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
May, 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
333-203040,
333-210810,
333-211512,
333-213412,
333-214843,
333-216883,
333-228576,
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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
 
 
Furnished as exhibits to this Report on Form
6-K
is information regarding the Company’s financial results for the fiscal quarter ended March 31, 2022.
Exhibits
 
Exhibit No.
  
Description
99.1
  
99.2
  
101.INS
  
XBRL Instance Document.
101.SCH
  
XBRL Taxonomy Extension Schema Document.
101.CAL
  
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
  
XBRL Taxonomy Extension Definition Linkbase Document.
101.IAB
  
XBRL Taxonomy Extension Labels Linkbase Document.
101.PRE
  
XBRL Taxonomy Extension Presentation Linkbase Document.
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: May 11, 2022
 
 
By:
 
/s/ Michael Wolff Jensen
 
 
 
Michael Wolff Jensen
 
 
 
Senior Vice President, Chief Legal Officer
EX-99.1
Exhibit 99.1
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, 2022 and
2021
     2  
Unaudited Condensed Consolidated Interim Statements of Financial Position as of March 31, 2022 and December 31, 2021
     3  
Unaudited Condensed Consolidated Interim Statements of Changes in Equity at March 31, 2022 and 2021
     4  
Unaudited Condensed Consolidated Interim Cash Flow Statements for the Three Months Ended March 31, 2022 and 2021
     5  
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
     6  

Unaudited Condensed Consolidated Interim Statements of Profit or Loss
and Comprehensive Income / (Loss) for the Three Months Ended March 31


 
  
 
 
  
Three Months Ended March 31
 
 
  
Notes
 
  
2022
 
 
2021
 
 
  
           
 
  
(EUR’000)
 
Statement of Profit or Loss
                         
Revenue
  
 
5
 
     6,828       746  
Cost of sales
              4,246        
             
 
 
   
 
 
 
Gross profit / (loss)
           
 
2,582
 
 
 
746
 
Research and development costs
              83,193       88,149  
Selling, general, and administrative expenses
              47,418       37,247  
             
 
 
   
 
 
 
Operating profit / (loss)
           
 
(128,029
 
 
(124,650
Share of profit / (loss) of associate
              (4,873     28,106  
Finance income
              13,044       34,430  
Finance expenses
              5,399       869  
             
 
 
   
 
 
 
Profit / (loss) before tax
           
 
(125,257
 
 
(62,983
Tax on profit / (loss) for the period
              (241     191  
             
 
 
   
 
 
 
Net profit / (loss) for the period
             
(125,498
)
 
 
 
(62,792
             
 
 
   
 
 
 
Attributable to owners of the Company
              (125,498     (62,792
             
 
 
   
 
 
 
Basic and diluted earnings / (loss) per share
            (2.21   (1.17
Number of shares used for calculation (basic and diluted) 
(1)
              56,720,063       53,759,952  
             
 
 
   
 
 
 
     
 
         
(EUR’000)
 
Statement of Comprehensive Income
                         
Net profit / (loss) for the period
           
 
(125,498
 
 
(62,792
Other comprehensive income / (loss)
                         
Items that may be reclassified subsequently to profit or loss:
                         
Exchange differences on translating foreign operations
              425       1,842  
             
 
 
   
 
 
 
Other comprehensive income / (loss) for the period, net of tax
           
 
425
 
 
 
1,842
 
             
 
 
   
 
 
 
Total comprehensive income / (loss) for the period, net of tax
           
 
(125,073
 
 
(60,950
             
 
 
   
 
 
 
Attributable to owners of the Company
              (125,073     (60,950
             
 
 
   
 
 
 
(1)
 
As of March 31, 2022, a total of 7,060,788
 warrants outstanding, each carrying the right to subscribe for one
ordinary share, and 575,000
 senior convertible 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 6,109,942
 warrants outstanding as of March 31, 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
.
 
2

Unaudited Condensed Consolidated Interim Statements of Financial Position
 
 
  
Notes
 
  
March 31,
2022
 
 
December 31,
2021
 
 
  
           
 
  
(EUR’000)
 
Assets
  
  
 
Non-current
assets
  
  
 
           
  
 
 
           
  
Intangible assets
             5,161       5,272  
Property, plant and equipment
             127,678       126,049  
Investment in associate
             35,023       38,345  
Other receivables
  
 
10
 
    1,822       1,808  
Marketable securities
  
 
10
 
    86,487       107,561  
            
 
 
   
 
 
 
            
 
256,171
 
 
 
279,035
 
            
 
 
   
 
 
 
Current assets
                        
Inventories
             92,436       75,405  
Trade receivables
  
 
10
 
    5,808       2,200  
Income tax receivables
             1,072       893  
Other receivables
  
 
10
 
    15,071       20,093  
Prepayments
             27,994       25,231  
Marketable securities
  
 
10
 
    223,055       235,797  
Cash and cash equivalents
  
 
10
 
    755,643       446,267  
            
 
 
   
 
 
 
            
 
1,121,079
 
 
 
805,886
 
            
 
 
   
 
 
 
Total assets
          
 
1,377,250
 
 
 
1,084,921
 
            
 
 
   
 
 
 
Equity and liabilities
                        
Equity
                        
Share capital
  
 
8
 
    7,649       7,646  
Distributable equity
             665,167       875,989  
            
 
 
   
 
 
 
            
 
672,816
 
 
 
883,635
 
            
 
 
   
 
 
 
Non-current
liabilities
                        
Borrowings
  
 
10
 
    464,736       97,966  
Derivative liabilities
  
 
10
 
    141,379           
Contract liabilities
             2,964       2,964  
            
 
 
   
 
 
 
            
 
609,079
 
 
 
100,930
 
            
 
 
   
 
 
