UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K/A

 

 

REPORT OF FOREIGN PRIVATE ISSUER

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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of June 2019

Commission File Number: 001-37993

 

 

OBSEVA SA

(Translation of registrant’s name into English)

 

 

Chemin des Aulx, 12

1228 Plan-les-Ouates

Geneva, Switzerland

(Address of principal executive office)

 

 

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):  ☐

 

 

 


EXPLANATORY NOTE

ObsEva SA (the “Company”) is amending its Report on Form 6-K furnished to the U.S. Securities and Exchange Commission (the “Commission”) on August 7, 2019 (the “Form 6-K”) solely to include the Interactive Data File with respect to the unaudited condensed consolidated financial statements included in the Form 6-K.

Except as expressly set forth above, this amendment to the Form 6-K does not amend, update or restate the information furnished on the Form 6-K or reflect any events that have occurred since the Form 6-K was originally filed.

EXHIBITS INDEX TO FORM 6-K/A

 

Exhibit Number    Description
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.LAB    XBRL Taxonomy Extension Label Linkbase Document
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document

This Report on Form 6-K/A shall be deemed to be incorporated by reference into the Registration Statements on Form F-3, as amended and supplemented (Registration Statement Nos. 333-233069, 333-222820 and 333-221462) of 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such registration statements) and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.


SIGNATURES

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

 

 

ObsEva SA

Date: August 9, 2019  

By:

 

/s/ Ernest Loumaye

   

Name

 

Ernest Loumaye

   

Title:

 

Chief Executive Officer

v3.19.2
Document and Entity Information
6 Months Ended
Jun. 30, 2019
Document and entity information [abstract]  
Document Type 6-K/A
Amendment Flag false
Document Period End Date Jun. 30, 2019
Entity Registrant Name OBSEVA SA
Entity Central Index Key 0001685316
Current Fiscal Year End Date --12-31
v3.19.2
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Current assets    
Cash and cash equivalents $ 98,492 $ 138,640
Other receivables 1,247 885
Prepaid expenses 4,285 5,715
Total current assets 104,024 145,240
Non-current assets    
Right-of-use assets 2,354  
Furniture, fixtures and equipment 280 319
Intangible assets 21,608 21,608
Other long-term assets 273 273
Total non-current assets 24,515 22,200
Total assets 128,539 167,440
Current liabilities    
Current tax liability 36  
Other payables and current liabilities 7,293 2,766
Accrued expenses 20,409 14,163
Current lease liabilities 597  
Total current liabilities 28,335 16,929
Non-current liabilities    
Non-current lease liabilities 1,841  
Post-employment obligations 3,637 3,547
Other long-term liabilities 422 48
Total non-current liabilities 5,900 3,595
Shareholders' equity    
Share capital 3,442 3,420
Share premium 317,397 314,565
Reserves 17,827 12,858
Accumulated losses (244,362) (183,927)
Total shareholders' equity 94,304 146,916
Total liabilities and shareholders' equity $ 128,539 $ 167,440
v3.19.2
Condensed Consolidated Statements of Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Statement of comprehensive income [abstract]        
Operating income other than revenue $ 1 $ 3 $ 6 $ 8
OPERATING EXPENSES        
Research and development expenses (28,438) (14,694) (48,578) (31,036)
General and administrative expenses (6,186) (3,501) (11,441) (7,150)
Total operating expenses (34,624) (18,195) (60,019) (38,186)
OPERATING LOSS (34,623) (18,192) (60,013) (38,178)
Finance income (56) 31 206 186
Finance expense (43)   (587)  
NET LOSS BEFORE TAX (34,722) (18,161) (60,394) (37,992)
Income tax expense (34) (25) (41)  
NET LOSS FOR THE PERIOD $ (34,756) $ (18,186) $ (60,435) $ (37,992)
Net loss per share        
Basic $ (0.80) $ (0.49) $ (1.39) $ (1.03)
Diluted $ (0.80) $ (0.49) $ (1.39) $ (1.03)
Items that will not be reclassified to profit and loss        
Remeasurements on post-employment benefit plans $ 0 $ 0 $ 0 $ 0
Items that may be reclassified to profit or loss        
Currency translation differences 0 0 0 0
TOTAL OTHER COMPREHENSIVE LOSS 0 0 0 0
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD $ (34,756) $ (18,186) $ (60,435) $ (37,992)
v3.19.2
Condensed Consolidated Statement of Cash Flows - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Statement of cash flows [abstract]    
NET LOSS BEFORE TAX FOR THE PERIOD $ (60,394) $ (37,992)
Adjustments for:    
Depreciation expense 367 53
Post-employment cost / (benefit) 59 (65)
Share-based compensation expense 6,411 4,574
Income tax paid 0 0
Finance result, net 381 (186)
(Increase) / decrease in other receivables (16) 153
Decrease / (increase) in prepaid expenses and other long term-assets 1,430 (590)
Increase / (decrease) in other payables and current liabilities 4,538 (1,336)
Increase in accrued expenses and other long-term liabilities 6,668 3,917
NET CASH FLOWS USED IN OPERATING ACTIVITIES (40,556) (31,472)
Payments for plant and equipment (23) (117)
NET CASH FLOWS USED IN INVESTING ACTIVITIES (23) (117)
Proceeds from issue of shares 977 93,128
Payment of share issuance costs (40) (5,718)
Proceeds from exercise of stock-options 113  
Principal elements of lease payments (281)  
Interest received 0 0
Interest paid (63)  
NET CASH FLOWS FROM FINANCING ACTIVITIES 706 87,410
Net (decrease) / increase in cash and cash equivalents (39,873) 55,821
Cash and cash equivalents as at January 1, 138,640 110,841
Effects of exchange rate changes on cash and cash equivalents (275) 173
Cash and cash equivalents as at June 30, $ 98,492 $ 166,835
v3.19.2
Condensed Consolidated Statement of Changes in Equity - USD ($)
$ in Thousands
Total
Share capital [Member]
Share premium [Member]
Share-based payments reserve [Member]
Foreign currency translation reserve [Member]
Total reserves [Member]
Accumulated losses [Member]
Beginning Balance at Dec. 31, 2017 $ 122,651 $ 2,864 $ 219,335 $ 7,608 $ (489) $ 7,119 $ (106,667)
Loss for the period (37,992)           37,992
Other comprehensive loss 0 0 0 0 0 0 0
Total comprehensive loss (37,992)           37,992
Issuance of shares - EIP 2013 14 14 1,504 (1,504)   (1,504)  
Issuance of shares - Follow-on offering 73,103 367 72,736        
Issuance of shares - ATM program 20,011 130 19,881        
Share issuance costs (5,713)   (5,713)        
Share-based remuneration 4,574     4,574   4,574  
Ending Balance at Jun. 30, 2018 176,648 3,375 307,743 10,678 (489) 10,189 (144,659)
Beginning Balance at Dec. 31, 2018 146,916 3,420 314,565 13,347 (489) 12,858 (183,927)
Loss for the period (60,435)           (60,435)
Other comprehensive loss 0 0 0 0 0 0 0
Total comprehensive loss (60,435)           (60,435)
Issuance of shares - EIP 2013 11 11 1,363 (1,363)   (1,363)  
Issuance of shares - ATM program 1,339 10 1,329        
Share issuance costs (51)   (51)        
Exercise of stock-options - EIP 2017 113 1 191 (79)   (79)  
Share-based remuneration 6,411     6,411   6,411  
Ending Balance at Jun. 30, 2019 $ 94,304 $ 3,442 $ 317,397 $ 18,316 $ (489) $ 17,827 $ (244,362)
v3.19.2
General information
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
General information

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 (linzagolix, nolasiban and OBE022) being developed in four indications. The Group has no currently marketed products.

These condensed consolidated 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 condensed consolidated financial statements were authorized for issue by the Audit Committee of the Company’s Board of Directors (the “Board of Directors”) on August 5, 2019.

v3.19.2
Accounting principles and scope of consolidation
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Accounting principles and scope of consolidation

2. Accounting principles and scope of consolidation

2.1 Basis of preparation and accounting principles

These unaudited three-month and six-month interim condensed consolidated financial statements (the “condensed consolidated 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”).

IFRS 16 - Leases

On January 1, 2019, the Group adopted IFRS 16 Leases, which replaced IAS 17 Leases and Related Interpretations. The Group has adopted IFRS 16 retrospectively from January 1, 2019, but has not restated comparatives for the year ended December 31, 2018, as permitted under the specific transitional provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the opening balance sheet on January 1, 2019. The new standard requires lessees to recognize a lease liability measured at the present value of the remaining lease payments and a right-of-use asset for virtually all lease contracts, removing the distinction between operating and finance leases.

The following table presents the reconciliation between the non-cancellable operating lease commitments reported as of December 31, 2018 and the lease liabilities recognized on January 1, 2019. The weighted average lessee’s incremental borrowing rate applied to the lease liabilities on January 1, 2019 was 4.9%.

