Form 8-K ARROWHEAD PHARMACEUTICAL For: Dec 11

December 11, 2018 4:06 PM

 

 

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): December 11, 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 December 11, 2018, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2018 financial results for the period ended September 30, 2018. 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 December 11, 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: December 11, 2018

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

Kenneth Myszkowski

 

 

Chief Financial Officer

 

 

Exhibit 99.1

PRESS RELEASE

Dec. 11, 2018

 

 

 

Arrowhead Pharmaceuticals Reports Fiscal 2018 Year End Results

 

-

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

PASADENA, Calif., Dec. 11, 2018 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2018 fourth quarter and year ended September 30, 2018. 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 6744427.

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 6744427.

Selected Fiscal 2018 and Recent Events

 

Hosted an Analyst R&D Day in September 2017 to highlight the following:

 

o

The Targeted RNAi Molecule platform, or TRiMTM, which utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting, while being structurally simple. The TRiMTM platform offers several potential competitive advantages including:

 

A more sophisticated RNAi trigger selection and screening process that identifies potent sequences rapidly in locations that RNAi competitors may miss


 

Multiple routes of administration including subcutaneous, intravenous, and inhaled

 

Faster time to clinical candidates

 

Optimal pharmacologic activity and long duration-of-effect

 

Potentially wide safety margins

 

Simplified manufacturing at reduced cost

 

And, the promise of taking RNAi to tissues beyond the liver

 

Presented new clinical data at HEP DART 2017 and EASL 2018 demonstrating up to 5.3 Log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following first generation RNAi therapy, ARC-520, in the 2001 open label extension study

 

o

One patient serocleared all viral markers, including HBsAg

 

Began a Phase 1 study of ARO-AAT, Arrowhead’s second generation subcutaneously administered RNAi therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency

 

Began a Phase 1/2 study of ARO-HBV, a third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential treatment for patients with chronic hepatitis B virus infection

 

Announced that Amgen had administered the first dose of AMG 890, formerly ARO-LPA, in a Phase 1 clinical study, which earned Arrowhead a $10 million milestone payment

 

Presented clinical data on ARO-AAT at the Alpha-1 National Education Conference and at the AASLD Liver Meeting 2018 demonstrating:

 

o

Three monthly doses of 300 mg ARO-AAT led to reductions in serum alpha-1 antitrypsin to below the level of quantitation in 100% of subjects

 

o

Reductions were sustained for greater than 14 weeks indicating that quarterly or less frequent dosing appears feasible

 

o

Single and multiple doses of ARO-AAT appeared to be well-tolerated at all doses tested

 

Presented clinical data on ARO-HBV at the World Gastroenterologists Summit and at the AASLD Liver Meeting 2018 demonstrating:

 

o

Mean HBsAg reduction of -1.9 Log10 (-98.7%) with a range of -1.3 Log10 (-95.0%) to -3.8 Log10 (-99.98%)

 

o

ARO-HBV appeared to be well-tolerated at monthly doses up to 400 mg


 

Signed a license agreement with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceuticals Companies of Johnson & Johnson, for ARO-HBV and a collaboration agreement for up to three RNAi therapeutic candidates that use our proprietary TRiMTM platform against new targets to be selected by Janssen

 

o

The total potential deal value is approximately $3.7 billion plus royalties on commercial sales

 

o

Received $175 million as an upfront payment and received $75 million in the form of an equity investment by Johnson & Johnson Innovation – JJDC, Inc., at a price of $23.00 per share of Arrowhead common stock

 

Hosted an R&D Day in October 2018 to discuss in more detail our emerging pipeline of RNAi therapeutics that leverage the TRiMTM platform

 

Filed for regulatory clearance to begin a Phase 1 study of ARO-ANG3, an RNAi-based investigational medicine targeting angiopoietin like protein 3 (ANGPTL3) being developed for the treatment of dyslipidemias and metabolic diseases



Selected Fiscal 2018 Year End Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

 

 

Year Ended September 30,

 

 

OPERATING SUMMARY

2018

 

 

2017

 

 

 

 

 

 

 

 

 

 

 

REVENUE

$

16,142,321

 

 

$

31,407,709

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

 

52,968,505

 

 

 

50,904,466

 

 

General and administrative expenses

 

19,110,051

 

 

 

17,499,152

 

 

TOTAL OPERATING EXPENSES

 

72,078,556

 

 

 

68,403,618

 

 

OPERATING LOSS

 

(55,936,235

)

 

 

(36,995,909

)

 

OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES

 

1,485,757

 

 

 

2,615,614

 

 

NET LOSS

$

(54,450,478

)

 

$

(34,380,295

)

 

 

 

 

 

 

 

 

 

 

NET LOSS PER SHARE (BASIC AND DILUTED):

$

(0.65

)

 

$

(0.47

)

 

WEIGHTED AVERAGE SHARES OUTSTANDING

 

83,638,469

 

 

 

73,898,598

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

September 30,

 

 

September 30,

 

 

 

2018

 

 

2017

 

 

CASH AND CASH EQUIVALENTS

$

30,133,213

 

 

$

24,838,567

 

 

SHORT-TERM INVESTMENTS

 

46,400,176

 

 

 

40,769,539

 

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

76,533,389

 

 

 

65,608,106

 

 

OTHER ASSETS

 

35,076,562

 

 

 

38,414,174

 

 

TOTAL ASSETS

 

111,609,951

 

 

 

104,022,280

 

 

TOTAL LIABILITIES

 

16,368,950

 

 

 

23,155,118

 

 

TOTAL STOCKHOLDERS' EQUITY

 

95,241,001

 

 

 

80,867,162

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

111,609,951

 

 

$

104,022,280

 

 

 

 

 

 

 

 

 

 

 

SHARES OUTSTANDING

 

88,505,302

 

 

 

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/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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