 
Current liabilities
                        
Borrowings
  
 
10
 
    8,926       6,995  
Contract liabilities
             265       2,601  
Trade payables and accrued expenses
  
 
10
 
    70,683       59,417  
Other liabilities
             12,536       29,952  
Income taxes payable
             499       198  
Provisions
             2,446       1,193  
            
 
 
   
 
 
 
            
 
95,355
 
 
 
100,356
 
            
 
 
   
 
 
 
Total liabilities
          
 
704,434
 
 
 
201,286
 
            
 
 
   
 
 
 
Total equity and liabilities
          
 
1,377,250
 
 
 
1,084,921
 
            
 
 
   
 
 
 
 
3

Unaudited Condensed Consolidated Interim Statements of Changes in Equity
 
                                                                                                                                                                                
    
Share
Capital
   
Distributable Equity
   
Total
 
   
Share
Premium
   
Treasury
Shares
   
Foreign
Currency
Translation
Reserve
    
Share-based
Payment
Reserve
   
Accumulated
Deficit
 
   
    
(EUR’000)
 
Equity at January 1, 2022
  
 
7,646
  
 
 
2,107,739
  
 
 
(21,605
 
 
3,779
 
  
 
199,931
  
 
 
(1,413,855
 
 
883,635
 
    
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
 
Loss for the period
  
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
—  
 
  
 
—  
 
 
 
(125,498
 
 
(125,498
Other comprehensive income/(loss), net of tax
  
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
425
 
  
 
—  
 
 
 
—  
 
 
 
425
 
    
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
 
Total comprehensive income/(loss)
  
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
4,204
 
  
 
—  
 
 
 
(125,498
 
 
(125,073
    
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
 
Transactions with Owners
                                                         
Share-based payment (Note 7)
  
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
—  
 
  
 
19,968
 
 
 
—  
 
 
 
19,968
 
Acquisition of treasury shares
  
 
—  
 
 
 
—  
 
 
 
(106,099
 
 
—  
 
  
 
—  
 
 
 
—  
 
 
 
(106,099
Capital increase
  
 
3
 
 
 
382
 
 
 
—  
 
 
 
—  
 
  
 
—  
 
 
 
—  
 
 
 
385
 
    
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
 
Equity at March 31, 2022
  
 
         7,649
 
 
 
  2,108,121
 
 
 
(127,704
 
 
         4,204
 
  
 
     219,899
 
 
 
(1,539,353
 
 
     672,816
 
    
 
 
   
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
 
 
                                                                                                                                                                                
          
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
 
    
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Loss for the period
  
 
—  
 
 
 
—  
 
 
 
—  
 
  
 
—  
 
 
 
—  
 
 
 
(62,792
 
 
(62,792
Other comprehensive income / (loss), net of tax
  
 
—  
 
 
 
—  
 
 
 
—  
 
  
 
1,842
 
 
 
—  
 
 
 
—  
 
 
 
1,842
 
    
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Total comprehensive income / (loss)
  
 
—  
 
 
 
—  
 
 
 
  
 
  
 
1,842
 
 
 
—  
 
 
 
(62,792
 
 
(60,950
    
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Transactions with Owners
                           
 
—  
 
                       
Share-based payment (Note 7)
  
 
—  
 
 
 
—  
 
 
 
—  
 
  
 
—  
 
 
 
23,076
 
 
 
—  
 
 
 
23,076
 
Capital increase
  
 
11
 
 
 
1,971
 
 
 
—  
 
  
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
1,982
 
    
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Equity at March 31, 2021
  
 
         7,228
 
 
 
  1,730,718
 
 
 
  
 
  
 
         1,766
 
 
 
     156,177
 
 
 
(1,093,070
 
 
     802,819
 
    
 
 
   
 
 
   
 
 
    
 
 
   
 
 
   
 
 
   
 
 
 
 
4

Unaudited Condensed Consolidated Interim Cash Flow Statements for the
Three Months Ended March 31

                  
                  
 
  
Three Months Ended
March 31,
 
 
  
2022
 
 
2021
 
 
  
(EUR’000)
 
Operating activities
  
 
           
  
 
 
           
  
Net profit / (loss) for the period
  
 
(125,498
 
 
(62,792
Reversal of finance income
  
 
(13,044
 
 
(34,430
Reversal of finance expenses
  
 
  5,399
 
 
 
    869
 
Reversal of tax charge
  
 
241
 
 
 
(191
Increase/(decrease) in provisions
  
 
1,215
 
 
 
  
 
Adjustments for
non-cash
items:
                
Non-cash
consideration relating to revenue
  
 
(632
 
 
(577
Share of profit / (loss) of associate
  
 
4,873
 
 
 
(28,106
Share-based payment
  
 
19,968
 
 
 
23,076
 
Depreciation
  
 
4,304
 
 
 
3,603
 
Amortization
  
 
111
 
 
 
111
 
Changes in working capital:
                
Inventories
  
 
(17,031
 
 
  
 
Receivables
  
 
(2,407
 
 
110
 
Prepayments
  
 
(2,728
 
 
(1,329
Contract liabilities (deferred income)
  
 
(2,338
 
 
(109
Trade payables, accrued expenses and other payables
  
 
(4,338
 
 
17,573
 
    
 
 
   
 
 
 
Cash flows generated from / (used in) operations
  
 
(131,905
 
 
(82,192
Finance income received
  
 
1,848
 
 
 
975
 
Finance expenses paid
  
 
(610
 
 
(374
Income taxes received / (paid)
  
 
(121
 
 
(28
    
 
 
   
 
 
 
Cash flows from / (used in) operating activities
  
 
(130,788
 
 
(81,619
    
 
 
   
 
 
 
Investing activities
                
Investment in associate
  
 
  
 
 
 
(10,187
Acquisition of property, plant and equipment
  
 
(3,818
 
 
(4,025
Reimbursement from acquisition of property, plant and equipment
  
 
3,794
 
 
 
