I.CERTIFICATION OF THE PERSON RESPONSIBLE FOR THE HALF-YEAR FINANCIAL REPORT
“I hereby certify that, to my knowledge, the condensed financial statements for the six-month period ended June 30, 2022 were prepared in accordance with applicable accounting principles and give a fair view of assets, financial position and results of the Company and all companies included in the scope of consolidation, and the half-year business report attached provides an accurate picture of the significant events during the first six months of the financial year, of their impact on the half-year financial statements, of the major transactions with related parties as well as a description of the main risks and uncertainties for the remaining six months of the financial year.”
Lyon, September 12, 2022
Gil BEYEN
Chief Executive Officer
II.BUSINESS REPORT
2.1MAJOR EVENTS OF THE PERIOD
Business
February 2022: Impact of the Conflict in Ukraine on Our Business
Beginning on February 24, 2022, Russia significantly intensified its military operations in Ukraine.
In response, the United States, the European Union and certain other countries have imposed significant sanctions and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations.
The United States, the European Union and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions should the conflict continue or worsen. To date, we have not experienced any material impact on our business, operations and clinical development timelines and plans. However, we cannot predict the specific extent, duration, or impact that the conflict in Ukraine and the related sanctions and export controls will have on our financial condition and operations.
We are closely monitoring developments in the current context and will take appropriate measures as necessary. The war in Ukraine did not impact our financial results for the period ended on June 30, 2022. Our business does not conduct any trial in Ukraine, Russia or Belarus and does not have any vendors located in these regions.
April 2022:
•Sale of ERYTECH’s U.S. cell therapy manufacturing facility to Catalent
In April 22, 2022, the Erytech Group has entered into an Asset Purchase Agreement ("APA") with Catalent. Under the terms of the deal, Catalent agreed to acquire ERYTECH’s state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for a total gross consideration of $44.5 million (€40.7 million) paid at the transaction closing. Catalent has extended offers of employment to approximately 40 people employed by Erytech at the Princeton facility.The sale of the facility resulted in a net gain on disposal of €24.4 million. The gain on the sale of ERYTECH’s U.S. cell therapy manufacturing facility to Catalent triggered an estimated income tax expense for ERYTECH’s U.S. subsidiary of €.3.7 million which was booked at June 30, 2022.
The parties also entered into an interim supply agreement, under which Catalent will manufacture ERYTECH’s lead product candidate eryaspase (GRASPA®) for clinical and commercial supply in the United States.
•New vesiculation technology
The company presented its red blood cell vesiculation technology at the 24th Meeting of the European Red Cell Society (ERCS) in April 2022.
May 2022:
•The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology annual meeting. See section 2.2. – activities of the Group and 2.5 - events after the reporting period for further information.
•Following the Catalent transaction, the company continues to evaluate other strategic options for leveraging its ERYCAPS® platform with complementary assets and/or a broader corporate transaction.
•On May 25, 2022, the management of Erytech Pharma (France) informed the employees of the start of a collective redundancy procedure, a job protection plan, involving the cuts of 52 positions out of 109. The consultation phase of the CSE has ended on July 31, 2022. The first departures could take place in October 2022.
2.2ACTIVITIES OF THE GROUP
Leveraging our proprietary ERYCAPS® platform, which uses a novel technology to encapsulate therapeutic drug substances inside erythrocytes, or red blood cells, or RBCs, we are developing a pipeline of product candidates for patients with high unmet medical needs. Our lead product candidate eryaspase, which we also refer to as GRASPA®, targets the metabolism of cancer cells by depriving them of asparagine, an amino acid necessary for their survival and critical in maintaining the cells’ rapid growth rate.
We are developing eryaspase for the treatment of patients with severe forms of cancer, currently focusing on pancreatic cancer and triple negative breast cancer, or TNBC.
Since 2017, we have supported a Phase 2 clinical trial initiated and sponsored by investigators of the Nordic Society of Pediatric Hematology and Oncology, or NOPHO. This trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia, or ALL patients, who developed hypersensitivity reactions to prior asparaginase treatment or silent inactivation to pegylated L-asparaginase. In December 2020, positive results from the trial were presented at the American Society of Hematology 2020 Annual Meeting. The trial was conducted at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. The main objectives of the trial were the activity and safety of eryaspase. Both objectives were met. A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021 after which we confirmed our intention to submit a BLA, subject to successful completion of remaining activities, which included the submission of additional information to the FDA, responses to additional data requests, and the submission of the Initial Pediatric Study Plan (iPSP). We submitted our iPSP in July 2022 and received feedback from the FDA in August 2022. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape, we decided to halt the BLA process of seeking approval.
In 2018, we initiated a pivotal Phase 3 clinical trial of eryaspase for the treatment of second-line advanced pancreatic cancer patients. Patient enrollment in this trial, which we refer to as the TRYbeCA-1 trial, began in September 2018 in Europe. We have obtained clinical trial authorizations in the United States and from 11 European Union countries and have conducted the clinical trial at close to 90 clinical sites. In April 2020, the FDA, granted eryaspase Fast Track Designation as a potential second-line treatment for patients with metastatic pancreatic cancer. Eryaspase has also received orphan drug designation for pancreatic cancer in both the United States and Europe. We completed the patient enrollment in the TRYbeCA-1 trial in December 2020. A total of 512 patients participated in the trial, slightly above the target enrollment of 482 patients. We reported top-line final results on October 25, 2021. The Phase 3 TRYbeCA-1 trial did not meet the primary efficacy endpoint of overall survival (OS).
Following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April 2022, we appointed a specialized advisor to evaluate strategic options to leverage our ERYCAPS® platform with complementary assets and/or a broader corporate transaction. Multiple options are under review, and we expect to give further updates on these strategic initiatives in the fourth quarter of this year.
We are continuing to support a Phase 1 investigator-sponsored clinical trial, or IST, which we refer to as the rESPECT trial, evaluating the safety of eryaspase in combination with modified FOLFIRINOX for the treatment of first-line advanced pancreatic cancer patients. The Georgetown Lombardi Comprehensive Cancer Center is the sponsor of this trial. We announced the enrollment of the first patient in this trial in January 2021 and following evaluation of treatment response after two treatment cohorts, we announced in October 2021 the determination of the maximum tolerated dose. In January 2022, encouraging data from the study were presented at the American Society of Clinical Oncology (ASCO GI) Gastrointestinal Cancers Symposium, The trial has now completed enrollment, with 19 patients in the study, and reporting of final data is expected in the second half of 2022.
We launched a proof-of-concept Phase 2 clinical trial in TNBC in the European Union, which we refer to as the TRYbeCA-2 trial, in the fourth quarter of 2018. Following the publication of the negative results of the TRYbeCA-1 study, and with a goal of reducing costs and preserving cash flow, it has been announced in November 2021 that recruitment of new patients in this study will be stopped. In September 2022, TRYbeCA-2 trial’s Steering Committee met to review the results of the 25 evaluable patients. No clinical benefit was demonstrated, which could be attributed to the immature closure of the trial and the small number of patients. The treatment was well tolerated.
In addition to the encapsulation of L-asparaginase, we believe that our ERYCAPS® platform has broad potential application and can be used to encapsulate a wide range of therapeutic agents for which long-circulating therapeutic activity or rapid and specific targeting is desired. For example, we developed erymethionase, a preclinical product candidate which encapsulates methionine-γ-lyase in RBCs and is designed to target the amino acid metabolism of cancer cells and induce tumor starvation. We intend to continue to work on the development of erymethionase as well as potential other therapeutic strategies based on methionine depletion if appropriate financial resources can be secured. We have also developed two preclinical programs aimed at maximizing the value creation potential of our ERYCAPS® program, which we believe may result in attractive partnering opportunities: enzyme replacement and immune modulation. As part of our value creation strategy, in June 2019, we entered into a collaboration with SQZ Biotechnologies, a cell therapy company developing novel treatments in multiple therapeutic areas, to focus on the development of novel red blood cell-based therapeutics for the treatment of immuno-oncology and tolerance induction.
