | - | - | 1,975 | - | - | - | 1,975 |
| June 30, 2019 | 64,043,905 | 14,512 | 3,203 | 301,629 | (134,911) | (1,895) | 13,240 | 181,266 |
| December 31, 2019 | 78,811,114 | 14,507 | 3,941 | 369,617 | (134,912) | (472) | (20,759) | 217,416 |
| Net loss | - | - | - | - | - | - | (10 334) | (10 334) |
| Actuarial gains on defined benefit obligations | - | - | - | - | - | (131) | - | (131) |
| Foreign currency translation loss | - | - | - | - | (48) | 35 | - | (13) |
| Total comprehensive loss for the period | - | - | - | - | (48) | (96) | (10 334) | (10 478) |
| Allocation of prior period income (loss) | - | - | - | - | (20,759) | - | 20,759 | - |
| Exercise and subscription of equity instruments | 87,150 | - | 4 | (1) | - | - | - | - |
| Shared-based payment | - | - | - | 824 | - | - | - | - |
| June 30, 2020 | 78,898,264 | 14,507 | 3,946 | 370,440 | (155,719) | (568) | (10,334) | 207,764 |
| (1) | The interim condensed consolidated statement of changes in shareholders’ equity as June 30, 2019 includes impacts of the first-time application of IFRS 16 that became applicable on January 1, 2019. |
| (2) | In October 2019, Innate Pharma successfully completed its global offering, including its initial public offering on the Nasdaq Global Select Market raising approximately $79.1 million (€71.4 million) ) in gross proceeds (€66.0 million net proceeds) from the sale of American Depositary Shares (ADS) in the United States and a European Private Placement of ordinary shares. The global offering resulted in the issuance of 14,375,000 new ordinary shares, comprising 9,922,227 ADSs, at an offering price of $5.50 per ADS, and 4,452,773 ordinary shares in a concurrent European private placement (including France) at an offering price of €4.97 per ordinary share. Each ADS represents one ordinary share. |
Innate Pharma | Half-year financial report June 30, 2020 | 19 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| F. | Interim Condensed Notes to the Consolidated Financial Statements |
| 1. | The Company and key events |
| 1.1. | The company |
Innate Pharma S.A. (the “Company” and together with its subsidiaries, referred to as the “Group”) is a biotechnology company focused on discovering, developing and commercializing first-in-class therapeutic antibodies designed to harness the immune system for the treatment of oncology indications with significant unmet medical need.
The Company has extensive experience in research and development in immuno-oncology, having been pioneers in the understanding of natural killer cell, or NK cell, biology, and later expanding its expertise in the tumor microenvironment, tumor antigens and antibody engineering fields. The Company has built, internally and through its business development strategy, a broad and diversified portfolio including an approved product, three clinical product candidates and a robust preclinical pipeline. The Company has entered into collaborations with leaders in the biopharmaceutical industry, such as AstraZeneca and Sanofi.
From its inception, the Company has incurred losses due to its research and development (“R&D”) activity.
The six months ended June 30, 2020 generated a €10,334 thousand net loss. As of June 30, 2020, the shareholders’ equity amounted to €207,764 thousand. Subject to potential new milestone payments related to its collaboration agreements, the Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its product candidates in development.
The Company’s future operations are highly dependent on a combination of factors, including: (i) the success of its R&D; (ii) regulatory approval and market acceptance of the Company’s future product candidates; (iii) the timely and successful completion of additional financing; and (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies. As a result, the Company is and should continue, in the short to mid-term, to be financed through partnership agreements for the development and commercialization of its drug candidates and through the issuance of new equity instruments.
The Company’s activity is not subject to seasonal fluctuations.
As of June 30, 2020, the Company had two wholly owned subsidiaries: Innate Pharma, Inc., based in the United States, and Innate Pharma France SAS, based in France
| 1.2. | Key events for the six-month period ended June 30, 2020 |
· On November 22, 2019, AstraZeneca submitted to the European Medicines Agency (EMA) the Marketing Authorization Application (MAA) relating to the commercialization of Lumoxiti in Europe. According to the agreement related to Lumoxiti with AstraZeneca, AstraZeneca is entitled to a $15,000 thousand milestone that was paid by the Company in January 2020. On January 2, 2020, the Company announced that the EMA has accepted the MAA submission for Lumoxiti. The EMA filling acceptance follows the U.S. Food and Drug Administration (FDA) approval of Lumoxiti in September 2018.
· On January 10, 2020, the Company signed an amendment to the lease for the "Le Virage" building in order to expand its premises. This amendment also extends the duration of the contractual commitment. The effective date of this addendum is January 15, 2020. Consequently, and following the application of IFRS 16 standard, the impact on the consolidated financial statements are the following: recognition of a new right-of-use asset of €1,151 thousand and a new lease liability of €1,114 thousand.
· On March 10, 2020, the Company announced the dosing of the first patient on March 9, 2020 in the IPH5201 Phase I clinical trial. AstraZeneca made a $5,000 thousand (€4,365 thousand) milestone payment to Innate under the companies’ October 2018 multi productoncology development collaboration. Innate made a €2,700 thousand milestone payment to Orega Biotech SAS pursuant to Innate’s exclusive licensing agreement.
Innate Pharma | Half-year financial report June 30, 2020 | 20 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 2. | Basis of presentation and statement of compliance |
| 2.1. | Basis of preparation |
The interim condensed consolidated financial statements as of June 30, 2020 and for the six months ended June 30, 2020 and 2019 and the related notes (together, the “interim condensed consolidated financial statements”) have been prepared under the responsibility of the management of the Company in accordance with the underlying assumptions of going concern as the Company’s loss-making situation is explained by the innovative nature of the products developed, therefore involving a multi-year research and development phase.
The interim condensed consolidated financial statements were approved and authorized for issuance by the Executive Board on September 7, 2020. They have been prepared in accordance with IAS 34, ‘Interim Financial Reporting’ as issued by the International Accounting Standard Board (“IASB”).
Due to the listing of ordinary shares of the Company on Euronext Paris and in accordance with the European Union’s regulation No. 1606/2002 of July 19, 2002, the interim condensed consolidated financial statements are also prepared in accordance with IFRS, as adopted by the European Union (EU).
For the presented periods, the differences between IFRS as issued by IASB and IFRS adopted by EU had no impact on the interim condensed consolidated financial statements.
The general accounting conventions were applied in accordance with the underlying assumptions, namely (i) going concern, (ii) permanence of accounting methods from one year to the next and (iii) independence of financial years, and in conformity with the general rules for the preparation and presentation of consolidated financial statements in accordance with International Financial Reporting Standards (“IFRS”). The interim condensed consolidated financial statements do not include all disclosures required for annual financial statements and should therefore be read in conjunction with the consolidated financial statements as of and for the year ended December 31, 2019.
The results of the operations for the six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other interim period or for any year in the future.
Except for number of shares and per share amounts, all amounts are expressed in thousands of euros, unless stated otherwise. Some amounts may be rounded for the calculation of financial information contained in the interim condensed consolidated financial statements. Accordingly, the totals in some tables may not be the exact sum of the preceding figures.
| 2.2. | Use of judgments and estimates |
The preparation of financial statements in accordance with IFRS requires the Company to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period.
These estimates can be revised where the circumstances on which they are based change. The actual results may therefore differ from the estimates initially formulated. The estimates and judgments which are mainly used by the Company are detailed in note 18.2 in paragraph x) of the appendix to the consolidated financial statements as of December 31, 2019 of the Universal Registration Document published on April 24, 2020. Estimates and judgments which impact the condensed consolidated financial statements at June 30, 2020 are: :
| · | accounting for collaboration and licensing agreements (note 6 and 13); |
| · | measurement of the subcontracting costs relating to the clinical trial (note 14); |
| · | estimation of shared development costs and transition costs under the AstraZeneca monalizumab agreement and the AstraZeneca Lumoxiti in-licensing agreement (note 5 and 13); |
| · | estimate of the recoverable amount of the acquired and under progress licenses (note 6); |
| · | estimate of the useful life of the acquired licenses (note 6). |
Innate Pharma | Half-year financial report June 30, 2020 | 21 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 2.3. | Recently issued accounting standards and interpretations |
Application of the following amended standards is mandatory for the first time for the financial period beginning on January 1, 2020 and, as such, they have been adopted by the Company:
· Amendments to IFRS 3 “Definition of a business”, published on October 22, 2018.
· Amendments to IAS 1 and IAS 8 relating to the definition of materiality, published on October 31, 2018.
· Amendments to IAS 39, IFRS 7 and IFRS 9 relating to the interest rate benchmark reform.
· Conceptual framework for financial reporting and modifications to references to conceptual framework in IFRS standards.
Those amended standards have no impact on the interim condensed consolidated financial statements.
Application of the following amended standard is mandatory for the first time for the financial period beginning on June 1, 2020:
· Covid-19-Related Rent Concessions Amendment to IFRS 16
The Company has not early adopted this amendment
| 2.4. | Translation of transactions denominated in foreign currency |
Foreign currency transactions are translated into the presentation currency using the following exchange rates:
| June 30, 2019 | December 31, 2019 | June 30, 2020 | ||||
| €1 equals to | Average rate | Closing rate | Average rate | Closing rate | Average rate | Closing rate |
| USD | 1.1299 | 1.1380 | 1.1195 | 1.1234 | 1.1020 | 1.1198 |
| 3. | Management of financial risks |
The Company did not identify other risks than the ones presented in the consolidated financial statements as of and for the year ended December 31, 2019.
Innate Pharma | Half-year financial report June 30, 2020 | 22 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 4. | Cash, cash equivalents, short-term investments and non-current financial assets |
| (in thousands of euro) | June 30, 2020 | December 31, 2019 |
| Cash and cash equivalents | 131,542 | 202,887 |
| Short-term investments | 16,199 | 15,978 |
| Cash, cash equivalents and short-term investments | 147,741 | 218,865 |
| Non-current financial assets | 36,872 | 37,005 |
| Cash, cash equivalents and financial assets | 184,614 | 255,869 |
Cash and cash equivalents are mainly composed of current bank accounts, interest-bearing accounts and fixed-term accounts.
As of June 30, 2020, the Company also holds units in “SICAVs” and shares in mutual funds. When the maturity of shares in mutual funds is longer than one year, they are classified as non-current financial instruments.
Non-current financial assets generally include a guarantee of capital at the maturity date (which is always longer than one year). These instruments are defined by the Company as financial assets at fair value through profit or loss and classified as non-current due to their maturity.
As of June 30, 2020 and December 31, 2019, the amount of cash, cash equivalents and financials assets denominated in US dollars amounted to €50,380 thousand and €97,688 thousand, respectively.
Changes in short-term investments and non-current financial assets for the six months ended June 30, 2019 and 2020 are the following:
| (in thousands of euro) | December 31, 2019 |
Acquisitions | Disposals | Variance of fair value through the consolidated statement of income (loss) |
Variance of accrued interests |
Foreign currency effect |
June 30, 2020 |
| Short-term investments | 15,978 | - | - | 173 | - | 48 | 16,199 |
| Non-current financial assets | 37,005 | 3,000 | - | (2,709) | (425) | - | 36,872 |
| Total | 52,983 | 3,000 | - | (2,536) | (425) | 48 | 53,071 |
| (in thousands of euro) | December 31, 2018 |
Acquisitions | Disposals | Variance of fair value through the consolidated statement of income (loss) |
Variance of accrued interests |
Foreign currency effect |
June 30, 2019 |
| Short-term investments | 15,217 | - | - | 271 | 90 | 15,578 | |
| Non-current financial assets | 35,181 | - | (2,000) | 2,037 | 101 | - | 35,320 |
| Total | 50,398 | - | (2,000) | 2,308 | 101 | 90 | 50,898 |
In the six months ended June 30, 2020, variance of fair value through the consolidated statement of income (loss) is made of €2,709 thousand of unrealized losses on non-current financial assets and €173 thousand of unrealized gains on short-term investments. In the six months ended June 30, 2019, variance of fair value through the consolidated statement of income (loss) was only made of €2,308 thousand of unrealized gains on short-term investments and non-current financial assets.
Innate Pharma | Half-year financial report June 30, 2020 | 23 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 5. | Trade receivables and others |
| (in thousands of euro) | June 30, 2020 | December 31, 2019 |
| Other receivables | 254 | 544 |
| Accrued receivables excluding rebates related to capital expenditures | 149 | 691 |
| Other tax credits | 333 | 333 |
| Prepaid expenses | 9,308 | 5,403 |
| VAT refund | 2,725 | 1,995 |
| Trade account receivables | 2,601 | 2,816 |
| Prepayments made to suppliers | 577 | 197 |
| Refund to be received | - | - |
| Rebates related to capital expenditures(2) | - | 6,762 |
| Receivables and others | 15,948 | 18,741 |
| Research tax credit(1) | 23,447 | 16,737 |
| Receivables and others - non-current | 23,447 | 16,737 |
| Trade receivables and others excluding rebates related to capital expenditures | 39,394 | 28,716 |
(1) The Research tax credit is recognized as other operating income in the year to which the eligible research expenditure relates. The Company obtained the repayment of the Research tax credit for the tax year 2018 in the amount of €13,503 thousand in July 2019. The CIR for the tax year 2019 amounted to 16,737 thousand. Following the fact that the Company no longer meets the eligibility criteria for the SME status as of December 31, 2019, the CIR for the tax year 2019 will in principle be offset against the French corporate income tax due by the company with respect to the three following years, or refunded if necessary upon expiry of such a period. The Company recorded as of June 30, 2019 an additional Research tax credit for the six months ended June 30, 2020 of €6,710 thousand.
(2) This amount correspond as of December 31, 2019 to a definitive rebate of $7,580 thousand as of December 31, 2019 (estimate of $15,000 thousand or €13,100 thousand as of December 31, 2018 and $12,400 thousand or €10,896 thousand as of June 30, 2019) granted by AstraZeneca in connection with the acquisition of Lumoxiti rights. This amount has been paid in April 2020. This decrease of $ 7,420 thousand (€6,455 thousand) is based on the final cost figures for the 2019 financial year for Lumoxiti and invoiced by AstraZeneca. The carrying amount of the intangible asset has been adjusted accordingly (see note 6).
The net book value of the receivables is considered to be a reasonable approximation of their estimated fair value. Trade receivables and others have payment terms of less than one year. No valuation allowance was recognized on trade receivables and others as the credit risk of each debtor was considered as not significant.
Innate Pharma | Half-year financial report June 30, 2020 | 24 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 6. | Intangible assets |
| (in thousands of euro) | Purchased licenses |
Other intangible assets |
In progress | Total |
| January 1, 2019 | 44,184 | 345 | 40,000 | 84,529 |
| Acquisitions | - | 59 | - | 59 |
| Additional considerations | 9,260(1) | - | - | 9,260 |
| Disposals | - | - | - | - |
| Amortization | (5,769)(2) | (59) | - | (5,828) |
| Transfers | - | (139) | - | (139) |
| June 30, 2019 | 47,675 | 206 | 40,000 | 87,881 |
| January 1, 2020 | 56,851 | 116 | 40,000 | 96,967 |
| Acquisitions | - | 195 | - | 195 |
| Additional considerations | 3,685(3) | - | - | 3,685 |
| Disposals | - | - | - | - |
| Amortization | (5,545)(4) | (86) | - | (5,632) |
| Transfers | - | - | - | - |
| June 30, 2020 | 54,991 | 225 | 40,000 | 95,215 |
| (1) | This amount includes (i) an additional consideration of €7,000 thousand paid to Orega Biotech in June 2019 in relation to the IPH5201 rights, and (ii) the decrease of the estimated rebate granted by AstraZeneca in connection with the acquisition of Lumoxiti rights for an amount of €2,260 thousand (see note 5). |
| (2) | This amount includes the amortization of rights related to the monalizumab (€2,341 thousand), IPH5201 (€2,191 thousands) and Lumoxiti (€1,237 thousand) intangible assets. |
| (3) | This amount includes (i) an addition consideration of €2,685 thousand paid to Orega Biotech in April 2020 (€2,500 thousand) and June 2020 (€185 thousand) in relation to the IPH5201 rights following the first patient dosed in Phase 1 clinical trial in Mars 2020 and; (ii) an amount of €1,000 thousand to be paid to Novo Nordisk A/S following the launch of the first avdoralimab Phase I clinical trial. |
| (4) | This amount includes the amortization of rights related to the monalizumab (€1,686 thousand), IPH5201 (€1,818 thousands) and Lumoxiti (€2,041 thousand) intangible assets. |
Monalizumab rights under the 2014 monalizumab (NKG2A) Novo Nordisk agreement
Since their acquisition, monalizumab rights are amortized on a straight-line basis over the anticipated residual duration of the Phase II trials. The Company estimated that it would be fully amortized by the end of the first half of 2022, compared to end of 2021 as estimated as of December 31, 2019. This change is mainly explained by the lengthening of the duration of certain clinical trials which took place during the first half of 2020.
The net book values of the monalizumab rights were €6,255 thousand and €7,941 thousand as of June 30, 2020 and December 31, 2019, respectively.
IPH5201 (Anti-CD39) rights acquired from Orega Biotech
This asset is amortized on a straight-line basis since November 1, 2018 (corresponding to the effective beginning date of the collaboration) until the date the Company expects to fulfill its commitment (end of fiscal year 2020).
Lumoxiti rights acquired from AstraZeneca under the 2018 AstraZeneca multi-term agreement
The license is amortized on a straight-line basis until July 31, 2031, which corresponds to the expiration of the current composition of matter patent, not including any additional patent extensions or patents. The net book value of the Lumoxiti rights were €45,236 thousand and €47,276 thousand as of June 30, 2020 and December 31, 2019, respectively.
Innate Pharma | Half-year financial report June 30, 2020 | 25 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
The Company applied IAS 36-Impairment of assets and assessed whether there was any indication that an asset may be impaired. The Company estimated the recoverable amount of the Lumoxiti intangible asset using a discounting cash flow model which confirmed that this asset was not impaired. The main following assumptions were used to determine the recoverable amount, based on the cash-flows determined from the commercialization plan and the budget approved by Management:
· A discount rate of 12.3%;
· Assumptions related to selling price increase and sales volume based on the potential market and comparable products;
· Decrease in sales volume applied to the forecasted revenue once the related rights fall off-patent.
· Sensitivity testing regarding these actuarial assumptions and other assumptions such as: discount rate (+/- 1.5 point), selling price (+/- 5%) and decrease in sales volume once the related rights fall off-patent (+/- 5%) were performed. These tests did not reveal any impairment.
| 7. | Property and equipment |
| (in thousands of euro) | Lands and buildings |
Laboratory equipment and other |
In progress | Total | Of which finance leases |
| December 31, 2018 | 3,795 | 6,101 | 320 | 10,216 | 4,923 |
| Impact of first application of IFRS 16(1) | 1,028 | 69 | - | 1,097 | 1,097 |
| January 1, 2019 | 4,823 | 6,170 | 320 | 11,313 | 6,020 |
| Acquisitions | - | 755 | 202 | 957 | - |
| Disposals | - | (13) | - | (13) | - |
| Depreciation | (258) | (740) | - | (998) | (408) |
| Transfers | - | 256 | (117) | 139 | - |
| June 30, 2019 | 4,565 | 6,428 | 405 | 11,398 | 5,612 |
| (in thousands of euro) | Lands and buildings |
Laboratory equipment and other |
In progress | Total | Of which right of use assets(3) |
| January 1, 2020 | 5,356 | 5,947 | 369 | 11,672 | 6,270 |
| Acquisitions | 1,152 | 604 | 129 | 1,885 | 1,152 |
| Disposals | - | (36) | - | (36) | - |
| Depreciation | (342) | (745) | - | (1,087) | (442) |
| Transfers | - | - | - | - | - |
| June 30, 2020 | 6,166 | 5,770 | 498 | 12,434 | 6,980 |
| 8. | Trade payables and others |
| (in thousands of euro) | June 30, 2020 | December 31, 2019 |
| Suppliers (excluding payables related to capital expenditures) | 20,112 | 27 936 |
| Tax and employee-related payables | 5,132 | 6 999 |
| Other payables | 217 | 1 111 |
| Trade payables and others (excluding payables related to capital expenditures) | 25 461 | 36 047 |
| Payables related to capital expenditures | 1,083 | 13 458 |
| Payables and others | 26,544 | 49 504 |
The book value of trade payables and others is considered to be a reasonable approximation of their fair value.