 

(in USD ’000)    Total  
     unaudited  

Operating lease commitments disclosed as at December 31, 2018

     3,074  

Discounted using the Group’s incremental borrowing rate at the date of initial application

     2,772  

(Less): short-term and low-value leases recognized on a straight-line basis as expense

     (37

(Less): adjustments relating to changes in the index or rate affecting variable payments

     (28
  

 

 

 

Lease liability recognized as at January 1, 2019

     2,707  
  

 

 

 

Of which are:

  

Current lease liabilities

     577  

Non-current lease liabilities

     2,130  

Right-of use assets were measured at the amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to that lease recognised in the balance sheet as at December 31, 2018. Right-of-use assets mainly relate to office buildings.

The adoption of IFRS 16 Leases did not have a material impact on the Group’s net loss after tax or on the Group’s loss per share.

 

 

Other accounting policies

Other accounting policies used in the preparation and presentation of these condensed consolidated financial statements are consistent with those used in the consolidated financial statements for the year ended December 31, 2018 (the “annual financial statements”), which should be read in conjunction with these condensed consolidated financial statements as they provide an update of previously reported information.

Going concern

The Company has incurred recurring losses since inception, including net losses of $60.4 million for the six-month period ended June 30, 2019. As of June 30, 2019, the Company had accumulated losses of $274.9 million, out of which $30.6 million were offset with share premium. The Company expects to continue to generate operating losses in the foreseeable future. Further to the execution of a loan agreement with Oxford Finance on August 7, 2019, as described in note 11, the Group believes it will be able to meet all of its obligations as they fall due for at least 12 months from the date these financial statements are issued, hence, the unaudited condensed consolidated financial statements have been prepared on a going concern basis. However, the future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its future operations. The Company will seek additional funding through public or private financings, debt financing or collaboration agreements.

2.2 Use of estimates and assumptions

The preparation of condensed consolidated 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 condensed consolidated 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.

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 June 30, 2019 and 2018.

v3.19.2
Fair value estimation and financial instruments
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Fair value estimation and financial instruments

3. Fair value estimation and financial instruments

The carrying value less impairment provision of receivables and payables approximate their fair values due to their short-term nature.

All financial assets and liabilities, respectively, are held at their amortized cost.

The Group’s financial assets and liabilities consist of cash and cash equivalents, other receivables, other payables and accruals which are classified as loans and receivables at amortized cost according to IFRS 9.

v3.19.2
Cash and cash equivalents
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Cash and cash equivalents

4. Cash and cash equivalents

 

(in USD ‘000)    June 30,
2019
     December 31,
2018
 
     unaudited      audited  

Bank deposits

     98,492        138,640  

Interest bearing deposits

     —          —    
  

 

 

    

 

 

 

Total cash and cash equivalents

     98,492        138,640  
  

 

 

    

 

 

 
v3.19.2
Intangible assets
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Intangible assets

5. Intangible assets

As at June 30, 2019 and December 31, 2018, the Group holds a number of licenses to develop and commercialize several biopharmaceutical product candidates, the value of which is recorded at USD 21.6 million.

v3.19.2
Shareholders' equity
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Shareholders' equity

6. Shareholders’ equity

On March 16, 2018, the Company issued 3,499,990 common shares at par value of 1/13 of a Swiss franc per share. The shares were subscribed by the Company and are held as treasury shares, hence the operation did not impact the share capital. Share issuance costs of USD 11 thousand related to the operation were recorded as a deduction in equity.

On May 17 and 25, 2018, the Company sold 1,000,851 and 600,000 treasury shares, respectively, at a price of USD 12.50 per share, from its “at the market” (ATM) program, generating gross proceeds of USD 20.0 million. Directly related share issuance costs of USD 0.6 million were recorded as a deduction in equity.

On June 22, 2018, the Company completed an underwritten public offering of 4,750,000 common shares at a price of USD 15.39 per share, with an option to issue to an additional 712,500 common shares (the “follow-on offering”). The gross proceeds of USD 73.1 million resulting from this transaction have been recorded in equity net of directly related share issuance costs of USD 5.3 million. Subsequent to the initial closing of the follow-on offering, on July 19, 2018, the Company sold an additional 306,721 common shares for total gross proceeds of USD 4.7 million (USD 15.39 per share). These shares were sold pursuant to the 30-day option granted in connection with the follow-on offering to purchase up to an additional 712,500 common shares (“green-shoe”). Directly related share issuance costs amounted to USD 0.3 million.

In June 2019, the Company sold a total of 117,497 treasury shares at an average price of USD 11.40 per share, as part of its ATM program initiated in May 2018. These multiple daily transactions generated total gross proceeds of USD 1.3 million.