Finally, we presented our red blood cell vesiculation technology at the 24th Meeting of the European Red Cell Society (ERCS) in April 2022. RBC-derived extracellular vesicles are formed naturally during senescence and storage of mature RBCs and are a potentially attractive drug delivery system. Vesiculation of RBCs that have already been loaded with active therapeutic compounds utilizing the ERYCAPS® process, entails the potential of producing cargo-loaded RBC-derived extracellular vesicles for the development of novel therapeutic approaches.
2.3RESULTS
Operating income
To date, we have not generated any revenue from the sale of our products given our stage of development.
| | | | | | | | | | | | | | |
(in thousands of €) | | FOR THE SIX MONTHS ENDED JUNE 30, |
| | 2021 | | 2022 |
Research Tax Credit | | 2,132 | | | 860 | |
Subsidies | | 41 | | | 40 | |
Revenues from licenses or other contracts | | 97 | | | 54 | |
Net gain on disposal of tangible assets | | — | | | 24,351 | |
Operating income | | 2,270 | | | 25,304 | |
The reduction of €1,272K between the first half of 2022 and the same period in 2021 in the Research Tax Credit is related to the end of the TRYbeCA1 clinical trial.
The gain on the disposal of fixed assets relate to the sale of the Princeton plant to Catalent and break down as follows:
–Proceeds from the sale of €40,676k ($44,500k);
–The net book value of fixed assets of €(15,677)k ($(17,150)k);
–The net book value of the rights of use for €(3,022)k ($(3,307)k);
–The cancellation of the lease obligation for €5,419k ($5,928k);
–Transaction costs of €(3,046)k ($(3,333)k)
Operating expenses
Our research and development expenses are broken down as follows:
| | | | | | | | | | | | | | | | | | | | |
(in thousands of €) | | FOR THE SIX MONTHS ENDED JUNE 30, | | CHANGE |
| | 2021 | | 2022 | |
ERYASPASE | | 9,722 | | | 3,029 | | | (69 | %) |
ERYMETHIONASE | | 24 | | | — | | | (100 | %) |
IMMUNOTHERAPIES | | — | | | — | | | — | % |
ENZYME THERAPIES | | — | | | — | | | — | % |
Direct research and development expenses | | 9,746 | | | 3,029 | | | (69 | %) |
Consumables | | 1,111 | | | 269 | | | (76 | %) |
Rental and maintenance | | 748 | | | 831 | | | 11 | % |
Services, subcontracting and consulting fees | | 1,237 | | | 1,245 | | | 1 | % |
Personnel expenses | | 8,179 | | | 8,281 | | | 1 | % |
Depreciation and amortization expense | | 2,160 | | | 3,620 | | | 68 | % |
Other | | 28 | | | 24 | | | (14 | %) |
Indirect research and development expenses | | 13,463 | | | 14,270 | | | 6 | % |
Research and development expenses | | 23,209 | | | 17,300 | | | (25 | %) |
The decrease in research and development expenses is mainly related to the end of the treatment of patients in the Phase 3 study in pancreatic cancer (TRYbeCA1) for €5,798K.The decrease in personnel expenses is explained by the takeover by Catalent of the Princeton plant and the personnel required for its operation.
The personnel expense includes a €1,859K restructuring charge, €1691K for R&D and €168K for G&A, (refer to note 1 and 4.6 to the interim condensed consolidated financial statements).
The depreciation and amortization includes a €2,108K impairment charge for the facilities, fixtures, equipment and rights of use of the Adenine production unit in France (refer to notes 4.1 and 4.2 to the interim condensed consolidated financial statements).
Our general and administrative expenses are broken down as follows:
| | | | | | | | | | | | | | | | | | | | | |
| | FOR THE SIX MONTHS ENDED JUNE 30, | | CHANGE |
(in thousands of €) | | 2021 | | 2022 | |
Consumables | | 94 | | | 57 | | | (39 | %) | |
Rental and maintenance | | 578 | | | 175 | | | (70 | %) | |
Services, subcontracting, and consulting fees | | 3,292 | | | 3,446 | | | 5 | % | |
Personnel expenses | | 3,307 | | | 3,288 | | | (1 | %) | |
Depreciation and amortization expense | | 333 | | | 669 | | | 101 | % | |
Other | | 423 | | | 277 | | | (35 | %) | |
General and administrative expenses | | 8,027 | | | 7,911 | | | (1 | %) | |
The increase in net depreciation and provisions at June 30, 2022 is related to the €369K impairment charge for Bioserra office right of use in France (refer to notes 4.2 to the interim condensed consolidated financial statements).
The personnel expense at June 30, 2022 includes a €168K restructuring charge.
Financial income (loss)
| | | | | | | | | | | | | | |
(in thousands of €) | | FOR THE SIX MONTHS ENDED JUNE 30, |
| | 2021 | | 2022 |
Financial income | | 2,807 | | | 3,370 | |
Financial expenses | | (1,791) | | | (750) | |
Financial income (loss) | | 1,016 | | | 2,620 | |
Our financial income (loss) is mainly comprised of:
•Net foreign exchange gains of €1,436 thousand in 2021 and €2,868 thousand in 2022. The increase is due to an appreciation in the U.S. dollar against the euro over the periods presented;
•Income of €750K related to the change in fair value of derivative liabilities related to the convertible bonds and warrants from the drawdown of the three OCABSA tranches in the first half of 2021. There were no such income in 2022 in the absence of new drawdown and conversion of OCABSA
•Expense of €919 thousand related to the amortized cost of convertible notes in connection with the drawdown of the three OCABSA tranches in the first half of 2021. There were no such expense in 2022 in the absence of new drawdown and conversion of OCABSA
Cash flows
Our cash and cash equivalents were €53.3 million as of June 30, 2022 compared to €33.7 million as of December 31, 2021, representing a net increase in cash of €19.6 million during the first half of 2022 against an increase of €1.9 million during the same period in 2021.
| | | | | | | | | | | |
| FOR THE SIX MONTHS ENDED JUNE 30, |
(in thousands of €) | 2021 | | 2022 |
Net cash flows used in operating activities | (32,613) | | | (20,694) | |
Net cash flows from (used in) investing activities | (274) | | | 37,947 | |
Net cash flows from (used in) financing activities | 34,056 | | | 1,988 | |
Exchange rate effect on cash in foreign currency | 708 | | | 399 | |
Net increase (decrease) in cash and cash equivalents | 1,877 | | | 19,640 | |
The strong decrease in cash consumption from operating activities, with a reduction of €11,919k over the periods presented, is due to the combination of
•A decrease in operating expenses of €7,964k, This decrease is due to the completion of the pancreatic cancer clinical trial (TRYbeCA1 for €7.1m).
•A decrease in working capital of €3,955k, mainly due to the time lag between the recognition of hospital costs and the receipt of invoices for €2,071k and a decrease in CIR receivables of €1,155k.
During the first half of 2022, cash flows from investing activities are primarily related to the net proceed of €37.6m received in connection with the disposal of the Princeton plant.
During the first half of 2022, no capital increase was completed. There were no new OCABSA tranches drawn and therefore no bond conversions.
2.4PROGRESS AND OUTLOOK
In the second half of 2022, we will continue to focus on our late-stage clinical and preclinical development programs, and expect to report the following key milestones:
•Results of the Phase 2 clinical trial with eryaspase in TNBC.
•Top-line results of the RESPECT Phase 1 clinical trial with eryaspase in first-line pancreatic cancer.
