UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of May 2020

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):  

 

 


INCORPORATION BY REFERENCE

Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3, as amended (Registration No. 333-222820, 333-221462 and 333-233069) of ObsEva SA (including any prospectuses forming a part of such registration statements) and the registration statements on Form S-8 (Registration No. 333-216170 and 333-231629) of ObsEva SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

RISK FACTORS

The matters discussed in this Report on Form 6-K include forward-looking statements that involve risks or uncertainties. These statements are neither promises nor guarantees, but are based on various assumptions by management regarding future circumstances, over many of which we have little or no control. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, also may affect our business, financial condition and/or future operating results. A number of important risks and uncertainties, including those identified in the risk factors set forth in our Annual Report on Form 20-F for the year ended December 31, 2019, or our Annual Report, filed with the Securities and Exchange Commission on March 5, 2020, which are incorporated herein, could cause our actual results to differ materially from those in these forward-looking statements. Other than the factors set forth below, there are no material changes to the risk factors previously disclosed in our Annual Report.

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, or materially affect our operations globally, including at our headquarters in Geneva, Switzerland, which is currently subject to government restrictions in response to the COVID-19 pandemic, and at our clinical trial sites, as well as the business or operations of our manufacturers, clinical research organizations or other third parties with whom we conduct business.

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, which was declared by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of the disease, including government restrictions in Europe, the United States and other countries, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel. Some government restrictions in Switzerland will continue through the second quarter of 2020, unless further extended. As a result of these recent developments, we have implemented work-from-home policies for most of our employees. The effects of the government restrictions and our work-from-home policies may negatively impact productivity, disrupt our business and continue to delay certain of our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.

Quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur or be further extended, related to COVID-19 or other infectious diseases could impact personnel at third-party manufacturing facilities in Europe, the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain. Further, Kissei Pharmaceutical Co., Ltd., or Kissei, has the exclusive right to supply us with the active pharmaceutical ingredient for linzagolix for our clinical trials and commercial supplies, if approved, subject to limited specified exceptions within the control of Kissei. While many of these materials may be obtained by more than one supplier, restrictions resulting from the coronavirus pandemic in the regions our third-party suppliers and Kissei operate may disrupt our supply chain or limit our ability to obtain sufficient materials for our product candidates, which might impact and delay certain of our clinical programs and timelines.

In addition, our clinical trials have been affected by the ongoing COVID-19 pandemic. Site initiation and patient enrollment has been and may be further delayed due to prioritization of hospital resources toward the COVID-19 pandemic, and some patients may not be able or willing to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, has been delayed or disrupted, which has adversely impacted our clinical trial operations. For example, in view of the expected logistical challenges with initial screening and uncertainty about continuity of treatment for randomized patients because of the COVID-19 pandemic, we have placed a temporary hold on further screening and randomization of patients into our EDELWEISS 2 and EDELWEISS 3 trials until further notice. EDELWEISS 2 and EDELWEISS 3 clinical trial sites will be managing all randomized patients currently on treatment to proceed with enhanced safety measures and the trial protocol whenever feasible. Further delays may occur.

The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by, and the duration of, the COVID-19 pandemic, may be difficult to assess or predict, it is currently resulting in significant disruption of global financial markets. This disruption, if sustained or recurrent, could make it more difficult


for us to access capital, which could in the future negatively affect our liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our common stock.

The global pandemic of COVID-19 continues to rapidly evolve. The ultimate impact of the ongoing COVID-19 pandemic or a similar health pandemic or epidemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems or the global economy as a whole. These effects could have a material impact on our operations, and we will continue to monitor the COVID-19 situation closely.

 

 


EXHIBIT INDEX

 

Exhibit
No.

  

Description

 

 

99.1

  

Unaudited Condensed Consolidated Financial Statements

 

 

99.2

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

 

99.3

  

Press Release dated May 5, 2020

 

 

 

 

 


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: May 5, 2020

 

By:

 

/s/ Ernest Loumaye

 

 

 

 

Name

 

Ernest Loumaye

 

 

 

 

Title:

 

Chief Executive Officer

 

obsv-ex991_6.htm

Exhibit 99.1

OBSEVA SA

INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Unaudited Condensed Consolidated Balance Sheets as at March 31, 2020 and December 31, 2019

  

2

Unaudited Condensed Consolidated Statements of Comprehensive Loss for the three-month periods ended March 31, 2020

  

3

Unaudited Condensed Consolidated Statement of Cash Flows for the three-month period ended March 31, 2020

  

4

Unaudited Condensed Consolidated Statement of Changes in Equity for the three-month period ended March 31, 2020

  

5

Unaudited Notes to the Condensed Consolidated Financial Statements

  

6

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Unaudited Condensed Consolidated Balance Sheets

 

(in USD ’000)

Notes

 

March 31,

2020

 

 

December 31,

2019

 

ASSETS

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

4

 

 

62,042

 

 

 

69,370

 

Other receivables

 

 

 

514

 

 

 

1,044

 

Prepaid expenses

 

 

 

5,835

 

 

 

4,359

 

Total current assets

 

 

 

68,391

 

 

 

74,773

 

Non-current assets

 

 

 

 

 

 

 

 

 

Right-of-use assets

 

 

 

1,888

 

 

 

2,042

 

Furniture, fixtures and equipment

 

 

 

218

 

 

 

245

 

Intangible assets

5

 

 

26,608

 

 

 

26,608

 

Other long-term assets

 

 

 

276

 

 

 

275

 

Total non-current assets

 

 

 

28,990

 

 

 

29,170

 

Total assets

 

 

 

97,381

 

 

 

103,943

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

Other payables and current liabilities

 

 

 

12,023

 

 

 

8,432

 

Accrued expenses

 

 

 

11,141

 

 

 

10,418

 

Current lease liabilities

 

 

 

627

 

 

 

618

 

Total current liabilities

 

 

 

23,791

 

 

 

19,468

 

Non-current liabilities

 

 

 

 

 

 

 

 

 

Non-current lease liabilities

 

 

 

1,383

 

 

 

1,541

 

Non-current borrowings

6

 

 

25,012

 

 

 

24,917

 

Post-employment obligations

 

 

 

7,955

 

 

 

7,946

 

Other long-term liabilities

 

 

 

1,119

 

 

 

1,116

 

Total non-current liabilities

 

 

 

35,469

 

 

 

35,520

 

Shareholders’ equity

 

 

 

 

 

 

 

 

 

Share capital

 

 

 

3,699

 

 

 

3,499

 

Share premium

 

 

 

329,741

 

 

 

320,955

 

Reserves

 

 

 

23,955

 

 

 

21,912

 

Accumulated losses

 

 

 

(319,274

)

 

 

(297,411

)

Total shareholders’ equity

7

 

 

38,121

 

 

 

48,955

 

Total liabilities and shareholders’ equity

 

 

 

97,381

 

 

 

103,943

 

 

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


2

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Unaudited Condensed Consolidated Statements of Comprehensive Loss

 

(in USD ’000, except per share data)

 

 

Three-month period

ended March 31,

 

 

Notes

 

2020

 

 

2019

 

Operating income other than revenue

 

 

 

4

 

 

 

5

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

Research and development expenses

8

 

 

(17,188

)

 

 

(20,140

)

General and administrative expenses

 

 

 

(3,709

)

 

 

(5,255

)

Total operating expenses

 

 

 

(20,897

)

 

 

(25,395

)

OPERATING LOSS

 

 

 

(20,893

)

 

 

(25,390

)

Finance income

 

 

 

60

 

 

 

262

 

Finance expense

 

 

 

(1,011

)

 

