CureVac N.V.
Interim Condensed Consolidated Statements of Operations and
Other Comprehensive Income (Loss)
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| Three months ended March 31, | ||||
| Note |
| 2021 |
| 2022 | |
(in thousands of EUR, except per share amounts) | (unaudited) | |||||
Revenue | 3.1 |
| | | ||
Cost of sales | 3.2 |
| ( | ( | ||
Selling and distribution expenses | 3.3 |
| ( | ( | ||
Research and development expenses | 3.4 |
| ( | ( | ||
General and administrative expenses | 3.5 |
| ( | ( | ||
Other operating income | 3.6 |
| | | ||
Other operating expenses |
| ( | ( | |||
Operating loss |
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| ( | ( | ||
Finance income |
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Finance expenses |
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| ( | ( | ||
Loss before income tax |
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| ( | ( | ||
Income tax benefit/ (expense) | 12 |
| ( | | ||
Net loss for the period |
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| ( | ( | ||
Other comprehensive income (loss): |
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Foreign currency adjustments |
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| ( | ( | ||
Total comprehensive loss for the period |
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| ( | ( | ||
Net loss per share (basic and diluted) |
|
| ( | ( |
CureVac N.V.
Interim Condensed Consolidated Statements of Financial Position
| December 31, | March 31, | ||||
(in thousands of EUR) |
| Note |
| 2021 |
| 2022 |
(unaudited) | ||||||
Assets |
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Non-current assets |
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Intangible assets | 6.1 |
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Property, plant and equipment | 6.2 |
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Right-of-use assets |
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Other assets |
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Deferred tax assets | 12 |
| | | ||
Total non-current assets |
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Current assets |
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Inventories | 7 |
| | | ||
Trade receivables | 3.1 |
| | | ||
Other financial assets |
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Prepaid expenses and other assets | 8 |
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Cash and cash equivalents |
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Total current assets |
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Total assets |
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Equity and liabilities |
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Equity | 4 |
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Issued capital |
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Capital reserve |
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Treasury Shares | ( | ( | ||||
Accumulated deficit |
| ( | ( | |||
Other comprehensive income |
| ( | ( | |||
Total equity |
| | | |||
Non-current liabilities |
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Lease liabilities | | | ||||
Contract liabilities | 3.1 |
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Other liabilities |
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Total non-current liabilities |
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Current liabilities |
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Lease liabilities |
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Trade and other payables | 10 |
| | | ||
Other liabilities | 11 |
| | | ||
Income taxes payable | 12 |
| | | ||
Contract liabilities | 3.1 |
| | | ||
Total current liabilities |
| | | |||
Total liabilities |
| | | |||
Total equity and liabilities |
| | |
CureVac N.V.
Interim Condensed Consolidated Statements of Changes in Shareholders’ Equity
for the three months ended March 31, 2022 and 2021
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| Currency |
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Issued | Capital | Treasury | Accumulated | translation | Total | |||||||
(in thousands of EUR) | capital | reserve | Shares | deficit | reserve | equity | ||||||
Balance as of January 1, 2021 |
| |
| |
| — |
| ( |
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Net loss |
| — |
| — |
| — |
| ( |
| — |
| ( |
Other comprehensive income (loss) |
| — |
| — |
| — |
| — |
| ( |
| ( |
Total comprehensive income (loss) |
| — |
| — |
| — |
| ( |
| ( |
| ( |
Share-based payments (net of taxes) |
| — |
| |
| — |
| — |
| — |
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Issuance of share capital (net of transaction costs) | | | — | — | — | | ||||||
Exercise of options |
| |
| |
| — |
| — |
| — |
| |
Repurchase of common shares |
| — |
| — |
| ( |
| — |
| — |
| ( |
Balance as of March 31, 2021 (unaudited) |
| |
| |
| ( |
| ( |
| ( |
| |
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|
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| Currency |
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Issued | Capital | Treasury | Accumulated | translation | Total | |||||||
(in thousands of EUR) | capital | reserve | Shares | deficit | reserve | equity | ||||||
Balance as of January 1, 2022 |
| |
| |
| ( | ( |
| ( |
| | |
Net loss |
| — |
| — |
| — | ( |
| — |
| ( | |
Other comprehensive income (loss) |
| — |
| — |
| — | — |
| ( |
| ( | |
Total comprehensive income (loss) |
| — |
| — |
| — | ( |
| ( |
| ( | |
Share-based payments (net of taxes) |
| — |
| |
| — | — |
| — |
| | |
Exercise of options | — | ( | — | — | — | ( | ||||||
Settlement of Share Base Payment awards |
| — |
| ( |
| — |
| — |
| | ||
Balance as of March 31, 2022 (unaudited) |
| |
| |
| ( | ( |
| ( |
| |
CureVac N.V.
