arwr-8k_20210504.htm
false 0000879407 0000879407 2021-05-04 2021-05-04

 

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 4, 2021

 

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 (626304-3400

 

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 4, 2021, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2021 financial results for the period ended March 31, 2021. 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 4, 2021.

 

 

 

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 4, 2021

 

 

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

 

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

 

Kenneth Myszkowski

 

 

 

Chief Financial Officer

 

 

arwr-ex991_6.htm

 

EXHIBIT 99.1

PRESS RELEASE

May 4, 2021

 

 

 

Arrowhead Pharmaceuticals Reports Fiscal 2021 Second Quarter Results

 

-

Conference Call and Webcast Today, May 4, 2021 at 4:30 p.m. ET

PASADENA, Calif., May 4, 2021 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal second quarter ended March 31, 2021. The company is hosting a conference call today, May 4, 2021, at 4:30 p.m. ET to discuss the 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 3080187.

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 3080187.

Selected Recent Events

 

Announced positive interim 48-week liver biopsy results from the AROAAT2002 study, an open-label Phase 2 clinical study of ARO-AAT, the company’s second generation investigational RNA interference (RNAi) therapeutic being co-developed with Takeda Pharmaceutical Company Limited as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD). The interim readout demonstrated that ARO-AAT treatment led to:

 

o

Consistent and substantial reduction in intra-hepatic mutant AAT protein (Z-AAT), both Z-AAT monomer and Z-AAT polymer

 

o

Consistent decrease in histological globule burden


 

 

 

o

Improvements in fibrosis

 

o

Improvements in other relevant biomarkers of liver health

 

Arrowhead intends to present additional interim AROAAT2002 data at an upcoming medical congress, pending abstract acceptance.

 

Announced ARO-DUX4, Arrowhead’s first muscle targeted investigational RNAi therapeutic candidate to utilize its proprietary Targeted RNAi Molecule (TRIMTM) platform. ARO-DUX4 is designed to target the gene that encodes human double homeobox 4 (DUX4) protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy (FSHD).

 

Submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2b dose-finding clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with mixed dyslipidemia.

 

Submitted an IND to the FDA for a Phase 2b dose-finding clinical study of ARO-APOC3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with hypertriglyceridemia.


 

Selected Fiscal 2021 Second Quarter Financial Results

 

ARROWHEAD PHARMACEUTICALS, INC.

 

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended

March 31,

 

 

Six months ended

March 31,

 

OPERATING SUMMARY

 

2021

 

 

2020

 

 

2021

 

 

2020

 

REVENUE

 

$

32,811

 

 

$

23,529

 

 

$

54,113

 

 

$

52,983

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

44,697

 

 

 

29,443

 

 

 

81,251

 

 

 

52,817

 

General and administrative expenses

 

 

16,346

 

 

 

16,326

 

 

 

25,147

 

 

 

27,260

 

TOTAL OPERATING EXPENSES

 

 

61,043

 

 

 

45,769

 

 

 

106,398

 

 

 

80,077

 

OPERATING INCOME (LOSS)

 

 

(28,232

)

 

 

(22,240

)

 

 

(52,285

)

 

 

(27,094

)

OTHER INCOME/(EXPENSE)

 

 

1,414

 

 

 

2,404

 

 

 

4,735

 

 

 

4,585

 

NET INCOME (LOSS)

 

$

(26,818

)

 

$

(19,836

)

 

$

(47,550

)

 

$

(22,509

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS) PER SHARE (DILUTED)

 

$

(0.26

)

 

$

(0.20

)

 

$

(0.46

)

 

$

(0.23

)

WEIGHTED AVERAGE SHARES

   OUTSTANDING (DILUTED)

 

 

103,867

 

 

 

101,653

 

 

 

103,303

 

 

 

99,359

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

 

March 31,

 

 

September 30,

 

 

 

 

 

 

 

 

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS

 

$

372,377

 

 

$

143,583

 

 

 

 

 

 

 

 

 

SHORT-TERM INVESTMENTS AND

   MARKETABLE SECURITIES

 

 

204,941

 

 

 

171,910

 

 

 

 

 

 

 

 

 

LONG-TERM INVESTMENTS

 

 

97,490

 

 

 

137,487

 

 

 

 

 

 

 

 

 

TOTAL CASH RESOURCES (CASH AND

   INVESTMENTS)

 

 

674,808

 

 

 

452,980

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

 

81,987

 

 

 

69,524

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

 

756,795

 

 

 

522,504

 

 

 

 

 

 

 

 

 

TOTAL CURRENT DEFERRED REVENUE

 

 

144,879

 

 

 

19,291

 

 

 

 

 

 

 

 

 

OTHER LIABILITIES

 

 

166,367

 

 

 

41,434

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

311,246

 

 

 

60,725

 

 

 

 

 

 

 

 

 

TOTAL STOCKHOLDERS' EQUITY

 

 

445,549

 

 

 

461,779

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS'

   EQUITY

 

$

756,795

 

 

$

522,504

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHARES OUTSTANDING

 

 

104,020

 

 

 

102,376

 

 

 

 

 

 

 

 

 

 

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,” “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 businesses, 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 continuing impact of the COVID-19 pandemic, 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, 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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