Akebia Therapeutics, Inc. (AKBA) Business Model Canvas

Akebia Therapeutics, Inc. (AKBA): Business Model Canvas [Dec-2025 Updated]

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You're trying to get a clear picture of Akebia Therapeutics, Inc. (AKBA) now that they've moved past pure R&D and are driving the commercial launch of Vafseo while leaning on Auryxia revenue. Honestly, seeing the structure laid out is key, because the model is all about securing major dialysis organization deals for the new oral treatment while managing the costs of that launch-Q3 2025 revenue hit about $58.8 million across products and other streams against significant operating expenses. This Business Model Canvas distills the exact partnerships, the dual-product value proposition, and the financial levers you need to watch to gauge their trajectory; check out the details below to see how they are playing this hand.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Key Partnerships

The operational success of Akebia Therapeutics, Inc. hinges on a network of strategic alliances for product distribution, commercialization, and intellectual property management.

Major U.S. Dialysis Organizations for Vafseo Distribution

Vafseo, which began shipments to customers on January 9, 2025, and saw its first prescription written on January 13, 2025, relies heavily on U.S. dialysis provider relationships. Akebia Therapeutics launched Vafseo with commercial supply contracts covering nearly 100% of dialysis patients in the U.S.. By the end of Q3 2025, prescribing access across the customer base reached 60,000 patients, with an expectation to grow this to 275,000 patients by the end of the year. U.S. Renal Care (USRC) is a significant partner; the vast majority of Vafseo revenues in Q3 2025 were derived from USRC, where more than 85% of all USRC physicians had written a prescription. An operational pilot with DaVita was expected to complete in the fourth quarter of 2025.

Mitsubishi Tanabe Pharma Corporation for Vafseo Commercialization in Japan and Asia

The collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC) for vadadustat in Japan and certain other Asian countries began in 2015. MTPC received regulatory approval in Japan on June 29, 2020, for Vafseo, which is marketed under that trade name. Under the original agreement, MTPC made payments totaling $100 million for global Phase 3 program costs, including $40 million upon signing. Akebia Therapeutics is eligible to receive up to approximately $190 million in future milestone payments from MTPC. MTPC is also obligated to make tiered royalty payments to Akebia Therapeutics of up to 20% on sales of vadadustat in Japan and certain other Asian countries.

Averoa and MEDICE for Ferric Citrate and Vadadustat Rights in Europe/Middle East

The European strategy involves two key partners:

  • MEDICE Arzneimittel Pütter GmbH & Co. KG: Holds an exclusive license for Vafseo in the European Economic Area, the U.K., Switzerland, and Australia, signed on May 24, 2023. The initial upfront payment was $10 million, with up to $100 million in commercial milestones for rights to Vafseo in Europe and Australia. Akebia Therapeutics and Medice entered an amendment on November 12, 2025, modifying supply terms where Akebia Therapeutics will supply the drug substance. Medice launched Vafseo in the U.K. in Q1 2025.
  • Averoa: Licensed the rights to develop and commercialize ferric citrate in the European Economic Area and certain countries in Europe and the Middle East, starting with an agreement in 2022. On April 3, 2025, the CHMP of the European Medicines Agency adopted a positive opinion recommending approval for XOANACYL® (Ferric Citrate as Coordination Complex).

Panion & BF Biotech for the Exclusive Worldwide License to Ferric Citrate (Auryxia)

Akebia Therapeutics, through its subsidiary Keryx Biopharmaceuticals, Inc., holds the exclusive worldwide rights, excluding certain Asian-Pacific countries, for the development and commercialization of ferric citrate, marketed as AURYXIA® in the United States. Loss of market exclusivity for Auryxia occurred on March 20, 2025. Despite this, Auryxia net product revenues were $42.5 million in Q3 2025, compared to $35.6 million in Q3 2024. As of Q3 2025, only one authorized generic for Auryxia was sold by Akebia Therapeutics' distributor.

Distributors and Specialty Pharmacies for Product Logistics and Patient Access

Revenue streams for Akebia Therapeutics are generated primarily from sales of Auryxia and Vafseo through specialty pharmacies and dialysis organizations. Furthermore, License, collaboration and other revenues were reported at $2.0 million in the third quarter of 2025.

