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- **FDA Breakthrough**: First siRNA therapy approved for FCS, addressing 6,500 high-risk patients with $60k/year pricing.
- **Pipeline Expansion**: 20+ clinical candidates, including Phase III zodasiran (HoFH) and novel dual-target ARO-DIMER-PA.
- **Strategic Wins**: $400M from Novartis/Sarepta, extending cash runway to 2028.
- **CNS Innovation**: ARO-MAPT achieves 75% tau knockdown in monkeys, targeting Alzheimer's with CNS delivery.

**【CEO Summary Section】**
- **FDA Approval Milestone**: REDEMPLO approved for FCS, the first siRNA therapy for this indication, targeting 6,500 U.S. patients with triglycerides 10-100x normal levels.
- **Pricing Strategy**: One-REDEMPLO model sets $60,000 annual price across all indications, emphasizing value for high-risk patients with triglycerides >880 mg/dL.
- **Pipeline Progress**: Zodasiran (HoFH) in Phase III, ARO-DIMER-PA (mixed hyperlipidemia) files Phase I/II, and ARO-MAPT (Alzheimer's) initiates CNS delivery trials.
- **Strategic Deals**: $200M upfront from Novartis for Parkinson's collaboration, $200M milestone from Sarepta for ARO-DM1.

**【CFO Financial Commentary】**
- **FY25 Financials**: Net loss $2M (vs. $599M prior), revenue $829M (84% from Sarepta). Operating expenses $731M (+21%), driven by R&D (+33%) and commercial prep.
- **Cash Position**: $919M as of Q4, with runway to 2028. Received $200M from Novartis and $200M Sarepta milestone post-period.
- **Revenue Drivers**: Sarepta ($697M), Sanofi ($130M), GSK ($2.6M). FY26 expects no material REDEMPLO impact, focusing on pipeline.

**【Q&A Key Highlights】**
- **Pancreatitis Studies**: SHASTA-3/4 (SHTG) powered for triglyceride reduction, SHASTA-5 designed for acute pancreatitis as primary endpoint.
- **Obesity Drugs**: ARO-INHBE Phase I data due Q1 2026, targeting 20M mixed hyperlipidemia patients.
- **CNS Innovation**: ARO-MAPT achieves 75% tau knockdown in monkeys, with CSF data expected Q2 2026.
- **Pediatric Plans**: Developing weight-based dosing for REDEMPLO to address childhood FCS.
- **Dimer Potential**: ARO-DIMER-PA aims to lower LDL and triglycerides with quarterly dosing, CVOT planned post-Phase I/II.

Arrowhead Pharmaceuticals, Inc. (ARWR) Q4 2025 Earnings Call Transcript

- **Plozasiran Momentum**: Phase III trials for SHTG fully enrolled, with data expected mid-2026. FCS PDUFA date set for November 2025.
- **Strategic Deals**: $130M upfront from Sanofi for Greater China rights, plus $200M Sarepta milestone payment imminent.
- **Pipeline Expansion**: 20 clinical candidates expected by year-end, including 4 late-stage assets.
- **Financial Strength**: $900M cash balance supports near-term operations and pipeline growth.
- **Obesity Innovation**: First RNAi targeting adipose tissue (ARO-ALK7) enters clinic, with data expected late 2025.


