UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 7, 2014
Aradigm Corporation
(Exact name of registrant as specified in its charter)
California | 001-36480 | 94-3133088 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) | ||
3929 Point Eden Way, Hayward, California |
94545 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (510) 265-9000
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition.
On August 7, 2014, Aradigm Corporation (the Company) announced via press release the Companys financial results for its second quarter ended June 30, 2014. A copy of the Companys press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in the report, including Exhibit 99.1 attached hereto, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 | Press Release of Aradigm Corporation dated August 7, 2014. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Aradigm Corporation | ||||||
August 8, 2014 | By: | /s/ Nancy E. Pecota | ||||
Name: Nancy E. Pecota | ||||||
Title: Vice President, Finance and Chief Financial Officer and Corporate Secretary |
Exhibit 99.1
Aradigm Announces Second Quarter 2014 Financial Results
NASDAQ listing achieved upon completion of reverse split
Hayward, CA August 7, 2014 Aradigm Corporation (Nasdaq:ARDM) (the Company) today announced financial results for the second quarter and six months ended June 30, 2014.
Total revenue was $12.2 million for the second quarter of 2014, compared with $0.2 million in revenue for the second quarter of 2013. The increase in revenue was due to the recognition of revenue from the Grifols collaboration arrangement as the Company is being reimbursed for Pulmaquin® project-related costs, as well as the revenue recognized from work being conducted under NIH grants.
Total operating expenses for the second quarter of 2014 were $13.6 million, compared with total operating expenses of $2.5 million for the second quarter of 2013. The increase in operating expenses was primarily due to higher R&D expenses from Pulmaquin Phase III clinical trials which resulted in higher costs in contract manufacturing and testing as well as higher clinical trial expenses.
As of June 30, 2014, cash and cash equivalents totaled $50.3 million.
Recent Highlights
| May 2014 - U.S. Food and Drug Administration (FDA) has designated the Companys lead inhaled antibiotic candidate, Pulmaquin, as a Qualified Infectious Disease Product (QIDP). The QIDP designation, granted for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa, will make Pulmaquin eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. |
| June 2014 - The Company received the $5 million milestone payment from Grifols S.A. for enrolling and dosing of the first patient in the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Pulmaquin for the treatment of non-CF BE. |
| June 2014 - Aradigm common shares began trading on the NASDAQ Capital Market under the ticker symbol ARDM. |
| June 2014 Announced the dosing of the first patient in the ORBIT-4 Phase III pivotal clinical trial. ORBIT-4 is the second of the two Phase III pivotal clinical trials Aradigm is conducting with Pulmaquin in non-CF BE. The Company announced the dosing of the first patient in the ORBIT-3 clinical trial in April 2014. |
We are very pleased that the FDA has recognized Pulmaquin as being a potentially valuable antibacterial drug to treat serious or life-threatening infections with Pseudomonas aerugnosa in patients with non-CF bronchiectasis the condition currently being investigated in our two Phase III clinical trials. Pseudomonas aeruginosa are a significant risk factor in cystic fibrosis and COPD patients, too. We have encouraging preclinical data also with our liposomal inhaled antibiotic in several other serious infections including non-TB mycobacteria and agents that pose a potential bioterrorism threat, said Igor Gonda, Aradigms Chief Executive Officer.
About 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 addressing the treatment of 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 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 for cystic fibrosis (CF) in the U.S. and the E.U., and liposomal ciprofloxacin and ciprofloxacin for inhalation for the management of bronchiectasis in the U.S.
More information about Aradigm can be found at www.aradigm.com.
Forward-Looking Statements
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 Companys filings with the Securities and Exchange Commission (SEC), including the Companys Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 13, 2014, and the Companys Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of Aradigm Corporation.
SOURCE: Aradigm Corporation
Contact: Nancy Pecota, Chief Financial Officer, 510-265-8800
ARADIGM CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except per share data)
(Unaudited)
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Revenues |
$ | 12,245 | $ | 248 | $ | 18,876 | $ | 527 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating expenses: |
||||||||||||||||
Research and development |
11,656 | 1,423 | 17,452 | 3,407 | ||||||||||||
General and administrative |
1,931 | 1,118 | 3,582 | 2,338 | ||||||||||||
Restructuring and asset impairment |
5 | 7 | 11 | 14 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
13,592 | 2,548 | 21,045 | 5,759 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from operations |
(1,347 | ) | (2,300 | ) | (2,169 | ) | (5,232 | ) | ||||||||
Interest income |
1 | 1 | 3 | 3 | ||||||||||||
Interest expense |
| (407 | ) | (288 | ) | (801 | ) | |||||||||
Other expense |
(12 | ) | (4 | ) | (13 | ) | (5 | ) | ||||||||
Gain on assignment of royalty interests |
| | 5,823 | | ||||||||||||
Gain from extinguishment of debt |
| | 3,041 | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ | (1,358 | ) | $ | (2,710 | ) | $ | 6,397 | $ | (6,035 | ) | |||||
Change in unrealized gains (losses) on available-for-sale securities |
| | | | ||||||||||||
Comprehensive income (loss) |
$ | (1,358 | ) | $ | (2,710 | ) | $ | 6,397 | $ | (6,035 | ) | |||||
|
|
|
|
|
|
|
|
|||||||||
Basic net income (loss) per common share |
$ | (0.09 | ) | $ | (0.43 | ) | $ | 0.44 | $ | (0.96 | ) | |||||
|
|
|
|
|
|
|
|
|||||||||
Diluted net income (loss) per common share |
$ | (0.09 | ) | $ | (0.43 | ) | $ | 0.43 | $ | (0.96 | ) | |||||
Shares used in computing basic net income (loss) per common share |
14,697 | 6,260 | 14,683 | 6,255 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Shares used in computing diluted net income (loss) per common share |
14,697 | 6,260 | 14,717 | 6,255 |
ARADIGM CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
June 30, 2014 |
December 31, 2013 |
|||||||
(Unaudited) | * | |||||||
ASSETS | ||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 50,290 | $ | 48,131 | ||||
Restricted cash |
250 | | ||||||
Receivables |
1,068 | 92 | ||||||
Prepaid and other current assets |
975 | 1,448 | ||||||
|
|
|
|
|||||
Total current assets |
52,583 | 49,671 | ||||||
Property and equipment, net |
539 | 400 | ||||||
Other assets |
2,960 | 353 | ||||||
|
|
|
|
|||||
Total assets |
$ | 56,082 | $ | 50,424 | ||||
|
|
|
|
|||||
LIABILITIES AND SHAREHOLDERS EQUITY | ||||||||
Current liabilities: |
||||||||
Accounts payable |
3,979 | 619 | ||||||
Accrued clinical and cost of other studies |
1,717 | 1,831 | ||||||
Accrued compensation |
962 | 198 | ||||||
Deferred revenue |
438 | 4,379 | ||||||
Facility lease exit obligation |
180 | 168 | ||||||
Other accrued liabilities |
173 | 82 | ||||||
|
|
|
|
|||||
Total current liabilities |
7,449 | 7,277 | ||||||
Deferred rent |
120 | 132 | ||||||
Facility lease exit obligation, non-current |
210 | 297 | ||||||
Deferred revenue, long term |
7,816 | | ||||||
Note payable, net of discount and accrued interest |
| 9,035 | ||||||
Shareholders equity |
40,487 | 33,683 | ||||||
|
|
|
|
|||||
Total liabilities and shareholders equity |
$ | 56,082 | $ | 50,424 | ||||
|
|
|
|
* | The balance sheet at December 31, 2013 has been derived from the audited financial statements at that date. |
# # #