[August 07, 2014] |
|
Aradigm Announces Second Quarter 2014 Financial Results
HAYWARD, Calif. --(Business Wire)--
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 (News - Alert)), 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.
|
ARADIGM CORPORATION
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)
|
(In thousands, except per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Six months ended
|
|
|
June 30,
|
|
|
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,
|
|
|
December 31,
|
|
|
2014
|
|
|
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
|
|
|
|
|
|
|
|
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* The balance sheet at December 31, 2013 has been derived from the
audited financial statements at that date.
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