Arrowhead Pharmaceuticals, Inc.
ARROWHEAD PHARMACEUTICALS, INC. (Form: 8-K, Received: 02/09/2018 16:08:42)

 

 

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 9, 2018

 

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.)

 

225 South Lake Avenue, Suite 1050, Pasadena, CA 91101

(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.

 

 

 



Item 2.02 Results of Operations and Financial Condition

On February 9, 2018, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2018 first quarter financial results for the period ended December 31, 2017. 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 9, 2018.

 

 

 



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 9, 2018

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

Kenneth Myszkowski

 

 

Chief Financial Officer

 

 

Exhibit 99.1

PRESS RELEASE

Feb. 9, 2018

 

 

 

Arrowhead Pharmaceuticals Reports Fiscal 2018 First Quarter Results

 

-

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

PASADENA, Calif., Feb. 9 , 2018 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2018 first quarter ended December 31, 2017. 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 4788374.

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 4788374.

Selected Fiscal 2018 First Quarter and Recent Events

 

Filed a Clinical Trial Application for ARO-AAT, a second generation subcutaneously administered clinical candidate for the treatment of alpha-1 antitrypsin deficiency liver disease

 

Filed a Clinical Trial Application for ARO-HBV, a third generation subcutaneously administered clinical candidate for the treatment of chronic hepatitis B virus infection

 

Presented new clinical data at HEP DART 2017 demonstrating up to 5.0 log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following RNAi therapy, ARC-520, in the 2001 open-label extension study


 

Made continued progress on a two-product cardiovascular collaboration with Amgen, in which one that was previously called ARO-LPA against the target lipoprotein(a) has been formally nominated as a potential clinical candidate and which is now referred to as AMG 890 by Amgen

 

Expanded Arrowhead’s cardiometabolic pipeline, which now includes ARO-APOC3, targeting apolipoprotein C-III, and ARO-ANG3, targeting angiopoietin-like protein 3 (ANGPTL3); with CTA filings planned around the end of 2018

 

Achieved continued progress with the Company’s extra-hepatic platform and pipeline, including:

 

o

ARO-Lung1, Arrowhead’s first candidate against an undisclosed gene target in the lung, which achieved nearly 90% target knockdown following inhaled administration in rodents

 

o

ARO-HIF2, the Company’s candidate targeting renal cell carcinoma, which achieved 85% target gene knockdown in a rodent tumor model



Selected Fiscal 2018 First Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

 

OPERATING SUMMARY

 

2017

 

 

2016

 

 

 

 

 

 

 

 

 

 

 

 

REVENUE

 

$

3,509,821

 

 

$

4,365,496

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

Research and development

 

 

8,431,903

 

 

 

9,527,051

 

 

Salaries and payroll-related costs

 

 

3,986,367

 

 

 

4,276,105

 

 

General and administrative expenses

 

 

1,671,185

 

 

 

1,854,174

 

 

Stock-based compensation

 

 

2,092,541

 

 

 

2,424,442

 

 

Depreciation and amortization

 

 

1,141,173

 

 

 

1,185,611

 

 

TOTAL OPERATING EXPENSES

 

 

17,323,169

 

 

 

19,267,383

 

 

OPERATING LOSS

 

 

(13,813,348

)

 

 

(14,901,887

)

 

OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES

 

 

614,470

 

 

 

2,815,779

 

 

NET LOSS

 

$

(13,198,878

)

 

$

(12,086,108

)

 

 

 

 

 

 

 

 

 

 

 

NET LOSS PER SHARE (BASIC AND DILUTED):

 

$

(0.18

)

 

$

(0.17

)

 

WEIGHTED AVERAGE SHARES OUTSTANDING

 

 

74,831,415

 

 

 

71,444,600

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

 

December

 

 

September

 

 

 

 

31, 2017

 

 

30, 2017

 

 

CASH AND CASH EQUIVALENTS

 

$

11,531,345

 

 

$

24,838,567

 

 

SHORT-TERM INVESTMENTS

 

 

39,169,376

 

 

 

40,769,539

 

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

 

50,700,721

 

 

 

65,608,106

 

 

OTHER ASSETS

 

 

37,519,772

 

 

 

38,414,174

 

 

TOTAL ASSETS

 

 

88,220,493

 

 

 

104,022,280

 

 

TOTAL LIABILITIES

 

 

18,021,183

 

 

 

23,155,118

 

 

TOTAL STOCKHOLDERS' EQUITY

 

 

70,199,310

 

 

 

80,867,162

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 

$

88,220,493

 

 

$

104,022,280

 

 

 

 

 

 

 

 

 

 

 

 

SHARES  OUTSTANDING

 

 

74,917,876

 

 

 

74,785,426

 

 



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/alerts.cfm .

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 future success of our scientific studies, our ability to successfully develop 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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