Innate Pharma | Half-year financial report June 30, 2020 | 26 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 9. | Financial liabilities |
| (in thousands of euro) | December 31, 2019 |
Proceeds from borrowing |
Proceeds from lease liabilities (non cash) |
Repayments of borrowings/leases liabilities |
Exchange rate variation (non cash) |
June 30, 2020 |
| BPI PTZI IPH41(1) | 450 | - | - | - | - | 450 |
| Lease liabilities – Real estate property | 418 | - | - | (418) | - | - |
| Property transaction (down-payment) | (74) | - | - | 74 | - | - |
| Lease liabilities – Building "Le Virage" | 1,437 | - | 1,120 | - | - | 2,557 |
| Lease liabilities – Premises Innate Inc. | 496 | - | (3) | 9 | 502 | |
| Lease liabilities – Laboratory equipment | 815 | - | - | (87) | - | 728 |
| Lease liabilities – Vehicles | 37 | - | - | (9) | - | 28 |
| Borrowing – Equipment | 319 | - | - | (27) | - | 292 |
| Borrowing – Building | 14,826 | - | - | (567) | - | 14,259 |
| Total | 18,723 | - | 1,120 | (1,037) | 9 | 18,818 |
| (in thousands of euro) | December 31, 2018 |
Impact of first application of IFRS 16 (non cash) |
January 1, 2019 |
Repayments of borrowings/leases liabilities |
June 30, 2019 |
| BPI PTZI IPH41(1) | 750 | - | 750 | (75) | 675 |
| Lease liabilities – Real estate property | 1,345 | - | 1,345 | (459) | 886 |
| Property transaction (down-payment) | (234) | - | (234) | 80 | (154) |
| Lease liabilities – Building "Le Virage" | - | 1,099 | 1,099 | (142) | 957 |
| Lease liabilities – Laboratory equipment | 987 | - | 987 | (86) | 901 |
| Lease liabilities – Vehicles | - | 69 | 69 | (21) | 48 |
| Borrowing – Equipment | 372 | - | 372 | (26) | 346 |
| Borrowing – Building | 1,300 | - | 1,300 | - | 1,300 |
| Total | 4,522 | 1,168 | 5,690 | (729) | 4,959 |
| (1) | Interest free loan |
Innate Pharma | Half-year financial report June 30, 2020 | 27 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
The table below shows the schedule for the contractual repayment of financial liabilities (being principal and interest payments) as of June 30, 2020:
| (in thousands of euro) | Within 1 year | From 2nd to 5th year included | Over 5 years | Total |
| BPI PTZI IPH41 | 150 | 300 | - | 450 |
| Lease liabilities – Real estate property | - | - | - | - |
| Property transaction (down-payment) | - | - | - | - |
| Lease liabilities – Building "Le Virage" | 475 | 2,233 | - | 2,708 |
| Lease liabilities – Premises Innate Inc | 78 | 360 | 97 | 535 |
| Lease liabilities – Laboratory equipment | 179 | 584 | - | 763 |
| Lease liabilities – Vehicles | 14 | 14 | - | 28 |
| Loans – Equipment | 57 | 228 | 14 | 299 |
| Loans – Building | 1,427 | 5,706 | 8,678 | 15,811 |
| Total financial liabilities | 2,380 | 9,425 | 8,789 | 20,594 |
| 10. | Employee benefit |
Defined benefit obligation
| (in thousands of euro) | June 30, 2020 | December 31, 2019 |
| Allowance for retirement defined benefit | 3,668 | 3,281 |
| Allowance for seniority awards | 487 | 479 |
| Defined benefit obligations | 4,155 | 3,760 |
Amounts recognized in the statement of financial position are determined as follows (in thousand euros):
| As of January 1, 2019 | 3,697 |
| Service cost | 630 |
| Interest costs | 55 |
| Actuarial (gain) / loss | (622) |
| As of December 31, 2019 | 3,760 |
| Service cost | 246 |
| Interest costs | 18 |
| Actuarial (gain) / loss | 131 |
| As of June 30, 2020 | 4,155 |
Discount rates used by the Company to evaluate retirement benefits were based on iBox Corporate AA. They amounted to 0.9% and 1.05% as of June 30, 2020 and December 31, 2019, respectively.
Innate Pharma | Half-year financial report June 30, 2020 | 28 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 11. | Capital |
| 11.1. | Share capital |
The Company manages its capital to ensure that the Company will be able to continue as a going concern while maximizing the return to shareholders through the optimization of the debt and equity balance.
As of June 30, 2020, the Company’s share capital amounted to €3,945,639 divided into (i) 78,898,264 ordinary shares, each with a nominal value of €0.05; (ii) 6,926 “2016” preferred shares, each with a nominal value of €0.05, and (iii) 7,581 “2017” preferred shares, each with a nominal value of €0.05, respectively, fully paid up.
Share capital does not include BSAs, BSAAR, AGAs and AGAPs that have been granted to certain investors or natural persons, both employees and non-employees of the Company, but not yet exercised.
In October 21, 2019 and December 30, 2019, the retention period for the “2016 free preferred shares” has ended. The number of ordinary shares to which the conversion of one preferred share entitle has been determined according to the fulfilment of the performance criteria. Holders of “2016” preferred shares” are entitled to vote at our shareholders’ meetings, to dividends and to preferential subscription rights, on the basis of the number of ordinary shares to which they are entitled if they convert their preferred shares.
The Group issued preferred shares “2017 free preferred shares” which will become convertible into ordinary shares following a vesting period of one year and a retention period of two years if the performance criteria and presence are met at the end of the retention period. The number of ordinary shares to which the conversion of one preferred share will entitle will be determined according to the fulfilment of the performance criteria. During the retention period, holders of the 2017 preferred shares are entitled to vote the general shareholders’ meetings, to dividends and to preferential subscription rights, as if they held the same number of ordinary shares as their number of vested 2017 free preferred shares. The 2017 preferred shares are not transferrable during the retention period except under certain circumstances. After the end of the retention period, holders of all of preferred shares that have not yet converted them into our ordinary shares, are entitled to vote at our shareholders’ meetings, to dividends and to preferential subscription rights, on the basis of the number of ordinary shares to which they are entitled if they convert their preferred shares.
