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 April, 2023

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, 333-261550 and 333-270088) 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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 and for the period ended March 31, 2023, 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: April 27, 2023

By:

/s/ Michael Wolff Jensen

 

Michael Wolff Jensen

 

Executive Vice President, Chief Legal Officer

 

 


 

TABLE OF CONTENTS

1.

Unaudited Condensed Consolidated Interim Financial Statements – March 31, 2023

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 Months Ended March 31, 2023 and 2022

 F-2

Unaudited Condensed Consolidated Interim Statements of Financial Position as of March 31, 2023 and December 31, 2022

 F-3

Unaudited Condensed Consolidated Interim Statements of Changes in Equity at March 31, 2023 and 2022

 F-4

Unaudited Condensed Consolidated Interim Cash Flow Statements for the Three Months Ended March 31, 2023 and 2022

 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 Months Ended March 31, 2023 and 2022

 

 

 

 

Three Months Ended
March 31,

 

 

Notes

 

2023

 

 

2022

 

 

 

 

(EUR’000)

 

Consolidated Statement of Profit or Loss

 

 

 

 

 

 

 

 

Revenue

 

5

 

 

33,589

 

 

 

6,828

 

Cost of sales

 

 

 

 

4,621

 

 

 

4,246

 

Gross profit

 

 

 

 

28,968

 

 

 

2,582

 

Research and development costs

 

 

 

 

106,114

 

 

 

83,193

 

Selling, general and administrative expenses

 

 

 

 

66,539

 

 

 

47,418

 

Operating profit / (loss)

 

 

 

 

(143,685

)

 

 

(128,029

)

Share of profit / (loss) of associate

 

 

 

 

(1,227

)

 

 

(4,873

)

Finance income

 

 

 

 

45,135

 

 

 

13,044

 

Finance expenses

 

 

 

 

9,840

 

 

 

5,399

 

Profit / (loss) before tax

 

 

 

 

(109,617

)

 

 

(125,257

)

Income taxes (expenses)

 

 

 

 

(1,297

)

 

 

(241

)

Net profit / (loss) for the period

 

 

 

 

(110,914

)

 

 

(125,498

)

Attributable to owners of the Company

 

 

 

 

(110,914

)

 

 

(125,498

)

Basic and diluted earnings / (loss) per share

 

 

 

(1.98

)

 

(2.21

)

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

 

 

 

 

56,091,927

 

 

 

56,720,063

 

 

 

 

 

 

 

 

 

 

 

 

 

(EUR’000)

 

Statement of Comprehensive Income

 

 

 

 

 

 

 

 

Net profit / (loss) for the period

 

 

 

 

(110,914

)

 

 

(125,498

)

Other comprehensive income / (loss)

 

 

 

 

 

 

 

 

Items that may be reclassified subsequently to profit or loss:

 

 

 

 

 

 

 

 

Exchange differences on translating foreign operations

 

 

 

 

(787

)

 

 

425

 

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

 

 

 

 

(787

)

 

 

425

 

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

 

 

 

 

(111,701

)

 

 

(125,073

)

Attributable to owners of the Company

 

 

 

 

(111,701

)

 

 

(125,073

)

 

(1)
As of March 31, 2023 and March 31, 2022, a total of 6,761,296 and 7,060,788 warrants outstanding, respectively, 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.

F-2


 

Unaudited Condensed Consolidated Interim Statements of Financial Position

 

 

Notes

 

March 31,
2023

 

 

December 31,
2022

 

 

 

 

(EUR’000)

 

Assets

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

Intangible assets

 

 

 

 

4,717

 

 

 

4,828

 

Property, plant and equipment

 

 

 

 

127,762

 

 

 

129,095

 

Investment in associate

 

 

 

 

21,966

 

 

 

22,932

 

Other receivables

 

10

 

 

1,984

 

 

 

1,920

 

Marketable securities

 

10

 

 

 

 

 

7,492

 

 

 

 

 

156,429

 

 

 

166,267

 

Current assets

 

 

 

 

 

 

 

 

Inventories

 

 

 

 

150,850

 

 

 

130,673

 

Trade receivables

 

10

 

 

16,121

 

 

 

11,910

 

Income tax receivables

 

 

 

 

1,064

 

 

 

883

 

Other receivables

 

10

 

 

17,375

 

 

 

12,833

 

Prepayments

 

 

 

 

38,694

 

 

 

31,717

 

Marketable securities

 

10

 

 

84,460

 

 

 

290,688

 

Cash and cash equivalents

 

10

 

 

501,281

 

 

 

444,767

 

 

 

 

 

809,845

 

 

 

923,471

 

Total assets

 

 

 

 

966,274

 

 

 

1,089,738

 

 

 

 

 

 

 

 

 

Equity and liabilities

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

Share capital

 

