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SEC Filings

Form 424B4
OBSEVA SA filed this Form 424B4 on 01/27/2017
Document Outline
Entire Document (3568 KB)
Subdocument 1 - 424B4 - 424B4
Page 1 - Filed Pursuant to Rule 424(b)(4)
Page 2 - TABLE OF CONTENTS
Page 3 - PROSPECTUS SUMMARY
Page 4 - OBE2109 for the Treatment of Pain Associated with Endometriosis and Heavy Menstrual Bleeding Associa
Page 5 - OBE001 (nolasiban) to Improve IVF Outcomes
Page 6 - OBE022 for the Treatment of Preterm Labor
Page 7 - Risks Associated with Our Business
Page 8 - Implications of Being an Emerging Growth Company and a Foreign Private Issuer
Page 9 - The Offering
Page 10 - N/A
Page 11 - Summary Consolidated Financial Data
Page 12 - N/A
Page 13 - RISK FACTORS
Page 14 - We have a limited operating history and have never generated any revenue from product sales, which m
Page 15 - Raising additional capital may cause dilution to our shareholders, restrict our operations or requir
Page 16 - Fluctuations in exchange rates may adversely affect our results of operations.
Page 17 - Clinical trials are very expensive, time-consuming and difficult to design and implement and involve
Page 18 - The European Phase 3 clinical trial for OBE001 based on observations from our post-hoc analysis of t
Page 19 - N/A
Page 20 - The regulatory approval process of the FDA, EMA or any comparable foreign regulatory agency may be l
Page 21 - Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or se
Page 22 - We depend on enrollment of patients in our clinical trials for our product candidates. If we are una
Page 23 - We may not be successful in our efforts to in-license or acquire additional product candidates for o
Page 24 - We may expend our limited resources to pursue a particular product candidate or indication and fail
Page 25 - We operate in a highly competitive and rapidly changing industry.
Page 26 - The successful commercialization of certain of our product candidates will depend in part on the ext
Page 27 - Even if we obtain regulatory approval for OBE2109, OBE001, OBE022 or future product candidates, they
Page 28 - Off-label use is common in the indications for which our product candidates are under development, w
Page 29 - Even if any of our product candidates receives marketing approval, it may fail to achieve the degree
Page 30 - We currently have no marketing, sales or distribution infrastructure. If we are unable to develop sa
Page 31 - Risks Related to Our Dependence on Third Parties
Page 32 - We currently rely on third parties for the production of our clinical supply of our product candidat
Page 33 - We rely on our third-party manufacturers to source the supply of the materials for our product candi
Page 34 - We may in the future enter into collaborations with third parties to develop our product candidates.
Page 35 - If we are not able to establish or maintain collaborations, we may have to alter some of our future
Page 36 - Our reliance on third parties requires us to share our trade secrets, which increases the possibilit
Page 37 - N/A
Page 38 - N/A
Page 39 - Our business operations and current and future relationships with investigators, health care profess
Page 40 - N/A
Page 41 - Risks Related to Our Intellectual Property
Page 42 - We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope o
Page 43 - Patent terms may be inadequate to protect our competitive position on our product candidates for an
Page 44 - Changes in patent laws or patent jurisprudence could diminish the value of patents in general, there
Page 45 - Molecular Pathology v. Myriad Genetics, Inc.
Page 46 - We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors o
Page 47 - We may not be able to protect our intellectual property rights throughout the world, which could neg
Page 48 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 49 - Our inability to protect our confidential information and trade secrets would harm our business and
Page 50 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 51 - Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be s
Page 52 - Our employees, independent contractors, consultants, commercial collaborators, principal investigato
Page 53 - We will incur increased costs as a result of operating as a public company, and our management and b
Page 54 - There has been no public market for our common shares prior to this offering, and an active market i
Page 55 - We do not expect to pay dividends in the foreseeable future.
Page 56 - We are a Swiss stock corporation. The rights of our shareholders may be different from the rights of
Page 57 - Our status as a Swiss stock corporation means that our shareholders enjoy certain rights that may li
Page 58 - As a foreign private issuer and as permitted by the listing requirements of NASDAQ, we will have the
Page 59 - While we do not expect to be a passive foreign investment company, or PFIC, for U.S. federal income
Page 60 - We are an emerging growth company, and we cannot be certain if the reduced reporting requirements ap
Page 61 - If securities or industry analysts do not publish research, or publish inaccurate or unfavorable res
Page 62 - PRESENTATION OF FINANCIAL AND OTHER INFORMATION
Page 63 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 64 - N/A
Page 65 - INDUSTRY AND MARKET DATA
