EX-99.1 2 d382251dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

OBSEVA SA

INDEX TO UNAUDITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

 

Consolidated Balance Sheet as at March 31, 2017 (unaudited) and December 31, 2016    2
Unaudited Consolidated Statement of Comprehensive Loss for the three-month periods ended March 31, 2017 and 2016    3
Unaudited Consolidated Statement of Cash Flows for the three-month periods ended March 31, 2017 and 2016    4
Unaudited Statement of Changes in Equity for the period from January 1, 2016 to March 31, 2017    5
Unaudited Notes to the Consolidated Interim Financial Statements for the three-month period ended March 31, 2017    6


ObsEva SA

Consolidated Interim Financial Statements

Consolidated Balance Sheet

 

(in USD ’000)           As at March 31,
2017
    As at December
31, 2016
 
     Notes      unaudited     audited  

ASSETS

       

Current assets

       

Cash and cash equivalents

     3        104,158       25,508  

Other receivables

        988       783  

Prepaid expenses and deferred costs

        1,047       2,415  
     

 

 

   

 

 

 

Total current assets

        106,193       28,706  

Non-current assets

       

Plant and equipment

        118       121  

Intangible assets

     4        16,608       16,608  

Other long-term assets

        171       90  
     

 

 

   

 

 

 

Total non-current assets

        16,897       16,819  
     

 

 

   

 

 

 

Total assets

        123,090       45,525  
     

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS EQUITY

       

Current liabilities

       

Other payables and current liabilities

        1,836       2,383  

Accrued expenses

        6,912       4,269  
     

 

 

   

 

 

 

Total current liabilities

 

     8,748       6,652  

Non-current liabilities

       

Post-employment obligations

        2,859       2,832  
     

 

 

   

 

 

 

Total non-current liabilities

        2,859       2,832  

Shareholders’ equity

       

Share capital

        2,240       1,740  

Share premium

        160,260       71,966  

Reserves

        4,120       1,934  

Accumulated losses

        (55,137     (39,599
     

 

 

   

 

 

 

Total shareholders’ equity

     5        111,483       36,041  
     

 

 

   

 

 

 

Total liabilities and shareholders’ equity

        123,090       45,525  
     

 

 

   

 

 

 

The accompanying notes form an integral part of these consolidated interim financial statements.

 

2


ObsEva SA

Consolidated Interim Financial Statements

Consolidated Statement of Comprehensive Loss

 

(in USD ’000, except per share data)           Three-month period ended March 31,  
     Notes      2017     2016  
            unaudited  

Other operating income

        6       3  

OPERATING EXPENSES

       

Research and development expenses

     6        (13,057     (3,815

General and administrative expenses

        (2,745     (659
     

 

 

   

 

 

 

Total operating expenses

        (15,802     (4,474
     

 

 

   

 

 

 

OPERATING LOSS

        (15,796     (4,471
     

 

 

   

 

 

 

Finance income

        258       14  

Finance expense

              (224
     

 

 

   

 

 

 

NET LOSS BEFORE TAX

        (15,538     (4,681
     

 

 

   

 

 

 

Income tax expense

               
     

 

 

   

 

 

 

NET LOSS FOR THE PERIOD

        (15,538     (4,681
     

 

 

   

 

 

 

Net loss per share

       

Basic

     7        (0.58     (0.22

Diluted

     7        (0.58     (0.22

OTHER COMPREHENSIVE INCOME

       

Items that will not be reclassified to profit and loss

       
     

 

 

   

 

 

 

Remeasurements on post-retirement benefit plans

               

Items that may be reclassified to profit or loss

       

Currency translation differences

              2,403  
     

 

 

   

 

 

 

TOTAL OTHER COMPREHENSIVE INCOME

              2,403  
     

 

 

   

 

 

 

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

        (15,538     (2,278
     

 

 

   

 

 

 

The accompanying notes form an integral part of these consolidated interim financial statements.

