Arrowhead Pharmaceuticals Reports Fiscal 2021 Second Quarter Results
Conference Call and Webcast Today,
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 3080187.
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 3080187.
Selected Recent Events
-
Announced positive interim 48-week liver biopsy results from the AROAAT2002 study, an open-label Phase 2 clinical study of ARO-AAT, the company’s second generation investigational RNA interference (RNAi) therapeutic being co-developed with Takeda Pharmaceutical Company Limited as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD). The interim readout demonstrated that ARO-AAT treatment led to:
- Consistent and substantial reduction in intra-hepatic mutant AAT protein (Z-AAT), both Z-AAT monomer and Z-AAT polymer
- Consistent decrease in histological globule burden
- Improvements in fibrosis
- Improvements in other relevant biomarkers of liver health
- Arrowhead intends to present additional interim AROAAT2002 data at an upcoming medical congress, pending abstract acceptance.
- Announced ARO-DUX4, Arrowhead’s first muscle targeted investigational RNAi therapeutic candidate to utilize its proprietary Targeted RNAi Molecule (TRIMTM) platform. ARO-DUX4 is designed to target the gene that encodes human double homeobox 4 (DUX4) protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy (FSHD).
-
Submitted an Investigational New Drug Application (IND) to the
U.S. Food and Drug Administration (FDA) for a Phase 2b dose-finding clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with mixed dyslipidemia. - Submitted an IND to the FDA for a Phase 2b dose-finding clinical study of ARO-APOC3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with hypertriglyceridemia.
Selected Fiscal 2021 Second Quarter Financial Results
|
|
|||||||||||||||
CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) |
|
|||||||||||||||
(in thousands, except per share amounts) |
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Six months ended
|
|
||||||||||
OPERATING SUMMARY |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
REVENUE |
|
$ |
32,811 |
|
|
$ |
23,529 |
|
|
$ |
54,113 |
|
|
$ |
52,983 |
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
44,697 |
|
|
|
29,443 |
|
|
|
81,251 |
|
|
|
52,817 |
|
General and administrative expenses |
|
|
16,346 |
|
|
|
16,326 |
|
|
|
25,147 |
|
|
|
27,260 |
|
TOTAL OPERATING EXPENSES |
|
|
61,043 |
|
|
|
45,769 |
|
|
|
106,398 |
|
|
|
80,077 |
|
OPERATING INCOME (LOSS) |
|
|
(28,232 |
) |
|
|
(22,240 |
) |
|
|
(52,285 |
) |
|
|
(27,094 |
) |
OTHER INCOME/(EXPENSE) |
|
|
1,414 |
|
|
|
2,404 |
|
|
|
4,735 |
|
|
|
4,585 |
|
NET INCOME (LOSS) |
|
$ |
(26,818 |
) |
|
$ |
(19,836 |
) |
|
$ |
(47,550 |
) |
|
$ |
(22,509 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS) PER SHARE (DILUTED) |
|
$ |
(0.26 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.23 |
) |
WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED) |
|
|
103,867 |
|
|
|
101,653 |
|
|
|
103,303 |
|
|
|
99,359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL POSITION SUMMARY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
||
CASH AND CASH EQUIVALENTS |
|
$ |
372,377 |
|
|
$ |
143,583 |
|
|
|
|
|
|
|
|
|
SHORT-TERM INVESTMENTS AND MARKETABLE SECURITIES |
|
|
204,941 |
|
|
|
171,910 |
|
|
|
|
|
|
|
|
|
|
|
|
97,490 |
|
|
|
137,487 |
|
|
|
|
|
|
|
|
|
TOTAL CASH RESOURCES (CASH AND INVESTMENTS) |
|
|
674,808 |
|
|
|
452,980 |
|
|
|
|
|
|
|
|
|
OTHER ASSETS |
|
|
81,987 |
|
|
|
69,524 |
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
|
756,795 |
|
|
|
522,504 |
|
|
|
|
|
|
|
|
|
TOTAL CURRENT DEFERRED REVENUE |
|
|
144,879 |
|
|
|
19,291 |
|
|
|
|
|
|
|
|
|
OTHER LIABILITIES |
|
|
166,367 |
|
|
|
41,434 |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
311,246 |
|
|
|
60,725 |
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS' EQUITY |
|
|
445,549 |
|
|
|
461,779 |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
756,795 |
|
|
$ |
522,504 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHARES OUTSTANDING |
|
|
104,020 |
|
|
|
102,376 |
|
|
|
|
|
|
|
|
|
About
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,” “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 businesses, 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 continuing impact of the COVID-19 pandemic, 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, 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
Source:
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504005987/en/
626-304-3400
ir@arrowheadpharma.com
Investors:
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com
Media:
646-751-4361
jo@lifescicomms.com
www.lifescicommunications.com
Source: