Latest news with #ChristopherAnzalone
Business Wire
3 days ago
- Business
- Business Wire
Arrowhead Pharmaceuticals Redeems Approximately $50 Million of Arrowhead Stock and Will Receive Approximately $50 Million in Cash in Satisfaction of Milestone from Sarepta Therapeutics
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has elected to receive approximately $50 million worth of Arrowhead common stock and approximately $50 million in cash from Sarepta Therapeutics, satisfying the payment of a $100 million milestone owed to Arrowhead. This agreement pertains only to the $100 million milestone, which was announced on July 28, 2025, and earned after Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1). Any subsequent milestones earned will continue to be payable in cash. Sarepta previously owned 11,926,301 shares of Arrowhead stock. Today after market close, Sarepta sold the balance of its remaining holdings of Arrowhead common stock in a separate negotiated block trade. With a strong balance sheet anticipated to fund our company into fiscal 2028, we believe this direct stock buyback of Arrowhead shares from Sarepta is an attractive option, given Arrowhead's current stock price and the significant growth potential Share 'We are committed to supporting our broad and long-term collaboration and we are thrilled with the great progress we've made on multiple important clinical, preclinical, and discovery stage siRNA programs. While we remain confident that Sarepta will meet its financial obligations to Arrowhead, we believe reducing our outstanding shares by receiving approximately half of the $100 million due from Sarepta in cash and half in Arrowhead stock to be returned to treasury is a compelling opportunity,' said Christopher Anzalone, Ph.D., Arrowhead's President and CEO. 'With a strong balance sheet anticipated to fund our company into fiscal 2028, we believe this direct stock buyback of Arrowhead shares from Sarepta is an attractive option, given Arrowhead's current stock price and the significant growth potential, both near- and longer-term, as we pursue multiple commercial launches of wholly-owned and partnered candidates in the coming quarters and years.' About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Arrowhead Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as 'may,' 'will,' 'expect,' 'believe,' 'anticipate,' 'hope,' 'intend,' 'plan,' 'project,' 'could,' 'estimate,' 'continue,' 'target,' 'forecast' or 'continue' or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, including the timing of achievement of future milestones, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements, including our ability to achieve such milestones on projected timelines (if at all) and receive timely payment if milestones are achieved; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties; and our estimates for our projected cash runway. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We disclaim any intention to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc.
Yahoo
08-08-2025
- Business
- Yahoo
Arrowhead Pharmaceuticals Reports Fiscal 2025 Third Quarter Results
- Conference Call and Webcast Today, August 7, 2025, at 4:30 p.m. ET PASADENA, Calif., August 07, 2025--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2025 third quarter ended June 30, 2025. The Company is hosting a conference call today, August 7, 2025, at 4:30 p.m. ET to discuss the results. "Arrowhead continues to achieve strong execution in discovery, clinical and regulatory, and business development. Our pipeline has become quite mature, with four Arrowhead discovered candidates currently in pivotal Phase 3 studies. In addition, our commercial buildout is designed to make us launch ready on day one, should plozasiran receive regulatory approval on the November 18, 2025, PDUFA date," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. "We continue to maintain a strong balance sheet, which we believe gives us the financial resources to move multiple innovative new medicines through the clinical and regulatory process and ultimately get them to the patients who need them." Selected Recent Events Announced the signing of an asset purchase agreement between Sanofi and Visirna Therapeutics, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead's investigational cardiometabolic candidates in Greater China. Summary terms of the agreement include: Visirna will receive an upfront payment of $130 million from Sanofi. In addition, Visirna will be eligible to receive further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China. Sanofi will receive an exclusive license to develop and commercialize investigational plozasiran in Greater China from Visirna Therapeutics, offering potential treatment to people living with elevated triglycerides. Earned a $100 million milestone payment from Sarepta Therapeutics when Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta. Completed enrollment in investigational plozasiran clinical studies SHASTA-3, SHASTA-4, and MUIR-3, the company's global Phase 3 clinical studies designed to support regulatory submissions