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- **IBSRELA Breakthrough**: 92% YoY growth to $78.2 million, driven by patient satisfaction (85%+ adherence) and expanded prescriber engagement. ARDX-10531's preclinical success signals a return to pipeline development, with potential in broader NHE3-related indications. - **XPHOZAH Resilience**: 9% QoQ growth amid market turbulence, Ardelyx's ability to maintain stability underscores operational excellence. - **Strategic Reinvestment**: ARDX-10531 leverages existing expertise to diversify revenue streams, aligning with the company's $1 billion peak sales target for IBSRELA. - **Financial Discipline**: Stable gross to net metrics (~31% IBSRELA, ~29% XPHOZAH) reflect Ardelyx's ability to navigate challenges while investing in growth, the company's balance sheet remains strong, supporting future initiatives.

**【Management Opening Remarks】**
- Ardelyx delivered strong Q3 2025 performance with record-high revenue of $110.3 million, driven by 92% YoY growth in IBSRELA and 9% QoQ growth in XPHOZAH. The company announced ARDX-10531, a next-gen NHE3 inhibitor, signaling a return to pipeline development. CEO Michael Raab emphasized the team's ability to balance commercial execution with strategic investments.

**【CEO Commentary】**
- IBSRELA achieved $78.2 million in Q3 revenue, surpassing prior records. The molecule's differentiated mechanism addresses unmet needs in IBS-C, with 75% of patients reporting satisfaction. ARDX-10531 represents a potential expansion into broader therapeutic areas, leveraging Ardelyx's expertise in NHE3 inhibition, the company aims to generate $1 billion in peak sales, the leadership team highlighted disciplined capital allocation and pipeline development.

**【CFO Commentary】**
- Q3 gross to net deductions remained stable at ~31% for IBSRELA and ~29% for XPHOZAH, reflecting strong demand despite market turbulence. The company raised 2025 guidance to $270-275 million in IBSRELA revenue, driven by expanded prescriber engagement and pull-through improvements. The balance sheet remains robust with $242.7 million in cash, supporting future pipeline investments.

**【Q&A Highlights】**
- ARDX-10531's preclinical data demonstrates high potency and solubility, opening opportunities in hypertension, heart failure, and diabetes. The company plans to advance the molecule through Phase 1, aligning with strategic priorities to balance commercial execution with pipeline growth. The team is confident in maintaining momentum despite market challenges, with IBSRELA and XPHOZAH contributing to long-term value creation.

Ardelyx, Inc. (ARDX) Q3 2025 Earnings Call Transcript

- **Revenue Records**: Q2 2025 revenue up 33% YoY to $97.7M, driven by IBSRELA ($65M, +84% YoY) and XPHOZAH ($25M, +27% QoQ ex-reserve).
- **Guidance Raise**: IBSRELA 2025 sales target increased to $250-260M, with >$1B peak sales ambition.
- **Financial Strength**: $238.5M cash, $50M debt draw at 8.7%, and 53% QoQ net loss improvement.
- **Strategic Expansion**: New leadership team additions across CBO, CPO, CMO, CTO, and CHRO.
- **XPHOZAH Momentum**: Non-Medicare scripts growing, 3+ months of paid prescription growth, targeting $750M peak.

**【CEO Opening Remarks】**
- Q2 2025 total revenue: $97.7 million (33% YoY growth), driven by IBSRELA ($65M, 84% YoY) and XPHOZAH ($25M, 27% QoQ excluding one-time reserve). 
- Raised IBSRELA 2025 net sales guidance to $250-260M (prev $240-250M), targeting $1B+ peak sales.
- Strengthened balance sheet with $50M debt draw, total debt now $200M at 9.67% interest.
- Promoted leadership team expansion: CBO, CPO, CMO, CTO, and CHRO additions.
- CFO Justin Renz departing but staying through transition.

