EX-99.1 2 obsv-ex991_6.htm EX-99.1 obsv-ex991_6.htm

Exhibit 99.1

OBSEVA SA

INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Condensed Consolidated Balance Sheets

 

(in USD ’000)

Notes

 

September 30,

2018

 

 

December 31,

2017

 

 

 

 

unaudited

 

 

audited

 

ASSETS

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

4

 

 

156,439

 

 

 

110,841

 

Other receivables

 

 

 

695

 

 

 

783

 

Prepaid expenses

 

 

 

1,670

 

 

 

1,490

 

Total current assets

 

 

 

158,804

 

 

 

113,114

 

Non-current assets

 

 

 

 

 

 

 

 

 

Furniture, fixtures and equipment

 

 

 

292

 

 

 

323

 

Intangible assets

5

 

 

21,608

 

 

 

21,608

 

Other long-term assets

 

 

 

273

 

 

 

190

 

Total non-current assets

 

 

 

22,173

 

 

 

22,121

 

Total assets

 

 

 

180,977

 

 

 

135,235

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

Current tax liability

 

 

 

17

 

 

 

51

 

Other payables and current liabilities

 

 

 

1,474

 

 

 

2,865

 

Accrued expenses

 

 

 

11,600

 

 

 

6,514

 

Total current liabilities

 

 

 

13,091

 

 

 

9,430

 

Non-current liabilities

 

 

 

 

 

 

 

 

 

Post-employment obligations

 

 

 

3,004

 

 

 

3,099

 

Other long-term liabilities

 

 

 

49

 

 

 

55

 

Total non-current liabilities

 

 

 

3,053

 

 

 

3,154

 

Shareholders’ equity

 

 

 

 

 

 

 

 

 

Share capital

 

 

 

3,413

 

 

 

2,864

 

Share premium

 

 

 

313,628

 

 

 

219,335

 

Reserves

 

 

 

11,041

 

 

 

7,119

 

Accumulated losses

 

 

 

(163,249

)

 

 

(106,667

)

Total shareholders’ equity

6

 

 

164,833

 

 

 

122,651

 

Total liabilities and shareholders’ equity

 

 

 

180,977

 

 

 

135,235

 

 

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


2

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Condensed Consolidated Statements of Comprehensive Loss

 

(in USD ’000, except per share data)

 

 

Three-month period

ended September 30,

 

 

Nine-month period

ended September 30,

 

 

Notes

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

 

 

unaudited

 

 

unaudited

 

Operating income other than revenue

 

 

 

2

 

 

 

3

 

 

 

10

 

 

 

11

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

7

 

 

(15,909

)

 

 

(13,910

)

 

 

(46,945

)

 

 

(40,983

)

General and administrative expenses

 

 

 

(3,137

)

 

 

(3,001

)

 

 

(10,287

)

 

 

(9,601

)

Total operating expenses

 

 

 

(19,046

)

 

 

(16,911

)

 

 

(57,231

)

 

 

(50,584

)

OPERATING LOSS

 

 

 

(19,043

)

 

 

(16,908

)

 

 

(57,221

)

 

 

(50,573

)

Finance income

 

 

 

430

 

 

 

(106

)

 

 

616

 

 

 

754

 

Finance expense

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

NET LOSS BEFORE TAX

 

 

 

(18,613

)

 

 

(17,015

)

 

 

(56,605

)

 

 

(49,820

)

Income tax benefit / (expense)

8

 

 

23

 

 

 

21

 

 

 

23

 

 

 

(36

)

NET LOSS FOR THE PERIOD

 

 

 

(18,590

)

 

 

(16,994

)

 

 

(56,582

)

 

 

(49,856

)

Net loss per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

9

 

 

(0.42

)

 

 

(0.59

)

 

 

(1.45

)

 

 

(1.78

)

Diluted

9

 

 

(0.42

)

 

 

(0.59

)

 

 

(1.45

)

 

 

(1.78

)

OTHER COMPREHENSIVE LOSS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that will not be reclassified to profit and loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remeasurements on post-employment benefit plans

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that may be reclassified to profit or loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Currency translation differences

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL OTHER COMPREHENSIVE LOSS

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

 

 

 

(18,590

)

 

 

(16,994

)

 

 

(56,582

)

 

 

(49,856

)

 

 

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

 

3

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Condensed Consolidated Statement of Cash Flows

 

 

 

Nine-month period

ended September 30,

 

(in USD ’000)

Notes

 

2018

 

 

2017

 

 

 

 

unaudited

 

NET LOSS BEFORE TAX FOR THE PERIOD

 

 

 

(56,605

)

 

 

(49,820

)

Adjustments for:

 

 

 

 

 

 

 

 

 

Depreciation expense

 

 

 

80

 

 

 

45

 

Post-employment (benefit) / cost

 

 

 

(95

)

 

 

8

 

Share-based compensation expense

 

 