As at June 30, 2019, the total outstanding share capital of USD 3.4 million, fully paid, consists of 43,719,675 common shares, excluding 288,351 non-vested shares and 1,485,104 treasury shares. As at December 31, 2018, the total outstanding share capital of USD 3.4 million, fully paid, consists of 43,443,911 common shares, excluding 430,625 non-vested shares and 1,602,601 treasury shares. All shares have a nominal value of 1/13 of a Swiss franc, translated into USD using historical rates at the issuance date.

v3.19.2
Research and development expenses
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Research and development expenses

7. 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. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses as well as external costs of vendors engaged to conduct preclinical development activities and clinical trials.

v3.19.2
Income tax
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Income tax

8. Income tax

The Group is subject to income taxes in Switzerland, Ireland and the United States.

The Company is subject in Switzerland to a municipal and cantonal income tax rate of 22.6% and to a federal tax rate of 8.5% on its profits after tax. It is entitled to carry forward any loss incurred for a period of seven years and can offset such losses carried forward against future taxes. In 2015, the Company was granted by the State Council of the Canton of Geneva an exemption of income and capital tax at municipal and cantonal levels for the period from 2013 until 2022. Because of this exemption, and the fact that the Company has incurred net losses since its inception, no income tax expense at the municipal, cantonal or federal levels was recorded in the Company for the three-month and six-month periods ended June 30, 2019 and 2018. Additionally, due to the uncertainty as to whether it will be able to use its net loss carryforwards for tax purposes in the future, no deferred taxes have been recognized on the balance sheet of the Company as of June 30, 2019 and December 31, 2018.

The Company’s Irish subsidiary has no activity, and, therefore, no income tax expense was recorded in that entity for the three-month and six-month periods ended June 30, 2019 and 2018.

The Company’s U.S. subsidiary is a service organization for the Group and is therefore subject to taxes on the revenues generated from its services to the Group that are charged based upon the U.S. subsidiary’s cost plus arrangement with the Group. The profits of the U.S. subsidiary during the three-month and six-month periods ended June 30, 2019 and 2018 were each subject to a total U.S. income tax rate of 27.3% based on both the U.S. federal and Massachusetts state tax rates.

v3.19.2
Loss per share
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Loss per share

9. Loss per share

As of June 30, 2019 and 2018, the Company has one category of shares, which are common shares. The basic loss per share is calculated by dividing the loss of the period attributable to the common shares by the weighted average number of common shares outstanding during the period as follows:

 

    

Three-month period

ended June 30,

    

Six-month period

ended June 30,

 
     2019      2019  
     unaudited      unaudited  

Net loss attributable to shareholders (in USD ‘000)

     (34,756      (60,435

Weighted average number of common shares outstanding

     43,555,963        43,532,815  
  

 

 

    

 

 

 

Basic and diluted loss per share (in USD)

     (0.80      (1.39
  

 

 

    

 

 

 
    

Three-month period

ended June 30,

    

Six-month period

ended June 30,

 
     2018      2018  
     unaudited      unaudited  

Net loss attributable to shareholders (in USD ‘000)

     (18,186      (37,992

Weighted average number of common shares outstanding

     37,617,569        37,004,673  
  

 

 

    

 

 

 

Basic and diluted loss per share (in USD)

     (0.49      (1.03
  

 

 

    

 

 

 

For the three-month and six-month periods ended June 30, 2019, 288,351 non-vested shares and 3,167,572 shares issuable upon the exercise of stock-options, which would have an anti-dilutive impact on the calculation of the diluted earnings per share, were excluded from the calculation. For the three-month and six-month periods ended June 30, 2018, 600,822 non-vested shares and 1,849,240 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.

v3.19.2
Segment information
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Segment information

10. 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, in large part, on the success of the development phase. The Chief Executive Officer of the Company reviews the consolidated statements 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, and the Group’s activities are not affected by any significant seasonal effect.

The geographical analysis of non-current assets is as follows:

 

(in USD ‘000)    June 30,
2019
     December 31,
2018
 
     unaudited      audited  

Switzerland

     23,612        21,954  

USA

     903        246  
  

 

 

    

 

 

 

Total non-current assets

     24,515        22,200  
  

 

 

    

 

 

 

The geographical analysis of operating expenses is as follows:

 

unaudited

(in USD ’000)

   Three-month period
ended June 30,
     Six-month period
ended June 30,
 
     2019      2018      2019      2018  

Switzerland

     33,558        17,121        57,811        36,139  

USA

     1,066        1,074        2,208        2,047  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating expenses

     34,624        18,195        60,019        38,186  
  

 

 

    

 

 

    

 

 

    

 

 

 
v3.19.2
Events after the reporting period
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Events after the reporting period

11. Events after the reporting period

Milestone payment for linzagolix license

On May 9, 2019, the Group announced the initiation of its Phase 3 clinical program for linzagolix in endometriosis, which includes the EDELWEISS 2 and EDELWEISS 3 clinical trials. On July 19, 2019, the Group randomized the first patient as part of the EDELWEISS 2 trial, which triggered a commitment for the Company to pay USD 5 million to Kissei Pharmaceutical Co., Ltd., to be accounted for as an intangible asset.

