Akebia Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Akebia Therapeutics filed its 2023 10-K, detailing financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

Akebia Therapeutics, Inc. (AKBA) filed a Annual Report (10-K) with the SEC on March 14, 2024. Akebia Therapeutics, Inc. filed its 2023 Form 10-K on March 14, 2024. The filing covers the fiscal year ending December 31, 2023. Key financial data for 2023 and 2022 is presented, including revenue and net income. The company operates in the Pharmaceutical Preparations industry (SIC 2834). Akebia Therapeutics is incorporated in Delaware with its principal business address in Cambridge, MA.

Why It Matters

For investors and stakeholders tracking Akebia Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Akebia's financial health, operational results, and strategic positioning for the past fiscal year, crucial for investors assessing the company's performance and future prospects. The detailed financial statements and risk factors within the filing offer insights into potential challenges and opportunities, including customer concentration risks and product revenue streams.

Risk Assessment

Risk Level: — Akebia Therapeutics, Inc. shows moderate risk based on this filing. The company faces medium risk due to significant customer concentration, with a substantial portion of its sales revenue dependent on a few key customers like Fresenius Medical Care Rx, Cencora Inc., McKesson Corporation, Cardinal Health Inc., and Otsuka Pharmaceutical Company Limited.

Analyst Insight

Investors should closely monitor Akebia's revenue diversification strategies and its relationships with major customers to assess future growth and stability.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-14 — Filing Date (Date of submission)
• 2834 — SIC Code (Industry classification)

Key Players & Entities

• Akebia Therapeutics, Inc. (company) — Filer name
• 2023 (date) — Fiscal year end
• March 14, 2024 (date) — Filing date
• Cambridge, MA (location) — Business address
• Fresenius Medical Care Rx (company) — Customer
• Cencora Inc. (company) — Customer
• McKesson Corporation (company) — Customer
• Cardinal Health Inc (company) — Customer

FAQ

Risk Factors

• Customer Concentration Risk [medium — financial]: A significant portion of the company's net sales revenue is derived from a limited number of customers, including Fresenius Medical Care Rx, Cencora Inc., McKesson Corporation, Cardinal Health Inc., and Otsuka Pharmaceutical Company Limited.

Industry Context

Akebia Therapeutics operates within the Pharmaceutical Preparations industry, focusing on the development and commercialization of therapeutics.

Regulatory Implications

The company is subject to standard SEC regulations for public companies, including the requirement to file annual reports (10-K) detailing financial performance and business operations.

What Investors Should Do

1. Analyze the detailed financial statements in the 10-K to understand revenue trends and profitability.
2. Evaluate the risk factors, particularly customer concentration, and assess management's mitigation strategies.
3. Research any forward-looking statements or management discussions regarding future product development and market strategies.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-14: Filing Date — Date Akebia Therapeutics submitted its 10-K to the SEC.

Year-Over-Year Comparison

This filing is the 2023 annual report (10-K), providing updated financial and operational data compared to previous filings.

Key Financial Figures

• $0.00001 — ange on which registered Common Stock, $0.00001 par value per share AKBA The Nasdaq Ca

Filing Documents

• akba-20231231.htm (10-K) — 3096KB
• akbaex47formofwarrant.htm (EX-4.7) — 124KB
• akbaex1021thirdamendedandr.htm (EX-10.21) — 28KB
• akbaex1043akbaesa-elt52019.htm (EX-10.43) — 83KB
• akbaex1044akebia-formofcas.htm (EX-10.44) — 16KB
• akbaex10452023planformofof.htm (EX-10.45) — 56KB
• akbaex1046akebia-2023planf.htm (EX-10.46) — 65KB
• akbaex1047formofofficerind.htm (EX-10.47) — 55KB
• akbaex1066hadas_nicolexame.htm (EX-10.66) — 8KB
• akbaex1067dahan_michelxame.htm (EX-10.67) — 7KB
• akbaex1093akebiapharmakonf.htm (EX-10.93) — 75KB
• akbaex10102akebia_kreosxcr.htm (EX-10.102) — 528KB
• akbaex10103kreos-akebiaxwa.htm (EX-10.103) — 51KB
• akbaex231-eyakebiaconsent.htm (EX-23.1) — 9KB
• akbaex31112312023-10xk.htm (EX-31.1) — 11KB
• akbaex31212312023-10xk.htm (EX-31.2) — 11KB
• akbaex32112312023-10xk.htm (EX-32.1) — 9KB
• akbaex971-akbanasdaqcompli.htm (EX-97.1) — 20KB
• akba-20231231_g1.gif (GRAPHIC) — 4KB
• image_0.jpg (GRAPHIC) — 13KB
• image_01.jpg (GRAPHIC) — 13KB
• image_1.jpg (GRAPHIC) — 16KB
• image_11.jpg (GRAPHIC) — 16KB
• image_2.jpg (GRAPHIC) — 1KB
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• image_3.jpg (GRAPHIC) — 1KB
• image_31.jpg (GRAPHIC) — 1KB
• 0001628280-24-011270.txt (&nbsp;) — 13732KB
• akba-20231231.xsd (EX-101.SCH) — 102KB
• akba-20231231_cal.xml (EX-101.CAL) — 98KB
• akba-20231231_def.xml (EX-101.DEF) — 446KB
• akba-20231231_lab.xml (EX-101.LAB) — 1034KB
• akba-20231231_pre.xml (EX-101.PRE) — 731KB
• akba-20231231_htm.xml (XML) — 1467KB

Business

Business 7 Item 1A.