Here is a snapshot of key product-related financial performance tied to these partnerships as of late 2025:

Product/Region Partner/Channel Metric Value (Q3 2025)
Vafseo (U.S. Dialysis) USRC, DaVita, etc. Net Product Revenue $14.3 million
Vafseo (U.S. Dialysis) Customer Base Access Patients Reached (End of Q3) 60,000
Auryxia (U.S.) Direct Sales/Distributors Net Product Revenue $42.5 million
Vafseo (Japan/Asia) MTPC Potential Remaining Milestones Up to $190 million
Vafseo (Japan/Asia) MTPC Royalty Rate (Max) 20%
Auryxia (Worldwide License) Panion & BF Biotech Exclusivity End Date (U.S.) March 20, 2025
Collaboration/License Income All Partners License, Collaboration & Other Revenue $2.0 million

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Key Activities

You're looking at the core engine driving Akebia Therapeutics, Inc. right now, which is all about getting Vafseo (vadadustat) into the hands of the right dialysis patients and managing the associated operational complexity. This is where the rubber meets the road for their current revenue base.

U.S. commercial launch and market penetration of Vafseo (vadadustat)

The U.S. commercial launch for Vafseo began in January 2025, with shipments starting on January 9, 2025, and the first prescription written on January 13, 2025. Akebia Therapeutics, Inc. secured commercial supply contracts covering nearly 100% of U.S. dialysis patients before January 2025, which is a significant operational feat for a drug with Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement. The Wholesale Acquisition Cost (WAC) for Vafseo was set at $1,278 for a 30-day supply at the minimum starting dose. The focus has clearly shifted from initial adoption to accelerating utilization across the entire contracted base.

Here is a snapshot of the penetration metrics through the third quarter of 2025:

Metric Q1 2025 (End of March) Q2 2025 (End of June) Q3 2025 (End of September) Year-End 2025 Projection
Vafseo Net Product Revenue $12.0 million $13.3 million $14.3 million N/A
Total Prescribers More than 640 More than 725 Approximately 725 N/A
Average Prescriptions per Prescriber Nearly 12 More than 13 Approximately 12.7 N/A
Prescribing Access (Patients) N/A (Initial usage in small/mid-sized providers) N/A 60,000 Expected to reach 275,000
Refill Prescriptions Percentage About 1/3 More than 80% More than 85% N/A

The increase in the average dose of refills by approximately 25% from Q1 to Q2, and then another 5% increase in the average dose of refills from Q2 to Q3, shows that prescribers are gaining confidence and potentially increasing patient dosage over time. That's a good sign for future revenue per patient.

Manufacturing and supply chain management for two commercial products

Akebia Therapeutics, Inc. manages the supply chain for both Vafseo and Auryxia (ferric citrate). As of the first quarter of 2025, the company estimated it had at least 12 months of Vafseo inventory on hand in the U.S. based on its operating plan. For Vafseo, the cost of goods sold reported in Q3 2025 was derived from pre-launch inventory, meaning the full cost of manufacturing was not yet reflected in that quarter's COGS calculation. Auryxia net product revenue in Q3 2025 was $42.5 million, even after its loss of exclusivity on March 20, 2025, which suggests ongoing supply and demand management for that product line.

Clinical data generation and presentation to support Vafseo adoption

Generating incremental data to support Vafseo as the standard of care for dialysis patients is a clear activity. At the American Society of Nephrology (ASN) Kidney Week 2025, Akebia Therapeutics, Inc. and its partners presented data supporting the drug's profile. Specifically, a post-hoc analysis of the INNO2VATE trial demonstrated a statistically favorable composite of all-cause mortality and hospitalization outcomes when comparing vadadustat to Erythropoiesis-Stimulating Agents (ESAs). Furthermore, posters were presented detailing the trial designs for:

  • VOICE, a collaborative clinical trial conducted by US Renal Care (USRC) studying Vafseo three times weekly dosing.
  • VOCAL, a trial conducted by DaVita, Inc. studying Vafseo three times weekly dosing.

