Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) of the Securities Exchange Act of 1934, or Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation as of the end of the period covered by this Annual Report on Form 10-K of the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective at the reasonable assurance level in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:
(1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures are being made only in accordance with the authorizations of management and directors; and
(3) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework provided in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2020.
The effectiveness of our internal control over financial reporting as of December 31, 2020 has been audited by Ernst and Young LLP, an independent registered public accounting firm, as stated in their report, which is included herein.
Changes in Internal Control
As required by Rule 13a-15(d) of the Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation of the internal control over financial reporting to determine whether any changes occurred during the quarter ended December 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
Based on that evaluation, our principal executive officer and principal financial officer concluded no changes during the quarter ended December 31, 2020 materially affected, or were reasonably likely to materially affect, our internal controls over financial reporting.
74
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Ironwood Pharmaceuticals, Inc.
Opinion on Internal Control over Financial Reporting
We have audited Ironwood Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Ironwood Pharmaceuticals, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2020, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2020 and 2019, the related consolidated statements of comprehensive income (loss), shareholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2020, and the related notes and our report dated February 17, 2021 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Boston, Massachusetts
February 17, 2021
75
Table of Contents
Item 9B. Other Information
None.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
We have adopted a code of business conduct and ethics applicable to our directors, executive officers and all other employees. A copy of that code is available on our corporate website at http://www.ironwoodpharma.com. Any amendments to the code of business conduct and ethics, and any waivers thereto involving our executive officers, also will be available on our corporate website. A printed copy of these documents will be made available upon request. The content on our website is not incorporated by reference into this Annual Report on Form 10-K.
The other information required by this item is incorporated by reference from our proxy statement for our 2021 Annual Meeting of Stockholders.
Item 11. Executive Compensation
The information required by this item is incorporated by reference from our proxy statement for our 2021 Annual Meeting of Stockholders.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information relating to security ownership of certain beneficial owners of our common stock and information relating to the security ownership of our management required by this item is incorporated by reference from our proxy statement for our 2021 Annual Meeting of Stockholders.
The table below sets forth information with regard to securities authorized for issuance under our equity compensation plans as of December 31, 2020. As of December 31, 2020, we had three active equity compensation plans, each of which was approved by our stockholders:
● Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan;
● 2019 Equity Incentive Plan; and
● Amended and Restated 2010 Employee Stock Purchase Plan.
Plan Category
Number of securities to be issued upon exercise of outstanding options, warrants and rights (1)
Weighted-average exercise price of outstanding options, warrants, and rights (2)
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(a)
(b)
(c)
Equity compensation plans approved by security holders
18,216,454
$ 12.25
9,651,783
Equity compensation plans not approved by security holders
—
—
—
Total
18,216,454
$ 12.25
9,651,783
(1)
Amount includes the number of shares subject to issuance upon exercise of 13,459,671 outstanding stock options and vesting of 4,756,783 restricted stock units.
(2)
Amount includes all outstanding stock options but does not include restricted stock units, which do not have an exercise price.
76
Table of Contents
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated by reference from our proxy statement for our 2021 Annual Meeting of Stockholders.
Item 14. Principal Accountant Fees and Services
The information required by this item is incorporated by reference from our proxy statement for our 2021 Annual Meeting of Stockholders.
77
Table of Contents
PART IV
Item 15. Exhibits and Financial Statement Schedules
1.
List of documents filed as part of this report
1.
Consolidated Financial Statements listed under Part II, Item 8 and included herein by reference.
2.
Consolidated Financial Statement Schedules
No schedules are submitted because they are not applicable, not required or because the information is included in the Consolidated Financial Statements or Notes to Consolidated Financial Statements.
3.
Exhibits
Incorporated by reference herein
Number
Description
Form
Date
2.1
Separation Agreement, dated as of March 30, 2019, by and between Ironwood Pharmaceuticals, Inc. and Cyclerion Therapeutics, Inc.
Current Report on Form 8-K (File No. 001-34620)
April 4, 2019
3.1
Eleventh Amended and Restated Certificate of Incorporation
Annual Report on Form 10-K (File No. 001-34620)
March 30, 2010
3.2
Certificate of Retirement
Registration Statement on Form 8-A/A (File No. 001-34620)
January 3, 2019
3.3
Certificate of Amendment
Current Report on Form 8-K (File No. 001-34620)
May 31, 2019
3.4
Fifth Amended and Restated Bylaws
Annual Report on Form 10-K (File No. 001-34620)
March 30, 2010
4.1
Specimen Class A Common Stock certificate
Registration Statement on Form S-1, as amended (File No. 333-163275)
January 20, 2010
4.2
Indenture, dated as of June 15, 2015, by and between Ironwood Pharmaceuticals, Inc. and U. S. Bank National Association (including the form of the 2.25% Convertible Senior Note due 2022)
Current Report on Form 8-K (File No. 001-34620)
June 15, 2015
4.2.1
Supplemental Indenture dated as of April 5, 2019 by and between Ironwood Pharmaceuticals, Inc. and U.S. Bank National Association
Current Report on Form 8-K (File No. 001-34620)
April 8, 2019
4.2.2
Form of 2.25% Convertible Senior Note due 2022
Current Report on Form 8 K (File No. 001 34620)
June 15, 2015
4.3
Indenture, dated as of August 12, 2019, by and between Ironwood Pharmaceuticals, Inc. and U.S. Bank National Association (including the form of the 0.75% Convertible Senior Note due 2024)
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
78
Table of Contents
4.3.1
Form of 0.75% Convertible Senior Note due 2024
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
4.4
Indenture, dated as of August 12, 2019, by and between Ironwood Pharmaceuticals, Inc. and U.S. Bank National Association (including the form of the 1.50% Convertible Senior Note due 2026)
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
4.4.1
Form of 1.50% Convertible Senior Note due 2026
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
4.5*
Description of Securities of Ironwood Pharmaceuticals, Inc.
10.1#
Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan
Registration Statement on Form S-8, as amended (File No. 333-184396)
October 12, 2012
10.1.1#
Form of Stock Option Agreement under the Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
November 6, 2018
10.1.2#
Form of Restricted Stock Unit Agreement under the Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
November 6, 2018
10.2#
2019 Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
July 30, 2019
10.2.1#
Form of Non-statutory Stock Option Agreement under the 2019 Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
July 30, 2019
10.2.2#
Form of Restricted Stock Unit Agreement under the 2019 Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
July 30, 2019
10.2.3#
Form of Restricted Stock Agreement under the 2019 Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
July 30, 2019
10.2.4#
Form of Performance-Based Restricted Stock Unit Award Agreement under the 2019 Equity Incentive Plan
Quarterly Report on Form 10-Q (File No. 001-34620)
May 6, 2020
10.3#
Amended and Restated 2010 Employee Stock Purchase Plan
Annual Report on Form 10-K (File No. 001-34620)
February 13, 2020
10.4#
Change of Control Severance Benefit Plan, as amended and restated
Quarterly Report on Form 10-Q (File No. 001-34620)
April 29, 2014
10.5#
Form of Executive Severance Agreement
Annual Report on Form 10-K (File No. 001-34620)
February 25, 2019
79
Table of Contents
10.6#
Non-employee Director Compensation Policy, effective May 20, 2019
Quarterly Report on Form 10-Q (File No. 001-34620)
July 30, 2019
10.7#
Form of Indemnification Agreement with Directors and Officers
Registration Statement on Form S-1, as amended (File No. 333-163275)
December 23, 2009
10.8#
Offer Letter, dated January 3, 2019, between Ironwood Pharmaceuticals, Inc. and Mark Mallon
Current Report on Form 8-K (File No. 001-34620)
January 4, 2019
10.9+
Collaboration Agreement, dated as of September 12, 2007, as amended on November 3, 2009, by and between Forest Laboratories, Inc. and Ironwood Pharmaceuticals, Inc.
Registration Statement on Form S-1, as amended (File No. 333-163275)
February 2, 2010
10.9.1
Amendment No. 2 to the Collaboration Agreement, dated as of January 8, 2013, by and between Forest Laboratories, Inc. and Ironwood Pharmaceuticals, Inc .
Annual Report on Form 10-K (File No. 001-34620)
February 21, 2013
10.10+
Commercial Agreement, dated as of January 31, 2017, by and among Allergan USA, Inc., Forest Laboratories, LLC and Ironwood Pharmaceuticals, Inc.
Quarterly Report on Form 10-Q (File No. 001-34620)
May 8, 2017
10.11+
License Agreement, dated as of April 30, 2009, by and between Allergan Pharmaceuticals International Ltd. (formerly with Almirall, S.A.) and Ironwood Pharmaceuticals, Inc.
Registration Statement on Form S-1, as amended (File No. 333-163275)
February 2, 2010
10.11.1+
Amendment No. 1 to License Agreement, dated as of June 11, 2013, by and between Allergan Pharmaceuticals International Ltd. (formerly with Almirall, S.A.) and Ironwood Pharmaceuticals, Inc .
Quarterly Report on Form 10-Q (File No. 001-34620)
August 8, 2013
10.11.2+
Amendment to the License Agreement, dated as of October 26, 2015, by and between Allergan Pharmaceuticals International Ltd. and Ironwood Pharmaceuticals, Inc.
Annual Report on Form 10-K (File No. 001-34620)
February 19, 2016
10.11.3+
Amendment to the License Agreement dated as of January 31, 2017, by and between Allergan Pharmaceuticals International Ltd., and Ironwood Pharmaceuticals, Inc .
Quarterly Report on Form 10-Q (File No. 001-34620)
May 8, 2017
10.12+
Novation Agreement, dated as of October 26, 2015, by and among Almirall, S.A., Allergan Pharmaceuticals International Ltd. and Ironwood Pharmaceuticals, Inc .
Annual Report on Form 10-K (File No. 001-34620)
February 19, 2016
80
Table of Contents
10.13+
Amended and Restated License Agreement, dated as of August 1, 2019, by and between Ironwood Pharmaceuticals, Inc. and Astellas Pharma Inc .
Current Report on Form 8-K (File No. 001-34620
August 1, 2019
10.13.1*
Amendment to the Amended and Restated License Agreement, dated as of January 8, 2021, by and between Ironwood Pharmaceuticals, Inc. and Astellas Pharma Inc.
10.14+
Amended and Restated License and Collaboration Agreement, dated as of September 16, 2019, by and between AstraZeneca AB and Ironwood Pharmaceuticals, Inc.
Current Report on Form 8-K (File No. 001-34620)
September 18, 2019
10.15+
Commercial Supply Agreement, dated as of June 23, 2010, by and among PolyPeptide Laboratories, Inc. and Polypeptide Laboratories (SWEDEN) AB, Forest Laboratories, Inc. and Ironwood Pharmaceuticals, Inc .
Quarterly Report on Form 10-Q (File No. 001-34620)
August 10, 2010
10.16+
Commercial Supply Agreement, dated as of March 28, 2011, by and among Corden Pharma Colorado, Inc. (f/k/a Roche Colorado Corporation), Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc .
Quarterly Report on Form 10-Q (File No. 001-34620)
May 13, 2011
10.16.1+
Amendment No. 3 to Commercial Supply Agreement, dated as of November 26, 2013, by and between Corden Pharma Colorado, Inc. (f/k/a Roche Colorado Corporation), Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc.
Annual Report on Form 10-K (File No. 001-34620)
February 7, 2014
10.17
Lease Agreement for facilities at 100 Summer Street, Boston, Massachusetts, dated as of June 11, 2019, by and between Ironwood Pharmaceuticals, Inc. and MA-100 Summer Street Owner, L.L.C.
Current Report on Form 8-K (File No. 001-34620)
June 13, 2019
10.18
Tax Matters Agreement, dated as of March 30, 2019, by and between Ironwood Pharmaceuticals, Inc. and Cyclerion Therapeutics, Inc.
Current Report on Form 8-K (File No. 001-34620)
April 4, 2019
10.19
Employee Matters Agreement, dated as of March 30, 2019, by and between Ironwood Pharmaceuticals, Inc. and Cyclerion Therapeutics, Inc.
Current Report on Form 8-K (File No. 001-34620)
April 4, 2019
81
Table of Contents
10.20
Base Call Option Transaction Confirmation, dated as of June 10, 2015, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.21
Base Call Option Transaction Confirmation, dated as of June 10, 2015, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC, through its agent Credit Suisse Securities (USA) LLC
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.22
Base Warrants Confirmation, dated as of June 10, 2015, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.23
Base Warrants Confirmation, dated as of June 10, 2015, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC, through its agent Credit Suisse Securities (USA) LLC
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.24
Additional Call Option Transaction Confirmation, dated as of June 22, 2015, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.25
Additional Call Option Transaction Confirmation, dated as of June 22, 2015, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC, through its agent Credit Suisse Securities (USA) LLC
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.26
Additional Warrants Confirmation, dated as of June 22, 2015, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association, London Branch
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.27
Additional Warrants Confirmation, dated as of June 22, 2015, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC, through its agent Credit Suisse Securities (USA) LLC
Quarterly Report on Form 10-Q (File No. 001-34620)
August 7, 2015
10.28
Base Call Option Transaction Confirmation for the 2024 Notes, dated as of August 7, 2019, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.29
Base Call Option Transaction Confirmation for the 2026 Notes, dated as of August 7, 2019, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
82
Table of Contents
10.30
Base Call Option Transaction Confirmation for the 2024 Notes, dated as of August 7, 2019, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.31
Base Call Option Transaction Confirmation, for the 2026 Notes, dated as of August 7, 2019, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.32
Additional Call Option Transaction Confirmation for the 2024 Notes, dated as of August 12, 2019, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.33
Additional Call Option Transaction Confirmation for the 2026 Notes, dated as of August 12, 2019, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.34
Additional Call Option Transaction Confirmation for the 2024 Notes, dated as of August 12, 2019, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.35
Additional Call Option Transaction Confirmation for the 2026 Notes, dated as of August 12, 2019, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC
Current Report on Form 8-K (File No. 001-34620)
August 13, 2019
10.36
Call Spread Unwind Agreement, dated as of August 7, 2019, between Ironwood Pharmaceuticals, Inc. and JPMorgan Chase Bank, National Association
Annual Report on Form 10-K (File No. 001-34620)
February 13, 2020
10.37
Call Spread Unwind Agreement, dated as of August 7, 2019, between Ironwood Pharmaceuticals, Inc. and Credit Suisse Capital LLC
Annual Report on Form 10-K (File No. 001-34620)
February 13, 2020
21.1
Subsidiaries of Ironwood Pharmaceuticals, Inc.
Annual Report on Form 10-K (File No. 001-34620)
February 13, 2020
23.1*
Consent of Independent Registered Public Accounting Firm
31.1*
Certification of Chief Executive Officer pursuant to Rules 13a-14 or 15d-14 of the Exchange Act
83
Table of Contents
31.2*
Certification of Chief Financial Officer pursuant to Rules 13a-14 or 15d-14 of the Exchange Act
32.1‡
Certification of Chief Executive Officer pursuant to Rules 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350
32.2‡
Certification of Chief Financial Officer pursuant to Rules 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350
101.INS*
XBRL Instance Document – The Instance Document does not appear in the Interactive Data Files because its XBRL tags are embedded within the Inline XBRL document
101.SCH*
XBRL Taxonomy Extension Schema Document
101.CAL*
XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB*
XBRL Taxonomy Extension Label Linkbase Database
101.PRE*
XBRL Taxonomy ExtensionPresentation Linkbase Document
101.DEF*
XBRL Taxonomy Extension Definition Linkbase Document
104*
The cover page from this Annual Report on Form 10-K, formatted in Inline XBRL
*
Filed herewith.
‡
Furnished herewith.
+
Confidential treatment granted under 17 C.F.R. §§200.80(b)(4) and 230.406. The confidential portions of this exhibit have been omitted and are remeasured accordingly. The confidential portions have been provided separately to the SEC pursuant to the confidential treatment request.
#
Management contract or compensatory plan, contract, or arrangement.
Item 16. Form 10-K Summary
None.
84
Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Boston, Commonwealth of Massachusetts, on the 17 th day of February 2021.
Ironwood Pharmaceuticals, Inc.
By:
/s/ Mark Mallon
Mark Mallon
Chief Executive Officer
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated.
Signature
Title
Date
/s/ Mark Mallon
Chief Executive Officer and Director (Principal Executive Officer)
February 17, 2021
Mark Mallon
/s/ Gina Consylman
Senior Vice President, Chief Financial Officer (Principal Financial Officer)
February 17, 2021
Gina Consylman
/s/ Kelly MacDonald
Vice President, Finance and Chief Accounting Officer (Principal Accounting Officer)
February 17, 2021
Kelly MacDonald
/s/ Julie H. McHugh
Chair of the Board
February 17, 2021
Julie H. McHugh
/s/ Mark Currie
Director
February 17, 2021
Mark Currie
Director
Alexander Denner
/s/ Andrew Dreyfus
Director
February 17, 2021
Andrew Dreyfus
/s/ Jon Duane
Director
February 17, 2021
Jon Duane
/s/ Marla Kessler
Director
February 17, 2021
Marla Kessler
/s/ Catherine Moukheibir
Director
February 17, 2021
Catherine Moukheibir
/s/ Lawrence S. Olanoff
Director
February 17, 2021
Lawrence S. Olanoff
85
Table of Contents
/s/ Edward P. Owens
Director
February 17, 2021
Edward P. Owens
/s/ J AY P . S HEPARD
Director
February 17, 2021
Jay P. Shepard
86
Table of Contents
Index to Consolidated Financial Statements of
Ironwood Pharmaceuticals, Inc.
Page
Report of Independent Registered Public Accounting Firm
F-2
Consolidated Balance Sheets as of December 31, 2020 and 2019
F-4
Consolidated Statements of Operations for the Years Ended December 31, 2020, 2019, and 2018
F-5
Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2020, 2019, and 2018
F-6
Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended December 31, 2020, 2019, and 2018
F-7
Consolidated Statements of Cash Flows for the Years Ended December 31, 2020, 2019, and 2018
F-9
Notes to Consolidated Financial Statements
F-11
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Ironwood Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Ironwood Pharmaceuticals, Inc. (the Company) as of December 31, 2020 and 2019, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2020, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2020, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 17, 2021 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosure to which it relates.
Collaboration Agreement for North America with AbbVie Inc.
Description of the Matter
Revenue recognized from the Collaboration Agreement for North America with AbbVie Inc. (together with its affiliates, or “AbbVie”) was $368.6 million for the sale of LINZESS in the U.S. for the year ended December 31, 2020. As discussed in Note 6 to the consolidated financial statements, the Company generates the majority of its revenue from a collaboration arrangement with AbbVie related to linaclotide (LINZESS). The Company records its share of the net profits or net losses from the sales of LINZESS in the U.S., less commercial expenses, and presents the settlement payments to and from AbbVie as collaboration expense or collaborative arrangements revenue, as applicable.
F-2
Table of Contents
Auditing revenue recognition under the AbbVie collaboration is especially challenging and requires significant auditor judgment because complete and accurate information regarding net profits realized from sales of LINZESS in the U.S. and the costs incurred in selling it may not be available at the time the financial statements are prepared.
How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design and tested the operating effectiveness of the Company’s internal controls over its collaboration revenue process. The Company maintains and operates a suite of controls over the Company’s evaluation of the completeness and accuracy of its quarterly reporting from AbbVie.
Our audit procedures included, among others, reviewing the Company’s contract with AbbVie, reviewing information provided by AbbVie, performing auditing procedures over gross sales and adjustments to arrive at net sales, cost of goods sold, and selling and marketing costs contributing to Ironwood’s share of net profits, and obtaining confirmation directly from AbbVie.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 1998.
Boston, Massachusetts
February 17, 2021
F-3
Table of Contents
Ironwood Pharmaceuticals, Inc.
Consolidated Balance Sheet s
(In thousands, except share and per share amounts)
December 31,
December 31,
2020
2019
ASSETS
Current assets:
Cash and cash equivalents
$
362,564
$
177,023
Accounts receivable, net
122,351
11,279
Related party accounts receivable, net
—
105,967
Inventory, net
—
648
Prepaid expenses and other current assets
9,189
10,685
Restricted cash
1,735
1,250
Total current assets
495,839
306,852
Restricted cash, net of current portion
485
971
Accounts receivable, net of current portion
23,401
32,597
Property and equipment, net
8,929
12,429
Operating lease right-of-use assets
16,576
17,743
Convertible note hedges
13,065
31,366
Other assets
943
790
Total assets
$
559,238
$
402,748
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$
661
$
3,978
Related party accounts payable, net
—
1,509
Accrued research and development costs
1,898
2,956
Accrued expenses and other current liabilities
26,486
30,465
Current portion of operating lease liabilities
3,128
1,146
Deferred revenue
—
875
Total current liabilities
32,173
40,929
Note hedge warrants
12,088
24,260
Convertible senior notes
430,256
407,994
Operating lease obligations, net of current portion
20,318
22,082
Other liabilities
1,763
734
Commitments and contingencies
Stockholders’ equity (deficit):
Preferred stock, $ 0.001 par value, 75,000,000 shares authorized, no shares issued and outstanding
—
—
Class A Common Stock, $ 0.001 par value, 500,000,000 shares authorized and 160,616,675 shares issued and outstanding at December 31, 2020 and 500,000,000 shares authorized and 157,535,962 shares issued and outstanding at December 31, 2019
161
158
Additional paid-in capital
1,528,535
1,478,823
Accumulated deficit
( 1,466,056 )
( 1,572,232 )
Total stockholders’ equity (deficit)
62,640
( 93,251 )
Total liabilities and stockholders’ equity (deficit)
$
559,238
$
402,748
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
Ironwood Pharmaceuticals, Inc.
