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Arrowhead Pharmaceuticals(ARWR) - 2026 Q1 - Earnings Call Transcript
2026-02-05 22:32
Financial Data and Key Metrics Changes - The company reported a net income of $30.8 million for Q1 2026, translating to an income of $0.22 per share, a significant improvement from a net loss of $173.1 million or a loss of $1.39 per share in Q1 2025 [31] - Revenue for the quarter totaled $264 million, primarily driven by licensing collaborations with Sarepta and Novartis, with approximately $229 million from the Sarepta collaboration [31][32] - Total operating expenses increased to approximately $223 million from $164 million in the prior year, driven by higher R&D and SG&A expenses [33] Business Line Data and Key Metrics Changes - The company launched its first commercial product, REDEMPLO, which received FDA approval on November 18, 2025, and has seen over 100 prescriptions within the first 10 weeks of launch [5][7][20] - REDEMPLO is positioned as a treatment for familial chylomicronemia syndrome (FCS), with a median triglyceride reduction of 80% from baseline observed in clinical studies [6][22] - The cardiometabolic pipeline includes ongoing studies for zodasiran in homozygous familial hypercholesterolemia and several obesity treatment candidates, with promising early data reported for ARO-INHBE [8][9][29] Market Data and Key Metrics Changes - The company anticipates launching REDEMPLO in Canada and select EU countries later in 2026, with marketing in Greater China to be handled by Sanofi [8] - The U.S. market for mixed hyperlipidemia is estimated to include approximately 20 million people, with a focus on high-risk patients for REDEMPLO [11][12] Company Strategy and Development Direction - The company is committed to sustainable innovation and rational drug pricing, emphasizing the value of medicines to patients and healthcare systems [7] - Future strategic priorities include advancing the cardiometabolic and CNS pipelines, with a focus on addressing obesity, cardiovascular disease, and neurodegenerative conditions [15][13] - The company has strengthened its balance sheet with $1.33 billion in gross proceeds from various transactions, enabling multiple program advancements [17][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to build on recent achievements and highlighted the potential for significant growth in 2026 and beyond [5][37] - The company expects key events in 2026, including commercial sales progress for REDEMPLO and readouts from phase III studies for plozasiran, which could represent a $3 billion-$4 billion opportunity [37] Other Important Information - The company has received breakthrough therapy designation for plozasiran, expediting its development for severe hypertriglyceridemia [25] - The proprietary TRiM platform is being utilized to enhance delivery systems for CNS-targeted therapies, with ARO-MAPT and SRP-1005 as key programs [13][14] Q&A Session Summary Question: Can you provide a breakdown of patient categories for REDEMPLO? - The majority of patients are from the APOC3 naive segment, with the remainder split evenly between switch patients and those transitioning from the expanded access program [41][42] Question: What are the expectations for the obesity development path? - Discussions with the FDA are anticipated around mid-year, and not all data from cohorts are required before determining next steps [44] Question: What level of reduction in LDL-C and triglycerides is expected for ARO-DimerPA? - A reduction of around 40%-50% in both LDL and triglycerides would be encouraging for advancing the asset [47] Question: How is pricing being considered for ARO-INHBE and ARO-ALK7? - It is too early to speculate on pricing as the biology of the drug candidates is still being understood [50] Question: What are the expectations for pancreatitis event rates in ongoing trials? - Specific details on event rates are not being disclosed, but events are being observed [53] Question: How is payer feedback for REDEMPLO shaping up? - Positive feedback has been received, with discussions focused on ensuring coverage for high-risk patients [56][59]
Arbutus Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-13 12:30
Core Insights - Arbutus Biopharma Corporation reported a strong financial position with cash, cash equivalents, and marketable securities totaling $93.7 million as of September 30, 2025, down from $122.6 million at the end of 2024 [7][15] - The company is focused on the development of imdusiran (AB-729) for chronic hepatitis B virus (cHBV) infection, with promising clinical trial results indicating that 46% of Phase 2a patients were able to discontinue all treatment [2][13] - Ongoing litigation against Moderna and Pfizer/BioNTech regarding the use of Arbutus's patented LNP technology is a significant aspect of the company's corporate strategy, with a jury trial scheduled for March 2026 [6][21] Financial Results - Total revenue for Q3 2025 was $0.5 million, a decrease from $1.3 million in Q3 2024, primarily due to reduced license royalty revenues [8][14] - Research and development expenses decreased to $5.8 million in Q3 2025 from $14.3 million in Q3 2024, reflecting cost-saving measures [9][14] - The net loss for Q3 2025 was $7.7 million, or $0.04 per share, compared to a net loss of $19.7 million, or $0.10 per share, in Q3 2024 [11][14] Clinical Development - Imdusiran has shown sustained benefits in chronic hepatitis B patients, with 94% of long-term follow-up patients remaining off all treatment for over two years [2][5] - In Phase 1b trials, 100% of HBV DNA positive patients achieved HBV DNA levels below quantification after 18 weeks of treatment with imdusiran and nucleos(t)ide analogue therapy [5][13] - The company is dedicated to accelerating the development and potential approval of imdusiran, which targets all hepatitis B viral proteins and antigens [18][21] Corporate Updates - The company is actively consulting with Genevant Sciences to protect its intellectual property amid ongoing lawsuits [6][21] - A favorable claim construction ruling was issued in the Pfizer-BioNTech litigation in September 2025, which the company views positively [6] - Arbutus showcased data from its hepatitis B virus programs at AASLD 2025, highlighting beneficial clinical outcomes across all evaluated HBV genotypes [6]
Arbutus Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-06 11:30
Core Insights - Arbutus Biopharma Corporation reported a strong second quarter in 2025, with total revenue of $10.7 million, significantly up from $1.7 million in the same period in 2024, primarily due to the recognition of previously-deferred revenue following the conclusion of its partnership with Qilu Pharmaceutical [8][11] - The company has strengthened its leadership team by appointing Dr. Roger Sawhney to the Board of Directors and Dr. Harry Janssen to the Scientific Advisory Board, enhancing its expertise in chronic hepatitis B virus (cHBV) programs [2][6] - Arbutus maintains a solid financial position with cash, cash equivalents, and marketable securities totaling $98.1 million as of June 30, 2025, although this is a decrease from $122.6 million at the end of 2024 [7][15] Financial Performance - Total revenue for Q2 2025 was $10.7 million, a $9.0 million increase compared to Q2 2024, attributed to the conclusion of the partnership with Qilu and the recognition of deferred revenue [8][11] - Research and development expenses decreased to $5.5 million in Q2 2025 from $15.6 million in Q2 2024, reflecting cost-saving measures implemented by the company [9] - General and administrative expenses also saw a reduction, falling to $3.3 million in Q2 2025 from $7.5 million in Q2 2024, due to cost-cutting efforts [10] Corporate Developments - The company concluded its strategic partnership with Qilu Pharmaceutical for the development and commercialization of imdusiran in Greater China, regaining global rights for the compound [5][6] - Dr. Harry Janssen's appointment to the Scientific Advisory Board is expected to enhance the company's clinical development efforts in cHBV [2][6] - Anuj Hasija resigned from the Board of Directors to focus on a new role at Vertex Pharmaceuticals, and Dr. Roger Sawhney has been appointed to fill the vacancy [2][6] Legal and Intellectual Property - Arbutus is actively involved in litigation to protect its intellectual property related to its patented LNP technology, with ongoing lawsuits against Moderna and Pfizer/BioNTech [5] - The summary judgment phase of the litigation against Moderna began in July 2025, with a jury trial scheduled for March 2026 [5]