Interim / Quarterly Report • Jul 31, 2020
Interim / Quarterly Report
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| MANAGEMENT REPORT 2 | ||
|---|---|---|
| 1. | MAIN EVENT IN THE FIRST HALF YEAR OF 2020 2 | |
| 2. | FINANCIAL HIGHLIGHTS 4 | |
| 3. | 2020 OUTLOOK 5 | |
| 4. | RISK FACTORS 5 | |
| 5. | FORWARD-LOOKING STATEMENTS 5 | |
| UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION 7 | ||
| UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT AND LOSS AND OTHER COMPREHENSIVE INCOME 9 |
||
| UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF CASH FLOWS 10 | ||
| UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY 11 | ||
| NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 12 |
We refer to our Q1 2020 press release.
argenx continues to execute on its "argenx 2021" vision to become a fully integrated, global immunology company. The company continues to implement measures across the organization and in the operations of globally run clinical trials to minimize the impact of COVID-19 on employees, patients and their communities, physicians and ongoing business priorities.
Phase 2 BEACON trial of cusatuzumab in combination with azacitidine versus azacitidine alone in higher-risk patients with myelodysplastic syndromes (MDS) who are ineligible for intensive chemotherapy remains paused for enrollment
Part 1 dose escalation of Phase 1 study of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML ineligible for intensive chemotherapy, published in Nature Medicine
Total operating income decreased by €20.2 million for the six months ended June 30, 2020 to €31.1 million, compared to €51.3 million for the six months ended June 30, 2019. This decrease is primarily related to the milestone payments following the first-in-human clinical trial with ABBV-151 under the AbbVie collaboration which was achieved in the first six months of 2019, partly offset by (i) the revenue recognition of the transaction price related to the Janssen collaboration and (ii) the increase in other income mainly driven by higher payroll tax rebates for employing certain research and development personnel.
We realized a net loss of €205.6 million and an operating loss of €201.4 million for the six months ended June 30, 2020, compared to a net loss of €45.1 million and operating loss of €54.5 million for the six months ended June 30, 2019.
Our research and development expenses in the first six months of 2020 amounted to €171.7 million, compared to €78.3 million for the first six months of 2019. The increase resulted primarily from higher external research and development expenses, primarily related to our efgartigimod program in various indications, our Cusatuzumab program and other clinical and pre-clinical programs. Furthermore, the personnel expenses increased due to the increased headcount, as planned.
Our selling, general and administrative expenses totaled €61.6 million in the first six months of 2020, compared to €27.5 million for the first six months of 2019. This increase primarily resulted from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx's lead product candidate efgartigimod.
For the six months ended June 30, 2020, financial expenses, which is the net of primarily interest received and changes in fair value of current financial assets, amounted to €2.2 million compared to a financial income of €7.2 million for the six months ended. Financial expenses correspond mainly to a decrease in net asset value on the current financial assets following the impact of the COVID-19 outbreak on the financial markets.
Exchange gains totaled €0.2 million for the six months ended June 30, 2020, compared to €2.5 million for the six months ended June 30, 2019 and were mainly attributable to unrealized exchange rate gains on cash, cash equivalents and current financial assets.
On June 30, 2020, cash and cash equivalents and current financial assets totaled €1,932.8 million, compared to €1,335.8 million on December 31, 2019. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering, including a U.S. offering and a European private placement, which resulted in the receipt of €778.1 million in gross proceeds, decreased by €47.4 million of underwriter discounts and commissions, and offering expenses, of which €47.1 million has been deducted from equity, and net cash flows used in operating activities of €136.0 million.
Based on the current objectives of the Company's business plan, argenx expects that its existing cash, cash equivalents and investments will fund planned operating and capital expense requirements associated with the potential commercial launch of efgartigimod, continued research and development of its robust pipeline as well as early stage discovery activities. With the planned launch of its first product, the build-out of a commercial organization and the expansion of the Company's ambition level within its own growing business plan, argenx expects operating and capital expense requirements to continue to increase year-over-year.
We refer to the description of risk factors in the 2019 annual report, pp. 6-37 as supplemented by the description of risk factors in our annual report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 2-62. In summary, the principal risks and uncertainties faced by us relate to: our financial position and need for additional capital, development and clinical testing of our product candidates, commercialization of our product candidates, our business and industry, our dependence on third parties intellectual property, our organization and operations, and the ADSs.
We also refer to the description of our financial risk management given in the 2019 annual report, pp. 248-251, which remains valid.
