0001193125-14-301907.txt : 20140811 0001193125-14-301907.hdr.sgml : 20140811 20140808090006 ACCESSION NUMBER: 0001193125-14-301907 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140808 DATE AS OF CHANGE: 20140808 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARADIGM CORP CENTRAL INDEX KEY: 0001013238 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 943133088 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36480 FILM NUMBER: 141025734 BUSINESS ADDRESS: STREET 1: 3929 POINT EDEN WAY CITY: HAYWARD STATE: CA ZIP: 94545 BUSINESS PHONE: 5102659000 MAIL ADDRESS: STREET 1: 3929 POINT EDEN WAY CITY: HAYWARD STATE: CA ZIP: 94545 8-K 1 d771121d8k.htm FORM 8-K Prepared by R.R. Donnelley Financial -- Form 8-K

 

 

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)

Registrant’s 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 Company’s financial results for its second quarter ended June 30, 2014. A copy of the Company’s 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

EX-99.1 2 d771121dex991.htm EX-99.1 Prepared by R.R. Donnelley Financial -- EX-99.1

Exhibit 99.1

 

LOGO

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 Company’s 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, Aradigm’s 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 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.

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.

#         #         #

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