8

 

 

7,698

 

 

 

7,675

 

Distributable equity

 

 

 

 

159,503

 

 

 

255,673

 

Total equity

 

 

 

 

167,201

 

 

 

263,348

 

 

 

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

 

 

 

Borrowings

 

10

 

 

479,988

 

 

 

482,956

 

Derivative liabilities

 

10

 

 

116,768

 

 

 

157,950

 

Contract liabilities

 

 

 

 

3,956

 

 

 

14,213

 

 

 

 

 

 

600,712

 

 

 

655,119

 

Current liabilities

 

 

 

 

 

 

 

 

Borrowings

 

10

 

 

25,393

 

 

 

25,421

 

Contract liabilities

 

 

 

 

10,000

 

 

 

 

Trade payables and accrued expenses

 

10

 

 

131,438

 

 

 

101,032

 

Other liabilities

 

 

 

 

15,503

 

 

 

31,989

 

Income taxes payable

 

 

 

 

6,873

 

 

 

5,490

 

Provisions

 

 

 

 

9,154

 

 

 

7,339

 

 

 

 

 

 

198,361

 

 

 

171,271

 

Total liabilities

 

 

 

 

799,073

 

 

 

826,390

 

Total equity and liabilities

 

 

 

 

966,274

 

 

 

1,089,738

 

 

F-3


 

Unaudited Condensed Consolidated Interim Statements of Changes in Equity

 

 

 

 

Distributable Equity

 

 

 

 

 

Share
Capital

 

 

Share
Premium

 

 

Treasury
Shares

 

 

Foreign
Currency
Translation
Reserve

 

 

Accumulated
Deficit

 

 

Total

 

 

(EUR’000)

 

Equity at January 1, 2023

 

 

7,675

 

 

 

2,112,863

 

 

 

(149

)

 

 

3,452

 

 

 

(1,860,493

)

 

 

263,348

 

Net profit / (loss) for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(110,914

)

 

 

(110,914

)

Other comprehensive income / (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

(787

)

 

 

 

 

 

(787

)

Total comprehensive income / (loss)

 

 

 

 

 

 

 

 

 

 

 

(787

)

 

 

(110,914

)

 

 

(111,701

)

Transactions with Owners

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payment (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13,688

 

 

 

13,688

 

Capital increase

 

 

23

 

 

 

1,843

 

 

 

 

 

 

 

 

 

 

 

 

1,866

 

Equity at March 31, 2023

 

 

7,698

 

 

 

2,114,706

 

 

 

(149

)

 

 

2,665

 

 

 

(1,957,719

)

 

 

167,201

 

 

 

 

 

 

Distributable Equity

 

 

 

 

 

Share
Capital

 

 

Share
Premium

 

 

Treasury
Shares

 

 

Foreign
Currency
Translation
Reserve

 

 

Accumulated
Deficit

 

 

Total

 

 

(EUR’000)

 

Equity at January 1, 2022

 

 

7,646

 

 

 

2,107,739

 

 

 

(21

)

 

 

3,779

 

 

 

(1,235,508

)

 

 

883,635

 

Net profit / (loss) for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(125,498

)

 

 

(125,498

)

Other comprehensive income / (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

425

 

 

 

 

 

 

425

 

Total comprehensive income / (loss)

 

 

 

 

 

 

 

 

 

 

 

425

 

 

 

(125,498

)

 

 

(125,073

)

Transactions with Owners

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payment (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

19,968

 

 

 

19,968

 

Acquisition of treasury shares (Note 9)

 

 

 

 

 

 

 

 

(134

)

 

 

 

 

 

(105,965

)

 

 

(106,099

)

Capital increase

 

 

3

 

 

 

382

 

 

 

 

 

 

 

 

 

 

 

 

385

 

Equity at March 31, 2022

 

 

7,649

 

 

 

2,108,121

 

 

 

(155

)

 

 

4,204

 

 

 

(1,447,003

)

 

 

672,816

 

F-4


 

Unaudited Condensed Consolidated Interim Cash Flow Statements for the

Three Months Ended March 31, 2023 and 2022

 

Three Months Ended
March 31,

 

 

2023

 

 

2022

 

 

(EUR’000)

 

Operating activities

 

 

 

 

 

 

Net profit / (loss) for the period

 

 

(110,914

)

 

 

(125,498

)

Reversal of finance income

 

 

(45,135

)

 

 

(13,044

)

Reversal of finance expenses

 

 

9,840

 

 

 

5,399

 

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

 

 

21

 

 

 

 

Reversal of income taxes (expenses)

 

 

1,297

 

 

 

241

 

Increase / (decrease) in provisions

 

 

1,983

 

 

 

1,215

 

Adjustments for non-cash items:

 

 

 

 

 

 

Non-cash consideration relating to revenue

 