 

(544

)

NET LOSS BEFORE TAX

 

 

 

(21,844

)

 

 

(25,672

)

Income tax expense

9

 

 

(19

)

 

 

(7

)

NET LOSS FOR THE PERIOD

 

 

 

(21,863

)

 

 

(25,679

)

Net loss per share

 

 

 

 

 

 

 

 

 

Basic

10

 

 

(0.48

)

 

 

(0.59

)

Diluted

10

 

 

(0.48

)

 

 

(0.59

)

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

 

 

 

(21,863

)

 

 

(25,679

)

 

 

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

 

3

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Unaudited Condensed Consolidated Statements of Cash Flows

 

 

 

 

Three-month period

ended March 31,

 

(in USD ’000)

Notes

 

2020

 

 

2019

 

NET LOSS BEFORE TAX FOR THE PERIOD

 

 

 

(21,844

)

 

 

(25,672

)

Adjustments for:

 

 

 

 

 

 

 

 

 

Depreciation expense

 

 

 

181

 

 

 

183

 

Post-employment (benefit) / cost

 

 

 

(10

)

 

 

5

 

Share-based compensation expense

 

 

 

2,746

 

 

 

3,317

 

Finance result, net

 

 

 

952

 

 

 

282

 

Decrease / (increase) in other receivables

 

 

 

253

 

 

 

(113

)

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

 

 

 

(1,476

)

 

 

177

 

Increase in other payables and current liabilities

 

 

 

3,409

 

 

 

869

 

Increase in accrued expenses and other long-term liabilities

 

 

 

726

 

 

 

19

 

NET CASH FLOWS USED IN OPERATING ACTIVITIES

 

 

 

(15,063

)

 

 

(20,933

)

Payments for plant and equipment

 

 

 

 

 

 

(9

)

NET CASH FLOWS USED IN INVESTING ACTIVITIES

 

 

 

 

 

 

(9

)

Proceeds from issue of shares

 

 

 

8,799

 

 

 

 

Payment of share issuance costs

 

 

 

(264

)

 

 

 

Proceeds from exercise of stock-options

 

 

 

 

 

 

101

 

Principal elements of lease payments

 

 

 

(151

)

 

 

(140

)

Interest paid

 

 

 

(387

)

 

 

(32

)

NET CASH FLOWS FROM / (USED IN) FINANCING ACTIVITIES

 

 

 

7,997

 

 

 

(71

)

Net decrease in cash and cash equivalents

 

 

 

(7,066

)

 

 

(21,013

)

Cash and cash equivalents as at January 1,

 

 

 

69,370

 

 

 

138,640

 

Effects of exchange rate changes on cash and cash equivalents

 

 

 

(262

)

 

 

(306

)

Cash and cash equivalents as at March 31,

 

 

 

62,042

 

 

 

117,321

 

 

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

 

4

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Unaudited Condensed Consolidated Statements of Changes in Equity

 

(in USD ’000)

 

Share

capital

 

 

Share

premium

 

 

Share-based

payments

reserve

 

 

Foreign

currency

translation

reserve

 

 

Total

reserves

 

 

Accumulated

losses

 

 

Total

 

January 1, 2019

 

 

3,420

 

 

 

314,565

 

 

 

13,347

 

 

 

(489

)

 

 

12,858

 

 

 

(183,927

)

 

 

146,916

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,679

)

 

 

(25,679

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,679

)

 

 

(25,679

)

Issuance of shares - EIP 2013

 

 

6

 

 

 

720

 

 

 

(720

)

 

 

 

 

 

(720

)

 

 

 

 

 

6

 

Exercise of stock-options - EIP 2017

 

 

1

 

 

 

171

 

 

 

(71

)

 

 

 

 

 

(71

)

 

 

 

 

 

101

 

Share-based remuneration

 

 

0

 

 

 

0

 

 

 

3,317

 

 

 

 

 

 

3,317

 

 

 

 

 

 

3,317

 

March 31, 2019

 

 

3,427

 

 

 

315,456

 

 

 

15,873

 

 

 

(489

)

 

 

15,384

 

 

 

(209,606

)

 

 

124,661

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 1, 2020

 

 

3,499

 

 

 

320,955

 

 

 

22,401

 

 

 

(489

)

 

 

21,912

 

 

 

(297,411

)

 

 

48,955

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,863

)

 

 

(21,863

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,863

)

 

 

(21,863

)

Issuance of shares - EIP 2013

 

 

5

 

 

 

703

 

 

 

(703

)

 

 

 

 

 

(703

)

 

 

 

 

 

5

 

Issuance of shares - ATM program

 

 

195

 

 

 

8,339

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,534

 

Share issuance costs

 

 

 

 

 

(256

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(256

)

Share-based remuneration

 

 

 

 

 

 

 

 

2,746

 

 

 

 

 

 

2,746

 

 

 

 

 

 

2,746

 

March 31, 2020

 

 

3,699

 

 

 

329,741

 

 

 

24,444

 

 

 

(489

)

 

 

23,955

 

 

 

(319,274

)

 

 

38,121

 

 

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

 

5

 


ObsEva SA

Condensed Consolidated Financial Statements

 

Notes to the Unaudited Condensed Consolidated Financial Statements

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, OBE022 and nolasiban) 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 May 4, 2020.

2. Accounting principles and scope of consolidation

2.1 Basis of preparation and accounting principles

These unaudited three-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”).

Accounting policies

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, 2019 (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 USD 21.9 million for the three-month period ended March 31, 2020. As of March 31, 2020, the Company had accumulated losses of USD 349.9 million, out of which USD 30.6 million were offset with share premium. The Company expects to continue to generate operating losses in the foreseeable future, even though certain spending associated with its ongoing clinical trials might be delayed as a result of the COVID-19 pandemic. The Company expects 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. The inability to obtain funding, as and when needed, would have a negative impact on the Company’s financial condition and ability to pursue its business strategies. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management intends to pursue plans to obtain additional funding to finance its operations, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all, which could have material adverse effect on the Group’s business, results of operations and financial conditions.

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. The Company bases the estimates on historical experience and on various other assumptions that the Company believes are reasonable, the results of which form the basis for making judgments about the carrying value of assets, liabilities and equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including but not limited to expenses, progress of the Company’s

6

 


ObsEva SA

Condensed Consolidated Financial Statements

 

clinical trials, research and development costs and employee related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the extent to which the COVID-19 pandemic will impact worldwide macroeconomic conditions including interest rates, employment rates and health insurance coverage, the speed of the anticipated recovery, and governmental and business reactions to the pandemic. The Company has made estimates of the impact of COVID-19 within these condensed consolidated 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 March 31, 2020 and 2019.

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)

 

March 31,

2020

 

 

December 31,

2019

 

Bank deposits

 

 

62,042

 

 

 

69,370

 

Interest bearing deposits

 

 

 

 

 

 

Total cash and cash equivalents

 

 

62,042

 

 

 

69,370

 

5. Intangible assets

As at March 31, 2020 and December 31, 2019, the Group holds a number of licenses to develop and commercialize several biopharmaceutical product candidates, the value of which is recorded at USD 26.6 million.

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, resulting in a milestone payment of USD 5 million to Kissei Pharmaceutical Co., Ltd., accounted for as an intangible asset.