for marketing approval in the treatment of severe hypertriglyceridemia. Arrowhead anticipates completing the primary portion of these studies in mid-2026 with topline data expected shortly thereafter and planned submissions for regulatory review and potential approval to follow. The company previously submitted a New Drug Application (NDA) for plozasiran based on positive Phase 3 PALISADE study results in patients with familial chylomicronemia syndrome, which the U.S. FDA has accepted with a Prescription Drug User Fee Act (PDUFA) action date set for November 18, 2025. Dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company's investigational RNAi therapeutic being developed as a potential treatment for homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that leads to severely elevated LDL-cholesterol and early onset cardiovascular disease. Zodasiran is the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage pivotal studies, after investigational drugs plozasiran, fazirsiran (licensed to Takeda) and olpasiran (licensed to Amgen). Dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, the company's investigational RNAi therapeutic being developed as a potential treatment for obesity. ARO-ALK7 is designed to intervene in a known pathway that signals the body to store fat in adipose tissue with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies. The study initiates in otherwise healthy obese subjects using single and multiple escalating doses of ARO-ALK7 monotherapy and is expected to progress rapidly to investigate combinations of ARO-ALK7 with tirzepatide in obese patients with and without type 2 diabetes. Selected Fiscal 2025 Third Quarter Financial Results ARROWHEAD PHARMACEUTICALS, INC. CONSOLIDATED CONDENSED FINANCIAL INFORMATION (in thousands, except per share amounts) Three Months Ended June 30, OPERATING SUMMARY 2025 2024 (Unaudited) Revenue $ 27,767 $ — Operating Expenses: Research and development 162,368 152,431 General and administrative expenses 30,949 23,710 Total operating expenses 193,317 176,141 Operating loss (165,550 ) (176,141 ) Total other (expense) income (13,539 ) 2,164 Loss before income tax expense and noncontrolling interest (179,089 ) (173,977 ) Income tax (benefit) expense (437 ) — Net loss including noncontrolling interest (178,652 ) (173,977 ) Net loss attributable to noncontrolling interest, net of tax (3,411 ) (3,184 ) Net loss attributable to Arrowhead Pharmaceuticals, Inc. $ (175,241 ) $ (170,793 ) Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted $ (1.26 ) $ (1.38 ) Weighted-average shares used in calculating - Diluted 139,039 124,199 FINANCIAL POSITION SUMMARY June 30, 2025 September 30, 2024 (unaudited) Cash, cash equivalents and restricted cash $ 129,793 $ 102,685 Available-for-sale securities, at fair value 770,579 578,276 Total cash resources (Cash, cash equivalents and restricted cash and Available-for-sale securities, at fair value) 900,372 680,961 Other current and long-term assets 480,240 458,841 Total Assets $ 1,380,612 $ 1,139,802 Liability related to the sale of future royalties $ 360,254 $ 341,361 Credit Facility 240,332 393,183 Deferred revenue 22,979 — Other liabilities 237,241 214,195 Total Liabilities $ 860,806 $ 948,739 Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity 522,313 185,444 Noncontrolling Interest (2,507 ) 5,619 Total Noncontrolling Interest and Stockholders' Equity $ 519,806 $ 191,063 Total Liabilities, Noncontrolling Interest and Stockholders' Equity $ 1,380,612 $ 1,139,802 Shares Outstanding 138,144 124,376 Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate," "continue," "target," "forecast" or "continue" or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, including the timing of achievement of the next ARO-DM1 milestone, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements, including our ability to achieve such milestones on projected timelines (if at all) and receive timely payment if milestones are achieved; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We disclaim any intention to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on Contacts Arrowhead Pharmaceuticals, Anzalone, CFA626-304-3400ir@ Investors: LifeSci Advisors, LLCBrian Ritchie212-915-2578britchie@ Media: LifeSci Communications, LLCKendy Guarinoni, Ph.D.724-910-9389kguarinoni@
Business Wire
01-08-2025
- Business
- Business Wire
Arrowhead Subsidiary Visirna Sells Rights to Hypertriglyceridemia Candidate Plozasiran in Greater China to Sanofi