•Update on ongoing strategic partnering activities.
2.5EVENTS AFTER THE CLOSE OF THE REPORTING PERIOD
August 2022:
•ERYTECH is no longer seeking approval for Graspa® in hypersensitive acute lymphoblastic leukemia (ALL) following feedback from the U.S. Food and Drug Administration (FDA).
•Following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April 2022, the Company appointed a specialized advisor to evaluate strategic options to leverage its ERYCAPS® platform with complementary assets and/or a broader corporate transaction. Multiple options are under review, and the Company expects to give further updates on these strategic initiatives in the fourth quarter of this year.
September 2022:
•On September 2, 2022 the restructuring plan (PSE) was formally approved by the French State department of labour (DREETS).
•In September 2022, TRYbeCA-2 trial’s Steering Committee met to review the results of the 25 evaluable patients. No clinical benefit was demonstrated, which could be attributed to the immature closure of the trial and the small number of patients. The treatment was well tolerated.
2.6TRANSACTIONS WITH RELATED PARTIES
Transactions with related parties are consistent with those set out in items 6.B “Compensation” and 7.B “Related party transactions” of the Company’s Annual Report on Form 20- F for the year ended December 31, 2021 filed with the United States Securities and Exchange Commission (“SEC”) on April 27, 2022 (the “2021 Annual Report”).
The remuneration of directors and other members of the executive committee is disclosed in the note 5 of the Company’s unaudited interim condensed consolidated financial statements.
2.7RISK FACTORS
The risks and uncertainties likely to have a significant impact on the Company’s financial situation and results are consistent with those set out in Item 3.D “Risk factors” of the Annual Report on Form 20- F filed with the SEC on April 27, 2022. The halt of the
submission process of the BLA dossier for ALL with the FDA, announced by the Company on August 24, 2022, is expected to further increase the risk for the Company of not being able to secure appropriate funding for its future developments.
III. UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2022
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF INCOME (LOSS)
| | | | | | | | | | | | | | | | | |
(Amounts in thousands of euros, except loss per share) | | | 06/30/2021 | | 06/30/2022 |
Notes | | (6 months) | | (6 months) |
Revenues | | | — | | | — | |
Other income | 3.1 | | 2,270 | | | 25,304 | |
Operating income | | | 2,270 | | | 25,304 | |
Research and development | 3.2.1 | | (23,209) | | | (17,300) | |
General and administrative | 3.2.2 | | (8,027) | | | (7,911) | |
Operating expenses | | | (31,236) | | | (25,211) | |
Operating loss | | | (28,966) | | | 93 | |
Financial income | 3.4 | | 2,807 | | | 3,370 | |
Financial expenses | 3.4 | | (1,791) | | | (750) | |
Financial income (loss) | | | 1,016 | | | 2,620 | |
Income tax | 3.5 | | (2) | | | (3,737) | |
Net loss | | | (27,952) | | | (1,024) | |
Basic / Diluted loss per share (€/share) | 3.6 | | (1.22) | | | (0.03) | |
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (LOSS)
| | | | | | | | | | | | | | | | | |
| | | 06/30/2021 | | 06/30/2022 |
(Amounts in thousands of euros) | | | (6 months) | | (6 months) |
Net loss | | | (27,952) | | | (1,024) | |
Elements that may be reclassified subsequently to income (loss) | | | | | |
Currency translation adjustment | | | (153) | | | 66 | |
Elements that may not be reclassified subsequently to income (loss) | | | | | |
Remeasurement of defined benefit liabilities | | | 42 | | | 224 | |
Other comprehensive income (loss) | | | (111) | | | 290 | |
Comprehensive income (loss) | | | (28,063) | | | (734) | |
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| | | | | | | | | | | | | | | | | |
| | | As of |
(Amounts in thousands of euros) | Notes | | December 31, 2021 | | June 30, 2022 |
ASSETS | | | | | |
Non-current assets | | | | | |
Intangible assets | | | 15 | | | 8 | |
Property, plant and equipment | 4.1 | | 18,960 | | | 1,014 | |
Right of use | 4.2 | | 6,869 | | | 2,641 | |
Other non-current assets | | | 876 | | | 205 | |
Total non-current assets | | | 26,720 | | | 3,868 | |
Current assets | | | | | |
Trade and other receivables | 4.3 | | 12 | | | 306 | |
Other current assets | 4.3 | | 6,337 | | | 8,474 | |
Cash and cash equivalents | 4.4 | | 33,699 | | | 53,339 | |
Total current assets | | | 40,048 | | | 62,119 | |
TOTAL ASSETS | | | 66,768 | | | 65,987 | |
| | | | | |
| | | As of |
(Amounts in thousands of euros) | Notes | | December 31, 2021 | | June 30, 2022 |
LIABILITIES AND SHAREHOLDERS' EQUITY | | | | | |
Shareholders’ equity | | | | | |
Share capital | | | 3,102 | | | 3,102 | |
Premiums related to share capital | | | 97,618 | | | 48,975 | |
Reserves | | | (25,293) | | | (29,897) | |
Translation reserve | | | 1,215 | | | 1,281 | |
Net loss for the period | | | (53,797) | | | (1,024) | |
Total shareholders’ equity | 4.5 | | 22,845 | | | 22,436 | |
Non-current liabilities | | | | | |
Provisions - non-current portion | | | 524 | | | 248 | |
Financial liabilities – non-current portion | 4.7 | | 15,232 | | | 12,762 | |
Lease liabilities - non-current portion | 4.8 | | 8,162 | | | 2,980 | |
Total Non-current liabilities | | | 23,918 | | | 15,990 | |
Current liabilities | | | | | |
Provisions - current portion | 4.6 | | — | | | 1,859 | |
Financial liabilities – current portion | 4.7 | | 164 | | | 5,774 | |
Lease liabilities - current portion | 4.8 | | 1,817 | | | 1,027 | |
Trade and other payables | 4.9 | | 14,154 | | | 11,994 | |
Other current liabilities | 4.9 | | 3,870 | | | 6,907 | |
Total current liabilities | | | 20,005 | | | 27,561 | |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | | | 66,768 | | | 65,987 | |
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW
| | | | | | | | | | | | | | | | | |
| | | 06/30/2021 | | 06/30/2022 |
(Amounts in thousands of euros) | Notes | | (6 months) | | (6 months) |
Cash flows from operating activities | | | | | |
Net loss | | | (27,952) | | | (1,024) | |
Non-cash expenses (income) | | | | | |
Gain or loss on exchange | | | (1,436) | | | (2,743) | |
Amortization and depreciation | | | 2,494 | | | 4,289 | |
Provision | | | 71 | | | 1,807 | |
Change in fair value of derivative liabilities | | | (750) | | | — | |
Expenses related to share-based payments | 3.3 | | 707 | | | 326 | |
Net (Gain) or loss on disposal of tangible assets | | | — | | | (24,351) | |
Interest expense (income) | 3.4 | | 1,182 | | | 242 | |
Income tax expense (income) | | | 2 | | | 3,737 | |
Operating cash flow before change in working capital | | | (25,682) | | | (17,717) | |
(Increase) decrease in trade and other receivables | 4.3 | | (10) | | | (278) | |
(Increase) decrease in other current assets | 4.3 | | (2,686) | | | 720 | |
Increase (decrease) in trade and other payables | 4.8 | | (3,639) | | | (2,351) | |
Increase (decrease) in other current liabilities | 4.8 | | (594) | | | (1,065) | |
Change in working capital | | | (6,929) | | | (2,974) | |
Income tax paid | | | (2) | | | (3) | |
Net cash flow used in operating activities | | | (32,613) | | | (20,694) | |
Cash flows from investing activities | | | | | |
Acquisition of property, plant and equipment | | | (146) | | | (7) | |
Increase in non-current & current financial assets | | | (130) | | | (5) | |
Disposal of property, plant and equipment | | | — | | | 37,630 | |
Decrease in non-current & current financial assets | | | 2 | | | 329 | |
Net cash flow used in investing activities | | | (274) | | | 37,947 | |
Cash flows from financing activities | | | | | |
Capital increases, net of transaction costs | 4.5 | | 29,320 | | | — | |
Proceeds from borrowings, net of transaction costs | 4.6 | | 5,712 | | | 3,088 | |
Repayment of lease liability (IFRS 16) | 4.7 | | (830) | | | (907) | |
Interests received (paid) | | | (146) | | | (193) | |
Net cash flow from (used in) financing activities | | | 34,056 | | | 1,988 | |
Exchange rate effect on cash in foreign currency | | | 708 | | | 399 | |
Increase (Decrease) in cash and cash equivalents | | | 1,877 | | | 19,640 | |
