Arrowhead Pharmaceuticals(ARWR) - 2025 Q2 - Quarterly Results

Fiscal 2025 Second Quarter Results Business and Strategic Overview Arrowhead is financially strong, anticipating plozasiran's 2025 launch, funded into 2028 by Sarepta, and leveraging TRiM™ technology - The company is on schedule to launch plozasiran this year for familial chylomicronemia syndrome (FCS), pending regulatory approval[2] - Following the agreement with Sarepta Therapeutics, Arrowhead is funded into 2028 with no current need for additional cash from equity raises[2] - The company's TRiM™ technology platform is considered a key asset, providing opportunities for additional capital from business development in areas outside its core commercial focus[2] Key Operational Highlights Key operational highlights include the Sarepta collaboration, plozasiran NDA acceptance, positive pipeline data, and a CFO transition Sarepta Therapeutics Collaboration The Sarepta Therapeutics collaboration involves substantial upfront and potential future payments Sarepta Therapeutics Agreement Financials | Payment Type | Amount | | :--- | :--- | | Upfront Consideration | $825 million ($500M cash, $325M equity) | | Future Payments | $250 million (over five years) | | Near-Term Payments | Up to $300 million | | Potential Milestones | Approximately $10 billion | Plozasiran NDA for Familial Chylomicronemia Syndrome (FCS) FDA accepted plozasiran NDA for FCS, with November 2025 PDUFA date, supported by positive Phase 3 data - The FDA has accepted the New Drug Application (NDA) for plozasiran for the treatment of familial chylomicronemia syndrome (FCS)[3] - The PDUFA action date is set for November 18, 2025, and the FDA is not currently planning to hold an advisory committee meeting[3] - The NDA submission is supported by positive findings from the Phase 3 PALISADE study, which met its primary and all key secondary endpoints, including significant reductions in triglycerides and pancreatitis incidence[3] Pipeline and Preclinical Developments Positive preclinical data for obesity treatments and ARO-C3 Phase 1/2 results for IgA nephropathy were announced - Presented positive preclinical data for two potential obesity treatments, ARO-INHBE and ARO-ALK7, which may preserve lean muscle mass better than current therapies[4] - Announced positive topline results from a Phase 1/2 study of ARO-C3 in patients with IgA nephropathy, showing deep and sustained reductions in complement activity and a 41% mean reduction in proteinuria by week 24[4] Management Changes CFO Ken Myszkowski will retire effective May 13, 2025, and will be succeeded by Daniel Apel - Effective May 13, 2025, CFO Ken Myszkowski will retire after 16 years and be succeeded by Daniel Apel[4] Financial Performance Arrowhead reported Q2 FY2025 net income of $370.4 million from $542.7 million revenue, increasing cash and investments to $1.1 billion Statement of Operations The statement of operations reflects a significant increase in revenue and a turnaround to net income Operating Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $542,709 | $— | | Research and development | $133,102 | $101,122 | | General and administrative | $28,405 | $25,069 | | Operating income (loss) | $381,202 | ($126,191) | | Net income (loss) attributable to Arrowhead | $370,445 | ($125,300) | | Diluted Net income (loss) per share | $2.75 | ($1.02) | Financial Position The company's financial position significantly strengthened, with total cash resources increasing to over $1 billion Financial Position Summary (in thousands) | Metric | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Total cash resources (cash and investments) | $1,097,409 | $680,961 | | Total Assets | $1,573,498 | $1,139,802 | | Total Liabilities | $889,273 | $948,739 | | Total Arrowhead Stockholders' Equity | $683,321 | $185,444 |