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consolidated statements of comprehensive income/(loss) (in thousands)
| For the three months ended September 30 | For the nine months ended September 30 | |||||||||||||||||||
| Note | 2019 | 2018 | 2019 | 2018 | ||||||||||||||||
| Revenue | 3 | 2,103 | 306 | 17,464 | 988 | |||||||||||||||
| Other income net | 49 | (259 | ) | 332 | (221 | ) | ||||||||||||||
| Research and development expenses | (11,721 | ) | (9,787 | ) | (31,253 | ) | (23,332 | ) | ||||||||||||
| General and administrative expenses | (2,790 | ) | (2,389 | ) | (7,566 | ) | (6,591 | ) | ||||||||||||
| Operating income / (loss) | (12,359 | ) | (12,129 | ) | (21,023 | ) | (29,156 | ) | ||||||||||||
| Finance income / (costs) net | 4 | 1,475 | 109 | 1,655 | 920 | |||||||||||||||
| Loss before tax | (10.884 | ) | (12,020 | ) | (19,368 | ) | (28,236 | ) | ||||||||||||
| Income taxes | 0 | 0 | (4 | ) | (1 | ) | ||||||||||||||
| Loss for the period | (10,884 | ) | (12,020 | ) | (19,372 | ) | (28,237 | ) | ||||||||||||
| Other comprehensive income / (loss) Items that will not be reclassified to profit or loss Equity investments at fair value OCI net change in fair value | 5 | (555 | ) | 53 | (531 | ) | 264 | |||||||||||||
| Other comprehensive income / (loss) | (555 | ) | 53 | (531 | ) | 264 | ||||||||||||||
| Total comprehensive loss | (11,439 | ) | (11,967 | ) | (19,903 | ) | (27,973 | ) | ||||||||||||
| Loss per share in per share | (0.17 | ) | (0.19 | ) | (0.31 | ) | (0.47 | ) | ||||||||||||
| (undiluted = diluted) | ||||||||||||||||||||
| Weighted number of common shares outstanding | 62,443,550 | 62,400,484 | 62,437,673 | 59,876,197 |
The Notes are an integral part of these consolidated financial statements.
Consolidated statements of financial position (in thousands)
| September 30, 2019 | December 31, 2018 | |||||||||
| (unaudited) | ||||||||||
| ASSETS | Note | |||||||||
| Non-current assets | ||||||||||
| Intangible assets | 149 | 56 | ||||||||
| Leasehold improvements and equipment | 2,021 | 1,414 | ||||||||
| Long term financial assets | 5 | 3,294 | 3,825 | |||||||
| Right-of-use assets | 2 | 556 | 0 | |||||||
| 6,020 | 5,295 | |||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 59,995 | 94,829 | ||||||||
| Financial assets | 6 | 16,530 | 13,974 | |||||||
| Trade and other receivables | 1,184 | 1,429 | ||||||||
| Inventories | 330 | 260 | ||||||||
| Other assets | 1,491 | 387 | ||||||||
| 79,530 | 110,879 | |||||||||
| TOTAL ASSETS | 85,550 | 116,174 | ||||||||
| EQUITY AND LIABILITIES | ||||||||||
| Equity | ||||||||||
| Issued capital | 624 | 624 | ||||||||
| Capital reserves | 241,062 | 239,055 | ||||||||
| Fair value reserves | 2,063 | 2,594 | ||||||||
| Accumulated deficit | (221,516 | ) | (202,144 | ) | ||||||
| Total equity | 7 | 22,233 | 40,129 | |||||||
| Non-current liabilities | ||||||||||
| Borrowings | 10 | 300 | 1,690 | |||||||
| Contract liabilities | 33,672 | 37,512 | ||||||||
| Lease liabilities | 192 | 0 | ||||||||
| Total non-current liabilities | 34,164 | 39,202 | ||||||||
| Current liabilities | ||||||||||
| Trade and other payables | 7,633 | 9,425 | ||||||||
| Provisions | 9 | 1,131 | 0 | |||||||
| Borrowings | 10 | 2,960 | 3,083 | |||||||
| Lease liabilities | 337 | 0 | ||||||||
| Contract liabilities | 17,092 | 24,335 | ||||||||
| Total current liabilities | 29,153 | 36,843 | ||||||||
| TOTAL EQUITY AND LIABILITIES | 85,550 | 116,174 |
The Notes are an integral part of these consolidated financial statements.
