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 December 2022

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

 

 


 

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. 333-221462, 333-260974, 333-262820, and 333-266492) of ObsEva SA (or the “Company,” “we,” “our” or “us”) (including any prospectuses forming a part of such registration statements) and the registration statements on Form S-8 (Registration No. 333-249457, 333-231629, 333-216170 and 333-263234) of ObsEva SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 the Company has little or no control. Additional risks and uncertainties not currently known to the Company, or that the Company currently deems to be immaterial, also may affect its 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 the Company’s Annual Report on Form 20-F for the year ended December 31, 2021 (the “Annual Report”), filed with the Securities and Exchange Commission (“SEC”) on March 10, 2022, and in the Forms 6-K filed with the SEC on May 17, 2022 and August 17, 2022, which are incorporated herein, could cause the Company’s 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 the Annual Report.

Risks and uncertainties associated with our restructuring process and our application to the competent court in Geneva, Switzerland for a court-sanctioned moratorium may lead to potential adverse effects on our operations, financial condition or business prospects.

Based on an evaluation of our current assets and liabilities and cash runway, in July 2022 we applied to the competent court in Geneva, Switzerland, for a court-sanctioned moratorium. If granted, the moratorium will provide us with temporary protection against debt-enforcement and bankruptcy proceedings in Switzerland, with a view to make it possible for us to undertake restructuring measures under the supervision of one or more court-appointed administrators. On October 20, 2022, we attended our first hearing with the competent court in Geneva, Switzerland. At the hearing, our request to suspend proceedings through November 30, 2022 was granted, and we were subsequently granted until December 15, 2022 to provide the Swiss courts with Swiss statutory financial information, at which time we intend to withdraw the moratorium proceedings before the Swiss courts, however there is no assurance that we will be able to withdraw such moratorium proceedings.

We are subject to a number of risks and uncertainties associated with our ongoing corporate restructuring process and our filing to the competent court in Geneva, Switzerland for a court-sanctioned moratorium, which may lead to potential adverse effects on our operations, financial condition or business prospects. We cannot assure you of the outcome of our application for a court-sanctioned moratorium, including the length of time of any moratorium or whether such moratorium will be approved. Risks associated with the restructuring process and moratorium filing may include an adverse impact on the following:

 

our ability to continue as a going concern;

 

our ability to obtain court approval with respect to our application for a court-sanctioned moratorium, the length of time of any such moratorium, and the impact of such moratorium if approved;

 

our ability to successfully restructure our operations and development strategy;

 

our ability to consummate and implement a plan of reorganization, including with respect to our commercial arrangements and agreements with third parties;

 

risks associated with third party motions or other relief sought in connection with any such moratorium, and their potential impact on our operations and restructuring plan, if such moratorium is approved;

 

our ability to maintain sufficient liquidity throughout the restructuring process and/or moratorium period;

 

increased costs related to the moratorium filing or other litigation;

 

our ability to manage agreements that are critical to our operations and, to obtain and maintain appropriate terms with our current or future collaborators and other third parties; and

 

our ability to maintain existing collaborations and vendor relationships.

 

Because the majority of our assets are located outside of the United States, they may be outside of the jurisdiction of U.S. courts to administer if we are the subject of an insolvency or bankruptcy proceeding resulting from any such moratorium, if approved. As a result, if we declared bankruptcy or insolvency, our shareholders may not receive the distributions on liquidation that they would otherwise be entitled to if our assets were to be located within the U.S., under U.S. bankruptcy law. If we were deemed to be

2

 


insolvent, distributions, or part of them, may be delayed while the court administrator determines the extent of potential creditor claims. In these circumstances, prior payments made by us may be deemed voidable transactions. 

Although we expect that the sale proceeds from our recent transaction with XOMA Corporation (“XOMA”) for the sale of our rights to ebopiprant will enable us to resolve our current over-indebtedness position and withdraw our pending moratorium proceedings, there is no assurance that we will be able to withdraw such moratorium proceedings.  

Any financial or strategic alternatives we pursue may not be successful.

As part of our planned restructuring process, we have taken steps to resize the company to be able to meet our outstanding license obligations and assess strategic options with respect to pipeline development.  For example, on October 26, 2022, following the assignment of substantially all clinical, manufacturing, and scientific contracts related to the development of linzagolix, we announced that the transition of the linzagolix program to Kissei Pharmaceutical Co., Ltd. was substantially complete. In addition, on November 21, 2022, we entered into an IP Acquisition Agreement (the “IP Acquisition Agreement”) with XOMA for the sale of all of our rights to ebopiprant, for an upfront payment of USD 15 million and future milestone payments of up to approximately USD 98 million upon the achievement of certain development and regulatory milestones and sales milestones under the July 2021 license agreement with Organon & Co. There is no finite timetable for completion of our strategic review process, and we can provide no assurance that any strategic alternatives we pursue will have a positive impact on our operations or financial condition, or our ability to pursue our business strategies or continue our operations.

 

Our workforce reduction announced on September 13, 2022 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.

 

On September 13, 2022, we announced as part of our restructuring plans that our board of directors had authorized the termination of approximately 70% of our employees, including our former Chief Strategy Officer. We expect to substantially complete the terminations during the fourth quarter of 2022 and estimate that we will reduce our operating expenses going forward. However, these estimates are subject to several assumptions, and actual results may differ. We may not realize, in full or in part, the anticipated benefits and savings from this plan due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected cost savings from the announced plan, our operating results and financial condition could be adversely affected. The workforce reduction may be disruptive to our operations and could yield unanticipated consequences, such as attrition beyond planned staff reductions, increased difficulties in our day-to-day operations and reduced employee morale. If employees who were not affected by the workforce reduction seek alternative employment, this could result in our seeking contractor support at unplanned additional expense or harm the Company’s productivity. Our workforce reductions could also harm our ability to attract and retain qualified management, scientific, clinical, and/or manufacturing personnel. Any failure to attract or retain qualified personnel could prevent us from successfully developing potential product candidates or supporting our existing license agreements.

The availability or incurrence of debt may impact our financial position and may subject us to additional financial and operating restrictions. In addition, we may experience difficulties in complying with covenants contained in one or more of our financing agreements, which could result in events of default and our bankruptcy or liquidation.

In October 2021, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain funds and accounts managed by JGB Management Inc. (“JGB”), which is structured to provide up to USD 135 million in borrowing capacity, available in nine tranches through the issuance of convertible notes (the “Notes”) to JGB, together with warrants to purchase our common shares in an amount equal to 20% of the funded amount for such tranche. In January 2022, we amended the Securities Purchase Agreement with respect to certain terms and conditions for the second tranche under the Securities Purchase Agreement, and accelerated the issuance of the second tranche, among other changes. The availability of each of the seven remaining tranches is subject to our meeting certain conditions, including, among others, that our volume-weighted average price is not below USD 3.00 per share for five or more trading days during the 30 days prior to a tranche funding date (the “Minimum Stock Price Condition”). As of May 25, 2022, the funding date of the third tranche, we had not met the Minimum Stock Price Condition for the third tranche.  On May 27, 2022, we entered into a waiver and amendment agreement with JGB, whereby JGB agreed to waive its right to terminate its obligation to fund future tranches under the Securities Purchase Agreement, which JGB would have been entitled to as a result of our failure to meet the Minimum Stock Price Condition and in exchange, we agreed to establish a “blocked” account control agreement with respect to the existing account control agreement in favor of JGB, which previously held USD 31.0 million in such controlled deposit account (the “Account Balances”).

In July 2022, we applied for a court-sanctioned moratorium to the courts of competent jurisdiction of the Swiss canton of Geneva, which resulted in certain events of default under the Outstanding Notes (as such term is defined below) (the “Events of Default”). On July 31, 2022, we entered into an amendment and forbearance agreement (the “Amendment”) with JGB in relation to the Securities Purchase Agreement, that certain Senior Secured Convertible Note due October 12, 2024, in the aggregate original principal amount of approximately $31.5 million (the “First Tranche Note”), and that certain Senior Secured Convertible Note due January 28, 2025, in the aggregate original principal amount of USD 10.5 million (the “Second Tranche Note”, and together with the First Tranche Note,

3

 


the “Outstanding Notes”, and together with the Securities Purchase Agreement and ancillary agreements thereto, the “Transaction Agreements”). Pursuant to the Amendment, we and JGB agreed to apply the Account Balances against the Outstanding Notes on a pro rata basis, and JGB waived any application of the 25% prepayment premium permitted under the Outstanding Notes with respect to the Account Balances. In addition, JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Transaction Agreements with respect to the Events of Default until the earlier to occur of (i) October 29, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the waiver of the prepayment penalty and forbearance on exercising such rights and remedies, USD 1.5 million was added to the outstanding principal balance under the Outstanding Notes, resulting in an aggregate outstanding balance of approximately USD 11.0 million under the Outstanding Notes, the conversion price of the Outstanding Notes was adjusted to a conversion price of USD 0.26 per share (subject to adjustment as provided in the Outstanding Notes) and our right to mandatory conversion of any convertible notes issued pursuant to the Securities Purchase Agreement, including the Outstanding Notes, was terminated. In addition, JGB is no longer obligated to fund any future mandatory or optional tranche closing under the Securities Purchase Agreement.

On October 26, 2022, we entered into an amendment and forbearance extension agreement (the “Extension Amendment”) with JGB in relation to the Securities Purchase Agreement and the Outstanding Notes. Pursuant to the Extension Amendment, JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Transaction Agreements with respect to the Events of Default until the earlier to occur of (i) December 1, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the forbearance on exercising such rights and remedies, (i) the conversion price for USD 1.5 million of outstanding principal amount of the Outstanding Notes was adjusted to a conversion price of USD 0.19 per share (subject to adjustment as provided in the Outstanding Notes), and (ii) an aggregate of USD 500,000 of outstanding principal and all accrued and unpaid interest on the Outstanding Notes through and including October 31, 2022 was converted at the new conversion price of USD 0.19 per share for 2,631,579 common shares, resulting in an aggregate outstanding balance of approximately USD 6.7 million under the Outstanding Notes.

On November 21, 2022, in connection with our entry into the IP Acquisition Agreement with XOMA, we entered into a consent and amendment agreement (the “Consent”) with JGB related to the Securities Purchase Agreement and the Outstanding Notes. Pursuant to the Consent, JGB consented to our entry into the IP Acquisition Agreement, and we and JGB also agreed (i) to amend the maturity date of each of the Outstanding Notes to December 31, 2023 and (ii) that we will maintain in a control account pursuant to the Transaction Agreements a minimum cash balance equal to the aggregate outstanding principal balance under the Outstanding Notes as of November 21, 2022, provided such minimum cash balance shall be correspondingly reduced upon any conversion of the outstanding balance or payoff of the Outstanding Notes. As of November 21, 2022, the aggregate outstanding principal of the Outstanding Notes was approximately USD 6.7 million.

Our overall leverage and certain covenants and obligations contained in the related documentation could adversely affect our financial health and business and future operations by, among other things:

 

making it more difficult to satisfy our obligations, including under the terms of the Securities Purchase Agreement and the Notes;

limiting our ability to refinance our debt on terms acceptable to us or at all;

 

limiting our flexibility to plan for and adjust to changing business and market conditions and increasing our vulnerability to general adverse economic and industry conditions;

limiting our ability to use our available cash flow to fund future acquisitions and to make dividend payments; and

 

limiting our ability to obtain additional financing for working capital, to fund growth or for general corporate purposes, even when necessary to maintain adequate liquidity.

We may experience difficulties in complying with the covenants contained in the Transaction Agreements resulting in additional events of default, including, following the forbearance period (as extended by the Extension Amendment), the Events of Default. If an event of default occurs under the Transaction Agreements, JGB may declare all outstanding principal and accrued and unpaid interest under the Notes immediately due and payable and exercise the other rights and remedies provided for under the Transaction Agreements, including application of the 25% prepayment premium permitted under the Outstanding Notes. Should an event of default occur, JGB could institute foreclosure proceedings against our assets, and we could be forced into bankruptcy or liquidation. We may in the future need to obtain additional waivers from JGB under the Transaction Agreements to avoid being in default. If we breach our covenants under the Transaction Agreements and seek a waiver, we may not be able to obtain a waiver, and if this results in an event of default, the lenders could exercise their rights, as described above, and we could be forced into bankruptcy or liquidation.

4

 


Our recurring losses, negative cash flows and significant accumulated deficit have raised substantial doubt regarding our ability to continue as a going concern.

We have incurred recurring losses since inception, including net losses of USD 58.4 million for the year ended December 31, 2021 and net losses of USD 56.7 million for the nine-months ended September 30, 2022. As of September 30, 2022, we have accumulated losses of USD 518.7 million, of which USD 30.6 million were offset with share premium. We expect to continue to generate operating losses for the foreseeable future. As of September 30, 2022, we had cash and cash equivalents of USD 9.7 million. We have prepared our unaudited condensed consolidated financial statements assuming that we will continue as a going concern which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Securities Purchase Agreement is structured to provide USD 135 million in borrowing capacity, available in nine tranches, with the first tranche funded at the initial closing in October 2021 and the second tranche funded in January 2022 in connection with certain amendments to the Securities Purchase Agreement. The subsequent tranches under the Securities Purchase Agreement will be available subject to our meeting certain conditions, including, among others, the Minimum Stock Price Condition, and will be funded at JGB’s sole discretion.

To date, we have funded our operations through equity and debt offerings, through payments from licensors and through the sale of our rights to ebopiprant. We believe that our current cash and cash equivalents, after taking into account the proceeds from the IP Acquisition Agreement with XOMA and our corporate restructuring actions, including a mass dismissal process pursuant to Swiss law, are only sufficient to fund our operating expenses through the fourth quarter of 2023 and this raises substantial doubt about our ability to continue as a going concern. These factors individually and collectively indicate that a material uncertainty exists that may cast significant doubt about our ability to continue as a going concern within one year from the date of the issuance of the unaudited condensed consolidated financial statements filed herewith. Our future viability is dependent on our ability to raise additional capital to finance our future operations and implement a successful corporate reorganization.  We may raise funds through equity or debt offerings.  The sale of additional equity may dilute existing shareholders and newly issued shares may contain senior rights and preferences compared to currently outstanding common shares. Issued debt securities may contain covenants and limit our ability to pay dividends or make other distributions to shareholders. We may receive future milestone payments from licensors or pursuant to the IP Acquisition Agreement, but that is dependent on achieving certain regulatory or commercial milestones that may never happen. We may seek additional funding through public or private financings, debt financing or collaboration agreements. We may also be subject to certain restrictions and limitations on raising funds if we are unable to withdraw our pending moratorium proceedings and the court-sanctioned moratorium is granted by the competent court in Geneva, Switzerland or if we do not regain compliance with the continued listing standards of the Nasdaq Stock Market LLC (“Nasdaq”). The inability to obtain funding, as and when needed, would have a negative impact on our operations, financial condition and ability to pursue our business strategies. If we are unable to obtain the required funding to run our operations and to develop and commercialize our product candidates, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Management continues to explore all potential options to obtain additional funding. However, there is no assurance that we will be successful in raising funds, closing a collaboration agreement, obtaining sufficient funding on terms acceptable to us, or if at all, which could have a material adverse effect on our business, results of operations and financial conditions.