Debt financing

On August 7, 2019, the Company entered into a loan and security agreement with Oxford Finance for a term loan of up to $75.0 million, subject to funding in three tranches. The Company received gross proceeds of $25.0 million from the first tranche of the credit facility upon signature of the agreement and intends to use the funds as part of its various clinical trials programs. The second tranche of $25.0 million may be drawn at the Company’s option between December 1, 2019 and January 31, 2020 upon positive results in the Phase 3 IMPLANT 4 clinical trial of nolasiban. The third tranche of $25.0 million may be drawn at the Company’s option between August 1, 2020 and September 30, 2020 upon positive results in the Phase 3 PRIMROSE 1 and 2 clinical trials of linzagolix. The credit facility is secured by substantially all of the Company’s assets, including the Company’s intellectual property. The loan bears a floating interest rate (partially based on thirty day U.S. LIBOR rate) currently amounting to 8.68% per year in total and will mature on August 1, 2024. The credit facility contains customary conditions to borrowings and events of default and contains various negative covenants limiting the Company’s ability to, among other things, transfer or sell certain assets, allow changes in business, ownership or business locations, consummate mergers or acquisitions, incur additional indebtedness, create liens, pay dividends or make other distributions and make investments.

Capital increase

On July 18, 2019, the Group announced the issuance of 3,064,048 common shares at par value of 1/13 of a Swiss franc per share. The shares were fully subscribed for by the Group, and listed on the SIX Swiss Exchange on July 23, 2019. The shares are held as treasury shares, hence the operation did not impact the share capital.

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

v3.19.2
Accounting principles and scope of consolidation (Policies)
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Basis of preparation and accounting principles

2.1 Basis of preparation and accounting principles

These unaudited three-month and six-month interim condensed consolidated financial statements (the “condensed consolidated 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”).

IFRS 16 - Leases

On January 1, 2019, the Group adopted IFRS 16 Leases, which replaced IAS 17 Leases and Related Interpretations. The Group has adopted IFRS 16 retrospectively from January 1, 2019, but has not restated comparatives for the year ended December 31, 2018, as permitted under the specific transitional provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the opening balance sheet on January 1, 2019. The new standard requires lessees to recognize a lease liability measured at the present value of the remaining lease payments and a right-of-use asset for virtually all lease contracts, removing the distinction between operating and finance leases.

The following table presents the reconciliation between the non-cancellable operating lease commitments reported as of December 31, 2018 and the lease liabilities recognized on January 1, 2019. The weighted average lessee’s incremental borrowing rate applied to the lease liabilities on January 1, 2019 was 4.9%.

 

(in USD ’000)    Total  
     unaudited  

Operating lease commitments disclosed as at December 31, 2018

     3,074  

Discounted using the Group’s incremental borrowing rate at the date of initial application

     2,772  

(Less): short-term and low-value leases recognized on a straight-line basis as expense

     (37

(Less): adjustments relating to changes in the index or rate affecting variable payments

     (28
  

 

 

 

Lease liability recognized as at January 1, 2019

     2,707  
  

 

 

 

Of which are:

  

Current lease liabilities

     577  

Non-current lease liabilities

     2,130  

Right-of use assets were measured at the amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to that lease recognised in the balance sheet as at December 31, 2018. Right-of-use assets mainly relate to office buildings.

The adoption of IFRS 16 Leases did not have a material impact on the Group’s net loss after tax or on the Group’s loss per share.

 

 

Other accounting policies

Other accounting policies used in the preparation and presentation of these condensed consolidated financial statements are consistent with those used in the consolidated financial statements for the year ended December 31, 2018 (the “annual financial statements”), which should be read in conjunction with these condensed consolidated financial statements as they provide an update of previously reported information.

Going concern

The Company has incurred recurring losses since inception, including net losses of $60.4 million for the six-month period ended June 30, 2019. As of June 30, 2019, the Company had accumulated losses of $274.9 million, out of which $30.6 million were offset with share premium. The Company expects to continue to generate operating losses in the foreseeable future. Further to the execution of a loan agreement with Oxford Finance on August 7, 2019, as described in note 11, the Group believes it will be able to meet all of its obligations as they fall due for at least 12 months from the date these financial statements are issued, hence, the unaudited condensed consolidated financial statements have been prepared on a going concern basis. However, the future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its future operations. The Company will seek additional funding through public or private financings, debt financing or collaboration agreements.

