6-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO SECTION 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November, 2022

Commission File Number: 001-36815

 

Ascendis Pharma A/S

(Exact Name of Registrant as Specified in Its Charter)

 

Tuborg Boulevard 12

DK-2900 Hellerup

Denmark

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

 


 

INCORPORATION BY REFERENCE

This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-228576, 333-203040, 333-210810, 333-211512, 333-213412, 333-214843, 333-216883, 333-254101, and 333-261550) and Form F-3 (Registration Numbers 333-209336, 333-211511, 333-216882, 333-223134, 333-225284, and 333-256571) of Ascendis Pharma A/S (the “Company”) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

Information Contained in this Form 6-K Report

Financial Statements

This report contains the Company’s Unaudited Condensed Consolidated Interim Financial Statements as of September 30, 2022, including Management’s Discussion and Analysis of Financial Condition and Results of Operations for the period presented therein.

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Ascendis Pharma A/S

 

 

 

 

Date: November 2, 2022

 

By:

/s/ Michael Wolff Jensen

 

 

 

Michael Wolff Jensen

 

 

 

Senior Vice President, Chief Legal Officer

 

 


 

TABLE OF CONTENTS

 

1.

Unaudited Condensed Consolidated Interim Financial Statements – September 30, 2022

F-1

2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

1

 

 

 


 

ASCENDIS PHARMA A/S

INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

 

 

Page

Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income / (Loss) for the Three and Nine Months Ended September 30, 2022 and 2021

 F-2

Unaudited Condensed Consolidated Interim Statements of Financial Position as of September 30, 2022 and December 31, 2021

 F-3

Unaudited Condensed Consolidated Interim Statements of Changes in Equity at September 30, 2022 and 2021

 F-4

Unaudited Condensed Consolidated Interim Cash Flow Statements for the Nine Months Ended September 30, 2022 and 2021

 F-5

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

 F-6

 

 

F-1


 

Unaudited Condensed Consolidated Interim Statements of Profit or Loss

and Comprehensive Income / (Loss) for the Three and Nine Months Ended September 30, 2022 and 2021

 

 

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

Notes

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

(EUR’000)

 

 

(EUR’000)

 

Statement of Profit or Loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

5

 

 

15,290

 

 

 

1,113

 

 

 

28,278

 

 

 

2,881

 

Cost of sales

 

 

 

 

1,693

 

 

 

 

 

 

7,025

 

 

 

 

Gross profit

 

 

 

 

13,597

 

 

 

1,113

 

 

 

21,253

 

 

 

2,881

 

Research and development costs

 

 

 

 

97,431

 

 

 

58,761

 

 

 

271,006

 

 

 

230,216

 

Selling, general and administrative expenses

 

 

 

 

60,671

 

 

 

39,284

 

 

 

164,675

 

 

 

111,876

 

Operating profit / (loss)

 

 

 

 

(144,505

)

 

 

(96,932

)

 

 

(414,428

)

 

 

(339,211

)

Share of profit / (loss) of associate

 

 

 

 

(3,696

)

 

 

(3,855

)

 

 

(9,736

)

 

 

19,434

 

Finance income

 

 

 

 

20,326

 

 

 

21,321

 

 

 

73,797

 

 

 

44,589

 

Finance expenses

 

 

 

 

41,247

 

 

 

877

 

 

 

25,381

 

 

 

2,580

 

Profit / (loss) before tax

 

 

 

 

(169,122

)

 

 

(80,343

)

 

 

(375,748

)

 

 

(277,768

)

Tax on profit / (loss) for the period

 

 

 

 

167

 

 

 

(5

)

 

 

(28

)

 

 

253

 

Net profit / (loss) for the period

 

 

 

 

(168,955

)

 

 

(80,348

)

 

 

(375,776

)

 

 

(277,515

)

Attributable to owners of the Company

 

 

 

 

(168,955

)

 

 

(80,348

)

 

 

(375,776

)

 

 

(277,515

)

Basic and diluted earnings / (loss) per share

 

 

 

(3.03

)

 

(1.47

)

 

(6.70

)

 

(5.13

)

Number of shares used for calculation (basic and diluted) (1)

 

 

 

 

55,831,561

 

 

 

54,639,597

 

 

 

56,115,782

 

 

 

54,085,793

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(EUR’000)

 

 

(EUR’000)

 

Statement of Comprehensive Income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net profit / (loss) for the period

 

 

 

 

(168,955

)

 

 

(80,348

)

 

 

(375,776

)

 

 

(277,515

)

Other comprehensive income / (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that may be reclassified subsequently to profit or loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange differences on translating foreign operations

 

 

 

 

(2,207

)

 

 

1,016

 

 

 

(2,538

)

 

 

2,781

 

Other comprehensive income / (loss) for the period, net of tax

 

 

 

 

(2,207

)

 

 

1,016

 

 

 

(2,538

)

 

 

2,781

 

Total comprehensive income / (loss) for the period, net of tax

 

 

 

 

(171,162

)

 

 

(79,332

)

 

 

(378,314

)

 

 

(274,734

)

Attributable to owners of the Company

 

 

 

 

(171,162

)

 

 

(79,332

)

 

 

(378,314

)

 

 

(274,734

)

 

(1)
As of September 30, 2022, a total of 6,937,495 warrants outstanding, each carrying the right to subscribe for one ordinary share, and 575,000 convertible senior notes which can potentially be converted into 3,456,785 ordinary shares, can potentially dilute earnings per share in the future but have not been included in the calculation of diluted earnings per share because they are antidilutive for the periods presented. Similarly, a total of 6,046,356 warrants outstanding as of September 30, 2021, are also considered antidilutive for the periods presented and have not been included in the calculation. The weighted average number of shares takes into account the weighted average effect of changes in treasury shares during the period.

 

F-2


 

Unaudited Condensed Consolidated Interim Statements of Financial Position

 

 

 

Notes

 

September 30,
2022

 

 

December 31,
2021

 

 

 

 

 

(EUR’000)

 

Assets

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

Intangible assets

 

 

 

 

4,939

 

 

 

5,272

 

Property, plant and equipment

 

 

 

 

139,345

 

 

 

126,049

 

Investment in associate

 

 

 

 

32,001

 

 

 

38,345

 

Other receivables

 

10

 

 

1,895

 

 

 

1,808

 

Marketable securities

 

10

 

 

15,338

 

 

 

107,561

 

 

 

 

 

 

193,518

 

 

 

279,035

 

Current assets

 

 

 

 

 

 

 

 

Inventories

 

 

 

 

103,975

 

 

 

75,405

 

Trade receivables

 

10

 

 

6,655

 

 

 

2,200

 

Income tax receivables

 

 

 

 

1,630

 

 

 

893

 

Other receivables

 

10

 

 

13,264

 

 

 

20,093

 

Prepayments

 

 

 

 

34,568

 

 

 

25,231

 

Marketable securities

 

10

 

 

311,480

 

 

 

235,797

 

Cash and cash equivalents

 

10

 

 

608,330

 

 

 

446,267

 

 

 

 

 

 

1,079,902

 

 

 

805,886

 

Total assets

 

 

 

 

1,273,420

 

 

 

1,084,921

 

 

 

 

 

 

 

 

 

 

Equity and liabilities

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

Share capital

 

8

 

 

7,658

 

 

 

7,646

 

Distributable equity

 

 

 

 

443,894

 

 

 

875,989

 

 

 

 

 

 

451,552

 

 

 

883,635

 

Non-current liabilities

 

 

 

 

 

 

 

 

Borrowings

 

10

 

 

533,145

 

 

 

97,966

 

Derivative liabilities

 

10

 

 

132,731

 

 

 

 

Contract liabilities

 

 

 

 

13,154

 

 

 

2,964

 

 

 

 

 

 

679,030

 

 

 

100,930

 

Current liabilities

 

 

 

 

 

 

 

 

Borrowings

 

10

 

 

20,096

 

 

 

6,995

 

Contract liabilities

 

 

 

 

3,137

 

 

 

2,601

 

Trade payables and accrued expenses

 

10

 

 

86,102

 

 

 

59,417

 

Other liabilities

 

 

 

 

26,578

 

 

 

29,952

 

Income taxes payable

 

 

 

 

126

 

 

 

198

 

Provisions

 

 

 

 

6,799

 

 

 

1,193

 

 

 

 

 

 

142,838

 

 

 

100,356

 

Total liabilities

 

 

 

 

821,868

 

 

 

201,286

 

Total equity and liabilities

 

 

 

 

1,273,420

 

 

 

1,084,921

 

 

F-3


 

Unaudited Condensed Consolidated Interim Statements of Changes in Equity

 

 

 

 

 

 

Distributable Equity

 

 

 

 

 

 

Share
Capital

 

 

Share
Premium

 

 

Treasury
Shares

 

 

Foreign
Currency
Translation
Reserve

 