 

(614

)

 

 

(632

)

Share of profit / (loss) of associate

 

 

1,227

 

 

 

4,873

 

Share-based payment

 

 

13,688

 

 

 

19,968

 

Depreciation

 

 

4,435

 

 

 

4,304

 

Amortization

 

 

111

 

 

 

111

 

Changes in working capital:

 

 

 

 

 

 

Inventories

 

 

(20,178

)

 

 

(17,031

)

Receivables

 

 

(9,608

)

 

 

(2,407

)

Prepayments

 

 

(10,176

)

 

 

(2,728

)

Contract liabilities (deferred income)

 

 

(256

)

 

 

(2,338

)

Trade payables, accrued expenses and other payables

 

 

14,236

 

 

 

(4,338

)

Cash flows generated from / (used in) operations

 

 

(150,043

)

 

 

(131,905

)

Finance income received

 

 

3,879

 

 

 

1,848

 

Finance expenses paid

 

 

(906

)

 

 

(610

)

Income taxes received / (paid)

 

 

26

 

 

 

(121

)

Cash flows from / (used in) operating activities

 

 

(147,044

)

 

 

(130,788

)

Investing activities

 

 

 

 

 

 

Acquisition of property, plant and equipment

 

 

(1,085

)

 

 

(3,818

)

Reimbursement from acquisition of property, plant and equipment

 

 

 

 

 

3,794

 

Purchase of marketable securities

 

 

 

 

 

(26,311

)

Settlement of marketable securities

 

 

211,731

 

 

 

64,877

 

Cash flows from / (used in) investing activities

 

 

210,646

 

 

 

38,542

 

Financing activities

 

 

 

 

 

 

Payment of principal portion of lease liabilities

 

 

(2,568

)

 

 

(1,950

)

Net proceeds from convertible senior notes

 

 

 

 

 

504,454

 

Proceeds from exercise of warrants

 

 

1,866

 

 

 

385

 

Acquisition of treasury shares, net of transaction costs

 

 

 

 

 

(105,154

)

Cash flows from / (used in) financing activities

 

 

(702

)

 

 

397,735

 

Increase / (decrease) in cash and cash equivalents

 

 

62,900

 

 

 

305,489

 

Cash and cash equivalents at January 1

 

 

444,767

 

 

 

446,267

 

Effect of exchange rate changes on balances held in foreign currencies

 

 

(6,386

)

 

 

3,887

 

Cash and cash equivalents at March 31

 

 

501,281

 

 

 

755,643

 

Cash and cash equivalents include:

 

 

 

 

 

 

Bank deposits

 

 

501,281

 

 

 

754,497

 

Short-term marketable securities

 

 

 

 

 

1,146

 

Cash and cash equivalents at March 31

 

 

501,281

 

 

 

755,643

 

 

F-5


 

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Note 1—General Information

Ascendis Pharma A/S, together with its subsidiaries, is applying its innovative TransCon technologies to build a leading, fully integrated, global, biopharma company. Ascendis Pharma A/S was incorporated in 2006 and is headquartered in Hellerup, Denmark. Unless the context otherwise requires, references to the “Company,” “we,” “us,” and “our,” refer to Ascendis Pharma A/S and its subsidiaries.

The address of the Company’s registered office is Tuborg Boulevard 12, DK-2900, Hellerup, Denmark.

On February 2, 2015, the Company completed an initial public offering which resulted in the listing of American Depositary Shares (“ADSs”), representing the Company’s ordinary shares, under the symbol “ASND” in the United States on The Nasdaq Global Select Market.

The Company’s Board of Directors (the “Board”) approved these unaudited condensed consolidated interim financial statements on April 27, 2023.

Note 2—Summary of Significant Accounting Policies

Basis of Preparation

The unaudited condensed consolidated interim financial statements of the Company are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been condensed or omitted. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2022, and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board (the “IASB”) and as adopted by the European Union (the “EU”).

The accounting policies applied are consistent with those of the previous financial year. A description of the accounting policies is provided in the Accounting Policies section of the audited consolidated financial statements as of and for the year ended December 31, 2022.

The preparation of financial statements in conformity with IFRS requires the use of certain significant accounting estimates and requires management to exercise its judgement in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the unaudited condensed consolidated interim financial statements are disclosed in Note 3, “Significant Accounting Judgements and Estimates.”

New International Financial Reporting Standards Not Yet Effective

The IASB has issued a number of new or amended standards, which have not yet become effective or have not yet been adopted by the EU. Therefore, these new standards have not been incorporated in these unaudited condensed consolidated interim financial statements.

