Arrowhead Reports Fiscal 2016 Second Quarter Results
– Conference Call and Webcast Today at 4:30 p.m. EDT
PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial
results for its fiscal 2016 second quarter ended March 31, 2016. 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 enter Conference ID 5054757.
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 5054757.
Fiscal 2016 Second Quarter and Recent Company Highlights
Corporate Events
-
Completed corporate name change to Arrowhead Pharmaceuticals, Inc. to
better reflect the company’s stage of development and launched a new
website at ArrowheadPharma.com with an updated corporate identity
ARC-520
-
Began dosing patients in three Phase 2b studies: the MONARCH study,
2007 long-term extension, and 2001 open-label extension
-
Presented promising ARC-520 hepatitis B data at The International
Liver Congress™ 2016, including the following key findings:
-
ARC-520 and entecavir produced rapid HBV DNA suppression with all
hepatitis B e-antigen (HBeAg) positive, treatment naïve patients
achieving serum HBV DNA reductions of up to 5.5 log (99.9997%),
and all HBeAg negative, treatment naïve patients achieving
reductions that put them below the limit of quantitation
-
ARC-520 effectively inhibited HBV cccDNA-derived mRNA with
observed viral protein reduction in HBV patients of up to 2.0 log
(99%) after a single dose
-
ARC-520 had a long duration of effect with HBsAg still reduced by
83% after 2 months and 75% after 3 months, which is the final time
point of the study, after a single dose
-
Based on HBsAg epitope profile analysis, poster authors and
Arrowhead collaborators had previously identified a predictive
hepatitis B surface-antigen (HBsAg) Clearance Profile associated
with HBsAg clearance in antiviral therapy cohorts
-
There was a significant association between the development of an
HBsAg Clearance Profile and ARC-520 therapy in HBV patients
-
Complexed HBsAg antibodies (anti-HBs) were developed and detected
in HBV patients treated with ARC-520, which may represent a
recovery of the immune system response
-
After monthly administration of 6-11 doses of ARC-520 in
chimpanzees chronically infected with HBV, the ARC-520 target site
sequences remained virtually unchanged, indicating that no drug
resistance developed during the treatment period
-
ARC-521
-
Filed for regulatory clearance to begin a Phase 1/2 first-in-human
study to assess single and multiple-doses of ARC-521 in healthy
volunteers and HBV patients
ARC-AAT
-
Received Orphan Drug Designation by the European Medicines Agency
Platform and Early Pipeline
-
Presented promising new preclinical data the 2016 American Academy of
Allergy, Asthma & Immunology Annual Meeting suggesting that ARC-F12,
an RNAi therapeutic that inhibits the production of Factor XII (F12),
has the potential to treat hereditary angioedema and to prevent
thrombosis
-
Presented data at the American Association for Cancer Research Annual
Meeting 2016 (AACR16), showing that ARC-HIF2 inhibited tumor growth
and promoted tumor cell death and structural degeneration in two
different renal cell carcinoma tumor bearing mouse models
-
These data also show that important advancements are being made to
Arrowhead’s Dynamic Polyconjugate™ (DPC™) delivery platform to
include extra-hepatic targeting capabilities
-
-
Presented data on ARC-LPA, a preclinical development program targeting
lipoprotein (a), or Lp(a), for the treatment of cardiovascular
disease, at the Arteriosclerosis, Thrombosis and Vascular Biology |
Peripheral Vascular Disease (ATVB|PVD) 2016 Scientific Sessions
-
These data show that ARC-LPA and Arrowhead’s new delivery vehicles
designed for subcutaneous administration can induce deep target
gene knockdown with long duration of effect that may enable
monthly, bi-monthly, or even less frequent administration
-
Selected Fiscal 2016 Second Quarter Financial Results
|
ARROWHEAD PHARMACEUTICALS, INC. |
||||||||||||||||
|
CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) |
||||||||||||||||
|
|
|
|
|
|||||||||||||
|
Three Months Ended |
Six Months Ended |
|||||||||||||||
|
March 31, |
March 31, |
|||||||||||||||
|
OPERATING SUMMARY |
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
||||
|
|
||||||||||||||||
|
REVENUE |
$ |
43,750 |
$ |
43,750 |
$ |
87,500 |
$ |
214,500 |
||||||||
|
OPERATING EXPENSES |
||||||||||||||||
|
Research and development |
10,020,826 |
11,640,794 |
20,359,659 |
29,387,524 |
||||||||||||
|
Acquired in-process research and development |
– |
10,142,786 |
– |
10,142,786 |
||||||||||||
|
Salaries and payroll-related costs |
4,248,693 |
3,541,652 |
8,168,579 |
6,692,268 |
||||||||||||
|
General and administrative expenses |
3,818,335 |
1,696,623 |
5,769,944 |
3,782,826 |
||||||||||||
|
Stock-based compensation |
2,416,839 |
2,205,079 |
4,797,182 |
4,219,935 |
||||||||||||
|
Depreciation and amortization |
|
803,912 |
|
|
449,559 |
|
|
1,598,261 |
|
|
739,598 |
|
||||
|
TOTAL OPERATING EXPENSES |
|
21,308,605 |
|
|
29,676,493 |
|
|
40,693,625 |
|
|
54,964,937 |
|
||||
|
OPERATING LOSS |
(21,264,855 |
) |
(29,632,743 |
) |
(40,606,125 |
) |
(54,750,437 |
) |
||||||||
|
OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES |
|
448,995 |
|
|
948,750 |
|
|
525,851 |
|
|
3,488,743 |
|
||||
|
NET LOSS |
$ |
(20,815,860 |
) |
$ |
(28,683,993 |
) |
$ |
(40,080,274 |
) |
$ |
(51,261,694 |
) |
||||
|
|
||||||||||||||||
|
EARNINGS PER SHARE (BASIC AND DILUTED): |
$ |
(0.35 |
) |
$ |
(0.51 |
) |
$ |
(0.67 |
) |
$ |
(0.93 |
) |
||||
|
WEIGHTED AVERAGE SHARES OUTSTANDING |
|
59,779,128 |
|
|
55,719,923 |
|
|
59,663,270 |
|
|
55,200,512 |
|
||||
|
|
||||||||||||||||
|
FINANCIAL POSITION SUMMARY |
March 31, |
September 30, |
||||||||||||||
|
|
2016 |
|
|
2015 |
|
|||||||||||
|
CASH AND CASH EQUIVALENTS |
50,300,847 |
81,214,354 |
||||||||||||||
|
SHORT-TERM INVESTMENTS |
|
11,160,442 |
|
|
17,539,902 |
|
||||||||||
|
TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) |
61,461,289 |
98,754,256 |
||||||||||||||
|
OTHER ASSETS |
|
33,146,182 |
|
|
33,513,658 |
|
||||||||||
|
TOTAL ASSETS |
|
94,607,471 |
|
|
132,267,914 |
|
||||||||||
|
TOTAL LIABILITIES |
20,681,234 |
22,646,280 |
||||||||||||||
|
TOTAL STOCKHOLDERS’ EQUITY |
|
73,926,237 |
|
|
109,621,634 |
|
||||||||||
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
94,607,471 |
|
|
132,267,914 |
|
||||||||||
|
|
||||||||||||||||
|
SHARES OUTSTANDING |
59,960,711 |
59,544,677 |
||||||||||||||
|
PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) |
62,631,701 |
62,215,667 |
||||||||||||||
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. The company’s pipeline includes ARC-520 and ARC-521 for
chronic hepatitis B virus infection, ARC-AAT for liver disease
associated with alpha-1 antitrypsin deficiency, ARC-F12 for hereditary
angioedema and thromboembolic disorders, ARC-LPA for cardiovascular
disease, and ARC-HIF2 for renal cell carcinoma.
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 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.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead
Pharmaceuticals, Inc.
Source: Arrowhead Pharmaceuticals, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160510006715/en/
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
or
Investor
Relations:
The Trout Group
Chad Rubin
646-378-2947
ir@arrowheadpharma.com
or
Media:
Russo
Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
Source: Arrowhead Pharmaceuticals, Inc.
News Provided by Acquire Media