Sales force training and protocol alignment within dialysis provider systems

The commercial success hinges on aligning internal protocols within the major dialysis providers. The company has been executing pilots and protocol rollouts with the large dialysis organizations (LDOs). Innovative Renal Care (IRC) implemented a standardized treatment protocol for Vafseo across its approximately 230 dialysis centers in mid-August 2025. The operational pilot with DaVita, involving over 100 clinics, was expected to complete in November 2025, which management believed would lead to the opportunity for broad prescribing before the end of 2025. The goal is to simplify and expand Vafseo prescribing for the sales force to target effectively.

Regulatory engagement for potential Vafseo label expansion (non-dialysis CKD)

The pursuit of label expansion for anemia in Chronic Kidney Disease (CKD) patients not on dialysis has been a key activity, though recently curtailed. Akebia Therapeutics, Inc. completed a Type C meeting with the U.S. Food and Drug Administration (FDA) in October 2025 regarding the VALOR clinical trial design for this indication. Based on the FDA feedback, the company announced it does not plan to initiate the VALOR trial and therefore does not expect to pursue a broad label for Vafseo in non-dialysis dependent CKD patients, as alignment would require a significantly larger number of patients, meaning meaningfully more time and cost. Vafseo remains approved in the U.S. for anemia due to CKD in adults who have been receiving dialysis for at least three months. The FDA feedback also noted that in large clinical trials for non-dialysis CKD patients, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Key Resources

You're looking at the core assets Akebia Therapeutics, Inc. needs to execute its strategy in late 2025. These aren't just line items; they are the tangible and intangible foundations supporting their commercial push in the kidney disease space. Honestly, the balance sheet strength right now is a key enabler for the Vafseo launch.

The financial bedrock is solid, giving the company runway to execute its current operating plan toward profitability. As of the end of the third quarter of 2025, Akebia Therapeutics, Inc. held cash and cash equivalents of approximately $166.4 million. This figure represents a significant jump from the $51.9 million reported at the end of 2024, partly due to a Q1 2025 public offering that brought in net proceeds of about $46.5 million.

The company's most critical tangible resources are its two commercial products, which are driving the current revenue stream.

Product FDA Approval Status Q3 2025 Net Product Revenue
Vafseo (vadadustat) Approved for anemia in dialysis patients (March 2024) $14.3 million
Auryxia (ferric citrate) Approved for hyperphosphatemia and iron deficiency anemia $42.5 million

The Intellectual Property landscape for these products presents a mixed picture. While Vafseo is protected by its novel mechanism and ongoing development, Auryxia faced a significant shift; IP exclusivity for Auryxia was lost in March 2025. Still, to date, no Abbreviated New Drug Application has been approved for Auryxia, and there is only one authorized generic for Auryxia being sold by Akebia's distributor.

Intangible assets are centered around their scientific foundation. Akebia Therapeutics, Inc. possesses a proprietary Hypoxia-Inducible Factor (HIF) technology platform. This platform, which mimics the body's response to high altitude to stimulate red blood cell production, is the basis for Vafseo and supports several pipeline programs, including AKB-9090 for acute kidney injury and AKB-10108 for retinopathy of prematurity.

The U.S. commercial infrastructure is specifically tailored to the nephrology community, which is essential for the Vafseo launch. This resource includes established relationships and contracts that facilitate patient access:

  • Secured contracts covering nearly 100% of U.S. dialysis patients as of January 2025.
  • Access expected for 275,000 total patients across the customer base by the end of 2025.
  • Market research suggested 99% of nephrologists would consider prescribing Vafseo to certain eligible patients.

The company is actively using this infrastructure to pursue label expansion for Vafseo into the non-dialysis Chronic Kidney Disease (CKD) population, which is viewed as a potential multiple billion-dollar market opportunity. Finance: draft 13-week cash view by Friday.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Value Propositions

You're looking at the core benefits Akebia Therapeutics, Inc. is offering to its customers, which are primarily healthcare providers and, ultimately, patients dealing with kidney disease complications. These propositions center on two key products: Vafseo and Auryxia.

Vafseo: Oral treatment for anemia in dialysis patients, an alternative to injectable ESAs.