  
 
Development expenditures (software)
  
 
  
 
 
 
(530
Purchase of marketable securities
  
 
(26,311
 
 
(39,444
Settlement of marketable securities
  
 
64,877
 
 
 
24,069
 
    
 
 
   
 
 
 
Cash flows from / (used in) investing activities
  
 
38,542
 
 
 
(30,117
    
 
 
   
 
 
 
Financing activities
                
Payment of principal portion of lease liabilities
  
 
(1,950
 
 
(1,962
Net proceeds from convertible senior notes
  
 
504,454
 
 
 
  
 
Proceeds from exercise of warrants
  
 
385
 
 
 
1,982
 
Acquisition of treasury shares, net of transaction costs
  
 
(105,154
 
 
  
 
    
 
 
   
 
 
 
Cash flows from / (used in) financing activities
  
 
397,735
 
 
 
20
 
    
 
 
   
 
 
 
Increase / (decrease) in cash and cash equivalents
  
 
305,489
 
 
 
(111,716
    
 
 
   
 
 
 
Cash and cash equivalents at January 1
  
 
446,267
 
 
 
584,517
 
Effect of exchange rate changes on balances held in foreign currencies
  
 
3,887
 
 
 
22,246
 
    
 
 
   
 
 
 
Cash and cash equivalents at March 31
  
 
755,643
 
 
 
495,047
 
    
 
 
   
 
 
 
Cash and cash equivalents include:
                
Bank deposits
  
 
754,497
 
 
 
495,047
 
Short-term marketable securities
  
 
1,146
 
 
 
  
 
    
 
 
   
 
 
 
Cash and cash equivalents at March 31
  
 
755,643
 
 
 
495,047
 
    
 
 
   
 
 
 
 
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 biopharmaceutical 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 approved these unaudited condensed consolidated interim financial statements on May 11, 2022.
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, 2021, 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 our accounting policies is provided in the Accounting Policies section of the audited consolidated financial statements as of and for the year ended December 31, 2021. In addition, the accounting policy for convertible senior notes applied for the first time in this reporting period, is described below.
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”.
Convertible Senior Notes
Convertible senior notes (“convertible notes”) are separated into a financial liability and an embedded derivative component based on the terms and conditions of the contract. The embedded derivative component is accounted for separately if this is not deemed closely related to the financial liability.
The convertible notes include an embedded equity conversion option which is not deemed closely related to the financial liability, and initially recognized and measured separately at fair value as derivative liabilities based on the stated terms upon issuance of the convertible notes. The conversion option is classified as a foreign currency conversion option and thus not convertible into a fixed number of shares for a fixed amount of cash. Accordingly, the conversion option is subsequently recognized and measured as a derivative liability at fair value through profit or loss, with any subsequent remeasurement gains or losses recognized as part of financial income or expenses.
In addition, the convertible notes include a redemption option, which entitle the Company to redeem the notes at a cash amount equal to the principal amount of the convertible notes, plus accrued and unpaid interest. The redemption option is closely related to the financial liability, and not separately accounted for. The initial carrying amount of the financial liability component including the redemption option is the residual amount of the proceeds, net of transaction costs, after separating the derivative component.
Transaction costs are apportioned between the financial liability and derivative component based on the allocation of proceeds when the instrument is initially recognized. Transaction costs apportioned to the financial liability component form part of the effective interest and are amortized over the expected lifetime of the liability. Transaction costs allocated to the derivative component are expensed as incurred.
The financial liability is subsequently measured at amortized cost until it is extinguished on conversion, optional redemption or upon repayment at maturity. The financial liability is presented as part of borrowings on the statement of financial position.
 
6

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
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.
If approved by the EU, the amendments are effective for annual reporting periods beginning on or after January 1, 2023 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, presented as
non-current
liabilities at March 31, 2022, to be presented as current liabilities. On March 31, 2022, the carrying amount of convertible notes and derivative liabilities were €365.6 million and €141.4 million, respectively.
The consolidated financial statements are not expected to be affected by other new or amended standards.
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, 2021.
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.
Other than as set out below, there have been no other changes to the application of significant accounting judgements, or estimation uncertainties regarding accounting estimates compared to December 31, 2021.
Valuation of Embedded Derivatives
Foreign currency conversion options, embedded in the convertible notes, are accounted for separately as derivative liabilities at fair value through profit or loss.
Fair value cannot be measured based on quoted prices in active markets, or other observable input, and accordingly, derivative liabilities are measured by use of valuation techniques in form of the Black-Scholes Option Pricing model. Subjective judgements and assumptions, which are subject to estimation uncertainties, need to be exercised in determining the appropriate input to the valuation model (Level 3 in the fair value hierarchy). These inputs include volatility of the Company’s share price for a historic period, reflecting the assumption that the historical volatility is indicative of a period similar to the expected lifetime of the options.
Changes in assumptions relating to these factors could affect the reported fair value of derivative liabilities.
 
7

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
Note 4—Significant Events in the Reporting Period
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.
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.
Leases
An additional facility lease in Germany with an enforceable lease term of four years
commenced in January 2022, and an
 initial lease liability and corresponding
right-of-use
asset of €2.3 million
 was recognized
. In addition, in February 2022, the Company entered into a facility lease in Germany with an enforceable lease term of 15 years, which is expected to commence in 2025. Subject to
 changes in
terms and conditions and development in interest rates, an initial lease liability and corresponding
right-of-use
asset of €55.2 million is expected to be recognized at the commencement date.
Convertible Senior Notes Offering
On March 29, 2022 (trade date, March 25, 2022), the Company issued an aggregate principal amount of $575.0 million of fixed rate 2.25% convertible notes. The net proceeds from the offering were $557.9 million (€503.3 million), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses.
Further details are disclosed in Note 10, “Financial
Assets and Financial Liabilities
”.
Acquisition of Treasury Shares
The Company used $116.7 million (€105.2 million) of the net proceeds from the offering of the convertible notes to repurchase 1,000,000 ADSs representing the Company’s ordinary shares. Total holding of treasury shares is disclosed in Note 9, “Treasury Shares”.
 
