EX-99.1 2 d753121dex991.htm EX-99.1 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, 2019 and 2018

     2  

Unaudited Condensed Consolidated Interim Statements of Financial Position as of March 31, 2019 and December 31, 2018

     3  

Unaudited Condensed Consolidated Interim Statements of Changes in Equity at March 31, 2019 and 2018

     4  

Unaudited Condensed Consolidated Interim Cash Flow Statements for the Three Months Ended March 31, 2019 and 2018

     5  

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

     6  


Unaudited Condensed Consolidated Interim Statements of Profit or Loss

and Other Comprehensive Income / (Loss) for the Three Months Ended March 31

 

     Notes      2019     2018  
            (EUR’000)  

Revenue

     4        5,414       28  

Research and development costs

        (51,259     (30,540

General and administrative expenses

        (10,436     (4,662
     

 

 

   

 

 

 

Operating profit / (loss)

        (56,281     (35,174

Share of profit/(loss) of associate

        (1,852     —    

Finance income

        4,620       702  

Finance expenses

        (194     (7,010
     

 

 

   

 

 

 

Profit / (loss) before tax

        (53,707     (41,482

Tax on profit / (loss) for the period

        70       107  
     

 

 

   

 

 

 

Net profit / (loss) for the period

        (53,637     (41,375
     

 

 

   

 

 

 

Other comprehensive income / (loss)

       

Items that may be reclassified subsequently to profit or loss:

       

Exchange differences on translating foreign operations

        559       (9
     

 

 

   

 

 

 

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

        559       (9
     

 

 

   

 

 

 

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

        (53,078     (41,384
     

 

 

   

 

 

 

Profit / (loss) for the period attributable to owners of the Company

        (53,637     (41,375

Total comprehensive income / (loss) for the period attributable to owners of the Company

        (53,078     (41,384
            EUR     EUR  

Basic and diluted earnings / (loss) per share

        (1.24     (1.07

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

        43,371,559       38,699,204  
     

 

 

   

 

 

 

 

(1)

A total of 5,650,777 warrants outstanding as of March 31, 2019 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 period presented. Similarly, a total of 4,657,891 warrants outstanding as of March 31, 2018 are also considered antidilutive for the period presented and have not been included in the calculation.

 

2


Unaudited Condensed Consolidated Interim Statements of Financial Position

 

     Notes      March 31,
2019
     December 31,
2018
 
            (EUR’000)  

Assets

        

Non-current assets

        

Intangible assets

        3,495        3,495  

Property, plant and equipment

     7        24,032        4,325  

Investment in associate

        17,476        17,083  

Deposits

        1,161        1,158  
     

 

 

    

 

 

 
        46,164        26,061  
     

 

 

    

 

 

 

Current assets

        

Trade receivables

        4        6  

Other receivables

        6,863        1,775  

Prepayments

        11,282        12,415  

Income taxes receivable

        962        849  

Cash and cash equivalents

        696,664        277,862  
     

 

 

    

 

 

 
            715,775      292,907  
     

 

 

    

 

 

 

Total assets

        761,939        318,968  
     

 

 

    

 

 

 

Equity and liabilities

        

Equity

        

Share capital

     8        6,301        5,659  

Distributable equity

        710,360        274,391  
     

 

 

    

 

 

 

Total equity

        716,661        280,050  
     

 

 

    

 

 

 

Non-current liabilities

        

Lease liabilities

     2, 7        13,213        —    
     

 

 

    

 

 

 
        13,213        —    

Current liabilities

        

Lease liabilities

     2, 7        4,271        —    

Contract liabilities

        3,073        6,902  

Trade payables

        19,237        19,740  

Other payables

        5,445        12,267  

Income taxes payable

        39        9  
     

 

 

    

 

 

 
        32,065        38,918  
     

 

 

    

 

 

 

Total liabilities

        45,278        38,918  
     

 

 

    

 

 

 

Total equity and liabilities

        761,939        318,968  
     

 