Interim Condensed Consolidated Statements of Cash Flows
| For the three months ended March 31, | |||
| 2021 |
| 2022 | |
(in thousands of EUR) | (unaudited) | |||
Operating activities | ||||
Loss before income tax | ( | ( | ||
Adjustments to reconcile loss before tax to net cash flows |
|
| ||
Finance income | ( | ( | ||
Finance expense | | | ||
Depreciation and impairment of property, plant and equipment and right-of-use assets | | | ||
Impairment of inventory and prepayments | — | | ||
Share-based payment expense | | | ||
Non-cash income from release of provisions | — | ( | ||
Working capital changes |
| |||
Decrease / (increase) in trade receivables and contract assets | ( | ( | ||
Decrease / (increase) in inventory | ( | | ||
Decrease / (increase) in other assets | ( | ( | ||
(Decrease) / increase in trade and other payables and contract liabilities | | ( | ||
(Decrease) / Increase in other current financial and other liabilities | | — | ||
Interest received | | — | ||
Interest paid | ( | ( | ||
Net cash flow (used in) operating activities | ( | ( | ||
Investing activities |
| |||
Purchase of property, plant and equipment | ( | ( | ||
Purchase of intangible assets | ( | ( | ||
Net cash flow (used in) investing activities | ( | ( | ||
Financing activities |
| |||
Payments on lease obligations | ( | ( | ||
Payment on Treasury Shares | — | | ||
Proceeds on exercise of options | — | ( | ||
Proceeds from the issuance of shares (net of transaction costs) | | — | ||
Net cash flow (used in)provided by financing activities | | ( | ||
Net increase (decrease) in cash and cash equivalents | | ( | ||
Currency translation gains (losses) on cash and cash equivalents | | | ||
Cash and cash equivalents, beginning of period | | | ||
Cash and cash equivalents, end of period | | |
1. Corporate Information
CureVac N.V. (“CureVac” or “CV” or the “Company”) is the parent company of CureVac Group (“Group”) and, along with its subsidiaries, is a global biopharmaceutical company developing a new class of transformative medicines based on the messenger ribonucleic acid (mRNA) that has the potential to improve the lives of people.
The Company is incorporated in the Netherlands and is registered in the commercial register at the Netherlands Chamber of Commerce under RSIN 861149336. The Company’s registered headquarters is Friedrich-Miescher-Strasse 15, 72076 Tuebingen, Germany. During 2021 until now, Dievini Hopp BioTech holding GmbH & Co. KG (dievini), which is an investment company dedicated to the support of companies in health and life sciences, is the largest shareholder of CureVac. Together with its related parties, dievini has held shares and voting rights in CureVac between appr. 46 – 49 % during that period. dievini is thus considered to be the de facto parent of the Group. Dietmar Hopp, Daniel Hopp and Oliver Hopp are the ultimate controlling persons (of the main shareholders) of dievini, and, therefore, control the voting and investment decisions of dievini.
2. Basis of preparation
The interim condensed consolidated financial statements for the three months ended March 31, 2022 have been prepared in accordance with IAS 34 Interim Financial Reporting.
The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual consolidated financial statements and should be read in conjunction with the Group’s annual consolidated financial statements as at December 31, 2021 and 2020 and for the three years in the period ended December 31, 2021. The interim condensed consolidated financial statements were authorized by the Management Board for presentation to the Supervisory Board on May 25, 2022. The Group’s interim condensed consolidated financial statements are presented in Euros (“EUR”). Unless otherwise stated, amounts are rounded to thousands of Euros, except per share amounts.
New standards, interpretations and amendments adopted by the Group
The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2021. The new and amended standards and interpretations applied for the first time as of January 1, 2022, as disclosed in the notes to the consolidated financial statements as at December 31, 2021, had no impact on the interim condensed consolidated financial statements of the Group as of and for the three months ended March 31, 2022. The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
Impact of COVID-19 and the Russia-Ukraine Conflict
As the Group is currently devoting significant resources to the development of COVID vaccines, such development may impair the ability to timely progress other product candidates in clinical trials or into clinical trials from their current preclinical stage. In addition, enrollment in other programs may be delayed as a result of the COVID-19 pandemic and could have a negative impact on revenue recognition related to non-COVID-19 collaborations. For instance, the Group’s flu program with Bill & Melinda Gates Foundation was delayed. The partial disruption, even temporary, may negatively impact the Company’s operations and overall business by delaying the progress of its clinical trials and preclinical studies. The Group’s operations, including research and manufacturing, could also be disrupted due to the potential of the impact of staff absences as a result of self-isolation procedures or extended illness. However, the Group has taken a series of actions aimed at safeguarding its employees and business associates, including implementing a work-from-home policy for employees except for those related to its laboratory and production operations. The Group is running COVID antigen tests on a weekly basis for employees on the premises.