Vafseo, which launched in the U.S. in January 2025, directly challenges the standard of care by offering an oral option instead of injectable Erythropoiesis-Stimulating Agents (ESAs). The commercial traction shows adoption:

  • Vafseo net product revenue reached $14.3 million in the third quarter of 2025.
  • Total number of prescribers in Q3 2025 was approximately 725.
  • More than 85% of US Renal Care (USRC) physicians have written a Vafseo prescription since launch.
  • More than 85% of Q3 prescriptions were refill prescriptions.
  • The average dose of refills increased by 5% over Q2 2025.

Vafseo: Post-hoc data suggests a statistically more favorable mortality/hospitalization composite.

The company presented incremental data to inform care decisions, specifically a post-hoc win-odds analysis from the Phase 3 INNO2VATE dialysis trials at ASN Kidney Week on November 6, 2025. This analysis compared Vafseo to the ESA darbepoetin alfa on a composite endpoint of death or hospitalization.

Analysis Metric Inverted Win-Odds P-Value
On Study Analysis 0.93 (95% CI 0.87-0.99) P=0.03
On Treatment + 28 Days 0.86 (95% CI 0.81-0.95) P<0.0001

This demonstrated statistically significant effects favoring Vafseo relative to the injectable ESA on this composite endpoint.

Auryxia: Dual-action therapy for hyperphosphatemia and iron deficiency anemia.

Auryxia continues to be a significant revenue driver, treating both hyperphosphatemia and iron deficiency anemia. Even after loss of exclusivity on March 20, 2025, the product maintained strong performance, partly due to new payment structures.

  • Auryxia net product revenue for Q3 2025 was $42.5 million, up from $35.6 million in Q3 2024.
  • Phosphate binders, including Auryxia, qualified for TDAPA (Transitional Drug Add-on Payment Adjustment) in January 2025, providing an additional payment for each service where it is used.
  • To date, no Abbreviated New Drug Application (ANDA) has been approved for Auryxia, and only one authorized generic is sold by Akebia Therapeutics, Inc.'s distributor.

Simplified logistics for home dialysis patients with an oral dose form.

The oral formulation of Vafseo offers a clear logistical advantage over injectable ESAs, which is critical for patients, especially those on home dialysis. The commercial rollout metrics suggest this convenience is being realized:

  • Prescribing access across the customer base reached 60,000 patients by the end of Q3 2025.
  • Access is expected to grow to 275,000 patients by the end of the year.
  • The operational pilot with DaVita at over 100 clinics was expected to complete in the fourth quarter.

Overall net product revenues for Q3 2025, combining both products, were $56.8 million.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Customer Relationships

You're looking at how Akebia Therapeutics, Inc. manages its relationships with the key decision-makers and facilities that will drive Vafseo adoption. This is all about access and education in the specialized world of nephrology and dialysis.

Contractual relationships with dialysis organizations to secure patient access are foundational to the commercial launch strategy. Akebia Therapeutics announced a multi-year commercial contract with a top kidney care service provider in October 2024, aiming to expand patient access to Vafseo for over 200,000 dialysis patients nationwide. By January 2025, Akebia had secured commercial supply agreements with dialysis organizations treating nearly 100% of dialysis patients in the U.S..

The operational engagement with major providers is showing traction. DaVita, Inc. initiated an operational pilot at over 100 dialysis clinics on August 18, 2025, with expectations for wide availability to DaVita patients upon pilot completion in November 2025. Furthermore, Innovative Renal Care (USRC) implemented a standardized treatment protocol for Vafseo across its approximately 230 dialysis centers in mid-August 2025. The vast majority of Vafseo revenues in Q3 2025, which totaled $14.3 million, were derived from US Renal Care (USRC). Prescribing access across the entire customer base grew to 60,000 patients by the end of Q3 2025, with an expectation to reach 275,000 patients by the end of the year.

The impact of the dedicated sales and medical affairs teams is reflected in prescriber engagement metrics, which show consistent growth in adoption following the January 2025 U.S. market availability.