Unaudited consolidated statements of cash flows (in thousands)
| For the nine months ended September 30 | ||||||||||||
| Note | 2019 | 2018 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (19,372 | ) | (28,237 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 4 | 1 | ||||||||||
| - Depreciation and amortization | 648 | 303 | ||||||||||
| - Net gain from disposal of leasehold improvements and equipment | (9 | ) | 15 | |||||||||
| - Share based payments | 8 | 1,981 | 1,523 | |||||||||
| - Finance income / costs net | 4 | (1,655 | ) | (920 | ) | |||||||
| (18,403 | ) | (27,315 | ) | |||||||||
| Change in trade and other receivables | 458 | (344 | ) | |||||||||
| Change in inventories | (70 | ) | (79 | ) | ||||||||
| Change in other assets | (1,104 | ) | (549 | ) | ||||||||
| Change in trade, other payables, provisions and contract liabilities | (11,727 | ) | 3,473 | |||||||||
| Cash used in operating activities | (30,846 | ) | (24,814 | ) | ||||||||
| Interest received | 413 | 159 | ||||||||||
| Paid interest | (180 | ) | (268 | ) | ||||||||
| Paid income tax | 0 | (1 | ) | |||||||||
| Net cash used in operating activities | (30,613 | ) | (24,924 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (143 | ) | (27 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (926 | ) | (448 | ) | ||||||||
| Cash received from the sale of leasehold improvements and equipment | 0 | 1 | ||||||||||
| Cash paid for investments in financial assets | (39,733 | ) | 0 | |||||||||
| Cash received from maturity of financial assets | 38,270 | 0 | ||||||||||
| Net cash used for investing activities | (2,532 | ) | (474 | ) | ||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 26 | 25,110 | ||||||||||
| Transaction costs related to issue of common shares | 0 | (1,702 | ) | |||||||||
| Proceeds from borrowings | 10 | 562 | 0 | |||||||||
| Repayment of lease liabilities | (299 | ) | 0 | |||||||||
| Repayment of borrowings | 10 | (2,339 | ) | (2,250 | ) | |||||||
| Cash flow from financing activities | (2,050 | ) | 21,158 | |||||||||
| Exchange-rate related changes of cash and cash equivalents | 361 | 1,479 | ||||||||||
| Net changes to cash and cash equivalents | (35,195 | ) | (4,240 | ) | ||||||||
| Cash and cash equivalents at the beginning of the period | 94,829 | 39,837 | ||||||||||
| Cash and cash equivalents at the end of the period | 59,995 | 37,076 |
The Notes are an integral part of these consolidated financial statements.
Unaudited consolidated statements of changes in equity (in thousands)
| Note | Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||||||||||||||||
| Balance as of January 1, 2018 | 468 | 213,778 | 7,325 | (182,667 | ) | 38,904 | ||||||||||||||||||
| Issue of common shares | 156 | 23,170 | 23,326 | |||||||||||||||||||||
| Exercise of share based payment awards | 68 | 68 | ||||||||||||||||||||||
| Equity-settled share based payment awards | 8 | 1,523 | 1,523 | |||||||||||||||||||||
| Loss for the period | (28,237 | ) | (28,237 | ) | ||||||||||||||||||||
| Other comprehensive income | 264 | 264 | ||||||||||||||||||||||
| Balance as of September 30, 2018 | 624 | 238,539 | 7,589 | (210,904 | ) | 35,848 | ||||||||||||||||||
| Balance as of January 1, 2019 | 624 | 239,055 | 2,594 | (202,144 | ) | 40,129 | ||||||||||||||||||
| Exercise of share based payment awards | 26 | 26 | ||||||||||||||||||||||
| Equity-settled share based payment awards | 8 | 1,981 | 1,981 | |||||||||||||||||||||
| Loss for the period | (19,372 | ) | (19,372 | ) | ||||||||||||||||||||
| Other comprehensive income | (531 | ) | (531 | ) | ||||||||||||||||||||
| Balance as of September 30, 2019 | 624 | 241,062 | 2,063 | (221,516 | ) | 22,233 |
The Notes are an integral part of these consolidated financial statements.
Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands. The
consolidated financial statements are comprised of Affimed N.V., and its controlled (and wholly owned) subsidiaries Affimed GmbH, Heidelberg, Germany, AbCheck s.r.o., Plzen, Czech Republic, Affimed Inc., Delaware, USA and AbCheck Inc.,
Delaware, USA (together Affimed , the Company or the Group ).
