Aradigm Announces Third Quarter 2014 Financial Results
Aradigm Corporation (Nasdaq:ARDM) (the “Company”) today announced financial results for the third quarter and nine months ended September 30, 2014.
Total revenue was approximately $6.6 million for the third quarter of 2014 compared with revenue of approximately $4.6 million for the third quarter of 2013. Revenue for both periods consisted primarily of revenue from the Grifols collaboration arrangement as the Company is being reimbursed for Pulmaquin(R) inhaled ciprofloxacin project-related costs.
The Company’s net loss for the third quarter of 2014 was approximately $0.9 million, or $0.06 per share, compared with a net loss of approximately $14.9 million, or $1.59 per share, for the third quarter of 2013. The net loss in 2013 resulted primarily from the one-time, non-cash collaboration arrangement acquisition cost associated with the Grifols collaboration agreement. Total operating expenses for the third quarter of 2014 were approximately $7.5 million, compared with total operating expenses of approximately $19.0 million for the third quarter of 2013. In the third quarter of 2013, the Company recorded $15.9 million as a one-time, non-cash collaboration arrangement acquisition cost resulting from the Grifols collaboration agreement. The increase in other operating expenses was primarily due to higher R&D expenses from the Pulmaquin Phase III clinical trials which resulted in higher clinical trial expenses compared to the prior year period.
As of September 30, 2014, cash and cash equivalents totaled approximately $48.5 million.
“We are very pleased that, as a result of the FDA’s initiatives to accelerate the development of qualified anti-infective drugs, in the third quarter of 2014 we were granted Fast Track Designation to develop our investigational drug, Pulmaquin, for patients in need. Despite enormous progress in medicine, severe infections are a growing problem in our society. This is exemplified by the unmet medical need for effective therapies in non-cystic fibrosis bronchiectasis patients with chronic infections with Pseudomonas aeruginosa. This orphan condition is associated with frequent pulmonary exacerbations, poor quality of life and reduced life expectancy,” said Dr. Juergen Froehlich, Chief Medical Officer of Aradigm.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases. Aradigm has product candidates under development for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE), cystic fibrosis and prevention of respiratory and other diseases in tobacco smokers through smoking cessation. Aradigm is also developing Pulmaquin and a liposomal ciprofloxacin formulation as potential medications for patients with chronic lung infections with non-tuberculous mycobacteria (NTM), and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, Q fever and inhaled anthrax.
Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP). The QIDP designation is granted for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014.
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 that involve risk and uncertainties, including those related to the ORBIT-3 and ORBIT-4 clinical trials, 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, 2013 filed with the SEC on March 13, 2014, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except per share data)
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Contract revenue – related party||$||6,573||$||4,301||$||24,988||$||4,301|
|Research and development||6,047||1,593||23,499||5,000|
|General and administrative||1,443||1,463||5,025||3,801|
|Collaboration arrangement acquisition cost||–||15,943||–||15,943|
|Restructuring and asset impairment||4||7||15||21|
|Total operating expenses||7,494||19,006||28,539||24,765|
|Loss from operations||(877||)||(14,454||)||(3,046||)||(19,686||)|
|Other income (expense), net||(42||)||–||(55||)||(5||)|
|Gain on assignment of royalty interests||–||–||5,823||–|
|Gain from extinguishment of debt||–||–||3,041||–|
|Net income (loss)||$||(914||)||$||(14,874||)||$||5,483||$||(20,909||)|
|Change in unrealized gains (losses) on available-for-sale securities||–||–||–||–|
|Comprehensive income (loss)||$||(914||)||$||(14,874||)||$||5,483||$||(20,909||)|
|Basic and diluted net income (loss) per common share||$||( 0.06||)||$||(1.59||)||$||0.37||$||(2.87||)|
|Shares used in computing basic net income (loss) per common share||14,706||9,353||14,691||7,298|
|Shares used in computing diluted net income (loss) per common share||14,706||9,353||14,722||7,298|
CONDENSED CONSOLIDATED BALANCE SHEETS
|September 30,||December 31,|
|Cash and cash equivalents||$||48,492||$||48,131|
|Prepaid and other current assets||972||1,448|
|Total current assets||49,805||49,671|
|Property and equipment, net||582||400|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Accrued clinical and cost of other studies||1,669||1,831|
|Facility lease exit obligation||187||168|
|Other accrued liabilities||247||82|
|Total current liabilities||5,540||7,277|
|Facility lease exit obligation, non-current||153||297|
|Deferred revenue, long term||7,839||–|
|Note payable, net of discount and accrued interest||–||9,035|
|Total liabilities and shareholders’ equity||$||53,353||$||50,424|
* The balance sheet at December 31, 2013 has been derived from the audited financial statements at that date.
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