 

3


ObsEva SA

Consolidated Interim Financial Statements

Consolidated Statement of Cash Flows

 

     Three-month period ended March 31,  
(in USD ’000)    2017     2016  
     unaudited  
  

 

 

   

 

 

 

NET LOSS BEFORE TAX FOR THE PERIOD

     (15,538     (4,681
  

 

 

   

 

 

 

Adjustments for:

    

Depreciation

     12       11  

Post-employment benefit

     27       (12

Share-based payments

     2,324       216  

Finance (income) / expense, net

     (258     210  

Increase in other receivables

     (205     (35

Decrease / (increase) in prepaid expenses, other long-term assets and deferred costs payable

     1,081       (802

(Decrease) / increase in other payables and current liabilities

     (547     976  

Increase / (decrease) in accrued expenses

     2,513       (664
  

 

 

   

 

 

 

NET CASH FLOWS USED IN OPERATING ACTIVITIES

     (10,591     (4,781
  

 

 

   

 

 

 

Payments for plant and equipment

     (9     (17
  

 

 

   

 

 

 

NET CASH FLOWS USED IN INVESTING ACTIVITIES

     (9     (17
  

 

 

   

 

 

 

Proceeds from issue of shares

     96,754       2  

Share issuance costs

     (7,769      

Interest received

           14  

Interest paid

           (6
  

 

 

   

 

 

 

NET CASH FLOWS FROM FINANCING ACTIVITIES

     88,985       10  
  

 

 

   

 

 

 

Net increase / (decrease) in cash and cash equivalents

     78,385       (4,788
  

 

 

   

 

 

 

Cash and cash equivalents as at January 1,

     25,508       54,275  
  

 

 

   

 

 

 

Effects of exchange rate changes on cash and cash equivalents

     265       1,633  

Cash and cash equivalents as at March 31,

     104,158       51,120  
  

 

 

   

 

 

 

The accompanying notes form an integral part of these consolidated interim financial statements.

 

4


ObsEva SA

Consolidated Interim Financial Statements

Consolidated Statement of Changes in Equity

(in USD ’000)

 

unaudited

 

   Share
capital
     Share
premium
    Share-based
payments
reserve
    Foreign
currency
translation
reserve
    Total
reserves
    Accumulated
losses
    Total  

January 1, 2016

            1,694        99,597          3,227          (406          2,821       (39,437     64,675  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

                                    (4,681     (4,681
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income

                        2,403       2,403             2,403  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

                        2,403       2,403       (4,681     (2,278
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Issuance of non-voting shares

     2        72       (72           (72           2  

Share-based remuneration

                  216             216             216  

Offset of accumulated losses with share premium

            (30,639                       30,639        
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

March 31, 2016

     1,696        69,030       3,371       1,997       5,368       (13,479     62,615  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

January 1, 2017

     1,740        71,966       2,423       (489     1,934       (39,599     36,041  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

                                    (15,538     (15,538
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive loss

                                           
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

                                    (15,538     (15,538
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Issuance of shares - IPO

     496        96,254                               96,750  

Issuance of shares - equity incentive plan

     4        138       (138           (138           4  

Share issuance costs

            (8,098                             (8,098

Share-based remuneration

                  2,324             2,324             2,324  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

March 31, 2017

     2,240        160,260       4,609       (489     4,120       (55,137     111,483  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes form an integral part of these consolidated interim financial statements.

 

5


ObsEva SA

Consolidated Interim Financial Statements

 

Notes to the Consolidated Interim Financial Statements for the three-month period ended March 31, 2017

(unaudited)

 

1. General information

ObsEva SA (the “Company”) was founded on November 14, 2012, and its address is 12 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland. The terms “ObsEva” or “the Group” refer to ObsEva SA together with its subsidiaries included in the scope of consolidation (note 2.3).