In the six months ended June 30, 2020, a capital increase of €4,358 (including share premium) occurred as a result of:
| · | the Executive Board decision on January 27, 2020, subsequent to the definitive acquisitions of (i) 85,650 free shares granted on January 14, 2019 under the “AGA Employees 2018” plan and (ii) the exercise of 1,500 “2012” BSAAR, to carry out a capital increase of €4,358 and a decrease in share premium of €1,298 , broken down as follows: (i) a creation of 85,650 ordinary shares, with a nominal value of €0.05per share issued free and (ii) a creation of 1,500 ordinary shares, with a nominal value of €0.05, for an issue price of €2.04 per share. |
| 11.2. | Treasury shares |
The Company held 18,575 of its own shares as of June 30, 2020 and December 31, 2019, respectively.
| 11.3. | Share based payments |
The Company has issued BSAs, BSAARs, AGAs and AGAPs as follows:
Innate Pharma | Half-year financial report June 30, 2020 | 29 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| Date | Types | Number of warrants issued as of 06/30/2020 | Number of warrants void as of 06/30/2020 | Number of warrants exercised as of 06/30/2020 | Number of warrants outstanding as of 06/30/2020 | Maximum number of shares to be issued as of 06/30/2020 | Exercise price per share (in €) | |||||||
| Sept. 9, 2011 | BSAAR 2011 | 650,000 | - | 395,000 | 255,000 | 255,000 | 2.04 | |||||||
| May 27, 2013 | BSAAR 2012 | 146,050 | - | 85,950 | 60,100 | 60,100 | 2.04 | |||||||
| July 1, 2015 | BSAAR 2015 | 1,050,382 | 2,720 | 1,940 | 1,045,722 | 1,045,722 | 7.20 | |||||||
| October 21, 2016 | AGAP Management 2016-1 | 2,000 | 550 | - | 1,450 | 188,500 | - | |||||||
| October 21, 2016 | AGAP Employees 2016-1 | 2,486 | 251 | 5 | 2,230 | 289,900 | - | |||||||
| October 21, 2016 | AGA Management 2016-1 | 50,000 | - | 50,000 | - | - | - | |||||||
| December 30, 2016 | AGAP Management 2016-2 | 3,000 | - | - | 3,000 | 333,000 | - | |||||||
| December 30, 2016 | AGA Management 2016-2 | 250,000 | - | 250,000 | - | - | - | |||||||
| April 3,2018 | AGAP Employees 2017-1 | 5,725 | 652 | - | 5,073 | 507,300 | - | |||||||
| April 3,2018 | AGAP Management 2017-1 | 2,400 | 800 | - | 1,600 | 160,000 | - | |||||||
| April 3,2018 | AGA Employees 2017 | 114,500 | 4,000 | 110,500 | - | - | - | |||||||
| July 3, 2018 | AGA Bonus 2018-1 | 67,028 | 469 | 66,559 | - | - | - | |||||||
| November 20, 2018 | AGAP Perf Employees 2018-1 | 327,500 | 37,500 | - | 290,000 | 290,000 | - | |||||||
| November 20, 2018 | AGAP Perf Management 2018-1 | 260,000 | 60,000 | - | 200,000 | 200,000 | - | |||||||
| January 14, 2019 | AGA Employees 2018 | 90,650 | 5,000 | 86 | 0 | 0 | - | |||||||
| April 29, 2019 | AGA New Members 2017-1 | 25,000 | - | - | 25,000 | 25,000 | - | |||||||
| July 3, 2019 | AGA Bonus 2019-1 | 57,376 | - | - | 57,376 | 57,376 | - | |||||||
| November 4, 2019 | AGAP Perf Employees 2019 | 546,700 | 41,100 | - | 505,600 | 505,600 | - | |||||||
| November 4, 2019 | AGAP Perf Management 2019 | 355,000 | 30,000 | - | 325,000 | 325,000 | - | |||||||
| July 29, 2011 | BSA 2011-2 | 225,000 | - | 158,060 | 66,940 | 66,940 | 1.77 | |||||||
| July 17, 2013 | BSA 2013 | 237,500 | - | 191,140 | 46,360 | 46,360 | 2.36 | |||||||
| July 16, 2014 | BSA 2014 | 150,000 | - | 75,000 | 75,000 | 75,000 | 8.65 | |||||||
| April 27, 2015 | BSA 2015-1 | 70,000 | - | - | 70,000 | 70,000 | 9.59 | |||||||
| July 1, 2015 | BSA 2015-2 | 14,200 | - | - | 14,200 | 14,200 | 14.05 | |||||||
| September 20, 2017 | BSA 2017 | 37,000 | - | - | 37,000 | 37,000 | 11.00 | |||||||
| Total au 30/06/2020 | 4,739,497 | 183,042 | 1,469,804 | 3,086,651 | 4,551,998 | 0 |
Innate Pharma | Half-year financial report June 30, 2020 | 30 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 12. | Financial instruments recognized in the statement of financial position and related effect on the income statement |
The following tables show the carrying amounts and fair values of financial assets and financial liabilities. The tables do not include fair value information for financial assets and financial liabilities not measured at fair value if the carrying amount is a reasonable approximation of fair value.
| As of June 30, 2020 (in thousands of euro) |
Book value on the statement of financial position | Fair value through profit and loss (1) | Amortized cost(2) | Fair value |
| Financial assets | ||||
| Non-current financial assets | 36,872 | 36,872 | - | 36,872 |
| Trade receivables and others | 39,394 | - | 39,394 | 39,394 |
| Short-term investments | 16,199 | 16,199 | - | 16,199 |
| Cash and cash equivalents | 131,542 | 131,542 | - | 131,542 |
| Total financial assets | 224,008 | 184,613 | 39,394 | 224,008 |
| Financial liabilities | ||||
| Financial liabilities—non-current portion | 16,781 | - | 16,781 | 16,781 |
| Financial liabilities—current portion | 2,035 | - | 2,035 | 2,035 |
| Trade payables and others | 26,544 | - | 26,544 | 26,544 |
| Total financial liabilities | 45,361 | - | 45,361 | 45,361 |
| As of December 31, 2019 (in thousands of euro) |
Book value on the statement of financial position | Fair value through profit and loss (1) | Amortized cost(2) | Fair value |
| Financial assets | ||||
| Non-current financial assets | 37,005 | 37,005 | - | 37,005 |
| Trade receivables and others | 35,477 | - | 35,477 | 35,477 |
| Short-term investments | 15,978 | 15,978 | - | 15,978 |
| Cash and cash equivalents | 202,887 | 202,887 | - | 202,887 |
| Total financial assets | 291,347 | 255,869 | 35,477 | 291,347 |
| Financial liabilities | ||||
| Financial liabilities—non-current portion | 16,593 | - | 16,593 | 16,593 |
| Financial liabilities—current portion | 2,130 | - | 2,130 | 2,130 |
| Trade payables and others | 49,504 | - | 49,504 | 49,504 |
| Total financial liabilities | 68,227 | - | 68,227 | 68,227 |
(1) The fair value of financial assets classified as fair value through profit and loss corresponds to the market value of the assets, which are primarily determined using level 2 measurements.
(2) The book amount of financial assets and liabilities measured at amortized cost was deemed to be a reasonable estimation of fair value.
