1 unchanged sentence
Evaluation of Disclosure Controls and Procedures.
−Removed: We conducted an evaluation as of December 31, 2022, under the supervision and with the participation of our management, including our chief executive officer and chief accounting officer, of the effectiveness of the design and operation of our disclosure controls and procedures, which are defined under SEC rules as 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 under the Securities Exchange Act of 1934 (Exchange Act) is recorded, processed, summarized and reported within required time periods specified in the Commission’s rules and forms and controls and procedures that are designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decision regarding required disclosure.
+Added: We conducted an evaluation as of December 31, 2023, under the supervision and with the participation of our management, including our chief executive officer and chief accounting officer, of the effectiveness of the design and operation of our disclosure controls and procedures, which are defined under SEC rules as 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 under the Securities Exchange Act of 1934 (Exchange Act) is recorded, processed, summarized and reported within required time periods specified in the Commission’s rules and forms and controls and procedures that are designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decision regarding required disclosure.
Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance levels.
−Removed: Management’s Report on Internal Control over Financial Reporting
−Removed: Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a‑15(f) of the Exchange Act.
+Added: Management’s Report on Internal Control over Financial Reporting
+Added: Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a‑15(f) of the Exchange Act.
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 our assets;
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and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
−Removed: Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework).
−Removed: Management’s assessment included evaluation of such elements as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment.
+Added: Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework).
+Added: Management’s assessment included evaluation of such elements as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment.
Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2023.
−Removed: Our management’s assessment of the effectiveness of internal control over financial reporting as of December 31, 2022 excluded the internal control over financial reporting at La Jolla and Entasis, which constituted approximately 33% of total assets and 6% of total revenue in our consolidated financial statements as of and for the year ended December 31, 2022.
−Removed: We acquired La Jolla on August 22, 2022 and Entasis on July 11, 2022 and had not completed our evaluation of the internal controls of the acquired businesses as of December 31, 2022.
−Removed: This exclusion was in accordance with Securities and Exchange Commission guidance that an assessment of a recently acquired business may be omitted in management’s report on internal controls over financial reporting in the year of acquisition.
Our independent registered public accounting firm, Deloitte & Touche LLP, has audited our internal control over financial reporting as of December 31, 2023.
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Changes in Internal Control over Financial Reporting
−Removed: During the year ended December 31, 2022, we completed our acquisitions of Entasis and La Jolla.
−Removed: We are currently in the process of integrating the acquired operations and processes into our internal control environment and implementing necessary changes to our internal control over financial reporting, including, but not limited to, the creation of new controls related to inventory management, research and development activities and product sales.
+Added: We completed our acquisitions of Entasis and La Jolla in 2022.
+Added: We integrated the acquired operations and processes into our internal control environment and implemented necessary changes to our internal control over financial reporting, including, but not limited, to the creation of new controls related to inventory management, research and development activities and product sales.
Other than the above, there have been more material changes to our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) for the year ended December 31, 2023 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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We have audited the internal control over financial reporting of Innoviva, Inc.
−Removed: and subsidiaries (the “Company”) as of December 31, 2022, based on criteria established in Internal Control —
−Removed: Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
−Removed: In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control —
−Removed: Integrated Framework (2013) issued by COSO.
+Added: and subsidiaries (the “Company”) as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
+Added: In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2023, of the Company and our report dated February 29, 2024, expressed an unqualified opinion on those financial statements.
−Removed: As described in Management’s Report on Internal Control over Financial Reporting, management excluded from its assessment the internal control over financial reporting at Entasis Therapeutics Holdings Inc.
−Removed: which was acquired on July 11, 2022, and La Jolla Pharmaceutical Company which was acquired on August 22, 2022, and whose financial statements constitute 33% of total assets and 6% of total revenue in the consolidated financial statement amounts as of and for the year ended December 31, 2022.
−Removed: Accordingly, our audit did not include the internal control over financial reporting at Entasis Therapeutics Holdings Inc.