 

The conversion of some or all of the Outstanding Notes, as well as the exercise of our outstanding warrants, could result in significant dilution to existing common shareholders, adversely affect the market price of our common shares and impair our ability to raise capital through the sale of additional equity securities.

 

Following our execution of the Extension Amendment with JGB, the Outstanding Notes had an aggregate outstanding balance of approximately USD 6.7 million, and the conversion price for USD 1.5 million of outstanding principal amount of the Outstanding Notes was adjusted to a conversion price of USD 0.19 per share (subject to adjustment as provided in the Outstanding Notes), and the conversion price for the remaining outstanding balance under the Outstanding Notes remained at USD 0.26 per share (subject to adjustment as provided in the Outstanding Notes). In addition, our right to mandatory conversion of any convertible notes issued pursuant to the Securities Purchase Agreement, including the Outstanding Notes, has been terminated. The conversion of some or all of the Outstanding Notes, as well as the exercise of our Outstanding warrants, could result in significant dilution to existing common shareholders, adversely affect the market price of our common shares and impair our ability to raise capital through the sale of additional equity securities. In addition, the existence of the Notes may encourage short selling by market participants because the conversion of the Notes could be used to satisfy short positions, or anticipated conversion of the Notes into common shares could depress the price of our common shares.

 

 

Our common shares could be delisted by Nasdaq, and if such delisting occurs it could limit the liquidity of our common shares, increase its volatility and hinder our ability to raise capital.

 

Our common shares are currently listed on the Nasdaq Global Select Market. We may be subject to delisting by Nasdaq if we no longer meet the continuing listing requirements necessary to maintain our listing on Nasdaq, including, among other requirements, to

5

 


maintain a minimum bid price of USD 1.00 per share. On September 12, 2022, we received a notification letter from Nasdaq advising us that we were not in compliance with Listing Rule 5450(a)(1) because, for a period of thirty (30) consecutive business days, the bid price of our common shares had closed below the minimum USD 1.00 per share requirement for continued listing.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days, or until March 13, 2023, to regain compliance with the minimum bid price requirement. We will regain compliance with the minimum bid price requirement if at any time during the 180-day period, the bid price of our common shares closes at or above USD 1.00 per share for a minimum of ten (10) consecutive business days. While we may be able to qualify for additional time to attempt to regain compliance, there can be no assurance that we will qualify for additional time to regain compliance, or that we will regain compliance with or without such additional time. If we are unable to meet Nasdaq’s listing maintenance standards for any reason within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, our common shares could be delisted from the Nasdaq Global Select Market.

We intend to monitor the closing bid price of common shares and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules, including implementing a reverse stock split. However, there can be no assurance that a reverse stock split, or any other alternatives we may consider to regain compliance with the minimum bid price requirement, would be approved or would result in a sustained higher stock price that would allow us to meet Nasdaq’s minimum bid price listing requirements.

In addition, on August 19, 2022, we received a notification letter from Nasdaq advising us that we were not in compliance with Nasdaq Listing Rule 5450(b)(1)(A) requiring companies listed on the Nasdaq Global Select Market to maintain a minimum of USD 10 million in stockholders’ equity for continued listing. We submitted our plan to regain compliance on August 29, 2022. While the sale proceeds from the IP Acquisition Agreement with XOMA are expected to improve our ability to regain compliance with this requirement, there is no assurance that we will regain compliance with this requirement.

In addition to compliance with the continued listing requirements noted above, Nasdaq may use its discretionary authority to delist our common shares in connection with the court-sanctioned moratorium in Switzerland.

If our common shares were to be delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our common shares could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common shares, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common shares to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on a major exchange. In addition, such delisting could have an adverse impact or result in an event of default under one or more of our commercial agreements, including the Transaction Agreements with JGB.

We have determined that we no longer meet the requirements for being a foreign private issuer and, as of January 1, 2023 we will have to comply with the domestic reporting requirements of the Exchange Act, which may cause us to incur significant additional legal, accounting and other expenses.

We are currently a foreign private issuer and therefore, are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. In order to maintain our current status as a foreign private issuer, either (1) a majority of our common shares must be either directly or indirectly owned of record by non-residents of the United States or (2)(a) a majority of our executive officers or directors may not be United States citizens or residents, (b) more than 50% of our assets cannot be located in the United States and (c) our business must be administered principally outside the United States. While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually as of the end of the most recently completed second fiscal quarter. As of June 30, 2022, the last business day of our second quarter, more than 50% of our securities were held by U.S. residents and more than 50% of our board and executive team were residents of the United States. Therefore, we no longer qualify as a foreign private issuer as of June 30, 2022 under Rule 3b-4(c) of the Securities Exchange Act of 1934. We will become a U.S. domestic filer for all our filings with the SEC from January 1, 2023 onwards and will thus file our Annual Report on Form 10-K for the year ended December 31, 2022 as such. We will be required to comply with reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers, amongst other things would include the filing of financial statements, which have previously been prepared in accordance with IFRS, in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”). Such conversion of our financial statements to U.S. GAAP will involve significant time and cost. We may also be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq listing rules. The regulatory and compliance costs to us under U.S. securities laws to comply with the reporting requirements applicable to a U.S. domestic issuer may be significantly higher than the cost we would incur as a foreign private issuer. As a result, we expect that our loss of foreign private issuer status will increase our legal and financial compliance costs and would make some activities highly time-consuming and costly. If we are unable to devote adequate funding and the resources needed to maintain compliance with U.S. securities laws, while continuing our operations, we could be forced to deregister with the SEC. A deregistration would substantially reduce or effectively terminate the trading of our securities in the United States. We also expect that having to comply with the rules and regulations applicable to U.S. domestic issuers would make it more difficult and expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors.

6

 


Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.

In the United States, the European Union, and other foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the United States federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers. Among the provisions of the ACA, those of greatest importance to the pharmaceutical and biotechnology industries include:

 

an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, which is apportioned among these entities according to their market share in certain government healthcare programs;

 

a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

 

new requirements to report certain financial arrangements, including reporting “transfers of value” made or distributed to physicians, as defined by such law, and teaching hospitals and reporting investment interests held by such healthcare providers and their immediate family members;

 

an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;

 

a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

 

extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

 

expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;

 

expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

 

a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and

 

establishment of a Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

There have been executive, judicial and Congressional challenges to certain aspects of the ACA. For example, legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act, or Tax Act, included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the individual mandate was repealed by Congress. Prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period that remained open from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. On August 16, 2022, President Biden signed the Inflation

7

 


Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost through a newly established manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and other litigation, and the healthcare reform measures of the Biden administration will impact the ACA and our business.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect until 2031, except for a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic, unless additional Congressional action is taken. Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other health care funding, which could have an adverse effect on our customers and accordingly, our financial operations.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, the Medicare Access and CHIP Reauthorization Act of 2015 ended the use of the statutory formula, also referred to as the Sustainable Growth Rate, for clinician payment and established a quality payment incentive program, also referred to as the Quality Payment Program. This program provides clinicians with two ways to participate, including through the Advanced Alternative Payment Models, or APMs, and the Merit-based Incentive Payment System, or MIPS.  In November 2019, CMS issued a final rule finalizing the changes to the Quality Payment Program. At this time, the full impact to overall physician reimbursement under the Medicare program as a result of the introduction of the Quality Payment Program remains unclear. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. 

In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, including several recent Presidential executive orders, Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare and reform government program reimbursement methodologies for products. Additionally, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, the U.S. Department of Health and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA, among other things, (1) directs HHS to negotiate the price of certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. Further, the Biden administration released an additional executive order on October 14, 2022, directing HHS to submit a report within 90 days on how the Center for Medicare and Medicaid Innovation can be further leveraged to test new models for lowering drug costs for Medicare and Medicaid beneficiaries. We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

At the state level, individual states in the United States have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our

8

 


products or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

In the European Union, similar political, economic and regulatory developments may affect our ability to profitably commercialize any of our product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the European Union or member state level may result in significant additional requirements or obstacles that may increase our operating costs. The delivery of healthcare in the European Union, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than European Union, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing European Union and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to commercialize any products for which we obtain marketing approval. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states, and parallel trade, i.e., arbitrage between low-priced and high-priced member states, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries. In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. 

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we or our collaborators are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or our collaborators are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability, which would adversely affect our business. 

9

 


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 December 1, 2022.

 

 

 

 

 

 

10

 


 

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: December 1, 2022

 

By:

 

/s/ Brian O’Callaghan

 

 

 

 

Name

 

Brian O’Callaghan

 

 

 

 

Title:

 

Chief Executive Officer

 

11

 

Exhibit 99.1

OBSEVA SA

INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Unaudited Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021

2

Unaudited Condensed Consolidated Statements of Comprehensive Loss for the three-month and nine-month periods ended September 30, 2022

3

Unaudited Condensed Consolidated Statement of Cash Flows for the nine-month period ended September 30, 2022

4

Unaudited Condensed Consolidated Statement of Changes in Equity for the nine-month period ended September 30, 2022

5

Notes to the Unaudited Condensed Consolidated Financial Statements

6

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

Unaudited Condensed Consolidated Balance Sheets

(in USD ’000)

Notes

 

September 30,

2022

 

 

December 31,

2021

 

ASSETS

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

4

 

 

9,684

 

 

 

54,734

 

Other receivables

 

 

 

174

 

 

 

3,560

 

Prepaid expenses

 

 

 

1,705

 

 

 

5,223

 

Total current assets

 

 

 

11,563

 

 

 

63,517

 

Non-current assets

 

 

 

 

 

 

 

 

 

Right-of-use assets

 

 

 

313

 

 

 

625

 

Furniture, fixtures and equipment

 

 

 

45

 

 

 

58

 

Intangible assets

5

 

 

4,503

 

 

 

24,503

 

Other long-term assets

 

 

 

383

 

 

 

288

 

Total non-current assets

 

 

 

5,244

 

 

 

25,474

 

Total assets

 

 

 

16,807

 

 

 

88,991

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

 

Other payables and current liabilities

 

 

 

7,213

 

 

 

9,038

 

Accrued expenses

10

 

 

2,353

 

 

 

13,783

 

Current borrowings

6

 

 

8,902

 

 

 

 

Current lease liabilities

 

 

 

367

 

 

 

686

 

Total current liabilities

 

 

 

18,835

 

 

 

23,507

 

Non-current liabilities

 

 

 

 

 

 

 

 

 

Non-current lease liabilities

 

 

 

 

 

 

240

 

Non-current borrowings

6

 

 

 

 

 

25,733

 

Post-employment obligations

14

 

 

568

 

 

 

6,581

 

Other long-term liabilities

 

 

 

553

 

 

 

591

 

Total non-current liabilities

 

 

 

1,121

 

 

 

33,145

 

Shareholders’ equity

 

 

 

 

 

 

 

 

 

Share capital

 

 

 

8,467

 

 

 

6,489

 

Share premium

 

 

 

441,306

 

 

 

430,630

 

Reserves

 

 

 

35,129

 

 

 

32,195

 

Accumulated losses

 

 

 

(488,051

)

 

 

(436,975

)

Total shareholders’ equity

7

 

 

(3,149

)

 

 

32,339

 

Total liabilities and shareholders’ equity

 

 

 

16,807

 

 

 

88,991

 

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


2

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

Unaudited Condensed Consolidated Statements of Comprehensive Loss

 

(in USD ’000, except per share data)

 

 

Three-month period

ended September 30,

 

 

Nine-month period

ended September 30,

 

 

Notes

 

2022

 

 

2021

 

 

2022

 

 

2021

 

OPERATING INCOME OTHER THAN REVENUE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other operating income

8

 

 

3

 

 

 

20,098

 

 

 

4,852

 

 

 

20,108

 

Assignment income

8

 

 

3,709

 

 

 

 

 

 

3,709

 

 

 

 

Total operating income other than revenue

 

 

 

3,712

 

 

 

20,098

 

 

 

8,561

 

 

 

20,108

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

9

 

 

(692

)

 

 

(11,531

)

 

 

(13,411

)

 

 

(41,532

)

General and administrative expenses

 

 

 

(3,649

)

 

 

(7,035

)

 

 

(18,393

)

 

 

(15,114

)

Impairment of intangible asset

5

 

 

 

 

 

 

 

 

(19,400

)

 

 

 

Total operating expenses

 

 

 

(4,341

)

 

 

(18,566

)

 

 

(51,204

)

 

 

(56,646

)

OPERATING (LOSS) INCOME

 

 

 

(629

)

 

 

1,532

 

 

 

(42,643

)

 

 

(36,538

)

Finance income

 

 

 

2,885

 

 

 

128

 

 

 

2,385

 

 

 

702

 

Finance expense

 

 

 

(2,494

)

 

 

(822

)

 

 

(4,472

)

 

 

(2,423

)

Loss on event of default

6

 

 

(17,586

)

 

 

 

 

 

(17,586

)

 

 

 

Gain on debt extinguishment

6

 

 

5,713

 

 

 

 

 

 

5,713

 

 

 

 

NET (LOSS) INCOME BEFORE TAX

 

 

 

(12,111

)

 

 

838

 

 

 

(56,603

)

 

 

(38,259

)

Income tax income (expense)

11

 

 

54

 

 

 

(19

)

 

 

(53

)

 

 

(70

)

NET (LOSS) INCOME FOR THE PERIOD

 

 

 

(12,057

)

 

 

819

 

 

 

(56,656

)

 

 

(38,329

)

Net (loss) income per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

12

 

 

(0.13

)

 

 

0.01

 

 

 

(0.65

)

 

 

(0.52

)

OTHER COMPREHENSIVE INCOME

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that will not be reclassified to profit and loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remeasurements on post-employment benefit plans, net of tax

