arwr-8k_20200805.htm
false 0000879407 0000879407 2020-08-05 2020-08-05

 

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): August 5, 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 (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 August 5, 2020, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2020 third quarter financial results for the period ended June 30, 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 August 5, 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: August 5, 2020

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

Kenneth Myszkowski

 

 

Chief Financial Officer

 

 

arwr-ex991_6.htm

Exhibit 99.1

PRESS RELEASE

Aug. 5, 2020

 

 

 

Arrowhead Pharmaceuticals Reports Fiscal 2020 Third Quarter Results

 

-

Conference Call and Webcast Today, August 5 at 4:30 p.m. EDT

PASADENA, Calif., Aug. 5, 2020 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal third quarter ended June 30, 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 6856804.

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 6856804.

Selected Recent Events

 

Earned a $20 million milestone payment from Amgen following the administration of the first dose of AMG 890, formerly referred to as ARO-LPA, in a Phase 2 clinical study

 

Hosted a key opinion leader webinar on ARO-ENaC, the company’s investigational RNAi therapeutic being developed as a treatment for patients with cystic fibrosis

 

Completed dosing in healthy volunteer cohorts 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 dosing of the first sequential cohort and collected the first 6-month repeat biopsy 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 and dosing of 93 subjects in AROANG1001, a Phase 1/2 clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed for the treatment of mixed dyslipidemia

 

Completed planned enrollment and dosing of 80 subjects in AROAPOC31001, a Phase 1/2 clinical study of ARO-APOC3, the company’s investigational RNAi therapeutic being developed for the treatment of hypertriglyceridemia, and expanded the study to include up 112 subjects

 



Selected Fiscal 2020 Third Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

OPERATING SUMMARY

2020

 

 

2019

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REVENUE

$

27,375,778

 

 

$

42,696,636

 

 

$

80,359,211

 

 

$

125,502,807

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

32,573,134

 

 

 

19,291,710

 

 

 

85,390,086

 

 

 

57,662,381

 

 

General and administrative expenses

 

10,748,506

 

 

 

4,809,177

 

 

 

38,008,836

 

 

 

16,287,841

 

 

TOTAL OPERATING EXPENSES

 

43,321,640

 

 

 

24,100,887

 

 

 

123,398,922

 

 

 

73,950,222

 

 

OPERATING INCOME (LOSS)

 

(15,945,862

)

 

 

18,595,749

 

 

 

(43,039,711

)

 

 

51,552,585

 

 

OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES

 

2,334,649

 

 

 

1,739,959

 

 

 

6,919,200

 

 

 

4,717,359

 

 

NET INCOME (LOSS)

$

(13,611,213

)

 

$

20,335,708

 

 

$

(36,120,511

)

 

$

56,269,944

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS) PER SHARE (DILUTED)

$

(0.13

)

 

$

0.21

 

 

$

(0.36

)

 

$

0.58

 

 

WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED)

 

101,843,436

 

 

 

98,884,744

 

 

 

100,184,216

 

 

 

97,814,019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

June 30,

 

 

September 30,

 

 

 

 

 

 

 

 

 

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS

$

219,322,617

 

 

$

221,804,128

 

 

 

 

 

 

 

 

 

 

SHORT-TERM INVESTMENTS

 

67,709,263

 

 

 

36,899,894

 

 

 

 

 

 

 

 

 

 

LONG-TERM INVESTMENTS

 

177,529,881

 

 

 

44,175,993

 

 

 

 

 

 

 

 

 

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

464,561,761

 

 

 

302,880,015

 

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

91,166,311

 

 

 

46,965,422

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

555,728,072

 

 

 

349,845,437

 

 

 

 

 

 

 

 

 

 

TOTAL CURRENT DEFERRED REVENUE

 

26,274,362

 

 

 

77,769,629

 

 

 

 

 

 

 

 

 

 

TOTAL LONG TERM DEFERRED REVENUE

 

-

 

 

 

5,035,142

 

 

 

 

 

 

 

 

 

 

OTHER LIABILITIES

 

36,868,505

 

 

 

23,004,414

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

63,142,867

 

 

 

105,809,185

 

 

 

 

 

 

 

 

 

 

TOTAL STOCKHOLDERS' EQUITY

 

492,585,205

 

 

 

244,036,252

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

555,728,072

 

 

$

349,845,437

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHARES OUTSTANDING

 

102,250,872

 

 

 

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.

 

# # #

 

 

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Aug. 05, 2020
Cover [Abstract]  
Entity Registrant Name Arrowhead Pharmaceuticals, Inc.
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Entity Central Index Key 0000879407
Document Type 8-K
Document Period End Date Aug. 05, 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
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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