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 14, 2016
Arrowhead Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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0-21898 |
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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) |
Item 2.02 Results of Operations and Financial Condition
On December 14, 2016, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2016 fourth quarter and year-end financial results for the period ended September 30, 2016. 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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Press Release, dated December 14, 2016. |
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 14, 2016
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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 December 14, 2016 |
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Arrowhead Reports Fiscal 2016 Year End Results
- Conference Call and Webcast Today at 4:30 p.m. EST
PASADENA, Calif., Dec. 14, 2016 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2016 fourth quarter and year ended September 30, 2016. 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 enter Conference ID 33791749.
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 404-537-3406 and enter Conference ID 33791749.
Selected Fiscal 2016 and Recent Events
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Discontinued development of ARC-520, ARC-521, and ARC-AAT in November 2016 |
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The Company announced that it would be discontinuing these clinical programs, which utilized the intravenously administered DPCivTM, or EX1, delivery vehicle, and redeploying its resources and focus toward utilizing the Company’s new proprietary subcutaneous and extra-hepatic delivery systems |
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The decision to discontinue development of EX1-containing programs was based primarily on two factors: |
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The Company has made substantial advances in RNA chemistry and targeting resulting in large potency gains for subcutaneous administered and extra-hepatic RNAi-based development programs |
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Because of the discontinuation of its existing clinical programs, the Company also reduced its workforce by approximately 30%, while maintaining resources necessary to support current and potential partner-based programs and the Company’s pipeline |
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Entered into two collaboration and license agreements with Amgen |
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Total deal value of up to $673.5 million |
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Arrowhead received $56.5 million upfront: |
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$35 million in upfront cash payments, $21.5 million equity investment |
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Up to low double-digit royalties for ARO-LPA and single-digit royalties for the undisclosed target, ARO- AMG1 |
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Amgen receives: |
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Exclusive license to ARO-LPA program |
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Option for an additional candidate against an undisclosed target, ARO- AMG1 |
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Amgen will be wholly responsible for funding and conducting all clinical development and commercialization |
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Continued progress on preclinical candidates including ARO-HBV, ARO-AAT, ARO-F12, ARO-LPA, and ARO-HIF2 |
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Regarding ARO-F12 and ARO-LPA: |
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Presented preclinical data at the American Heart Association’s Scientific Sessions 2016 for two development programs using Arrowhead’s proprietary subcutaneous delivery platform: |
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RNAi triggers against Factor 12 (F12) showed dose dependent reductions in serum F12 |
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A statistically significant reduction (p=0.002) in thrombus weight was observed at greater than 95% F12 knockdown in a rat arterio-venous shunt model |
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There was no increased bleeding risk in ARO- F12-treated mice, even with greater than 99% knockdown of F12 levels |
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RNAi triggers against Lipoprotein (a) [Lp(a)] led to greater than 98% maximum knockdown after a single 3 mg/kg SQ dose in Transgenic mice |
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In an atherosclerosis model, data suggest that RNAi triggers can be effectively delivered to a fatty liver using the subcutaneous delivery platform |
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Regarding ARO-HIF2 |
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Presented preclinical data showing that ARO-HIF2 inhibited renal cell carcinoma growth and promoted tumor cell death in its preclinical studies |
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Strengthened the Company’s balance sheet with August 2016 private offering and Amgen agreement upfront payments |
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In August 2016, the Company sold 7.6 million shares of Common Stock to certain institutional investors and received net proceeds of approximately $43.2 million |
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As part of the collaboration and license agreements as well as a Common Stock Purchase Agreement with Amgen, $14 million of the total $56.5 million upfront cash payments and equity investments were received in September 2016, and the remaining $42.5 million was received in November 2016 |
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Continued progress on former drug candidates prior to the discontinuations |
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Presented preclinical and clinical data on former drug candidate ARC-AAT at the Liver Meeting |
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In a first-in-human clinical study, ARC-AAT was well tolerated and induced deep and durable reduction of the target AAT protein |
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The preclinical data suggest a possible improvement of liver health and arrest of further damage from treatment with ARC-AAT |
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Advanced former drug candidate ARC-521 into a Phase 1/2 study |
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Conducted multiple dose and combination studies of former drug candidate ARC-520 |
Selected Fiscal 2016 Year End Financial Results
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ARROWHEAD PHARMACEUTICALS, INC. |
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CONSOLIDATED FINANCIAL INFORMATION |
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Year Ended September 30 |
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OPERATING SUMMARY |
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2016 |
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2015 |
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REVENUE |
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$ |
158,333 |
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$ |
382,000 |
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OPERATING EXPENSES |
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Research and development |
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41,454,452 |
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47,267,361 |
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Acquired in-process research and development |
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10,142,786 |
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Salaries and payroll-related costs |
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19,461,656 |
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16,554,008 |
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General and administrative expenses |
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9,940,737 |
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7,931,184 |
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Stock-based compensation |
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11,595,816 |
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10,232,897 |
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Depreciation and amortization |
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3,260,045 |
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2,336,207 |
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Impairment expense |
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2,050,817 |
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Contingent consideration - fair value adjustments |
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(5,862,464 |
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1,891,533 |
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TOTAL OPERATING EXPENSES |
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81,901,059 |
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96,355,976 |
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OPERATING LOSS |
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(81,742,726 |
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(95,973,976 |
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OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES |
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19,724 |
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4,033,094 |
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NET LOSS |
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$ |
(81,723,002 |
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$ |
(91,940,882 |
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EARNINGS PER SHARE (BASIC AND DILUTED): |
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$ |
(1.34 |
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(1.60 |
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WEIGHTED AVERAGE SHARES OUTSTANDING |
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61,050,880 |
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57,358,442 |
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FINANCIAL POSITION SUMMARY |
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September 30, |
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2016 |
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2015 |
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CASH AND CASH EQUIVALENTS |
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85,366,448 |
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81,214,354 |
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SHORT-TERM INVESTMENTS |
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17,539,902 |
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TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) |
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85,366,448 |
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98,754,256 |
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OTHER ASSETS |
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42,810,057 |
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33,513,658 |
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TOTAL ASSETS |
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128,176,505 |
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132,267,914 |
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TOTAL LIABILITIES |
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33,152,246 |
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22,646,280 |
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TOTAL STOCKHOLDERS' EQUITY |
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95,024,259 |
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109,621,634 |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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128,176,505 |
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132,267,914 |
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SHARES OUTSTANDING |
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69,746,685 |
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59,544,677 |
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PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) |
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72,417,675 |
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62,215,667 |
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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/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
Investor Relations:
The Trout Group
Chad Rubin
646-378-2947
ir@arrowheadpharma.com
Media:
Russo Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
Source: Arrowhead Pharmaceuticals, Inc.
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