 

    

 

 

 

 

3


Unaudited Condensed Consolidated Interim Statements of Changes in Equity

 

            Distributable Equity        
     Share
Capital
     Share
Premium
    Foreign
Currency
Translation
Reserve
    Share-based
Payment
Reserve
     Accumulated
Deficit
    Total  
     (EUR’000)  

Equity at January 1, 2019

     5,659        625,250       3       42,445        (393,307     280,050  

Loss for the period

     —          —         —         —          (53,637     (53,637

Other comprehensive income / (loss), net of tax

     —          —         559       —          —         559  
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive income / (loss)

     —          —         559       —          (53,637     (53,078
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Share-based payment (Note 6)

     —          —         —         9,435        —         9,435  

Capital increase

     642        511,313         —          —         511,955  

Cost of capital increase

     —          (31,701     —         —          —         (31,701
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Equity at March 31, 2019

     6,301        1,104,862       562       51,880        (446,944     716,661  
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 
            Distributable Equity        
     Share
Capital
     Share
Premium
    Foreign
Currency
Translation
Reserve
    Share-based
Payment
Reserve
     Accumulated
Deficit
    Total  
     (EUR’000)  

Equity at January 1, 2018

     4,967        422,675       (14     22,793        (263,210     187,211  

Loss for the period

     —          —         —         —          (41,375     (41,375

Other comprehensive income / (loss), net of tax

     —          —         (9     —          —         (9
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Total comprehensive income / (loss)

     —          —         (9     —          (41,375     (41,384
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Share-based payment (Note 6)

     —          —         —         4,679        —         4,679  

Capital increase

     610        209,415       —         —          —         210,025  

Cost of capital increase

     —          (13,118     —         —          —         (13,118
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Equity at March 31, 2018

     5,577        618,972       (23     27,472        (304,585     347,413  
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

 

4


Unaudited Condensed Consolidated Interim Cash Flow Statements for the

Three Months Ended March 31

 

     Notes      2019     2018  
            (EUR’000)  

Operating activities

       

Net profit / (loss) for the period

        (53,637     (41,375

Reversal of non-cash consideration regarding revenue

        (1,581     —    

Reversal of share of profit/(loss) of associate

        1,852       —    

Reversal of finance income

        (4,620     (702

Reversal of finance expenses

        194       7,010  

Reversal of tax charge

        (70     (107

Adjustments for:

       

Share-based payment

        9,435       4,679  

Depreciation and amortization

        1,296       198  

Changes in working capital:

       

Deposits

        (2     (819

Trade receivables

        2       154  

Other receivables

        (5,195     282  

Prepayments

        1,133       (211

Contract liabilities (deferred income)

        (3,829     —    

Trade payables and other payables

        (7,324     (6,364
     

 

 

   

 

 

 

Cash flows generated from / (used in) operations

        (62,346     (37,255

Finance income received

        1,555       702  

Finance expenses paid

        (57     (4

Income taxes received / (paid)

        (13     (183
     

 

 

   

 

 

 

Cash flows from / (used in) operating activities

        (60,861     (36,740
     

 

 

   

 

 

 

Investing activities

       

Acquisition of property, plant and equipment

        (2,469     (102
     

 

 

   

 

 

 

Cash flows from / (used in) investing activities

        (2,469     (102
     

 

 

   

 

 

 

Financing activities

       

Capital increase

        511,955       210,025  

Cost of capital increase

        (31,701     (13,118

Payment of lease liabilities

        (1,188     —    
     

 

 

   

 

 

 

Cash flows from / (used in) financing activities

        479,066       196,907  
     

 

 

   

 

 

 

Increase / (decrease) in cash and cash equivalents

        415,736       160,065  
     

 

 

   

 

 

 

Cash and cash equivalents at January 1

        277,862       195,351  

Effect of exchange rate changes on balances held in foreign currencies

        3,066       (7,006
     

 

 

   

 

 

 

Cash and cash equivalents at March 31

        696,664       348,410  
     

 

 

   

 

 

 

Restricted cash included in cash and cash equivalents

        5,674       5,142  
     

 

 

   

 

 

 

 

5


Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Note 1—General Information

Ascendis Pharma A/S, together with its subsidiaries, is a biopharmaceutical company applying its innovative TransCon technologies to build a leading, fully integrated 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,” “Ascendis,” “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, or IPO, which resulted in the listing of American Depositary Shares, or 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 30, 2019.