Net cash and cash equivalents at the beginning of the period | 4.4 | | 44,446 | | | 33,699 | |
Net cash and cash equivalents at the closing of the period | 4.4 | | 46,323 | | | 53,339 | |
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(Amount in thousands of euros, except number of shares) | Share capital | | Premiums related to the share capital | | Reserves | | Translation reserve | | Net (income) loss | | Total shareholders’ equity |
As of December 31, 2020 | 2,006 | | | 120,705 | | | (24,616) | | | 1,744 | | | (73,300) | | | 26,539 | |
Net loss for the period | | | | | | | | | (27,952) | | | (27,952) | |
Other comprehensive income | | | | | 42 | | | (153) | | | | | (111) | |
Total comprehensive income (loss) | — | | | — | | | 42 | | | (153) | | | (27,952) | | | (28,063) | |
Allocation of prior period loss | | | (71,037) | | | (2,263) | | | | | 73,300 | | | — | |
Issue of ordinary shares | 638 | | | 39,196 | | | | | | | | | 39,834 | |
Transaction costs | | | (2,655) | | | | | | | | | (2,655) | |
Share-based payment | | | | | 707 | | | | | | | 707 | |
As of June 30, 2021 | 2,644 | | | 86,209 | | | (26,130) | | | 1,591 | | | (27,952) | | | 36,362 | |
| | | | | | | | | | | |
As of December 31, 2021 | 3,102 | | | 97,618 | | | (25,293) | | | 1,215 | | | (53,797) | | | 22,845 | |
Net loss for the period | | | | | | | | | (1,024) | | | (1,024) | |
Other comprehensive income | | | | | 224 | | | 66 | | | | | 290 | |
Total comprehensive income (loss) | — | | | — | | | 224 | | | 66 | | | (1,024) | | | (734) | |
Allocation of prior period loss | | | (48,643) | | | (5,154) | | | | | 53,797 | | | — | |
Share-based payment | | | | | 326 | | | | | | | 326 | |
As of June 30, 2022 | 3,102 | | | 48,975 | | | (29,897) | | | 1,281 | | | (1,024) | | | 22,436 | |
NOTES TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The notes are an integral part of the accompanying unaudited interim condensed consolidated financial statements. The unaudited interim condensed consolidated financial statements were approved and authorized for issuance by the Board of Directors of the Company on September 8, 2022.
1.DESCRIPTION OF THE BUSINESS
ERYTECH Pharma S.A. (“ERYTECH” and together with its subsidiary the “Company”) is incorporated in Lyon, France, and was founded in 2004 to develop and market innovative red blood cell-based therapeutics for cancer and orphan diseases.
The Company completed its initial public offering on Euronext Paris in May 2013, raising €17.7 million, and on the Nasdaq Global Select Market in November 2017, raising €124.0 million ($144.0 million) on a gross basis before deducting offering expenses.
The Company has incurred losses and negative cash flows from operations since its inception and had shareholders’ equity of €22,436 thousand as of June 30, 2022 as a result of several financing rounds, including an initial public offering. 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 research and development ; (ii) regulatory approval and market acceptance of the Company’s proposed future products; (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 debt or equity instruments.
The situation on the financial markets, the negative TRYBeCA-1 study result reported in the fourth quarter of 2021 and the announcement that the Company is no longer seeking approval for Graspa® in hypersensitive ALL (see section 2.8 – post-balance sheet event) may impair the ability of the Company to raise capital when needed or on attractive terms.
In the above context and following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April 2022 (see below), the Company appointed a specialized advisor to evaluate strategic options to leverage its ERYCAPS® platform with complementary assets and/or a broader corporate transaction. Multiple options are under review, and the Company expects to give further updates on these strategic initiatives in the fourth quarter of this year.
The accompanying unaudited interim condensed consolidated financial statements and related notes (the “Unaudited Interim Condensed Consolidated Financial Statements”) present the operations of ERYTECH Pharma S.A. and its subsidiary, ERYTECH Pharma, Inc.
Major events of the first half of 2022
Business
February 2022: Impact of the Conflict in Ukraine on Our Business
Beginning on February 24, 2022, Russia significantly intensified its military operations in Ukraine.
In response, the United States, the European Union and certain other countries have imposed significant sanctions and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations.
The United States, the European Union and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions should the conflict continue or worsen. To date, we have not experienced any material impact on our business, operations and clinical development timelines and plans. However, we cannot predict the specific extent, duration, or impact that the conflict in Ukraine and the related sanctions and export controls will have on our financial condition and operations.
We are closely monitoring developments in the current context and will take appropriate measures as necessary. The war in Ukraine did not impact our financial results for the period ended on June 30, 2022. Our business does not conduct any trial in Ukraine, Russia or Belarus and does not have any vendors located in these regions.
April 2022:
•Sale of ERYTECH’s U.S. cell therapy manufacturing facility to Catalent
In April 2022, the Group Erytech has entered into an Asset Purchase Agreement ("APA") with Catalent. Under the terms of the deal, Catalent agreed to acquire ERYTECH’s state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for a total gross consideration of $44.5 million (€40.7 million) paid at the transaction closing which occurred on April 22, 2022. Catalent has extended offers of employment to approximately 40 people employed by Erytech at the Princeton facility.The sale of the facility resulted in a net gain on disposal of €24.4 million. The gain on the sale of ERYTECH’s U.S. cell therapy manufacturing facility to Catalent triggered an estimated income tax expense for ERYTECH’s U.S. subsidiary of €3.7 million which was booked at June 30, 2022.
The parties also entered into an interim supply agreement, under which Catalent will manufacture ERYTECH’s lead product candidate eryaspase (GRASPA®) for clinical and commercial supply in the United States.
•New vesiculation technology
The company presented its red blood cell vesiculation technology at the 24th Meeting of the European Red Cell Society (ERCS) in April 2022.
May 2022:
•The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology annual meeting. See 2.8 - Events after the close of reporting period for further information.
•Following the Catalent transaction, the company continues to evaluate other strategic options for leveraging its ERYCAPS® platform with complementary assets and/or a broader corporate transaction.
•On May 25, 2022, the management of Erytech Pharma (France) informed the employees of the start of a collective redundancy procedure, a job protection plan, involving the cuts of 52 positions out of 109. The consultation phase of the CSE ended on July 31, 2022. The first departures could take place in October 2022. See 4.6 – provision for risks and charges.
2.ACCOUNTING RULES AND METHODS
2.1.Basis of preparation
The Interim Condensed Consolidated Financial Statements have been prepared 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 Company has historically financed its growth by strengthening its equity in the form of capital increases and issuance of convertible bonds.
The Board of Directors has prepared the financial statements on a going concern basis, as the Company has the necessary means to finance its activities for at least 12 months after the closing date, taking into account the following items:
–53.3 million in cash and cash equivalents held by the Company as of June 30, 2022, consisting mainly of cash and term deposits that can be drawn down immediately without penalty,
–Cash consumption forecasts for the 12 months following the closing date.