14

 

 

5,581

 

 

 

 

 

 

5,581

 

 

 

 

TOTAL OTHER COMPREHENSIVE INCOME

 

 

 

5,581

 

 

 

 

 

 

5,581

 

 

 

 

TOTAL COMPREHENSIVE (LOSS) INCOME FOR THE PERIOD

 

 

 

(6,476

)

 

 

819

 

 

 

(51,075

)

 

 

(38,329

)

 

 

 

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

 

3

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

Unaudited Condensed Consolidated Statements of Cash Flows

 

 

 

 

Nine-month period

ended September 30,

 

(in USD ’000)

Notes

 

2022

 

 

2021

 

NET LOSS BEFORE TAX FOR THE PERIOD

 

 

 

(56,603

)

 

 

(38,259

)

Adjustments for:

 

 

 

 

 

 

 

 

 

Impairment of intangible asset

 

 

 

19,400

 

 

 

 

Loss on event of default

 

 

 

17,586

 

 

 

 

 

Gain on debt extinguishment

 

 

 

(5,713

)

 

 

 

Depreciation expense

 

 

 

341

 

 

 

621

 

Post-employment cost

 

 

 

8

 

 

 

374

 

Share-based compensation expense

 

 

 

2,933

 

 

 

4,661

 

Finance expense, net

 

 

 

2,086

 

 

 

1,720

 

Other operating income

 

 

 

(4,852

)

 

 

(20,095

)

Assignment income

 

 

 

(3,709

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

Other receivables

 

 

 

3,384

 

 

 

(2,896

)

Prepaid expenses, deferred costs and other long-term assets

 

 

 

3,423

 

 

 

(357

)

Other payables and current liabilities

 

 

 

652

 

 

 

(3,790

)

Accrued expenses and other long-term liabilities

 

 

 

(10,003

)

 

 

474

 

NET CASH FLOWS USED IN OPERATING ACTIVITIES

 

 

 

(31,067

)

 

 

(57,547

)

Net proceeds from disposal of intangible assets

 

 

 

5,691

 

 

 

22,200

 

Payments for plant and equipment

 

 

 

(15

)

 

 

(14

)

NET CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

5,676

 

 

 

22,186

 

Prepayment of convertible debt

 

 

 

(31,000

)

 

 

 

Proceeds from issuance of shares

 

 

 

6,596

 

 

 

49,049

 

Proceeds from issuance of convertible debt

 

 

 

8,610

 

 

 

 

Proceeds from issuance of warrants

 

 

 

915

 

 

 

 

Proceeds from exercise of warrants

 

 

 

 

 

 

22,117

 

Issuance costs related to convertible debt and warrant

 

 

 

(1,766

)

 

 

 

Share issuance costs

 

 

 

(224

)

 

 

(1,683

)

Principal elements of lease payments

 

 

 

(522

)

 

 

(508

)

Interest paid

 

 

 

(1,926

)

 

 

(1,725

)

NET CASH FLOWS (USED IN) FROM FINANCING ACTIVITIES

 

 

 

(19,317

)

 

 

67,250

 

Net (decrease) increase in cash, cash equivalents and restricted cash

 

 

 

(44,708

)

 

 

31,889

 

Cash, cash equivalents and restricted cash at January 1,

 

 

 

54,734

 

 

 

31,183

 

Effects of exchange rate changes on cash, cash equivalents and restricted cash

 

 

 

(342

)

 

 

(188

)

Cash, cash equivalents and restricted cash at September 30,

 

 

 

9,684

 

 

 

62,884

 

 

 

 

 

 

 

 

 

 

 

NON-CASH FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

 

Issuance of common shares (in connection with conversion of convertible debt)

 

 

 

5,271

 

 

 

 

 

 

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

 

4

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

Unaudited Condensed Consolidated Statements of Changes in Equity

 

(in USD ’000)

 

Share

capital

 

 

Treasury

shares

 

 

Share

premium

 

 

Reserves

 

 

Accumulated

losses

 

 

Total

 

January 1, 2021

 

 

4,878

 

 

 

(304

)

 

 

356,822

 

 

 

26,353

 

 

 

(379,395

)

 

 

8,354

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,329

)

 

 

(38,329

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,329

)

 

 

(38,329

)

Issuance of treasury shares

 

 

1,515

 

 

 

(1,515

)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares - ATM program

 

 

 

 

 

1,189

 

 

 

47,860

 

 

 

 

 

 

 

 

 

49,049

 

Share issuance costs

 

 

 

 

 

 

 

 

(1,683

)

 

 

 

 

 

 

 

 

(1,683

)

Exercise of warrants

 

 

555

 

 

 

 

 

 

21,562

 

 

 

 

 

 

 

 

 

22,117

 

Share-based remuneration

 

 

 

 

 

 

 

 

 

 

 

4,661

 

 

 

 

 

 

4,661

 

September 30, 2021

 

 

6,948

 

 

 

(630

)

 

 

424,561

 

 

 

31,014

 

 

 

(417,724

)

 

 

44,169

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 1, 2022

 

 

6,948

 

 

 

(459

)

 

 

430,629

 

 

 

32,196

 

 

 

(436,976

)

 

 

32,338

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(56,656

)

 

 

(56,656

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,581

 

 

 

5,581

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(51,075

)

 

 

(51,075

)

Issuance of treasury shares

 

 

1,947

 

 

 

(1,947

)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares - ATM program

 

 

 

 

 

588

 

 

 

6,008

 

 

 

 

 

 

 

 

 

6,596

 

Share issuance costs - ATM program

 

 

 

 

 

 

 

 

(224

)

 

 

 

 

 

 

 

 

(224

)

Conversion rights value - convertible notes

 

 

 

 

 

 

 

 

290

 

 

 

 

 

 

 

 

 

290

 

Issuance of shares - convertible notes

 

 

1,390

 

 

 

 

 

 

3,881

 

 

 

 

 

 

 

 

 

5,271

 

Reclassification of warrants

 

 

 

 

 

 

 

 

722

 

 

 

 

 

 

 

 

 

722

 

Share-based remuneration

 

 

 

 

 

 

 

 

 

 

 

2,933

 

 

 

 

 

 

2,933

 

September 30, 2022

 

 

10,285

 

 

 

(1,818

)

 

 

441,306

 

 

 

35,129

 

 

 

(488,051

)

 

 

(3,149

)

 

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

 

5

 


ObsEva SA

Unaudited 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 (see Note 2.3).

The Group is focused on the development of novel therapeutics to improve women’s reproductive health and pregnancy. The Group has a portfolio of one in-licensed mid-stage development compound (nolasiban). The Group has no currently marketed products.

On July 27, 2022, the Company announced plans to initiate a corporate restructuring and refocus the Company’s development and commercialization strategy. The Board of Directors decided to undertake the following actions: (i) give notice of termination of the Company’s license agreement with Kissei Pharmaceutical Co., Ltd (“Kissei”) for the development and commercialization of linzagolix (the “Kissei License Agreement”); (ii) commence planned corporate restructuring to resize the Company to be able to meet its license obligations and assess strategic options with respect to pipeline development; and (iii) file an application to the competent court in Geneva, Switzerland for a court-sanctioned moratorium to facilitate the planned restructuring.

Following the termination of the Kissei License Agreement, the Company began a process to transition the linzagolix program to Kissei, including the assignment of clinical, manufacturing, and scientific contracts related to the development of linzagolix.  As of the issuance date of the unaudited condensed consolidated financial statements, the Company has assigned substantially all contracts, representing approximately USD 5.0 million in transferred obligations to Kissei.

On September 12, 2022, following a consultation process with the Company’s employees, the Board of Directors authorized the termination of approximately 70% of employees, which the Company expects to substantially complete during the fourth quarter of 2022.

On October 20, 2022, the Company attended the first hearing with the competent court in Geneva, Switzerland, whereby the Company’s request to suspend proceedings through November 30, 2022 was granted.  

On November 21, 2022, the Company entered into an IP Acquisition Agreement (the “IP Acquisition Agreement”) with XOMA Corporation (“XOMA”) for the sale of all of its rights to ebopiprant, for an upfront payment of USD 15 million and future milestone payments of up to approximately USD 98 million upon the achievement of certain development and regulatory milestones and sales milestones under the July 2021 license agreement with Organon & Co. (“Organon”). See Note 16 for future information on the IP Acquisition Agreement and related agreements. We expect the sale proceeds from this recent transaction with XOMA to enable the Company to resolve the over-indebtedness position.  The Company has until December 15, 2022 to provide Swiss statutory financial information to the competent court in Geneva, Switzerland, at which time the Company intends to withdraw its moratorium proceedings. There is no assurance that we will be able to withdraw such moratorium proceedings. The Company continues to progress various corporate initiatives intended to resolve its over-indebtedness and support future pipeline development.

These unaudited 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 unaudited condensed consolidated financial statements were authorized for issue by the Audit Committee of the Company’s Board of Directors (the “Board of Directors”) on November 30, 2022.

2. Accounting principles and scope of consolidation

2.1 Basis of preparation and accounting principles

These unaudited three-month and nine-month interim condensed consolidated financial statements (the “unaudited 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 unaudited condensed consolidated financial statements are consistent with those used in the consolidated financial statements for the year ended December 31, 2021 (the “annual financial statements”), which should be read in conjunction with these unaudited condensed consolidated financial statements as they provide an update of previously reported information.

Operating income other than revenue

6

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

Other operating income includes royalty and milestone income from the out-licensing of intellectual property when ObsEva retains an interest in the intellectual property through a license. Milestone income is recognized at the point in time when it is highly probable that the relevant milestone event criteria are met, and the risk of reversal of revenue recognition is remote.  Royalty income earned through a license is recognized when the underlying sales have occurred.

Assignment income represents contractual obligations transferred upon assignment of vendor contracts to a third party and is recognized upon execution of the assignment contract.  

Going concern

The Company has incurred recurring losses since inception, including net losses of USD 56.7 million for the nine-month period ended September 30, 2022. As of September 30, 2022, the Company had accumulated losses of USD 518.7 million, of which USD 30.6 million were offset with share premium. The Company expects to continue to generate operating losses for the foreseeable future. As of September 30, 2022, the Company had cash and cash equivalents of USD 9.7 million. These unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. To date, the Company has funded its operations through equity and debt offerings and through payments from licensors. The Company believes that its current cash and cash equivalents, after taking into account the upfront payment of USD 15 million from the IP Acquisition Agreement with XOMA and the Company’s corporate restructuring actions, including a mass dismissal process pursuant to Swiss law, are sufficient to fund its operating expenses through the fourth quarter of 2023 and this raises substantial doubt about the Company’s ability to continue as a going concern. These factors individually and collectively indicate that a material uncertainty exists that may cast significant doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these unaudited condensed consolidated financial statements. The future viability of the Company is dependent on its ability to implement a successful corporate reorganization and to raise additional capital to finance its future operations. The Company may receive future milestone payments from licensors or pursuant to the IP Acquisition Agreement, but that is dependent on achieving certain regulatory or commercial milestones that may never happen. The Company may seek additional funding through public or private financings, debt financing or collaboration agreements. The sale of additional equity may dilute existing shareholders and newly issued shares may contain senior rights and preferences compared to currently outstanding common shares. Issued debt securities may contain covenants and limit the Company’s ability to pay dividends or make other distributions to shareholders. The Company may also be subject to certain restrictions and limitations on raising funds if the Company is unable to withdraw its pending moratorium proceedings and the court-sanctioned moratorium is granted by the competent court in Geneva, Switzerland or if the Company does not regain compliance with the continued listing standards of Nasdaq. The inability to obtain funding, as and when needed, would have a negative impact on the Company’s operations, financial condition and ability to pursue its business strategies. If the Company is unable to obtain the required funding to run its operations and to develop and commercialize its product candidates, 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. Management continues to explore all potential options to obtain additional funding. However, there is no assurance that the Company will be successful in raising funds, obtaining sufficient funding on terms acceptable to the Company, or if at all, which could have a material adverse effect on the Group’s business, results of operations and financial conditions.

2.2 Use of estimates and assumptions

The preparation of unaudited 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. If in the future such estimates and assumptions, which are based on management’s best judgment at the date of the unaudited 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

The Company consolidates the financial operations of its four fully-owned subsidiaries, ObsEva Ireland Ltd, which is registered in Cork, Ireland and organized under the laws of Ireland, ObsEva Europe B.V., which is registered and organized under the laws of Netherlands, ObsEva Switzerland SA, which is registered and organized under the laws of Switzerland, and ObsEva USA Inc., which is registered and organized under the laws of Delaware, USA. ObsEva Ireland Ltd, ObsEva Europe B.V., and ObsEva Switzerland SA had no operations and no results of operations to report as of September 30, 2022 and 2021.

7

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

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.

The Company’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.

Assets recorded at fair value on a nonrecurring basis, such as intangible assets are recognized at fair value when they are impaired.

4. Cash and cash equivalents

 

Cash and cash equivalents include cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value, and bank overdrafts.  

5. Intangible assets

The Company’s intangible assets consisted of the following:

 

 

September 30, 2022

 

(in USD ‘000)

 

Gross Carrying Value

 

 

Disposal

 

 

Impairment

 

 

Net Book Value

 

Intangible assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Linzagolix

 

 

20,000

 

 

 

(600

)

 

 

(19,400

)

 

 

 

Nolasiban

 

 

4,503

 

 

 

 

 

 

 

 

 

4,503

 

Total

 

 

24,503

 

 

 

(600

)

 

 

(19,400

)

 

 

4,503

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2021

 

(in USD ‘000)

 

Gross Carrying Value

 

 

Disposal

 

 

Impairment

 

 

Net Book Value

 

Intangible assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Linzagolix

 

 

20,000

 

 

 

 

 

 

 

 

 

20,000

 

Nolasiban

 

 

4,503

 

 

 

 

 

 

 

 

 

4,503

 

Ebopiprant

 

 

2,105

 

 

 

(2,105

)

 

 

 

 

 

 

Total

 

 

26,608

 

 

 

(2,105

)

 

 

 

 

 

24,503

 

On February 10, 2022, the Company entered into a strategic licensing agreement with Theramex HQ UK Limited (“Theramex”) to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia (“Theramex License Agreement”). Given the out-licensing of linzagolix in certain territories to Theramex, the Company concluded that a portion of the linzagolix intangible assets should be de-recognized.  The Company calculated the out-licensed territories as representing 3% of the probability-weighted gross profit from linzagolix product sales world-wide and as a result, recorded a partial derecognition of USD 0.6 million of intangible asset.