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 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 annual consolidated financial statements for the year ended December 31, 2018 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, and as adopted by the European Union.

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

Changes in Accounting Policies

As of January 1, 2019, the Company has adopted IFRS 16, “Leases” (“IFRS 16”). IFRS 16 requires, with a few exceptions, lessees to recognize assets (“right-of-use assets”) and liabilities for most leases. Accordingly, lease payments under contracts previously classified as operating leases, will be recognized over the non-cancellable lease period as depreciation included in research and development costs and general and administrative expenses, respectively, and as interest expenses included in finance expenses. Previously, lease payments under operating leases were recognized as research and development costs and general and administrative expenses, respectively.

Impact from IFRS 16 “Leases”

The Company primarily leases office- and laboratory facilities and equipment. Lease arrangements are typically entered into for fixed periods but may have extension options. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions.

We have implemented IFRS 16 by applying the modified retrospective approach. Accordingly, no comparative information is restated. The lease liability and corresponding right-of-use assets is measured at the present value of the remaining lease payments, discounted using an estimated incremental borrowing rate at January 1, 2019.

In connection with the transition to IFRS 16, we have reviewed our operating lease agreements’ contractual terms including lease payment structure. Fixed payments, and variable lease payments that depend on an index or a rate, are included in lease payments, while other variable lease payments are excluded. Additionally, payments related to non-lease components are excluded, and thus treated as either research and development costs, or general and administrative expenses.

 

1


Notes to the Unaudited Condensed Consolidated Interim Financial Statements

 

For lease arrangements other than those relating to short-term leases and leases of low value assets, lease liabilities have been determined according to the fixed lease payments and variable lease payments that depend on an index or a rate in the non-cancellable periods, discounted by the incremental borrowing rate. Accordingly, at January 1, 2019, we have recognized a lease liability on €17.7 million.

Operating lease commitments under IAS 17 “Leases”, and as disclosed for the annual reporting period ended December 31, 2018 was €19.6 million. The transition to the lease liabilities recognized in the unaudited condensed consolidated interim financial position at January 1, 2019, in accordance with IFRS 16, is summarized below:

 

     (EUR ‘000)  

Operating lease commitments as per December 31, 2018

     19,627  

Short-term contracts, and low value assets

     (169
  

 

 

 

Undiscounted, operating lease commitments as per January 1, 2019

     19,458  
  

 

 

 

Lease liabilities discounted by incremental borrowing rates as per January 1, 2019

     17,700  
  

 

 

 

The associated right-of-use assets primarily relate to office- and laboratory facilities. At January 1, 2019, right-of-use assets of €18.4 million, which include prepaid leases, were recognized as property, plant and equipment.

The transition to IFRS 16 had no impact on retained earnings.

Separate note disclosures on right-of-use assets and lease liabilities and payments for the three months ended March 31, 2019, are included in Note 7.

Several other amendments to and interpretations of IFRS apply for the first time in 2019, but do not have an impact on the accounting policies applied by the Company. Thus, except for the adoption of IFRS 16, the accounting policies applied when preparing these unaudited condensed consolidated interim financial statements have been applied consistently to all the periods presented, unless otherwise stated, and are consistent with those of the Company’s most recent audited annual consolidated financial statements.

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, 2018.

Note 3—Critical Accounting Judgments and Key Sources of Estimation Uncertainty

In the application of our accounting policies, we are required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods.