Amendments to IAS 1, “Classification of Liabilities as Current or Non-current”

In January 2020, the IASB issued amendments to paragraphs 69 to 76 of IAS 1, “Presentation of Financial Statements,” to specify the requirements for classifying liabilities as current or non-current. The amendments clarify:

What is meant by a right to defer settlement;
That a right to defer must exist at the end of the reporting period;
That classification is unaffected by the likelihood that an entity will exercise its deferral right; and
That only if an embedded derivative in a convertible liability is itself an equity instrument would the terms of a liability not impact its classification.

F-6


 

If approved by the EU, the amendments are effective for annual reporting periods beginning on or after January 1, 2024, and must be applied retrospectively. The amendments are expected to require the convertible notes (presented as part of borrowings on the statement of financial position) and derivative liabilities, both presented as non-current liabilities at March 31, 2023, to be presented as current liabilities.

On March 31, 2023, the carrying amount of convertible notes and derivative liabilities were €399.9 million and €116.8 million, respectively.

The consolidated financial statements are not expected to be affected by other new or amended standards.

F-7


 

Note 3—Significant Accounting Judgements and Estimates

In the application of the Company’s accounting policies, management is required to make judgements, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. Judgements, estimates and assumptions applied are based on historical experience and other factors that are relevant, and which are available at the reporting date. Uncertainty concerning estimates and assumptions could result in outcomes that require a material adjustment to assets and liabilities in future periods.

The unaudited condensed consolidated interim financial statements do not include all disclosures for significant accounting judgements, estimates and assumptions, that are required in the annual consolidated financial statements, and therefore should be read in conjunction with the Company’s audited consolidated financial statements as of and for the year ended December 31, 2022.

Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized prospectively. While the application of critical accounting estimates is subject to material estimation uncertainties, management’s ongoing revisions of critical accounting estimates and underlying assumptions have not revealed any material impact in any of the periods presented in the unaudited condensed consolidated interim financial statements. Additionally, there have been no other changes to the application of significant accounting judgements, or estimation uncertainties regarding accounting estimates compared to December 31, 2022.

Note 4—Significant Events in the Reporting Period

Global Banking Situation

In March 2023, the Federal Deposit Insurance Corporation (the “FDIC”) announced that Silicon Valley Bank (“SVB”) had been closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. The Company did not hold deposits or securities or maintain any accounts at SVB. Following the closure of SVB and subsequent developments in the global banking sector, the Company considered the risk of expected credit loss on bank deposits and marketable securities, including the hypothetical impact arising from the probability of default, which is considered in conjunction with the expected loss caused by default by banks or securities with similar credit-ratings and attributes.

In line with previous periods, this assessment did not reveal a material impairment loss, and accordingly no provision for expected credit loss has been recognized.

Conflict in the Region Surrounding Ukraine and Russia

The ongoing conflict in the region surrounding Ukraine and Russia has impacted our ability to continue clinical trial activities in those countries. The conflict did not have a direct material impact on the unaudited condensed consolidated interim financial statements.

COVID-19 Pandemic

The COVID-19 pandemic has affected countries where we are operating, where we have planned or have ongoing clinical trials, and where we rely on third-parties to manufacture preclinical, clinical and commercial supply.

COVID-19 did not have a direct material impact on the unaudited condensed consolidated interim financial statements.

F-8


 

Note 5—Revenue

Revenue from commercial sale of products relates to sale of SKYTROFA® (lonapegsomatropin-tcgd) on the U.S. market, which is sold to specialty pharmacies and a specialty distributor (“commercial customers”). Customer payment terms are typically 30 days from the transaction date. SKYTROFA was approved by the U.S. Food and Drug Administration in August 2021, and the Company began shipping products to commercial customers in the fourth quarter of 2021.

Other revenue is generated primarily from three license agreements, which were entered into in 2018. The licenses grant VISEN Pharmaceuticals exclusive rights to develop and commercialize TransCon hGH, TransCon PTH and TransCon CNP in Greater China.

 

Three Months Ended
March 31,

 

 

2023

 

 

2022

 

 

(EUR’000)

 

Revenue from external customers

 

 

 

 

 

 

Commercial sale of products

 

 

31,551

 

 

 

1,888

 

Rendering of services

 

 

1,170

 

 

 

372

 

Sale of clinical supply

 

 

254

 

 

 

3,936

 

Licenses

 

 

614

 

 

 

632

 

Total revenue from external customers

 

 

33,589

 

 

 

6,828

 

Attributable to

 

 

 

 

 

 

Commercial customers

 

 

31,551

 

 

 

1,888

 

Collaboration partners and license agreements

 

 

2,038

 

 

 

4,940

 

Total revenue from external customers

 

 

33,589

 

 

 

6,828

 

Specified by timing of recognition

 

 

 

 

 

 

Recognized over time

 

 

1,170

 

 

 

372

 

Recognized at a point in time

 

 

32,419

 

 

 

6,456

 

Total revenue from external customers

 

 

33,589