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should" and include statements argenx makes concerning its 2020 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx's, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx's expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx's reliance on collaborations with third parties; estimating the commercial potential of argenx's product candidates; argenx's ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx's limited operating history; and argenx's ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forwardlooking statements, except as may be required by law.
We hereby certify that, to the best of our knowledge, the unaudited condensed consolidated interim financial statements of argenx SE as of and for the six months ended June 30, 2020, prepared in accordance with IAS 34 'Interim Financial Reporting' as adopted by the European Union, give a true and fair view of the assets, liabilities, financial position and total comprehensive loss of the Company and the undertakings included in the consolidation as a whole, and that the management report includes a fair review of the development and performance of the business and the position of the Company and the undertakings included in the consolidation taken as a whole, together with a decription of the principal risks and uncertainties that they face.
On behalf of the Board of Directors Tim van Hauwermeiren, CEO July 30, 2020
| As of | ||||
|---|---|---|---|---|
| June 30, | December 31, | |||
| (in thousands of €) | Note | 2020 | 2019 | |
| ASSETS | ||||
| Current assets | ||||
| Cash and cash equivalents | 5 | € 1,201,443 |
€ | 331,282 |
| Research and development incentive receivables — current |
377 | 261 | ||
| Financial assets — current |
6 | 731,355 | 1,004,539 | |
| Prepaid expenses | 10,864 | 9,022 | ||
| Inventories | 7 | 4,977 | — | |
| Trade and other receivables | 8,561 | 28,115 | ||
| Total current assets | € 1,957,577 € | 1,373,219 | ||
| Non‑current assets | ||||
| Restricted cash — non-current |
632 | 630 | ||
| Research and development incentive receivables — non-current |
11,050 | 8,566 | ||
| Financial assets — non-current |
14 | 3,444 | 2,596 | |
| Property, plant and equipment | 8,801 | 8,167 | ||
| Intangible assets | 40,945 | 40,161 | ||
| Total non‑current assets | € 64,872 € |
60,120 | ||
| TOTAL ASSETS | € 2,022,449 € | 1,433,339 |
| As of | |||
|---|---|---|---|
| June 30, | December 31, | ||
| (in thousands of €) | Note | 2020 | 2019 |
| EQUITY AND LIABILITIES | |||
| Equity | 8 | ||
| Equity attributable to owners of the parent | |||
| Share capital | € 4,711 |
€ 4,276 |
|
| Share premium | 2,043,653 | 1,308,539 | |
| Accumulated losses | (538,205) | (332,568) | |
| Other reserves | 106,295 | 70,499 | |
| Total equity | € 1,616,454 | € 1,050,746 |
|
| Deferred tax liabilities | 871 | — | |
| Non-current liabilities | |||
| Provisions for employee benefits | 64 | 64 | |
| Non-current lease liabilities | 4,669 | 4,540 | |
| Deferred revenue — non-current |
202,560 | 218,032 | |
| Total non-current liabilities | 207,293 | 222,636 | |
| Current liabilities | |||
| Current lease liabilities | 2,256 | 1,974 | |
| Trade and other payables | 127,850 | 85,301 | |
| Tax liabilities | 431 | 344 | |
| Deferred revenue — current |
67,294 | 72,338 | |
| Total current liabilities | 197,831 | 159,957 | |
| Total liabilities | € 405,995 |
€ 382,593 |
|
| TOTAL EQUITY AND LIABILITIES | € 2,022,449 | € 1,433,339 |
| Six Months Ended June 30, |
||||||
|---|---|---|---|---|---|---|
| (in thousands of € except for shares and EPS) | Note | 2020 | 2019 | |||
| Revenue | 10 | € | 22,388 | € | 43,532 | |
| Other operating income | 8,729 | 7,767 | ||||
| Total operating income | 31,117 | 51,299 | ||||
| Research and development expenses | 12 | (171,718) | (78,304) | |||
| Selling, general and administrative expenses | 13 | (61,644) | (27,462) | |||
| Total operating expenses | (233,362) | (105,767) | ||||
| Change in fair value on non-current financial assets | 14 | 848 | — | |||
| Operating loss | € | (201,397) | € | (54,467) | ||
| Financial income/(expense) | (2,178) | 7,210 | ||||
| Exchange gains/(losses) | 199 | 2,486 | ||||
| Loss before taxes | € | (203,376) | € | (44,771) | ||
| Income tax (expense)/benefit | € | (2,261) | € | (350) | ||
| Loss for the year and total comprehensive loss | € | (205,637) | € | (45,121) | ||
