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    AFMD   NL0010872420

AFFIMED N.V.

(AFMD)
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AFFIMED N : UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS (Form 6-K)

09/08/2021 | 08:02am EDT

AFFIMED N.V.

UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

Unaudited interim consolidated statements of comprehensive income / (loss)

(in € thousand)

For the three months

For the six months

ended June 30

ended June 30

Note

2021

2020

2021

2020

Revenue

3

9,707

2,934

21,366

8,069

Other income - net

332

85

479

28

Research and development expenses

(21,800)

(11,697)

(33,205)

(23,146)

General and administrative expenses

(5,439)

(2,606)

(9,925)

(6,131)

Operating loss

(17,200)

(11,284)

(21,285)

(21,180)

Finance income / (costs) - net

4

(1,552)

(954)

3,947

653

Loss before tax

(18,752)

(12,238)

(17,338)

(20,527)

Income taxes

0

0

(2)

0

Loss for the period

(18,752)

(12,238)

(17,340)

(20,527)

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

(4,097)

(71)

(5,349)

10

Other comprehensive income / (loss)

(4,097)

(71)

(5,349)

10

Total comprehensive income / (loss)

(22,849)

(12,309)

(22,689)

(20,517)

Earnings / (loss) per share in € per share (undiluted = diluted)

(0.16)

(0.16)

(0.15)

(0.26)

Weighted number of common shares outstanding

119,645,207

79,189,686

117,924,831

77,719,793

The Notes are an integral part of these condensed interim consolidated financial statements.

Unaudited interim consolidated statements of financial position

(in € thousand)

Note

June 30,

December 31,

2021

2020

(unaudited)

ASSETS

Non-current assets

Intangible assets

1,661

1,718

Leasehold improvements and equipment

3,447

2,226

Long term financial assets

5

14,693

20,042

Right-of-use assets

1,036

940

20,837

24,926

Current assets

Cash and cash equivalents

222,676

146,854

Trade and other receivables

6

3,763

2,439

Inventories

612

246

Other assets

7

135

1,260

227,186

150,799

TOTAL ASSETS

248,023

175,725

EQUITY AND LIABILITIES

Equity

Issued capital

1,197

983

Capital reserves

446,525

345,164

Fair value reserves

(3,629)

1,720

Accumulated deficit

(293,214)

(275,874)

Total equity

8

150,879

71,993

Non current liabilities

Borrowings

10

10,025

231

Contract liabilities

3

19,361

35,992

Lease liabilities

601

482

Total non-current liabilities

29,987

36,705

Current liabilities

Trade and other payables

15,838

11,394

Borrowings

10

93

92

Lease liabilities

523

492

Contract liabilities

3

50,703

55,049

Total current liabilities

67,157

67,027

TOTAL EQUITY AND LIABILITIES

248,023

175,725

The Notes are an integral part of these condensed interim consolidated financial statements.

Unaudited interim consolidated statements of cash flows

(in € thousand)

For the six months ended

June 30

Note

2021

2020

Cash flow from operating activities

Loss for the period

(17,340)

(20,527)

Adjustments for the period:

- Income taxes

2

0

- Depreciation and amortisation

624

551

- Share based payments

9

4,695

1,410

- Finance income / costs - net

4

(3,947)

(653)

(15,966)

(19,219)

Change in trade and other receivables

(1,324)

(649)

Change in inventories

(366)

(125)

Change in other assets

924

0

Change in trade, other payables, provisions and contract liabilities

(16,262)

(11,757)

Cash used in operating activities

(32,994)

(31,750)

Interest received

0

276

Paid interest

(377)

(64)

Paid income tax

(2)

0

Net cash used in operating activities

(33,373)

(31,538)

Cash flow from investing activities

Purchase of intangible assets

(5)

(2)

Purchase of leasehold improvements and equipment

(1,502)

(174)

Cash paid for investments in financial assets

0

(8,101)

Cash received from maturity of financial assets

0

9,088

Net cash used for investing activities

(1,507)

811

Cash flow from financing activities

Proceeds from issue of common shares, including exercise of share based payment awards

8

103,242

21,785

Transaction costs related to issue of common shares

8

(6,447)

(754)

Proceeds from borrowings

10

10,000

0

Transaction costs related to borrowings

(236)

0

Repayment of lease liabilities

(228)

(257)

Repayment of borrowings

(46)

(1,128)

Cash flow from financing activities

106,285

19,646

Exchange-rate related changes of cash and cash equivalents

4,417

431

Net changes to cash and cash equivalents

71,405

(11,081)

Cash and cash equivalents at the beginning of the period

146,854

95,234

Cash and cash equivalents at the end of the period

222,676

84,584

The Notes are an integral part of these condensed interim consolidated financial statements.