Use of estimates and assumptions

2.2 Use of estimates and assumptions

The preparation of condensed consolidated 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 condensed consolidated 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.

Scope of consolidation

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 June 30, 2019 and 2018.

v3.19.2
Accounting principles and scope of consolidation (Tables)
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Schedule of Reconcilation between the Non-cancellable Operating Lease

The following table presents the reconciliation between the non-cancellable operating lease commitments reported as of December 31, 2018 and the lease liabilities recognized on January 1, 2019. The weighted average lessee’s incremental borrowing rate applied to the lease liabilities on January 1, 2019 was 4.9%.

 

(in USD ’000)    Total  
     unaudited  

Operating lease commitments disclosed as at December 31, 2018

     3,074  

Discounted using the Group’s incremental borrowing rate at the date of initial application

     2,772  

(Less): short-term and low-value leases recognized on a straight-line basis as expense

     (37

(Less): adjustments relating to changes in the index or rate affecting variable payments

     (28
  

 

 

 

Lease liability recognized as at January 1, 2019

     2,707  
  

 

 

 

Of which are:

  

Current lease liabilities

     577  

Non-current lease liabilities

     2,130  
v3.19.2
Cash and cash equivalents (Tables)
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Schedule of Cash and Cash Equivalents
(in USD ‘000)    June 30,
2019
     December 31,
2018
 
     unaudited      audited  

Bank deposits

     98,492        138,640  

Interest bearing deposits

     —          —    
  

 

 

    

 

 

 

Total cash and cash equivalents

     98,492        138,640  
  

 

 

    

 

 

 
v3.19.2
Loss per share (Tables)
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Schedule of Basic and Diluted Loss per Share

The basic loss per share is calculated by dividing the loss of the period attributable to the common shares by the weighted average number of common shares outstanding during the period as follows:

 

    

Three-month period

ended June 30,

    

Six-month period

ended June 30,

 
     2019      2019  
     unaudited      unaudited  

Net loss attributable to shareholders (in USD ‘000)

     (34,756      (60,435

Weighted average number of common shares outstanding

     43,555,963        43,532,815  
  

 

 

    

 

 

 

Basic and diluted loss per share (in USD)

     (0.80      (1.39
  

 

 

    

 

 

 
    

Three-month period

ended June 30,

    

Six-month period

ended June 30,

 
     2018      2018  
     unaudited      unaudited  

Net loss attributable to shareholders (in USD ‘000)

     (18,186      (37,992

Weighted average number of common shares outstanding

     37,617,569        37,004,673  
  

 

 

    

 

 

 

Basic and diluted loss per share (in USD)

     (0.49      (1.03
  

 

 

    

 

 

 
v3.19.2
Segment information (Tables)
6 Months Ended
Jun. 30, 2019
Text block [abstract]  
Summary of Geographical Analysis of Non-Current Assets

The geographical analysis of non-current assets is as follows:

 

(in USD ‘000)    June 30,
2019
     December 31,
2018
 
     unaudited      audited  

Switzerland

     23,612        21,954  

USA

     903        246  
  

 

 

    

 

 

 

Total non-current assets

     24,515        22,200  
  

 

 

    

 

 

 
Summary of Geographical Analysis of Operating Expenses

The geographical analysis of operating expenses is as follows:

 

unaudited

(in USD ’000)

   Three-month period
ended June 30,
     Six-month period
ended June 30,
 
     2019      2018      2019      2018  

Switzerland

     33,558        17,121        57,811        36,139  

USA

     1,066        1,074        2,208        2,047  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating expenses

     34,624        18,195        60,019        38,186  
  

 

 

    

 

 

    

 

 

    

 

 