| Loss for the year and total comprehensive loss attributable to: | ||||||
| Owners of the parent | (205,637) | (45,121) | ||||
| Weighted average number of shares outstanding | 43,476,103 | 37,764,237 | ||||
| Basic and diluted loss per share (in €) | (4.73) | (1.19) |
| Six Months Ended June 30, |
|||||
|---|---|---|---|---|---|
| (in thousands of €) | Note | 2020 | 2019 | ||
| Operating result | € | (201,397) | € | (54,467) | |
| Adjustments for non-cash items | |||||
| Amortization of intangible assets | 55 | 12 | |||
| Depreciation of property, plant and equipment | 1,492 | 915 | |||
| Expense recognized in respect of share-based payments | 9 | 35,797 | 17,199 | ||
| Fair value gains on financial assets at fair value through profit or loss | 14 | (848) | — | ||
| € | (164,901) | € | (36,341) | ||
| Movements in current assets/liabilities | |||||
| (Increase)/decrease in trade and other receivables | 17,525 | (179) | |||
| (Increase)/decrease in inventories | 7 | (4,977) | — | ||
| (Increase)/decrease in other current assets | (1,957) | (5,331) | |||
| Increase/(decrease) in trade and other payables | 42,768 | 17,996 | |||
| Increase/(decrease) in deferred revenue — current |
(5,044) | 38,657 | |||
| Movements in non-current assets/liabilities | |||||
| (Increase)/decrease in other non‑current assets | (2,485) | (2,767) | |||
| Increase/(decrease) in deferred revenue — non-current |
(15,472) | 217,143 | |||
| Cash flows (used in) / from operating activities | (134,542) | 229,178 | |||
| Interest paid | (142) | (47) | |||
| Income taxes paid | (1,303) | (794) | |||
| Net cash flows (used in) / from operating activities | € | (135,987) | € | 228,337 | |
| Purchase of intangible assets | (839) | (35,429) | |||
| Purchase of property, plant and equipment | (672) | (678) | |||
| (Increase)/decrease in financial assets — current |
6 | 271,658 | (488,534) | ||
| Interest received | 4,775 | 1,384 | |||
| Net cash flows (used in) / from investing activities | € | 274,922 | € (523,257) | ||
| Principal elements of lease payments | (1,056) | (536) | |||
| Proceeds from issue of new shares, gross amount | 8 | 731,546 | 176,725 | ||
| Issue costs paid | 8 | (551) | — | ||
| Exchange gain from currency conversion on proceeds from issue of new | |||||
| shares | 62 | — | |||
| Proceeds from exercise of stock options | 8 | 4,554 | 3,144 | ||
| Net cash flows from/used in (-) financing activities | € | 734,554 | € | 179,333 | |
| Increase/decrease (-) in cash and cash equivalents | € | 873,489 | € (115,587) | ||
| Cash and cash equivalents at the beginning of the period | € | 331,282 | € | 281,040 | |
| Exchange gains/(losses) on cash & cash equivalents |
€ | (3,327) | € | 2,340 | |
| Cash and cash equivalents at the end of the period | € | 1,201,443 | € | 167,793 |
| Attributable to Owners of the Parent | ||||||
|---|---|---|---|---|---|---|
| (in thousands of €) | Share Capital |
Share Premium |
Accumulated Losses |
Other Reserves |
Total Equity Attributable to Owners of the Parent |
Total Equity |
| Balance year ended December | € 3,597 € | 673,454 € (169,603) € | 30,947 € | 538,395 | € 538,395 |
|
| 31, 2018 | ||||||
| Total comprehensive loss of the | ||||||
| period | € | € | € (45,121) |
€ | € (45,121) |
€ (45,121) |
| Share-based payment | 17,199 | 17,199 | 17,199 | |||
| Issue of new shares | 177 | 176,548 | 176,725 | 176,725 | ||
| Accounting treatment of the share | ||||||
| subscription agreement | (24,948) | (24,948) | (24,948) | |||
| Exercise of stock options | 36 | 3,108 | 3,144 | 3,144 | ||
| Balance period ended June 30, | ||||||
| 2019 | € 3,810 € | 828,162 € (214,724) € | 48,146 € | 665,394 | € 665,394 |
|
| Balance year ended December | ||||||
| 31, 2019 | € 4,276 € 1,308,539 € (332,568) € | 70,499 € 1,050,746 | € 1,050,746 | |||
| Total comprehensive loss of the | ||||||
| period | € | € | € (205,637) |
€ | € (205,637) |
€ (205,637) |
| Share-based payment | 35,796 | 35,796 | 35,796 | |||
| Issue of new shares | 421 | 731,125 | 731,546 | 731,546 | ||
| Share issue costs | (551) | (551) | (551) | |||
| Exercise of stock options | 14 | 4,540 | 4,554 | 4,554 | ||
| Balance period ended June 30, | ||||||
| 2020 | € 4,711 | € 2,043,653 | € (538,205) | € 106,295 | € 1,616,454 | € 1,616,454 |
Please refer to note 8 for more information on the share capital and movement in number of shares and note 9 for more information on the share-based payments.