During the second quarter of 2022, the Company identified an interim impairment trigger for the linzagolix intangible asset resulting from the review issues communicated by the U.S. Food and Drug Administration (FDA) regarding deficiencies in the New Drug Application (NDA) for linzagolix for uterine fibroids. After performing an interim impairment assessment, the Company concluded that the full remaining net book value of the asset was impaired as of June 30, 2022 and recorded a charge of USD 19.4 million. The impairment charge is recorded in impairment of intangible asset on the unaudited condensed consolidated statements of comprehensive loss.

6. Borrowings

In October 2021, the Company entered into a convertible note financing agreement (the “Securities Purchase Agreement”) with certain funds and accounts managed by JGB Management Inc. (“JGB”), which is structured to provide up to USD 135 million in borrowing capacity, available in nine tranches.  In connection with the initial closing which included a borrowing amount of USD 31.5 million (offer issue discount of USD 1.5 million) for the first tranche, the Company received gross proceeds of USD 30.0 million.  The following is the activity of the Company’s borrowings for the nine-months ended September 30, 2022:

8

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

(in USD ‘000)

 

2022

 

Borrowings as of January 1,

 

$

25,733

 

Issuance of convertible note, net of transaction costs

 

 

6,879

 

Loss on event of default

 

 

17,586

 

Prepayment of convertible notes

 

 

(31,000

)

Gain on debt extinguishment

 

 

(5,713

)

Change in value of conversion price

 

 

(163

)

Conversion of convertible note

 

 

(4,901

)

Change in estimated prepayment penalty

 

 

(970

)

Interest expense

 

 

3,663

 

Interest paid

 

 

(2,212

)

Borrowings as of September 30,

 

$

8,902

 

 

 

 

 

 

 

On January 28, 2022, the Company entered into an amendment agreement (the “Amendment Agreement”) with JGB regarding the second tranche of the Securities Purchase Agreement (the “Second Tranche”), which adjusted the principal balance payable at maturity for the Second Tranche to USD 10.5 million (USD 975 thousand of original issue discount). In addition, as adjusted pursuant to the Amendment Agreement, the Company issued a warrant to purchase 1,018,716 common shares of the Company at an exercise price of $1.87 per share. The fair value of the second tranche was determined to equal the USD 9.5 million in cash proceeds received and was allocated by using the fair value of the warrants (USD 900 thousand), the fair value of the liability portion of the convertible feature (USD 8.4 million) and the fair value of the conversion option (USD 200 thousand). The proceeds from the issuance of the second tranche convertible note was USD 6.9 million, net of 1.5 million in transaction costs.  

 

On July 27, 2022, the Company’s previously announced application to the courts of competent jurisdiction of the Swiss canton of Geneva for a preliminary moratorium resulted in certain events of default (the “Events of Default”) under the outstanding convertible notes issued under the Securities Purchase Agreement (the “Notes”). Upon the Event of Default, the gross carrying value of the Notes was adjusted from the previous carrying amount of USD 33.0 million to USD 50.6 million to reflect the estimated contractual cash flows.  The adjustment of USD 17.6 million included a 25% prepayment penalty of USD 10.1 million (as provided in the Transaction Agreements) and the unamortized original issue discount of USD 7.5 million and was recognized as ‘Loss on event of default’ within the unaudited condensed consolidated statement of comprehensive loss for the three- and nine- month period ending September 30, 2022.

 

On July 31, 2022, the Company entered into an amendment and forbearance agreement (the “Amendment”) with JGB in relation to the Securities Purchase Agreement, that certain Senior Secured Convertible Note due October 12, 2024, in the aggregate original principal amount of approximately $31.5 million (the “First Tranche Note”), and that certain Senior Secured Convertible Note due January 28, 2025, in the aggregate original principal amount of USD 10.5 million (the “Second Tranche Note”, and together with the First Tranche Note, the “Outstanding Notes”, and together with the Securities Purchase Agreement and ancillary agreements thereto, the “Transaction Agreements”). Pursuant to the Amendment, the Company and JGB agreed to apply USD 31.0 million (the “Account Balances”) previously held in a control account in accordance with the Transaction Agreements against the Outstanding Notes on a pro rata basis, and JGB waived any application of the 25% prepayment premium permitted under the Outstanding Notes with respect to the Account Balances through the forbearance period. In addition, JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Securities Purchase Agreement, the Notes, or any ancillary agreements thereto (the “Transaction Agreements”), with respect to the Events of Default until the earlier to occur of (i) October 29, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the waiver of the prepayment penalty and forbearance on exercising such rights and remedies, USD 1.5 million was added to the outstanding principal balance under the Outstanding Notes, resulting in an aggregate outstanding balance of approximately USD 11.0 million under the Outstanding Notes, the conversion price of the Outstanding Notes was adjusted to a conversion price of USD 0.26 per share (subject to adjustment as provided in the Outstanding Notes) and the Company’s right to mandatory conversion of any convertible notes issued pursuant to the Securities Purchase Agreement, including the Outstanding Notes, was terminated. In addition, JGB is no longer obligated to fund any future mandatory or optional tranche closing under the Securities Purchase Agreement.

 

The modification of the Notes was evaluated under IFRS 9, “Financial Instruments”.  According to the guidance, the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. As a result, the Company recorded a gain on debt extinguishment of USD 5.7 million during the three- and nine-months ended September 30, 2022, which represents the difference between the consideration paid of USD 44.9 million and the carrying value of the Outstanding Notes upon extinguishment of USD 50.6 million.   The consideration paid included the USD 31.0 million in cash paid, the USD 11.0 million in

9

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

convertible notes issued, the USD 2.7 million of prepayment penalty applied to the new debt and value of the change in conversion price of USD 0.2 million.

 

During the nine-month period ended September 30, 2022, JGB converted USD 4.9 million of the outstanding principal balance and USD 0.4 million of accrued and unpaid interest under the Outstanding Notes into 17,246,134 common shares.  In connection with the note conversions in the third quarter, approximately USD 1.0 million of the estimated prepayment penalty was reversed and recorded as finance income on the Company’s unaudited condensed consolidated statements of comprehensive loss.

 

The balances of the Outstanding Notes are measured as the value of the expected future cash flows and classified as short-term on the unaudited condensed consolidated balance sheets as of September 30, 2022.

 

On October 26, 2022, the Company entered into an amendment and forbearance extension agreement (the “Extension Amendment”) with JGB. Pursuant to the Extension Amendment, JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Transaction Agreements with respect to the Events of Default until the earlier to occur of (i) December 1, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the forbearance on exercising such rights and remedies, (i) the conversion price for USD 2,000,000 of outstanding principal amount of the Outstanding Notes was adjusted to a conversion price of USD 0.19 per share (subject to adjustment as provided in the Outstanding Notes), and (ii) an aggregate of USD 500,000 of outstanding principal amount (such amount a part of the USD 2,000,000 principal amount with a conversion price of USD 0.19 per share) and all accrued and unpaid interest on the Outstanding Notes through and including October 31, 2022, was exchanged for 2,631,579 common shares, representing a conversion price of USD 0.19 per share.

 

On November 21, 2022, the Company and JGB entered into a Consent and Amendment Agreement (the “Consent”), whereby the Company agreed to maintain restricted cash equal to the total amount of outstanding principal and accrued interest of USD 6.8 million under the Outstanding Notes, subject to reduction upon conversion or payoff of the notes and agreed to amend the maturity date for each Outstanding Note to December 31, 2023.

7. Shareholders’ equity

Share capital and share premium

As of September 30, 2022, the total outstanding share capital of USD 8.5 million, fully paid, consists of 104,022,489 common shares, excluding 21,844,489 treasury shares. As of December 31, 2021, the total outstanding share capital of USD 6.5 million, fully paid, consisted of 79,955,268 common shares, excluding 5,265,203 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.

During the nine-months ended September 30, 2022, JGB converted USD 5.4 million of the outstanding principal and USD 0.4 million of the accrued and unpaid interest under the Outstanding Notes into 17,246,134 common shares. As the conversions were completed within the terms of the Securities Purchase Agreement, no gain or loss was recognized as a result of these conversions.

In February 2022, the Company announced the issuance of 23,400,000 common shares at par value of 1/13 of a Swiss franc per share. The shares were fully subscribed for by a fully owned subsidiary of the Company and listed on the SIX Swiss Exchange accordingly. The shares were initially held as treasury shares.

During the nine-months period ended September 30, 2022, the Company sold a total of 6,821,086 treasury shares at an average price of USD 0.97 per share, as part of its ATM program with SVB Leerink LLC. These multiple daily transactions generated total gross proceeds of USD 6.6 million. Directly related share issuance costs of USD 0.2 million were recorded as a deduction in equity. The Company’s ATM program with SVB Leerink LLC expired during the three-months ended September 30, 2022.

During the nine-months ended September 30, 2021, the Company sold a total of 13,949,613 treasury shares at an average price of USD 3.51 per share, as part of its expired ATM programs. These multiple daily transactions generated total gross proceeds of USD 49.0 million. Directly related share issuance costs of USD 1.5 million were recorded as a deduction in equity. In addition, during the first quarter of 2021, the Company received proceeds of USD 22.1 million from the exercise of 6,448,240 warrants.

Warrants issued with Securities Purchase Agreement with JGB

On January 28, 2022, in connection with the second tranche under the Securities Purchase Agreement, the Company issued to JGB a warrant to purchase 1,018,716 common shares of the Company. The warrant has an exercise price of USD 1.87 per share. The Company determined the fair value of the warrant on January 28, 2022 using the Black Scholes model by using a risk-free interest rate of 1.78%, an expected term of 3 years, and an implied volatility of 96.5%. The fair value was calculated to be approximately USD 915 thousand on January 28, 2022. This valuation is considered to be Level 2 in the fair value hierarchy. The Company allocated the

10

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

transaction fees, including the USD 1.25 million waiver payment,  associated with the Securities Purchase Agreement based on the debt balance and the fair value of the warrant liability on January 28, 2022. The allocation of the transaction fees associated with the warrant liability was USD 163 thousand and was recorded as a period cost and included in finance expense on the Company’s unaudited condensed consolidated statements of comprehensive loss.

Because the warrants were not exercisable until its affiliated registration statement was declared effective, the Company had to revalue the warrant liability on the date of the effective date of the registration statement which was March 1, 2022. The Company revalued the fair value of the warrants on March 1, 2022 using the Black Scholes model by using a risk-free interest rate of 1.72%, an expected term of 3 years, and an implied volatility of 95.8%. The fair value was calculated to be approximately USD 722 thousand on March 1, 2022. The resulting change in fair values from January 28, 2022 to March 1, 2022 of USD 193 thousand is recorded as a period cost and is included in finance income on the Company’s unaudited condensed consolidated statements of comprehensive loss.

8. Operating income other than revenue

On February 10, 2022, the Company entered into the Theramex License Agreement with Theramex to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia. Under the terms of the Theramex License Agreement, the Company was entitled to receive royalties of a mid-thirties percentage on commercial sales up to EUR 72.75 million in upfront and milestone payments, including EUR 5 million obtained upon signing, up to EUR 13.75 million in development and commercial milestones and up to EUR 54 million in sales-based milestones.

As the Company received marketing authorization for the uterine fibroid indication in the European Union and the UK, the upfront payment of EUR 5.0 million was fully recognized during the nine-months ended September 30, 2022. The gain on the disposal of the asset, net of de-recognition of intangible asset, of USD 4.8 million is recorded in Other operating income on the Company’s unaudited condensed consolidated statements of comprehensive loss.

As a result of termination of the Kissei License Agreement, the Theramex License Agreement was automatically assigned to Kissei and the Company has no further rights or obligations under the agreement. In addition, the Company assigned to Kissei a number of clinical, manufacturing, and scientific contracts related to the development of linzagolix.  These assignments resulted in the transfer of USD 3.7 million in contractual obligations to Kissei, which was recognized as Assignment income on the unaudited condensed consolidated statements of comprehensive loss in the three- and nine-month periods ended September 30, 2022.  

Subsequent to September 30, 2022, the Company assigned substantially all remaining contracts which represented an incremental USD 1.3 million in transferred contractual obligations. See Note 16 for the events occurring after the reporting period for further information.

9. Research and development expenses

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.

10. Accrued expenses

Accrued expenses as of September 30, 2022 and December 31, 2021 consist of the following:

 

in USD ‘000

 

September 30,

2022

 

 

December 31,

2021

 

Accrued research and development expenses

 

835

 

 

 

10,123

 

Accrued compensation-related expenses

 

 

1,318

 

 

 

3,125

 

Accrued other expenses

 

 

200

 

 

 

535

 

Total accrued expenses

 

 

2,353

 

 

 

13,783

 

Accrued research and development expenses decreased as of September 30, 2022 as compared to December 31, 2021 as a result of the Company’s termination of the Linzagolix program and the assignment of contractual obligations to Kissei. The decrease in accrued compensation-related expenses was primarily due to adjustments to the estimated accrued bonus expense as a result of the Company’s corporate restructuring.  

11. Income tax

The Group is subject to income taxes in various jurisdictions, including primarily in Switzerland and the United States.

11

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

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. It is entitled to carry forward any loss incurred for a period of seven years and can offset such losses carried forward against future taxes. In 2015, the Company was granted by the State Council of the Canton of Geneva an exemption of income and capital tax at municipal and cantonal levels for the period from 2013 until 2022. Because of this exemption, and the fact that the Company has incurred net losses since its inception, no income tax expense at the municipal, cantonal or federal levels was recorded in the Company for the three-month and nine-month periods ended September 30, 2022 and 2021. Additionally, due to the uncertainty as to whether it will be able to use its net loss carryforwards for tax purposes in the future, no deferred taxes have been recognized on the balance sheet of the Company as of September 30, 2022 and December 31, 2021.

The Company’s U.S. subsidiary is a service organization for the Group and is therefore subject to taxes on the revenues generated from its services to the Group that are charged based upon the U.S. subsidiary’s cost-plus arrangement with the Group. The profits of the U.S. subsidiary during the three-month and nine-month periods ended September 30, 2022 and 2021 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.