In the longer term, the Company will have to find additional funds. In this context the Company appointed a specialized advisor to evaluate strategic options to leverage its ERYCAPS® platform with complementary assets and/or a broader corporate transaction.
The condensed consolidated interim financial statements have been prepared under the historical cost convention with the exception of certain categories of assets and liabilities measured at fair value in accordance with IFRS.
Unless otherwise indicated, all amounts are presented in thousands of euros.
2.2.Statement of compliance
The Condensed Consolidated Financial Statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standard Board (“IASB”) and were approved and authorized for issuance by the Board of Directors of the Company on September 8, 2022.
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 Unaudited Interim Condensed Consolidated Financial Statements of the Company are also prepared in accordance with IAS 34, Interim financial reporting, as adopted by the European Union (EU).
As of June 30, 2022, all IFRS that the IASB had published and that are mandatory are the same as those adopted by the EU and mandatory in the EU. As a result, the Unaudited Interim Condensed Consolidated Financial Statements comply with International Financial Reporting Standards as published by the IASB and as adopted by the EU.
As condensed financial statements, they do not include all information that would be required by the full IFRS standards. They must be read in conjunction with the consolidated financial statements for the year ended December 31, 2021.
The standards applied in the preparation of the Condensed Consolidated Financial Statements are the same as those applied to prepare the financial statements as of December 31, 2021.
The new applicable standards, amendments and interpretations since January 1, 2022 have had no significant impact on the Company’s interim condensed consolidated financial statements.
Recently issued accounting pronouncements that may be relevant to the Company’s operations are as follows:
•Amendments to IAS 1 - Classification of liabilities as current or non-current;
•Amendments to IAS 8 - Definition of Accounting Estimates ;
•Amendments to IAS 12 - Deferred Tax related to Assets and Liabilities arising from a Single Transaction ;
The Company does not expect any significant impact resulting from the future adoption of these standards
2.3Scope of consolidation
Details of the Company’s subsidiary as of June 30, 2022 are as follows:
| | | | | | | | | | | | | | | | | |
| Date of incorporation | | Percent of ownership interest | | Accounting method |
ERYTECH Pharma, Inc. | April 2014 | | 100% | | Consolidated |
There was no change in the scope of consolidation during the period.
2.4Foreign currencies
Functional Currency and Translation of Financial Statements into Presentation Currency
The Unaudited Interim Condensed Consolidated Financial Statements are presented in euros, which is also the functional currency of the parent company, ERYTECH Pharma S.A..
The exchange rates used for the translation of the financial statements of ERYTECH Pharma, Inc. are as follows:
| | | | | | | | | | | | | | | | | |
Exchange rate (USD per EUR) | 06/30/2021 | | 12/31/2021 | | 06/30/2022 |
Weighted average rate | 1.2057 | | 1.1835 | | 1.0940 |
Closing rate | 1.1884 | | 1.1326 | | 1.0387 |
2.5Use of estimates and judgments
The preparation of the Unaudited Interim Condensed Consolidated Financial Statements in accordance with the rules prescribed by the IFRS requires the use of estimates and the formulation of assumptions having an impact on the financial statements. 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 main areas of estimates are described in the annual consolidated financial statements.
The use of estimates and judgements relates mainly to the valuation of :
•share-based payments in accordance with IFRS 2;
•Accrued expenses for hospital costs;
•Income tax expense;
•Recoverable value of right of use and tangible fixed asset in France.
2.6Presentation of the statement of income (loss)
The Company presents its statement of income (loss) by function. As of today, the main activity of the Company is research and development. Consequently, only research and development expenses and general administrative expenses functions are considered to be representative of the Company's activity. This distinction reflects the analytical assignment of the personnel, external expenses and depreciation and amortization. The detail of the expenses by nature is disclosed in note 3.2.
2.7Segment reporting
In accordance with IFRS 8 “Operating Segments”, reporting by operating segment is derived from the internal organization of the Company’s activities; it reflects management’s viewpoint and is established based on internal reporting used by the chief operating decision maker (the Chief Executive Officer) to allocate resources and to assess performance.
Information per operating segment
The Company operates in a single operating segment: the conducting of research and development of innovative red blood cell-based therapeutics for cancer and orphan diseases in order to market them in the future.
Information per geographical segment
| | | | | | | | | | | |
Revenues from external customers (amounts in thousands of euros) | 06/30/2021 | | 06/30/2022 |
| (6 months) | | (6 months) |
France | — | | | — | |
United States | 97 | | | 54 | |
Total | 97 | | | 54 | |
2.8Events after the close of the reporting period
August 2022:
•ERYTECH is no longer seeking approval for Graspa® in hypersensitive acute lymphoblastic leukemia (ALL) following feedback from the U.S. Food and Drug Administration (FDA).
•Following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April 2022, the Company appointed a specialized advisor to evaluate strategic options to leverage its ERYCAPS® platform with complementary assets and/or a broader corporate transaction. Multiple options are under review, and the Company expects to give further updates on these strategic initiatives in the fourth quarter of this year.
September 2022:
•On September 2, 2022 the restructuring plan (PSE) was formally approved by the French State department of labour (DREETS-DDETS).
•In September 2022 TRYbeCA-2 trial’s Steering Committee met to review the results of the 25 evaluable patients. No clinical benefit was demonstrated, which could be attributed to the immature closure of the trial and the small number of patients. The treatment was well tolerated.
3.NOTES RELATED TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF INCOME (LOSS)
3.1Operating income
The Company does not generate any revenue from the sale of its products considering its stage of development.
| | | | | | | | | | | |
(amounts in thousands of euros) | 06/30/2021 | | 06/30/2022 |
| (6 months) | | (6 months) |
Research Tax Credit | 2,132 | | | 860 | |
Subsidies | 41 | | | 40 | |
Revenues from licenses or other contracts | 97 | | | 54 | |
Net gain on disposal of tangible assets | — | | 24,351 |
Total | 2,270 | | | 25,304 |
The reduction in the research tax credit is related to the end of the TRYbeCA1 clinical trial.
The net gain from the disposal of fixed assets is related to the sale of the Princeton plant to Catalent and breaks down as follows :
–Proceeds from the sale of €40,676k ($44,500k);
–The net book value of fixed assets of €(15,677)k ($(17,150)k);
–The net book value of the rights of use for €(3,022)k ($(3,307)k);
–The cancellation of the lease obligation for €5,419k ($5,928k);
–Transaction costs of €(3,046)k ($(3,333)k)
3.2Operating expenses by nature
3.2.1Research and development expenses
| | | | | | | | | | | | | | | | | |
For the six months ended June 30, 2021 (amounts in thousands of euros) | R&D | | Clinical studies | | Total |
Consumables | 82 | | | 2,114 | | | 2,196 | |
Rental and maintenance | 77 | | | 675 | | | 752 | |
Services, subcontracting and fees | 312 | | | 9,581 | | | 9,893 | |
Personnel expenses | 1,045 | | | 7,134 | | | 8,179 | |
Depreciation, amortization & provision | 177 | | | 1,983 | | | 2,160 | |
Other | — | | | 29 | | | 29 | |
Total | 1,693 | | | 21,516 | | | 23,209 | |
| | | | | | | | | | | | | | | | | |
For the six months ended June 30, 2022 (amounts in thousands of euros) | R&D | | Clinical studies | | Total |
Consumables | — | | | 450 | | | 450 | |
Rental and maintenance | 66 | | | 765 | | | 831 | |
Services, subcontracting and fees | 237 | | | 3,850 | | | 4,087 | |
Personnel expenses | 785 | | | 7,577 | | | 8,362 | |
Depreciation, amortization & provision | 178 | | | 3,443 | | | 3,621 | |
Other | 7 | | | (58) | | | (51) | |
Total | 1,273 | | | 16,027 | | | 17,300 | |
The decrease in research and development expenses is mainly due to a decrease in services, related to the end of the treatment of patients in the clinical trial in pancreatic cancer for €5,798K. The costs of the contract research organization (CRO) decreased by €3,177K and hospital costs decreased by €1,752K. There is also a decrease in consumables of €1,015K linked to the end of this study.