6. Borrowings

In August 2019, the Company entered into a loan and security agreement with Oxford Finance for a term loan of up to USD 75.0 million, subject to funding in three tranches. The Company received gross proceeds of USD 25.0 million, net of transaction costs of USD 0.3 million, from the first tranche of the credit facility upon entering into the agreement and intends to use the funds for its various clinical trials programs. The Company could not draw the second tranche of USD 25.0 million due to the failure to meet the primary endpoint of the Phase 3 IMPLANT 4 clinical trial of nolasiban. Pursuant to an amendment to the loan and security agreement signed in April 2020, the third tranche of USD 25.0 million may be drawn at any time between April 7, 2020 and August 1, 2024 upon request of the Company and at the lender’s discretion.

The credit facility is secured by substantially all of the Company’s assets, including the Company’s intellectual property. Each tranche bears interest at a floating interest rate of thirty day U.S. LIBOR, plus 6.25%, or a minimum of 8.68% per year in total. The Company is required to make monthly interest-only payments on each tranche through the amortization start date on August 1, 2022. The credit facility will mature on August 1, 2024, at which date a final fee payment of 6.75% of each funded tranche will be due, resulting in an effective interest rate of 10.32% per year. The credit facility contains customary conditions to borrowings and events of default and

7

 


ObsEva SA

Condensed Consolidated Financial Statements

 

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. As of March 31, 2020, the Company was in compliance with its covenants.

7. Shareholders’ equity

In 2019, the Company sold a total of 691,133 treasury shares at an average price of USD 5.14 per share, as part of its “at the market” (ATM) program initiated in May 2018. These multiple daily transactions generated total gross proceeds of USD 3.6 million. Directly related share issuance costs of USD 0.1 million were recorded as a deduction in equity.

During the three-month period ended March 31, 2020, the Company sold a total of 2,463,274 treasury shares at an average price of USD 3.46 per share, as part of its ATM program. These multiple daily transactions generated total gross proceeds of USD 8.5 million. Directly related share issuance costs of USD 0.3 million were recorded as a deduction in equity.

As at March 31, 2020, the total outstanding share capital of USD 3.7 million, fully paid, consists of 46,947,132 common shares, excluding 108,231 non-vested shares and 1,512,242 treasury shares. As at December 31, 2019, the total outstanding share capital of USD 3.5 million, fully paid, consists of 44,423,448 common shares, excluding 168,641 non-vested shares and 3,975,516 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.

8. 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.

As a result of the COVID-19 pandemic, research and development activities associated with certain ongoing clinical trials are being delayed, that may consequently impact and also delay the timing of recognition of such research and development activities in the profit and loss accounts. Especially, on March 23, 2020, the Group announced its decision to place a temporary hold on further screening and randomization of patients into its EDELWEISS 2 and EDELWEISS 3 clinical trials until further notice. EDELWEISS 2 and EDELWEISS 3 clinical trial sites will be managing all randomized patients currently on treatment to proceed with enhanced safety measures and the trial protocol whenever feasible.

9. Income tax

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

Since January 1, 2020, the Company is subject in Switzerland to a municipal and cantonal income tax rate of 14.0% and to a federal tax rate of 8.5% on its profits after tax (2019 : 22.6% and 8.5%, respectively). 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 periods ended March 31, 2020 and March 31, 2019. 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 March 31, 2020 and December 31, 2019.

On May 19, 2019, the Canton of Geneva approved the implementation of the national proposal of the tax law named “Federal Act on Tax Reform and AHV Financing” (TRAF). This new tax law results in the abolition of special tax status companies at cantonal level (privileged taxation as holding company, mixed company and domiciliary company), and introduces a range of tax measures including the reduction of corporate income tax rate and capital tax base. Since the Company has incurred recurring losses since inception, it does not expect a significant impact resulting from the implementation of the TRAF.

The Company’s Irish subsidiary has no activity, and, therefore, no income tax expense was recorded in that entity for the three-month periods ended March 31, 2020 and March 31, 2019 .

8

 


ObsEva SA

Condensed Consolidated Financial Statements

 

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 periods ended March 31, 2020 and March 31, 2019 were each subject to a total U.S. income tax rate of 27.3% based on both the U.S. federal and state tax rates.

10. Loss per share

As of March 31, 2020 and 2019, 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 March 31,

 

 

 

2020

 

Net loss attributable to shareholders (in USD ‘000)

 

 

(21,863

)

Weighted average number of common shares outstanding

 

 

45,725,561

 

Basic and diluted loss per share (in USD)

 

 

(0.48

)

 

 

Three-month period

ended March 31,

 

 

 

2019

 

Net loss attributable to shareholders (in USD ‘000)

 

 

(25,679

)

Weighted average number of common shares outstanding

 

 

43,488,440

 

Basic and diluted loss per share (in USD)

 

 

(0.59

)

 

For the three-month period ended March 31, 2020, 108,231 non-vested shares and 5,721,075 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 period ended March 31, 2019, 354,021 non-vested shares and 3,067,750 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.

11. 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)

 

March 31,

2020

 

 

December 31,

2019

 

Switzerland

 

 

28,273

 

 

 

28,391

 

USA

 

 

717

 

 

 

779

 

Total non-current assets

 

 

28,990

 

 

 

29,170

 

 

The geographical analysis of operating expenses is as follows:

 

 

(in USD ’000)

 

Three-month period

ended March 31,

 

 

 

2020

 

 

2019

 

Switzerland

 

 

19,575

 

 

 

24,253

 

USA

 

 

1,322

 

 

 

1,142

 

Total operating expenses

 

 

20,897

 

 

 

25,395

 

9

 


ObsEva SA

Condensed Consolidated Financial Statements

 

 

12. Events after the reporting period

ATM proceeds

From April 1, 2020 until April 30, 2020, the Group sold an additional 899,658 treasury shares at an average price of USD 2.36 per share, as part of its ATM program. Total gross proceeds amounted to USD 2.1 million.

 

Capital increase

On April 14, 2020, the Group announced the issuance of 3,308,396 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 April 29, 2020. The shares are held as treasury shares, hence the operation did not impact the outstanding share capital.

 

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

10

 

obsv-ex992_7.htm

Exhibit 99.2

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

Overview

We are a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. We are focused on providing therapeutic solutions for women between puberty and menopause who suffer from reproductive health conditions that affect their quality of life, ability to conceive or that complicate pregnancy and the health of newborns. Our goal is to build the leading women’s reproductive health and pregnancy company focused on conditions where current treatment options are limited and significant unmet needs exist.

Linzagolix for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.

We are developing linzagolix as a novel, oral gonadotropin releasing hormone, or GnRH, receptor antagonist, for the treatment of pain associated with endometriosis and heavy menstrual bleeding (HMB) associated with uterine fibroids in pre-menopausal women. Aimed at addressing the need of the largest possible population in each indication, our clinical trials for both of these indications are designed to assess and potentially support the registration of two regimens of administration for linzagolix i.e. (i) a moderate dose of linzagolix without hormonal add-back therapy (ABT; 1mg E2 / 0.5mg NETA) and (ii) a high dose of linzagolix with hormonal ABT.

We are conducting two Phase 3 clinical trials of linzagolix in patients with HMB associated with uterine fibroids, the PRIMROSE 1 (conducted in the US) and the PRIMROSE 2 (conducted in Europe and in the US) clinical trials. In both trials, patients are being administered linzagolix doses of 100 mg or 200mg, both with and without hormonal ABT, or placebo. The primary end point of the PRIMROSE 1 and 2 clinical trials is response rate, assessing reduction in heavy menstrual bleeding due to uterine fibroids, as measured by the alkaline hematin method.  