8

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
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 specialty distributors (“commercial customers”). Customer payment terms are typically 30 days from the transaction date. SKYTROFA (lonapegsomatropin-tcgd) was approved by the U.S. Food and Drug Administration on August 25, 2021, and the Company began shipping products to commercial customers in the fourth quarter of 2021.
In addition, other revenue is generated primarily from three license agreements, which were entered into in 2018. The licenses grant VISEN Pharmaceuticals (“VISEN”) exclusive rights to develop and commercialize TransCon hGH, TransCon PTH and TransCon CNP in Greater China. As consideration for the granting of such rights, the Company received
up-front,
non-refundable,
non-cash
consideration of $40.0 million in the form of 50% ownership in VISEN. At the reporting date, the Company retains approximately 44% of VISEN’s issued and outstanding shares.
 
                                                   
    
Three Months ended
March 31,
 
    
2022
    
2021
 
   
    
(EUR’000)
 
Revenue from external customers
                 
Commercial sale of products
  
 
1,888
 
  
 
  
 
Rendering of services
  
 
372
 
  
 
169
 
Sale of clinical supply
  
 
3,936
 
  
 
 
Licenses
  
 
632
 
  
 
577
 
    
 
 
    
 
 
 
Total revenue
  
 
         6,828
 
  
 
         746
 
    
 
 
    
 
 
 
Attributable to
                 
Commercial customers
  
 
1,888
 
  
 
 
Collaboration partners and license agreements
(1)
  
 
4,940
 
  
 
746
 
    
 
 
    
 
 
 
Total revenue
  
 
6,828
 
  
 
746
 
    
 
 
    
 
 
 
Specified by timing of recognition
                 
Recognized over time
  
 
372
 
  
 
169
 
Recognized at a point in time
  
 
6,456
 
  
 
577
 
    
 
 
    
 
 
 
Total revenue
  
 
6,828
 
  
 
746
 
    
 
 
    
 
 
 
Specified by geographical location
                 
Europe
  
 
135
 
  
 
  
 
North America
  
 
6,456
 
  
 
686
 
China
  
 
237
 
  
 
60
 
    
 
 
    
 
 
 
Total revenue
  
 
6,828
 
  
 
746
 
    
 
 
    
 
 
 
 
(1)
 
For the three months ended March 31, 2022 and 2021, “Total revenue” includes recognition of previously deferred revenue/internal profit from associate of €0.6
 million and €0.6
 million, respectively.
 
9

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
Note 6—Segment Information
The Company is managed and operated as one business unit. No separate business areas or separate business units have been identified in relation to product candidates or geographical markets. Accordingly, no additional information on business segments or geographical areas is disclosed.
Note 7—Share-based Payment
As an incentive to the Executive Board, employees, members of the Board of Directors and select consultants, Ascendis Pharma A/S has established warrant programs and, since December 2021, a Restricted Stock Unit program (“RSU program”), which are equity-settled share-based payment transactions.
Share-based Compensation Costs
Share-based compensation costs are determined
using
the grant date fair value of warrants and Restricted Stock Units (“RSUs”) granted, and are recognized over the vesting period as research and development costs, selling, general and administrative expenses, or cost of sales. For the three months ended March 31, 2022 and 2021, share-based compensation costs recognized in the unaudited condensed consolidated interim statement of profit or loss was €20.0 million and €23.1 million, respectively.
Restricted Stock Unit Program
RSUs are granted by the Board of Directors in accordance with authorizations given to it by the shareholders of Ascendis Pharma A/S to the Executive Board, select employees and members of the Board of Directors
(“RSU-holders”)
in accordance with the Company’s Restricted Stock Unit Program adopted in December 2021. Further, RSUs may be granted to select consultants. One RSU represents a right for the
RSU-holder
to receive one ADS of Ascendis Pharma A/S upon vesting if the vesting conditions are met or waived by the Board of Directors at its discretion.
All RSUs are hedged by treasury shares that have been repurchased in the market. Upon vesting, the Company may at its sole discretion choose to make a cash settlement instead of delivering ADSs.
RSU Activity
The following table specifies the number of RSUs granted, and outstanding RSUs at March 31, 2022:
 
                          
    
Total
RSUs
 
Outstanding at January
 1, 2022
  
 
         148,148
 
    
 
 
 
Granted during the period
  
 
  
 
Settled during the period
  
 
  
 
Transferred during the period
  
 
  
 
Forfeited during the period
  
 
(1,338
    
 
 
 
Outstanding at March 31, 2022
  
 
146,810
 
    
 
 
 
Specified by vesting date
        
December, 2022
  
 
48,937
 
December, 2023
  
 
48,937
 
December, 2024
  
 
48,936
 
    
 
 
 
Outstanding at March 31, 2022
  
 
146,810
 
    
 
 
 
 
The fair value of RSUs at the date of grant was €123.46 for the years ended December 31, 2021, which was the first date of granting RSUs.
Warrant program
Warrants are granted by the Board of Directors in accordance with authorizations given to it by the shareholders of Ascendis Pharma A/S to all employees, members of the Board of Directors and select consultants (“warrantholders”). Each warrant carries the right to subscribe for one ordinary share of a nominal value of DKK 1. The exercise price is fixed at the fair market value of the Company’s ordinary shares at the time of grant as determined by the Board of Directors. Vested warrants may be exercised in two or four annual exercise periods.
 