**【CEO Summary Section】**
- **Sarepta Partnership Update**: Despite Sarepta's recent challenges, Arrowhead remains confident in the collaboration. Sarepta has reaffirmed its commitment to Arrowhead's assets, with clear termination provisions protecting Arrowhead's interests.
- **Plozasiran Progress**: 
  - U.S. NDA for FCS treatment with PDUFA date on November 18, 2025.
  - SHASTA-3 and SHASTA-4 Phase III trials for SHTG fully enrolled (2,200 patients across 24 countries), targeting 12-month triglyceride reduction data in mid-2026.
  - MUIR-3 trial provides additional safety data for SHTG filing.
- **Zodasiran Development**: Phase III YOSEMITE trial for HoFH initiated, with first patient dosed in July. Study aims to demonstrate LDL-C reduction over 12 months.
- **Pipeline Expansion**: 
  - Fazirsiran (Alpha-1 Antitrypsin Liver Disease) partnered with Takeda, with Phase III enrollment expected this year.
  - Olpasiran (ASCVD) licensed to Amgen, with Phase III cardiovascular outcomes trial fully enrolled in 2024.
  - 20 clinical candidates expected by end-2025, including 11 wholly-owned programs.
- **Capital Generation**: 
  - $130M upfront from Sanofi for plozasiran in Greater China, plus up to $265M in milestones.
  - $100M milestone payment from Sarepta for ARO-DM1 enrollment, with $200M due by year-end.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: 
  - Net loss: $175.2M (-$1.26/share) vs. $170.8M (-$1.38/share) in Q3 2024.
  - Revenue: $27.8M (95% from Sarepta collaboration).
  - Operating expenses: $193.3M (+$17.2M YoY), driven by Phase III trials and commercial prep.
- **Balance Sheet**: $900.4M in cash as of June 30, 2025, supporting near-term operations and pipeline expansion.
- **Upcoming Revenue**: 
  - $130M from Sanofi upfront in Q4 2025.
  - $200M Sarepta milestone payment expected by year-end.

**【Q&A Key Highlights】**
- **SHTG Competition**: Management emphasizes plozasiran's deep triglyceride reduction (80% in Phase II) and convenience (quarterly dosing), contrasting with Ionis' broader abdominal pain endpoint.
- **Payer Strategy**: Focused on educating payers about plozasiran's unique benefit in reducing acute pancreatitis risk, with 85% of U.S. covered lives engaged.
- **Obesity Pipeline**: 
  - ARO-INHBE and ARO-ALK7 Phase I/II trials dosing patients, with data expected late 2025.
  - ARO-MAPT targeting CNS Tau protein, with CTA submission expected by year-end.
- **Commercial Readiness**: U.S. launch team assembled for plozasiran, with pre-approval activities on track for November 2025 PDUFA date.


Arrowhead Pharmaceuticals (ARWR)-7 Aug 25-2025 Q3 Earnings call transcript

- **$1.375B Sarepta Deal Transforms Liquidity**: Arrowhead funded through 2028 with $500M upfront, $325M equity, and $50M annual payments.
- **Plozasiran on Track for 2025 Launch**: 80% triglyceride reduction in FCS, 75% of patients <880 mg/dL, with U.S. PDUFA date November 18.
- **Innovative Obesity Pipeline**: Dual siRNA programs targeting visceral fat reduction with Phase 1 data expected late 2025.
- **CNS Breakthrough Potential**: First siRNA for Alzheimer's (ARO-MAPT) entering Phase 1, leveraging novel brain delivery platform.
- **Strong Financial Position**: $1.1B cash, $370M net income Q2, no equity dilution needed for commercialization.

**【CEO Summary Section】**
- Arrowhead reported Q2 2025 revenue of $542.7 million, driven by the Sarepta collaboration agreement. CEO Chris Anzalone highlighted the company's transition to a commercial-stage biotech with the planned launch of plozasiran for FCS in late 2025. Key pipeline updates include:
  - **Plozasiran**: Phase III data shows 80% triglyceride reduction in FCS patients, with 75% achieving <880 mg/dL and 50% <500 mg/dL. Regulatory submissions in the U.S. and EU are under review with a PDUFA date of November 18, 2025.
  - **Obesity Programs**: ARO-INHBE and ARO-ALK7 Phase 1/2 studies are enrolling obese patients, targeting pathways to reduce visceral fat while preserving lean mass.
  - **CNS Pipeline**: First siRNA for Alzheimer's (ARO-MAPT) expected to enter Phase 1 in late 2025, leveraging a novel blood-brain barrier delivery platform.
- The Sarepta collaboration brought $1.375 billion in upfront payments, equity, and milestones, funding Arrowhead through 2028.

**【CFO Financial Commentary】**
- Q2 2025 net income: $370.4 million ($2.75/share) vs. Q2 2024 loss of $125.3 million. Revenue growth driven by Sarepta collaboration.
- Operating expenses: $161.5 million (+28% YoY), driven by clinical trial costs.
- Cash balance: $1.1 billion, with $460.1 million net cash inflow from operations.
- 2025 milestones include $300 million in potential DM1 program payments and regulatory approvals for plozasiran and zodasiran.

