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ARDELYX, INC. (ARDX)·Q3 2025 Earnings Summary

Executive Summary

  • Ardelyx delivered a clear beat and a “raise” quarter: Q3 revenue was $110.3M vs S&P Global consensus $100.5M, and EPS was $0.00 vs -$0.07 consensus; management raised 2025 IBSRELA revenue guidance to $270–$275M (from $250–$260M), citing sustained demand and improved pull-through . Q3 consensus values marked with * and sourced from S&P Global.
  • Product mix remains the story: IBSRELA ($78.2M, +20% q/q, +92% y/y) offset headwinds in XPHOZAH ($27.4M, +9% q/q), where loss of Medicare Part D coverage continues to pressure y/y comps, though sequential momentum remains positive .
  • Operating leverage inflected: EBIT turned positive to $4.7M (EBIT margin ~4.2%), SG&A remained consistent with Q2 while revenue grew, and cash/cash equivalents and ST investments increased to $242.7M at quarter-end .
  • Pipeline catalyst added: the company unveiled RDX10531, a next-generation NHE3 inhibitor, targeting an IND in 2026; management highlighted its potency/solubility and multi-therapeutic potential, reinforcing long-term optionality .

What Went Well and What Went Wrong

  • What Went Well

    • IBSRELA outperformance: “IBSRELA continues to outperform,” with $78.2M revenue in Q3 (+92% y/y), driven by broad-based demand and better pull-through, and FY25 guidance raised to $270–$275M .
    • XPHOZAH sequential growth: $27.4M in Q3 (+9% q/q) with the second consecutive quarter of growth in non‑Medicare segments; management cites improving access and pull-through (“more patients have access to XPHOZAH today than ever before”) .
    • Profitability progress: Positive operating income ($4.7M) with revenue growth outpacing opex; Q3 net loss narrowed to ~$1.0M (less than a penny per share) and quarter saw positive cash flow .
  • What Went Wrong

    • XPHOZAH y/y comp still pressured: Q3 XPHOZAH revenue declined y/y due to the January 1 shift eliminating Medicare Part D coverage; management continues to avoid providing full‑year guidance for the product .
    • Elevated opex to support growth: SG&A at $83.6M (+28% y/y) remained high to fund commercial scale (consistent with Q2), pressuring bottom line despite revenue strength .
    • Royalty/interest headwinds persist: Non‑cash interest expense ($2.2M) related to future royalties and ongoing interest expense ($5.8M) remained notable, partly offset by non‑cash royalty/milestone revenue ($4.8M) .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Total Revenue ($M)$98.241 $97.662 $110.329
Net Loss per Share (Basic/Diluted)$(0.00) $(0.08) $(0.00)
Income (Loss) from Operations ($M)$2.233 $(14.395) $4.668
EBIT Margin %2.3% (calc) -14.7% (calc) 4.2% (calc)

Notes: EBIT Margin % calculated as Income (loss) from operations / Total Revenue, using cited figures.

Segment breakdown (net product revenue):

MetricQ3 2024Q2 2025Q3 2025
IBSRELA Revenue ($M)$40.638 $65.045 $78.158
XPHOZAH Revenue ($M)$51.452 $25.032 $27.357
Product Supply Revenue ($M)$5.322 $6.185 $—
Licensing Revenue ($M)$0.020 $0.020 $0.025
Non‑cash Royalty/Milestone Revenue ($M)$0.809 $1.380 $4.789

KPIs and operating metrics:

KPIQ1 2025Q2 2025Q3 2025
IBSRELA Gross‑to‑Net (%)34.8% 32.2% ~31%
XPHOZAH Gross‑to‑Net (%)~32% (ex-returns); 18% reported with reserve release ~29% ~29%
Cash, Cash Equivalents & ST Investments ($M)$214 (3/31/25) $238.5 (6/30/25) $242.7 (9/30/25)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IBSRELA RevenueFY 2025$250–$260M $270–$275M Raised
XPHOZAH RevenueFY 2025Not provided Not provided Maintained (no guidance)
SG&A Run‑Rate2H 2025~$90M/quarter with incremental increases No update; Q3 SG&A consistent with Q2 Maintained commentary