Risk Factors

Risk Factors 50 Item 1B. Unresolved Staff Comments 105 Item 1C. Cybersecurity 105 Item 2.

Properties

Properties 106 Item 3.

Legal Proceedings

Legal Proceedings 106 Item 4. Mine Safety Disclosures 109 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 110 Item 6. [Reserved] 110 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 110 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 124 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 125 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 166 Item 9A.

Controls and Procedures

Controls and Procedures 166 Item 9B . Other Information 169 Item 9C . Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 170 PART III Item 10. Directors, Executive Officers and Corporate Governance 170 Item 11.

Executive Compensation

Executive Compensation 170 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 170 Item 13. Certain Relationships and Related Transactions, and Director Independence 170 Item 14. Principal Accountant Fees and Services 170 PART IV 171 Item 15. Exhibits and Financial Statement Schedules 171 Item 16. Form 10-K Summary 180

SIGNATURES

SIGNATURES 181 In this Annual Report on Form 10-K, or Form 10-K , unless otherwise stated or the context otherwise requires, references to "Akebia," "we," "us," "our," "the Company," "our Company" and similar references refer to Akebia Therapeutics, Inc. and, where appropriate, its consolidated subsidiaries. On December 12, 2018, in connection with the consummation of the merger, or Merger , with Keryx Biopharmaceuticals, Inc., or Keryx , Keryx became a wholly owned subsidiary of the Company. AURYXIA, AKEBIA Therapeutics, Vafseo and their associated logos are trademarks of Akebia and/or its affiliates. All other trademarks, trade names and service marks appearing in this Form 10-K are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this Form 10-K may appear without the or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies' trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other company. Akebia Therapeutics, Inc. | Form 10-K | Page 1 Table of Content s CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Form 10-K , contains forward-looking statements that are being made pursuant to the provisions of the U.S. Private Securities Litigation Reform Act of 1995 with the intention of obtaining the benefits of the "safe harbor" provisions of that Act. All statements contained in this Form 10-K other than statements of historical fact are forward-looking statements. These forward-looking statements may be accompanied by words such as "anticipate," "believe," "build," "can," "contemplate," "continue," "could," "should," "designed," "estimate," "project," "expect," "forecast," "fut

Business

Item 1. Business Overview We are a fully integrated, commercial-stage biopharmaceutical company committed to addressing patients' unmet needs. We have built a business focused on developing and commercializing innovative therapeutics that we believe serve as a foundation for future growth. Our purpose is to better the life of each person impacted by kidney disease, and we have established ourselves as a leader in the kidney community. We believe our demonstrated ability to deliver value broadly to the kidney community has enabled us to build a sustainable company. Upon this solid foundation and our continued commitment to patients, we believe focusing on all patients who can realize a meaningful benefit from our medicines will deliver value for our shareholders. Our current portfolio and hypoxia-inducible factor (HIF)-based pipeline includes: Product Indication Region(s) Discovery Phase 1 Phase 2 Phase 3 Regulatory Review Commercial Approval In Market Auryxia (ferric citrate) Hyperphosphatemia, IDA United States 1 , Japan 2 and Taiwan 2 Vafseo Anemia DD-CKD, Anemia NDD-CKD Japan 3 Vafseo Anemia DD-CKD European Union 4 , United Kingdom 4 , Switzerland 4 , Australia 4 , Taiwan 5 and Korea 5 Vadadustat Anemia DD-CKD United States 1 Vadadustat Anemia NDD-CKD Global 6 AKB-9090 AKI, ARDS Global 1 AKB-10108 ROP Global 1 1 Marketed by Akebia 2 Marketed by JT Torii 3 Marketed by MTPC 4 To be marketed by Medice 5 To be marketed by MTPC 6 To be marketed by Akebia; MTPC and Medice have certain rights in their territories Auryxia (ferric citrate) is an orally administered medicine approved and marketed in the United States, or U.S. , for two indications: (1) the control of serum phosphorus levels in adult patients with dialysis dependent chronic kidney disease, or DD-CKD , and (2) the treatment of iron deficiency anemia, or IDA , in adult patients with non-dialysis-dependent chronic kidney disease, or NDD-CKD . Today, we market

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