In December 2019, we announced positive Phase 3 trial results from the PRIMROSE 2 trial of linzagolix for the treatment of HMB due to uterine fibroids. The PRIMROSE 2 trial enrolled 535 women with uterine fibroids. The trial was conducted in Europe and the US, and evaluated the efficacy and safety of once daily oral linzagolix, including 100 mg and 200 mg doses, both with and without hormonal ABT. The primary efficacy endpoint was the reduction in HMB at 24 weeks; responders were defined as patients with menstrual blood loss volume of ≤ 80 mL and a 50 percent or greater reduction from baseline in menstrual blood loss volume, measured using the alkaline hematin method. Bone mineral density (BMD) was measured centrally via Dual Energy X-ray Absorptiometry (DEXA) scan at baseline and 24 weeks. The responder rate was 93.9% (p < 0.001) for patients receiving 200 mg with ABT and 56.7% for patients receiving 100 mg without ABT (p < 0.001), compared to 29.4% in the placebo group. Both doses achieved significant rates of amenorrhea (p< 0.001), reduction in pain (p < 0.001), and improvement in quality of life (p < 0.001). Additionally, significant improvement (p< 0.001) in Hb levels, a reduction in number of days of bleeding and reduction in uterine volume were observed. A significant reduction in fibroid volume was also observed for the 200 mg dose with ABT (p = 0.008). The overall safety profile was in line with expectations. The most frequently observed adverse events (occurring in > 5% of patients) were headache, hot flushes, and anemia. Mean percentage change from baseline in BMD was consistent with previous clinical data.

We expect to report both the primary endpoint results following 24 weeks of treatment from the PRIMROSE 1 trial conducted in the U.S. and the 52 weeks of treatment results from PRIMROSE 2 trial in the second quarter of 2020. Pending positive PRIMROSE 1 results and additional feedback from regulatory agencies, a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) is planned prior to the end of 2020, and New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) is planned in the first half of 2021.

In addition to linzagolix development for uterine fibroids, we are presently conducting two Phase 3 clinical trials for the treatment of endometriosis associated pain, the EDELWEISS 2 (conducted in the US) and EDELWEISS 3 (conducted in Europe and in the US) Phase 3 clinical trials which were initiated in May 2019. These Phase 3 trials will each enroll approximately 450 patients with endometriosis associated pain, with a co-primary endpoint of patients’ response on both dysmenorrhea (menstrual pain) and non-menstrual pelvic pain. Both trials include a 75 mg once daily dose without hormonal ABT (1mg E2 / 0.5mg NETA) option, and a 200 mg once daily dose in combination with ABT option.

On March 23, 2020 and in view of the expected logistical challenges with initial screening and uncertainty about continuity of treatment for randomized patients because of the COVID-19 pandemic, we announced our decision to place a temporary hold on further screening and randomization of patients into our EDELWEISS 2 and EDELWEISS 3 clinical trials until further notice. EDELWEISS 2 and EDELWEISS 3 clinical trial sites will be managing all randomized patients currently on treatment to proceed with enhanced safety measures and the trial protocol whenever feasible. We remain ready and committed to resume patient screening and randomization as the situation permits. Simultaneously, we announced that our PRIMROSE 1 and PRIMROSE 2 trial results remain on track to be announced in the second quarter of 2020, as previously planned. As the COVID-19 pandemic continues to rapidly evolve, we do not yet know the full extent of its potential effects on our business, our clinical trials, our anticipated timelines for the development of our product candidates, or on the supply chain for our clinical supplies. These effects could have a material adverse impact on our business and financial condition.

1


OBE022 for the treatment of preterm labor

We are developing OBE022, an oral and selective prostaglandin F2α receptor antagonist, for preterm labor in weeks 24 to 34 of pregnancy. In December 2017, we announced the initiation of our Phase 2a proof-of-concept clinical trial of OBE022 known as PROLONG which is being conducted in two parts: Part A and Part B. Part A is an open-label trial assessing the safety and pharmacokinetics of OBE022 in pregnant women, who were already receiving standard of care therapy for preterm labor, atosiban infusion. Part B, is a randomized, double-blind, placebo-controlled, parallel-group trial to assess the efficacy, safety and pharmacokinetics of OBE022. In December 2018, following completion of the open-label Part A and based on the favorable safety and pharmacokinetics results, we announced the initiation of the randomized placebo-controlled Part B of the trial. Part B will enroll up to 120 women at 24-34 weeks gestation who are experiencing preterm labor symptoms. In the first quarter of 2020, the IDMC recommended continuing the ongoing PROLONG trial with no modifications based on safety data from the first 90 patients enrolled in Part B. Enrollment of PROLONG Part B was completed in March 2020 and final PROLONG trial results (up to 28 days follow-up after all patients delivery) are anticipated in the second half of 2020.

 

Nolasiban for the improvement of pregnancy and birth rates in women undergoing embryo transfer following in-vitro fertilization.

We have been developing nolasiban, an oral oxytocin receptor antagonist, to improve clinical pregnancy and live birth rates in women undergoing in-vitro fertilization, or IVF. We completed randomization of 778 patients in our European Phase 3 clinical trial in women undergoing IVF, or the IMPLANT 2 clinical trial, in 2017 and reported positive results for the primary endpoint of ongoing pregnancy 10 weeks post embryo transfer in February 2018, and positive live birth rate results in October 2018. Nolasiban was observed to be well tolerated with a safety profile not different from placebo. 28-day neonatal safety data from the IMPLANT 2 trial did not reveal any adverse consequences from nolasiban treatment.

 

Based on feedback received in the third quarter of 2018 from regulatory authorities in Europe on our nolasiban development program, we initiated in November 2018 an additional Phase 3 trial primarily in Europe, with some additional sites in Canada and Russia, also known as the IMPLANT 4 trial. In June 2019, we announced completion of patient recruitment in the IMPLANT 4 trial. In addition, we announced the clearance of our investigational new drug (IND) in October 2019 for the U.S. Phase 3 clinical trial of nolasiban, known as IMPLANT 3.

 

In November 2019, we announced that the IMPLANT 4 trial did not meet the primary endpoint of an increase in ongoing pregnancy rate at 10 weeks, (39.1 % placebo vs 40.5 % nolasiban) (p = 0.745). As these results did not confirm the prior positive Phase 3 IMPLANT 2 trial findings, we discontinued our previously ongoing development of nolasiban for IVF, and are exploring further development of the compound through assessment of higher dose levels and longer exposure to nolasiban based upon results from a meta-analysis of all clinical trials and a mechanism of action study. In January 2020, we and Hangzhou YuYuan BioScience Technology Co., Ltd. (YuYuan) entered into a sublicense agreement to develop and commercialize nolasiban for improving clinical pregnancy and live birth rates in women undergoing embryo transfer as part of an IVF cycle in the People's Republic of China (PRC). Under the terms of the agreement, YuYuan has the exclusive rights to develop and commercialize nolasiban in the PRC, and will fund all development and registration activities in the PRC, starting with the commitment to conduct Phase 1 trials and a Phase 2 proof-of-concept trial in China. We retain all rights to nolasiban outside of PRC, and will collaborate with YuYuan on its global development. ObsEva’s development and commercialization partnership with YuYuan proceeded during the first quarter of 2020 with steering committee meetings to define the development plan for nolasiban in China for women undergoing ET following IVF. An investigational new drug submission in China by YuYuan to initiate clinical development is expected for the second half of 2020.

2


We were founded in November 2012 and our operations to date have included organizing and staffing our company, raising capital, in-licensing rights to linzagolix, OBE022 and nolasiban and conducting nonclinical studies and clinical trials. To date, we have not generated any revenue from product sales as none of our product candidates have been approved for commercialization. We have historically financed our operations mostly through the sale of equity. From inception through March 31, 2020, we have raised an aggregate of $342.5 million of net proceeds from the sale of equity securities, as well as $25.0 million from the issuance of debt instruments.