10

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
Warrant Activity
The following table specifies the warrant activity during the three months ended March 31, 2022:
 
                                                   
    
Total
Warrants
   
Weighted
Average
Exercise Price
EUR
 
Outstanding at January 1, 2022
  
 
  7,085,073
 
 
 
         80.30
  
    
 
 
   
 
 
 
Granted during the period
  
 
66,950
 
 
 
102.70
 
Exercised during the period
  
 
(20,709
 
 
17.97
 
Forfeited during the period
  
 
(70,526
 
 
119.20
 
    
 
 
   
 
 
 
Outstanding at March
 31, 2022
  
 
7,060,788
 
 
 
80.31
 
    
 
 
   
 
 
 
Vested at March 31, 2022
  
 
4,248,774
 
 
 
55.53
 
    
 
 
   
 
 
 
The exercise prices of outstanding warrants under the Company’s warrant programs range from €6.48 to €145.5 depending on the grant dates.
Note 8—Share Capital
The share capital of Ascendis Pharma A/S consists of 56,958,391 fully paid shares at a nominal value of DKK 1, all in the same share class.
Note 9—Treasury Shares
The holding of treasury shares is specified below:
 
                                                                            
    
Nominal
values
    
Holding
    
Holding in
% of total
outstanding
shares
 
     
    
(EUR’000)
    
(Number)
 
Treasury shares
 
 
 
 
 
 
 
 
 
 
 
 
At January 1, 2022
  
 
        21
 
  
 
  154,837
 
  
 
    0.27
Acquired from third-parties
  
 
134
 
  
 
1,000,000
 
  
 
  
 
    
 
 
    
 
 
    
 
 
 
At March 31, 2022
  
 
155
 
  
 
1,154,837
 
  
 
2.03
    
 
 
    
 
 
    
 
 
 
 
11

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
Note 10 —Financial
Assets and Financial Liabilities
Financial assets and liabilities comprise the following:
 
                                                   
    
March 31,

2022
    
December 31,
2021
 
   
    
(EUR’000)
 
Financial assets by category
                 
Trade receivables
  
 
5,808
 
  
 
2,200
 
Other receivables (excluding VAT receivables)
  
 
8,093
 
  
 
12,276
 
Marketable securities
  
 
309,542
 
  
 
343,358
 
Cash and cash equivalents
  
 
755,643
 
  
 
446,267
 
    
 
 
    
 
 
 
Financial assets measured at amortized cost
  
 
1,079,086
 
  
 
804,101
 
    
 
 
    
 
 
 
Total financial assets
  
 
1,079,086
 
  
 
804,101
 
    
 
 
    
 
 
 
Classified in the statement of financial position
                 
Non-current
assets
  
 
88,309
 
  
 
109,369
 
Current assets
  
 
990,777
 
  
 
694,732
 
    
 
 
    
 
 
 
Total financial assets
  
 
1,079,086
 
  
 
804,101
 
    
 
 
    
 
 
 
 
                                                   
    
March 31,

2022
    
December 31,
2021
 
   
    
(EUR’000)
 
Financial liabilities by category
                 
Borrowings
                 
Convertible senior notes
  
 
365,562
 
  
 
  
 
Lease liabilities
  
 
108,100
 
  
 
104,961
 
Trade payables and accrued expenses
  
 
70,683
 
  
 
59,417
 
    
 
 
    
 
 
 
Financial liabilities measured at amortized cost
  
 
544,345
 
  
 
164,378
 
    
 
 
    
 
 
 
Derivative liabilities
  
 
141,379
 
  
 
  
 
    
 
 
    
 
 
 
Financial liabilities measured at fair value through profit or loss
  
 
141,379
 
  
 
  
 
    
 
 
    
 
 
 
Total financial liabilities
  
 
685,724
 
  
 
164,378
 
    
 
 
    
 
 
 
Classified in the statement of financial position
                 
Non-current
liabilities
  
 
606,115
 
  
 
97,966
 
Current liabilities
  
 
79,609
 
  
 
66,412
 
    
 
 
    
 
 
 
Total financial liabilities
  
 
  685,724
 
  
 
164,378
 
    
 
 
    
 
 
 
 
12

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
Marketable Securities
Marketable securities are measured at amortized cost, and fair values are determined based on quoted market prices or for marketable securities with short-term and infrequent market trades on mathematical calculations applying observable inputs (Level 1 or 2 in the fair value hierarchy).
The composition of the portfolio is specified in the following table:
 
                                                                                                     
    
March 31, 2022
   
December 31, 2021
 
    
Carrying
amount
   
Fair value
   
Carrying
amount
   
Fair value
 
   
    
(EUR’000)
 
Marketable securities
                                
U.S. Government bonds
  
 
89,376
 
 
 
88,341
 
 
 
95,408
 
 
 
95,211
 
Commercial papers
  
 
  
 
 
 
  
 
 
 
2,207
 
 
 
2,207
 
Corporate bonds
  
 
200,806
  
 
 
199,189
  
 
 
226,771
  
 
 
226,379
  
Agency bonds
  
 
19,360
 
 
 
19,198
 
 
 
18,972
 
 
 
18,934
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Total marketable securities
  
 
     309,542
 
 
 
     306,728
 
 
 
     343,358
 
 
 
     342,731
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Classified based on maturity profiles
                                
Non-current
assets
  
 
86,487
 
 
 
84,909
 
 
 
107,561
 
 
 
107,175
 
Current assets
  
 
223,055
 
 
 
221,819
 
 
 
235,797
 
 
 
235,556
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Total marketable securities
  
 
309,542
 
 
 
306,728
 
 
 
343,358
 
 
 
342,731
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Specified by rate structure
                                
Fixed rate
  
 
293,837
 
 
 
291,035
 
 
 
323,176
 
 
 
322,556
 
Floating rate
  
 
15,705
 
 
 