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced the signing of an asset purchase agreement between Sanofi and Visirna Therapeutics, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead's investigational cardiometabolic candidates in Greater China. Under the terms, Sanofi will acquire rights to develop and commercialize investigational plozasiran, Arrowhead's first-in-class RNA interference (RNAi) therapeutic candidate designed to reduce production of apolipoprotein C-III (APOC3) as a potential treatment for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG), in Greater China. Sanofi to pay $130 million upfront and up to $265 million in potential regulatory milestones to Visirna Therapeutics, a majority-owned subsidiary of Arrowhead, which was previously granted rights to investigational plozasiran in Greater China Share Visirna has completed a Phase 3 clinical trial (CTR20231418/NCT05902598) of investigational plozasiran in Chinese patients with familial chylomicronemia syndrome (FCS), which successfully met its primary efficacy endpoint and all key secondary endpoints. Visirna subsequently submitted a New Drug Application (NDA) for plozasiran to the National Medical Products Administration (NMPA) in China for the treatment of FCS and received official acceptance in January 2025. Plozasiran has also been granted Breakthrough Therapy Designation in the treatment of patients with FCS and Priority Review Designation by the China NMPA. 'When we founded Visirna in 2022, we believed that Greater China represented an important potential future market for multiple programs in Arrowhead's pipeline of investigational RNAi-based candidates for cardiometabolic diseases,' said Christopher Anzalone, Ph.D., Arrowhead's President and CEO. 'The team at Visirna understand the intricacies of China's clinical, regulatory, and commercial environment and have done impressive work moving plozasiran through clinical studies and into the regulatory submission and review process. We now look forward to working with Sanofi and believe they are extremely well positioned as a global company with a strong presence in China.' Wayne Shi, President, Sanofi Greater China, added, 'We are pleased to have concluded this agreement to enable us to advance plozasiran in Greater China where Sanofi has deep roots and a proud heritage of serving people living with a wide range of diseases. Plozasiran has shown considerable potential in studies across diverse patient populations where serious illness is caused by elevated triglycerides. With our strong presence in China's cardiometabolic field, we now look forward to bringing it forward to address unmet need.' Upon closing of the Asset Purchase Agreement, Visirna will receive an upfront payment of $130 million from Sanofi. In addition, Visirna will be eligible to receive further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China. Arrowhead is further eligible to receive royalties on net commercial product sales in Greater China as part of the Arrowhead-Visirna license which was assigned in part to Sanofi. Gibson, Dunn & Crutcher LLP and Sidley Austin LLP are serving as legal advisors to Arrowhead. About Plozasiran Plozasiran, previously called ARO-APOC3, is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (APOC3) which is a component of triglyceride rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. APOC3 increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by receptors in the liver. The goal of treatment with plozasiran is to reduce the level of APOC3, thereby reducing triglycerides and restoring lipids to more normal levels. In multiple clinical studies, investigational plozasiran has demonstrated reductions in triglycerides and multiple atherogenic lipoproteins in patients with familial chylomicronemia syndrome (FCS), severe hypertriglyceridemia (SHTG), and mixed hyperlipidemia. Plozasiran has been generally well tolerated to date with treatment emergent adverse events reported that generally reflect the comorbidities and underlying conditions of the study populations. Across clinical studies and study populations, the most frequently reported treatment emergent adverse events for the 25 mg dose that is proposed for marketing approval were COVID-19, upper respiratory tract infection, headache, Type 2 diabetes mellitus, and abdominal pain. Plozasiran is being investigated in the SUMMIT program of clinical studies, which includes the PALISADE Phase 3 study in patients with FCS, the SHASTA Phase 2 and Phase 3 studies in patients with SHTG, and the MUIR Phase 2 and Phase 3 studies in patients with mixed hyperlipidemia. Plozasiran in the treatment of patients with FCS has been granted Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation by the U.S. Food and Drug Administration and Orphan Medicinal Product Designation by the European Medicines Agency. Investigational plozasiran has been submitted for marketing authorization in treatment of FCS to multiple global regulatory authorities but has not been reviewed or approved to treat any disease. About Visirna Therapeutics Visirna Therapeutics was founded in 2022 as a majority owned subsidiary of Arrowhead Pharmaceuticals. Headquartered in China with a global perspective, Visirna strives to emerge as a frontrunner in the advancement of siRNA therapeutics. The existing product portfolio comprises clinical stage siRNA candidates with a focus on cardiovascular/metabolic, and auto-immune ailments. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as 'may,' 'will,' 'expect,' 'believe,' 'anticipate,' 'hope,' 'intend,' 'plan,' 'project,' 'could,' 'estimate,' 'continue,' 'target,' 'forecast' or 'continue' or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc.