We have never been profitable and have incurred significant net losses in each period since our inception. Our net losses were $21.9 million and $25.7 million for the three-month periods ended March 31, 2020 and 2019, respectively. As of March 31, 2020, we had accumulated losses of $349.9 million, out of which $30.6 million were offset with share premium. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We used $15.1 million and $20.9 million of cash in operations in the three-month periods ended March 31, 2020 and 2019, respectively, and we anticipate that our expenses will remain significant in connection with our ongoing activities as we:

 

continue to invest in the clinical development of our product candidates and specifically in connection with our ongoing PRIMROSE 1 and 2 and PROLONG clinical trials, and our EDELWEISS 2 and 3 clinical trials, for which we have placed a temporary hold on further screening and randomization of patients, and any additional clinical trials, nonclinical studies and pre-commercial activities that we may conduct for product candidates;

 

hire additional research and development, and general and administrative personnel;

 

maintain, expand and protect our intellectual property portfolio;

 

identify and in-license or acquire additional product candidates;

 

prepare for the commercialization of certain product candidates, and

 

continue to incur additional costs associated with operating as a public company.

We will need substantial additional funding to support our operating activities as we advance our product candidates through clinical development, seek regulatory approval and prepare for and invest in future commercialization of these candidates, if approved. Adequate funding may not be available to us on acceptable terms, or at all. We are also exploring various alternatives for the future potential commercialization of linzagolix, including through collaborations with third parties.

We have no manufacturing facilities, and all of our manufacturing activities are contracted out to third parties. We currently utilize third-party contract research organizations, or CROs, to carry out our clinical development and trials. Additionally, we do not have a commercialization organization.

COVID-19 Business Update

With the global spread of the ongoing COVID-19 pandemic in the first quarter of 2020, we have implemented a number of plans and policies designed to address and mitigate the impact of the COVID-19 pandemic on our employees and our business. We continue to closely monitor the COVID-19 situation and will evolve our plans and policies as needed going forward. In March 2020, some of our workforce transitioned to working remotely. We plan to reopen our offices to allow employees to return when appropriate. These plans will be based on a phased approach consistent with local government requirements, and focused on employee safety. We are working closely with our vendors to manage our supply chain activities and mitigate any potential disruptions to our clinical trial supplies as a result of the COVID-19 pandemic. If the COVID-19 pandemic persists for an extended period of time and begins to impact essential distribution systems, we could experience disruptions to our supply chain and operations, and associated delays in the manufacturing of clinical trial supply. For some of our clinical development programs, we are experiencing, and may continue to experience, a disruption or delay in our ability to initiate trial sites and enroll and assess patients. In addition, we rely on CROs or other third parties to assist us with clinical trials, and we cannot guarantee that they will continue to perform their contractual duties in a timely and satisfactory manner as a result of the COVID-19 pandemic.

Senior Management Changes

On April 6, 2020, we announced the nomination of Fabien de Ladonchamps, Vice President Corporate Affairs & Finance, as interim Chief Financial Officer and member of the Executive Committee, following the resignation of Tim Adams as Chief Financial Officer, effective April 10, 2020. Mr. Ladonchamps joined ObsEva in 2013 and has served in various financial and operational roles, most recently as Vice President Corporate Affairs & Finance.

3


Strategic Licensing Agreements

Linzagolix

In November 2015, we entered into the Kissei license and supply agreement with Kissei Pharmaceutical Co., Ltd., or Kissei. Pursuant to the Kissei license and supply agreement we received an exclusive license to develop, manufacture and commercialize products, or the Product, containing the compounds which is a specified GnRH antagonist and covered by certain licensed patent rights, or the Compound, throughout the world except for specified Asian countries. We arranged to exclusively acquire from Kissei the material necessary to produce linzagolix.

In consideration for the license, we made an initial $10.0 million upfront payment. In addition, we agreed to make aggregate milestone payments of up to $63.0 million upon the achievement of specified developmental milestones, such as the initiation of clinical trials and receipt of regulatory approvals. In connection with the initiations of the Phase 3 clinical programs for linzagolix in uterine fibroids in 2017 and endometriosis in 2019, two $5.0 million milestones were paid. With respect to any products we commercialize under the Kissei license and supply agreement, we agreed to make further payments of up to an additional $125.0 million to Kissei upon the achievement of specified commercial milestones.

Pursuant to the Kissei license and supply agreement, we have agreed to exclusively purchase the active pharmaceutical ingredient for linzagolix from Kissei. During the development stage, we are obligated to pay Kissei a specified supply price. Following the first commercial sale of licensed product, we are obligated to pay Kissei a royalty in the low twenty percent range as a percentage of net sales. This payment includes Kissei’s supply of the active pharmaceutical ingredient until the latest of (i) the date that the valid claim of a patent for the Product has expired, (ii) the expiration of our regulatory exclusivity period, or (iii) 15 years from the first commercial sale of such product on a country-by-country and product-by-product basis. During the term, we are restricted from developing, marketing and selling GnRH agonists and GnRH antagonists other than the Compound to the extent allowed by applicable laws.

OBE022

In June 2015, we entered into the 2015 license agreement with Merck Serono, which we amended in July 2016, pursuant to which we received a worldwide exclusive license to develop, manufacture and commercialize compounds covered by the licensed patent rights, including OBE022. In consideration for the license, we issued 325,000 Series A preferred shares to Merck Serono in September 2016 upon the initiation of a Phase 1 clinical trial for a licensed product. With respect to any products we commercialize under the 2015 license agreement, we agreed to pay Merck Serono royalties based on a mid-single-digit percentage of annual net sales of each product, subject to specified reductions, until the later of (i) the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or (ii) ten years from the first commercial sale of such product on a country-by-country and product-by-product basis.

Nolasiban

In August 2013, we entered into the 2013 license agreement with Ares Trading S.A., an affiliate of Merck Serono, or Merck Serono, pursuant to which we received a worldwide exclusive license to develop, manufacture and commercialize compounds covered by the licensed patent rights, including nolasiban. In consideration for the license, we issued 914,069 Series A preferred shares to Merck Serono at the time of our Series A financing, which had a fair-value of $4.9 million based on an exchange rate of $1.00 for CHF 0.9244 as of the date of the transaction. With respect to any products we commercialize under the 2013 license agreement, we agreed to pay Merck Serono royalties based on a high-single-digit percentage of annual net sales of each product, subject to specified reductions, until the later of (i) the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis, or (ii) ten years from the first commercial sale of such product on a country-by-country and product-by-product basis.

In January 2020, we entered into a sublicense agreement, or the 2020 sublicense agreement, with YuYuan, pursuant to which we granted to YuYuan an exclusive sublicense under certain of our patents, trademarks and know-how to use, register, import, develop, market, promote, distribute, offer for sale and commercialize nolasiban for use in humans in the People’s Republic of China, including Hong Kong and Macau. In consideration for entering into the 2020 sublicense agreement, YuYuan has agreed to make aggregate milestone payments of up to $17.0 million upon the achievement of specified development, regulatory and first sales milestones and aggregate milestone payments of up to $115.0 million upon the achievement of additional, tiered sales milestones. In addition, YuYuan has agreed to pay tiered royalties on net sales at percentages ranging from high-single digit to low-second decile, subject to specified reductions, until the later of the expiration of the last valid claim covering the product in China and ten years from the first commercial sale of the product in China.