**【Q&A Highlights】**
- **Plozasiran Labeling**: Management expects FCS approval based on Phase III data showing 59% triglyceride reduction vs. placebo. SHASTA-5 outcome study for SHTG pancreatitis risk reduction is ongoing but not required for initial approval.
- **Commercialization**: U.S. launch team building for FCS, with European partnerships under evaluation. Sarepta collaboration provides $50M annual payments through 2030.
- **Obesity Strategy**: ARO-INHBE and ARO-ALK7 Phase 1 data expected late 2025. Combination with GLP-1 receptor agonists (e.g., tirzepatide) being tested to enhance efficacy.
- **CNS Risk**: Blood-brain barrier siRNA platform shows preclinical efficacy in Alzheimer's models. Phase 1 safety data expected late 2025.

Arrowhead Pharmaceuticals (ARWR)-12 May 25-2025 Q2 Earnings call transcript

- **$11B Deal Closure**: Secured $1.375B upfront from Sarepta, with potential total value exceeding $11B, enhancing 2028+ cash runway.
- **Plozasiran Launch Momentum**: FDA NDA accepted for FCS, targeting late 2025 launch; SHTG market could drive $2-3B annual revenue.
- **Obesity Innovation**: ARO-INHBE/ALK7 Phase I/II trials underway, leveraging adipocyte-targeting RNAi for fat loss without muscle wasting.
- **CNS Breakthrough**: TRiM platform enables CNS delivery; Huntington's/Alzheimer's/Parkinson's programs advancing to IND stage.
- **Financial Strength**: Pro forma cash of $1.4B post-deal, supporting core R&D while reducing non-core expenses.
- **Strategic Focus**: Prioritizing plozasiran, obesity, and CNS; exploring partnerships for non-core assets like pulmonary and C3.

**【CEO Summary Section】**
- Announced a $1.375 billion upfront payment from Sarepta Therapeutics, with potential total deal value exceeding $11 billion, including royalties.
- Highlighted three key growth drivers: plozasiran (FCS/SHTG), obesity programs (ARO-INHBE, ARO-ALK7), and CNS pipeline (ARO-HTT, ARO-MAPT, ARO-SNCA).
- Plozasiran expected to launch late 2025, with potential $2-3 billion annual revenue in SHTG.
- CNS programs (TRiM platform) targeting Huntington's, Alzheimer's, and Parkinson's diseases, with IND filings planned for 2025-2026.
- 2028+ cash runway supported by Sarepta deal, reducing R&D expenses and enabling focus on core assets.

**【CFO Financial Commentary】**
- Q1 2025 net loss: $173.1 million ($1.39/share) vs. $132.9 million ($1.20/share) in Q1 2024.
- Pro forma cash post-Sarepta deal: $1.4 billion, with $1 billion expected by end-2025.
- Revenue: $2.5 million (down from $3.6 million) due to expiring collaborations.
- Operating expenses: $163.9 million (up 17% YoY) driven by clinical pipeline expansion.

**【Clinical Updates】**
- **Plozasiran**: NDA accepted for FCS, with Phase III SHASTA-3/4/MUIR-3 studies on track for 2026 sNDA filing.
- **Obesity**: ARO-INHBE Phase I/II initiated, ARO-ALK7 regulatory clearance in NZ; preclinical data show fat loss without lean mass reduction.
- **CNS**: ARO-HTT/MAAP/SCNA IND filings planned; TRiM platform enables subcutaneous delivery to brain.
- **Zodasiran**: Phase III for HoFH to start Q2 2025, leveraging existing plozasiran infrastructure.

