On February 6, 2023 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal first quarter ended December 31, 2022 (Press release, Arrowhead Research Corporation, FEB 6, 2023, View Source [SID1234626876]). The company is hosting a conference call today, February 6, 2023, at 4:30 p.m. ET to discuss the results.
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Conference Call and Webcast 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/BI9b2661110f7a4b0ebc648bf42d2a403f. 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
•Announced topline results with Takeda from the Phase 2 SEQUOIA clinical study of investigational fazirsiran for the treatment of liver disease associated with alpha-1 antitrypsin deficiency and provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda. Key results from SEQUOIA included the following:
◦Fibrosis regression observed in 50% of patients receiving fazirsiran
◦Median reductions of 94% of Z-AAT accumulation in the liver and mean reduction of 68% in histologic globule burden
◦Treatment emergent adverse events were generally well balanced between fazirsiran and placebo groups
◦Results consistent with AROAAT-2002 open-label study previously published in The New England Journal of Medicine
•Earned a $25 million milestone payment from Amgen after the first subject was enrolled in Amgen’s Phase 3 trial of olpasiran for the treatment of cardiovascular disease
•Earned a $15 million milestone payment from Horizon Therapeutics after the first subject was enrolled in Horizon’s Phase 1 study of HZN-457, formerly called ARO-XDH, for the treatment of gout
•Initiated dosing in AROMMP7-1001 (NCT05537025), a Phase 1/2a single ascending dose and multiple ascending dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7, an investigational RNAi therapeutic designed to reduce expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF), in up to 56 healthy volunteers and in up to 21 patients with IPF
•Presented interim data on the cardiometabolic pipeline in three late-breaking oral presentations at the American Heart Association (AHA) Scientific Sessions 2022 and at a virtual analyst and investor event. Key results included the following:
◦ARO-APOC3, an investigational RNAi therapeutic targeting apolipoprotein C-III (APOC3) being developed as a treatment for patients with cardiovascular disease, severe hypertriglyceridemia (SHTG), and familial chylomicronemia syndrome (FCS), decreased triglycerides by 86%, and non-HDL-C by 45% while increasing HDL-C by 99% in patients with severe hypertriglyceridemia
◦ARO-ANG3, an investigational RNAi therapeutic designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3) being developed as a treatment for patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH), decreased triglycerides by 59%, LDL-C by 32%, and was associated with a relative reduction in liver fat fraction in patients with mixed dyslipidemia
◦Olpasiran, which was originally developed by Arrowhead using its proprietary Targeted RNAi Molecule (TRiM) platform and licensed to Amgen in 2016 and is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically-determined independent risk factor for cardiovascular disease, reduced Lp(a) levels by more than 95% in patients with established atherosclerotic cardiovascular disease. These data were simultaneously published in the New England Journal of Medicine (NEJM)
•Strengthened the balance sheet with the sale of Arrowhead’s royalty interest in olpasiran to Royalty Pharma for:
◦$250 million in cash upfront
◦Up to $160 million in additional payments contingent on the achievement of certain clinical, regulatory, and sales milestones
◦Retained rights to $400 million in development, regulatory, and sales milestone payments potentially due from Amgen from the 2016 out-licensing agreement
Selected Fiscal 2022 Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION
(in thousands, except per share amounts)
Year Ended December 31,
OPERATING SUMMARY 2022 2021
(unaudited)
Revenue $ 62,546 $ 27,439
Operating Expenses:
Research and development 83,695 65,765
General and administrative expenses 20,985 24,995
Total Operating Expenses 104,680 90,760
Operating loss (42,134) (63,321)
Other income, net 340 449
Loss before income tax expense and noncontrolling interest (41,794) (62,872)
Income tax expense 17 —
Net loss including noncontrolling interest (41,811) (62,872)
Net loss attributable to noncontrolling interest, net of tax (486) —
Net loss attributable to Arrowhead Pharmaceuticals, Inc. $ (41,325) $ (62,872)
Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. – Diluted $ (0.39) $ (0.60)
Weighted-average shares used in calculating – Diluted 106,039 104,534
FINANCIAL POSITION SUMMARY December 31,
2022 September 30,
2022
(unaudited)
Cash, cash equivalents and restricted cash $ 202,249 $ 108,005
Short-term investments 299,582 268,391
Long-term investments 115,774 105,872
Total cash resources (cash and investments) 617,605 482,268
Other assets 273,884 209,671
Total Assets $ 891,489 $ 691,939
Current deferred revenue $ 66,281 $ 74,099
Long-term deferred revenue 40,789 55,950
Other liabilities 388,047 143,551
Total Liabilities $ 495,117 $ 273,600
Total Arrowhead Pharmaceuticals, Inc. Stockholders’ Equity $ 377,039 $ 398,520
Noncontrolling Interest 19,333 19,819
Total Noncontrolling Interest and Stockholders’ Equity 377,039 418,339
Total Liabilities, Noncontrolling Interest and Stockholders’ Equity $ 872,156 $ 691,939
Shares Outstanding 106,140 105,960