Arrowhead Pharmaceuticals, Inc.
ARROWHEAD PHARMACEUTICALS, INC. (Form: 8-K, Received: 05/03/2017 16:09:38)

 

 

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 3, 2017

 

Arrowhead Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

Delaware

 

0-21898

 

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 May 3, 2017, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2017 second quarter financial results for the period ended March 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 May 3, 2017.

 

 

 



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 3, 2017

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

Kenneth Myszkowski

 

 

Chief Financial Officer

 

 

Exhibit 99.1

PRESS RELEASE

May 3, 2017

 

 

Arrowhead Reports Fiscal 2017 Second Quarter Results

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

PASADENA, Calif., May 3 , 2017 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR), today announced financial results for its fiscal 2017 second quarter ended March 31, 2017. 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 enter Conference ID 12326590.

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 enter Conference ID 12326590.

Selected Fiscal 2017 Second Quarter and Recent Events

 

Presented clinical data on former drug candidates ARC-520, ARC-521, and ARC-AAT at the EASL International Liver Congress with data that included the following findings:

 

o

Multiple-dose treatment with ARC-520 in combination with entecavir led to:

 

Reductions in hepatitis B surface antigen, or HBsAg, of up to 3.1 logs with a mean maximum reduction of 2.2 logs

 

Reductions in HBV DNA of several logs and to an undetectable level in many patients

 

o

ARC-521 appeared active against HBV gene products derived from both cccDNA and integrated HBV DNA


 

o

ARC-AAT treatment led to deep , durable, and dose- dependent reductions of serum AAT with similar levels of knockdown observed in healthy volunteers and patients

 

Continued progress on preclinical pipeline including ARO-HBV, ARO-AAT, ARO-F12, ARO-HIF2 and additional programs against undisclosed targets

 

Continued progress on cardiovascular disease collaboration with Amgen, which includes ARO-LPA and ARO-AMG1

 

Made key advancements in platform technology development including:

 

o

A proprietary subcutaneously administered, liver-targeted delivery vehicle

 

o

An extra-hepatic delivery platform, which includes multiple designs and structures depending on the type of extra-hepatic tissue that is being targeted



Selected Fiscal 2017 Second Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

 

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

March 31,

 

 

Six Months Ended

March 31,

 

OPERATING SUMMARY

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REVENUE

 

$

8,985,930

 

 

$

43,750

 

 

$

13,351,426

 

 

$

87,500

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

6,976,825

 

 

 

10,020,826

 

 

 

16,503,876

 

 

 

20,359,659

 

Salaries and payroll-related costs

 

 

3,583,999

 

 

 

4,248,693

 

 

 

7,860,105

 

 

 

8,168,579

 

General and administrative expenses

 

 

1,622,873

 

 

 

3,818,335

 

 

 

3,477,048

 

 

 

5,769,944

 

Stock-based compensation

 

 

1,744,231

 

 

 

2,416,839

 

 

 

4,168,673

 

 

 

4,797,182

 

Depreciation and amortization

 

 

1,187,644

 

 

 

803,912

 

 

 

2,373,255

 

 

 

1,598,261

 

TOTAL OPERATING EXPENSES

 

 

15,115,572

 

 

 

21,308,605

 

 

 

34,382,957

 

 

 

40,693,625

 

OPERATING LOSS

 

 

(6,129,642

)

 

 

(21,264,855

)

 

 

(21,031,531

)

 

 

(40,606,125

)

OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES

 

 

87,085

 

 

 

448,995

 

 

 

2,902,864

 

 

 

525,851

 

NET LOSS

 

$

(6,042,557

)

 

$

(20,815,860

)

 

$

(18,128,667

)

 

$

(40,080,274

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS PER SHARE (BASIC AND DILUTED):

 

$

(0.08

)

 

$

(0.35

)

 

$

(0.25

)

 

$

(0.67

)

WEIGHTED AVERAGE SHARES OUTSTANDING

 

 

74,629,855

 

 

 

59,779,128

 

 

 

73,019,726

 

 

 

59,663,270

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

 

March

 

 

September

 

 

 

 

 

 

 

 

 

 

 

31, 2017

 

 

30, 2016

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS

 

 

61,718,971

 

 

 

85,366,448

 

 

 

 

 

 

 

 

 

SHORT-TERM INVESTMENTS

 

 

24,910,492

 

 

 

-

 

 

 

 

 

 

 

 

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

 

86,629,463

 

 

 

85,366,448

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

 

40,242,180

 

 

 

42,810,057

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

 

126,871,643

 

 

 

128,176,505

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

33,535,154

 

 

 

33,152,246

 

 

 

 

 

 

 

 

 

TOTAL STOCKHOLDERS' EQUITY

 

 

93,336,489

 

 

 

95,024,259

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

126,871,643

 

 

 

128,176,505

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHARES  OUTSTANDING

 

 

74,772,103

 

 

 

69,746,685

 

 

 

 

 

 

 

 

 



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

Matthew P. Duffy
212-915-0685

matthew@lifesciadvisors.com

www.lifesciadvisors.com

 

Source: Arrowhead Pharmaceuticals, Inc.

 

 

 

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