 
v3.19.2
General Information - Additional Information (Detail)
6 Months Ended
Jun. 30, 2019
Disclosure Of General Information About Financial Statements [abstract]  
Name of reporting entity ObsEva SA
Date of foundation of entity Nov. 14, 2012
Country of incorporation Geneva, Switzerland
Details about operations of the entity 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 (linzagolix, nolasiban and OBE022) being developed in four indications. The Group has no currently marketed products.
v3.19.2
Accounting Principles and Scope of Consolidation - Additional Information (Detail) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Jan. 01, 2019
Basis of accounting [abstract]          
Weighted average lessee's incremental borrowing rate applied to lease liabilities recognised at date of initial application of IFRS 16         4.90%
Net losses $ (34,722) $ (18,161) $ (60,394) $ (37,992)  
Accumulated losses before offset with share premium $ 274,900   274,900    
Offset of accumulated losses with share premium     $ (30,600)    
v3.19.2
Accounting Principles and Scope of Consolidation - Schedule of Reconcilation between the Non-cancellable Operating Lease (Detail) - USD ($)
$ in Thousands
Jun. 30, 2019
Jan. 01, 2019
Dec. 31, 2018
Lease liabilities [abstract]      
Operating lease commitments disclosed as at December 31, 2018     $ 3,074
Discounted using the Group's incremental borrowing rate at the date of initial application   $ 2,772  
(Less): short-term and low-value leases recognized on a straight-line basis as expense   (37)  
(Less): adjustments relating to changes in the index or rate affecting variable payments   (28)  
Lease liability recognized as at January 1, 2019   2,707  
Current lease liabilities $ 597 577  
Non-current lease liabilities $ 1,841 $ 2,130  
v3.19.2
Cash and Cash Equivalents - Schedule of Cash and Cash Equivalents (Detail) - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Jun. 30, 2018
Dec. 31, 2017
Cash and cash equivalents [abstract]        
Bank deposits $ 98,492 $ 138,640    
Interest bearing deposits 0 0    
Total cash and cash equivalents $ 98,492 $ 138,640 $ 166,835 $ 110,841
v3.19.2
Intangible Assets - Additional Information (Detail) - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Disclosure of detailed information about intangible assets [abstract]    
Intangible assets $ 21,608 $ 21,608
v3.19.2
Shareholders' Equity - Additional Information (Detail)
$ / shares in Units, $ in Thousands
1 Months Ended 6 Months Ended 12 Months Ended
Jul. 19, 2018
USD ($)
$ / shares
shares
Jun. 22, 2018
USD ($)
$ / shares
shares
Mar. 16, 2018
USD ($)
shares
Jun. 30, 2019
USD ($)
$ / shares
shares
May 25, 2018
USD ($)
$ / shares
shares
Jun. 30, 2019
USD ($)
$ / shares
shares
Jun. 30, 2018
USD ($)
Dec. 31, 2018
USD ($)
shares
Jun. 30, 2019
SFr / shares
Dec. 31, 2018
SFr / shares
May 17, 2018
$ / shares
shares
Disclosure of classes of share capital [line items]                      
Issuance of shares     3,499,990                
Par value per share     0.0769                
Share issue related cost | $     $ 11     $ 51 $ 5,713        
Share capital | $       $ 3,442   $ 3,442   $ 3,420      
Treasury non-voting shares       1,485,104   1,485,104   1,602,601      
Issuance Of Issuance Of Non Vested Non Voting Shares Fully Paid           288,351   430,625      
Nominal value per share of non-voting shares | SFr / shares                 SFr 0.0769 SFr 0.0769  
Common shares [Member]                      
Disclosure of classes of share capital [line items]                      
Share capital | $       $ 3,400   $ 3,400   $ 3,400      
Number of shares issued and fully paid       43,719,675   43,719,675   43,443,911      
IPO [Member]                      
Disclosure of classes of share capital [line items]                      
Share issue related cost | $ $ 300                    
Number of shares issued 306,721                    
Share price | $ / shares $ 15.39                    
Proceeds from issue of common shares | $ $ 4,700                    
IPO [Member] | Underwritten public offering [member]                      
Disclosure of classes of share capital [line items]                      
Share issue related cost | $   $ 5,300                  
Number of shares issued   4,750,000                  
Share price | $ / shares   $ 15.39                  
Proceeds from issue of common shares | $   $ 73,100                  
IPO [Member] | Follow-on offering [member]                      
Disclosure of classes of share capital [line items]                      
Number of shares issued   712,500                  
IPO [Member] | Green-shoe [member]                      
Disclosure of classes of share capital [line items]                      
Number of shares issued 712,500                    
IPO [Member] | Treasury Shares [member]                      
Disclosure of classes of share capital [line items]                      
Share issue related cost | $         $ 600            
Number of shares issued         600,000           1,000,851
Share price | $ / shares         $ 12.50           $ 12.50
Proceeds from sale of treasury shares | $         $ 20,000            
