Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file under the Exchange Act of 1934, as amended, with the U.S. Securities and Exchange Commission, or the SEC, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2020 and concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of that date. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits 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 a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Due to the COVID-19 pandemic, in March 2020, certain of our employees began working remotely. We have not identified any material changes in our internal control over financial reporting as a result of these changes to the working environment. We continue to monitor and assess the COVID-19 situation to determine any potential impact on the design and operating effectiveness of our internal controls over financial reporting.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rules 13a-15(f). Our internal control over financial reporting is a process designed under the supervision of our Chief Executive Officer and Chief Financial Officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external purposes in accordance with U.S. generally accepted accounting principles.
195
As of December 31, 20 20 , we assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting under the 2013 “Internal Control—Integrated Framework,” issued by the Committee of Sponsoring Organizations, or COSO, of the Treadway Commission, under the supervision of, and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer. Based on that assessment, our management concluded that we maintained effective internal control over financial reporting as of December 31, 20 20 .
Deloitte & Touche LLP, an independent registered public accounting firm, audited the effectiveness of our internal control over financial reporting as of December 31, 2020, as stated in their attestation report, which is included elsewhere herein.
ITEM 9B. OTHER INFORMATION
None.
196
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Except as set forth below, the information required by this Item is incorporated by reference from our definitive proxy statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2020.
We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer, controller or persons performing similar functions. A current copy of the code is posted on the Corporate Governance section of our website, which is located at https://bridgebio.com. If we make any substantive amendments to, or grant any waivers from, the code of business conduct and ethics for our principal executive officer, principal financial officer, principal accounting officer, controller or persons performing similar functions, or any officer or director, we will disclose the nature of such amendment or waiver on our website or in a current report on Form 8-K.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2020.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2020.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2020.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2020.
197
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
The following documents are filed as part of this Annual Report on Form 10‑K:
1.
Financial Statements:
The following financial statements and schedules of the Registrant are contained in Part II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report on Form 10‑K:
Page
Consolidated Balance Sheets as of December 31, 2020 and 2019
136
Consolidated Statements of Operations for each of the three years in the period ended December 31, 2020
137
Consolidated Statements of Comprehensive Loss for each of the three years in the period ended December 31, 2020
138
Consolidated Statements of Redeemable Convertible Noncontrolling Interests and Stockholders’ Equity for each of the three years in the period ended December 31, 2020
139
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2020
140
Notes to Consolidated Financial Statements
141
Report of Independent Registered Public Accounting Firm
192
2.
Financial Statement Schedules:
All schedules have been omitted because of the absence of conditions under which they are required or because the required information, where material, is shown in the financial statements, financial notes or supplementary financial information.
(b)
Exhibits required by Item 601 of Regulation S‑K:
The exhibits listed in the accompanying Exhibit Index are filed as part of, or incorporated by reference into, this Annual Report on Form 10 K.
198
ITEM 16. FORM 10 ‑K SUMMARY
None.
Exhibits
Exhibit
Number
Exhibit Title
Form
File No.
Exhibit
Filing Date
2.1
Agreement and Plan of Merger, dated as of October 5, 2020, by and among BridgeBio Pharma, Inc., Eidos Therapeutic, Inc., Globe Merger Sub I, Inc. and Globe Merger Sub II, Inc. (incorporated by reference to Exhibit 2.1 to BridgeBio’s Current Report on Form 8-K filed with the SEC on October 6, 2020).
8-K
001-38959
2.1
January 26, 2021
3.1
Amended and Restated Certificate of Incorporation of the Registrant, as currently in effect .
8-K
001-38959
3.1
July 3, 2019
3.2
Amended and Restated Bylaws of the Registrant, as currently in effect .
S-4
333-249944
3.2
November 6, 2020
4.1
Specimen Common Stock Certificate.
S-1
333- 231759
4.1
June 24, 2019
4.2
Form of Registration Rights Agreement, among the Registrant and certain of its shareholders, dated June 26, 2019.
S-1
333-231759
4.3
June 24, 2019
4.3
Description of Securities.
—
—
—
Filed herewith
4.4
Indenture, dated as of March 9, 2020, by and between BridgeBio Pharma, Inc. and U.S. Bank National Association, as Trustee.
8-K
001-38959
4.1
March 10, 2020
4.5
Form of Global Note, representing BridgeBio Pharma, Inc.’s 2.50% Convertible Senior Notes due 2027 .
8-K
001-38959
4.2
March 10, 2020
4.6
Indenture, dated as of January 28, 2021, by and between BridgeBio Pharma, Inc. and U.S. Bank National Association, as Trustee.
8-K
001-38959
4.1
January 29, 2021
4.7
Form of Global Note, representing BridgeBio Pharma, Inc.’s 2.50% Convertible Senior Notes due 2027.
8-K
001-38959
4.2
January 29, 2021
10.1#
Amended and Restated 2019 Stock Option and Incentive Plan and forms of award agreements thereunder.
S-8
333-239718
99.1
July 7, 2020
10.2#
Amended and Restated 2019 Employee Stock Purchase Plan.
10-Q
001-38959
10.3
November 5, 2020
10.3#
Senior Executive Cash Incentive Bonus Plan.
S-1
333-231759
10.3
June 24, 2019
199
10.4#
Form of Indemnification Agreement, between the Registrant and each of its directors.
S-1
333-231759
10.4
June 24, 2019
10.5#
Form of Indemnification Agreement, between the Registrant and each of its executive officers.
S-1
333-231759
10.5
June 24, 2019
10.6
Loan and Security Agreement, between BridgeBio Pharma LLC and Hercules Capital, Inc., dated as of June 19, 2018.
S-1
333-231759
10.6
May 24, 2019
10.7
First Amendment to the Loan and Security Agreement, between BridgeBio Pharma LLC and Hercules Capital, Inc., dated as of December 28, 2018.
S-1
333-231759
10.7
May 24, 2019
10.8
Lease Agreement, between BridgeBio Pharma LLC and Michael J. Harbour, dated as of March 23, 2017.
S-1
333-231759
10.8
May 24, 2019
10.9†
Exclusive (Equity) Agreement, by and between Eidos Therapeutics, Inc. and the Board of Trustees of the Leland Stanford Junior University, effective as of April 10, 2016, as amended by Amendment No. 1 effective September 25, 2017.
S-1
333-231759
10.9
May 24, 2019
10.10†
License Agreement, between QED Therapeutics, Inc. and Novartis International Pharmaceutical Ltd., dated as of January 29, 2018.
S-1
333-231759
10.10
May 24, 2019
10.11†
Asset Purchase Agreement, among BridgeBio Pharma LLC, Origin Biosciences, Inc., and Alexion Pharma Holding Unlimited Company, dated as of June 7, 2018.
S-1
333-231759
10.11
May 24, 2019
10.12†
Option Agreement, among PellePharm, Inc., Leo Pharma A/S and Leo Spiny Merger Sub, Inc., dated as of November 19, 2018, as amended on March 13, 2019.
S-1
333-231759
10.12
May 24, 2019
10.13†
Asset Purchase Agreement, among Phoenix Tissue Repair, Inc., Shire Human Genetic Therapies, Inc., and Lotus Tissue Repair, Inc., dated as of July 21, 2017.
S-1
333-231759
10.13
May 24, 2019
10.14†
Exclusive License Agreement, between The Regents of the University of California and TheRas, Inc., dated September 28, 2016, as amended by First Amendment effective January 10, 2017, Second Amendment effective August 10, 2017 and Third Amendment effective September 7, 2018.
S-1
333-231759
10.14
May 24, 2019
200
10.14A†
Fourth Amendment to the Exclusive License Agreement, between The Regents of the University of California and TheRas, Inc., dated December 16, 2019.
10-K
001-38959
10.14A
March 3, 2020
10.15†
Collaboration and License Agreement, between Navire Pharma, Inc. (formerly known as PTP Pharmaceuticals, Inc.) and the Board of Regents of the University of Texas System and The University of Texas M.D. Anderson Cancer Center, dated March 3, 2017, as amended by Amendment No. 1 dated July 10, 2017.
S-1
333-231759
10.15
May 24, 2019
10.16†
Exclusive Patent License Agreement, between The Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, Inc., under sponsorship from the National Cancer Institute, and TheRas, Inc., dated December 14, 2018.
S-1
333-231759
10.16
May 24, 2019
10.17†
Cell Line License Agreement, by and between Life Technologies Corporation and BridgeBio Services, Inc., effective as of November 15, 2018.
S-1
333-231759
10.17
May 24, 2019
10.18
Second Amendment to the Loan and Security Agreement, between BridgeBio Pharma LLC and Hercules Capital Inc., dated as of May 17, 2019.
S-1
333-231759
10.18
May 24, 2019
10.19#
Offer Letter, between BridgeBio Services, Inc. and Neil Kumar, dated December 14, 2017.
S-1
333-231759
10.19
June 11, 2019
10.20#
Offer Letter, between BridgeBio Services, Inc. and Brian Stephenson, dated October 28, 2018.
S-1
333-231759
10.20
June 11, 2019
10.21#
Offer Letter, between Eidos Therapeutics, Inc. and Uma Sinha, dated June 1, 2016, as amended on May 24, 2018.
S-1
333-231759
10.21
June 11, 2019
10.22#
Offer Letter, between BridgeBio Services, Inc. and Charles Homcy, dated February 20, 2019.
S-1
333-231759
10.22
June 11, 2019
10.23#
Offer Letter, between BridgeBio Services, Inc. and Richard Scheller, dated April 5, 2019.
S-1
333-231759
10.23
June 11, 2019
10.24#
Offer Letter, between BridgeBio Services, Inc. and Michael Henderson, dated March 22, 2016, as amended on May 5, 2017.
S-1
333-231759
10.24
June 11, 2019
201
10.25#
Offer Letter, between Eidos Therapeutics, Inc. and Cameron Turtle, dated June 13, 2018.
S-1
333-231759
10.26
June 11, 2019
10.26 #
Offer Letter, between BridgeBio Pharma, Inc. and Brian Stolz, dated September 19, 2019.
10-Q
000-38959
10.2
November 8, 2019
10.27 #
Offer Letter, between and BridgeBio Services, Inc. and Yi Ching Yau, dated September 9, 2019.
10-Q
000-38959
10.3
November 8, 2019
10.28#
Consulting Agreement, between Jennifer E. Cook and the Registrant, effective as of October 14, 2019.
10-K
001-38959
10.28
March 3, 2020
10.29
Loan and Security Agreement, by and between Eidos Therapeutics, Inc., Silicon Valley Bank and Hercules Capital, Inc., dated November 13, 2019.
8-K
000-38959
10.1
November 19, 2019
10.30
Form of Tax Sharing Agreement, between the Registrant and each of its subsidiaries.
S-1
333-231759
10.27
June 24, 2019
10.31
Indemnification Agreement, between BridgeBio Pharma LLC and KKR Genetic Disorder, L.P., dated March 26, 2016.
S-1
333-231759
10.28
June 24, 2019
10.32†
License Agreement, by and between Eidos Therapeutics, Inc. and Alexion Pharma International Operations Unlimited Company, dated September 9, 2019 .
10-Q
000-38959
10.1
November 8, 2019
10.33†
Collaboration Agreement, by and between BridgeBio Gene Therapy, LLC and Catalent Maryland, Inc., formerly Paragon Bioservices, Inc., dated December 31, 2019.
10-K
001-38959
10.33
March 3, 2020
10.34#
BridgeBio Pharma, Inc. 2019 Inducement Equity Plan.
S-8
333-234803
99.1
November 20, 2019
10.35#
Form of Restricted Stock Award Agreement under BridgeBio Pharma, Inc. 2019 Inducement Equity Plan.
S-8
333-234803
99.2
November 20, 2019
10.36#
Form of Non-Qualified Stock Option Agreement under BridgeBio Pharma, Inc. 2019 Inducement Equity Plan.
S-8
333-234803
99.3
November 20, 2019
10.37#
Form of Restricted Stock Unit Award Agreement under BridgeBio Pharma, Inc. 2019 Inducement Equity Plan.
S-8
333-234803
99.4
November 20, 2019
10.38#
Offer Letter, between BridgeBio Pharma, Inc. and James C. Momtazee, dated February 23, 2020.
10-K
001-38959
10.38
March 3, 2020
202
10.39#
Director Compensation Policy.
10-K
001-38959
10.39
March 3, 2020
10.40
Third Amendment to the Loan and Security Agreement, between BridgeBio Pharma LLC and Hercules Capital, Inc., dated as of March 2, 2020.
—
—
—
Filed herewith
10.41†
Fourth Amendment to the Loan and Security Agreement, between BridgeBio Pharma LLC and Hercules Capital, Inc., dated as of April 27, 2020 .
10-Q
000-38959
10.1
August 11, 2020
10.42
Open Market Sale Agreement SM , dated as of July 7, 2020 .
S-3
333-239734
1.2
July 7, 2020
10.43
Form of Confirmation for Capped Call Transactions .
8-K
001-38959
10.1
March 10, 2020
10.44
Purchase Agreement, dated January 25, 2021, by and among BridgeBio Pharma, Inc. and J.P. Morgan Securities LLC and Mizuho Securities USA LLC, as representatives of the several Initial Purchasers.
8-K
001-38959
10.1
January 26, 2021
10.45
Form of Confirmation for Capped Call Transactions.
8-K
001-38959
10.1
January 29, 2021
10.46
Fifth Amendment to the Loan and Security Agreement, between BridgeBio Pharma LLC and Hercules Capital, Inc., dated as of January 25, 2021.
—
—
—
Filed herewith
21
List of Subsidiaries of the Registrant.
—
—
—
Filed herewith
23.1
Consent of Independent Registered Public Accountant Firm.
—
—
—
Filed herewith
24
Power of Attorney (reference is made to signature page hereto).
—
—
—
Filed herewith
31.1
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
—
—
—
Filed herewith
31.2
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
—
—
—
Filed herewith
32.1*
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
—
—
—
Filed herewith
203
32.2*
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
—
—
—
Filed herewith
101.INS
Inline XBRL Instance Document.
—
—
—
Filed herewith
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
—
—
—
Filed herewith
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
—
—
—
Filed herewith
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
—
—
—
Filed herewith
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
—
—
—
Filed herewith
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
—
—
—
Filed herewith
104
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101).
—
—
—
Filed herewith
*
This certification is deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.
#
Indicates a management contract or any compensatory plan, contract or arrangement.
†
Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit in accordance with the rules of the Securities and Exchange Commission.
204
SIGNAT URES
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.
BridgeBio Pharma, Inc.
Date: February 25, 2021
By:
/s/ Neil Kumar
Neil Kumar, Ph.D.
Chief Executive Officer, Director
(Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Neil Kumar and Brian Stephenson, as their true and lawful attorney‑in‑fact and agent, with full power of substitution and resubstitution, for such person and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to the Annual Report on Form 10‑K, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney‑in‑fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she could do in person, hereby ratifying and confirming all that said attorney‑in‑fact and agent, or his substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements 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 dates indicated.
Signature
Title
Date
/s/ Neil Kumar
President, Chief Executive Officer and Director
(Principal Executive Officer)
February 25, 2021
Neil Kumar, Ph.D.
/s/ Brian Stephenson
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
February 25, 2021
Brian Stephenson, Ph.D., CFA
/s/ Eric Aguiar
Director
February 25, 2021
Eric Aguiar, M.D.
/s/ Jennifer E. Cook
Director
February 25, 2021
Jennifer E. Cook
/s/ Ronald J. Daniels
Director
February 25, 2021
Ronald J. Daniels
/s/ Charles Homcy
Director
February 25, 2021
Charles Homcy, M.D.
/s/ Andrew W. Lo
Director
February 25, 2021
Andrew W. Lo, Ph.D.
205
/s/ James C. Momtazee
Director
February 25, 2021
James C. Momtazee
/s/ Ali Satvat
Director
February 25, 2021
Ali Satvat
/s/ Brenton L. Saunders
Director
February 25, 2021
Brenton L. Saunders
/s/ Randal Scott
Director
February 25, 2021
Randal Scott, Ph.D.
/s/ Richard H. Scheller
Director
February 25, 2021
Richard H. Scheller, Ph.D.
206