Executive Summary

Q4 2024 revenue declined year over year as Auryxia volumes fell ahead of 2025 reimbursement changes, while operating loss and net loss widened on lower revenue and non‑cash interest tied to the Vifor settlement royalty liability .
Early U.S. launch metrics for Vafseo are strong: management guided to Q1 2025 net product revenue of $10–$11M and has contracts covering nearly 100% of U.S. dialysis patients; 3 of the top 4 dialysis organizations have already placed orders .
Operational updates highlight rapid prescriber adoption (500+ prescribers; ~8 prescriptions per prescriber on average), specialty pharmacy backlogs that are easing, and growing Medicare Advantage coverage (>15% of prescriptions in February) .
Regulatory path for label expansion is progressing: FDA offered a meeting to discuss the Phase 3 VALOR protocol for non‑dialysis CKD; Akebia expects to initiate VALOR in 2H 2025; VOICE outcomes study enrollment is >50% toward its 2,200‑patient target .
Cash of $51.9M at 12/31/24 plus post‑year‑end ATM proceeds ($18.4M) and credit draw ($9.3M) extend runway; management expects cash resources and operations to fund the plan for at least two years .

What Went Well and What Went Wrong

What Went Well
- “We expect $10 million to $11 million in net product revenue for Vafseo in the first quarter, a very strong start and well ahead of current analyst estimates.” — John Butler, CEO .
- Broad market access at launch: “We launched Vafseo with commercial supply contracts in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S.” .
- Prescriber momentum: “Over 500 physicians have prescribed Vafseo with an average of approximately 8 prescriptions each” through February; sales to 3 of top 4 dialysis organizations; channel inventory ~3–4 weeks .
What Went Wrong
- Revenue contraction: Q4 2024 total revenue fell to $46.5M (−17% YoY) driven by lower Auryxia volume; license/other revenue also declined YoY .
- Profitability pressure: Q4 net loss of $22.8M vs net income of $0.6M in Q4 2023; non‑cash interest expense from the Vifor settlement royalty liability was $4.9M in Q4 .
- Launch logistics: Early Q1 specialty pharmacy capacity constraints created a several‑week prescription backlog across TDAPA products, though conditions improved toward ~5 days by late quarter .

Financial Results

Summary vs prior quarters (USD Millions unless noted)

Metric	Q2 2024	Q3 2024	Q4 2024
Total Revenues ($)	43.648	37.428	46.497
Auryxia Net Product Revenues ($)	41.209	35.592	44.370
License/Collab/Other Revenues ($)	2.439	1.836	2.127
Cost of Goods Sold ($)	17.047	14.161	20.365
Operating Income (Loss) ($)	(8.725)	(12.505)	(14.307)
Net Income (Loss) ($)	(8.582)	(20.039)	(22.804)
Diluted EPS ($)	(0.04)	(0.10)	(0.10)
Gross Margin %	60.9%	62.2%	56.2%
Operating Margin %	(20.0)%	(33.4)%	(30.8)%

Segment/Revenue components (USD Millions)

Revenue Component	Q2 2024	Q3 2024	Q4 2024
Auryxia Net Product Revenues	41.209	35.592	44.370
License/Collab/Other Revenues	2.439	1.836	2.127
Total Revenues	43.648	37.428	46.497

Q4 2024 YoY context and non‑GAAP/one‑offs:
- Revenues: $46.5M vs $56.2M in Q4 2023 (lower Auryxia volume; price and contracting partially offset) .
- COGS benefited from previously written‑down inventory sold (FY 2024 benefit $12.3M; Q4 2023 benefit $4.3M); amortization of intangibles was $9.0M in Q4 .
- Non‑cash interest expense from settlement royalty liability: $4.9M in Q4 .
- Cash and cash equivalents: $51.9M at 12/31/24; working capital $32.9M .
Cash runway and subsequent financing:
- Management expects cash resources and cash from operations to fund the plan for at least two years .
- Post year‑end: ATM sales raised $18.4M; drew $9.3M from BlackRock credit agreement (Tranche C) .
KPI highlights tied to early Vafseo launch (as disclosed on 3/13):
- Q1 2025 Vafseo net revenue guidance: $10–$11M .
- Prescriber adoption: >500 prescribers; ~8 prescriptions/prescriber on average through February .
- Channel inventory: ~3–4 weeks in channel .
- Payer mix early read: >15% of February prescriptions under payers beyond Medicare FFS (e.g., Medicare Advantage) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Vafseo Net Product Revenue	Q1 2025	Not previously quantified	~$10–$11M	Introduced
VALOR Phase 3 (Non‑Dialysis) Start	2025	Exploring/anticipated; timing not fixed	Initiate 2H 2025	Timing specified/maintained toward 2H
Cash Runway	Multi‑year	≥2 years	≥2 years	Maintained
VOICE Outcomes Study	Ongoing	Initiated Sep 2024	>50% of 2,200 patients enrolled	Operational progress