Unaudited interim consolidated statements of changes in equity

(in € thousand)

Issued

Capital

Fair Value

Accumulated

Total

Note

capital

reserves

reserves

deficit

equity

Balance as of January 1, 2020

762

270,451

1,962

(234,508)

38,667

Issue of common shares

83

20,859

20,942

Equity-settled share based payment awards

9

1,410

1,410

Loss for the period

(20,527)

(20,527)

Other comprehensive income

10

10

Balance as of June 30, 2020

845

292,720

1,972

(255,035)

40,502

Balance as of January 1, 2021

983

345,164

1,720

(275,874)

71,993

Issue of common shares

8

205

94,135

94,340

Exercise of share based payment awards

9

2,531

2,540

Equity-settled share based payment awards

9

4,695

4,695

Loss for the period

(17,340)

(17,340)

Other comprehensive income

(5,349)

(5,349)

Balance as of June 30, 2021

1,197

446,525

(3,629)

(293,214)

150,879

The Notes are an integral part of these condensed interim consolidated financial statements.

1. Reporting entity

Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands.

The condensed interimconsolidated 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 (collectively '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.

2. Basis of preparation and changes to Group's accounting policies

Statement of compliance

The condensed interim consolidated financial statements (referred to as 'interim financial statements') for the three and six months ended June 30, 2021 and 2020 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 consolidated annual financial statements, and should be read in conjunction with Affimed N.V.'s annual consolidated financial statements as of December 31, 2020.

The interim financial statements were authorized for issuance by the management board on September 8, 2021.

Critical judgments and accounting estimates

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 of and for the year ended December 31, 2020.

Functional and presentation currency

These interim financial statements are presented in Euro. The functional currency of the Group's subsidiaries is also the Euro. All financial information presented in Euro has been rounded to the nearest thousand (abbreviated €) or million (abbreviated € million).

Significant accounting policies

The accounting policies applied by the Group in these interim financial statements are the same as those applied by the Group in its consolidated financial statements as of and for the year ended December 31, 2020.

New standards and interpretations applied for the first time

The following new standards and amendments to standards have not been applied in preparing these consolidated financial statements.

Standard/interpretation

Effective Date

Amendments to IFRS 3 Business Combinations

January 1, 2022

Amendments to IAS 16 Property, Plant and Equipment

January 1, 2022

Amendments to IAS 37 Provisions, Contingent Liabilities and Contingent Assets

January 1, 2022

Annual Improvements 2018-2020

January 1, 2022

Amendments to IAS 1 Presentation of Financial Statements:

Classification of Liabilities as Current or Non-current

January 1, 2023

Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of Accounting policies

January 1, 2023

Amendments to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates

January 1, 2023

Amendments to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction

January 1, 2023

The amended standards are not expected to have a significant effect on the consolidated financial statements of the Group.

Fair Value Measurement

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:

Level 1 - Prices for identical assets or liabilities quoted in active markets (non-adjusted)
Level 2 - Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is directly or indirectly observable for on the market
Level 3 - Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is not directly or indirectly observable for on the market

The carrying amount of all trade and other receivables, other assets, certificates of deposit, cash and cash equivalents and trade and other payables 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 3 and 2 measurement procedures, respectively (see notes 5 and 9).

3. Revenue

Collaboration agreement The Leukemia & Lymphoma Society (LLS)

Affimed is party to a collaboration with LLS to fund the development of specific product candidates (immune cell engagers). Under the terms of the agreement, LLS has agreed to contribute up to $4.4million 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 combination therapeutic approaches so that the milestones now relate primarily to the development of a combination therapy.

During the six months ended June 30, 2021, the Company did not recognize any revenue in this regard (2020: €0.1million).

Collaboration with Genentech Inc.