 

6,561

 

 

 

6,825

 

Income tax paid

 

 

 

(12

)

 

 

 

Finance result

 

 

 

(616

)

 

 

(753

)

Decrease in other receivables

 

 

 

88

 

 

 

100

 

(Increase) / decrease in prepaid expenses and other long term-assets

 

 

 

(179

)

 

 

532

 

(Decrease) / increase in other payables and current liabilities

 

 

 

(1,308

)

 

 

258

 

Increase in accrued expenses and other long-term liabilities

 

 

 

5,798

 

 

 

1,266

 

NET CASH FLOWS USED IN OPERATING ACTIVITIES

 

 

 

(46,288

)

 

 

(41,539

)

Cash used for rental deposits

 

 

 

(83

)

 

 

(96

)

Payments for plant and equipment

 

 

 

(129

)

 

 

(148

)

Payments for intangible assets

 

 

 

 

 

 

(5,000

)

NET CASH FLOWS USED IN INVESTING ACTIVITIES

 

 

 

(212

)

 

 

(5,244

)

Proceeds from issue of shares

 

 

 

97,855

 

 

 

96,779

 

Payment of share issuance costs

 

 

 

(6,877

)

 

 

(7,899

)

Proceeds from exercise of stock-options

 

 

 

504

 

 

 

 

Interest received

 

 

 

 

 

 

(1

)

NET CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

91,482

 

 

 

88,879

 

Net increase in cash and cash equivalents

 

 

 

44,982

 

 

 

42,096

 

Cash and cash equivalents as at January 1,

 

 

 

110,841

 

 

 

25,508

 

Effects of exchange rate changes on cash and cash equivalents

 

 

 

616

 

 

 

754

 

Cash and cash equivalents as at September 30,

 

 

 

156,439

 

 

 

68,358

 

 

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

 

4

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Condensed 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, 2017

 

 

1,740

 

 

 

71,966

 

 

 

2,423

 

 

 

(489

)

 

 

1,934

 

 

 

(39,599

)

 

 

36,041

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(49,856

)

 

 

(49,856

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(49,856

)

 

 

(49,856

)

Issuance of shares - IPO

 

 

496

 

 

 

96,254

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

96,750

 

Issuance of shares - Incentive Plan

 

 

29

 

 

 

2,984

 

 

 

(2,984

)

 

 

 

 

 

(2,984

)

 

 

 

 

 

29

 

Share issuance costs

 

 

 

 

 

(8,222

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,222

)

Share-based remuneration

 

 

 

 

 

 

 

 

6,825

 

 

 

 

 

 

6,825

 

 

 

 

 

 

6,825

 

September 30, 2017

 

 

2,265

 

 

 

162,982

 

 

 

6,264

 

 

 

(489

)

 

 

5,775

 

 

 

(89,455

)

 

 

81,567

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 1, 2018

 

 

2,864

 

 

 

219,335

 

 

 

7,608

 

 

 

(489

)

 

 

7,119

 

 

 

(106,667

)

 

 

122,651

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(56,582

)

 

 

(56,582

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(56,582

)

 

 

(56,582

)

Issuance of shares - Incentive Plan

 

 

21

 

 

 

2,291

 

 

 

(2,291

)

 

 

 

 

 

(2,291

)

 

 

 

 

 

21

 

Issuance of shares - Follow-on Offering

 

 

392

 

 

 

77,431

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

77,823

 

Issuance of shares - ATM program

 

 

130

 

 

 

19,881

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

20,011

 

Share issuance costs

 

 

 

 

 

(6,156

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,156

)

Exercise of stock-options

 

 

6

 

 

 

846

 

 

 

(348

)

 

 

 

 

 

(348

)

 

 

 

 

 

504

 

Share-based remuneration

 

 

 

 

 

 

 

 

6,561

 

 

 

 

 

 

6,561

 

 

 

 

 

 

6,561

 

September 30, 2018

 

 

3,413

 

 

 

313,628

 

 

 

11,530

 

 

 

(489

)

 

 

11,041

 

 

 

(163,249

)

 

 

164,833

 

 

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

 

5

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Notes to the Condensed Consolidated Financial Statements for the three-month and nine-month periods ended September 30, 2018

(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 (linzagolix (OBE2109), nolasiban (OBE001) 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 November 5, 2018.

2. Accounting principles and scope of consolidation

2.1 Basis of preparation and accounting principles

These unaudited three-month and nine-month condensed interim 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”).

On January 1, 2018, the Group adopted IFRS 9 Financial Instruments, which replaced IAS 39 Financial Instruments: Recognition and Measurement. The adoption of the standard had no impact on the Group’s condensed consolidated financial statements.

