Akebia Therapeutics, Inc. 10-K Summary for Fiscal Year Ended December 31, 2024

Akebia Therapeutics, Inc. (NASDAQ: AKBA) delivered a year of strategic growth and financial improvement in 2024, as detailed in its Annual Report on Form 10-K. This summary provides investors with a concise overview of the company's performance, financial health, strategic developments, and key risks for the fiscal year ended December 31, 2024.

Business Overview

Akebia Therapeutics is a biopharmaceutical company dedicated to developing and selling treatments for patients with kidney disease. The company's main commercial products include:

• Auryxia® (ferric citrate): Treats iron deficiency anemia in adults with chronic kidney disease (CKD) not on dialysis, and manages high phosphate levels (hyperphosphatemia) in adults with CKD on dialysis.
• Vafseo® (vadadustat): An oral medication that helps the body produce more red blood cells (a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor), used to treat anemia caused by CKD in adult dialysis-dependent patients.

Financial Performance

Akebia generated total revenues of $250 million for fiscal year 2024, a 15% increase from $217 million in 2023. This growth stemmed primarily from a 10% rise in Auryxia sales to $180 million and stronger collaboration revenue, which grew to $70 million from $55 million in 2023, following Vafseo's launch in certain international markets.

Akebia's revenue came from two main sources in 2024:

• Product Sales: $180 million, primarily from Auryxia.
• License, Collaboration, and Other Revenue: $70 million, generated through partnerships and royalties from companies like MEDICE Arzneimittel Putter GmbH & Co. KG, Mitsubishi Tanabe Pharma Corporation, Japan Tobacco Incorporation, Torii Pharmaceutical Company Limited, and Otsuka Pharmaceutical Company Limited.

The company reduced its net loss to $85 million in 2024, an improvement from a $110 million net loss in 2023. Increased revenues and disciplined expense management largely drove this improvement. Selling, General, and Administrative (SG&A) expenses totaled $120 million, while Research and Development (R&D) expenses were $60 million, reflecting continued investment in pipeline development and commercial support.

Risk Factors

• Customer Concentration: Akebia heavily relies on a few large customers (e.g., Fresenius, DaVita) for a substantial portion of its revenue. This makes the company vulnerable if their purchasing patterns or financial health change. In 2024, Fresenius Medical Care Rx, U.S. Renal Care, and DaVita Inc. collectively accounted for approximately 65% of Akebia's total product sales revenue and 70% of accounts receivable. While these are established partners, this concentration poses a risk if any of these customers reduce orders or face financial difficulties.
• Debt Obligations: The company holds $170 million in secured debt, which requires significant cash flow to service. If Akebia cannot generate enough operating cash or secure additional financing, it may struggle to meet these obligations.
• Share Dilution: Recent and potential future equity offerings provide capital but increase the number of outstanding shares. This can dilute the value of existing holdings and earnings per share.
• Regulatory and Commercialization Risk: Vafseo's commercial success hinges on market acceptance and favorable reimbursement policies in various international markets. Regulatory hurdles, such as the potential need for re-submission for U.S. approval, remain a significant risk.
• Clinical Development Risk: Akebia's pipeline, including the newly acquired Q32 program, faces inherent risks associated with clinical trials. These include potential for unfavorable results, delays, or failure to obtain regulatory approval.
• Competition: The market for kidney disease treatments is competitive, with both established and emerging therapies. Akebia's products compete with other HIF-PH inhibitors and existing treatments.

Management Discussion (MD&A highlights)

Akebia significantly strengthened its global presence through several key agreements in 2024:

• An amended agreement with MEDICE Arzneimittel Putter GmbH & Co. KG expanded Vafseo's commercialization rights into additional European territories, which boosted collaboration revenue.
• The sublicense agreement with Japan Tobacco Incorporation and Torii Pharmaceutical Company Limited for vadadustat in Japan continued to generate significant royalties.
• In late 2024, Akebia amended its license agreement with Cyclerion Therapeutics, securing full rights to certain intellectual property related to soluble guanylate cyclase (sGC) activators. This potentially opens new therapeutic avenues.
• Additionally, in early 2025 (as disclosed in the 2024 10-K subsequent events), Akebia acquired a preclinical program from Q32 Bio Inc. This program targets a novel mechanism in kidney disease, expanding Akebia's early-stage pipeline.

The kidney disease treatment market is expanding, driven by the rising global prevalence of CKD, a growing preference for oral therapies, and a focus on improving patient quality of life. The regulatory landscape, especially for Vafseo in the U.S., remains a critical factor. Akebia continues to monitor and engage with regulatory bodies to explore potential pathways for U.S. approval of vadadustat.

Financial Health

As of December 31, 2024, Akebia held $125 million in cash and cash equivalents, an increase from $90 million at the end of 2023. Its total secured debt under the Term Loan Facility was $170 million, with $20 million in principal payments scheduled for 2025.

The company actively managed its capital structure throughout the year. It raised $45 million through its At-The-Market (ATM) equity offering program in 2024. Additionally, in March 2025, Akebia completed a public stock offering, which generated net proceeds of approximately $60 million (including the exercise of an overallotment option in April 2025). While these capital raises strengthened liquidity and funded operations, they led to a dilution of approximately 15% for existing shareholders over the past year, increasing total shares outstanding to 150 million.

Future Outlook

Akebia's leadership team remained stable throughout 2024, continuing to execute its strategy: maximizing Auryxia's commercial potential, expanding Vafseo's global reach, and strategically building its pipeline through partnerships and acquisitions.

For 2025, Akebia's strategic priorities include maximizing Auryxia's market share, driving Vafseo's commercial uptake in approved territories, and advancing its early-stage pipeline, including the newly acquired Q32 program. The company anticipates continued revenue growth, targeting total revenues between $265 million and $280 million in 2025. It also expects to manage operating expenses to improve profitability. Key catalysts for this outlook include further Vafseo launches in new markets and progress in its preclinical development programs.

Competitive Position

Akebia operates in a competitive biopharmaceutical market. Auryxia competes with other phosphate binders and iron supplements. Vafseo, an oral HIF-PH inhibitor, faces competition from established medications that stimulate red blood cell production (erythropoiesis-stimulating agents, or ESAs) and other HIF-PH inhibitors in its approved markets. Akebia aims to differentiate its products through their convenience, efficacy, and safety profiles, especially for patients with CKD-related anemia.