In August 2018, Affimed entered into a strategic collaboration agreement with Genentech Inc., headquartered in South San Francisco, USA. Under the terms of the agreement Affimed is providing services related to the development of novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the beginning of October 2018. Under the terms of the agreement, Affimed received $96.0million (€83.2million) in initial upfront and committed funding on October 31, 2018.

The Group recognized €3.6million and €12.0million as revenue during the three and six months ended June 30, 2021 (2020: €2.7million and €7.6million). As of June 30, 2021, the Group heldcontract liabilities of €29.9million (December 31, 2020: €41.9million), which will be recognized as revenue in subsequent periods as services are provided.

Under the terms of the agreement, Affimed is eligible to receive up to an additional $5.0billion over time, including payments upon achievement of specified development, regulatory and commercial milestones. Affimed is also eligible to receive royalties on any potential sales. During the second quarter of 2021, Genentech Inc. has informed Affimed that the Phase 1 study of RO7297089 (anti-BCMA/CD16A) was discontinued. A portion of these potential milestone payments are associated with that molecule. This has no impact on the current contract liabilities and future revenue of €29.9million.

Collaboration with Roivant Sciences Ltd.

On November 9, 2020, Affimed and Pharmavant 6 GmbH, a subsidiary of Roivant Sciences Ltd., announced a strategic collaboration agreement which grants Roivant a license to the preclinical molecule AFM32. Under the terms of the agreement, Affimed received $60million in upfront consideration, comprised of $40million in cash and pre-funded research and development funding, and $20million of common shares in Roivant. Affimed is eligible to receive additional proceeds in the form of option fees contingent on the commencement of additional programs contemplated under the agreement. The Company is eligible to receive up to an additional $2billion in milestone payments over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

For the three and six months ended June 30, 2021 the Group has recognized €5.9million and €8.9million as revenue and held €40.1million under contract liabilities as of June 30, 2021 (December 31, 2020: €49.0million), which is recognized as revenue in subsequent periods as services are provided.

Research service agreements

The Group, through its subsidiary AbCheck s.r.o., has entered into certain research service agreements. These research service agreements provide for non-refundable upfront technology access research funding or capacity reservation fees and milestone payments. The Group recognized €0.2million and €0.5million as revenue in the three and six months ended June 30, 2021 (2020: €0.2million and €0.4million).

Contract balances

The following table provides information about receivables and contract liabilities from contracts with customers.

June 30, 2021

December 31, 2020

Receivables

393

0

Contract liabilities

70,064

91,041

Amounts of €9.5million and €20.9million recognized in contract liabilities at the beginning of the period have been recognized as revenue during the three and six months ended June 30, 2021, in respect of Genentech and Roivant.

The remaining performance obligations as of June 30, 2021 are approximately €70million and are expected to be recognized as revenue to a large extent over the next two years.

Disaggregation of revenue

Geographic information

Three months

Three months

Six months

Six months

ended

ended

ended

ended

June 30, 2021

June 30, 2020

June 30, 2021

June 30, 2020

Revenue:

Germany

222

0

458

75

Europe

0

0

0

2

USA

9,485

2,934

20,908

7,992

9,707

2,934

21,366

8,069

Major service lines

Three months

Three months

Six months

Six months

ended

ended

ended

ended

June 30, 2021

June 30, 2020

June 30, 2021

June 30, 2020

Collaboration revenue

9,485

2,793

20,888

7,716

Service revenue

222

141

478

353

9,707

2,934

21,366

8,069

Timing on revenue recognition

Three months ended

Three months ended

Six months ended

Six months ended

June 30, 2021

June 30, 2020

June 30, 2021

June 30, 2020

Point in time

120

106

180

283

Over time

9,587

2,828

21,186

7,786

9,707

2,934

21,366

8,069

4. Finance income and finance costs

Three months ended

Three months ended

Six months ended

Six months ended

June 30, 2021

June 30, 2020

June 30, 2021

June 30, 2020

Interest SVB Loan Agreement

(208)

(59)

(281)

(116)

Foreign exchange differences

(1,209)

(1,022)

4,413

554

Finance cost lease liability

(13)

(6)

(25)

(13)

Other finance income/finance costs

(122)

71

(160)

166

Gain from the modification of SVB Loan Agreement

0

62

0

62

Finance income/costs - net

(1,552)

(954)

3,947

653

5. Long term financial assets

The Group holds preferred shares in Amphivena recognized at their fair value of €3million. During the six months ended June 30, 2021 the fair value increased by €0.1million due to exchange rate differences recognized in other comprehensive income.

