arwr-8k_20200507.htm

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

Date of Report (Date of earliest event reported): May 7, 2020

Arrowhead Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)



Delaware	001-38042	46-0408024
(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) (Zip Code)

Registrant’s telephone number, including area code (626) 304-3400

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)

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. ☐


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

Item 2.02 Results of Operations and Financial Condition

On May 7, 2020, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2020 second quarter financial results for the period ended March 31, 2020. 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		Press Release, dated May 7, 2020.

104	Cover Page Interactive 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: May 7, 2020



ARROWHEAD PHARMACEUTICALS, INC.

By:		/s/ Kenneth Myszkowski
		Kenneth Myszkowski
		Chief Financial Officer

arwr-ex991_6.htm

Exhibit 99.1

PRESS RELEASE

May 7, 2020

Arrowhead Pharmaceuticals Reports Fiscal 2020 Second Quarter Results

Conference Call and Webcast Today, May 7 at 4:30 p.m. EDT

PASADENA, Calif., May 7, 2020 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal second quarter ended March 31, 2020. The company is hosting a conference call at 4:30 p.m. EDT to discuss results.

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company's website at http://ir.arrowheadpharma.com/events.cfm. For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 7566917.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 7566917.

Selected Recent Events

•

Dosed the first patients in AROHSD1001, a Phase 1/2 clinical study of ARO-HSD, the company’s investigational RNAi therapeutic being developed as a treatment for patients with alcohol related and nonalcohol related liver diseases, such as nonalcoholic steatohepatitis

•

Completed enrollment of the first sequential cohort in the AROAAT2002 study, a pilot open-label, multi-dose, Phase 2 study to assess changes in a novel histological activity scale in response to ARO-AAT over time in patients with alpha-1 antitrypsin deficiency associated liver disease

•

Completed planned enrollment in AROANG1001, a Phase 1 clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed for the treatment of mixed dyslipidemia

•

Completed discovery and optimization work and advanced ARO-Lung2, Arrowhead’s investigational RNAi therapeutic being developed for the treatment of chronic obstructive pulmonary disorder (COPD), into IND-enabling studies with a planned CTA filing in in the first half of 2021. ARO-Lung2 is against an undisclosed gene target and is the company’s second inhaled RNAi candidate to leverage the Targeted RNAi Molecule (TRiM^TM) platform to the target pulmonary epithelium

•

Started a development program to address the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens. No additional details about this program are being disclosed at this time

•

Reported interim multiple-dose results on two cardiometabolic candidates ARO-APOC3, being developed as a potential treatment for patients with severe hypertriglyceridemia, and ARO-ANG3, being developed for the treatment of mixed dyslipidemia, showing high levels of reduction in APOC3, ANGPTL3, triglycerides, and other lipid parameters

•

Completed a regulatory submission to begin a Phase 1/2a clinical trial of ARO-ENaC, the company’s investigational RNAi therapeutic being developed as a treatment for patients with cystic fibrosis

•

Expanded Arrowhead’s senior management team with the hiring of Jim Hassard as chief commercial officer

•

Opened a second Research and Development facility in San Diego, which allows Arrowhead to tap into additional skill sets in one the country’s premier biotech hubs and also expands capacity for preclinical models to do more early research work in parallel

Selected Fiscal 2020 Second Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

	Three Months Ended March 31,					Six Months Ended March 31,
OPERATING SUMMARY	2020			2019		2020			2019

REVENUE	$	23,528,853		$	48,148,275	$	52,983,433		$	82,806,171
OPERATING EXPENSES
Research and development		29,443,335			20,798,628		52,816,951			38,370,671
General and administrative expenses		16,325,773			5,338,955		27,260,330			11,478,664
TOTAL OPERATING EXPENSES		45,769,108			26,137,583		80,077,281			49,849,335
OPERATING INCOME (LOSS)		(22,240,255	)		22,010,692		(27,093,848	)		32,956,836
OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES		2,404,685			1,886,290		4,584,550			2,977,399
NET INCOME (LOSS)	$	(19,835,570	)	$	23,896,982	$	(22,509,298	)	$	35,934,235

NET INCOME (LOSS) PER SHARE (DILUTED)	$	(0.20	)	$	0.24	$	(0.23	)	$	0.37
WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED)		101,653,136			98,082,644		99,359,140			97,214,546

FINANCIAL POSITION SUMMARY	March 31,			September 30,
	2020			2019
CASH AND CASH EQUIVALENTS	$	256,650,727		$	221,804,128
SHORT-TERM INVESTMENTS		50,959,058			36,899,894
LONG-TERM INVESTMENTS		190,618,075			44,175,993
TOTAL CASH RESOURCES (CASH AND INVESTMENTS)		498,227,860			302,880,015
OTHER ASSETS		62,847,842			46,965,422
TOTAL ASSETS		561,075,702			349,845,437
TOTAL CURRENT DEFERRED REVENUE		33,174,765			77,769,629
TOTAL LONG TERM DEFERRED REVENUE		-			5,035,142
OTHER LIABILITIES		34,337,467			23,004,414
TOTAL LIABILITIES		67,512,232			105,809,185
TOTAL STOCKHOLDERS' EQUITY		493,563,470			244,036,252
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	561,075,702		$	349,845,437

SHARES OUTSTANDING		101,748,107			95,506,271

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. 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 various factors and uncertainties, including the safety and efficacy of our product candidates, 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, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. 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 and Media:

LifeSci Advisors, LLC

Brian Ritchie
212-915-2578

britchie@lifesciadvisors.com

www.lifesciadvisors.com

Source: Arrowhead Pharmaceuticals, Inc.

# # #

Document and Entity Information	May 07, 2020
Cover [Abstract]
Entity Registrant Name	Arrowhead Pharmaceuticals, Inc.
Amendment Flag	false
Entity Central Index Key	0000879407
Document Type	8-K
Document Period End Date	May 07, 2020
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
Entity Emerging Growth Company	false
Title of 12(b) Security	Common Stock, Par Value $0.001 per share
Trading Symbol	ARWR
Security Exchange Name	NASDAQ