15,693
 
 
 
17,975
 
 
 
17,968
 
Zero-coupon
  
 
  
 
 
 
  
 
 
 
2,207
 
 
 
2,207
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Total marketable securities
  
 
309,542
 
 
 
306,728
 
 
 
343,358
 
 
 
342,731
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Specified by investment grade credit rating
                                
High grade
  
 
127,447
 
 
 
126,100
 
 
 
144,307
 
 
 
144,030
 
Upper medium grade
  
 
179,921
 
 
 
178,472
 
 
 
196,909
 
 
 
196,566
 
Lower medium grade
  
 
2,174
 
 
 
2,156
 
 
 
2,142
 
 
 
2,135
 
    
 
 
   
 
 
   
 
 
   
 
 
 
Total marketable securities
  
 
309,542
 
 
 
306,728
 
 
 
343,358
 
 
 
342,731
 
    
 
 
   
 
 
   
 
 
   
 
 
 
The Company’s marketable securities are all denominated in U.S. Dollars. At March 31, 2022 and December 31, 2021, the portfolio
had
a weighted average duration of 5.7 and 5.8 months for current positions, and 15.5 and 16.7 months for
non-current
positions, respectively. At March 31, 2022 and December 31, 2021, the entire portfolio
had
a weighted average duration of 8.4 months and 9.2 months, respectively.
All marketable securities have investment grade ratings, and accordingly, the risk from probability of default is low. The risk of expected credit loss over marketable securities has been considered, including the hypothetical impact arising from the probability of default which is considered in conjunction with the expected loss given default from securities with similar credit ratings and attributes. This assessment did not reveal a material expected credit loss, and accordingly, no provision for expected credit loss has been recognized.
Convertible Senior Notes
On March 29, 2022 (trade date, March 25, 2022) the Company issued an aggregate principal amount of $575.0 million of fixed rate 2.25% convertible senior notes (“convertible notes”). The net proceeds from the offering of the convertible notes were $557.9 million (€503.3 million), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses. The convertible notes rank equally in right of payment with all of existing and future senior unsecured indebtedness. Unless earlier converted or redeemed the convertible notes will mature on April 1, 2028.
The convertible notes will accrue interest at a rate of 2.25% per annum, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2022. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their convertible notes at their option into the Company’s ordinary shares represented by ADSs, together, if applicable, with cash in lieu of any fractional ADS, at the then-applicable conversion rate. The initial conversion rate is 6.0118 ADSs per $1,000 principal amount of convertible notes, which represents an initial conversion price of $166.34 per ADS. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events.
 
13

Notes to the Unaudited Condensed Consolidated Interim Financial Statements
 
The convertible notes will be optionally redeemable, in whole or in part (subject to certain limitations), at the Company’s option at any time, and from time to time, on or after April 7, 2025, but only if the last reported sale price per ADS exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related optional redemption notice; and (ii) the trading day immediately before the date the Company sends such notice.
On March 31, 2022, the carrying amount of the convertible notes were €365.6 million, and the fair value
was
approximately €379.8 
million. Fair value cannot be
measured 
based on quoted
prices
in active markets, or other observable input, and accordingly the fair value was estimated by using an estimated market rate for an equivalent non-convertible instrument, and by excluding transaction costs (Level 3 in the fair value hierarchy). 
Derivative Liabilities
Derivative liabilities relate to foreign currency conversion options embedded in the convertible notes.
Fair value cannot be measured based on quoted prices in active markets, or other observable input, and accordingly, derivative liabilities are measured by use of valuation techniques in form of the Black-Scholes Option Pricing model (Level 3 in the fair value hierarchy). Fair value of the options is calculated, applying following assumptions: (1) conversion price; (2) own share price at the reporting
date; 
(3) maturity of the options; (4) a risk-free interest rate equaling the effective interest rate on a U.S. government bond with the same lifetime as the maturity of the options; (5) no payment of
dividends;
and (6) an expected volatility using the Company’s own share price 
(47.98 as of March 2022).
Derivative liabilities were recognized on March 25, 2022, at the initial fair value of €142.5 million. For the three months ended March 31, 2022, remeasurement gains recognized in the unaudited condensed consolidated interim statement of profit or loss was €1.1 million.
Sensitivity Analysis
On March 31, 2022, all other inputs and assumptions held
constant
, a 10% increase in
volatility
,
will increase the fair value of derivative liabilities by approximately €15.5 million and indicates a decrease in profit or loss and equity before tax. Similarly, a 10%
decrease in volatility indicates the opposite impact.
Similarly, on March 31, 2022, all other inputs and assumptions held constant, a 10% increase in the share price, will increase the fair value of derivative liabilities by approximately €23.6 million and indicates a decrease in profit or loss and equity before tax. Similarly, a 10% decrease in the share price indicates the opposite impact.
Maturity Analysis
Maturity analysis (on an undiscounted basis) for
non-derivative
financial liabilities recognized in the unaudited condensed consolidated statements of financial position at March 31, 2022 is specified below.
 
                                                                                                                              
    
< 1 year
   
1-5 years
   
>5 years
   
Total
contractual
cash-flows
   
Carrying
amount
 
   
    
(EUR’000)
 
March 31, 2022
                                        
Borrowings
                                        
Convertible senior notes
  
 
         11,654
  
 
 
         46,617
  
 
 
       529,626
  
 
 
     587,897
  
 
 
    365,562
  
Lease liabilities
  
 
9,079
 
 
 
53,620
 
 
 
66,995
 
 
 
129,694
 
 
 
108,100
 
Trade payables and accrued expenses
  
 
70,683
 
 
 
 
 
 
 
 
 
70,683
 
 
 
70,683
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total financial liabilities
  
 
91,416
 
 
 
100,237
 
 
 
596,621
 
 
 
788,274
 
 
 
544,345
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Note 11—Subsequent Events
No events have occurred after the reporting date that would influence the evaluation of these unaudited condensed consolidated interim financial statements.
 