The ongoing military conflict between Russia and Ukraine has not and is not expected to have a material direct or indirect effect on the Group’s operations or financial condition: however, the Group is currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine. The Group’s business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from the conflict in Ukraine or any other geopolitical tensions.
3. Notes to the consolidated financial statements
3.1 Revenue from contract with customers
The Group recognized the following revenues:
| Three months ended March 31 | |||
2021 |
| 2022 | ||
EUR k | EUR k | |||
Belgium | ||||
GSK | | | ||
Germany |
|
|
| |
Boehringer Ingelheim |
| | — | |
Switzerland |
|
| ||
CRISPR |
| | | |
Netherlands | ||||
Genmab | | | ||
Total |
| | |
Of these revenues, all of which were recognized over time as part of collaboration agreements, during the three months ended March 31, 2022 EUR
In the three months ended March 31, 2022, EUR
The Group has received upfront payments which were initially deferred and are subsequently recognized as revenue as the Group renders services over the performance period. Below is a summary of such payments and the related revenues recognized:
Upfront and | Upfront and | Revenue recognized from | ||||||||
milestones payments included | milestones payments included | upfront and milestones payments | ||||||||
in contract | in contract | for three months ended | ||||||||
| Upfront payments |
| liabilities at |
| liabilities at |
| March 31, | |||
Customer | March 31, 2022 | December 31, 2021 | March 31, 2022 | 2021 |
| 2022 | ||||
(EUR k) | (EUR k) | (EUR k) | ||||||||
GSK |
| EUR |
| |
| |
| | | |
CRISPR |
| USD |
| |
| |
| | | |
Boehringer Ingelheim |
| EUR |
| — |
| — |
| | — | |
Genmab |
| USD |
| |
| |
| | | |
Total |
|
| |
| |
| | |
* Translated at the currency exchange rate prevailing on the transaction date.
Contract balances:
| December 31, |
| March 31, | |
2021 | 2022 | |||
EUR k | EUR k | |||
Trade receivables |
| |
| |
Contract liabilities |
| |
| |
Trade receivables are non-interest bearing and are generally settled within 30 to 45 days. The contract liabilities contain upfront payments and milestone payments from Collaboration agreements.
3.2 Cost of sales
The cost of sales consists of the following:
| Three months ended March 31, | |||
2021 |
| 2022 | ||
EUR k | EUR k | |||
Personnel |
| ( | ( | |
Materials |
| ( | ( | |
Third-party services |
| ( | ( | |
Maintenance and lease |
| ( | ( | |
Amortization and depreciation |
| ( | ( | |
Other |
| ( | ( | |
Total |
| ( | ( |
During the three months ended March 31, 2022, cost of sales mainly increased compared to the same period of 2021 due to increased write-offs for raw materials, which were procured for manufacture into products to sell to GSK are now no longer expected to be purchased.
