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SEC Filings

Form 20-F
OBSEVA SA filed this Form 20-F on 03/05/2019
Document Outline
Entire Document (9183 KB)
Subdocument 1 - 20-F - 20-F
Page 1 - UNITED STATES
Page 2 - Securities registered or to be registered pursuant to Section 12(b) of the Act.
Page 3 - TABLE OF CONTENTS
Page 4 - N/A
Page 5 - INTRODUCTION
Page 6 - N/A
Page 7 - PART I
Page 8 - B. Capitalization and Indebtedness
Page 9 - We have a limited operating history and have never generated any revenue from product sales, which m
Page 10 - Raising additional capital may cause dilution to our shareholders, restrict our operations or requir
Page 11 - Fluctuations in exchange rates may adversely affect our results of operations.
Page 12 - Clinical trials are very expensive, time-consuming and difficult to design and implement and involve
Page 13 - N/A
Page 14 - The regulatory approval process of the FDA, EMA or any comparable foreign regulatory agency may be l
Page 15 - We have previously sought, and intend to seek in the future, formal advice and guidance from the FDA
Page 16 - We depend on enrollment of patients in our clinical trials for our product candidates. If we are una
Page 17 - We may not be successful in our efforts to in-license or acquire additional product candidates for o
Page 18 - We may expend our limited resources to pursue a particular product candidate or indication and fail
Page 19 - We operate in a highly competitive and rapidly changing industry.
Page 20 - N/A
Page 21 - The successful commercialization of certain of our product candidates will depend in part on the ext
Page 22 - Even if we obtain regulatory approval for linzagolix, nolasiban, OBE022 or future product candidates
Page 23 - Even if any of our product candidates receives marketing approval, it may fail to achieve the degree
Page 24 - We currently have no marketing, sales or distribution infrastructure. If we are unable to develop sa
Page 25 - Risks Related to Our Dependence on Third Parties
Page 26 - We rely on our third-party manufacturers to source the supply of the materials for our product candi
Page 27 - We may in the future enter into collaborations with third parties to develop our product candidates.
Page 28 - N/A
Page 29 - If we are not able to establish or maintain collaborations, we may have to alter some of our future
Page 30 - Risks Related to Regulatory Compliance
Page 31 - N/A
Page 32 - Our business operations and current and future relationships with investigators, health care profess
Page 33 - N/A
Page 34 - Risks Related to Our Intellectual Property
Page 35 - We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope o
Page 36 - Intellectual property rights do not necessarily address all potential threats to our business.
Page 37 - Molecular Pathology v. Myriad Genetics, Inc. Mayo Collaborative Services v. Prometheus Laboratories,
Page 38 - We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors o
Page 39 - We may not be able to protect our intellectual property rights throughout the world, which could neg
Page 40 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 41 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 42 - Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be s
Page 43 - We expect to expand our development and regulatory capabilities and potentially implement sales, mar
Page 44 - Concentration of ownership of our common shares among our existing executive officers, directors and
Page 45 - Future sales, or the possibility of future sales, of a substantial number of our common shares could
Page 46 - Our common shares are traded on more than one market and this may result in price variations and adv
Page 47 - We are a foreign private issuer and, as a result, are not subject to U.S. proxy rules and are subjec
Page 48 - Although we do not believe that we were a passive foreign investment company, or PFIC, for U.S. fede
Page 49 - As a result of changes in tax laws, treaties, rulings, regulations or agreements, or their interpret
Page 50 - We are an emerging growth company, and we cannot be certain if the reduced reporting requirements ap
Page 51 - Item 4. Information on the Company.