In January 2016, the IASB issued IFRS 16 Leases, which replaced IAS 17 Leases and Related Interpretations. The new standard, which will be effective on January 1, 2019 requires lessees to recognize a lease liability reflecting future lease payments and a right-of-use asset for virtually all lease contracts, removing the distinction between operating and finance leases. As at September 30, 2018, the Group has non-cancellable operating lease commitments of USD 3 million (excluding short-term and low-value leases) and expects to recognise right-of-use assets and lease liabilities of approximately USD 2.7 million on January 1, 2019. The Group does not expect a significant impact on the net profit after tax resulting from the adoption of IFRS 16.

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, 2017 (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.

The Group believes it will be able to meet all of its obligations as they fall due for at least 12 months from September 30, 2018, hence, the unaudited condensed consolidated financial statements have been prepared on a going concern basis.

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,

6

 


ObsEva SA

Condensed Consolidated Financial Statements

 

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 September 30, 2018 and 2017.

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.

4. Cash and cash equivalents

 

(in USD ‘000)

 

September 30,

2018

 

 

December 31,

2017

 

 

 

unaudited

 

 

audited

 

Bank deposits

 

 

156,439

 

 

 

110,841

 

Interest bearing deposits

 

 

 

 

 

 

Total cash and cash equivalents

 

 

156,439

 

 

 

110,841

 

5. Intangible assets

As at September 30, 2018 and December 31, 2017, 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.

6. Shareholders’ equity

On January 30, 2017, the Company completed an IPO and issued 6,450,000 common 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 gross proceeds of USD 96.8 million have been recorded in equity net of directly related share issuance costs of USD 8.2 million.

On October 13, 2017, the Company completed a private placement with institutional investors and issued 7,500,000 common shares at a subscription price of USD 8.00 per share and a par value of 1/13 of a Swiss franc per share. The gross proceeds of USD 60.0 million have been recorded in equity net of directly related share issuance costs of USD 3.7 million.

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 5.1 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.

As at September 30, 2018, the total outstanding share capital of USD 3.4 million, fully paid, consists of 43,342,232 common shares, excluding 508,502 non-vested shares and 1,602,601 treasury shares. As at December 31, 2017, the total outstanding share capital of USD 2.9 million, fully paid, consists of 36,342,945 common shares, excluding 778,134 non-vested shares and 10,183 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.

7

 


ObsEva SA

Condensed Consolidated Financial Statements

 

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.

8. Income tax expense

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 nine-month periods ended September 30, 2018 and 2017. 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 September 30, 2018 and December 31, 2017.

The Company’s Irish subsidiary has no activity, and, therefore, no income tax expense was recorded in that entity for the three-month and nine-month periods ended September 30, 2018 and 2017.

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 nine-month periods ended September 30, 2018 and 2017 were subject to a total U.S. income tax rate of 27.3% and 39.3%, respectively, based on both the U.S. federal and Massachusetts state tax rates.

9. Loss per share

As of September 30, 2018 and 2017, 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 September 30,

 

Nine-month period

ended September 30,

 

 

 

2018

 

2018

 

 

 

unaudited

 

unaudited

 

Net loss attributable to shareholders (in USD ‘000)

 

 

(18,590

)

 

(56,582

)

Weighted average number of common shares outstanding

 

 

43,196,686

 

 

39,092,256

 

Basic and diluted loss per share (in USD)

 

 

(0.42

)

 

(1.45

)

 

 

Three-month period

ended September 30,

 

Nine-month period

ended September 30,

 

 

 

2017

 

2017

 

 

 

unaudited

 

unaudited

 

Net loss attributable to shareholders (in USD ‘000)

 

 

(16,994

)

 

(49,856

)

Weighted average number of common shares outstanding

 

 

28,627,148

 

 

28,047,694

 

Basic and diluted loss per share (in USD)

 

 

(0.59

)

 

(1.78

)

 

For the three-month and nine-month periods ended September 30, 2018, 508,502 non-vested shares, 1,602,601 treasury shares and 1,802,157 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 nine-month periods ended September 30, 2017, 862,980 non-vested shares, 10,183 treasury shares and 693,450 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.

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

8

 


ObsEva SA

Condensed Consolidated Financial Statements

 

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, 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)

 

September 30,

2018

 

 

December 31,

2017

 

 

 

unaudited

 

 

audited

 

Switzerland

 

 

21,917

 

 

 

21,832

 

USA

 

 

256

 

 

 

289

 

Total non-current assets

 

 

22,173

 

 

 

22,121

 

 

The geographical analysis of operating expenses is as follows:

 

unaudited

(in USD ’000)

 

Three-month period

ended September 30,

 

 

Nine-month period

ended September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Switzerland

 

 

18,070

 

 

 

15,849

 

 

 

54,209

 

 

 

48,179

 

USA

 

 

975

 

 

 

1,062

 

 

 

3,022

 

 

 

2,405

 

Total operating expenses

 

 

19,046

 

 

 

16,911

 

 

 

57,231

 

 

 

50,584

 

 

11. Events after the reporting period

There were no material events after the balance sheet date.

9