arwr-8k_20210204.htm
false 0000879407 0000879407 2021-02-04 2021-02-04

 

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): February 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 February 4, 2021, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2021 financial results for the period ended December 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 February 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: February 4, 2021

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

Kenneth Myszkowski

 

 

Chief Financial Officer

 

 

arwr-ex991_6.htm

Exhibit 99.1

 

 

PRESS RELEASE

Feb. 4, 2021

 

 

 

Arrowhead Pharmaceuticals Reports Fiscal 2021 First Quarter Results

 

-

Conference Call and Webcast Today, February 4 at 4:30 p.m. EST

PASADENA, Calif., Feb. 4, 2021 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal first quarter ended December 31, 2020. The company is hosting a conference call at 4:30 p.m. EST 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 1307499.

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 1307499.

Selected Recent Events

 

Submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration 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

 

Presented new clinical data from Phase 1/2 studies of both wholly owned cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, at the American Heart


 

Association meetings and subsequently hosted key opinion leader webinars to discuss the data and plans for future development of the product candidates

 

Closed an agreement with Takeda to co-develop and co-commercialize ARO-AAT, which includes $300 million upfront, $740 million in potential milestone payments, a 50/50 profit sharing agreement in the U.S., and 20-25% royalty on net sales outside the U.S.

 

Presented new clinical data at The Liver Meeting Digital Experience, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) on ARO-AAT, Arrowhead’s candidate against liver disease associated with alpha-1 antitrypsin deficiency, showing that ARO-AAT strongly reduced the production of mutant Z-AAT protein and led to improvements in multiple biomarkers of alpha-1 liver disease

 


Selected Fiscal 2021 First Quarter Financial Results

 

ARROWHEAD PHARMACEUTICALS, INC.

 

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended

December 31,

 

OPERATING SUMMARY

 

2020

 

 

2019

 

REVENUE

 

$

21,303

 

 

$

29,455

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

 

 

36,555

 

 

 

23,374

 

General and administrative expenses

 

 

8,802

 

 

 

10,934

 

TOTAL OPERATING EXPENSES

 

 

45,357

 

 

 

34,308

 

OPERATING INCOME (LOSS)

 

 

(24,054

)

 

 

(4,853

)

OTHER INCOME/(EXPENSE)

 

 

3,322

 

 

 

2,180

 

NET INCOME (LOSS)

 

$

(20,732

)

 

$

(2,673

)

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS) PER SHARE (DILUTED)

 

$

(0.20

)

 

$

(0.03

)

WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED)

 

 

102,757

 

 

 

97,090

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

 

December 31,

 

 

September 30,

 

 

 

2020

 

 

2020

 

CASH AND CASH EQUIVALENTS

 

$

139,921

 

 

$

143,583

 

SHORT-TERM INVESTMENTS AND MARKETABLE SECURITIES

 

 

165,406

 

 

 

171,910

 

LONG-TERM INVESTMENTS

 

 

110,855

 

 

 

137,487

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

 

416,182

 

 

 

452,980

 

OTHER ASSETS

 

 

83,069

 

 

 

69,524

 

TOTAL ASSETS

 

 

499,251

 

 

 

522,504

 

TOTAL CURRENT DEFERRED REVENUE

 

 

6,744

 

 

 

19,291

 

OTHER LIABILITIES

 

 

38,035

 

 

 

41,434

 

TOTAL LIABILITIES

 

 

44,779

 

 

 

60,725

 

TOTAL STOCKHOLDERS' EQUITY

 

 

454,472

 

 

 

461,779

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 

$

499,251

 

 

$

522,504

 

 

 

 

 

 

 

 

 

 

SHARES OUTSTANDING

 

 

103,194

 

 

 

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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