14
EX-99.2

Exhibit 99.2

ASCENDIS PHARMA A/S

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND

RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated interim financial statements, including the notes thereto, included with this report and the section contained in our Annual Report on Form 20-F for the year ended December 31, 2021 – “Item 5. Operating and Financial Review and Prospects”. The following discussion is based on our financial information prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been condensed or omitted. IFRS as issued by the International Accounting Standards Board, and as adopted by the European Union, might differ in material respects from generally accepted accounting principles in other jurisdictions.

Special Note Regarding Forward-Looking Statements

This report contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

 

   

the timing or likelihood of regulatory filings and approvals for our product candidates;

 

   

our expectations regarding the commercial availability of TransCon Growth Hormone, or TransCon hGH, and related patient support services;

 

   

the commercialization of TransCon hGH and our other product candidates, if approved;

 

   

our commercialization, marketing and manufacturing capabilities of TransCon hGH and our other product candidates and associated devices;

 

   

the scope, progress, results and costs of developing our product candidates or any other future product candidates, and conducting preclinical studies and clinical trials;

 

   

our pursuit of oncology as our second of three independent therapeutic areas of focus, and our development of a pipeline of product candidates related to oncology;

 

   

our expectations regarding the potential market size and the size of the patient populations for TransCon hGH and our other product candidates, if approved for commercial use;

 

   

our expectations regarding the potential advantages of TransCon hGH and our other product candidates over existing therapies;

 

   

our ability to enter into new collaborations;

 

   

our expectations with regard to the ability to develop additional product candidates using our TransCon technologies and file Investigational New Drug Applications, or INDs, or similar for such product candidates;

 

   

our expectations with regard to the ability to seek expedited regulatory approval pathways for our product candidates, including the potential ability to rely on the parent drug’s clinical and safety data with regard to our product candidates;

 

1


   

our expectations with regard to our current and future collaboration partners to pursue the development of our product candidates and file INDs or similar for such product candidates;

 

   

our development plans with respect to TransCon hGH and our other product candidates;

 

   

our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials;

 

   

the implementation of our business model and strategic plans for our business, TransCon hGH and our other product candidates and technologies, including global commercialization strategies;

 

   

the scope of protection we are able to establish and maintain for intellectual property rights covering TransCon hGH and our other product candidates;

 

   

estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;

 

   

our financial performance;

 

   

developments and projections relating to our market conditions, competitors and industry; and

 

   

the potential effects on our business of the worldwide COVID-19 pandemic.

These forward-looking statements are based on senior management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this report may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section in our Annual Report on Form 20-F for the year ended December 31, 2021 — “Item 3.D. Risk Factors”. You are urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this report. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Given these risks and uncertainties, you are cautioned not to rely on such forward-looking statements as predictions of future events.

You should read this report and the documents that we reference in this report and have filed as exhibits to this report completely and with the understanding that our actual future results may be materially different from what we expect. You should also review the factors and risks we describe in the reports we will file or submit from time to time with the Securities and Exchange Commission after the date of this report. We qualify all of our forward-looking statements by these cautionary statements.

Overview

We are applying our innovative TransCon technologies to build a leading, fully integrated, global biopharmaceutical company and develop a pipeline of product candidates with potential best-in-class profiles to address unmet medical needs.

Our product candidates combine our TransCon technologies with clinically-validated parent drugs and pathways, with the goal of optimizing therapeutic effect and improving tolerability and convenience.

We have applied these technologies in combination with a clinically-validated parent drug or pathway using our algorithm for product innovation with the goal of creating product candidates with the potential to be best-in-class in endocrinology rare diseases and oncology. In addition, we plan to apply this algorithm for product innovation and selection in new therapeutic areas. We believe our approach to product innovation may reduce the risks associated with traditional drug development, and that our TransCon technologies have been validated by non-clinical and clinical programs completed to date.

We had a net loss of €125.5 million for the three months ended March 31, 2022, and a net loss of €383.6 million for the year ended December 31, 2021. Our total equity was €672.8 million as of March 31, 2022 compared to €883.6 million as of December 31, 2021.

 

2


Ascendis Algorithm for Product Innovation

 

LOGO

When we apply our TransCon technologies to already approved drug compounds, we may benefit from established clinical safety and efficacy data, which we believe increases the probability of success compared to traditional drug development. As presented above, our algorithm for product innovation focuses on identifying indications that have an unmet medical need, have a clinically-validated parent drug or pathway, are suitable to our TransCon technologies, have potential for creating a clearly differentiated product, have an established development pathway and have a large potentially addressable market.

We currently have one marketed product and a diversified portfolio of five product candidates in clinical development in the areas of endocrinology rare diseases and oncology. We are also evaluating additional therapeutic areas and indications.

 

   

First Marketed Product – Our first marketed product is SKYTROFA® (lonapegsomatropin-tcgd), developed as TransCon Growth Hormone (“TransCon hGH”), which has received regulatory approval in the United States for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone, also known as growth hormone deficiency (“GHD”) and which is now commercially available for prescription in the United States. TransCon hGH is also approved in the European Union (“EU”) under the name Lonapegsomatropin Ascendis Pharma for the treatment of children and adolescents aged from 3 years up to 18 years with growth failure due to insufficient endogenous growth hormone secretion.