The Group is focused on the development and commercialization of novel therapeutics for serious conditions that compromise women’s reproductive health and pregnancy. The Group has a portfolio of three mid- to late-stage development in-licensed compounds (OBE2109, OBE001 (“nolasiban”) and OBE022) developed in four indications. The Group has no currently marketed products.

These consolidated interim financial statements are presented in dollars of the United States (USD), rounded to the nearest thousand, except share and per share data, and have been prepared on the basis of the accounting principles described in note 2.

These consolidated interim financial statements were authorized for issue by the Audit Committee of the Company’s Board of Directors (the “Board of Directors”) on May 12, 2017.

 

2. Accounting principles and scope of consolidation

2.1 Basis of preparation and accounting principles

These unaudited three-month consolidated interim financial statements (the “interim financial statements”) are prepared in accordance with International Accounting Standard (“IAS”) 34 Interim Financial Reporting as issued by the International Accounting Standards Board (the “IASB”).

As from January 1, 2017, due to a change of the primary economic environment of the Company, the functional currency of ObsEva SA became the USD, which is also the presentation currency of the Group.

Other accounting policies used in the preparation and presentation of these consolidated interim financial statements are consistent with those used in the consolidated financial statements for the year ended December 31, 2016 (the “annual financial statements”), which should be read in conjunction with these consolidated interim financial statements as they provide an update of previously reported information.

The Group believes it will be able to meet all of its obligations as they fall due for a further 12 months from March 31, 2017, hence, the unaudited consolidated interim financial statements have been prepared on a going concern basis.

2.2 Use of estimates and assumptions

The preparation of consolidated interim financial statements requires management to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent liabilities at the date of the interim financial statements. If in the future such estimates and assumptions, which are based on management’s best judgment at the date of the consolidated interim financial statements, deviate from the actual circumstances, the original estimates and assumptions will be modified as appropriate during the period in which the circumstances change.

The Group’s activities are not affected by any significant seasonal effect.

 

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ObsEva SA

Consolidated Interim Financial Statements

 

  2.3 Scope of consolidation

There was no change to the scope of consolidation during the reporting period and the Company consolidates the financial operations of its two fully-owned subsidiaries, ObsEva Ireland Ltd, which is registered in Cork, Ireland and organized under the laws of Ireland, and ObsEva USA Inc., which is registered and organized under the laws of Delaware, USA. ObsEva Ireland Ltd had no operations and no results of operations to report as of March 31, 2017.

 

3. Cash and cash equivalents

 

(in USD ‘000)        As at March 31,    
2017
     As at December 31,
2016
 
     unaudited      audited  

Bank deposits

     104,158        23,292  

Interest bearing deposits

            2,216  
  

 

 

    

 

 

 

Total cash and cash equivalents

     104,158        25,508  
  

 

 

    

 

 

 

 

4. Intangible assets

As at March 31, 2017 and December 31, 2016, the Group held a number of licenses to operate several biopharmaceutical product candidates, the value of which is recorded at USD 16.6 million.

 

5. Shareholders’ equity

On February 23, 2016, the shareholders approved for statutory purposes a resolution to offset the accumulated losses with the share premium balance for an amount of USD 30.6 million. This transaction had no impact on the overall equity position.

On January 25, 2017, the Company raised gross proceeds of USD 96.8 million in an IPO on The NASDAQ Global Select Market, a U.S. market. The IPO closed on January 30, 2017 with the issuance of 6,450,000 new ordinary shares at a subscription price of USD 15.00 per share and a par value of 1/13 of a Swiss franc per share. The proceeds have been recorded in equity net of directly related share issuance costs of USD 8.1 million.

 

6. Research and development expenses

Due to the difficulty in assessing when research and development projects would generate revenue, the Group expenses all research and development costs to the profit and loss accounts.

For the three-month periods ended March 31, 2017 and 2016, the Group pursued its research and development programs totaling expenses of USD 13.1 million and USD 3.8 million, respectively.

