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 8, 2019
Arrowhead Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-38042 |
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46-0408024 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b) |
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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. ☐
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, Par Value $0.01 per share |
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ARWR |
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The Nasdaq Global Select Market |
Item 2.02 Results of Operations and Financial Condition
On May 8. 2019, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2019 second quarter financial results for the period ended March 31, 2019. 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
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Exhibit No. |
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Description |
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99.1 |
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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 8, 2019
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ARROWHEAD PHARMACEUTICALS, INC. |
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By: |
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/s/ Kenneth Myszkowski |
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Kenneth Myszkowski |
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Chief Financial Officer |
Exhibit 99.1
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PRESS RELEASE May 8, 2019 |
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Arrowhead Pharmaceuticals Reports Fiscal 2019 Second Quarter Results
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Conference Call and Webcast Today at 4:30 p.m. EDT |
PASADENA, Calif., May 8, 2019 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2019 second quarter ended March 31, 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 5049067.
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 5049067.
Selected Fiscal 2019 Second Quarter and Recent Events
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Began dosing in a Phase 1 single and multiple dose study of ARO-ANG3, a subcutaneously administered RNAi therapeutic targeting angiopoietin like protein 3, being developed as a potential treatment for patients with dyslipidemias and metabolic diseases |
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Began dosing in a Phase 1 single and multiple dose study of ARO-APOC3, a subcutaneously administered RNAi therapeutic targeting apolipoprotein C-III, being developed as a potential treatment for patients with hypertriglyceridemia |
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Presented data on both the AAT and hepatitis B programs at the EASL International Liver Congress™ 2019. Key findings included the following: |
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Sustained RNAi reduction of the mutant Z-AAT protein in PiZ mice, which harbor the human Z-AAT gene and recapitulate many features of human AAT deficiency liver disease, treated for 33 weeks substantially reversed the disease phenotype |
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JNJ-3989, formerly ARO-HBV, rapidly reduced hepatitis B surface antigen (HBsAg) in patients that had 24 weeks or more of HBsAg assay results (n=40) to thresholds possibly associated with improved chances of HBsAg seroclearance in many patients, after only 3 doses |
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100% of patients (40 of 40) achieved ≥1.0 Log10 IU/mL HBsAg reduction |
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88% of patients (35 of 40) achieved HBsAg <100 IU/mL |
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JNJ-3989 reduced all measurable viral products, including HBsAg in hepatitis B e-antigen (HBeAg) positive or HBeAg negative patients |
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JNJ-3989 administered subcutaneously was well tolerated at doses up to 400 mg in all chronic hepatitis B patients |
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Expanded the AROHBV1001 Phase 1/2 study to include a new triple combination cohort that includes JNJ-3989 and additional undisclosed agents selected by Arrowhead’s partner, Janssen Pharmaceuticals, Inc. |
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In connection with the start of dosing of this cohort, Arrowhead earned a $25 million milestone payment from Janssen |
Selected Fiscal 2019 Second Quarter Financial Results
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ARROWHEAD PHARMACEUTICALS, INC. |
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CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) |
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Three Months Ended March 31, |
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Six Months Ended March 31, |
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OPERATING SUMMARY |
2019 |
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2018 |
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2019 |
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2018 |
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REVENUE |
$ |
48,148,275 |
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$ |
650,125 |
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$ |
82,806,171 |
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$ |
4,159,946 |
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OPERATING EXPENSES |
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Research and development |
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20,798,628 |
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12,002,354 |
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38,370,671 |
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24,921,972 |
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General and administrative expenses |
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5,338,955 |
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3,681,830 |
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11,478,664 |
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8,085,381 |
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TOTAL OPERATING EXPENSES |
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26,137,583 |
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15,684,184 |
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49,849,335 |
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33,007,353 |
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OPERATING INCOME (LOSS) |
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22,010,692 |
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(15,034,059 |
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32,956,836 |
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(28,847,407 |
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OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES |
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1,886,290 |
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149,748 |
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2,977,399 |
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764,218 |
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NET INCOME (LOSS) |
$ |
23,896,982 |
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(14,884,311 |
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$ |
35,934,235 |
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$ |
(28,083,189 |
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NET INCOME (LOSS) PER SHARE (DILUTED) |
$ |
0.24 |
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(0.18 |
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$ |
0.37 |
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(0.35 |
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WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED) |
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98,082,644 |
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84,083,937 |
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97,214,546 |
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79,406,838 |
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FINANCIAL POSITION SUMMARY |
March 31, |
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September 30, |
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2019 |
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2018 |
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CASH AND CASH EQUIVALENTS |
$ |
161,639,208 |
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$ |
30,133,213 |
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SHORT-TERM INVESTMENTS |
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56,560,674 |
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46,400,176 |
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LONG-TERM INVESTMENTS |
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67,536,054 |
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TOTAL CASH RESOURCES (CASH AND INVESTMENTS) |
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285,735,936 |
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76,533,389 |
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OTHER ASSETS |
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48,204,497 |
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35,076,562 |
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TOTAL ASSETS |
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333,940,433 |
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111,609,951 |
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TOTAL CURRENT DEFERRED REVENUE |
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90,889,801 |
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600 |
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TOTAL LONG TERM DEFERRED REVENUE |
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29,732,938 |
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OTHER LIABILITIES |
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12,677,458 |
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16,368,350 |
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TOTAL LIABILITIES |
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133,300,197 |
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16,368,950 |
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TOTAL STOCKHOLDERS' EQUITY |
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200,640,236 |
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95,241,001 |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
333,940,433 |
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$ |
111,609,951 |
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SHARES OUTSTANDING |
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94,665,718 |
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88,502,302 |
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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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