Metric End of February 2025 End of March 2025 Q3 2025 (Approximate)
Total Number of Prescribers More than 500 More than 640 Approximately 725
Prescriber Growth (Feb to Mar) N/A Nearly 25% increase N/A
Average Prescriptions per Prescriber N/A Nearly 12 Approximately 12.7
Refill Prescription Rate N/A About 1/3 of prescriptions were refills More than 85%

Educational programs are clearly influencing prescribing behavior, especially within key accounts. Since launch, more than 85% of all USRC physicians have written a Vafseo prescription. Initial market research, shared in January 2025, suggested 99% of nephrologists would consider prescribing Vafseo, with 75% intending to do so within 6 months of availability.

The financial results underscore the scale of these customer relationship efforts. Vafseo net product revenue was $12.0 million in Q1 2025, increased to $13.3 million in Q2 2025, and reached $14.3 million in Q3 2025.

The focus on prescriber education regarding the clinical profile and the three-times-weekly (TIW) dosing strategy is supported by the refill rate trend. The average dose of refills increased by 5% over Q2 in Q3 2025.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Channels

The Channels component of Akebia Therapeutics, Inc.'s business model centers on getting Vafseo and Auryxia to the patient through established healthcare infrastructure and direct engagement.

Direct sales to major U.S. dialysis organizations (e.g., USRC, DaVita, IRC)

The commercial strategy heavily involves securing protocols and access within the largest U.S. dialysis providers for Vafseo, which launched in the U.S. market in the first quarter of 2025. By the end of the third quarter of 2025, prescribing access across the customer base reached 60,000 patients, with an expectation to grow this to 275,000 patients by the end of 2025. This access growth followed an increase from about 40,000 patients at the end of the second quarter of 2025.

  • Through the end of April 2025, the top five dialysis organizations placed Vafseo orders.
  • Innovative Renal Care (IRC) implemented a standardized treatment protocol for Vafseo across its approximately 230 dialysis centers by mid-August 2025.
  • A collaborative clinical trial of Vafseo conducted by US Renal Care (USRC) completed patient enrollment.
  • Since launch, more than 85% of all USRC physicians have written a Vafseo prescription.
  • An operational pilot of Vafseo at DaVita, involving 100+ DaVita dialysis clinics, was expected to complete in November 2025.

Direct-to-prescriber engagement via the commercial field force

The field force drives initial adoption and volume growth by engaging nephrologists directly. The number of prescribers and their average prescription volume are key metrics for this channel.

Metric Time Period Value
Total Number of Prescribers Q3 2025 Approximately 725
Total Number of Prescribers Through end of March 2025 More than 640
Average Prescriptions Per Prescriber Q3 2025 Approximately 12.7
Average Prescriptions Per Prescriber Through end of March 2025 Nearly 12
Prescription Demand Growth (vs. Q1 2025) Q2 2025 Approximately 55%

Refill rates indicate sustained use; in the second quarter of 2025, more than 80% of Vafseo prescriptions were refills.

Specialty distributors and wholesalers for product delivery

This channel is evidenced by the distribution of product versions, specifically the authorized generic for Auryxia.

  • Only one authorized generic for Auryxia is sold by Akebia Therapeutics, Inc.'s distributor as of the third quarter of 2025.

International partners (MTPC, Averoa, MEDICE) for ex-U.S. market access

International market access is managed through specific regional partnerships.

  • Akebia's partner, Medice, launched Vafseo in the U.K. in the first quarter of 2025.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Customer Segments

You're looking at the core patient and provider groups Akebia Therapeutics, Inc. (AKBA) targets with its therapies, primarily Vafseo (vadadustat) and Auryxia (ferric citrate). The focus is heavily on the established dialysis population right now, but the potential for the non-dialysis segment is massive, even if the company has recently adjusted its near-term plans for Vafseo expansion.