−Removed: and La Jolla Pharmaceutical Company.
Basis for Opinion
−Removed: 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 Report on Internal Control over Financial Reporting.
−Removed: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
+Added: 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 Report on Internal Control over Financial Reporting.
+Added: 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.
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Definition and Limitations of Internal Control over Financial Reporting
−Removed: 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.
−Removed: 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;
+Added: 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.
+Added: 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;
−Removed: 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.
+Added: 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.
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OTHER INFORMATION
+Added: Trading Arrangements
+Added: None of the Company’s directors or officers adopted , modified , or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the Company’s fiscal quarter ended December 31, 2023.
DISCL OSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
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Number of securities to be issued upon exercise of outstanding options and vesting of outstanding restricted stock units and restricted stock awards
−Removed: Weighted‑average exercise price of outstanding options
+Added: Weighted‑average exercise price of outstanding options
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
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EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
−Removed: (a) The following documents are filed as part of this Annual Report on Form 10‑K:
+Added: (a) The following documents are filed as part of this Annual Report on Form 10‑K:
Financial Statements:
−Removed: The following financial statements and schedules of the Registrant are contained in Part II, Item 8, “Financial Statements and Supplementary Data”
−Removed: of this Annual Report on Form 10‑K:
+Added: 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:
Consolidated Balance Sheets as of December 31, 2023 and 2022
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Consolidated Statements of Comprehensive Income for each of the three years in the period ended December 31, 2023
−Removed: Consolidated Statements of Stockholders’
−Removed: Equity for each of the three years in the period ended December 31, 2022
+Added: Consolidated Statements of Stockholders’ Equity for each of the three years in the period ended December 31, 2023
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2023
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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.
−Removed: (b) Exhibits required by Item 601 of Regulation S‑K:
+Added: (b) Exhibits required by Item 601 of Regulation S‑K:
The information required by this Item is set forth on the exhibit index that follows the signature page of this report.
−Removed: FORM 10‑K SUMMARY
+Added: FORM 10‑K SUMMARY
Incorporated by Reference
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Amended and Restated Certificate of Incorporation
−Removed: Certificate of Amendment of Restated Certificate of Incorporation
−Removed: Certificate of Ownership and Merger Merging LABA Merger Sub, Inc.
−Removed: with and into Theravance, Inc., as filed with the Secretary of State of the State of Delaware, effective on January 7, 2016
−Removed: Amended and Restated Bylaws, amended and restated as of February 8, 2017
+Added: Amended and Restated Bylaws, amended and restated as of January 1, 2023
Specimen certificate representing the common stock of the registrant
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Form of 2.125% Convertible Subordinated Note Due 2023 (included in Exhibit 4.4 )
−Removed: Indenture (including form of Note) with respect to Innoviva’s 2.50% Convertible Senior Notes due 2025, dated as of August 7, 2017, between Innoviva and The Bank of New York Mellon Trust Company, N.A., as trustee
−Removed: Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
+Added: Indenture (including form of Note) with respect to Innoviva’s 2.50% Convertible Senior Notes due 2025, dated as of August 7, 2017, between Innoviva and The Bank of New York Mellon Trust Company, N.A., as trustee
+Added: Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
Indenture (including form of Note) with respect to Innoviva's 2.125% Convertible Senior Notes due 2028, dated as of March 7, 2022, between Innoviva, Inc.
and The Bank of New York Mellon Trust Company, N.A., as trustee
−Removed: Employee Stock Purchase Plan, as amended April 27, 2010
Collaboration Agreement between the registrant and Glaxo Group Limited, dated as of November 14, 2002
−Removed: Amended and Restated Investors’
−Removed: Rights Agreement by and among the registrant and the parties listed therein, dated as of May 11, 2004
+Added: Amended and Restated Investors’ Rights Agreement by and among the registrant and the parties listed therein, dated as of May 11, 2004
Strategic Alliance Agreement between the registrant and Glaxo Group Limited, dated as of March 30, 2004
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First Amendment to 2009 Change In Control Severance Plan (Renamed 2009 Severance Plan)
−Removed: Form of Notice of Performance‑Based Restricted Stock Award and Restricted Stock Award Agreement under 2012 Equity Incentive Plan (director form)
+Added: Form of Notice of Performance‑Based Restricted Stock Award and Restricted Stock Award Agreement under 2012 Equity Incentive Plan (director form)
Second Amendment to 2009 Severance Plan
18 unchanged sentences
Third Amendment to Collaboration Agreement, dated July 13, 2022, by and among Innoviva, Inc., Glaxo Group Limited, and Theravance Respiratory Company, LLC.
+Added: Transition Agreement between Larry Edwards and Innoviva Specialty Therapeutics, Inc., dated February 23, 2023, and Release of Claims form signed by Larry Edwards, dated April 5, 2023
+Added: 2023 Employee Stock Purchase Plan
+Added: Offer Letter between Innoviva, Inc.
+Added: and Stephen Basso dated July 28, 2023
List of Subsidiaries
2 unchanged sentences
Consent of Ernst & Young LLP Independent Registered Public Accounting Firm of Armata Pharmaceuticals, Inc.**
−Removed: Power of Attorney (see signature page to this Annual Report on Form 10‑K)
−Removed: Certification of Principal Executive Officer Pursuant to Rule 13a‑14 under the Securities Exchange Act of 1934
−Removed: Certification of Principal Financial Officer Pursuant to Rule 13a‑14 under the Securities Exchange Act of 1934
+Added: Power of Attorney (see signature page to this Annual Report on Form 10‑K)
+Added: Certification of Principal Executive Officer Pursuant to Rule 13a‑14 under the Securities Exchange Act of 1934
+Added: Certification of Principal Financial Officer Pursuant to Rule 13a‑14 under the Securities Exchange Act of 1934
Certifications Pursuant to 18 U.S.C.
+Added: Innoviva Clawback Policy (effective as of October 2, 2023)
Audited Consolidated Financial Statements of Armata Pharmaceuticals, Inc.
7 unchanged sentences
Cover Page Interactive Data File (embedded within the Inline XBRL document)
−Removed: + Management contract or compensatory plan or arrangement required to be filed pursuant to Item 15(b) of Form 10‑K.
+Added: + Management contract or compensatory plan or arrangement required to be filed pursuant to Item 15(b) of Form 10‑K.
* Confidential treatment has been granted for certain portions which are omitted in the copy of the exhibit electronically filed with the Securities and Exchange Commission.
−Removed: The omitted information has been filed separately with the Securities and Exchange Commission pursuant to Innoviva, Inc.’s application for confidential treatment.
+Added: The omitted information has been filed separately with the Securities and Exchange Commission pursuant to Innoviva, Inc.’s application for confidential treatment.
** To be filed by amendment to this Annual Report on Form 10-K.
7 unchanged sentences
POWER OF ATTORNEY
−Removed: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Pavel Raifeld, 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.
+Added: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Pavel Raifeld, 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.
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February 29, 2024
−Removed: /s/ MARIANNE ZHEN
−Removed: Marianne Zhen
−Removed: Chief Accounting Officer (Principal
+Added: /s/ STEPHEN BASSO
+Added: Stephen Basso
+Added: Chief Financial Officer (Principal
Financial Officer)
February 29, 2024
−Removed: /s/ GEORGE BICKERSTAFF
−Removed: George Bickerstaff, III
+Added: /s/ MARK DIPAOLO
+Added: Mark DiPaolo, Esq.
Chairman of the Board
3 unchanged sentences
February 29, 2024
−Removed: /s/ MARK DIPAOLO
−Removed: Mark DiPaolo, Esq.
−Removed: February 28, 2023
/s/ JULES HAIMOVITZ
4 unchanged sentences
February 29, 2024
−Removed: /s/ DEBORAH L.
−Removed: February 28, 2023
/s/ SAPNA SRIVASTAVA
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.