On February 6, 2024 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2024 first quarter ended December 31, 2023 (Press release, Arrowhead Research Corporation, FEB 6, 2024, View Source [SID1234639864]). The company is hosting a conference call today, February 6, 2024, at 4:30 p.m. ET to discuss the results.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Webcast and Conference Call and Details
Investors may access a live audio webcast on the Company’s website at View Source 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/BId9fba8b41eb34305a8f07de301a9d42c. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.
Selected Recent Events
•Continued to build the cardiometabolic vertical to include two new additional complementary medicines designed to treat obesity and metabolic disease, both of which are on schedule for clinical trial application (CTA) filings before the end of 2024
◦ARO-INHBE utilizes the liver targeted TRiMTM platform and targets the INHBE gene. INHBE expression is increased in obesity and INHBE loss-of-function variants identified in human genetic databases are protective of type 2 diabetes and are associated with reduced visceral fat and a reduced waste to hip ratio
◦The second is based on Arrowhead’s adipose tissue targeting TRiMTM platform and addresses an undisclosed gene target
•Performed a portfolio review and R&D organization restructuring resulting in key changes, including:
◦Arrowhead will focus investment in late-stage clinical development and build out commercial infrastructure to support sales and marketing of medicines primarily in the cardiometabolic and pulmonary verticals
◦Engaged Bruce Given, M.D., Arrowhead’s former chief operating officer and head of R&D for Arrowhead for several years before his retirement in 2020 after a more than 30-year career in biotechnology and pharmaceutical research, development, and sales and marketing, on an interim basis to serve as chief medical scientist to help with restructuring efforts and the process to recruit new therapeutic area experts to decentralize the chief medical officer function
◦Identified opportunities to reduce forward operating cash burn guidance by up to $100 million, approximately $30 million per quarter, while retaining full funding and investment in core cardiometabolic and pulmonary programs
◦Focused R&D spending for non-core programs on development activities that advance candidates to an attractive stage for potential partnerships
◦Terminated development of ARO-SOD1 and HZN-457
•Strengthened the balance sheet through an underwritten registered offering of common stock gross proceeds of approximately $450 million, before deducting underwriting discounts, commissions, and other offering expenses payable by the company
•Presented data on cardiometabolic pipeline at the American Heart Association Scientific Sessions in November 2023
◦Presented new Phase 2 clinical data from the ongoing SHASTA-2 and MUIR studies of plozasiran (ARO-APOC3) and the ARCHES-2 study of zodasiran (ARO-ANG3)
◦Hosted a webinar to discuss plozasiran featuring experts in the treatment and management of lipid and lipoprotein disorders
•Completed chronic GLP toxicology for pulmonary candidates ARO-RAGE, designed to reduce expression of the receptor for advanced glycation end products as a potential treatment for inflammatory pulmonary diseases, and ARO-MMP7, designed to reduce expression of matrix metalloproteinase 7 as a potential treatment for idiopathic pulmonary fibrosis
◦Results were highly encouraging and suggest sufficient safety margins to proceed to Phase 2 studies
•Filed for regulatory clearance to initiate a Phase 1/2a study of ARO-CFB, Arrowhead’s RNAi therapeutic candidate for patients with complement renal disease such as immunoglobulin A nephropathy (IgAN), which is the world’s most common glomerular disease
•Filed for regulatory clearance to initiate a Phase 1/2a study of Arrowhead’s second RNAi therapeutic candidate targeting skeletal muscle, ARO-DM1, for patients with type 1 myotonic dystrophy
Selected Fiscal 2024 Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION
(in thousands, except per share amounts)
Year Ended
December 31,
OPERATING SUMMARY 2023 2022
(Unaudited)
Revenue $ 3,551 $ 62,546
Operating Expenses:
Research and development 116,491 83,695
General and administrative expenses 23,605 20,985
Total Operating Expenses 140,096 104,680
Operating loss (136,545) (42,134)
Total other (expense) income (2,144) 340
Loss before income tax (benefit) expense and noncontrolling interest (138,689) (41,794)
Income tax (benefit) expense (3,313) 17
Net loss including noncontrolling interest (135,376) (41,811)
Net loss attributable to noncontrolling interest, net of tax (2,512) (486)
Net loss attributable to Arrowhead Pharmaceuticals, Inc. $ (132,864) $ (41,325)
Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. – Diluted $ (1.24) $ (0.39)
Weighted-average shares used in calculating – Diluted 107,415 106,039
FINANCIAL POSITION SUMMARY December 31,
2023 September 30,
2023
(unaudited)
Cash, cash equivalents and restricted cash $ 58,215 $ 110,891
Investments 162,064 292,735
Total cash resources (cash and investments) 220,279 403,626
Other assets 406,007 361,926
Total Assets $ 626,286 $ 765,552
Current deferred revenue $ — $ 866
Other liabilities 452,572 477,524
Total Liabilities $ 452,572 $ 478,390
Total Arrowhead Pharmaceuticals, Inc. Stockholders’ Equity $ 160,407 $ 271,343
Noncontrolling Interest 13,307 15,819
Total Noncontrolling Interest and Stockholders’ Equity $ 173,714 $ 287,162
Total Liabilities, Noncontrolling Interest and Stockholders’ Equity $ 626,286 $ 765,552
Shares Outstanding 107,500 107,312