Executive Summary

Strong quarter with broad-based growth: total revenues rose to $62.5M, up 43% YoY, driven by Vafseo U.S. launch and higher Auryxia sales; GAAP net income of $0.2M vs a loss of $(8.6)M last year .
Material beat vs Wall Street: revenue beat consensus by ~$15.0M and EPS swung to a profit versus an expected loss; revenue actual $62.5M vs $47.2M est; EPS actual $0.027 vs $(0.016) est (S&P Global) — a clear upside surprise on both top and bottom line. Values retrieved from S&P Global.*
Commercial momentum building: Vafseo net product revenue reached $13.3M with ~55% QoQ demand growth; >725 prescribers, >80% refills, and average refill dose up ~25%, indicating deepening utilization .
Near-term catalysts: DaVita ordering for an operational pilot across 100+ clinics beginning August, expected to enable broad prescribing before year-end; protocols at DCI/IRC expected by September, expanding access to >75,000 patients by end of Q3 .

What Went Well and What Went Wrong

What Went Well

Broad beat vs estimates: revenue and EPS surpassed Street expectations with strong product momentum (see Estimates Context). Values retrieved from S&P Global.*
Vafseo commercial traction: ~55% QoQ demand growth, >725 prescribers, >80% of scripts were refills, and average refill dose up ~25%, signaling retention and dose optimization .
Expanding dialysis access and enterprise pilots: DCI and IRC protocols by September and DaVita operational pilot in Q3 across 100+ clinics — positioning for broader 2H adoption . CEO: “launch momentum builds… progress efforts to further expand patient access… expect… DaVita… operational pilot… lead to the opportunity for broad prescribing before year end” .

What Went Wrong

Non-cash items offsetting profitability: $7.0M non-cash expense from change in warrant liability fair value and $5.4M non-cash interest expense tied to settlement royalty liability tempered operating upside .
Higher R&D spend: R&D rose to $11.0M (from $7.6M) on increased clinical activities (VOCAL, VOICE, VALOR preparations), diluting near-term operating leverage .
Continued safety and boxed warning communication burden: extensive Vafseo safety/boxed warnings maintained in materials, requiring ongoing prescriber education and monitoring .

Financial Results

Income Statement Snapshot vs Prior Periods

Metric (USD)	Q4 2024	Q1 2025	Q2 2025
Product revenue, net	$44.37M	$55.79M	$60.46M
License, collaboration & other	$2.13M	$1.55M	$2.01M
Total revenues	$46.50M	$57.34M	$62.47M
Total COGS	$20.37M	$7.63M	$9.92M
R&D expense	$11.79M	$9.75M	$11.01M
SG&A expense	$27.67M	$25.74M	$26.56M
Income (loss) from operations	$(14.31)M	$13.51M	$14.09M
Net income (loss)	$(22.80)M	$6.11M	$0.25M
Diluted EPS	$(0.10)	$0.03	$0.00

Notes: Q2 YoY comparison cited in press release: total revenues $62.5M vs $43.6M in Q2 2024; Auryxia $47.2M vs $41.2M; license & other $2.0M vs $2.4M .

Product and Mix

Metric (USD)	Q1 2025	Q2 2025
Vafseo net product revenue	$12.0M	$13.3M
Auryxia net product revenue	$43.8M	$47.2M
License, collaboration & other	$1.5M	$2.0M

Profitability Metrics

Metric	Q1 2025	Q2 2025
EBITDA	$14.0M*	$14.5M*
EBITDA Margin %	24.40%*	23.22%*
EBIT Margin %	23.85%*	22.71%*
Net Income	$6.11M	$0.25M

Values retrieved from S&P Global.*

Commercial KPIs (Vafseo U.S.)

KPI	Q1 2025	Q2 2025
Prescribers	>640 prescribers; avg ~12 scripts per prescriber	>725 prescribers; avg >13 scripts per prescriber
Refill mix	~1/3 of scripts refills	>80% of scripts refills
Dose trend	Refill data show rising average dose	Avg refill dose +~25%
Demand growth	Launch quarter baseline —	Rx demand +~55% QoQ
Access runway	Top 5 dialysis orgs placed orders	Access protocols to reach >75,000 patients by end Q3 (from ~40,000 end Q2)
DaVita pilot	—	Ordering for operational pilot at 100+ clinics, August start

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Vafseo prescribing access	Through Q3 2025	~40,000 patients enabled (end Q2)	>75,000 patients enabled by end Q3	Raised (operational access)
DaVita engagement	Q3–Q4 2025	n/a	Operational pilot at 100+ clinics begins August; expect broad prescribing opportunity before year-end	New
DCI/IRC protocols	By September 2025	n/a	Protocols operationalized to simplify/expand prescribing	New
VOICE trial (USRC)	Early 2027	75% enrolled (Q1 update)	Enrollment completed (2,116 pts); topline early 2027	Milestone reached
VOCAL trial	2025–2026	n/a	Initiated; ~350 pts across 18 DaVita clinics; endpoints include Hb change and safety	New
VALOR (NDD-CKD Phase 3)	2H 2025 start target	Plan to initiate 2H 2025	Working to initiate by year-end; Type-C FDA meeting requested	Timing refined
Profitability runway	Multi-year	Expect financed to achieve profitability (Q1)	“Financed to achieve profitability” reiterated with $137.3M cash at 6/30	Maintained