3.3 Selling and distribution expenses
Selling and distribution expenses consist of the following:
| Three months ended March 31, | |||
2021 |
| 2022 | ||
EUR k | EUR k | |||
Personnel |
| ( | ( | |
Amortization and depreciation |
| ( | ( | |
Other |
| ( | ( | |
Total |
| ( | ( |
Personnel expenses mainly include salary and salary-related expenses, during the three months ended March 31, 2022 of EUR
3.4 Research and development expenses
R&D expenses consists of the following:
| Three months ended March 31, | |||
2021 |
| 2022 | ||
EUR k | EUR k | |||
Materials |
| ( | ( | |
Personnel |
| ( | ( | |
Amortization and depreciation |
| ( | ( | |
Patents and fees to register a legal right |
| ( | ( | |
Third-party services |
| ( | | |
Maintenance and lease |
| ( | ( | |
Other |
| ( | ( | |
Total |
| ( | ( |
During the three months ended March 31, 2022, research and development expenses decreased in comparison to the same period of 2021. The reason is that 2021 was highly impacted by the Group´s CVnCoV program. In prior year, these expenses consist primarily of cost incurred to CROs involved in the CVnCoV development as well as materials used in the administration of clinical trials. As a result of renegotiations, the estimated outstanding costs for the CVnCoV studies decreased resulting in reversal of provision for onerous contracts in the amount of EUR
Personnel expenses mainly include salary and salary-related expenses, during the three months ended March 31, 2022 of EUR
3.5 General and administrative expenses
General and administrative expenses consist of the following:
Three months ended March 31, | ||||
2021 |
| 2022 | ||
| EUR k |
| EUR k | |
Personnel |
| ( | ( | |
Maintenance and lease |
| ( | ( | |
Third-party services |
| ( | ( | |
Legal and other professional services |
| ( | ( | |
Amortization and depreciation |
| ( | ( | |
Other |
| ( | ( | |
Total |
| ( | ( |
Personnel expenses mainly include salary and salary-related expenses, during the three months ended March 31, 2022, of EUR
3.6 Other operating income
Three months ended March 31, | ||||
2021 |
| 2022 | ||
| EUR k |
| EUR k | |
Compensation for CMO transfer | — | | ||
Grants and other cost reimbursements from government agencies and similar bodies | | | ||
Other |
| | | |
Total |
| | |
In March 2022, CureVac AG and GlaxoSmithKline Biologicals SA amended and restated the 2020 GSK agreement and the GSK COVID Agreement in connection with GSK entering into a direct agreement with Novartis for use of Novartis as a CMO at the same time as CureVac exits its CMO agreement with Novartis. Additionally, under the restated agreement, CureVac is entitled to further compensation by GSK. The compensations mainly consist of a consideration for set-up activities undertaken by CureVac (EUR
During the three months ended March 31, 2022 and 2021, income from grants with government agencies and similar bodies resulted from the following:
German Federal Ministry of Education and Research (BMBF)
In 2020, the Company received a grant from BMBF to support the development of its COVID-19 vaccine candidate for which it was determined that the arrangement contained two components: a grant component (in the scope of IAS 20) and a supply component (in the scope of IFRS 15). The grant terminated in 2021. With regard to the grant component, during the three months ended March 31, 2021, the Group has recognized grant income in the amount of EUR
Coalition for Epidemic Preparedness Innovations (CEPI)
In January 2020, CureVac and CEPI entered into a collaboration to develop a vaccine against the new coronavirus SARS-CoV-2. The aim of the cooperation is to safely advance vaccine candidates into clinical testing as quickly as possible. The agreement builds upon the existing partnership between CureVac and CEPI to develop a rapid-response vaccine platform and included additional initial funding of up to USD
For the three months ended March 31, 2022, CureVac recognized the reimbursement by CEPI of approved expenses of EUR
Bill & Melinda Gates Foundation (BMGF)
For the three months ended March 31, 2021, CureVac recognized EUR
4. Issued Capital and Reserves
According to the Company’s articles of association, the Company’s authorized shares are divided into
As of March 31, 2022,
All payments received from shareholders in excess of the nominal value of the shares issued and net of transaction costs are recognized in capital reserves. Capital reserves also consists of recognition of share-based payments and the equity components of convertible loans. The Company may only make distributions, whether a distribution of profits or of freely distributable reserves, to shareholders to the extent shareholders’ equity exceeds the sum of the paid-in and called-up share capital plus any reserves required by Dutch law or by the Company’s articles of association.
The number of shares issued and outstanding developed as follows:
Common shares issued and outstanding at December 31, 2021 |
| |
Share option exercises between Jan and March 2022 | | |
Treasury shares | ( | |
Common shares issued and outstanding at March 31, 2022 | |
5. Share-based payments
During the three months ended March 31, 2022 and 2021, the Group recognized share-based based payments expenses of EUR
Three months period ended March 31:
| 2021 |
| 2022 | |
EUR k | EUR k | |||
Research and development expenses |
| | | |
Sales and marketing expenses |
| | | |
General and administrative expenses |
| | | |
Total |
| | |
Expense recognized for the equity-settled programs was as follows:
Three months ended March 31:
Program |
| 2021 |
| 2022 |
EUR k | EUR k | |||
LTIP | | | ||
RSU | — | | ||
New VSOP | | | ||
Prior VSOP |
| | | |
Total |
| | |
On November 16, 2020, CureVac granted
On July 1, 2021, CureVac granted
On March 1, 2022, CureVac granted
The expenses recognized for employee services received under the LTIP during the three months ended March 31, 2022, is in an amount of EUR
In 2021, as part of the LTIP program, the group awarded RSUs (restricted stock units) to senior executives as well as supervisory board members. On June 24, 2021, the group awarded
The related RSU expense is recorded in the functional cost category to which the award recipient’s costs are classified.
On February 10, 2022, CureVac awarded
The remaining expense results from additional grants under the New VSOP and continued vesting of grants under the Prior VSOP.