Page 52 - N/A
Page 53 - N/A
Page 54 - N/A
Page 55 - N/A
Page 56 - N/A
Page 57 - Our Strengths
Page 58 - Linzagolix: Investigational GnRH Receptor Antagonist for Symptoms Associated with Endometriosis and
Page 59 - Background of Endometriosis and Uterine Fibroids
Page 60 - Limitations of Current Therapies for Endometriosis and Uterine Fibroids
Page 61 - Mechanism of Action and Limitations of GnRH Agonists
Page 62 - Linzagolix s Potential Clinical Profile
Page 63 - Preclinical Studies and Phase 1 Clinical Trial
Page 64 - Completed Phase 2a Clinical Trials
Page 65 - Figure 3: Average Change in Severity of Pelvic Pain Over Time (Menstrual and Non-menstrual Pain Comb
Page 66 - Figure 4: Design of Phase 2b EDELWEISS Clinical Trial
Page 67 - N/A
Page 68 - Figure 5: Primary and key secondary efficacy endpoints
Page 69 - Figure 6: Design of Phase 3 EDELWEISS 2/3 Clinical Trials
Page 70 - Figure 7: Percentage of Days with Bleeding During 12-Week Treatment Period
Page 71 - Figure 8: Time to No Bleeding for Uterine Fibroids Patients in KLH1202 Trial
Page 72 - Figure 9: Change in Uterine Volume over Time
Page 73 - Figure 10: Design of Phase 3 PRIMROSE Clinical Trials
Page 74 - Nolasiban in IVF
Page 75 - N/A
Page 76 - Role of Oxytocin in Embryo Implantation
Page 77 - Potential Therapeutic Benefits of nolasiban
Page 78 - Completed Phase 2 Clinical Trial
Page 79 - Efficacy Results
Page 80 - Figure 12
Page 81 - Ongoing Phase 3 Clinical Trial and Clinical Development Plan
Page 82 - Figure 15
Page 83 - Figure 17
Page 84 - Role of Prostaglandins in Preterm Labor
Page 85 - OBE022 Preclinical and Clinical Development
Page 86 - Figure 19:
Page 87 - Commercialization
Page 88 - N/A
Page 89 - Intellectual Property
Page 90 - 2013 License Agreement with Merck Serono
Page 91 - License and Supply Agreement with Kissei
Page 92 - Government Regulation
Page 93 - Clinical Trials
Page 94 - The FDA s Decision on an NDA
Page 95 - Post-approval Requirements
Page 96 - Healthcare Reform
Page 97 - Coverage, Reimbursement and Pricing
Page 98 - N/A
Page 99 - Sales and Marketing
Page 100 - Foreign Regulation
Page 101 - National Authorization Procedures
Page 102 - D. Property, Plants and Equipment.
Page 103 - N/A
Page 104 - Strategic Licensing Agreements
Page 105 - Components of Results of Operations
Page 106 - General and Administrative Expenses
Page 107 - Years Ended December 31, 2018 and 2017
Page 108 - Years Ended December 31, 2017 and 2016
Page 109 - B. Liquidity and Capital Resources
Page 110 - Operating Activities
Page 111 - Investing Activities
Page 112 - G. Safe Harbor
Page 113 - Jean-Pierre Gotteland
Page 114 - Barbara Duncan
Page 115 - Jacky Vonderscher
Page 116 - Authorized Shares
Page 117 - Corporate Transactions
Page 118 - Audit Committee
Page 119 - Other Corporate Governance Matters
Page 120 - D. Employees.
Page 121 - N/A
Page 122 - N/A
Page 123 - B. Related Party Transactions.
Page 124 - Registration Rights Agreement
Page 125 - Dividend Distribution Policy
Page 126 - Item 10. Additional Information.
Page 127 - Underwriting Agreement
Page 128 - remboursements li s la r duction de la valeur nominale des actionsr serves issues d apports de capit
Page 129 - r duction pour participationremboursements li s la r duction de la valeur nominale des actionsr serv
Page 130 - Gift and Inheritance Tax
Page 131 - Passive Foreign Investment Company Rules
Page 132 - de minimis
Page 133 - Sale or Other Taxable Disposition of Common Shares
Page 134 - F. Dividends and Paying Agents.
Page 135 - Transactional Risk
Page 136 - PART II
Page 137 - Internal Control Integrated Framework
Page 138 - Audit-Related Fees
Page 139 - Item 16H. Mine Safety Disclosure.
Page 140 - PART III
Page 141 - N/A
Page 142 - Index to Financial Statements
Page 143 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 144 - Consolidated Balance Sheet
Page 145 - Consolidated Statement of Comprehensive Loss
Page 146 - Consolidated Statement of Cash Flows
Page 147 - Consolidated Statement of Changes in Equity
Page 148 - Notes to the Consolidated Financial Statements
Page 149 - IFRS 16 Leases, effective for annual periods beginning on or after January 1, 2019
Page 150 - Intangible assets
Page 151 - Research and development
Page 152 - Share-based compensation
Page 153 - 2.5 Critical accounting estimates and judgments
Page 154 - 3. Financial risk management
Page 155 - Liquidity risk
Page 156 - 6. Prepaid and accrued expenses
Page 157 - Amortization and impairment
Page 158 - N/A
Page 159 - N/A
Page 160 - 11. Shareholders equity
Page 161 - Share capital and share premium
Page 162 - 13. Operating expenses by nature
Page 163 - Expiring tax losses
Page 164 - 17. Loss per share
Page 165 - 18. Share-based compensation
Page 166 - Employee equity incentive plan 2017
Page 167 - 19. Commitments and contingencies
Page 168 - 20. Related parties transactions
Page 169 - SIGNATURES
Subdocument 2 - EX-12.1 - EX-12.1
Page 1 - N/A
Subdocument 3 - EX-12.2 - EX-12.2
Page 1 - N/A
Subdocument 4 - EX-13.1 - EX-13.1
Page 1 - N/A
Subdocument 5 - EX-13.2 - EX-13.2
Page 1 - N/A
Subdocument 6 - EX-15.1 - EX-15.1
Page 1 - N/A
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