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Akebia Therapeutics, Inc. (AKBA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $58.8M and diluted EPS was $0.00; both beat consensus ($56.4M revenue, -$0.015 EPS), driven by strong Auryxia sales ($42.5M) and initial Vafseo revenue ($14.3M). Bold catalysts: broad DaVita rollout and favorable INNO2VATE win-odds analysis for vadadustat ; estimates from S&P Global.
  • Management emphasized operational challenges (first-refill adherence, protocol logistics) but expanded prescribing access to ~260,000–275,000 patients (DaVita village-wide now enabled; USRC TIW dosing protocol rolling into Q1 2026), setting up 2026 momentum .
  • Non-dialysis label pursuit paused: no FDA alignment on VALOR; focus stays on dialysis market and real-world TIW dosing trials (VOICE fully enrolled; VOCAL enrollment progressing) .
  • COGS benefited from end of Auryxia amortization and Vafseo pre-launch inventory (partial manufacturing costs previously expensed to R&D), supporting a $0.5M net income vs a $(20.0)M loss last year .
  • Near-term trading setup: potential inventory normalization and patient-start timing may temper Q4 Vafseo revenue, but expanding access and TIW adoption, plus new outcomes data, are likely to drive estimate revisions for 2026 .

What Went Well and What Went Wrong

What Went Well

  • “Through 41 weeks of launch, Vafseo has generated more total prescriptions than any recent launch in dialysis,” underscoring strong prescriber interest and clinical appeal .
  • Prescribing access expanded materially: DaVita pilot completed with “village-wide” rollout (~200k patients), plus IRC activation and multiple independents; total access ~260k with expectation to reach ~275k by year-end .
  • Post-hoc INNO2VATE win-odds analysis showed statistically significant favorable composite outcomes (death/hospitalization) for vadadustat vs darbepoetin; on-treatment inverted win-odds ratio 0.86 (95% CI 0.81–0.95, p<0.0001) .

What Went Wrong

  • CEO acknowledged “not satisfied with generating $14.3 million in revenue this quarter,” highlighting launch friction despite positive indicators .
  • Initial adherence at USRC lower than expected, especially around the first refill due to titration and hemoglobin dip management; management is retraining and adjusting protocols to improve adherence .
  • Non-dialysis label path setback: FDA Type C meeting did not produce alignment; Akebia will not initiate the VALOR trial, reducing the near-term label expansion optionality .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD Millions)$37.4 $62.5 $58.8
Net Income ($USD Millions)$(20.0) $0.247 $0.540
Diluted EPS ($USD)$(0.10) $0.00 $0.00
Net Income Margin %-53.5%*0.4%*0.9%*
EBIT Margin %-33.4%*22.7%*7.6%*

Values with * retrieved from S&P Global.

Segment/Line-item breakdown:

MetricQ3 2024Q2 2025Q3 2025
Vafseo Net Product Revenue ($USD Millions)N/A$13.3 $14.3
Auryxia Net Product Revenue ($USD Millions)$35.6 $47.2 $42.5
License/Collab/Other Revenues ($USD Millions)$1.8 $2.0 $2.0
Cost of Goods Sold ($USD Millions)$14.2 $9.9 $9.4

Actual vs Wall Street Consensus (S&P Global):

MetricConsensus (Q3 2025)Actual (Q3 2025)Surprise
Revenue ($USD)$56.419M$58.766M +$2.347M (+4.2%)
Primary EPS ($USD)-$0.015$0.00 +$0.015

Estimates from S&P Global.

KPIs:

KPIQ3 2024Q2 2025Q3 2025
Prescribers (count)N/A>725 ~725
Avg prescriptions per prescriberN/A>13 ~12.7
Refill share (%)N/A>80% >85%
Avg dose change vs prior quarterN/A+~25% +5% vs Q2; +32% above starting dose
Prescribing access patients (cumulative)N/A~40k end-Q2 ~60k end-Q3; targeting 275k YE
DaVita accessN/APilot initiated Village-wide rollout (~200k patients)
Cash & Cash Equivalents ($USD Millions)N/A$137.3 $166.4

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Prescribing Access (patients)YE 2025>75k by end-Q3 ~275k by YE 2025 Raised materially
DaVita rollout statusH2 2025Pilot in 100+ clinics; broad prescribing “before year end” “Village-wide” availability as of Nov 10 (~200k patients) Brought forward/confirmed
USRC TIW dosing protocolQ1 2026Not previously datedTIW protocol across clinics targeted for Q1 2026 New operational timing
Non-dialysis VALOR Phase 32H 2025Planned Type C and initiate in 2H 2025 Not initiating; not pursuing broad NDD-CKD label Lowered/withdrawn

