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SEC Filings

Form 20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
Document Outline
Entire Document (8032 KB)
Subdocument 1 - 20-F - FORM 20-F
Page 1 - FORM 20-F
Page 2 - AC IMMUNE SA
Page 3 - PRESENTATION OF FINANCIAL AND OTHER INFORMATION
Page 4 - ENFORCEMENT OF JUDGMENTS
Page 5 - Not applicable.
Page 6 - Not applicable.
Page 7 - Results of early clinical studies may not be predictive of future study results.
Page 8 - Additional competitors could enter the market with generic versions of our products, which may resul
Page 9 - One of our collaboration partners is evaluating a product candidate in the same indication as our le
Page 10 - Our products may not gain market acceptance, in which case we or our collaboration partners may not
Page 11 - If serious adverse, undesirable or unacceptable side effects are identified during the development o
Page 12 - We operate in highly competitive and rapidly changing industries, which may result in others discove
Page 13 - We may not be successful in our efforts to use and expand our Morphomer proprietary technology platf
Page 14 - We have no history of commercializing pharmaceutical products, which may make it difficult to evalua
Page 15 - We may become exposed to costly and damaging liability claims, either when testing our product candi
Page 16 - Due to our limited resources and access to capital, we must prioritize development of certain produc
Page 17 - Business disruptions could seriously harm our future revenue and financial condition and increase ou
Page 18 - We may seek to form additional strategic alliances in the future with respect to our product candida
Page 19 - We rely on third parties to conduct our nonclinical and clinical studies and perform other tasks for
Page 20 - We currently rely on third-party suppliers and other third parties for production of our product can
Page 21 - We or our licensing or collaboration partners may become subject to intellectual property-related li
Page 22 - If we or our licensing or collaboration partners are unable to obtain and maintain effective patent
Page 23 - We may be subject to claims challenging the inventorship of our patents and other intellectual prope
Page 24 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 25 - The patent protection and patent prosecution for some of our product candidates is dependent on thir
Page 26 - We may not be successful in obtaining or maintaining necessary rights to our product candidates thro
Page 27 - We may be subject to claims that our employees, consultants, or independent contractors have wrongfu
Page 28 - We may not be able to protect our intellectual property rights throughout the world.
Page 29 - We expect that we will need substantial additional funding before we can expect to become profitable
Page 30 - Raising additional capital may cause dilution to our shareholders, restrict our operations or requir
Page 31 - Our ability to use tax loss carryforwards in Switzerland may be limited.
Page 32 - Clinical drug development involves a lengthy and expensive process with uncertain timelines and unce
Page 33 - Even if we obtain and maintain approval for our drug candidates from one jurisdiction, we may never
Page 34 - Even if our product candidates obtain regulatory approval, we will be subject to ongoing obligations
Page 35 - Enacted and future legislation may increase the difficulty and cost for us to obtain marketing appro
Page 36 - Our business is subject to complex and evolving U.S. and international laws and regulations regardin
Page 37 - Our relationships with clinical centers, customers and payors will be subject to applicable anti-kic
Page 38 - Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely
Page 39 - Risks Related to Our Common Shares
Page 40 - Future sales, or the possibility of future sales, of a substantial number of our common shares could
Page 41 - Our common shares are issued under the laws of Switzerland, which may not protect investors in a sim
Page 42 - U.S. shareholders may not be able to obtain judgments or enforce civil liabilities against us or our
Page 43 - Our status as a Swiss corporation means that our shareholders enjoy certain rights that may limit ou
Page 44 - As a foreign private issuer and as permitted by the listing requirements of Nasdaq, we rely on certa
Page 45 - We are an emerging growth company, and we cannot be certain if the reduced reporting requirements ap
Page 46 - An increase in our tax rate could occur, which could adversely affect our financial results.