argenx SE is a Dutch European public company with limited liability incorporated under the laws of the Netherlands. The company (COC 24435214) has its official seat in Rotterdam, the Netherlands, and its registered office is at Willemstraat 5, 4811 AH, Breda, the Netherlands.
argenx SE is a publicly traded company with ordinary shares listed on Euronext Brussels under the symbol "ARGX" since July 2014 and with American Depositary Shares listed on Nasdaq under the symbol "ARGX" since May 2017.
The current unprecedented challenges as a result of the COVID-19 outbreak have impacted how we operate. We have been taking, and continue to take, the necessary steps in terms of safety, risk mitigation, and financial measures to best manage through these challenging times. We have currently experienced limited impact on our financial performance and financial position, although we continue to face additional risks and challenges associated with the impact of the outbreak.
See our Interim management report and Universal Registration Statement filed with the AFM for a more detailed discussion about the impact of the COVID-19 outbreak on argenx during the six months ended June 30, 2020.
The unaudited condensed consolidated interim financial statements for the six months ended June 30, 2020 have been prepared in accordance with IAS 34 'Interim Financial Reporting' as issued by the IASB and adopted by the European Union. The unaudited condensed consolidated interim financial statements should be read in conjunction with the annual financial statements for the year ended December 31, 2019.
All amounts herein are presented in thousands of €, unless otherwise indicated, rounded to the nearest € '000.
The unaudited condensed consolidated financial statements have been approved for issue by the Company's Board of Directors (the Board) on July 29, 2020.
There were no significant changes in accounting policies, critical accounting judgements and key sources of estimation uncertainty applied by us in these unaudited condensed interim financial statements compared to those used in the annual consolidated financial statements as of December 31, 2019, except for
Inventories are stated at cost or net realisable value, whichever is lower. Cost is determined using the first-in, firstout method. Cost comprises of costs of purchase, costs of conversion and other costs incurred in bringing the inventories to their present location and condition.
If the expected sales price less completion costs to execute sales (net realizable value) is lower than the carrying amount, a write-down is recognised for the amount by which the carrying amount exceeds its net realisable value.
Included in inventory are products which could, besides commercial activities, be used in preclinical and clinical programs as well as in non-reimbursed Early Access Programs. These products are charged to research & development expenses or selling, general and administrative expenses, respectively, when dedicated to this channel.
We capitalize inventory costs associated with products prior to the regulatory approval of these products, or for inventory produced in new production facilities, when it is highly probable that the pre-approval inventories will be saleable. The determination to capitalized is based on the particular facts and circumstances relating to the expect regulatory approval of the product or production facility being considered. The assessment of whether or not the product is considered highly probable to be saleable is made on a quarterly basis and includes, but is not limited to, how far a particular product or facility has progressed along the approval process, any known safety or efficacy concern, potential labelling restrictions and other impediments.
Previously capitalized costs related to pre-launch inventories could be required to be written down upon a change in such judgement or due to a denial or delay of approval by regulatory bodies, a delay in commercialization or other potential factors, which will be recorded to research and development expenses.
| Six Months Ended June 30, |
Year Ended December 31, |
|||
|---|---|---|---|---|
| (in thousands of €) | 2020 | 2019 | ||
| Cash equivalents | € | 1,146,936 | € | 252,550 |
| Cash and bank balances | 54,507 | 78,732 | ||
| € | 1,201,443 | € | 331,282 |
On June 30, 2020, cash and cash equivalents amounted to €1,201.4 million, compared to €331.3 million on December 31, 2019 and included cash equivalents and cash and bank balances held in different financial institutions. Cash and bank balances were mainly composed of saving accounts and current accounts. Cash equivalents comprised of term accounts with an original maturity of 3 months or less and money market funds that are readily convertible to cash and are subject to an insignificant risk of changes in value.