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Vafseo launch demand & adherenceStrong early demand; refills ~1/3; inventory 2–4 weeks Refills >80%; avg dose +~25% Refills >85%; avg dose +5% QoQ; adherence challenges at USRC first-refill stage Mixed (demand steady; adherence improving slowly)
Access expansion (DaVita/IRC/DCI)LDO pilots planned; small/mid-sized driving revs DaVita pilot ordering; DCI/IRC protocols by Sept DaVita fully rolled out; IRC standardized protocol; DCI pending Positive
TIW dosing pushDiscussed TIW benefits conceptually VOCAL trial initiated (TIW vs ESA) USRC implementing TIW protocol; FDA engagement on label addition planned Positive
Outcomes data (INNO2VATE win-odds)N/AAnnounced upcoming ASN content Statistically significant composite benefit; strong clinician enthusiasm Positive
Auryxia generics/LOEAG entry; first-filer timing uncertain No ANDA approved; strong sales Still no ANDA approved; caution future predictability Neutral near-term; risk medium-term
Regulatory (non-dialysis label)Pursue VALOR in 2H 2025 Requested Type C meeting No FDA alignment; VALOR not initiated Negative

Management Commentary

  • CEO on Q3 revenue: “I’m not satisfied with generating $14.3 million in revenue this quarter…we are pleased with the direction of all the important launch indicators” .
  • On DaVita rollout: “DaVita…rolled out village-wide…200,000 patients as of today” .
  • On adherence drivers: “First refill…patients…experiencing…a hemoglobin dip…anemia manager…switching the patient back to an ESA as opposed to titrating…It’s a titratable drug” .
  • On outcomes: “Win-odds…showed patients randomized to Vafseo experienced a lower risk of death or hospitalization…clinicians…were incredibly excited” .
  • On non-dialysis: “Did not achieve alignment…does not plan to initiate VALOR…does not expect to pursue a broad label…for CKD non-dialysis dependent patients” .

Q&A Highlights

  • Strategies to improve adherence: enhanced messaging/training for anemia managers on titration; protocol adjustments; early signs of higher first-refill rates; TIW adoption expected to raise adherence .
  • DaVita pilot learnings: streamlined processes for clinical and reimbursement reviews; prescriber-driven rollout mitigates early adherence issues seen at USRC .
  • Inventory implications: USRC pivot from 150mg home tablets to 300mg in-center TIW; may reduce Q4 inventory levels; some physicians may delay starts until TIW protocols fully available .
  • Auryxia generics: No ANDA approved; revenue strong but future levels hard to predict .

Estimates Context

  • Q3 2025 beat: revenue $58.8M vs $56.4M consensus; EPS $0.00 vs -$0.015 consensus; 4 covering estimates for both ; estimates from S&P Global.
  • Street implications: Access expansion (DaVita, IRC) and TIW protocols support higher 2026 adoption assumptions, while Q4 patient starts may be deferred to align with TIW, moderating near-term growth; adherence commentary suggests gradual improvement, potentially lifting forward revenue/unit dose assumptions .

Key Takeaways for Investors

  • Q3 was a clean beat on both revenue and EPS; operational issues are the main brake, not prescriber demand—management is actively addressing adherence/protocol logistics .
  • The DaVita “village-wide” rollout (~200k patients) is a step-function access catalyst, with broader momentum into 2026; monitor TIW protocol adoption across providers .
  • TIW dosing shift may temporarily slow Q4 new starts (physicians waiting for in-center dosing), but should improve adherence and dose titration over time—constructive for LTV per patient .
  • Outcomes data (win-odds) strengthens the clinical narrative versus ESAs; watch for publication and integration into field messaging, potential to accelerate prescriber confidence .
  • Auryxia continues to over-deliver given lack of ANDA approvals; treat as near-term cash flow tailwind with medium-term erosion risk .
  • Non-dialysis label pathway is paused; valuation should pivot to dialysis execution and TIW outcomes (VOICE early 2027; VOCAL late 2026/2027) .
  • Trading lens: Any near-term softness tied to inventory normalization or delayed starts could be a buyable dip given clear access expansion and improving adherence trajectory; monitor Q4 ordering patterns and TIW availability milestones .