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SEC Filings

Form F-1/A
OBSEVA SA filed this Form F-1/A on 01/23/2017
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Subdocument 1 - F-1/A - AMENDMENT NO. 3 TO FORM F-1
Page 1 - As filed with the Securities and Exchange Commission on January 23, 2017.
Page 2 - The information contained in this preliminary prospectus is not complete and may be changed. We may
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - OBE2109 for the Treatment of Pain Associated with Endometriosis and Heavy Menstrual Bleeding Associa
Page 6 - OBE001 (nolasiban) to Improve IVF Outcomes
Page 7 - OBE022 for the Treatment of Preterm Labor
Page 8 - Risks Associated with Our Business
Page 9 - Implications of Being an Emerging Growth Company and a Foreign Private Issuer
Page 10 - The Offering
Page 11 - N/A
Page 12 - Summary Consolidated Financial Data
Page 13 - N/A
Page 14 - RISK FACTORS
Page 15 - We have a limited operating history and have never generated any revenue from product sales, which m
Page 16 - Raising additional capital may cause dilution to our shareholders, restrict our operations or requir
Page 17 - Fluctuations in exchange rates may adversely affect our results of operations.
Page 18 - Clinical trials are very expensive, time-consuming and difficult to design and implement and involve
Page 19 - The European Phase 3 clinical trial for OBE001 based on observations from our post-hoc analysis of t
Page 20 - N/A
Page 21 - The regulatory approval process of the FDA, EMA or any comparable foreign regulatory agency may be l
Page 22 - Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or se
Page 23 - We depend on enrollment of patients in our clinical trials for our product candidates. If we are una
Page 24 - We may not be successful in our efforts to in-license or acquire additional product candidates for o
Page 25 - We may expend our limited resources to pursue a particular product candidate or indication and fail
Page 26 - We operate in a highly competitive and rapidly changing industry.
Page 27 - The successful commercialization of certain of our product candidates will depend in part on the ext
Page 28 - Even if we obtain regulatory approval for OBE2109, OBE001, OBE022 or future product candidates, they
Page 29 - Off-label use is common in the indications for which our product candidates are under development, w
Page 30 - Even if any of our product candidates receives marketing approval, it may fail to achieve the degree
Page 31 - We currently have no marketing, sales or distribution infrastructure. If we are unable to develop sa
Page 32 - Risks Related to Our Dependence on Third Parties
Page 33 - We currently rely on third parties for the production of our clinical supply of our product candidat
Page 34 - We rely on our third-party manufacturers to source the supply of the materials for our product candi
Page 35 - We may in the future enter into collaborations with third parties to develop our product candidates.
Page 36 - If we are not able to establish or maintain collaborations, we may have to alter some of our future
Page 37 - Our reliance on third parties requires us to share our trade secrets, which increases the possibilit
Page 38 - N/A
Page 39 - N/A
Page 40 - Our business operations and current and future relationships with investigators, health care profess
Page 41 - N/A
Page 42 - Risks Related to Our Intellectual Property
Page 43 - We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope o
Page 44 - Patent terms may be inadequate to protect our competitive position on our product candidates for an
Page 45 - Changes in patent laws or patent jurisprudence could diminish the value of patents in general, there
Page 46 - Molecular Pathology v. Myriad Genetics, Inc.
