SEC Filings
Form 10-Q
COLLEGIUM PHARMACEUTICAL, INC filed this Form 10-Q on 08/08/2018
Document Outline
Entire Document (4072.9 KB)
Subdocument 1 - 10-Q - 10-Q
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - FORWARD-LOOKING STATEMENTS
Page 4 - PART I FINANCIAL INFORMATION
Page 5 - Collegium Pharmaceutical, Inc.
Page 6 - Collegium Pharmaceutical, Inc.
Page 7 - Collegium Pharmaceutical, Inc.
Page 8 - Significant Accounting Policies
Page 9 - Advertising and Product Promotion Costs
Page 10 - Customers
Page 11 - Adoption of ASC Topic 606, Revenue from Contracts with Customers
Page 12 - Disaggregation of Revenue
Page 13 - 4. Loss per Common Share
Page 14 - 6. Inventory
Page 15 - Nucynta Asset Acquisition Obligations
Page 16 - Onsolis Intangible Asset
Page 17 - 8. Accrued Expenses
Page 18 - 10. Equity
Page 19 - N/A
Page 20 - Employee Stock Purchase Plan
Page 21 - Nucynta Litigation
Page 22 - Opioid Litigation
Page 23 - Outlook
Page 24 - CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Page 25 - RESULTS OF OPERATIONS
Page 26 - Comparison of the six months ended months June 30, 2018 and June 30, 2017
Page 27 - LIQUIDITY AND CAPITAL RESOURCES
Page 28 - Cash Flows
Page 29 - ADDITIONAL INFORMATION
Page 30 - CONTRACTUAL OBLIGATIONS
Page 31 - Item 4. Controls and Procedures.
Page 32 - PART II OTHER INFORMATION
Page 33 - If we require additional capital to fund our operations and we fail to obtain necessary financing, w
Page 34 - Raising additional capital may cause dilution to our existing shareholders, restrict our operations
Page 35 - The Commercialization Agreement with Depomed, pursuant to which we assumed responsibility for the sa
Page 36 - We have been and may be the subject of litigation matters, including government investigations, for
Page 37 - Risks Related to our Products and Product Candidates
Page 38 - Despite receiving approval by the FDA, additional data may emerge that could change the FDA s positi
Page 39 - Our decision to seek approval of our product candidates under Section 505(b)(2) increases the risk t
Page 40 - N/A
Page 41 - Development of our product candidates is not complete, and we cannot be certain that our product can
Page 42 - If we fail to comply with our obligations in the agreements under which we license intellectual prop
Page 43 - Although Xtampza has been approved with abuse deterrent labeling, the FDA could require changes to s
Page 44 - Failure to comply with ongoing governmental regulations for marketing any product, including Xtampza
Page 45 - Xtampza, the Nucynta Products and our product candidates contain controlled substances, the manufact
Page 46 - Because the results of preclinical studies and early-stage clinical trials are not necessarily predi
Page 47 - Xtampza, the Nucynta Products, and our product candidates may be associated with undesirable adverse
Page 48 - N/A
Page 49 - If we are unable to obtain or maintain intellectual property rights for our technology, products and
Page 50 - We may be forced to litigate to enforce or defend our intellectual property, which could be expensiv
Page 51 - If we are unable to protect the confidentiality of our trade secrets, our business and competitive p
Page 52 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 53 - If physicians, patients, healthcare payors and the medical community do not accept and use Xtampza,
Page 54 - Recently enacted and future legislation may increase the difficulty and cost for us to commercialize
Page 55 - Our products and any of our product candidates (if approved) may become subject to unfavorable prici
Page 56 - Social issues around the abuse of opioids, including law enforcement concerns over diversion of opio
Page 57 - If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent
Page 58 - Guidelines and recommendations published by various organizations can reduce the use of our products
Page 59 - Because we currently rely on a sole supplier to manufacture the active pharmaceutical ingredient of
Page 60 - N/A
Page 61 - Xtampza and the Nucynta Products are, and product candidates for which we obtain marketing approval
Page 62 - We may rely on collaborators to market and commercialize our products, and, if approved, our product
Page 63 - Risks Related to Our Business and Strategy
Page 64 - The use of legal and regulatory strategies by competitors with innovator products may delay or preve
Page 65 - We will need to grow the size of our organization, and we may experience difficulties in managing th
Page 66 - Our employees, independent contractors, principal investigators, CROs, consultants and vendors may e
Page 67 - N/A
Page 68 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 69 - Risks Related to Our Common Stock
Page 70 - Sales of a substantial number of shares of our common stock in the public market could cause our sto
Page 71 - Future issuances of our common stock or rights to purchase common stock, including pursuant to our e
Page 72 - N/A
Page 73 - We may fail to qualify for continued listing on The NASDAQ Global Select Market which could make it
Page 74 - If we fail to maintain an effective system of internal control over financial reporting, we may not
Page 75 - We have broad discretion in the use of our cash and cash equivalents, and, despite our efforts, we m
Page 76 - PURCHASE OF EQUITY SECURITIES
Page 77 - Item 6. Exhibits.
Page 78 - SIGNATURES
Subdocument 2 - EX-10.3 - EX-10.3
Page 1 - Exhibit 10.3
Page 2 - Equity Incentive AwardRSU AwardPlan
Page 3 - Termination without Cause or for Good Reason
Page 4 - Section 5.3
Page 5 - Board
Page 6 - ConfidentialityRegulators
Page 7 - Property of the Company
Page 8 - Intellectual Property
Page 9 - Judicial Modification
Page 10 - Survival
Page 11 - Signature Page to Employment Agreement
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - N/A
Subdocument 6 - EX-32.2 - EX-32.2
Page 1 - N/A
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