ATM [member] | Treasury Shares [member]                      
Disclosure of classes of share capital [line items]                      
Number of shares issued       117,497   117,497          
Share price | $ / shares       $ 11.40   $ 11.40          
Proceeds from sale of treasury shares | $       $ 1,300              
v3.19.2
Income Tax - Additional Information (Detail) - USD ($)
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Dec. 31, 2018
Disclosure Of Income Taxes [line items]          
Statutory tax rate (blended at Group level)     8.50%    
ObsEva Ireland Ltd [Member]          
Disclosure Of Income Taxes [line items]          
Current tax expense (income) $ 0 $ 0 $ 0 $ 0  
ObsEva USA Inc [Member]          
Disclosure Of Income Taxes [line items]          
Statutory tax rate (blended at Group level) 27.30% 27.30% 27.30% 27.30%  
Switzerland [Member]          
Disclosure Of Income Taxes [line items]          
Tax loss carryforward period     7 years    
Current tax expense (income)     $ 0   $ 0
Deferred taxes $ 0   $ 0   $ 0
Switzerland [Member] | Municipal and Cantonal Tax Rate [Member]          
Disclosure Of Income Taxes [line items]          
Statutory tax rate (blended at Group level)     22.60%    
Switzerland [Member] | Federal Tax Rate [Member]          
Disclosure Of Income Taxes [line items]          
Statutory tax rate (blended at Group level)     8.50%    
v3.19.2
Loss Per Share - Schedule of Basic and Diluted Loss per Share (Detail) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Basic and diluted loss per share [abstract]        
Net loss attributable to shareholders $ (34,756) $ (18,186) $ (60,435) $ (37,992)
Weighted average number of common shares outstanding 43,555,963 37,617,569 43,532,815 37,004,673
Basic and diluted loss per share (in USD) $ (0.80) $ (0.49) $ (1.39) $ (1.03)
v3.19.2
Loss Per Share - Additional Information (Detail) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Earnings per share [abstract]        
Anti-dilutive non-vested securities excluded from calculation of diluted earnings per share 288,351 600,822 3,167,572 1,849,240
v3.19.2
Segment Information (Detail)
6 Months Ended
Jun. 30, 2019
Segments
Disclosure of operating segments [abstract]  
Number of operating segments 1
v3.19.2
Segment Information - Summary of Geographical Analysis of Non-current Assets (Detail) - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Disclosure of geographical areas [line items]    
Total non-current assets $ 24,515 $ 22,200
Switzerland [Member]    
Disclosure of geographical areas [line items]    
Total non-current assets 23,612 21,954
USA [Member]    
Disclosure of geographical areas [line items]    
Total non-current assets $ 903 $ 246
v3.19.2
Segment Information - Summary of Geographical Analysis of Operating Expenses (Detail) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Disclosure of geographical areas [line items]        
Total operating expenses $ 34,624 $ 18,195 $ 60,019 $ 38,186
Switzerland [Member]        
Disclosure of geographical areas [line items]        
Total operating expenses 33,558 17,121 57,811 36,139
USA [Member]        
Disclosure of geographical areas [line items]        
Total operating expenses $ 1,066 $ 1,074 $ 2,208 $ 2,047
v3.19.2
Events After Reporting Period - Additional Information (Detail)
$ in Millions
Aug. 07, 2019
USD ($)
Jul. 19, 2019
USD ($)
Jul. 18, 2019
SFr / shares
shares
Entering into significant commitments or contingent liabilities [member] | Kissei Pharmaceuticals Co Ltd [member]      
Disclosure of non-adjusting events after reporting period [line items]      
Commitment to pay to Kissei pharmaceutical Co.   $ 5.0  
Debt financing [member]      
Disclosure of non-adjusting events after reporting period [line items]      
Aggregate amount of debt $ 75.0    
Borrowing interest rate basis The loan bears a floating interest rate (partially based on thirty day U.S. LIBOR rate) currently amounting to 8.68% per year    
Borrowing interest rate 8.68%    
Borrowing Maturity August 1, 2024    
Debt financing [member] | First tranche [member]      
Disclosure of non-adjusting events after reporting period [line items]      
Aggregate amount of debt $ 25.0    
Proceeds from loan 25.0    
Debt financing [member] | Second tranche [member]      
Disclosure of non-adjusting events after reporting period [line items]      
Aggregate amount of debt $ 25.0    
Date loan may be drawn May be drawn at the Company's option between December 1, 2019 and January 31, 2020 upon positive results in the Phase 3 IMPLANT 4 clinical trial of nolasiban.    
Debt financing [member] | Third tranche [member]      
Disclosure of non-adjusting events after reporting period [line items]      
Aggregate amount of debt $ 25.0    
Date loan may be drawn May be drawn at the Company's option between August 1, 2020 and September 30, 2020 upon positive results in the Phase 3 PRIMROSE 1 and 2 clinical trials of linzagolix.    
Major ordinary share transactions [Member] | Common shares [Member]      
Disclosure of non-adjusting events after reporting period [line items]      
Number of shares issued | shares     3,064,048
Par value per shares | SFr / shares     SFr 0.07692