Business Wire
12-05-2025
- Business
- Business Wire
Arrowhead Pharmaceuticals Reports Fiscal 2025 Second Quarter Results
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2025 second quarter ended March 31, 2025. The Company is hosting a conference call today, May 12, 2025, at 4:30 p.m. ET to discuss the results. Arrowhead is in a strong and stable position as a business, and we have made meaningful progress towards our long-term goal of developing and ultimately commercializing new innovative medicines for millions of patients. Share 'Arrowhead is in a strong and stable position as a business, and we have made meaningful progress towards our long-term goal of developing and ultimately commercializing new innovative medicines for millions of patients. We are on schedule to launch plozasiran this year, pending regulatory approval, with what we think is a best-in-class profile with meaningful differentiation from currently available therapies in FCS. We are also well on our way to fully enrolling Phase 3 studies designed to support regulatory submissions for the large SHTG patient population,' said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. 'Following the closing last quarter of the agreement with Sarepta Therapeutics, Arrowhead is now funded into 2028 with no current needs for further cash infusions from an equity raise or other sources. During that period, we see the potential for multiple commercial launches of both wholly owned programs that we intend to launch independently, and programs being developed and commercialized by partners. In addition, we believe our TRiM TM technology platform is the broadest and best in the field, giving us many opportunities to receive additional capital inflows from business development in areas that are outside of our core commercial focus.' Selected Recent Events Closed a licensing and collaboration agreement with Sarepta Therapeutics and received $825 million, consisting of $500 million cash and $325 million as an equity investment priced at $27.25, representing a 35% premium to the 30-day volume weighted average price. Arrowhead will also receive $250 million to be paid over five years. Arrowhead is also eligible to receive an additional $300 million in near-term payments, royalties on commercial sales, and approximately $10 billion in potential milestone payments. Announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease. The clinical basis of the NDA submission is comprised of the positive findings from the Phase 3 PALISADE study with supportive confirmatory evidence from the Phase 2 clinical studies of the SUMMIT program. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides, apolipoprotein C-III, and the incidence of acute pancreatitis. The FDA provided a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025, and indicated it is not currently planning to hold an advisory committee meeting. Launched new patient-centric resources for those affected by FCS. New Patient Resource Hub: Arrowhead expands its We'll Get There Soon campaign with the launch of a dedicated patient website, providing education, tools, and support for those living with FCS and extremely high triglycerides. Amplifying Patient Voices: The Spotlight on FCS white paper shares real patient experiences, highlighting the challenges of managing this ultra-rare disease and the need for greater awareness. Commitment to the FCS Community: On Rare Disease Day and beyond, Arrowhead remains dedicated to elevating patient voices and fostering community engagement. #ForFCS. Presented preclinical data supporting the advancement of two first-in-class clinical stage, RNAi-based investigational therapeutics being developed for the treatment of obesity and metabolic diseases. ARO-INHBE and ARO-ALK7 both target a known pathway that signals the body to store fat in adipose tissue with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies. Data highlight Arrowhead's leadership in the use of RNA interference to potentially treat obesity. Announced topline results from Part 2 of a Phase 1/2 Study of ARO-C3 in patients with IgA nephropathy ARO-C3 achieved deep and sustained reductions in alternative pathway complement activity and proteinuria Mean sustained reductions in C3 of greater than 87%, AH50 of greater than 76%, and Wieslab AP of greater than 89% through week 24 Mean reduction in spot urine protein-to-creatinine ratio (UPCR) of 41% by week 24 Announced that, effective May 13, 2025, Arrowhead's Chief Financial Officer, Ken Myszkowski, will retire after 16 years of service to the company and will be succeeded by Daniel Apel, who has been appointed as the company's new Chief Financial Officer. Selected Fiscal 2025 Second Quarter Financial Results Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as 'may,' 'will,' 'expect,' 'believe,' 'anticipate,' 'hope,' 'intend,' 'plan,' 'project,' 'could,' 'estimate,' 'continue,' 'target,' 'forecast' or 'continue' or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc.
Yahoo
11-02-2025
- Business
- Yahoo
Arrowhead Pharmaceuticals Inc (ARWR) Q1 2025 Earnings Call Highlights: Strategic Collaborations ...