Consolidated Statements of Operations
(In thousands, except per share amounts)
Years Ended December 31,
2020
2019
2018
Revenues:
Collaborative arrangements revenue
$
381,545
$
379,652
272,839
Product revenue, net
—
—
3,445
Sale of active pharmaceutical ingredient
7,978
48,761
70,355
Total revenues
389,523
428,413
346,639
Cost and expenses:
Cost of revenues, excluding amortization of acquired intangible assets
3,136
23,875
32,751
Write-down of commercial supply and inventory to net realizable value and (settlement) loss on non-cancellable purchase commitments
—
( 3,530 )
247
Research and development
88,062
115,044
101,060
Selling, general and administrative
140,003
172,450
219,676
Amortization of acquired intangible assets
—
—
8,111
Gain on fair value remeasurement of contingent consideration
—
—
( 31,045 )
Gain on lease modification
—
( 3,169 )
—
Restructuring expenses
15,382
3,620
14,715
Impairment of intangible assets
—
—
151,794
Total cost and expenses
246,583
308,290
497,309
Income (loss) from operations
142,940
120,123
( 150,670 )
Other (expense) income:
Interest expense
( 29,478 )
( 36,602 )
( 37,724 )
Interest and investment income
1,504
2,862
2,991
Gain (loss) on derivatives
( 6,129 )
3,023
( 8,743 )
Loss on extinguishment of debt
—
( 30,977 )
—
Other income
24
514
—
Other expense, net
( 34,079 )
( 61,180 )
( 43,476 )
Income (loss) from continuing operations, before income taxes
108,861
58,943
( 194,146 )
Income tax expense
2,685
—
—
Income (loss) from continuing operations
106,176
58,943
( 194,146 )
Loss from discontinued operations, net of income taxes
—
( 37,438 )
( 88,222 )
Net income (loss)
$
106,176
$
21,505
$
( 282,368 )
Income (loss) per share from continuing operations, net of income taxes—basic
$
0.67
$
0.38
$
( 1.27 )
Income (loss) per share from continuing operations, net of income taxes—diluted
$
0.66
$
0.38
$
( 1.27 )
Loss per share from discontinued operations, net of income taxes—basic and diluted
$
—
$
( 0.24 )
$
( 0.58 )
Net income (loss) per share—basic
$
0.67
$
0.14
$
( 1.85 )
Net income (loss) per share—diluted
$
0.66
$
0.14
$
( 1.85 )
Weighted average shares used in computing net income per share—basic:
159,427
156,023
152,634
Weighted average shares used in computing net income per share—diluted:
160,655
156,023
152,634
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Table of Contents
Ironwood Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Income (Los s)
(In thousands)
Years Ended December 31,
2020
2019
2018
Net income (loss)
$
106,176
$
21,505
$
( 282,368 )
Other comprehensive income:
Unrealized gains on available-for-sale securities
—
—
79
Total other comprehensive income
—
—
79
Comprehensive income (loss)
$
106,176
$
21,505
$
( 282,289 )
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Table of Contents
Ironwood Pharmaceuticals, Inc.
Consolidated Statements of Stockholders’ Equit y (Deficit)
(In thousands, except share amounts)
Accumulated
Class A
Class B
Additional
other
Total
Common Stock
Common Stock
paid-in
Accumulated
comprehensive
Stockholders’
Shares
Amount
Shares
Amount
capital
deficit
income (loss)
equity (deficit)
Balance at December 31, 2017
136,465,526
137
13,983,762
14
1,318,536
( 1,308,760 )
( 79 )
9,848
Issuance of common stock related to share-based awards and employee stock purchase plan
3,201,042
3
764,361
—
32,058
—
—
32,061
Conversion of Class B Common Stock to Class A Common Stock
14,748,123
14
( 14,748,123 )
( 14 )
—
—
—
—
Share-based compensation expense related to share-based awards to non-employees
—
—
—
—
—
—
—
—
Share-based compensation expense related to share-based awards to employees and employee stock purchase plan
—
—
—
—
44,009
—
—
44,009
Unrealized gains on available-for-sale securities
—
—
—
—
—
—
79
79
Net loss
—
—
—
—
—
( 282,368 )
—
( 282,368 )
Balance at December 31, 2018
154,414,691
154
—
—
1,394,603
( 1,591,128 )
—
( 196,371 )
Issuance of common stock related to share-based awards and employee stock purchase plan, net of cancellations
3,121,271
4
—
—
13,597
—
—
13,601
Share-based compensation expense related to share-based awards and employee stock purchase plan
—
—
—
—
32,331
—
—
32,331
Equity component of convertible senior notes
—
—
—
—
92,502
—
—
92,502
Equity component of issuance costs for convertible senior notes
—
—
—
—
( 2,092 )
—
—
( 2,092 )
Purchase of capped calls
—
—
—
—
( 25,159 )
—
—
( 25,159 )
Equity component of partial repurchase of 2022 Convertible Notes
—
—
—
—
( 26,959 )
—
—
( 26,959 )
Dividend of SGC business
—
—
—
—
—
( 2,609 )
—
( 2,609 )
Net income
—
—
—
—
—
21,505
—
21,505
Balance at December 31, 2019
157,535,962
$
158
—
$
—
$
1,478,823
$
( 1,572,232 )
$
—
$
( 93,251 )
The accompanying notes are an integral part of these consolidated financial statements.
F-7
Table of Contents
Ironwood Pharmaceuticals, Inc.
Consolidated Statements of Stockholders’ Equity (Deficit)
(In thousands, except share amounts)
Class A
Additional
Total
Common Stock
paid-in
Accumulated
Stockholders’
Shares
Amount
capital
deficit
equity (deficit)
Balance at December 31, 2019
157,535,962
158
1,478,823
( 1,572,232 )
( 93,251 )
Issuance of common stock related to share-based awards and employee stock purchase plan
3,080,713
3
18,537
—
18,540
Share-based compensation expense related to share-based awards and employee stock purchase plan
—
—
31,175
—
31,175
Net income
—
—
—
106,176
106,176
Balance at December 31, 2020
160,616,675
$
161
$
1,528,535
$
( 1,466,056 )
$
62,640
The accompanying notes are an integral part of these consolidated financial statements.
F-8
Table of Contents
Ironwood Pharmaceuticals, Inc.
Consolidated Statements of Cash Flow s
(In thousands)
Year Ended December 31,
2020
2019
2018
Cash flows from operating activities:
Net income (loss)
$
106,176
$
21,505
$
( 282,368 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization
3,564
5,580
3,859
Amortization of acquired intangible assets
—
—
8,111
Impairment of intangible assets
—
—
151,794
Loss (gain) on disposal of property and equipment
470
146
( 1,867 )
Share-based compensation expense
31,175
31,278
40,526
Gain on lease modification
—
( 3,169 )
—
Change in fair value of note hedge warrants
( 12,172 )
16,232
( 58,425 )
Change in fair value of convertible note hedges
18,301
( 19,255 )
67,168
Write-down of commercial supply and inventory to net realizable value and (settlement) loss on non-cancellable purchase commitments
—
( 3,530 )
219
Write-down of excess non-cancellable ZURAMPIC and DUZALLO sample purchase commitments
—
—
390
Accretion of discount/premium on investment securities
—
—
( 165 )
Non-cash interest expense
22,263
19,590
17,601
Non-cash change in fair value of contingent consideration
—
—
( 31,045 )
Loss on extinguishment of debt
—
30,977
—
Changes in assets and liabilities:
Accounts receivable and related party accounts receivable, net
4,091
( 68,893 )
1,207
Inventory, net
648
—
( 806 )
Prepaid expenses and other current assets
1,515
( 1,046 )
( 3,727 )
Operating lease right-of-use assets
1,167
14,141
—
Other assets
( 153 )
159
702
Accounts payable, related party accounts payable and accrued expenses
( 7,523 )
( 32,700 )
2,678
Accrued research and development costs
( 1,058 )
( 483 )
542
Operating lease liabilities
218
( 12,046 )
—
Deferred revenue
( 875 )
875
—
Deferred rent
—
—
916
Other liabilities
1,029
—
—
Net cash provided by (used in) continuing operating activities
168,836
( 639 )
( 82,690 )
Net cash provided by discontinued operating activities
—
11,364
11,808
Net cash provided by (used in) operating activities
168,836
10,725
( 70,882 )
Cash flows from investing activities:
Purchases of available-for-sale securities
—
—
( 3,241 )
Sales and maturities of available-for-sale securities
—
—
99,165
Purchases of property and equipment
( 1,842 )
( 7,189 )
( 351 )
Proceeds from sale of property and equipment
—
268
1,563
Net cash (used in) provided by continuing investing activities
( 1,842 )
( 6,921 )
97,136
Net cash used in discontinued investing activities
—
( 4,223 )
( 8,270 )
Net cash (used in) provided by investing activities
( 1,842 )
( 11,144 )
88,866
Cash flows from financing activities:
Proceeds from issuance of convertible senior notes
—
400,000
—
Purchase of capped calls
—
( 25,159 )
—
Proceeds from partial termination of convertible note hedges and note hedge warrants
—
3,174
—
Costs associated with issuance of convertible senior notes
—
( 9,048 )
—
Proceeds from exercise of stock options and employee stock purchase plan
18,546
13,595
32,061
Payments on capital lease obligations
—
—
( 1,824 )
Payments for partial repurchase of 2022 Convertible Notes
—
( 227,338 )
—
Payments on 8.375% Notes due 2026
—
( 156,409 )
—
Payments on contingent purchase price consideration
—
—
( 165 )
Net cash provided by (used in) continuing financing activities
18,546
( 1,185 )
30,072
Net cash used in discontinued financing activities
—
—
—
Net cash provided by (used in) financing activities
18,546
( 1,185 )
30,072
Net increase (decrease) in cash, cash equivalents and restricted cash
185,540
( 1,604 )
48,056
Cash, cash equivalents and restricted cash, beginning of period
179,244
180,848
132,792
Cash, cash equivalents and restricted cash, end of period
$
364,784
$
179,244
$
180,848
Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets
F-9
Table of Contents
Cash and cash equivalents
$
362,564
$
177,023
$
173,172
Restricted cash
2,220
2,221
7,676
Total cash, cash equivalents, and restricted cash
$
364,784
$
179,244
$
180,848
Supplemental cash flow disclosure:
Cash paid for interest
$
7,216
$
17,584
$
18,235
Cash paid for income taxes
$
1,848
$
—
$
—
Non-cash investing and financing activities
Purchases under capital leases
$
—
$
—
$
664
Extinguishment of capital leases
$
—
$
—
$
2,687
Recognition of asset retirement obligation
$
—
$
486
$
—
Fixed asset purchases in accounts payable and accrued expenses
$
—
$
1,282
$
439
The accompanying notes are an integral part of these consolidated financial statements.
F-10
Table of Contents
Ironwood Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
1. Nature of Business
Ironwood Pharmaceuticals, Inc. (“Ironwood” or the “Company”) is a gastrointestinal (“GI”) healthcare company dedicated to advancing the treatment of GI diseases and redefining the standard of care for GI patients. The Company is focused on the development and commercialization of innovative GI product opportunities in areas of significant unmet need, leveraging its demonstrated expertise and capabilities in GI diseases.
LINZESS ® (linaclotide), the Company’s commercial product, is the first product approved by the United States Food and Drug Administration (the “U.S. FDA”) in a class of GI medicines called guanylate cyclase type C agonists and is indicated for adult men and women suffering from irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”). LINZESS is available to adult men and women suffering from IBS-C or CIC in the United States (the “U.S.”) and Mexico and to adult men and women suffering from IBS-C in Japan and China. Linaclotide is available under the trademarked name CONSTELLA ® to adult men and women suffering from IBS-C or CIC in Canada and to adult men and women suffering from IBS-C in certain European countries.
The Company has strategic partnerships with leading pharmaceutical companies to support the development and commercialization of linaclotide throughout the world. The Company and its partner, AbbVie Inc. (together with its affiliates, “AbbVie”) (successor to Allergan plc (together with its affiliates), “Allergan”), began commercializing LINZESS in the U.S. in December 2012. Under the Company’s collaboration with AbbVie for North America, total net sales of LINZESS in the U.S., as recorded by AbbVie, are reduced by commercial costs incurred by each party, and the resulting amount is shared equally between the Company and AbbVie. AbbVie also has an exclusive license from the Company to develop and commercialize linaclotide in all countries other than China (including Hong Kong and Macau), Japan and the countries and territories of North America (the “AbbVie License Territory”). On a country-by-country and product-by-product basis in the AbbVie License Territory, AbbVie pays the Company a royalty as a percentage of net sales of products containing linaclotide as an active ingredient. In addition, AbbVie has exclusive rights to commercialize linaclotide in Canada as CONSTELLA and in Mexico as LINZESS.
Astellas Pharma Inc. (“Astellas”), the Company’s partner in Japan, has an exclusive license to develop and commercialize linaclotide in Japan. In March 2017, Astellas began commercializing LINZESS for the treatment of adults with IBS-C in Japan, and in September 2018, Astellas began commercializing LINZESS for the treatment of adults with chronic constipation in Japan. In August 2019, the Company amended and restated its license agreement with Astellas. Effective in 2020, Company is no longer responsible for the supply of linaclotide active pharmaceutical ingredient (“API”) to Astellas (Note 6).
In October 2012, the Company and AstraZeneca AB (together with its affiliates) (“AstraZeneca”) entered into a collaboration agreement to co-develop and co-commercialize linaclotide in China (including Hong Kong and Macau) (the “AstraZeneca License Territory”). In September 2019, the Company amended and restated its existing collaboration agreement with AstraZeneca whereby AstraZeneca obtained the exclusive right to develop, manufacture, and commercialize products containing linaclotide in the AstraZeneca License Territory (Note 6). In November 2019, AstraZeneca began commercializing LINZESS for the treatment of adults with IBS-C in China.
The Company and AbbVie are exploring ways to enhance the clinical profile of LINZESS by studying linaclotide in additional indications, populations and formulations to assess its potential to treat various conditions. In September 2020, based on the Phase IIIb data demonstrating efficacy and safety of LINZESS 290 mcg on the overall abdominal symptoms of bloating, pain and discomfort in adult patients with IBS-C, the U.S. FDA approved the Company’s Supplemental New Drug Application to include a more comprehensive description of the effects of LINZESS in its approved label. In June 2020 and July 2020, the United States Patent and Trademark Office granted patents covering the formulation of the 72 mcg dose of LINZESS and methods of using the formulation, respectively. The patents are expected to expire in 2031.
The Company and AbbVie were developing MD-7246, a delayed release formulation of linaclotide. In May 2020, the Company and AbbVie announced top-line data from a Phase II trial evaluating MD-7246 in adult patients with
F-11
Table of Contents
abdominal pain associated with irritable bowel syndrome with diarrhea. The Phase II trial did not meet its primary or key secondary endpoints. Based on these findings, the Company and AbbVie discontinued the development of MD-7246.
The Company was developing IW-3718, a gastric retentive formulation of a bile acid sequestrant, in a Phase III program. In September 2020, the Company announced that one of its two identical Phase III trials for the potential treatment of refractory gastroesophageal reflux disease (“refractory GERD”) did not meet the pre-specified criteria associated with a planned early efficacy assessment. Based on these findings, the Company is discontinuing development of IW-3718. In connection with this decision, the Company reduced its workforce by approximately 100 full-time employees. This workforce reduction affected both field-based and home-office employees, including the relevant general and administrative support functions. The Company substantially completed the reduction in its workforce in the fourth quarter of 2020 (Note 18).
Additionally, the Company periodically enters into co-promotion agreements to bolster its salesforce productivity. In August 2019, the Company entered into a disease education and promotional agreement with Alnylam Pharmaceuticals, Inc. (“Alnylam”) for Alnylam’s GIVLAARI ® (givosiran) for the treatment of acute hepatic porphyria (“AHP”). Under the agreement, the Company performs disease awareness activities related to AHP and sales detailing activities of GIVLAARI.
These and other agreements are more fully described in Note 6, Collaboration, License, Co-Promotion and Other Commercial Agreements, to these consolidated financial statements.
On April 1, 2019, Ironwood completed the separation (the “Separation”) of its soluble guanylate cyclase (“sGC”) business, and certain other assets and liabilities, into Cyclerion Therapeutics, Inc (“Cyclerion”). The Separation was effected by means of a distribution of all of the outstanding shares of common stock, with no par value, of Cyclerion through a dividend of all outstanding shares of Cyclerion’s common stock, to Ironwood’s stockholders of record as of the close of business on March 19, 2019 (Note 3).
The Company was incorporated in Delaware on January 5, 1998 as Microbia, Inc. On April 7, 2008, the Company changed its name to Ironwood Pharmaceuticals, Inc. To date, the Company has dedicated a majority of its activities to the research, development and commercialization of linaclotide, as well as to the research and development of its other product candidates. Prior to the year ended December 31, 2019, the Company incurred net losses in each year since its inception in 1998. For the years ended December 31, 2020 and 2019, the Company recorded net income of approximately $ 106.2 million and approximately $ 21.5 million, respectively. As of December 31, 2020, the Company had an accumulated deficit of approximately $ 1.5 billion.
2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Ironwood and its wholly-owned subsidiaries, as of December 31, 2020, Ironwood Pharmaceuticals Securities Corporation and Ironwood Pharmaceuticals GmbH. Cyclerion was a wholly-owned subsidiary until it became an independent publicly-traded company on April 1, 2019. All intercompany transactions and balances are eliminated in consolidation.
Segment Information
Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision-maker in deciding how to allocate resources and in assessing performance. The Company currently operates in one reportable business segment—human therapeutics.
F-12
Table of Contents
Reclassifications
Certain prior period financial statement items have been reclassified to conform to current period presentation.
Discontinued Operations
The Company determined that its sGC business, which was disposed on April 1, 2019, met the criteria for classification as a discontinued operation in accordance with Accounting Standards Codification (“ASC”) Subtopic 205-20, Discontinued Operations (“ASC 205-20”). Accordingly, the accompanying consolidated financial statements as of and for the year ended December 31, 2019 and all prior periods present the balance sheet, operations, and cash flows associated with the sGC business as discontinued operations. For additional information related to discontinued operations, refer to Note 3, Cyclerion Separation , to these consolidated financial statements.
Use of Estimates
The preparation of consolidated financial statements in accordance with U.S. generally accepted accounting principles requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the amounts of revenues and expenses during the reported periods. On an ongoing basis, the Company’s management evaluates its estimates, judgments and methodologies. Significant estimates and assumptions in the consolidated financial statements include those related to revenue recognition; accounts receivable; inventory valuation and related reserves; useful lives of long-lived assets, impairment of long-lived assets, including its acquired intangible assets and goodwill; valuation procedures for right-of-use assets and operating lease liabilities; valuation procedures for the issuance and repurchase of convertible notes; balance sheet classification of convertible notes; valuation of assets and liabilities held for disposition and losses related to discontinued operations; fair value of derivatives; income taxes, including the valuation allowance for deferred tax assets; research and development expenses; contingencies and share-based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
Cash and Cash Equivalents
The Company considers all highly liquid investment instruments with a remaining maturity when purchased of three months or less to be cash equivalents. Investments qualifying as cash equivalents primarily consist of money market funds, U.S. government-sponsored securities, and repurchase agreements. The carrying amount of cash equivalents approximates fair value. The amount of cash equivalents included in cash and cash equivalents was approximately $ 349.0 million and approximately $ 177.0 million at December 31, 2020 and 2019, respectively.
Restricted Cash
The Company is contingently liable under unused letters of credit with a bank, related to the Company’s facility lease and vehicle lease agreements, in the amount of approximately $ 2.2 million as of December 31, 2020 and 2019. The Company records as restricted cash the collateral used to secure these letters of credit. The amount of restricted cash included in current assets and non-current assets was approximately $ 1.7 million and $ 0.5 million at December 31, 2020, respectively. The amount of restricted cash in current assets and non-current assets was approximately $1.2 million and $ 1.0 million at December 31, 2019, respectively.
Concentrations of Suppliers
The Company relies on its collaboration partners and their suppliers to manufacture linaclotide API, linaclotide finished drug product, and finished goods.
If any of the Company’s collaboration partners and their suppliers were to limit or terminate production or otherwise fail to meet the quality or delivery requirements needed to satisfy the supply commitments, the process of locating and qualifying alternate sources could require up to several months, during which time production could be
F-13
Table of Contents
delayed. Such delays could have a material adverse effect on the Company’s business, financial position and results of operations.
Accounts Receivable and Related Valuation Account
The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for credit losses when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not specifically reviewed. The Company’s receivables relate primarily to amounts reimbursed under its collaboration, license and co-promotion agreements. The Company believes that credit risks associated with these partners are not significant. The Company reviews the need for an allowance for credit losses for its receivables based on various factors including payment history and historical bad debt experience. The Company had no allowance for credit losses as of December 31, 2020 or 2019.
Concentrations of Credit Risk
Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents, restricted cash, and accounts receivable. The Company maintains its cash and cash equivalent balances with high-quality financial institutions and the Company believes that such funds are subject to minimal credit risk. The Company has adopted an investment policy which limits the amounts the Company may invest in certain types of investments, and requires all investments held by the Company to be at least AA- rated, thereby reducing credit risk exposure.
Accounts receivable primarily consist of amounts due under the linaclotide collaboration agreement with AbbVie for North America (Note 6). The Company does not obtain collateral for its accounts receivable. The Company previously reflected amounts due from Allergan, net of amounts payable to Allergan, prior to its acquisition by AbbVie as related party accounts receivable, net. Following the acquisition of Allergan by AbbVie, the Company determined that AbbVie is not a related party to the Company (Note 17).
The percentages of revenue recognized from significant collaborative partners of the Company in the years ended December 31, 2020, 2019 and 2018 as well as the account receivable balances, net of any payables due, at December 31, 2020 and 2019 are included in the following table:
Accounts
Receivable
Revenue
December 31,
Year Ended December 31,
2020
2019
2020
2019
2018
Collaborative Partner:
AbbVie (North America and Europe)
76
%
90
%
96
%
78
%
77
%
Astellas (Japan)
1
%
8
%
1
%
13
%
20
%
For the years ended December 31, 2020, 2019 and 2018, no additional customers accounted for more than 10% of the Company’s revenue.
Property and Equipment
Property and equipment, including leasehold improvements, are recorded at cost, and are depreciated when placed into service using the straight-line method based on their estimated useful lives as follows:
Estimated Useful Life
Asset Description
(In Years)
Laboratory equipment
5
Computer and office equipment
3
Furniture and fixtures
7
Software
3
Included in property and equipment are certain costs of software obtained for internal use. Costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software. The Company also capitalizes costs
F-14
Table of Contents
related to specific upgrades and enhancements when it is probable the expenditures will result in additional functionality. Maintenance and training costs related to software obtained for internal use are expensed as incurred.
Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the lease term.
Costs for capital assets not yet placed into service have been capitalized as construction in process, and will be depreciated in accordance with the above guidelines once placed into service. Maintenance and repair costs are expensed as incurred.
Finite Lived Intangible Assets
The Company records the fair value of purchased intangible assets with finite useful lives as of the transaction date of a business combination. Purchased intangible assets with finite useful lives are amortized to their estimated residual values over their estimated useful lives. The value of the Company’s finite-lived intangible assets was based on the future expected net cash flows related to ZURAMPIC and DUZALLO (the “Lesinurad Products”), which included significant assumptions around future net sales and the respective investment to support these products. During the year ended December 31, 2018, the Company recorded an impairment charge of approximately $ 151.8 million to fully write-off its ZURAMPIC and DUZALLO intangible assets.
Impairment of Long-Lived Assets
The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist, which warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value.
Income Taxes
The Company provides for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates in effect when the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization.
The Company accounts for uncertain tax positions recognized in the consolidated financial statements in accordance with the provisions of ASC Topic 740, Income Taxes , by prescribing a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company evaluates uncertain tax positions on a quarterly basis and adjusts the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Any changes to these estimates, based on the actual results obtained and/or a change in assumptions, could impact the Company’s income tax provision in future periods. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as a provision for income tax in the Company’s consolidated statement of operations.
Financing Costs
Financing costs include costs directly attributable to the Company’s offerings of its equity securities and its debt financings. Costs attributable to equity offerings are charged as a reduction to stockholders’ equity against the proceeds of the offering once the offering is completed. Costs attributable to debt financings are deferred and amortized to interest expense over the term of the debt using the effective interest method. Costs incurred in connection with convertible debt securities are allocated between the liability and equity components. In accordance with ASC 835, Interest , the Company presents debt issuance costs on the balance sheet as a direct deduction from the associated debt liability.
F-15
Table of Contents
Leases
Effective January 1, 2019 , the Company adopted ASC Topic 842, Leases (“ASC 842”), using the optional transition method . The adoption of ASC 842 represented a change in accounting principle that aimed to increase transparency and comparability among organizations by requiring the recognition of right-of-use assets and lease liabilities on the balance sheet for both operating and finance leases. In addition, the standard required enhanced disclosures that meet the objective of enabling financial statement users to assess the amount, timing, and uncertainty of cash flows arising from leases.
As part of the ASC 842 adoption, the Company elected certain practical expedients, which include:
● Accounting policy election to use the short-term lease exception by asset class; and
● Election of the practical expedient package during transition, which includes:
o An entity need not reassess whether any expired or existing contracts are or contain leases.
o An entity need not reassess the classification for any expired or existing leases. As a result, all leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases under ASC 842, and all leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases under ASC 842.
o An entity need not reassess initial direct costs for any existing leases.
Subsequent to the Company’s adoption of ASC 842, the Company elected the post-transition practical expedient, by class of underlying asset, to account for lease components and non-lease components together as a single component for the asset class of operating lease right-of-use real estate assets.
The Company’s lease portfolio for the year ended December 31, 2020 included: a lease for its headquarters location, a data center colocation lease, vehicle leases for its salesforce representatives, and leases for computer and office equipment. The Company determines if an arrangement is a lease at the inception of the contract. The asset component of the Company’s operating leases is recorded as operating lease right-of-use assets, and the liability component is recorded as current portion of operating lease liabilities and operating lease liabilities, net of current portion in the Company’s consolidated balance sheets. As of December 31, 2020, the Company did not record any finance leases.
Right-of-use assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term at the lease inception date. Existing leases in the Company’s lease portfolio as of the adoption date were valued as of January 1, 2019. The Company uses an incremental borrowing rate based on the information available at lease inception in determining the present value of lease payments, if an implicit rate of return is not provided with the lease contract. Operating lease right-of-use assets are adjusted for incentives expected to be received.
Right-of-use assets and operating lease liabilities are remeasured upon certain modifications to leases using the present value of remaining lease payments and estimated incremental borrowing rate upon lease modification.
Lease cost is recognized on a straight-line basis over the lease term, and includes amounts related to short-term leases. The Company recognizes variable lease payments as operating expenses in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes, insurance, and other operating costs that are passed on from the lessor in proportion to the space leased by the Company.
Derivative Assets and Liabilities
In June 2015, the Company issued 2.25 % Convertible Senior Notes due June 15, 2022 (the “2022 Convertible Notes”) and in August 2019, the Company issued 0.75 % Convertible Senior Notes due 2024 (the “2024 Convertible Notes”) and 1.50 % Convertible Senior Notes due 2026 (the “2026 Convertible Notes”) (together with the “2022 Convertible Notes” and the “2024 Convertible Notes”, the “Convertible Senior Notes”). In June 2015, in connection with the issuance of the 2022 Convertible Notes, the Company entered into convertible note hedge transactions (the “Convertible Note Hedges”). Concurrently with entering into the Convertible Note Hedges, the Company also entered into certain warrant transactions in which it sold note hedge warrants (the “Note Hedge Warrants”) to the Convertible
F-16
Table of Contents
Note Hedge counterparties to acquire shares of the Company’s Class A Common Stock, subject to customary anti-dilution adjustments (Note 11). In connection with the partial repurchase of the 2022 Convertible Notes in August 2019, the Company terminated its Convertible Note Hedges and Note Hedge Warrants proportionately. These instruments are derivative financial instruments under ASC Topic 815, Derivatives and Hedging (“ASC 815”).
These derivatives are recorded as assets or liabilities at fair value each reporting date and the fair value is determined using the Black-Scholes option-pricing model. The changes in fair value are recorded as a component of other (expense) income in the consolidated statements of operations. Significant inputs used to determine the fair value include the price per share of the Company’s Class A Common Stock on the date of valuation, expected term of the derivative instruments, strike prices of the derivative instruments, risk-free interest rate, and expected volatility of the Company’s Class A Common Stock. Changes to these inputs could materially affect the valuation of the Convertible Note Hedges and Note Hedge Warrants in future periods.
In August 2019, in connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes, the Company entered into the Capped Calls. The Capped Calls cover the same number of shares of Class A Common Stock that initially underlie the 2024 Convertible Notes and the 2026 Convertible Notes (subject to anti-dilution and certain other adjustments). These instruments meet the conditions outlined in ASC 815 to be classified in stockholders’ equity (deficit) and are not subsequently remeasured as long as the conditions for equity classification continue to be met.
Revenue Recognition
The Company’s revenues are generated primarily through collaborative arrangements and license agreements related to the research and development and commercialization of linaclotide, as well as co-promotion arrangements in the U.S. The terms of the collaborative research and development, license, co-promotion and other agreements contain multiple performance obligations which may include (i) licenses, (ii) research and development activities, including participation on joint steering committees, (iii) the manufacture of finished drug product, API, or development materials for a partner, which are reimbursed at a contractually determined rate, and (iv) education or co-promotion activities by the Company’s clinical sales specialists. Non-refundable payments to the Company under these agreements may include (i) up-front license fees, (ii) payments for research and development activities, (iii) payments for the manufacture of finished drug product, API, or development materials, (iv) payments based upon the achievement of certain milestones, (v) payments for sales detailing, promotional support services and medical education initiatives, and (vi) royalties on product sales. The Company receives its share of the net profits or bears its share of the net losses from the sale of linaclotide in the U.S. through its collaboration agreement with AbbVie for North America. The Company has adopted a policy to recognize revenue net of tax withholdings, as applicable.
Collaboration, License, Co-Promotion and Other Commercial Agreements
Upon licensing intellectual property to a customer, the Company determines if the license is distinct from the other performance obligations identified in the arrangement. The Company recognizes revenues from the transaction price, including non-refundable, up-front fees allocated to the license when the license is transferred to the customer if the license has distinct benefit to the customer. For licenses that are combined with other promises, the Company assesses the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. For performance obligations that are satisfied over time, the Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
The Company’s license and collaboration agreements include milestone payments, such as development and other milestones. The Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method at the inception of the agreement. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. The Company re-evaluates the probability of achievement of such milestones and any related constraint at each reporting period, and any adjustments are recorded on a cumulative catch-up basis.
F-17
Table of Contents
Agreements that include the supply of API or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to its partner, and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded as revenue when the customer obtains control of the goods, which is typically upon shipment for sales of API and finished drug product.
For agreements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur.
Net Profit or Net Loss Sharing
In accordance with ASC 808 Topic, Collaborative Arrangements (“ASC 808”), the Company considers the nature and contractual terms of the arrangement and the nature of the Company’s business operations to determine the classification of payments under the Company’s collaboration agreements. While ASC 808 provides guidance on classification, the standard is silent on matters of separation, initial measurement, and recognition. Therefore, the Company applies the separation, initial measurement, and recognition principles of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), as applicable.
The Company’s collaborative arrangements revenues generated from sales of LINZESS in the U.S. are considered akin to sales-based royalties. In accordance with the sales-based royalty exception, the Company recognizes its share of the pre-tax commercial net profit or net loss generated from the sales of LINZESS in the U.S. in the period the product sales are earned, as reported by AbbVie, and related cost of goods sold and selling, general and administrative expenses as incurred by the Company and AbbVie. These amounts are partially determined based on amounts provided by AbbVie and involve the use of estimates and judgments, such as product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and contractual rebates, wholesaler fees, product returns, and co-payment assistance costs, which could be adjusted based on actual results in the future. The Company is highly dependent on AbbVie for timely and accurate information regarding net revenues from sales of LINZESS in the U.S. in accordance with both ASC 808 and ASC 606, and the related costs, in order to accurately report its results of operations. If the Company does not receive timely and accurate information or incorrectly estimates activity levels associated with the collaboration at a given point in time, the Company could be required to record adjustments in future periods.
In accordance with ASC 606-10-55, Principal Agent Considerations , the Company records revenue transactions as net product revenue in its consolidated statements of operations if it is deemed the principal in the transaction, which includes being the primary obligor, retaining inventory risk, and control over pricing. Given that the Company is not the primary obligor and does not have the inventory risks in the collaboration agreement with AbbVie for North America, it records its share of the net profits or net losses from the sales of LINZESS in the U.S. on a net basis and presents the settlement payments to and from AbbVie as collaboration expense or collaborative arrangements revenue, as applicable. The Company and AbbVie settle the cost sharing quarterly such that the Company’s statements of operations reflect 50 % of the pre-tax net profit or loss generated from sales of LINZESS in the U.S.
Product Revenue, Net
Product revenue consisted of sales of the Lesinurad Products, in the U.S. until the termination of the exclusive license to develop, manufacture, and commercialize in the U.S. products containing lesinurad as an active ingredient (the “Lesinurad License”) in January 2019. The Company sold the Lesinurad Products principally to a limited number of national wholesalers and selected regional wholesalers (the “Distributors”). The Distributors resold the Lesinurad Products to retail pharmacies and healthcare providers, who then sold to patients.
Net product revenue was recognized when the Distributor obtained control of the Company’s product, which occurred at a point in time, typically upon shipment of Lesinurad Products to the Distributor. When the Company performed shipping and handling activities after the transfer of control to the Distributor (e.g., when control transfers prior to delivery), they were considered fulfillment activities, and accordingly, the costs were accrued for when the related revenue was recognized. The Company expensed incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that the Company would have recognized was one year or less.
F-18
Table of Contents
The Company evaluated the creditworthiness of each of its Distributors to determine whether it was probable that a significant reversal in the amount of the cumulative revenue recognized would not occur. The Company calculated its net product revenue based on the wholesale acquisition cost that the Company charged its Distributors for the Lesinurad Products less variable consideration. The product revenue variable consideration consisted of estimates relating to (i) trade discounts and allowances, such as invoice discounts for prompt payment and distributor fees, (ii) estimated government and private payor rebates, chargebacks and discounts, such as Medicaid reimbursements, (iii) reserves for expected product returns and (iv) estimated costs of incentives offered to certain indirect customers including patients. These estimates would be adjusted based on actual results in the period such variances became known.
Product revenue was recorded net of the trade discounts, allowances, rebates, chargebacks, discounts, product returns, and other incentives. Certain of these adjustments were recorded as an accounts receivable reserve, while certain of these adjustments were recorded as accrued expenses.
Sale of Active Pharmaceutical Ingredient
During the years ended December 31, 2020, 2019, and 2018, the Company produced linaclotide API, finished drug product, finished goods, and/or development materials for certain of its partners. As of December 31, 2020, the Company is no longer responsible for the supply of linaclotide API, finished drug product, finished goods or development materials to its partners.
As it relates to development materials and API produced for Astellas, the Company was reimbursed at a contracted rate. Such reimbursements were considered as part of revenue generated pursuant to the Astellas license agreement and are presented as collaborative arrangements revenue. Any linaclotide API, finished drug product, finished goods, and development materials AbbVie is responsible for producing for the U.S. are recognized in accordance with the cost-sharing provisions of the collaboration agreement with AbbVie for North America. Prior to the execution of the Amended AstraZeneca Agreement in September 2019, any linaclotide API, finished drug product, and development materials produced for AstraZeneca for China (including Hong Kong and Macau) were recognized in accordance with the cost-sharing provisions of the AstraZeneca collaboration agreement.
The Company recognized revenue on linaclotide API, finished drug product, finished goods, and development materials when control has transferred to the partner, which generally occurs upon shipment after the material passed all quality testing required for acceptance by the partner.
Other
The Company’s deferred revenue balance consists of advance billings and payments received from customers in excess of revenue recognized.
Cost of Revenues
Cost of revenues includes cost related to the sales of linaclotide API and finished drug product, as well as the cost of product revenue related to sales of the Lesinurad Products in the U.S. Cost related to the sales of linaclotide API, finished drug product, and finished goods are generally recognized upon shipment to certain of the Company’s partners outside of the U.S. The Company’s cost of revenues for linaclotide consists of the internal and external costs of producing such API and finished drug product. Cost of product revenue related to the sales of the Lesinurad Products in the U.S. includes the cost of producing finished goods that correspond with product revenue for the reporting period, such as third-party supply and overhead costs, as well as certain period costs related to freight, packaging, stability and quality testing, and customer acquisition.
Research and Development Costs
The Company generally expenses research and development costs to operations as incurred. The Company capitalizes nonrefundable advance payments made by the Company for research and development activities and defers expense recognition until the related goods are received or the related services are performed.
F-19
Table of Contents
Research and development expenses are comprised of costs incurred in performing research and development activities, including salary, benefits, share-based compensation, and other employee-related expenses; laboratory supplies and other direct expenses; facilities expenses; overhead expenses; third-party contractual costs relating to nonclinical studies and clinical trial activities and related contract manufacturing expenses, development of manufacturing processes and regulatory registration of third-party manufacturing facilities; licensing fees for the Company’s product candidates; and other outside expenses.
The Company has certain collaboration agreements pursuant to which it shares or has shared research and development expenses related to linaclotide. The Company records expenses incurred under such linaclotide collaboration arrangements as research and development expense. Prior to the execution of the Amended AstraZeneca Agreement in September 2019, under the Company’s collaboration agreement with AstraZeneca for China (including Hong Kong and Macau), the Company was reimbursed for certain research and development expenses and it netted these reimbursements against its research and development expenses as incurred. In connection with the execution of the Amended AstraZeneca Agreement, AstraZeneca is fully responsible for all research and development costs incurred related to the development, manufacture, and commercialization of linaclotide in China (including Hong Kong and Macau). Under the Company’s collaboration agreement with AbbVie for North America, the Company is reimbursed for certain research and development expenses and nets these reimbursements against its research and development expenses as incurred. Amounts owed to AbbVie or AstraZeneca under the Company’s respective collaboration agreements were recorded as incremental research and development expense.
Restructuring Expenses
Restructuring expenses are comprised primarily of costs associated with exit and disposal activities in accordance with ASC 420, Exit or Disposal Cost Obligations , and include one-time termination benefits and contract-related costs. Such costs are based on estimates of fair value in the period liabilities are incurred. The Company evaluates and adjusts these costs for changes in circumstances as additional information becomes available.
Selling, General and Administrative Expenses
The Company expenses selling, general and administrative costs to operations as incurred. Selling, general and administrative expenses consist primarily of compensation, benefits and other employee-related expenses for personnel in the Company’s administrative, finance, legal, information technology, business development, commercial, sales, marketing, communications and human resource functions. Other costs include the legal costs of pursuing patent protection of the Company’s intellectual property, general and administrative related facility costs, insurance costs and professional fees for accounting, tax, consulting, legal and other services.
Prior to the execution of the Amended AstraZeneca Agreement, the Company was reimbursed for certain selling, general and administrative expenses and the Company netted these reimbursements against the Company’s selling, general and administrative expenses as incurred. In connection with the Amended AstraZeneca Agreement, effective in September 2019, AstraZeneca will be fully responsible for all costs related to the development, manufacture, and commercialization of linaclotide in China (including Hong Kong and Macau). The Company includes AbbVie’s selling, general and administrative cost-sharing payments in the calculation of the net profits and net losses from the sale of LINZESS in the U.S. and presents the net payment to or from AbbVie as collaboration expense or collaborative arrangements revenue, respectively.
Share-Based Compensation Expense
The Company grants awards under its share-based compensation programs, including stock awards, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) (including both time-based and performance-based RSUs), stock options, and shares issued under the Company’s employee stock purchase plan (“ESPP”). Share-based compensation is recognized as expense in the consolidated statements of operations based on the grant date fair value over the requisite service period, net of estimated forfeitures. The Company estimates forfeitures over the requisite service period using historical forfeiture activity and records share-based compensation expense only for those awards that are expected to vest.
The Company estimates the fair value of stock options using the Black-Scholes option-pricing model, which requires the use of subjective assumptions including volatility and expected term, among others. The fair value of stock
F-20
Table of Contents
awards, RSAs, and RSUs is based on the market value of the Company’s Class A Common Stock on the date of grant, with the exception of performance-based RSUs with market conditions, which are measured using the Monte Carlo simulation method on the date of grant (Note 14). Discounted stock purchases under the Company’s ESPP are valued on the first date of the offering period using the Black-Scholes option-pricing model to compute the fair value of the lookback provision plus the purchase discount.
For awards that vest based on service conditions and market conditions, the Company uses a straight-line method to recognize compensation expense over the respective service period. For awards that contain performance conditions, the Company determines the appropriate amount to expense at each reporting date based on the anticipated achievement of performance targets, which requires judgement, including forecasting the achievement of future specified targets. At the date performance conditions are determined to be probable of achievement, the Company records a cumulative expense catch-up, with remaining expense amortized over the remaining service period. Throughout the performance period, the Company re-assesses the estimated performance and updates the number of performance-based awards that it believes will ultimately vest. Discounted stock purchases under the Company’s ESPP are recognized over the offering period.
Compensation expense related to modified awards is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite remaining service period, as appropriate.
While the assumptions used to calculate and account for share-based compensation awards represent management’s best estimates, these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if revisions are made to the Company’s underlying assumptions and estimates, the Company’s share-based compensation expense could vary significantly from period to period.
Patent Costs
The Company incurred and recorded as operating expense legal and other fees related to patents of approximately $ 2.3 million, approximately $ 7.8 million, and approximately $ 5.0 million for the years ended December 31, 2020, 2019 and 2018, respectively. These costs were charged to selling, general and administrative expenses as incurred.
Net Income (Loss) Per Share
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the diluted number of shares outstanding during the period. Except where the result would be antidilutive to net income (loss), diluted net income (loss) per common share is computed assuming the conversion of the 2022 Convertible Notes, the 2024 Convertible Notes and the 2026 Convertible Notes, the exercise of outstanding common stock options and the vesting of RSUs and RSAs (using the treasury stock method), as well as their related income tax effects.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions, and other events and circumstances from non-owner sources and consists of net income (loss) and changes in unrealized gains and losses on available-for-sale debt securities in the periods presented in the Company’s consolidated statements of comprehensive income (loss).
Subsequent Events
The Company considers events or transactions that have occurred after the balance sheet date of December 31, 2020, but prior to the filing of the financial statements with the Securities and Exchange Commission (“SEC”) to provide additional evidence relative to certain estimates or to identify matters that require additional recognition or disclosure. Subsequent events have been evaluated through the filing of the financial statements accompanying this Annual Report on Form 10-K.
F-21
Table of Contents
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Except as set forth below, the Company did not adopt any new accounting pronouncements during the year ended December 31, 2020 that had a material effect on its consolidated financial statements.
In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 changed how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies are required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. Subsequent to the issuance of ASU 2016-13, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , Topic 815, Derivatives and Hedging , and Topic 825, Financial Instruments , ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326) : Targeted Transition Relief (“ASU 2019-05”), ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326) , Derivatives and Hedging (Topic 815) , and Leases (Topic 842): Effective Date , ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , ASU No. 2020-02, Financial Instruments—Credit Losses (Topic 326) and Leases (Topic 842) : Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases (Topic 842) to provide additional guidance on the adoption of ASU 2016-13. Early adoption was permitted. The Company adopted these ASUs during the three months ended March 31, 2020 . The adoption of these ASUs did not have a material impact on the Company’s financial position and results of operations.
In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350) (“ASU 2017-04”) to simplify the accounting for goodwill impairment by removing Step 2 of the goodwill impairment test and to eliminate the required quantitative analysis for reporting units with negative carrying value. ASU 2017-04 is effective for fiscal years beginning after December 15, 2019. Early adoption was permitted. The Company adopted ASU 2017-04 during the three months ended March 31, 2020 . The adoption of ASU 2017-04 did not have a material impact on the Company’s financial position and results of operations.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework— Changes to the Disclosure Requirement for Fair Value Measurement (“ASU 2018-13”) which amends the disclosure requirements for fair value measurements. The amendments in ASU 2018-13 are effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-13 during the three months ended March 31, 2020 . The adoption of ASU 2018-13 did not have a material impact on the Company’s financial statement disclosures.
In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract (a consensus of the FASB Emerging Issues Task Force) (“ASU 2018-15”) which provides guidance on the accounting for costs of implementation activities performed in a cloud computing arrangement that is a service contract. ASU 2015-18 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance to determine which implementation costs to capitalize as assets or expense as incurred. The internal-use software guidance requires that certain costs incurred during the application development stage be capitalized and other costs incurred during the preliminary project and post-implementation stages be expensed as they are incurred. A customer’s accounting for the hosting component of the arrangement is not affected by this guidance. The amendments in ASU 2018-15 are effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-15 using the prospective transition method during the three months ended March 31, 2020 . The adoption of ASU 2018-15 did not have a material impact on the Company’s financial position and results of operations.
In October 2018, the FASB issued ASU No. 2018-17, Consolidation (Topic 810): Targeted Improvements to Related Party Guidance for Variable Interest Entities (“ASU 2018-17”). The update is intended to improve general purpose financial reporting by considering indirect interests held through related parties in common control arrangements on a proportional basis for determining whether fees paid to decision makers and service providers are variable interests. The amendments in ASU 2018-17 will be effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-17 during the three months ended
F-22
Table of Contents
March 31, 2020 . The adoption of ASU 2018-17 did not have a material impact on the Company’s financial position and results of operations.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 , with early adoption permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2019-12 may have on the Company’s financial position and results of operations.
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The amendments in ASU 2020-06 simplify the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. Under ASU 2020-06, a convertible debt instrument will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. These changes will reduce reported interest expense and increase reported net income for entities that have issued a convertible instrument that was bifurcated under previously existing guidance. The new guidance also requires the if-converted method to be applied for all convertible instruments. The standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021 . Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2020-06 may have on the Company’s financial position and results of operation.
Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the consolidated financial statements upon future adoption.
3. Cyclerion Separation
On April 1, 2019, Ironwood completed the separation of its sGC business, and certain other assets and liabilities, into Cyclerion. The Separation was effected by means of a distribution of all of the outstanding shares of common stock, with no par value, of Cyclerion through a dividend of Cyclerion’s common stock, to Ironwood’s stockholders of record as of the close of business on March 19, 2019. Prior to the Separation on April 1, 2019, as described in Note 1, Nature of Business , Cyclerion was a wholly owned subsidiary of the Company. On March 30, 2019, the Company entered into certain agreements with Cyclerion relating to the Separation, including a separation agreement, a tax matters agreement, and an employee matters agreement.
Agreements with Cyclerion
The separation agreement with Cyclerion, dated as of March 30, 2019, sets forth, among other things, the Company’s agreements with Cyclerion regarding the principal actions to be taken in connection with the Separation, including the dividend, which was effective as of April 1, 2019. The separation agreement identifies assets transferred, liabilities assumed by and contracts assigned to each of Cyclerion and Ironwood as part of the Separation, and provides for when and how these transfers, assumptions and assignments occur. The purpose of the separation agreement was to provide Cyclerion and Ironwood with assets to operate their respective businesses and retain or assume liabilities related to those assets.
F-23
Table of Contents
The transfer of assets and liabilities to Cyclerion was effected through a contribution in accordance with the separation agreement as summarized below (in thousands):
As of April 1, 2019
Assets:
Prepaid expenses and other current assets
$
1,169
Property and equipment, net
10,241
Other assets
21
$
11,431
Liabilities:
Accrued research and development costs
$
5,673
Accrued expenses and other current liabilities
3,149
$
8,822
Net Assets Transferred to Cyclerion
$
2,609
In addition, the Company received approximately $ 1.3 million during the year ended December 31, 2019 associated with tenant improvement reimbursement provisions related to the Cyclerion lease in accordance with the separation agreement.
The tax matters agreement, dated as of March 30, 2019, governs each party’s rights, responsibilities and obligations with respect to taxes, including taxes, if any, incurred as a result of any failure of the Separation to qualify as tax-free. In general, if the parties incur tax liabilities in the event that the Separation is not tax-free, each party is expected to be responsible for any taxes imposed on Ironwood or Cyclerion that arise from the failure of the Separation to qualify as a transaction that is generally tax-free for U.S. federal income tax purposes, under Sections 355 and 368(a)(1)(D) and certain other relevant provisions of the Internal Revenue Code of 1986, as amended, to the extent that the failure to so qualify is attributable to an acquisition of stock or assets of, or certain actions, omissions or failures to act of, such party. If both Ironwood and Cyclerion are responsible for such failure, liability will be shared according to relative fault. U.S. tax otherwise resulting from the failure of the Separation to qualify as a transaction that is tax-free generally will be the responsibility of Ironwood. Each party otherwise agreed to indemnify the other party from and against any liability for taxes allocated to such party under the tax matters agreement and any taxes resulting from breach of any such party’s covenants under the tax matters agreement, the separation agreement, or any ancillary agreement entered into in connection with the Separation. Cyclerion agreed to certain covenants that contain restrictions intended to preserve the tax-free status of the distribution and certain related transactions.
The employee matters agreement, dated as of March 30, 2019, allocates assets, liabilities and responsibilities relating to the employment, compensation, and employee benefits of Ironwood and Cyclerion employees, and other related matters in connection with the Separation, including the treatment of outstanding Ironwood incentive equity awards. Pursuant to the employee matters agreement, the outstanding Ironwood equity awards held by Cyclerion and Ironwood employees were adjusted in connection with the Separation, with the intent to maintain, immediately following the Separation, the economic value of the awards. No incremental stock-based compensation expense related to the Separation-related adjustments was recognized during the year ended December 31, 2019 (Note 14).
Additionally, the Company entered into two transition services agreements and a development agreement with Cyclerion.
Pursuant to the transition service agreements, the Company was obligated to provide and was entitled to receive certain transition services related to corporate functions, such as finance, procurement, facilities and development. As of December 31, 2020, both transition service agreements had terminated. Amounts received for services provided to Cyclerion were recorded as other income and amounts paid for services provided by Cyclerion were recorded as selling, general and administrative expense and research and development expense, as applicable. During the years ended December 31, 2020 and 2019, the Company recorded an insignificant amount and approximately $ 0.3 million, respectively, as other income for services provided to Cyclerion. During each of the years ended December 31, 2020 and 2019, the Company recorded an insignificant amount in both selling, general and administrative expense and research and development expense for services provided by Cyclerion, respectively.
F-24
Table of Contents
Pursuant to the development agreement, Cyclerion is obligated to provide the Company with certain research and development services with respect to certain of Ironwood’s products and product candidates for an initial period of two years, unless earlier terminated or extended. Such research and development activities are governed by a joint steering committee comprised of representatives from both Cyclerion and Ironwood. Services received are paid at a mutually agreed upon rate. The Company recorded approximately $ 2.3 million and $ 4.5 million in research and development expenses under the development agreement during the years ended December 31, 2020 and 2019, respectively. The Company had an insignificant amount and approximately $ 1.5 million of accounts payable due to Cyclerion as of December 31, 2020 and 2019, respectively.
Discontinued Operations
Upon the Separation, the Company determined its sGC business qualified for discontinued operations accounting treatment in accordance with ASC 205-20. There were no discontinued operations during year ended December 31, 2020. The following is a summary of expenses of Cyclerion classified as discontinued operations for years ended December 31, 2019 and 2018 (in thousands):
Year Ended December 31,
2019
2018
Costs and expenses:
Research and development
$
21,792
$
65,443
Selling, general and administrative
15,646
21,615
Restructuring expenses
—
1,164
Net loss from discontinued operations
$
37,438
$
88,222
There were no assets or liabilities related to discontinued operations as of either December 31, 2020 or December 31, 2019, as all balances were transferred to Cyclerion upon Separation.
4. Net Income (Loss) Per Share
The following table sets forth the computation of basic and diluted net income (loss) per common share (in thousands, except per share amounts):
Year Ended December 31,
2020
2019
2018
Numerator:
Net income (loss)
$
106,176
$
21,505
$
( 282,368 )
Denominator:
Weighted average number of common shares outstanding used in net income (loss) per share — basic
159,427
156,023
152,634
Effect of dilutive securities:
Stock options
367
—
—
Time-based restricted stock units
766
—
—
Performance-based restricted stock units
1
—
—
Restricted stock
94
—
—
Dilutive potential common shares
Weighted average number of common shares outstanding used in net income (loss) per share — diluted
160,655
156,023
152,634
Net income (loss) per share — basic
0.67
0.14
( 1.85 )
Net income (loss) per share — diluted
$
0.66
$
0.14
$
( 1.85 )
F-25
Table of Contents
The outstanding securities have been excluded from the computation of diluted weighted average shares outstanding, as applicable, as their effect would be anti-dilutive (in thousands):
Year Ended December 31,
2020
2019
2018
Stock options
11,746
17,194
20,457
Restricted stock awards
2
182
65
Time-based restricted stock units
209
3,207
3,058
Performance-based restricted stock units
93
—
—
Note Hedge Warrants
8,318
8,318
20,250
2022 Convertible Notes
8,318
8,318
20,250
2024 Convertible Notes
14,934
14,934
—
2026 Convertible Notes
14,934
14,934
—
58,554
67,087
64,080
The potentially dilutive impact of the 2022 Convertible Notes, 2024 Convertible Notes and 2026 Convertible notes (together, the “Convertible Senior Notes”) (Note 11) is determined using the treasury stock method. Under this method, no numerator or denominator adjustments arise from the principal and interest components of the Convertible Senior Notes because the Company has the intent and ability to settle the Convertible Senior Notes’ principal and interest in cash. Instead, the Company is required to increase the diluted net income (loss) per share denominator by the variable number of shares that would be issued upon conversion if it settled the conversion spread obligation with shares. For diluted net income (loss) per share purposes, the conversion spread obligation is calculated based on whether the average market price of the Company’s Class A Common Stock during the reporting period is in excess of the conversion price of the Convertible Senior Notes. There was no calculated spread added to the denominator for the years ended December 31, 2020, 2019, or 2018.
5. Goodwill and Intangible Assets
The Company closed a transaction with AstraZeneca (the “Lesinurad Transaction”) on June 2, 2016 (the “Acquisition Date”) pursuant to which the Company received an exclusive license to develop, manufacture and commercialize the Lesinurad Products in the U.S. In August 2018, the Company delivered to AstraZeneca a notice of termination of the lesinurad license agreement, which termination was made with respect to all products under the lesinurad license agreement.
The value of the developed technology – ZURAMPIC and developed technology – DUZALLO intangible assets as of the Acquisition Date was approximately $ 22.0 million and approximately $ 145.1 million, respectively. As of July 31, 2018, the accumulated amortization for developed technology – ZURAMPIC and developed technology – DUZALLO intangible assets was approximately $ 3.6 million and approximately $ 11.7 million, respectively.
During the year ended December 31, 2018, the Company completed its initiative to evaluate the optimal mix of investments for the lesinurad franchise for uncontrolled gout using a comprehensive marketing mix in select test markets (with paired controls). Data from the test markets did not meet expectations. As a result, during the year ended December 31, 2018, the Company reduced its projected revenue and net cash flow assumptions associated with the value of its developed technology – ZURAMPIC and developed technology – DUZALLO intangible assets. Accordingly, the Company evaluated its developed technology – ZURAMPIC and developed technology – DUZALLO intangible assets for impairment and recorded an approximately $ 151.8 million impairment charge during the year ended December 31, 2018. The impairment assessment performed utilized the revised projected revenue and net cash flows assumed through the termination of the lesinurad license agreement, resulting in an impairment of the full carrying value of the intangible assets. The impairment charge was recorded as impairment of intangible assets in the Company’s consolidated statement of operations.
The Company tests its goodwill for impairment annually as of October 1 st , or more frequently if events or changes in circumstances indicate an impairment may have occurred (Note 2). There were no impairments of goodwill during the years ended December 31, 2020, 2019, and 2018.
F-26
Table of Contents
6. Collaboration, License, Co-Promotion and Other Commercial Agreements
For the year ended December 31, 2020, the Company had linaclotide collaboration agreements with AbbVie for North America and AstraZeneca for China (including Hong Kong and Macau), as well as linaclotide license agreements with Astellas for Japan and with AbbVie for the AbbVie License Territory. The Company also had an agreement with Alnylam to perform disease awareness activities for AHP and sales detailing activities for GIVLAARI. The following table provides amounts included in the Company’s consolidated statements of operations as collaborative arrangements revenue and sale of API primarily attributable to transactions from these arrangements (in thousands):
Year Ended December 31,
Collaborative Arrangements Revenue
2020
2019
2018
Linaclotide Collaboration and License Agreements:
AbbVie (North America)
$
370,902
$
327,591
$
266,177
AbbVie (Europe and other)
2,196
1,718
1,146
AstraZeneca (China, including Hong Kong and Macau)
682
32,628
—
Astellas (Japan)
2,128
10,147
—
Co-Promotion and Other Agreements:
AbbVie (VIBERZI) (1)
—
3,723
4,290
Alnylam (GIVLAARI)
4,302
2,000
—
Other
1,335
1,845
1,226
Total collaborative arrangements revenue
$
381,545
$
379,652
$
272,839
Sale of API
Linaclotide Agreements:
Astellas (Japan)
$
2,017
$
45,788
$
69,599
AstraZeneca (China, including Hong Kong and Macau)
5,540
2,973
—
Other
421
—
756
Total sale of API
$
7,978
$
48,761
$
70,355
(1) The Company had an agreement with AbbVie to perform sales detailing activities for VIBERZI® (eluxadoline) which terminated as of December 31, 2019.
Accounts receivable, net, included approximately $ 145.8 million primarily related to collaborative arrangements revenue and sale of API, collectively, as of December 31, 2020, including approximately $ 110.9 million of accounts receivable, net, which includes approximately $ 4.3 million of accounts payable from the Company’s partner, AbbVie. Accounts receivable, net, included approximately $ 43.9 million related to collaborative arrangements revenue and sale of API, collectively, as of December 31, 2019.
The Company previously reflected amounts due from Allergan prior to its acquisition by AbbVie in May 2020 as related party accounts receivable. As of December 31, 2019, related party accounts receivable, net, included approximately $ 110.1 million related to collaborative arrangements revenue, net of approximately $ 4.1 million of related party accounts payable. Following acquisition of Allergan by AbbVie, the Company determined that AbbVie is not a related party to the Company (Note 17).
At December 31, 2019, deferred revenue was approximately $ 0.9 million related to the disease education and promotional agreement with Alnylam. At December 31, 2020, no deferred revenue was recorded.
The Company routinely assesses the creditworthiness of its license and collaboration partners. The Company has not experienced any material losses related to receivables from its license or collaboration partners during the years ended December 31, 2020, 2019, or 2018.
F-27
Table of Contents
Linaclotide Agreements
Collaboration Agreement for North America with AbbVie
In September 2007, the Company entered into a collaboration agreement with AbbVie to develop and commercialize linaclotide for the treatment of IBS-C, CIC, and other GI conditions in North America. Under the terms of this collaboration agreement, the Company received a non-refundable, upfront licensing fee and shares equally with AbbVie all development costs as well as net profits or losses from the development and sale of linaclotide in the U.S. The Company receives royalties in the mid-teens percent based on net sales in Canada and Mexico. AbbVie is solely responsible for the further development, regulatory approval and commercialization of linaclotide in those countries and funding any costs. The collaboration agreement for North America also includes contingent milestone payments, as well as a contingent equity investment, based on the achievement of specific development and commercial milestones. At December 31, 2019, $ 205.0 million in license fees and all six development milestone payments had been received by the Company, as well as a $ 25.0 million equity investment in the Company’s capital stock. The Company can also achieve up to $ 80.0 million in a sales-related milestone if certain conditions are met, which will be recognized as collaborative arrangements revenue when it is probable that a significant reversal of revenue would not occur, and the associated constraints have been lifted.
During the years ended December 31, 2020, 2019 and 2018, the Company incurred approximately $ 20.1 million, approximately $ 37.6 million, and approximately $ 39.2 million in total research and development expenses under the linaclotide collaboration for North America. As a result of the research and development cost-sharing provisions of the linaclotide collaboration for North America, the Company incurred approximately $ 5.6 million during the year ended December 31, 2020, and offset approximately $ 7.2 million and approximately $ 9.0 million in research and development costs during the years ended December 31, 2019 and 2018, respectively, to reflect the obligations of each party under the collaboration to bear 50 % of the development costs incurred.
The Company and AbbVie began commercializing LINZESS in the U.S. in December 2012. The Company receives 50 % of the net profits and bears 50 % of the net losses from the commercial sale of LINZESS in the U.S. Net profits or net losses consist of net sales of LINZESS to third-party customers and sublicense income in the U.S. less the cost of goods sold as well as selling, general and administrative expenses. LINZESS net sales are calculated and recorded by AbbVie and may include gross sales net of discounts, rebates, allowances, sales taxes, freight and insurance charges, and other applicable deductions.
The Company evaluated its collaboration arrangement for North America with AbbVie and concluded that all development-period performance obligations had been satisfied as of September 2012. However, the Company has determined that there are three remaining commercial-period performance obligations, which include the sales detailing of LINZESS, participation in the joint commercialization committee, and approved additional trials. The consideration remaining includes cost reimbursements in the U.S., as well as commercial sales-based milestones and net profit and loss sharing payments based on net sales in the U.S. Additionally, the Company receives royalties in the mid-teens percent based on net sales in Canada and Mexico. Royalties, commercial sales-based milestones, and net profit and loss sharing payments will be recorded as collaborative arrangements revenue or expense in the period earned, as these payments relate predominately to the license granted to AbbVie. The Company records royalty revenue in the period earned based on royalty reports from its partner, if available, or based on the projected sales and historical trends. The cost reimbursements received from AbbVie during the commercialization period will be recognized as earned in accordance with the right-to-invoice practical expedient, as the Company’s right to consideration corresponds directly with the value of the services transferred during the commercialization period.
Under the Company’s collaboration agreement with AbbVie for North America, LINZESS net sales are calculated and recorded by AbbVie and include gross sales net of discounts, rebates, allowances, sales taxes, freight and insurance charges, and other applicable deductions, as noted above. These amounts include the use of estimates and judgments, which could be adjusted based on actual results in the future. The Company records its share of the net profits or net losses from the sales of LINZESS in the U.S. on a net basis less commercial expenses, and presents the settlement payments to and from AbbVie as collaboration expense or collaborative arrangements revenue, as applicable. This treatment is in accordance with the Company’s revenue recognition policy, given that the Company is not the primary obligor and does not have the inventory risks in the collaboration agreement with AbbVie for North America. The Company relies on AbbVie to provide accurate and complete information related to net sales of LINZESS
F-28
Table of Contents
in accordance with U.S. generally accepted accounting principles in order to calculate its settlement payments to and from AbbVie and record collaboration expense or collaborative arrangements revenue, as applicable.
From time to time, in accordance with the terms of the collaboration with AbbVie for North America, the Company engages an independent certified public accounting firm to review the accuracy of the financial reporting from AbbVie to the Company. In connection with such a review during the three months ended September 30, 2018, AbbVie reported to the Company an approximately $ 59.3 million negative adjustment to LINZESS net sales. The adjustment related to the cumulative difference between certain previously estimated LINZESS gross-to-net sales reserves and allowances made by AbbVie during the years ended December 31, 2015, 2016 and 2017, and subsequent actual payments made. This adjustment was primarily associated with estimated governmental and contractual rebates, as reported by AbbVie. Upon receiving this information from AbbVie, the Company recorded a change in accounting estimate to reduce collaborative arrangements revenue by approximately $ 29.7 million during the three months ended September 30, 2018 related to the Company’s share of this adjustment. In addition, during the three months ended December 31, 2018, AbbVie reported to the Company a true-up of approximately $ 0.2 million related to the previously reported adjustment for the cumulative difference between certain previously estimated LINZESS gross-to-net sales reserves and allowances.
The Company recognized collaborative arrangements revenue from the AbbVie collaboration agreement for North America during the years ended December 31, 2020, 2019, and 2018 as follows (in thousands):
Year Ended December 31,
2020
2019
2018
Collaborative arrangements revenue related to sales of LINZESS in the U.S.
$
368,603
$
325,429
$
264,243
Royalty revenue
2,299
2,162
1,934
Total collaborative arrangements revenue
$
370,902
$
327,591
$
266,177
The collaborative arrangements revenue recognized in the years ended December 31, 2020, 2019, and 2018 primarily represents the Company’s share of the net profits and net losses on the sale of LINZESS in the U.S.
The following table presents the amounts recorded by the Company for commercial efforts related to LINZESS in the U.S. in the years ended December 31, 2020, 2019, and 2018 (in thousands):
Year Ended December 31,
2020
2019
2018
Ironwood's collaborative arrangement revenue
$
368,603
$
325,429
$
264,243
Selling, general and administrative costs incurred by the Company (1)
( 39,312 )
( 38,123 )
( 42,435 )
Ironwood's share of net profits (2)
$
329,291
$
287,306
$
221,808
(1) Includes Ironwood’s selling, general and administrative expenses attributable to the cost-sharing arrangement with AbbVie. Excludes approximately $ 0.6 million, approximately $ 2.4 million, and approximately $ 2.2 million for the years ended December 31, 2020, 2019, and 2018 respectively, related to patent prosecution and patent litigation costs recognized in connection with the collaboration agreement with AbbVie.
(2) Ironwood has recalculated its share of net profit on sales of LINZESS in the U.S. to conform with AbbVie’s recast of historically reported LINZESS U.S. net sales (previously reported by Allergan).
In May 2014, CONSTELLA ® became commercially available in Canada and, in June 2014, LINZESS became commercially available in Mexico. The Company records royalties on sales of CONSTELLA in Canada and LINZESS in Mexico in the period earned. The Company recognized approximately $ 2.3 million, approximately $ 2.2 million, and approximately $ 1.9 million of combined royalty revenues from Canada and Mexico during the years ended December 31, 2020, 2019, and 2018, respectively.
License Agreement with AbbVie (All countries other than the countries and territories of North America, China (including Hong Kong and Macau), and Japan)
In April 2009, the Company entered into a license agreement with Almirall, S.A. (“Almirall”) to develop and commercialize linaclotide in Europe (including the Commonwealth of Independent States and Turkey) for the treatment
F-29
Table of Contents
of IBS-C, CIC and other GI conditions (the “European License Agreement”). In accordance with the European License Agreement, the Company granted Almirall a right to access its U.S. Phase III clinical trial data for the purposes of supporting European regulatory approval. In October 2015, Almirall transferred its exclusive license to develop and commercialize linaclotide in Europe to AbbVie.
Additionally, in October 2015, the Company and AbbVie separately entered into an amendment to the European License Agreement relating to the development and commercialization of linaclotide in Europe. Pursuant to the terms of the amendment, (i) certain sales-based milestones payable to the Company under the European License Agreement were modified to increase the total milestone payments such that, when aggregated with certain commercial launch milestones, they could total up to $ 42.5 million, (ii) the royalties payable to the Company during the term of the European License Agreement were modified such that the royalties based on sales volume in Europe begin in the mid-single digit percent and escalate to the upper-teens percent by calendar year 2019, and (iii) AbbVie assumed responsibility for the manufacturing of linaclotide API for Europe from the Company, as well as the associated costs. The Company concluded that the 2015 amendment to the European License Agreement was not a modification to the linaclotide collaboration agreement with AbbVie for North America.
In January 2017, the Company and AbbVie entered into an amendment to the European License Agreement (the “2017 Amendment”). The 2017 Amendment extended the license to develop and commercialize linaclotide in all countries other than China (including Hong Kong and Macau), Japan, and the countries and territories of North America. On a country-by-country and product-by-product basis in such additional territory, AbbVie is obligated to pay the Company a royalty as a percentage of net sales of products containing linaclotide as an active ingredient in the upper-single digits for five years following the first commercial sale of a linaclotide product in a country, and in the low-double digits thereafter. The royalty rate for products in the expanded territory will decrease, on a country-by-country basis, to the lower-single digits , or cease entirely, following the occurrence of certain events. The 2017 Amendment did not modify any of the milestones or royalty terms related to Europe.
In evaluating the terms of the European License Agreement, as amended, the Company determined that there are no remaining performance obligations as of September 2012. However, the Company continues to be eligible to receive consideration in the form of commercial launch milestones, sales-based milestones, and royalties.
The commercial launch milestones, sales-based milestones and royalties under the European License Agreement and the 2017 Amendment relate predominantly to the license granted to AbbVie. The Company records royalties on sales of CONSTELLA in Europe in the period earned based on royalty reports from its partner, if available, or the projected sales and historical trends under the sales-based royalty exception. The commercial launch milestones are recognized as revenue when it is probable that a significant reversal of revenue would not occur and the associated constraint has been lifted.
The Company recognized approximately $ 2.2 million, approximately $ 1.7 million and approximately $ 1.1 million of royalty revenue from the Amended European License Agreement during the years ended December 31, 2020, 2019, and 2018, respectively.
License Agreement for Japan with Astellas
In November 2009, the Company entered into a license agreement with Astellas, as amended, to develop and commercialize linaclotide for the treatment of IBS-C, CIC and other GI conditions in Japan (the “2009 License Agreement with Astellas”). Astellas is responsible for all activities relating to development, regulatory approval and commercialization in Japan as well as funding the associated costs and the Company was required to participate on a joint development committee over linaclotide’s development period. During the year ended December 31, 2017, the Company and Astellas entered into a commercial API supply agreement (the “Astellas Commercial Supply Agreement”). Pursuant to the Astellas Commercial Supply Agreement, the Company sells linaclotide API supply to Astellas at a contractually defined rate and recognizes related revenue as sale of API. Under the 2009 License Agreement with Astellas, the Company received royalties which escalated based on sales volume, beginning in the low-twenties percent, less the transfer price paid for the API included in the product sold and other contractual deductions.
Under the 2009 License Agreement with Astellas, the Company received an up-front licensing fee of $ 30.0 million and three development milestone payments that totaled $ 45.0 million, which were recognized as revenue prior to the adoption of ASC 606 on January 1, 2018.
F-30
Table of Contents
The Company evaluated the terms of the 2009 License Agreement with Astellas and determined that there were no remaining performance obligations as of the adoption of ASC 606. Additionally, under the terms of the Astellas Commercial Supply Agreement, the Company determined it had an ongoing performance obligation to supply API.
During the years ended December 31, 2019 and 2018, the Company recognized revenue of approximately $ 27.5 million and approximately $ 69.6 million, respectively, from the sale of API to Astellas under the 2009 License Agreement with Astellas and the Astellas Commercial Supply Agreement. The royalties on sales of LINZESS in Japan did not exceed the transfer price of API sold and other contractual deductions during each of the periods presented.
In August 2019, the Company and Astellas amended and restated the 2009 License Agreement with Astellas (the “Amended Astellas License Agreement”). This amendment to the 2009 License Agreement with Astellas was accounted for as a separate contract. Under the terms of the Amended Astellas License Agreement, the Company is no longer responsible for the supply of linaclotide API to Astellas, and Astellas assumed responsibility for its own supply of linaclotide API in Japan in 2020.
In connection with the execution of the Amended Astellas License Agreement, Astellas paid the Company a non-refundable, upfront payment of $ 10.0 million in August 2019. Further, Astellas, in lieu of the royalty payment terms set forth in the 2009 License Agreement with Astellas, pays royalties to the Company at rates beginning in the mid-single digit percent and escalating to low-double-digit percent, based on aggregate annual net sales in Japan of products containing linaclotide API. These royalty payments are subject to reduction following the expiration of certain licensed patents and the occurrence of generic competition in Japan. The Company continued to supply linaclotide API for Japan during 2019 and 2020 at a contractually defined rate. Additionally, Astellas reimbursed the Company for the Company’s performance of adverse event reporting services at a fixed monthly rate until such services were terminated in February 2020.
The Company identified the following performance obligations under the Amended Astellas License Agreement:
● delivery of the expanded license of intellectual property, including the applicable manufacturing know-how;
● obligation to supply linaclotide API for 2019; and
● adverse event reporting services.
The Company allocated the $ 10.0 million upfront payment to the delivery of the expanded license of intellectual property and recognized it as collaborative arrangements revenue at contract inception. The Company allocated the approximately $ 20.4 million in remaining purchase orders for API to the obligation to supply linaclotide API to Astellas for 2019. Consideration for the supply of linaclotide API is recognized over the performance period as linaclotide API is shipped to Astellas. Consideration allocated to the adverse event reporting services is recognized as such services are provided over the performance period based on the amount to which the Company has a right to invoice.
Royalties on sales of LINZESS in Japan relate predominantly to the license granted to Astellas. Accordingly, the Company applies the sales-based royalty exception and records royalties on sales of LINZESS in Japan in the period earned based on royalty reports from its partner, if available, or the projected sales and historical trends.
The Company recognized $ 10.0 million in collaborative arrangements revenue during the year ended December 31, 2019 related to the upfront fee associated with the execution of the Amended Astellas License Agreement. The Company recognized approximately $ 2.0 million and approximately $ 18.3 million from the sale of API to Astellas under the Amended License Agreement during the years ended December 31, 2020 and 2019, respectively. The Company recognized approximately $ 2.1 million of royalty revenue during the year ended December 31, 2020. The Company recognized an insignificant amount of collaborative arrangements revenue related to adverse event reporting services in each of the years ended December 31, 2020 and 2019.
Collaboration Agreement for China (including Hong Kong and Macau) with AstraZeneca
In October 2012, the Company entered into a collaboration agreement with AstraZeneca to co-develop and co-commercialize linaclotide in the AstraZeneca License Territory (the “AstraZeneca Collaboration Agreement”). The
F-31
Table of Contents
collaboration provided AstraZeneca with an exclusive nontransferable license to exploit the underlying technology in the AstraZeneca License Territory. The parties shared responsibility for continued development and commercialization of linaclotide under a joint development plan and a joint commercialization plan, respectively, with AstraZeneca having primary responsibility for the local operational execution.
In September 2019, the Company and AstraZeneca entered into an amendment and restatement of the AstraZeneca Collaboration Agreement (the “Amended AstraZeneca Agreement”) under which AstraZeneca obtained the exclusive right to develop, manufacture and commercialize products containing linaclotide in the AstraZeneca License Territory (the “AstraZeneca License”).
Prior to the execution of the Amended AstraZeneca Agreement, the Company identified the following performance obligations under the AstraZeneca Collaboration Agreement:
● research, development and regulatory services pursuant to the development plan (“R&D Services”);
● Joint Development Committee (“JDC”) services;
● obligation to supply clinical trial material; and
● Joint Commercialization Committee services.
Under the original AstraZeneca Collaboration Agreement, the Company shared development costs with AstraZeneca, with AstraZeneca incurring 55 % of the net losses from the development and commercialization of linaclotide in the AstraZeneca License Territory. Payments from AstraZeneca with respect to both research and development and selling, general and administrative costs incurred by the Company prior to the commercialization of linaclotide in the AstraZeneca License Territory were recorded as a reduction in expense. Development costs incurred by the Company that pertained to the joint development plan and subsequent amendments to the joint development plan, as approved by the JDC, were recorded as research and development expense as incurred. Payments to AstraZeneca were recorded as incremental research and development expense. During the years ended December 31, 2019 and 2018, the Company incurred approximately $ 1.2 million and approximately $ 0.9 million, respectively, related to pre-launch commercial services and supply chain services.
Under the Amended AstraZeneca Agreement, the Company is entitled to receive non-contingent payments totaling $ 35.0 million in three installments through 2024, of which $ 10.0 million was received in January 2021. In addition, AstraZeneca may be required to make milestone payments totaling up to $ 90.0 million contingent on the achievement of certain sales targets and will be required to pay tiered royalties to the Company at rates beginning in the mid-single-digit percent and increasing up to twenty percent based on the aggregate annual net sales of products containing linaclotide in the AstraZeneca License Territory. In connection with the Amended AstraZeneca Agreement, the Company and AstraZeneca entered into a transition services agreement (“AstraZeneca TSA”) and an amended commercial supply agreement (“AstraZeneca CSA”). Under the terms of the AstraZeneca TSA, the Company will provide certain regulatory and administrative services for a term of approximately two years from the date of execution, unless earlier terminated or extended. Services performed are paid at a mutually agreed upon rate. Amounts for AstraZeneca TSA services are recorded as collaborative arrangements revenue. Under the terms of the AstraZeneca CSA, the Company supplied linaclotide API, finished drug product and finished goods for the Licensed Territory through March 31, 2020 at predetermined rates.
The Company evaluated the Amended AstraZeneca Agreement and determined that it would be accounted for as a separate contract because it adds a distinct good or service at an amount that reflects standalone selling price. The following performance obligations under the Amended AstraZeneca Agreement were identified:
● delivery of the expanded AstraZeneca License;
● AstraZeneca TSA services; and
● supply of linaclotide API, finished drug product and finished goods under the AstraZeneca CSA.
F-32
Table of Contents
The Company determined that the non-contingent payments should be allocated to the delivery of the expanded AstraZeneca License. The Company determined that the performance obligation related to the transfer of the AstraZeneca License was satisfied as of the execution date of the Amended AstraZeneca Agreement. As a portion of the payments relating to the transfer of the AstraZeneca License are due significantly after the performance obligation was satisfied, the Company adjusted its transaction price for the significant financing component of approximately $ 2.6 million. Accordingly, the Company recognized approximately $ 32.4 million relating to the delivery of the AstraZeneca License as collaborative arrangements revenue at contract inception and will recognize the approximately $ 2.6 million relating to the significant financing component as interest income through 2024 using the effective interest method. Consideration allocated to the AstraZeneca TSA services will be recognized as collaborative arrangements revenue as such services are provided over the performance period based on the amount to which the Company has a right to invoice. Consideration for the supply of linaclotide API, finished drug product and finished goods under the AstraZeneca CSA was recognized over the performance period as linaclotide API, finished drug product and finished goods were shipped to AstraZeneca.
During the year ended December 31, 2020, the Company recognized approximately $ 0.7 million in collaborative arrangements revenue related to the Amended AstraZeneca License, of which approximately $ 0.6 million related to the AstraZeneca TSA services and approximately $ 0.1 million related to royalties. During the year ended December 31, 2020, the Company recognized approximately $ 5.5 million of sale of API on its consolidated statement of operations relating to the supply of linaclotide finished drug product and finished goods under the AstraZeneca CSA. During the year ended December 31, 2019, the Company recognized approximately $ 32.6 million in collaborative arrangements revenue related to the Amended AstraZeneca License, of which approximately $ 32.4 million related to the delivery of the AstraZeneca License and approximately $ 0.2 million related to the AstraZeneca TSA services. During the year ended December 31, 2019, the Company recognized approximately $ 3.0 million of sale of API on its consolidated statement of operations relating to the supply of linaclotide finished drug product and finished goods under the AstraZeneca CSA.
Co-Promotion and Other Agreements
Disease Education and Promotional Agreement with Alnylam
In August 2019, the Company and Alnylam entered into a disease education and promotional agreement for Alnylam’s GIVLAARI, and this agreement was subsequently amended in December 2020 (the “Alnylam Agreement”). GIVLAARI was approved by the U.S. FDA in November 2019 for the treatment of adult patients with AHP. Under the terms of the Alnylam Agreement, the Company’s sales force is performing disease awareness activities and sales detailing activities for GIVLAARI to gastroenterologists and health care practitioners to whom they detail LINZESS in the first position over the term of the agreement, which is approximately three years.
Under the Alnylam Agreement, the Company received service fees, totaling approximately $ 5.5 million for services rendered through December 31, 2020. The Company also is eligible to receive royalties based on a percentage of net sales of GIVLAARI that are directly attributable to the Company’s promotional efforts over the term of the agreement. The Company identified the following performance obligation under the Alnylam Agreement:
● performance of disease education activities for AHP and performance of sales details for GIVLAARI (together “Givosiran Education and Promotion Activities”).
The Company allocated the service fees to the performance of Givosiran Education and Promotion Activities and recognized collaborative arrangements revenue through December 31, 2020 as the services were performed based on the amount to which the Company had a right to invoice. Royalties are recognized as collaborative arrangements revenue for Givosiran Education and Promotion Activities based on the amount to which the Company has a right to invoice when the associated constraints have been lifted.
During the years ended December 31, 2020 and 2019, the Company recognized approximately $ 3.5 million and approximately $ 2.0 million, respectively, in collaborative arrangements revenue related to the service fees. During the year ended December 31, 2020, the Company recognized approximately $ 0.8 million in royalty revenue related to the Alnylam Agreement. The Company did not recognize any royalty revenue related to the Alnylam Agreement during the year ended December 31, 2019. As of December 31, 2019, the Company had a deferred revenue balance of
F-33
Table of Contents
approximately $ 0.9 million related to advance billings of service fees. As of December 31, 2020, the Company had no deferred revenue.
7. Fair Value of Financial Instruments
The tables below present information about the Company’s assets that are measured at fair value on a recurring basis as of December 31, 2020 and 2019 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize observable inputs such as quoted prices in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are either directly or indirectly observable, such as quoted prices for similar instruments in active markets, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the Company to develop its own assumptions for the asset or liability.
The Company’s investment portfolio may include fixed income securities that do not always trade on a daily basis. As a result, the pricing services used by the Company apply other available information as applicable through processes such as benchmark yields, benchmarking of like securities, sector groupings and matrix pricing to prepare valuations. In addition, model processes are used to assess interest rate impact and develop prepayment scenarios. These models take into consideration relevant credit information, perceived market movements, sector news and economic events. The inputs into these models may include benchmark yields, reported trades, broker-dealer quotes, issuer spreads and other relevant data. The Company validates the prices provided by its third party pricing services by obtaining market values from other pricing sources and analyzing pricing data in certain instances. The Company also invests in certain reverse repurchase agreements, which are collateralized by Government Securities and Obligations for an amount not less than 102 % of their principal amount. The Company does not record an asset or liability for the collateral as the Company is not permitted to sell or re-pledge the collateral. The collateral has at least the prevailing credit rating of U.S. Government Treasuries and Agencies. The Company utilizes a third party custodian to manage the exchange of funds and ensure the collateral received is maintained at 102 % of the reverse repurchase agreements principal amount on a daily basis.
The following tables present the assets and liabilities the Company has measured at fair value on a recurring basis (in thousands):
Fair Value Measurements at Reporting Date Using
Quoted Prices in
Significant Other
Significant
Active Markets for
Observable
Unobservable
December 31,
Identical Assets
Inputs
Inputs
2020
(Level 1)
(Level 2)
(Level 3)
Assets:
Cash and cash equivalents:
Money market funds
$
349,014
$
349,014
$
—
$
—
Restricted cash:
Money market funds
2,221
2,221
—
—
Convertible note hedges
13,065
—
—
13,065
Total assets measured at fair value
$
364,300
$
351,235
$
—
$
13,065
Liabilities:
Note hedge warrants
$
12,088
$
—
$
—
$
12,088
Total liabilities measured at fair value
$
12,088
$
—
$
—
$
12,088
F-34
Table of Contents
Fair Value Measurements at Reporting Date Using
Quoted Prices in
Significant Other
Significant
Active Markets for
Observable
Unobservable
December 31,
Identical Assets
Inputs
Inputs
2019
(Level 1)
(Level 2)
(Level 3)
Assets:
Cash and cash equivalents:
Money market funds
$
139,190
$
139,190
$
—
$
—
Repurchase agreements
37,800
37,800
—
—
Restricted cash:
Money market funds
2,221
2,221
—
—
Convertible note hedges
31,366
—
—
31,366
Total assets measured at fair value
$
210,577
$
179,211
$
—
$
31,366
Liabilities:
Note hedge warrants
$
24,260
$
—
$
—
$
24,260
Total liabilities measured at fair value
$
24,260
$
—
$
—
$
24,260
There were no transfers between fair value measurement levels during each of the years ended December 31, 2020 or 2019.
Cash equivalents, accounts receivable, related party accounts receivable, prepaid expenses and other current assets, accounts payable, related party accounts payable, accrued research and development costs, accrued expenses and other current liabilities, current portion of operating lease obligations, and deferred revenue at December 31, 2020 and 2019 are carried at amounts that approximate fair value due to their short-term maturities.
Convertible Note Hedges and Note Hedge Warrants with Respect to 2022 Convertible Notes
The Company’s Convertible Note Hedges and the Note Hedge Warrants are recorded as derivative assets and liabilities, respectively, and are classified as Level 3 measurements under the fair value hierarchy. These derivatives are not actively traded and are valued using the Black-Scholes option-pricing model, which requires the use of subjective assumptions. Significant inputs used to determine the fair value as of December 31, 2020 included the price per share of the Company’s Class A Common Stock, expected terms of the derivative instruments, strike prices of the derivative instruments, risk-free interest rates, and expected volatility of the Company’s Class A Common Stock. Changes to these inputs could materially affect the valuation of the Convertible Note Hedges and Note Hedge Warrants.
The following inputs were used in the fair market valuation of the Convertible Note Hedges and Note Hedge Warrants as of December 31, 2020 and 2019:
December 31,
December 31,
2020
2019
Convertible
Note Hedge
Convertible
Note Hedge
Note Hedges
Warrants
Note Hedges
Warrants
Risk-free interest rate (1)
0.1
%
0.1
%
1.6
%
1.6
%
Expected term
1.5
2.0
2.5
3.0
Stock price (2)
$
11.39
$
11.39
$
13.31
$
13.31
Strike price (3)
$
14.51
$
18.82
$
14.51
$
18.82
Common stock volatility (4)
46.7
%
50.3
%
49.1
%
46.5
%
Dividend yield (5)
—
%
—
%
—
%
—
%
(1) Based on U.S. Treasury yield curve, with terms commensurate with the expected terms of the Convertible Note Hedges and the Note Hedge Warrants.
(2) The closing price of the Company’s Class A Common Stock on the last trading days of the years ended December 31, 2020 and 2019, respectively.
(3) As per the respective agreements for the Convertible Note Hedges and Note Hedge Warrants.
(4) Expected volatility based on historical volatility of the Company’s Class A Common Stock.
F-35
Table of Contents
(5) The Company has not paid and does not anticipate paying cash dividends on its shares of common stock in the foreseeable future; therefore, the expected dividend yield is assumed to be zero .
The Convertible Note Hedges and the Note Hedge Warrants are recorded at fair value at each reporting date and changes in fair value are recorded in other (expense) income, net within the Company's consolidated statements of operations.
The following table reflects the change in the Company's Level 3 Convertible Note Hedges and Note Hedge Warrants from December 31, 2018 through December 31, 2020 (in thousands):
Convertible
Note Hedge
Note Hedges
Warrants
Balance at December 31, 2018
$
41,020
$
( 33,763 )
Cash settlement (received) paid upon early termination of derivatives (Note 11)
( 28,909 )
25,735
Change in fair value, recorded as a component of gain (loss) on derivatives
19,255
( 16,232 )
Balance at December 31, 2019
$
31,366
$
( 24,260 )
Change in fair value, recorded as a component of (loss) gain on derivatives
( 18,301 )
12,172
Balance at December 31, 2020
$
13,065
$
( 12,088 )
Convertible Senior Notes
In June 2015, the Company issued approximately $ 335.7 million aggregate principal amount of its 2022 Convertible Notes. In August 2019, the Company issued $ 200.0 million aggregate principal amount of its 2024 Convertible Notes and $ 200.0 million aggregate principal amount of its 2026 Convertible Notes, and used a portion of the proceeds from such issuances to repurchase $ 215.0 million aggregate principal amount of its 2022 Convertible Notes. The Company separately accounted for the liability and equity components of each of the 2022 Convertible Notes, 2024 Convertible Notes, and 2026 Convertible Notes, by allocating the proceeds between the liability component and equity component (Note 11). The fair value of the respective convertible senior notes, which differs from their carrying value, is influenced by interest rates, the price of the Company’s Class A Common Stock and the volatility thereof, and the prices for the respective convertible senior notes observed in market trading, which are Level 2 inputs.
The estimated fair value of the 2022 Convertible Notes as of December 31, 2020 and 2019 was approximately $ 130.2 million and $ 141.3 million, respectively. The estimated fair value of the 2024 Convertible Notes as of December 31, 2020 and 2019 was approximately $ 222.3 million and $ 235.7 million, respectively. The estimated fair value of the 2026 Convertible Notes as of December 31, 2020 and 2019 was approximately $ 224.1 million and $ 240.1 million, respectively.
Capped Calls with Respect to 2024 Convertible Notes and 2026 Convertible Notes
In connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes, the Company entered into the Capped Calls with certain financial institutions. The Capped Calls cover 29,867,480 shares of Class A Common Stock (subject to anti-dilution and certain other adjustments), which is the same number of shares of Class A Common Stock that initially underlie the 2024 Convertible Notes and the 2026 Convertible Notes. The Capped Calls have an initial strike price of approximately $ 13.39 per share, which corresponds to the initial conversion price of the 2024 Convertible Notes and the 2026 Convertible Notes, and have a cap price of approximately $ 17.05 per share (Note 11). The strike price and cap price are subject to anti-dilution adjustments generally similar to those applicable to the 2024 Convertible Notes and the 2026 Convertible Notes. These instruments meet the conditions outlined in ASC 815 to be classified in stockholders’ equity (deficit) and are not subsequently remeasured as long as the conditions for equity classification continue to be met (Note 11).
8. Leases
Effective January 1, 2019 , the Company adopted ASC 842 using the optional transition method . The Company’s lease portfolio for the year ended December 31, 2020 includes: a lease for its current headquarters location, a data center colocation lease, vehicle leases for its salesforce representatives, and leases for computer and office equipment.
F-36
Table of Contents
Lease cost is recognized on a straight-line basis over the lease term. The components of lease cost for the year ended December 31, 2020 and 2019 are as follows (in thousands):
Year Ended December 31,
2020
2019
Operating lease cost during period, net (1)
$
2,530
$
16,452
Variable lease payments
—
1,526
Short-term lease cost
1,420
1,512
Total lease cost
$
3,950
$
19,490
(1) Operating lease cost is presented net of approximately $ 0.3 million of sublease income for the year ended December 31, 2019 related to a sublease agreement between Ironwood and Cyclerion executed upon Separation. The sublease agreement terminated in May 2019.
Supplemental cash flow information related to leases for the periods reported is as follows:
Year Ended December 31,
2020
2019
Right-of-use assets obtained in exchange for new operating lease upon adoption of ASC 842 (in thousands)
$
—
$
88,299
Adjustment to right-of-use assets as a result of the lease modification upon Separation (in thousands)
—
( 40,427 )
Adjustment to right-of-use assets as a result of the termination of the Binney Street Lease (in thousands)
—
( 34,440 )
Right-of-use assets obtained in exchange for new operating lease liabilities upon execution of Summer Street Lease (in thousands)
—
18,452
Cash paid for amounts included in the measurement of lease liabilities (in thousands)
1,146
18,598
Weighted-average remaining lease term of operating leases (in years)
9.3
10.2
Weighted-average discount rate of operating leases
5.8
%
5.8
%
Future minimum lease payments under non-cancelable operating leases as of December 31, 2020 are as follows (in thousands):
Operating
Lease
Payments
2021
$
3,128
2022
3,129
2023
3,065
2024
3,126
2025
3,189
2026 and thereafter
14,856
Total future minimum lease payments
30,493
Less: present value adjustment
( 7,047 )
Operating lease liabilities at December 31, 2020
23,446
Less: current portion of operating lease liabilities
( 3,128 )
Operating lease liabilities, net of current portion
$
20,318
Summer Street Lease (current headquarters)
In June 2019, the Company entered into a non-cancelable operating lease (the “Summer Street Lease”) for approximately 39,000 square feet of office space on the 23 rd floor of 100 Summer Street, Boston, Massachusetts, which began serving as the Company’s headquarters in October 2019, replacing its prior headquarters at 301 Binney Street in Cambridge, Massachusetts. The Summer Street Lease terminates on June 11, 2030 and includes a 2 % annual rent escalation, free rent periods, a tenant improvement allowance, and an option to extend the term of the lease for an
F-37
Table of Contents
additional five years at a market base rental rate. The rent expense, inclusive of the escalating rent payments and lease incentives, is recognized on a straight-line basis over the lease term. Additionally, the Summer Street Lease requires a letter of credit to secure the Company’s obligations under the lease agreement of approximately $ 1.0 million, which is collateralized by a money market account recorded as restricted cash on the Company’s consolidated balance sheet as of December 31, 2020.
At lease inception, the Company recorded a right-of-use asset and a lease liability associated with the Summer Street Lease using an incremental borrowing rate of approximately 5.8 %. At December 31, 2020, the balances of the right-of-use asset and operating lease liability were approximately $ 16.6 million and approximately $ 23.2 million, respectively. At December 31, 2019, the balances of the right-of-use asset and operating lease liability were approximately $ 17.7 million and approximately $ 22.8 million, respectively.
Lease costs related to the Summer Street Lease recorded during the years ended December 31, 2020 and 2019 were approximately $ 2.5 million and approximately $ 1.5 million, respectively.
Binney Street Lease (prior headquarters)
The Company rented office space at 301 Binney Street, Cambridge, Massachusetts under a non-cancelable operating lease entered into in January 2007, as amended (“Binney Street Lease”) through October 2019.
On April 1, 2019, the Company modified the Binney Street Lease to reduce its leased premises to approximately 108,000 rentable square feet of office space on the first and third floors. The surrendered portion of approximately 114,000 rentable square feet on the first and second floor of the building was subsequently occupied by Cyclerion under a direct lease between Cyclerion and the Binney Street landlord. As a result of the modification, the Company adjusted the value of its right-of-use asset and operating lease liability using an incremental borrowing rate of approximately 5.1 %, and recognized a gain of approximately $ 3.2 million, which was recorded as a reduction to operating expenses on its consolidated statement of operations. The Company elected to determine the proportionate reduction in the right-of-use asset based on the reduction to the lease liability.
As of January 1, 2019, in conjunction with the adoption of ASC 842, the Company recorded a right-of-use asset of approximately $ 87.7 million and a lease liability of approximately $ 94.3 million associated with the Binney Street Lease.
On June 11, 2019, the Company entered into a lease termination agreement (the “Lease Termination”) with the Binney Street landlord to terminate the Company’s lease for approximately 108,000 square feet of office space. The Lease Termination was effective during the fourth quarter of 2019 in exchange for an approximately $ 9.0 million payment. The Lease Termination was accounted for as a lease modification that reduces the term of the existing lease and the Company adjusted the value of its right-of-use asset and operating lease liability using an incremental borrowing rate of approximately 4.0 %.
Lease cost related to the Binney Street Lease recorded during the year ended December 31, 2019 was approximately $ 16.3 million, net of sublease income of approximately $ 0.3 million. Under ASC 840, rent expense related to the Binney Street Lease recorded during the year ended December 31, 2018 was approximately $ 10.0 million.
Vehicle fleet leases
During April 2018, the Company entered into a master services agreement containing 12-month leases (the “2018 Vehicle Leases”) for vehicles within its fleet for its field-based sales force and medical science liaisons. These leases are classified as short-term in accordance with the practical expedient in ASC 842. The 2018 Vehicle Leases expire at varying times, with a monthly renewal provision. In accordance with the terms of the 2018 Vehicle Leases, the Company maintains a letter of credit securing its obligation under the lease agreements of $ 1.3 million, which is collateralized by a money market account recorded as restricted cash on the Company’s consolidated balance sheets as of December 31, 2020 and 2019.
Lease cost related to the 2018 Vehicle Leases was approximately $ 1.4 million and approximately $ 1.5 million, respectively, for the years ended December 31, 2020 and 2019. Under ASC 840, lease cost related to the 2018 Vehicle Leases was approximately $ 0.8 million for the year ended December 31, 2018.
F-38
Table of Contents
9. Property and Equipment
Property and equipment, net consisted of the following (in thousands):
December 31,
2020
2019
Software
$
8,615
$
9,568
Leasehold improvements
7,407
7,318
Laboratory equipment
1,898
2,193
Furniture and fixtures
1,517
1,508
Computer and office equipment
1,297
1,293
Construction in process
—
631
20,734
22,511
Less accumulated depreciation and amortization
( 11,805 )
( 10,082 )
$
8,929
$
12,429
Depreciation expense of property and equipment was approximately $ 2.3 million and $ 5.6 million for the years ended December 31, 2020 and 2019, respectively. Depreciation and amortization expense of property and equipment, including amounts recorded under capital leases under ASC 840, was approximately $ 3.9 million for the year ended December 31, 2018.
During the year ended December 31, 2020, the Company recorded approximately $ 1.2 million in restructuring expenses in its consolidated statement of operations related to the impairment of certain fixed assets as a result of its decision to discontinue IW-3718 development.
10. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
December 31,
2020
2019
Accrued incentive compensation
$
8,719
$
11,760
Accrued vacation
2,625
2,540
Professional fees
530
1,421
Salaries
627
2,973
Other employee benefits
1,442
1,260
Restructuring liabilities
10,510
179
Other
2,033
10,332
$
26,486
$
30,465
As of December 31, 2020, other accrued expenses of approximately $ 2.0 million included approximately $ 1.6 million of uninvoiced vendor liabilities and approximately $ 0.3 million of accrued interest.
As of December 31, 2019, other accrued expenses of approximately $ 10.3 million included approximately $ 4.1 million related to API batches uninvoiced, approximately $ 0.9 million related to activities associated with the Company’s move to the 100 Summer Street headquarters, approximately $ 0.6 million related to unbilled inventory, approximately $ 0.3 million of accrued interest, and approximately $ 0.2 million related to equipment for clinical studies.
11. Notes Payable
8.375 % Notes due 2026
On September 23, 2016, the Company closed a direct private placement, pursuant to which the Company issued $ 150.0 million in aggregate principal amount of 8.375 % Notes due 2026 (the “2026 Notes”) and received net proceeds of approximately $ 11.2 million. The Company capitalized approximately $ 0.5 million of debt issuance costs, which were netted against the carrying value of the 2026 Notes. Proceeds from the issuance of the 2024 Convertible Notes and the
F-39
Table of Contents
2026 Convertible Notes were used, in part, to redeem the outstanding principal balance of the 2026 Notes in September 2019. The Company retired the 2026 Notes, which had an outstanding aggregate principal balance of approximately $ 116.5 million, for a redemption price of approximately $ 123.0 million. The redemption of the 2026 Notes resulted in a loss on extinguishment of debt of approximately $ 7.6 million related to the prepayment premium and write-off of the unamortized debt issuance costs and unamortized debt discount.
The 2026 Notes had an annual interest rate of 8.375 %, with interest payable March 15, June 15, September 15 and December 15 of each year (each an “ 8.375 % Payment Date”). Principal of the 2026 Notes was payable on the 8.375 % Payment Dates beginning March 15, 2019. From March 15, 2019, the Company made quarterly payments on the 2026 Notes equal to the greater of (i) 7.5 % of net sales of linaclotide in the U.S. for the preceding quarter (the “ 8.375 % Synthetic Royalty Amount”) and (ii) accrued and unpaid interest on the 2026 Notes (the “ 8.375 % Required Interest Amount”). Principal on the 2026 Notes was due to be repaid in an amount equal to the 8.375 % Synthetic Royalty Amount minus the 8.375 % Required Interest Amount, when this was a positive number, until the principal had been paid in full.
Convertible Senior Notes
2.25 % Convertible Senior Notes due 2022
In June 2015, the Company issued approximately $ 335.7 million aggregate principal amount of the 2022 Convertible Notes. The Company received net proceeds of approximately $ 324.0 million from the sale of the 2022 Convertible Notes, after deducting fees and expenses of approximately $ 11.7 million. The Company used approximately $ 21.1 million of the net proceeds from the sale of the 2022 Convertible Notes to pay the net cost of the Convertible Note Hedges (after such cost was partially offset by the proceeds to the Company from the sale of the Note Hedge Warrants), as described below.
The 2022 Convertible Notes are governed by an indenture (the “2022 Indenture”) between the Company and U.S. Bank National Association, as trustee (the “Trustee”). The 2022 Convertible Notes are senior unsecured obligations and bear cash interest at the annual rate of 2.25 %, payable on June 15 and December 15 of each year. The 2022 Convertible Notes will mature on June 15, 2022, unless earlier converted or repurchased. The Company may settle conversions of the 2022 Convertible Notes through payment or delivery, as the case may be, of cash, shares of the Company’s Class A Common Stock or a combination of cash and shares of Class A Common Stock, at the Company’s option (subject to, and in accordance with, the settlement provisions of the 2022 Indenture). The initial conversion rate for the 2022 Convertible Notes was 60.3209 shares of Class A Common Stock (subject to adjustment as provided for in the 2022 Indenture) per $ 1,000 principal amount of the 2022 Convertible Notes, which was equal to an initial conversion price of approximately $ 16.58 per share and 20,249,665 shares.
In connection with the Separation, in April 2019, the conversion rate under the 2022 Indenture was adjusted to equal 68.9172 shares of Class A Common Stock per $ 1,000 principal amount of the 2022 Convertible Notes, which is equal to an adjusted conversion price of approximately $ 14.51 per share and 23,135,435 shares.
Holders of the 2022 Convertible Notes may convert their 2022 Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding December 15, 2021 in multiples of $ 1,000 principal amount, only under the following circumstances:
● during any calendar quarter commencing after the calendar quarter ending on September 30, 2015 (and only during such calendar quarter), if the last reported sale price of the Company’s Class A Common Stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price for the 2022 Convertible Notes on each applicable trading day;
● during the five business day period after any five consecutive trading day period (the “measurement period”) in which the “trading price” (as defined in the 2022 Indenture) per $ 1,000 principal amount of the 2022 Convertible Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of the Company’s Class A Common Stock and the conversion rate for the 2022 Convertible Notes on each such trading day; or
F-40
Table of Contents
● upon the occurrence of specified corporate events described in the 2022 Indenture.
On or after December 15, 2021, until the close of business on the second scheduled trading day immediately preceding June 15, 2022, holders may convert their 2022 Convertible Notes, in multiples of $ 1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.
The Company may not redeem the 2022 Convertible Notes prior to the maturity date and no “sinking fund” is provided for by the 2022 Convertible Notes, which means that the Company is not required to periodically redeem or retire the 2022 Convertible Notes. Upon the occurrence of certain fundamental changes involving the Company, holders of the 2022 Convertible Notes may require the Company to repurchase for cash all or part of their 2022 Convertible Notes at a repurchase price equal to 100 % of the principal amount of the 2022 Convertible Notes to be repurchased, plus accrued and unpaid interest. If a make-whole fundamental change, as described in the 2022 Indenture, occurs and a holder elects to convert its 2022 Convertible Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the conversion rate as described in the 2022 Indenture.
The 2022 Indenture does not contain any financial covenants or restrict the Company’s ability to repurchase the Company’s securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Company’s level of indebtedness. The 2022 Indenture provides for customary events of default. In the case of an event of default with respect to the 2022 Convertible Notes arising from specified events of bankruptcy or insolvency, all outstanding 2022 Convertible Notes will become due and payable immediately without further action or notice. If any other event of default with respect to the 2022 Convertible Notes under the 2022 Indenture occurs or is continuing, the Trustee or holders of at least 25 % in aggregate principal amount of the then outstanding 2022 Convertible Notes may declare the principal amount of the 2022 Convertible Notes to be immediately due and payable. Notwithstanding the foregoing, the 2022 Indenture provides that, upon the Company’s election, and for up to 180 days , the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the 2022 Indenture consists exclusively of the right to receive additional interest on the 2022 Convertible Notes.
In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability and equity components of the 2022 Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option, or equity component, due to the Company's ability to settle the 2022 Convertible Notes in cash, its Class A Common Stock, or a combination of cash and Class A Common Stock at the option of the Company. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated conversion feature. The equity component of the 2022 Convertible Notes was recognized as a debt discount and represents the difference between the gross proceeds from the issuance of the 2022 Convertible Notes and the fair value of the liability component of the 2022 Convertible Notes on their respective dates of issuance. The debt discount is amortized to interest expense using the effective interest method over seven years , or the expected life of the 2022 Convertible Notes. The equity component is not remeasured as long as it continues to meet the conditions for equity classification.
In connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes in August 2019, the Company repurchased $ 215.0 million aggregate principal amount of the 2022 Convertible Notes. The 2022 Convertible Notes were repurchased at a premium totaling approximately $ 227.3 million. The Company recognized a loss on extinguishment of debt of approximately $ 23.4 million during the year ended December 31, 2019 related to the prepayment premium and proportional write-off of the 2022 Convertible Notes unamortized debt issuance costs and unamortized debt discount. Additionally, the repurchase resulted in a reduction to additional paid-in capital of approximately $ 27.0 million during the year ended December 31, 2019 related to the equity component of the 2022 Convertible Notes.
0.75 % Convertible Senior Notes due 2024 and 1.50 % Convertible Senior Notes due 2026
In August 2019, the Company issued $ 200.0 million aggregate principal amount of the 2024 Convertible Notes and $ 200.0 million aggregate principal amount of the 2026 Convertible Notes. The Company received net proceeds of approximately $ 391.0 million from the sale of the 2024 Convertible Notes and 2026 Convertible Notes, after deducting fees and expenses of approximately $ 9.0 million. The Company used approximately $ 25.2 million of the net proceeds from the sale of the 2024 Convertible Notes and 2026 Convertible Notes to pay the cost of the Capped Calls, as
F-41
Table of Contents
described below. For purposes of this section, “Notes” refer to the 2024 Convertible Notes and the 2026 Convertible Notes, collectively.
The 2024 Convertible Notes and 2026 Convertible Notes were issued by the Company on August 12, 2019, pursuant to separate Indentures, each dated as of such date (each an “Indenture” and together the “Indentures”), between the Company and the Trustee. The 2024 Convertible Notes bear cash interest at the annual rate of 0.75 % and the 2026 Convertible Notes bear cash interest at the annual rate of 1.50 %, each payable on June 15 and December 15 of each year. The 2024 Convertible Notes will mature on June 15, 2024 and the 2026 Convertible Notes will mature on June 15, 2026, unless earlier converted or repurchased. The Company will settle conversions of the 2024 Convertible Notes and 2026 Convertible Notes through payment or delivery, as the case may be, of cash, shares of the Company’s Class A Common Stock or a combination of cash and shares of Class A Common Stock, at the Company’s option (subject to, and in accordance with, the settlement provisions of the applicable Indenture). The initial conversion rate for each of the 2024 Convertible Notes and the 2026 Convertible Notes is 74.6687 shares of Class A Common Stock (subject to adjustment as provided for in the applicable Indenture) per $ 1,000 principal amount of the 2024 Convertible Notes and 2026 Convertible Notes, which is equal to an initial conversion price of approximately $ 13.39 per share.
Holders of the 2024 Convertible Notes and 2026 Convertible Notes may convert their Notes at their option at any time prior to the close of business on the business day immediately preceding December 15, 2023, with respect to the 2024 Convertible Notes, and December 15, 2025, with respect to the 2026 Convertible Notes, in multiples of $ 1,000 principal amount, only under the following circumstances:
● during any calendar quarter commencing after the calendar quarter ending on December 31, 2019 (and only during such calendar quarter), if the last reported sale price of Class A Common Stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price for the Notes on each applicable trading day;
● during the five business day period after any five consecutive trading day period (the “measurement period”) in which the “trading price” (as defined in each Indenture) per $ 1,000 principal amount of Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of Class A Common Stock and the conversion rate for the Notes on each such trading day; or
● upon the occurrence of specified corporate events described in each Indenture.
On or after December 15, 2023, with respect to the 2024 Convertible Notes, and December 15, 2025, with respect to the 2026 Convertible Notes, until the close of business on the second scheduled trading day immediately preceding the applicable maturity date, the holders of the Notes may convert their Notes, in multiples of $ 1,000 principal amount, regardless of the foregoing conditions.
If the Company experiences a fundamental change, as described in the Indentures, prior to the maturity date of the respective Notes, holders of such Notes will, subject to specified conditions, have the right, at their option, to require the Company to repurchase for cash all or a portion of their Notes at a repurchase price equal to 100 % of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but not including, the fundamental change repurchase date. If a make-whole fundamental change, as described in the Indentures, occurs and a holder elects to convert its Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the conversion rate as described in the Indentures.
The Indentures do not contain any financial covenants or restrict the Company’s ability to repurchase the Company’s securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Company’s level of indebtedness. The Indentures provide for customary events of default. In the case of an event of default with respect to a series of Notes arising from specified events of bankruptcy or insolvency, all outstanding Notes of such series will become due and payable immediately without further action or notice. If any other event of default with respect to a series of Notes under the relevant Indenture occurs or is continuing, the Trustee or holders of at least 25 % in aggregate principal amount of the then outstanding Notes of such series may declare the principal amount of such Notes to be immediately due and payable.
F-42
Table of Contents
In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability and equity components of the 2024 Convertible Notes and the 2026 Convertible Notes by allocating the proceeds between the liability components and the embedded conversion options, or equity components, due to the Company’s ability to settle the 2024 Convertible Notes and the 2026 Convertible Notes in cash, its Class A Common Stock, or a combination of cash and Class A Common Stock at the option of the Company. The carrying amount of the respective liability components were calculated by measuring the fair value of a similar liability that does not have an associated conversion feature. The respective equity components of the 2024 Convertible Notes and the 2026 Convertible Notes were recognized as a debt discount and represent the difference between the gross proceeds from the issuance of the 2024 Convertible Notes and 2026 Convertible Notes and the fair value of the liability of the 2024 Convertible Notes and 2026 Convertible Notes on their respective dates of issuance. The debt discount is amortized to interest expense using the effective interest method over approximately five and seven years , or the expected life of the 2024 Convertible Notes and the 2026 Convertible Notes, respectively. The respective equity components are not remeasured as long as they continue to meet the conditions for equity classification.
The Company’s outstanding balances for the convertible senior notes as of December 31, 2020 and 2019 consisted of the following (in thousands):
December 31,
2020
2019
Liability component:
Principal:
2022 Convertible Notes
$
120,699
$
120,699
2024 Convertible Notes
200,000
200,000
2026 Convertible Notes
200,000
200,000
Less: unamortized debt discount
( 83,900 )
( 104,700 )
Less: unamortized debt issuance costs
( 6,543 )
( 8,005 )
Net carrying amount
$
430,256
$
407,994
Equity component:
2022 Convertible Notes
19,807
19,807
2024 Convertible Notes
41,152
41,152
2026 Convertible Notes
51,350
51,350
Total equity component
$
112,309
$
112,309
In connection with the issuance of the 2022 Convertible Notes, the Company incurred approximately $ 11.7 million of debt issuance costs, which primarily consisted of initial purchasers’ discounts and legal and other professional fees. The Company allocated these costs to the liability and equity components based on the allocation of the proceeds. The portion of these costs allocated to the equity components totaling approximately $ 4.0 million were recorded as a reduction to additional paid-in capital upon issuance. The portion of these costs allocated to the liability components totaling approximately $ 7.7 million were recorded as a reduction in the carrying value of the debt on the consolidated balance sheet and are amortized to interest expense using the effective interest method over the expected life of the 2022 Convertible Notes. In connection with the partial repurchase of the 2022 Convertible Notes, the Company recorded a loss on extinguishment of debt of approximately $ 23.4 million, of which approximately $ 2.8 million related to the initial debt issuance costs, during the year ended December 31, 2019.
The Company determined the expected life of the 2022 Convertible Notes was equal to their seven-year term. The effective interest rate on the liability components of the 2022 Convertible Notes for the period from the date of issuance through June 30, 2019 was 9.34 %. From the date of the partial repurchase of the 2022 Convertible Notes in August 2019 through December 31, 2020, the effective interest rate on the liability component of the 2022 Convertible Notes was 9.7 %.
In connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes, the Company incurred approximately $ 9.0 million of debt issuance costs, which primarily consisted of initial purchaser’s discounts and legal and other professional fees. The Company allocated these costs to the liability and equity components based on the allocation of the proceeds. The portion of these costs allocated to the equity components totaling approximately $ 2.1 million were recorded as a reduction to additional paid-in capital. The portion of these costs allocated to the liability components totaling approximately $ 6.9 million were recorded as a reduction in the carrying value of the debt on the
F-43
Table of Contents
consolidated balance sheet and are amortized to interest expense using the effective interest method over the expected lives of the 2024 Convertible Notes and the 2026 Convertible Notes.
The Company determined the expected life of the 2024 Convertible Notes and the 2026 Convertible Notes was equal to their approximately five and seven-year terms, respectively. The effective interest rates on the liability components of the 2024 Convertible Notes and the 2026 Convertible Notes for the period from the date of issuance through December 31, 2020 was 6.3 % and 6.6 %, respectively.
The following table sets forth total interest expense recognized related to convertible senior notes during the years ended December 31, 2020, 2019, and 2018 (in thousands):
Year Ended December 31,
2020
2019
2018
Contractual interest expense
$
7,216
$
7,361
$
7,553
Amortization of debt issuance costs
1,462
1,190
971
Amortization of debt discount
20,800
17,683
15,437
Total interest expense
$
29,478
$
26,234
$
23,961
Future minimum payments under the convertible senior notes as of December 31, 2020, are as follows (in thousands):
2021
$
7,216
2022
126,557
2023
4,500
2024
203,750
2025
3,000
2026
201,500
Total future minimum payments under the convertible senior notes
546,523
Less: amounts representing interest
( 25,824 )
Less: unamortized debt discount
( 83,900 )
Less: unamortized debt issuance costs
( 6,543 )
Convertible senior notes balance
$
430,256
Convertible Note Hedge and Note Hedge Warrant Transactions with Respect to 2022 Convertible Notes
To minimize the impact of potential dilution to the Company's Class A common stockholders upon conversion of the 2022 Convertible Notes, the Company entered into the Convertible Note Hedges covering 20,249,665 shares of the Company’s Class A Common Stock in connection with the issuance of the 2022 Convertible Notes. The Convertible Note Hedges had an initial exercise price of $ 16.58 per share, subject to adjustment upon the occurrence of certain corporate events or transactions, and are exercisable if the 2022 Convertible Notes are converted. In connection with the adjustment to the conversion rate of the 2022 Convertible Notes related to the Separation in April 2019, the exercise price of the Convertible Note Hedges was adjusted to $ 14.51 per share and the number of shares underlying the Convertible Note Hedges was increased to 23,135,435 shares. If upon conversion of the 2022 Convertible Notes, the price of the Company’s Class A Common Stock is above the exercise price of the Convertible Note Hedges, the counterparties are obligated to deliver shares of the Company’s Class A Common Stock and/or cash with an aggregate value approximately equal to the difference between the price of the Company’s Class A Common Stock at the conversion date and the exercise price, multiplied by the number of shares of the Company’s Class A Common Stock related to the Convertible Note Hedge being exercised.
Concurrently with entering into the Convertible Note Hedges, the Company sold Note Hedge Warrants to the Convertible Note Hedge counterparties to acquire 20,249,665 shares of the Company’s Class A Common Stock, subject to customary anti-dilution adjustments. The strike price of the Note Hedge Warrants was initially $ 21.50 per share, subject to adjustment, and such warrants are exercisable over the 150 trading day period beginning on September 15, 2022. In connection with the Separation in April 2019, the exercise price was adjusted to $ 18.82 per share and the number of shares underlying the Note Hedge Warrants was increased to 23,135,435 shares. The Note Hedge Warrants
F-44
Table of Contents
could have a dilutive effect on the Class A Common Stock to the extent that the market price per share of the Company’s Class A Common Stock exceeds the applicable strike price of such warrants.
The Convertible Note Hedges and the Note Hedge Warrants are separate transactions entered into by the Company and are not part of the terms of the 2022 Convertible Notes. Holders of the Convertible Note Hedges and the Note Hedge Warrants do not have any rights with respect to the 2022 Convertible Notes. The Company paid approximately $ 91.9 million for the Convertible Note Hedges and received approximately $ 70.8 million for the Note Hedge Warrants, resulting in a net cost to the Company of approximately $ 21.1 million.
In August 2019, concurrently with the repurchase of $ 215.0 million aggregate principal amount of the 2022 Convertible Notes, the Company terminated the respective portion of the Convertible Note Hedges and Note Hedge Warrants. The Company received approximately $ 3.2 million of termination payments from the counterparties of the Convertible Note Hedges and Note Hedge Warrants.
The Convertible Note Hedges and Note Hedge Warrants are accounted for as derivative assets and liabilities, respectively, in accordance with ASC 815, and are remeasured to fair value at each reporting date (Note 7).
Capped Calls with Respect to 2024 Convertible Notes and 2026 Convertible Notes
To minimize the impact of potential dilution to the Company’s Class A common stockholders upon conversion of the 2024 Convertible Notes and the 2026 Convertible Notes, the Company entered into separate Capped Calls in connection with the issuance of the 2024 Convertible Notes and the 2026 Convertible Notes. The Company paid the counterparties approximately $ 25.2 million to enter into the Capped Calls.
The Capped Calls have an initial strike price of approximately $ 13.39 per share, which corresponds to the initial conversion price of the 2024 Convertible Notes and the 2026 Convertible Notes and is subject to anti-dilution adjustments generally similar to those applicable to the 2024 Convertible Notes and the 2026 Convertible Notes. The Capped Calls have a cap price of approximately $ 17.05 per share, subject to certain adjustments. The Capped Calls cover 29,867,480 shares of Class A Common Stock (subject to anti-dilution and certain other adjustments), which is the same number of shares of Class A Common Stock that initially underlie the 2024 Convertible Notes and the 2026 Convertible Notes.
The Capped Calls are expected generally to reduce the potential dilution to the Class A Common Stock upon conversion of the 2024 Convertible Notes and the 2026 Convertible Notes in the event that the market price per share of Class A Common Stock is greater than the strike price of the Capped Calls as adjusted pursuant to the anti-dilution adjustments. If, however, the market price per share of Class A Common Stock exceeds the cap price of the Capped Calls, there would nevertheless be dilution upon conversion of the 2024 Convertible Notes and the 2026 Convertible Notes to the extent that such market price exceeds the cap price of the Capped Calls.
The Capped Calls are separate transactions entered into by and between the Company and the Capped Calls counterparties and are not part of the terms of the 2024 Convertible Notes or the 2026 Convertible Notes. Holders of the 2024 Convertible Notes and the 2026 Convertible Notes do not have any rights with respect to the Capped Calls. The Company recorded a reduction to additional paid-in capital of approximately $ 25.0 million during the year ended December 31, 2019 related to the premium payments for the Capped Calls. Additionally, the Company recorded an approximately $ 0.2 million reduction to equity related to transaction costs incurred in connection with the Capped Calls during the year ended December 31, 2019. These instruments meet the conditions outlined in ASC 815 to be classified in stockholders’ equity (deficit) and are not subsequently remeasured as long as the conditions for equity classification continue to be met.
F-45
Table of Contents
12. Commitments and Contingencies
Commitments with AbbVie
The Company and AbbVie are jointly obligated to make minimum purchases of linaclotide API for the territories covered by the Company’s collaboration with AbbVie for North America. Currently, AbbVie fulfills all such minimum purchase commitments.
Under the collaboration agreement with AbbVie for North America, the Company shares all development and commercialization costs related to linaclotide in the U.S. with AbbVie. The actual amounts that the Company pays to AbbVie or that AbbVie pays to the Company will depend on numerous factors outside of the Company’s control, including the success of certain clinical development efforts with respect to linaclotide, the content and timing of decisions made by the regulators, the reimbursement and competitive landscape around linaclotide and the Company’s other product candidates, and other factors.
Other Funding Commitments
As of December 31, 2020, the Company has on-going studies in various pre-clinical and clinical trial stages. The Company’s most significant clinical trial expenditures are to contract research organizations. These contracts are generally cancellable, with notice, at the Company’s option and do not have any significant cancellation penalties.
Guarantees
As permitted under Delaware law, the Company indemnifies its directors and certain of its officers for certain events or occurrences while such director or officer is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that is intended to limit its exposure and enable it to recover a portion of any future amounts paid.
The Company enters into certain agreements with other parties in the ordinary course of business that contain indemnification provisions. These typically include agreements with business partners, contractors, landlords, clinical sites and customers. Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company’s activities. These indemnification provisions generally survive termination of the underlying agreements. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions is unlimited. However, to date the Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of these obligations is minimal. Accordingly, the Company did not have any liabilities recorded for these obligations as of December 31, 2020 and 2019.
Litigation
From time to time, the Company is involved in various legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. While the outcome of these other claims cannot be predicted with certainty, management does not believe that the outcome of any of these ongoing legal matters, individually and in aggregate, will have a material adverse effect on the Company’s consolidated financial statements.
In January 2020, the Company and AbbVie entered into settlement agreements with Sandoz Inc. and Teva Pharmaceuticals, USA resolving patent litigation brought in response to the last outstanding abbreviated new drug applications seeking approval to market generic versions of LINZESS prior to the expiration of the Company’s and AbbVie’s applicable patents.
In connection with litigation settlements the Company entered into in 2018, the Company agreed to pay an aggregate of $ 4.0 million in avoidance of litigation fees and expenses during the year ended December 31, 2018.
F-46
Table of Contents
13. Stockholders’ Equity
Preferred Stock
The Company’s preferred stock may be issued from time to time in one or more series, with each such series to consist of such number of shares and to have such terms as adopted by the board of directors. Authority is given to the board of directors to determine and fix such voting powers, full or limited, or no voting powers, and such designations, preferences and relative participating, optional or other special rights, and qualifications, limitation or restrictions thereof, including without limitation, dividend rights, conversion rights, redemption privileges and liquidation preferences.
Common Stock
The Company has one class of common stock (“Class A Common Stock”). Class A Common Stock is entitled to one vote per share. The Company has reserved, out of its authorized but unissued shares of Class A Common Stock, sufficient shares to effect the conversion of the convertible senior notes and the Note Hedge Warrants pursuant to the terms thereof (Note 11).
The Company’s shareholders are entitled to dividends if and when declared by the board of directors.
14. Employee Stock Benefit Plans
The Company has several share-based compensation plans under which stock options, RSAs, RSUs, and other share-based awards are available for grant to employees, officers, directors and consultants of the Company.
The following table summarizes share-based compensation expense by award type (in thousands):
Year Ended December 31,
2020
2019
2018
Stock options
$
7,680
$
12,526
$
20,478
Time-based restricted stock units
18,624
15,488
17,160
Performance-based restricted stock units
2,190
—
—
Restricted stock awards
1,886
2,095
2,330
Employee stock purchase plan
722
1,115
1,097
Stock awards
73
54
17
$
31,175
$
31,278
$
41,082
The following table summarizes the share-based compensation expense reflected in the consolidated statements of operations (in thousands):
Years Ended December 31,
2020
2019
2018
Research and development
$
5,569
$
6,343
$
11,500
Selling, general and administrative
23,825
24,281
27,440
Restructuring expenses
1,781
654
2,142
$
31,175
$
31,278
$
41,082
Restructuring expenses include modifications to share-based awards held by employees impacted by the various workforce reductions (Note 18).
In April 2019, in connection with the Separation, all outstanding share-based payment awards were modified in accordance with the equity conversion-related provisions of the employee matters agreement with Cyclerion. No share-based compensation expense was recognized in connection with these modifications. Additionally, modifications with respect to the Company’s ESPP were made due to the change in share price as a result of the Separation. As a result of the modification to the ESPP, the Company recorded approximately $ 0.3 million of share-based compensation expense for the year ended December 31, 2019.
F-47
Table of Contents
In connection with certain other modifications of share-based payment awards for the years ended December 31, 2020 and 2019, the Company recognized an insignificant amount and approximately $ 3.0 million in share-based compensation expense, respectively.
Stock Benefit Plans
As of December 31, 2020, the Company has the following active stock benefit plans pursuant to which awards are currently outstanding: the 2019 Equity Incentive Plan (the “2019 Equity Plan”), the Amended and Restated 2010 Employee Stock Purchase Plan (the “2010 Purchase Plan”) and the Amended and Restated 2010 Employee, Director, and Consultant Equity Incentive Plan (the “2010 Equity Plan”). At December 31, 2020, there were 14,357,176 shares available for future grant under the 2019 Equity Plan and the 2010 Purchase Plan.
2019 Equity Plan
During 2019, the Company’s stockholders approved the 2019 Equity Plan under which stock options, RSAs, RSUs, and other stock-based awards may be granted to employees, officers, directors, or consultants of the Company. Under the 2019 Equity Plan, 10,000,000 shares of Class A Common Stock were initially reserved for issuance. Awards that are returned to the 2010 Equity Plan as a result of their expiration, cancellation, termination or repurchase are automatically made available for issuance under the 2019 Equity Plan. Awards that expire, cancel, terminate, or are repurchased under the 2019 Equity Plan will no longer be available for future grant. As of December 31, 2020, 9,651,783 shares were available for future grant under the 2019 Equity Plan.
2010 Purchase Plan
During 2010, the Company’s stockholders approved the 2010 Purchase Plan, which gives eligible employees the right to purchase shares of common stock at the lower of 85 % of the fair market value on the first or last day of an offering period. Each offering period is six months . There were 400,000 shares of common stock initially reserved for issuance pursuant to the 2010 Purchase Plan. The number of shares available for future grant under the 2010 Purchase Plan may be increased on the first day of each fiscal year by an amount equal to the lesser of: (i) 1,000,000 shares, (ii) 1 % of the Class A shares of common stock outstanding on the last day of the immediately preceding fiscal year, or (iii) such lesser number of shares as is determined by the board of directors. As of December 31, 2020, there were 4,705,393 shares available for future grant under the 2010 Purchase Plan.
2010 Equity Plan
The 2010 Equity Plan provided for the granting of stock options, RSAs, RSUs, and other share-based awards to employees, officers, directors, consultants, or advisors of the Company. At December 31, 2020, there were no shares available for future grant under the 2010 Equity Plan.
Restricted Stock Awards
RSAs are granted to non-employee members of the board of directors under restricted stock agreements in accordance with the terms of the 2019 Equity Plan and the Company’s non-employee director compensation policy, effective May 2019. Annual restricted stock grants to each non-employee member of the board of directors vest ratably over the period of service from the grant date through the Company’s 2021 annual meeting of stockholders, provided the individual continues to serve on the Company’s board of directors through each vest date. Initial restricted stock grants to new non-employee members of the board of directors vest annually over a three-year period from the date of grant provided the individual continues to serve on the Company’s board of directors through each vest date.
F-48
Table of Contents
A summary of restricted stock activity for the year ended December 31, 2020 is presented below:
Weighted-
Average
Number of
Grant Date
Shares
Fair Value
Unvested as of December 31, 2019
181,648
$
10.76
Granted
246,500
10.16
Vested
( 181,648 )
10.46
Forfeited
—
—
Unvested as of December 31, 2020
246,500
$
10.38
The weighted-average grant date fair value per share of restricted stock awards granted during the years ended December 31, 2020, 2019, and 2018 was $ 10.16 , $ 10.96 , and $ 18.58 , respectively. Amounts relating to restricted stock awards granted prior to the Separation have not been adjusted to reflect the effect of the Separation on the Company’s stock price.
Restricted Stock Units
RSUs granted under the Company’s equity plans represent the right to receive one share of the Company’s Class A Common Stock pursuant to the terms of the applicable award agreement. Shares of the Company’s Class A Common Stock are delivered to the employee upon vesting, subject to payment of applicable withholding taxes.
Time-based RSUs
Time-based RSUs generally vest over a two -to- four-year period on the approximate anniversary of the date of grant until fully vested, provided the individual remains in continuous service with the Company through each vesting date. The fair value of all time-based RSUs is based on the market value of the Company's Class A Common Stock on the date of grant. Compensation expense, including the effect of estimated forfeitures, is recognized over the applicable service period.
A summary of time-based RSU activity for the year ended December 31, 2020 is as follows:
Weighted-
Average
Number
Grant Date
of RSUs
Fair Value
Outstanding as of December 31, 2019
3,207,089
$
12.33
Granted
2,708,200
11.59
Vested and released
( 965,625 )
12.37
Forfeited
( 779,038 )
11.96
Outstanding as of December 31, 2020
4,170,626
$
11.90
The weighted-average grant date fair value per share of time-based RSUs granted during the years ended December 31, 2020, 2019, and 2018 was $ 11.59 , $ 12.11 , and $ 15.63 , respectively. Amounts relating to time-based RSUs granted prior to the Separation have not been adjusted to reflect the effect of the Separation on the Company’s stock price.
Performance-based RSUs
Performance-based RSUs (“PSUs”) were granted to certain executives in 2020. PSUs vest upon the achievement of specified performance criteria over a two to three-year performance period, generally subject to the executive remaining in continuous service with the Company through the applicable vesting dates. The performance criteria applicable to the PSUs were (i) gaining the U.S. FDA’s acceptance of one or more additional New Drug Applications through internal development or acquisition of development-stage or commercial-stage programs (“Pipeline PSUs”), (ii) achieving certain profitability metrics (“Profitability PSUs”) and (iii) realizing relative total shareholder return goals (the “Relative TSR PSUs”).
F-49
Table of Contents
The fair value of Pipeline PSUs and Profitability PSUs is based on the market value of the Company's Class A Common Stock on the date of grant. The Relative TSR PSUs are valued using the Monte Carlo simulation method on the date of grant. The weighted average assumptions used to estimate the fair value of Relative TSR PSUs were as follows for the year ended December 31, 2020:
Year Ended December 31,
2020
Fair value of common stock
$ 11.78
Expected volatility
53.3
%
Expected term (in years)
2.8
Risk-free interest rate
1.0
%
Expected dividend yield
—
%
A summary of PSU activity for the year ended December 31, 2020 is as follows:
Weighted-
Average
Number
Grant Date
of RSUs
Fair Value (1)
Outstanding as of December 31, 2019
—
$
—
Granted
586,157
12.48
Vested and released
—
—
Forfeited
—
—
Outstanding as of December 31, 2020
586,157
$
12.48
No PSUs were granted prior to the year ended December 31, 2020.
Stock Options
Stock options granted under the Company’s equity plans represent the right to purchase one share of the Company’s Class A Common Stock pursuant to the terms of the applicable award agreement. Shares of the Company's Class A Common Stock are delivered to the employee upon exercise, subject to payment of applicable withholding taxes.
As of April 2020, the Company no longer grants stock options. Stock options previously granted under the Company’s equity plans generally have a ten-year term and vest over a period of four years , provided the individual continues to serve at the Company through the vesting dates. Options granted under all equity plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant. The estimated fair value of options, including the effect of estimated forfeitures, is recognized over the requisite service period, which is typically the vesting period of each option.
The weighted average assumptions used to estimate the fair value of the stock options using the Black-Scholes option-pricing model were as follows for the years ended December 31, 2020, 2019, and 2018:
Years Ended December 31,
2020
2019
2018
Expected volatility
46.6
%
46.3
%
43.7
%
Expected term (in years)
6.1
6.1
6.0
Risk-free interest rate
1.5
%
2.5
%
2.7
%
Expected dividend yield
—
%
—
%
—
%
Expected volatility is based on the historical volatility of the Company’s Class A Common Stock. The Company estimates the expected term using historical data. The risk-free interest rate used for each grant is based on a zero-coupon U.S. Treasury instrument with a remaining term similar to the expected term of the share-based award. The
F-50
Table of Contents
Company has not paid and does not anticipate paying cash dividends on its shares of common stock in the foreseeable future; therefore, the expected dividend yield is assumed to be zero .
The weighted-average grant date fair value per share of options granted during the years ended December 31, 2020, 2019, and 2018 was $ 5.89 , $ 6.10 , and $ 6.81 , respectively. Amounts relating to stock options granted prior to the Separation have not been adjusted to reflect the effect of the Separation on the Company’s stock price.
The Company historically granted to certain employees performance-based options to purchase shares of common stock. These options are subject to performance-based milestone vesting. During the years ended December 31, 2020 and 2019, there were no shares that vested as a result of performance milestone achievements. The Company recorded no share-based compensation expense related to these performance-based options during each of the years ended December 31, 2020, 2019, and 2018.
The following table summarizes stock option activity under the Company’s share-based compensation plans, including performance-based options:
Weighted-
Weighted-
Number of
Average
Average
Aggregate
Stock
Exercise
Contractual
Intrinsic
Options
Price (1)
Life
Value
(in years)
(in thousands)
Outstanding at December 31, 2019
17,194,239
$
12.13
5.11
$
25,226
Granted
55,000
12.84
—
—
Exercised
( 1,735,081 )
10.21
—
—
Cancelled
( 2,054,487 )
13.00
—
—
Outstanding at December 31, 2020
13,459,671
12.25
4.27
5,613
Vested or expected to vest at December 31, 2020
13,280,456
12.26
4.23
5,575
Exercisable at December 31, 2020
11,963,812
12.26
3.90
5,371
(1) Exercise prices relating to stock options granted prior to the Separation have not been adjusted to reflect the effect of the Separation on the stock options.
The total intrinsic value of options exercised during the years ended December 31, 2020, 2019, and 2018 was approximately $ 3.5 million, approximately $ 5.1 million, and approximately $ 20.1 million, respectively. The intrinsic value was calculated as the difference between the fair value of the Company’s Class A Common Stock and the exercise price of the option issued.
The following table sets forth the Company's unrecognized share-based compensation expense, net of estimated forfeitures, as of December 31, 2020, by type of award and the weighted-average period over which that expense is expected to be recognized:
Unrecognized
Weighted-Average
Expense, Net
Remaining
of Estimated
Recognition
Forfeitures
Period
(in thousands)
(in years)
Type of award:
Stock options with time-based vesting
$
6,557
1.84
Restricted stock awards
1,473
0.92
Time-based restricted stock units
26,934
2.22
Performance-based restricted stock units
3,291
1.70
Stock options with time-based and performance-based vesting (1)
88
—
(1) The weighted-average remaining recognition period cannot be determined for performance-based or time-accelerated options due to the nature of such awards, as detailed above.
F-51
Table of Contents
The total unrecognized share-based compensation cost will be adjusted for future changes in estimated forfeitures.
15. Income Taxes
During the year ended December 31, 2020, the Company recorded approximately $ 2.7 million in income tax expense related to state income tax, which primarily resulted from a change in California tax which temporarily disallows the use of net operating losses to offset taxable income. The Company did not record a provision for federal income taxes for the period ended December 31, 2020, as it offset taxable income with federal net operating losses and continues to record a full valuation allowance against net deferred tax assets. The Company did not record a provision for federal, state, or foreign income taxes for the period ended December 31, 2019 and 2018, respectively, because the Company incurred a tax loss during these years and offset the benefit of these tax losses with valuation allowance. The Company has not recorded a foreign tax provision as it has had cumulative net operating losses outside of the United States since inception.
On March 27, 2020. the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was enacted and signed into law. The Company benefitted from certain provisions of the CARES Act, specifically, the increase in allowable business interest deduction from 30% of adjusted taxable income to 50% of adjusted taxable income, which allowed the Company to take additional interest deductions for the period ended December 31, 2020. Additionally, the Company was able to claim 100% bonus depreciation on leasehold improvements incurred in the period ended December 31, 2019 and 2020.
A reconciliation of income taxes computed using the U.S. federal statutory rate of 21 % to that reflected in the consolidated statements of operations are as follows (in thousands):
Year Ended December 31,
2020
2019
2018
Income tax benefit using U.S. federal statutory rate
$
22,861
$
4,517
$
( 59,297 )
Permanent differences
74
65
218
State income taxes, net of federal benefit
7,565
( 1,902 )
( 17,121 )
Disallowed Separation related costs
—
4,658
—
Executive compensation - Section 162(m)
1,718
662
8
Meals and entertainment
395
495
995
Non-deductible share-based compensation
( 144 )
( 1,202 )
( 494 )
Excess tax benefits
5,132
3,324
( 1,223 )
Fair market valuation of Note Hedge Warrants and Convertible Note Hedges
1,680
( 290 )
2,367
Tax credits
( 3,149 )
( 4,374 )
( 7,863 )
Expiring net operating losses and tax credits
1,991
3,764
250
Effect of change in state tax rate on deferred tax assets and deferred tax liabilities
( 208 )
( 2,563 )
1,476
Change in the valuation allowance
( 35,230 )
( 7,154 )
80,684
Income tax expense
$
2,685
$
—
$
—
F-52
Table of Contents
Deferred tax assets and liabilities were determined based on the difference between financial statement and tax bases using enacted tax rates in effect for the year in which the differences are expected to reverse. The components of the Company’s deferred tax assets and liabilities are as follows (in thousands):
December 31,
2020
2019
Deferred tax assets:
Net operating loss carryforwards
$
234,772
$
265,494
Tax credit carryforwards
60,607
59,892
Capitalized research and development
7,498
9,952
Share-based compensation
21,848
24,401
Basis difference on collaboration agreement for North America with AbbVie
62,629
48,594
Accruals and reserves
6,114
6,415
Basis difference on 2022 Convertible Notes
6,183
4,322
Interest expense
3,386
22,020
Operating lease liability
6,504
6,421
Other
5,049
5,295
Total deferred tax assets
414,590
452,806
Deferred tax liabilities:
Basis difference on 2024 Convertible Notes
( 5,951 )
( 7,381 )
Basis difference on 2026 Convertible Notes
( 9,022 )
( 10,276 )
Operating lease right-of-use assets
( 4,603 )
( 4,905 )
Total deferred tax liabilities
( 19,576 )
( 22,562 )
Net deferred tax asset
395,014
430,244
Valuation allowance
( 395,014 )
( 430,244 )
Net deferred tax asset
$
—
$
—
On a periodic basis, the Company reassesses the valuation allowance on its deferred income tax assets weighing positive and negative evidence to assess the recoverability of the deferred tax assets. Management evaluated the positive evidence, including income during the year ended December 31, 2020, and negative evidence, including its cumulative losses in recent years and its plan to build its innovative GI pipeline through potential acquisition or in-licensing externally development products, and concluded that it is more likely than not that the Company will not realize the benefit of its deferred tax assets for the year ended December 31, 2020. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance as of December 31, 2020 and 2019. Management re-evaluates the positive and negative evidence on a quarterly basis. Based on the Company’s financial performance and its future projections, it may record a reversal of all, or a portion of the valuation allowance associated with its deferred tax assets in future periods. However, any such change is subject to actual performance and other considerations that may present positive or negative evidence at the time of the assessment. The Company’s total deferred tax asset balance subject to a valuation allowance was $ 395.0 million and approximately $ 430.2 million as of December 31, 2020 and 2019, respectively.
The valuation allowance decreased approximately $ 35.2 million during the year ended December 31, 2020 primarily due to the Company’s offsetting taxable income with previously disallowed interest expense and net operating losses, partially offset by an increase in deferred tax asset for the basis difference of the collaboration agreement for North America with AbbVie.
The valuation allowance decreased approximately $ 29.1 million during the year ended December 31, 2019 primarily due to establishment of a deferred tax liability for a basis difference in the 2024 Convertible Notes and 2026 Convertible Notes, partially offset by an increase in the deferred tax asset for temporarily disallowed interest expense.
Subject to the limitations described below, at December 31, 2020, the Company had federal net operating loss carryforwards of approximately $ 1.1 billion of which approximately $ 1.0 billion is subject to an expiration between 2021 and 2037 and $ 0.1 billion may be carried forward indefinitely. As of December 31, 2020, the Company had state net operating loss carryforwards of approximately $ 0.9 billion to offset future state taxable income, which is subject to expiration between 2021 and 2039. The Company also had tax credit carryforwards of approximately $ 65.3 million as of December 31, 2020 to offset future federal and state income taxes, which is subject to expiration at various times through 2040.
F-53
Table of Contents
Utilization of net operating loss carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986 (“IRC Section 382”) and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change, as defined by IRC Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period.
The following table summarizes the changes in the Company’s unrecognized income tax benefits for the years ended December 31, 2020, 2019, and 2018 (in thousands):
Year Ended December 31,
2020
2019
2018
Balance at the beginning of the period
$
53,099
$
38,551
$
24,078
Increases based on tax positions related to the current period
66,687
51,699
38,551
Increases for tax positions related to prior periods
—
1,400
—
Decreases for tax positions in prior periods
( 51,699 )
( 38,551 )
( 24,078 )
Balance at the end of the period
$
68,087
$
53,099
$
38,551
The Company had gross unrecognized tax benefits of approximately $ 68.1 million, approximately $ 53.1 million, and approximately $ 38.6 million as of December 31, 2020, 2019 and 2018 , respectively . Of the approximately $ 68.1 million of total unrecognized tax benefits at December 31, 2020, approximately $ 0.8 million would, if recognized, affect the Company’s effective tax rate, and the remaining amount would not affect the Company’s effective tax rate due to a valuation allowance against the Company’s net deferred tax assets. A reserve for uncertain tax positions of approximately $ 0.8 million is recorded in other liabilities on the Company’s consolidated balance sheet as of December 31, 2020.
The Company will recognize interest and penalties, if any, related to uncertain tax positions in income tax expense. As of December 31, 2020, no interest or penalties have been accrued.
The statute of limitations for assessment by the Internal Revenue Service (“IRS”) and state tax authorities is open for tax years ended December 31, 2017 through the present, although net operating losses generated from years prior to 2017 could be subject to examination and adjustments to the extent utilized in future years. There are currently no federal or state income tax audits in progress.
16. Defined Contribution Plan
The Ironwood Pharmaceuticals, Inc. 401(k) Savings Plan is a defined contribution plan in the form of a qualified 401(k) plan in which substantially all employees are eligible to participate upon employment. Subject to certain IRS limits, eligible employees may elect to contribute from 1 % to 100 % of their compensation. Company contributions to the plan are at the sole discretion of the Company’s board of directors. Currently, the Company provides a matching contribution of 75 % of the employee’s contributions, up to $ 6,000 annually. During the years ended December 31, 2020, 2019, and 2018, the Company recorded approximately $ 1.8 million, approximately $ 2.2 million, and approximately $ 3.2 million of expense related to its 401(k) company match, respectively.
17. Related Party Transactions
The Company previously reflected amounts due to and due from Allergan prior to its acquisition by AbbVie as related party accounts payable and related party accounts receivable, respectively. Following the acquisition of Allergan by AbbVie, the Company determined that AbbVie is not a related party to the Company. As such, only historical amounts paid to and received from Allergan (prior to its acquisition by AbbVie) are considered related party accounts payable and related party accounts receivable, respectively. Balances of related party accounts payable and related party accounts receivable, respectively, were reported net of any balances due to or from the related party.
F-54
Table of Contents
In connection with the Separation, the Company executed certain contracts with Cyclerion, whose President and Chief Scientific Officer at the time of the Separation became a member of the Company’s Board of Directors in April 2019 (Note 3). As of December 31, 2020, Cyclerion was no longer considered a related party.
18. Workforce Reductions and Restructuring
During the years ended December 31, 2020, 2019, and 2018 the Company recorded approximately $ 15.4 million, approximately $ 3.6 million, and approximately $ 14.7 million in restructuring expenses, respectively, in its consolidated statement of operations.
In January 2018, the Company commenced an initiative to evaluate the optimal mix of investments for the lesinurad franchise. As part of this effort, the Company reduced its field-based workforce by approximately 60 employees, primarily consisting of field-based sales representatives that promoted DUZALLO or ZURAMPIC in the first position. During the three months ended March 31, 2018, the Company substantially completed this reduction in field-based workforce and recorded approximately $ 2.4 million of severance, benefits and related costs as restructuring expenses during the year ended December 31, 2018 related to this reduction in workforce.
In June 2018, the Company determined the initial organizational designs of the two new businesses, including employees’ roles and responsibilities, in connection with the Separation. As part of this process, the Company initiated a reduction in its headquarters-based workforce by approximately 40 employees and substantially completed the reduction in its workforce during the year ended December 31, 2018. During the year ended December 31, 2018, the Company recorded approximately $ 4.0 million of severance, benefits and related costs as restructuring expenses related to this reduction in workforce.
In August 2018, the Company initiated a reduction in its workforce by approximately 100 employees, primarily consisting of field-based sales representatives in connection with the termination of the Lesinurad License and substantially completed the reduction in its workforce and recorded associated costs during the year ended December 31, 2018. During the years ended December 31, 2020 and 2019, the Company recorded an insignificant amount of adjustments to restructuring costs related to this workforce reduction. During the year ended December 31, 2018, the Company recorded approximately $ 8.3 million of restructuring expenses, including approximately $ 5.4 million of severance, benefits and related costs and approximately $ 2.9 million of contract-related costs, including the write-down of certain prepaid assets and deposits, in connection with this reduction in workforce.
In February 2019, following further analysis of the Company’s strategy and core business needs, and in an effort to further strengthen the operational efficiency of the organization, the Company commenced a reduction in workforce by approximately 35 employees, primarily based in the home office and substantially completed the reduction in its workforce and recorded associated costs during the year ended December 31, 2019. During the year ended December 31, 2019, the Company recorded approximately $ 3.7 million of severance, benefits and related costs as restructuring expenses related to this reduction in workforce.
In September 2020, the Company announced that one of its two identical Phase III trials evaluating IW-3718 in refractory GERD did not meet certain criteria, including the study’s primary endpoint of achieving a statistically significant improvement in heartburn severity. Based on these findings, the Company is discontinuing development of IW-3718. In connection with this decision, the Company reduced its workforce by approximately 100 full-time employees. This workforce reduction affected both field-based and home-office employees, including the relevant general and administrative support functions. The Company substantially completed the reduction in its workforce in the fourth quarter of 2020. The Company incurred approximately $ 15.5 million during the year ended December 31, 2020 in restructuring expenses, primarily for severance, benefits and related costs related to this reduction in force. Restructuring expenses during the year ended December 31, 2020 also included approximately $ 1.2 million related to the impairment of certain fixed assets as a result of the Company’s decision to discontinue IW-3718 development.
F-55
Table of Contents
The following table summarizes the accrued liabilities activity recorded in connection with the reductions in workforce and related restructuring activities during the year ended December 31, 2020 (in thousands):
Amounts
Amounts
Accrued at
Accrued at
December 31, 2019
Charges
Amount Paid
Adjustments
December 31, 2020
Employee severance, benefits and related costs
February 2019 Reduction
75
—
( 75 )
—
—
September 2020 Reduction
—
11,563
( 661 )
—
10,902
Total
$
75
$
11,563
$
( 736 )
$
—
$
10,902
Contract related costs
August 2018 Reduction
$
104
$
—
$
—
$
( 104 )
$
—
September 2020 Reduction
—
108
( 103 )
—
5
Total
$
104
$
108
$
( 103 )
$
( 104 )
$
5
The following table summarizes the accrued liabilities activity recorded in connection with the reductions in workforce and related restructuring activities during the year ended December 31, 2019 (in thousands):
Amounts
Amounts
Accrued at
Accrued at
December 31, 2018
Charges
Amount Paid
Adjustments
December 31, 2019
Employee severance, benefits and related costs
June 2018 Reduction
$
696
$
16
$
( 689 )
$
( 23 )
$
—
August 2018 Reduction
1,756
—
( 1,708 )
( 48 )
—
February 2019 Reduction
—
3,182
( 2,968 )
( 139 )
75
Total
$
2,452
$
3,198
$
( 5,365 )
$
( 210 )
$
75
Contract related costs
August 2018 Reduction
$
433
$
—
$
( 287 )
$
( 42 )
$
104
Total
$
433
$
—
$
( 287 )
$
( 42 )
$
104
19. Selected Quarterly Financial Data (Unaudited)
The following table contains quarterly financial information for the years ended December 31, 2020 and 2019. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair presentation of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period.
First
Second
Third
Fourth
Total
Quarter
Quarter
Quarter
Quarter
Year
(in thousands, except per share data)
2020
Total revenues (1)
$
79,943
$
89,432
$
103,468
$
116,680
$
389,523
Total cost and expenses (2)
66,716
56,719
57,852
65,296
246,583
Other expense, net (3)
( 9,882 )
( 7,509 )
( 9,804 )
( 6,884 )
( 34,079 )
Net income and comprehensive income
3,345
25,204
34,423
43,204
106,176
Net income per share—basic
0.02
0.16
0.22
0.27
0.67
Net income per share—diluted
0.02
0.16
0.21
0.27
0.66
F-56
Table of Contents
First
Second
Third
Fourth
Total
Quarter
Quarter
Quarter
Quarter
Year
(in thousands, except per share data)
2019
Total revenues (4)
$
68,730
$
102,215
$
131,167
$
126,301
$
428,413
Total cost and expenses (5)
85,663
80,638
65,280
76,709
308,290
Other expense, net (6)
( 4,912 )
( 9,294 )
( 45,239 )
( 1,735 )
( 61,180 )
Net (loss) income from continuing operations
( 21,846 )
12,283
20,648
47,858
58,943
Net loss from discontinued operations (7)
( 37,438 )
—
—
—
( 37,438 )
Net income (loss) and comprehensive income (loss)
( 59,284 )
12,283
20,648
47,858
21,505
Income per share from continuing operations, net of income taxes—basic
$
( 0.14 )
$
0.08
$
0.13
$
0.31
$
0.38
Income per share from continuing operations, net of income taxes—diluted
( 0.14 )
0.08
0.13
0.30
0.38
Net loss per share from discontinued operations—basic and diluted
( 0.24 )
—
—
—
( 0.24 )
Net income (loss) per share—basic
( 0.38 )
0.08
0.13
0.31
0.14
Net income (loss) per share—diluted
( 0.38 )
0.08
0.13
0.30
0.14
(1) Total revenues includes approximately $ 8.0 million of revenue from sales of linaclotide API to the Company’s linaclotide partners for the year ended December 31, 2020.
(2) Total costs and expenses includes approximately $ 15.4 million in restructuring expenses for the year ended December 31, 2020.
(3) Other expense, net includes approximately $ 6.1 million loss on fair value remeasurement of derivatives for the year ended December 31, 2020.
(4) Total revenues includes approximately $ 48.8 million of revenue from sales of linaclotide API to the Company’s linaclotide partners, primarily driven by the commercialization of linaclotide in Japan for the year ended December 31, 2019, as well as approximately $ 32.4 million related to the non-contingent payments from the Amended AstraZeneca Agreement and a $ 10.0 million upfront fee from the Amended Astellas License Agreement, both executed during the third quarter of 2019.
(5) Total costs and expenses includes approximately $ 3.6 million in restructuring expenses for the year ended December 31, 2019, as well as approximately $ 3.2 million related to the gain on lease modification in April 2019.
(6) Other expense, net includes approximately $ 31.0 million in loss on extinguishment of debt related to the partial repurchase of the 2022 Convertible Notes and the redemption of the 2026 Notes, and approximately $ 3.0 million gain on fair value remeasurement of derivatives for the year ended December 31, 2019.
(7) During the year ended December 31, 2019, the Company completed the Separation. Certain amounts related to Cyclerion have been reclassified as discontinued operations for the year ended December 31, 2019.
20. Subsequent Events
On February 4, 2021, Mark Mallon notified the Company that he is resigning from his position as Chief Executive Officer of the Company and a member of the Company’s board of directors, in each case effective March 12, 2021 (the “Transition Date”). Upon the Transition Date, Thomas McCourt, who is the President of the Company, also will become the Company’s interim Chief Executive Officer. Mr. Mallon’s resignation is not due to any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.
F-57
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.