Critical judgments made in the process of applying our accounting policies and that have the most significant effect on the amounts recognized in our unaudited condensed consolidated interim financial statements relate to revenue recognition, share-based payment, internally generated intangible assets, joint arrangements / collaboration agreements, and to our investment in associate.

The key sources of estimation uncertainty that have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities within the next financial year relate to impairment of goodwill and to recognition of accruals for manufacturing and clinical trial activities. No significant adjustments to accruals recognized during the first 3 months of 2019 or 2018, due to conditions that existed at December 31, 2018, or 2017, have been recognized. Additionally, there have been no changes to the application of significant accounting estimates, and no impairment losses have been recognized during the first three months of 2019 or 2018.

 

2


Notes to the Unaudited Condensed Consolidated Interim Financial Statements

 

In connection with adopting IFRS 16, the following are assessed as key assumptions concerning estimation uncertainty that have a significant risk of causing a material adjustment to the carrying amount of right-to-use assets and lease liabilities within the next financial year.

Extension Options

Lease arrangements regarding our office- and laboratory facilities are subject to extension options, providing us with the right (not the obligation) to extend the lease terms after the initial term. Extension options cover periods in the range from 2-6 years in addition to the non-cancellable periods. Except for already exercised extension options at January 1, 2019, no extension options are deemed reasonably certain to be exercised. Accordingly, the lease terms reflect only the non-cancellable periods.

Incremental Borrowing Rate

Lease payments are discounted over the non-cancelable periods, applying each contract’s incremental borrowing rate. In determining incremental borrowing rates, we have considered the contracts’ specific repayment profiles and relevant currencies, and thus applied a corresponding risk-free interest rate, individual credit spread and eventual asset specific adjustment. The incremental borrowing rates applied are 2.5% and 5.0% for lease contracts denominated in EUR or Danish Kroner, and US Dollars, respectively.

The unaudited condensed consolidated interim financial statements do not include all disclosures for critical accounting estimates and judgments that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the year ended December 31, 2018.

Note 4—Revenue

 

     Three Months Ended
March 31,
 
     2019      2018  
     (EUR’000)  

Revenue from the rendering of services (recognized over time)

     5,414        28  
  

 

 

    

 

 

 

Total revenue

     5,414        28  
  

 

 

    

 

 

 

Revenue from external customers (geographical)

     

North America

     5,414        28  
  

 

 

    

 

 

 

Total revenue

     5,414        28  
  

 

 

    

 

 

 

Note 5—Segment Information

We are 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, we do not disclose information on business segments or geographical markets, except for the geographical information on revenue included in Note 4.

Note 6—Warrants and Share-based Payment

Share-based payment

Ascendis Pharma A/S has established warrant programs, equity-settled share-based payment transactions, as an incentive for all our employees, members of our Board of Directors and select external consultants.

Warrants are granted by the Board of Directors in accordance with authorizations given to it by the shareholders of Ascendis Pharma A/S. As of March 31, 2019, 8,132,687 warrants had been granted, of which 19,580 warrants have been cancelled, 2,212,528 warrants have been exercised, 2,168 warrants have expired without being exercised, and 247,634 warrants have been forfeited. As of March 31, 2019, our Board of Directors was authorized to grant up to 2,483,625 additional warrants to our employees, board members and select consultants without pre-emptive subscription rights for the shareholders of Ascendis Pharma A/S. 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 our ordinary shares at the time of grant as determined by our Board of Directors.

 

3


Notes to the Unaudited Condensed Consolidated Interim Financial Statements

 

The exercise prices of outstanding warrants under our warrant programs range from €6.48 to €62.15 depending on the grant dates. Vested warrants may be exercised in two or four annual exercise periods. Apart from exercise prices and exercise periods, the programs are similar.