Exercise of share-based payments
Refer to Note 4 regarding the exercise of certain virtual shares during the three months ended March 31, 2022.
For the New VSOP plan, the IPO was a triggering event, by which all outstanding options, under the plan, became exercisable;
6. Fixed Assets
6.1 Intangible assets
During the three months ended March 31, 2022, the Group acquired intangible assets of EUR
6.2 Property, plant and equipment
During the three months ended March 31, 2022, the increase in property, plant and equipment was due primarily to the purchase of technical equipment and machines and other equipment of EUR
recognized as construction in progress of EUR
7. Inventories
Inventories include the following:
| December 31, 2021 |
| March 31, 2022 | |
EUR k | EUR k | |||
Raw materials |
| | | |
Finished goods |
| — | — | |
Total |
| | |
During the three months ended March 31, 2022, the decrease in inventory of EUR
8. Prepaid expenses and other assets (current)
Prepaid expenses and other current assets as of March 31, 2022 amounted to EUR
9. Financial assets and financial liabilities
Fair values of cash and cash equivalents, trade receivables, trade payables, and other current liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.
There were
10. Trade and other payables
During the three months ended March 31, 2022, the decrease of EUR
11. Other liabilities
During the three months ended March 31, 2022, the decrease of EUR
12. Loans
As of March 31, 2021, CureVac had drawn the first of the three tranches of the EIB loan received in June 2020 and, thus, EUR
During the year ended December 31, 2021, CureVac decided to early terminate the EIB loan for a total cash consideration of EUR
13. Income tax
The Group calculates the interim income tax benefit or expense using the best estimate of the weighted average annual effective income tax rate expected for the full financial year.
For the three months ended March 31, 2022 and 2021, the Group recorded a consolidated income tax benefit (March 31, 2021: tax expense) EUR
14. Disclosure of financial instruments and risk management
As the Group requires significant liquid funds available for the financing of its COVID-19 and influenza research and development activities, during the three months ended March 31, 2022, it has maintained funds as cash and cash equivalents and not in less liquid financial instruments. The Group has distributed the cash amongst several banks and amongst the legal entities in the Group in order to reduce negative interest penalties.
Refer to note 15 to the consolidated financial statements as of December 31, 2021 for additional information on the Group’s risk management activities. As of March 31, 2022, the Group held cash and cash equivalents of USD
15. Earnings per share
Earnings per share is calculated pursuant to IAS 33 Earnings per Share by dividing the consolidated net loss in CureVac N.V. by the average weighted number of shares outstanding in the fiscal period, retrospectively adjusted for the effect of the corporate reorganization.
The weighted number of shares outstanding for the three months ended March 31, 2022 was
16. Related party disclosures
Dietmar Hopp
During fiscal 2019, Dietmar Hopp, principal of dievini Hopp BioTech holding GmbH & Co. KG (dievini), the largest shareholder of the Group, granted
Antony Blanc
In 2020, a consulting agreement between CureVac AG and Clarentis SRL was made. Clarentis SRL is a wholly owned consulting company of Antony Blanc, PhD, the CBO of CureVac. After the transition of Antony Blanc to the Management Board in February 2021, the contract was no longer active and no new orders were placed. In Q3 2021, a milestone payment, which related to the submission of the EMA dossier for CVnCoV, and amounts to EUR
BePharBel Manufacturing S.A.
In December 2020, CureVac Real Estate GmbH and BePharBel Manufacturing S.A., entered into a commercial supply agreement to develop and manufacture the diluent that was expected to be used to dilute the Group’s first concentrated COVID-19 vaccine candidate, CVnCoV, to the amount specified by each dose level. Pursuant to the terms of the agreement, it was intended that BePharBel Manufacturing would manufacture and deliver to CureVac Real Estate GmbH a low seven figure amount of commercial batches of diluent per year, in 2021 and 2022. Following the withdrawal of the CVnCoV in October 2021 due to COVID-19 virus drift, WHO COVID vaccine efficiency recommendation and market expectations, CureVac Real Estate GmbH terminated the commercial and supply agreement with BePahrBel and entered into negotiations on a structured and rapid wind-down of the ordered production. The Parties agreed on a settlement in May 2022 of all claims resulting from the commercial and supply agreement for an amount of €
board member, holds directly and indirectly
17. Subsequent events
In April 2022, the Company and GSK entered into a contract with the German federal government to supply mRNA vaccines within a broader tender for pandemic preparedness in Germany. Following a setup period of a maximum of two years, the contract grants the German federal government access to CureVac’s manufacturing capacity until 2029, enabling rapid availability of