No explicit quantitative full-year revenue/EPS/OpEx guidance provided in materials reviewed.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
Market access & protocols	Commercial contracts covering nearly 100% of U.S. dialysis patients at launch ; Top 5 dialysis orgs placed orders	DCI/IRC protocols by Sept; DaVita pilot in August; access to >75k patients by end Q3	Improving
Payer mix (Medicare Advantage)	Not quantified	~20% of total prescriptions in Medicare Advantage; growing faster than FFS via TDAPA coverage	Improving
Patient segments	Not detailed	Home patients ~12% of scripts; high-dose ESA patients top-of-mind for switches; broad protocols for in-center and home	Stable/expanding
Vafseo product performance	Strong early launch; $12.0M Q1 revenue	$13.3M Q2 revenue; 55% Rx demand growth; >80% refills; rising dose	Improving
R&D execution	VOICE >50% enrolled; VALOR planned 2H’25	VOICE enrollment completed; VOCAL initiated; VALOR Type‑C meeting requested	Improving
Tariffs/supply chain	12+ months of tariff‑free inventory on hand (Q1)	No incremental update in Q2 materials	Stable
Regulatory/legal	NICE recommendation, UK launch (partner)	Continued global clinical publications; U.S. label expansion efforts ongoing	Stable/advancing

Management Commentary

“Vafseo… U.S. product launch momentum builds as we continued to add new prescribers, increase volume… and… expand patient access… we expect… DCI and IRC… will have operationalized protocols… DaVita has begun ordering Vafseo to support an operational pilot in Q3… lead to… broad prescribing before year end.” — John P. Butler, CEO .
“By the end of Q3, we expect dialysis organizations will have… protocols enabling Vafseo prescribing access to more than 75,000 patients, an increase from about 40,000… at the end of Q2.” — Company update .
“USRC completed enrollment in VOICE… 2,116 patients and top line data are expected in early 2027.” — Company update .
“To date, we’re seeing about 20% of total prescriptions being filled in the Medicare Advantage segment… they have significant Medicare Advantage contracts already in place that will support Vafseo through additional TDAPA coverage.” — Nicholas Grund, CCO .

Q&A Highlights

Patient segmentation: Usage mirrors market segmentation; ~12% home patients; focus on home patients and high-dose ESA patients as early adopters given oral convenience and potential CV risk considerations with high ESA doses .
Payer mix: ~20% of scripts in Medicare Advantage currently, with expectations for faster growth as additional MA contracts support TDAPA coverage, potentially expanding eligible patient pools .
Protocol breadth: Anticipated broad protocols across IRC, DCI, and DaVita for both in-center and home use, sustaining wide adoption potential .
Dose dynamics: Average refill dose increased, consistent with Q2 KPI disclosures suggesting intensifying therapy among continuing patients .

Estimates Context

Metric	Period	S&P Global Consensus*	Actual
Revenue	Q2 2025	$47.24M (5 ests)*	$62.47M
Primary EPS	Q2 2025	$(0.016) (5 ests)*	$0.027 (S&P actual)* and $0.00 diluted EPS per company

Results were a clear beat on both metrics; management attributed upside to Vafseo launch momentum and Auryxia strength despite LOE and presence of an authorized generic .
Values retrieved from S&P Global.*

Key Takeaways for Investors

Clear execution beat with accelerating commercial KPIs; top-line outperformance and positive EPS vs expected loss are likely to support positive estimate revisions near term. Values retrieved from S&P Global.*
Near-term adoption catalysts (DaVita pilot in Q3; DCI/IRC protocols by September) could unlock broader prescribing breadth into year-end, a potential stock driver on incremental access announcements .
Auryxia resilience (no approved ANDA to date; one authorized generic via distributor) provides a near-term revenue floor supporting the Vafseo build .
Watch non-cash items (warrant liability fair value; settlement royalty interest) that can mask underlying operating momentum in reported net income .
Cash of $137.3M and reiterated view of being financed to achieve profitability provide runway to pursue label expansion and ongoing studies (VOCAL, VALOR) .
Mid-term thesis: if enterprise protocols and MA coverage scale as indicated, Vafseo could gain share in both in-center and home dialysis settings, with VOICE (2027) and VALOR (late-stage NDD-CKD) as optionality on broader clinical positioning .
Risk checks: boxed warning/safety profile necessitates ongoing prescriber education; competitive ESA dynamics and generic Auryxia overhang require monitoring .

Additional Source Detail

8‑K and press release, Q2 2025 results: revenues/mix, costs, net income/expenses, cash .
Q2 2025 press release commercial and clinical updates (Vafseo KPIs, DaVita/DCI/IRC, VOICE, VOCAL, VALOR; Auryxia status) .
Q2 2025 call transcript excerpt (patient segments, MA mix, protocol breadth) .
Prior quarters: Q1 2025 (revenue/mix, cash, early KPIs) ; Q4 2024 (baseline financials, launch context) .
JASN subgroup analyses publication notice for vadadustat (context) .

Akebia Therapeutics, Inc. (AKBA)·Q2 2025 Earnings Summary