The Group also holds common shares in Roivant Sciences Ltd. at their fair value of €11.7million. During the three and six months ended June 30, 2021 the fair value decreased by €4.0million and €5.4million, due to the implied value of the Roivant common shares as reflected in the proposed merger with Montes Archimedes Acquisition Corp, which was announced in May 2021. The decrease has been recognized in other comprehensive income.

For the valuation of the shares of Amphivena, the Group based its estimate primarily on observable financing round valuations and considered certain other publicly available information as well as relevant qualitative information provided by Amphivena as of the respective valuation dates (level 3). The fair value of the shares in Roivant was based on the implied value of the Roivant common shares as reflected in the proposed merger with Montes Archimedes Acquisition Corp, as announced in May 2021 (level 3).

6. Trade and other receivables

Trade and other receivables mainly comprise Directors and Officers liability insurance prepayment of €0.9million (December 31, 2020: €0million) and value-added tax receivables of €1.6million (December 31, 2020: €1.3million).

7. Other assets

The other assets as of June 30, 2021 of €0.1million (December 31, 2020: €1.3million) are short-term in nature, do not bear interest and are not impaired. These assets mainly comprise a deferred prepayment of €0.1million in respect of a research project where certain milestone payments are due.

8. Equity

As of June 30, 2021 the share capital of €1,197(December 31, 2020: €983) is divided into 119,731,915(December 31, 2020: 98,287,333) common shares with a par value of €0.01per share.

During the six months ended June 30, 2021, the Group issued approximately 1.2million common shares under its ATM program, generating net proceeds of approximately €5.7million. In connection with these common share issues an amount of €0.2million of direct and incremental transaction costs were deducted from equity.

On January 15, 2021 the Group issued 19,166,667common shares at a price of $6.00per share in a public offering, resulting in net proceeds of approximately €88.7million, incurring €6.1million in underwriting commissions, legal and consulting expenses which were deducted from equity.

In April 2021 Silicon Valley Bank exercised all of its warrants and accordingly, the Group issued 173,482common shares, refer note 10.

9. Share-based payments

In 2014, an equity-settled share-based payment program was established by Affimed N.V. (ESOP 2014). Under this program, the Company granted awards to certain members of the Management Board, the Supervisory Board, non-employee consultants and employees.

Share based payments with service condition

The majority of the awards vest in instalments over three yearsand can be exercised up to 10 yearsafter the grant date. In the three and six months ended June 30, 2021, the group granted 195,100and 3,514,576awards. 52,226and 194,740ESOP 2014 awards were cancelled or forfeited, and 605,353and 947,275options were exercised during the three and six months ended June 30, 2021. As of June 30, 2021, 10,415,902ESOP 2014 options (December 31, 2020: 8,043,341) were outstanding, and 4,588,682awards (December 31, 2020: 4,712,122) had vested. The options outstanding as of June 30, 2021 had an exercise price in the range of $1.30to $13.47and a weighted-average exercise price of $5.12.

Share based payment expense

In the three and six months ended June 30, 2021, compensation expense of €3,586and €4,695was recognized affecting research and development expenses (€1,810and €2,279)and general and administrative expenses (€1,776and €2,416). In the three and six months ended June 30, 2020, compensation expense of €684and €1,410was recognized affecting research and development expenses (€400and €717)and general and administrative expenses (€284and €693).

Fair value measurement

The fair value of options was determined using the Black-Scholes valuation model. The significant inputs into the valuation model of share based payment grants with service conditions are as follows (weighted average):

June 30, 2021

June 30, 2020

Fair value at grant date

$

6.78

$

1.81

Share price at grant date

$

8.48

$

2.50

Exercise price

$

8.48

$

2.50

Expected volatility

95

%

91

%

Expected life

5.86

5.90

Expected dividends

0.00

0.00

Risk-free interest rate

1.12

%

1.30

%

Expected volatility is estimated based on the observed daily share price returns of Affimed measured over a historic period equal to the expected life of the awards.

The risk-free interest rates are based on the yield to maturity of U.S. Treasury strips (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the Grant Date.