12. Loss per share

As of September 30, 2022 and 2021, the Company has one category of shares, which are common shares. The basic loss per share is calculated by dividing the loss of the period attributable to the common shares by the weighted average number of common shares outstanding during the period as follows:

 

 

 

Three-month period

ended September 30,

 

Nine-month period

ended September 30,

 

 

 

2022

 

2022

 

Net loss attributable to shareholders (in USD ‘000)

 

 

(12,057

)

 

(56,656

)

Weighted average number of common shares outstanding

 

 

95,979,383

 

 

87,318,374

 

Basic and diluted loss per share (in USD)

 

 

(0.13

)

 

(0.65

)

 

 

 

Three-month period

ended September 30,

 

Nine-month period

ended September 30,

 

 

 

2021

 

2021

 

Net income (loss) attributable to shareholders (in USD ‘000)

 

 

819

 

 

(38,329

)

Weighted average number of common shares outstanding

 

 

77,971,008

 

 

74,152,705

 

Basic and diluted income (loss) per share (in USD)

 

 

0.01

 

 

(0.52

)

 

For the three-month and nine-months ended September 30, 2022, 11,282,406 shares issuable upon the exercise of stock-options and 30,044,464 shares issuable upon conversion of notes and/or exercise of warrants issued to JGB pursuant to the Securities Purchase Agreement, which would have an anti-dilutive impact on the calculation of the diluted earnings per share, were excluded from the calculation. For the three-month and nine-month periods ended September 30, 2021, 9,188,388 shares issuable upon the exercise of stock-options and warrants, respectively, which would have an anti-dilutive impact on the calculation of the diluted earnings per share, were excluded from the calculation.  Furthermore, the inclusion of dilutive shares for the three-month period ended September 30, 2021 would have no impact on the determined income (loss) per share.

12

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

13. Leases

On May 10, 2022, the Company entered into a 120-month lease for office space and parking spaces in Geneva, Switzerland. The lease was for approximately 7,513 square feet and 4 parking spaces with the Company planned to gain access to the leased areas on October 1, 2022.  On September 30, 2022, the landlord terminated this lease.

14. Post-employment benefits

In accordance with the mandatory Swiss pension fund law, all Swiss employees of the Company participate in a retirement defined benefit plan. As a result of the workforce reductions described in Note 1, the Company remeasured pension assets and benefit obligations as of September 30, 2022, which resulted in a reduction to its plan benefit obligations of USD 5.4 million. This remeasurement resulted in a non-cash, pre-tax net actuarial gain of $5.4 million for the three-months ended September 30, 2022. This net actuarial gain, which includes a curtailment gain of $0.2 million, is presented in the Unaudited Condensed Consolidated Statements of Comprehensive Loss for the three- and nine- months ended September 30, 2022, as a component of Other comprehensive income.

 

in USD ‘000

 

2022

 

Change in defined benefit obligation

 

 

 

 

Defined benefit obligation at January 1,

 

 

(21,643

)

Current service cost

 

 

(1,299

)

Interest cost

 

 

(51

)

Net benefits paid

 

 

2,424

 

Currency translation effects

 

 

1,158

 

Remeasurements:

 

 

 

 

Curtailment

 

 

9,274

 

Effect of changes in financial assumptions

 

 

4,665

 

Effect in experience assumptions

 

 

840

 

Defined benefit obligation at September 30,

 

 

(4,632

)

 

 

 

 

 

in USD ‘000

 

 

2022

 

Change in plan assets

 

 

 

 

Fair value of plan assets at January 1,

 

 

15,063

 

Interest income

 

 

36

 

Employer contributions

 

 

533

 

Employee contributions

 

 

533

 

Net benefits paid

 

 

(2,424

)

Curtailment

 

 

(9,034

)

Currency translation effects

 

 

(719

)

Remeasurements: return on plan assets (excluding

   interest income)

 

 

76

 

Fair value of plan assets at September 30,

 

 

4,064

 

 

 

 

 

 

 

 

Year ended September 30,

 

in USD ‘000

 

 

2022

 

Components of defined benefit cost

 

 

 

 

Current service cost

 

 

1,299

 

Interest expense on defined benefit obligation

 

 

51

 

Interest income on plan assets

 

 

(36

)

Employee contributions

 

 

(533

)

Impact of plan amendment

 

 

(240

)

Total included in staff costs

 

 

541

 

 

 

 

 

 

13

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

 

 

 

 

 

Year ended September 30,

 

in USD ‘000

 

 

2022

 

Remeasurements recognized in other comprehensive loss

 

 

 

 

Effect of changes in financial assumptions

 

 

4,665

 

Effect in experience assumptions

 

 

840

 

Return on plan assets (excluding interest income)

 

 

76

 

Total remeasurements recognized as other

   comprehensive loss

 

 

5,581

 

Cumulative amount of remeasurements immediately

   recognized in other comprehensive loss

 

 

(1,461

)

 

 

 

 

 

 

 

As of September 30,

 

in USD ‘000

 

2022

 

Amounts recognized in the statement of financial position

 

 

 

 

Defined benefit obligation

 

 

(4,632

)

Fair value of plan assets

 

 

4,064

 

Net liability

 

 

(568

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

in USD ‘000

 

2022

 

Change in defined benefit liability

 

 

 

 

Net defined benefit liability at January 1,

 

 

(6,581

)

Defined benefit cost included in statement of

comprehensive loss

 

 

(541

)

Total remeasurements included in other

comprehensive loss

 

 

5,581

 

Employer contributions

 

 

533

 

Currency translation effects

 

 

440

 

Net defined benefit liability at September 30,

 

 

(568

)

 

The principal actuarial assumptions used were as follows:

 

 

2022

 

Discount rate

 

2.15%

 

Salary increase (including inflation)

 

1.00%

 

Rate of pension increases

 

0.25%

 

Post-employment mortality table

 

LPP 2020 G

 

15. 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)

 

September 30,

2022

 

 

December 31,

2021

 

Switzerland

 

 

5,153

 

 

 

25,385

 

USA

 

 

91

 

 

 

89

 

Total non-current assets

 

 

5,244

 

 

 

25,474

 

14

 


ObsEva SA

Unaudited Condensed Consolidated Financial Statements

 

 

 

The geographical analysis of operating expenses is as follows:

 

 

(in USD ’000)

 

Three-month period

ended September 30,

 

 

Nine-month period

ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Switzerland

 

 

4,553

 

 

 

17,131

 

 

 

50,470

 

 

 

52,016

 

USA

 

 

(212

)

 

 

1,435

 

 

 

734

 

 

 

4,630

 

Total operating expenses

 

 

4,341

 

 

 

18,566

 

 

 

51,204

 

 

 

56,646

 

 

 

16. Events after the reporting period

 

Subsequent to September 30, 2022, following the termination of the Kissei License Agreement, the Company completed the assignment of substantially all of the remaining contracts related to the ongoing development of linzagolix to Kissei with contractual obligations of approximately USD 1.3 million. Refer to Note 1 and Note 8 above for further information on the termination of the Kissei License Agreement.

 

On October 26, 2022, the Company entered into the Extension Amendment with JGB. Refer to Note 6 for further information on the Extension Amendment and the Company’s Securities Purchase Agreement and Outstanding Notes with JGB.

 

On November 22, 2022, the Company announced that it had entered into the IP Acquisition Agreement with XOMA for the sale of all of its rights to ebopiprant, an investigational, orally active, selective prostaglandin F2α (PGF2α) receptor antagonist being evaluated as a potential treatment for preterm labor by reducing inflammation and uterine contractions, for an upfront payment of USD 15 million and future milestone payments of up to approximately USD 98 million upon the achievement of certain development and regulatory milestones and sales milestones under the July 2021 license agreement with Organon. Under the terms of the agreement, the Company sold to XOMA all of its rights, including the assignment of its license agreements with Organon and Merck Serono, and the intellectual property estate of ebopiprant. The Company does not have material remaining performance obligations related to Organon or XOMA for ebopiprant.

 

In conjunction with the execution of the IP Acquisition Agreement, the Company and JGB entered into a Consent and Amendment Agreement (the “Consent”), whereby JGB consented to the Company’s transaction with XOMA, and the Company agreed to maintain restricted cash equal to the total amount of outstanding principal and accrued interest of USD 6.8 million under the outstanding convertible notes held by certain funds and accounts managed by JGB, subject to reduction upon conversion or payoff of the notes, and agreed to amend the maturity date for each Outstanding Note to December 31, 2023.

 

In November 2022, following the execution of the Consent, JGB converted an aggregate of USD 0.2 million of the outstanding principal under the Outstanding Notes into 1,052,632 common shares.

 

On December 1, 2022, the competent court in Geneva, Switzerland granted the Company until December 15, 2022 to provide the Swiss courts with Swiss statutory financial information, at which time the Company intends to withdraw its moratorium proceedings. There is no assurance that the Company will be able to withdraw such moratorium proceedings.

 

 

15

 

Obseva SA

Exhibit 99.2

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

Overview

We are a biopharmaceutical company focused on the development of novel therapies to improve women’s reproductive health. We are advancing a development program focused on improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization.

 

On July 27, 2022, we announced plans to initiate a corporate restructuring and refocus our development and commercialization strategy. We believed these changes were necessary due to the commercial landscape and potential additional capital needed to fund the completion of the linzagolix clinical development program, as the U.S. Food and Drug Administration (“FDA”) notified us of review issues regarding deficiencies in the New Drug Application (“NDA”) for linzagolix for uterine fibroids. These review issues precluded discussion of labeling and post-marketing commitments. As a result, our Board of Directors decided to undertake the following actions in July 2022: (i) give notice of termination of our license agreement with Kissei Pharmaceutical Co., Ltd (“Kissei”) for the development and commercialization of linzagolix (the “Kissei License Agreement”); (ii) commence planned corporate restructuring to resize the Company to be able to meet its license obligations and assess strategic options with respect to pipeline development; and (iii) file an application to the competent court in Geneva, Switzerland for a court-sanctioned moratorium to facilitate the planned restructuring.

 

As a result of the termination of the Kissei License Agreement, our licensing agreement with Theramex HQ UK Limited (“Theramex”) for the commercialization and further development of linzagolix across global markets outside of the U.S., Canada and Asia (the “Theramex License Agreement”), was automatically assigned to Kissei and we have no further rights or obligations under the agreement. In addition, we assigned to Kissei a number of clinical, manufacturing, and scientific contracts related to the development of linzagolix.  As of the issuance date of the unaudited condensed consolidated financial statements, we have assigned substantially all contracts associated with the linzagolix program which represents approximately USD 5.0 million in transferred obligations to Kissei.  

 

On September 12, 2022, following a consultation process with our employees, the Board of Directors authorized the termination of approximately 70% of employees. We expect to substantially complete the terminations during the fourth quarter of 2022, and to achieve savings of approximately $7.6 million on an annual basis, which represents estimated cash compensation related to salary, bonus, and benefits to affected employees.

 

On October 20, 2022, we attended the first hearing with the competent court in Geneva, Switzerland, whereby our request to suspend proceedings through November 30, 2022 was granted.  On December 1, 2022, the competent court in Geneva, Switzerland granted the Company until December 15, 2022 to provide the Swiss courts with Swiss statutory financial information, at which time we intend to withdraw our moratorium proceedings, however there is no assurance that we will be able to withdraw such moratorium proceedings.

 

On October 26, 2022, we entered into an amendment and forbearance extension agreement (the “Extension Amendment”) with certain funds and accounts managed by JGB Management, Inc. (“JGB”) related to our securities purchase agreement (the “Securities Purchase Agreement”), that certain Senior Secured Convertible Note due October 12, 2024, in the aggregate original principal amount of approximately $31.5 million (the “First Tranche Note”), and that certain Senior Secured Convertible Note due January 28, 2025, in the aggregate original principal amount of USD 10.5 million (the “Second Tranche Note”, and together with the First Tranche Note, the “Outstanding Notes”, and together with the Securities Purchase Agreement and ancillary agreements thereto, the “Transaction Agreements”) with JGB. Pursuant to the Extension Amendment, JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Transaction Agreements with respect to the events of default under the Outstanding Notes resulting from our previously announced application to the courts of competent jurisdiction of the Swiss canton of Geneva for a preliminary moratorium (the “Events of Default”) until the earlier to occur of (i) December 1, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the forbearance on exercising such rights and remedies, (i) the conversion price for USD 2.0 million of outstanding principal amount of the Outstanding Notes was adjusted to a conversion price of USD 0.19 per share (subject to adjustment as provided in the Outstanding Notes), and (ii) an aggregate of USD 0.5 million of outstanding principal amount (such amount a part of the USD 2.0 million principal amount with a conversion price of USD 0.19 per share) and all accrued and unpaid interest on the Outstanding Notes through and including October 31, 2022, was exchanged for 2,631,579 common shares, representing a conversion price of USD 0.19 per share.

 

On November 21, 2022, we announced that we had entered into an IP Acquisition Agreement (the “IP Acquisition Agreement”) with XOMA Corporation (“XOMA”) for the sale of all of our rights to ebopiprant, , an investigational, orally active, selective prostaglandin F2α (PGF2α) receptor antagonist being evaluated as a potential treatment for preterm labor by reducing inflammation

1


Obseva SA

and uterine contractions, for an upfront payment of USD 15 million and future milestone payments of up to approximately USD 98 million upon the achievement of certain development and regulatory milestones and sales milestones under the July 2021 license

agreement with Organon. Under the terms of the agreement, we sold to XOMA all of our rights, including the assignment of our July 2021 license agreement with Organon & Co. (“Organon”) and June 2015 license agreement with Merck KGaA, Darmstadt, Germany related to ebopiprant, and the intellectual property estate, to ebopiprant. As consideration for the sale of all of our rights to ebopiprant, we received an upfront cash payment of USD 15 million upon the closing of the transaction, and we are eligible to receive up to approximately USD 98 million upon the achievement of certain development and regulatory milestones and sales milestones under our July 2021 license agreement with Organon for ebopiprant that was sold to XOMA in the transaction. We do not have any remaining performance obligations related to Organon or XOMA for ebopiprant.

 

We expect proceeds from the IP Acquisition Agreement with XOMA to resolve our overindebted position, enabling us to apply to the Swiss courts for the dismissal of moratorium proceedings and regain compliance with The Nasdaq Stock Market (“Nasdaq”) stockholders’ equity requirement for continued listing. On December 1, 2022, the competent court in Geneva, Switzerland granted us until December 15, 2022 to provide the Swiss courts with Swiss statutory financial information, at which time we intend to withdraw our moratorium proceedings, however there is no assurance that we will be able to withdraw such moratorium proceedings.

 

On November 21, 2022, we and JGB entered into a Consent and Amendment Agreement (the “Consent”), whereby JGB consented to our transaction with XOMA, and we agreed to maintain restricted cash equal to the total amount of outstanding principal under the Outstanding Notes, subject to reduction upon conversion or payoff of the notes and agreed to amend the maturity date for each Outstanding Note to December 31, 2023.