**【Q&A Highlights】**
- **Obesity Strategy**: Testing ARO-INHBE as monotherapy and combo with GLP-1; no pre-defined success metrics.
- **Lp(a) Landscape**: Excited about plozasiran's triglyceride-lowering efficacy vs. competitors; CVOT potential but dependent on capital.
- **Commercialization**: Europe planning for plozasiran launch; Sarepta to handle DM1/DM4 post-Phase II.
- **CNS Partnerships**: Open to discovery collaborations but retaining MAPT/ALK7 ownership.
- **Cash Allocation**: Focus on plozasiran, obesity, CNS; non-core assets (e.g., pulmonary, C3) up for partnering.


Arrowhead Pharmaceuticals (ARWR)-10 Feb 25-2025 Q1 Earnings call transcript

Arrowhead Pharmaceuticals (ARWR)-8 Aug 24-2024 Q3 Earnings call transcript

Arrowhead Pharmaceuticals (ARWR)-9 May 24-2024 Q2 Earnings call transcript

Arrowhead Pharmaceuticals (ARWR)-6 Feb 24-2024 Q1 Earnings call transcript

Arrowhead Pharmaceuticals, Inc. (ARWR) Q4 2023 Earnings Call Transcript

Arrowhead Pharmaceuticals (ARWR)-7 Aug 23-2023 Q3 Earnings call transcript

- **Pulmonary Breakthrough**: 90% RAGE knockdown in healthy volunteers, enabling potential monthly dosing for asthma. 
- **CNS Innovation**: 95% SOD1 knockdown in primates; ARO-SOD1 targeting rare ALS subset. 
- **Financial Strength**: $559M cash balance supports $70-90M quarterly spend, with $250M Royalty Pharma payment offsetting R&D. 
- **Pipeline Expansion**: 14+ clinical candidates by year-end, targeting 20+ by 2025 across 4 organ systems. 
- **Strategic Milestones**: Phase 3 PALISADE readout Q2 2024; ARO-ANG3 Phase 2 data this year. 


**【CEO Summary Section】**
- Arrowhead reported 12 clinical-stage RNAi drug candidates across two organ systems, with 3 Phase 3 studies ongoing and 5 partnerships. 
- Pulmonary platform achieved 90% RAGE knockdown in healthy volunteers, suggesting potential for monthly dosing. 
- CNS platform showed 95% SOD1 knockdown in non-human primates, with ARO-SOD1 targeting ALS patients with SOD1 mutations. 
- Adipose tissue platform demonstrated >90% gene silencing in non-human primates, targeting liver fat reduction. 
- Phase 3 PALISADE study for ARO-APOC3 in FCS nearing completion with 72/72 patients enrolled. 
- ARO-ANG3 Phase 2 studies in HoFH and mixed dyslipidemia on track for 2023 readouts. 

**【CFO Financial Commentary】**
- Q2 2023 revenue: $146.3M (vs $151.8M YoY), driven by Takeda and GSK collaborations. 
- Operating expenses: $98.1M (vs $110.3M YoY), down 12% due to reduced R&D costs. 
- Net cash used: $107.2M (vs $1.4M YoY), reflecting $250M Royalty Pharma payment offset by R&D investments. 
- Cash balance: $559.8M (vs $482.3M Sep 2022), supporting $70-90M quarterly cash burn. 
- CapEx: $90M+ planned for 2023 to expand Verona manufacturing (total $280M project). 

**【Q&A Highlights】**
- **Pulmonary Progress**: ARO-RAGE Phase 1/2 data shows durable knockdown; ARO-MUC5AC and ARO-MMP7 patient cohorts starting Q3. 
- **CNS Strategy**: ARO-SOD1 targeting 200-300 ALS patients with SOD1 mutations; intrathecal dosing every 3-6 months vs Biogen's monthly therapy. 
- **Financial Strategy**: $40M Takeda milestone (fazirsiran Phase 3) and $30M GSK milestone (ARO-HSD Phase 2b) to be recognized in Q2. 
- **Platform Expansion**: 14+ clinical candidates by year-end, targeting 20+ by 2025 across liver, lung, CNS, adipose. 
- **Partnership Approach**: Open to partnerships for DUX4 but prioritizing internal development for high-value assets. 
- **HBV Update**: Janssen leading HBV collaboration; no updates provided. 
- **CapEx Plan**: $200-260M total for Verona facility, with $90M+ spent in 2023 and $100M+ in 2024. 


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