Page 47 - We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors o
Page 48 - We may not be able to protect our intellectual property rights throughout the world, which could neg
Page 49 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 50 - Our inability to protect our confidential information and trade secrets would harm our business and
Page 51 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 52 - Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be s
Page 53 - Our employees, independent contractors, consultants, commercial collaborators, principal investigato
Page 54 - We will incur increased costs as a result of operating as a public company, and our management and b
Page 55 - There has been no public market for our common shares prior to this offering, and an active market i
Page 56 - Future sales, or the possibility of future sales, of a substantial number of our common shares could
Page 57 - We have broad discretion in the use of the net proceeds from this offering and may not use them effe
Page 58 - U.S. shareholders may not be able to obtain judgments or enforce civil liabilities against us or our
Page 59 - We are a foreign private issuer and, as a result, we will not be subject to U.S. proxy rules and wil
Page 60 - Following the consummation of this offering, we may lose our foreign private issuer status, which wo
Page 61 - As a result of changes in tax laws, treaties, rulings, regulations or agreements, or their interpret
Page 62 - If securities or industry analysts do not publish research, or publish inaccurate or unfavorable res
Page 63 - PRESENTATION OF FINANCIAL AND OTHER INFORMATION
Page 64 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 65 - N/A
Page 66 - INDUSTRY AND MARKET DATA
Page 67 - USE OF PROCEEDS
Page 68 - DIVIDEND POLICY
Page 69 - CAPITALIZATION
Page 70 - DILUTION
Page 71 - N/A
Page 72 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 73 - N/A
Page 74 - MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
Page 75 - Strategic Licensing Agreements
Page 76 - OBE001
Page 77 - General and Administrative Expenses
Page 78 - Finance Result, Net
Page 79 - Nine Months Ended September 30, 2016 and 2015
Page 80 - Years Ended December 31, 2015 and 2014
Page 81 - Liquidity and Capital Resources
Page 82 - Operating Activities
Page 83 - Investing Activities
Page 84 - Off-Balance Sheet Arrangements
Page 85 - Impairments
Page 86 - Employee Benefits
Page 87 - Foreign Currency Exchange Risk
Page 88 - N/A
Page 89 - BUSINESS
Page 90 - N/A
Page 91 - N/A
Page 92 - Our Strengths
Page 93 - Our Strategy
Page 94 - OBE2109: Investigational GnRH Receptor Antagonist for Symptoms Associated with Endometriosis and Ute
Page 95 - The Role of GnRH
Page 96 - Mechanism of Action and Limitations of GnRH Agonists
Page 97 - OBE2109 s Mechanism of Action and Solution to GnRH Agonist Drawbacks and Limitations
Page 98 - OBE2109 Preclinical and Clinical Development for Pain Associated with Endometriosis
Page 99 - N/A
Page 100 - Completed Phase 2a Clinical Trials
Page 101 - Figure 3: Average Change in Severity of Pelvic Pain Over Time (Menstrual and Non-menstrual Pain Comb
Page 102 - Figure 4: Median Estradiol Levels Over Time
Page 103 - Figure 5: Percent of Patients at Various Estradiol Levels in KLH1202 Trial at Week 12
Page 104 - Figure 6: Design of Phase 2b EDELWEISS Clinical Trial
Page 105 - OBE2109 Clinical Development for Heavy Menstrual Bleeding Associated with Uterine Fibroids
Page 106 - Figure 8: Time to No Bleeding for Uterine Fibroids Patients in KLH1202 Trial
Page 107 - Figure 9: Change in Uterine Volume over Time