Warrant Activity

The following table specifies the warrant activity during the three months ended March 31, 2019:

 

     Total
Warrants
     Weighted
Average
Exercise
Price
EUR
 

Outstanding at January 1, 2019

     5,611,629        29.03  
  

 

 

    

 

 

 

Granted during the period

     54,500        62.05  

Exercised during the period

     —        —    

Forfeited during the period

     (15,352      40.07  

Expired during the period

     —        —  
  

 

 

    

 

 

 

Outstanding at March 31, 2019

     5,650,777        29.32  
  

 

 

    

 

 

 

Vested at the balance sheet date

     2,786,556        17.70  
  

 

 

    

 

 

 

Warrant Compensation Costs

Warrant compensation costs are determined with basis in the grant date fair value of the warrants granted and recognized over the vesting period.

 

     Three months Ended
March 31,
 
     2019      2018  
     (EUR’000)  

Research and development costs

     4,934        2,386  

General and administrative expenses

     4,501        2,293  
  

 

 

    

 

 

 

Total warrant compensation costs

     9,435        4,679  
  

 

 

    

 

 

 

Note 7—Leases

The following sections summarize the disclosures of the Company’s lease arrangements for the three months ended March 31, 2019. Additional information on the exposure from the Company’s lease arrangements is included in Note 2 and 3.

Right-of-use Assets

At March 31, 2019, the total balance of property, plant and equipment of €24.0 million include right-of-use-assets of €17.5 million. For the three months ended March 31, 2019, additions to right-of-use assets was €68 thousand and relate to office facilities.

At March 31, 2019, depreciation on right-of-use assets amounts to €1.0 million, recognized as research and development costs, and general and administrative expenses, by €0.8 million and €0.2 million, respectively.

Lease Liabilities and Payments

In the unaudited condensed consolidated interim statement of financial position at March 31, 2019, the carrying amount of lease liabilities of €17.5 million is presented as non-current- and current liabilities by €13.2 million and €4.3 million, respectively.

 

4


Notes to the Unaudited Condensed Consolidated Interim Financial Statements

 

The table below summarizes the maturity profile of the Company’s lease liabilities based on contractual undiscounted payments:

 

     Carrying
amount
     < 1 year      1-5 years      >5 years      Total contractual
cashflows
 
     (EUR’000)  

March 31, 2019

              

Lease liabilities

     17,484        4,342        11,281        3,185        18,808  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

For the three months ended March 31, 2019, interest on lease liabilities amounts to €137 thousand, which is recognized in finance expenses.

Payments relating to short-term leases and leases of low value assets are recognized either as research and development costs or general and administrative expenses on a straight-line basis according to their lease term. Additionally, lease payments classified as variable, that do not depend on an index or a rate, are expensed as incurred.

At March 31, 2019, the Company’s commitments for short-term leases are deemed immaterial for the unaudited condensed consolidated interim financial statements.

Note 8—Share Capital

The share capital of Ascendis Pharma A/S consists of 46,927,115 shares at a nominal value of DKK 1, all in the same share class.

On March 5, 2019, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Credit Suisse Securities (USA) LLC, and Evercore Group L.L.C., as representatives of the several underwriters named therein (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell 4,166,667 ADSs to the Underwriters (the “March 2019 Offering”). The ADSs were sold at a public offering price of $120.00 per ADS and were purchased by the Underwriters from the Company at a price of $112.80 per ADS. Under the terms of the Underwriting Agreement, the Company granted the Underwriters the right, for 30 days, to purchase from the Company up to 625,000 additional ADSs at the public offering price, less the underwriting commissions. On March 11, 2019, the Underwriters exercised their option in full to purchase the additional 625,000 ADSs.

On March 14, 2019, the March 2019 Offering closed and the Company completed the sale and issuance of an aggregate of 4,791,667 ADSs. The Company received net proceeds from the March 2019 Offering of €480.3 million ($539.4 million) after deducting the Underwriters’ commissions and the Company’s offering expenses.

Note 9—Subsequent Events

No events have occurred after the balance sheet date that would have a significant impact on the results or financial position of the Company.

 

5