4


Components of Results of Operations

Revenue

To date, we have not generated any revenue from product sales and we do not expect to generate revenue unless and until we successfully complete development and obtain regulatory approval for one of our product candidates.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred in connection with our research and development activities and consist mainly of direct research and development costs, which include: costs associated with the use of CROs and consultants hired to assist on our research and development activities; personnel expenses, which include salaries, benefits and share-based compensation expenses for our employees; expenses related to regulatory affairs and intellectual property; manufacturing costs in connection with conducting nonclinical studies and clinical trials; and depreciation expense for assets used in research and development activities. Research and development costs are generally expensed as incurred. However, costs for certain activities, such as manufacturing and nonclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.

Our employee, consultant and infrastructure resources are typically utilized across our multiple research and development programs. We track outsourced research and development costs by product candidate or nonclinical program, but we do not allocate personnel costs, other internal costs or external consultant costs to specific product candidates.

From inception through March 31, 2020, we have incurred $277.8 million in research and development expenses to advance the development of our product candidates. The following table provides a breakdown of our outsourced research and development expenses that are directly attributable to the specified product candidates for the three-month periods ended March 31, 2020 and March 31, 2019, respectively.

 

 

Three-month period

ended March 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Linzagolix

 

$

(11,722

)

 

$

(11,293

)

Nolasiban

 

 

(706

)

 

 

(4,570

)

OBE022

 

 

(505

)

 

 

(508

)

Total outsourced research and development expenses

 

$

(12,933

)

 

$

(16,371

)

 

We expect our research and development expense will remain significant for the foreseeable future as we seek to advance the development of our product candidates through clinical trials and toward regulatory submissions. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidates. This is due to the numerous risks and uncertainties associated with developing such product candidates, including:

 

the number of clinical sites included in the trials;

 

the length of time required to enroll suitable patients;

 

the number of patients that ultimately participate in the trials;

 

the number of doses patients receive;

 

the duration of patient follow-up;

 

the duration, severity and impact on our operations of the COVID-19 pandemic;

 

the results of our clinical trials; and

 

regulatory requirements in support of potential approvals.

In addition, the probability of success for any of our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability. A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate.

5


General and Administrative Expenses

General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and share-based compensation expense, related to executive, finance, accounting, business development, legal and human resource functions. General and administrative expense also includes facility costs not otherwise included in research and development expenses, legal fees related to corporate matters, fees for accounting and consulting services, and costs of director and officer insurance.

We anticipate that our general and administrative expenses will remain significant in the future to support continued research and development activities. We also anticipate that we will keep spending material accounting, audit, legal, regulatory and compliance costs, as well as investor and public relations expenses, associated with operating as a public company.

Finance Result, Net

Finance result, net, consists mainly of foreign exchange loss and gain, as well as interest expense associated with our lease liabilities and debt instruments.

Taxation

We are subject to corporate taxation in Switzerland, Ireland and the United States.

In 2015, the Canton of Geneva granted us a ten-year tax holiday for all income and capital taxes on a communal and cantonal level commencing in fiscal year 2013 and valid through to 2022, subject to our Swiss domiciliation and compliance with certain reporting provisions. We remain subject to Swiss federal income tax on our profits after tax but have only incurred net losses since our inception. We are entitled under Swiss laws to carry forward any losses incurred for a period of seven years and can offset such losses carried forward against future taxes. As of December 31, 2019, we had tax loss carryforwards totaling $287.6 million. We do not believe it is probable that we will generate sufficient profits to avail ourselves of these tax loss carryforwards.

Our Irish subsidiary had no activity in the three-month periods ended March 31, 2020 and March 31, 2019, and our U.S. subsidiary, as a service organization to the group under cost plus arrangement, was the only entity to generate income tax expenses during these periods.

Analysis of Results of Operations

Comparison of the three-month periods ended March 31, 2020 and March 31, 2019

Operating Expenses

Research and Development Expenses

 

 

Three-month period

ended March 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Research and development expenses by product candidate

 

 

 

 

 

 

 

 

Linzagolix

 

$

(11,722

)

 

$

(11,293

)

Nolasiban

 

 

(706

)

 

 

(4,570

)

OBE022

 

 

(505

)

 

 

(508

)

Unallocated expenses

 

 

 

 

 

 

 

 

Staff costs

 

 

(3,618

)

 

 

(3,040

)

Other research and development costs

 

 

(637

)

 

 

(729

)

Total research and development expenses

 

$

(17,188

)

 

$

(20,140

)

 

Research and development expenses decreased by $3.0 million in the three-month period ended March 31, 2020 compared to the three-month period ended March 31, 2019 primarily due to lower costs for our nolasiban program which was discontinued in the fourth quarter of 2019 after the results of our IMPLANT 4 trial conducted in 2019.

6


General and Administrative Expenses

 

 

Three-month period

ended March 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Staff costs

 

$

(2,490

)

 

$

(3,217

)

Professional fees

 

 

(684

)

 

 

(1,715

)

Other general and administrative costs

 

 

(535

)

 

 

(323

)

Total general and administrative expenses

 

$

(3,709

)

 

$

(5,255

)

 

General and administrative expenses in the three-month periods ended March 31, 2020 decreased by $1.5 million compared to the three-month period ended March 31, 2019, primarily due to lower professional fees and decreased staff costs of $0.7 million, mostly due to share-based compensation.

Finance Result, Net

 

 

Three-month period

ended March 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands)

(unaudited)

 

Foreign exchange (loss) / gain

 

$

(282

)

 

$

(250

)

Interest expense

 

 

(669

)

 

 

(32

)

Finance result, net

 

$

(951

)

 

$

(282

)

 

Finance result, net in the three-month periods ended March 31, 2020 and March 31, 2019 primarily consisted of foreign exchange loss and gain, respectively, as well as, in 2020, interest expense associated with our lease liabilities and debt instruments.

 

 

Liquidity and Capital Resources

Since our inception, we have not generated any revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations primarily through the sale of equity. From inception through March 31, 2020, we have raised an aggregate of $342.5 million of net proceeds from the sale of equity securities. In August 2019, we borrowed $25.0 million under our senior secured term loan credit facility.

During the year ended December 31, 2019, we sold a total of 691,133 treasury shares at an average price of $5.14 per share, as part of our ATM program initiated in May 2018, and received net proceeds of $3.5 million after deducting $0.1 million of directly-related issuance costs.

During the three-month period ended March 31, 2020, we sold a total of 2,463,274 treasury shares at an average price of $3.46 per share, as part of our ATM program, and received net cash proceeds of $8.5 million after deducting $0.3 million of directly-related issuance costs.

As of March 31, 2020, we had $62.0 million in cash and cash equivalents.

On August 7, 2019, we entered into a loan and security agreement, or the Credit Facility Agreement, with Oxford Finance, or Oxford, for a term loan of up to $75.0 million, subject to funding in three tranches. We received gross proceeds of $25.0 million from the first tranche of the credit facility upon entering into the agreement and intend to use the funds as part of our various clinical trials programs. We could not draw the second tranche of $25.0 million due to the failure to meet the primary endpoint of the Phase 3 IMPLANT 4 clinical trial of nolasiban. Pursuant to an amendment to the Credit Facility Agreement signed in April 2020, the third tranche of $25.0 million may be drawn at any time between April 7, 2020 and August 1, 2024 upon our request and at Oxford’s discretion. The credit facility is secured by substantially all of our assets, including our 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 includes affirmative and negative covenants applicable to us and our subsidiaries. The affirmative covenants include, among other things, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding deposit accounts. Further, subject to certain exceptions, the credit facility contains customary negative covenants limiting our 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.