 

Our portfolio currently consists of one mid-stage development in-licensed compounds (nolasiban) in development to address areas that we believe present significant unmet medical needs:

 

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

  

In January 2020, we and Hangzhou YuYuan BioScience Technology Co., Ltd., or YuYuan, entered into a sublicense agreement (the “YuYuan Sublicense Agreement”) to develop and commercialize nolasiban, an oral oxytocin receptor antagonist, to improve clinical pregnancy and live birth rates in women undergoing in-vitro fertilization, or IVF, in the People's Republic of China. Under the terms of the agreement, YuYuan has the exclusive rights to develop and commercialize nolasiban in China and will fund all development and registration activities in China. On October 13, 2022, we announced that Yuyuan’s IND application for a Phase 1 trial of nolasiban was approved by the Center for Drug Evaluation at the Chinese National Medical Products Administration. Yuyuan plans to initiate a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of nolasiban in healthy adult female subjects. We retain all rights to the product outside of China and have agreed to collaborate with YuYuan on its global development. Our development and commercialization partnership with YuYuan continues with steering committee meetings to define the development plan for nolasiban in China for women undergoing embryo transfer following IVF.

 

We were founded in November 2012 and our operations to date have included organizing and staffing our company, raising capital, in-licensing rights to our portfolio 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 and debt. From inception through September 30, 2022, we raised an aggregate of USD 447.7 million of net proceeds from the sale of equity securities and USD 64.5 million from the issuance of debt instruments, of which USD 56.0 million has been repaid.

 

We have never been profitable and have incurred significant net losses in each period since our inception. Our net losses were USD 56.7 million and USD 38.3 million for the nine-months ended September 30, 2022 and September 30, 2021, respectively. As of September 30, 2022, we had accumulated losses of USD 518.7 million, out of which USD 30.6 million were offset with share premium. We expect to continue to incur operating losses for the foreseeable future. We used USD 31.1 million and USD 57.5 million of cash in operations in the nine-months ended September 30, 2022 and September 30, 2021, respectively.

We anticipate that our expenses will remain substantial in connection with our ongoing activities as we continue to invest in the clinical development of nolasiban and any clinical trials, nonclinical studies and pre-commercial activities that we may conduct for nolasiban. We will need substantial additional funding to support our operating activities as we advance our product candidate through clinical development, seek regulatory approval and prepare for and invest in future commercialization of this candidate, 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 development and commercialization of our product candidate, including through collaborations with third parties.

2


Obseva SA

We have no manufacturing facilities, and all of our product manufacturing is contracted out to third parties. We currently utilize third-party contract research organizations, or CROs, to carry out our clinical development and trials.

COVID-19 and Geopolitical Events Business Update

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 ongoing COVID-19 situation and will evolve our plans and policies as needed going forward. If the COVID-19 pandemic continues to persist for an extended period 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.

The full extent to which the COVID-19 pandemic will directly or indirectly impact our business and operations, or the business and operations of our strategic partners, will depend on future developments that are highly uncertain, including the duration and spread of the pandemic, and the actions taken to contain it, such as the impact and effectiveness of any current or future governmental measures implemented in response thereto, or new information that may emerge concerning COVID-19.

In addition, the U.S. government and other nations have imposed significant restrictions on most companies’ ability to do business in Russia as a result of the ongoing military conflict between Russia and Ukraine. It is not possible to predict the broader or longer-term consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, security conditions, currency exchange rates and financial markets. Such geopolitical instability and uncertainty could have a negative impact on our business, ability to develop our product candidates, our supply chain or our collaborators.

Strategic Licensing Agreements

Linzagolix

Kissei

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

In July 2022, in connection with our plans to initiate a corporate restructuring and refocus our development and commercialization strategy, the Kissei License Agreement was terminated.

Theramex

In February 2022, we entered into the Theramex License Agreement with Theramex for the commercialization and further development of linzagolix across global markets outside of the U.S., Canada and Asia.   As a result of termination of the Kissei License Agreement in July 2022, the Theramex License Agreement was automatically assigned to Kissei and we have no further rights or obligations under the agreement.

Ebopiprant

Merck Serono

In June 2015, we entered into the 2015 license agreement with Merck Serono (the “Merck Serono License Agreement”), 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 ebopiprant.

As a result of the IP Acquisition Agreement with XOMA, the Merck Serono License Agreement was automatically assigned to XOMA and we have no further rights or obligations under the agreement.

Organon

In July 2021, we entered into an agreement with Organon (the “Organon License Agreement”), pursuant to which we granted to Organon exclusive rights to develop, use, register, import, export, manufacture, market, promote, distribute, offer for sale and commercialize ebopiprant worldwide. In consideration for entering into the agreement, Organon has agreed to make up to USD 500

3


Obseva SA

million in upfront and milestone payments, including USD 25 million that was paid at signing, up to USD 90 million in development and regulatory milestones and up to USD 385 million in sales-based milestones. In addition, Organon has agreed to pay us tiered double-digit royalties on annual net sales of all products, subject to specified reductions, until, on a country-by-country and product-by-product basis, the latest of (i) the expiration of the last valid claim covering such product in such country, (ii) expiration of regulatory exclusivity for such product in such country, and (iii) ten years from the first commercial sale of such product in such country.

As a result of the IP Acquisition Agreement with XOMA, the Organon License Agreement was automatically assigned to XOMA. As consideration for the sale of all of our rights to ebopiprant, we received from XOMA an upfront cash payment of USD 15 million upon the closing of the transaction, and we are eligible to receive up to approximately USD 98 million upon the achievement of certain development and regulatory milestones and sales milestones under the Organon License Agreement. We have no further rights or obligations under the agreement.

Nolasiban

Ares Trading

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 USD 4.9 million based on an exchange rate of USD 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.

YuYuan

In January 2020, we entered into the YuYuan Sublicense Agreement with YuYan, 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 YuYuan Sublicense Agreement, YuYuan has agreed to make aggregate milestone payments of up to USD 17.0 million upon the achievement of specified development, regulatory and first sales milestones and aggregate milestone payments of up to USD 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 digits, 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.

Components of Results of Operations

Operating income other than 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 our product candidate.

Operating income other than revenue consists primarily of gains on disposal of intangible assets and the assignment of contractual obligations.

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.

4


Obseva SA

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.

 

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 candidate through clinical trials and regulatory submissions. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidate. This is due to the numerous risks and uncertainties associated with developing such product candidate, 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 results of our clinical trials; and

 

regulatory requirements in support of potential approvals.

In addition, the probability of success for our product candidate 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 our product candidate would significantly change the costs, timing and viability associated with the development of that product candidate.

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 commercialization readiness costs, 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 decrease in the future as a result of our corporate restructuring. We also anticipate that we will continue 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 Expense, Net

Finance expense, net, consists of foreign exchange loss and gain, interest expense associated with our lease liabilities and debt instruments, and the change in estimated cash flows from financial liabilities. We anticipate that our finance expense, net will decrease in the future as the principal balance on the outstanding convertible notes held by JGB has decreased substantially in 2022. See Liquidity and Capital Resources – Sources of Funds – Securities Purchase Agreement below for further information on the Securities Purchase Agreement and outstanding convertible notes held by JGB.

Loss on event of default

Loss on event of default represents the charge associated with the certain events of default under the outstanding convertible notes with JGB. See Liquidity and Capital Resources – Sources of Funds – Securities Purchase Agreement below for further information on the Securities Purchase Agreement and outstanding convertible notes held by JGB.

Gain on debt extinguishment

Gain on debt extinguishment represents the benefit associated with the early retirement of the outstanding convertible notes under the Securities Purchase Agreement with JGB. See Liquidity and Capital Resources – Sources of Funds – Securities Purchase Agreement below for further information on the Securities Purchase Agreement and outstanding convertible notes held by JGB.

Taxation

5


Obseva SA

We are subject to corporate taxation in Switzerland, Ireland, Netherlands 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, 2021, we had tax loss carryforwards totaling USD 422.1 million. We do not believe it is probable that we will generate sufficient profits to avail ourselves of these tax loss carryforwards.

Our Swiss, Irish and Dutch subsidiaries had no activity in 2022 or 2021. Our US subsidiary, as a service organization to the group under cost plus arrangement, was the only entity to generate income tax expenses during 2022 and 2021.

Analysis of Results of Operations

Comparison of the three-month periods ended September 30, 2022 and September 30, 2021

Operating income other than revenue

Operating income other than revenue decreased by USD 16.4 million in the three-month period ended September 30, 2022 compared to the three-month period ended September 30, 2021, as USD 3.7 million in assignment income was recognized following the assignment of linzagolix contractual obligations to Kissei in the current period as compared to the net proceeds of USD 20.1 million received from the Organon License Agreement in the prior period.

Operating Expenses

Research and Development Expenses

 

 

 

Three-month period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Directly allocable research and development expenses

 

$

(165

)

 

$

(7,998

)

 

$

7,833

 

Unallocated expenses

 

 

 

 

 

 

 

 

 

 

 

 

Staff costs

 

 

(52

)

 

 

(2,724

)

 

 

2,672

 

Other research and development costs

 

 

(475

)

 

 

(809

)

 

 

334

 

Total research and development expenses

 

$

(692

)

 

$

(11,531

)

 

$

10,839

 

 

Research and development expenses decreased by USD 10.8 million in the three-month period ended September 30, 2022 compared to the three-month period ended September 30, 2021, primarily due to the transfer of contractual obligations on the linzagolix program following the termination of the Kissei License Agreement in July 2022 and related vendor contracts, as well as lower salaries, bonus estimates, and share based compensation expense resulting from our termination of approximately 70% of our employees as announced in September 2022 and other actions related to our corporate restructuring.  

General and Administrative Expenses

 

 

 

Three-month period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Staff costs

 

$

(1,442

)

 

$

(2,345

)

 

$

903

 

Professional fees

 

 

(1,259

)

 

 

(3,810

)

 

 

2,551

 

Other general and administrative costs

 

 

(948

)

 

 

(880

)

 

 

(68

)

Total general and administrative expenses

 

$

(3,649

)

 

$

(7,035

)

 

$

3,386

 

 

General and administrative expenses in the three-month period ended September 30, 2022 decreased by USD 3.4 million compared to the three-month period ended September 30, 2021, primarily due to decreased professional fees resulting from the reduction of consulting services following the termination of the Kissei License Agreement, as well as decreased salary and share based compensation expenses resulting from our termination of approximately 70% of our employees as announced in September 2022 and other actions related to our corporate restructuring.

6


Obseva SA

Finance Expense, Net

 

 

Three-month period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

(unaudited)

 

Loss on event of default

 

$

(17,586

)

 

$

 

 

$

(17,586

)

Gain on debt extinguishment

 

 

5,713

 

 

 

 

 

 

5,713

 

Interest expense

 

 

(631

)

 

 

(703

)

 

 

72

 

Foreign exchange gain / (loss)

 

 

52

 

 

 

10

 

 

 

42

 

Other finance income

 

 

970

 

 

 

 

 

 

970

 

Finance expense, net

 

$

(11,482

)

 

$

(693

)

 

$

(10,789

)

 

Finance expense, net in the three-month period ended September 30, 2022 increased by USD 10.8 million compared to the three-month period ended September 30, 2021, primarily due to a loss on the Event of Default under the Outstanding Notes, partially offset by a gain recognized on the extinguishment of debt resulting from our JGB Amendment and Forbearance Agreement with JGB entered into in July 2022 (the "Amendment and Forbearance Agreement”) related to the Securities Purchase Agreement and the Outstanding Notes, and other finance income recognized upon the release of a portion of the prepayment penalty upon conversion of a portion of the outstanding principal balance under the Outstanding Notes during the three months ended September 30, 2022.

 

Comparison of the nine-month periods ended September 30, 2022 and September 30, 2021

Operating income other than revenue

Operating income other than revenue decreased in the nine-month period ended September 30, 2022 by USD 11.5 million as compared to the nine-month period ended September 30, 2021 due to the difference in the assignment income recognized during the nine months ended September 30, 2022 following the termination of the Kissei License Agreement and assignment of linzagolix contractual obligations related to the linzagolix program to Kissei, compared to the aggregate upfront proceeds of USD 20.1 million received pursuant to the Theramex License Agreement and the Organon License Agreement, net of the derecognition of the related intangible assets, during the nine-month period ended September 30, 2021.

 

Operating Expenses

Research and Development Expenses

 

 

 

Nine months period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Directly allocable research and development expenses

 

$

(5,909

)

 

$

(30,610

)

 

$

24,701

 

Unallocated expenses

 

 

 

 

 

 

 

 

 

 

 

 

Staff costs

 

 

(5,192

)

 

 

(8,762

)

 

 

3,570

 

Other research and development costs

 

 

(2,310

)

 

 

(2,160

)

 

 

(150

)

Total research and development expenses

 

$

(13,411

)

 

$

(41,532

)

 

$

28,121

 

 

Research and development expenses decreased by USD 28.1 million in the nine-month period ended September 30, 2022 compared to the nine-month period ended September 30, 2021, primarily due lower expenditures in our linzagolix program resulting from the termination of the Kissei License Agreement and assignment of linzagolix contractual obligations related to the linzagolix program to Kissei, and lower salary, bonus, and share based compensation expenses as a result of our termination of approximately 70% of our employees as announced in September 2022 and other actions related to our corporate restructuring.  

7


Obseva SA

General and Administrative Expenses

 

 

 

Nine months period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Staff costs

 

$

(6,443

)

 

$

(6,140

)

 

$

(303

)

Professional fees

 

 

(8,773

)

 

 

(6,317

)

 

 

(2,456

)

Other general and administrative costs

 

 

(3,177

)

 

 

(2,657

)

 

 

(520

)

Total general and administrative expenses

 

$

(18,393

)

 

$

(15,114

)

 

$

(3,279

)

 

General and administrative expenses in the nine-month period ended September 30, 2022 increased by USD 3.3 million compared to the nine-month period ended September 30, 2021, primarily due to increased professional fees resulting from legal fees incurred for our restructuring, licensing, and debt transactions entered into during the nine months ended September 30, 2022.