The personnel expense at June 30, 2022 includes a €1,691K restructuring charge (refer to note 1 and 4.6).
The depreciation and amortization includes a €2,108K impairment charge for the facilities, fixtures, equipment and rights of use of the Adenine production unit in France (refer to notes 4.1 and 4.2).”
3.2.2General and administrative expenses
| | | | | | | | | | | |
(amounts in thousands of euros) | 06/30/2021 | | 06/30/2022 |
| (6 months) | | (6 months) |
Consumables | 94 | | | 57 | |
Rental and maintenance | 578 | | | 175 | |
Services, subcontracting and fees | 3,292 | | | 3,446 | |
Personnel expenses | 3,307 | | | 3,288 | |
Depreciation and amortization | 333 | | | 669 | |
Other | 423 | | | 277 | |
Total | 8,027 | | | 7,911 | |
The increase in net depreciation and provisions at June 30, 2022 is related to a €369k impairment charge for Bioserra office right of use in France (refer to notes 4.2).
The personnel expense at June 30, 2022 includes a €168K restructuring charge.
3.3Personnel expenses
3.3.1Research and development expenses
| | | | | | | | | | | | | | | | | |
For the six months ended June 30, 2021 (amounts in thousands of euros) | R&D | | Clinical studies | | Total |
Wages and salaries | 700 | | | 5,256 | | | 5,956 | |
Share-based payments (employees and executives) | 55 | | | 295 | | | 350 | |
Social security expenses | 290 | | | 1,583 | | | 1,873 | |
Total personnel expenses | 1,045 | | | 7,134 | | | 8,179 | |
| | | | | | | | | | | | | | | | | |
For the six months ended June 30, 2022 (amounts in thousands of euros) | R&D | | Clinical studies | | Total |
Wages and salaries | 533 | | | 4,618 | | | 5,151 | |
Share-based payments (employees and executives) | 17 | | | (27) | | | (10) | |
Social security expenses | 235 | | | 1,295 | | | 1,530 | |
Restructuring charge | — | | | 1,691 | | 1,691 |
Total personnel expenses | 785 | | | 7,577 | | | 8,362 | |
The weighted average full-time employees (FTE) was 155 during the first half of 2021 and 117 during the first half of 2022.The decrease in FTE is mainly related to the disposal of the Princeton plant.
3.3.2General and administrative expenses
| | | | | | | | | | | |
(amounts in thousands of euros) | 06/30/2021 | | 06/30/2022 |
| (6 months) | | (6 months) |
Wages and salaries | 2,140 | | | 2,051 | |
Share-based payments (employees and executives) | 311 | | | 304 | |
Social security expenses | 856 | | | 766 | |
Restructuring charge | 0 | | | 168 | |
Total personnel expenses | 3,307 | | | 3,288 | |
The weighted average full-time employees (FTE) was 41 during the first half of 2021 and 32 during the first half of 2022.
3.3.3 Share-based payments (IFRS 2)
Stock-options (“SO”) plan
No new plans were created during the first half of 2022. and no new grants under plans from the prior year.
Free shares (“AGA”) plan
No new plans were created during the first half of 2022, and no new grants under plans from the prior year.
Breakdown of expenses
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Plan name | | Amount in P&L in euros thousands as of June 30, 2021 | | of which employees | | of which executives | | of which directors |
AGA | | 308 | | | 120 | | | 47 | | | — | |
BSA | | 1 | | | — | | | — | | | 29 | |
SO | | 398 | | | 46 | | | 142 | | | — | |
Total | | 707 | | | 166 | | | 512 | | | 29 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Plan name | | Amount in P&L in euros thousands as of June 30, 2022 | | of which employees | | of which executives | | of which directors |
AGA | | 202 | | | 31 | | | 171 | | | — | |
BSA | | — | | | — | | | — | | | — | |
SO | | 124 | | | 53 | | | 71 | | | — | |
Total | | 326 | | | 84 | | | 242 | | | — | |
As of June 30, 2022, the outstanding equity instruments could lead to the issuance of 2,227,125 potential shares.
3.4Financial income (loss)
| | | | | | | | | | | |
(amounts in thousands of euros) | 06/30/2021 | | 06/30/2022 |
| (6 months) | | (6 months) |
Income from short term deposits | 11 | | | 6 | |
Change in fair value of derivative liabilities | 750 | | | — | |
Foreign exchange gains | 1,993 | | | 3,348 | |
Other financial income | 53 | | | 16 | |
Financial income | 2,807 | | | 3,370 | |
Amortized cost of convertible notes | (919) | | | (22) | |
Financial expenses on lease liability | (156) | | | (108) | |
Interest expense related to borrowings | (158) | | | (140) | |
Foreign exchange loss | (557) | | | (480) |
Other financial expenses | (1) | | | — | |
Financial expenses | (1,791) | | | (750) | |
Financial income (loss) | 1,016 | | | 2,620 | |
3.5 Income tax
In June 2022 an estimation of the Income tax related to the Princeton facility sale was recorded for € (3,737)k , $ (4,086)k.
3.6Basic earnings per share and diluted earnings (loss) per share
| | | | | | | | | | | |
| 06/30/2021 | | 06/30/2022 |
| (6 months) | | (6 months) |
Net loss (in thousands of euros) | (27,952) | | | (1,024) | |
Weighted number of shares for the period (1) | 22,842,857 | | | 31,016,053 | |
Basic loss per share (€/share) | (1.22) | | | (0.03) | |
Diluted loss per share (€/share) | (1.22) | | | (0.03) | |
(1)after deduction of treasury shares (2,500 shares are held by the Company as treasury shares and recognized as a deduction of shareholders’ equity).
4.NOTES RELATED TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
4.1Property, plant and equipment
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(amounts in thousands of euros) | General equipment, fixtures and fittings | | Plant, equipment and tooling | | Office equipment and computers | | Assets under construction | | Advance payment | | TOTAL |
GROSS VALUE | | | | | | | | | | | |
As of December 31, 2021 | 22,090 | | | 5,916 | | | 1,117 | | | 112 | | | — | | | 29,235 | |
Increase | | | 79 | | | | | 3 | | | | | 82 | |
Decrease | (19,862) | | | (2,070) | | | (383) | | | (54) | | | | | (22,369) | |
FX rate impact | 690 | | | 165 | | | 15 | | | 2 | | | | | 872 | |
Reclassification | | | (17) | | | 2 | | | 15 | | | | | — | |
As of June 30, 2022 | 2,918 | | | 4,073 | | | 751 | | | 78 | | | — | | | 7,820 | |
| | | | | | | | | | | |
ACCUMULATED DEPRECIATION | | | | | | | | | | | |
As of December 31, 2021 | (6,454) | | | (3,102) | | | (719) | | | — | | | — | | | (10,275) | |
Amortization | (723) | | | (466) | | | (88) | | | (75) | | | — | | | (1,352) | |
Depreciation | (719) | | | (771) | | | (123) | | | | | | | (1,613) | |
Decrease | 5,437 | | | 1,036 | | | 222 | | | — | | | — | | | 6,695 | |
FX rate impact | (179) | | | (75) | | | (8) | | | — | | | — | | | (262) | |
Reclassification | | | | | | | — | | | — | | | — | |
As of June 30, 2022 | (2,638) | | | (3,378) | | | (716) | | | (75) | | | — | | | (6,807) | |
| | | | | | | | | | | |
NET VALUE | | | | | | | | | | | |
As of December 31, 2021 | 15,636 | | | 2,814 | | | 398 | | | 112 | | | — | | | 18,960 | |
As of June 30, 2022 | 280 | | | 695 | | | 35 | | | 3 | | | — | | | 1,014 | |
The gross value of the property, plant and equipment transferred to Catalent is €22,353k ($24,454k).