 

   

Endocrinology Rare Disease Pipeline – We are developing three product candidates in our endocrinology rare disease portfolio spanning seven different clinical programs. These include TransCon hGH for pediatric GHD in Japan; TransCon hGH for adults with GHD; TransCon PTH for adult hypoparathyroidism; the last classical hormone deficiency for which complete hormone replacement has been elusive; and TransCon CNP for pediatric achondroplasia, the most common form of dwarfism. VISEN Pharmaceuticals (“VISEN”) is also developing TransCon hGH, TransCon PTH and TransCon CNP in China. In addition, we are planning new trials in other endocrinology rare disease indications, including TransCon hGH for Turner Syndrome; TransCon PTH for pediatric hypoparathyroidism; and TransCon CNP for infants (age 0-2 years) with achondroplasia.

 

   

Oncology Pipeline – In oncology, we are leveraging our TransCon technologies in effort to enhance anti-tumor effects of clinically-validated parent drugs and pathways and to provide sustained modulation of tumor microenvironments and activate cytotoxic immune cells. We have initiated clinical development of two product candidates: TransCon TLR7/8 Agonist, an investigational, long-acting prodrug of resiquimod, a small molecule agonist of Toll like receptors (“TLR”) 7 and 8 for intratumoral delivery and TransCon IL-2 ß/g for systemic delivery, which is designed for prolonged exposure to an IL-2 variant that selectively activates the IL-2Rß/g, with minimal binding to IL-2Ra. Our clinical development program for these product candidates also includes evaluation of them as a potential combination therapy.

 

3


TransCon Product and Product Candidate Pipeline

 

LOGO

 

1

Developed under the name TransCon hGH

2

In development in Greater China through strategic investment in VISEN Pharmaceuticals.

3

Japanese riGHt Trial.

4

Global foresiGHt Trial.

5

Top-line results from the North American and European PaTHway Trial were reported on March 13, 2022.

6

Japanese PaTHway Japan Trial.

7

North America, Europe, and Oceania ACcomplisH Trial.

8

transcendIT-101 Trial.

9

IL-ßeliege Trial.

TransCon Technologies

Our TransCon technologies are designed to combine the benefits of conventional prodrug and sustained release technologies to solve the fundamental limitations seen in other approaches to extending duration of a drug’s action in the body with the goal of developing highly differentiated product candidates based on potential safety and efficacy. In addition to retaining the original mode of action of the parent drug and potentially supporting dosing frequency from daily up to six months or more, we believe that predictable release over time can improve treatment efficacy, increase the likelihood of clinical development success, and provide intellectual property benefits.

TransCon molecules have three components: a parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, the unmodified parent drug is released in a predictable manner. Depending upon the type of TransCon carrier we employ, we can design our TransCon prodrugs for sustained localized or systemic delivery.

 

4


LOGO

TransCon Growth Hormone

TransCon hGH is a long-acting prodrug of somatropin (“hGH”) composed of an unmodified somatropin that is transiently bound to a carrier and proprietary linker. TransCon hGH is designed to maintain the same mode of action as daily therapies by releasing the same recombinant growth hormone molecule, somatropin, as used in extensively proven daily hGH therapy which is the current standard of care for growth hormone deficiency.

On August 25, 2021, the FDA approved TransCon hGH, known by its brand name SKYTROFA (lonapegsomatropin-tcgd), for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone, also known as GHD. Once-weekly SKYTROFA (lonapegsomatropin-tcgd) is the first FDA approved product that delivers somatropin, or growth hormone, by sustained release over one week.

The FDA approval of SKYTROFA (lonapegsomatropin-tcgd) was based on results from the Phase 3 heiGHt Trial, a 52-week, global, randomized, open-label, active-controlled, parallel-group trial that compared once-weekly TransCon hGH to daily somatropin (Genotropin®) in 161 treatment-naïve children with GHD. The primary endpoint was annualized height velocity (“AHV”) at 52 weeks for weekly SKYTROFA (lonapegsomatropin-tcgd) and the daily hGH treatment groups. Other endpoints included adverse events, injection-site reactions, incidence of anti-hGH antibodies, annualized height velocity, change in height standard deviation score (“SDS”), proportion of subjects with IGF-1 SDS (0.0 to +2.0), PK/PD in subjects > 3 years, and preference for and satisfaction with SKYTROFA (lonapegsomatropin-tcgd).

We believe once-weekly SKYTROFA (lonapegsomatropin-tcgd) offers patients benefits compared to daily growth hormone:

 

   

A national study has shown 66%, or 2/3 of patients miss more than one injection per week. We believe reducing injection frequency is associated with better adherence and thus may improve height velocity.

 

   

In a Phase 3 clinical study, TransCon hGH demonstrated higher AHV compared to daily somatropin with similar safety profile in treatment-naïve children with GHD.

 

   

With a weekly injection, patients switching from daily injections can experience up to 86% fewer injection days per year.

 

   

After first removed from a refrigerator, SKYTROFA (lonapegsomatropin-tcgd) can be stored at room temperature for up to six months.

On January 12, 2022, the European Commission granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone.

In September 2020, we filed a Clinical Trial Notification, or CTN, with the Pharmaceuticals and Medical Devices Agency (“PMDA”), in Japan, to initiate our Phase 3 riGHt Trial of lonapegsomatropin for the treatment of pediatric GHD. The primary objective of the riGHt Trial is to evaluate and compare the AHV of 40 Japanese prepubertal treatment naïve children with GHD treated with weekly lonapegsomatropin to that of a commercially available daily somatropin formulation at 52 weeks.

In October 2019, we received Orphan Designation (“OD”) from the European Commission for TransCon hGH for GHD. OD is granted to therapies aimed at the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating, affects no more than five in 10,000 persons in the EU, or the product, without the benefits derived from orphan status, would not

 

5


generate sufficient return in the EU to justify investment and for which no satisfactory method of diagnosis, prevention, or treatment has been authorized (or if such a method exists, the product would provide significant additional benefit over existing therapies). We received Orphan Drug Designation (“ODD”) from the FDA for TransCon hGH as a treatment for GHD in April 2020.

Additionally, we continue to enroll patients in the fo