- Conference Call and Webcast Today at 4:30
p.m. EDT
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160510006715/en/
Arrowhead Pharmaceuticals, Inc.Vince Anzalone,
CFA626-304-3400ir@arrowheadpharma.comorInvestor
Relations:The Trout GroupChad
Rubin646-378-2947ir@arrowheadpharma.comorMedia:Russo
PartnersMatt Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.com
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