Innate Pharma | Half-year financial report June 30, 2020 | 31 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 13. | Revenue and government financing for research expenditures |
| 13.1. | Revenue from collaboration and licensing agreements |
The Company’s revenue from collaboration and licensing agreements amounts to €29,841 thousand and €51,588 thousand for the six-month periods ended June 30, 2020 and 2019 respectively.
| (in thousands of euro) | June 30, 2020 | June 30, 2019 |
| Proceeds from collaboration and licensing agreements | 28,349 | 46,770 |
| of which monalizumab agreement | 19,636 | 24,293 |
| of which IPH5201 agreement | 8,713 | 22,478 |
| Invoicing of R&D costs (IPH5201 and avdoralimab agreements) | 1,090 | 4,418 |
| Exchange gains on collaboration agreement | 403 | 400 |
| Revenue from collaboration and licensing agreements | 29,841 | 51,588 |
a) Revenue recognition related to monalizumab AZ agreements and amendments
Change in deferred revenue relating to monalizumab agreement:
| (in thousands of euro) | Total |
| As of December 31, 2018 | 104,925 |
| Revenue for the six months ended June 30, 2019 | (24,293) |
| Transfer from / (to) collaboration liabilities | 210 |
| As of June 30, 2019 | 80,844 |
| As of December 31, 2019 | 62,657 |
| Revenue for the six months ended June 30, 2020 | (19,636) |
| Transfer from / (to) collaboration liabilities | (3,055) |
| As of June 30, 2020 | 39,966 |
Change in collaboration liabilities relating to monalizumab agreement:
| (in thousands of euro) | Total |
| As of December 31, 2018 | 31,656 |
| Additions | - |
| Deductions | (3,818) |
| As of June 30, 2019 | 27,838 |
| As of December 31, 2019 | 21,304 |
| Additions | 3,055 |
| Deductions | (12,347) |
| As of June 30, 2020 | 12,012 |
Innate Pharma | Half-year financial report June 30, 2020 | 32 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
b) Revenue recognition related to IPH5201 AstraZeneca collaboration and option agreement
Change in deferred revenue relating to IPH5201 agreement
| (in thousands of euro) | Total |
| As of December 31, 2018 | 27,869 |
| Revenue for the six months ended June 30, 2019 | (22,478) |
| As of June 30, 2019 | 5,391 |
| As of December 31, 2019 | 9,053 |
| Revenue for the six months ended June 30, 2020 | (8,713) |
| Increase in deferred revenue resulting from the $5M milestone relating to the dosage of the first Phase I patient dosed(1) | 4,365 |
| As of June 30, 2020 | 4,705 |
(1) See Note 1.2
The increase in deferred revenue between June 30 and December 31, 2019 results from the extension by one year of the contribution of Innate Pharma to the development works. The recognition of the initial payment was revise accordingly.
c) Schedule of variance of deferred revenue
| (in thousands of euro) | As of December 31, 2019 | Recognition in P&L | Proceeds | Transfer from / (to) collaboration liabilities | As of June 30, 2020 |
| Monalizumab | 62,657 | (19,636) | - | (3,055) | 39,966 |
| IPH5201 | 9,054 | (8,713) | 4,365 | - | 4,706 |
| Preclinical molecules | 17,400 | - | - | - | 17,400 |
| Total | 89,111 | (28,349) | 4,365 | (3,055) | 62,072 |
| (in thousands of euro) | As of December 31, 2018 | Recognition in P&L | Transfer from / (to) collaboration liabilities | As of June 30, 2019 |
| Monalizumab | 104,925 | (24,293) | 210 | 80,842 |
| IPH5201 | 27,869 | (22,478) | - | 5,392 |
| Preclinical molecules | 17,400 | - | - | 17,400 |
| Total | 150,195 | (46,770) | 210 | 103,636 |
| 13.2. | Government financing for research expenditures |
The Company receives grants from the European Commission, French government and state organizations in several different forms:
| · | Research Tax Credits; and |
| · | Investment and operating grants. |
As of June 30, 2020, estimate of the amount of research tax credit for the first half period is calculated on the basis of eligible expenses in the period. However, since the fiscal year 2015, the Company reached the limitation relating to the eligible subcontracting costs.
As of June 30, 2020 and 2019, a limitation representing 50% of the annual limitation was applied.
The total amount for government financing for research expenditures recorded as other income in the income statement can be analysed as follows:
Innate Pharma | Half-year financial report June 30, 2020 | 33 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| (in thousands of euro) | June 30, 2020 | June 30, 2019 |
| Research tax credit | 6,733 | 7,494 |
| Grant | 171 | 73 |
| Government financing for research expenditures | 6,904 | 7,567 |
| 14. | Operating expenses |
| (in thousands of euro) | June 30, 2020 | June 30, 2019 | ||||
| R&D | SG&A | Total | R&D | G&A | Total | |
| Subcontracting costs(1) | (14,394) | - | (14,394) | (19,471) | - | (19,471) |
| Cost of supplies and consumable materials | (1,865) | - | (1,865) | (1,673) | - | (1,673) |
| Personnel expenses other than share-based compensation | (7,644) | (5,989) | (13,633) | (7,165) | (2,778) | (9,943) |
| Share-based compensation | (377) | (447) | (824) | (643) | (1,332) | (1,975) |
| Personnel expenses | (8,021) | (6,436) | (14,457) | (7,808) | (4,111) | (11,918) |
| Non-scientific advisory and consulting(2) | (20) | (4,109) | (4,129) | (54) | (2,332) | (2,386) |
| Leasing and maintenance | (408) | (665) | (1,073) | (447) | (473) | (920) |
| Travel expenses and meeting attendance | (145) | (128) | (273) | (367) | (316) | (682) |
| Marketing, communication and public relations | (70) | (725) | (795) | (47) | (259) | (307) |
| Scientific advisory and consulting(3) | (140) | - | (140) | (256) | - | (256) |
| Other purchases and external expenses | 190 | (911) | (722) | 96 | (694) | (597) |
| Depreciation and amortization | (6,145) | (574) | (6,718) | (6,348) | (478) | (6,826) |
| Intellectual property expenses | (122) | (398) | (520) | (180) | (468) | (648) |
| Other income and (expenses), net | (358) | (545) | (904) | (30) | (164) | (193) |
| Total operating expenses | (31,499) | (14,490) | (45,989) | (36,584) | (9,295) | (45,879) |
| (1) | The Company subcontracts a significant part of its pre-clinical (pharmaceutical development, tolerance studies and other model experiments, etc.) and clinical operations (coordination of trials, hospital costs, etc.) to third parties. Associated costs are recorded in subcontracting on the basis of the level of completion of the clinical trials. |
| (2) | Non-scientific advisory and consulting are services performed to support the selling, general and administration activities of the Company, such as legal, accounting and audit fees as well as business development support. |
| (3) | Scientific advisory and consulting expenses relate to consulting services performed by third parties to support the research and development activities of the Company. |
| 14.1. | Personnel expenses other than share-based compensation |
The line item amounted to €13,633 thousand and €9,943 thousand for the six months ended June 30, 2020 and 2019 respectively. The Company had 247 employees at June 30, 2020, compared to 206 at June 30, 2019.
| 14.2. | Depreciation and amortization |
The line item is mainly composed of the amortization of the monalizumab, IPH5201 and Lumoxiti intangible assets (see Note 6).