Other: Company introduced RDX10531 (next‑gen NHE3 inhibitor), with IND targeting 2026 .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
IBSRELA commercial execution & pull‑throughQ1: Strong demand despite market contraction; expanding field access team to improve pull‑through . Q2: Record IBSRELA revenue; salesforce hitting stride; raised FY IBSRELA to $250–$260M .Record IBSRELA quarter; continued gains in new/total writers, refills; raised FY guidance to $270–$275M .Improving
XPHOZAH access strategy post‑Medicare changeQ1: Strategy focused on ArdelyxAssist and non‑Medicare growth; avoided guidance; mix shifting . Q2: Sequential growth; non‑Medicare momentum; GtN ~29% .+9% q/q revenue growth; second consecutive quarter of non‑Medicare growth; “more patients have access… than ever” .Improving sequentially; y/y still pressured
Gross‑to‑Net dynamicsQ1: IBSRELA 34.8%; XPHOZAH ~32% ex‑reserve . Q2: IBSRELA ~32.2%; XPHOZAH ~29% .IBSRELA ~31%; XPHOZAH ~29% .Stabilizing
Pipeline/BDQ1–Q2: Exploring BD; building team (CBO) .Announced RDX10531; IND planned 2026; highlights potency/solubility .Emerging pipeline
Capital allocation & balance sheetQ2: Drew $50M debt; optionality for additional $100M; cash $238.5M .Positive operating cash flow; cash $242.7M; CFO transition announced/effective Nov 4 .Strengthening

Management Commentary

  • “IBSRELA continues to outperform, driven by sustained demand… Our strategy translated into expanded patient adoption, accelerated revenue growth and increased conviction for the long‑term value of this franchise.” — Mike Raab, CEO .
  • “In Q3… revenue was $78.2 million… We delivered record highs in new writers and total writers… increased rates of prior authorization approvals and resubmission approvals.” — Eric Foster, CCO .
  • “XPHOZAH delivered another solid quarter… $27.4 million… Our gross‑to‑net deduction of approximately 29% was consistent with the second quarter.” — Justin Renz, CFO/COO .
  • On RDX10531: “Highly potent, highly soluble… could open development opportunities across a broad range of therapeutic areas… [IND] in 2026.” — Mike Raab .

Q&A Highlights

  • IBSRELA trajectory and first‑line use: Management emphasized organic first‑line growth while core strategy focuses on second/third‑line positioning due to payer dynamics; confident in path to >$1B peak sales .
  • XPHOZAH access model: Prescriptions adjudicated via ArdelyxAssist; non‑Medicare growth continued; on Medicare side, access fulfilled via patient assistance; “more patients have access… than ever before” .
  • Gross‑to‑Net: Q3 GtN ~31% (IBSRELA) and ~29% (XPHOZAH); expected to remain broadly consistent into Q4 .
  • Capital deployment: Balance sheet supports pipeline investment; BD remains opportunistic; RDX10531 prioritized as internal program .
  • Guidance posture: IBSRELA guidance raised; management remains conservative on XPHOZAH guidance pending continued consistency in trends .

Estimates Context

Actual vs S&P Global consensus (Q3 2025):

MetricConsensus*Actual
Revenue ($M)$100.544*$110.329
Primary EPS ($)-0.0675*0.000
  • Surprise: Revenue +$9.8M; EPS +$0.07 vs consensus (beat). Q4 2025 consensus: Revenue $118.809M*, EPS $0.008* (as of latest S&P Global pull). Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Beat-and-raise quarter anchored by IBSRELA; sustained execution supports higher FY25 revenue guide to $270–$275M and positive operating leverage (trading implications: upward estimate revisions and potential multiple support) .
  • XPHOZAH sequential recovery continuing despite Medicare headwinds; non‑Medicare momentum and stable GtN underpin improving run‑rate into Q4 (watch for ongoing access indicators) .
  • Margin trajectory improving: EBIT positive (~4.2% margin) with SG&A steady vs Q2; continued revenue growth could drive incremental operating margin expansion .
  • Balance sheet healthy ($242.7M cash/ST investments) and generating positive Q3 cash flow; provides optionality for targeted pipeline/BD investments .
  • New pipeline program (RDX10531) adds medium‑term optionality; IND in 2026 is a potential narrative catalyst for diversified growth beyond IBSRELA/XPHOZAH .
  • Near‑term focus: monitor IBSRELA script momentum and pull‑through, XPHOZAH non‑Medicare growth cadence, GtN stability, and any updates on XPHOZAH guidance as trends persist .
  • Additional supportive datapoints post‑quarter: real‑world XPHOZAH evidence at ASN Kidney Week showed meaningful serum phosphate reductions, adding clinical conviction to the access‑driven strategy .

Additional Press Releases and Context (Q3 timeframe)

  • Executive leadership changes announced Aug 4, 2025; CFO transition update reiterated in Q3 materials .
  • Post‑quarter, Ardelyx presented first real‑world XPHOZAH effectiveness data at ASN Kidney Week (Nov 7), supporting clinical value and patient satisfaction under current access dynamics .

S&P Global disclaimer: All values marked with * are retrieved from S&P Global.