Adult patients with anemia due to Chronic Kidney Disease (CKD) on dialysis

This is the current commercial base for Vafseo. Anemia is a major complication, affecting a significant portion of the CKD population. As of March 31, 2025, there were 516,837 patients on dialysis in the United States, with 433,396 receiving in-center hemodialysis specifically. Akebia estimates that approximately 5.7 million people with CKD in the U.S. alone are affected by anemia. Vafseo is approved for patients on dialysis for at least three months. The revenue generated from this segment shows clear traction: Vafseo net product revenue was $12.0 million in Q1 2025, growing to $13.3 million in Q2 2025, and reaching $14.3 million in Q3 2025. For comparison, Auryxia net product revenues were $42.5 million in Q3 2025. The wholesale acquisition cost for a 30-day supply of Vafseo is $1,278.

Here's a look at the revenue performance for Akebia Therapeutics, Inc. in this core segment:

Metric Value (Q3 2025) Value (Q2 2025)
Vafseo Net Product Revenue $14.3 million $13.3 million
Auryxia Net Product Revenue $42.5 million $47.2 million
Total Net Product Revenues $56.8 million $60.5 million

Nephrologists and other healthcare providers managing dialysis patients

These providers are the direct prescribers. Their adoption rate and prescribing habits define near-term success for Vafseo. The data suggests increasing utilization among those who have started prescribing. In Q3 2025, the average number of prescriptions written per prescriber was approximately 12.7. Furthermore, more than 85% of Vafseo prescriptions written in Q3 2025 were refill prescriptions, which tells you that once they start, they tend to stay on the therapy. The average dose of those refills also increased by 5% over Q2 2025.

  • Total number of Vafseo prescribers in Q3 2025: Approximately 725.
  • Vafseo prescription demand grew by approximately 55% over Q1 2025 (as of Q2 2025 data).
  • The average dose of Vafseo refills increased by 5% from Q2 2025 to Q3 2025.

Large and mid-sized U.S. dialysis organizations (e.g., DaVita, USRC)

These organizations control the physical access points and protocols for the majority of dialysis patients. Akebia is making progress here, though access is still being built out. The vast majority of Vafseo revenues in Q3 2025 were derived from U.S. Renal Care (USRC). More than 85% of all USRC physicians have written a Vafseo prescription since launch. DaVita, a dominant player, began an operational pilot at over 100 dialysis clinics on August 18, 2025. The U.S. dialysis market itself was expected to be valued at $30.9 billion in 2025.

Here is the scale of the largest domestic players (data as of 2024):

Organization Approximate U.S. Centers Approximate U.S. Market Share
DaVita 2,657 About 37%
Fresenius Medical Care 2,600-2,800 Roughly 38%

Collectively, these two control almost 80% of U.S. dialysis facilities. Akebia also expected Dialysis Clinics, Inc. (DCI) and Innovative Renal Care (IRC) to have operationalized protocols by September 2025.

Potential future segment: Late-stage CKD patients not on dialysis (multi-billion dollar market)

This segment represents a significant untapped opportunity, though Akebia Therapeutics, as of its Q3 2025 report, stated it does not plan to initiate the VALOR clinical trial and therefore does not expect to pursue a broad label for Vafseo in this population. However, the market size remains substantial. Akebia previously estimated around 550,000 U.S. patients with stage 4 or 5 CKD who are anemic and not on dialysis. They also asserted that only 25% of those patients are currently treated for anemia. The broader U.S. End-Stage Renal Disease (ESRD) Market was projected to reach $41.0 billion in 2025. The entire North America Chronic Kidney Disease Market size was estimated at $14,623.07 million in 2025.

Market context for the non-dialysis CKD anemia patient pool:

  • Estimated U.S. patients with Stage 4 or 5 CKD who are anemic and not on dialysis: 550,000.
  • Estimated percentage of that non-dialysis group currently treated for anemia: 25%.
  • Projected U.S. End-Stage Renal Disease (ESRD) Market size in 2025: $41.0 billion.
  • North America Chronic Kidney Disease Market size in 2025: $14,623.07 million.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Cost Structure

You're looking at the hard numbers driving Akebia Therapeutics' operational burn rate as of late 2025. The cost structure is heavily weighted toward commercialization efforts for Vafseo, alongside ongoing R&D to support the product's lifecycle.