7


Upon the occurrence and during the continuance of an event of default, Oxford may declare all outstanding principal and accrued and unpaid interest under the credit facility immediately due and payable and exercise the other rights and remedies provided for under the credit facility and related loan documents. The events of default under the credit facility include, among other things, payment defaults, breaches of covenants or representations and warranties, material adverse changes, certain bankruptcy events, cross defaults with certain other indebtedness and judgment defaults.

Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. Other than our Credit Facility Agreement with Oxford, we have no other ongoing material financing commitments, such as lines of credits or guarantees.

We expect our expenses to remain significant in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate clinical trials of, and seek marketing approval for, our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we may incur significant commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential commercial partners. Furthermore, we expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

We expect our existing cash and cash equivalents and potential availability of $25.0 million under the Credit Facility Agreement will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2021. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

 

the scope, progress, results and costs of our ongoing and future nonclinical studies and clinical trials for linzagolix, OBE022 and nolasiban;

 

the cost and timing of ongoing and future manufacturing activities including active pharmaceutical ingredient and drug product pharmaceutical development and clinical trial supplies production for linzagolix, OBE022 and nolasiban;

 

the timing and amount of milestone and royalty payments we are required to make under our license agreements;

 

the extent to which we in-license or acquire other product candidates and technologies;

 

the number and development requirements of other product candidates that we may pursue;

 

the costs, timing and outcome of regulatory review of our product candidates;

 

the duration and severity of the COVID-19 pandemic currently delaying spending on certain of our clinical trials, and the impact of the COVID-19 pandemic on our operations and on global capital markets, which may affect our ability to access our ATM program;

 

the costs and timing of future commercialization activities, including drug manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

 

the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

 

our ability to establish strategic collaborations; and

 

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims.

Identifying potential product candidates and conducting nonclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.

Until such time that we can generate substantial product revenue, if ever, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, shareholder ownership interest may be diluted, and the terms of any additional securities may include liquidation or other preferences that adversely affect the rights of shareholders. Debt financing, such as the Credit Facility Agreement and others, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

8


If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

The following table shows a summary of our cash flows for the three-month periods ended March 31, 2020 and March 31, 2019:

 

 

Three-month period

ended March 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Cash and cash equivalents at beginning of period

 

$

69,370

 

 

$

138,640

 

Net cash used in operating activities

 

 

(15,063

)

 

 

(20,933

)

Net cash used in investing activities

 

 

 

 

 

(9

)

Net cash from / (used in) financing activities

 

 

7,997

 

 

 

(71

)

Effect of exchange rates

 

 

(262

)

 

 

(306

)

Cash and cash equivalents at end of period

 

$

62,042

 

 

$

117,321

 

 

Operating Activities

Net cash used in operating activities consists of net loss before tax adjusted for changes in net working capital, or current assets less current liabilities, and for non-cash items such as depreciation and amortization and the value of share-based compensation.

During the three-month period ended March 31, 2020, cash used in operating activities was $15.1 million, primarily as the result of our net loss before tax of $21.8 million, as adjusted for non-cash items and changes in net working capital. Non-cash items amounted to $3.9 million and mainly consisted of share-based payments. Changes in net working capital included primarily a $3.4 million increase in other payables and current liabilities as well as a $1.5 million increase in prepaid expenses due to the significant progress made on our various Phase 3 trials, and the invoicing schedules of our main vendors, respectively.

During the three-month period ended March 31, 2019, cash used in operating activities was $20.9 million, primarily as the result of our net loss before tax of $25.7 million, as adjusted for non-cash items and changes in net working capital. Non-cash items amounted to $3.8 million and mainly consisted of share-based payments. Changes in net working capital included primarily a $0.9 million increase in other payables and current liabilities mainly due to the invoice phasing of certain Phase 1 and non-clinical studies.

Investing Activities

During the three-month period ended March 31, 2020 and March 31, 2019, net cash used in investing activities consisted primarily of investments in leasehold improvements, furniture and fixtures.

Financing Activities

During the three-month period ended March 31, 2020, net cash from financing activities consisted primarily of the proceeds from the sales of treasury shares under our ATM program, which were partially offset by the principal elements of lease payments as well as interest expense associated with our leases and debt instruments.

During the three-month period ended March 31, 2019, net cash used in financing activities consisted primarily of the principal elements of lease payments and associated interest expense, net of proceeds from the exercise of stock options.

Main Contractual Obligations and Commitments

Under our license agreements with Kissei and Merck Serono, we may be required to pay royalties in the future. In addition, pursuant to the Kissei license and supply agreement, we have agreed to make aggregate milestone payments of up to $63.0 million upon the achievement of specified developmental milestones, such as the initiation of clinical trials and receipt of regulatory approvals, out of which $10.0 million were already paid as of March 31, 2020. With respect to any product we commercialize under the Kissei license and supply agreement, we have agreed to make additional aggregate milestone payments of up to $125.0 million to Kissei upon the achievement of specified commercial milestones.

9


We enter into contracts in the normal course of business with CROs for clinical trials, nonclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and we believe that our non-cancelable obligations under these agreements are not material.

Off-Balance Sheet Arrangements

As of the date of this discussion and analysis, and during the periods presented, we did not have any off-balance sheet arrangements.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated interim financial statements, which we have prepared in accordance with International Accounting Standard 34 Interim Financial Reporting as issued by the International Accounting Standards Board.

With the exception of the recent accounting pronouncements described below, the 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, 2019, which should be read in conjunction with these consolidated interim financial statements and management’s discussion and analysis as they provide an update of previously reported information.

The preparation of our consolidated interim financial statements requires us 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. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.

Recent Accounting Pronouncements

The adoption of IFRS standards as issued by the IASB and interpretations issued by the IFRS interpretations committee that are effective for the first time for the financial year beginning on or after January 1, 2020 had no material impact on our financial position.

JOBS Act Exemption

In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

As an emerging growth company, subject to certain conditions, we are relying on certain of exemptions under the JOBS Act, including without limitation, (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering in January 2017, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the U.S. Securities and Exchange Commission, which means the market value of our common shares that is held by non-affiliates exceeds $700 million as of the prior June 30, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. As of March 31, 2020, none of these criteria are met by the Company.

10


Cautionary Statement Regarding Forward-Looking Statements

Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”, “objective”, “plan”, “potential”, “predict”, “should”, “will” and “would”, or the negative of these and similar expressions. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled “Item 3.D—Risk Factors” in the Annual Report on Form 20-F for the year ended December 31, 2019, or the Annual Report, filed with the U.S. Securities and Exchange Commission, or the SEC, pursuant to the U.S. Securities and Exchange Act of 1934, as amended. These risks and uncertainties include factors relating to:

 

the success, cost, timing and potential indications of our product candidates’ development activities and clinical trials, including our ongoing and future trials of linzagolix, OBE022 and nolasiban;

 

our ability to obtain and maintain regulatory approval of our product candidates, including linzagolix, OBE022 and nolasiban, in any of the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved product;

 

the results of ongoing or future clinical trials, including of linzagolix, OBE022 and nolasiban;

 

our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates, and the terms on which we are able to raise that additional capital;

 

our plans to research, develop and commercialize our product candidates;

 

the timing of our regulatory filings for our product candidates;

 

the clinical utility of our product candidates;

 

the size and growth potential of the markets for our product candidates;

 

our commercialization, marketing and manufacturing capabilities and strategy;

 

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others;

 

the timing and amount of milestone and royalty payments we are required to make under our license agreements;

 

our ability to attract and retain qualified employees and key personnel;

 

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

 

the activities of our competitors and the success of competing therapies that are or become available;

 

our plans to in-license or acquire additional product candidates;

 

how long we will qualify as an emerging growth company or a foreign private issuer;

 

our estimates regarding future revenue, expenses and needs for additional financing;

 

our ability to build our commercialization organization;

 

the duration, severity and impact on our operations and clinical trials of the COVID-19 pandemic;

 

regulatory developments in the United States and foreign countries; and

 

other risks and uncertainties, including those listed in the Annual Report, titled “Item 3.D—Risk Factors”.

Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

11

obsv-ex993_12.htm

Exhibit 99.3

 

ObsEva Announces First Quarter 2020 Financial Results and Business Update

 

 

No impact from COVID-19 expected on timing of PRIMROSE 1 and 2 and PROLONG trial readouts, enrollment of new patients in EDELWEISS 2 and 3 on temporary hold

 

Linzagolix Phase 3 PRIMROSE 1 six-month primary endpoint results and PRIMROSE 2 twelve-month data on track for Q2:20 readout

 

Actively discussing commercial partnership to maximize linzagolix best-in-class potential

 

OBE022 Phase 2 PROLONG trial results on track for 2H:20

 

YuYuan Bioscience Technology partnership for nolasiban advancing to IND filing in China 2H:20  

 

 

GENEVA, Switzerland and BOSTON, MA (May 5, 2020) – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported financial results for the quarter ended March 31, 2020 and provided a business update.

 

"The first quarter of 2020 began very challenging times as we all faced the impact of the global COVID-19 pandemic”, said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. “We acted very early on, taking appropriate operational and clinical trial measures to support the safety of patients in ObsEva’s trials, employees, and healthcare professionals. I am pleased that through our hard work and commitment, we remain on track to generate important Phase 3 clinical trial results later this quarter for linzagolix in the treatment of women with heavy menstrual bleeding (HMB) due to uterine fibroids”.

 

Pipeline Update

 

Linzagolix for the treatment of uterine fibroids and endometriosis

 

 

Phase 3 PRIMROSE 1 and PRIMROSE 2 trials of linzagolix remain on track:  As announced on March 23, 2020, due to the COVID-19 pandemic, safety measures were undertaken, including remote patient visits. These trials have each enrolled approximately 500 women with HMB due to uterine fibroids. The efficacy and safety of two oral doses of linzagolix are being evaluated, including 100mg once daily without hormonal add-back therapy (ABT) and 200mg once daily with ABT.  


 

 

New patient enrollment in Phase 3 trials EDELWEISS 2 (U.S.) and EDELWEISS 3 (U.S. and Europe) placed on temporary hold: As announced on March 23, 2020, due to the COVID-19 pandemic, the decision was made to temporarily stop enrolling new patients in order to ensure patient safety and prudent trial conduct.  Monitoring and follow-up of patients already randomized into the trial continues with the appropriate safety measures recommended by regulatory authorities.  Trial enrollment is expected to resume in the coming months once patient safety and continuity of care is deemed acceptable. Each of these trials is designed to assess two oral doses of linzagolix in women with endometriosis-associated pain, including 75mg once daily without low-dose ABT and 200mg once daily with ABT.

 

 

Linzagolix commercial partnership: ObsEva is engaged in active discussions with several parties for a commercial partnership to maximize the best-in-class potential of linzagolix.

 

 

 

OBE022 to delay childbirth in pregnant women with preterm labor at 24-34 weeks of gestation

 

 

Enrollment completed in Phase 2 PROLONG part B: Part B is the multicenter, randomized, double-blind, placebo-controlled portion of the PROLONG trial that aimed to enroll up to 120 women with preterm labor at a gestational age between 24 and 34 weeks. Enrollment in Part B was completed in March 2020. In the first quarter of 2020, the independent data monitoring committee (IDMC) recommended continuing the ongoing PROLONG trial with no modifications based on safety data from the first 90 patients enrolled in Part B. 

 

Nolasiban for improving pregnancy and live birth in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF)

 

 

Nolasiban partnership with YuYuan BioScience Technology (YuYuan) for development and commercialization in China: ObsEva’s development and commercialization partnership with YuYuan proceeded during the first quarter of 2020 with steering committee meetings to define the development plan for nolasiban in China for women undergoing ET following IVF.

 

Anticipated Milestones

 

ObsEva expects to achieve the following clinical and regulatory milestones in 2020-21:

 

Second Quarter 2020 (June)

 

 

Linzagolix:

 

Report six-month primary endpoint data from the Phase 3 PRIMROSE 1 trial (U.S.) of linzagolix for the treatment of HMB due to uterine fibroids.

 

 

Report twelve-month results from the Phase 3 PRIMROSE 2 trial (U.S. and Europe) of linzagolix for the treatment of HMB due to uterine fibroids.

 


Second Half 2020

 

 

OBE022: Report final safety and efficacy results from the PROLONG trial encompassing maternal and neonatal follow-up.

 

 

Nolasiban: Investigational new drug submission in China by YuYuan Bioscience Technology to initiate clinical development.

 

 

Fourth Quarter 2020/First Half 2021

 

 

Linzagolix:

 

Pending feedback from National Authorities, submit a Marketing Authorization Application (MAA) in Europe through a centralized procedure for the uterine fibroid indication prior to the end of 2020.

 

 

Following recent receipt of feedback from the U.S. FDA on regulatory filing requirements, as well as expectations for follow-up safety data collection amid the COVID-19 pandemic, submit an NDA for the uterine fibroid indication in 1H 2021.  

 

First Quarter 2020 Financial Results

 

Net loss for the quarter ending March 31, 2020 was $21.9 million, or $0.48 per share, compared with a net loss of $25.7 million, or $0.59 per share, for the quarter ending March 31, 2019.  Research and development expenses were $17.2 million and general and administrative expenses were $3.7 million for the quarter, compared with $20.1 million and $5.3 million, respectively, for the prior year quarter.  The net loss for the quarter included non-cash expenses of $2.7 million for stock-based compensation, compared with $3.3 million a year ago.  

 

As of March 31, 2020, ObsEva had cash and cash equivalents of $62.0 million, compared with $69.4 million as of December 31, 2019.

The first quarter 2020 financial report will be available in the financial reports section of the Company’s website.

 

 

About ObsEva

 

ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving IVF outcomes. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

 

 

Cautionary Note Regarding Forward-Looking Statements


Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials, including the impact of the COVID-19 pandemic on such trials, ObsEva’s plan to submit its MAA in Europe and NDA in the U.S., and YuYuan’s submission of an investigational new drug application in China, the results of interactions with regulatory authorities and ObsEva’s ability to enter into a future commercial partnership for linzagolix. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the effects of the COVID-19 pandemic, any benefits from the joint collaboration with YuYuan or any future commercial partnership for linzagolix may not be fully realized or may take longer to realize than expected and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

For further information, please contact:

 

 

CEO Office Contact:

Shauna Dillon

Shauna.dillon@obseva.ch

+41 22 552 1550

 

Investor Contact:

Mario Corso

Vice President, Investor Relations

mario.corso@obseva.com

+1 857 972 9347 Office

+1 781 366 5726 Mobile

 

 



Consolidated Statements of Comprehensive Loss

 

 

Three-month period

ended March 31,

 

(in USD ’000, except share and per share data) - unaudited

 

2020

 

 

2019

 

Operating income other than revenue

 

 

4

 

 

 

5

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development expenses

 

 

(17,188

)

 

 

(20,140

)

General and administrative expenses

 

 

(3,709

)

 

 

(5,255

)

Total operating expenses

 

 

(20,897

)

 

 

(25,395

)

OPERATING LOSS

 

 

(20,893

)

 

 

(25,390

)

Finance income

 

 

60

 

 

 

262

 

Finance expense

 

 

(1,011

)

 

 

(544