 

7. Loss per share

As of March 31, 2017, the Company had one category of shares, which are common shares. As of March 31, 2016, the Company’s shares were comprised of ordinary shares, consisting of both common shares and non-voting shares, and series A and series B preferred shares. The Company’s non-voting shares and series A and series B preferred shares were converted into common shares on January 25, 2017.

 

7


ObsEva SA

Consolidated Interim Financial Statements

 

For the three-month period ended March 31, 2016, since the series A and series B preferred shares participated with ordinary shares in the profit or loss on a pro-rata basis, the net loss was allocated to each class pro-rata to their weighted average number of shares outstanding during the period. The basic loss per share is calculated by dividing the loss of the period attributable to the ordinary shares by the weighted average number of ordinary shares (common and non-voting) outstanding during the period as follows:

 

     Three-month period
ended March 31, 2017
 
     (unaudited)  
     Common shares  

Net loss attributable to shareholders (in USD ‘000)

     (15,538

Weighted average number of shares outstanding

     26,623,553  
  

 

 

 

Basic and diluted loss per share (in USD)

     (0.58
  

 

 

 

 

     Three-month period ended March 31, 2016
(unaudited)
 
         Preferred B    
shares
         Preferred A    
shares
     Common and
non-voting shares
 

Net loss attributable to shareholders (in USD ‘000)

     (2,428      (1,689      (564

Weighted average number of shares outstanding

     11,079,549        7,706,777        2,573,408  
  

 

 

    

 

 

    

 

 

 

Basic and diluted loss per share (in USD)

     (0.22      (0.22      (0.22
  

 

 

    

 

 

    

 

 

 

For the three-month period ended March 31, 2017, 1,184,023 non-vested shares, 5,200 treasury shares and 428,450 shares issuable upon the exercise of stock-options, which would have an anti-dilutive impact on the calculation of the diluted earnings per share, are excluded from the calculation (three-month period ended March 31, 2016: 587,815 non-vested shares, 80,353 treasury shares and no shares issuable upon the exercise of stock-options were excluded).

 

8. Financial instruments

The Group’s financial assets consist of cash and cash equivalents and other receivables which are classified as assets at amortized costs according to IAS 39. The Group’s financial liabilities consist of other payables and accruals which are classified as other liabilities at amortized costs according to IAS 39.

 

9. Segment information

The Group operates in one segment, which is the research and development of innovative women’s reproductive, health and pregnancy therapeutics. The marketing and commercialization of such therapeutics depend on the success of the clinical development phase. The Chief Executive Officer of the Company reviews the consolidated statement of operations of the Group on an aggregated basis and manages the operations of the Group as a single operating segment.

The Group currently generates no revenue from the sales of therapeutics products.

 

8


ObsEva SA

Consolidated Interim Financial Statements

 

The geographical analysis of assets is as follows:

 

(in USD ‘000)        As at March 31,    
2017
     As at December 31,
2016
 
     unaudited      audited  

Switzerland

     122,165        45,525  

USA

     925         
  

 

 

    

 

 

 

Total assets

     123,090        45,525  
  

 

 

    

 

 

 

All capital expenditures during the three-month period ended March 31, 2017 and 2016 were made in Switzerland.

The geographical analysis of operating expenses is as follows:

 

     Three-month period ended March 31,  
(in USD ‘000)    2017      2016  
     unaudited  

Switzerland

     15,232        4,474,  

USA

     570         
  

 

 

    

 

 

 

Total operating expenses

     15,802        4,474  
  

 

 

    

 

 

 

 

10. Events after the reporting period

On April 25, 2017, the Group announced the initiation of its Phase 3 clinical program for OBE2109 in uterine fibroids and related activation of sites and start of recruitment, which triggered a commitment for the Company to pay a USD 5 million milestone to Kissei Pharmaceutical Co., Ltd., to be accounted for as intangible asset.

There were no other material events after the balance sheet date.

 

9