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Press Release Details

Arrowhead Pharmaceuticals Reports Fiscal 2019 Third Quarter Results

August 5, 2019

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

PASADENA, Calif.--(BUSINESS WIRE)--Aug. 5, 2019-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2019 third quarter ended June 30, 2019. 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 3249189.

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 3249189.

Selected Fiscal 2019 Third Quarter and Recent Events

  • Received U.S. Food and Drug Administration (FDA) clearance to begin an adaptive design Phase 2/3 trial, called SEQUOIA, with the potential to serve as a pivotal registrational 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
  • Secured first regulatory clearance in the United Kingdom for the ARO-AAT 2002 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
  • Expanded the AROHBV1001 Phase 1/2 study to include a new triple combination cohort that includes: JNJ-3989, formerly ARO-HBV; JNJ-6379, Janssen’s investigational orally administered capsid assembly modulator of the class that forms normal capsid structures; and, a nucleos(t)ide analog, or NUC
    • In connection with the start of dosing of this cohort, Arrowhead earned a $25 million milestone payment from Janssen
  • Received orphan drug designation from FDA for ARO-APOC3 for the treatment of familial chylomicronemia syndrome
  • Received FDA Fast Track designation for ARO-AAT
    • Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier
  • Received orphan drug designation from FDA for ARO-ANG3 for the treatment of homozygous familial hypercholesterolemia
  • Completed discovery and development work on ARO-HSD, a previously undisclosed liver-targeted candidate targeting HSD17B13, a hydroxysteroid dehydrogenase involved in the metabolism of hormones, fatty acids and bile acids, that is now in IND-enabling GLP-toxicology studies, and, pending success in the tox program, on schedule for a CTA filing at the end of 2019
  • Started IND-enabling GLP-toxicology studies for ARO-HIF2, designed to inhibit the production of HIF-2a for the treatment of clear cell renal cell carcinoma, to support, pending success in the tox program, a CTA filing at the end of 2019
  • Completed dosing in the single-ascending dose portions of the Phase 1 studies of Arrowhead’s two wholly-owned cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, and progressed towards the multiple-dose portions of the Phase 1 studies in various patient populations

Selected Fiscal 2019 Third Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

OPERATING SUMMARY

2019

 

 

2018

 

2019

 

2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REVENUE

$

42,696,636

 

 

$

727,375

 

 

$

125,502,807

 

 

$

4,887,321

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

19,291,710

 

 

 

12,052,653

 

 

 

57,662,381

 

 

 

36,974,675

 

 

General and administrative expenses

 

4,809,177

 

 

 

4,594,441

 

 

 

16,287,841

 

 

 

12,679,822

 

 

TOTAL OPERATING EXPENSES

 

24,100,887

 

 

 

16,647,094

 

 

 

73,950,222

 

 

 

49,654,497

 

 

OPERATING INCOME (LOSS)

 

18,595,749

 

 

 

(15,919,719

)

 

 

51,552,585

 

 

 

(44,767,176

)

 

OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES

 

1,739,959

 

 

 

313,702

 

 

 

4,717,359

 

 

 

1,077,919

 

 

NET INCOME (LOSS)

$

20,335,708

 

 

$

(15,606,017

)

 

$

56,269,944

 

 

$

(43,689,257

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS) PER SHARE (DILUTED)

$

0.21

 

 

$

(0.18

)

 

$

0.58

 

 

$

(0.53

)

 

WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED)

 

98,884,744

 

 

 

87,634,435

 

 

 

97,814,019

 

 

 

82,149,381

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

June 30,

 

 

September 30,

 

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS

$

188,331,747

 

 

$

30,133,213

 

 

 

 

 

 

 

 

 

 

RESTRICTED CASH

 

1,000,000

 

 

 

-

 

 

 

 

 

 

 

 

 

 

SHORT-TERM INVESTMENTS

 

48,567,215

 

 

 

46,400,176

 

 

 

 

 

 

 

 

 

 

LONG-TERM INVESTMENTS

 

57,555,499

 

 

 

-

 

 

 

 

 

 

 

 

 

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

295,454,461

 

 

 

76,533,389

 

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

41,373,984

 

 

 

35,076,562

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

336,828,445

 

 

 

111,609,951

 

 

 

 

 

 

 

 

 

 

TOTAL CURRENT DEFERRED REVENUE

 

78,681,868

 

 

 

600

 

 

 

 

 

 

 

 

 

 

TOTAL LONG TERM DEFERRED REVENUE

 

22,258,994

 

 

 

-

 

 

 

 

 

 

 

 

 

 

OTHER LIABILITIES

 

10,217,543

 

 

 

16,368,350

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

111,158,405

 

 

 

16,368,950

 

 

 

 

 

 

 

 

 

 

TOTAL STOCKHOLDERS' EQUITY

 

225,670,040

 

 

 

95,241,001

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

336,828,445

 

 

$

111,609,951

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHARES OUTSTANDING

 

95,207,637

 

 

 

88,502,302

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

Source: Arrowhead Pharmaceuticals, Inc.

Source: Arrowhead Pharmaceuticals Inc.

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