For the third quarter of 2025, the core operating expenses were clearly defined. Selling, General & Administrative (SG&A) expenses totaled $29.1 million. This increase from the prior year was largely due to higher marketing costs tied to the Vafseo U.S. launch, plus increased headcount-related expenses to support the commercial build-out. Research & Development (R&D) expenses were $14.9 million in Q3 2025, reflecting continued investment in clinical trial program activities, such as the VOICE and VOCAL studies.

The Cost of Goods Sold (COGS) for the quarter, covering both Vafseo and Auryxia, came in at $9.4 million. It's worth noting that this COGS figure benefited from the fact that a non-cash intangible amortization charge of $9.0 million per quarter, previously associated with Auryxia, was fully amortized by the end of 2024. Also, Vafseo-related COGS in the quarter was partially derived from pre-launch inventory, meaning it didn't include the full cost of manufacturing, as some of those expenses were recorded in R&D prior to Vafseo's FDA approval.

Here's a quick look at the key operating expenses for Q3 2025:

Expense Category Q3 2025 Amount (in millions USD)
Selling, General & Administrative (SG&A) $29.1
Research & Development (R&D) $14.9
Cost of Goods Sold (COGS) $9.4

The cost structure also includes significant variable costs tied to product sales agreements. Royalty payments on Vafseo U.S. net sales to CSL Vifor represent a material outflow, structured in two main parts following the termination of the prior license agreement:

  • Working Capital Fund (WCF) Royalty Payments: These payments range from 8% to 14% of Vafseo net sales in the Territory. They commenced on July 1, 2025, and continue until the cumulative total reaches $40 million or May 31, 2028.
  • Settlement Royalty Payments: These are separate quarterly payments that vary based on annual sales volume. They range from a high single-digit percentage of net sales up to $450 million, down to a mid-single digit percentage on net sales above $450 million in a calendar year.

Regarding the Transitional Drug Add-on Payment Adjustment (TDAPA) period, Akebia Therapeutics submitted its application in June 2024 and expected full TDAPA designation by January 1, 2025. While the company is benefiting from this reimbursement structure for Vafseo, a specific dollar amount for the associated costs in Q3 2025 was not explicitly detailed as a separate line item in the reported operating expenses.

Akebia Therapeutics, Inc. (AKBA) - Canvas Business Model: Revenue Streams

You're looking at the core money-makers for Akebia Therapeutics, Inc. as of late 2025, and the picture is clearly shifting from one product to two, plus some other income. The third quarter of 2025 showed total revenues hitting $58.8 million, a significant jump from the $37.4 million seen in Q3 2024. That growth is what you need to track. It's all about the execution on the commercial side now.

The bulk of that income comes directly from the two commercialized products. Honestly, seeing the new product contribute meaningfully while the legacy product holds steady is a good sign of early traction. Here's the quick math on the product revenue breakdown for the third quarter ending September 30, 2025:

Revenue Source Q3 2025 Amount (USD)
Auryxia Net Product Revenue $42.5 million
Vafseo Net Product Revenue $14.3 million
Total Net Product Revenue $56.8 million

That $56.8 million in net product revenue for the quarter is the engine right now. You'll notice that Vafseo, which only started shipping in January 2025, is already making up a quarter of the product sales.

Beyond the main drugs, there are a few other important, albeit smaller, streams you need to account for in the model. These are the supporting pillars:

  • License, collaboration, and other revenues totaled $2.0 million in Q3 2025.
  • Sales of the authorized generic version of Auryxia are occurring, as there is one authorized generic being sold by Akebia Therapeutics, Inc.'s distributor, following the loss of exclusivity on March 20, 2025.

Regarding Vafseo, its revenue generation is tied to its initial U.S. launch period. The $14.3 million in Q3 2025 net product revenue reflects its early uptake, particularly within the dialysis segment. While the term TDAPA reimbursement period (Transitional Drug Add-on Payment Adjustment) is relevant to new Part B drugs like Vafseo, the reported $14.3 million is the concrete financial result for that period in Q3 2025, showing the initial pricing power and utilization in the market.

The company is focused on expanding access to accelerate that Vafseo revenue stream further. Prescribing access was at 60,000 patients by the end of Q3 and is expected to grow to 275,000 patients by the end of 2025. That planned expansion is the key action item for Q4 revenue growth, you see.


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