Affimed is a clinical-stage biopharmaceutical company
focused on discovering and developing highly targeted cancer immunotherapies. The Group s product candidates are developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the
body s own immune defenses to fight tumor cells. Affimed has its own research and development programs, strategic collaborations and service contracts, where the Group is performing research services for third parties.
The interim financial statements for the three and nine months ended September 30, 2019 and 2018 have been prepared in accordance with IAS 34 Interim
Financial Reporting. The interim financial statements do not include all the information and disclosures required in the annual financial statements and should be read in conjunction with Affimed N.V. s annual consolidated financial statements
as of December 31, 2018.
The interim financial statements were authorized for issuance by the management board on November 19, 2019.
The preparation of the interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the
application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting
estimates are recognized in the period in which the estimates are revised and in any future periods affected.
In preparing these interim financial statements, the critical judgments made by management in applying the
Company s accounting policies were the same as those that applied to the consolidated financial statements as at and for the year ended December 31, 2018 except for the following:
As a result of the first-time adoption of IFRS 16 on January 1, 2019, the Company recognized right-of-use assets of 0.7 million. The right-of-use model requires management to make significant judgements related
to extension and termination options as well as the applied discount rate.
In the second quarter of 2019, Affimed decided to terminate the Phase 1
clinical program of AFM11, a CD19/CD3-targeting bispecific T cell engager as a part of its strategic plans (see note 9).
Functional and presentation currency
financial statements are presented in Euros, which is the Company s functional currency. All financial information presented in Euros has been rounded to the nearest thousand (abbreviated ) or million (abbreviated million).
Significant accounting policies
policies applied by the Company in these interim financial statements are the same as those applied by the Company in its consolidated financial statements as at and for the year ended December 31, 2018, with the exception of new amendments to
standards and new or amended interpretations applied for the first time as described below.
New standards and interpretations applied for the first
The following amendments to standards and new or amended interpretations are effective for annual periods beginning on or after January 1,
2019, and have been applied in preparing these financial statements:
| Standard/interpretation | Effective Date | |
| IFRS 16 Leases | January 1, 2019 | |
| Amendments to IFRS 9: Prepayment Features With | ||
| Negative Compensation | January 1, 2019 | |
| Amendments to IAS 28: Long-Term Interests in | ||
| Associates and Joint Ventures | January 1, 2019 | |
| Annual Improvements to IFRS Standards 2015-2017 Cycle | January 1, 2019 | |
| Amendments to IAS 19: Plan Amendment, Curtailment or Settlement | January 1, 2019 | |
| IFRIC 23 Uncertainty Over Income Tax Treatments | January 1, 2019 |
Affimed has applied IFRS 16 using the modified retrospective approach, under which the cumulative effect of initial
application is recognized in retained earnings as of January 1, 2019. Accordingly, any comparative information presented for any periods in 2018 has not been restated i.e. it is presented, as previously reported, under IAS 17 and related
interpretations. The nature and effect of the application of IFRS 16 are summarized below.
The other amendments had no effect on the interim consolidated financial statements of the Company.
The new standard specifies how to recognize, measure, present and disclose lease agreements. The standard provides a single lessee accounting model, requiring
lessees to recognize right-of-use assets representing its rights to use the underlying assets and lease liabilities representing its obligation to make lease payments.
Lessor accounting remains similar to previous accounting policies.
Under IAS 17, Affimed determined at contract inception whether an arrangement was or
contained a lease under IFRIC 4 Determining Whether an Arrangement contains a Lease. Under IFRS 16, Affimed now assesses whether a contract is or contains a lease based on the new definition of a lease. This definition says that a contract is
or contains a lease if the contract conveys a right to control the use of an identified asset for a period of time in exchange for consideration.
On transition to IFRS 16, Affimed elected to
apply the practical expedient to grandfather the assessment of which transactions are leases. It applied IFRS 16 only to contracts that were previously identified as leases. Contracts that were previously not identified as leases were not
As a lessee, Affimed previously classified leases as operating or finance leases based on its assessment of whether the lease transferred
substantially all of the risks and rewards of ownership. Under IFRS 16, Affimed recognizes right-of-use assets and lease liabilities for most leases i.e. these
leases are on-balance sheet.
At transition, for leases classified as operating leases under IAS 17, lease
liabilities were measured at the present value of the remaining lease payments, discounted at the Company s incremental borrowing rates for similar assets as of January 1, 2019. Right-of-use assets are measured at an amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments.
However, Affimed has elected not to recognize right-of-use assets and lease
liabilities for some short-term leases (leases with less than 12 months of lease term). Lease payments associated with these leases are recognized as an expense on a straight-line basis over the lease term.
