8-K
Arrowhead Pharmaceuticals, Inc. (ARWR)
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 7, 2020
Arrowhead Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38042 | 46-0408024 |
|---|---|---|
| (State or other jurisdiction<br><br><br>of incorporation) | (Commission<br><br><br>File Number) | (IRS Employer<br><br><br>Identification No.) |
177 E. Colorado Blvd, Suite 700, Pasadena, CA 91105
(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. ☐
| Securities registered pursuant to Section 12(b) of the Act: | ||
|---|---|---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, Par Value $0.001 per share | ARWR | The Nasdaq Global Select Market |
Item 2.02 Results of Operations and Financial Condition
On May 7, 2020, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2020 second quarter financial results for the period ended March 31, 2020. 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 May 7, 2020. |
| 104 | Cover Page Interactive 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: May 7, 2020
| ARROWHEAD PHARMACEUTICALS, INC. | |
|---|---|
| By: | /s/ Kenneth Myszkowski |
| Kenneth Myszkowski | |
| Chief Financial Officer |
arwr-ex991_6.htm
Exhibit 99.1
| PRESS RELEASE<br><br><br>May 7, 2020 |
|---|
Arrowhead Pharmaceuticals Reports Fiscal 2020 Second Quarter Results
| - | Conference Call and Webcast Today, May 7 at 4:30 p.m. EDT |
|---|
PASADENA, Calif., May 7, 2020 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal second quarter ended March 31, 2020. 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 7566917.
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 7566917.
Selected Recent Events
| • | Dosed the first patients in AROHSD1001, a Phase 1/2 clinical study of ARO-HSD, the company’s investigational RNAi therapeutic being developed as a treatment for patients with alcohol related and nonalcohol related liver diseases, such as nonalcoholic steatohepatitis |
|---|---|
| • | Completed enrollment of the first sequential cohort in the AROAAT2002 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 |
| --- | --- |
| • | Completed planned enrollment in AROANG1001, a Phase 1 clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed for the treatment of mixed dyslipidemia |
| --- | --- |
| • | Completed discovery and optimization work and advanced ARO-Lung2, Arrowhead’s investigational RNAi therapeutic being developed for the treatment of chronic obstructive pulmonary disorder (COPD), into IND-enabling studies with a planned CTA filing in in the first half of 2021. ARO-Lung2 is against an undisclosed gene target and is the company’s second inhaled RNAi candidate to leverage the Targeted RNAi Molecule (TRiM^TM^) platform to the target pulmonary epithelium |
| --- | --- |
| • | Started a development program to address the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens. No additional details about this program are being disclosed at this time |
| --- | --- |
| • | Reported interim multiple-dose results on two cardiometabolic candidates ARO-APOC3, being developed as a potential treatment for patients with severe hypertriglyceridemia, and ARO-ANG3, being developed for the treatment of mixed dyslipidemia, showing high levels of reduction in APOC3, ANGPTL3, triglycerides, and other lipid parameters |
| --- | --- |
| • | Completed a regulatory submission to begin a Phase 1/2a clinical trial of ARO-ENaC, the company’s investigational RNAi therapeutic being developed as a treatment for patients with cystic fibrosis |
| --- | --- |
| • | Expanded Arrowhead’s senior management team with the hiring of Jim Hassard as chief commercial officer |
| --- | --- |
| • | Opened a second Research and Development facility in San Diego, which allows Arrowhead to tap into additional skill sets in one the country’s premier biotech hubs and also expands capacity for preclinical models to do more early research work in parallel |
| --- | --- |
Selected Fiscal 2020 Second Quarter Financial Results
| ARROWHEAD PHARMACEUTICALS, INC. | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) | ||||||||||
| Three Months Ended March 31, | Six Months Ended March 31, | |||||||||
| OPERATING SUMMARY | 2020 | 2019 | 2020 | 2019 | ||||||
| REVENUE | $ | 23,528,853 | $ | 48,148,275 | $ | 52,983,433 | $ | 82,806,171 | ||
| OPERATING EXPENSES | ||||||||||
| Research and development | 29,443,335 | 20,798,628 | 52,816,951 | 38,370,671 | ||||||
| General and administrative expenses | 16,325,773 | 5,338,955 | 27,260,330 | 11,478,664 | ||||||
| TOTAL OPERATING EXPENSES | 45,769,108 | 26,137,583 | 80,077,281 | 49,849,335 | ||||||
| OPERATING INCOME (LOSS) | (22,240,255 | ) | 22,010,692 | (27,093,848 | ) | 32,956,836 | ||||
| OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES | 2,404,685 | 1,886,290 | 4,584,550 | 2,977,399 | ||||||
| NET INCOME (LOSS) | $ | (19,835,570 | ) | $ | 23,896,982 | $ | (22,509,298 | ) | $ | 35,934,235 |
| NET INCOME (LOSS) PER SHARE (DILUTED) | $ | (0.20 | ) | $ | 0.24 | $ | (0.23 | ) | $ | 0.37 |
| WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED) | 101,653,136 | 98,082,644 | 99,359,140 | 97,214,546 | ||||||
| FINANCIAL POSITION SUMMARY | March 31, | September 30, | ||||||||
| 2020 | 2019 | |||||||||
| CASH AND CASH EQUIVALENTS | $ | 256,650,727 | $ | 221,804,128 | ||||||
| SHORT-TERM INVESTMENTS | 50,959,058 | 36,899,894 | ||||||||
| LONG-TERM INVESTMENTS | 190,618,075 | 44,175,993 | ||||||||
| TOTAL CASH RESOURCES (CASH AND INVESTMENTS) | 498,227,860 | 302,880,015 | ||||||||
| OTHER ASSETS | 62,847,842 | 46,965,422 | ||||||||
| TOTAL ASSETS | 561,075,702 | 349,845,437 | ||||||||
| TOTAL CURRENT DEFERRED REVENUE | 33,174,765 | 77,769,629 | ||||||||
| TOTAL LONG TERM DEFERRED REVENUE | - | 5,035,142 | ||||||||
| OTHER LIABILITIES | 34,337,467 | 23,004,414 | ||||||||
| TOTAL LIABILITIES | 67,512,232 | 105,809,185 | ||||||||
| TOTAL STOCKHOLDERS' EQUITY | 493,563,470 | 244,036,252 | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 561,075,702 | $ | 349,845,437 | ||||||
| SHARES OUTSTANDING | 101,748,107 | 95,506,271 |
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.