Impairment expense

 

 

Nine months period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

(unaudited)

 

Impairment of intangible asset

 

$

(19,400

)

 

 

 

 

$

(19,400

)

 

Impairment expense in the nine-month period ended September 30, 2022 increased by USD 19.4 million compared to the nine-month period ended September 30, 2021, due to the review issues communicated by the FDA regarding deficiencies in the NDA for linzagolix for uterine fibroids in June 2022. We concluded that the full remaining net book value of the asset was impaired as of June 30, 2022 and recorded a charge of USD 19.4 million.

 

Finance Expense, Net

 

 

Nine months period

ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

(unaudited)

 

Loss on event of default

 

$

(17,586

)

 

$

 

 

$

(17,586

)

Gain on debt extinguishment

 

 

5,713

 

 

 

 

 

 

5,713

 

Interest expense

 

 

(3,571

)

 

 

(2,049

)

 

 

(1,522

)

Foreign exchange gain / (loss)

 

 

514

 

 

 

329

 

 

 

185

 

Other finance income

 

 

970

 

 

 

 

 

 

970

 

Finance expense, net

 

$

(13,960

)

 

$

(1,720

)

 

$

(12,240

)

 

Finance expense, net in the nine-month period ended September 30, 2022 increased by USD 12.2 million compared to the nine-month period ended September 30, 2021, primarily due to the loss on the Event of Default under the outstanding convertible notes held by JGB, partially offset by the gain recognized on the extinguishment of debt resulting from the Amendment and Forbearance Agreement and other finance income recognized upon the release of a portion of the prepayment penalty upon conversion of a portion of the outstanding principal balance under the Outstanding Notes during the nine months ended September 30, 2022, as well as incremental interest expense associated with our Outstanding Notes and our lease liabilities.

Liquidity and Capital Resources

Sources of Funds

As of September 30, 2022, we had USD 9.7 million in cash and cash equivalents.

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, debt financing and license of our product candidates. From inception through September 30, 2022, we raised an aggregate of USD 447.7 million of net proceeds from the sale of equity securities, through public and private offerings and our at-the-market programs. As of September 30, 2022, we have net borrowings of USD 8.9 million under our Securities Purchase Agreement with JGB, a portion of which was used to fully retire our prior credit facility, or the Oxford Credit Facility, with Oxford Finance LLC in October 2021. In July 2021, we received USD 25.0 million from Organon in connection

8


Obseva SA

with the licensing agreement for ebopiprant. In February 2022, we received EUR 5.0 million from Theramex in connection with the Theramax License Agreement. As of September 30, 2022, we recognized USD 3.7 million through the assignment of contractual obligations related to our linzagolix program to Kissei, following the termination of the Kissei License Agreement in July 2022.

Securities Purchase Agreement

On October 12, 2021, we entered into the Securities Purchase Agreement with JGB, which is structured to provide up to USD 135 million in borrowing capacity, available in nine tranches. We received gross proceeds of USD 30 million at closing and used the proceeds to repay all amounts outstanding under the Oxford Credit Facility. On January 28, 2022, we entered into an amendment agreement and an amended and restated securities purchase agreement (the “Amendment Agreements”), with JGB regarding the second tranche under the Securities Purchase Agreement. In connection with the Amendment Agreements, we received proceeds of USD 10.5 million (USD 975 thousand of original issue discount) in the second tranche, funded on January 28, 2022, and the conversion price for the note issued in the second tranche was adjusted to a price of USD 1.66 per common share. In addition, as adjusted pursuant to the Amendment Agreements, we issued a warrant to purchase 1,018,716 of our common shares at an exercise price of USD 1.87 per share.

On July 27, 2022, our announced application to the courts of competent jurisdiction of the Swiss canton of Geneva for a preliminary moratorium resulted in the Events of Default under the Outstanding Notes (the “Events of Default”).

On July 31, 2022, we entered into the Amendment and Forbearance Agreement with JGB, pursuant to which we and JGB agreed to apply USD 31.0 million (the “Account Balances”) previously held in a control account in accordance with the Transaction Agreements against the Outstanding Notes on a pro rata basis, and JGB waived any application of the 25% prepayment premium permitted under the Outstanding Notes with respect to the Account Balances through the forbearance period. In addition, JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Transaction Agreements with respect to the Events of Default until the earlier to occur of (i) October 29, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the waiver of the prepayment penalty and forbearance on exercising such rights and remedies, USD 1.5 million was added to the outstanding principal balance under the Outstanding Notes, resulting in an aggregate outstanding balance of approximately USD 11.0 million under the Outstanding Notes, the conversion price of the Outstanding Notes was adjusted to a conversion price of USD 0.26 per share (subject to adjustment as provided in the Outstanding Notes) and our right to mandatory conversion of any convertible notes issued pursuant to the Securities Purchase Agreement, including the Outstanding Notes, was terminated. In addition, JGB is no longer obligated to fund any future mandatory or optional tranche closing under the Securities Purchase Agreement.

Following the execution of the amendment, JGB converted USD 3.8 million of the outstanding principal balance and USD 0.4 million of accrued and unpaid interest under the Outstanding Notes into 16,346,135 common shares.  

On October 26, 2022, we entered into the Extension Amendment with JGB, pursuant to which JGB agreed to refrain and forebear from exercising or pursuing any rights or remedies under the Transaction Agreements with respect to the Events of Default until the earlier to occur of (i) December 1, 2022, (ii) the occurrence of any event of default under the Transaction Agreements (other than the Events of Default), and (iii) the date upon which a preliminary moratorium has been granted by the courts of competent jurisdiction of the Swiss canton of Geneva. In exchange for the forbearance on exercising such rights and remedies, (i) the conversion price for USD 2,000,000 of outstanding principal amount of the Outstanding Notes was adjusted to a conversion price of USD 0.19 per share (subject to adjustment as provided in the Outstanding Notes), and (ii) an aggregate of USD 500,000 of outstanding principal amount (such amount a part of the USD 2,000,000 principal amount with a conversion price of USD 0.19 per share) and all accrued and unpaid interest on the Outstanding Notes through and including October 31, 2022, was exchanged for 2,631,579 common shares, representing a conversion price of USD 0.19 per share.

On November 21, 2022, we and JGB entered into the “Consent, whereby JGB consented to our transaction with XOMA, and we agreed to maintain restricted cash equal to the total amount of outstanding principal and accrued interest of USD 6.8 million under the Outstanding Notes, subject to reduction upon conversion or payoff of the notes and agreed to amend the maturity date for each Outstanding Note to December 31, 2023.

ATM Program

During the nine-months period ended September 30, 2022, we sold a total of 6,821,086 treasury shares at an average price of USD 1.39 per share, as part of our ATM program with SVB Leerink LLC. These multiple daily transactions generated total gross proceeds of USD 6.6 million. Directly related share issuance costs of USD 0.2 million were recorded as a deduction in equity. During the three months ended September 30, 2022, our ATM program expired.

Material Cash Requirements

9


Obseva SA

Our primary uses of cash are to fund 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. As of September 30, 2022, other than our Securities Purchase Agreement with JGB, we have no other ongoing material financing commitments, such as lines of credits or guarantees.

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 may be unable to continue operations or we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

We have incurred recurring losses since inception, including net losses of USD 56.7 million for the nine-month period ended September 30, 2022. As of September 30, 2022, we had accumulated losses of USD 518.7 million, out of which USD 30.6 million were offset with share premium. We expect to continue to generate operating losses for the foreseeable future. As of September 30, 2022, we had cash and cash equivalents of USD 9.7 million. We have prepared our unaudited condensed consolidated financial statements assuming that we will continue as a going concern which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. To date, we have funded our operations through equity and debt offerings and through payments from licensors. We believe that our current cash and cash equivalents, after taking into account the upfront payment of USD 15 million from the IP Acquisition Agreement with XOMA and our corporate restructuring actions, including a mass dismissal process pursuant to Swiss law, are only sufficient to fund our operating expenses through the fourth quarter of 2023 and this raises substantial doubt about our ability to continue as a going concern. These factors individually and collectively indicate that a material uncertainty exists that may cast significant doubt about our ability to continue as a going concern within one year from the date of the issuance of the consolidated financial statements. Our future viability is dependent on our ability to raise additional capital to finance our future operations and implement a successful corporate reorganization. We may raise funds through equity or debt offerings. The sale of additional equity may dilute existing shareholders and newly issued shares may contain senior rights and preferences compared to currently outstanding common shares. Issued debt securities may contain covenants and limit our ability to pay dividends or make other distributions to shareholders. We may receive future milestone payments from licensors or pursuant to the IP Acquisition Agreement, but that is dependent on achieving certain regulatory or commercial milestones that may never happen. We may seek additional funding through public or private financings, debt financing or collaboration agreements. We may also be subject to certain restrictions and limitations on raising funds if we are unable to withdraw our pending moratorium proceedings and the court-sanctioned moratorium is granted by the competent court in Geneva, Switzerland or if do not regain compliance with the continued listing standards of Nasdaq. The inability to obtain funding, as and when needed, would have a negative impact on our operations, financial condition and ability to pursue our business strategies. If we are unable to obtain the required funding to run our operations and to develop and commercialize our product candidates, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Management continues to explore all potential options to obtain additional funding. However, there is no assurance that we will be successful in raising funds, or obtain sufficient funding on terms acceptable to us, or if at all, which could have a material adverse effect on our business, results of operations and financial conditions. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we currently expect.

Our future material cash requirements will depend on many factors, including:

 

actions taken in connection with or as a result of our corporate restructuring to resize the Company and be able to meet other license obligations and assess strategic options with respect to pipeline development;

 

our ability to withdraw our pending moratorium proceedings and the court-sanctioned moratorium is granted by the competent court in Geneva, Switzerland;

 

our ability to regain compliance with the continued listing standards of Nasdaq;

 

the scope, progress, results and costs of nonclinical studies and clinical trials for our product candidate nolasiban;

 

the cost and timing of ongoing and planned manufacturing activities including active pharmaceutical ingredient and drug product pharmaceutical development and clinical trial supplies production for 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 candidate;

 

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

 

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

10


Obseva SA

 

 

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, product candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from royalties and milestone payments. We may be unable to derive revenue from sales of products, on a timely basis or 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, 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.

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.

We may be subject to certain restrictions and limitations on raising funds if we are unable to withdraw our pending moratorium proceedings and the court-sanctioned moratorium is granted by the competent court in Geneva, Switzerland or if we do not regain compliance with the continued listing standards of Nasdaq. If we are unable to raise additional funds through equity or debt financings when needed, we may be unable to continue operations or 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 nine-month periods ended September 30, 2022 and September 30, 2021:

 

 

 

Nine months period

ended September 30,

 

 

 

2022

 

 

2021

 

 

 

(in thousands)

 

 

 

(unaudited)

 

Cash and cash equivalents at beginning of period

 

$

54,734

 

 

$

31,183

 

Net cash used in operating activities

 

 

(31,067

)

 

 

(57,547

)

Net cash from investing activities

 

 

5,676

 

 

 

22,186

 

Net cash (used in) from financing activities

 

 

(19,317

)

 

 

67,250

 

Effect of exchange rates

 

 

(342

)

 

 

(188

)

Cash and cash equivalents at end of period

 

$

9,684

 

 

$

62,884

 

 

Operating Activities

Net cash used in operating activities was USD 31.1 million for the nine-month period ended September 30, 2022 compared to USD 57.5 million for the nine-month period ended September 30, 2021.  The decrease in our cash used in operating activities of USD 26.5 million is due to an increase in net loss before taxes of USD 18.5 million, offset by changes in net working capital of USD 4.2 million and a decrease in non-cash items of USD 40.8 million.  

Investing Activities

Net cash from investing activities was USD 5.7 million for the nine-month period ended September 30, 2022, compared to net cash from investing activities of USD 22.2 million for the nine-month period ended September 30, 2021.  The decrease in net cash from investing activities of USD 16.5 million is due primarily to the difference in a gain on debt extinguishment recognized during the nine-month period ended September 30, 2022 compared to the aggregate upfront proceeds received during the nine-month period ended September 30, 2021 from the Theramex License Agreement and Organon License Agreement, net of the derecognition of the related intangible assets.

11


Obseva SA

Financing Activities

Net cash used in financing activities was USD 19.3 million for the nine-month period ended September 30, 2022 compared to net cash provided by financing activities of USD 67.3 million for the nine-month period ended September 30, 2021. The decrease in net cash from financing activities of USD 84.0 million is primarily due to the USD 31.0 million prepayment of convertible debt, a decrease in proceeds from the issuance of shares of USD 42.5 million from our expired ATM programs (USD 6.6 million in proceeds received in the nine-month period ending September 30, 2022 compared to the USD 49.0 million in proceeds received in the nine-month period ending September 30, 2021) and a decrease in the proceeds from the exercise of warrants of USD 22.1 million, offset by USD 8.6 million in proceeds from the issuance of convertible debt under the Securities Purchase Agreement with JGB.

Main Contractual Obligations and Commitments

We enter into contracts in the normal course of business with clinical research organizations 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.

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 (IASB).

As described below, the accounting policies used in the preparation and presentation of these unaudited condensed consolidated financial statements are consistent with those used in the consolidated financial statements for the year ended December 31, 2021, which should be read in conjunction with the unaudited condensed consolidated financial statements and management’s discussion and analysis as they provide an update of previously reported information.

The preparation of our unaudited condensed consolidated 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 International Financial Reporting Standards (IFRS) 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, 2022 had no material impact on our financial position.

JOBS Act Exemption

In April 2012, the U.S. 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 U.S. 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 USD 1.235 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 (SEC), which means the market value of our common shares that is held by non-affiliates exceeds USD 700 million as of the prior June 30, and (2) the date on which we have issued more than USD 1.0 billion in non-convertible debt during the prior three-year period. We will be an “emerging growth company” until December 31, 2022.

U.S. Domestic Filer Status

12


Obseva SA

We are currently a foreign private issuer and therefore, are not required to comply with all of the periodic disclosure and current reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) applicable to U.S. domestic issuers. In order to maintain our current status as a foreign private issuer, either (1) a majority of our common shares must be either directly or indirectly owned of record by non-residents of the United States or (2)(a) a majority of our executive officers or directors may not be United States citizens or residents, (b) more than 50% of our assets cannot be located in the United States and (c) our business must be administered principally outside the United States. While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually as of the end of the most recently completed second fiscal quarter. As of June 30, 2022, the last business day of our second fiscal quarter, more than 50% of our securities were held by U.S. residents and more than 50% of our board and executive team were residents of the United States. Therefore, we have determined that we will lose this status beginning in 2023, and will be required to comply with Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers, including the filing of financial statements in accordance with United States Generally Accepted Accounting Principles.

