SEC Filings
Form 10-Q
COLLEGIUM PHARMACEUTICAL, INC filed this Form 10-Q on 11/08/2018
Document Outline
Entire Document (4635.4 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 - 2. Summary of Significant Accounting Policies
Page 9 - Advertising and Product Promotion Costs
Page 10 - Subsequent Events
Page 11 - Customers
Page 12 - Adoption of ASC Topic 606, Revenue from Contracts with Customers
Page 13 - Disaggregation of Revenue
Page 14 - 4. Loss per Common Share
Page 15 - 6. Inventory
Page 16 - Nucynta Asset Acquisition Obligations
Page 17 - Onsolis Intangible Asset
Page 18 - 8. Accrued Expenses
Page 19 - 10. Equity
Page 20 - N/A
Page 21 - Employee Stock Purchase Plan
Page 22 - Nucynta Litigation
Page 23 - Opioid Litigation
Page 24 - Item 2. Management s Discussion and Analysis of Financial Condition and Results of Operations.
Page 25 - CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Page 26 - Revenue Recognition
Page 27 - Comparison of the nine months ended months September 30, 2018 and September 30, 2017
Page 28 - LIQUIDITY AND CAPITAL RESOURCES
Page 29 - Cash Flows
Page 30 - ADDITIONAL INFORMATION
Page 31 - CONTRACTUAL OBLIGATIONS
Page 32 - Item 4. Controls and Procedures.
Page 33 - PART II OTHER INFORMATION
Page 34 - If we require additional capital to fund our operations and we fail to obtain necessary financing, w
Page 35 - Raising additional capital may cause dilution to our existing shareholders, restrict our operations
Page 36 - Our ability to use our net operating loss carryforwards and certain other tax attributes may be limi
Page 37 - We have been and may be the subject of litigation matters, including government investigations, for
Page 38 - Despite receiving approval by the FDA, additional data may emerge that could change the FDA s positi
Page 39 - The regulatory approval processes of the FDA are lengthy, time-consuming and unpredictable, and if w
Page 40 - Development of our product candidates is not complete, and we cannot be certain that our product can
Page 41 - Xtampza and the Nucynta Products are subject to mandatory REMS programs, which could increase the co
Page 42 - Although Xtampza has been approved with abuse deterrent labeling, the FDA could require changes to s
Page 43 - Failure to comply with ongoing governmental regulations for marketing any product, including Xtampza
Page 44 - Our products and our product candidates contain controlled substances, the manufacture, use, sale, i
Page 45 - Because the results of preclinical studies and early-stage clinical trials are not necessarily predi
Page 46 - Our products and our product candidates may be associated with undesirable adverse reactions or have
Page 47 - Risks Related to Intellectual Property
Page 48 - If we are unable to obtain or maintain intellectual property rights for our technology, products and
Page 49 - We may be forced to litigate to enforce or defend our intellectual property, which could be expensiv
Page 50 - We may be subject to claims by third parties of ownership of what we regard as our own intellectual
Page 51 - Risks Related to the Commercialization of Our Products and Product Candidates
Page 52 - Recently enacted and future legislation may increase the difficulty and cost for us to commercialize
Page 53 - N/A
Page 54 - Our products and any of our product candidates (if approved) may become subject to unfavorable prici
Page 55 - N/A
Page 56 - If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent
Page 57 - N/A
Page 58 - Because we currently rely on a sole supplier to manufacture the active pharmaceutical ingredient of
Page 59 - Our products and product candidates for which we obtain marketing approval could be, subject to post
Page 60 - We may rely on collaborators to market and commercialize our products, and, if approved, our product
Page 61 - Manufacturing issues may arise that could increase product and regulatory approval costs, delay comm
Page 62 - The use of legal and regulatory strategies by competitors with innovator products may delay or preve
Page 63 - Our future success depends on our ability to retain our key personnel.
Page 64 - We may acquire other assets or businesses, or form collaborations or make investments in other compa
Page 65 - Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse
Page 66 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 67 - Our business and operations would suffer in the event of computer system failures, accidents or secu
Page 68 - Sales of a substantial number of shares of our common stock in the public market could cause our sto
Page 69 - Actual or potential sales of our common stock by our directors or employees, including our executive
Page 70 - We are subject to anti-takeover provisions in our amended and restated articles of incorporation and
Page 71 - If securities or industry analysts do not publish research or publish inaccurate or unfavorable rese
Page 72 - If we fail to maintain an effective system of internal control over financial reporting, we may not
Page 73 - We have broad discretion in the use of our cash and cash equivalents, and, despite our efforts, we m
Page 74 - PURCHASE OF EQUITY SECURITIES
Page 75 - Item 6. Exhibits.
Page 76 - SIGNATURES
Subdocument 2 - EX-10.2 - EX-10.2
Page 1 - Exhibit 10.2
Page 2 - N/A
Page 3 - N/A
Subdocument 3 - EX-10.3 - EX-10.3
Page 1 - Exhibit 10.3
Page 2 - Termination Payment.
Page 3 - N/A
Page 4 - REMAINING SPACE PLAN
Subdocument 4 - EX-10.4 - EX-10.4
Page 1 - Exhibit 10.4
Page 2 - Repayment
Page 3 - 2.4 Payments; Application of Payments; Debit of Accounts.
Page 4 - Status of Lenders
Page 5 - Refunds
Page 6 - 3.2 Conditions Precedent to all Credit Extensions
Page 7 - 4.2 Priority of Security Interest
Page 8 - 5.2 Collateral
Page 9 - 5.7 Subsidiaries; Investments
Page 10 - 6.2 Financial Statements, Reports, Certificates.
Page 11 - 6.5 Insurance
Page 12 - 6.7 Financial Covenant Liquidity Ratio
Page 13 - 7.2 Changes in Business, Management, Control or Business Locations.
Page 14 - 7.8 Transactions with Affiliates.
Page 15 - 8.4 Attachment; Levy; Restraint on Business.
Page 16 - 8.12 Minimum Quarterly Payments
Page 17 - 9.2 Power of Attorney
Page 18 - 10. NOTICES
Page 19 - BOTH PARTIES TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL
Page 20 - 12.7 Amendments in Writing; Waiver; Integration
Page 21 - 12.13 Construction of Agreement
Page 22 - Bank Expenses
Page 23 - Claims
Page 24 - Default Rate
Page 25 - Final Payment
Page 26 - Insolvency Proceeding
Page 27 - Liquidity Ratio
Page 28 - Patents
Page 29 - Permitted Liens
Page 30 - Person
Page 31 - Registered Organization
Page 32 - Trademarks
Page 33 - IN WITNESS WHEREOF
Page 34 - EXHIBIT A COLLATERAL DESCRIPTION
Page 35 - EXHIBIT B
Page 36 - Other Matters
Page 37 - Schedule 1 to Compliance Certificate
Page 38 - EXHIBIT C LOAN PAYMENT/ADVANCE REQUEST FORM
Subdocument 5 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 6 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 7 - EX-32.1 - EX-32.1
Page 1 - N/A
Subdocument 8 - EX-32.2 - EX-32.2
Page 1 - N/A
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