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Arrowhead Pharmaceuticals Is Finally Arriving
Seeking Alpha· 2025-03-21 21:56
Group 1 - Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has seen a decline of over 50% since the last coverage a year ago, indicating significant volatility in its stock performance [1] - The company is recognized as a leader in RNAi therapeutics, highlighting its position within the biotechnology sector [1] Group 2 - The Total Pharma Tracker offers tools for DIY investors, including a software that provides extensive curated research material for various stocks [2] - In-house experts are available to assist investors by identifying the best investible stocks along with buy/sell strategies and alerts [2]
Arrowhead Pharmaceuticals: Progress During Adverse Market Conditions
Seeking Alpha· 2025-02-19 16:53
Core Insights - Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported fiscal Q1 2025 results and provided a pipeline update, highlighting the return of zodasiran to clinical trials for treating a rare disease known as HoFH [2] Group 1 - The company has a model portfolio consisting of 15-20 names that are updated regularly, along with a top picks list of up to 10 stocks expected to perform well in the current calendar year [2] - The focus is on attractive risk/reward situations, with trading ideas targeting both short-term and medium-term moves [2]
Arrowhead Pharmaceuticals(ARWR) - 2025 Q1 - Earnings Call Transcript
2025-02-11 02:35
Financial Data and Key Metrics Changes - The net loss for Q1 2025 was $173.1 million, or $1.39 per share, compared to a net loss of $132.9 million, or $1.24 per share, in Q1 2024 [63] - Revenue for Q1 2025 was $2.5 million, down from $3.6 million in Q1 2024, primarily due to changes in collaboration agreements [64] - Total operating expenses increased to $163.9 million in Q1 2025 from $140.1 million in Q1 2024, driven by higher candidate costs and salaries [65] Business Line Data and Key Metrics Changes - The company closed a significant collaboration agreement with Sarepta Therapeutics, which includes a $500 million upfront payment and potential total cash payments exceeding $1.375 billion [2][4] - The deal allows Arrowhead to focus on its cardiometabolic pipeline, particularly in obesity and CNS areas, while reducing R&D expenses as Sarepta assumes clinical development responsibilities [6][7] Market Data and Key Metrics Changes - The FDA accepted the NDA for plozasiran, with a PDUFA action date set for November 18, 2025, marking a significant milestone for the company [27][34] - The company anticipates a commercial launch of plozasiran in the U.S. and potentially in the EU, pending regulatory approvals [70][106] Company Strategy and Development Direction - Arrowhead aims to build a robust cardiometabolic pipeline, focusing on plozasiran, obesity treatments, and CNS programs, with a strategy to partner non-core assets for capital [8][16] - The company is also exploring additional obesity candidates and plans to expand its presence in the cardiometabolic space with new therapies targeting APOC3 and PCSK9 [22][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential driven by plozasiran, obesity programs, and CNS pipeline, with expectations for multiple key events in 2025 [69] - The company believes it is well-positioned for growth through 2028, supported by the recent capital infusion from the Sarepta agreement [8][67] Other Important Information - Arrowhead's cash and investments totaled $552.9 million at the end of Q1 2025, with pro forma cash expected to reach $1.4 billion after accounting for the Sarepta agreement [67] - The company is on track to complete enrollment for several Phase III studies, which could lead to significant milestone payments [39][71] Q&A Session Summary Question: Can you elaborate on the obesity program ARO-INHBE? - The company is studying ARO-INHBE as both a monotherapy and in combination with tirzepatide, with no specific bogey set for data expectations [76][78] Question: What feedback are you receiving from doctors regarding APOC3? - Physicians remain enthusiastic about plozasiran, viewing it as highly differentiating based on its attributes [86][87] Question: What are the plans for plozasiran in Europe? - The company is planning for commercialization in European markets alongside a commercial partner [106] Question: How does plozasiran compare to olozarsen? - Key differentiators for plozasiran include a significant reduction in triglycerides, achieving guideline-directed risk thresholds, and a favorable safety profile with less frequent dosing [110][113] Question: What are the attractive targets for the adipose tissue targeting platform? - The company is evaluating various targets for obesity, type 2 diabetes, and lipodystrophy, with updates expected as they reach clinical stages [111][124]
Arrowhead Pharmaceuticals(ARWR) - 2025 Q1 - Quarterly Results
2025-02-10 21:03
EXHIBIT 99.1 PRESS RELEASE Feb. 10, 2025 Arrowhead Pharmaceuticals Reports Fiscal 2025 First Quarter Results Conference Call and Webcast Today, February 10, 2025 at 4:30 p.m. ET PASADENA, Calif., Feb. 10, 2025 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2025 first quarter ended December 31, 2024. The Company is hosting a conference call today, February 10, 2025, at 4:30 p.m. ET to discuss the results. "During the recent period, Arrowhead signed and close ...