Page 108 - Figure 10: Design of Phase 3 PRIMROSE Clinical Trials
Page 109 - Background on Assisted Reproductive Technology (IVF/ICSI)
Page 110 - N/A
Page 111 - Role of Oxytocin in Embryo Implantation
Page 112 - Potential Therapeutic Benefits of OBE001
Page 113 - Efficacy Results
Page 114 - Figure 11
Page 115 - Figure 12
Page 116 - Figure 13
Page 117 - Background and Impact of Preterm Labor
Page 118 - Figure 15: Weighted Percentages of Tocolytic Agents for Efficacy
Page 119 - Preclinical Development
Page 120 - Commercialization
Page 121 - Competition
Page 122 - Intellectual Property
Page 123 - 2013 License Agreement with Merck Serono
Page 124 - 2015 License Agreement with Merck Serono
Page 125 - Government Regulation
Page 126 - Clinical Trials
Page 127 - Submission of an NDA
Page 128 - The FDA s Decision on an NDA
Page 129 - Post-approval Requirements
Page 130 - Healthcare Reform
Page 131 - Coverage, Reimbursement and Pricing
Page 132 - Sales and Marketing
Page 133 - N/A
Page 134 - Foreign Regulation
Page 135 - National Authorization Procedures
Page 136 - Employees
Page 137 - MANAGEMENT
Page 138 - Timothy Adams
Page 139 - Barbara Duncan
Page 140 - Rafa le Tordjman
Page 141 - Board Committees
Page 142 - Compensation, Nominating and Corporate Governance Committee
Page 143 - Other Corporate Governance Matters
Page 144 - 2017 Equity Incentive Plan
Page 145 - Section 162(m) Limits
Page 146 - Plan Amendment or Termination
Page 147 - RELATED-PARTY TRANSACTIONS
Page 148 - Sale of Series A Preferred Shares
Page 149 - Series B Shareholders Agreement
Page 150 - N/A
Page 151 - PRINCIPAL SHAREHOLDERS
Page 152 - N/A
Page 153 - N/A
Page 154 - DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION
Page 155 - droit pr f rentiel de souscription
Page 156 - Conditional Share Capital for Equity Incentive Plans
Page 157 - Voting and Quorum Requirements
Page 158 - Notice
Page 159 - Dividends and Other Distributions
Page 160 - registre des actions
Page 161 - Board of Directors
Page 162 - Indemnification of Executive Management and Directors
Page 163 - Borrowing Powers
Page 164 - Repurchases of Shares and Purchases of Own Shares
Page 165 - COMPARISON OF SWISS LAW AND DELAWARE LAW
Page 166 - N/A
Page 167 - N/A
Page 168 - N/A
Page 169 - N/A
Page 170 - N/A
Page 171 - N/A
Page 172 - COMMON SHARES ELIGIBLE FOR FUTURE SALE
Page 173 - Rule 701
Page 174 - N/A
Page 175 - MATERIAL INCOME TAX CONSIDERATIONS
Page 176 - Individual and Corporate Income Tax on Dividends
Page 177 - Wealth and Annual Capital Tax on Holding of Common Shares
Page 178 - Gift and Inheritance Tax
Page 179 - Passive Foreign Investment Company Rules
Page 180 - de minimis
Page 181 - Taxation of Distributions
Page 182 - Sale or Other Taxable Disposition of Common Shares
Page 183 - UNDERWRITING
Page 184 - N/A
Page 185 - NASDAQ
Page 186 - Price Stabilization, Short Positions and Penalty Bids
Page 187 - Selling Restrictions
Page 188 - Notice to Prospective Investors in Switzerland
Page 189 - Notice to Prospective Investors in Hong Kong
Page 190 - Notice to Canadian Residents
Page 191 - Other Relationships
Page 192 - EXPENSES OF THIS OFFERING
Page 193 - LEGAL MATTERS
Page 194 - ENFORCEMENT OF JUDGMENTS
Page 195 - WHERE YOU CAN FIND ADDITIONAL INFORMATION
Page 196 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 197 - ObsEva SA
Page 198 - ObsEva SA
Page 199 - ObsEva SA
Page 200 - ObsEva SA
Page 201 - ObsEva SA
Page 202 - ObsEva SA
Page 203 - ObsEva SA
Page 204 - ObsEva SA
Page 205 - ObsEva SA
Page 206 - ObsEva SA
Page 207 - ObsEva SA
Page 208 - ObsEva SA