The depreciation of the property, plant and equipment transferred to Catalent is €6,677k ($7,304k).
The net book value of the property, plant and equipment transferred to Catalent is 15,677k€ ($17,150k).
The depreciation (impairment loss) was recognized in relation to the decision to engage in a restructuring of the Company’s activities in France, and in particular the decision to start a collective redundancy procedure (see notes 1 and 4.6) which will result in substantial changes to our manufacturing capacities . The impairment loss was included in research and development expenses (see note 3.2.1) and in general and administrative expenses (see note 3.2.2).
Accordingly, management estimated the recoverable amount of the Company’s assets as of June 30, 2022. The recoverable amount was estimated based on its fair value less costs of disposal after considering the specialized nature of the assets and market prices, if any, for similar assets. The fair value measurement was categorized as a Level 2 fair value based on the inputs in the valuation technique used.
At June 30, 2022, the recoverable amount of the property, plant and equipment assets in France was as follows:
| | | | | |
| As of June 30, 2022 |
General equipment, fixtures and fittings | 231 | |
Plant, equipment and tooling | 177 | |
Office equipment and computers | 25 | |
4.2Right of use
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(amounts in thousands of euros) | Buildings | | Plant, equipment and tooling | | Transport equipment | | Office equipment and computers | | TOTAL |
GROSS VALUE | | | | | | | | | |
As of December 31, 2021 | 9,445 | | | 1,350 | | | 106 | | | 118 | | | 11,019 | |
Increase | — | | | — | | | 6 | | | — | | | 6 | |
Decrease | (3,130) | | | | | — | | | — | | | (3,130) | |
FX rate impact | 149 | | | | | — | | | — | | | 149 | |
Reclassification | (1,263) | | | — | | | — | | | — | | | (1,263) | |
As of June 30, 2022 | 5,201 | | | 1,350 | | | 112 | | | 118 | | | 6,781 | |
| | | | | | | | | |
ACCUMULATED DEPRECIATION | | | | | | | | | |
As of December 31, 2021 | (2,934) | | | (1,033) | | | (65) | | | (118) | | | (4,150) | |
Amortization | (468) | | | (26) | | | (13) | | | — | | | (507) | |
Depreciation | (811) | | | | | | | | | (811) | |
Decrease | 108 | | | — | | | — | | | — | | | 108 | |
FX rate impact | (39) | | | (3) | | | — | | | — | | | (42) | |
Reclassification | 1,263 | | | — | | | — | | | — | | | 1,263 | |
As of June 30, 2022 | (2,881) | | | (1,063) | | | (78) | | | (118) | | | (4,140) | |
| | | | | | | | | |
NET VALUE | | | | | | | | | |
As of December 31, 2021 | 6,511 | | | 317 | | | 41 | | | — | | | 6,869 | |
As of June 30, 2022 | 2,320 | | | 287 | | | 34 | | | — | | | 2,641 | |
The gross value of the rights of use assigned to Catalent is €3,130k ($3,425k). The amortization of the rights of use transferred to Catalent is €108k ($118k).
The net book value of the rights of use transferred to Catalent is €3,022k ($3,307k).
The depreciation (impairment loss) was recognized in relation to the decision to engage in a restructuring of the Company’s activities in France (see note 4.1).
Management estimated the recoverable amount of the Company’s right of use of buildings in France as of June 30, 2022. The recoverable amount was estimated based on its fair value less costs of disposal after considering the characteristics of the buildings (including the ability to sublease the asset), the terms of the lease agreement (in particular the contractual term, and the rents) as compared to market rents for similar buildings. The fair value measurement was categorized as a Level 2 fair value based on the inputs in the valuation technique used.
At June 30, 2022, the recoverable amount of the right of use assets in France includes buildings for €2,607K.
4.3Trade receivables and other current assets
| | | | | | | | | | | |
(amounts in thousands of euros) | 12/31/2021 | | 06/30/2022 |
Trade and other receivables | 12 | | | 306 | |
Total current trade receivables | 12 | | | 306 | |
Research Tax Credit | 3,549 | | | 4,409 | |
Other receivables (including tax and social receivables) | 669 | | | 444 | |
Net investment in a sublease | 479 | | | 309 | |
Advance payments to suppliers | 377 | | 31 |
Prepaid expenses | 1,256 | | | 2,574 | |
Other financial assets | 7 | | 707 |
Total other current assets | 6,337 | | | 8,474 | |
Research Tax Credit (Crédit d’Impôt Recherche or “CIR”)
As of June 30, 2022, the CIR receivable included the Research Tax Credit for the 2021 financial year and the CIR estimate for the first half of 2022.
Prepaid expenses
Prepaid expenses mainly related to advance payments for directors and officers' insurance (€1,826 thousand).
Other financial assets
During the first half of 2022, the increase of €700K in other current financial assets is related to the maturity of receivables which were non current at December 31, 2021 and have become current (due within one year) at June 30, 2022.
4.4Cash and cash equivalents
| | | | | | | | | | | |
(amounts in thousands of euros) | 12/31/2021 | | 06/30/2022 |
Current account | 24,593 | | | 44,219 | |
Term deposits | 9,106 | | | 9,120 | |
Total cash and cash equivalents as reported in statement of financial position | 33,699 | | | 53,339 | |
Bank overdrafts | — | | | — | |
Total cash and cash equivalents as reported in statement of cash flow | 33,699 | | | 53,339 | |
As of December 31, 2021, term deposits included a term deposit of €9.1 million with a maturity of one month and deposits of €0.1 million convertible into cash immediately.
As of June 30, 2022, term deposits included a term deposit of €9.1 million with a maturity of one month and deposits of €116k that can be drawn down immediately.
4.5Shareholders’ equity
As of June 30, 2022, the capital of the Company consisted of 31,018,553 shares, fully paid up, with a nominal value of 0.10 euro. There was no change in the number of shares over the period.
4.6Provisions for risks and charges
| | | | | | | | | | | |
(en K€) | 12/31/2021 | | 06/30/2022 |
Provision for retirement indemnities | 524 | | 248 |
Provisions - non-current portion | 524 | | 248 |
Restructuring provision | — | | 1,859 |
Provisions - current portion | — | | 1,859 |
On 25 May 2022, the management of Erytech Pharma informed the employees of the start of a collective redundancy procedure, a job protection plan, involving the loss of 52 out of 109 jobs. The consultation phase of the Social and Economic Committee ended on 31 July 2022. On September 2, 2022 the restructuring plan (PSE) was formally approved by the French State department of labour (DREETS-DDETS). The first departures could take place in October 2022. A restructuring provision of €1,859 thousand was booked at 30 June to recognize the costs associated with this restructuring (redundancy payments, notice periods, support measures and external service providers).
The provision for retirement indemnity has therefore been reduced by €105k to take into account the departures planned as part of the plan.
4.7Financial liabilities
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(amounts in thousands of euros) | Convertible notes | | Conditional advances | | Bank loans | | Other | | Total |
As of December 31, 2021 | — | | 5,281 | | 10,077 | | 38 | | 15,396 |
Increase | | | | | | | 3,088 | | 3,088 |
Fair value of embedded derivatives | | | | | | | | | — |
Amortized cost | | | | | 52 | | | | 52 |
Conversion | | | | | | | | | — |
Repayment | | | | | | | | | — |
FX rate impact | | | | | | | | | — |
As of June 30, 2022 | — | | 5,281 | | 10,129 | | 3,126 | | 18,536 |
During the first half of 2022, the Company entered into a new financing agreement with Société Générale for an amount of €3,551k, of which €3,081k was received at June 30, 2022. This financing agreement is secured by the Company’s 2021 CIR receivable (see note 4.3).
