On may 10, 2016 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2016 second quarter ended March 31, 2016 (Press release, Arrowhead Research Corporation, MAY 10, 2016, View Source [SID:1234512232]). The company is hosting a conference call at 4:30 p.m. EDT to discuss results.
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Conference Call and Webcast Details
Investors may access a live audio webcast on the Company’s website at View Source 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 (AACR) (Free AACR Whitepaper) 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)