Page 209 - ObsEva SA
Page 210 - ObsEva SA
Page 211 - ObsEva SA
Page 212 - ObsEva SA
Page 213 - ObsEva SA
Page 214 - ObsEva SA
Page 215 - ObsEva SA
Page 216 - ObsEva SA
Page 217 - ObsEva SA
Page 218 - ObsEva SA
Page 219 - ObsEva SA
Page 220 - ObsEva SA
Page 221 - ObsEva SA
Page 222 - ObsEva SA
Page 223 - ObsEva SA
Page 224 - ObsEva SA
Page 225 - ObsEva SA
Page 226 - ObsEva SA
Page 227 - ObsEva SA
Page 228 - ObsEva SA
Page 229 - ObsEva SA
Page 230 - ObsEva SA
Page 231 - N/A
Page 232 - PART II
Page 233 - Issuances Under Our Equity Plans
Page 234 - bona fide
Page 235 - SIGNATURES
Page 236 - N/A
Page 237 - EXHIBIT INDEX
Subdocument 2 - EX-1.1 - EX-1.1
Page 1 - Exhibit 1.1
Page 2 - Additional Registration Statement
Page 3 - Securities Laws
Page 4 - Issuer Free Writing Prospectuses
Page 5 - Offered Securities
Page 6 - Debt Repayment Triggering Event
Page 7 - USPTO
Page 8 - Regulatory Matters: Manufacturing
Page 9 - Environmental Laws
Page 10 - IFRS
Page 11 - Investment Company Act
Page 12 - Anti-Money Laundering Laws
Page 13 - Dividend Restrictions
Page 14 - Optional Closing Date
Page 15 - Board Resolution and Registration of Firm Capital Increase
Page 16 - Subscription and Issuance of Optional Securities.
Page 17 - provided
Page 18 - Certain Agreements of the Company
Page 19 - Rule 158.
Page 20 - Use of Proceeds.
Page 21 - Permitted Free Writing Prospectus
Page 22 - Opinion of U.S. Counsel for the Company.
Page 23 - Indemnification and Contribution
Page 24 - Contribution.
Page 25 - Termination of this Agreement.
Page 26 - Call Option
Page 27 - Sale of Firm Securities or Applicable Optional Securities.
Page 28 - Notices
Page 29 - Authorized Agent
Page 30 - [Signature Page to Underwriting Agreement]
Page 31 - SCHEDULE A
Page 32 - SCHEDULE B
Page 33 - SCHEDULE C
Page 34 - SCHEDULE D
Page 35 - Exhibit A
Page 36 - Exhibit B
Page 37 - N/A
Page 38 - Pro-rata Release
Page 39 - Release Date
Page 40 - N/A
Page 41 - Exhibit C
Page 42 - N/A
Subdocument 3 - EX-4.1 - EX-4.1
Page 1 - Exhibit 4.1
Page 2 - TABLE OF CONTENTS
Page 3 - REGISTRATION RIGHTS AGREEMENT
Page 4 - Derivative Securities
Page 5 - Initiating Holders
Page 6 - Series A Preferred Shares
Page 7 - provided
Page 8 - Underwriting Requirements
Page 9 - Subsection 2.3(b)
Page 10 - provided that
Page 11 - Selling Holder Counsel
Page 12 - provided
Page 13 - Subsection 2.8
Page 14 - Limitations on Subsequent Registration Rights
Page 15 - Subsection 2.11
Page 16 - Termination of Registration Rights
Page 17 - Titles and Subtitles
Page 18 - Aggregation of Shares
Page 19 - Delays or Omissions
Page 20 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 21 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 22 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 23 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 24 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 25 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 26 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 27 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 28 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 29 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 30 - SIGNATURE PAGE TO REGISTRATION RIGHTS AGREEMENT
Page 31 - SCHEDULE A
Page 32 - ORBIMED PRIVATE INVESTMENTS V, LP
Subdocument 4 - EX-5.1 - EX-5.1
Page 1 - Exhibit 5.1
Page 2 - N/A
Page 3 - N/A
Page 4 - Lenz Staehelin
Subdocument 5 - EX-8.1 - EX-8.1
Page 1 - Exhibit 8.1
Page 2 - N/A
Page 3 - Lenz Staehelin
Subdocument 6 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 7 - EX-99.1 - EX-99.1
Page 1 - Exhibit 99.1