HAYWARD, Calif.--(BUSINESS WIRE)-- Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced financial results for the third quarter and nine months ended September 30, 2011.
Total revenue was approximately $0.2 million for the third quarter of 2011, compared with approximately $0.2 million for the third quarter of 2010. Revenue for both periods reflects the quarterly royalty payment from Zogenix, Inc. for product sales of SUMAVEL® DosePro™ needle-free delivery system for the treatment of acute migraine and cluster headaches.
The Company’s net loss for the third quarter of 2011 was approximately $2.4 million, or $0.01 per share, compared with net income of approximately $1.3 million, or $0.01 per share, for the third quarter of 2010. Net income for the third quarter of 2010 was derived from the non-cash gain on the extinguishment of debt from the Novo Nordisk A/S equity for debt transaction. Total operating expenses for the third quarter of 2011 were approximately $2.3 million, compared with total operating expenses of approximately $3.3 million for the third quarter of 2010. The decrease in operating expenses was primarily due to expense reduction efforts and lower clinical and manufacturing costs for the inhaled ciprofloxacin program versus the prior year period.
As of September 30, 2011, cash, cash equivalents and short-term investments totaled approximately $10.7 million.
About inhaled ciprofloxacin
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF patients. The Company’s once-a-day novel inhaled formulations of ciprofloxacin are encapsulated in liposomes, allowing for a sustained release of the drug within the lung and improving airway tolerability. The formulations are to be used for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. Lipoquin™ (CFI, ARD-3100) is a liposomal formulation of ciprofloxacin. Pulmaquin™ is a dual release formulation (DRCFI, ARD-3150) that is a mixture of Lipoquin with unencapsulated ciprofloxacin.
The Phase 2b study ORBIT-2 (Once-Daily Respiratory Bronchiectasis Inhalation Treatment) was a 168 day, double-blind, placebo-controlled trial in 42 randomized BE patients with once daily Pulmaquin (ARD-3150) that resulted in excellent reduction of Pseudomonas aeruginosa colony forming units (CFUs), as well as a significant increase in the time to first exacerbation in the active group vs. placebo. Most recently, the Company reported positive top line data from the Phase 2b study ORBIT-1 with Lipoquin (ARD-3100) in patients with non-cystic fibrosis bronchiectasis. The primary endpoint – the mean change in Pseudomonas aeruginosa CFUs from baseline to day 28 – was met in the full analysis population with both the 2 mL and 3 mL doses vs. placebo. The Company previously reported positive results in Phase 2a studies of 22 CF patients and 36 BE patients who received Lipoquin (ARD-3100) once-a-day for 2 (CF) or 4 (BE) weeks, respectively. The Company is also developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia. Aradigm has been granted orphan drug designation for liposomal ciprofloxacin for cystic fibrosis in the U.S. and the E.U., and for liposomal ciprofloxacin and for inhaled ciprofloxacin for BE in the U.S.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. The Company has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation anthrax and tularemia infections and smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news release contains forward-looking statements, including, but not limited to, statements regarding the product development efforts for the inhaled liposomal ciprofloxacin program and continued receipt of royalties from Zogenix, Inc. These forward-looking statements involve risk and uncertainties, as well as the other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2010 filed with the SEC on March 25, 2011, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm, the Aradigm Logo, Lipoquin and Pulmaquin are registered trademarks of Aradigm Corporation.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three months ended
Nine months ended
|Research and development||1,292||2,403||4,356||7,976|
|General and administrative||1,020||895||3,595||3,530|
|Restructuring and asset impairment||10||11||30||37|
|Total operating expenses||2,322||3,309||7,981||11,543|
|Loss from operations||(2,080||)||(3,070||)||(7,373||)||(7,304||)|
Other income, net
|Gain from extinguishment of debt||-||4,462||-||4,462|
|Net income /(loss)||$||(2,449||)||$||1,315||$||(7,790||)||$||(3,017||)|
|Basic and diluted net income /(loss) per common share||$||(0.01||)||$||0.01||$||(0.04||)||$||(0.03||)|
|Shares used in computing basic net income /(loss) per common share||194,549||139,167||178,561||114,787|
|Shares used in computing diluted net income /(loss) per common share||194,549||140,177||178,561||114,787|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||2,074||$||5,295|
|Prepaid and other current assets||396||180|
|Total current assets||11,179||5,906|
|Property and equipment, net||1,215||1,553|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accrued clinical and cost of other studies||538||993|
|Facility lease exit obligation||114||99|
|Other accrued liabilities||485||450|
|Total current liabilities||1,659||2,126|
|Facility lease exit obligation, non-current||640||729|
|Other non-current liabilities||75||75|
|Note payable, net of discount and accrued interest||8,208||-|
|Total liabilities and shareholders' equity||$||13,018||$||7,628|
* The balance sheet at December 31, 2010 has been derived from the audited financial statements at that date.
Nancy Pecota, 510-265-8800
Chief Financial Officer
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical