Innoviva, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Innoviva, Inc. has filed its 2023 10-K report, detailing its financial performance and business operations.</b>

AI Summary

Innoviva, Inc. (INVA) filed a Annual Report (10-K) with the SEC on February 29, 2024. Innoviva, Inc. filed its annual report for the fiscal year ending December 31, 2023. The company's principal executive offices are located at 1350 Old Bayshore Highway, Suite 400, Burlingame, CA 94010. Innoviva, Inc. was formerly known as Theravance Inc. and Advanced Medicine Inc. The company is incorporated in Delaware and operates within the Pharmaceutical Preparations industry (SIC 2834). The filing includes information related to various financial instruments and agreements, including convertible notes and collaborative arrangements.

Why It Matters

For investors and stakeholders tracking Innoviva, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Innoviva's financial health, strategic initiatives, and risk factors for the fiscal year 2023, crucial for investors to assess the company's current standing and future prospects. The detailed information on financial instruments, past company names, and business address helps in understanding the company's evolution and operational base, offering context for its market position.

Risk Assessment

Risk Level: low — Innoviva, Inc. shows low risk based on this filing. The filing is a standard 10-K annual report, which typically contains routine financial and operational disclosures rather than immediate, significant negative events.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand Innoviva's performance and outlook for the upcoming fiscal year.

Key Numbers

• 20231231 — Fiscal Year End (Conformed period of report)
• 20240229 — Filing Date (Filed as of date)
• 0000950170-24-023237 — Accession Number (Unique identifier for the filing)
• 000-30319 — SEC File Number (SEC's file number for the company)

Key Players & Entities

• Innoviva, Inc. (company) — Filer name
• 1350 Old Bayshore Highway (location) — Business address street 1
• Burlingame (location) — Business address city
• CA (location) — Business address state
• 94010 (location) — Business address zip
• Theravance Inc. (company) — Former company name
• Advanced Medicine Inc. (company) — Former company name
• 2834 (industry) — Standard Industrial Classification

FAQ

Industry Context

Innoviva, Inc. operates in the Pharmaceutical Preparations industry, focusing on the development and commercialization of medicines.

Regulatory Implications

As a pharmaceutical company, Innoviva is subject to regulatory oversight from bodies like the FDA, governing drug development, approval, and marketing.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management discussion.
2. Analyze the risk factors section for potential challenges and uncertainties.
3. Compare the 2023 results with previous years to identify trends and performance changes.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, providing the latest annual overview of the company's operations and financial status.

Key Financial Figures

• $0.01 — ange On Which Registered Common Stock $0.01 Par Value INVA The Nasdaq Stock Mar
• $3.0 billion — EO ELLIPTA as follows: 15% on the first $3.0 billion of annual global net sales and 5% for a
• $220.0 million — we paid milestone fees to GSK totaling $220.0 million during the year ended December 31, 2014

Filing Documents

• inva-20231231.htm (10-K) — 4444KB
• inva-ex21_1.htm (EX-21.1) — 30KB
• inva-ex23_1.htm (EX-23.1) — 4KB
• inva-ex23_2.htm (EX-23.2) — 3KB
• inva-ex31_1.htm (EX-31.1) — 13KB
• inva-ex31_2.htm (EX-31.2) — 13KB
• inva-ex32.htm (EX-32) — 14KB
• inva-ex97.htm (EX-97) — 50KB
• img11953243_0.jpg (GRAPHIC) — 182KB
• img11953243_1.jpg (GRAPHIC) — 163KB
• img11953243_2.jpg (GRAPHIC) — 78KB
• img11953243_3.jpg (GRAPHIC) — 57KB
• img11953243_4.jpg (GRAPHIC) — 145KB
• img11953243_5.jpg (GRAPHIC) — 204KB
• img11953243_6.jpg (GRAPHIC) — 89KB
• img11953243_7.jpg (GRAPHIC) — 208KB
• img11953243_8.jpg (GRAPHIC) — 90KB
• img11953243_9.jpg (GRAPHIC) — 89KB
• img11953243_10.jpg (GRAPHIC) — 41KB
• img11953243_11.jpg (GRAPHIC) — 38KB
• img11953243_12.jpg (GRAPHIC) — 115KB
• img11953243_13.jpg (GRAPHIC) — 88KB
• img11953243_14.jpg (GRAPHIC) — 55KB
• img11953243_15.jpg (GRAPHIC) — 65KB
• img11953243_16.jpg (GRAPHIC) — 68KB
• img11953243_17.jpg (GRAPHIC) — 77KB
• img11953243_18.jpg (GRAPHIC) — 56KB
• img11953243_19.jpg (GRAPHIC) — 63KB
• img11953243_20.jpg (GRAPHIC) — 203KB
• 0000950170-24-023237.txt (&nbsp;) — 23607KB
• inva-20231231.xsd (EX-101.SCH) — 2664KB
• inva-20231231_htm.xml (XML) — 3480KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 34 Item 1B. Unresolved Staff Comments 74 Item 1C. Cybersecurity 74 Item 2.

Properties

Properties 75 Item 3.

Legal Proceedings

Legal Proceedings 75 Item 4. Mine Safety Disclosures 75 PART II Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 76 Item 6. [Reserved] 77 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 78 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 91 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 92 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 141 Item 9B. Other Information 144 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 144 PART III Item 10. Directors, Executive Officers and Corporate Governance 145 Item 11.

Executive Compensation

Executive Compensation 145 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 145 Item 13. Certain Relationships and Related Transactions, and Director Independence 145 Item 14. Principal Accountant Fees and Services 145 PART IV Item 15. Exhibits and Financial Statement Schedules 146 Item 16. Form 10K Summary 146 Exhibits 147

Signatures

Signatures 150 3 Table of Contents Special Note Regarding ForwardLooking Statements This Annual Report on Form 10K contains forwardlooking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Securities Act"). Such forwardlooking statements involve substantial risks, uncertainties and assumptions. All statements in this Annual Report on Form 10K, other than statements of historical fact, including, without limitation, statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, intentions, expectations, goals and objectives may be forwardlooking statements. The words "anticipates," "believes," "could," "designed," "estimates," "expects," "goal," "intends," "may," "objective," "plans," "projects," "pursuing," "will," "would" and similar expressions (including the negatives thereof) are intended to identify forwardlooking statements, although not all forwardlooking statements contain these identifying words. We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forwardlooking statements and the assumptions underlying our forwardlooking statements may prove incorrect. Therefore, you should not place undue reliance on our forwardlooking statements. Actual results or events could differ materially from the plans, intentions, expectations and objectives disclosed in the forwardlooking statements that we make. All written and verbal forwardlooking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Important factors that we believe could cause actual results or events to differ materially from our forwardlooking statements include, but are not limited to, risks related to: lower than expected future royalty revenue from r

BUSINESS

ITEM 1. BUSINESS Overview Innoviva, Inc. ("Innoviva", the "Company", the "Registrant" or "we" and other similar pronouns) is a company with a portfolio of royalties and innovative healthcare assets. We currently have three primary sets of assets: a royalty portfolio, operating assets in critical care and infectious disease, and other strategic healthcare assets. Our royalty portfolio contains respiratory assets partnered with Glaxo Group Limited ("GSK"), including RELVAR /BREO ELLIPTA (fluticasone furoate/vilanterol, "FF/VI") and ANORO ELLIPTA (umeclidinium bromide/vilanterol, "UMEC/VI"). Under the Long-Acting Beta2 Agonist ("LABA") Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR /BREO ELLIPTA as follows: 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales above $3.0 billion; and royalties from the sales of ANORO ELLIPTA , which tier upward at a range from 6.5% to 10%. We expanded our portfolio through the acquisition of Entasis Therapeutics Holdings Inc. ("Entasis") on July 11, 2022 and the acquisition of La Jolla Pharmaceutical Company ("La Jolla") on August 22, 2022. Our commercial and marketed products include GIAPREZA (angiotensin II), approved in the United States ("U.S.") to increase blood pressure in adults with septic or other distributive shock, and XERAVA (eravacycline) approved in the U.S. for the treatment of complicated intra-abdominal infections in adults. On May 23, 2023, XACDURO (formerly known as sulbactam-durlobactam or SUL-DUR), was approved by the United States Food and Drug Administration ("FDA") and we commenced commercial sales of XACDURO in the third quarter of 2023. Our development pipeline includes zoliflodacin, an investigational treatment for uncomplicated gonorrhea that reported positive data in a pivotal Phase 3 clinical trial on November 1, 2023. As such, we have a wholly owned robust critical care and infectious disease operating platfo

View Full Filing

View this 10-K filing on SEC EDGAR