0001628280-23-040222.txt : 20231129 0001628280-23-040222.hdr.sgml : 20231129 20231129161057 ACCESSION NUMBER: 0001628280-23-040222 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231129 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231129 DATE AS OF CHANGE: 20231129 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARROWHEAD PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0000879407 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 460408024 STATE OF INCORPORATION: DE FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38042 FILM NUMBER: 231452311 BUSINESS ADDRESS: STREET 1: 177 E COLORADO BLVD STREET 2: SUITE 700 CITY: PASADENA STATE: CA ZIP: 91105 BUSINESS PHONE: 626-696-4702 MAIL ADDRESS: STREET 1: 177 E COLORADO BLVD STREET 2: SUITE 700 CITY: PASADENA STATE: CA ZIP: 91105 FORMER COMPANY: FORMER CONFORMED NAME: ARROWHEAD RESEARCH CORP DATE OF NAME CHANGE: 20040112 FORMER COMPANY: FORMER CONFORMED NAME: INTERACTIVE GROUP INC DATE OF NAME CHANGE: 20020509 FORMER COMPANY: FORMER CONFORMED NAME: INTERACTIVE INC DATE OF NAME CHANGE: 19940224 8-K 1 arwr-20231129.htm 8-K arwr-20231129
0000879407FALSE00008794072022-11-282022-11-28

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
November 29, 2023
Date of Report
(Date of earliest event reported)
Arrowhead Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware001-3804246-0408024
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
177 E. Colorado Blvd, Suite 700, Pasadena, CA 91105
(Address of principal executive offices, including Zip Code)
(626) 304-3400
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share ARWR The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.



Item 2.02 Results of Operations and Financial Condition
On November 29, 2023, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2023 financial results for the period ended September 30, 2023. A copy of the press release is furnished herewith as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.


Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Description
 
99.1
104Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document).



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: November 29, 2023
ARROWHEAD PHARMACEUTICALS, INC.
  
By:/s/ Kenneth Myszkowski
 Kenneth Myszkowski
 Chief Financial Officer

EX-99.1 2 arwr-20231129x8kex991.htm EX-99.1 Document

EXHIBIT 99.1
ghvnqo5ppwcq000001.jpg

PRESS RELEASE
November 29, 2023

Arrowhead Pharmaceuticals Reports Fiscal 2023 Year End Results
Conference Call and Webcast Today, November 29, 2023 at 4:30 p.m. ET

PASADENA, Calif., November 29, 2023 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal year ended September 30, 2023. The company is hosting a conference call today, November 29, 2023, at 4:30 p.m. ET to discuss the results.

Webcast and Conference Call and Details
Investors may access a live audio webcast on the Company's website at http://ir.arrowheadpharma.com/events.cfm. 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/BIa77ccad14f0a463c87758bb2f025af22. 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
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) at the American Heart Association (AHA) Scientific Sessions. Key updates included:
Plozasiran achieved mean max reductions of up to 90% in APOC3, 87% in triglycerides, and 63% in remnant cholesterol in patients with severe hypertriglyceridemia. In patients with mixed dyslipidemia, plozasiran achieved a mean max reduction in APOC3 of up to 89%, leading to robust and durable improvements in multiple atherogenic lipoproteins
Zodasiran treatment resulted in substantial reductions of ANGPTL3, triglycerides, and LDL-cholesterol in patients with mixed dyslipidemia
Plozasiran and zodasiran continue to show favorable safety profiles. Treatment emergent adverse events reported to date reflect the comorbidities and underlying conditions of the study populations

Hosted a webinar featuring experts in the treatment and management of lipid and lipoprotein disorders to discuss plozasiran
Daniel Gaudet, MD, PhD, Professor of Medicine at Université de Montréal, discussed plozasiran in the context of the current treatment landscape for severe hypertriglyceridemia
Børge Nordestgaard, MD, Professor & Chief Physician, Copenhagen University Hospital, University of Copenhagen, Denmark, discussed the emergent role of remnant cholesterol in cardiovascular disease
Steven Nissen, MD, Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, discussed why the decrease in atherogenic lipoproteins observed with plozasiran has the potential to prevent cardiovascular outcomes

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

Presented data on the company’s pipeline of pulmonary targeted RNAi therapeutic candidates, including clinical results for ARO-RAGE, at the European Respiratory Society (ERS) International Congress 2023. Key results included:
Late-breaking clinical data for ARO-RAGE demonstrated deep and durable gene silencing in healthy volunteers and in patients with asthma
Promising preclinical data across multiple pulmonary programs suggested broad potential applications for Arrowhead’s TRiMTM platform

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

Announced that GSK plc reached an agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, to transfer exclusive worldwide rights to further develop and commercialize JNJ-3989. JNJ-3989 (formerly ARO-HBV) was initially in-licensed by Janssen from Arrowhead in 2018




Selected Fiscal 2023 Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION
(in thousands, except per share amounts)

 
Year Ended
September 30,
OPERATING SUMMARY20232022
Revenue$240,735 $243,231 
Operating Expenses:  
Research and development353,188 297,307 
General and administrative expenses92,549 124,431 
Total Operating Expenses445,737 421,738 
Operating loss(205,002)(178,507)
Interest income15,299 5,033 
Interest expense(18,326)— 
Other, net1,538 765 
Loss before income tax expense and noncontrolling interest(206,491)(172,709)
Income tax expense2,784 3,785 
Net loss including noncontrolling interest(209,275)(176,494)
Net loss attributable to noncontrolling interest, net of tax(4,000)(431)
Net loss attributable to Arrowhead Pharmaceuticals, Inc.$(205,275)$(176,063)
   
Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted$(1.92)$(1.67)
Weighted-average shares used in calculating - Diluted106,750 105,426 
FINANCIAL POSITION SUMMARYSeptember 30,
2023
September 30,
2022
Cash, cash equivalents and restricted cash$110,891 $108,005 
Investments292,735 374,263 
Total cash resources (cash and investments)403,626 482,268 
Other assets361,926 209,671 
Total Assets$765,552 $691,939 
Current deferred revenue$866 $74,099 
Long-term deferred revenue— 55,950 
Other liabilities477,524 143,551 
Total Liabilities$478,390 $273,600 
Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity$271,343 $398,520 
Noncontrolling Interest15,81919,819
Total Noncontrolling Interest and Stockholders' Equity$287,162 $418,339 
 Total Liabilities, Noncontrolling Interest and Stockholders' Equity$765,552 $691,939 
Shares Outstanding107,312 105,960 





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 www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.
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,” or “continue” 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 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.
Contacts:
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investors:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com
Media:
LifeSci Communications, LLC
Josephine Belluardo, Ph.D.
646-751-4361
jo@lifescicomms.com
www.lifescicommunications.com

Source: Arrowhead Pharmaceuticals, Inc.
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Cover
Nov. 28, 2022
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 29, 2023
Entity Registrant Name Arrowhead Pharmaceuticals, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38042
Entity Tax Identification Number 46-0408024
Entity Address, Address Line One 177 E. Colorado Blvd
Entity Address, Address Line Two Suite 700
Entity Address, City or Town Pasadena
Entity Address, State or Province CA
Entity Address, Postal Zip Code 91105
City Area Code 626
Local Phone Number 304-3400
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol ARWR
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0000879407
Amendment Flag false
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