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 our Annual Report on Form 20-F for the year ended December 31, 2021, or the Annual Report, filed with the U.S. Securities and Exchange Commission, or the SEC, on March 10, 2022, and the Risk Factors disclosed in our Report on Form 6-K filed with the SEC on May 17, 2022 and August 17, 2022, and our Report on Form 6-K filed with the SEC on December 1, 2022, to which this Exhibit is attached, and other filings we make with the SEC. These risks and uncertainties include factors relating to:

 

the outcome and potential impact of our filing to the competent court in Geneva, Switzerland for a court-sanctioned moratorium, including with respect to our agreements with third parties, including the Securities Purchase Agreement with JGB, of our mass dismissal process, and in our ability to successfully restructure our operations and refocus our development and commercialization strategy;

 

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

 

our or our partners’ ability to obtain and maintain regulatory approval of our product candidate in any of the indications for which we or our partners plan to develop them, and any related restrictions, limitations or warnings in the label of an approved product;

 

our ability to continue as a going concern and to obtain funding for our operations, and the terms on which we are able to raise that additional capital;

 

the ability of our common shares to continue being listed on the Nasdaq Global Select Market based on compliance;

 

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 or that we may receive under our license agreements;

 

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

13


Obseva SA

 

 

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;

 

our ability to support our operations as a public company upon losing emerging growth company status and becoming a domestic filer effective as of January 1, 2023;

 

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 or other geopolitical events;

 

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. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. 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, except as required by law.

14

Exhibit 99.3

 

ObsEva Announces Third Quarter 2022 Financial Results and Provides a Business Update

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

GENEVA, Switzerland – December 1, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN) (“ObsEva” or the “Company”), a biopharmaceutical company developing novel therapies for women’s health, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.

“We are pleased to have neared the completion of a restructuring process that allowed us to generate an important influx of capital, positioned us to resolve our over-indebted position, and streamlined our cost-structure,” said Brian O’Callaghan, CEO of ObsEva. “We are now well-positioned to support the development of nolasiban, a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization, and we look forward to the initiation of our partner’s (Yuyuan BioScience) clinical trial following the recent approval of their IND in China.”

Recent Business Highlights:

 

 

IND Acceptance for Nolasiban in China: Nolasiban is a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization. ObsEva retains worldwide, exclusive, commercial rights for nolasiban, except for the People’s Republic of China where it has been sub-licensed to Yuyuan BioScience (“Yuyuan”). Yuyuan’s IND application for a Phase 1 clinical trial of nolasiban has been accepted by the Center for Drug Evaluation at the Chinese National Medical Products Administration. Yuyuan plans to initiate a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of nolasiban in healthy adult female subjects.

 

Sale of Ebopiprant Rights to XOMA: On November 22, 2022, ObsEva announced the sale of the Ebopiprant royalty and milestone license to XOMA Corporation (“XOMA”) for an upfront payment of $15 million and future milestone payments of up to approximately $98 million. Sale proceeds have positioned ObsEva to resolve its over-indebtedness position and ObsEva has been granted until December 15, 2022 to provide Swiss statutory financial information to the Swiss courts, at which time it intends to withdraw its previously announced moratorium proceedings. The Ebopiprant sale proceeds are also anticipated to position ObsEva to regain compliance with the minimum stockholders’ equity requirement for continued listing of the Company’s common

1

 


 

shares on The Nasdaq Stock Market (“Nasdaq”). Following the transaction, ObsEva now expects it has cash runway through Q4 2023, providing strategic optionality.

 

Assignment of linzagolix contracts to Kissei: Transition of the linzagolix program to Kissei Pharmaceutical Co., Ltd. (“Kissei”) is complete following the assignment of clinical, manufacturing, and scientific contracts related to the development of linzagolix. These assignments represent savings of approximately $16.0 million in contractual commitments, including $5.0 million of accounts payable and accrued expenses recognized as assignment income during Q3 and expected to be recognized as assignment income during Q4 2022.

 

Reduction-in-force: Termination of approximately 70% of employees has been substantially completed, with expected savings of approximately $7.6 million on an annual basis, which represents estimated cash compensation related to salary, bonus, and benefits to affected employees.

 

Debt restructuring: The Company restructured its debt owed to certain funds and accounts managed by JGB Management, Inc. (“JGB”) via the early retirement of debt and certain reductions in the conversion price such that approximately $6.5 million of convertible notes are currently outstanding as of December 1, 2022, compared with approximately $41 million outstanding at June 30, 2022.

 

Financial Results for the Third Quarter Ended September 30, 2022

 

ObsEva had cash and cash equivalents of $9.7 million at September 30, 2022 compared to $54.7 million at December 31, 2021. Subsequent to September 30, 2022 the Company received $15 million from XOMA related to the sale of all rights related to Ebopiprant, and estimates that it has approximately $16.0 million of cash, restricted cash, and cash equivalents on hand as of November 30, 2022 following the payment of substantially all accounts payable currently due.

 

Operating income other than revenue was $3.7 million for the quarter ended September 30, 2022 compared to $20.1 million in the prior year period. The $3.7 million in assignment income was recognized following the assignment of linzagolix contractual obligations to Kissei in the current period as compared to the net proceeds of $20.1 million received from the Organon License Agreement in the prior period. Subsequent to September 30, 2022, the Company recognized an additional $1.3 million in assignment income from the further assignment of linzagolix contracts.

 

Research and development expenses were approximately $0.7 million for the quarter ended September 30, 2022, compared to approximately $11.5 million in the prior year period, representing a decrease of approximately $10.8 million. The decrease was primarily due to transfer of development activities for the linzagolix program following the termination of the Kissei license arrangement and related vendor contracts, as well as lower salaries, bonus estimates, and share based compensation expense resulting from the termination of approximately 70% of our employees as announced in September 2022 and other actions related to the planned corporate restructuring.  

2

 


 

General and administrative expenses were $3.6 million for the quarter ended September 30, 2022 compared to $7.0 million in the prior year period, a decrease of $3.4 million. The decrease was primarily due to decreased professional fees resulting from the reduction of consulting services following the termination of the Kissei License Agreement, as well as decreased salary and share based compensation expenses resulting from the corporate restructuring.

 

Finance expense, net was approximately $11.5 million for the quarter ended September 30, 2022, compared to $0.7 million for the prior year period. The decrease was primarily due to a loss on the event of default under the current outstanding notes, partially offset by a gain recognized on the extinguishment of debt resulting from the Amendment and Forbearance Agreement with JGB executed in July 2022 and other finance income recognized upon the release of a portion of the prepayment penalty upon conversion of a portion of the outstanding principal balance under the current outstanding notes during the three months ended September 30, 2022.

 

Net loss for the quarter ended September 30, 2022 was approximately $12.1 million, or $0.13 net loss per share, compared to net income of $0.8 million in the prior year period, or $0.01 net income per share.

 

The third quarter 2022 financial statements can be accessed in the financial reports section here of the Company’s website, or directly here.

About Nolasiban

Nolasiban is a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization. ObsEva retains worldwide, exclusive, commercial rights for nolasiban, except for the People’s Republic of China where it has been sub-licensed to Yuyuan. Under the sublicense agreement with Yuyuan for nolasiban, ObsEva is entitled to receive aggregate milestone payments of up to $17 million upon the achievement of specified development, regulatory, and first sales milestones, and aggregate milestone payments of up to $115 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 digits.

About ObsEva

ObsEva is a biopharmaceutical company developing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a development program focused on improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

Cautionary Note Regarding Forward-Looking Statements

3

 


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 “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”, “objective”, “plan”, “potential”, “predict”, “should”, “will”, “would”, or the negative of these and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include statements regarding the status of ObsEva’s restructuring process, expected benefits from the sale of rights to ebopiprant to XOMA, ObsEva’s cash runway and indebtedness position, the ability of ObsEva to support the development of nolasiban, the receipt of potential milestone payments under the agreement with XOMA,  the receipt of potential milestone and royalty payments under the sublicense agreement with YuYuan,  Yuyuan’s plans to initiate a Phase 1 clinical trial for nolasiban as designed, expected savings from the workforce reduction, the timing, outcome and potential impact of ObsEva’s intended withdrawal of the pending moratorium proceedings before Swiss courts, and ObsEva’s plans for and ability to regain compliance with Nasdaq’s continued listing requirements. 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 in the ability of the proceeds from the sale of rights to ebopiprant to XOMA to provide the expected benefits, ObsEva’s cash requirements and ability to resolve its current indebtedness position, the achievement of milestones under the agreement with XOMA,  the achievement of milestones under the sublicense agreement with YuYuan,  the ability of Yuyuan to conduct a Phase 1 clinical trial for nolasiban as designed, the workforce reduction to provide the anticipated savings, the outcome and potential impact of ObsEva’s intended withdrawal of the pending moratorium proceedings before Swiss courts, including with respect to ObsEva’s agreements with third parties and outstanding debt obligations, ObsEva’s ability to successfully restructure its operations,  ObsEva’s ability to regain compliance with the continued listing rules of Nasdaq and the potential for Nasdaq to use its discretionary authority to delist ObsEva’s common shares in connection with the pending Swiss moratorium proceedings if ObsEva is not able to withdraw such proceedings,  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, ObsEva’s reliance on third parties over which it may not always have full control, and the capabilities of such third parties, the impact of the ongoing novel coronavirus outbreak and other geopolitical events, 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, 2021 filed with Securities and Exchange Commission (the “SEC”) on March 10, 2022, in the Reports on Form 6-K filed with the SEC on May 17, 2022, August 17, 2022 and December 1, 2022 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at 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, except as required by law, 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:

4

 


CEO Administrative Contact

Shauna Dillon

shauna.dillon@obseva.ch

+41 22 552 1550

Investor Contact

Will Brown

will.brown@obseva.com

+1 (334) 313-2319


5

 


 

Unaudited Condensed Consolidated Statements of Comprehensive Loss

 

 

Three-Month Period

Ended September 30,

 

 

Nine-Month Period

Ended September 30,

 

(in USD ’000, except per share data)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

OPERATING INCOME OTHER THAN REVENUE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other operating income

 

 

3

 

 

 

20,098

 

 

 

4,852

 

 

 

20,108

 

Assignment income

 

 

3,709

 

 

 

 

 

 

3,709

 

 

 

 

Total operating income other than revenue

 

 

3,712

 

 

 

20,098

 

 

 

8,561

 

 

 

20,108

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

(692

)

 

 

(11,531

)

 

 

(13,411

)

 

 

(41,532

)

General and administrative expenses

 

 

(3,649

)

 

 

(7,035

)

 

 

(18,393

)

 

 

(15,114

)

Impairment of intangible asset

 

 

 

 

 

 

 

 

(19,400

)

 

 

 

Total operating expenses

 

 

(4,341

)

 

 

(18,566

)

 

 

(51,204

)

 

 

(56,646

)

OPERATING (LOSS) INCOME

 

 

(629

)

 

 

1,532

 

 

 

(42,643

)

 

 

(36,538

)

Finance income

 

 

2,885

 

 

 

128

 

 

 

2,385

 

 

 

702

 

Finance expense

 

 

(2,494

)

 

 

(822

)

 

 

(4,472

)

 

 

(2,423

)

Loss on event of default

 

 

(17,586

)

 

 

 

 

 

(17,586

)

 

 

 

Gain on debt extinguishment

 

 

5,713

 

 

 

 

 

 

5,713

 

 

 

 

NET (LOSS) INCOME BEFORE TAX

 

 

(12,111

)

 

 

838

 

 

 

(56,603

)

 

 

(38,259

)

Income tax income (expense)

 

 

54

 

 

 

(19

)

 

 

(53

)

 

 

(70

)

NET (LOSS) INCOME FOR THE PERIOD

 

 

(12,057

)

 

 

819

 

 

 

(56,656

)

 

 

(38,329

)

Net (loss) income per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

 

(0.13

)

 

 

0.01

 

 

 

(0.65

)

 

 

(0.52

)

OTHER COMPREHENSIVE INCOME

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that will not be reclassified to profit and loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remeasurements on post-employment benefit plans, net of tax

 

 

5,581

 

 

 

 

 

 

5,581

 

 

 

 

TOTAL OTHER COMPREHENSIVE INCOME

 

 

5,581

 

 

 

 

 

 

5,581

 

 

 

 

TOTAL COMPREHENSIVE (LOSS) INCOME FOR THE PERIOD

 

 

(6,476

)

 

 

819

 

 

 

(51,075

)

 

 

(38,329

)

 


6

 


 

Unaudited Condensed Consolidated Balance Sheets

(in USD ’000)

 

September 30,

2022

 

 

December 31,

2021

 

ASSETS

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

9,684

 

 

 

54,734

 

Other receivables

 

 

174

 

 

 

3,560

 

Prepaid expenses

 

 

1,705

 

 

 

5,223

 

Total current assets

 

 

11,563

 

 

 

63,517

 

Non-current assets

 

 

 

 

 

 

 

 

Right-of-use assets

 

 

313

 

 

 

625

 

Furniture, fixtures and equipment

 

 

45

 

 

 

58

 

Intangible assets

 

 

4,503

 

 

 

24,503

 

Other long-term assets

 

 

383

 

 

 

288

 

Total non-current assets

 

 

5,244

 

 

 

25,474

 

Total assets

 

 

16,807

 

 

 

88,991

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Other payables and current liabilities

 

 

7,213

 

 

 

9,038

 

Accrued expenses

 

 

2,353

 

 

 

13,783

 

Current borrowings

 

 

8,902

 

 

 

 

Current lease liabilities

 

 

367

 

 

 

686

 

Total current liabilities

 

 

18,835

 

 

 

23,507

 

Non-current liabilities

 

 

 

 

 

 

 

 

Non-current lease liabilities

 

 

 

 

 

240

 

Non-current borrowings

 

 

 

 

 

25,733

 

Post-employment obligations

 

 

568

 

 

 

6,581

 

Other long-term liabilities

 

 

553

 

 

 

591

 

Total non-current liabilities

 

 

1,121

 

 

 

33,145

 

Shareholders’ equity

 

 

 

 

 

 

 

 

Share capital

 

 

8,467

 

 

 

6,489

 

Share premium

 

 

441,306

 

 

 

430,630

 

Reserves

 

 

35,129

 

 

 

32,195

 

Accumulated losses

 

 

(488,051

)

 

 

(436,975

)

Total shareholders’ equity

 

 

(3,149

)

 

 

32,339

 

Total liabilities and shareholders’ equity

 

 

16,807

 

 

 

88,991

 

 

7