Please also refer to note 14 for more information on the financial instruments.
On June 30, 2020, the current financial assets amounted to €731.4 million, compared to €1,004.5 million on December 31, 2019. These current financial assets relate to term accounts with an original maturity longer than 3 months and money market funds which do not qualify as cash equivalents.
Please also refer to note 14 for more information on the financial instruments.
| Six Months Ended June 30, |
Year Ended December 31, |
|||
|---|---|---|---|---|
| (in thousands of €) | 2020 | 2019 | ||
| Raw materials and consumables | € | 4,977 | € | — |
| Inventories in process | — | — | ||
| Finished Goods | — | — | ||
| € | 4,977 | € | — |
On June 30, 2020, inventories amounted to €5.0 million and related to pre-launch efgartigimod-inventory, capitalized subsequent to the announcement of the topline data from the pivotal Adapt trial of efgartigimod. As of June 30, 2020, no inventory write-downs were recorded.
On June 30, 2020, argenx SE's share capital was represented by 47.108.499 shares. All shares were issued, fully paid up and of the same class. The table below summarizes our capital increases, as a result of the global offering and the exercise of stock options under the argenx Employee Stock Option Plan, for the period ended June 30, 2020.
| Number of shares outstanding on December 31, 2019 | 42,761,528 |
|---|---|
| Exercise of options | 139,679 |
| Global public offering on Euronext and Nasdaq on May 28, 2020 | 3,658,515 |
| Over-allotment option exercised by underwriters on May 29, 2020 | 548,777 |
| Number of shares outstanding on June 30, 2020 | 47,108,499 |
On May 12, 2020, at the annual general meeting, the shareholders of the Company approved the authorization to the Board to issue:
On May 28, 2020, argenx SE offered 3,658,515 of its ordinary shares through a global offering which consisted of (i) a public offering of 2,584,138 ADSs in the U.S. and certain other countries outside the European Economic Area (EEA) at a price of \$205.00 per ADS, before underwriting discounts and commissions and offering expenses; and (ii) a concurrent private placement of 1.074.377 ordinary shares in the European Economic Area at a price of €186.52 per share, before underwriting discounts and commissions and offering expenses. On May 29, 2020, the underwriters of the offering exercised their over-allotment option to purchase 548,777 additional ADSs in full. As a result, argenx SE received €778.1 million in gross proceeds from this offering, decreased by €47.4 million of underwriter discounts and commissions, and offering expenses, of which €47.1 million has been deducted from equity. The total net cash proceeds from the offering amounted to €730.7 million.
On April 14 and June 25, 2020, the Company granted a total of 692,790 stock options to certain of its employees, Board members and consultants. Below is an overview of the parameters used in relation to the new grant during 2020:
| Stock options granted in | April 2020 | June 2020 (1) | |
|---|---|---|---|
| Number of options granted | 142,700 | 550,090 | |
| Average fair value of options (in | |||
| EUR) | € | 62,31 - 120,63 € |
87,96 - 90,74 |
| Share price (in EUR) | € | 126,50 - 205,60 € |
203.8 |
| Exercise price (in EUR) | € | 119.53 € |
196.15 |
| Expected volatility | % | 44,44 - 64,77 % |
45,09 - 45,34 |
| Average expected option life (in | |||
| years) | 4 - 6,68 |
6,15 - 6,68 |
|
| Risk‑free interest rate | % | (0,32) - (0,18) % |
(0,31) - (0,29) |
| Expected dividends | — | — |
(1) The beneficiary can choose between a contractual term of five or ten years. This estimate will be reassessed once the acceptance period of 60 days has passed and the beneficiaries will have made a choice between a contractual term of five or ten years. The total fair value of these grant would range from €39.6 million to €49.0 million.
The total share-based payment expense recognized in the unaudited condensed consolidated statement of profit and loss and other comprehensive income totaled €35.8 million for the six months ended June 30, 2020 compared to €17.2 million for the six months ended June 30, 2019.