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024 call)	Trend
Vafseo launch access/contracting	WAC set; contracting accelerating; ~60% coverage; TDAPA/HCPCS obtained	Contracts covering nearly 100% of dialysis patients; 3 of top 4 LDOs ordering; focus on protocol operationalization	Improving coverage and pull‑through
Prescriber demand	High intent; targeting home patients and high‑dose ESA segments	>500 prescribers; ~8 scripts/MD avg in 7 weeks; breadth first, then depth	Strong initial adoption
Distribution/specialty pharmacy	Anticipated supply‑chain shifts with binders entering bundle	Early Q1 backlog across TDAPA products; easing to ~5 days; Akebia leveraged network to re‑route capacity	Operational friction easing
Reimbursement	TDAPA confirmed; HCPCS for billing	>15% of prescriptions under non‑FFS (incl. MA) in Feb; expect broader MA access over time	Coverage broadening beyond FFS
Pricing/gross‑to‑net	WAC $1,278 per 30 days at 300mg; volume‑based rebates; ESA‑like price post‑TDAPA	Gross‑to‑net higher initially; declines as volume‑based rebates scale; dosing expected to average ~400mg/day over time	Economics normalize with scale
Non‑dialysis label expansion	Planning path; FDA engagement anticipated	FDA offered Type C meeting for VALOR protocol; initiate in 2H 2025	Advancing regulatory dialogue
Clinical evidence	VOICE initiated at USRC (2,200 pts)	>50% enrolled; aims to show hospitalization benefit vs ESAs	Evidence building toward standard‑of‑care

Management Commentary

“We expect $10 million to $11 million in net product revenue for Vafseo in the first quarter, a very strong start and well ahead of current analyst estimates.” — John Butler, CEO .
“We launched Vafseo with commercial supply contracts in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S.” — John Butler, CEO .
“Over 500 physicians have prescribed Vafseo with an average of approximately 8 prescriptions each…There are currently approximately 3 to 4 weeks of inventory in the channel.” — Nicholas Grund, CCO .
“In our latest communication from the FDA, they offered the opportunity to meet with them to discuss the protocol for our planned Phase 3 clinical trial (VALOR)…We expect to initiate the VALOR study in the second half of this year.” — John Butler, CEO .
“We expect this cash and cash from operations will be sufficient to fund our current operating plan…for at least 2 years.” — Erik Ostrowski, CFO .

Q&A Highlights

Stocking and revenue phasing: Q1 Vafseo revenue includes some initial channel inventory (target 2–4 weeks) given specialty distribution model .
Dosing and protocols: Early use is predominantly daily dosing (QD); some centers starting TIW protocols; protocol operationalization at large LDOs is pacing broad rollout .
Specialty pharmacy backlog: Early January shift of binders into the bundle moved dispensing into specialty channels, creating temporary capacity backlogs across TDAPA products; Akebia mitigated via network re‑routing; backlog narrowed to ~5 days .
Reimbursement mix: >15% of prescriptions in February were for payers beyond Medicare FFS, indicating early Medicare Advantage traction; commercial remains small share .
Gross‑to‑net and price mechanics: WAC $1,278 per 30‑day bottle at 300mg starting dose; gross‑to‑net expected to decline with higher volume rebates; dosing expected to trend toward ~400mg/day observed in trials over time .

Estimates Context

We attempted to retrieve S&P Global consensus for Q4 2024 and forward periods, but access was unavailable at query time (SPGI daily request limit exceeded). As a result, we cannot quantify beat/miss vs Street for revenue or EPS for Q4 2024 at this time.
Management asserted Q1 2025 Vafseo net revenue guidance of $10–$11M is “well ahead of current analyst estimates,” suggesting upward revisions to launch trajectories may be needed if execution continues at current pace .
We will update with S&P Global consensus figures when available.

Key Takeaways for Investors

Vafseo’s U.S. launch is off to a strong start with breadth of access (contracts covering nearly all dialysis patients) and rapid prescriber adoption, positioning for meaningful Q1 contribution ($10–$11M guide) despite early specialty channel friction .
Near‑term stock catalysts include sequential launch metrics (prescriber count, prescriptions per prescriber), Medicare Advantage coverage expansion, and LDO protocol go‑lives in H2 2025 .
Medium‑term thesis hinges on: (1) sustaining TDAPA‑period adoption and pricing discipline; (2) VOICE outcomes data to support standard‑of‑care positioning post‑TDAPA; and (3) VALOR progress toward non‑dialysis label expansion .
Legacy Auryxia remains a cash‑generating asset but faces structural headwinds; watch mix/volume and pricing as bundled dynamics and generic timing unfold through 2025 .
Operating leverage should improve if Vafseo revenue scales and specialty pharmacy friction continues to ease; non‑cash amortization and settlement‑related interest are important lens points in modeling margins and EPS .
Liquidity is adequate for execution and pipeline advancement over at least the next two years, augmented by ATM proceeds and credit draw, reducing near‑term financing overhang .

Additional Tables: Actuals vs Estimates (where available)

Metric	Q4 2024 Actual	Wall St. Consensus (S&P Global)	vs. Consensus
Total Revenues ($M)	46.497	N/A – unavailable via S&P Global at query time	N/A
Diluted EPS ($)	(0.10)	N/A – unavailable via S&P Global at query time	N/A

Notes: We attempted to source S&P Global estimates but could not retrieve due to access limits at the time of analysis; we will refresh when available.

Other Relevant Press Releases in Q4 2024

CMS granted TDAPA for Vafseo effective Jan 1, 2025; HCPCS code assigned to facilitate reimbursement .
Contracting progress and VOICE trial initiation were highlighted ahead of launch; >300,000 dialysis patients (~60% of lives) covered by Q3 update .

Sources: Q4 2024 8‑K press release and financials ; Q4 2024 earnings call transcript ; parallel transcript version ; Q3 2024 8‑K/press release and call ; Q2 2024 8‑K and call ; CMS TDAPA press release .

Akebia Therapeutics, Inc. (AKBA)·Q4 2024 Earnings Summary