Page 47 - Figure 1
Page 48 - Figure 2: Our broad and robust pipeline
Page 49 - Figure 3: AC Immune 3-pillars business strategy
Page 50 - ACI-24 in AD. One phase 2 study has been initiated in 2018 in order to assess the safety, tolerabili
Page 51 - Our Approach to Treating Diseases Related to Protein Misfolding
Page 52 - Challenges in targeting misfolded proteins
Page 53 - Opportunity for AC Immune in Neurodegenerative Diseases
Page 54 - Our Proprietary Technology Platforms
Page 55 - Mechanism of Action:
Page 56 - Figure 8: Crenezumab overview
Page 57 - Figure 9: Binding profile of crenezumab
Page 58 - Figure 11: The crystal structure of crenezumab
Page 59 - Figure 12: The Abeta salt-bridge hairpin
Page 60 - Figure 13: Microglia phagocytosis by crenezumab
Page 61 - Phase 2 Studies
Page 62 - Figure 15: ABBY high dose arm: Change in ADAS-Cog 12
Page 63 - Figure 16: ABBY high dose arm: Change in CDR-SB
Page 64 - Figure 17: Blaze High Dose ARM: Amyloid PET Results
Page 65 - Phase 1b Study to explore higher doses
Page 66 - Phase 2 AD Prevention Study
Page 67 - ACI-24
Page 68 - ACI-24 in Down syndrome
Page 69 - Figure 21: Anti-Tau antibody RG6100 (Phase 1 results)
Page 70 - ACI-35
Page 71 - Figure 23: Morphomers derived of proprietary Morphomer platform
Page 72 - Figure 25: ACI -3024 s effect on neuroinflammation
Page 73 - Morphomer alpha-synuclein: Our Morphomer alpha-synuclein product candidate is a small molecule that
Page 74 - Figure 27: Selectivity of Tau Pet PI-2620
Page 75 - Figure 29: Cortical update of PI-2620 in amyloid positive patients
Page 76 - Figure 31: Overview of our alpha-synuclein PET program and current clinical candidate profile
Page 77 - License Agreements and Collaborations
Page 78 - Competition
Page 79 - ACI-24 in Down syndrome: ACI-24 is the first disease-modifying vaccine candidate addressing AD in Do
Page 80 - Intellectual Property
Page 81 - ACI-24
Page 82 - Compliance with Governing Rules and Quality Requirements
Page 83 - Product Approval Process
Page 84 - N/A
Page 85 - N/A
Page 86 - N/A
Page 87 - Special Protocol Assessment
Page 88 - Post-Approval Requirements
Page 89 - Non-U.S. Regulation
Page 90 - Regulation in the European Union
Page 91 - N/A
Page 92 - Orphan Drug Regulation
Page 93 - Advertising
Page 94 - Other Healthcare Laws
Page 95 - Pharmaceutical Coverage, Pricing and Reimbursement
Page 96 - Healthcare Reform
Page 97 - Physician Payment Sunshine Act
Page 98 - Facilities
Page 99 - Strategic Collaborations and Licensing Agreements
Page 100 - N/A
Page 101 - Janssen Pharmaceuticals
Page 102 - Life Molecular Imaging SA (formerly Piramal Imaging SA)
Page 103 - Alpha-synuclein and TDP-43 PET Imaging Tracers Collaboration with Biogen
Page 104 - Michael J. Fox Foundation for Parkinson s Research
Page 105 - Accrued Research and Development Costs
Page 106 - Share-Based Compensation
Page 107 - Financial Operations Overview
Page 108 - Research and Development Expenses
Page 109 - General and Administrative Expenses
Page 110 - Comparison of the Years Ended December 31, 2018 and 2017
Page 111 - Detailed Research and Development Expenditures by Major Development Category
Page 112 - General and Administrative Expenses
Page 113 - Research and Development Expenses
Page 114 - General and Administrative Expenses
Page 115 - Cash Flows
Page 116 - Cash Flows
Page 117 - N/A
Page 118 - Loss per Share to Adjusted Loss per Share
Page 119 - Executive Officers
Page 120 - Piergiorgio Donati, Head of Technical Operations and Program Management: Mr. Donati joined AC Immune
Page 121 - Friedrich von Bohlen und Halbach, Ph.D., Director: Dr. von Bohlen has served on our board since Octo
Page 122 - Equity Incentive Plans
Page 123 - Equity Compensation
Page 124 - Committees of the Board of Directors
Page 125 - Compensation, Nomination and Governance Committee
Page 126 - N/A
Page 127 - Holders
Page 128 - Registration Rights Agreement
Page 129 - Related Person Transaction Policy
Page 130 - N/A
Page 131 - Taxation of AC Immune SA
Page 132 - Swiss cantonal and communal private wealth tax and capital tax
Page 133 - Swiss Federal Stamp Taxes
Page 134 - Taxation of Distributions
Page 135 - Passive Foreign Investment Company Rules
Page 136 - Information Reporting and Backup Withholding
Page 137 - The Company s activities expose it to the following financial risks: market risk (currency and inter
Page 138 - N/A
Page 139 - Code of business conduct and ethics
Page 140 - Pre-Approval Policies and Procedures
Page 141 - We have responded to Item 18 in lieu of this item.
