SEC Filings

Form 10-K
MOMENTA PHARMACEUTICALS INC filed this Form 10-K on 02/22/2019
Document Outline
Entire Document (7861.2 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - MANAGEMENT'S DISCUSSION
Page 3 - CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 4 - PART I
Page 5 - Novel Therapeutics
Page 6 - Our Programs
Page 7 - M254 - Hyper-sialylated IgG Candidate
Page 8 - M710 Biosimilar EYLEA (aflibercept) Candidate
Page 9 - Enoxaparin Sodium Injection Generic LOVENOX
Page 10 - Mylan
Page 11 - Sandoz
Page 12 - Manufacturing
Page 13 - Sales, Marketing and Distribution
Page 14 - Approval Process for Biosimilars
Page 15 - Manufacturing Requirements
Page 16 - Post-Approval Requirements
Page 17 - Foreign Regulation
Page 18 - Hazardous Materials
Page 19 - M254 Competing Immunoglobulins
Page 20 - Research and Development Expenses
Page 21 - If we or our collaborative partners encounter difficulties in our supply or manufacturing arrangemen
Page 22 - The development and commercialization of our lead biosimilar product candidate, M923, could be delay
Page 23 - GLATOPA 40 mg/mL was launched prior to final resolution of product-related patent infringement litig
Page 24 - If our appeal in the patent litigation against Amphastar related to Enoxaparin Sodium Injection is n
Page 25 - Even if we receive approval to market our product candidates, the market may not be receptive to our
Page 26 - Our business and operations would suffer in the event of system failures or security breaches.
Page 27 - If we fail to maintain appropriate internal controls in the future, we may not be able to report our
Page 28 - Risks Relating to Our Financial Position and Need for Additional Capital
Page 29 - Raising additional capital by issuing securities or through collaboration and licensing arrangements
Page 30 - Our product candidates may cause serious adverse events or undesirable side effects or have other pr
Page 31 - Interim, top-line and preliminary data from our clinical trials that we announce or publish from tim
Page 32 - Although the BPCI Act establishes a regulatory pathway for the approval by the FDA of biosimilars, t
Page 33 - Our opportunity to realize value from the potential of the biosimilars market is difficult and chall
Page 34 - Even if we obtain regulatory approvals, our marketed products will be subject to ongoing regulatory
Page 35 - If third-party payers do not adequately reimburse customers for any of our approved products, they m
Page 36 - Federal legislation will increase the pressure to reduce prices of pharmaceutical products paid for
Page 37 - Foreign governments tend to impose strict price or reimbursement controls, which may adversely affec
Page 38 - If other generic versions of the brand name drugs, or other biosimilars of the reference products, f
Page 39 - If an alternative version of a reference product, such as COPAXONE, HUMIRA or EYLEA , is developed t
Page 40 - If the market for a reference product, such as COPAXONE, HUMIRA or EYLEA, significantly declines, sa
Page 41 - Third parties may allege that we are infringing their intellectual property rights, forcing us to ex
Page 42 - If we remain involved in patent litigation or other proceedings to determine or enforce our intellec
Page 43 - The Mylan Collaboration Agreement is important to our business. If we or Mylan fail to adequately pe
Page 44 - We may need to enter into additional strategic alliances with other companies that can provide capab
Page 45 - If we are unable to establish sales and marketing capabilities or enter into agreements with third p
Page 46 - Our stock price may be volatile, and purchasers of our common stock could incur substantial losses.
Page 47 - We could be subject to class action litigation due to stock price volatility, which, if it occurs, w
Page 48 - M834-Related Proceedings
Page 49 - Item 4. MINE SAFETY DISCLOSURES
Page 50 - PART II
Page 51 - Stock Performance Graph
Page 52 - Financial Statements and Supplementary DataManagement's Discussion and Analysis of Financial Conditi
Page 53 - Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Page 54 - GLATOPA (glatiramer acetate injection) 40 mg/mL Generic Three-times-weekly COPAXONE (glatiramer acet
Page 55 - Novel Therapeutics
Page 56 - Product Revenue
Page 57 - Research and Development Revenue
Page 58 - N/A
Page 59 - 2018 vs 2017
Page 60 - 2018 vs 2017
Page 61 - Cash (used in) provided by operating activities
Page 62 - Cash provided (used in) by investing activities
Page 63 - Collaboration and License Arrangements
Page 64 - Collaborative Arrangements
Page 65 - Share-Based Compensation
Page 66 - Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Page 67 - MOMENTA PHARMACEUTICALS, INC.
Page 68 - MOMENTA PHARMACEUTICALS, INC.
Page 69 - MOMENTA PHARMACEUTICALS, INC.
Page 70 - MOMENTA PHARMACEUTICALS, INC.
Page 71 - MOMENTA PHARMACEUTICALS, INC.
Page 72 - Collaborative Arrangements
Page 73 - Collaboration Receivable
Page 74 - Collaboration Liability
Page 75 - Property and Equipment
Page 76 - Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting
Page 77 - Accounting Pronouncements Adopted
Page 78 - 3. Fair Value Measurements
Page 79 - 4. Cash, Cash Equivalents and Marketable Securities
Page 80 - 5. Property and Equipment and Assets Held-for-Sale
Page 81 - 7. Restricted Cash
Page 82 - 9. Collaboration and License Agreements
Page 83 - 2006 Sandoz Agreement
Page 84 - Collaborative Agreements
Page 85 - Upfront Payments for License of Intellectual Property
Page 86 - CSL License and Option Agreement
Page 87 - Co-funding Costs and Reimbursements
Page 88 - 10. Preferred, Common and Treasury Stock
Page 89 - Common Stock
Page 90 - Share-Based Compensation
Page 91 - Restricted Stock and Restricted Stock Units
Page 92 - 2018 Performance-Based Restricted Stock Units
Page 93 - Share-Based Compensation
Page 94 - N/A
Page 95 - 14. Restructuring
Page 96 - Purchase Obligations
Page 97 - M834-Related Proceedings
Page 98 - 16. 401(k) Plan
Page 99 - 18. Selected Quarterly Financial Data (Unaudited)
Page 100 - Management's Annual Report on Internal Control Over Financial Reporting
Page 101 - Basis for Opinion
Page 102 - PART III
Page 103 - PART IV
Page 104 - EXHIBIT INDEX
Page 105 - N/A
Page 106 - N/A
Page 107 - N/A
Page 108 - Item 16. FORM 10-K SUMMARY
Subdocument 2 - EX-10.35 - EXHIBIT 10.35
Page 1 - Exhibit 10.35
Page 2 - Execution Copy
Page 3 - Execution Copy
Page 4 - Execution Copy
Page 5 - Execution Copy
Page 6 - Execution Copy
Subdocument 3 - EX-10.36 - EXHIBIT 10.36
Page 1 - Exhibit 10.36
Page 2 - Execution Copy
Page 3 - Execution Copy
Page 4 - Execution Copy
Page 5 - Execution Copy
Page 6 - Execution Copy
Subdocument 4 - EX-10.37 - EXHIBIT 10.37
Page 1 - Exhibit 10.37
Page 2 - Execution Copy
Page 3 - Execution Copy
Page 4 - Execution Copy
Page 5 - Execution Copy
Page 6 - Execution Copy
Subdocument 5 - EX-10.38 - EXHIBIT 10.38
Page 1 - Exhibit 10.38
Page 2 - Change in Control
Page 3 - Good Reason
Page 4 - Injunctive Relief
Page 5 - Acknowledgment
Page 6 - N/A
Page 7 - AmendmentCompanyEmployee
Page 8 - Contribution Period
Subdocument 6 - EX-10.39 - EXHIBIT 10.39
Page 1 - Exhibit 10.39
Page 2 - Change in Control Date
Page 3 - Cause
Page 4 - Injunctive Relief
Page 5 - Successors and Assigns
Page 6 - Miscellaneous
Page 7 - AmendmentCompanyEmployee
Page 8 - Contribution Period
Subdocument 7 - EX-10.41.6 - EXHIBIT 10.41.6
Page 1 - Exhibit 10.41.6
Page 2 - sstorer@momentapharma.com
Page 3 - N/A
Subdocument 8 - EX-21 - EXHIBIT 21
Page 1 - N/A
Subdocument 9 - EX-23.1 - EXHIBIT 23.1
Page 1 - N/A
Subdocument 10 - EX-31.1 - EXHIBIT 31
Page 1 - N/A
Subdocument 11 - EX-31.2 - EXHIBIT 31.2
Page 1 - N/A
Subdocument 12 - EX-32.1 - EXHIBIT 32.1
Page 1 - Exhibit 32.1
Page 2 - N/A
Subdocument - EX-101.INS - XBRL INSTANCE DOCUMENT
Subdocument - EX-101.SCH - XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT
Subdocument - EX-101.CAL - XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT
Subdocument - EX-101.DEF - XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT
Subdocument - EX-101.LAB - XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT
Subdocument - EX-101.PRE - XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT
Subdocument - XBRL Viewer