Innate Pharma | Half-year financial report June 30, 2020 | 34 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 14.3. | Cost of suppliers and consumable materials |
Cost of supplies and consumable materials consists mainly of the cost of procurement of the Company’s drug substance and/or drug product that is manufactured by third-parties, respectively.
| 15. | Net income / (loss) from distribution agreements |
During the transition period which will end on September 30, 2020, Lumoxiti products are commercialized in the US by AstraZeneca who is the owner of the regulatory approval. The Company concluded that it did not meet the criteria for being principal under IFRS 15. Consequently, the net result resulting from all Lumoxiti marketing’s operations is disclosed in the item line “Net income / (loss) from distribution agreements.”
The Company recognized a €896 thousand net gain and a €3,820 thousand net loss for the six months ended June 30, 2020 and 2019, respectively, corresponding to production and marketing costs, net of sales proceeds, as invoiced by AstraZeneca in relation to Lumoxiti distribution agreement for the period.
| 16. | Net financial loss |
Net financial loss can be analyzed as follows:
| (in thousands of euro) | June 30, 2020 | June 30, 2019 |
| Interests on financial assets | 343 | 893 |
| Change in valuation allowance on financial instruments | 173 | 2,309 |
| Foreign exchange gains | 1,929 | 2,511 |
| Other financial income | 1 | 5 |
| Financial income | 2,446 | 5,717 |
| Foreign exchange losses | (1,545) | (1,888) |
| Unrealized losses on financial assets | (2,712) | - |
| Interest on financial liabilities | (173) | (45) |
| Other financial expenses | (1) | - |
| Financial expenses | (4,431) | (1,933) |
| Net financial income (loss) | (1,986) | 3,784 |
For the six months ended June 30, 2020 and 2019, the foreign exchange gains and losses mainly result from the variance of the exchange rate between the Euro and the US dollar on US dollars denominated cash and cash equivalent and financial assets accounts.
| 17. | Income tax / (expense) |
Due to the Company’s early stage of development, it is not probable that future taxable profit will be available against which the unused tax losses can be utilized. As a consequence, deferred tax assets are recognized up to deferred tax liabilities.
The Company did not recognize a current tax expense as at June 30, 2020 regarding a projected tax rate of nil as of December 31, 2020.
As of June 30, 2020, the accumulated tax losses carryforwards of Innate Pharma SA and Innate Pharma France SAS were €231,167 thousand with no expiration date (same amount as of December 31, 2019). As of June 30, 2020, the accumulated tax losses carryforwards of Innate Pharma Inc. was €5,114 thousand, or $5,727 thousand, (same amounts as of December 31, 2019), with a 20-year period expiration.
For the six months ended June 30, 2018, the Company opted for the carry back mechanism which gave rise to a €333 thousand tax credit tax
Innate Pharma | Half-year financial report June 30, 2020 | 35 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 18. | Commitments, contingencies and litigation |
| 18.1. | Commitments |
The Company has identified the following changes in off-balance sheet commitments since December 31, 2019:
· non-cancellable purchase commitments as of June 30, 2020 for a total of €1,995 thousand with various CMOs.
| 18.2. | Contingencies and litigations |
The Company is exposed to contingent liabilities relating to legal actions before the labor court or intellectual property issues happening in the ordinary course of its activities. Each pre-litigation, known litigation or procedure in course the Company is involved in is analyzed at each closing date after consultation of legal counsel. There is no acknowledged litigation as of June 30, 2020.
| 18.3. | Provisions |
Provisions amounted to €433 thousand and €256 thousand as of June 30, 2020 and December 31, 2019, respectively. They consisted mainly of the employer contribution in respect of the grants of employee equity instruments and provision for employee severance pay. In accordance with IFRS 2, when a Company decides to provide its employees with shares bought back on the market, a provision has to be recognized upon the decision to allocate free shares that are spread over the vesting period.
| 19. | Related party transactions |
Members of the Executive Board and Other Executive Members
For each of the period presented, the following compensation was granted to the members of the Executive Committee of the Company and were recognized as expense:
| (in thousands of euro) | June 30, 2020 | June 30, 2019 |
| Personnel and other short-term employee benefits | 1,461 | 1,159 |
| Extra pension benefits | - | 12 |
| Share-based compensation | 336 | 1,174 |
| Executive Board Members and other Executive Members compensation | 1,797 | 2,345 |
Odile Laurent was appointed as members of the Other Executive Members on January 22, 2020 as human resources director.
Personnel and other short-term employee benefits correspond to amounts included in personnel expenses for the six-month periods ended June 30, 2002 and 2019 respectively.
Members of the Supervisory Board
The Company recognized a provision of €143 thousand for attendance fees (jetons de presence) relating to the six months ended June 30, 2020. This amount includes the compensation for the Chairman of the Supervisory Board.
Related parties
Novo Nordisk A/S is a shareholder, Supervisory Board member and is related to the Company by three licensing agreements related to the drug-candidates lirilumab, monalizumab and avdoralimab. Under the terms of the agreements, Novo Nordisk A/S is eligible to receive milestone payments as well as royalties on future sales. As of June 30, 2020, the Company has no liability to Novo Nordisk A/S.
AstraZeneca is a shareholder and is related to the Company through several collaboration and option licensing or license agreements for different drug candidates (monalizumab, avdoralimab, IPH5201 and preclinical molecules) and a license agreement for the rights of the drug Lumoxiti. The payments between the two companies as well as the liabilities and receivables as of June 30, 2019 are as follows:
Innate Pharma | Half-year financial report June 30, 2020 | 36 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| As of June 30,2020 | ||
| (in thousands of euro) | Payments | Assets/Liabilities |
| Collection (AstraZeneca to the Company) / Receivables | 14,467 | 2,596 |
| Payments (the Company to AstraZeneca) / Liabilities | (33,298) | (7,132) |
| Total(1) | (18,831) | (4,537) |
(1) In addition, the Company recognized in the income statement a net Income of €896 thousand as net result from distribution agreements linked to Lumoxiti (see Note 15) and an R&D expense of €1,797 thousand.
BPI is a board member and has granted the Company a €1,500 thousand interest free loan (Prêt à Taux Zéro Innovation, or “PTZI”). This loan will be reimbursed starting September 2016 over a 5-year period.