Page 142 - N/A
Page 143 - Signatures
Page 144 - INDEX TO FINANCIAL STATEMENTS
Page 145 - Report of Independent Registered Public Accounting Firm
Page 146 - Report of Independent Registered Public Accounting Firm
Page 147 - Financial Statements (IFRS)
Page 148 - tatements of Loss
Page 149 - Statements of Changes in Equity
Page 150 - Statements of Cash Flows
Page 151 - Supplementary non-cash activity include the following:
Page 152 - Notes to the Financial Statements
Page 153 - Current vs. non-current classification
Page 154 - Research and Development Services
Page 155 - Fair value of financial assets and liabilities
Page 156 - Employee benefits
Page 157 - Provisions
Page 158 - Income taxes
Page 159 - N/A
Page 160 - N/A
Page 161 - Preferred Shares
Page 162 - Follow-On Offerings
Page 163 - N/A
Page 164 - N/A
Page 165 - N/A
Page 166 - N/A
Page 167 - N/A
Page 168 - N/A
Page 169 - N/A
Page 170 - Research and Development
Page 171 - N/A
Page 172 - N/A
Page 173 - N/A
Page 174 - N/A
Page 175 - N/A
Page 176 - N/A
Page 177 - N/A
Page 178 - N/A
Page 179 - Foreign exchange risk
Page 180 - N/A
Page 181 - N/A
Page 182 - N/A
Subdocument 2 - EX-4.14 - EXHIBIT 4.14
Page 1 - Exhibit 4.14
Page 2 - TABLE OF CONTENTS
Page 3 - N/A
Page 4 - SCHEDULES
Page 5 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 6 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 7 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 8 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 9 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 10 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 11 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 12 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 13 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 14 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 15 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 16 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 17 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 18 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 19 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 20 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 21 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 22 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 23 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 24 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 25 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 26 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 27 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
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Page 34 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 35 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 36 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 37 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 38 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 39 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
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Page 48 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
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Page 53 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 54 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 55 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 56 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 57 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
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Page 62 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
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Page 65 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 66 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 67 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 68 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 69 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 70 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 71 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 72 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 73 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 74 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 75 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 76 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 77 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 78 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 79 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 80 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 81 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 82 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 83 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
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Page 89 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 90 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 91 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Page 92 - CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
Subdocument 3 - EX-4.15 - EXHIBIT 4.15
Page 1 - Exhibit 4.15
Page 2 - TABLE OF CONTENTS
Page 3 - Preamble
Page 4 - N/A
Page 5 - Long Stop Date ) shall automatically be converted into common shares of the Company (such shares, in
Page 6 - N/A
Page 7 - N/A
Page 8 - N/A
Page 9 - Intellectual Property means all patents, patent applications, patent rights, inventions, know-how, t
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - N/A
Page 17 - N/A
Page 18 - Annexes
Page 19 - Annex 1
Page 20 - N/A
Page 21 - Annex 2
Page 22 - Annex 3
Page 23 - N/A
Subdocument 4 - EX-12.1 - EXHIBIT 12.1
Page 1 - N/A
Subdocument 5 - EX-12.2 - EXHIBIT 12.2
Page 1 - N/A
Subdocument 6 - EX-13.1 - EXHIBIT 13.1
Page 1 - N/A
Subdocument 7 - EX-13.2 - EXHIBIT 13.2
Page 1 - N/A
Subdocument 8 - EX-15.1 - EXHIBIT 15.1
Page 1 - N/A
Subdocument 9 - EX-15.2 - EXHIBIT 15.2
Page 1 - N/A
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