ARROWHEAD PHARMACEUTICALS, INC. quarterly report, Q1 FY2014

Arrowhead Research Corporation — Q1 FY2014 10-Q

Reporting period: Three months ended December 31, 2013. The filing identifies the registrant as Arrowhead Research Corporation; the request metadata says Arrowhead Pharmaceuticals, Inc.

Business context

Arrowhead was a development-stage biopharmaceutical company developing targeted RNAi therapeutics and delivery technologies. Its pipeline included internal programs for chronic hepatitis B and obesity, plus partnered oncology programs. ARC-520 completed anticipated enrollment in a Phase 1 trial in Australia; the company was preparing a Phase 2a pilot efficacy study in chronically infected HBV patients.

Financial performance and liquidity

MetricQ1 FY2014 / December 31, 2013Comparable / prior balance
Revenue$43,750 in the financial statements; MD&A reports $42,750$159,016 in Q1 FY2013
Operating expenses$7.05 million$4.97 million
Operating loss$7.01 million$4.81 million
Net loss attributable to Arrowhead$10.63 million; basic and diluted loss per share $0.28$4.61 million; loss per share $0.33
Operating cash flow-$7.02 million-$3.84 million
Cash and cash equivalents$59.7 million$19.1 million at September 30, 2013
Investments$25.75 million amortized cost; $25.53 million fair value$10.73 million amortized cost at September 30, 2013
Total assets / stockholders’ equity$92.7 million / $80.9 million$37.3 million / $25.7 million at September 30, 2013

Cash plus investments totaled approximately $85.5 million. The company reported $62.8 million of financing cash inflow, principally from an October 2013 equity financing: $64 million gross and approximately $60 million net proceeds, plus $2.8 million from warrant and option exercises. Investing cash outflow was $15.1 million, including net purchases of fixed-income securities; capital expenditures were $0.1 million.

Current liabilities were $9.0 million, including $5.1 million of derivative liabilities and $1.05 million of notes payable. Long-term liabilities were $2.8 million, including $1.0 million of capital lease obligations. There is no meaningful operating margin given the minimal revenue and development-stage losses.

Changes versus the prior period

  • Revenue declined from $159,016 to a figure reported inconsistently as $42,750 in MD&A and $43,750 in the statements; the filing attributes current-period revenue to three technology license agreements.
  • Operating expenses rose 42% to $7.05 million, largely reflecting higher R&D spending: $3.13 million versus $1.58 million. Drug manufacturing, clinical trials, and outside laboratory services increased as ARC-520 advanced.
  • Net loss attributable to Arrowhead more than doubled. Other expense was $3.68 million, chiefly a $3.52 million noncash loss from remeasurement of derivative liabilities, versus modest other income in the prior-year quarter.
  • Cash increased substantially following the October equity financing; common shares outstanding rose to 39.0 million from 32.5 million at September 30, 2013. Preferred shares outstanding were 51,291, convertible into common shares subject to ownership limits.

Outlook, risks, and unusual items

  • Management stated that existing resources and its operating plan were expected to fund operations for at least the next 12 months. It also expected significant continuing cash investment in R&D, clinical trials, and drug manufacturing; no specific financial or clinical guidance was provided.
  • Key risks include clinical and regulatory uncertainty, the need for substantial future financing, and volatility in derivative valuations. Management noted that changes in assumptions—particularly the company’s stock price—can materially affect derivative liabilities and reported earnings.
  • Calando had ceased operations, lacked resources to repay its notes, and owed Arrowhead approximately $4.5 million under intercompany advances eliminated in consolidation. An involuntary Chapter 7 petition against Calando was filed January 29, 2014; Arrowhead did not expect a material impairment because substantially all Calando assets had already been impaired or reserved.
  • Calando’s $1.0 million note payable was past due; related accrued interest of $167,000 was included in accrued expenses. A separate Calando promissory note owed to another party, with principal and interest totaling $1.167 million, was also past due and unpaid.
  • Investment-grade corporate bonds were classified as held-to-maturity; their $25.75 million amortized cost exceeded fair value by $217,216. The company said it planned to hold them to maturity.
  • The filing reported effective disclosure controls, no material change in internal controls, and no litigation expected to have a material adverse effect. It stated there were no material changes to the risk factors in the latest Form 10-K.

Important facts for investors to verify

  • Reconcile the filing’s revenue discrepancy: $43,750 in the statements versus $42,750 in MD&A.
  • Review the assumptions and potential dilution associated with derivative warrants and convertible preferred shares; derivative liabilities were $5.1 million at quarter-end.
  • Track ARC-520 Phase 2a study initiation, progress, safety, and efficacy, along with manufacturing and clinical-trial spending.
  • Assess cash burn against management’s stated 12-month liquidity outlook and the company’s ongoing need for external capital.
  • Monitor the Calando bankruptcy, past-due obligations, and any resulting effects on Arrowhead despite management’s expectation of no material charge.