Arrowhead Pharmaceuticals(ARWR) - 2025 Q1 - Quarterly Report
2025-02-10 21:02
Financial Performance - Net loss attributable to Arrowhead Pharmaceuticals, Inc. was $173.1 million for the three months ended December 31, 2024, compared to $132.9 million for the same period in 2023, representing an increase of 30.3%[127] - Total revenue for the three months ended December 31, 2024, was $2.5 million, down from $3.6 million in the same period of 2023, a decrease of 30.6%[135] - Cash flow used in operating activities was $146.3 million for the three months ended December 31, 2024, primarily due to ongoing R&D and general administrative expenses[161] - Cash, cash equivalents, and restricted cash decreased to $53.9 million as of December 31, 2024, down from $102.7 million as of September 30, 2024[158] - The Company believes its current financial resources are sufficient to fund operations for at least the next twelve months[161] Research and Development - Research and development (R&D) expenses totaled $137.0 million for the three months ended December 31, 2024, an increase of 17.6% from $116.5 million in the same period of 2023[142] - Candidate costs within R&D expenses increased by $23.9 million, or 45%, for the three months ended December 31, 2024, primarily due to the progression of the pipeline into clinical trials[142] - R&D salaries increased by $4.6 million, or 20%, for the three months ended December 31, 2024, compared to the same period in 2023, primarily due to increased headcount and annual salary increases[144] - The Company presented interim results from a Phase 1/2a clinical study of ARO-CFB, showing up to 90% reduction in circulating CFB protein with greater than 3 months duration[129] - The Company filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-ALK7, targeting obesity[129] Expenses - General and administrative expenses, excluding non-cash expenses, increased by $6.2 million, or 50%, for the three months ended December 31, 2024, driven by higher salaries and professional services[150] - Professional, outside services, and other expenses surged by $4.9 million, or 94%, for the three months ended December 31, 2024, mainly due to costs associated with commercialization and business development efforts[151] - Facilities-related expenses rose by $1.2 million, or 18%, for the three months ended December 31, 2024, mainly due to property taxes for newly completed facilities in Verona, Wisconsin[145] - Stock compensation expense decreased by $1.5 million, or 16%, for the three months ended December 31, 2024, primarily due to the cancellation of awards upon employee departures[146] - Depreciation and amortization expense increased by $0.9 million, or 23%, for the three months ended December 31, 2024, attributed to the completion of facility build-outs in Verona, Wisconsin[147] - Other expense increased by $11.6 million for the three months ended December 31, 2024, primarily due to non-cash interest expense related to future royalties and the Credit Facility[155] Collaborations and Milestones - A global collaboration agreement with Sarepta Therapeutics, Inc. resulted in an equity investment of $325.0 million and an upfront payment of $500.0 million expected in the second quarter of fiscal 2025[129] - GSK dosed the fifth patient in a Phase 2 trial in December 2024, triggering a $2.5 million milestone payment to the Company[129] - The Company submitted a New Drug Application (NDA) to the FDA on November 16, 2024, with a PDUFA action date set for November 18, 2025[129]
Arrowhead Pharmaceuticals(ARWR) - 2024 Q4 - Earnings Call Transcript
2024-11-27 04:08
Financial Data and Key Metrics Changes - The net loss for fiscal 2024 was $599.5 million or $5 per share, compared to a net loss of $205.3 million or $1.92 per share for 2023 [71] - Revenue in 2024 was $3.6 million, a significant decrease from $240.7 million in 2023, primarily due to no new partnership agreements or major milestones triggered during the year [72] - Total operating expenses for fiscal 2024 were $604.6 million, up from $445.7 million in 2023, with R&D costs being the key driver of this increase [73][74] - Cash and investments totaled $681 million at September 30, 2024, compared to $403.6 million at the same date in 2023, primarily due to a $450 million equity issuance and a $400 million debt facility [76] Business Line Data and Key Metrics Changes - The company is focusing on its cardiometabolic pipeline, with key programs including plozasiran, zodasiran, and ARO-INHBE, which are progressing towards commercialization [22][30] - The partnership with Sarepta includes select clinical candidates and non-clinical programs, which will allow Arrowhead to focus on its core cardiometabolic assets while generating substantial upfront and milestone payments [10][17] Market Data and Key Metrics Changes - The company expects to launch plozasiran for patients with familial chylomicronemia syndrome (FCS) in mid-2025, with potential expansion into the severe hypertriglyceridemia (SHTG) market thereafter [82] - The market for plozasiran is estimated to be significant, with potential annual revenues of $2 billion to $3 billion, particularly in the underserved SHTG population [33] Company Strategy and Development Direction - The company aims to build a focused pipeline around cardiometabolic programs while retaining select early-stage programs for future value creation [84] - The partnership with Sarepta is seen as transformational, providing immediate capital and a clearer path to profitability while allowing Arrowhead to concentrate on its core therapeutic areas [9][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position, stating that it is funded into 2028 and has a robust pipeline that spans early discovery to Phase-3 ready programs [34][81] - The company is optimistic about the potential for plozasiran and other cardiometabolic programs to generate substantial revenue and address significant unmet medical needs [82][84] Other Important Information - The company has decided not to pursue further development of ARO-MUC5AC due to challenges in assessing target engagement, reallocating resources to more promising programs [28] - The collaboration with Sarepta includes a manufacturing component that will utilize Arrowhead's new Verona manufacturing plant, enhancing operational efficiency [25] Q&A Session Summary Question: Future of Arrowhead CNS franchise and plans for zodasiran - Management is excited about the subcutaneous CNS platform and is considering potential partnerships for non-core CNS assets while retaining key programs [86][88] - Regarding zodasiran, there is a protocol ready for a Phase-3 study to support HoFH, with ongoing exploration of other opportunities for the asset [89] Question: Reaction to Eli Lilly discontinuing their siRNA for APOC3 and competitiveness of the Sarepta deal - Management noted that while the reasons for Lilly's decision are unclear, plozasiran is a strong drug that may have set a high bar [94] - The Sarepta deal was competitive, with discussions ongoing with other companies, but this partnership was deemed the most beneficial [95] Question: Plans for paying down debt and R&D savings - Debt will be paid down through cash inflows from the Sarepta deal and other potential partnerships, with ongoing R&D costs expected to remain stable over the next two years [100] Question: Importance of obesity programs and Phase-1 study designs - The obesity programs ARO-INHBE and ARO-ALK7 are strategically important, with plans for placebo-controlled Phase-1 studies to assess safety and early efficacy [102][103]
Arrowhead Pharmaceuticals(ARWR) - 2024 Q4 - Annual Results
2024-11-26 21:19
Financial Performance - Arrowhead Pharmaceuticals reported a revenue of $3.551 million for the fiscal year ended September 30, 2024, a significant decrease from $240.735 million in the previous year, representing a decline of approximately 98.5%[11] - The company incurred a net loss attributable to Arrowhead Pharmaceuticals of $599.493 million, compared to a net loss of $205.275 million in the prior year, indicating an increase in losses of about 192%[11] - Arrowhead's total cash resources increased to $680.961 million in 2024, up from $403.626 million in 2023, reflecting a growth of approximately 68.7%[11] Collaborations and Agreements - Arrowhead strengthened its balance sheet through a licensing and collaboration agreement with Sarepta Therapeutics, which will provide $825 million, including $500 million in cash and $325 million as an equity investment[3] - Arrowhead is eligible to receive approximately $10 billion in potential milestone payments from the collaboration with Sarepta Therapeutics, in addition to royalties on commercial sales[3] Product Development - The company submitted its first New Drug Application (NDA) to the U.S. FDA for investigational plozasiran, aiming for a potential commercial launch in 2025, pending FDA approval[4] - Plozasiran demonstrated mean reductions in triglycerides of up to 73% in patients from the MUIR study and 86% in patients from the SHASTA-2 study, with favorable reductions in remnant cholesterol and non-HDL cholesterol[5] - The company initiated pivotal Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in patients with severe hypertriglyceridemia[6] Manufacturing and Operations - Arrowhead's manufacturing facility in Verona, WI, successfully completed requirements to manufacture GMP drug substance, enabling support for clinical trials in the U.S. and abroad[7] Community Engagement - The company launched a new disease awareness campaign, 'We'll Get There Soon,' aimed at the rare disease community affected by familial chylomicronemia syndrome[7]
Arrowhead Pharmaceuticals(ARWR) - 2024 Q4 - Annual Report
2024-11-26 21:18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________________________ FORM 10-K __________________________________________________________________ (Mark One) x ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2024 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38042 _________ ...
Arrowhead Pharmaceuticals Stock Climbs on Plans To Seek FDA Approval for New Drug
Investopedia· 2024-09-03 15:01
Core Insights - Arrowhead Pharmaceuticals reported that its Phase-3 study for Plozasiran, a treatment for familial chylomicronemia syndrome (FCS), met all primary and key secondary endpoints [1] - The company plans to file a new drug application with the FDA by the end of the year and will also seek approval from other countries [1] - Following the announcement of positive trial results, Arrowhead's shares increased by approximately 2%, although they have lost over 20% of their value since the beginning of the year [1] Company Developments - Plozasiran is aimed at treating FCS, a rare genetic disorder with no currently approved treatments available [1] - Arrowhead's Chief Medical Scientist, Dr. Bruce Given, described Plozasiran as "potentially best-in-class" and supportive of development across various triglyceride disorders [1] Market Reaction - Arrowhead Pharmaceuticals' stock (ARWR) experienced a 2% increase in early trading following the positive trial results [1] - Despite the recent gains, the stock has seen a significant decline of over 20% year-to-date [1]
Arrowhead Pharmaceuticals, Inc. (ARWR) 2024 Summer Series R&D Webinar: Obesity/Metabolic - ARO-INHBE Conference (Transcript)
Seeking Alpha· 2024-08-14 22:59
Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) 2024 Summer Series R&D Webinar: Obesity/Metabolic - ARO-INHBE Conference August 14, 2024 2:00 PM ET Company Participants Vincent Anzalone - Vice President and Head of Investor Relations Dr. Carel Le Roux - Chair of Metabolic Medicine, University College Dublin Erik Bush - Senior Vice President, Biology Tao Pei - Senior Vice President, Discovery Chemistry James Hamilton - SVP, Discovery and Translational Medicine Operator Good afternoon, and welcome to the Arrowh ...