Page 66 - USE OF PROCEEDS
Page 67 - DIVIDEND POLICY
Page 68 - CAPITALIZATION
Page 69 - DILUTION
Page 70 - N/A
Page 71 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 72 - N/A
Page 73 - MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
Page 74 - Strategic Licensing Agreements
Page 75 - OBE022
Page 76 - General and Administrative Expenses
Page 77 - Finance Result, Net
Page 78 - General and Administrative Expenses
Page 79 - Years Ended December 31, 2015 and 2014
Page 80 - Liquidity and Capital Resources
Page 81 - Operating Activities
Page 82 - Investing Activities
Page 83 - Off-Balance Sheet Arrangements
Page 84 - Impairments
Page 85 - Employee Benefits
Page 86 - Foreign Currency Exchange Risk
Page 87 - N/A
Page 88 - BUSINESS
Page 89 - N/A
Page 90 - N/A
Page 91 - Our Strengths
Page 92 - Our Strategy
Page 93 - OBE2109: Investigational GnRH Receptor Antagonist for Symptoms Associated with Endometriosis and Ute
Page 94 - The Role of GnRH
Page 95 - Mechanism of Action and Limitations of GnRH Agonists
Page 96 - OBE2109 s Mechanism of Action and Solution to GnRH Agonist Drawbacks and Limitations
Page 97 - OBE2109 Preclinical and Clinical Development for Pain Associated with Endometriosis
Page 98 - N/A
Page 99 - Completed Phase 2a Clinical Trials
Page 100 - Figure 3: Average Change in Severity of Pelvic Pain Over Time (Menstrual and Non-menstrual Pain Comb
Page 101 - Figure 4: Median Estradiol Levels Over Time
Page 102 - Figure 5: Percent of Patients at Various Estradiol Levels in KLH1202 Trial at Week 12
Page 103 - Figure 6: Design of Phase 2b EDELWEISS Clinical Trial
Page 104 - OBE2109 Clinical Development for Heavy Menstrual Bleeding Associated with Uterine Fibroids
Page 105 - Figure 8: Time to No Bleeding for Uterine Fibroids Patients in KLH1202 Trial
Page 106 - Figure 9: Change in Uterine Volume over Time
Page 107 - Figure 10: Design of Phase 3 PRIMROSE Clinical Trials
Page 108 - Background on Assisted Reproductive Technology (IVF/ICSI)
Page 109 - N/A
Page 110 - Role of Oxytocin in Embryo Implantation
Page 111 - Potential Therapeutic Benefits of OBE001
Page 112 - Efficacy Results
Page 113 - Figure 11
Page 114 - Phase 2 Clinical Safety Results
Page 115 - Clinical Development Plan
Page 116 - Role of Prostaglandins in Preterm Labor
Page 117 - Figure 15: Weighted Percentages of Tocolytic Agents for Efficacy
Page 118 - Clinical Development Plan
Page 119 - Commercialization
Page 120 - N/A
Page 121 - Intellectual Property
Page 122 - 2013 License Agreement with Merck Serono
Page 123 - License and Supply Agreement with Kissei
Page 124 - Government Regulation
Page 125 - Clinical Trials
Page 126 - Submission of an NDA
Page 127 - The FDA s Decision on an NDA
Page 128 - Post-approval Requirements
Page 129 - N/A
Page 130 - Coverage, Reimbursement and Pricing
Page 131 - Sales and Marketing
Page 132 - N/A
Page 133 - Foreign Regulation
Page 134 - National Authorization Procedures
Page 135 - Employees
Page 136 - MANAGEMENT
Page 137 - Timothy Adams
Page 138 - Barbara Duncan
Page 139 - Rafa le Tordjman
Page 140 - Board Committees
Page 141 - Compensation, Nominating and Corporate Governance Committee
Page 142 - Other Corporate Governance Matters
Page 143 - 2017 Equity Incentive Plan
Page 144 - Performance Awards
Page 145 - Plan Amendment or Termination
Page 146 - RELATED-PARTY TRANSACTIONS
Page 147 - Sale of Series B Preferred Shares
Page 148 - Registration Rights Agreement
Page 149 - N/A
Page 150 - PRINCIPAL SHAREHOLDERS
Page 151 - N/A
Page 152 - N/A
Page 153 - DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION
Page 154 - droit pr f rentiel de souscription
Page 155 - Conditional Share Capital for Equity Incentive Plans
Page 156 - Voting and Quorum Requirements
Page 157 - Notice
Page 158 - Dividends and Other Distributions
Page 159 - registre des actions
Page 160 - Board of Directors
Page 161 - Indemnification of Executive Management and Directors
Page 162 - Borrowing Powers
Page 163 - Repurchases of Shares and Purchases of Own Shares
Page 164 - COMPARISON OF SWISS LAW AND DELAWARE LAW
Page 165 - N/A
Page 166 - N/A
Page 167 - N/A
Page 168 - N/A
Page 169 - N/A
Page 170 - N/A
Page 171 - COMMON SHARES ELIGIBLE FOR FUTURE SALE
Page 172 - Rule 701
Page 173 - MATERIAL INCOME TAX CONSIDERATIONS
Page 174 - Individual and Corporate Income Tax on Dividends
Page 175 - Wealth and Annual Capital Tax on Holding of Common Shares
Page 176 - Gift and Inheritance Tax
Page 177 - Passive Foreign Investment Company Rules
Page 178 - de minimis
Page 179 - Taxation of Distributions
Page 180 - Sale or Other Taxable Disposition of Common Shares
Page 181 - UNDERWRITING
Page 182 - N/A
Page 183 - NASDAQ
Page 184 - Price Stabilization, Short Positions and Penalty Bids
Page 185 - Selling Restrictions
Page 186 - Notice to Prospective Investors in Switzerland
Page 187 - Notice to Prospective Investors in Hong Kong
Page 188 - Notice to Canadian Residents
Page 189 - Other Relationships
Page 190 - EXPENSES OF THIS OFFERING
Page 191 - LEGAL MATTERS
Page 192 - ENFORCEMENT OF JUDGMENTS
Page 193 - WHERE YOU CAN FIND ADDITIONAL INFORMATION
Page 194 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 195 - ObsEva SA
Page 196 - ObsEva SA
Page 197 - ObsEva SA
Page 198 - ObsEva SA
Page 199 - ObsEva SA
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Page 229 - N/A