Affimed presents right-of-use assets in a separate line item from the line
item Leasehold improvements and equipment that presents other assets of the same nature that Affimed owns. The carrying amounts of right-of-use assets are
| January 1 to September 30, 2019 | Carrying amount | |||||||||||
| Buildings | Cars | Total | ||||||||||
| Balance as of January 1, 2019 | 695 | 22 | 717 | |||||||||
| Balance as of September 30, 2019 | 543 | 13 | 556 |
Significant Accounting Policies
Affimed recognizes a right-of-use asset and a lease liability at the lease
commencement date. The right-of-use asset is initially measured at cost, and subsequently at cost less any accumulated depreciation and impairment losses and adjusted
for certain remeasurements of the lease liability.
The lease liability is initially measured at the present value of the lease payments that are not paid
at the commencement date, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, Affimed s incremental borrowing rate. Generally, Affimed uses its incremental borrowing rate as the discount rate.
The lease liability is subsequently increased by the interest cost on the lease liability and decreased by lease payments made. It is remeasured when
there is a change in future lease payments arising from a change in an index or rate, a change in the estimate of the amount expected to be payable under a residual value guarantee, or as appropriate, changes in the assessment of whether a purchase
or extension option is reasonably certain to be exercised or a termination option is reasonably certain not to be exercised.
judgement to determine the lease term for some lease contracts in which it is a lessee that include renewal options. The assessment of whether Affimed is reasonably certain to exercise such options impacts the lease term, which significantly affects
the amount of lease liabilities and right-of-use assets recognized.
Impacts on Transition
On transition to IFRS 16, the
Company recognized additional right-of-use assets, including property, plant and equipment and additional lease liabilities. The impact on transition is summarized
| January 1, 2019 | ||||
| Right-of-use assets | 717 | |||
| Lease liabilities | 717 |
The Group discounted lease payments using a weighted average discount rate of 4.05% as of January 1, 2019.
In relation to those leases under IFRS 16, Affimed has recognized depreciation and interest costs, instead of operating lease expense. During the nine months
ended September 30, 2019, the Group recognized depreciation expense for right-of-use assets of 272 and interest cost related to the lease liability of
18 instead of operating lease expense of 290.
The transition between operating lease commitments disclosed applying IAS 17 as of
December 31, 2018 and the lease liabilities recognized in the statement of financial position at the date of initial application, January 1, 2019, is shown below.
| January 1, 2019 | ||||
| Operating lease commitment as of December 31, 2018 | 1,154 | |||
| Recognition exemption for short-term leases | (98 | ) | ||
| Payments for incidental rental costs and other rental payments (Not part of the lease) | (312 | ) | ||
| Discounting using the incremental borrowing rate as of January 1, 2019 | (27 | ) | ||
| Lease liabilities as of January 1, 2019 | 717 |
All assets and liabilities for which fair value is recognized in the interim financial statements are classified in accordance with the following fair value
hierarchy, based on the lowest level input parameter that is significant on the whole for fair value measurement:
The carrying amount of all trade and
other receivables, certificates of deposit, cash and cash equivalents, trade and other payables and provisions is a reasonable approximation of the fair value and therefore information about the fair values of those financial instruments has not
been disclosed. The measurement of the fair value of the shares held by the Group and note disclosure for the fair value of a loan (financial liability) is based on level 2 measurement procedures (see notes 5 and 10).
The following standards, amendments to standards and interpretations are effective for annual periods beginning after December 31, 2018 and have not been
applied in preparing these consolidated financial statements.
| Standard/interpretation | Effective Date | |
| Amendments to References to the Conceptional Framework | January 1, 2020 | |
| Amendments to IAS 1 and IAS 8: Definition of Material | January 1, 2020 |
Collaboration agreement The Leukemia & Lymphoma Society ( LLS )
Affimed is party to a collaboration with LLS to fund the development of a specific product candidates (immune cell engagers). Under the terms of the agreement,
LLS has agreed to contribute up to $4.4 million contingent upon the achievement of certain milestones.
In the event that the research and
development is successful, Affimed must proceed with commercialization of the licensed product. If Affimed decides for business reasons not to continue the commercialization, Affimed must at its option either repay the amount funded or grant a
license to LLS to enable LLS to continue with the development program. In addition, LLS is entitled to receive royalties from Affimed based on the Group s future revenue from any licensed product, with the amount of royalties not to exceed
three times the amount funded.
In June 2016, the research funding agreement with LLS was amended to reflect a shift to the development of