10. Borrowings

Silicon Valley Bank

On November 30, 2016, Affimed entered into a loan agreement with Silicon Valley Bank (the 'SVB loan') for an initial tranche of €5.0million and a second tranche drawn in May 2017 of €2.5million. As of December 31, 2020, the loan was fully repaid.

Pursuant to the loan agreement of 2016, the Group also granted the lender warrants to purchase common shares of Affimed at the respective exercise price for a period of ten yearsfrom the date of grant. In April 2021 Silicon Valley Bank exercised its warrants and the Group issued 173,482common shares to Silicon Valley Bank.

In January 2021, the Group entered into a new loan agreement with Silicon Valley Bank German Branch (SVB) which provides Affimed with up to €25million in term loans in three tranches: €10million available at closing, an additional €7.5million upon the achievement of certain conditions, including milestones related to Affimed's pipeline and market capitalization, and a third tranche of €7.5million upon the achievement of certain additional conditions related to Affimed's pipeline and liquidity. The first tranche of €10million was drawn in February 2021. Pursuant to the terms of the agreement, the loans will bear interest at the greater of the European Central Bank Base Rate and 0%, plus 5.5%, and Affimed is entitled to make interest only payments through December 1, 2022, or June 1, 2023 if Affimed draws on the third tranche of the loans. The loans will mature at the end of November 2025. As of June 30, 2021, the fair value of the liability did not differ significantly from its carrying amount (€9.8million).

UniCredit Leasing CZ

In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for €562. After an initial instalment of €127in the second quarter of 2019, repayment is effected in monthly instalments of €8until May 2024. As of June 30, 2021, an amount of €277(December 31, 2020: €323) was outstanding, of which €93was classified as current liabilities (December 31, 2020: €92). As of June 30, 2021, the fair value of the liability did not differ significantly from its carrying amount.

11. Related parties

The supervisory directors of Affimed N.V. received compensation for their services on the supervisory board of €94and €192(€96and €181) in the three and six months ended June 30, 2021 (2020), remuneration of managing directors and other key management personnel amounted to €876and €1,753(€593and €1,198).

The Company recognized share-based payment expenses of €242and €350(€17and €53) for supervisory directors and €1,624and €2,271(€361and €721) for managing directors and other key management personnel in the three and six months ended June 30, 2021 (2020).

The following table provides the outstanding balances for management and supervisory board remuneration.

Outstanding balances

June 30,

December 31,

2021

2020

Adi Hoess

0

2

Dr. Thomas Hecht

23

16

Ferdinand Verdonck

10

10

Dr. Ulrich Grau

13

14

Dr. Bernhard Ehmer

16

15

Uta Kemmerich-Keil

7

0

Harry Welten

12

8

Annalisa Jenkins

11

8

Mathieu Simon

9

7

Disclaimer

Affimed NV published this content on 08 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 September 2021 12:01:06 UTC.


© Publicnow 2021
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Net income 2021 -58,5 M -68,1 M -68,1 M
Net Debt 2021 - - -
P/E ratio 2021 -10,5x
Yield 2021 -
Capitalization 616 M 717 M 716 M
Capi. / Sales 2021 16,2x
Capi. / Sales 2022 12,7x
Nbr of Employees 153
Free-Float 97,2%
Chart AFFIMED N.V.
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Affimed N.V. Technical Analysis Chart | AFMD | NL0010872420 | MarketScreener
Technical analysis trends AFFIMED N.V.
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TrendsBearishBearishNeutral
Income Statement Evolution
Consensus
Sell
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Mean consensus BUY
Number of Analysts 6
Last Close Price 5,14 €
Average target price 11,37 €
Spread / Average Target 121%
EPS Revisions
Managers and Directors
Adolf Hoess Chief Executive Officer
Angus W. Smith Chief Financial Officer
Thomas O. Hecht Chairman-Supervisory Board
Andreas Harstrick Chief Medical Officer
Arndt Schottelius Chief Scientific Officer
Sector and Competitors
1st jan.Capi. (M$)
AFFIMED N.V.2.92%717
GILEAD SCIENCES, INC.15.41%84 306
BIONTECH SE241.44%67 225
WUXI APPTEC CO., LTD.24.51%64 578
REGENERON PHARMACEUTICALS18.47%59 507
VERTEX PHARMACEUTICALS-22.35%47 610