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)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
(Address of principal executive offices, including Zip Code)
(626 ) 304-3400
(Registrant’s telephone number, including area code)
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)) | |||||
| Securities registered pursuant to Section 12(b) of the Act: | ||||||||||||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
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 February 6, 2023 , Arrowhead Pharmaceuticals, Inc. announced and commented on its financial results for the first quarter ended December 31, 2022. 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 | ||||||||
| 104 | Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). | |||||||
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: February 6, 2023
| ARROWHEAD PHARMACEUTICALS, INC. | ||||||||
| By: | /s/ Kenneth Myszkowski | |||||||
| Kenneth Myszkowski | ||||||||
| Chief Financial Officer | ||||||||
EXHIBIT 99.1
Press Release
February 6, 2023
Arrowhead Pharmaceuticals Reports Fiscal 2023 First Quarter Results
–Conference Call and Webcast Today, February 6, 2023 at 4:30 p.m. ET
PASADENA, Calif., February 6, 2023 — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR)
today announced financial results for its fiscal first quarter ended December 31, 2022. The company is hosting a conference call today, February 6, 2023, at 4:30 p.m. ET to discuss the 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. A replay of the webcast will be available approximately two hours after the conclusion of the call.
For analysts that wish to participate in the conference call, please register at https://register.vevent.com/register/BI9b2661110f7a4b0ebc648bf42d2a403f. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.
Selected Recent Events
•Announced topline results with Takeda from the Phase 2 SEQUOIA clinical study of investigational fazirsiran for the treatment of liver disease associated with alpha-1 antitrypsin deficiency and provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda. Key results from SEQUOIA included the following:
◦Fibrosis regression observed in 50% of patients receiving fazirsiran
◦Median reductions of 94% of Z-AAT accumulation in the liver and mean reduction of 68% in histologic globule burden
◦Treatment emergent adverse events were generally well balanced between fazirsiran and placebo groups
◦Results consistent with AROAAT-2002 open-label study previously published in The New England Journal of Medicine
•Earned a $25 million milestone payment from Amgen after the first subject was enrolled in Amgen’s Phase 3 trial of olpasiran for the treatment of cardiovascular disease
•Earned a $15 million milestone payment from Horizon Therapeutics after the first subject was enrolled in Horizon’s Phase 1 study of HZN-457, formerly called ARO-XDH, for the treatment of gout
•Initiated dosing in AROMMP7-1001 (NCT05537025), a Phase 1/2a single ascending dose and multiple ascending dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7, an investigational RNAi therapeutic designed to reduce expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF), in up to 56 healthy volunteers and in up to 21 patients with IPF
•Presented interim data on the cardiometabolic pipeline in three late-breaking oral presentations at the American Heart Association (AHA) Scientific Sessions 2022 and at a virtual analyst and investor event. Key results included the following:
◦ARO-APOC3, an investigational RNAi therapeutic targeting apolipoprotein C-III (APOC3) being developed as a treatment for patients with cardiovascular disease, severe hypertriglyceridemia (SHTG), and familial chylomicronemia syndrome (FCS), decreased triglycerides by 86%, and non-HDL-C by 45% while increasing HDL-C by 99% in patients with severe hypertriglyceridemia
◦ARO-ANG3, an investigational RNAi therapeutic designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3) being developed as a treatment for patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH), decreased triglycerides by 59%, LDL-C by 32%, and was associated with a relative reduction in liver fat fraction in patients with mixed dyslipidemia
◦Olpasiran, which was originally developed by Arrowhead using its proprietary Targeted RNAi Molecule (TRiM™) platform and licensed to Amgen in 2016 and is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically-determined independent risk factor for cardiovascular disease, reduced Lp(a) levels by more than 95% in patients with established atherosclerotic cardiovascular disease. These data were simultaneously published in the New England Journal of Medicine (NEJM)
•Strengthened the balance sheet with the sale of Arrowhead’s royalty interest in olpasiran to Royalty Pharma for:
◦$250 million in cash upfront
◦Up to $160 million in additional payments contingent on the achievement of certain clinical, regulatory, and sales milestones
◦Retained rights to $400 million in development, regulatory, and sales milestone payments potentially due from Amgen from the 2016 out-licensing agreement
Selected Fiscal 2022 Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION
(in thousands, except per share amounts)
Year Ended December 31, | |||||||||||
| OPERATING SUMMARY | 2022 | 2021 | |||||||||
| (unaudited) | |||||||||||
| Revenue | $ | 62,546 | $ | 27,439 | |||||||
| Operating Expenses: | |||||||||||
| Research and development | 83,695 | 65,765 | |||||||||
| General and administrative expenses | 20,985 | 24,995 | |||||||||
| Total Operating Expenses | 104,680 | 90,760 | |||||||||
| Operating loss | (42,134) | (63,321) | |||||||||
| Other income, net | 340 | 449 | |||||||||
| Loss before income tax expense and noncontrolling interest | (41,794) | (62,872) | |||||||||
| Income tax expense | 17 | — | |||||||||
| Net loss including noncontrolling interest | (41,811) | (62,872) | |||||||||
| Net loss attributable to noncontrolling interest, net of tax | (486) | — | |||||||||
| Net loss attributable to Arrowhead Pharmaceuticals, Inc. | $ | (41,325) | $ | (62,872) | |||||||
| Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted | $ | (0.39) | $ | (0.60) | |||||||
| Weighted-average shares used in calculating - Diluted | 106,039 | 104,534 | |||||||||
| FINANCIAL POSITION SUMMARY | December 31, 2022 | September 30, 2022 | |||||||||
| (unaudited) | |||||||||||
| Cash, cash equivalents and restricted cash | $ | 202,249 | $ | 108,005 | |||||||
| Short-term investments | 299,582 | 268,391 | |||||||||
| Long-term investments | 115,774 | 105,872 | |||||||||
| Total cash resources (cash and investments) | 617,605 | 482,268 | |||||||||
| Other assets | 273,884 | 209,671 | |||||||||
| Total Assets | $ | 891,489 | $ | 691,939 | |||||||
| Current deferred revenue | $ | 66,281 | $ | 74,099 | |||||||
| Long-term deferred revenue | 40,789 | 55,950 | |||||||||
| Other liabilities | 388,047 | 143,551 | |||||||||
| Total Liabilities | $ | 495,117 | $ | 273,600 | |||||||
| Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity | $ | 377,039 | $ | 398,520 | |||||||
| Noncontrolling Interest | 19,333 | 19,819 | |||||||||
| Total Noncontrolling Interest and Stockholders' Equity | 377,039 | 418,339 | |||||||||
| Total Liabilities, Noncontrolling Interest and Stockholders' Equity | $ | 872,156 | $ | 691,939 | |||||||
| Shares Outstanding | 106,140 | 105,960 | |||||||||
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. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” or “continue” are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. 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 numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, 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, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. 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:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com
Media:
LifeSci Communications, LLC
Josephine Belluardo, Ph.D.
646-751-4361
jo@lifescicomms.com
www.lifescicommunications.com
Source: Arrowhead Pharmaceuticals, Inc.
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