Latest news with #plozasiran
Yahoo
13-05-2025
- Business
- Yahoo
Arrowhead Pharmaceuticals Inc (ARWR) Q2 2025 Earnings Call Highlights: Strong Financials and ...
Net Income: $370.4 million or $2.75 per share for the quarter ended March 31, 2025. Revenue: $542.7 million for the quarter ended March 31, 2025. Operating Expenses: $161.5 million for the quarter ended March 31, 2025. Cash and Investments: $1.1 billion as of March 31, 2025. Common Shares Outstanding: 138.1 million as of March 31, 2025. Cash Flow from Operating Activities: $460.1 million provided during the quarter ended March 31, 2025. Sarepta Agreement Revenue Recognition: $542.7 million recognized during the quarter ended March 31, 2025. Future Revenue Guidance: $90 million to $125 million expected over the next 12 months from initial fixed contract revenue. Warning! GuruFocus has detected 5 Warning Signs with ARWR. Release Date: May 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) is on track to launch its first commercial product, plozasiran, this year, pending regulatory approval. The company has a strong financial position, with $1.1 billion in cash and investments, and is funded into 2028. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) has a robust pipeline with multiple Phase III studies and potential launches in the coming years. The company has secured a significant partnership with Sarepta Therapeutics, bringing in $500 million upfront and additional potential milestones. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) is making progress in expanding its RNAi technology to new areas, including CNS and obesity treatments. The biotech market remains uncertain, which could impact future funding and partnerships. Regulatory approval for plozasiran is still pending, with a PDUFA date set for November 18, 2025. There is competition in the triglyceride-lowering market, which could impact the commercial success of plozasiran. The company faces challenges in patient identification and market education for its rare disease treatments. Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) has not yet finalized its commercialization strategy for plozasiran outside the U.S., which could delay international market entry. Q: For INHIBNY and ALK7, how are you setting expectations for initial monotherapy and potential combo data, including changes on weight loss, body composition, and relevant biomarkers? A: James Hamilton, Chief of Discovery and Translational Medicine, stated that they are not providing guidance on expectations as this is a first-in-human study. The animal data were compelling, showing good weight loss both as a monotherapy and in combination with tirzepatide. They are particularly interested in the quality of weight loss, such as the loss of visceral fat and retention of lean muscle mass, which was observed in animal models. Initial data is expected towards the end of the year. Q: Ahead of the plozasiran FDA review decision, how do you think about the robustness of your pancreatitis data and potential label differentiation? A: Bruce Given, Chief Operating Officer and Head of Research and Development, mentioned that they haven't had labeling negotiations with the FDA yet. They are confident in their data, which focused on confirmed pancreatitis using the AtLAA criteria, unlike Ionis, which included possible and probable cases. The focus is on achieving low triglyceride levels, which correlates with reduced pancreatitis risk. Q: For plozasiran in SHTG, what is the expected baseline rate of acute pancreatitis in your population for SHASTA-3 and 4, and what magnitude of effect do you expect to show? A: Christopher Anzalone, President and CEO, explained that they expect to replicate Phase II results, with mean triglycerides around 850 to 900 and a placebo-adjusted change of 53% reduction. For the pancreatitis study, the baseline might be closer to the PALISADE study, around 2,000, as patients with a history of pancreatitis are more susceptible even at lower triglyceride levels. Q: How are you thinking about advancing both ARO-ALK7 and ARO-INHBE through clinical development, and do you have interest or capacity to advance both? A: James Hamilton stated that both programs are being advanced through Phase I to assess safety, PD, and efficacy data. ARO-INHBE uses the well-vetted GalNAc technology, while ARO-ALK7 uses a new platform. They plan to choose one to move forward after reviewing the data, with potential for partnership opportunities. Q: How are you thinking about commercialization of plozasiran ex-U.S.? Are you planning to do that by yourself or looking for a partner? A: Christopher Anzalone mentioned that they are preparing for commercialization in Europe and are open to finding partners. They believe the European markets, particularly the large four European markets and the U.K., are well-suited for commercialization of a rare disease like FCS, with limited infrastructure and resources needed to reach centers of excellence. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
15-04-2025
- Business
- Yahoo
Arrowhead Pharmaceuticals Appoints Daniel Apel as Chief Financial Officer
PASADENA, Calif., April 15, 2025--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today 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. Mr. Myszkowski will continue to serve as an employee adviser to assist and facilitate an effective transition. "Ken has been a valuable member of the Arrowhead team, and he retires at a time of great financial strength for the company. The finance organization that Ken built over the years is very capable and provides strong support to our ambitious development and commercialization plans. I want to thank him for all his important contributions to Arrowhead," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. "I am also excited for Dan Apel to join Arrowhead as we make the transition from development stage to commercial stage, with the planned launch of plozasiran this year, pending regulatory review and approval. Dan is an accomplished pharmaceutical executive who can make an immediate and important impact on our business." Mr. Apel joins the company from Walgreens Boots Alliance, where he served as Global Head of Financial Planning and Analysis from 2019 through 2024. Prior to joining Walgreens, Mr. Apel served in various significant roles in his nearly 20-year career at Bayer, including as Chief Financial Officer for Bayer U.S. from 2016 through 2019 and as Chief Financial Officer for Bayer Canada and global Head of Accounting for the Bayer Healthcare Segment, based in Germany. Mr. Apel has served on the boards of the Biotechnology Innovation Organization (BIO) and the Organization for International Investment, as well as a Trustee for the Health Institute of New Jersey. Mr. Apel earned his Master's degree in Business Administration from the University of California, Berkeley, a Bachelors of Arts Degree from the University of Pennsylvania, and is a licensed Certified Public Accountant. 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. View source version on Contacts Arrowhead Pharmaceuticals, Anzalone, CFA626-304-3400ir@ Investors: LifeSci Advisors, LLCBrian Ritchie 212-915-2578britchie@ Media: LifeSci Communications, LLCKendy Guarinoni, Ph.D.724-910-9389kguarinoni@ Sign in to access your portfolio