**【CCO Commercial Update】**
- **IBSRELA**: 
  - Q2 net sales $65M (84% YoY, 46% QoQ), record highs in new prescriptions, refills, and pull-through.
  - 84% of secretagogue users dissatisfied; targeting 1/4 of this population.
  - Field access team improving prior auth success, 3Q execution focus.
  - 2025 peak sales target >$1B.
- **XPHOZAH**: 
  - Q2 net sales $25M (27% QoQ ex-reserve), growth in non-Medicare (commercial/Medicaid) scripts.
  - ArdelyxAssist support driving 3+ month streak of paid prescription growth.
  - 2025 peak sales target $750M.

**【CFO Financial Review】**
- **Revenue**: 
  - IBSRELA: $65M (84% YoY), gross-to-net 32.2% (improving from 34.5% Q1).
  - XPHOZAH: $25M (29% gross-to-net, stable vs. Q1 31%).
  - Product supply sales: $6.3M (Kyowa Kirin Japan partnership).
- **Expenses**: 
  - R&D: $15.7M (12% YoY), SG&A: $84M (30% YoY) due to commercial scale-up.
  - Net loss: $19.1M (vs. $16.5M Q2 2024), 53% improvement vs. Q1 2025 ($41M).
- **Cash**: $238.5M (including $48.7M debt draw), $100M undrawn capacity.

**【Q&A Highlights】**
- **IBSRELA**: 
  - 3Q scripts strong despite summer seasonality; refill rate >50%.
  - 2025 guidance raise reflects demand, not team size changes.
  - Peak sales trajectory supports >$1B target.
- **XPHOZAH**: 
  - Non-Medicare mix 50/50 commercial/Medicaid, stable gross-to-net 30%.
  - Month-over-month growth since March; 2025 guidance pending consistency.
- **Cash Flow**: 
  - Breakeven achievable with current trajectory; 2026 free cash flow possible.
  - $50M debt draw for flexibility, no immediate plans for additional draws.
- **Legal**: 
  - CMS arguments Sept 25, no timeline for ruling.
  - No impact on XPHOZAH non-Medicare business.


Ardelyx, Inc. (ARDX) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: Q1 2025 revenue up 61% YoY to $74 million, driven by 57% IBSRELA and 55% XPHOZAH growth.
- **IBSRELA Momentum**: Highest prescription demand quarter on record, with 2025 guidance reaffirmed at $240-250 million.
- **XPHOZAH Resilience**: 30% YoY growth (non-Medicare segment dominant), peak potential of $750 million.
- **Financial Health**: $214 million cash, net loss narrowing 55% YoY to $41.1 million.
- **China Expansion**: $5 million milestone received for Tenapanor approval, with long-term revenue potential.

**【CEO Opening Remarks】**
- Q1 2025 revenue grew 61% YoY to $74 million, driven by strong performance of IBSRELA and XPHOZAH.
- IBSRELA net sales reached $44.4 million (+57% YoY), with Q1 prescription demand at record levels despite market contraction.
- XPHOZAH net sales were $23.4 million (+55% YoY), excluding a one-time $3.8 million returns reserve release.
- Reaffirmed 2025 guidance for IBSRELA: $240-250 million net sales, with peak potential exceeding $1 billion.
- XPHOZAH strategy focuses on non-Medicare patients, with 40% of dialysis population (220,000 patients) as addressable market.

**【CCO Commercial Update】**
- IBSRELA: 57% YoY growth, highest prescription demand quarter on record, exiting Q1 with strong momentum.
- XPHOZAH: 30% YoY growth (excluding reserve release), new prescribers and refill prescriptions despite Medicare Part D disruption.
- Commercial team expanded field access management to enhance patient access, with ArdelyxAssist supporting 60% of prescriptions.
- Both products demonstrate clinical value, with high patient satisfaction and unmet need in IBSC and hyperphosphatemia markets.

**【CFO Financial Review】**
- Total revenue: $74.1 million (61% YoY growth), driven by IBSRELA (+57%) and XPHOZAH (+55%).
- Gross to net deductions: 34.8% for IBSRELA (expected to improve), 18% for XPHOZAH (32% excluding reserve release).
- R&D expenses: $14.9 million (+40% YoY), reflecting increased clinical engagement.
- SG&A expenses: $83.2 million (+57% YoY), supporting commercial expansion and patient access programs.
- Net loss: $41.1 million (-55% YoY), with $214 million cash on hand.
- Received $5 million milestone from China partner for Tenapanor approval.

**【Q&A Key Takeaways】**
- **IBSC Market Dynamics**: Q1 contraction (~10%) expected, but IBSRELA outperformed peers with 57% growth. Q2+ growth to accelerate as market normalizes.
- **XPHOZAH Access**: 80% of prescriptions from non-Medicare patients post-Medicare Part D loss. Patient assistance program supports continuity for Medicare patients.
- **Financial Model**: Gross to net ~30-35% for IBSRELA, ~30% for XPHOZAH. 2025 SG&A ~$90 million, R&D ~$15 million.
- **China Expansion**: Partner Fosun Pharma expects Tenapanor launch in 2025, with potential for $100 million+ revenue by 2030.
- **Litigation Risk**: CMS appeal decision pending; positive outcome could restore Medicare coverage but logistics for rapid reinstatement unclear.


Ardelyx (ARDX)-1 May 25-2025 Q1 Earnings call transcript

- **IBSRELA Q4 Surge**: 32% QoQ growth to $53.8M, driven by 2025 sales force expansion and new prescriber pipeline.
- **XPHOZAH Resilience**: $160.9M 2024 sales despite CMS changes; 2025 patient access maintained via 4 pathways (existing Medicare/non-Medicare, new Medicare/non-Medicare).
- **Financial Fortitude**: $250M cash on hand; 2025 IBSRELA guidance $240-250M, XPHOZAH targeting $750M peak.
- **Growth Drivers**: Omnichannel patient engagement, field-based Access Managers, and strategic pipeline expansion.

**【CEO Opening Remarks】**
- **IBSRELA Growth**: Q4 2024 sales increased 32% QoQ, driven by expanded sales team and new prescriber growth. Full-year 2024 revenue reached $158.3M, up 97% YoY.
- **XPHOZAH Launch Success**: Achieved $160.9M in U.S. net sales in 2024, with 11% QoQ growth in Q4. Despite CMS coverage changes, early 2025 data shows uninterrupted patient access across 4 key pathways.
- **Financial Strength**: Ended 2024 with $250.1M cash, up 35% YoY, supporting 2025 growth initiatives.

**【CFO Financial Highlights】**
- **Q4 2024 Results**: Total revenue $116.1M (IBSRELA: $53.8M, XPHOZAH: $57.2M). Full-year 2024 revenue $333.6M vs. $124.5M prior year.
- **Gross to Net Deductions**: IBSRELA 28.5% (Q4), XPHOZAH 20.3% (Q4). 2025 XPHOZAH GTS expected less favorable due to payer mix shift.
- **2025 Guidance**: IBSRELA $240-250M net sales; XPHOZAH targeting $750M peak pre-patent expiry. SG&A to increase $10M/Q4 in 2025 for commercial expansion.

**【Q&A Key Takeaways】**
- **XPHOZAH Access**: 60% Medicare, 40% non-Medicare in 2024. 2025 patient assistance program covers Medicare-eligible patients, maintaining 4 access pathways (existing Medicare, non-Medicare, new Medicare, new non-Medicare).
- **IBSRELA Strategy**: 2025 investments in omnichannel patient engagement, field-based Access Managers to improve pull-through rates. Targeting $1B+ annual sales pre-patent expiry.
- **Pipeline Expansion**: Actively evaluating external opportunities, prioritizing assets with commercial fit and clinical validation.


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