For the six months ended June 30, 2020, the majority of the revenue was generated under the collaboration agreements signed with AbbVie and Janssen. These agreements comprise elements of upfront payments, milestone payments based on development criteria and research and development service fees.
| Six Months Ended June 30, |
|||||
|---|---|---|---|---|---|
| (in thousands of €) | 2020 2019 |
||||
| Upfront payments | € | 18,680 | € | 8,615 | |
| Janssen | 18,383 | 6,625 | |||
| AbbVie | 264 | 472 | |||
| Agomab | — | 1,498 | |||
| Other | 33 | 20 | |||
| Milestone payments | 1,833 | 26,135 | |||
| Janssen | 1,438 | — | |||
| AbbVie | 378 | 26,125 | |||
| Other | 17 | 10 | |||
| Research and development service fees | 1,875 | 8,782 | |||
| Janssen | 1,805 | 8,684 | |||
| Other | 70 | 98 | |||
| Total revenue | € | 22,388 | € | 43,532 |
The Company operates from the Netherlands, Belgium, the United States and Japan. Revenues are generated by external customers with their main registered office geographically located as shown in the table below. In prior periods this has been presented based on the geographical location of the contracting entity.
| Six Months Ended | June 30, | |||
|---|---|---|---|---|
| (in thousands of €) | 2020 | 2019 | ||
| Denmark | € | 120 | € | 128 |
| Belgium | — | 1,498 | ||
| United States | 22,268 | 41,906 | ||
| Total | € | 22,388 | € | 43,532 |
| Six Months Ended June 30, |
||||
|---|---|---|---|---|
| (in thousands of €) | 2020 | 2019 | ||
| Personnel expense | € | 34,043 | € | 22,887 |
| External research and development expenses | 125,096 | 46,780 | ||
| Materials and consumables | 1,267 | 878 | ||
| Depreciation and amortization | 1,096 | 932 | ||
| Other expenses | 10,216 | 6,827 | ||
| € | 171,718 | € | 78,304 |
| Six Months Ended June 30, |
||||
|---|---|---|---|---|
| (in thousands of €) | 2020 | 2019 | ||
| Personnel expense | € | 36,549 | € | 17,132 |
| Consulting fees | 18,998 | 6,795 | ||
| Supervisory board | 2,194 | 1,424 | ||
| Other expense | 3,903 | 2,111 | ||
| € | 61,644 | € | 27,462 |
The Company carried the following assets at fair value on June 30, 2020 and December 31, 2019 respectively:
| At June 30, 2020 | ||||
|---|---|---|---|---|
| (in thousands of €) | Level 1 | Level 2 | Level 3 | |
| Non-current financial assets | € | € | € | 3,444 |
| Cash Equivalents | 1,201,443 | |||
| Current financial assets | 731,355 | |||
| Assets carried at fair value | € 1,932,798 | € — |
€ | 3,444 |
| At December 31, 2019 | |||||
|---|---|---|---|---|---|
| (in thousands of €) | Level 1 | Level 2 | Level 3 | ||
| Non-current financial assets | € | € | € | 2,596 | |
| Current financial assets | 1,004,539 | ||||
| Assets carried at fair value | € 1,004,539 | € — |
€ | 2,596 |
In March 2019, the Company entered into a license agreement with AgomAb Therapeutics NV for the use of HGFmimetic SIMPLE Antibodies™, developed under the Company's Innovative Access Program. In exchange for granting this license, the Company received a profit share in AgomAb Therapeutics NV. The Company assessed the accounting treatment and concluded that the license agreement is in scope of IFRS 15 and that any revenue should be recognized at once at the effective date of the agreement. The profit share has been designated as a non-current financial asset held at fair value through profit or loss. Since AgomAb Therapeutics NV is a private company, the valuation of the profit share is based on level 3 assumptions.
In April 2020, AgomAb Therapeutics NV secured €3.3 million in Series A financing round by issuing 49,877 of Preferred A Shares. The Company used the post-money valuation of this Series A financing round and the number of outstanding shares in determining the fair value of the profit-sharing instrument, which results in a change in fair value of current financial assets of €0.8 million recorded through profit or loss.
The Company's manufacturing commitments with Lonza, its drug substance manufacturing contractor, relate to the ongoing execution of the biologic license application (BLA) services for efgartigimod and its manufacturing activities related to the potential future commercialisation. In December 2018, the Company signed its first commercial supply agreement with Lonza related to the reservation of commercial drug substance supply capacity for efgartigimod. In the aggregate, the Company has outstanding commitments for efgartigimod under the first commercial supply agreement of €70.6 million.
In addition, the Company also has contractual obligations with Lonza for ARGX-117 of €3.4 million.
We refer to our 2019 annual report for a description of our contingent liabilities and assets.
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