Arrowhead Pharmaceuticals Reports Fiscal 2024 Third Quarter Results

- Conference Call and Webcast Today, August 8, 2024, at 4:30 p.m. ET

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2024 third quarter ended June 30, 2024. The Company is hosting a conference call today, August 8, 2024, at 4:30 p.m. ET to discuss the results.

“Arrowhead had a very productive quarter with several high-profile presentations at medical and scientific congresses, as well as publications in high impact journals. Our clinical results have been strong and are receiving significant attention,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. “Across our diverse pipeline, we continue to make good progress in later-stage clinical studies and are approaching commercialization of both our wholly owned and partnered RNAi therapeutics. We also made critical progress on the financial front with two separate inflows that strengthen our balance sheet following our strategic decision to focus our resources in cardiometabolic on plozasiran, our most near-term commercial opportunity with a potential launch in 2025, provided plozasiran receives regulatory approval in familial chylomicronemia syndrome.”

Webcast and Conference Call and Details

Investors may access a live audio webcast on the Company's website at https://ir.arrowheadpharma.com/events-and-presentations. 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 https://register.vevent.com/register/BI3ff87234939a4106b58ec6d3e72eb33c. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.

Selected Recent Financial Events

• Strengthened the balance sheet to immediately enhance the ability of plozasiran to advance towards launch in 2025, if approved, and to expand the possibilities to fund innovation and growth across Arrowhead’s robust and diverse pipeline of RNAi therapeutics. Two key balance sheet events were:
  • Closed a strategic financing agreement with Sixth Street for significant, long-term, non-dilutive capital. The $500 million senior secured credit facility includes $400 million funded at close with an additional $100 million available at Arrowhead’s option, subject to mutual agreement between Sixth Street and Arrowhead, during the seven-year term of the agreement.
  • Received a $50 million milestone payment from Royalty Pharma plc following the completion of enrollment of the Phase 3 OCEAN(a) - Outcomes Trial of olpasiran, being conducted by Amgen. Olpasiran, a small interfering RNA originally developed by Arrowhead using its proprietary Targeted RNAi Molecule (TRiMTM) platform, is designed to lower levels of lipoprotein(a), a genetically determined risk factor for cardiovascular disease.

Selected Recent R&D Events

• Reported successful topline results from the pivotal Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome (FCS). Plozasiran is the company’s first investigational RNAi-based therapy to show clinical efficacy in a Phase 3 study. Topline results included the following:
  • Plozasiran achieved statistically significant median reductions in triglycerides up to 80% and mean reductions in APOC3 up to 94% at month 10.
  • In addition to meeting the primary endpoint, plozasiran met all key secondary endpoints and demonstrated statistical significance versus placebo.
  • Plozasiran achieved a statistically significant reduction in incidence of acute pancreatitis versus placebo.
  • Plozasiran demonstrated a favorable safety profile in the PALISADE study. The number of subjects reporting treatment emergent adverse event (AEs) were similar in plozasiran and placebo groups. Severe and serious AEs were less common with plozasiran than with placebo. The most common AEs reported were abdominal pain, COVID-19, nasopharyngitis, headache and nausea.
• Additional data from the PALISADE study of plozasiran will be presented in a late-breaking oral prestation at the European Society of Cardiology (ESC) Congress 2024 which is being held on September 2, 2024, in London. Details on the ESC presentation are listed below:

Title: A phase 3 study to evaluate the efficacy and safety of ARO-APOC3 in adults with familial chylomicronemia syndrome Date/Time: September 2, 2024, 11:48 a.m. BST Presenter: Professor Gerald Watts Session: Small trials, trial updates, and other studies on lipid therapy Session Type: Late Breaking Science

• Initiated pivotal Phase 3 SHASTA-3 and SHASTA-4 studies of plozaisran in patients with severe hypertriglyceridemia
• Announced plans to advance plozasiran into a Phase 3 cardiovascular outcomes trial called CAPITAN.
  • CAPITAN builds upon existing SUMMIT program of pivotal Phase 3 clinical studies of plozasiran including PALISADE in patients with FCS and the SHASTA studies in patients with severe hypertriglyceridemia
• Presented new Phase 2 data from the MUIR study of investigational plozasiran in patients with mixed hyperlipidemia and from the ARCHES-2 study of investigational zodasiran in patients with mixed hyperlipidemia at the European Atherosclerosis Society (EAS) 92nd Congress. Both studies were simultaneously published in the New England Journal of Medicine.
  • Select MUIR results included the following:
    • By silencing Apolipoprotein C-III (APOC3), plozasiran significantly reduced triglycerides and atherogenic triglyceride rich lipoproteins and increased HDL, across all dose levels at Week 24 in patients with mixed dyslipidemia.
    • At week 24, representing trough effect after two quarterly doses, plozasiran treatment was associated with placebo adjusted reductions in triglycerides of -50%, -56%, and -62% (all p