Financial liabilities by maturity
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
June 30, 2022 (in thousands of euros) | Less than one year | | One to three years | | Three to five years | | More than five years | | Total |
Convertible notes | — | | — | | — | | — | | — |
Conditional advances | — | | — | | — | | 5,281 | | 5,281 |
Bank loans | 1,502 | | 5,071 | | 2,399 | | 1,157 | | 10,129 |
Other | 3,126 | | — | | — | | — | | 3,126 |
Total financial liabilities | 4,628 | | 5,071 | | 2,399 | | 6,438 | | 18,536 |
4.7.1.Convertible notes
During the first half of 2022, no new tranches were drawn up. All convertible bonds were converted. Following the conversion of these bonds, 5,072,591 shares were created. As at 30 June 2022, 303,030 warrants remained outstanding.
4.8Lease liabilities
| | | | | |
(in thousands of euros) | Lease liabilities |
As of December 31, 2021 | 9,979 | |
Increase without cash impact | 6 | |
Repayment | (907) | |
Decrease without cash impact | (5,296) | |
FX rate impact | 225 | |
Capitalized interests | — | |
As of June 30, 2022 | 4,007 | |
The lease liability decreased by €5,296k with the sale of the Princeton plant to Catalent. The repayment includes €246K for the Cambridge premises and €361K for the Lyon sites.
Lease liabilities by maturity
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Less than one year | | One to three years | | Three to five years | | More than five years | | Total |
As of June 30, 2022 | | 1,027 | | | 1,164 | | | 894 | | | 922 | | | 4,007 | |
4.9Trade payables and other current liabilities
| | | | | | | | | | | |
(amounts in thousands of euros) | 12/31/2021 | | 06/30/2022 |
Vendors | 2,485 | | | 2,493 | |
Vendors - accruals | 11,669 | | | 9,501 | |
Total trade and other payables | 14,154 | | | 11,994 | |
Social liabilities, taxation and social security | 3,716 | | | 6,682 | |
Fixed assets payables | 2 | | | 97 | |
Deferred revenue | 93 | | | 61 | |
Other payables | 59 | | | 67 | |
Total other current liabilities | 3,870 | | | 6,907 | |
Hospital costs accruals amounted to €9,259 thousand as of December 31, 2021 and €7,188 thousand as of June 30, 2022.
4.10 Financial instruments recognized in the consolidated statement of financial position and effect on net income (loss)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of December 31, 2021 (amounts in thousands of euros) | Carrying amount on the statement of financial position (1) | | Fair value through profit and loss | | Fair value through other comprehensive income | | Financial assets at amortized cost | | Financial liabilities at amortized cost | | Fair value |
Other non-current assets | 876 | | | | | | | 876 | | | | | 876 | |
Other financial assets | 1,260 | | | | | | | 1,260 | | | | | 1,260 | |
Trade and other receivables | 12 | | | | | | | 12 | | | | | 12 | |
Other current assets | 4,218 | | | | | | | 4,218 | | | | | 4,218 | |
Cash and cash equivalents (2) | 33,699 | | | 33,699 | | | | | | | | | 33,699 | |
Total financial assets | 40,065 | | | 33,699 | | | — | | | 6,366 | | | — | | | 40,065 | |
Financial liabilities - non current portion (3) | 15,232 | | | | | | | | | 15,232 | | | 15,232 | |
Lease liabilities - non current portion (4) | 8,162 | | | | | | | | | 8,162 | | | 8,162 | |
Financial liabilities - current portion (3) | 164 | | | | | | | | | 164 | | | 164 | |
Lease liabilities - current portion (4) | 1,817 | | | | | | | | | 1,817 | | | 1,817 | |
Trade and other payables | 14,154 | | | | | | | | | 14,154 | | | 14,154 | |
Other current liabilities | 3,777 | | | | | | | | | 3,777 | | | 3,777 | |
Total financial liabilities | 43,306 | | | — | | | — | | | — | | | 43,306 | | | 43,306 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of June 30, 2022 (amounts in thousands of euros) | Carrying amount on the statement of financial position (1) | | Fair value through profit and loss | | Fair value through other comprehensive income | | Financial assets at amortized cost | | Financial liabilities at amortized cost | | Fair value |
Other non-current assets | 205 | | | | | | | 205 | | | | | 205 | |
Other current financial assets | 707 | | | | | | | 707 | | | | | 707 | |
Trade and other receivables | 306 | | | | | | | 306 | | | | | 306 | |
Other current assets | 5,900 | | | | | | | 5,900 | | | | | 5,900 | |
Cash and cash equivalents (2) | 53,339 | | | 53,339 | | | | | | | | | 53,339 | |
Total financial assets | 60,457 | | | 53,339 | | | — | | | 7,118 | | | — | | | 60,457 | |
Financial liabilities - non current portion (3) | 12,762 | | | | | | | | | 12,762 | | | 12,762 | |
Lease liabilities - non current portion (4) | 2,980 | | | | | | | | | 2,980 | | | 2,980 | |
Financial liabilities - current portion (3) | 5,774 | | | | | | | | | 5,774 | | | 5,774 | |
Lease liabilities - current portion (4) | 1,027 | | | | | | | | | 1,027 | | | 1,027 | |
Trade and other payables | 11,994 | | | | | | | | | 11,994 | | | 11,994 | |
Other current liabilities | 6,846 | | | | | | | | | 6,846 | | | 6,846 | |
Total financial liabilities | 41,383 | | | — | | | — | | | — | | | 41,383 | | | 41,383 | |
(1)The carrying amount of these assets and liabilities is a reasonable approximation of their fair value.
(2)Cash and cash equivalents are comprised of cash in bank and term deposit accounts, which are measured using level 1 measurements.
(3)The fair value of financial liabilities is determined using level 2 measurements.
(4)The fair value of lease liabilities is determined using level 2 measurements.
5.RELATED PARTIES
As at June 30, 2022, the Company’s related parties include the Chairman of the Board of Directors (Jean-Paul Kress), the Chief Executive Officer (Gil Beyen), the two Deputy General Managers (Jérôme Bailly and Eric Soyer), members of the Board of Directors and members of the executive committee.
The remuneration of directors and other members of the executive committee was as set forth in the table below.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 06/30/2021 | | 06/30/2022 |
(amounts in thousands of euros) | Salary / fees | | Retirement benefits | | Share based payments | | Salary / fees | | Retirement benefits | | Share based payments |
Executive officers / VP and qualified person | 593 | | | 11 | | | 254 | | | 630 | | | 110 | | | 222 | |
Executive committee | 764 | | | 12 | | | 183 | | | 993 | | | 61 | | | 20 | |
Board of directors | 153 | | | 0 | | 1 | | | 193 | | | | | |
Total | 1,510 | | | 23 | | | 438 | | | 1,816 | | | 171 | | | 242 | |
The Company has no other related parties.
6.OFF-BALANCE SHEET COMMITMENTS
The off-balance-sheet commitments as of December 31, 2021 have not changed significantly during the first half of 2022, except for the following commitments:
Sublease in the United-States
In May 2021, the Company signed a sublease agreement for a portion of its premises located in Cambridge. As part of this agreement, the security deposit received is as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Sublease to be received |
As of June 30, 2022 | Total | | Less than one year | | One to five years | | More than five years |
Sublease in US | 311 | | | 311 | | | — | | | — | |
Total | 311 | | | 311 | | | — | | | — | |