Subsidiaries
The business relationships between the Company and its subsidiaries are governed by intra-group and commercial agreements, concluded at market standard conditions on an arm’s length basis.
| 20. | Income / (loss) per share |
| 20.1. | Basic income / (loss) per share |
Basic income / (loss) per share are calculated by dividing the net earnings attributable to equity holders of the Company by the weighted average number of ordinary shares in issue during the period.
| In thousands of euro, except for data share | June 30, 2020 | June 30, 2019 |
| Net income/(loss) | (10,334) | 13,240 |
| Weighted average number of ordinary shares in circulation | 78,892,031 | 63,987,582 |
| Basic income/(loss) per share (€ per share) | (0.13) | 0.21 |
| 20.2. | Diluted income / (loss) per share |
Diluted income (loss) per share is calculated by dividing the net income (loss) attributable to equity holders of the Company by the weighted average number of ordinary shares in circulation during the corresponding period, increased by all dilutive potential common shares.
| In thousands of euro, except for data share | June 30, 2020 | June 30, 2019 |
| Net income/(loss) | (10,334) | 13,240 |
| Weighted average number of ordinary shares in circulation | 78,892,031 | 63,987,582 |
| Adjustment for share instruments | 1,523,324 | 1,368,600 |
| Diluted income/(loss) per share (€ per share) | (0.13) | 0.20 |
Innate Pharma | Half-year financial report June 30, 2020 | 37 |
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2020 |
Interim Condensed Notes to the Consolidated Financial Statements |
| 21. | Events after the reporting date |
· On July 9, 2020, the Company filed authorization requests with the regulatory authorities for an extension of the IPH2201-203 clinical trial. This trial will be part of the monalizumab collaboration with AstraZeneca.
· On July 13, 2020, the Executive Board granted free shares to members of the management (“AGA Bonus Management 2020-1” and “AGA Bonus Management 2020-2”).
· On July 13, 2020, subsequent to the definitive acquisitions 57,376 free shares granted on July 3, 2019, under the “AGA Bonus Management 2019-1” plan and the exercise of 25,000 “2011-2” BSA , to carry out a capital increase of €4,119 and an increase in share premium of €43,000, that can be broken down as follows: (i) a creation of 57,376 ordinary shares, with a nominal value of €0.05 issued free of charge by deduction from the issue premium, and (ii) a creation of 25,000 ordinary shares, with a nominal value of €0.05, for an issue price of €1.77 per share.
On July 16, 2020, the Company announced the departure of Pierre Dodion, Chief Medical Officer, and the nomination of Joyson Karakunnel.
· On July 21, 2020, the Executive Board granted 102,000 stock options to members of the management and employees of the subsidiary Innate Pharma Inc ("2020-1 Incentive Stock Options").
· On August 5 2020, the Executive Board granted 769,202 free performances shares to employees of the Company (“AGA Perf Employees 2020-1”), and 710,000 free performances shares to members of the management (“AGA Perf Management 2020-1”).
· On August 11, 2020, the Company announced that it has obtained funding signed a financing contract with BPIfrance Financement as part of the program established by the French government to support the development of therapeutic solutions with a preventative or curative aim for COVID-19. This funding, in a maximum aggregate amount of €6.8 million, consists of (i) an advance reimbursable only upon technical and commercial success and (ii) a non-reimbursable grant. This funding will be received in four consecutive tranches. The first tranche of €1.7m was received at signing, and the three remaining tranches will be received upon achievement of certain clinical milestones, particularly around the FORCE Phase 2 trial.
· On September 7, 2020, the Company signed an amendment to the monalizumab collaboration and license agreement concluded with AstraZeneca in 2015. Following review of longer patient follow-up and maturing survival data from Cohort 2, and following discussions with AstraZeneca, the Company has agreed to amend the agreement. It will now receive a $50 million payment upon AstraZeneca’s dosing of the first patient in the Phase 3 trial, and a $50 million payment after the interim analysis demonstrates the combination meets a pre-defined threshold of clinical activity1. All other potential development and commercial milestones related to the agreement remains unchanged. The Company is planning to present updated and longer term Cohort 2 data at a future scientific conference. The Phase 3 trial evaluating monalizumab is expected to commence in the second half of 2020.
____________________________
1 Amended from the initially agreed $100M milestone due upon dosing of the first patient at initiation.
Innate Pharma | Half-year financial report June 30, 2020 | 38 |
STATUTORY AUDITORS' REVIEW REPORT ON THE HALF-YEARLY FINANCIAL INFORMATION |
|
STATUTORY AUDITORS' REVIEW REPORT ON THE HALF-YEARLY FINANCIAL INFORMATION
To the Shareholders of INNATE PHARMA,
In compliance with the assignment entrusted to us by your Annual General Meeting and in accordance with the requirements of article L. 451-1-2-III of the French Monetary and Financial Code ("code monétaire et financier"), we hereby report to you on:
| · | the review of the accompanying condensed half-yearly consolidated financial statements of Innate Pharma, for the period from January 1 to June 30, 2020, |
| · | the verification of the information presented in the half-yearly management report. |
These half-year condensed consolidated financial statements were prepared under the responsibility of the Executive Board on September 7, 2020 on the basis of the information available at that date in the evolving context of the crisis related to Covid-19 and of difficulties in assessing its impact and future prospects. Our role is to express a conclusion on these financial statements based on our review.
Conclusion on the financial statements
We conducted our review in accordance with professional standards applicable in France. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with professional standards applicable in France and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the accompanying condensed half-yearly consolidated financial statements are not prepared, in all material respects, in accordance with IAS 34, the IFRS standard as adopted by the European Union applicable to interim financial information.
Specific verification
We have also verified the information presented in the half-yearly management report commenting the condensed half-yearly consolidated financial statements subject to our review prepared on September 7, 2020. We have no matters to report as to its fair presentation and consistency with the condensed half-yearly consolidated financial statements.
Marseille, September 7, 2020
The Statutory Auditors
| Audit Conseil Expertise SAS | Deloitte & Associés |
| Membre de PKF International | |
| Guy CASTINEL | St éphane MENARD |
Innate Pharma | Half-year financial report June 30, 2020 | 39 |
|
DECLARATION BY THE PERSON RESPONSIBLE FOR THIS HALF-YEAR FINANCIAL REPORT |
|
DECLARATION BY THE PERSON RESPONSIBLE FOR THIS HALF-YEAR FINANCIAL REPORT
I hereby declare, to the best of my knowledge, that the condensed consolidated interim financial statements for the six months ended June 30, 2020 have been prepared in accordance with applicable accounting standards and give a true and fair view of the assets, liabilities, financial position and results of the Company and the subsidiaries included in the consolidation, and that the half year management reviews stated on page 5 gives a fair description of the material events that occurred in the first six months of the financial year and their impact on the interim financial statements, as well as a description of the principal risks and uncertainties for the remaining six months of the year, along with the principal transactions with related parties.
Chairman of the Executive Board
Mr Mondher Mahjoubi
Innate Pharma | Half-year financial report June 30, 2020 | 40 |
INVESTOR RELATIONS
investors@innate-pharma.com