Net Loss: $173.1 million or $1.39 per share for the quarter ended December 31, 2024. Revenue: $2.5 million for the quarter ended December 31, 2024. Total Operating Expenses: $163.9 million for the quarter ended December 31, 2024. Cash and Investments: $552.9 million at December 31, 2024; pro forma cash and investments would be $1.4 billion including Sarepta payments. Cash Used by Operating Activities: $146.3 million for the quarter ended December 31, 2024. Common Shares Outstanding: 125.6 million at December 31, 2024. Warning! GuruFocus has detected 5 Warning Signs with ARWR. Release Date: February 10, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) closed a significant license and collaboration agreement with Sarepta Therapeutics, expected to bring in $1.375 billion in cash payments. The company is now funded into 2028, with potential for multiple commercial launches by Arrowhead and its partners. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) anticipates its first commercial launch of plozasiran, which could drive substantial growth pending FDA approval. The company is focusing on three primary value drivers: plozasiran, obesity, and CNS, which are expected to fuel growth in the near term. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) has a robust potential catalyst calendar for 2025, with multiple key events expected throughout the year. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) reported a net loss of $173.1 million for the quarter ended December 31, 2024, compared to a net loss of $132.9 million in the previous year. Revenue for the quarter was $2.5 million, down from $3.6 million in the same quarter of the previous year. The company experienced increased operating expenses, primarily due to higher candidate costs and salaries as its pipeline of clinical candidates advanced. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) needs additional capital to start a cardiovascular outcomes trial (CVOT) for plozasiran, despite having a significant cash balance. The company faces challenges in expanding the market for its products, as the industry requires education and awareness to address largely untreated diseases. Q: Can you discuss the potential of ARO-INHBE in obesity treatment and its role as a standalone or combination therapy? A: James Hamilton, Chief of Discovery and Translational Medicine, explained that ARO-INHBE is being studied both as a monotherapy and in combination with tirzepatide. The development path will depend on the data outcomes, and there is no specific target to hit at this stage. The obesity market is diverse, and Arrowhead is developing a suite of drug candidates to address various needs. Q: What feedback have you received from doctors regarding APOC3 and current commercial launches? A: Christopher Anzalone, President and CEO, noted that feedback on plozasiran has been positive, with physicians and patient societies expressing enthusiasm due to its differentiating attributes, despite other available options. Q: Will the Phase I/IIa trial for ARO-INHBE and ARO-ALK7 provide weight loss or body composition data? A: James Hamilton confirmed that the trial will assess body composition using full-body MRI and weight loss, alongside safety, plasma PK, and biomarker activity in the blood. Q: Can you provide more details on the SHASTA-5 study and its potential impact on pancreatitis outcomes? A: The SHASTA-5 study is the first of its kind focusing on pancreatitis as the primary endpoint. Enrollment timelines are uncertain, and the study will continue until the required number of events are observed. It is expected to be significant for payers and health technology assessment organizations, particularly outside the US. Q: What are Arrowhead's plans for plozasiran's commercialization in Europe? A: Andy Davis, Senior Vice President, Cardiovascular/Metabolic Franchise Head, stated that Arrowhead plans to commercialize plozasiran in European markets with a commercial partner, with more details to be provided in the future. Q: How does Arrowhead view plozasiran's competitive positioning relative to olozarsen in FCS and severe hypertriglyceridemia? A: Andy Davis highlighted plozasiran's unprecedented triglyceride reduction, ability to achieve guideline-directed risk thresholds, and statistically significant reduction in acute pancreatitis risk as key differentiators. Bruce Given added that the market is more about expansion and education rather than direct competition. Q: What is the strategy for the CVOT study for plozasiran, and what are the gating factors for its initiation? A: Christopher Anzalone stated that the CVOT study is contingent on securing additional capital. The study is scientifically important to assess residual cardiovascular risk related to triglycerides, and Arrowhead is exploring partnerships to fund it. Q: What are the plans for zodasiran in HoFH, and how does it compare to existing treatments? A: Bruce Given explained that zodasiran targets the same patient population as existing treatments but offers quarterly dosing and potentially fewer allergic reactions. The focus is on patients with high LDL cholesterol despite high-dose statins and PCSK9 inhibitors. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