 

Share-based
Payment
Reserve

 

 

Accumulated
Deficit

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

(EUR’000)

 

 

 

 

 

 

 

 

 

 

Equity at January 1, 2022

 

 

7,646

 

 

 

2,107,739

 

 

 

(21,605

)

 

 

3,779

 

 

 

199,931

 

 

 

(1,413,855

)

 

 

883,635

 

Net profit / (loss) for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(375,776

)

 

 

(375,776

)

Other comprehensive income / (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

(2,538

)

 

 

 

 

 

 

 

 

(2,538

)

Total comprehensive income / (loss)

 

 

 

 

 

 

 

 

 

 

 

(2,538

)

 

 

 

 

 

(375,776

)

 

 

(378,314

)

Transactions with Owners

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payment (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

50,307

 

 

 

 

 

 

50,307

 

Acquisition of treasury shares (Note 9)

 

 

 

 

 

 

 

 

(106,099

)

 

 

 

 

 

 

 

 

 

 

 

(106,099

)

Capital increase

 

 

12

 

 

 

2,011

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,023

 

Equity at September 30, 2022

 

 

7,658

 

 

 

2,109,750

 

 

 

(127,704

)

 

 

1,241

 

 

 

250,238

 

 

 

(1,789,631

)

 

 

451,552

 

 

 

 

 

 

 

Distributable Equity

 

 

 

 

 

 

Share
Capital

 

 

Share
Premium

 

 

Treasury
Shares

 

 

Foreign
Currency
Translation
Reserve

 

 

Share-based
Payment
Reserve

 

 

Accumulated
Deficit

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

(EUR’000)

 

 

 

 

 

 

 

 

 

 

Equity at January 1, 2021

 

 

7,217

 

 

 

1,728,747

 

 

 

 

 

 

(76

)

 

 

133,101

 

 

 

(1,030,278

)

 

 

838,711

 

Net profit / (loss) for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(277,515

)

 

 

(277,515

)

Other comprehensive income / (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

2,781

 

 

 

 

 

 

 

 

 

2,781

 

Total comprehensive income / (loss)

 

 

 

 

 

 

 

 

 

 

 

2,781

 

 

 

 

 

 

(277,515

)

 

 

(274,734

)

Transactions with Owners

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payment (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

52,684

 

 

 

 

 

 

52,684

 

Capital increase

 

 

421

 

 

 

396,647

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

397,068

 

Cost of Capital increase

 

 

 

 

 

(20,167

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(20,167

)

Equity at September 30, 2021

 

 

7,638

 

 

 

2,105,227

 

 

 

 

 

 

2,705

 

 

 

185,785

 

 

 

(1,307,793

)

 

 

993,562

 

 

 

F-4


 

Unaudited Condensed Consolidated Interim Cash Flow Statements for the

Nine Months Ended September 30, 2022 and 2021

 

 

 

Nine Months Ended
September 30,

 

 

 

2022

 

 

2021

 

 

 

(EUR’000)

 

Operating activities

 

 

 

 

 

 

Net profit / (loss) for the period

 

 

(375,776

)

 

 

(277,515

)

Reversal of finance income

 

 

(73,797

)

 

 

(44,589

)

Reversal of finance expenses

 

 

25,381

 

 

 

2,580

 

Reversal of gain and loss on disposal of property, plant and equipment

 

 

22

 

 

 

 

Reversal of tax charge

 

 

28

 

 

 

(253

)

Increase / (decrease) in provisions

 

 

4,954

 

 

 

 

Adjustments for non-cash items:

 

 

 

 

 

 

Non-cash consideration relating to revenue

 

 

(1,913

)

 

 

(1,749

)

Share of profit / (loss) of associate

 

 

9,736

 

 

 

(19,434

)

Share-based payment

 

 

50,307

 

 

 

52,684

 

Depreciation

 

 

12,988

 

 

 

10,784

 

Amortization

 

 

333

 

 

 

333

 

Changes in working capital:

 

 

 

 

 

 

Inventories

 

 

(28,571

)

 

 

(55,270

)

Receivables

 

 

(6,074

)

 

 

(9,295

)

Prepayments

 

 

(8,869

)

 

 

(8,246

)

Contract liabilities (deferred income)

 

 

10,727

 

 

 

(327

)

Trade payables, accrued expenses and other payables

 

 

22,528

 

 

 

54,302

 

Cash flows generated from / (used in) operations

 

 

(357,996

)

 

 

(295,995

)

Finance income received

 

 

6,808